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Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)

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CHAPTER IU.K.SCOPE AND DEFINITIONS

Article 1U.K.Purpose and subject matter

1.The purpose of this Regulation is to improve the functioning of the F1... market through F2... rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. Particular attention shall be paid to the protection of vulnerable groups.

2.This Regulation lays down rules for:

(a)the establishment at [F3Great Britain] level of a list of active substances which may be used in biocidal products;

(b)the authorisation of biocidal products;

F4(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)the making available on the market and the use of biocidal products within [F5Great Britain];

(e)the placing on the market of treated articles.

Textual Amendments

Article 2U.K.Scope

1.This Regulation shall apply to biocidal products and treated articles. A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V.

2.Subject to any explicit provision to the contrary in this Regulation or other F6... legislation, this Regulation shall not apply to biocidal products or treated articles that are within the scope of the following instruments:

(a)Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community(1);

(b)[F7the Medical Devices Regulations 2002];

(c)[F8the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012];

(d)Regulation (EC) No 1831/2003;

(e)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs(2) and Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(3);

(f)Regulation (EC) No 1333/2008;

(g)Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods(4);

(h)Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed(5);

(i)Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market(6);

(j)Regulation (EC) No 1223/2009;

[F9(k)the Toys (Safety) Regulations 2011.]

Notwithstanding the first subparagraph, when a biocidal product falls within the scope of one of the abovementioned instruments and is intended to be used for purposes not covered by those instruments, this Regulation shall also apply to that biocidal product insofar as those purposes are not addressed by those instruments.

3.Subject to any explicit provision to the contrary in this Regulation F10..., this Regulation shall be without prejudice to the following instruments:

(a)Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(7);

(b)Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(8);

(c)Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work(9);

(d)Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption(10);

(e)Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(11);

(f)Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work(12);

(g)Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(13);

(h)Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work(14);

(i)Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants(15);

(j)Regulation (EC) No 1907/2006;

(k)Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising(16);

(l)Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals(17);

(m)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures(18);

(n)Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides(19);

(o)Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer(20);

(p)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes(21);

(q)Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions(22).

4.Article 69 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.

5.This Regulation shall not apply to:

(a)food or feed used as repellents or attractants;

[F11(b)biocidal products when used as processing aids within the meaning of Regulation (EC) No 1831/2003 and Regulation (EC) No 1333/2008.]

6.Biocidal products which obtained final approval under the International Convention for the Control and Management of Ships’ Ballast Water and Sediments shall be considered as authorised under [F12Chapter VI] of this Regulation. Articles 47 and 68 shall apply accordingly.

7.Nothing in this Regulation shall prevent [F13the competent authority or any other relevant authority from] from restricting or banning the use of biocidal products in the public supply of drinking water.

8.[F14The Secretary of State] may allow for exemptions from this Regulation in specific cases for certain biocidal products, on their own or in a treated article, where necessary in the interests of defence.

9.The disposal of active substances and biocidal products shall be carried out in accordance with F15... national waste legislation in force.

Textual Amendments

Article 3U.K.Definitions

1.For the purposes of this Regulation, the following definitions shall apply:

(a)‘biocidal product’ means

  • (a)any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

  • any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

A treated article that has a primary biocidal function shall be considered a biocidal product.

(b)‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths;

(c)‘active substance’ means a substance or a micro-organism that has an action on or against harmful organisms;

(d)‘existing active substance’ means a substance which was on the market on 14 May 2000 [F16, in a country which was a Member State of the EU on that date,] as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

(e)‘new active substance’ means a substance which was not on the market on 14 May 2000 [F17in a country which was a Member State of the EU on that date] as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

(f)‘substance of concern’ means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect.

Such a substance would, unless there are other grounds for concern, normally be:

  • (f)F18...

  • a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation,

  • a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(g)‘harmful organism’ means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment;

(h)‘residue’ means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance’s metabolites, breakdown or reaction products;

(i)‘making available on the market’ means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge;

(j)‘placing on the market’ means the first making available on the market of a biocidal product or of a treated article;

(k)‘use’ means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside [F19Great Britain];

(l)‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;

(m)‘national authorisation’ means an administrative act by which the competent authority F20... authorises the making available on the market and the use of a biocidal product or a biocidal product family F21...;

[F22(n)‘Union authorisation’ means the administrative act by which the Commission authorised the making available on the market and use of a biocidal product or a product family in the territory of the Union or part thereof before IP completion day;]

(o)‘authorisation’ means national authorisation F23... or authorisation in accordance with Article 26;

(p)‘authorisation holder’ means the person established [F24in the United Kingdom] who is responsible for the placing on the market of a biocidal product in [F25Great Britain] and specified in the authorisation;

(q)‘product-type’ means one of the product-types specified in Annex V;

(r)‘single biocidal product’ means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;

[F11(s)‘biocidal product family’ means a group of biocidal products having:

(i)

similar uses;

(ii)

the same active substances;

(iii)

similar composition with specified variations; and

(iv)

similar levels of risk and efficacy;]

(t)‘letter of access’ means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by [F26the competent authority] for the purposes of this Regulation;

(u)‘food’ and ‘feed’ mean food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation;

F27(v). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(w)‘technical equivalence’ means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;

F28(x). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(y)‘advertisement’ means a means of promoting the sale or use of biocidal products by printed, electronic or other media;

(z)‘nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.

Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

  • (z)‘particle’ means a minute piece of matter with defined physical boundaries,

  • ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components,

  • ‘aggregate’ means a particle comprising strongly bound or fused particles;

(aa)‘administrative change’ means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family;

(ab)‘minor change’ means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family;

(ac)‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor change;

(ad)‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products. These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents;

(ae)‘small and medium-sized enterprises’ or ‘SMEs’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises(23).

[F29(af)‘the consent requirement’ means the requirement for consent in accordance with Article 83B;

(ag)‘the UK List’ means the list of approved substances established and maintained in accordance with Article 8A;

(ah)‘the Simplified Active Substance List’ means the list of active substances which can be used in biocidal products that qualify for the simplified authorisation procedure, established and maintained in accordance with Article 24A.

(ai)“appropriate fee” means the fee payable for the activity concerned in regulations made under section 43 of the Health and Safety at Work etc. Act 1974 where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;

(aj)“Devolved Authority” means—

(i)the Scottish Ministers, or

(ii)the Welsh Ministers.]

2.For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EC) No 1907/2006 shall apply for the following terms:

(a)‘substance’;

(b)‘mixture’;

(c)‘article’;

(d)‘product and process-orientated research and development’;

(e)‘scientific research and development’.

[F303.The Secretary of State may issue a decision which is to be published, as to whether a substance is a nanomaterial, having regard in particular to Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial and whether a specific product or group of products is a biocidal product or a treated article or neither.

4.A decision issued under paragraph 3 above is subject to the consent requirement.

5.The Secretary of State may by regulations adapt the definition of nanomaterial set out in point (z) of paragraph 1 of this Article in view of technical and scientific progress, taking into account the Recommendation referred to in paragraph 3 above.

6.Regulations made under paragraph 5 above are subject to the consent requirement.

7.Where any of the Devolved Authorities makes proposals in relation to adaptations under paragraph 5 above, the Secretary of State must have regard to such proposals in deciding whether to exercise functions in that paragraph.]

Textual Amendments

CHAPTER IIU.K.APPROVAL OF ACTIVE SUBSTANCES

Article 4U.K.Conditions for approval

1.An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.

2.The approval of an active substance shall be restricted to those product-types for which relevant data have been submitted in accordance with Article 6.

3.The approval shall specify the following conditions, as appropriate:

(a)the minimum degree of purity of the active substance;

(b)the nature and maximum content of certain impurities;

(c)the product-type;

(d)manner and area of use including, where relevant, use in treated articles;

(e)designation of categories of users;

(f)where relevant, characterisation of the chemical identity with regard to stereoisomers;

(g)other particular conditions based on the evaluation of the information related to that active substance;

(h)the date of approval and the expiry date of the approval of the active substance.

4.The approval of an active substance shall not cover nanomaterials except where explicitly mentioned.

Article 5U.K.Exclusion criteria

1.Subject to paragraph 2, the following active substances shall not be approved:

(a)active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;

(b)active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;

(c)active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;

(d)active substances which [F31meet the criteria in Regulation (EU) No 2100/2017] are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;

(e)active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.

2.Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:

(a)the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment;

(b)it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or

(c)not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration.

The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. F32...

F333.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 6U.K.Data requirements for an application

1.An application for approval of an active substance shall contain at least the following elements:

(a)a dossier for the active substance satisfying the requirements set out in Annex II;

(b)a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and

(c)if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.

2.Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:

(a)the data are not necessary owing to the exposure associated with the proposed uses;

(b)it is not scientifically necessary to supply the data; or

(c)it is not technically possible to generate the data.

However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the F34... competent authority under Article 8(2).

3.An applicant may propose to adapt the data as part of the dossiers required under points (a) and (b) of paragraph 1 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.

4.The [F35Secretary of State may by regulations amend the criteria] for determining what constitutes adequate justification to adapt the data requirements under paragraph 1 of this Article on the grounds referred to in point (a) of paragraph 2 of this Article.

[F365.Regulations made under paragraph 4 above are subject to the consent requirement.

6.Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 4 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.]

Textual Amendments

Article 7U.K.Submission and validation of applications

[F371.The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the competent authority.]

F382.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.Within 30 days of the [F39competent authority receiving] an application, [F40it] shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1), and any justifications for the adaptation of data requirements, have been submitted.

In the context of the validation referred to in the first subparagraph, the F41... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

The F42... competent authority shall, as soon as possible after [F43it has received] an application, inform the applicant of the fees payable F44... and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

4.Where the F45... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F45... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.

The F45... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F46.... In such cases, part of the fees paid F47... shall be reimbursed.

5.On validating an application in accordance with paragraph 3 or 4, the F48... competent authority shall without delay inform the applicant F49... accordingly, indicating the date of the validation.

F506.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 8U.K.Evaluation of applications

1.The F51... competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and [F52produce] an assessment report and [F53evaluation conclusions].

[F54The competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The competent authority shall take due account of those comments.]

2.Where it appears that additional information is necessary to carry out the evaluation, the F55... competent authority shall ask the applicant to submit such information within a specified time limit F56.... As specified in the second subparagraph of Article 6(2), the F55... competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1). The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

[F572A.The competent authority may request from the applicant available information on, and take into account, evaluations undertaken by third countries in order to complete its evaluation. The weight given to those third country evaluations shall take into account the equivalence of the evaluation process.]

3.Where the F58... competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.

[F594.Within 270 days of producing its assessment reports and evaluation conclusions the competent authority shall prepare and submit an opinion on the approval of the active substance to the Secretary of State and the Devolved Authorities.]

Textual Amendments

[F60Article 8AU.K.The GB List

The competent authority shall establish, maintain and make electronically available to the public a list of approved active substances (“the GB List”).]

Textual Amendments

Article 9U.K.Approval of an active substance

1.The [F61Secretary of State] shall, on receipt of the opinion of the [F62competent authority] referred to in Article 8(4), either:

(a)[F63issue a decision] providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or

(b)in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, [F64issue a] decision that an active substance is not approved.

F65...

[F661A. A decision issued under paragraph 1 is subject to the consent requirement.]

[F672.Approved active substances shall be included in the GB List established under Article 8A of this Regulation.]

Textual Amendments

Article 10U.K.Active substances which are candidates for substitution

1.An active substance shall be considered a candidate for substitution if any of the following conditions are met:

(a)it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);

(b)it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;

(c)its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;

(d)it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(e)there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;

(f)it contains a significant proportion of non-active isomers or impurities.

2.When preparing its opinion on the approval or renewal of the approval of an active substance, the [F68competent authority] shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion.

3.Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the [F69Secretary of State and the Devolved Authorities], the [F70competent authority] shall make publicly available, without prejudice to Articles 66 and 67, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. The [F70competent authority] shall take due account of the information received when finalising its opinion.

4.By way of derogation from Article 4(1) and Article 12(3), the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.

5.Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in the relevant [F71decision issued] in accordance with Article 9.

Textual Amendments

F72Article 11U.K.Technical guidance notes

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

Textual Amendments

CHAPTER IIIU.K.RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

Article 12U.K.Conditions for renewal

1.The [F73Secretary of State] shall renew the approval of an active substance if the active substance still meets the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).

2.In the light of scientific and technical progress, the [F74Secretary of State] shall review and, where appropriate, amend the conditions specified for the active substance referred to in Article 4(3).

3.The renewal of an approval of an active substance shall be for 15 years for all product-types to which the approval applies, unless a shorter period is specified in the [F75decision issued] in accordance with point (a) of Article 14(4) renewing such an approval.

[F764.The renewal of an approval under paragraph 1 or amendment of the conditions in paragraph 2 is subject to the consent requirement.]

Textual Amendments

Article 13U.K.Submission and acceptance of applications

1.Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the [F77competent authority] at least 550 days before the expiry of the approval. Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.

2.When applying for the renewal of the approval of the active substance, the applicant shall submit:

(a)without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and

(b)its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.

F783.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F794.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 14U.K.Evaluation of applications for renewal

1.On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for approval or, as appropriate, the previous renewal, the F80... competent authority shall, within 90 days of [F81receiving] an application in accordance with Article [F8213], decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

2.Where the F83... competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1, 2 and 3 of Article 8.

Where the F83... competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of [F84receiving] the application in accordance with Article [F8513], prepare and submit to the [F86Secretary of State and the Devolved Authorities] a recommendation on the renewal of the approval of the active substance. It shall provide the applicant with a copy of its recommendation.

The F83... competent authority shall, as soon as possible after [F87it has received] an application, notify the applicant of the [F88appropriate fees]. The F83... competent authority shall reject the application if the applicant fails to pay the fees within 30 days of the notification and shall inform the applicant accordingly.

3.Within 270 days of [F89the completion of the evaluation conclusions], if it has carried out a full evaluation of the application, or 90 days otherwise, the [F90competent authority] shall prepare and submit to the [F91Secretary of State and the Devolved Authorities] an opinion on renewal of the approval of the active substance.

4.The [F92Secretary of State] shall, on receipt of the opinion of the [F93competent authority], [F94issue]:

(a)[F95a decision] providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or

(b)[F96a] decision that the approval of an active substance is not renewed.

F97...

Article 9(2) shall apply.

[F984A.The competent authority shall update the GB List with details of the renewal of the approval of the active substance]

[F995.Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Secretary of State shall issue a decision postponing the expiry date of approval for a period sufficient to enable the competent authority to examine the application.]

[F1005A.A decision issued under paragraph 4 or 5 above is subject to the consent requirement.]

6.Where the [F101Secretary of State] decides not to renew or decides to amend the approval of an active substance for one or more product-types, the [F102competent authority] shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.

Textual Amendments

[F103Article 15U.K.Review of approval of an active substance

1.The Secretary of State may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Secretary of State may also review the approval of an active substance for one or more product-types at the request of the competent authority if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Secretary of State shall make publically available the information that it is carrying out a review and shall provide an opportunity for the applicant to submit comments. The Secretary of State shall take due account of those comments in the review.

2.Where any of the Devolved Authorities proposes that an active substance should be reviewed the Secretary of State shall have regard to such proposals in deciding whether to review the approval of an active substance.

3.Where those indications are confirmed, the Secretary of State shall issue a decision amending the conditions of approval of an active substance or cancelling its approval. Article 9(2) shall apply. The competent authority shall inform the initial applicants for the approval accordingly.

4.On duly justified imperative grounds of urgency the Secretary of State may issue immediately applicable decisions.

5.Paragraphs 1, 3 and 4 are subject to the consent requirement.

6.Where the Secretary of State decides to cancel or amend the approval of an active substance for one or more product-types the competent authority shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.]

Textual Amendments

F104Article 16U.K.Implementing measures

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Textual Amendments

CHAPTER IVU.K.GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Article 17U.K.Making available on the market and use of biocidal products

1.Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.

2.Applications for authorisation shall be made by, or on behalf of, the prospective authorisation holder [F105to the competent authority].

F106...

F107...

3.An authorisation may be granted for a single biocidal product or a biocidal product family.

4.An authorisation shall be granted for a maximum period of 10 years.

5.Biocidal products shall be used in compliance with the terms and conditions of the authorisation stipulated in accordance with Article 22(1) and the labelling and packaging requirements laid down in Article 69.

Proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken.

[F108The competent authority] shall take necessary measures to provide the public with appropriate information about the benefits and risks associated with biocidal products and ways of minimising their use.

6.The [F109biocidal product family authorisation holder shall notify the competent authority] of each product within the biocidal product family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. F110...

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Textual Amendments

[F112Article 17AU.K. NI Product Market Access

1.Subject to paragraphs 5-8, a biocidal product is to be treated as if it was authorised by the competent authority under Article 30 or, where relevant, Article 26, under the same terms and conditions as the product is authorised or permitted in Northern Ireland where—

(a)each of the following conditions are met—

(i)the biocidal product—

(aa)is a qualifying Northern Ireland good, and

(bb)has a Relevant NI Permission at that time;

(ii)the authorisation holder or the person with a Relevant NI Permission (as the case may be) is established in Northern Ireland;

(iii)all the active substances in the biocidal product are entered in—

(aa)the list prepared pursuant to Article 8A (the GB List), or

(bb)the list prepared pursuant to Article 24A (the Simplified Active Substance List);

(iv)the person referred to in point (a)(ii) notifies the competent authority no later than 90 days in advance of making the biocidal product available on the market by submitting in full to the competent authority the information that the person submitted in their application under Regulation (EU) No 528/2012 as it has effect in EU law to the evaluating competent authority, reference Member State or Northern Ireland competent authority (as the case may be), for the Relevant NI Permission together with a copy of any relevant NI authorisation or permit;

(v)the competent authority takes no action pursuant to paragraph 2;

(b)if the person referred to in point (a)(ii) intends to make any changes to the product, that person notifies the competent authority no later than 90 days in advance of the date on which such changes will apply, with the information submitted to the reference Member State pursuant to Article 5 of Commission Implementing Regulation (EU) No 354/2013 as it has effect in EU law, or for administrative changes other than those referred to in the second subparagraph of Article 6(2) of that Regulation, that person notifies the competent authority within 12 months of making the change;

(c)if the person referred to in point (a)(ii) intends to renew the authorisation of the product in Northern Ireland, that person notifies the competent authority no later than 90 days in advance of the date of renewal by submitting in full the information that the person submitted to the reference Member State pursuant to Articles 31(1) or 45(1) of Regulation (EU) No 528/2012 as it has effect in EU law or, where relevant, Article 2 of Commission Delegated Regulation (EU) No 492/2014 as it has effect in EU law.

2.The competent authority may prohibit a biocidal product notified under paragraph 1 from being made available on the market in Great Britain where—

(a)such action can be justified on any of the following grounds—

(i)the protection of the environment,

(ii)public policy or security,

(iii)the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants,

(iv)the protection of national treasures possessing artistic, historic or archaeological value,

(v)the target organisms not being present in harmful quantities, or

(b)the competent authority considers that the biocidal product does not meet the criteria set out in Articles 19 or 25.

3.The competent authority may amend the terms and conditions under which a biocidal product may be made available on the market in Great Britain where—

(a)this can be justified on the grounds in paragraph 2(a), or

(b)the competent authority considers that the biocidal product does not meet the criteria set out in Articles 19 or 25.

4.Where the competent authority intends to take action under paragraphs 2 or 3, or identifies concerns as to whether the biocidal product meets the criteria in Articles 19 or 25, the competent authority—

(a)must inform the notifier, and

(b)may request additional information.

5.The period of 90 days referred to in paragraphs 1(a)(iv), (b) and (c) is suspended—

(a)where the competent authority takes action under paragraph 4(b), until the competent authority receives the additional information, and

(b)from the point when the competent authority receives the additional information, for a further period of 90 days to allow the competent authority to consider that additional information.

6.Where any information submitted to the competent authority under this Article includes one or more letters of access, the competent authority may reject the letter of access where it does not hold the relevant data.

7.Where the additional information has not been submitted to the competent authority within 90 days of a request under paragraph 4(b), the notification made under paragraph 1 is to be treated as withdrawn.

8.Where the competent authority has amended the terms and conditions under which a biocidal product may be made available on the market under paragraph 3, that product must not be made available and used in Great Britain other than under those amended terms and conditions.

9.Where a biocidal product has been treated as authorised due to meeting the requirements of paragraph 1 but ceases to satisfy those requirements—

(a)there is deemed to be a cancellation of the authorisation of that product by the competent authority, and

(b)the period of grace provided for in Article 52 applies.

10.For the purposes of this Article—

(a)“NI competent authority” means the competent authority appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013;

(b)“qualifying Northern Ireland good” has the meaning given by regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

(c)“Relevant NI Permission” means any of the following—

(i)a national authorisation granted by the NI competent authority under Article 30 of Regulation (EU) No 528/2012 as it has effect in EU law or under Article 5 of Regulation (EU) No 414/2013 as it has effect in EU law;

(ii)an authorisation granted by mutual recognition by the NI competent authority under Articles 33 or 34 of Regulation (EU) No 528/2012 as it has effect in EU law;

(iii)a Union authorisation granted by the Commission under Article 44 of Regulation (EU) No 528/2012 as it has effect in EU law or under Article 6 of Regulation (EU) No 414/2013 as it has effect in EU law;

(iv)an authorisation granted by the NI competent authority under the simplified procedure in accordance with Article 26 of Regulation (EU) No 528/2012 as it has effect in EU law or Article 6a of Regulation (EU) No 414/2013 as it has effect in EU law;

(v)a biocidal product permitted on the market by the NI competent authority under the Parallel Trade procedure in Article 53(1) of Regulation (EU) No 528/2012 as it has effect in EU law;

(vi)a critical use permit granted in Northern Ireland under Article 55(1) of Regulation (EU) No 528/2012 as it has effect in EU law;

(vii)a provisional authorisation under Article 55(2) of Regulation (EU) No 528/2012 as it has effect in EU law;

(viii)a cultural heritage authorisation granted under Article 55(3) of Regulation (EU) No 528/2012 as it has effect in EU law;

(ix)an essential use authorisation granted under regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013.]

Textual Amendments

F113Article 18U.K.Measures geared to the sustainable use of biocidal products

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Textual Amendments

Article 19U.K.Conditions for granting an authorisation

1.A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:

[F11(a)the active substances are included in [F114the Simplified Active Substance List] or approved for the relevant product-type and any conditions specified for those active substances are met;]

(b)it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:

(i)

the biocidal product is sufficiently effective;

(ii)

the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;

(iii)

the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;

(iv)

the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:

  • the fate and distribution of the biocidal product in the environment,

  • contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,

  • the impact of the biocidal product on non-target organisms,

  • the impact of the biocidal product on biodiversity and the ecosystem;

(c)the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;

(d)the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product;

[F11(e)where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93(24), Regulation (EC) No 396/2005 of the European Parliament and of the Council(25), Regulation (EC) No 470/2009 of the European Parliament and of the Council(26) or Directive 2002/32/EC of the European Parliament and of the Council(27), or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council(28);]

(f)where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.

2.The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:

(a)realistic worst case conditions under which the biocidal product may be used;

(b)the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;

(c)the consequences of use and disposal of the biocidal product;

(d)cumulative effects;

(e)synergistic effects.

3.A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20.

4.A biocidal product shall not be authorised for making available on the market for use by the general public where:

F115(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F11(b)it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:

  • [F11(b)acute oral toxicity category 1, 2 or 3,

  • acute dermal toxicity category 1, 2 or 3,

  • acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3,

  • acute inhalation toxicity (vapours) category 1 or 2,

  • specific target organ toxicity by single or repeated exposure category 1,

  • a category 1A or 1B carcinogen,

  • a category 1A or 1B mutagen, or

  • toxic for reproduction category 1A or 1B;

(c)it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;]

(d)it has endocrine-disrupting properties; or

(e)it has developmental neurotoxic or immunotoxic effects.

5.Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.

The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. F116...

[F116.The assessment of the biocidal product family conducted according to the common principles set out in Annex VI shall consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family.

A biocidal product family shall be authorised only if:

(a)the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and

(b)it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.

7.Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, or for the establishment of specific migration limits or limits for the residual content in food contact materials with respect to such substances in accordance with Regulation (EC) No 1935/2004.]

F1178.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9.Where a biocidal product is intended for direct application to the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product pursuant to Regulation (EC) No 1223/2009.

Textual Amendments

Article 20U.K.Requirements for applications for authorisation

1.The applicant for an authorisation shall submit the following documents together with the application:

(a)for biocidal products other than biocidal products meeting the conditions laid down in Article 25:

(i)a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;

(ii)a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;

(iii)a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;

[F118the competent authority may refuse to accept a letter of access for the purposes of this Article if it does not hold the relevant data.]

(b)for biocidal products that the applicant considers meet the conditions laid down in Article 25:

(i)

a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;

(ii)

efficacy data; and

(iii)

any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.

[F1192.Applications must be submitted in English.]

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Textual Amendments

Article 21U.K.Waiving of data requirements

1.By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:

(a)the data are not necessary owing to the exposure associated with the proposed uses;

(b)it is not scientifically necessary to supply the data; or

(c)it is not technically possible to generate the data.

2.The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with reference to the specific rules in Annex IV.

F1213.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 22U.K.Content of authorisation

1.An authorisation shall stipulate the terms and conditions relating to the making available on the market and use of the single biocidal product or the biocidal product family and include a summary of the biocidal product characteristics.

2.Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:

(a)trade name of the biocidal product;

(b)name and address of the authorisation holder;

(c)date of the authorisation and its date of expiry;

(d)authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;

(e)qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;

(f)manufacturers of the biocidal product (names and addresses including location of manufacturing sites);

(g)manufacturers of the active substances (names and addresses including location of manufacturing sites);

(h)type of formulation of the biocidal product;

(i)hazard and precautionary statements;

(j)product-type and, where relevant, an exact description of the authorised use;

(k)target harmful organisms;

(l)application doses and instructions for use;

(m)categories of users;

(n)particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;

(o)instructions for safe disposal of the product and its packaging;

(p)conditions of storage and shelf-life of the biocidal product under normal conditions of storage;

(q)where relevant, other information about the biocidal product.

Article 23U.K.Comparative assessment of biocidal products

1.The [F122competent authority] shall perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 10(1).

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[F113.The [F124competent authority ], shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where a comparative assessment F125... demonstrates that both of the following criteria are met:]

(a)for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages;

(b)the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.

4.By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution may be authorised for a period of up to four years without comparative assessment in exceptional cases where it is necessary to acquire experience first through using that product in practice.

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6.Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years.

7.Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect four years after that decision. However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date.

Textual Amendments

F127Article 24U.K.Technical guidance notes

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Textual Amendments

[F128Article 24AU.K.The Simplified Active Substance List

The competent authority must establish, maintain and make electronically available “the Simplified Active Substance List” of active substances that can be used in products that qualify for the simplified authorisation procedure under Article 25 of this Regulation.]

Textual Amendments

CHAPTER VU.K.SIMPLIFIED AUTHORISATION PROCEDURE

Article 25U.K.Eligibility for the simplified authorisation procedure

For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure. A biocidal product shall be eligible if all the following conditions are met:

(a)

all the active substances contained in the biocidal product appear in [F129the Simplified Active Substance List] and satisfy any restriction specified in [F130that list];

(b)

the biocidal product does not contain any substance of concern;

(c)

the biocidal product does not contain any nanomaterials;

(d)

the biocidal product is sufficiently effective; and

(e)

the handling of the biocidal product and its intended use do not require personal protective equipment.

Textual Amendments

Article 26U.K.Applicable procedure

1.Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the [F131competent authority], F132....

2.The F133... competent authority shall inform the applicant of the [F134appropriate fees] and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

Upon receipt of the [F134appropriate fees], the F133... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

[F1352A.Where the application is one to which paragraph 2B applies, paragraph 2 applies as if for “shall inform the applicant of the appropriate fees” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fees”.

2B.This paragraph applies to—

(a)an application in respect of a relevant category B product that is resubmitted by virtue of Article 95E; or

(b)an application that is resubmitted under Article 95FA.

2C.A “relevant category B product” is a product containing an active substance falling within category B of the Simplified Active Substance List that before IP completion day was—

(a)approved; or

(b)included in Annex 1 to 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.]

3.[F136Subject to paragraph 3A,] within 90 days of accepting an application, the F133... competent authority shall authorise the biocidal product if satisfied that the product meets the conditions laid down in Article 25.

[F1373A.Where a relevant application is accepted before 2nd October 2027, the competent authority must authorise the application before 31st December 2027 if it is satisfied that the product meets the conditions laid down in Article 25.

3B.In paragraph 3A, “relevant application” is one that is submitted in respect of a product containing an active substance that before IP completion day was—

(a)approved; or

(b)included in Annex 1 to 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.]

4.Where the F133... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F133... competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25.

[F138Where paragraph 3A applies, the deadline of 31st December 2027 referred to in that paragraph is to be extended by a number of days equal to the number of days beginning with the date on which the competent authority requested additional information and ending with the date on which the information was received by the competent authority plus 90 days.]

The F133... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, where fees have been paid, part of the fees F139... shall be reimbursed.

Textual Amendments

F140Article 27U.K.Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure

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Textual Amendments

Article 28U.K.Amendment of [F141the Simplified Active Substance List]

[F1421.The competent authority must, after receiving the decision of the Secretary of State, update the Simplified Active Substance List in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.]

2.Active substances give rise to concern where:

(a)they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:

  • (a)explosive/highly flammable,

  • organic peroxide,

  • acutely toxic of category 1, 2 or 3,

  • corrosive of category 1A, 1B or 1C,

  • respiratory sensitiser,

  • skin sensitiser,

  • germ cell mutagen of category 1 or 2;

  • carcinogen of category 1 or 2,

  • human reproductive toxicant of category 1 or 2 or with effects on or via lactation,

  • specific target organ toxicant by single or repeated exposure, or

  • toxic to aquatic life of acute category 1;

(b)they fulfil any of the substitution criteria set out in Article 10(1); or

(c)they have neurotoxic or immunotoxic properties.

Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.

[F1433.The Secretary of State may agree to the restriction or removal of an entry of an active substance to the Simplified Active Substance List on the recommendation of the competent authority if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25.

4.Paragraph 1 or 3 shall apply at the initiative of the Secretary of State or at the request of an economic operator or at the request of a Devolved Authority providing the necessary evidence as referred to in those paragraphs.

5.The Secretary of State may make regulations to further specify the procedures to be followed with respect to the amendment of the Simplified Active Substance List.

6.A decision issued or a function carried out under paragraph 1, 3 or 5 is subject to the consent requirement.

7.Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 5 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.]

Textual Amendments

CHAPTER VIU.K.NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

Article 29U.K.Submission and validation of applications

1.Applicants wishing to apply for a national authorisation in accordance with Article 17 shall submit an application to the F144... competent authority. The F144... competent authority shall inform the applicant of the [F145appropriate fees], and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly. Upon receipt of the [F145appropriate fees], the F144... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

[F1461A.Where the application is one that has been resubmitted by virtue of any of the Articles listed in paragraph 1B, paragraph 1 applies as if for “shall inform the applicant of the appropriate fees” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fees”.

1B.The Articles are—

(a)Article 95B;

(b)Article 95D;

(c)Article 95F;

(d)Article 95H.]

2.Within 30 days of acceptance, the F144... competent authority shall validate the application if [F147the relevant information referred to in Article 20 has been submitted]

F148(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F149(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

In the context of the validation referred to in the first subparagraph, the F144... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

3.Where the F144... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F144... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in paragraph 2.

The F144... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

F1504.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.If paragraph 3 does not apply and the F144... competent authority considers that the application is complete, it shall validate the application and without delay inform the applicant accordingly, indicating the date of the validation.

Textual Amendments

Article 30U.K.Evaluation of applications

1.[F151Subject to paragraph 1A,] the F152... competent authority shall, within 365 days of the validation of an application in accordance with Article 29, decide whether to grant an authorisation in accordance with Article 19. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

[F1531A.Where an application for a relevant product is validated in accordance with Article 29 before 31st December 2026, the competent authority must decide before 31st December 2027 whether to grant an authorisation in accordance with Article 19. It must take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

1B.In paragraph 1A a “relevant product” is a product containing an active substance in respect of which the implementing regulation providing that the substance is approved entered into force before IP completion day.

1C.In paragraph 1B “implementing regulation” has the same meaning as 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 as it had effect immediately before IP completion day.]

2.[F154Subject to paragraph 2A,] where it appears that additional information is necessary to carry out the evaluation, the F152... competent authority shall ask the applicant to submit such information within a specified time limit. The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

The F152... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

[F1552A.Where paragraph 1A applies and it appears that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 1A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 180 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.

The competent authority must reject the application if the applicant fails to submit the requested information within the specified time limit and must inform the applicant accordingly.]

3.[F156Subject to paragraph 4,] within the 365-day period referred to in paragraph 1, the F152... competent authority shall:

(a)draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the ‘assessment report’);

(b)send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and

(c)take due account of those comments when finalising its assessment.

[F1574.Where paragraph 1A applies, the competent authority must comply with the requirements in paragraph 3(a), (b) and (c)—

(a)before 31st December 2027; or

(b)where the applicant has been asked to submit additional information under paragraph 2A, before the date to which the deadline of 31st December 2027 has been extended under that paragraph.]

Textual Amendments

Article 31U.K.Renewal of a national authorisation

1.An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the F158... competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.

2.The F158... competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

3.When applying for renewal, the applicant shall submit:

(a)without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and

(b)its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.

4.The F158... competent authority shall inform the applicant of the [F159appropriate fees] and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

Upon receipt of the [F159appropriate fees], the F158... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

5.On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for authorisation or, as appropriate, the previous renewal, the F158... competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

6.Where the F158... competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.

Where the F158... competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.

7.Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the F158... competent authority shall grant a renewal for the period necessary to complete the evaluation.

Textual Amendments

CHAPTER VIIU.K.MUTUAL RECOGNITION PROCEDURES

F160Article 32U.K.Authorisation through mutual recognition

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Textual Amendments

F160Article 33U.K.Mutual recognition in sequence

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Textual Amendments

F160Article 34U.K.Mutual recognition in parallel

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Textual Amendments

F160Article 35U.K.Referral of objections to the coordination group

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Textual Amendments

F160Article 36U.K.Referral of unresolved objections to the Commission

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Textual Amendments

F160Article 37U.K.Derogations from mutual recognition

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Textual Amendments

F160Article 38U.K.Opinion of the Agency

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Textual Amendments

F160Article 39U.K.Application for mutual recognition by official or scientific bodies

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Textual Amendments

F160Article 40U.K.Supplementary rules and technical guidance notes

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Textual Amendments

CHAPTER VIIIU.K.UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS

SECTION 1U.K.Granting of Union authorisations

F160Article 41U.K.Union authorisation

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Textual Amendments

F160Article 42U.K.Biocidal products for which Union authorisation may be granted

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Textual Amendments

F160Article 43U.K.Submission and validation of applications

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Textual Amendments

F160Article 44U.K.Evaluation of applications

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Textual Amendments

SECTION 2U.K.Renewal of Union authorisations

F160Article 45U.K.Submission and acceptance of applications

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Textual Amendments

F160Article 46U.K.Evaluation of applications for renewal

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Textual Amendments

CHAPTER IXU.K.CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

Article 47U.K.Obligation for notification of unexpected or adverse effects

1.On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority F161.... In particular, the following shall be notified:

(a)new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;

(b)any data indicating the potential of the active substance for the development of resistance;

(c)new data or information indicating that the biocidal product is not sufficiently effective.

2.The competent authority F162..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.

F1633.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 48U.K.Cancellation or amendment of an authorisation

1.Without prejudice to Article 23, the competent authority F164... shall at any time cancel or amend an authorisation it has granted where it considers that:

(a)the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied;

(b)the authorisation was granted on the basis of false or misleading information; or

(c)the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.

2.Where the competent authority F165... intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit. The [F166competent authority] shall take due account of those comments when finalising its decision.

3.Where the competent authority F167... cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder F168....

F169...

F170...

Textual Amendments

Article 49U.K.Cancellation of an authorisation at the request of the authorisation holder

At the reasoned request of an authorisation holder, the competent authority F171... shall cancel the authorisation. F172...

Textual Amendments

Article 50U.K.Amendment of an authorisation at the request of the authorisation holder

F1731.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent [F174authority]. [F175The competent authority shall] decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.

The application shall be accompanied by the [F176appropriate fees].

3.An amendment to an existing authorisation shall fall under one of the following categories of changes:

(a)administrative change;

(b)minor change; or

(c)major change.

Textual Amendments

F177Article 51U.K.Detailed rules

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Textual Amendments

[F11Article 52U.K. Period of grace

Notwithstanding Article 89, where the competent authority F178... cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.

The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.]

Textual Amendments

CHAPTER XU.K.PARALLEL TRADE

F179Article 53U.K.Parallel trade

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Textual Amendments

CHAPTER XIU.K.TECHNICAL EQUIVALENCE

Article 54U.K.Assessment of technical equivalence

[F111.Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (‘the applicant’) shall submit an application to the [F180competent authority].]

2.The applicant shall submit all data that the [F180competent authority] requires to assess technical equivalence.

[F113.The [F180competent authority] shall inform the applicant of the [F181appropriate fees] and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.]

4.After giving the applicant the opportunity to submit comments, the [F180competent authority] shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it F182... to the applicant.

5.Where, in the opinion of the [F180competent authority], additional information is necessary to carry out the assessment of technical equivalence, the [F180competent authority] shall ask the applicant to submit such information within a time limit specified by the [F180competent authority]. The [F180competent authority] shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.

F1836.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.An appeal may be brought, in accordance with Article 77, against decisions of the [F180competent authority] under paragraphs 3, 4 and 5 of this Article.

F1848.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

CHAPTER XIIU.K.DEROGATIONS

[F185Article 55U.K.Derogation from the requirements

1.By way of derogation from Articles 17 and 19, the competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.

On receipt of a reasoned request from the competent authority, the Secretary of State or a Devolved Authority shall issue a decision, with or without conditions, on whether the action taken may be extended for a period not exceeding 550 days if they have competence to exercise the derogation within the meaning in paragraphs 4 to 8.

2.By way of derogation from point (a) of Article 19(1) and until an active substance is approved, the competent authority may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.

Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the competent authority has produced an assessment report and evaluation conclusions on the new active substance and consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).

If the Secretary of State decides not to approve the new active substance, the competent authority shall cancel that authorisation.

Where a decision on the approval of the new active substance has not yet been made by the Secretary of State when the period of three years expires, the competent authority may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).

3.By way of derogation from point (a) of Article 19(1), the Secretary of State or a Devolved Authority shall issue a decision allowing the competent authority to authorise a biocidal product containing a non-approved active substance if the Secretary of State or a Devolved Authority is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available. To obtain such a derogation, the competent authority shall apply to the Secretary of State or a Devolved Authority providing due justification.

4.The Secretary of State has competence to grant a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure—

(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).

5.The Scottish Ministers have competence to grant a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

6.The Welsh Ministers have competence to exercise a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

7.Where the Secretary of State grants a derogation, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises a derogation, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision.]

Textual Amendments

Article 56U.K.Research and development

[F111.By way of derogation from Article 17, an experiment or a test for the purposes of scientific or product and process-orientated research and development involving an unauthorised biocidal product or a non-approved active substance intended exclusively for use in a biocidal product (‘experiment’ or ‘test’) may take place only under the conditions provided for in this Article.]

Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authority on request.

2.Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the competent authority F186.... The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment. The person concerned shall make available any other information requested by the competent [F187authority].

In the absence of an opinion from the competent authority within 45 days of the notification referred to in the first subparagraph, the notified experiment or test may take place.

3.If the experiments or tests could have harmful effects, whether immediate or delayed, on the health of humans, particularly of vulnerable groups, or animals, or any unacceptable adverse effect on humans, animals or the environment, the [F188competent authority] may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences. F189...

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Textual Amendments

Article 57U.K.Exemption from registration under Regulation (EC) No 1907/2006

In addition to the active substances referred to in Article 15(2) of Regulation (EC) No 1907/2006, active substances manufactured or imported for use in biocidal products authorised for placing on the market in accordance with Article F191... 55 or 56 shall be regarded as being registered and the registration as completed for manufacture or import for use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5, Title II of Regulation (EC) No 1907/2006.

Textual Amendments

CHAPTER XIIIU.K.TREATED ARTICLES

Article 58U.K.Placing on the market of treated articles

1.This Article shall apply exclusively to treated articles that are not biocidal products. It shall not apply to treated articles where the sole treatment undertaken was the fumigation or disinfection of premises or containers used for storage or transport and where no residues are expected to remain from such treatment.

2.A treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in [F192the Simplified Active Substance List], and any conditions or restrictions specified therein are met.

[F113.The person responsible for the placing on the market of a treated article shall ensure that the label provides the information listed in the second subparagraph, where:]

  • in the case of a treated article containing a biocidal product, a claim is made by the manufacturer of that treated article regarding the biocidal properties of the article, or

  • in relation to the active substance(s) concerned, having particular regard to the possibility of contact with humans or the release into the environment, the conditions associated with the approval of the active substance(s) so require.

The label referred to in the first subparagraph shall provide the following information:

(a)a statement that the treated article incorporates biocidal products;

(b)where substantiated, the biocidal property attributed to the treated article;

(c)without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;

(d)the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;

(e)any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.

This paragraph shall not apply where at least equivalent labelling requirements already exist under sector-specific legislation for biocidal products in treated articles to meet information requirements concerning those active substances.

4.Notwithstanding the labelling requirements set out in paragraph 3, the person responsible for the placing on the market of a treated article shall label it with any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals and the environment.

5.Notwithstanding the labelling requirements set out in paragraph 3, the supplier of a treated article shall, where a consumer so requests, provide that consumer, within 45 days, free of charge, with information on the biocidal treatment of the treated article.

6.The labelling shall be clearly visible, easily legible and appropriately durable. Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty in [F193English]. In the case of treated articles that are not produced as part of a series but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the customer with the relevant information.

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8.Where there are significant indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), Article 5(2) or Article 25, [F195the Secretary of State] shall review the approval of that active substance or its inclusion in [F196the Simplified Active Substance List] in accordance with Article 15(1) or Article 28(2).

[F1979.Where any of the Devolved Authorities proposes that an active substance should be reviewed in accordance with paragraph 8 above, the Secretary of State shall have regard to such proposals in deciding whether to review the active substance.]

Textual Amendments

CHAPTER XIVU.K.DATA PROTECTION AND DATA-SHARING

Article 59U.K.[F198Protection of data held by the competent authority]

1.Without prejudice to Articles 62 and 63, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by [F199the competent authority] for the benefit of a subsequent applicant, except where:

(a)the subsequent applicant submits a letter of access; or

(b)the relevant time limit for data protection has expired.

2.When submitting data to [F200the] competent authority F201... for the purposes of this Regulation the applicant shall, where relevant, indicate the name and contact details of the data owner for all data submitted. The applicant shall also specify whether it is the data owner or holds a letter of access.

3.The applicant shall, without delay, inform the competent authority F202... about any changes to the ownership of the data.

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Textual Amendments

Article 60U.K.Data protection periods

1.Data submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article. The protection period for the data shall start when they are submitted for the first time.

Data protected under this Article or for which the protection period under this Article has expired shall not be protected again.

2.The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.

The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.

The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) concerning the renewal or the review.

[F113.The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3) [F204or 30(1)].

The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3) [F204or 30(1)].]

The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end five years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.

[F2054.The protection period for data submitted for biocidal products containing only existing active substances which were authorised in the United Kingdom prior to IP completion day shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5) of this Regulation as it had effect immediately before IP completion day.

5.The protection period for data submitted for biocidal products containing a new active substance which were authorised in the United Kingdom prior to IP completion day shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5) of this Regulation as it had effect immediately before IP completion day.]

Textual Amendments

Article 61U.K.Letter of access

1.A letter of access shall contain at least the following information:

(a)the name and contact details of the data owner and the beneficiary;

(b)the name of the active substance or biocidal product for which access to the data is authorised;

(c)the date on which the letter of access takes effect;

(d)a list of the submitted data to which the letter of access grants citation rights.

2.Revocation of a letter of access shall not affect the validity of the authorisation issued on the basis of the letter of access in question.

Article 62U.K.Data sharing

1.In order to avoid animal testing, testing on vertebrates for the purposes of this Regulation shall be undertaken only as a last resort. Testing on vertebrates shall not be repeated for the purposes of this Regulation.

2.Any person intending to perform tests or studies (‘the prospective applicant’)

(a)shall, in the case of data involving tests on vertebrates; and

(b)may, in the case of data not involving tests on vertebrates,

submit a written request to the [F206competent authority] to determine whether such tests or studies have already been submitted to the F207... competent authority in connection with a previous application under this Regulation [F208or Regulation (EU) No 528/2012 as it had effect immediately before IP completion day] or Directive 98/8/EC. [F209The competent authority must] verify whether such tests or studies have already been submitted [F210and whether the competent authority has access to the tests or studies].

Where such tests or studies have already been submitted to the F211... competent authority in connection with a previous application, under this Regulation [F212or Regulation (EU) No 528/2012 as it had effect immediately before IP completion day] or Directive 98/8/EC, [F213and where the competent authority has access to the tests or studies the competent authority must], without delay, communicate the name and contact details of the data submitter and data owner to the prospective applicant.

The data submitter shall, where relevant, facilitate contacts between the prospective applicant and the data owner.

Where the data acquired under those tests or studies are still protected under Article 60, the prospective applicant:

(a)shall, in the case of data involving tests on vertebrates; and

(b)may, in the case of data not involving tests on vertebrates,

request from the data owner all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications under this Regulation.

Textual Amendments

Article 63U.K.Compensation for data sharing

1.Where a request has been made in accordance with Article 62(2), the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant. Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.

2.Where such agreement is reached, the data owner shall make all the scientific and technical data related to the tests and studies concerned available to the prospective applicant or shall give the prospective applicant permission to refer to the data owner’s tests or studies when submitting applications under this Regulation.

3.Where no agreement is reached with respect to data involving tests or studies on vertebrates, the prospective applicant shall inform the [F214competent authority] and the data owner thereof, at the earliest one month after the prospective applicant receives the name and address of the data submitter from the [F214competent authority].

Within 60 days of being informed, the [F214competent authority] shall give the prospective applicant permission to refer to the requested tests or studies on vertebrates, provided that the prospective applicant demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner a share of the costs incurred. Where the prospective applicant and data owner cannot agree, national courts shall decide on the proportionate share of the cost that the prospective applicant is to pay to the data owner.

The data owner shall not refuse to accept any payment offered pursuant to the second subparagraph. Any acceptance is without prejudice, however, to his right to have the proportionate share of the cost determined by a national court, in accordance with the second subparagraph.

4.Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner, having regard to the guidance [F215either specified or referred to by the competent authority]. The prospective applicant shall be required to share only in the costs of information that it is required to submit for the purposes of this Regulation.

5.An appeal may be brought, in accordance with Article 77, against decisions of the [F216competent authority] under paragraph 3 of this Article.

Textual Amendments

Article 64U.K.Use of data for subsequent applications

1.Where the relevant data protection period according to Article 60 has expired in relation to an active substance, [F217the competent authority] may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant [F218, where the data was provided to the competent authority,] in so far as the subsequent applicant can provide evidence that the active substance is technically equivalent to the active substance for which the data protection period has expired, including the degree of purity and the nature of any relevant impurities.

Where the relevant data protection period according to Article 60 has expired in relation to a biocidal product, [F217the competent authority] may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant [F218, where the data was provided to the competent authority,] in so far as the subsequent applicant can provide evidence that the biocidal product is the same as the one already authorised, or the differences between them are not significant in relation to the risk assessment and the active substance(s) in the biocidal product are technically equivalent to those in the biocidal product already authorised, including the degree of purity and the nature of any impurities.

An appeal may be brought, in accordance with Article 77, against decisions of the [F219competent authority] under the first and second subparagraphs of this paragraph.

2.Notwithstanding paragraph 1, subsequent applicants shall provide the following data accordingly to the [F220competent authority] F221...:

(a)all necessary data for the identification of the biocidal product, including its composition;

(b)the data needed to identify the active substance and to establish technical equivalence of the active substance;

(c)the data needed to demonstrate the comparability of the risk from and efficacy of the biocidal product to that of the authorised biocidal product.

Textual Amendments

CHAPTER XVU.K.INFORMATION AND COMMUNICATION

SECTION 1U.K.Monitoring and reporting

Article 65U.K.Compliance with requirements

1.[F222The competent authority] shall make the necessary arrangements for the monitoring of biocidal products and treated articles which have been placed on the market to establish whether they comply with the requirements of this Regulation. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products(29) shall apply accordingly.

2.[F223The competent authority] shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation.

In order to facilitate such enforcement, manufacturers of biocidal products placed [F224on the market in Great Britain] shall maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product to be placed on the market and shall store production batch samples. The documentation shall include as a minimum:

(a)safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;

(b)records of the various manufacturing operations performed;

(c)results of internal quality controls;

(d)identification of production batches.

F225...

Measures taken pursuant to this paragraph shall avoid causing disproportionate administrative burden to economic operators and [F226the competent authority].

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Textual Amendments

Article 66U.K.Confidentiality

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2.The [F230competent authority] shall refuse access to information where disclosure would undermine the protection of the commercial interests or the privacy or safety of the persons concerned.

Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned:

(a)details of the full composition of a biocidal product;

(b)the precise tonnage of the active substance or biocidal product manufactured or made available on the market;

(c)links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product;

(d)names and addresses of persons involved in testing on vertebrates.

However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the [F231competent authority] shall disclose the information referred to in this paragraph.

3.Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused:

(a)the name and address of the authorisation holder;

(b)the name and address of the biocidal product manufacturer;

(c)the name and address of the active substance manufacturer;

(d)the content of the active substance or substances in the biocidal product and the name of the biocidal product;

(e)physical and chemical data concerning the biocidal product;

(f)any methods for rendering the active substance or biocidal product harmless;

(g)a summary of the results of the tests required pursuant to Article 20 to establish the product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;

(h)recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;

(i)safety data sheets;

(j)methods of analysis referred to in Article 19(1)(c);

(k)methods of disposal of the product and of its packaging;

(l)procedures to be followed and measures to be taken in the case of spillage or leakage;

(m)first aid and medical advice to be given in the case of injury to persons.

[F114.Any person submitting information related to an active substance or a biocidal product to the F232... competent authority for the purposes of this Regulation may request that the information in Article 67(3) and (4) not be made available, including a justification as to why the disclosure of the information could be harmful for that person’s commercial interests or those of any other party concerned.]

Textual Amendments

Article 67U.K.Electronic public access

[F111.From the date on which the [F233Secretary of State issues a decision] providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information [F234, where] held by the [F235competent authority] on that active substance shall be made publicly and easily available free of charge:]

(a)where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;

(b)if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;

(c)the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);

(d)physicochemical endpoints and data on pathways and environmental fate and behaviour;

(e)the result of each toxicological and ecotoxicological study;

(f)acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;

(g)the guidance on safe use provided in accordance with Annexes II and III;

(h)analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.

2.[F236From the date on which a biocidal product is authorised, the following up-to-date information, where held by the competent authority, shall be made publicly and easily available free of charge—]

(a)the terms and conditions of the authorisation;

(b)the summary of the biocidal product characteristics; and

(c)analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.

[F113.From the date on which the [F237Secretary of State issues a decision] providing that an active substance is approved, as referred to in point (a) of Article 9(1), the [F238competent authority] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority F239... as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information [F240where held by the competent authority] on that active substance:]

(a)if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;

(b)the study summaries or robust study summaries of studies submitted to support the approval of the active substance;

(c)information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;

(d)the trade name(s) of the substance;

(e)the assessment report.

4.From the date on which a biocidal product is authorised, the [F241competent authority] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority F242... as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information [F243where held by the competent authority]:

(a)study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and

(b)the assessment report.

Textual Amendments

Article 68U.K.Record-keeping and reporting

1.Authorisation holders shall keep records of the biocidal products they place on the market for at least 10 years after placing on the market, or 10 years after the date on which the authorisation was cancelled or expired, whichever is the earlier. They shall make available the relevant information contained in these records to the competent authority on request.

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Textual Amendments

SECTION 2U.K.Information about biocidal products

Article 69U.K.Classification, packaging and labelling of biocidal products

1.Authorisation holders shall ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of biocidal product characteristics, in particular the hazard statements and the precautionary statements, as referred to in point (i) of Article 22(2) F245... and, where applicable, Regulation (EC) No 1272/2008.

In addition, products which may be mistaken for food, including drink, or feed shall be packaged to minimise the likelihood of such a mistake being made. If they are available to the general public, they shall contain components to discourage their consumption and, in particular, shall not be attractive to children.

2.In addition to compliance with paragraph 1, authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications. In addition, the label must show clearly and indelibly the following information:

(a)the identity of every active substance and its concentration in metric units;

(b)the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;

(c)the authorisation number allocated to the biocidal product by the competent authority F246...;

(d)the name and address of the authorisation holder;

(e)the type of formulation;

(f)the uses for which the biocidal product is authorised;

(g)directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;

(h)particulars of likely direct or indirect adverse side effects and any directions for first aid;

(i)if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;

(j)directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;

(k)the formulation batch number or designation and the expiry date relevant to normal conditions of storage;

(l)where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;

(m)where applicable, the categories of users to which the biocidal product is restricted;

(n)where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;

(o)for biocidal products containing micro-organisms, labelling requirements in accordance with [F247the Control of Substances Hazardous to Health Regulations 2002].

By way of derogation from the first subparagraph, where this is necessary because of the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.

3.[F248The competent authority] may require:

(a)the provision of models or drafts of the packaging, labelling and leaflets;

(b)that biocidal products made available on the market [F249be labelled in English].

Textual Amendments

F250Article 70U.K.Safety data sheets

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Textual Amendments

Article 71U.K.[F251Exchange of information]

[F2521.The competent authority shall establish and maintain a system for the exchange of information between the competent authority and applicants.]

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3.Applicants shall use the [F254system referred to in paragraph 1] to submit applications and data for all procedures covered by this Regulation.

4.Upon submission of applications and data by applicants, the [F255competent authority] shall check that these have been submitted in the correct format F256....

Where the [F255competent authority] decides that the application has not been submitted in the correct format, it shall reject the application and inform the applicant accordingly.

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Textual Amendments

Article 72U.K.Advertising

1.Any advertisement for biocidal products shall, in addition to complying with Regulation (EC) No 1272/2008, include the sentences ‘Use biocides safely. Always read the label and product information before use.’. The sentences shall be clearly distinguishable and legible in relation to the whole advertisement.

2.Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type being advertised.

3.Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or any similar indication.

Article 73U.K.Poison control

Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.

CHAPTER XVIU.K.THE AGENCY

F258Article 74U.K.Role of the Agency

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Textual Amendments

F258Article 75U.K.Biocidal Products Committee

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Textual Amendments

F258Article 76U.K.Secretariat of the Agency

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Textual Amendments

[F259Article 77U.K.Appeals

1.Decisions of the competent authority taken pursuant to this Regulation may be appealed against in accordance with regulation 14 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013.

2.Fees may be payable as appropriate by the person bringing an appeal.

3.An appeal lodged pursuant to paragraph 1 shall have suspensive effect.]

Textual Amendments

F260Article 78U.K.The budget of the Agency

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Textual Amendments

[F261Article 79U.K.Formats for submission of information to the competent authority

The competent authority shall specify formats for submission of information. Applicants shall use these formats in their submissions to the competent authority pursuant to this Regulation.]

Textual Amendments

CHAPTER XVIIU.K.FINAL PROVISIONS

F262Article 80U.K.Fees and charges

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Textual Amendments

Article 81U.K.[F263The competent authority]

[F2641. The competent authority responsible for the application of this Regulation—

(a)is the competent authority as appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013, and

(b)must have a sufficient number of suitably qualified and experienced staff to enable the obligations provided for in this Regulation to be carried out efficiently and effectively. ]

2.[F265The competent authority] shall provide advice to applicants, in particular to SMEs, and to any other interested parties on their respective responsibilities and obligations under this Regulation. That shall include the provision of advice about the possibility of adapting the data requirements of Articles 6 and 20, the grounds on which such an adaptation can be made, and on how to prepare a proposal. F266...

[F267The competent authority] may in particular provide advice by establishing [F268a helpdesk]. Helpdesks already established under Regulation (EC) No 1907/2006 may act as helpdesks under this Regulation.

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Textual Amendments

F270Article 82U.K.Committee procedure

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Textual Amendments

F271Article 83U.K.Exercise of the delegation

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Textual Amendments

[F272Article 83AU.K.Regulation procedure

1.Regulations made by the Secretary of State under this Regulation are to be made by statutory instrument.

2.Such regulations may—

(a)contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

(b)make different provision for different purposes.

3.A statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

Textual Amendments

Article 83BU.K.The consent requirement

1.Where any provision of this Regulation states that a function is subject to the consent requirement, 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 and 3.

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 the United Kingdom 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 the United Kingdom other than Wales.]

Textual Amendments

F273Article 84U.K.Urgency procedure

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Textual Amendments

[F274Article 85U.K.Adaptation to scientific and technical progress

1.The Secretary of State may by regulations amend Annexes II, III and IV to this Regulation to take account of current scientific and technical knowledge.]

2.Regulations made under paragraph 1 above shall be subject to the consent requirement.

Textual Amendments

[F11Article 86U.K. Active substances included in Annex I to Directive 98/8/EC

Active substances [F275included] in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation on the date of inclusion and shall be included in the list referred to in Article 9(2). Approval shall be subject to the conditions set out in those Commission directives.]

Textual Amendments

F276Article 87U.K.Penalties

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Textual Amendments

[F277Article 88U.K.Safeguard clause

1.Where on the basis of new evidence the competent authority has justifiable grounds to consider that a biocidal product, although authorised in accordance with this Regulation, constitutes a serious immediate or long-term risk to the health of humans, particularly of vulnerable groups, or animals, or to the environment, it may take appropriate provisional measures.

2.The Secretary of State or a Devolved Authority shall issue a decision to either permit the provisional measure for a time period defined in the decision or require the competent authority to revoke the provisional measure if they have competence to issue the decision within the meaning in paragraphs 3 to 5.

3.The Secretary of State has competence to issue a decision if, or to the extent that, the exercise of the function to take that measure—

(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).

4.The Scottish Ministers have competence to issue the decision if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

5.The Welsh Ministers have competence to issue a decision if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

6.Where the Secretary of State issues the decision under paragraph 2 the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority issues the decision under paragraph 2, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision.]

Textual Amendments

[F278Article 89U.K.Existing transitional measures

1.The competent authority shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 31 December 2024.

2.The Secretary of State may by regulations—

(a)extend the date for the systematic examination of all existing active substances referred to in this Article;

(b)specify matters in relation to the carrying out of the work programme and the related rights and obligations of the competent authority and the participants in the programme.

3.Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 2, the Secretary of State must have regard to such proposals in deciding whether to exercise functions under that paragraph.

4.Regulations made under paragraph 2 above are subject to the consent requirement.

5.In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Secretary of State shall either issue decisions providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, issue decisions stating that an active substance is not approved. Decisions approving an active substance shall specify the date of approval. Article 9(2) shall apply.

6.A decision made under paragraph 5 is subject to the consent requirement.

7.[F279Subject to paragraph 7A,] by way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1, 2 and 9 of this Article, the current system or practice of making available on the market or using a given biocidal product continues to apply for up to three years after the date of approval of the last of the active substances to be approved in that biocidal product. The competent authority may, in accordance with the current system or practice, authorise the making available on the market or use of a biocidal product containing only—

(a)existing active substances which—

(i)have been evaluated under Commission Regulation (EC) No 1062/2014 but which have not yet been approved of that product-type;

(ii)are being evaluated under that Regulation but have not yet been approved for that product-type; or

(b)a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation.

[F2807A.By way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1, 2 and 9 of this Article, where paragraph 7B or 7C applies the current system or practice of making available on the market or using a biocidal product is to apply until the relevant date or, if earlier, the date on which the product is authorised under this Regulation. The competent authority may, in accordance with the current system or practice, authorise the making available on the market or use of the biocidal product.

7B.This paragraph applies to a biocidal product—

(a)that contains at least one existing active substance that was approved before IP completion day; and

(b)the application in respect of which—

(i)is one to which a relevant provision applies;

(ii)was received no later than the date of approval of the last of the active substances to be approved for that product-type; and

(iii)was resubmitted by virtue of Article 95B, 95D, 95E, 95F, 95FA or 95H.

7C.This paragraph applies to a biocidal product—

(a)that contains at least one active substance in respect of which the implementing regulation providing that the substance is approved entered into force before IP completion day;

(b)to which paragraph 7B does not apply; and

(c)the application in respect of which—

(i)is one to which a relevant provision applies;

(ii)was received no later than the date of approval of the last of the active substances to be approved for that product-type; and

(iii)was received after IP completion day.]

8.By way of derogation from [F281paragraphs 7 and 7A], in the case of a decision not to approve an active substance, the competent authority may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with paragraph 5, and may continue to apply the current system or practice of using biocidal products for up to 18 months after that decision.

9.Following a decision to approve a particular active substance for a specific product-type, the competent authority shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled, as appropriate, in accordance with this Regulation within three years of the date of approval [F282or, where paragraph 7A applies, before the relevant date].

To that effect, those wishing to apply for the authorisation of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation no later than the date of approval of the active substance or substances. In the case of biocidal products containing more than one active substance, applications shall be submitted no later than the date of approval of the last active substance for that product-type.

[F2839A.Where, in relation to a particular case the application in respect of which is one to which a relevant provision applies, the deadline by which a competent authority must authorise a biocidal product is extended under Article 26(4), Article 29(3) or Article 30(2A), the relevant date for the purposes of paragraphs 7A and 9 is to be extended by the same number of days in relation to that particular case.]

10.Where no application for authorisation has been submitted in accordance with paragraph 9 above—

(a)the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance or substances; and

(b)use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance or substances.

11.Where the competent authority decides to reject an application submitted in accordance with paragraph 9 for authorisation of a biocidal product already made available on the market, or decides not to grant an authorisation or to impose conditions for the authorisation making it necessary to change such a product, the following shall apply—

(a)a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the competent authority; and

(b)use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the competent authority.]

[F28412.In this Article—

  • “implementing regulation” has the same meaning as 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 as it had effect immediately before IP completion day;

  • “relevant date” means—

    (a)

    where Article 26(2A) applies, 29th April 2028;

    (b)

    where Article 26(3A) or 30(1A) applies, 31st December 2027;

    (c)

    where Article 29(1A) applies, 1st March 2029; or

    (d)

    where Article 5(2) or 6A(1A) of Commission Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council applies, 31st December 2027;

  • “relevant provision” means—

    (a)

    Article 26(2A);

    (b)

    Article 26(3A);

    (c)

    Article 29(1A);

    (d)

    Article 30(1A);

    (e)

    Article 5(2) of Commission Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; or

    (f)

    Article 6A(1A) of that Regulation.]

Textual Amendments

Article 90U.K.Transitional measures concerning active substances evaluated under Directive 98/8/EC

F2851.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.Applications submitted for the purposes of Directive 98/8/EC for which the F286... evaluation in accordance with Article 11(2) of Directive 98/8/EC [F287had] not been completed by 1 September 2013 shall be evaluated by the competent [F288authority] in accordance with the provisions of this Regulation and, where relevant, Regulation (EC) No [F2891062/2014].

That evaluation shall be carried out on the basis of the information provided in the dossier submitted under Directive 98/8/EC.

Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.

Every effort shall be made to avoid additional testing on vertebrates and to avoid causing delays to the review programme laid down in Regulation (EC) No [F2891062/2014] as a result of these transitional arrangements.

F290...

Textual Amendments

Article 91U.K.Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC

Applications for biocidal product authorisations submitted for the purposes of Directive 98/8/EC for which the evaluation [F291had] not been completed by 1 September 2013 shall be evaluated by the competent [F292authority] in accordance with that Directive.

Notwithstanding the first paragraph, the following shall apply:

  • where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 5(1) is met, the biocidal product shall be authorised in accordance with Article 19,

  • where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 10 is met, the biocidal product shall be authorised in accordance with Article 23.

Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.

Textual Amendments

Article 92U.K.Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC

1.Biocidal products for which an authorisation or registration in accordance with Article 3, 4, 15 or 17 of Directive 98/8/EC was granted before 1 September 2013 can continue to be made available on the market and used subject, where applicable, to any conditions of authorisation or registration stipulated under that Directive until the expiry date of the authorisation or registration or its cancellation.

[F2931A.The competent authority may request further data relating to the original authorisation as necessary.

1B.It is the duty of the authorisation holder to provide the necessary data within 60 days of such a request.

1C.The competent authority may cancel the authorisation if this Article is not complied with and the period of grace set out in the second paragraph of Article 52 shall apply.]

2.Notwithstanding paragraph 1, this Regulation shall apply to biocidal products referred to in that paragraph from 1 September 2013.

[F294Biocidal products authorised in accordance with Article 3 or 4 of Directive 98/8/EC shall be considered as authorised in accordance with Article 17 of this Regulation.]

Textual Amendments

[F11Article 93U.K. Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC

By way of derogation from Article 17(1), [F295the] current system or practice of making available on the market and using a biocidal product not covered by the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013 [F296, shall continue to apply—]F297...

(a)

where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, [F298were] submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph [F299Article 89(7), in Article 89(8) to (10) and in Article 89(11); or]

(b)

where an application [F300was] not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.]

Textual Amendments

[F11Article 94U.K. Transitional measures concerning treated articles

1.By way of derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing only active substances that are under examination for the relevant product-type in the work programme referred to in Article 89(1) on 1 September 2016 or for which an application for approval for the relevant product-type is submitted by that date, or containing only a combination of such substances and active substances included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use or included in [F301the Simplified Active Substance List], may be placed on the market until one of the following dates:

(a)in the case of a decision adopted [F302by the Commission after 1 September 2016 but before IP completion day or issued by the Secretary of State after IP completion day] to reject the application for approval of, or not to approve, one of the active substances for the relevant use, the date falling 180 days after such a decision;

(b)in other cases, the date of approval for the relevant product-type and use of the last active substance to be approved and contained in the biocidal product.

F3032.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 95U.K. Transitional measures concerning access to the active substance dossier

1.[F304The competent authority] shall make publicly available and shall regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive (‘the complete substance dossier’) [F305is] submitted and accepted or validated by [F306the competent authority] in a procedure provided for by this Regulation or that Directive (‘the relevant substances’). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the [F307competent authority] in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, and the product-type(s) for which they have made a submission, as well as the date of inclusion of the substance in the list.

A person established within the [F308United Kingdom] who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the product supplier’), may at any time submit to the [F309competent authority] either a complete substance dossier for that relevant substance, a [F310letter of access which provides the competent authority with access to a complete substance dossier], or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the [F309competent authority] a letter of access to all the data which was considered by the F311... competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (‘the relevant data’).

The [F312competent authority] shall inform the submitting supplier of the [F313appropriate fees]. It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.

Upon receipt of the [F314appropriate fees], the [F315competent authority] shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.

2.As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not be made available on the market unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product-type(s) to which the product belongs.

3.For the purposes of making a submission in accordance with the second subparagraph of paragraph 1 of this article, Article 63(3) of this Regulation shall apply to all toxicological, ecotoxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrates.

4.A substance supplier or a product supplier included in the list referred to in paragraph 1 to whom a letter of access has been issued for the purpose of this Article or a right to refer to a study has been granted in accordance with paragraph 3 shall be entitled to allow applicants for the authorisation of a biocidal product to make reference to that letter of access or that study for the purposes of Article 20(1) [F316, where that letter of access gives the competent authority direct access to the information, and where the competent authority holds the relevant data].

5.By way of derogation from Article 60, all data protection periods for active substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but for which a decision on inclusion in Annex I to Directive 98/8/EC was not taken before 1 September 2013, shall end on 31 December 2025.

6.Paragraphs 1 to 5 shall not apply to substances listed in [F317the Simplified Active Substance List] in [F318categories A and C] or to biocidal products containing only such substances.

7.The [F319competent authority] shall regularly update the list referred to in paragraph 1 of this Article. Following the renewal of the approval of an active substance, the [F319competent authority] shall remove from the list any substance supplier or product supplier who has not, within 12 months of the renewal, submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 of this Article or in an application in accordance with Article 13.]

[F3208.The competent authority may refuse to accept a letter of access for the purposes of this Article if they do not hold the relevant data.]

Textual Amendments

[F321Article 95AU.K. Transitional measures for simplified notification procedure

1.Where, before IP completion day, a product was authorised in a country which was a Member State of the EU other than the United Kingdom in accordance with Article 26 of Regulation (EU) No 528/2012, and was placed on the market in the United Kingdom in accordance with Article 27 of Regulation (EU) No 528/2012—

(a)it is to be treated as if it were authorised by the competent authority under Article 26 of this Regulation, and

(b)the competent authority must grant an authorisation under Article 26 of this Regulation.

2.The authorisation must be cancelled and Article 52 of this Regulation will apply where—

(a)the authorisation holder is not established in the United Kingdom within 12 months from IP completion day, or

(b)the authorisation holder does not supply the competent authority with relevant scientific and authorisation data by whichever is the earlier of the following—

(i)the date of any application for renewal or the date of any application for amendment of the authorisation under Article 50 of this Regulation, or

(ii)within 60 days of any request made by the competent authority to the authorisation holder.

Textual Amendments

Article 95BU.K. Transitional measures for mutual recognition applications

1.This Article applies where—

(a)an application for mutual recognition of a national authorisation of a biocidal product was made before IP completion day in accordance with Articles 33, 34 or 39 of Regulation (EU) No 528/2012, and

(b)a decision was not made before IP completion day.

2.Paragraphs 3, 4, 7 and 8 apply where the United Kingdom was the reference Member State, before exit day, for an application for mutual recognition under Article 34 of Regulation (EU) No 528/2012.

3.The application for mutual recognition is to be treated as having been made under Article 29 of this Regulation, and the time limits under Articles 29 and 30 are suspended until—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

4.On receipt of the resubmitted application and data to the competent authority, the time limits under Articles 29 and 30 of this Regulation apply, less any time which expired between the date of acceptance of the application and data under Article 34 of Regulation (EU) No 528/2012 and exit day.

[F3224A.But paragraph 4 does not apply so as to shorten—

(a)the deadline in paragraph 1 of Article 29, as it is modified by paragraph 1A of that Article; or

(b)the deadlines in paragraphs 1A, 2A and 4 of Article 30.]

5.Paragraphs 6, 7 and 8 apply where, before IP completion day, the United Kingdom was the Member State concerned in relation to an application for mutual recognition under Articles 33, 34 or 39 of Regulation (EU) No 528/2012.

6.The application is to be treated as having been made under Article 29 of this Regulation, and the time limits under Articles 29 and 30 apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

7.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).

8.Anything done before IP completion day by the United Kingdom competent authority, where the United Kingdom was either the Member State concerned or the reference Member State, is taken as having been done by the competent authority under this Regulation.

9.The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

10.The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

Article 95CU.K. Renewal of authorisations subject to mutual recognition under Regulation 492/2014

1.This Article applies where—

(a)an application for the renewal of a biocidal product authorisation subject to mutual recognition was made before IP completion day in accordance with Article 3 of Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for renewal of authorisations of biocidal products subject to mutual recognition, and

(b)a decision on the renewal of the authorisation was not made before IP completion day.

2.Paragraph 3 applies where, before exit day, the United Kingdom was the reference Member State for an application for renewal.

3.The application is to be treated as having been made under Article 31 of this Regulation and the time limits under Article 31 are suspended until—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

4.On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 30 and 31 (where applicable) of this Regulation apply less any time which expired between the date of acceptance of the application and data under Articles 3 and 4 of Regulation (EU) No 492/2014 and exit day.

[F3234A.But paragraph 4 does not apply so as to shorten the deadlines in paragraphs 1A, 2A and 4 of Article 30.]

5.Paragraph 6 applies where, before IP completion day, the United Kingdom was the Member State concerned for an application for renewal.

6.The application is to be treated as having been made under Article 31 of this Regulation, and the time limits under Articles 30 and 31 apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

7.Anything done before IP completion day by the United Kingdom, either as the Member State concerned or as the reference Member State, is taken as having been done by the competent authority under this Regulation.

8.The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

9.The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

10.Where the applicant or authorisation holder does not meet the requirements of this Article—

(a)the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9), and

(b)the authorisation must be cancelled by the competent authority and Article 52 applies.

Textual Amendments

Article 95DU.K.Transitional measure for national authorisation applications

1.This Article applies where—

(a)an application was made before IP completion day to the United Kingdom competent authority under Articles 29 or 31 of Regulation (EU) No 528/2012, and

(b)a decision was not made before IP completion day.

2.The application is to be treated as having been made under this Regulation and the time limits under Articles 29, 30 and 31 as appropriate apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.Where the applicant or authorisation holder does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).

4.Anything done before IP completion day by the United Kingdom competent authority as the receiving competent authority is taken as having been done by the competent authority under this Regulation.

5.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

Textual Amendments

Article 95EU.K.Transitional measures simplified authorisation applications

1.This Article applies where—

(a)an application was made to the United Kingdom competent authority before IP completion day under Articles 25 or 26 of Regulation (EU) No 528/2012, and

(b)a decision was not made before IP completion day.

2.Where the application was made to the United Kingdom competent authority as the receiving competent authority, the application is to be treated as having been made under this Regulation and the time limits under Article 26 apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.In a case where an application was made but the United Kingdom competent authority was not the receiving competent authority, the application is to be treated as having been made under this Regulation and the time limits under Article 26 apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

4.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).

5.Anything done before IP completion day by the United Kingdom competent authority as the receiving competent authority is taken as having been done by the competent authority under this Regulation.

6.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

7.The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

Article 95FU.K.Transitional measures for applications for same biocidal product authorisations

1.This Article applies where—

(a)an application was made to the United Kingdom competent authority before IP completion day under Articles 3 or 4 of Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council, and

(b)a decision was not made before IP completion day.

2.The application is to be treated as having been made under Articles 3 or 4 (as appropriate) of Regulation (EU) No 414/2013 and the time limits under those Articles are apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).

4.For the purposes of this Article, data submitted by the applicant or the data owner must include relevant data for the reference product.

5.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

[F324Article 95FAU.K.Transitional measures for applications for same biocidal product authorisations under the simplified procedure

1.This Article applies where—

(a)an application was made to the United Kingdom competent authority before IP completion day under Article 4a of Commission Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; and

(b)a decision was not made before IP completion day.

2.The application is to be treated as having been made under Article 4a of Regulation (EU) 414/2013.

3.The applicant must—

(a)resubmit the application and any supporting data to the competent authority; or

(b)where the applicant relies on a letter of access—

(i)resubmit the application; and

(ii)ensure that the data owner resubmits the data.

4.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).

5.For the purposes of this Article, data resubmitted by the applicant or the data owner must include relevant data for the reference product.

6.The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 before 31 January 2023.]

Textual Amendments

Article 95GU.K.Transitional measures for Regulation (EU) No 528/2012 authorisations

1.This Article applies to authorisations granted by the United Kingdom competent authority before IP completion day under Articles 19, 26, 30, 31, 33, 34, 36, 39 or 44 of Regulation (EU) No 528/2012.

2.The authorisation is to be treated as if it were authorised by the competent authority under the relevant Article of this Regulation.

3.The authorisation must be cancelled and Article 52 of this Regulation will apply where—

(a)the authorisation holder is not established in the United Kingdom within 12 months after IP completion day, or

(b)the authorisation holder does not supply the competent authority with relevant scientific and authorisation data by whichever is the earlier of the following—

(i)the date of any application for renewal or for amendment of the authorisation under Article 50 of this Regulation, or

(ii)within 60 days of any request made by the competent authority to the authorisation holder.

Textual Amendments

Article 95HU.K.Transitional measures for ongoing applications for Union authorisations

1.This Article applies where—

(a)an application for Union authorisation was made before IP completion day in accordance with Articles 42, 43 or 45 of Regulation (EU) No 528/2012, and

(b)a decision was not made before IP completion day.

2.Paragraph 3 applies where, before IP completion day, the United Kingdom competent authority was the evaluating competent authority for applications for Union authorisations made under Regulation (EU) No 528/2012.

3.The application is to be treated as being made under Articles 29 or 31 of this Regulation and the time limits under Articles 29, 30 or 31 are suspended until—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the applicant relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

4.On receipt of the resubmitted application and data to the competent authority, the time limits under Article 29, 30 or 31 of this Regulation apply less any time which expired between the date of acceptance of the application and data under Articles 43, 44, 45 or 46 of Regulation (EU) No 528/2012 and exit day.

[F3254A.But paragraph 4 does not apply so as to shorten—

(a)the deadline in paragraph 1 of Article 29, as it is modified by paragraph 1A of that Article; or

(b)the deadlines in paragraphs 1A, 2A and 4 of Article 30.]

5.Paragraph 6 applies to those ongoing Union authorisation applications made under Regulation (EU) No 528/2012 where the United Kingdom competent authority was not the evaluating competent authority.

6.The application is to be treated as having been made under Articles 29, 30 or 31 of this Regulation, and the time limits under those Articles apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

7.Where the applicant or authorisation holder does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).

8.Anything done before IP completion day by the United Kingdom competent authority as the evaluating competent authority is taken as having been done by the competent authority under this Regulation.

9.The resubmission of any application and data referred to in paragraph 3 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

10.The resubmission of any application and data referred to in paragraph 6 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

Article 95IU.K.Transitional measures for Article 95 List

1.This Article applies to the list prepared pursuant to Article 95 of Regulation (EU) No 528/2012 (“the Article 95 pre-IP completion day List”) of active substances and persons having made submissions in relation to those active substances.

2.Subject to paragraph 3, from IP completion day the entries included in the Article 95 pre-IP completion day List are to be included in the list prepared pursuant to Article 95 of this Regulation (“the Article 95 List”).

3.An entry on the Article 95 List must be removed if either of the following conditions are not met within 2 years from IP completion day—

(a)the person must be established in the United Kingdom;

(b)the person must provide to the competent authority any of the following—

(i)a complete dossier for the relevant active substance;

(ii)a reference to a complete active substance dossier for which all data protection periods have expired and the competent authority is able to obtain all the data;

(iii)a letter of access to a complete active substance dossier, where that dossier has been submitted to the competent authority within 2 years of IP completion day.

4.Where an entry is removed from the Article 95 List for reasons beyond the control of the supplier of a biocidal product containing the relevant active substance, the competent authority may grant a period of grace for the making available on the market of that biocidal product, except in cases where the continued making available on the market of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.

5.A period of grace in excess of 180 days may only be granted under paragraph 4 in exceptional circumstances.

6.Where a period of grace is granted in accordance with paragraph 4, and the supplier of a biocidal product does not comply with the second subparagraph of Article 95(1) during that period, the prohibition in Article 95(2) applies.

Textual Amendments

Article 95JU.K.Transitional measure for active substance applications made to the United Kingdom competent authority before 30 March 2019 and subsequently reallocated

1.This Article applies where—

(a)an application was made to the United Kingdom competent authority as evaluating competent authority before 30 March 2019 under Article 7 of Regulation (EU) No 528/2012,

(b)the competent authority had not completed its evaluation of the application before IP completion day due to the evaluation being reallocated at EU level, and

(c)a decision was not made before IP completion day.

2.An application referred to in paragraph 1 is to be treated as if it were made under Article 7 of this Regulation, and the time limits in Articles 7 and 8 are suspended until—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 7 and 8 apply, less any time which expired between the date of acceptance of the application and data under Article 7 of Regulation (EU) No 528/2012 and—

(a)30 March 2019 for active substances listed in the Annex to Commission Delegated Regulation (EU) 2019/227, or

(b)exit day for other substances.

4.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.

5.Anything done before exit day by the competent authority as the evaluating competent authority under Regulation (EU) No 528/2012 is taken as having been done by the competent authority under this Regulation.

6.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

Textual Amendments

Article 95KU.K.Transitional measure for active substance applications made before IP completion day pursuant to Article 93 where the United Kingdom competent authority was not the evaluating competent authority

1.This Article applies where—

(a)an application to approve an active substance was made before IP completion day under Article 7 of Regulation (EU) No 528/2012 and in compliance with point (a) of Article 93,

(b)the United Kingdom competent authority was not the evaluating competent authority, and

(c)a decision was not made before IP completion day.

2.An application referred to in paragraph 1 is to be treated as if it were made under Article 7 of this Regulation, and the time limits under Articles 7 and 8 apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.

4.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

Article 95LU.K.Transitional measures for renewal of an approval of an active substance

1.This Article applies where—

(a)an application for renewal of an approval of an active substance was made before IP completion day in accordance with Article 13 of Regulation (EU) No 528/2012, and

(b)a decision was not made before IP completion day.

2.Where the United Kingdom competent authority was the evaluating competent authority before exit day, the application is to be treated as if it were made under Article 13 of this Regulation, and the time limits under Articles 13 and 14 are suspended until—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.On receipt of the resubmitted application and data by the competent authority, the time limits under Articles 13 and 14 of this Regulation apply less any time which expired between the date of acceptance of the application and data under Article 13 and 30 March 2019.

4.Where the United Kingdom competent authority was not the evaluating competent authority before exit day, the application is to be treated as if it were made under Article 13 of this Regulation and the time limits under Articles 13 and 14 apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

5.Where the applicant does not meet the requirements of this Article, the approval must not be renewed by the competent authority and Article 52 applies to any biocidal product containing the active substance.

6.Anything done before IP completion day by the United Kingdom competent authority as the evaluating competent authority under Regulation (EU) No 528/2012 is taken as having been done by the competent authority under this Regulation.

7.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 90 days of IP completion day.

8.The resubmission of any application and data referred to in paragraph 4 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

Article 95MU.K.Transitional measures for ongoing applications to change or amend authorisations

1.This Article applies where—

(a)an application was made before IP completion day to the United Kingdom competent authority under Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation EU (No) 528/2012 of the European Parliament and of the Council, and

(b)a decision was not made before IP completion day.

2.An application referred to in paragraph 1 is to be treated as having been made under Regulation (EU) No 354/2013 and the time limits under that Regulation apply from—

(a)the date on which the applicant resubmits the application and any supporting data to the competent authority, or

(b)where the application relies on a letter of access, whichever is the later of the following—

(i)the applicant resubmits the application, or

(ii)the data owner resubmits the data.

3.Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority.

4.For the purposes of this Article, data submitted by the applicant or the data owner for changes to authorisations issued under Commission Implementing Regulation (EU) No 414/2013 must include relevant data on the reference product.

5.The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.

Textual Amendments

Article 95NU.K.Interpretation of Articles 95A to 95M

1.For the purposes of Articles 95A to 95M, the following definitions apply—

  • “evaluating competent authority” has the meaning given in Article 7 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day;

  • “Member State concerned” has the meaning given in Articles 33 and 34 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day;

  • “receiving competent authority” has the meaning given in Article 17 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day;

  • “reference Member State” has the meaning given in Articles 33 and 34 of Regulation (EU) No 528/2012 as it had effect immediately before IP completion day.]

Textual Amendments

Article 96U.K.Repeal

[F11Without prejudice to Articles 86, 89 to 93 and 95 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013.]

References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.

Textual Amendments

Article 97U.K.Entry into force

F326. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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