With Comments from AISE, BASF, CEFIC, DE, FR, SE and UK

EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate D - Water, Marine Environment & Chemicals ENV.D.3 - Chemicals, Biocides and Nanomaterials

CA-July12-Doc.2 with comments from AISE, BASF, CEFIC, DE, FR, SE and UK

DRAFT MINUTES 46th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market

23-25 May 2012

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11

E-mail: [email protected] 1. Adoption of the agenda

The Swedish CA requested the addition of the document on mutagenicitiymutagenicity that it had sent the Commission in early May 2012. The Commission representatives apologised for having failed to distribute this document in advance of the meeting despite the fact that the Swedish CA had sent it to them well in advance of the CA meeting. The issue was added as agenda item 6.1c.

At the request of the Latvian CA, a question regarding technical equivalence was added as agenda point 14.2. LV undertook to send a document to the Commission representatives for distribution as a room document.

The Commission representatives proposed to add a presentation of CIRCABC as agenda point 14.3.

With these amendments to the document CA-May12-Doc.1 rev1, the agenda was adopted.

1.1. New transparency policy for expert meetings

The Commission representatives informed the meeting that, in accordance with the new, general transparency policy of the Commission, all documents tabled for expert groups such as the biocides CA meetings will, by default, be made public on publicly available CIRCABC spaces in advance of the Biocides CA meetings. They also informed participants about their possibility to request confidential treatment of single documents on justified grounds, in which case they will table those documents on the CIRCABC space restricted to CAs. MSs took note, and had no comments to this new policy.

2. Adoption of the draft minutes of the CA meeting held on 29 February – 2 March 2012

It was agreed to indicate in section 2 that comments from the UK had also been taken into account.

It was agreed that the second subparagraph of section 3.2, beginning by " The chairman concluded …" should read as follows: "The chairman concluded that the CA meeting discussion was finalised and that the proposal would be submitted to the 2 March meeting of the Standing Committee for an opinion."

It was agreed that the first sentences of the second subparagraph of section 4.4, currently beginning by "A MS pointed out" should read as follows: "The UK pointed out that the patterns of uses assessed for cis-tricos-9-ene are very similar to the ones assessed for ZE-TDA that is already included into the Annex I/IA: similar provisions should therefore be foreseen in the inclusion of cis-tricos-9-ene."

It was agreed that the 7th sentence of section 4.3, beginning with "The RMS replied…" should be replaced by the following: "The RMS replied that the actual classification of the product is eye irritation, category 2 and not eye damage, category 1 and this will be clarified in the text.”

2 With these amendments to the document CA-May12-Doc.2 – with comments from CEFIC, FR, SE and UK, the minutes were endorsed.

3. Final discussions before vote of Standing Committee

3.1. Draft Commission Decision and draft assessment report non-inclusion of bifenthrin for PT 18 into Annex I, IA or IB to Directive 98/8/EC

It was noted that the draft assessment report presented in document CA-May12-Doc.3.1a and the draft non-inclusion decision presented in document CA-May12-Doc.3.1 had already been discussed in the February/March 2012 CA meeting, and that the letter contained in the document CA-May12-Doc.3.1b contained no new elements compared to those presented to the Biocides Technical Meetings in which this substance had been discussed.

The applicant had declined the RMS's and the Commission's invitation to attend the meeting, and was not present. Neither CAs, nor other meeting participants made any further comments. It was concluded that the CA meeting discussions arewere finalised, and that the draft assessment report presented in document CA-May12-Doc.3.1a and the draft non-inclusion decision presented in document CA-May12-Doc.3.1 will be submitted to the Biocidal Products Standing Committee meeting of 25 May 2012.

3.2. Draft Commission Directive amending the headings of Annex I to Directive 98/8/EC

It was noted that the draft directive resulted from the first discussion held in the February/March 2012 CA meeting. Following a discussion with CAs, the following points were agreed.

The technical equivalence requirement does not only apply in case the alternative source has a lower purity than the evaluated source, but also in case the alternative source has a higher purity. In this context, the proposed wording could be misleading. Therefore, the first footnote to the proposed new Annex I-heading should read as follows: "The active substance in the product placed on the market can be of equal or different purity if it has been proven to the technically equivalent with the evaluated substance." Recital 5 shall be amended accordingly.

The proposed extended deadline for mutual recognition of products for which the first authorisation has been granted too late should be extended not only in cases where the first authorisation has been granted "less than 120 days before the deadline for compliance with Article 16(3)", but also in cases where that authorisation has been granted after the normal deadline for compliance with Article 16(3). Therefore, the provision in question in the second sentence of the second footnote to the proposed new Annex I-heading should refer to cases where the first authorisation has been granted "later than 120 days before the deadline for compliance with Article 16(3). Recital 8 should be amended accordingly.

In accordance with the gentleman's agreement between biocides CAs for mutual recognition, the deadline for submitting a complete application for mutual recognition as a condition for deadline extension indicated in the second sentence of the second footnote to the proposed new Annex I-heading should be 60 days instead of the proposed 30 days. Recital 8 should be amended accordingly.

3 Since applications for mutual recognition are sometimes submitted in several stages (sometimes starting before the first authorisation is even granted, and ending after that authorisation is granted), the provision in question in the second sentence of the second footnote to the proposed new Annex I-heading should refer not merely to the reception of the application for mutual recognition (which could be understood as meaning the reception of the first part of the application for mutual recognition, which might occur before the first authorisation is even granted), but to the reception of the complete application for mutual recognition. Recitals 7 and 8 should be amended accordingly.

It was noted that the issues that are being solved by this draft Commission directive will remain in the future BPR, as it is foreseen in article 89(2) of the BPR that MS may continue to apply there national system for 2 years after the approval: a MR in parallel might take more than 2 years when additional time is given to an applicant during the validation phase and the evaluation phase to provide additional information.

The Commission representatives undertook to circulate the amended version thus agreed in a CA meeting room document named CA-May12-Doc.3.2 rev2 post CA, and that this document would be submitted for a vote to the Biocidal Products Standing Committee meeting of 25 May 2012.

3.3. Draft Commission Directive and draft assessment report to extend the inclusion of nonanoic acid for PT 2 into Annex I to Directive 98/8/EC

It was noted that the draft assessment report presented in document CA-May12-Doc.3.3a and the draft inclusion directive presented in document CA-May12-Doc.3.3 were results of the first discussion held in the February/March 2012 CA meeting.

The applicant had declined the RMS's invitation to the meeting, and was not present.

One CA indicated that its MS would vote against the draft inclusion directive in the Standing Committee. That was mainly because there was a mismatch between the efficacy assessment and the risk assessment. In consequence, the application rate required for the effective use of products containing the active substance would probably be higher than that used for the risk assessment, and would therefore risk leading to unacceptable effects. Furthermore, in The CA also objected to the proposal to include the active substance on Annex I when the classification of the product according to CLP will lead to a requirement for the non- professional user to wear eye protection. This objection is in view of this CA,paragraph 73 of Annex VI of the Biocidal Products Directive where it is stated that products will not normally be authorised if risks can only be reduced to an acceptable level by a requirement for non- professional users could not be expected to apply the risk mitigation measures recommendedto wear personal protective equipment. The CA did not consider there were any grounds to deviate from this principle in the assessment report to contain the risk of eye irritationthis case.

Other CAs were of the opinion that the efficacy evidence (for which, in general, the requirements are not very high at the stage of annex I inclusion) is not weaker for this substance than for other biocidal active substances included in Annex I, and that the risks to human health were not remarkable. It was concluded that the CA meeting discussions are finalised, and that the draft assessment report presented in document CA-May12-Doc.3.3a and the draft inclusion directive presented in document CA-May12-Doc.3.3 will be submitted to the Biocidal Products Standing Committee meeting of 25 May 2012.

4 3.4. Draft Commission Directive and draft assessment report for the inclusion of cis-tricos-9-ene for PT 19 into Annex I to Directive 98/8/EC

It was noted that the draft assessment report presented in document CA-May12-Doc.3.4a and the draft inclusion directive presented in document CA-May12-Doc.3.4 were results of the first discussion held in the February/March 2012 CA meeting.

The applicant had declined the RMS's invitation to the meeting, and was not present. Neither CAs, nor other meeting participants made any further comments. It was concluded that the CA meeting discussions arewere finalised, and that the draft assessment report presented in document CA-May12-Doc.3.4a and the draft non-inclusion decision presented in document CA-May12-Doc.3.4 will be submitted to the Biocidal Products Standing Committee meeting of 25 May 2012.

3.5. Draft Commission Directive and draft assessment report for the inclusion of hydrogen cyanide for PTs 8 ,14 and 18 into Annex I to Directive 98/8/EC

It was noted that the draft assessment reports presented in documents CA-May12-Doc.3.5a, CA-May12-Doc.3.5b and CA-May12-Doc.3.5c and the draft inclusion directive presented in document CA-May12-Doc.3.5 were results of the first discussion held in the February/March 2012 CA meeting.

The applicant was present in the meeting but made no comments.

CAs made, in particular, the following comments: The inclusion directive should be more specific, and require, e.g., the use of specific PPE. The exclusion zone should be re-defined to take into account the fact that professional operators may be much more frequently exposed to the substance in that zone than the occasional by-stander. Wood intended to be preserved should be excluded from the requirement to remove porous materials before fumigation. Furthermore, that requirement for other porous materials should not be absolute, but there should be an alternative option to prevent absorption in those materials by covering them. For PT 14, the efficacy is of concern, and data should be submitted in this respect at product authorisation stage. It should be clarified that the products will never be used in houses where people live. It should be required that the professionals for which the products can be authorised are "adequately trained" and that suitable guidance on use is made available to users by the authorisation holder. The specific conditions in the inclusion directive should be re-organised to indicate the most important requirements first.

A couple of CAs advocated a non-inclusion, since they perceive the chemical as very dangerous and non-essential.

It was concluded that the draft inclusion directive and the draft assessment report need to be re-worked before the Standing Committee vote in the light of the comments received in the CA meeting. The Commission representatives undertook to re-work the inclusion directive and circulate an amended version in a CA meeting room document named CA-May12- Doc.3.5 rev2 post CA, and to submit this document for a vote to the Biocidal Products

5 Standing Committee meeting of 25 May 2012. The RMS CA undertook to re-work the assessment reports and submit them for endorsement in the same SC meeting.

3.6. Draft Commission Directive correcting the entry for disodium tetraborate in Annex I to Directive 98/8/EC

It was noted that the draft assessment report presented in document CA-May12-Doc.3.6a and the draft inclusion directive presented in document CA-May12-Doc.3.6 were results of the first discussion held in the February/March 2012 CA meeting.

Neither CAs, nor other meeting participants made any substantial comments. It was concluded that the CA meeting discussions are finalised, and that the draft assessment report presented in document CA-May12-Doc.3.6a and the draft non-inclusion decision presented in document CA-May12-Doc.3.6 will be submitted to the Biocidal Products Standing Committee meeting of 25 May 2012.

4. First discussions before vote of Standing Committee

4.1. Draft Commission Directive and draft assessment report for the inclusion of chlorfenapyr for PT 8 into Annex I to Directive 98/8/EC

It was noted that the draft assessment report and the draft inclusion directive were discussed in the CA meeting for the first time.

CAs made, in particular, the following comments: The risk identified during storage of treated wood, as well as the risk identified in wood use class 3, should result in unconditional restrictions in the inclusion directive. The assessment report should clearly state that the substance is persistent and toxic, since this will make the substance a candidate for substitution under BPR. The assessment report should clearly indicate which conclusion applies to which product. The assessment should be updated to make reference to the new CLP legislation.

One CA raised a fundamental issue: The only use having been fondfound safe in the assessment report is in fact not a PT 8 use, but a PT 18 use, as clarified in the TNsG for PT 18 published in 2010. It was therefore suggested that all references to that use be moved to the PT 18 dossier, which is currently under evaluation. However, in consequence, no safe use would have been proven for PT 8. It was therefore questioned whether the dossier was ready for a CA meeting, and whether it could form the basis of an inclusion directive for PT 8.

The applicant indicated that at the time of submission of the dossier almost a decade ago, it was not clear what PT the use in question belonged to, and that the choice of PT 8 had been made in good faith and following a recommendation from the RMS. In addition, the applicant pointed out that another representative product (Meganium), a “true” wood preservative product, was included in the original dossier. According to the applicant, a risk assessment for the environment is presented in the draft AR leading to favourable conclusion, but no risk assessment for human health is presented although decision was made at TM IV2010 to use the dermal absorption value generated with Mythic.

6 The Commission representatives expressed understanding for the applicant's choice of PT in the light of this explanation, but highlighted the importance of attributing reference product(s) to the correct product type for the purpose of avoiding complications at the stage of product authorisation.

It was concluded that a revised assessment report based on this CA meeting discussion and any subsequent written comments, and a revised inclusion Directive based on that report, will be submitted for discussion in the CA meeting of July 2012. CAs wishing to submit written comments to the RMS prior to the RMS' submission to the Commission of the revised assessment report were invited to do so by 15 June 2012.

4.2. Draft Commission Directive and draft assessment report for the inclusion of diflubenzuron for PT 18 into Annex I to Directive 98/8/EC

It was noted that the draft assessment report and the draft inclusion directive were discussed in the CA meeting for the first time.

It was noted that certain amendments to the draft assessment reports had already been agreed bilaterally between the RMS CA and other CAs. The applicant confirmed that it had just submitted a specification of physical-chemical data requested recently requested by the RMS

In addition, CAs made, in particular, the following comments: The restriction relating to use in water should not be conditional, but absolute. The inclusion directive should perhaps list more specific conditions, including the requirement for professional users to wear PPE.

One CA questioned whether the TM discussion was finalised. with respect to the metabolite para-chloroaniline. In addition, the CA questioned the acceptability of the biocidal products and plant protection product areas applying different toxicological reference values derived from the same data in their respective risk assessments. The RMS replied that the TM discussion had been finalised, although some of the one of the experts had expressed strong concern with the difference in approach between the two regulatory areas. However, the expert disagreedhad concurred with the conclusions drawn at TM conclusion. The Commission representatives concurred with this view.

4.3. Draft Commission Directive and draft assessment report for the inclusion of pyriproxyfen for PT 18 into Annex I to Directive 98/8/EC

It was noted that the draft assessment report and the draft inclusion directive were discussed in the CA meeting for the first time.

CAs made, in particular, the following comments: The identified risk for direct application to surface water should result in a restriction in the inclusion directive. One CA raised the question on the number of FOCUS step 3 run-off and drainage scenarios to be without risk for Annex I inclusion. COM agreed to forward this question to the ECHA experts. The

7 requirement for professional users to wear PPE should also be indicated in the inclusion directive. The rationale for basing conclusions on a "reverse dietary risk assessment" was questioned. It was suggested to clarify how many safe uses had been identified.

In response to a CS'sCA's concern over the proportion of non-active isomers, and the consequences under BPR, the applicant indicated that the rationratio of active to non-active isomers is around 50/50.

It was suggested that the inclusion directive should highlight the need to comply with existing or set new MRLs. In this respect, the applicant pointed out that the substance has an MRL under the PPP legislation.

4.4. Draft Commission Directive and draft assessment report for the inclusion of DDAC for PT 8 into Annex I to Directive 98/8/EC

4.5. Draft Commission Directive and draft assessment report for the inclusion of ADBAC for PT 8 into Annex I to Directive 98/8/EC

Agenda points 4.4 and 4.5 were discussed at the same time. It was noted that the draft assessment reports and the draft inclusion directives were discussed in the CA meeting for the first time.

The applicant was present in the meeting but made no comments.

CAs made, in particular, the following comments: Since risks have been identified in use class 3, albeit based on badpoor leaching tests, the inclusion directives should contain a restriction conditional upon submission of better data at product authorisation stage. The inclusion directive should contain additional restrictions for professional users of treated wood. The assessment report should clarify the local effects and risks associated with the manipulation of treated wood by professionals or non-professionnals. Both the assessment report and the inclusion directive should be more similar to those of DDACarbonate. The issue of ethanolmethanol as an impurity should be addressed in the AR. Further comments will be sent in written.

It was pointed out that there is a 2nd dossier for DDAC in PT 8, and questioned why these dossiers are not submitted to the CA meeting for discussion at the same time. The RMS explained that the other dossier was submitted much later than the one currently under discussion, and that further delays have occurred in that evaluation due to that applicant's request for permission to submit further data.

8 It was concluded that a revised assessment report based on this CA meeting discussion and any subsequent written comments, and a revised inclusion Directive based on that report, will be submitted for discussion in the CA meeting of July 2012. CAs wishing to submit written comments to the RMS prior to the RMS' submission to the Commission of the revised assessment report were invited to do so by 15 June 2012.

5. Revision of Directive 98/8/EC

5.1. Progress report on the major revision For information

The Chairman reported that the Council adopted the new Regulation on 10 May and that the publication of the text was expected by the end of June.

5.2. Preparation of implementation of BPR

5.2.a. Tasks overview

The agenda for the part of the meeting dedicated to the preparatory activities for the Biocidal Products Regulation included: general progress, preparations for the Biocidal Products Committee (BPC), the Biocides Fee Regulation and IT.

5.2.b. Biocidal Product Committee

As an introduction to the discussion COM expressed its views and expectations of the BPC. The BPC will be a regulatory and scientific committee where COM expects that the majority (COM indicated 95%) of the Agency opinions can be adopted in the Standing Committee without any further discussion.

ECHA presented their vision for the BPC which generally was well received and supported. A number of specific suggestions were made by the CAs for the further development of the BPC as described below.

Appointment process – some of the CAs queried how the process for the appointment of members would take place. ECHA explained that in the autumn 2012 a formal invitation would be sent to the Member State Permanent Representations from ECHA inviting them to appoint their one member and one alternate. Some CAs requested that when the invitation is sent out a copy is also sent to the CAs and in addition an explanation of the dual regulatory/scientific nature of the body (confirmed by COM). One CA wished to provide comments on the draft expertise grids after the meeting and one asked for a copy of ECHA’s declaration of interests form.

Meeting schedule – the CAs were keen to know the proposed schedule and location for the meetings of the BPC. It was explained that whilst the plans are not yet fixed, three preparatory meetings are planned for 2013, with at least one in Helsinki. Thereafter, the BPC

9 is expected to meet 5 times/year in Helsinki.

Working groups (WGs) – two alternative proposals for WGs were presented: either one WG covering all disciplines, or three WGs according to disciplines as currently covered by the Technical Meeting (TM). All were proposed to work electronically, rather than via physical meetings and with between 5-10 members/WG.

The CAs expressed their support for three WGs, but several expressed their preference to allow as many CAs to participate as wished in each WG, particularly since the WGs are expected to be the initial working space for the Committee. COM indicated that working entirely by electronic means may not be possible and up to 4 meetings/year may be more appropriate combined with ad hoc meetings/discussions on individual dossiers. One CA asked COM/ECHA were asked to provide a structure mapping from the old to the new systems.

Rapporteurs –the CAs expressed their support for the role of the rapporteur to be to introduce and steer the dossier through the opinion-forming process and for the rapporteur to be from the evaluating Competent Authority (ECA) for the main processes (approval of active substances and Union Authorisation). ECHA indicated that the role of the rapporteur needs further consideration internally in particular in relation to ECHA’s policy on conflicts of interest.

Several CAs urged ECHA to consider applying the mutatis mutandis clause in the BPR by not appointing rapporteurs where it does not appear proportionate to do so e.g. for administrative changes to Union authorisations. One CA explained that discussions in Council on the draft Regulation had not intended the mutatis mutandis phrase to hinder a flexible approach. , quite the opposite that it had been understood that it would allow flexibility.

Some of the CAs expressed their support for appointing co-rapporteurs from a third country, partly to reduce the possibility that there could be a perceived conflict of interest and also to distribute the work of the rapporteurs more evenly within the Committee. In the later discussion on the Fee Regulation one CA suggested co-rapporteurs could be funded by a proportion of the fees.

Ensuring quality and overall coordination – a number of CAs and COM expressed their support for ECHA’s proposal for upstream dialogue with the ECAs when developing their assessments to identify and discuss any particular issues arising that could cause problems at the Committee phase of the process. Particular support was voiced for the idea of ensuring input quality to the Committee process and agreed for ECHA to explore the proposed mechanisms (e.g. accordance check, list of issues) further.

The role of the Secretariat – the CAs generally supported the proposed role and support to be provided by the ECHA Secretariat. SeveralThe support provided by ECHA would be important in ensuring the efficiency of the Committee work. Several CAs asked for further specification of the role to include: recording clear precedents for the Committee, helping rapporteurs document discussions and the realisation of the final assessment reports (public and confidential versions), and preparing draft opinions and to summarise discussions at the WG level.

5.2.c. IT

10 ECHA reported on general progress with respect to the R4BP and IUCLID and on the meeting with Member States and industry in ECHA on 15-16 May. ECHA highlighted the future use of IUCLID for all dossier submissions. Following a question from COM, ECHA stated it is reconsidering the current security system in place for REACH IT which will also have consequences for the future security system for the R4BP. It was understood that some MS were concerned about the proportionality of the requirements for REACH IT.

5.2.d. Fee Regulation

A number of CAs questioned the level of the fees to be paid to ECHA. It was suggested to examine closely how ECHA's costs could be lowered in the long term. CAs also underlined that they expect ECHA to be very effective in its support, notably to reduce the work of CAs where it makes sense.

Industry representatives said that, besides the levels of fees, the predictability in the fee levels will often be more important for companies than the levels themselves, and that an even more important factor for companies than keeping fees down will beand ensuring high quality of ECHA's support, e.g. good guidance documents, are also important factors for companies.

The Chairman concluded that discussions will continue, and expressed the Commission services' intention to table a draft Regulation for a vote in the Standing Committee in December 2012. The Chairman asked CAs for written contributions to the discussion by 15 June and announced the Commission services' intention to circulate a revised version for discussion in the July CA meeting.

5.2.e. Fee Guidance

The purpose of the document was discussed. Some CAs favoured a document with clear recommendations to Member States, for the purpose of achieving harmonisation and thus indicating to companies what they can expect. CAs also discussed the usefulness of indicating relative amounts. It was noted that, on the one hand, CAs should be allowed to charge fees covering the actual costs of various tasks, and on the other hand, an indication of relative amounts might be useful for CAs who so far lack experience of authorisation of biocidal products.

The Commission representatives indicated that the main purpose of the guidance they currently had in mind would not be to impose harmonisation, but to disseminate best practices among Member States. The Chairman asked CAs for written contributions to the discussion by 15 June and announced the Commission services' intention to circulate a revised version for discussion in the July CA meeting.

5.2.f. Same Products Authorisation

The Chairman reported on the discussions held in the PA&MRFG meeting on this concept paper and expressed the Commission services' intention to table a draft Regulation for a vote in the Standing Committee in December 2012. The Chairman asked CAs for written

11 contributions to the discussion by 15 June and announced the Commission services' intention to circulate a revised version for discussion in the July CA meeting.

5.2.g. Market freeze for treated articles

Industry representatives expressed deep concern about Articles 94 and 58 of BPR, which, in their view, would lead to a 3 year freeze of the market for treated articles.

The Commission representatives indicated that they shared the concern, but that, in their interpretation, the situation was even worse, since the market freeze for articles treated with a given active substance will apply until that substance has been approved. That is because the derogation in Article 94 as currently drafted only applies to articles that were on the market inbefore September 2013, and hence any new articlesarticle will not be covered by Article 94, not even after 2016. The Commission representatives questioned whether this had really been the intention of the legislator.

A large majority of CAs shared the interpretation that the market freeze will last until the approval of the active substance in the treated articles, and expressed deep concern about this unintentional result of the legal drafting. They requested the Commission services to investigate how the issue could be solved, and the Commission representatives undertook to do so. SE pointed out, however, that it would not be able to support a redrafting that would allow all treated articles to remain on the market for an extended period of time. Instead SE suggested that COM and MS consider a proposal that only articles treated with active

6. Policy matters

6.2. Technical meetings

6.1.a.Report of meeting held in March For information 2012

The JRC gave an overview of the outcome of the last TM.

6.1.b.Groundwater scenarios For discussion

CA-May12-Doc.6.1b

The Commission representatives reported that since last CA meeting, some comments on the document were received. Based on these comments the following 3 provisional conclusions were drawn and CAs were asked to comment.

1) The results of all 9 scenarios should be provided by the applicant and should be presented in the CAR. This does not represent an additional burden for the applicant as the FOCUS model already calculates all 9 scenarios.

A MS said that it might be a waste of time to do all of them but it is not an extra burden, so even if it is not necessary it was agreed to have them all calculated.

12 2) Only one scenario without risk is not enough. The proposal is to have 5 scenarios that show no risk for annex I inclusion, based on the fact that this number should allow covering for different environments and situations of use.

A discussion took place on the number of scenarios necessary, but no agreement was found.

3) As the FOCUS groundwater model PEARL is applied also to other PT, the decision on the number of safe scenarios taken for PT 18 can be extended also to other PTs.

MSs agreed.

CA meeting agreed on conclusions 1 and 3. Regarding conclusion 2, as there are different opinions, CAs are invited to send their preference by the 15th June and the final discussion will take place at the next CA meeting.

2.1.c Mutagenicity

The Swedish CA introduced the room document CA May12 Doc.6.1c. It was concluded that the question would be referred to the Biocides Technical Meeting of June, and that the CA meeting of July would seek to conclude on the issue in the light of the input from the Technical meetingMeeting.

2.2 Guidance documents

6.2.a.Note for guidance on in situ generated active substances

The document CA-May12-Doc.6.2a was tabled for final discussion and endorsement by the CA meeting. It was agreed to add a title to the document, and to delete the reference to "Chlorine / hypochlorous acid / hypochlorite" on page 5 of the document, since it was questioned whether this reference was technically correct. With these amendments, the CA meeting endorsed the document, and the Commission representatives undertook to publish the endorsed document (CA-May12-Doc.6.2a Final post CA) on the public biocides space on CIRCABC.

13 6.2.b.Use of open source data

The Commission representatives indicated that no amendments to the document had been made since the March 2012 CA meeting in which it was first discussed. It was suggested to delete the sentence "Data on human health and environmental properties from experiments not carried out according to GLP or the relevant test methods can still be accepted in case some conditions are met" from the fourth paragraph of section 2.2 of the document. With this amendment, the CA meeting endorsed the document, and the Commission representatives undertook to publish the endorsed document (CA-May12-Doc.6.2b Final post CA) on the public biocides space on CIRCABC.

6.2.c.Borderline cosmetics/biocides

The Commission representatives presented the document and pointed out that the issue is still being discussed between DG ENV and DG SANCO. Several CAs welcomed the attempt to provide guidance and supported the views presented in the document. One CA expressed strong reservations to those views, with the argument that double regulation should be avoided and that the proposed interpretation did was not supported by the legal text in the Regulation. Other CAs pointed out that companies can avoid double regulation by abstaining from putting down two functions in the same product. The example of a sun lotion with an insect repellent was put forward by some CAs as an illustration of a product whose dual function is clearly inappropriate, since the two functions call for different conditions of use (ex: application rates, frequency of application, etc.).

A representative of the cosmetics industry expressed the view that the Commission services' interpretation did not accord with the legal text of the legislation is illegalRegulation.

The Commission representatives indicated that discussions with DG SANCO will continue, and asked CAs for written contributions to the discussion by 30 June.

6.2.d.Treated articles

The Commission representatives introduced the documents and highlighted the importance of reaching a harmonised approach on the issue as early as possible in order to facilitate companies' compliance with BPR. They pointed out that the Commission will eventually be empowered to take legally binding decisions on the issue, and announced their intention to use guidance endorsed as broadly as possible by CAs for the purpose of adopting those decisions. They also stressed their conviction already at this stage about the solution proposed for treated articles with several modes of action on the same target organism (e.g. bednets treated with an insecticide).

CAs welcomed the document and requested further time to reflect on it. One CA stressed the importance of, as a starting point, distinguishing articles from mixtures. Another CA indicated that it had worked on a similar decision making tree and offered to submit it to the Commission. Some CAs expressed reservation against the Commission services' conclusion

14 regarding articles such as bednets treated with insecticides. Other CAs agreed with the Commission services' position.

The Chairman asked CAs for written contributions to the discussion by 30 June.

6.2.e.Disinfectant by-products For information

CA-May12-Doc.6.2d

The Commission representative reported that at the last TM MSs asked for some more time for commenting, so a real discussion did not take place yet. The discussion on NL documents is foreseen for the ENV and TOX sessions of TM II 2012.

NL presented their document and asked the CA to endorse the second last paragraph of the introductory paper: “to use the WHO drinking-water guidelines unless at least one member states have lower national limits for Annex I inclusion. The wish to see a maximal acceptable cancer risk of 1 x 10-6 where there would be exposure to non-professional users or to the public (for example, in swimming pools) instead of the figure of 1 x 10-5 for genotoxic substances will be covered by the use of the lowest drinking water limits in the EU. Having lower limits for the genotoxic substances for biocides application whereas the drinking water values are based on a 1 x 10-5 cancer risk seems therefore not necessary.”..”

The general decision was to take the WHO values, but if a MS has a lower national level, that level can be used for Annex I inclusion. This would avoid problems at mutual recognition stage.

MSs agreed.

One CA proposes some amendments to one of the tables, as in their country the authorisation for bromine contenting products does not exist.

CA endorsed the proposal, so the TM can continue working on the topic. The room document is considered as accepted.

6.2.f. Date of application of guidance documents

The Commission representatives introduced the document and summarised the discussion of the PA&MRFG on the same document. In reaction to a comment made in the PA&MRFG, that mutual recognition is in any event normally not granted for a period going beyond the expiry of the first authorisation, one CA commented that this does not reflect its practice.

An industry representative questioned why valid studies submitted for Annex I inclusion would at all have to be replaced by new studies at product authorisation stage.

The Chairman asked CAs for written contributions to the discussion by 15 June and announced the Commission services' intention to circulate a revised version for discussion in the July CA meeting.

15 6.2.g.Biocides and nanomaterials

The Commission representatives introduced the paper CA-May12-Doc.6.2g, and highlighted the policy options identified therein. CAs welcomed the paper and pointed out that the issue deserves thorough reflection.

One CA opposed the idea of excluding nano-forms of existing active substances from the review programme, since this could be seen as changing the goal posts in the course of the process. Another CA pointed out that nano-forms not supported by data would in any event be excluded from the approvals eventually, and that it would be in the interest of companies to know sooner rather than later whether they would have to submit additional data. The Commission representatives pointed out that any exclusion of nanomaterials from the review programme should be accompanied by a possibility to escape market withdrawal by submitting data on those materials. An industry representative underlined the importance of allowing newgiving other companies the opportunity to support nano-forms of existing active substances in the review programme, should the current participants not wish not to do so.

It was discussed to what extent active substances in the review programme are manufactured as nanomaterials. There was a widespread presumption that most of those active substances do not have nano-forms. One CA suggested that all RMSs check this with the applicants.

CAs expressed opposing views on the question whether the OECD results should be awaited before information requirements are defined.

The Chairman asked CAs for written contributions to the discussion by 30 June.

6.2.h.Application of BPD in EEZs

The Commission representatives indicated that no written comments had been received on the paper CA-March12-Doc.7.2, which had been presented and agreed without any objections in the March 2012 CA meeting, and that the paper had thus been considered endorsed by CAs and published on the public biocides space on CIRCABC.

7. Update of the Manual of Decisions

7.1 Regulatory status of products to control moss

The Commission representatives introduced the paper CA-May12-Doc.7.1. Many CAs expressed their agreement with the legal interpretation expressed in the paper, and no CA objected to it. It was noted, however, that the solution is cumbersome and makes enforcement difficult. The Chairman concluded that the discussion on this issue was closed.

16 7.2 Bed nets with insecticidal properties

The Commission representatives introduced the paper CA-May12-Doc.7.2.

With reference to the paper CA-May12-Doc.6.2d, and the general discussion on treated articles held earlier during the CA meeting, the Commission representatives stated that, in their view, the nets described in the paper CA-May12-Doc.7.2 should be considered as having a "primary biocidal function" in accordance with Article 3(1)(a) of BPR, and therefore are to be considered as biocidal products.

Some CAs expressed support for the Commission's conclusion. Other CAs expressed preliminary support, subject to finalisation and endorsement of the general approach for identifying treated articles with primary biocidal function. The Austrian and the Dutch CAs opposed the Commission's view, and the UK CA reserved its view.

The Commission representatives highlighted the urgent need to guide companies on this question in order to facilitate their intentions to comply with the legislation. They also pointed out that BPR will allow the Commission to adopt legally binding decisions on matters like the present. Therefore, and in view of the relatively large support from CAs, the Commission services will advise the company Bestnet based on their view. The Chairman concluded that the discussion on this issue was closed.

8. Review programme

8.1. Progress report on substances under evaluation

The CA meeting took note of the documents CA-May12-Doc.8.1 rev1 and CA-May12-Doc.8.1a rev1.

8.2. Annex I-inclusions – Deadlines for decision making

The CA meeting took note of the document CA-May12-Doc.8.2. It was noted that no new assessment report will be finalised for a first discussion in the July 2012 CA meeting.

8.3. Substances not notified (in the correct PT) in the review programme

The Commission representatives introduced the explanatory document CA-May12-Doc.8.3 and the draft Regulation presented in the document CA-May12-Doc.8.3a.

An industry representative and several CAs questioned the appropriateness of creating a new Annex to Regulation (EC) No 1451/2007, and suggested that it might be a better option to place the substances in question directly on Annex II, possibly in a "part B" of Annex II. One argument raised was that much legislation, both national and EU legislation (including BPR)

17 refer to Annex II of Regulation (EC) No 1451/2007. The Commission representatives undertook to reflect on this option.

The Chairman asked CAs for written contributions to the discussion and comments on the draft Regulation by 30 June.

8.4. Sulphur dioxide

The Commission representatives reported that the European wine producing industry represented by CEEV is still committed to submitting a dossier for SO 2 in PT 4, and is keeping the Commission updated on the progress made. The latest previsionsprediction of CEEV isare that the dossier will be submitted by the beginning of November 2012. CAs took note of this report and made no comments.

8.5. Guidance note on late withdrawal – policy refinement

The Commission representatives introduced the document CA-May12-Doc.8.5.

One CA commented that the document and the proposed changes make it look as if an excuse is sought for stopping the evaluation, when in reality the fact that the applicant has withdrawn should be reason enough. The Commission representatives explained that the intention of the document is to provide CAs with a harmonised approach that fully respects Article 16(2) of BPD, which limits substances for which non-inclusion decisions can be taken to cases where either the data has not been submitted, or the requirements for inclusion are not satisfied.

The Chairman asked CAs for written contributions to the discussion by 15 June and announced the Commission services' intention to circulate a revised version for discussion and endorsement in the July CA meeting.

9. New active substances

1.1 Progress report on substances under evaluation

The CA meeting took note of the document CA-May12-Doc.9.1 rev 1.

10. Enforcement issues

1.1 ICSMS and market surveillance for biocidal products

The Chairman, in line with the conclusions of the previous CA meeting, invited again CAs to establish contact with ICSMS contact point and explore further the benefits that ICSMS could bring.

18 11. Product authorisations

1.1 Report from the Product Authorisation and Mutual Recognition Facilitation Group

In agreement with all CAs, this point was deleted from the agenda for reasons of time constraints and the Chairman invited CAs to consult the minutes of the PA&MRFG, when available.

11.2 Mutual recognition of difethialone containing products

The Commission representatives reported that the vote in the Standing committeeCommittee on the three notifications from Germany, Denmark and Sweden of derogation from mutual recognition of products containing difethialone had been finalised with unanimous support for the draft Commission Decisions, and that as soon as the linguistic check of the valid language versions of the decisions would be finalised with the help of the German, Danish and Swedish CAs, they intended to proceed with formal Commission adoption. CAs made no comments.

11.3 Mutual recognition of difenacoum containing products

The Commission representatives reported that the 90 day commenting period in relation to the notification from Germany of derogation from mutual recognition of products containing difenacoum had expired without any comments having been received, and that they would proceed as quickly as possible with a draft Commission Decision to be submitted for vote in the Standing Committee.

11.4 Mutual recognition of indoxacarb containing products

The Commission representatives reported that the notification from Germany of derogation from mutual recognition of products containing indoxacarb had been discussed in the PA&MRFG meeting. They indicated that they were currently of the opinion that the product should be authorised as a biocide, and that CAs had broadly supported this view in the PA&MRFG. CAs made no comments induring the CA meeting.

11.5 Mutual recognition of IPBC containing products

The Commission representatives reported that the notification from the Czech Republic of derogation from mutual recognition of products containing indoxacarbIPBC had been discussed in the PA&MRFG meeting, and that the matter had been referred to the June Biocides Technical meeting. CAs made no comments induring the CA meeting.

19 11.6 Mutual recognition of rodenticides – General guidance

The Commission representatives reported that the paper CA-May12-Doc.11.6 had been discussed and broadly supported in the PA&MRFG meeting, and that the only amendment suggested in that meeting had been to make scenarios 1 and 2 refer to extension or restriction of use area in more general terms. With these amendments, the CA meeting endorsed the document, and the Commission representatives undertook to publish the endorsed document (CA-May12-Doc.11.6 Final post CA) on the public biocides space on CIRCABC.

11.7 Proposal for a Commission Regulation on changes to product authorisation

The Chairman introduced the changes made to this latest version of the draft proposal and reported on the discussions held in the PA&MRFG meeting.

The Chairman invited comments by 15 June in particular on the new drafting of Article 13 and on the new Article 14a, as well as on points 7, 16 and 20 of Annex I on changes concerning non-active substances.

12 New policy developments which may affect the biocides regulatory framework

12.1 Commission recommendation establishing guidelines for the distinction between feed materials, feed additives, biocidal products and veterinary medicinal products

The Commission representatives introduced the paper CA-May12-Doc.12.1 rev1 and reported that many CAs had indicated their support for opinion a) during the electronic email consultation.

A number ofDuring the CA meeting, a few CAs indicated that they believe that option b) is correct. One CA clarified that it would have preferred option a), but did not believe that the legal texts allowed for this interpretation. It raised the question whether the feed additive legislation should be amended.

The Chairman asked those CAs who had not yet sent written contributions to the discussion to do so by 15 June.

12.2 Community Rolling Action Plan (CoRAP)

This agenda point was postponed until the next CA meeting.

13 International Matters

Nothing was reported or discussed under this agenda point.

20 14 AOB

1.1. List of Competent Authorities and other Contact Points and of list of Members of the Consultation Group

CAs took note of the document CA-May12-Doc. 14.1.

0.2 LV question on technical equivalence

The Latvian CA introduced room document CA-May12-Doc.14.2. Another CA indicated that it had advised the company in question to approach the Latvian CA. It was noted that the first question to decideaddress is whether the company's substance is covered by the Annex I- inclusion of hydrochloric acid. It was concluded that the CA meeting would need more information to take a position on the issue, and that the two CAs having been in contact with the applicant should advise it to write an explanatory letter that could be tabled for a future CA meeting.

14.3 Presentation CircaBC

In agreement with all CAs, this point was deleted from the agenda for reasons of time constraints.