CA-July13-Doc.2 Draft Minutes

EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate A – Green Economy ENV.A.3 - Chemicals

CA-July13-Doc.2 – Draft minutes

DRAFT MINUTES

51st 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

15-17 May 2013

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

E-mail: [email protected] 15 MAY

REGISTRATION 09:00 – 09:30

Morning Session 09:30 – 13:00

1. Adoption of the agenda For adoption CA-May13-Doc.1

The agenda was adopted as proposed.

2. Adoption of the draft minutes of For adoption the previous CA meeting CA-May13-Doc.2 – with comments from FR, SK and UK

The minutes were adopted as proposed.

3. Final discussions on draft regulatory measures

3.0 Note on the principles for taking For discussion decisions on the approval of active CA-May13-Doc.3.0 substances

The Commission presented a document in order to clarify the principles for taking decisions on the approval of active substances under the BPR. In particular, evaluations made for the purpose of establishing compliance with the BPD would be regarded as sufficient for establishing compliance with the BPR and to take a decision on an approval; the Rapporteur Member State should have a particular attention to the new elements brought by the BPR (exclusion, substitution criteria, nanomaterials, treated articles and annex I); and existing approvals should only be reviewed in case of a particular concern not identified at the time of the original decision. For draft CARs already submitted by the Rapporteur Member States (RMSs), the Commission pointed out the difference between the evaluation that has rightfully been done according to the BPD requirements, and the criteria to be taken into account during the peer review and by the Commission in the end when adopting decisions to approve active substances. Indeed, decisions that will be adopted and will enter into application as from 1st September have to take into account the BPR principles.

Industry representatives considered that there was a discrepancy between the evaluation made under the BPD and the decision that would be taken under the BPR principles. In particular, industry considered that active substances already fulfilling the substitution criteria but that were already approved under the BPD would not benefit from the public consultation organised by ECHA in the context of Article 10(4) of the BPR. The Commission's

2 interpretation is nevertheless that, according to Articles 10(1), 23 and 91, it is sufficient that the active substance meets the substitution criteria for the product to be subject to a comparative assessment. Such a substance doesn't need to be flagged as such in the approval list.

Concerning the provisions related to treated articles, the progressive approach presented in the document was supported (i.e. restriction for general substances when a risk is identified, and positive listing when a substance meets exclusion criteria, or other high concern criteria on a case-by-case basis). On food contact materials (FCMs), the objective of the provision is to ensure that SMLs are established before applying for a product authorisation or importation of such FCMs. Industry representatives would like to know if some withdrawal notices would be published in the case of positive listing, and would like to have more guidance on the case-by- case approach. One Member State wanted to be sure that the approach on SMLs is not more restrictive than the one followed on MRLs.

Concerning the application of the BPR principles to the draft CARs already available, some Member States needed further examination, as they considered that the peer review of some criteria was carried out without the same attention as if it would have led to consequence on the decision-making (ex: 2 out of the 3 PBT criteria, or on endocrine disruption properties). Another Member State considered that more flexibility could be given for submission of additional information in connection with the application of the BPR. More guidance was needed. The Commission noted the concerns, and clarified that there will be a new Regulation that will replace the current review Regulation (EC) No 1451/2007, in particular to introduce the references to the BPC opinions.

The Commission also clarified that it considered that it was not possible to review the existing approval of a substance if it was already know that the substance was fulfilling 2 out of the 3 PBT criteria. Another Member State considered that the principles of the BPR on exclusion, substitution, or treated articles were new and could be considered as sufficient to review the existing approval of active substances.

The Commission concluded on the general support of Member States on the principles presented in the document, although a few Member States needed still some reflexion. The Commission will check with DG SANCO the provisions on SMLs, and reflect on the need of a withdrawal notice in case of the positive listing. Member States and stakeholders were invited to send comments to the Commission by June 15th.

These principles will be used for the drafting of all decisions subject to discussion during the CA meeting.

3.1. Draft Commission implementing For discussion Regulation and draft assessment RMS: BE report for the approval of CA-May13-Doc.3.1 cypermethrin for PT 8 CA-May13-Doc.3.1a

The RMS presented the revised AR on Cypermethrin as well as the revised decision. Both follow the new template that reflects the objective of the adoption an approval decision under the BPR. In addition, bilateral discussions took place between the RMS and some other Member States that will be reflected in the next version on the report. One Member State suggested to add a specific paragraph in the AR in section 3.3 concerning dermal adsorption that should be justified in the applications for product authorisation, and proposed as well a

3 revised provision concerning the need to establish collective protection before using PPE. Both provisions should be taken into account in all reports and decisions for active substance, where appropriate.

Another Member State pointed out that one of the metabolites of cypermethrin might fulfil 2 out of 3 or the PBT criteria, which should be investigated.

With the above-mentioned clarifications, it was agreed that the discussion was finalised. Only the potential issue with the metabolite should be clarified.

The Commission indicated that the proposal will be presented for the vote to the Standing Committee on Biocidal Products in July.

3.2. Draft Commission implementing For discussion Regulation and draft assessment RMS: FI report for the approval of CA-May13-Doc.3.2 propiconazole for PT 9 CA-May13-Doc.3.2a

The RMS presented the revised AR on propiconazole for PT09, as well as the revised decision that followed the new template to adopt an approval decision under the BPR. This substance has already been included for PT08 uses.

One Member state pointed out that this substance is a skin sensitizer, but mentioned that no information is presented in AR concerning the local risk assessment. This should be clarified. Another Member State had some concerns about the potential of development of resistance to propiconazole and other substances of this family, in particular with Aspergillus. The applicant indicated that some work has been carried out on that topic by an Industry expert group called 'the Fungicide resistance action committee' that focused its work on the use on crops. A Member State also indicated its reserve on the approval decision in relation with the on-going discussions on the principles to approve an active substance with treated articles.

Similarly to cypermethrin, a specific paragraph concerning dermal adsorption in the applications for product authorisation will be added in section 3.3 of the AR, and the provision concerning the need to establish collective protection before using PPE will be revised.

The Commission concluded that some clarifications will have to be brought on the issue of resistance and will check with DG SANCO. In addition, it will reflect on the need to have provisions on treated articles in relation with the sensitizing properties.

The Commission indicated that the proposal will be presented for the vote to the Standing Committee on Biocidal Products in July and that, if necessary, it could also be discussed before during the CA meeting.

4 4. First discussions on draft regulatory measures

4.1. Draft Commission implementing For discussion Regulation and draft assessment RMS: DK report for the approval of IPBC for CA-May13-Doc.4.1 PT 6 CA-May13-Doc.4.1a

The RMS presented the AR on IPBC for PT06. This substance has already been included for PT08 uses.

A MS requested that a provision should be established to protect the user from treated articles treated with or incorporating IPBC, considering its sensitizing potential, but other MSs considered that such measure was not needed considering the fact that it was in-can preservative use. Another MS wanted to have some clarifications on the local risk assessment due its sensitizing properties. The RMS clarified that some measures are already established in the section 3.3 in the elements that needs to be taken into account at the product authorisation stage.

There is a need to clarify if the potential for sensitization should entail some provisions in relation with treated articles.

The revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

4.2. Draft Commission implementing For discussion Regulation and draft assessment RMS: DK report for the approval of CA-May13-Doc.4.2 Tebuconazole for PT 7 and 10 CA-May13-Doc.4.2a CA-May13-Doc.4.2b

The RMS presented the ARs on Tebuconazole for PT07 and PT10. This substance has already been included for PT08 uses. As the evaluation concludes that this substance is Persistent and Toxic, it will be flagged as candidate for substitution, and approved for 7 years only. Some modifications will be made in the report to reflect that the protected sealant is a treated article, and that the real biocidal product is the formulation used to treat the sealant.

On endocrine disrupting properties, the RMS pointed out that this substance was a borderline case.

A MS pointed out that only industrial users needed to wear PPEs. Another MS mentioned that a risk was identified for the environment due to leaching when 2 houses using this sealant are next to each other, in a surface of 0.2 m².

5 Similarly to cypermethrin, a specific paragraph concerning dermal adsorption in the applications for product authorisation will be added in section 3.3 of the AR, and the provision concerning the need to establish collective protection before using PPE will be revised.

The Commission concluded that the issue on endocrine disrupting properties will be flagged in the report, in order to consider this element when more guidance will be available.

The applicant considered that the P, B, T criteria needed further discussion, which was not accepted during the meeting as clear conclusions were drawn up in the Technical meeting. Furthermore, this substance has already been reviewed for PT08 before and it was the second time that the applicant had the opportunity to discuss these criteria.

With the above-mentioned clarifications, it was agreed that the discussions were finalised. The provision on the need for professionals to wear PPE will be removed, and the need for a provision on the leaching issue will be investigated. The revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

4.3. Draft Commission implementing For discussion Regulation and draft assessment RMS: DE report for the approval of Benzoic CA-May13-Doc.4.3 acid for PT 3 and 4 CA-May13-Doc.4.3a CA-May13-Doc.4.3b

The RMS presented the ARs on Benzoic acid PT03 and PT04, and the proposed approval. One Member State questioned the need to have a specific provision for the PT04 decision about the establishment of SMLs for use in food contact materials. Indeed, this substance did not need any MRLs in the PPP framework and is used as a food additive.

The Commission concluded that it will check with DG SANCO on the provisions on SMLs. With the above-mentioned clarifications, the revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

4.4. Draft Commission implementing For discussion Regulation and draft assessment RMS: DE report for the approval of Aluminium CA-May13-Doc.4.4 phosphide for PT 20 CA-May13-Doc.4.4a

The RMS presented the AR on Aluminium phosphide for PT20. This substance has already been included into Annex I of the BPD for PT14 and 18. The use as PT20 against moles or rabbits is very similar to the use as a PT14 rodenticide. Only editorial modifications were proposed during the meeting.

It has been brought to the attention of the Commission that the need for a socio-economic analysis concerning the use of this substance was raised during the TM by a Member State, motivated by the level of risk of the soil compartment. This element surprised the

6 Commission, as the potential of re-colonisation of the soil by organisms was an accepted justification for PT14 to consider the risk as acceptable. The Commission requested some clarifications during the meeting, but no explanation could be given. The Commission therefore concluded that no specific alert should be mentioned in the AR on the need of a benefit/risk analysis.

The revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

15 MAY

Afternoon SESSION 14:30 – 18:00

4.5. Draft Commission implementing For discussion Regulation and draft assessment RMS: AT report for the approval of Etofenprox CA-May13-Doc.4.5 for PT 18 CA-May13-Doc.4.5a

The RMS presented the AR on Etofenprox for PT18. This substance has already been included into Annex I of the BPD for PT8. As the evaluation concludes that this substance is Bioaccumulable and Toxic, it will have to be flagged as candidate for substitution.

No comments were raised during the meeting. The applicant asked some clarifications concerning the fact that the approval decision will flag this substance as candidate for substitution, and will be approved for 7 years only. The Commission gave some explanations, and referred to the discussion that took place on item 3.0 on the agenda of the CA meeting.

The revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

4.6. Draft Commission implementing For discussion Regulation and draft assessment RMS: AT report for amending the conditions of CA-May13-Doc.4.6 approval of Nonanoic acid for PT 2 CA-May13-Doc.4.6a

The RMS presented the AR on Nonanoic acid for PT02. It was pointed out that the dossier was originally submitted to support the active substance under PT 10 "Masonry preservatives" under the BPD, but the use as an algaecide for remedial treatment of construction material has moved from PT10 under the BPD to PT02 under the BPR. As a decision has previously been taken on the inclusion of this substance into Annex I of the BPD for PT02, there is a need to modify the conditions of approval for PT02.

7 One Member State considered that the ESD used for the assessment needed to be improved and asked ECHA to include this work in its future tasks. Another Member State suggested having more general provisions in the approval decision to mitigate the risks for the environment. A Member State also questioned the efficacy of this active substance, and considered that further data should be submitted to justify the efficiency of the substance; otherwise it could not be approved. To solve this issue, it was suggested to add further explanations in the AR concerning the mode of action of the substance.

Similarly to cypermethrin, a specific paragraph concerning dermal adsorption in the applications for product authorisation will be added in section 3.3 of the AR.

Looking at the timing for discussion of the active substance in CA meetings, and with a view to ensure that as many substances could be finalised before the end of the year, it was agreed that the former 90-day commenting period on the draft final CAR should be reduced from now on and until the new BPC procedure is in place, to 30 days, as an exceptional measure.

With the above-mentioned clarifications on efficacy and modifications of the provisions to protect the environment, the revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

4.7. Draft Commission implementing For discussion Regulation and draft assessment RMS: ES report for the approval of CA-May13-Doc.4.7 Bromoacetic acid for PT 4 CA-May13-Doc.4.7a

The RMS presented the AR on Bromoacetic acid for PT04. One Member State pointed out that this substance is a skin sensitizer and a skin corrosive, and that specific measures should therefore be established for treated articles treated with or incorporating bromoacetic acid. It was however indicated that the applicant do not intend to incorporate this substance in treated articles.

Another Member State questioned the dietary risk assessment performed and considered that it was not the realistic worst case scenario looking at supported uses. In addition, some clarifications were needed to indicate if the specifications were set on the dry form or in solution, as it has some consequences on the remaining impurities.

With the above-mentioned clarifications on the dietary risk assessment, the specifications and the need for further reflection on provisions treated articles, the revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

8 4.8. Draft Commission implementing For discussion Regulation and draft assessment RMS: FR report for the approval of Copper CA-May13-Doc.4.8 sulphate for PT 2 CA-May13-Doc.4.8a

The RMS presented the AR on Copper sulphate for PT02. The RMS pointed out that, contrary to the information mentioned in the AR and the approval decision, the Persistent criteria is not applicable to inorganic substances. As a consequence, this substance cannot be considered as Persistent and is therefore not subject to substitution. The approval should therefore be given for 10 years.

A Member State asked for further clarifications concerning the risk assessment, as unacceptable risks were pointed out in the report but a reverse approach seems to have been presented to come to an acceptable risk. The RMS clarified that the assessment was based on a reference product that contained not only copper sulphate as an active substance. Therefore a basic efficacy test was requested and showed an inherent efficacy at 14 g/L. At that dose, unacceptable risks were demonstrated, but this dose was not realistic. Further information was provided, which made a refinement possible and showed acceptable risks. Consequently, the RMS was asked to make appropriate clarifications in the report.

In addition, it was also requested to modify the last specific provisions in the substance approval in order to follow a more general writing.

With the above-mentioned clarifications on the risk assessment, the revised AR and approval regulation will be put on the agenda of the next CA meeting for the final discussion.

4.9. Proposal for a Commission For discussion implementing Regulation specifying CA-May13-Doc.4.9 the procedures to amend Annex I

The Commission introduced its first draft of a proposal for a Commission implementing Regulation specifying the procedures to amend Annex I.

The Commission indicated that its objective was to submit the proposal to the Standing Committee on Biocidal Products at its September meeting, inviting participants to send comments by 15 June, in particular on the data that should be required for the purpose of including a substance in Annex I.

4.10. Proposal for a Commission For information Regulation (delegated act) concerning the review programme

The Commission informed the participants that it was aiming at presenting a first draft of a proposal for a Commission Regulation concerning the review programme at the next meeting.

9 16 MAY

Morning SESSION 9:30 – 12:30

5. New Regulation

5.1. Preparation of implementation

5.1.a. Tasks overview For information CA-May13-Doc.5.1.a CA-May13-Doc.5.1.aa

The Commission and ECHA reported on the on-going preparatory activities not subject of a specific agenda item.

5.1.b. Follow-up from previous For information discussions  Report from the CA / ECHA MB meeting held on 18/19 April 2013  Technical equivalence  Confidentiality claims check (with some clarification on dissemination)  IT security requirements  IT roll-out plan  Draft Article 95 list

The meeting was informed on how to submit evaluations for active substances after 1 September 2013 to ECHA. The features in R4BP to submit an evaluation for new active substance approval under the BPR will be in place by 1 September 2013 and are triggered by the creation of a “case” when the applicant starts the respective application procedure in R4BP. However, for the existing active substances evaluations of the Review Programme or new active substance evaluations submitted under Article 11 of the BPD transitional measures are needed as the case creation step is missing since the applications were submitted outside R4BP. ECHA informed that the following will apply:

- Starting from 1 September until 31 December 2013, the CARs should be sent in the current way (e.g. by registered mail or access to a secure server) to ECHA.

- Starting 1 January 2014, CARs should be submitted via R4BP since by then “cases” for the existing active substances evaluations of the Review Programme or new active

10 substance evaluations submitted under Article 11 of the BPD will be migrated into R4BP and will be available in the system.

ECHA stated it will inform also the BPC in its second meeting on this issue. In addition ECHA raised its concerns that not all Member States that are a RMS in the Review Programme have appointed a member for the BPC.

On confidentiality claims, participants were invited to send further comments by 15 June.

On the draft Article 95 list, a member State suggested that the list should also make reference to the supported PTs. The Commission took note of the suggestion and explained that it intended to have a final draft list ready for the next CA meeting and that afterwards, the list would passed on to ECHA, which could make a final check before the publication of the list in September.

5.1.c. Draft ECHA Guidance document on For discussion information requirements CA-May13-Doc.5.1.c

The CA meeting was consulted on this draft guidance document prepared by ECHA (under BIP number 6.1). Following comments from DE, ECHA stated: i) it will be checked if the sections on the testing strategies have been discussion at the Technical Meeting; ii) section 7.6.4 on treated articles will not be modified although ECHA realises more work is required on for example exposure assessment for workers; iii) section 11.1 will be modified, if needed, in line with the discussion at this meeting on the “order of risk management measures”.

Following a comment from UK, ECHA stated it will modify section 1.3.2 (page 27) to adequately reflect the use of REACH guidance. ECHA indicated that the deadline for commenting on the draft guidance document was 20 May.

5.1.d.Treated articles For discussion CA-May13-Doc.5.1.d

The Commission presented an updated guidance note on treated article, taking into account the comments received after the presentation of the document at CA49 and the discussion on specific points at CA50. Numerous changes were made to clarify proposed answers, with more substantial revisions of the sections on active substance approval and determination of primary biocidal function. It was further stated that the transitional provisions addressed in Questions 50-58 will be reviewed once the amendment to the BPR has been finalised.

MS in general welcomed the changes to the draft document.

On the role of a public health claim to determine a possible primary biocidal function of a treated article, CAs stated difficulties with delineating of public health claims and requested more detailed guidance on what is a public health claim. A CA asked for inclusion also of examples for claims that would not be considered public health-related. Several participants (CA and Industry) reiterated concerns in relation to the use of health claims as a decisive element to determine the classification of treated articles as biocidal products and questioned the legal basis. One CA stated that in the distinction between treated articles and biocidal products, the use of the article needs to be taken into account in addition to claims. Another CA expressed support for the strict handling of public health claims, as a stronger obligation to prove claims will promote their careful use. Another CA stated that the actual problem is

11 how to prevent mislabelling of articles (i.e. claims that are not substantiated by data) and that they thought it disproportionate to approach this by classifying articles as biocidal products just on the basis of this concern, as there are other mechanisms available to tackle this problem like a better surveillance of the market. They considered that the consequences of such guidance should better analysed, to not end up with an unmanageable situation.

The Commission clarified that all properties of a treated articles (including the elements given in Q15 and others, as appropriate) need to be taken into account for the decision, and not only the notion of public health claim. The intended use of an article indeed is an important element that will be covered better in the updated document.

In relation to concern expressed about the legal basis for criteria to decide on the classification as biocidal products, the Commission clarified that the legal text clearly provides for certain articles to be classified as biocidal products, but does not give very clear elements to determine which articles are concerned, as it does not define the notion of "primary biocidal function". Therefore, any guidance given on this issue cannot be based on the legal text alone, but has to be sought in the objective of the legal text. The legal interpretation will be defined by practice, with the help of the Commission implementing acts according to Article 3(3).

One MS stated in relation to Q41 on the location of the label on treated articles that according to the recitals of the BPR the label is intended to enable the consumer to make an informed choice, therefore the requirements for the label locations need to be clearly defined.

Several CAs raised questions on the requirement to substantiate claims made in relation to treated articles according to Article 58(3)(b). Especially if public health claims are made, efficacy needs to be ensured. The efficacy assessment of treated articles will need to be done under realistic conditions of use.

One CA stated that the requirement to trace treatments in the supply chain for complex articles will pose practical problems, therefore the application of the treated article provisions should be restricted to "articles of concern" An Industry association seconded this concern and claimed it being an immense burden for importers to get such information. The BPR was viewed as overly strict in this respect, without setting a threshold and even including treatments that leave not traces in the product. Another association claimed that the provisions give uncertainty to the industry about possible classification of their articles as biocidal products. It was claimed that a primary biocidal function would be rarely applicable, as the main function of articles in question is mainly physical. If public health claims have a role for classification, they should be defined more specifically, e.g. only claims to be efficient against certain disease-relevant organisms.

The Commission invited participants to submit further written comments by 15 June and indicated that the document would be proposed for endorsement at the next meeting.

5.1.e. Borderline cosmetics/biocides For discussion CA-May13-Doc.5.1.e

The Commission informed participants that the document was still under consideration by DSG SANCO and the Competent Authorities for cosmetics.

The Commission invited participants to submit final comments on the document by 15 June and indicated that the document would be proposed for endorsement at the next meeting.

12 5.1.f. Biocides and food contact materials For information

The Commission invited participants to submit final comments on the document by 15 June and indicated that the document would be proposed for endorsement at the next meeting.

5.1.g.Biocides and nanomaterials For endorsement CA-May13-Doc.5.1.g

As a follow up to the document "CA-Fev3-Doc.5.1.j - Nano transition.doc", the Commission proposed to endorse the approach discussed at the last CA meeting and summarized in the document. The main evolution concern the fact the Commission will not publish anymore a notice to the attention of current participants, but instead will send a formal letter by e-mail to them to enquire what the current situation on their active substance is.

One Member State questioned if the applicants could be required to submit a joint dossier when they support the same nanomaterial, or if they should "only" preferably submit a joint dossier. The Commission pointed out that current participants were also encouraged to collaborate but to little avail as too many multiple dossiers were submitted that complicate the review programme. That is why the proposal was made to ensure that no multiple dossiers are sent anymore. The Commission will further reflect on that when the provisions will have to be established in the new review regulation.

The general approach and provisions presented in the document were nevertheless endorsed.

5.1.h.Comparative assessment For discussion CA-May13-Doc.5.1.h

The Commission introduced document CA-May13-Doc.5.1.h, which aims to reach consensus with MSs and stakeholders on some key policy issues linked to comparative assessment before drafting the technical guidance note as provided for by Art. 24 of the BPR. The underlying principle in the paper is to optimise the regulatory effort and avoid work duplication to reduce any potential negative impact on the whole system.

The key elements of the proposal to that end were highlighted: i) the RMS's role to avoid the full replication of the exercise in each CMS; ii) the grouping of products with the same intended uses at the renewal's comparative assessment and the validity of conclusions from a previous comparative assessment already done until new alternatives have become available; iii) applicants' contribution to comparative assessment when required by substance approval or on a voluntary basis.

Some preliminary criteria to consider whether specific questions linked to comparative assessment should be better addressed at EU level where also introduced. Finally, the proposed tired approach was described, showing the different degree of detail for the comparative assessment depending on the hazard properties of the active substance (e.g. substitution vs. exclusion criteria).

The chairman proposed to focus the discussion on the three following topics: the role of the RMS, the eligibility of biocidal products to be compared, and the optimisation of the public consultation on alternatives done during substance approval in accordance with Article 10(3) of the BPR.

13 On the eligibility of biocidal products to be included in the comparative assessment, MSs and stakeholders supported that only products authorised in accordance to BPD or BPR should be included, so excluding those authorised during the transitional period according to the national rules.

Concerning the optimisation of the public consultation on alternatives, MSs supported the proposed approach and suggested to boost the ECHA's work by spreading that consultation through national stakeholders and providing some feedback to ECHA in due time. Some MSs also suggested the possibility of carrying out another public consultation in the context of the comparative assessment as a mean of getting additional information on alternatives generated from the active substance approval onwards.

On the role of the RMS, several MSs highlighted the amount of work to be done, some lack of expertise on the assessment of non-chemical alternatives or of socio-economic aspects and the essential need for good search functionalities in the R4BP3. It was also mentioned that the RMS can only be expected to do a "reasonably good" job to be then completed by CMSs, where appropriate. One CA also suggested that comparative assessment could be a good example for work-sharing initiatives under a pilot project.

Several MSs also commented on the tiered approach proposed in the document. It was mentioned that chemical diversity should be in connection with the active substance's mode of action. The approach to the "significantly lower overall risk" was also briefly discussed, suggesting the inclusion of a reference to biological significance and questioning whether the overall risk should not be lower for all three fields (human health, animal health and environment). Some MSs suggested focusing first on the easiest elements to be compared or on those which comparison is likely to stop first the comparative assessment (e.g. avoiding unnecessary effort). On Tier I, one CA asked whether SoC could be also considered within the flow chart.

Industry was concerned about the lack of tools to properly assess how the non-chemical alternatives pose "significantly lower overall risk" than biocidal products. Industry also supported the idea of working on a pilot project (e.g. rodenticides) and learning from experience for other PTs.

COM summarised the discussions and noted the support from the meeting to the general approach presented in the paper, and in particular that only BPD/BPR authorised products should be considered during the comparative assessment. On the issue of the role of the RMS, the Commission noted the need for further reflection and discussion.

MSs and stakeholders were invited to submit written comments on these three discussion points as well as on the rest of the paper by 15 June.

14 16 MAY

Afternoon Session 14:30 – 18:00

5.1.i. MRLs For information

The Commission informed the participants on the state of preparation of the proposal to amend Regulation (EC) No 396/2005 to allow the establishment of MRLs for substances only used in biocidal products.

5.1.j. Mutual recognition agreement with For information Switzerland

The Commission informed the participants on the on-going discussions with Switzerland regarding the extension of the current mutual recognition agreement to the BPR.

5.1.k. Biocides and Medical For endorsement Devices CA-May13-Doc.5.1.k

The document was endorsed.

5.2. Problems identified in new Regulation

5.2.a.Draft Commission proposal to amend For information Regulation (EU) No 528/2012

The Commission informed the participants that its proposal to amend Regulation (EU) No 528/2012 to correct some obvious errors and bring important clarifications was expected to be adopted on 20 May and transmitted the next day to the Parliament and Council.

5.3. Questions regarding the new For endorsement Regulation CA-May13-Doc.5.3

As the Commission indicated that questions relating to the implementation of Article 91 would be the subject of a separate document for discussion at the next CA meeting, the question and answer relating to Article 91 were removed.

A few other editorial changes were made, in particular to refer to the supply chain and not to the making available in the market, in the answer to the question relating to Article 92(1).

15 With these changes and clarifications, the document was endorsed.

5.3.a Additional questions regarding the For discussion new Regulation CA-May13-Doc.5.3.a CA-May13-Doc.5.3.b

The Commission briefly introduced document CA-May13-Doc.5.3.a, containing a series of new questions raised by DE and BE on the implementation of the BPR with regard to in situ generated biocidal products.

On question 1 it was agreed to replace the word "claim" by "intention" in the context of the reference to Document CA-May12-Doc.6.2.a.

On question 2, it was also considered that the "intention of the person placing the precursor on the market" is the key element to consider whether it falls within the BPR scope (e.g. salt sold with an electrolysis device).

On question 3, the constraints of considering the final user as the authorisation holder were shared by MSs.

MSs were invited to submit comments in writing by 15 June. The Commission will also consider producing a broader paper addressing in situ issues for the next meeting.

Document CA-May13-Doc.5.3.b was not discussed due to lack of time.

5.4. Classification and labelling For endorsement CA-May13-Doc.5.4

The document was endorsed, subject to the scrutiny reservation of two Member States.

16 17 MAY

Morning Session 9:30 – 12:30

6. Policy matters

6.1. Technical meetings

The Commission reported on the last technical meeting.

6.2. Guidance documents

6.2.a. Guidance documents on For information environmental risk mitigation measures for PT 1-5

The Commission informed participants that the adoption of the guidance document for a 6- month consultation of stakeholders was scheduled for the next meeting.

6.2.b. Guidance document on the For endorsement evaluation of efficacy of CA-May13-Doc.6.2.b disinfectants PT2

The guidance document was endorsed for a 6-month consultation of stakeholders.

6.2.c. Food and feed derogation For endorsement CA-May13-Doc.6.2.c

The Commission briefly introduced document CA-May13-Doc.6.2.c, which was endorsed by the PA&MRFG in February. This document provides an interpretation on the food and feed derogation of Art. 6 of the Review programme Regulation, as well as some criteria to be consider under a more harmonised approach whether an active substance contained in repellent or attractant biocidal products is eligible for such derogation.

CAs made some comments on the interpretation of extracts, and a clarification was added on paragraphs 8 and 14 to mention that the active substance is eligible where the substance itself is food or feed. With these amendments, the document was endorsed.

17 The CA meeting also encouraged MSs to share through the PA&MRFG the list of products benefiting from such derogation.

6.2.d. Evaluation manual for For endorsement product authorisation CA-May13-Doc.6.2.d

The revised version of the Evaluation manual for product authorisation was endorsed, subject to some changes to be made to Appendix C on encoded standard instruction phrases and to making some minor editorial verifications (e.g. use of the word active ingredient instead of active substance, addition of the page numbers, checking abbreviations).

7. Requests for opinions

7.1. Chlorine generated by combination For endorsement of urea and sodium hypochlorite CA-May13-Doc.7.1

The proposal was endorsed.

7.2. Preservatives in dipping baths For discussion CA-May13-Doc.7.2

The proposal was endorsed.

7.3. Appropriate PT for biocides used in For discussion oil extraction CA-May13-Doc.7.3

As it appeared that they were different views within industry on the appropriate PT for biocides used in oil extraction, the Commission undertook to discuss the matter bilaterally with CEFIC.

8. Review programme

8.1. Progress report on substances under For information evaluation CA-May13-Doc.8.1

A progress report on the review of applications on existing active substances was communicated to attendees, and available on CIRCABC.

8.2. Annex I-inclusions - Deadlines for For information decision making CA-May13-Doc.8.2

The deadlines for decision-making on the substances subject to discussion in the 2 next meetings were presented in the document.

18 For substances subject to a final discussion and possibly a vote at the next SCB, revised ARs and decisions should be sent to COM by 31/05/2013.

For substances subject to a 1st discussion in July and possibly a vote at the SCB in September, draft ARs should be sent to COM by 06/06/2013.

8.3. Establishment of a work programme For discussion to meet the 2024 deadline1 CA-May13-Doc.8.3

In the continuity of the discussion that took place during the last CA meeting, the Commission introduced a proposal for the organisation of the review programme, both in term of stepwise objectives to be fulfilled and in term of general principles to be followed. The overall objective is to ensure that the review programme of existing active substances is finished by the new 2024 deadline and that all products placed on the market for specific PTs are progressively subject to the authorisation scheme. Consequently, some priorities would therefore be established to ensure a proper progression of the work, while keeping some flexibility in the detailed organisation of the agenda and discussions in the Biocidal Product Committee for the delivery of opinions on active substances / PTs combinations.

In relation with the enquiry performed by the Commission and ECHA, a Member State regretted that its individual work plan was not entirely taken into account in the proposal. The Commission answered that for the benefit of the system and its global implementation at EU level, there was a need to set some priorities in the peer review of active substances: for instance, it would not be acceptable that some CARs on PT18 active substances would still be submitted in 2020 and decisions taken later on, although the applications were submitted in 2006, that most substances for that use would have been approved several years before and that guidance documents and grounds for decision making would have evolved over the time. This was the reason why deadlines were set in a stepwise approach.

The Commission also insisted that the dates mentioned in document were deadlines, and that it would still be possible, and encouraged, to send draft CARs well before a deadline. As well, discussions could take place in the BPC well before a deadline subject to the capacity of work of the BPC. Some flexibility was therefore foreseen in the proposed approach. Finishing well before 2024 would, of course, be appreciated if it could be achieved.

At the request of a Member State, the deadlines for the 1st priority list (PT8,14,16,18,19,21) for submission of all draft CARs and the subsequent delivery of all opinions by ECHA could be postponed by 1 year.

Several Member States raised concerns on the proposal that they could only send a draft CARs if the harmonised C&L and the PBT status have been clarified. These concerns were motivated by the fear to have to drastically delay the sending of the CARs if the Risk Assessment Committee (RAC) would not be able to cope with the workload generated by the biocide review programme. The RAC shall deliver its opinion within 18 months, which was considered by biocides CAs of Member States as a long period of time to wait. On the other hand, the Commission saw some benefit in having the C&L and PBT status clarified before a draft CAR is sent to ECHA, considering that ECHA has already around 3 years of work ahead with the backlog dossiers, that it would limit the need to re-open the CARs and change the

1 This item will be discussed on 16 May (afternoon)

19 conclusions, and would ease the peer review discussion and the opinion making of the BPC regarding the exclusion/substitution criteria.

The Commission concluded that there was inevitably a need to set some priorities, and would go for a stepwise approach. Discussions need to take place in the BPC to establish the detailed work programme for the coming years. Member States and stakeholders were invited to send comments to the Commission by 15 June.

8.4. Questions on in situ generated CO2 For discussion CA-May13-Doc.8.4

This topic has been raised by FR, which is the RMS for CO2 under the review programme. FR introduced its paper, which aimed at clarify the requirement for the approval of CO2 based on the current submission, and as well as what will be requested later on for the product authorisation stage.

Industry representatives pointed out that it was important for Industry to have a clear view on the approach that are followed by Member States and the Commission on this issue., and generally for in situ generation. In particular, it is important to know clearly what technical situations (for instance, what precursors on the in situ generated substance etc…) are currently covered by the dossiers currently under examination in RMSs, what companies need to do.

Looking at the various questions, the Commission proposed to draft a more general paper on in-situ generation for the next CA meeting. Member States and stakeholders were invited to send comments to the Commission by 15 June.

8.5. Policy issues related to the For information evaluation of silver CA-May13-Doc.8.5a-c

The discussion of this agenda item was postponed to the next meeting.

9. New active substances

9.1. Progress report on substances under For information evaluation CA-May13-Doc.9.1

A progress report on the review of applications on new active substances was communicated to attendees, and available on CIRCABC.

10. Enforcement and implementation issues

10.1. Use of copper in PT2, 5 and 11 For information CA-May13-Doc.10.1

The Commission listed all the application submitted so far from UK, ES and NO. Most of the 60-day commenting periods according to Article 5 of the Regulation (EC) 1451/2007 were

20 over, and the Commission will now take into account the comments received to propose a decision on each application.

FR, BE and IT informed that they were considering to send an application. The Commission urged MS that are planning to make such application to submit it as soon as possible considering that the placing on the EU market, and in these countries, is no longer possible since 1 February 2013.

10.2. Report on Risk mitigation measures For information for rodenticides CA-May13-Doc.10.2 CA-May13-Doc.10.2.a

The Commission introduced Dr. Philippe Berny (VetAgro Sup, Veterinary School of Lyon), who is the principal contractor for the project funded by DG ENV on this topic.

Dr. Berny made a presentation summarising the outcome of the first phase of the project, which was focused on the state of the art for anticoagulant rodenticides. According to the conclusions presented, anticoagulant rodenticides are still necessary, as few complementary alternatives are available today. The following recommendations were also highlighted: development of other alternatives (including bait formulation); enforcement of resistance management and integrated rodent control programs; and enhancement of professional training.

Both the presentation and the preliminary draft report on the bibliographic review carried out by the contractor have been uploaded on CIRCABC under the 51st CA meeting folder.

The Commission also invited CAs and Industry to assist the contractor where appropriate for the next steps of the project.

11. Product authorisations

11.1. Report from the Product For information Authorisation and Mutual Recognition Facilitation Group

Due to time constraints, the chairman referred participants to the minutes of the meeting.

11.2. Status report on notifications made in For information accordance with Article 4(4) of the CA-May13-Doc.11.2 Directive

Due to time constraints, the chairman invited the CA meeting to take note of the document.

11.3. Application of Article 23(4) of the For discussion BPR to anticoagulant rodenticides for CA-May13-Doc.11.3 which the authorisation decision will be taken after 1 September 2013

21 Due to time constraints, the chairman suggested postponing this agenda item to the next CA meeting in July.

17 MAY

Afternoon Session 14:00 – 16:00

12. New policy developments which may affect the biocides regulatory framework

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

The Commission briefly reported that additional discussions between DG ENV and DG SANCO are needed. There is also an on-going discussion on the approval of the orthophosphoric acid as feed preservative, while the EFSA opinion also covered its use as drinking water preservative. DG SANCO proposes to only authorise the use in feed, but DG ENV wants an explicit reference to the non-approval of the drinking water use as it is under the biocides legislation scope (PT 5).

12.2. 6th ad hoc group meeting under the For information Community Strategy for endocrine disruptors

The Commission reported on the latest discussions held at the 6th meeting of the ad hoc group under the Community Strategy for endocrine disruptors.

12.3. Commission proposal for a Directive For information of the European Parliament and of CA-May13-Doc.12.3 the Council amending Directives 2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy

The Commission reported on the agreement reach between the European Parliament and the Council on its proposal concerning priority substances in the field of water policy, and in particular on the articulation between the amended legal framework on water and the BPR.

22 12.4. EFSA conclusions on neonicotinoids For information and bees.

The Commission reported on the latest development under the Plant Protection Products legislation regarding neonicotinoids and bees.

13. International Matters

13.1. FAO code of conduct For information CA-May13-Doc.13.1

The Commission informed participants of the availability of the new FAO code of conduct.

14. AOB

14.1. List of Competent Authorities and For information other Contact Points and of list of CA-May13-Doc. 14.1 Members of the Consultation Group CA-May13-Doc. 14.1a

The Commission invited participants to send to it by e-mail any revised contact details.

23 Next meetings (provisional):

2013

PA&MRFG CA TM BPC 14 May 2013 15 -17 May 2013 TM II 10-14 June 2013 29-30 May 2013 9 July 2013 10 - 12 July 2013 24 - 25 September 25 - 27 September 2013 TM III 16-20 September 9-10 October 2013 2013 2013 8 October 2013 (pm) (tbd) December 2013 10 - 12 December 2013 TM IV 25-29 November 2013

2014-2015

CG CA BPC 15 January 2014 11-13 February 2014 11 March 2014 12-14 March 2014 8-10 April 2014 13 May 2014 14-16 May 2014 17-19 June 2014 10 July 2014 30 September - 2 October 2014 16 September 2014 17-19 September 2014 2-4 December 2014 11 November 2014 12-14 November 2014 3-5 February 2015 14-16 April 2015 16-18 June 2015 29 September - 1 October 2015 1-3 December 2015