CA-July13-Doc.2 – Draft minutes with comments from AISE, DE,Lanxess and the UK
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
1
15 MayRegistration 09:00 – 09:30
Morning Session / 09:30 – 13:00
- Adoption of the agenda
CA-May13-Doc.1
The agenda was adopted as proposed.
- Adoption of the draft minutes of the previousCA meeting
CA-May13-Doc.2 – with comments from FR, SK and UK
The minutes were adopted as proposed.
- Final discussions on draft regulatory measures
3.0Note on the principles for taking decisions on the approval of active substances / For discussion
CA-May13-Doc.3.0
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 apay particular attention to the new elements brought introduced 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 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 substanceswhen 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 MemberState 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 consequencesonforthe decision-making (ex: 2 out of the 3 PBT criteria, or on endocrine disruption properties). Another MemberState 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 MemberState 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 concludedon the general support of Member States on the principles presented in the document, although a few Member States needed still some reflexionreflection. The Commission will check with DG SANCO the provisions on SMLs, and reflect on the need of for a withdrawal notice in case of the positive listing. MemberStates 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 Regulation and draft assessment report for the approvalof cypermethrin for PT 8 / For discussionRMS: BE
CA-May13-Doc.3.1
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 MemberStates 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 adsorptionabsorption that should be justified in the applications for product authorisation, and proposed as well a 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 MemberState 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 Regulation and draft assessment report for the approvalof propiconazole for PT 9 / For discussionRMS: FI
CA-May13-Doc.3.2
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 MemberState 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 MemberState 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 adsorptionabsorption 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.
- First discussions on draft regulatory measures
4.1.Draft Commission implementing Regulation and draft assessment report for the approvalof IPBC for PT 6 / For discussion
RMS: DK
CA-May13-Doc.4.1
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 a 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.
Similarly to cypermethrin, a specific paragraph concerning dermal adsorptionabsorption in the applications for product authorisation will be added in section 3.3 of the AR, and the provisionconcerning the need to establish collective protection before using PPE will be revised.
There is a need to clarify if the potential for sensitization should entail some provisions in relation with to 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 Regulation and draft assessment report for the approvalof Tebuconazole for PT 7 and 10 / For discussionRMS: DK
CA-May13-Doc.4.2
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 a 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.
Similarly to cypermethrin, a specific paragraph concerning dermal adsorptionabsorption in the applications for product authorisation will be added in section 3.3 of the AR, and the provisionconcerning 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 (specially the classification as vP in sediment) according to REACH needed further discussion, which was not accepted during the meeting as clear a conclusions for the water compartment according to the TGD was had been drawn up in the Technical meeting. Furthermore, this substance has already been reviewed for PT08 before and so it was the second time that the applicant had the opportunity to discuss these this 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 Regulation and draft assessment report for the approvalof Benzoic acid for PT 3 and 4 / For discussionRMS: DE
CA-May13-Doc.4.3
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 MemberState 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 RMS will check whether a specific paragraph concerning dermal absorption is necessary.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.
A MS noted that there was no information on the environment risk assessment in Section 3.1 and that there was misleading information which needed to be altered regarding benzoic acid being ubiquitous and residues from the application of biocidal products not being expected to occur.
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 Regulation and draft assessment report for the approvalof Aluminium phosphide for PT 20 / For discussionRMS: DE
CA-May13-Doc.4.4
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, although one MS suggested that the Implementing Regulation should include a specific provision to restrict bystander access to the site being treated.
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 MemberState, motivated by the level of risk of the soil compartment. This element surprised the Commission, as the potential of for 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 MayAfternoon SESSION / 14:30 – 18:00
4.5.Draft Commission implementing Regulation and draft assessment report for the approvalof Etofenprox for PT 18 / For discussion
RMS: AT
CA-May13-Doc.4.5
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.
Similarly to cypermethrin, a specific paragraph concerning dermal adsorptionabsorption in the applications for product authorisation will be addedin section 3.3 of the AR, and the provisionconcerning the need to establish collective protection before using PPE will be revised.
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 Regulation and draft assessment report for amending the conditions ofapprovalof Nonanoic acid for PT 2 / For discussionRMS: AT
CA-May13-Doc.4.6
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.
One MemberState considered that the ESD used for the assessment needed to be improved and asked ECHA to include this work in its future tasks. Another MemberState suggested having more general provisions in the approval decision to mitigate the risks for the environment. A MemberState 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 adsorptionabsorption 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 Regulation and draft assessment report for the approvalof Bromoacetic acid for PT 4 / For discussionRMS: ES
CA-May13-Doc.4.7
CA-May13-Doc.4.7a
The RMS presented the AR on Bromoacetic acid for PT04. One MemberState 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 does not intend to incorporate this substance in treated articles.
Another MemberState 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.