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[X1 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 [F1market 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 [F3Regulation (EC) No 1107/2009] ;

(b) uses in biocidal products within the scope of [F4Regulation (EU) No 528/2012] ;

(c) use as motor fuels covered by [F5the 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 [F6Regulation (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. [F7The 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 F8 ... 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 F9 ... 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 [F10within 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 [F11appropriate 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 F12 ... legislation shall not be included in Annex XIV or shall be removed from it.

[F13 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.]

[F149. 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).

[F151A. 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. [F16An 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 [F17the GB mandatory classification and labelling list] .] The Agency shall make this dossier available to the [F18appropriate authorities] .

3. [F19The Agency] may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 F20 .... [F2The dossier may be limited, if appropriate, to a reference to an entry in [F21the GB mandatory classification and labelling list] .] The Agency shall make this dossier available [F22to 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.

F23 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. If the Agency does not receive F24 ... 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 F25 ... received, the Agency [F26must consider the comments and make a decision on the identification of the substance within 45 days of the deadline specified in paragraph 4] .

F27 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F27 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

Editorial Information