DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D - Water, Marine Environment & Chemicals
ENV.D.3 - Chemicals, Biocides and Nanomaterials
Representatives of Member States Competent Authorities for the placing of biocidal products on the market (Directive 98/8/EC)
Product Authorisation and Mutual Recognition Facilitation Group
Ad HocWorking Group on Substances of Concern
10th December 2012 – Brussels, ENV ROOM BU-5 0/B (Beaulieu)
From 14.30 to 17.30
Draft minutes
The working group welcomed industry (IND) representatives from CEFIC and AISE. A. Las Heras also introduced Karin Kilian, thenew colleague in DGENVbiocides team. Karin has been working in DG SANCO and has expertise in dealing with scientific committees and issues related to cosmetic products.
- Adoption of draft agenda (PA&MRFG-SoCWG-Dec12-Doc01)
The proposed agenda was adopted without further additions.
- WG mandate and objectives (PA&MRFG-SoCWG-Dec12-Doc02)
The Commission (COM) introduced the updated version of the document, which was intended for adoption. CEFIC proposed an editorial change in the text. AISE also proposed to add to the WG instruments some information from REACH, or other sources, such as OECD chem-portal or the use of QSAR. AISEagreed to send a proposal for this sentence.
CEFIC has also concerns about the mention in the text to carry out a "full" risk assessment of the SoC. DK clarified that it should be a risk assessment done according to point 5 of Annex VI to BPR. The extent of the risk assessment could vary, but it has to be done in the same manner as for the active substance. However, the purpose is to be as much pragmatic as possible in terms of data requirement and make use of REACH information, etc. SE proposed to remove the “full”, but to keep the risk assessment, as mentioned in the Regulation. It was concluded to delete the word “full” for the risk assessment.It was also agreed to delete the half-sentence "…and also taking into consideration the exclusion criteria as referred to in article 5.1" – as it is referred to active substances.
On the revision of the TNsG on this topic,CEFIC proposed to make the connection with the Evaluation Manual (EM) for Product Authorization. COM will to check if the EM contains section on SoC, and to comment on that.
Conclusions: COM to amend the paper according to the discussion and AISE's contribution. Updatedversion to be forwarded to the WG for final adoption.
- Feedback from the TM discussion:
COM briefly introduced this agenda itemand apologized for some papers being made available with short notice before the meeting. It was mentioned that the outcome from the TM discussions was not conclusive so additional discussion will be still needed both in the WG and at TM level.
a) Human health issues(PA&MRFG-SoCWG-Dec12-Doc03.a.1-5)
COM presented the TM outcome, which did not cover all the issues sent by the WG in September, as well as the different documents and reactions from MSs following the TM meetings.
On the check-list, SE explained that they were surprised following the TM discussions, as the list prepared by them was a pre-screening tool, and not a decision tool. CEFIC raised some concerns on the checklist criteria as it seems to be considered as a positive checklist;if so then a negative checklist should be also proposed. The key aspect is to make clear when you do need to do the risk assessment. SEclarifiedthat for ENV, as shown in the DK proposal, the checklist is just the first step. SE intended to have a tool after which to have a quantitative risk assessment,or in other cases,a qualitative risk assessment. It is also up to IND to demonstrate why you do not need to do a risk assessment for a particular SoC in the context of a givenproduct.
UKunderlined thatafter applying this checklist, a lot of SoC will be identified, so more work need to be done on what to do after you identify a SoC following this checklist. In this context, JRC asked for clearer guidance to inform further discussions on the HH session of TM.
DKsupports the checklist is for both HH and ENV sessions (SDS- not to be used for the ENV part).DK does not agree with the concentration limit proposed by UK, giving examples of rodenticides, with active substances less than 0.05%. SE does not want to have a general concentration limit of 0.1%. UKclarified that theproposed concentration limit of 0.1% came from REACH, also proposing their comments be fed to the TM. For the ENV part, DK does not want to have the concentration limit, to comply with point 48 of Annex VI to BPR (PBT, vPvB, endocrine disruptors). DE shared the concerns of DK on the concentrations of the SoC, for example in the case of rodenticides. It would be difficult to send a generic concentration limit, having in mind that the REACH evaluation is still going on. The generic concentration limit should not be part of the list.
AISE asked for clarification on how to deal with substances identified then.DKstated that if you have a group of substances flagged under REACH, you can use that for biocides as well for Annex I inclusion. NL mentioned that the CLP would only come later for some substances, and how to do with the biocides evaluation until then? UKwere concerned that the some of the suggestionsmade for co-formulants (general chemicals) go beyond the requirements of the REACH and CLP Regulations.
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SEstated that it would be difficult to have a generic concentration limit, but this may be used as an explanation from IND in the context of the SoC identification.DK is not against a concentration limit.
On the request of the COM,SE clarified that the checklist was intended both for the HH and ENV parts. AISE asked if there will be Phys-Chem part, to which SE responded that they did not envisage a different checklist for the Phys-Chem part.
UKasked for more detailed discussion at the TM. COM supported this option, which is also pending for the rest of questions sent to TM. JRC highlighted the busy agendas and the lack of time in the HH session to discuss all the outstanding issues in depth.
Conclusions:
- It was agreed that a workshop would be the better format to discuss all the HH issues at TM.COM and JRC to discuss on the logistic details.
- UK to share the document with the comments submitted by MSs for TM IV with the WG. WG to reflect on these comments to better focus discussionsat TM.
- SE to revise the checklist document and provide some ideas of further steps following the screening list (i.e. in the form of decision tree). The updated document to be shared with the WG before being sent for the next TM.
b) Environmental issues(PA&MRFG-SoCWG-Dec12-Doc03.b.1)
COM introduced the TM outcome from the ENV part, where the two proposals from DK and UK are available. It was also highlighted the possibility to make a side by-side comparison of the two approaches before taking a final decision.
DE welcomed the proposal from UK at page 7 of the UKdocument; namely, comparing PEC/PNEC on SoC. NO also recognized the updated UK paper addressed some of the concerns expressed before, so therefore it should be given an opportunity to check how it works.
UK supported the comparison of the both approaches, whileDKunderlined that this exercise would be highly resources consuming. COM would also favor such a comparisonas it could be the only way of having a clear picture on how they would work and workload necessary (which is relevant for CAs), and presenting this to the TM so TM could give a clearer opinion to the SoC WG.
AISE asked consistency in biocides with the mixtures under REACH. COM clarified that the discussion about mixtures are the next agenda point. DE mentioned that the workshop on mixtures took place in connection to TM, and now DE is drafting the guidance.
Conclusions:
- WG decided to carry out the comparison between examples of various PTs (i.e. PT8 and one disinfectant) under both DK and UK proposals.
- DK and UK to consult bilaterally and get also help from other MSs. This may take time, and it may not be ready for TM I 2013.
4. Other on-going discussions:
Due to the lack of time, the following points were only briefly discussed:
b. List of available sources of information:
COM made the connection of this point with the discussion on the mandate for the WG, informing about the possibility to include in the SoC guidance an Annex with the available sources of information. AISEsuggested to add the OECD Chem Portal, for which access is also available via ECHA website. AISE asked if the list of available sources only gives examples or if all them are expected to be checked. COM and SE responded that these are examples. SE mentioned that there are also other lists for other Regulations, like cosmetics, which could also be used.
DE also raised the issue of the discrepancies between the classifications in different SDSs as well as within the information available at the ECHA website, which deals with MR problems. The need for MSs to use all a harmonised approach was stressed.
c. SoC database
COM mentioned that in the R4BP it could possible to flag that a substance is SoC, and this could help MSs later on to optimize resources when performing the product assessment. NO mentioned that flagging a substance as SoC depends on some specific product features, including concentration, so this could only be done in the context of a given product assessment. In addition, this would be available to MSs, and not to IND which is responsible for the identification on SoC. Debates on the ownership of the data of the databases that can be taken in consideration.
DE started compiling info on substances that DE did assess, as a database for potential SoC. Itwas based on classification (a presentation on this database was made in the Vienna Conference by Dr. Worseck).UKbelieved that for human healththe primary source of information on co-formulants should be the supplier SDS and that, at a maximum, the only other information sources to check be the Annex VI of the CLP, the C&L inventory and the REACH dissemination website. The UK also felt that a harmonised process needed to establishedincluding which data sources should be used, what to do if thesources contain more than one value (e.g. choose worst case?),and that this needed technicalinput.
5. Interactions with other on-going initiatives(PA&MRFG-SoCWG-Dec12-Doc05.b[1])
b. Workshop on mixture toxicity assessment in biocidal product authorization
DE presented the work on the mixture toxicity workshop, and the work done on the draft guidance which will be released for consultation with WS participants. It will be then submitted to next TM. DE also highlighted that SoC are includedin the guidance document, so the outcome of this WG is relevant for the future of this document. DK mentioned that their proposal for the ENV side is based on the cumulative assessment approach.DE stated this WG should provide a tool to identify SoCs and decide on the data to be required to perform risk assessment according to the mixture toxicity guidance.
6. Any other business
None.
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[1]This document has been uploaded in the December meeting folder of the WG space on CIRCABC.