Suggestions to Amend

CA-Sept13-Doc.5.1.j Rev.1

Suggestions to amend

Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

For discussion

Suggestion to amend Recital 2 and Article 1

On the basis of the proposal from Finland to amend Recital 2 and Article 1, the following wording could be considered:

Recital (2)

In Article 19(1)(e) and Article 19(7) of Regulation (EU) No 528/2012, it should beclarified that the limits required to be established in accordance with 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 food4 are specific migration limits or limits on the residual content in the food contact material[1].

4 OJ L 338, 13.11.2004, p. 4.

Article 1

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

(1) Article 19 is amended as follows:

(a) in paragraph 1, 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 of 8 February 1993 laying down Community procedures for contaminants in food*, 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**, 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*** or Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed****, or specific migration limits or limits for the residual content in the food contact material 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 of 27 October 2004 on materials and articles intended to come into contact with food*****.

"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) No315/93, Regulation (EC) No396/2005, Regulation (EC) No470/2009 or Directive2002/32/EC, or for the establishment of specific migration limits or limits for the residual content in the food contact materialwith respect to such substances in accordance with Regulation(EC) No1935/2004.";

* OJ L 37, 13.2.1993, p. 1.

** OJ L 70, 16.3.2005, p. 1.

*** OJ L 152, 16.6.2009, p. 11.

**** OJ L 140, 30.5.2002, p. 10.

Suggestion regarding article 89 paragraph 4

On the basis of the proposal from Germany to amend Article 89 and considering the original proposal from the United Kingdom, the following wording could be considered:

Article 1 - Point 11 (c)

Article 89 of the Biocidal Products Regulation:

"…

4. Where a Member State's competent authority or, where relevant, the Commission,decides to reject the application submitted in accordance with paragraph 3for authorisation of a biocidal product already being placed on the market, decides not to grant authorisation, or decides to impose conditions of the authorisation making it necessary to change such a product, the following shall apply:

(a)the 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 365 days after the date of the decision of the authority, if the necessary changes refer to labelling information according to Article 69 paragraph 2 littera a, c, d and k or with effect from 180 days after the date of the decision in all other cases.”

Background:

Germany welcomes the initiative made by United Kingdom according to Doc. 12736/13 concerning the provision under Article 89 para 4 of the aforementioned Proposal. We share the concerns which UK has outlined within its justification and believe that a solution should be found in the context of the forthcoming Amendment.

We recognize that some MemberStates as well as the Commission hesitate to accept the British proposal as there are doubts about legal certainty. Especially concerns have been raised whether Member States authorities are able to discriminate between “differences of purely administrative nature not affecting the properties, efficacy and use of the product” and substantial differences in a reliable and legally sound way.

We therefore submit a proposal which is based on the British proposal but should provide for more legal certainty.

Suggestion regarding Articles 22 and 69

On the basis of the French proposal to amend Articles 22 and 69, the following wording could be considered:

Article 22

Content of authorisation

[…]

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

[…]

(i) any relevant hazard and precautionary statements;

[…]

Article 69

Classification, packaging and labelling of biocidal products

1. Authorisation holders shall ensure that biocidal products are classified, packaged and labelled inaccordance with the approved summary of biocidal product characteristics[2], in particular the hazard statements and the precautionary statements, as referred to in point (i) of Article 22(2), and with Directive 1999/45/EC and, where applicable, Regulation (EC) No 1272/2008.

Justification:

Existing provisions of Regulation (EU) ° 528/2012 transfer the responsibility of classification from theauthorisation holder to the MemberState that delivered the authorisation. This transfer is a threat to the whole system, as it will increase significantly the number of authorisation to deliver or modify, without any added value in terms of protection of health or environment.

CLP regulation applies to Biocidal Products, as to any other chemical. According to article 4 of this regulation, suppliers have to classify their substances and mixtures before making them available on the market. As a consequence, they are responsible for the classification of their product. However, according to articles 22-2 and 69 of the Biocidal Product Regulation, classification on the label is the one that appears in the authorisation.

The update of the classification on the labels following the adoption of an ATP on one of the constituents of the product or in 2015, when all mixture will be subject to classification according to CLP regulation, will imply a revision of all national authorisations, leading to delays to update the labels and a significant increase of the number of authorisations to deliver. This will impact the delays to deliver the other authorisations (first authorisation or MR).

As an example, if all the products that contain sodium hypochlorite were authorised, 1671 authorisation would have to be updated in France after the introduction of a m-factor in 2015 by the CLP regulation: considering that 200 to 300 authorisations are delivered in France every year, this massive increase of demands would not be manageable.

Additional suggestions

Article 58– paragraph 3

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

Justification:

The word 'such' is creating some confusion as certain stakeholders are reported to believe that it refers to treated articles referred to under Article 58(2) and that therefore the labelling provisions only applies once the substances used to treat the articles have been approved. This was obviously not the intention of the legislator.

<Article2>Article 54 – paragraph 3</Article2>

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 and the evaluating competent authority accordingly.

Justification:

As no evaluating competent authority is involved for technical equivalence, there is no need for ECHA to inform a/the evaluating competent authority.

Article 76

Additional point in paragraph1

(l) providing support and assistance to Member States control and enforcement activities.

Justification:

To clarify that ECHA can also spend resources in the area of BPR enforcement coordination.

Article 95

Additional sentence in the second subparagraph of paragraph1

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').

New paragraph 8

8. The Agency shall regularly update the list referred to in paragraph 1. Following the renewal of the approval of an active substance, the Agency shall remove from the list any substance supplier or product supplier included therein who has not within 12 months from 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 or in an application in accordance with Article13.

Justification

To encourage cost sharing and transparency in the market in relation to any new data generated for the purpose if renewing a substance approval.

Annex V

Product-type 2: Disinfectants and products to control lichens, algae or bryophytes and algaecides not intended for direct application to humans or animals

Amendments to Regulation (EU) No 1107/2009

Articles 2(1) (d) and (e) of Regulation (EU) No 11079/2009 shall be amended as follows:

(d) destroying undesired plants or parts of plants, except algae, lichens, bryophytesand bacteria unless the products are applied on soil or water to protect plants;

(e) checking or preventing undesired growth of plants, except algae, lichens, bryophytes and bacteria unless the products are applied on soil or water to protect plants.

Justification:

Under the current legislative framework, products intended to remove lichens, algae, or bacteria from hard surfaces are biocidal products, whilst productsintended to bryophytes(i.e. mosses) from hard surfaces are plant protection products. As the data requirements and conditions of authorisations are fairly similar between the plant protection products and biocidal products legislations, it is suggested to regulate all these products under the same instrument in a spirit of simplification.

[1] By differenceto the proposal from Finland, it is suggested to make referenceto 'limits for the residual content in the food contact material' rather than to replace 'migration limits' by 'measures for groups of food contact materials and articles'. In addition, the words 'where appropriate' in both paragraphs 1 and 7 of Article 19 leave the door open for other measures being taken than the fixation of migration or residual content limits.

[2] By difference to the proposal from France, it is suggested keeping the words ' the approved summary of biocidal product characteristics' in Article 69