FR proposal for fine-tuning the substance evaluation process
This proposal has been prepared after the Workshop on Substance Evaluation (SEv) organized by ECHA on the 23 - 24 May 2013 and in response to ECHA’s document AHCA/09/2013 on substance evaluation (presented at the ad hoc meeting of the MSCAs in July 2013). It presents the French position on the Substance evaluation process, notably on the various points discussed during the workshop and/or raised by ECHA in relation to SEv.
1. Introduction
These proposals are based on the experience gained after the first round of SEv during which Anses[1] evaluated 3 substances, after 2 rounds of manual screening and after 3 updates of the CoRAP.
2. Main topics for discussion and agreement
2.1 SEv process – Experience from the first year of evaluation
· Interaction between evaluating MSCAs (eMSCAs) and Registrants.
FR believes that European harmonised approach regarding eMSCA interaction with the Registrants is imperative to ensure equal treatment.
Based on its experience, FR is convinced by the added value of interacting with the registrant while evaluating the substance. In some cases, the registrants have already contacted Anses when the substance appears in the CoRAP. FR proposes to ensure that registrant will be contacted (by email for example) as soon as CoRAP has been updated. Early contacts explaining the concept and content of SEv to registrant(s) will allow them to update their dossier upfront SEv in order to increase the overall quality of the dossier(s) evaluated and to avoid later updates during SEv. Additional e-mail exchanges with the lead (as a minimum) are also possible if needed.
Robust study summaries are, for most of the cases, not sufficient to discuss the study (assessment factor, DNEL…), evaluate the rational (which is the key study…) of the evaluation performed by registrant. Thais is whihy full study reports are sometimes asked by Anses who believes that they are useful for performing a relevant evaluation, especially on the endpoints of concern.
However, FR thinks that the outcome of the evaluation process (i.e Sev report and DD) does not have to be discussed with the registrants; FR is not in favor of sending SEv report nor DD to the registrant(s) for comments before submitting it to ECHA.
FR encountered difficulties during SEv because of the poor information on certain uses/ exposure from downstream uses. Requesting these clarifications in the DD does not allow obtaining them because most of the DU are not involved in the commenting of this DD.
Registrants should be requested to improve the communication along their supply chain.
· Lessons learned from consistency screening of draft decisions (DDs).
The consistency screening performed by ECHA on FR’s DDs was very valuable. Because this greatly improved the quality and the homogeneity of the DDs, FR thinks this service should be carried on again if possible and notes that ECHA would appreciate receiving DDs for consistency screening earlier and more evenly distributed during the next evaluation round.
2.1 SEv process – How to improve documentation and harmonize information request
Although the role and content of the DD is obvious, FR is willing to discuss in details the purpose and format of the substance evaluation report (SEv report)
· SEv DD template
FR has no comment on this revised DD template and agrees to use this template for evaluations in 2013. We welcome the fact that reference to the annexes can be used as an added reason for requesting a study during SEv.
· (Interim) SEv report.
Opportunity/Role of SEv report: FR is of the opinion that each eMSCA shall systematically draft a living SEv report to document the progress and intermediate conclusions of each substance evaluation. This report should in particular serve as a basis for discussion with other MSCAs, when discussing DDs (during the decision making process) and conclusion documents (in Rime Meetings).
Content of the SEv report: FR points out that it is not necessary to duplicate the SEv information (annotated aggregated IUCLID dataset and SEv report). Instead, FR is willing to create a document having a real added value (ie not (ONLY) a copy paste of the IUCLID by using the CSR-plugging) regarding the rationale for the DD. FR would welcome a document aiming to explain the reasoning of the evaluation outcomes performed by eMSCA. FR agrees with DK that there should be a synergy between the format and structure of registrants’ Chemical Safety Reports, SEV reports, and reports for proposing harmonised Classification & Labelling, identification of substances for the candidate list and restrictions. ECHA is developing SER-plug-in and FR is willing to see the outcome. We hope that this plug-in will incorporate the annotation and exclude the CBI information.
(interim) Confidential SEv report should be shared with the other MSCAs but not with the Registrants, because of CBI information contained in the aggregated dossier coming from various registrants and that might be difficult to separate at the end of the process (e.g. FR would like to recall that in the case of Formaldehyde’s evaluation, FR and NL have to deal with approximately 100 dossiers).
FR agrees with ECHA that DD is a self-standing document and the only document to be formally submitted to the registrants. All relevant background information/justification and reasoning relating to the requests need to be present in the DD text.
The interim SEv report is a working document allowing eMSCA to record/check the work done and explaining to the other Member States the complete rationale behind the outcome of SEv (DD or conclusion document to be produced later).
FR agrees that the final SEv report should be published on ECHA’s website at the end of SEv as supporting document of the Conclusion document. FR believes that ECHA should ensure that (or at least should provide dedicated legal support to eMSCA asking for it to ensure that) the final SEv report (for publication) does not include any CBI nor violation of copyright. Indeed, ECHA has a recognized expertise and experience of CBI and copyright issues, which many of (not to say all) eMSCAs have not.
· How to improve exposure assessment under substance evaluation.
FR believes that ENES is helping a lot clarifying the issues on human exposure. The level of requirement when evaluating exposure scenarios (assessment of the calculation of each exposure scenario, representativity of the data provided, efficiency of the RMM/ PPE proposed, management of the diffuse emissions, local vs regional scale…) still needs to be harmonized among MSs. Up to now, it seems that the workload represented by this evaluation is greatly dependant on the number of dossiers per substance and of the level of detail/justification found in these dossiers.
This is while evaluating exposure scenarios that DU implication is necessary to carry on an efficient and valuable substance evaluation in terms of safe use of chemicals.
· Aggregated IUCLID dataset.
FR finds appropriate receiving aggregated IUCLID data sets within 1 month of the official starting date of SEv. This lets enough time to check if any technical problem occurs with the aggregated dossier (eg. Copy protected ESR).
It is important that eMSCAs are informed of any dossier updates received. FR strongly encourages that ECHA provides information by Reach IT or by e-mail on the updates for substances undergoing evaluation until the conclusion document is agreed.
2.3 Interface between SEv and other evaluation processes SEv
In a general manner, FR supports the general principles of the CCH approach for CoRAP substances. FR emphasizes the importance of collaboration between eMSCA and ECHA, during drafting CCh DD, while discussing with registrant and when receiving the requested additional information.
Regarding CCH for substances in the CoRAP, it could be efficient to give the possibility to eMSCAs to ask for a CCH before SEv at the manual screening step. Until now, the format of the justification document’s template is not designed to do this. An additionnal case “CCH prior to SEv” would be useful and would help the prioritization of the substances in the CoRAP.
2.4 SEV process – Submission of outcome documents and further steps in the process
· Extension of the period for Registrants’ comments on the draft decision.
Although FR recognizes the difficulty for industry to gather the comments in 30 days, FR prefers to stick to REACh and agrees on option 2 (keep an official 30 days commenting period, with derogation made by ECHA on a case-by-case basis). FR welcomes the proposal to let this decision at the discretion of ECHA.
The added value of the commenting period will not be increased by extending the duration of the commenting period but by ensuring DU involvement. Information on ECHA website might be a way to inform DU on the commenting phases ongoing.
· Consideration of dossier updates before the notification of the DD for
PfAs.
FR agrees that eMSCAs consider dossier updates submitted within the period for commenting of the DD and interfering with the content of the submitted DD before it is notified to other MSCAs and ECHA for PfAs. If the Registrant has indicated the intention to provide information relevant to the DD within a reasonable and specified time following the expiry of the commenting deadline, that has been agreed with the eMSCA (agreed deadline), this update might also be taken into account. So FR favors Option 1 (Only if the dossier update is submitted within the period for commenting of the DD) by default and Option 3 (Only if the dossier update is agreed in advance with the eMSCA with a specific deadline for the submission in specific and RARE cases)
FR proposes that dossier updates received while evaluating are not taken into account after the first trimester of starting the evaluation unless the dossier update is agreed in advance with the eMSCA with a specific deadline for the submission in specific and RARE cases.
Late updates during the SEv process and those received during the commenting period (before it is notified to other MSCAs and ECHA for PfAs) will be taken into account in the case they are relevant for the concerns dealed within the DD.
FR would welcome receiving clarifications from ECHA on how to consider “new registrant(s)” after the DD was sent for 30 day-comments to other registrants (“new registrant(s)” being owners of registration dossiers which were submitted to ECHA after the evaluation year, when other/old registrants were in their DD-commenting period). Indeed, these new registrants may provide new important information that justify adding a request in the DD, and such information may not be necessarily submitted by the lead registrant. These new registrants will not be addressees of the DD for comments (as their dossier did not exist at the time of the DD notification by the eMSCA to the “old” registrants). However, the final decision sent to “concerned registrants” (presumably the registrants that could comment on the DD) mentions that “This decision is based on the registration dossier(s) on [date], i.e. the day on which the draft decision was notified to the Registrant(s) pursuant to Article 50(1) of the REACH Regulation. / This decision is based on the registration dossier(s) on [date], i.e. the day until which the evaluating MSCA granted an extension for submitting dossier updates which it would take into consideration.”: therefore if the other/old registrants comment on the DD, should the eMSCA take into account the dossiers of the “new registrants” (as previously defined) or not ? If yes, how should the eMSCA proceed (considering that the final decision cannot be sent to the new registrants if these registrants were not given the right to comment on the DD)?
· Should information linked to new registrants’ dossier be requested in a decision sent to other (old) registrants ? or
· Should the eMSCA organise officially a second 30days commenting round for these “new registrants”?
One important issue is also to make it really clear what information has been taken into account or not for the evaluation. Substances uses are evolving everyday and a registrant must update its dossier as often as needed. It is therefore important to link a SEv conclusion to a date and a version of each dossier evaluated and to specify if known dossiers have not been taken into account and why (i.e. too late in the process, dossier with pending status in the conformity check procedure, etc). It would help a lot future evaluation.
· Follow up - preparation of the conclusion document.
After finalizing the SEv, the conclusion document in accordance with Article 48 of REACH will be prepared.
FR agrees that the draft template contain the RMO analysis in order to minimize the number of documents to be prepared.
As stated during the SEv workshop, FR believes that the content of the conclusion document shall always be discussed in a RIME meeting with other MSCAs before being published.
The document presented by ECHA at the July ad’hoc meeting mentions that “no clear need for consultation was raised for cases where no follow-up action is proposed” by the eMSCA. FR does not agree and believes that the conclusion document should always be discussed in RiME including where no follow-up action is proposed. In particular if a substance evaluation is concluded without DD, the case may arise where other eMSCAs may never cross-check the evaluation of one eMSCA, which is clearly not suitable (considering in particular that once evaluated, a substance should not be evaluated again).