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Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)

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[X1TITLE I U.K. GENERAL ISSUES

CHAPTER 1 U.K. Aim, scope and application

Article 1 U.K. Aim and scope

1 . The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances F1 ... while enhancing competitiveness and innovation.

2 . This Regulation lays down provisions on substances and [F2mixtures] within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in [F2mixtures] or in articles and to the placing on the market of [F2mixtures] .

3 . This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.

Textual Amendments

Article 2 U.K. Application

1. This Regulation shall not apply to:

(a) radioactive substances within the scope of [F3retained EU law that transposed Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation] ;

(b) substances, on their own, in a [F2mixture] or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

(c) non-isolated intermediates;

(d) the carriage of dangerous substances and dangerous substances in dangerous [F2mixtures] by rail, road, inland waterway, sea or air.

2. Waste as defined in [F4Article 3(1) of Directive 2008/98/EC] of the European Parliament and of the Council (1) is not a substance, [F2mixture] or article within the meaning of Article 3 of this Regulation.

[F52A. For the purposes of this Regulation, “ Directive 2008/98/EC ” means that Directive as last amended by Directive (EU) 2018/851 , and read in accordance with paragraphs 2B and 2C.

2B. Article 5 is to be read as if—

(a) in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

(b) after paragraph 1 there were inserted—

“1A. Any decision as to whether a substance or object is a by-product must be made—

(a) in accordance with any regulations setting out detailed criteria on the application of the conditions in paragraph 1 to specific substances or objects; and

(b) having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.” ;

(c) paragraphs 2 and 3 were omitted.

2C. Article 6 is to be read as if—

(a) in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

(b) after paragraph 1 there were inserted—

“1A. Any decision as to whether a substance or object has ceased to be waste must be made—

(a) in accordance with any regulations or retained direct EU legislation setting out detailed criteria on the application of the conditions in paragraph 1 to specific types of waste; and

(b) having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.” ;

(c) in paragraph 2—

(i) the first subparagraph were omitted;

(ii) in the second subparagraph, for “Those detailed criteria” there were substituted “Any detailed criteria set out in guidance as referred to in paragraph 1A”;

(iii) the third and fourth subparagraphs were omitted;

(d) paragraph 3 were omitted;

(e) in paragraph 4—

(i) in the first subparagraph—

(aa) in the first sentence, for the words from the beginning to “Member State”, there were substituted “Where criteria have not been set out as referred to in paragraph 1A(a), the appropriate agency”;

(bb) the second sentence were omitted;

(ii) in the second subparagraph—

(aa) for “Member States” there were substituted “The appropriate agency”;

(bb) “by competent authorities” were omitted.

2D. In paragraphs 2B and 2C, “appropriate agency” means—

(a) the Environment Agency, in relation to England;

(b) the Natural Resources Body for Wales, in relation to Wales;

(c) the Scottish Environment Protection Agency, in relation to Scotland.]

3. [F6The Secretary of State] may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a [F2mixture] or in an article, where necessary in the interests of defence.

F7 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. The provisions of Titles II, V, VI and VII shall not apply to the extent that a substance is used:

[F8(a) in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;]

(b) in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

(i)

[F9as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;]

(ii)

[F10as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;]

(iii)

as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (2) ;

(iv)

[F11in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009 .]

6. The provisions of Title IV shall not apply to the following [F2mixtures] in the finished state, intended for the final user:

[F12(a) medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;]

[F13(b) cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;]

[F14(c) medical devices which are invasive or used in direct physical contact with the human body in so far as legislation relating to the classification and labelling of dangerous substances and mixtures applies to them which ensures the same level of information provision and protection as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;]

(d) food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

(i)

[F15as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;]

(ii)

[F15as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;]

(iii)

as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;

(iv)

[F16in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009 .]

7. The following shall be exempted from Titles II, V and VI:

(a) substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;

(b) substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;

(c) substances on their own or in [F2mixtures] , registered in accordance with Title II, exported [F17from Great Britain] by an actor in the supply chain and re-imported [F18into Great Britain] by the same or another actor in the same supply chain who shows that:

(i)

the substance being re-imported is the same as the exported substance;

(ii)

he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance;

(d) substances, on their own, in [F2mixtures] or in articles, which have been registered in accordance with Title II and which are recovered in [F19Great Britain] if:

(i)

the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and

(ii)

the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.

8 . On-site isolated intermediates and transported isolated intermediates shall be exempted from:

(a) Chapter 1 of Title II, with the exception of Articles 8 and 9; and

(b) Title VII.

9 . The provisions of Titles II and VI shall not apply to polymers.

Textual Amendments

CHAPTER 2 U.K. Definitions and general provision

[F20Article 2A U.K. The Agency

1. The functions and powers of the Agency under the REACH legislation are to be functions and powers of the HSE.

Accordingly, any reference to the Agency in the REACH legislation must be read as meaning the HSE.

2. The general incidental powers of the HSE are to be exercisable for the purpose of carrying out the functions of the Agency under the REACH legislation.

But that does not limit the powers which the HSE has under the REACH legislation.

3. The non-REACH functions of the HSE are not limited by the functions of the Agency under the REACH legislation.

Accordingly, the HSE is not prevented from carrying out non-REACH functions in relation to a matter just because any of the functions of the Agency under the REACH legislation is also exercisable, or has been exercised, in relation to that matter.

4. The power of the Secretary of State under section 12(2)(a) of HASWA 1974 to give directions (as read with section 12(4) of HASWA 1974) is to be exercisable with respect to the functions of the Agency under the REACH legislation.

The Secretary of State may not give any such directions with regard to the enforcement of the REACH legislation in any particular case.

The Secretary of State must consider any request made by any of the other appropriate authorities for the Secretary of State to give a direction by virtue of this paragraph.

The function of giving directions by virtue of this section is subject to the consent requirement in Article 4A (whether or not there has been a request under the previous subparagraph).

5. In this Article—

  • “ general incidental powers ” means the powers which the HSE has under—

    (a)

    section 13 of HASWA 1974, and

    (b)

    Schedule 2 to HASWA 1974;

  • “ HASWA 1974 ” means the Health and Safety at Work etc. Act 1974;

  • “ HSE ” means the Health and Safety Executive;

  • “ non-REACH function ” means any function which arises otherwise than under the REACH legislation;

  • “ REACH legislation ” means—

    (a)

    this Regulation,

    (b)

    any instrument made under this Regulation, and

    (c)

    any retained direct EU legislation that was originally made under EU REACH.

Textual Amendments

Article 2B U.K. Advice from Environment Agency or other environmental regulators to Agency

1. The Agency must comply with paragraph 2 when exercising—

(a) its functions under—

(i) Article 7(5),

(ii) Article 9(4), (7) and (8),

(iii) Article 21,

(iv) Articles 40(1) and (3), 41(1), (3) and (5), 42(1), 43, 44, 45, 46(1) and (3), 48, 49, 51 and 52,

(v) Articles 58(3) and (4) and 59(1), (2), (3), (6) and (7),

(vi) Article 64(1), (3), (4), (5) and (6),

(vii) Articles 69, 70 and 71, and

(b) any of its other functions under this Regulation,

if, and to the extent that, the exercise of the function involves consideration of any relevant environmental issues.

2. The Agency must—

(a) obtain the advice of the Environment Agency before exercising the function concerned, and

(b) use the advice obtained when exercising the function concerned.

3. Whenever the advice of the Environment Agency is sought by the Agency under this Article, the Environment Agency must collaborate with the other environmental regulators when formulating the advice.

4. If, as part of a collaboration under paragraph 3, one of the other environmental regulators gives advice to the Environment Agency, the Environment Agency must pass that advice on to the Agency if that other environmental regulator requires it to do so.

5. In this Article—

  • “ other environmental regulator ” means—

    (a)

    in relation to Wales, the Natural Resources Body for Wales;

    (b)

    in relation to Scotland, the Scottish Environment Protection Agency;

  • “ relevant environmental issue ” means—

    (a)

    exposure of the environment to chemicals;

    (b)

    exposure of humans to chemicals in the environment;

    (c)

    assessment of the potential effect of chemicals on the environment;

    (d)

    measures aimed at controlling the release of chemicals into the environment.]

Textual Amendments

Article 3 U.K. Definitions

For the purposes of this Regulation:

A1.

[F21EU REACH: means Regulation (EC) No 1907/2006 of the European Parliament and of the Council as it has effect in EU law;]

A2.

[F21appropriate authority: means—

(a)

the Secretary of State, in relation to England;

(b)

the Scottish Ministers, in relation to Scotland;

(c)

the Welsh Ministers, in relation to Wales;]

1.

substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

2.

[F2mixture] : means a mixture or solution composed of two or more substances;

3.

article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

4.

producer of an article: means any natural or legal person who makes or assembles an article within [F22Great Britain] ;

5.

polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

(a)

a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(b)

less than a simple weight majority of molecules of the same molecular weight.

In the context of this definition a ‘ monomer unit ’ means the reacted form of a monomer substance in a polymer;

6.

monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

7.

registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;

8.

manufacturing: means production or extraction of substances in the natural state;

9.

manufacturer: means any natural or legal person established within [F23Great Britain] who manufactures a substance within [F23Great Britain] ;

10.

import: means the physical introduction into [F24Great Britain] ;

10A.

[F25protected NI import: has the meaning given by Article 139A(2);]

10B.

[F25qualifying Northern Ireland good: has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;]

11.

importer: means any natural or legal person established within [F26Great Britain] who is responsible for import;

12.

placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

13.

downstream user: means any natural or legal person established within [F27Great Britain] , other than the manufacturer or the importer, who uses a substance, either on its own or in a [F2mixture] , in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;

14.

distributor: means any natural or legal person established within [F28Great Britain] , including a retailer, who only stores and places on the market a substance, on its own or in a [F2mixture] , for third parties;

15.

intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

(a)

non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

(b)

on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;

(c)

transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

16.

site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

17.

actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain;

18.

[F29Agency: see Article 2A;]

18A.

[F29ECHA: means the European Chemicals Agency established under EU REACH;]

19.

F30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20.

phase-in substance: means a substance which meets at least one of the following criteria:

(a)

it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);

(b)

[F31it was manufactured in the [F32European Community] , or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, but not placed on the market by the manufacturer or importer, at least once in the 15 years before [F331 June 2007] , provided the manufacturer or importer has documentary evidence of this;

(c)

it was placed on the market in the [F34European Community] , or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, by the manufacturer or importer before [F351 June 2007] and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, including proof that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive;]

21.

notified substance: means a substance for which a notification [F36was] submitted and which could be placed on the market in accordance with Directive 67/548/EEC;

22.

product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in [F2mixtures] or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;

23.

scientific research and development: means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year;

24.

use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

25.

registrant's own use: means an industrial or professional use by the registrant;

26.

identified use: means a use of a substance on its own or in a [F2mixture] , or a use of a [F2mixture] , that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user;

27.

full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed;

28.

robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;

29.

study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;

30.

per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;

31.

restriction: means any condition for or prohibition of the manufacture, use or placing on the market;

32.

supplier of a substance or a [F2mixture] : means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a [F2mixture] , or a [F2mixture] ;

33.

supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;

34.

recipient of a substance or a [F2mixture] : means a downstream user or a distributor being supplied with a substance or a [F2mixture] ;

35.

recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;

36.

SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (3) [F37and, in its application for the purposes of this paragraph, the Annex to that Recommendation has effect with the following modifications—

(a)

in Article 2(1)—

(i)

the reference to EUR 50 million has effect as a reference to £43.650 million;

(ii)

the reference to EUR 43 million has effect as a reference to £37.539 million;

(b)

in Article 2(2) the reference to EUR 10 million has effect as a reference to £8.730 million;

(c)

in Article 2(3) the reference to EUR 2 million has effect as a reference to £1.746 million;

(d)

in Article 3(2)—

(i)

in point (a), the reference to EUR 1,250,000 has effect as a reference to £1,091,250;

(ii)

in point (d), the reference to EUR 10 million has effect as a reference to £8.730 million;]

37.

exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;

38.

use and exposure category: means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;

39.

substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;

40.

not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;

41.

alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.

42.

[F38GB mandatory classification and labelling list: the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008 .]

43.

[F38GB notification database: the database established in accordance with Article 42 of Regulation (EC) No 1272/2008 .]

Textual Amendments

Article 4 U.K. General provision

Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.

[F39Article 4A U.K. The consent requirement

1. Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

2. The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998), whether or not the exercise of the function also relates to a part of Great Britain other than Scotland.

3. The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006) whether or not the exercise of the function also relates to a part of Great Britain other than Wales.]

Textual Amendments

Editorial Information

TITLE II U.K. REGISTRATION OF SUBSTANCES

CHAPTER 1 U.K. General obligation to register and information requirements

Article 5 U.K. No data, no market

Subject to Articles 6, 7 [F40and 21] , substances on their own, in [F2mixtures] or in articles shall not be manufactured in [F41Great Britain] or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.

Textual Amendments

Article 6 U.K. General obligation to register substances on their own or in [F2mixtures]

1. Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more [F2mixture] (s), in quantities of one tonne or more per year shall submit a registration to the Agency.

2. For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply.

3. Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met:

(a) the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);

(b) the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

4. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Textual Amendments

Article 7 U.K. Registration and notification of substances in articles

1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

A submission for registration shall be accompanied by the fee required in accordance with Title IX.

2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the substance is present in those articles above a concentration of 0,1  % weight by weight (w/w).

3. Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.

4. The information to be notified shall include the following:

(a) the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;

(b) the registration number(s) referred to in Article 20(1), if available;

(c) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;

(d) the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;

(e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);

(f) the tonnage range of the substance(s), such as 1 to 10 tonnes, 10 to 100 tonnes and so on.

5. The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the Agency has grounds for suspecting that:

(i)

the substance is released from the articles, and

(ii)

the release of the substance from the articles presents a risk to human health or the environment;

(c) the substance is not subject to paragraph 1.

A submission for registration shall be accompanied by the fee required in accordance with Title IX.

6. Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use.

7. [F42Paragraphs] 2, 3 and 4 of this Article shall apply six months after a substance is identified in accordance with Article 59(1).

8. [F43Any measures for the implementation of paragraphs 1 to 7 shall be adopted by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.]

Textual Amendments

Article 8 U.K. Only representative of a [F44non-Great British] manufacturer

1 . A natural or legal person established outside [F45Great Britain] who manufactures a substance on its own, in [F2mixtures] or in articles, formulates a [F2mixture] or produces an article that is imported into [F45Great Britain] may by mutual agreement appoint a natural or legal person established in [F45Great Britain] to fulfil, as his only representative, the obligations on importers under this Title.

2 . The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.

3 . If a representative is appointed in accordance with paragraphs 1 and 2, the [F46non-Great British] manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

Textual Amendments

Article 9 U.K. Exemption from the general obligation to register for product and process orientated research and development (PPORD)

1 . Articles 5, 6, 7, 17, 18 and 21 shall not apply for [F47a five-year exemption period] to a substance manufactured in [F48Great Britain] or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development.

[F491A. In paragraph 1 “ five-year exemption period ” means a period of five years beginning when Articles 5, 6, 7, 17, 18 and 21 would otherwise apply to the substance (if it were not manufactured or imported as mentioned in paragraph 1).]

2. For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Agency of the following information:

(a) the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI;

(b) the identity of the substance, as specified in section 2 of Annex VI;

(c) the classification of the substance as specified in section 4 of Annex VI, if any;

(d) the estimated quantity as specified in section 3.1 of Annex VI;

(e) the list of customers referred to in paragraph 1, including their names and addresses.

The notification shall be accompanied by the fee required in accordance with Title IX.

The period set out in paragraph 1 shall begin at receipt of the notification at the Agency.

3. The Agency shall check the completeness of the information supplied by the notifier and Article 20(2) shall apply adapted as necessary. The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of articles concerned. The Agency shall also communicate this information to the [F50appropriate authorities that request it] .

4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the [F2mixture] or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a [F2mixture] or article and that remaining quantities will be re-collected for disposal after the exemption period.

In such cases, the Agency may ask the notifier to provide additional necessary information.

5. In the absence of any indication to the contrary, the manufacturer or importer of the substance or the producer or importer of articles may manufacture or import the substance or produce or import the articles not earlier than two weeks after the notification.

6. The manufacturer or importer or producer of articles shall comply with any conditions imposed by the Agency in accordance with paragraph 4.

7. The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme.

8. The Agency shall forthwith communicate any draft decisions to the [F51appropriate authorities that request them] .

When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by [F52the appropriate authorities] .

9. The Agency and the [F53appropriate authorities] shall always keep confidential the information submitted in accordance with paragraphs 1 to 8.

10. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 4 and 7 of this Article.

Textual Amendments

Article 10 U.K. Information to be submitted for general registration purposes

A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:

(a)

a technical dossier including:

(i)

the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI;

(ii)

the identity of the substance as specified in section 2 of Annex VI;

(iii)

information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories;

(iv)

the classification and labelling of the substance as specified in section 4 of Annex VI;

(v)

guidance on safe use of the substance as specified in Section 5 of Annex VI;

(vi)

study summaries of the information derived from the application of Annexes VII to XI;

(vii)

robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I;

(viii)

an indication as to which of the information submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience;

(ix)

proposals for testing where listed in Annexes IX and X;

(x)

for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;

(xi)

a request as to which of the information in Article 119(2) the manufacturer or importer considers should not be made available on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests.

Except in cases covered under Article 25(3) [F54or Article 27(6)] , the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration;

(b)

a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this report may include, if the registrant considers appropriate, the relevant use and exposure categories.

Textual Amendments

Article 11 U.K. Joint submission of data by multiple registrants

1. When a substance is intended to be manufactured in [F55Great Britain] by one or more manufacturers and/or imported by one or more importers, and/or is subject to registration under Article 7, the following shall apply.

Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant).

Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).

The registrants may decide themselves whether to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Article 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.

2. Each registrant need only comply with paragraph 1 for items of information specified in Article 10(a)(iv), (vi), (vii) and (ix) that are required for the purposes of registration within his tonnage band in accordance with Article 12.

3. A registrant may submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:

(a) it would be disproportionately costly for him to submit this information jointly; or

(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

(c) he disagrees with the lead registrant on the selection of this information.

If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be.

4. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Textual Amendments

Article 12 U.K. Information to be submitted depending on tonnage

1. The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:

(a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;

(b) the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;

(c) the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;

(d) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;

(e) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.

2. As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary.

3. This Article shall apply to producers of articles adapted as necessary.

Article 13 U.K. General requirements for generation of information on intrinsic properties of substances

1. Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, Sections 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3.

2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. [F56The Secretary of State,] following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the [F57Test Methods Regulation] , and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. [F58Amendments to the Test Methods Regulation may be made by regulations made by the Secretary of State. Amendments to the Annexes of this Regulation may be made by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament. The functions of making regulations under this paragraph are subject to the consent requirement in Article 4A.]

3. Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in [F59the Test Methods Regulation] or in accordance with other international test methods recognised by F60... the Agency as being appropriate. F61...

Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met.

4. Ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in [F62the Good Laboratory Practice Regulations 1999] or other international standards recognised as being equivalent by F63... the Agency and with the provisions of [F64the Animals (Scientific Procedures) Act 1986] , if applicable.

5. If a substance has already been registered, a new registrant shall be entitled to refer to the study summaries or robust study summaries, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that the previous registrant(s) have given permission to refer to the full study reports for the purpose of registration.

A new registrant shall not refer to such studies in order to provide the information required in Section 2 of Annex VI.

[F656. In this Article “ Test Methods Regulation ” means Commission Regulation (EU) No 440/2008.]

Textual Amendments

Article 14 U.K. Chemical safety report and duty to apply and recommend risk reduction measures

1. [F66A] chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant.

The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a [F2mixture] or in an article or a group of substances.

[F22. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than:

(a) the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;

(b) 0,1  % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.]

3. A chemical safety assessment of a substance shall include the following steps:

(a) human health hazard assessment;

(b) physicochemical hazard assessment;

(c) environmental hazard assessment;

(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.

[F24. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(c) hazard class 4.1;

(d) hazard class 5.1,

or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:]

(a) exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;

(b) risk characterisation.

The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant.

5. The chemical safety report need not include consideration of the risks to human health from the following end uses:

(a) in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (4) ;

(b) in cosmetic products within the scope of [F67Regulation (EC) No 1223/2009 on cosmetic products] .

6. Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 31.

7. Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.

Textual Amendments

CHAPTER 2 U.K. Substances regarded as being registered

Article 15 U.K. Substances in plant protection and biocidal products

[F68 1. The following are regarded as being registered, and the registration as completed, for manufacture or import for the use as a plant protection product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title—

(a) active substances manufactured or imported for use in plant protection products only and included in the approvals register in relation to at least one constituent territory;

(b) co-formulants manufactured or imported for use in plant protection products only and not included in the unacceptable co-formulants register in relation to the whole of the UK;

(c) any substance in relation to which the applicant has been notified in accordance with Article 9(3) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market.

1A. In paragraph 1—

(a) in point (a)—

(i) “ approvals register ” means the register maintained in accordance with Article 27A of Regulation (EC) No 1107/2009 ;

(ii) “ constituent territory ” has the meaning given by Article 3A of Regulation (EC) No 1107/2009 ;

(b) in point (b), “ unacceptable co-formulants register ” means the register maintained in accordance with Article 27B of Regulation (EC) No 1107/2009 .]

[F69 2. Active substances manufactured or imported for use in biocidal products only and included either in the GB List or the Simplified Active Substance List defined in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products or Annex II of Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council, subject to the transitional measures detailed in Article 89 of Regulation (EU) No 528/2012, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title.]

Textual Amendments

Article 16 U.K. Duties of F70 ... registrants of substances regarded as being registered

F71 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Articles 21, 22 and 25 to [F7227] shall not apply to uses of substances regarded as registered according to Article 15.

Textual Amendments

CHAPTER 3 U.K. Obligation to register and information requirements for certain types of isolated intermediates

Article 17 U.K. Registration of on-site isolated intermediates

1. Any manufacturer of an on-site isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate.

2. A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing:

(a) the identity of the manufacturer as specified in Section 1 of Annex VI;

(b) the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in Section 4 of Annex VI;

(d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

(e) a brief general description of the use, as specified in Section 3.5 of Annex VI;

(f) details of the risk management measures applied.

Except in cases covered under Article 25(3) [F73or Article 27(6)] , the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in accordance with Title IX.

3. Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to minimise emission and any resulting exposure.

If these conditions are not fulfilled, the registration shall include the information specified in Article 10.

Textual Amendments

Article 18 U.K. Registration of transported isolated intermediates

1. Any manufacturer or importer of a transported isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate.

2. A registration for a transported isolated intermediate shall include all the following information:

(a) the identity of the manufacturer or importer as specified in Section 1 of Annex VI;

(b) the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in Section 4 of Annex VI;

(d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

(e) a brief general description of the use, as specified in Section 3.5 of Annex VI;

(f) information on risk management measures applied and recommended to the user in accordance with paragraph 4.

Except in cases covered under Article 25(3) [F74or Article 27(6)] , the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in accordance with Title IX.

3. A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2.

For the generation of this information, Article 13 shall apply.

4. Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:

(a) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;

(b) procedural and control technologies shall be used that minimise emission and any resulting exposure;

(c) only properly trained and authorised personnel handle the substance;

(d) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;

(e) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;

(f) substance-handling procedures are well documented and strictly supervised by the site operator.

If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.

Textual Amendments

Article 19 U.K. Joint submission of data on isolated intermediates by multiple registrants

1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in [F75Great Britain] by one or more manufacturers and/or imported by one or more importers, the following shall apply.

Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘ the lead registrant ’ ).

Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).

2. A manufacturer or importer may submit the information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:

(a) it would be disproportionately costly for him to submit this jointly; or

(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

(c) he disagrees with the lead registrant on the selection of this information.

If points (a), (b) or (c) apply, the manufacturer or importer shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment, or the nature of the disagreement, as the case may be.

3. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Textual Amendments

CHAPTER 4 U.K. Common provisions for all registrations

Article 20 U.K. Duties of the Agency

1. The Agency shall assign a submission number to each registration, which is to be used for all correspondence regarding the registration until the registration is deemed to be complete, and a submission date, which shall be the date of receipt of the registration at the Agency.

2. The Agency shall undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 or under Articles 17 or 18, as well as the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2), have been provided. The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.

The Agency shall undertake the completeness check within three weeks of the submission date F76 ....

If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week F77 ... period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.

The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.

3. Once the registration is complete, the Agency shall assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date. The Agency shall without delay communicate the registration number and registration date to the registrant concerned. The registration number shall be used for all subsequent correspondence regarding registration.

4. The Agency shall notify the [F78appropriate authorities that request the notification] within 30 days of the submission date, that the following information is available in the Agency database:

(a) the registration dossier together with the submission or registration number;

(b) the submission or registration date;

(c) the result of the completeness check; and

(d) any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.

F79 ...

F79 ...

The Agency shall forthwith notify the [F80appropriate authorities that request the notification] when any further information submitted by the registrant is available on the Agency database.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 2 of this Article.

6. Where additional information for a particular substance is submitted to the Agency by a new registrant, the Agency shall notify the existing registrants that this information is available on the database for the purposes of Article 22.

Textual Amendments

Article 21 U.K. Manufacturing and import of substances

1 . A registrant may start or continue the manufacture or import of a substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date, without prejudice to Article 27(8).

F81...

In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).

2 . If the Agency has informed the registrant that he is to submit further information in accordance with the third subparagraph of Article 20(2), the registrant may start the manufacture or import of a substance or production or import of an article if there is no indication to the contrary from the Agency within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to Article 27(8).

3 . If a lead registrant submits parts of the registration on behalf of one or more other registrants, as provided for in Articles 11 or 19, any of the other registrants may manufacture or import the substance or produce or import the articles only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and provided that there is no indication to the contrary from the Agency in respect of the registration of the lead registrant acting on behalf of the others and his own registration.

Textual Amendments

Article 22 U.K. Further duties of registrants

1. Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases:

(a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;

(b) any change in the composition of the substance as given in Section 2 of Annex VI;

(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;

(d) new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;

(e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;

(f) any change in the classification and labelling of the substance;

(g) any update or amendment of the chemical safety report or Section 5 of Annex VI;

(h) the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;

(i) any change in the access granted to information in the registration.

The Agency shall communicate this information to the [F82appropriate authorities that request it] .

2. A registrant shall submit to the Agency an update of the registration containing the information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance with Articles 60 and 73, within the deadline specified in that decision. The Agency shall notify the [F83appropriate authorities that request it] that the information is available on its database.

3. The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration. In cases where the update is in accordance with Article 12(2) and with paragraph 1(c) of this Article then the Agency shall check the completeness of the information supplied by the registrant and Article 20(2) shall apply adapted as necessary.

4. In cases covered by Articles 11 or 19, each registrant shall submit separately the information specified in paragraph 1(c) of this Article.

5. An update shall be accompanied by the relevant part of the fee required in accordance with Title IX.

Textual Amendments

CHAPTER 5 U.K. Transitional provisions applicable to phase-in substances and notified substances

F84 Article 23 U.K. Specific provisions for phase-in substances

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Textual Amendments

Article 24 U.K. Notified substances

F85 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 . If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles.

Textual Amendments

TITLE III U.K. DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

CHAPTER 1 U.K. Objectives and general rules

Article 25 U.K. Objectives and general rules

1. In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. It is also necessary to take measures limiting duplication of other tests.

2. The sharing and joint submission of information in accordance with this Regulation shall concern technical data and in particular information related to the intrinsic properties of substances. Registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares.

3. Any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regulation [F86, or under EU REACH before IP completion day] at least 12 years previously can be used for the purposes of registration by another manufacturer or importer.

Textual Amendments

CHAPTER 2 U.K. [F87Rules for registrants of substances]

Article 26 U.K. Duty to inquire prior to registration

1. Every potential registrant F88 ... shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry:

(a) his identity as specified in Section 1 of Annex VI, with the exception of the use sites;

(b) the identity of the substance, as specified in Section 2 of Annex VI;

(c) which information requirements would require new studies involving vertebrate animals to be carried out by him;

(d) which information requirements would require other new studies to be carried out by him.

2. If the same substance has previously not been registered, the Agency shall inform the potential registrant accordingly.

3. If [F89there is a previous registration of the same substance that is less than 12 years old] , the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries, as the case may be, already submitted by them.

[F90A registration of a substance is less than 12 years old if—

(a) in a case where the registration came into existence under Article 127A, the existing EU registration (as defined in Article 127D) began less than 12 years before the potential registrant's enquiry to the Agency;

(b) in any other case, the registration under this Regulation began less than 12 years before the potential registrant's enquiry to the Agency.]

Studies involving vertebrate animals shall not be repeated.

The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27.

4. If several potential registrants have made an inquiry in respect of the same substance, the Agency shall inform all potential registrants without delay of the name and address of the other potential registrants.

Textual Amendments

Article 27 U.K. Sharing of existing data in the case of registered substances

1. Where [F91there is a previous registration of a substance that is less than 12 years old] as referred to in Article 26(3), the potential registrant:

(a) shall, in the case of information involving tests on vertebrate animals; and

(b) may, in the case of information not involving tests on vertebrate animals,

request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.

[F92 2. Within one month of a request for information being made according to paragraph 1, the owner of the study shall provide proof of the cost of the information to the potential registrant(s) requesting it. The potential and the previous registrant(s) as referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.]

3. The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.

4. On agreement on the sharing of the information, the previous registrant shall [F93, within two weeks of receipt of payment,] make available to the new registrant the agreed information and shall give the new registrant the permission to refer to the previous registrant's full study report.

[F94 5. If the previous registrant as referred to in paragraph 1 refuses to provide either proof of the cost of that study or the study itself to a potential registrant, or there is failure to reach an agreement referred to in paragraph 4, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the previous registrant(s).]

6. Within one month from the receipt of the information referred to in paragraph 5, the Agency shall give the potential registrant permission to refer to the information requested by him in his registration dossier, subject to the potential registrant providing, upon request by the Agency, proof that he has paid the previous registrant(s) for that information a share of cost incurred. The previous registrant(s) shall have a claim on the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate share may be facilitated by the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national courts.

7. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 6 of this Article.

8. The registration waiting period in accordance with Article 21(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests.

Textual Amendments

Textual Amendments

CHAPTER 3 U.K. Rules for phase-in-substances

F95 Article 28 U.K. Duty to pre-register for phase-in substances

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F95 Article 29 U.K. Substance Information Exchange Forums

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Textual Amendments

F95 Article 30 U.K. Sharing of data involving tests

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Textual Amendments

TITLE IV U.K. INFORMATION IN THE SUPPLY CHAIN

Article 31 U.K. Requirements for safety data sheets

1. The supplier of a substance or a [F2mixture] shall provide the recipient of the substance or [F2mixture] with a safety data sheet compiled in accordance with Annex II:

[F2(a) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or]

(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or

(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).

2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a [F2mixture] and the actor in the supply chain has prepared a chemical safety assessment for that [F2mixture] , it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the [F2mixture] instead of with the chemical safety report for each substance in the [F2mixture] .

[F23. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

(a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2  % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or

(b) in an individual concentration of ≥ 0,1  % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

(c) a substance [F96in relation to which the law of any part of Great Britain provides] workplace exposure limits.]

[F24. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.]

5. The safety data sheet shall be supplied in [F97English and may also be supplied in any other language.]

6. The safety data sheet shall be dated and shall contain the following headings:

1.

identification of the substance/ [F2mixture] and of the company/undertaking;

2.

hazards identification;

3.

composition/information on ingredients;

4.

first-aid measures;

5.

fire-fighting measures;

6.

accidental release measures;

7.

handling and storage;

8.

exposure controls/personal protection;

9.

physical and chemical properties;

10.

stability and reactivity;

11.

toxicological information;

12.

ecological information;

13.

disposal considerations;

14.

transport information;

15.

regulatory information;

16.

other information.

7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI.

Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.

Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).

[F28. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.]

9. Suppliers shall update the safety data sheet without delay on the following occasions:

(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or [F2mixture] within the preceding 12 months. Any updates following registration shall include the registration number.

F98 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 32 U.K. Duty to communicate information down the supply chain for substances on their own or in [F2mixtures] for which a safety data sheet is not required

1. Any supplier of a substance on its own or in a [F2mixture] who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:

(a) the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;

(b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;

(c) details of any restriction imposed under Title VIII;

(d) any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.

2. The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a [F2mixture] F99... .

3. Suppliers shall update this information without delay on the following occasions:

(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or [F2mixture] within the preceding 12 months. Any updates following registration shall include the registration number.

Textual Amendments

Article 33 U.K. Duty to communicate information on substances in articles

1 . Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1  % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

2 . On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1  % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

The relevant information shall be provided, free of charge, within 45 days of receipt of the request.

Article 34 U.K. Duty to communicate information on substances and [F2mixtures] up the supply chain

Any actor in the supply chain of a substance or a [F2mixture] shall communicate the following information to the next actor or distributor up the supply chain:

(a)

new information on hazardous properties, regardless of the uses concerned;

(b)

any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.

Distributors shall pass on that information to the next actor or distributor up the supply chain.

Textual Amendments

Article 35 U.K. Access to information for workers

Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or [F2mixtures] that they use or may be exposed to in the course of their work.

Textual Amendments

Article 36 U.K. Obligation to keep information

1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or [F2mixture] . That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request F100... to the Agency [F101or to any appropriate authority] , without prejudice to Titles II and VI.

2. In the event of a registrant, downstream user or distributor ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the registrant, downstream user or distributor's undertaking or assuming responsibility for the placing on the market of the substance or [F2mixture] concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.

Textual Amendments

TITLE V U.K. DOWNSTREAM USERS

Article 37 U.K. Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures

1. A downstream user or distributor may provide information to assist in the preparation of a registration.

2. Any downstream user shall have the right to make a use, as a minimum the brief general description of use, known in writing (on paper or electronically) to the manufacturer, importer, downstream user or distributor who supplies him with a substance on its own or in a [F2mixture] with the aim of making this an identified use. In making a use known, he shall provide sufficient information to allow the manufacturer, importer or downstream user who has supplied the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the manufacturer, importer or downstream user's chemical safety assessment.

Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain.

3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a [F2mixture] to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later.

F102...

Where the manufacturer, importer or downstream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide the Agency and the downstream user with the reason(s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or importer shall include this use in Section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d).

4. A downstream user of a substance on its own or in a [F2mixture] shall prepare a chemical safety report in accordance with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against.

A downstream user need not prepare such a chemical safety report in any of the following cases:

(a) a safety data sheet is not required to be communicated with the substance or [F2mixture] in accordance with Article 31;

(b) a chemical safety report is not required to be completed by his supplier in accordance with Article 14;

(c) the downstream user uses the substance or [F2mixture] in a total quantity of less than one tonne per year;

(d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet;

(e) the substance is present in a [F2mixture] in a concentration lower than any of the concentrations set out in Article 14(2);

(f) the downstream user is using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment.

5. Any downstream user shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in any of the following:

(a) the safety data sheet(s) supplied to him;

(b) his own chemical safety assessment;

(c) any information on risk management measures supplied to him in accordance with Article 32.

6. Where a downstream user does not prepare a chemical safety report in accordance with paragraph 4(c), he shall consider the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that the risks to human health and the environment are adequately controlled. Where necessary, this information shall be included in any safety data sheet prepared by him.

7. Downstream users shall keep their chemical safety report up to date and available.

8. A chemical safety report prepared in accordance with paragraph 4 of this Article need not include consideration of the risks to human health from the end uses set out in Article 14(5).

Textual Amendments

Article 38 U.K. Obligation for downstream users to report information

1. Before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases:

(a) the downstream user has to prepare a chemical safety report in accordance with Article 37(4); or

(b) the downstream user is relying on the exemptions in Article 37(4)(c) or (f).

2. The information reported by the downstream user shall include the following:

(a) his identity and contact details as specified in Section 1.1 of Annex VI;

(b) the registration number(s) referred to in Article 20(3), if available;

(c) the identity of the substance(s) as specified in Section 2.1 to 2.3.4 of Annex VI;

(d) the identity of the manufacturer(s) or the importer(s) or other supplier as specified in Section 1.1 of Annex VI;

(e) a brief general description of the use(s), as specified in Section 3.5 of Annex VI, and of the conditions of use(s);

(f) except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.

3. The downstream user shall update this information without delay in the event of a change in the information reported in accordance with paragraph 1.

4. A downstream user shall report to the Agency if his classification of a substance is different to that of his supplier.

5. Except where a downstream user is relying on the exemption in Article 37(4)(c), reporting in accordance with paragraphs 1 to 4 of this Article shall not be required in respect of a substance, on its own or in a [F2mixture] , used by the downstream user in quantities of less than one tonne per year for that particular use.

Textual Amendments

Article 39 U.K. Application of downstream user obligations

1 . Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

2 . Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

TITLE VI U.K. EVALUATION

CHAPTER 1 U.K. Dossier evaluation

Article 40 U.K. Examination of testing proposals

[F21. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(c) hazard class 4.1;

(d) hazard class 5.1.]

2. Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3.

3. On the basis of the examination under paragraph 1, the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 50 and 51:

(a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;

(b) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;

(c) a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;

(d) a decision rejecting the testing proposal;

(e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.

4. The registrant or downstream user shall submit the information required to the Agency by the deadline set.

Textual Amendments

Article 41 U.K. Compliance check of registrations

1. The Agency may examine any registration in order to verify any of the following:

(a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;

(b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

(c) that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;

(d) that any explanation(s) submitted in accordance with Article 11(3) or Article 19(2) have an objective basis.

2. The list of dossiers being checked for compliance by the Agency shall be made available to [F103the appropriate authorities that request it] .

3. On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51.

4. The registrant shall submit the information required to the Agency by the deadline set.

5. [F104To check compliance of registration dossiers with this Regulation, the Agency shall select, until 31 December 2023 , a percentage of those dossiers no lower than 20 % of the total received by the Agency for registrations in tonnage bands of 100 tonnes or more per year.

The Agency shall, until 31 December 2027 , also select a percentage no lower than 20 % of the total received by the Agency for registrations in tonnage bands of less than 100 tonnes per year.

When selecting dossiers for compliance checking, the Agency shall give priority, but not exclusively, to dossiers meeting at least one of the following criteria:]

(a) the dossier contains information in Article 10(a)(iv), (vi) and/or (vii) submitted separately as per Article 11(3); or

(b) the dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or

(c) the dossier is for a substance listed in the F105 ... rolling action plan referred to in Article 44(2).

F106 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F107 7. The Secretary of State may, by regulations, make provision to modify the effect of paragraph 5 by—

(a) modifying the percentage of dossiers to be selected;

(b) modifying the criteria which determine the dossiers to which priority is to be given.

Regulations under this paragraph may amend paragraph 5.

The Secretary of State must consult the Agency before making regulations under this paragraph.

Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.]

Textual Amendments

Article 42 U.K. Check of information submitted and follow-up to dossier evaluation

1. The Agency shall examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropriate decisions in accordance with these Articles, if necessary.

2. Once the dossier evaluation is completed, the Agency shall notify the [F108appropriate authorities that request the notification] of the information obtained and any conclusions made. F109... The Agency shall use the information obtained from this evaluation for the purposes of Article 44.

Textual Amendments

Article 43 U.K. Procedure and time periods for examination of testing proposals

1. In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal.

2. In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3):

F110 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F110 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) by 1 June [F1112023] for any registrations containing testing proposals received [F112by ECHA] by 1 June 2018.

3. The list of registration dossiers being evaluated under Article 40 shall be made available to [F113appropriate authorities that request it] .

Textual Amendments

CHAPTER 2 U.K. Substance evaluation

Article 44 U.K. Criteria for substance evaluation

1. [F114The] Agency shall in cooperation with the [F115appropriate authorities] develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:

(a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

(b) exposure information;

(c) tonnage, including aggregated tonnage from the registrations submitted by several registrants.

2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft F116 ... rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. [F117The Agency must submit its draft rolling action plan to the appropriate authorities within 12 months of IP completion day and give the appropriate authorities the opportunity to comment on it. The Agency must submit a draft annual update to its rolling action plan by 31 May in each subsequent year and give the appropriate authorities the opportunity to comment on it. The Agency must adopt a final rolling annual action plan for each year (after taking account of any comments made on the draft by the appropriate authorities) and must publish it on its website.]

F118 ...

Textual Amendments

Article 45 U.K. [F119Evaluation of substances on the rolling action plan]

1. The Agency shall be responsible for F120 ... ensuring that substances on the F121 ... rolling action plan are evaluated. F122 ...

F123 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F123 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F123 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F123 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 46 U.K. Requests for further information and check of information submitted

1. If the [F124Agency] considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the F125 ... rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52.

2. The registrant shall submit the information required to the Agency by the deadline set.

3. The [F126Agency] shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted.

4. The [F127Agency] shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2 F128 .... If this deadline is exceeded, the evaluation shall be deemed to be finished.

Textual Amendments

Article 47 U.K. Coherence with other activities

1. An evaluation of a substance shall be based on all relevant information submitted on that particular substance and on any previous evaluation under this Title. Where information on intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also cover these related substances. In cases where a decision on an evaluation has been previously taken in accordance with Article 51 or Article 52, any draft decision requiring further information under Article 46 may be justified only by a change of circumstances or acquired knowledge.

F129 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F130 Article 48 U.K. Follow-up to substance evaluation

Once the substance evaluation has been completed, the Agency must consider how to use the information obtained from this evaluation for the purposes of Article 59(3) and Article 69(4). The Agency must inform the appropriate authorities and the registrant of its conclusions as to whether or how to use the information obtained.]

Textual Amendments

CHAPTER 3 U.K. Evaluation of intermediates

Article 49 U.K. Further information on on-site isolated intermediates

For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the [F131Agency] considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may:

(a)

require the registrant to submit further information directly related to the risk identified. This request shall be accompanied by a written justification;

(b)

examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identified in relation to the site in question.

[F132Where the appropriate authority in relation to the part of Great Britain where the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, that appropriate authority may request the Agency to take the steps set out in points (a) and (b) of the first paragraph.

The Agency must inform the appropriate authorities that request them of the results of an assessment under this Article.]

Textual Amendments

CHAPTER 4 U.K. Common provisions

Article 50 U.K. Registrants' and downstream users' rights

1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. F133 ...

2. If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. The Agency shall inform the [F134appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph] .

3. The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, shall inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. The Agency shall inform the [F135appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph] .

4. Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:

(a) where the [F136Agency] prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;

(b) where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.

The procedure in Articles 69 to 73 shall apply mutatis mutandis .

Textual Amendments

[F137 Article 51 U.K. Adoption of decisions under dossier evaluation

1. This Article applies where the Agency has notified its draft decision in accordance with Article 40 or 41.

2. If the Agency receives no comments from the registrant or downstream user, the Agency must make its decision in the version notified under paragraph 1.

3. If the Agency receives any comments from the registrant or downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version notified or vary the decision notified).

4. The Agency must notify the registrant or downstream user and the appropriate authorities of the decision made under paragraph 2 or 3.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.]

Textual Amendments

[F138 Article 52 U.K. Adoption of decisions under substance evaluation

1. This Article applies where the Agency has circulated its draft decision in accordance with Article 46.

2. If the Agency receives no comments from the registrant or the downstream user, the Agency must make its decision in the version circulated under paragraph 1.

3. If the Agency receives any comments from the registrant or the downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version circulated or vary the decision circulated).

4. The Agency must notify the registrant or the downstream user, and the appropriate authorities, of the decision made under paragraph 2 or 3.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.]

Textual Amendments

Article 53 U.K. Cost sharing for tests without an agreement between registrants and/or downstream users

1 . Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them.

2 . If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.

3 . In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the full study report.

4 . The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.

Article 54 U.K. Publication of information on evaluation

By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations.

TITLE VII U.K. AUTHORISATION

CHAPTER 1 U.K. Authorisation requirement

Article 55 U.K. Aim of authorisation and considerations for substitution

The aim of this Title is to ensure the good functioning of the [F139market in Great Britain] while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.

Textual Amendments

Article 56 U.K. General provisions

1. A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:

(a) the use(s) of that substance on its own or in a [F2mixture] or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or

(b) the use(s) of that substance on its own or in a [F2mixture] or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or

(c) the date referred to in Article 58(1)(c)(i) has not been reached; or

(d) the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or

(e) in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.

2. A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use.

3. Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted.

4. Paragraphs 1 and 2 shall not apply to the following uses of substances:

(a) uses in plant protection products within the scope of [F140Regulation (EC) No 1107/2009] ;

(b) uses in biocidal products within the scope of [F141Regulation (EU) No 528/2012] ;

(c) use as motor fuels covered by [F142the Motor Fuel (Composition and Content) Regulations 1999] ;

(d) uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.

5. In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:

(a) uses in cosmetic products within the scope of [F143Regulation (EC) No 1223/2009] ;

(b) uses in food contact materials within the scope of Regulation (EC) No 1935/2004.

6. Paragraphs 1 and 2 shall not apply to the use of substances when they are present in [F2mixtures] :

(a) for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1  % weight by weight (w/w);

[F2(b) for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.]

Textual Amendments

Article 57 U.K. Substances to be included in Annex XIV

The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

(a)

[F2substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;

(b)

substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;

(c)

substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;]

(d)

substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;

(e)

substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;

(f)

substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.

Textual Amendments

Article 58 U.K. Inclusion of substances in Annex XIV

1. [F144The Secretary of State may, by regulations, include in Annex 14 substances referred to in Article 57. The regulations must specify for each substance:]

(a) the identity of the substance as specified in Section 2 of Annex VI;

(b) the intrinsic property (properties) of the substance referred to in Article 57;

(c) transitional arrangements:

(i)

the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as the sunset date) which should take into account, where appropriate, the production cycle specified for that use;

(ii)

a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;

(d) review periods for certain uses, if appropriate;

(e) uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.

2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific F145 ... legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form.

3. Prior to a decision to include substances in Annex XIV, the Agency shall F146 ... recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with:

(a) PBT or vPvB properties; or

(b) wide dispersive use; or

(c) high volumes.

The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV [F147within 12 months of IP completion day] . The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.

4. Before the Agency sends its recommendation to the [F148appropriate authorities] it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement.

The Agency shall update its recommendation, taking into account the comments received.

5. Subject to paragraph 6, after inclusion of a substance in Annex XIV, this substance shall not be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the use of the substance on its own, in a [F2mixture] or incorporation of a substance in an article arising from the intrinsic properties specified in Annex XIV.

6. A substance listed in Annex XIV may be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the presence of the substance in (an) article(s).

7. Substances for which all uses have been prohibited under Title VIII or by other F149 ... legislation shall not be included in Annex XIV or shall be removed from it.

[F150 8. The Secretary of State may, by regulations, remove from Annex 14 substances which as a result of new information no longer meet the criteria of Article 57.]

[F1519. Regulations under paragraph 1 or 8 are to be made by statutory instrument; and a statutory instrument containing regulations under paragraph 1 or 8 is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under paragraph 1 or 8 is subject to the consent requirement in Article 4A.]

Textual Amendments

Article 59 U.K. Identification of substances referred to in Article 57

1. The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. The Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e).

[F1521A. The Agency must include in its candidate list every substance that is included in ECHA's candidate list under Article 59(1) of EU REACH immediately before IP completion day.]

2. [F153An appropriate authority] may ask the Agency to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. [F2The dossier may be limited, if appropriate, to a reference to an entry in [F154the GB mandatory classification and labelling list] .] The Agency shall make this dossier available to the [F155appropriate authorities] .

3. [F156The Agency] may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 F157 .... [F2The dossier may be limited, if appropriate, to a reference to an entry in [F158the GB mandatory classification and labelling list] .] The Agency shall make this dossier available [F159to the appropriate authorities] .

4. The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance. The Agency shall invite all interested parties to submit comments within a specified deadline to the Agency.

F160 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. If the Agency does not receive F161 ... any comments, it shall include this substance on the list referred to in paragraph 1. The Agency may include this substance in its recommendations under Article 58(3).

7. When comments are F162 ... received, the Agency [F163must consider the comments and make a decision on the identification of the substance within 45 days of the deadline specified in paragraph 4] .

F164 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F164 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10. The Agency shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclusion of a substance has been taken.

Textual Amendments

CHAPTER 2 U.K. Granting of authorisations

Article 60 U.K. Granting of authorisations

1. The [F165Secretary of State] shall be responsible for taking decisions on applications for authorisations in accordance with this Title. [F166That responsibility of the Secretary of State is subject to the provisions of this Title which make the exercise of certain functions subject to the consent requirement in Article 4A.]

2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the [F167Agency so far as the opinion relates to the elements] referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the [F168Secretary of State] shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.

The [F168Secretary of State] shall not consider the risks to human health arising from the use of a substance in a medical device regulated by [F169the Medical Devices Regulations 2002] .

3. Paragraph 2 shall not apply to:

(a) substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;

(b) substances meeting the criteria in Article 57(d) or (e);

(c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.

4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account [F170the elements] referred to in Article 64(4)(a) and (b):

(a) the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;

(b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;

(c) the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);

(d) available information on the risks to human health or the environment of any alternative substances or technologies.

5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the [F171Secretary of State] , including:

(a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;

(b) the technical and economic feasibility of alternatives for the applicant.

6. A use shall not be authorised if this would constitute a relaxation of a restriction set out in Annex XVII.

7. An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62.

8. Authorisations shall be subject to a time-limited review without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring. The duration of the time-limited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate.

9. The authorisation shall specify:

(a) the person(s) to whom the authorisation is granted;

(b) the identity of the substance(s);

(c) the use(s) for which the authorisation is granted;

(d) any conditions under which the authorisation is granted;

(e) the time-limited review period;

(f) any monitoring arrangement.

10. Notwithstanding any conditions of an authorisation, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible.

Textual Amendments

Article 61 U.K. Review of authorisations

1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the [F172Secretary of State] decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs.

A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application.

If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.

If any other elements of the original application have changed, he shall also submit updates of these element(s).

When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis .

[F173The function of deciding under this paragraph whether to amend or withdraw the authorisation is subject to the consent requirement in Article 4A.]

2. Authorisations may be reviewed at any time if:

(a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or

(b) new information on possible substitutes becomes available.

The [F174Secretary of State] shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 64.

[F175Any of the other appropriate authorities may request the Secretary of State to carry out a review of an authorisation under this paragraph.]

3. In its review decision the [F176Secretary of State] may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available. In the latter case the [F176Secretary of State] shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update.

In cases where there is a serious and immediate risk for human health or the environment, the [F176Secretary of State] may suspend the authorisation pending the review, taking into account the principle of proportionality.

[F177Where the Secretary of State is carrying out a review of an authorisation under this paragraph, any of the other appropriate authorities may request the Secretary of State to suspend the authorisation while the review is being carried out.

The function of deciding under the first subparagraph whether to amend or withdraw the authorisation, and the function of deciding under the second subparagraph whether to suspend the authorisation, are subject to the consent requirement in Article 4A.]

4. If an environmental quality standard F178 ... is not met, the authorisations granted for the use of the substance concerned may be reviewed.

5. If the [F179river basin] environmental objectives F180 ... are not met, the authorisations granted for the use of the substance concerned in the relevant river basin may be reviewed.

6. If a use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (5) , the [F181Secretary of State] shall withdraw the authorisation for that use.

[F1827. In this Article—

(a) “ environmental quality standard ” means the set of requirements which must be fulfilled at a given time in relation to a given environment or particular part thereof, as set out in retained EU law;

(c) “ river basin district in Scotland ” means an area designated as a river basin district by order under section 4(1) of the Water Environment and Water Services (Scotland) Act 2003;

(d) “ river basin environmental objectives ” means—

(i) in relation to the Northumbria River Basin District, the environmental objectives referred to in the WFD Regulations as applied by regulation 5 of the Water Environment (Water Framework Directive) (Northumbria River Basin District) Regulations 2003;

(ii) in relation to the Solway Tweed River Basin District, the environmental objectives as defined in regulation 2 of the Water Environment (Water Framework Directive) (Solway Tweed River Basin District) Regulations 2004;

(iii) in relation to any other river basin district within the meaning of the WFD Regulations, the environmental objectives referred to in those Regulations;

(iv) in relation to a river basin district in Scotland, the environmental objectives set under section 9(1)(a) of the Water Environment and Water Services (Scotland) Act 2003;

(e) “ the WFD Regulations ” means the Water Environment (Water Framework Directive) (England and Wales) Regulations 2017.]

Textual Amendments

Article 62 U.K. Applications for authorisations

1. An application for an authorisation shall be made to the Agency.

2. Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance. Applications may be made by one or several persons.

3. Applications may be made for one or several substances, that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market.

4. An application for authorisation shall include the following information:

(a) the identity of the substance(s), as referred to in Section 2 of Annex VI;

(b) the name and contact details of the person or persons making the application;

(c) a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in [F2mixtures] and/or the incorporation of the substance in articles, where this is relevant;

(d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;

(e) an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;

(f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.

5. The application may include:

(a) a socio-economic analysis conducted in accordance with Annex XVI;

(b) a justification for not considering risks to human health and the environment arising either from:

(i) emissions of a substance from an installation for which a permit [F183to carry out an activity referred to in Annex I to Directive 2010/75/EU was granted in accordance with retained EU law] ; or

[F184(ii) discharges of a substance from a point source governed by retained EU law that transposed the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy.]

6 . The application shall not include the risks to human health arising from the use of a substance in a medical device regulated by [F185the Medical Devices Regulations 2002] .

7 . An application for an authorisation shall be accompanied by the fee required in accordance with Title IX.

Textual Amendments

Article 63 U.K. Subsequent applications for authorisation

1 . If an application has been made for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant has permission from the previous applicant to refer to these parts of the application.

2 . If an authorisation has been granted for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant has permission from the holder of the authorisation to refer to these parts of the application.

3 . Before referring to any previous application in accordance with paragraphs 1 and 2, the subsequent applicant shall update the information of the original application as necessary.

Article 64 U.K. Procedure for authorisation decisions

1. The Agency shall acknowledge the date of receipt of the application. [F186The Agency must give its draft opinion within ten months of the date of receipt of the application] .

2. The Agency shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.

[F187 3. In preparing its opinion, the Agency must first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Agency must request additional information to bring the application into conformity with the requirements of Article 62. The Agency may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. The Agency, and any scientific adviser providing the Agency with scientific knowledge and advice in relation to the opinion, must take into account any information submitted by third parties.]

[F1883A. In paragraph 3 “ scientific adviser ” means a person who the Agency has commissioned (in compliance with the duty imposed by Article 77(A1)) to provide it with scientific knowledge and advice.]

4. The draft [F189opinion] shall include the following elements:

(a) F190 ... An assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;

(b) F191 ... An assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.

5. The Agency shall send [F192its draft opinion] to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it.

If the applicant does not wish to comment, the Agency shall send [F193its final opinion to the appropriate authorities] and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.

If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The [F194Agency] shall consider the comments and adopt [F195its] final [F196opinion] within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the [F196opinion] , with the written argumentation attached, to the [F197appropriate authorities] and the applicant.

6. The Agency shall determine in accordance with Articles 118 and 119 which parts of its [F198opinion] and parts of any attachments thereto should be made publicly available on its website.

7. In cases covered by Article 63(1), the Agency shall treat the applications together, provided the deadlines for the first application can be met.

[F199 8. The Secretary of State must make a decision granting or refusing the authorisation within six months of receipt of the opinion from the Agency.

The function in this paragraph of deciding whether to grant or refuse the authorisation is subject to the consent requirement in Article 4A.]

9. Summaries of the [F200decisions of the Secretary of State] , including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published [F201by the Secretary of State] and shall be made publicly available in a database established and kept up to date by the Agency.

10. In cases covered by Article 63(2), the deadline set out in paragraph 1 of this Article shall be shortened to five months.

Textual Amendments

CHAPTER 3 U.K. Authorisations in the supply chain

Article 65 U.K. Obligation of holders of authorisations

Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a [F2mixture] , shall include the authorisation number on the label before they place the substance or a [F2mixture] containing the substance on the market for an authorised use F202 .... This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9).

Textual Amendments

Article 66 U.K. Downstream users

1. Downstream users using a substance in accordance with Article 56(2) shall notify the Agency within three months of the first supply of the substance.

2. The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to this register to the [F203appropriate authorities] .

Textual Amendments

TITLE VIII U.K. RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, [F2MIXTURES] AND ARTICLES

CHAPTER 1 U.K. General issues

Article 67 U.K. General provisions

1. A substance on its own, in a [F2mixture] or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development. Annex XVII shall specify if the restriction shall not apply to product and process orientated research and development, as well as the maximum quantity exempted.

2. Paragraph 1 shall not apply to the use of substances in cosmetic products, as defined by [F204Regulation 1223/2009] , with regard to restrictions addressing the risks to human health within the scope of that [F205Regulation] .

F206 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

CHAPTER 2 U.K. Restrictions process

Article 68 U.K. Introducing new and amending current restrictions

1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, F207 ... Annex XVII shall be amended [F208by regulations made by the Secretary of State which provide for the adoption of new restrictions or the amendment of] current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in [F2mixtures] or in articles, pursuant to the procedure set out in Articles 69 to 73. [F209In exercising the power to make regulations under this paragraph, the Secretary of State] shall take into account the socio-economic impact of the restriction, including the availability of alternatives.

The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate.

[F22. For a substance on its own, in a mixture or in an article which meets the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, and could be used by consumers [F210the Secretary of State may propose restrictions. The function of proposing restrictions is subject to the consent requirement in Article 4A. The Secretary of State may, by regulations, amend Annex 17 to give effect to a proposed restriction.] Articles 69 to 73 shall not apply.]

[F2113. Regulations under paragraph 2 of this Article are to be made by statutory instrument; and a statutory instrument containing regulations made under paragraph 2 of this Article is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under paragraph 2 of this Article is subject to the consent requirement in Article 4A.]

Textual Amendments

Article 69 U.K. Preparation of a proposal

1. If [F212an appropriate authority] considers that the manufacture, placing on the market or use of a substance on its own, in a [F2mixture] or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XV.

2. After the date referred to in Article 58(1)(c)(i) for a substance listed in Annex XIV, the Agency shall consider whether the use of that substance in articles poses a risk to human health or the environment that is not adequately controlled. If the Agency considers that the risk is not adequately controlled, it shall prepare a dossier which conforms to the requirements of Annex XV.

3. Within 12 months of the receipt of the request from [F213an appropriate authority] in paragraph 1 and if this dossier demonstrates that action F214 ... is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.

[F215 4. If the Agency considers that the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, the Agency must prepare a dossier which conforms to the requirements and format of the relevant sections of Annex 15. If this dossier demonstrates that action is necessary, beyond any measures already in place, the Agency must initiate the restrictions process and must inform those who submitted a registration for that substance.

The Agency must refer to any dossier, chemical safety report or risk assessment submitted to it under this Regulation. The Agency must also refer to any relevant risk assessment submitted for other regulatory purposes. To this end other public bodies carrying out a similar task must provide information to the Agency on request.]

[F2165. The Agency must maintain a list of substances for which a dossier conforming to the requirements of Annex 15 is planned or underway for the purposes of a proposed restriction.]

[F2175A. The Agency or an appropriate authority may propose the re-examination of an existing restriction listed in Annex 17.

If the Agency is proposing the re-examination, it must notify the appropriate authorities of the proposal. If an appropriate authority is proposing a re-examination, it must notify the Agency and the other appropriate authorities of the proposal. Where a re-examination is proposed (by the Agency or an appropriate authority), the Secretary of State must decide, on the basis of evidence presented by whoever proposed the re-examination, whether the re-examination should take place. That function of deciding whether the re-examination should take place is subject to the consent requirement in Article 4A. If the Secretary of State decides that the re-examination should take place, the Agency must carry out the re-examination.]

6. Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication. The Agency shall invite all interested parties to submit individually or jointly within six months of the date of publication:

(a) comments on dossiers and the suggested restrictions;

(b) a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI.

Textual Amendments

Article 70 U.K. Agency opinion: [F218risk assessment]

Within nine months of the date of publication referred to in Article 69(6), the [F219Agency] shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the [F220dossier] , and the views of interested parties referred to in Article 69(6)(a).

Textual Amendments

Article 71 U.K. Agency opinion: [F221socio-economic analysis]

1. Within 12 months of the date of publication referred to in Article 69(6), the [F222Agency] shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to Article 69(6)(b), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion.

2. The [F223Agency] shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under Article 69(6)(b) and under paragraph 1 of this Article.

F224 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 72 U.K. Submission of an opinion to the [F225appropriate authorities]

1. The Agency shall submit to the [F226appropriate authorities] without delay [F227its opinions on risk assessment and socio-economic analysis] on restrictions suggested for substances on their own, in [F2mixtures] or in articles. If [F228the Agency does] not formulate an opinion by the deadline set in Article 70 and Article 71(1) the Agency shall inform the [F229appropriate authorities] accordingly, stating the reasons.

2. Without prejudice to Articles 118 and 119 the Agency shall publish [F230its opinions] on its website without delay.

3. The Agency shall provide the [F231appropriate authorities that request them] with all documents and evidence submitted to or considered by it.

Textual Amendments

Article 73 U.K. [F232Restriction decisions]

1. If the conditions laid down in Article 68 are fulfilled, the [F233Secretary of State must propose] a draft amendment to Annex XVII, within three months of receipt of [F234the Agency's opinions] . [F235The functions of deciding whether to propose a draft amendment, and of proposing a draft amendment, are subject to the consent requirement in Article 4A.]

Where the draft amendment diverges from the original proposal or if it does not take the opinions from the Agency into account, the [F236Secretary of State] shall annex a detailed explanation of the reasons for the differences.

[F2372. The Secretary of State may, by regulations, amend Annex 17 to include the draft amendment.

Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations made under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this Article is subject to the consent requirement in Article 4A.]

Textual Amendments

TITLE IX U.K. FEES AND CHARGES

Article 74 U.K. Fees and charges

1. [F238The Secretary of State may, by regulations, specify the fees] that are required according to Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2), Article 18(2), Article 19(3), Article 22(5) [F239and Article 62(7)] .

[F240Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations made under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this Article is subject to the consent requirement in Article 4A.]

2. A fee need not be paid for a registration of a substance in a quantity of between 1 and 10 tonnes where the registration dossier contains the full information in Annex VII.

3. F241 ...

In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered.

In all cases, a reduced fee shall be set for SMEs.

In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately.

In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification.

F242 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. The Agency may collect charges for other services it provides.

Textual Amendments

TITLE X U.K. AGENCY

F243 Article 75 U.K. Establishment and review

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Textual Amendments

F244 Article 76 U.K. Composition

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Textual Amendments

Article 77 U.K. Tasks

[F245A1. When forming opinions the Agency must take relevant scientific knowledge and advice into account (including any relevant knowledge and advice relating to socio-economic matters).

A2. The Agency may take any such knowledge or advice into account when forming an opinion only if—

(a) the knowledge or advice has been commissioned by the Agency, from one or more suitably qualified or experienced persons who are independent of the Agency, for the purposes of forming the opinion concerned, or

(b) the knowledge or advice—

(i) is already in existence (whether within the Agency or externally),

(ii) is produced within the Agency for the purposes of forming the opinion concerned, or

(iii) is, in accordance with Article 2B, produced by the Environment Agency or one of the other environmental regulators in connection with the Agency forming the opinion concerned and then passed on to the Agency, and the Agency considers that it is appropriate to take it into account, rather than to commission knowledge or advice in compliance with point (a).

The knowledge or advice that the Agency may take into account in compliance with point (b)(i) includes knowledge or advice which has previously been commissioned by the Agency from one or more suitably qualified or experienced persons who are independent of the Agency for the purposes of forming a previous opinion on any matter.

A3. The Agency must comply with this paragraph if —

(a) it is forming—

(i) an opinion in connection with deciding whether to grant an authorisation under Article 60,

(ii) an opinion under Article 70 as to whether suggested restrictions are appropriate in reducing the risk to human health or the environment, or

(iii) an opinion under Article 71 on suggested restrictions and on the related socio-economic impact, and

(b) it only takes into account knowledge or advice that is not commissioned in compliance with paragraph A2(a) for the purposes of forming that opinion.

The Agency must—

(a) produce an explanation of why it considered that it was appropriate to take only that knowledge or advice into account,

(b) publish the explanation, and

(c) send a copy of the explanation to the appropriate authorities.

A4. When exercising its functions, the Agency must act in a way that ensures a high degree of transparency.

A5. The Agency must produce and publish a statement of how it will comply with paragraphs A1, A2 and A4.

The Agency must produce and publish the first statement within the period of 3 months beginning with the day after IP completion day.

The Agency must consult such persons as it considers appropriate before producing the first, or any subsequent, statement.

A6. The statement must include—

(a) information about the qualifications or relevant experience that are suitable in order for persons to be commissioned to provide knowledge or advice to the Agency,

(b) examples of situations in which the Agency envisages that it might be appropriate to take existing knowledge or advice (rather than knowledge or advice commissioned as mentioned in paragraph A2(a)) into account.

A7. Paragraphs A1 to A6 do not limit the Agency's duties under Article 2B.]

1. The Agency shall provide the [F246appropriate authorities] with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation.

2. [F247The Agency] shall undertake the following tasks:

F248 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F248 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F248 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F248 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F2(e) establishing and maintaining database(s) with information on all registered substances F249 ....] It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. F250 ...;

(f) making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1);

(g) providing technical and scientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7 by producers and importers of articles;

F251 (h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(i) providing guidance to stakeholders F252 ... on communication to the public of information on the risks and safe use of substances, on their own, in [F2mixtures] or in articles;

(j) providing advice and assistance to manufacturers and importers registering a substance in accordance with Article 12(1);

(k) preparing explanatory information on this Regulation for other stakeholders;

(l) at the F253 ... request [F254of any appropriate authority] , providing technical and scientific support for steps to improve cooperation [F255with] international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries;

(m) keeping a Manual of Decisions and Opinions F256 ... regarding interpretation and implementation of this Regulation;

(n) notification of decisions taken by the Agency;

(o) provision of formats for submission of information to the Agency.

F257 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F257 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F258 Article 78 U.K. Powers of the Management Board

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Textual Amendments

F258 Article 79 U.K. Composition of the Management Board

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Textual Amendments

F258 Article 80 U.K. Chairmanship of the Management Board

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Textual Amendments

F258 Article 81 U.K. Meetings of the Management Board

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Textual Amendments

F258 Article 82 U.K. Voting of the Management Board

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Textual Amendments

Article 83 U.K. [F259Annual report by the Agency to the appropriate authorities ]

F260 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F260 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. Each year, the [F261Agency] shall submit the following to the [F262Secretary of State] for approval:

(a) a draft report covering the activities of the Agency in the previous year, including information about the number of registration dossiers received, the number of substances evaluated, the number of applications for authorisation received, the number of proposals for restriction [F263prepared by the Agency] , the time taken for completion of the associated procedures, and the substances authorised, dossiers rejected, substances restricted; [F264the Agency's compliance with Article 77(A1) by taking into account scientific knowledge and advice (including knowledge and advice relating to socio-economic matters);] complaints received and the action taken F265 ...;

(b) a draft work-programme for the coming year;

(c) the draft annual accounts;

(d) the draft forecast budget for the coming year;

(e) a draft multiannual work programme.

[F266The Agency must provide any draft submitted to the Secretary of State under points (a) to (e) to the other appropriate authorities at the same time it is submitted to the Secretary of State.

The Secretary of State must consult the other appropriate authorities before giving approval to any draft submitted under points (a) to (e).]

Textual Amendments

F267 Article 84 U.K. Appointment of the Executive Director

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Textual Amendments

F267 Article 85 U.K. Establishment of the Committees

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Textual Amendments

F267 Article 86 U.K. Establishment of the Forum

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Textual Amendments

F267 Article 87 U.K. Rapporteurs of Committees and use of experts

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Textual Amendments

Article 88 U.K. Qualification and interests

[F2681. The details of the suitably qualified or experienced persons that provide advice to the Agency under Article 77(A2)(a) must be made public. Individuals may request that their names not be made public if they believe that such publication could place them at risk. The Agency must decide whether to agree to such requests. When details are published, the professional qualifications of each suitably qualified or experienced person must be specified.]

2. [F269Suitably qualified or experienced persons that provide advice to the Agency pursuant to Article 77(A2)(a)] shall make a declaration of commitment to fulfil their duties and a declaration of interests which could be considered to be prejudicial to their independence. These declarations shall be made annually in writing and, without prejudice to paragraph 1, be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.

F270 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F271 Article 89 U.K. Establishment of the Board of Appeal

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Textual Amendments

F272 Article 90 U.K. Members of the Board of Appeal

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Textual Amendments

Article 91 U.K. Decisions subject to appeal

1. An appeal may be brought against decisions of the Agency taken pursuant to Article 9, Article 20, Article 27(6), [F273Article 51 and Article 52] .

[F2741A. An appeal pursuant to paragraph 1 lies to the First-tier Tribunal.]

2. An appeal lodged pursuant to paragraph 1 shall have suspensive effect.

[F2753. On an appeal pursuant to paragraph 1, the First-tier Tribunal—

(a) may dismiss the appeal, or

(b) if it allows the appeal may—

(i) quash the decision and (if appropriate) remit the matter to the Agency, or

(ii) substitute for the decision any other decision which could have been made by the Agency.]

Textual Amendments

Article 92 U.K. Persons entitled to appeal F276 ...

1. Any natural or legal person may appeal against a decision addressed to that person, or against a decision which, although addressed to another person, is of direct and individual concern to the former.

F277 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F277 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 93 U.K. [F278Change of decision where appeal made]

[F279 1. If—

(a) an appeal against a decision is brought pursuant to Article 91, and

(b) the Agency considers the appeal to be admissible and well founded,

the Agency may rectify the decision within the period of 30 days beginning with the day when the appeal is brought.]

F280 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F280 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F280 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F281 Article 94 U.K. Actions before the Court of First Instance and the Court of Justice

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Textual Amendments

Article 95 U.K. Conflicts of opinion with other bodies

1. The Agency shall take care to ensure early identification of potential sources of conflict between its opinions and those of other [F282public bodies] carrying out a similar task in relation to issues of common concern.

2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific or technical information is shared and to identify the scientific or technical points which are potentially contentious.

3. Where there is a fundamental conflict over scientific or technical points F283 ..., the Agency and the body concerned shall work together either to solve the conflict or to submit a joint document to the [F284appropriate authorities] clarifying the scientific and/or technical points of conflict.

Textual Amendments

F285 Article 96 U.K. The budget of the Agency

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Textual Amendments

F285 Article 97 U.K. Implementation of the budget of the Agency

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Textual Amendments

F285 Article 98 U.K. Combating fraud

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Textual Amendments

F285 Article 99 U.K. Financial rules

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Textual Amendments

F285 Article 100 U.K. Legal personality of the Agency

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Textual Amendments

F285 Article 101 U.K. Liability of the Agency

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Textual Amendments

F285 Article 102 U.K. Privileges and immunities of the Agency

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Textual Amendments

F285 Article 103 U.K. Staff rules and regulations

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Textual Amendments

F285 Article 104 U.K. Languages

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Textual Amendments

F285 Article 105 U.K. Duty of confidentiality

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Textual Amendments

F285 Article 106 U.K. Participation of third countries

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Textual Amendments

F285 Article 107 U.K. Participation of international organisations

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Textual Amendments

Article 108 U.K. Contacts with stakeholder organisations

The [F286Agency must develop appropriate contacts with] relevant stakeholder organisations.

Textual Amendments

Article 109 U.K. Rules on transparency

To ensure transparency, the [F287Agency must] adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in [F2mixtures] or in articles which is not of a confidential nature.

Textual Amendments

Article 110 U.K. Relations with relevant [F288public] bodies

1. The Agency shall cooperate with other [F289public] bodies to ensure mutual support in the accomplishment of their respective tasks in particular to avoid duplication of work.

2. The [F290Agency, having consulted the Food Standards Agency and Food Standards Scotland] shall establish rules of procedure concerning substances for which an opinion has been sought in a food safety context. F291 ...

This Title shall not otherwise affect the competences vested in the [F292Food Standards Agency and Food Standards Scotland] .

3. This Title shall not affect the competences vested in the [F293Medicines and Healthcare products Regulatory Agency] .

F294 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 111 U.K. Formats and software for submission of information to the Agency

The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. [F295Manufacturers] , importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1).

For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation.

Textual Amendments

F296 TITLE XI U.K. [F296CLASSIFICATION AND LABELLING INVENTORY

F296 Article 112 U.K. Scope

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F296 Article 113 U.K. Obligation to notify the Agency

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F296 Article 114 U.K. Classification and labelling inventory

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F296 Article 115 U.K. Harmonisation of classification and labelling

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F296 Article 116 U.K. Transitional arrangements]

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Textual Amendments

TITLE XII U.K. INFORMATION

Article 117 U.K. Reporting

F297 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Every five years, the Agency shall submit to the [F298appropriate authorities] a report on the operation of this Regulation. The Agency shall include in its report [F299sections on evaluation and enforcement,] information on the joint submission of information in accordance with Article 11 and an overview of the explanations given for submitting information separately.

The first report shall be submitted by [F3001 April 2022] .

3. Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the [F301appropriate authorities] a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of this Regulation.

The first report shall be submitted by [F3021 April 2022] .

4. Every five years, the [F303Secretary of State, in cooperation with the other appropriate authorities, must] publish a general report on:

(a) the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and;

(b) the amount and distribution of funding made available by the [F304appropriate authorities] for the development and evaluation of alternative test methods.

The first report shall be published by [F3051 April 2023] .

Textual Amendments

Article 118 U.K. Access to information

F306 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person:

(a) details of the full composition of a [F2mixture] ;

(b) without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or [F2mixture] , including information about its precise use as an intermediate;

(c) the precise tonnage of the substance or [F2mixture] manufactured or placed on the market;

(d) links between a manufacturer or importer and his distributors or downstream users.

Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.

3. The [F307Agency] shall adopt the practical arrangements for F308 ... appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request F309 ....

F310 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 119 U.K. Electronic public access

1 . The following information held by the Agency on substances whether on their own, in [F2mixtures] or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):

[F2(a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

  • [F2(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

  • hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

  • hazard class 4.1;

  • hazard class 5.1;]

(b) if applicable, the name of the substance as given in EINECS;

(c) the classification and labelling of the substance;

(d) physicochemical data concerning the substance and on pathways and environmental fate;

(e) the result of each toxicological and ecotoxicological study;

(f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;

(g) the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI;

(h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

2. The following information on substances whether on their own, in [F2mixtures] or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:

(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;

(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered;

(c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);

( d ) information, other than that listed in paragraph 1, contained in the safety data sheet;

(e) the trade name(s) of the substance;

[F2(f) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;]

[F2 subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:]

(i)

as an intermediate;

(ii)

in scientific research and development;

(iii)

in product and process orientated research and development.

Textual Amendments

Article 120 U.K. Cooperation with [F311other] countries and international organisations

Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of [F312another country or an international organisation in accordance with an agreement concluded between the United Kingdom and the other country or international organisation,] provided that both the following conditions are met:

(a)

the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;

(b)

the [F313other country or international organisation concerned] protects the confidential information as mutually agreed.

Textual Amendments

TITLE XIII U.K. [F314PROVISION OF INFORMATION]

F315 Article 121 U.K. Appointment

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Textual Amendments

F316 Article 122 U.K. Cooperation between competent authorities

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Textual Amendments

Article 123 U.K. Communication to the public of information on risks of substances

The [F317Agency] shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with [F318the appropriate authorities] and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in [F2mixtures] or in articles F319 ....

Textual Amendments

Article 124 U.K. Other responsibilities

F320 ...

[F321The Agency must establish a national helpdesk] to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g).

Textual Amendments

Textual Amendments

TITLE XIV U.K. ENFORCEMENT

F322 Article 125 U.K. Tasks of the Member States

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Textual Amendments

F323 Article 126 U.K. Penalties for non-compliance

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Textual Amendments

Article 127 U.K. Report

The report referred to in Article [F324117(2)] shall, in relation to enforcement, include the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures taken F325... during the previous reporting period. F326...

Textual Amendments

[F327TITLE 14A U.K. EU WITHDRAWAL: TRANSITIONAL PROVISION

Article 127A U.K. Existing EU registrations which have effect as GB registrations

1. An existing EU registration under Articles 6, 7(1), 7(5) or 24(1) of EU REACH has effect on and after IP completion day as a GB registration (the “transferred GB registration”) if the registration—

(a) has a current connection with Great Britain, or

(b) has a relevant past connection with Great Britain (but does not have a current connection with Great Britain).

2. A registration has a current connection with Great Britain if—

(a) the registrant immediately before IP completion day is a person established in Great Britain (a “current GB registrant”), and

(b) a registration of the substance concerned by the current GB registrant is a registration of a kind that could be submitted on IP completion day under Article 6 or 7(1) or (5) of this Regulation.

3. A registration has a relevant past connection with Great Britain if—

(a) the registrant at any time in the period beginning with 29 March 2017 and ending immediately before IP completion day was a person established in Great Britain (a “former GB registrant”), and

(b) a registration of the substance concerned by the former GB registrant is a registration of a kind that could be submitted on IP completion day under Article 6 or 7(1) or (5) of this Regulation.

4. Where an existing EU registration has effect by virtue of this Article as a transferred GB registration, it has effect—

(a) if it is an existing EU registration under Article 6 of EU REACH, as a transferred GB registration under Article 6 of this Regulation;

(b) if it is an existing EU registration under Article 7(1) of EU REACH, as a transferred GB registration under Article 7(1) of this Regulation;

(c) if it is an existing EU registration under Article 7(5) of EU REACH, as a transferred GB registration under Article 7(5) of this Regulation;

(d) if it is an existing EU registration that existed by virtue of Article 24(1) of EU REACH, as a transferred GB registration that exists by virtue of Article 6 of this Regulation.

6. Where a registration that has a relevant past connection with Great Britain has effect as a transferred GB registration by virtue of this Article, the former GB registrant becomes the registrant in relation to the transferred GB registration on IP completion day.

If two or more persons have been former GB registrants at different times in the period beginning with 29 March 2017 and ending immediately before IP completion day, only the person who was the former GB registrant most recently before IP completion day is to become registrant in relation to the transferred GB registration by virtue of this paragraph.

Article 127B U.K. Application of this Regulation to transferred GB registrations

1. The other Titles of this Regulation apply to a transferred GB registration as they would apply to the registration—

(a) if it had been submitted on IP completion day to the Agency under Article 6 or 7(1) or (5) (as the case may be);

(b) in a case where the existing EU registration came into existence by virtue of Article 24(1) of EU REACH, if it had been submitted on IP completion day to the Agency under Article 6.

Accordingly, no registration under that Article needs to be submitted.

2. But, in their application to the transferred GB registration, the other Titles of this Regulation have effect with the modifications set out in the following provisions of this Article.

3. In the case of—

(a) a transferred GB registration under Article 6, no fee is payable under Article 6(4);

(b) a transferred GB registration under Article 7, no fee is payable under Article 7(1) or (5).

4. The registrant must submit—

(a) the Article 10 information referred to in Article 10(a)(i), (ii), and (iii), and any relevant indication under Article 10(a)(viii), to the Agency within the 120 day post-IP completion period;

(b) the other Article 10 information to the Agency within the relevant post-IP completion period.

Where the existing EU registration existed by virtue of Article 24(1) of EU REACH, the duty under this paragraph does not apply in relation to a transferred GB registration unless Article 24(2) applied in relation to the notified substance concerned before IP completion day.

5. The technical dossier that is submitted in accordance with point (a) in Article 10 does not need to include the proposals for testing mentioned in paragraph (ix) if, before IP completion day, ECHA has made a decision under Article 40(3) of EU REACH in relation to the testing proposals included in the technical dossier that was included in the existing EU registration.

For further provision about certain cases where there is an existing EU decision on a testing proposal, see Article 127I.

6. The registrant must submit the registration number and registration date assigned to the existing EU registration by ECHA in accordance with Article 20(3) of EU REACH, and such other evidence as the Agency may require of the existing EU registration, to the Agency within the 120 day post-IP completion period.

7. Article 20 has effect with the following provision substituted for paragraphs 1 to 3—

“1. The Agency must assign a submission date to each transferred GB registration, which must be the date on which the registrant complies with paragraph 4(a) or (b) of Article 127B.

2. The Agency may undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 have been provided. The completeness check must not include an assessment of the quality or the adequacy of any data or justifications submitted.

If a registration is incomplete, the Agency must inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant must complete his registration and submit it to the Agency within the deadline set. The Agency must confirm the submission date of the further information to the registrant. The Agency must perform a further completeness check, considering the further information submitted.

3. Once the registrant has complied with paragraph 4(a) of Article 127B, the Agency must assign a registration number to the substance concerned and a registration date, which must be the same as the registration date for the existing EU registration.” .

8. Article 21 has effect with the following provision substituted for the first subparagraph of paragraph 1—

“1. A registrant of a transferred GB registration may continue the manufacture or import of a substance or production or import of an article from IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2).” .

9. The Agency is not required by Article 41(5) to carry out compliance checking of dossiers relating to transferred GB registrations in the tonnage bands of over 100 to 1,000 tonnes or over 1,000 tonnes.

10. The reference in Article 43(1) to the preparation of a draft decision within 180 days of receiving a registration has effect as a reference to the preparation of a draft decision within 180 days of receipt of the information required by Article 10(a)(ix) under paragraph 4.

Article 127C U.K. Decisions of ECHA relating to existing EU registrations

1. This Article applies in relation to an existing EU registration which has effect as a transferred GB registration under Article 127A.

2. Any existing ECHA decision which relates to the registration has effect on and after IP completion day as a decision of the Agency which relates to the transferred GB registration.

3. The registrant must—

(a) notify the Agency, within the 120 day post-IP completion period, of any existing ECHA decision which relates to the registration, and

(b) if required to do so by the Agency, supply the Agency, within the period specified by the Agency, with copies of any existing ECHA decision which relates to the registration.

4. The Agency may extend any period of time specified in an existing ECHA decision.

5. The other Titles of this Regulation apply to the decision as they would apply to it if it had been made by the Agency on IP completion day.

6. In this Article “ existing ECHA decision ” means a decision which has been made by ECHA under any provision of EU REACH and which is valid immediately before IP completion day.

Article 127D U.K. Interpretation of Articles 127A to 127C

1. In Articles 127A to 127C—

  • “ Article 10 information ” means the information which a registration is required to include by virtue of Article 10;

  • “ existing EU registration ” means a registration of a substance with ECHA which is subsisting immediately before IP completion day;

  • “ transferred GB registration ” has the meaning given in Article 127A(1);

  • “ GB registration ” means a registration of a substance with the Agency.

Article 127E U.K. Pre-IP completion downstream users and distributors that are to continue to be regarded as downstream users

1. This Article applies in a case where—

(a) a person is—

(i) an existing GB downstream user under EU REACH, or

(ii) an existing GB distributor under EU REACH,

in relation to a substance (the “GB user or distributor”), and

(b) there is a protected transitional import of the substance by the GB user or distributor.

2. There is a protected transitional import of the substance by the GB user or distributor if—

(a) the substance is imported to Great Britain on its own, in a mixture or in an article,

(b) the GB user or distributor is the importer in relation to the import,

(c) the import occurs during the relevant post-IP completion period, and

(d) either—

(i) the person who supplies the substance, mixture or article to the GB user or distributor for the import is a registrant or a downstream user under EU REACH as respects the substance as it is imported (the “relevant supplier”), or

(ii) an only representative appointed under Article 8(1) of EU REACH by the manufacturer, formulator or producer of the substance, mixture or article is a registrant under EU REACH as respects the substance as it is imported.

3. The GB user or distributor is to be treated for the purposes of this Regulation—

(a) as a downstream user as respects any protected transitional imports of the substance by them (if they are an existing GB downstream user under EU REACH), or

(b) as a distributor as respects any protected transitional imports of the substance by them (if they are an existing GB distributor under EU REACH).

4. For the purposes of deciding whether the requirement in paragraph 2(d)(i) is met in relation to a particular import, it does not matter whether the relevant supplier is—

(a) the person from which the GB user or distributor obtained supplies of the substance, mixture or article before IP completion day (and therefore the person in relation to which the GB user was a downstream user or distributor under EU REACH), or

(b) a different person.

5. For the purposes of deciding whether the requirement in paragraph 2(d)(ii) is met in relation to a particular import, it does not matter whether the manufacturer, formulator or producer who has appointed the only representative is—

(a) the person who was the manufacturer, formulator or producer of supplies of the substance, mixture or article which the GB user or distributor obtained before IP completion day, or

(b) a different person.

6. The provisions of this Regulation that apply to importers, including in respect of protected NI imports, do not apply to the GB user or distributor in relation to the protected transitional import of the substance by the GB user or distributor.

7. If the GB user or distributor imports the substance into Great Britain in quantities of 1 to 10 tonnes per year, they must within the 300 day post-IP completion period—

(a) supply the Agency with the information referred to in point (a)(i) of Article 10;

(b) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB user or distributor;

(c) supply the Agency with the information referred to in points (a) to (d) of Article 32(1) and otherwise comply with Article 32;

(d) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB user or distributor;

(e) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (c) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB user or distributor imports into Great Britain by protected transitional imports);

(f) if any part of the import is a protected NI import, notify the Agency of the quantity of the import that is a protected NI import.

8. If the GB user or distributor imports the substance into Great Britain in quantities of 10 tonnes or more per year, they must within the 300 day post-IP completion period—

(a) supply the Agency with the information referred to in point (a)(i) of Article 10;

(b) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB user or distributor;

(c) supply the Agency with the information referred to in—

(i) Article 14(6) to the extent that information is available to the GB user or distributor,

(ii) Article 31, and

(iii) Article 32(1)(a) to (d);

(d) otherwise comply with Articles 14(6), 31 and 32;

(e) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB user or distributor;

(f) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (c) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB user or distributor imports into Great Britain by protected transitional imports);

(g) if any part of the import is a protected NI import, notify the Agency of the quantity of the import that is a protected NI import.

9. The GB user or distributor must provide the Agency with updated information of the kind required by paragraph 7 or 8, in particular where the GB user or distributor begins to import the substance—

(a) from a different relevant supplier, or

(b) from a different manufacturer, formulator or producer who (as described in paragraph 2(d)(ii)) has appointed an only representative that is a registrant under EU REACH.

10. This Article ceases to apply to the GB user or distributor as respects a protected transitional import of the substance by them if they become a registrant or downstream user under this Regulation, or a notification is made under Article 139A, in relation to the substance as so imported by them.

For that purpose, a person is not to be treated as having become a downstream user because they are treated as one in accordance with paragraph 3(a).

11. Paragraphs 7, 8 and 9 are subject to paragraph 3 of Article 127EA and paragraph 6 of Article 127EB.

12. In this Article—

  • “ existing GB distributor under EU REACH ” means a person who was, at any time in the 2 year period before IP completion day, a distributor under EU REACH established in Great Britain in relation to a substance on its own, in a mixture or in an article;

  • “ existing GB downstream user under EU REACH ” means a person who was, at any time in the 2 year period before IP completion day, a downstream user under EU REACH established in Great Britain in relation to a substance on its own, in a mixture or in an article;

  • “ relevant supplier ” has the meaning given in paragraph 2(d)(i);

  • “ GB user or distributor ” has the meaning given in paragraph 1(a).

Article 127EA U.K. Appointment of only representative where Article 127E applies

1. This Article applies in relation to a protected transitional import of a substance by a GB user or distributor (within the meaning of Article 127E) that is not a protected NI import.

2. If, or to the extent that, the appointment of an only representative by the manufacturer, formulator or producer relates to the substance as imported, Article 8 has effect as if the following provision were substituted for paragraphs 1 to 3 of that Article—

“1. A person established outside Great Britain who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into Great Britain may by mutual agreement appoint a person established in Great Britain to fulfil, as his only representative, the obligations on the GB user or distributor under Article 127E.

1A. Article 36 applies to the representative.

2. The representative must have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, must keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.

3. If a representative is appointed in accordance with paragraphs 1 and 2, the non-Great British manufacturer shall inform the GB user or distributor of the appointment.” .

3. If the GB user or distributor is informed of the appointment of the only representative in accordance with paragraph 3 of Article 8 (as set out above), paragraphs 7, 8 and 9 of Article 127E cease to apply to the GB user or distributor as respects any protected transitional import where the manufacturer, formulator or producer is the person who appointed the representative.

Article 127EB U.K. Import from Northern Ireland where Article 127E applies

1. This Article applies in relation to a protected transitional import of a substance by a GB user or distributor (within the meaning of Article 127E) that is also a protected NI import.

2. A person established in Northern Ireland who manufactures a substance on its own, in mixtures or in articles, formulates a mixture, or produces an article that is imported into Great Britain may fulfil the obligations on the GB user or distributor under Article 127E (the “NI notifier”).

3. Article 36 applies to the NI notifier.

4. The NI notifier must, without prejudice to Article 36, keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.

5. A person who intends to act in accordance with paragraph 2 must inform the GB user or distributor that they intend to do so.

6. If the GB user or distributor is informed of the intention in accordance with paragraph 5, paragraphs 7 to 9 of Article 127E apply to the NI notifier instead of the GB user or distributor as respects any protected transitional import from the NI notifier.

Article 127F U.K. Existing EU authorisations

1. The holder of an existing EU authorisation which has the relevant connection with Great Britain must, before the end of the 60 day post-IP completion period, supply the Agency with the required technical information relating to the authorisation.

2. An existing EU authorisation which does not have the relevant connection with Great Britain ceases to have effect (as retained EU law) on IP completion day.

3. An existing EU authorisation has the relevant connection with Great Britain if the holder of the authorisation is established in Great Britain.

4. In this Article—

  • “ existing EU authorisation ” means an authorisation granted in accordance with Articles 60 to 64 of EU REACH which is subsisting immediately before IP completion day;

  • “ holder ”, in relation to an existing EU authorisation, means the person to whom the authorisation has been granted;

  • “ required technical information ”, in relation to an existing EU authorisation, means—

    (a)

    the information included in the application for the authorisation in accordance with Article 62(4) and (5) of EU REACH,

    (b)

    any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA's opinion in relation to the application for the authorisation, and

    (c)

    any information required to be submitted or recorded before IP completion day under any condition under which the authorisation is granted.

Article 127G U.K. Existing applications for EU authorisations

1. The Secretary of State must decide an existing application for an EU authorisation (as mentioned in Article 64(8)) if—

(a) the application—

(i) is at the final decision stage on IP completion day,

(ii) has the relevant connection with Great Britain; and

(b) the person who made the application—

(i) notifies the Secretary of State of the existence of the application,

(ii) provides the Secretary of State with copies of the application, the information included in it under Article 62(4) and (5) of EU REACH, and any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA's opinion in relation to the application for the authorisation, and

(iii) provides the Secretary of State with copies of the final opinions of ECHA referred to in Article 64(5) of EU REACH.

2. An application for an EU authorisation is at the final decision stage if—

(a) ECHA has adopted the final opinions referred to in Article 64(5) of EU REACH, but

(b) the Commission has not made a final decision granting or refusing the application.

3. An application for an EU authorisation has the relevant connection with Great Britain if the person making the application is established in Great Britain.

4. The period of six months for the Secretary of State to make an authorisation decision in accordance with Article 64(8) of this Regulation begins with the day on which paragraph 1(b) is complied with.

5. Where, immediately before IP completion day, a person may place a substance on the market for a use or use it himself in reliance on Article 56(1)(d) of EU REACH, the person may continue to do so on and after IP completion day in reliance on Article 56(1)(d) of this Regulation.

But this paragraph ceases to apply at the end of the 180 day post-IP completion period if the person does not comply with paragraph 1(b) of this Article before the end of that period.

6. In this Article “ existing application for an EU authorisation ” means an application made before IP completion day for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH.

Article 127GA U.K. Substances of very high concern: sunset dates and latest application dates

1. Paragraphs 2 and 3 apply where—

(a) immediately before IP completion day, a substance is included in Annex 14 to EU REACH;

(b) the EU latest application date fell before or during the relevant pre-IP completion period;

(c) the EU sunset date fell during the relevant pre-IP completion period;

(d) before the EU latest application date, an application had been made for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH in relation to the substance (the “authorisation application”); and

(e) immediately before IP completion day, the authorisation application was still under consideration (see paragraph 11).

2. Where, immediately before IP completion day, a person established in Great Britain may place the substance on the market or use it himself in reliance on Article 56(1)(d) of EU REACH by virtue of the authorisation application having been made, this Regulation has effect subject to the modifications set out in paragraph 3.

3. As respects that person placing the substance on the market or using it himself on and after IP completion day—

(a) the GB latest application date, and

(b) the GB sunset date,

both fall on the transitional cut-off date (rather than on the dates specified in Annex 14 for that substance).

4. Paragraphs 5 and 6 apply where—

(a) immediately before IP completion day, a substance is included in Annex 14 to EU REACH;

(b) the EU latest application date fell during the relevant pre-IP completion period;

(c) the EU sunset date falls after the end of that period;

(d) before the EU latest application date, an application had been made for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH in relation to the substance (the “authorisation application”); and

(e) immediately before IP completion day, the authorisation application was still under consideration (see paragraph 11).

5. Where, on and after the GB sunset date, a person established in Great Britain would be able to place the substance on the market or use it himself in reliance on Article 56(1)(d) of this Regulation had the authorisation application been made under this Regulation, this Regulation has effect subject to the modifications set out in paragraph 6.

6. As respects that person placing the substance on the market or using it himself on and after IP completion day—

(a) the GB latest application date, and

(b) the GB sunset date,

both fall on the transitional cut-off date (rather than on the dates specified in Annex 14 for that substance).

The effect of this paragraph is to be ignored in reading the reference to the GB sunset date in paragraph 5.

7. Paragraph 8 applies where—

(a) immediately before IP completion day, a substance is included in Annex 14 to EU REACH; and

(b) the GB latest application date falls during the 18 month post-IP completion period.

8. As respects a person established in Great Britain placing the substance on the market or using it himself on and after IP completion day, the GB latest application date falls on the transitional cut-off date (rather than on the date specified in Annex 14 for that substance).

9. Where paragraph 3, 6 or 8 modifies this Regulation, Article 56(1) has effect with the following provision substituted for point (d)—

“(d) the GB sunset date (within the meaning of Article 127GA) has been reached and he made an application before the GB latest application date (within the meaning of Article 127GA) but a decision on the application for authorisation has not yet been taken; or” .

10. Where paragraph 3 or 6 modifies the date that is the GB sunset date, any reference in this Regulation to the date of the kind referred to in Article 58(1)(c)(i) has effect subject to the modification made by paragraph 3 or 6.

11. For the purposes of paragraph 1(e) or 4(e), the authorisation application is “still under consideration” unless—

(a) the Commission has made a final decision granting or refusing the authorisation application, or

(b) the authorisation application—

(i) has the relevant connection with Great Britain (within the meaning of Article 127G), and

(ii) is at the final decision stage (within the meaning of Article 127G).

12. In this Article—

  • “ EU latest application date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(ii) of EU REACH that is specified in Annex 14 to EU REACH in relation to the substance;

  • “ EU sunset date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(i) of EU REACH that is specified in Annex 14 to EU REACH in relation to the substance;

  • “ relevant pre-IP completion period ” means the period that—

    (a)

    begins with 29 March 2017, and

    (b)

    ends immediately before IP completion day;

  • “ transitional cut-off date ” means the last day of the 18 month post-IP completion period;

  • “ GB latest application date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(ii) of this Regulation that is specified in Annex 14 to this Regulation in relation to the substance;

  • “ GB sunset date ”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(i) of this Regulation that is specified in Annex 14 to this Regulation in relation to the substance;

  • “ 18 month post-IP completion period ” means the period of 18 months beginning with the day after that on which IP completion day falls.

Article 127H U.K. Existing authorised downstream users under EU law

1. On and after IP completion day, a person who—

(a) is established in Great Britain, and

(b) is an existing authorised downstream user under EU law in relation to a substance,

is authorised to use that substance in accordance with Article 56(2).

2. Where Article 56(2) applies to the use of a substance by virtue of paragraph 1, a reference in Article 56(2) to an authorisation granted to a person up a supply chain is a reference to an existing EU authorisation relating to that use of the substance.

3. Accordingly, paragraph 1 ceases to apply to a person if the existing EU authorisation relating to that use of the substance ceases to have effect.

4. A person to whom paragraph 1 applies must, before the end of the 60 day post-IP completion period—

(a) confirm to the Agency that they are an existing authorised downstream user under EU law in relation to the substance, and

(b) notify the Agency of—

(i) the existing EU authorisation;

(ii) any conditions set out in the existing EU authorisation (as referred to in Article 56(2) of EU REACH);

(iii) the identity of the supplier of the substance to the person.

5. Article 66(1) does not apply to the use of a substance in accordance with Article 56(2) by virtue of this Article.

6. In this Article—

  • “ existing authorised downstream user under EU law ” means a person who, immediately before IP completion day, is authorised to use a substance in accordance with Article 56(2) of EU REACH;

  • “ existing EU authorisation ” means an authorisation granted to a person up a supply chain (as referred to in Article 56(2) of EU REACH) which is subsisting immediately before IP completion day, as it has effect in EU law;

Article 127I U.K. Existing examinations of testing proposals

1. On and after IP completion day, an existing EU decision on a testing proposal which has the relevant connection with Great Britain has effect as a decision by the Agency under Article 40(3) of this Regulation.

2. An existing EU decision on a testing proposal has the relevant connection with Great Britain if the registrant, or downstream user, concerned is established in Great Britain.

3. The Agency may extend any deadline specified in an existing EU decision on a testing proposal.

4. In this Article, “ existing EU decision on a testing proposal ” means a decision taken by ECHA—

(a) in accordance with Article 40(3)(a), (b), (c) or (e) of EU REACH, if the requirements of the decision have not been fulfilled, or

(b) in accordance with Article 40(3)(d) of EU REACH.

Article 127J U.K. Existing Article 7(2) notifications

1. This Article applies if—

(a) before IP completion day, a producer of articles established in Great Britain, or an importer of articles established in Great Britain, has given ECHA a notification under Article 7(2) of EU REACH in relation to a substance, and

(b) immediately before IP completion day, that person is not a registrant in relation to the substance concerned.

2. The person that gave the notification to ECHA must submit to the Agency, within the 60 day post-IP completion period, the information notified to ECHA in accordance with Article 7(2) and (4) of EU REACH.

Article 127K U.K. Existing Article 9 exemptions

1. This Article applies if—

(a) a five year exemption under Article 9(1) of EU REACH, or

(b) an extended exemption under Article 9(7) of EU REACH,

applies in relation to a substance immediately before IP completion day where the research and development concerned takes place in Great Britain.

2. On and after IP completion day—

(a) a five year exemption under Article 9(1) of this Regulation, or,

(b) an extended exemption under Article 9(7) of this Regulation,

(as the case may be) applies in relation to the substance, subject to the same conditions (if any) imposed by ECHA under Article 9(4) in relation to the corresponding exemption under EU REACH.

3. That exemption under Article 9(1) or (7) of this Regulation is to end on the same date that the corresponding exemption under EU REACH would have ended.

4. Where an exemption under Article 9(1) or (7) of this Regulation applies to a substance by virtue of this Article, the following duties must be complied with in relation to the exemption of the substance within the 120 day post-IP completion period—

(a) Article 9(2) must be complied with by the manufacturer or importer or producer, as the case may be (the “notifier”);

(b) the notifier must also notify the Agency of the number and notification date assigned by ECHA under Article 9(3) of EU REACH;

(c) the notifier must give the Agency copies of any additional necessary information given to ECHA under Article 9(4) of EU REACH.

Where the notifier complies with Article 9(2) in accordance with this paragraph, no fee is payable under Article 9(2).

Article 127L U.K. Existing Article 17 registrations

1. This Article applies if a registration with ECHA under Article 17 of EU REACH which relates to an on-site isolated intermediate that is manufactured in Great Britain is—

(a) subsisting immediately before IP completion day, and

(b) either—

(i) has a current connection with Great Britain, or

(ii) has a relevant past connection with Great Britain (but does not have a current connection with Great Britain).

2. On and after IP completion day, the registration has effect as a registration with the Agency under Article 17 of this Regulation.

3. Where paragraph 2 operates on a registration the manufacturer concerned must give the Agency—

(a) the information referred to in Article 17(2)(a), (b), (e) and (f) and the confirmation referred to in Article 17(3), within the 120 day post-IP completion period, and

(b) the information referred to in Article 17(2)(c) and (d) within the relevant post-IP completion period.

4. Article 19(1) does not apply to the giving of information in accordance with paragraph 3 of this Article.

5. The manufacturer concerned must submit the registration number and registration date assigned to the existing EU registration by ECHA in accordance with Article 20(3) of EU REACH, and such other evidence as the Agency may require of the existing EU registration, to the Agency within the 120 day post-IP completion period.

6. Where paragraph 2 operates on a registration, the other Titles of this Regulation apply to that registration as they would apply to the registration if it had been submitted to the Agency under Article 17 on IP completion day, but with the modifications set out in the following provisions of this Article.

7. No fee is payable under Article 17(2).

8. Article 20 has effect with the following provision substituted for paragraphs 1 to 3—

“1. The Agency must assign a submission date to each registration which has effect under Article 127L, which must be the date on which the registrant complies with paragraph 3(a) or (b) of Article 127L.

2. The Agency may undertake a completeness check of each registration in order to ascertain that all the elements required under Article 17 have been provided. The completeness check must not include an assessment of the quality or the adequacy of any data or justifications submitted.

If a registration is incomplete, the Agency must inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant must complete his registration and submit it to the Agency within the deadline set. The Agency must confirm the submission date of the further information to the registrant. The Agency must perform a further completeness check, considering the further information submitted.

3. Once the registrant has complied with paragraph 3(a) of Article 127L, the Agency must assign a registration number to the substance concerned and a registration date, which must be the same as the registration date for the existing EU registration.” .

9. Article 21 has effect with the following provision substituted for the first subparagraph of paragraph 1—

“1. A registrant may continue the manufacture of a substance from IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2).” .

Article 127M U.K. Existing Article 18 registrations

1. This Article applies if a registration with ECHA under Article 18 of EU REACH which relates to a transported isolated intermediate that is manufactured in or imported into Great Britain is—

(a) subsisting immediately before IP completion day, and

(b) either—

(i) has a current connection with Great Britain, or

(ii) has a relevant past connection with Great Britain (but does not have a current connection with Great Britain).

2. On and after IP completion day, the registration has effect as a registration with the Agency under Article 18 of this Regulation.

3. Where paragraph 2 operates on a registration, the manufacturer or importer concerned must give the Agency—

(a) the information referred to in Article 18(2)(a), (b), (e) and (f) and the confirmation referred to in Article 18(4), within the 120 day post-IP completion period, and

(b) the information referred to in Article 18(2)(c) and (d) and 18(3) within the relevant post-IP completion period.

4. Article 19(1) does not apply to the giving of information in accordance with paragraph 3 of this Article.

5. The manufacturer or importer concerned must submit the registration number and registration date assigned to the existing EU registration by ECHA in accordance with Article 20(3) of EU REACH, and such other evidence as the Agency may require of the existing EU registration, to the Agency within the 120 day post-IP completion period.

6. Where paragraph 2 operates on a registration, the other Titles of this Regulation apply to that registration as they would apply to the registration if it had been submitted to the Agency under Article 18 on IP completion day, but with the modifications set out in the following provisions of this Article.

7. No fee is payable under Article 18(2).

8. Article 20 has effect with the following provision substituted for paragraphs 1 to 3—

“1. The Agency must assign a submission date to each registration which has effect under Article 127M, which must be the date on which the registrant complies with paragraph 3(a) or (b) of Article 127M.

2. The Agency may undertake a completeness check of each registration in order to ascertain that all the elements required under Article 18 have been provided. The completeness check must not include an assessment of the quality or the adequacy of any data or justifications submitted.

If a registration is incomplete, the Agency must inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant must complete his registration and submit it to the Agency within the deadline set. The Agency must confirm the submission date of the further information to the registrant. The Agency must perform a further completeness check, considering the further information submitted.

3. Once the registrant has complied with paragraph 3(a) of Article 127M, the Agency must assign a registration number to the substance concerned and a registration date, which must be the same as the registration date for the existing EU registration.” .

9. Article 21 has effect with the following provision substituted for the first subparagraph of paragraph 1—

“1. A registrant may continue the manufacture or import of a substance from IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2).”

Article 127N U.K. Registrations under Article 127L and Article 127M

1. Articles 127L and 127M are to be read in accordance with paragraphs 2 to 5.

2. A registration under Article 17 or 18 of EU REACH (as the case may be) has a current connection with Great Britain if—

(a) the registrant immediately before IP completion day is a person established in Great Britain (a “current GB registrant”), and

(b) a registration of the substance concerned by the current GB registrant is a registration of a kind that could be submitted on IP completion day under Article 17 or 18 (as the case may be) of this Regulation.

3. A registration under Article 17 or 18 of EU REACH (as the case may be) has a relevant past connection with Great Britain if—

(a) the registrant at any time in the period beginning with 29 March 2017 and ending immediately before IP completion day was a person established in Great Britain (a “former GB registrant”), and

(b) a registration of the substance concerned by the former GB registrant is a registration of a kind that could be submitted on IP completion day—

(i) under Article 17 of this Regulation if the former GB registrant was the manufacturer of the on-site intermediate concerned on IP completion day, or

(ii) under Article 18 of this Regulation if the former GB registrant was the manufacturer or importer of the transported isolated intermediate concerned on IP completion day.

4. Where a registration that has a current connection with Great Britain has effect as a registration with the Agency by virtue of Article 127L or 127M, the current GB registrant becomes the registrant in relation to the registration with the Agency on IP completion day.

5. Where a registration that has a relevant past connection with Great Britain has effect as a registration with the Agency by virtue of Article 127L or 127M, the former GB registrant becomes the registrant in relation to the registration with the Agency on IP completion day.

If two or more persons have been former GB registrants at different times in the period beginning with 29 March 2017 and ending immediately before IP completion day, only the person who was the former GB registrant most recently before IP completion day is to become the registrant in relation to the registration with the Agency by virtue of this paragraph.

Article 127O U.K. Obligation to keep information

1. This Article applies to a person established in Great Britain who, immediately before IP completion day, is, as respects any information, bound by the obligation imposed by Article 36(1) of EU REACH.

2. On and after IP completion day, the person is, as respects the information concerned, bound by the obligation imposed by Article 36(1) of this Regulation.

3. Where paragraph 2 applies to a person, the person is not bound by the obligation imposed by Article 36(1) of this Regulation after the end of a 10 year period under Article 36(1) of EU REACH that was running at IP completion day (and the reference to the 10 year period in Article 36(1) of this Regulation is accordingly to be read as a reference to the remainder of the 10 year period under EU REACH that falls after IP completion day).

Article 127P U.K. Post-IP completion periods used in this Title

In this Title—

(1) “ 60 day post-IP completion period ” means the period of 60 days beginning with the day after that on which IP completion day falls;

(2) “ 90 day post-IP completion period ” means the period of 90 days beginning with the day after that on which IP completion day falls;

(3) “ 120 day post-IP completion period ” means the period of 120 days beginning with the day after that on which IP completion day falls;

(4) “ 180 day post-IP completion period ” means the period of 180 days beginning with the day after that on which IP completion day falls;

(4A) “300 day post-IP completion period” means the period of 300 days beginning with the day after that on which IP completion day falls;

(4B) “relevant post-IP completion period” means the period beginning with the day after that on which IP completion day falls and ending—

(a) two years after the end of the 300 day post-IP completion period in respect of—

(i) substances included on the candidate list by virtue of Article 59(1A),

(ii) substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008 and manufactured in Great Britain or imported, in quantities reaching one tonne or more per year per manufacturer or importer, at least once after IP completion day,

(iii) substances classified as aquatic chronic category 1 (very toxic to aquatic life with long lasting effects) or aquatic acute category 1 (very toxic to aquatic life) in accordance with Regulation (EC) No 1272/2008 and manufactured in Great Britain or imported, in quantities reaching 100 tonnes or more per year per manufacturer or importer, at least once after IP completion day,

(iv) substances manufactured in Great Britain or imported, in quantities reaching 1,000 tonnes or more per year per manufacturer or importer, at least once after IP completion day,

(b) four years after the end of the 300 day post-IP completion period in respect of—

(i) substances added to the candidate list referred to in Article 59(1), other than by virtue of Article 59(1A), before the end of the period referred to in subparagraph (a),

(ii) substances manufactured in Great Britain or imported, in quantities reaching 100 tonnes or more per year per manufacturer or importer, at least once after IP completion day,

(c) six years after the end of the 300 day post-IP completion period in respect of substances manufactured in Great Britain or imported, in quantities reaching 1 tonne or more per year per manufacturer or importer, at least once after IP completion day.]

Textual Amendments

TITLE XV U.K. F328... FINAL PROVISIONS

F329 Article 128 U.K. Free movement

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Textual Amendments

[F330 Article 129 U.K. Safeguard clause

1. An appropriate authority may impose an appropriate provisional restriction in respect of a substance if that authority—

(a) has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of the substance, on its own, in a mixture or in an article, even if satisfying the requirements of this Regulation, and

(b) has competence to impose the provisional restriction.

2. If an appropriate authority imposes a provisional restriction in accordance with paragraph 1, it must—

(a) immediately inform the Agency and the other appropriate authorities, giving reasons for its decision and submitting the scientific or technical information on which the provisional restriction is based, and

(b) within three months of its decision, request the Agency to initiate the procedure under Article 69.

3. When a decision has been reached under Article 73 (as part of the procedure under Article 69) the appropriate authority must revoke the provisional measure.

4. In this Article “ restriction ” means a restriction on the placing on the market or use of a substance.

5. The Secretary of State has competence to impose a provisional restriction if, or to the extent that, the exercise of that function to impose that restriction—

(a) relates to England;

(b) relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);

(c) relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

6. The Scottish Ministers have competence to impose a provisional restriction if, or to the extent that, the exercise of that function to impose that restriction is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

7. The Welsh Ministers have competence to impose a provisional restriction if, or to the extent that, the exercise of that function to impose that restriction is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).]

Textual Amendments

Article 130 U.K. Statement of reasons for decisions

The [F331appropriate authorities and] the Agency F332... shall state the reasons for all decisions they take under this Regulation.

Textual Amendments

[F333 Article 131 U.K. Amendments to the Annexes

1. The Secretary of State may, by regulations, make such amendments of the Annexes as the Secretary of State considers appropriate.

The Secretary of State must consider any request made by any of the other appropriate authorities for amendments of the Annexes to be made.

2. Regulations under this Article are to be made by statutory instrument; and a statutory instrument containing regulations under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this Article is subject to the consent requirement in Article 4A.]

Textual Amendments

[F334 Article 132 U.K. Implementing legislation

1. The Secretary of State may, by regulations, make such provision as the Secretary of State considers appropriate for putting the provisions of this Regulation efficiently into effect.

The Secretary of State must consider any request made by any of the other appropriate authorities for such provision to be made.

2. Regulations under this Article are to be made by statutory instrument; and a statutory instrument containing regulations under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this Article is subject to the consent requirement in Article 4A.]

Textual Amendments

[F335Article 132A U.K. Regulations under this Regulation

Any power to make regulations under this Regulation includes power to make supplementary, incidental, consequential, transitional, transitory or saving provision.]

Textual Amendments

F336 Article 133 U.K. Committee procedure

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Textual Amendments

F336 Article 134 U.K. Preparation of establishment of the Agency

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Textual Amendments

F336 Article 135 U.K. Transitional measures regarding notified substances

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Textual Amendments

F336 Article 136 U.K. Transitional measures regarding existing substances

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Textual Amendments

F336 Article 137 U.K. Transitional measures regarding restrictions

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Textual Amendments

Article 138 U.K. Review

1. [F337Within 18 months of IP completion day] , the [F338Secretary of State] shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. F339 ... When carrying out the review the [F338Secretary of State] shall take into account all relevant factors, including:

(a) the costs for manufacturers and importers of drawing up the chemical safety reports;

(b) the distribution of costs between actors in the supply chain and the downstream user;

(c) the benefits for human health and the environment;

[F340(d) the views of any appropriate authority.]

On the basis of these reviews, the [F338Secretary of State] may, if appropriate, [F341formulate] proposals to extend this obligation.

2. The [F338Secretary of State] may [F342formulate] proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following:

(a) the risks posed by polymers in comparison with other substances;

(b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other.

3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at one tonne but less than 10 tonnes per year per manufacturer or importer. On the basis of that review, the [F338Secretary of State] may [F343formulate] proposals to modify the information requirements for substances manufactured or imported in quantities of one tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs).

F344 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F344 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F344 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F344 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8. [F345Within 18 months of IP completion day] , the [F338Secretary of State] shall carry out a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis of that review, the [F338Secretary of State] may, if appropriate, [F346formulate] proposals to extend that obligation.

9. In accordance with the objective of promoting non-animal testing and the replacement, reduction or refinement of animal testing required under this Regulation, the [F338Secretary of State] shall review the testing requirements of Section 8.7 of Annex VIII by [F347within 18 months of IP completion day] .

[F348The Secretary of State may, by regulations, amend Annex 8 if the Secretary of State considers that it is appropriate to do so on the basis of this review, while ensuring a high level of protection of health and the environment.

Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this Article is subject to the consent requirement in Article 4A.]

Textual Amendments

Article 139 U.K. Repeals

Directive 91/155/EEC shall be repealed.

Directives 93/105/EC and 2000/21/EC and Regulations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from 1 June 2008 .

Directive 93/67/EEC shall be repealed with effect from 1 August 2008 .

Directive 76/769/EEC shall be repealed with effect from 1 June 2009 .

References to the repealed acts shall be construed as references to this Regulation.

F349 Article 140 U.K. Amendment of Directive 1999/45/EC

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Textual Amendments

F350 Article 141 U.K. Entry into force and application

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Textual Amendments

Textual Amendments

[F351TITLE 15A U.K. IMPORTS FROM NORTHERN IRELAND

Article 139A U.K. Protected NI imports

1. This Article applies in a case where there is a protected NI import of a substance.

2. There is a protected NI import of a substance if—

(a) a substance—

(i) has a relevant connection to Northern Ireland, and

(ii) is imported on its own, in a mixture or in an article,

(b) the substance, mixture or article is a qualifying Northern Ireland good, and

(c) the person who supplies the substance, mixture or article for the import is a registrant or a downstream user under EU REACH as respects the substance as it is imported.

3. A substance has a relevant connection to Northern Ireland if—

(a) it is—

(i) manufactured in Northern Ireland,

(ii) in a mixture that is manufactured or formulated in Northern Ireland, or

(iii) in an article that is manufactured or produced in Northern Ireland, and

(b) it is imported from a supplier established in Northern Ireland.

4. The importer of the substance (the “GB importer”) is to be treated for the purposes of this Regulation as a downstream user as respects any protected NI imports of the substance by them.

5. The provisions of this Regulation that apply to importers do not apply to the GB importer in relation to the protected NI import of the substance by the GB importer.

6. If the GB importer imports the substance in quantities of 1 to 10 tonnes per year they must, before they make a protected NI import—

(a) notify the Agency of their intention to make the protected NI import,

(b) supply the Agency with the information referred to in point (a)(i) of Article 10,

(c) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB importer,

(d) supply the Agency with the information referred to in points (a) to (d) of Article 32(1) and otherwise comply with Article 32,

(e) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB importer,

(f) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (d) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB importer imports into Great Britain by protected NI imports).

7. If the GB importer imports the substance in quantities of 10 tonnes or more per year they must, before they make a protected NI import—

(a) notify the Agency of their intention to make the protected NI import,

(b) supply the Agency with the information referred to in point (a)(i) of Article 10,

(c) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB importer,

(d) supply the Agency with the information referred to in—

(i) Article 14(6) to the extent that information is available to the GB importer,

(ii) Article 31, and

(iii) Article 32(1)(a) to (d),

(e) otherwise comply with Articles 14(6), 31 and 32,

(f) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB importer,

(g) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (d) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB importer imports into Great Britain by protected NI imports).

8. The GB importer must update the information provided to the Agency under paragraph 6 or 7 with any relevant new information and submit it to the Agency.

1. 9. Paragraphs 6, 7 and 8 are subject to paragraph 6 of Article 139B.

Article 139B U.K. Notification by Northern Irish supplier where Article 139A applies

1. This Article applies in relation to a protected NI import of a substance.

2. A person established in Northern Ireland who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into Great Britain may fulfil the obligations on the GB importer under Article 139A (the “NI notifier”).

3. Article 36 applies to the NI notifier.

4. The NI notifier must, without prejudice to Article 36, keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.

5. A person who intends to act in accordance with paragraph 2 must inform the GB importer that they intend to do so.

6. If the GB importer is informed of the intention in accordance with paragraph 5, then paragraphs 6 to 8 of Article 139A apply to the NI notifier instead of the GB importer as respects any protected NI import from the NI notifier.

Article 139C U.K. Authorisations and imports from Northern Ireland

Subject to Articles 139D and 139E, Title 7 applies to and in respect of substances imported from Northern Ireland as it applies to and in respect of other substances.

Article 139D U.K. Authorisations and qualifying Northern Ireland goods

1. This Article applies to a person (“P”) that is established in Northern Ireland that is a manufacturer, importer or downstream user of a substance under EU REACH.

2. P may apply for an authorisation in respect of that substance under Article 62 if the substance is a qualifying Northern Ireland good (“QNIG”).

3. A substance is a QNIG if it is a QNIG on its own, or contained in a mixture or article that is a QNIG.

4. This Regulation applies to P in respect of the application, and to the authorisation if it is granted, as if P was an only representative of P appointed in accordance with Article 8.

Article 139E U.K. Application of Article 127G to qualifying Northern Ireland goods

1. This Article applies to a person established in Northern Ireland that made an existing application for an EU authorisation within the meaning of Article 127G(6) (the “existing NI applicant”) that satisfies the condition in paragraph 2.

2. The condition is that the substance in respect of which the application was made is a qualifying Northern Ireland good (“QNIG”).

3. The condition in paragraph (2) is satisfied if the application was in respect of a substance that is a QNIG on its own, or a substance contained in a mixture or article that is a QNIG.

4. Paragraphs 1 to 4 and 6 of Article 127G apply to the existing NI applicant as if the references to “Great Britain” were to “the United Kingdom”.

5. If the authorisation is granted—

(a) it has no effect in Northern Ireland,

(b) this Regulation applies to the existing NI applicant in respect of the authorisation as if the existing NI applicant was an only representative of the existing NI applicant appointed in accordance with Article 8.]

Textual Amendments

This Regulation shall be binding in its entirety and directly applicable in all Member States.]

Yn ôl i’r brig

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