/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D - Water, Chemicals & Biotechnology
ENV.D.3 - Chemicals & Nanomaterials

CA-March12-Doc.2 - Final

Minutes

44thmeeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market

7-9December 2011 (Centre A. Borschette)

The Commission representatives reminded the meeting that, as indicated in the invitation, the meeting would be held in English without interpretation. They explained that expert meetings are only interpreted in case there is a real need for interpretation, and that they have re-considered the previous practice in the light of current resource constraints. One CA asked whether this new language regime is intended to be permanent. The Commission representatives replied that this is indeed the intention, if the present meeting works well even in the absence of interpretation.

  1. Adoption of the agenda (CA-Dec11-Doc.1 Rev.2)

The Austrian CA representative proposed to add another issue under point 14of the agenda, relating to the placing on the market of a rodenticidal concentrate. A room document (CADec11Doc.14.2) was circulated for this discussion. With this amendment, the agenda (CA-Dec11-Doc.1 Rev.2) was adopted.

  1. Adoption of the draft minutes of the CA meeting held on 7-8 July 2011(CA-Sept11 Draft minutes with comments from Cefic, FR, UK and SE Rev.1)

No further comments were made, and the minutes (CA-Sept11 Draft minutes with comments from Cefic, FR, UK and SE Rev.1) were endorsed.

  1. Final discussions before vote of Standing Committee
  2. Draft Commission Directive (CA-Dec11-Doc.3.1 Rev.1) and draft assessment report (CA-Dec11-Doc.3.1a) for the inclusion of margosa extract into Annex I to Directive 98/8/EC

The German CArepresentatives presented the assessment report as well as the amendments made to the report since the September 2011 CA meeting.

The Commission representatives explained that the two outstanding issues were 1) the question how to refer in the assessment report to the bird reproduction study available in the framework of the PPP area, which was raised in the September 2011 CA meeting, and 2) the precise identity of the substance to be included in Annex I to BPD.

1) The bird reproduction study available under PPP:CAs questioned the justification and the legal basis for proposing to request access to this study at product authorisation stage, pointing out, i.a., that this would place on the product formulators a burden which is normally placed on the substance manufacturer. It was recognised that this case would set a precedent. CAs asked whether this study had been necessary to conclude that the conditions for AnnexI inclusion were fulfilled. CAs drew the parallel with other evaluations, where applicants for Annex I inclusion have been asked to submit missing studies. CAs also questioned whether the bird reproduction study was protected under the PPP legislation, and what relevance any such protection would have for the question whether it can be used for the purpose on an application under BPD.

The German CArepresentatives explained that, at the time of the evaluation, they had not considered a bird reproduction study to be necessary for AnnexI inclusion. However, it had been suggested in the TM that such a study should be submitted. In reply to this suggestion, the German CA had made reference to the bird reproduction study which had already been submitted to them under PPP, since such data is not protected under Article12 of BPD. However, they do not consider that the study was essential for the conclusion that margosa extract can be included in AnnexI to BPD.

It was concluded that the assessment report should not make reference to the study, and that normal data requirements (Article8(2) of BPD)will apply at product authorisation.

2) The identity of the substance to be included in AnnexI to BPD:The German CArepresentatives explained that they had been in discussion with the Commission about how to indicate the identity of this UVCB substance, and that they wished to include margosa extract with a narrower definition than that proposed by the Commission. They explained that "margosa extract" could refer to several very different substances, Whereas the evaluation performed by the German CA concerned an extract from a specific part of the plant by a specific extraction method, an assessment of an extract from other parts of the plant or by other methods would give a different result. The German CA representatives therefore considered that, in analogy with REACH guidance, the substance should be defined as "margosa extract from the kernels of Azadirachta indica extracted with water and further processed with organic solvents".

Some CAs commented that even the definition proposed by the German representatives was not very pertinent, since, e.g., the extraction could be made with any of hundreds of organic solvents, and biological varieties of the tree would count. On the other hand, it was recognised that it could be better to narrow down the definition to the extent possible, than not at all. One CA said that some companies currently placing other forms on margosa extract on the market are likely to be expecting that their substances will not be included in AnnexI to BPD, since they know that their substances are very different from the one having been evaluated by the German CA.

The Commission representatives said that,if margosa extract was included in AnnexI without further specification, alternative sources would in any event have to pass through the control of product authorisation. The result would be that the placing on the market of all margosa extracts would relatively shortly be subject to product authorisation. On the other hand, a redefinition of the substance identified in AnnexII to Regulation(EC) No1451/2007 would have to be followed by a withdrawal notice, inviting companies to support forms of margosa extract covered by the definition in the Regulation but not by the AnnexI-inclusion. Whereas one CA questioned whether a withdrawal notice would really be necessary, others supported the Commission representatives in this conclusion.

The applicant confirmed that different margosa extracts have very different properties depending on the extraction method and on the part of the plant used. According to the applicant, in the PPP area a margosa extract task force was formed, and several extracts could be covered by the same AnnexI-inclusion thanks to quality controls guaranteeing that any new manufacturing process stayed within the spectrum covered by the evaluation made.

There was a broad support among CAs to specify the substance in accordance with the proposal of the German CA representatives.NoCA disagreed with that proposal.

It was concluded that the following would be added in the column for IUPAC name and ID number in the Annex to the inclusion directive: "Description: margosa extract from the kernels of Azadirachta indica extracted with water and further processed with organic solvents".

The chairman concluded that the CA meeting discussion was finalised, and that the draft assessment report and the draft inclusion directive would be submitted to the 9December meeting of the Standing Committee for an opinion.

3.2.Draft Commission Directive (CA-Dec11-Doc.3.2) and draft assessment report (CA-Dec11-Doc.3.2a) for the inclusion of hydrochloric acid into Annex I to Directive 98/8/EC; SE comments on inclusion directive (CA-Dec11-Doc.3.2b); room document circulated by LV (CA-Dec11-Doc.3.2c)

The Latvian CA representatives presented the assessment report as well as the amendments made to the report since the September 2011 CA meeting. In response to comments made by one CA during the meeting, the Latvian proposed to amend the assessment report as indicated in the room document CA-Dec11-Doc.3.2c.

The Swedish CA representatives requested that a provision regarding minimising exposure during use be added to the Annex of the inclusion directive, for the reasons set out in the document CA-Dec11-Doc.3.2b. The proposal received broad support from CAs. It was however questioned whether there could not be products with a lower concentration of the active substance, for which user exposure would not have to be minimised. The Commission representatives suggested that this possibility would be addressed by adding, in accordance with normal practice, that this risk mitigation measure is not necessary ifit isshown in the application for product authorisation that the risks are reduced by other means.

The chairman concluded that the CA meeting discussion was finalised and that the draft assessment report and the draft inclusion directive would be submitted to the 9December meeting of the Standing Committee for an opinion.

3.3.Draft Commission Decision (CA-Dec11-Doc.3.3) and draft assessment report (CA-Dec11-Doc.3.3a Rev.1) for the non-inclusion of dichlorvos for product type 18 into Annex I to Directive 98/8/EC

The Italian CA representatives presented the assessment report as well as the amendments made to the report since the September 2011 CA meeting. No further comments were provided by other CAs.

The chairman concluded that the CA meeting discussion was finalised, and that the draft assessment report and the draft non-inclusion decision would be submitted to the 9December meeting of the Standing Committee for an opinion.

3.4.Draft Commission Decision (CA-Dec11-Doc.3.4) and draft assessment report (CA-Dec11-Doc.3.4a) for the non-inclusion of naled into Annex I to Directive98/8/EC

The FrenchCA representatives presented the assessment report as well as the amendments made to the report since the September 2011 CA meeting. No further comments were provided by other CAs.

The chairman concluded that the CA meeting discussion was finalised, and that the draft assessment report and the draft non-inclusion decision would be submitted to the 9December meeting of the Standing Committee for an opinion.

  1. First discussions before vote of Standing Committee
  2. Draft Commission Directive (CA-Dec11-Doc.4.1 Rev.1) and draft assessment report (CA-Dec11-Doc.4.1a) for the inclusion of thiamethoxam into Annex I to Directive98/8/EC; Annex to CAR (CA-Dec11-Doc.4.1b); room document (CADec11-Doc.4.1c)

The Spanish CA representatives circulated room document CA-Dec11-Doc.4.1c and introduced the assessment report.

Several CAs pointed out that the report did not contain a risk assessment for bees. It was noted that this issue had not been raised in the TM. CAs made several suggestions how to address this issue. One suggestion made was to include in the specific provisions in the Annex to the inclusion directive that the risk to bees will have to be evaluated at the product authorisation stage. However, several CAs considered it essential to address the issue before including the substance in AnnexI to BPD, in order to avoid placing an inappropriate burden on product formulators at the product authorisation stage.

Moreover, one CA considered that such assessment is needed in order to conclude if such active substance can be included into Annex I, in accordance with article 10(2)(ii)(c) of dir 98/8/EC, especially for substances belonging to the neonicotinoïd family that raise a number of issues in relation with the risk for bees. 'According to this CA, such assessment has been performed for imidacloprid, previously included with a similar representative use.

The Commission representatives noted that the German CA has made an assessment of the risk for bees in the evaluation of clothianidin based on data from the PPP area. They suggested that the Spanish CA make a similar assessment for thiamethoxam, provided that PPP data is available. The representative of the applicant indicated that he thought some such data would be available. The Spanish CA representatives agreed to make such an assessment, but indicated that this would probably make it impossible to have the next CA meeting discussion any sooner than in the May2012 CA-meeting.

Some CAs suggested that the risk evaluation for bees be referred to the TM. Other CAs and the Commission questioned the usefulness of bringing the evaluation back to the TM, in particular since thiamethoxam is the last substance to be evaluated in its class of substances (which also includes imidacloprid and clothianidin).

In view of product authorisation, some CAs advocated the option to try and build harmonised scenario for bees in the TM over the next couple of years. The Commission representatives and the applicant favoured this option. The representatives of the French CA volunteered to contribute to this work, and the representatives of the Dutch CA volunteered to take the lead together with the French CA.

One CA suggested that the same PNEC for soil should be used as for clothianidin, since the latter it is a metabolite of thiamethoxam.

One CA suggested that paragraph 2 in section 3.2 in the AR ought to be deleted if it is not included in the ID and also that paragraph (d) in section 3.3 ought to be deleted or moved to section 3.2 and included in the ID. A question was also raised regarding what was the different requirements for product B3 in paragraph (b) and (c) in section 3.3. The CA would send comments to RMS in writing.Both these requests were contested by another CA.

The Chairman concluded that, when the Spanish CA had finalised the risk assessment for bees, this assessment would be included in the CAR, and a revised CAR would be circulated to the other Member States for consultation with their experts. Unless the other Member States indicated a need to refer the bee assessment back to the TM, a second discussion would subsequently be held in aforthcoming CA meeting (probably in May 2012), and the draft inclusion directive would be submitted for an opinion by the Standing Committee in the adjacent SC meeting.

4.2.Draft Commission Directive (CA-Dec11-Doc.4.2 Rev.1) and draft assessment report (CA-Dec11-Doc.4.2a) for the inclusion of DDACarbonate into Annex I to Directive98/8/EC

The UK CA representatives introduced the assessment report. They indicated i.a. that they were still discussing with the Commission how to refer to the minimum purity, and were concerned about the risk of excluding alternative sources which manufacture a more diluted form of the substance. CAs had different opinions on this issue. A parallel was drawn with the inclusion directive for K-HDO, where the minimum purity was calculated based on the dry weight. The UK CA representatives undertook to work on a solution together with the French and Austrian CAs.

CAs requested, i.a., better information on the degradation rate in soil. It was pointed out that there was a lack of clarity in the summary of the human health risk assessment which made it impossible for the reader, and especially CAs who must vote on the proposal for inclusion of the active substance, to determine whether the rapporteur’s claim that normal workplace risk mitigation measures would reduce risks to acceptable levels. The UK undertook to clarify the text accordingly.

The Chairman concluded that the proposal would be submitted to the February 2012 CA meeting for a second discussion and to the adjacent Standing Committee meeting for an opinion by the Standing Committee.

4.3.Corrigendum to Directive 2009/91/EC for the inclusion of disodium tetraborate into Annex I to Directive98/8/EC (CA-Dec11-Doc.4.3); Industry letter (CADec11-Doc.4.3a)

The Commission representatives introduced the proposed corrigendum. Some CAs confirmed that the error was real and that the correction proposed was appropriate. The Commission representatives asked all other CAs to check whether their experts agreed and submit any comments by the end of the week, and indicated that, in the absence of any comments, it would proceed with the corrigendum.

4.4.New deadline for submission of dossiers taken over (triclosan TP 2, 7, 9 and 2-phenoxyethanol TP3(CA-Dec11-Doc.4.4)

The Commission representatives introduced the proposal. In reply to a question from the Danish CA representative, the Commission representatives confirmed that, in their view, the assessment of triclosan in PT1 should go ahead as planned.

The Chairman concluded that the CA meeting discussion was finalised, and that the proposal would be submitted to the February 2012 CA meeting for information and to the adjacent Standing Committee meeting for an opinion by the Standing Committee.

  1. Revision of Directive 98/8/EC

A number of CAs asked the Commission representatives how a MemberState could prevent the placing on the market in its territory of articles and materials treated with biocides containing substances that are CMR or PBT but are nevertheless included in AnnexI, such as creosote. In such cases MS can indeed forbid the placing on the market of creosote to treat wood, but can not forbid the importation or placing on their market of wood already treated, which is inconsistent.

The Commission representatives replied that a provision to this effect had been on the table during the negotiations of BPR, but had not been taken on board in the final version of the text by the legislators. Against this background, they had difficulties seeing how the free circulation on the internal market of such products could be prevented.

5.1.Progress report on the major revision; Preparation of implementation of BPR (CA-Dec11-Doc.5.1; CA-Dec11-Doc.5.1a)

Two documents were presented. The first document indicated the BPR tasks. This document highlighted the task name and numbers (based on their place in the BPR with the relevant article detail provided). It indicated a start data for the task, when the task is scheduled to be completed by and what type of work was necessary i.e. Implementing Act, Delegated Act, Reports or Guidance by either COM or ECHA. The task list also identified Biocides Implementation Project (BIP-6) tasks which are being conducted by ECHA with the remaining tasks being carried out by DG ENV. The document also indicated interlinkages between some BIP-6 and DG ENV tasks and how these tasks would be coordinated.

The second document presented the MemberStates and Stakeholders interest in the BPR tasks. The document also indicated the DG ENV lead or participant for each task if this has been decided.

5.2.ECHA scoping document on the Biocidal Products Committee and Coordination Group (CA-Dec11-Doc.5.2)

A document highlighting the foreseen planning for setting up the BPC and CG was prepared by ECHA for the meeting. The following key issues arose in the discussion:

Clarification of the overall scientific/regulatory structure for biocides once the new Regulation is applied – several questions sought clarity on the function of the BPC and its members e.g. will it replace the current CA meeting and what will replace the current Technical Meeting? COM explained that it is intended that the BPC will have a regulatory and scientific function – therefore replacing some of the current function of the CA and the TM. COM stated they expect an outcome of the BPC foreseeing that the Agency opinions can be easily processed by the Commission in the Standing Committee for approval of active substances and Union authorisation. The CA would continue to meet if necessary to discuss strategic regulatory issues. A layer may also be formed under the BPC to prepare scientific and technical work before reaching the BPC – possibly as working groups (WGs). ECHA pointed to the need for an efficient and effective BPC that would necessitate continuity of membership and a streamlined approach to work. ECHA also explained the draft Regulation has provisions that allow for parallel Committees should the workload dictate this approach.