Legal provisions of COM(2013)288 - Amendment of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to certain conditions for access to the market

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dossier COM(2013)288 - Amendment of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with ...
document COM(2013)288 EN
date March 11, 2014

Contents

Article 1

Regulation (EU) No 528/2012 is amended as follows:

(1)in Article 2(5), point (b) is replaced by the following:

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

(2)Article 3(1) is amended as follows:

(a)point (s) is replaced by the following:

‘(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;’;

(b)point (v) is deleted;

(3)Article 19 is amended as follows:

(a)paragraph 1 is amended as follows:

(i)point (a) is replaced by the following:

‘(a)the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met;’;

(ii)point (e) is replaced by the following:

‘(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 (11), Regulation (EC) No 396/2005 of the European Parliament and of the Council (12), Regulation (EC) No 470/2009 of the European Parliament and of the Council (13) or Directive 2002/32/EC of the European Parliament and of the Council (14), 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 (15).

(11) Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1)."

(12) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1)."

(13) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11)."

(14) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10)."

(15) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).’;"

(b)in paragraph 4, points (b) and (c) are replaced by the following:

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

—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;’;

(c)paragraphs 6 and 7 are replaced by the following:

‘6.   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.’;

(4)in Article 23(3), the introductory part is replaced by the following:

‘3.   The receiving competent authority or, in the case of a decision on an application for a Union authorisation, the Commission, 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, performed in accordance with the technical guidance notes referred to in Article 24, demonstrates that both of the following criteria are met:’;

(5)in Article 34(4), the second subparagraph is replaced by the following:

‘Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30 and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.’;

(6)Article 35(3) is replaced by the following:

‘3.   Within the coordination group, all Member States referred to in paragraph 2 of this Article shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known. Where they reach agreement within 60 days of the referral of the points of disagreement referred to in paragraph 2 of this Article, the reference Member State shall record the agreement in the Register for Biocidal Products. The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(3) or 34(6) as appropriate.’;

(7)in Article 37(3), the second subparagraph is replaced by the following:

‘While the procedure under this Article is ongoing, the Member States’ obligation to authorise a biocidal product within three years of the date of approval, referred to in the first subparagraph of Article 89(3), shall be temporarily suspended.’;

(8)in Article 45(1), the second subparagraph is deleted;

(9)Article 52 is replaced by the following:

‘Article 52

Period of grace

Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, 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.’;

(10)in Article 53(1), the first subparagraph is replaced by the following:

‘1.   By way of derogation from Article 17, a competent authority of a Member State (“Member State of introduction”) shall, at the request of the applicant, grant a parallel trade permit for a biocidal product that is authorised in another Member State (“Member State of origin”) to be made available on the market and used in the Member State of introduction, if it determines in accordance with paragraph 3 that the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (“the reference product”).’;

(11)Article 54 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.   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 Agency.’;

(b)paragraph 3 is replaced by the following:

‘3.   The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.’;

(12)in Article 56(1), the first subparagraph is replaced by the following:

‘1.   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.’;

(13)in Article 58(3), the introductory part is replaced by the following:

‘3.   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:’;

(14)in Article 60(3), the first and second subparagraphs are replaced by the following:

‘3.   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), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).

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), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).’;

(15)Article 66(4) is replaced by the following:

‘4.   Any person submitting information related to an active substance or a biocidal product to the Agency or a 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.’;

(16)Article 67 is amended as follows:

(a)in paragraph 1, the introductory part is replaced by the following:

‘1.   From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information held by the Agency or the Commission on that active substance shall be made publicly and easily available free of charge:’;

(b)in paragraph 3, the introductory part is replaced by the following:

‘3.   From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency 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 on that active substance:’;

(17)in Article 76(1), the following point is added:

‘(l)providing support and assistance to Member States with regard to control and enforcement activities.’;

(18)in Article 77(1), the first subparagraph is replaced by the following:

‘1.   Appeals against decisions of the Agency taken pursuant to Articles 7(2), 13(3), 43(2) and 45(3), Article 54(3), (4) and (5), and Articles 63(3) and 64(1) shall lie with the Board of Appeal set up in accordance with Regulation (EC) No 1907/2006.’;

(19)in Article 78(2), the second subparagraph is replaced by the following:

‘Revenues of the Agency as referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Revenues of the Agency as referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency.’;

(20)Article 86 is replaced by the following:

‘Article 86

Active substances included in Annex I to Directive 98/8/EC

Active substances for which the Commission has adopted directives including them 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.’;

(21)Article 89 is amended as follows:

(a)paragraph 2 is replaced by the following:

‘2.   By way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue to apply its current system or practice of making available on the market or using a given biocidal product 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 Member State concerned may, in accordance with its national rules, authorise the making available on the market or use in its territory only of a biocidal product containing only:

(a)existing active substances which:

(i)have been evaluated under Commission Regulation (EC) No 1451/2007 (16), but which have not yet been approved for that product-type; or

(ii)are being evaluated, under Regulation (EC) No 1451/2007, but which 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.

By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State 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 the third subparagraph of paragraph 1, and may continue to apply its current system or practice of using biocidal products for up to 18 months after that decision.

(16) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).’;"

(b)paragraph 3 is replaced by the following:

‘3.   Following a decision to approve a particular active substance for a specific product-type, Member States 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.

To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel no later than the date of approval of the active substance(s). 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.

Where no application for authorisation or mutual recognition in parallel has been submitted in accordance with the second subparagraph:

(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(s); 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(s).’;

(c)paragraph 4 is replaced by the following:

‘4.   Where a Member State’s competent authority, or where relevant, the Commission, decides to reject an application submitted in accordance with paragraph 3 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 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 authority.’;

(22)in Article 92(2), the following sentence is added:

‘Biocidal 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.’;

(23)Article 93 is replaced by the following:

‘Article 93

Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC

By way of derogation from Article 17(1), a Member State may continue to apply its 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. The derogation shall apply until one of the following dates:

(a)where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, are submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4); or

(b)where an application is not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.’;

(24)Articles 94 and 95 are replaced by the following:

‘Article 94

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 Annex I, may be placed on the market until one of the following dates:

(a)in the case of a decision adopted after 1 September 2016 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.

2. By way of further derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing any active substances other than those referred to in paragraph 1 of this Article or those included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use or included in Annex I, may be placed on the market until 1 March 2017.

Article 95 - Transitional measures concerning access to the active substance dossier

1. As of 1 September 2013, the Agency 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”) has been submitted and accepted or validated by a Member State 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 Agency 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 Union 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 Agency either a complete substance dossier for that relevant substance, a letter of 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 Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (“the relevant data”).

The Agency shall inform the submitting supplier of the fees payable under Article 80(1). 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 fees payable under Article 80(1), the Agency 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).

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 Annex I in categories 1 to 5 and category 7 or to biocidal products containing only such substances.

7. The Agency shall regularly update the list referred to in paragraph 1 of this Article. Following the renewal of the approval of an active substance, the Agency 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.’;

(25)in Article 96, the first paragraph is replaced by the following:

‘Without 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.’;

(26)in Annex I, the title of category 6 is replaced by the following:

‘Category 6 — Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC’;

(27)in Annex V, the second paragraph under the heading ‘Product-type 4: Food and feed area’ is replaced by the following:

‘Products used to be incorporated into materials which may enter into contact with food.’.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Point 24 of Article 1 shall apply from 1 September 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.