European Centre for Ecotoxicology and Toxicology of Chemicals
ECETOC
ECETOC is a scientific, non-profit making, non-commercial trade association with a mission to act as an independent, peer-reviewed technical resource to all concerned with the identification of research needs and provision of scientific rationale for the assessment of health effects and environmental impact.
ID: 07168816617-21
Lobbying Activity
Response to Introducing new hazard classes–CLP revision
18 Oct 2022
ECETOC welcomes the opportunity to comment on the proposed inclusion of the new hazard classes, including for substances considered as persistent, mobile and toxic (PMT), and/or very persistent and very mobile (vPvM), by amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (CLP Regulation).
Development of guidance:
For a successful implementation of the new hazard classes in the CLP Regulation, a thorough and clear guidance needs to be available before the entry into force of the regulatory requirements. For that, appropriate transitional periods need to be established.
PMT/vPvM criteria:
ECETOC established a task force (TF) in January 2019 to support the underlying criteria for the protection of European Union (EU) drinking water resources from chemical contamination. The aim was to critically evaluate criteria for identifying PMT and vPvM chemicals under the EU REACH Regulation that were initially proposed by the German Environment Agency (Umweltbundesamt – UBA) . The work was completed in 2021 (ECETOC Technical Report No. 139) and is available through the ECETOC website .
The main findings are summarized within a manuscript that was recently submitted to a peer reviewed scientific journal . Within this manuscript, the TF focused on the scientific basis for mobility which dictates the migration of chemicals drinking water sources. This scientific basis was evaluated and a critical analysis of the deviation of sorption metrics from simple behaviour was carried out. Based on the TFs evaluation, a Koc may be used for non-ionic substances on a screening level only, requiring a subsequent higher tier assessment. The TF further recommended to use the Koc to develop one or several leachability indices (e.g. GUS index) at the screening level. Use of Koc is considered inappropriate for hydrophilic and ionizable chemicals, particularly for soils with low organic carbon (OC) contents, and further research effort is required to determine which metric could be applied as a reasonable surrogate.
In order to inform the EU Commission´s work on the introduction of new hazard classes for PMT and vPvM substances into the European CLP legislation, the derivation of a tiered approach was proposed by the TF (Figures 4.4 and 4.5 of ECETOC Technical Report No. 139). The proposed tiered approach utilises the weight of evidence (WoE) available, with adoption of appropriate higher tier models/tools commensurate with the nature of the substance and the data available, which is in-line with the WoE proposal indicated in Section 4.4.2.4.1 of the Draft Delegated Regulation Annexes. Furthermore, ECETOC notes the importance of developing sound science-based approaches to facilitate the successful implementation of a WoE approach for Mobility, and, would be willing to discuss such technical developments with the Commission and ECHA in due course.
ECETOC supports further clarification, related to the applicability of such higher tier information similar to the bioaccumulative (B)/very bioaccumulative (vB) assessment within the EU criteria for persistent, bioaccumulative and toxic (PBT)/very persistent and very bioaccumulative (vPvB) substances. In fact, ECETOC suggests that the need to generate such higher tier test information may be limited to substances meeting the screening criteria for M and/or vM only.
It is noted that one finding of the TF was that the detection of chemical substances in drinking water sources did not seem to be correlated to Koc and biodegradability, alone, in EU-wide monitoring campaigns. This suggests that these simplistic metrics may not identify the chemicals that are likely to contaminate drinking water sources, and hence consideration of higher tier information is key.
We remain available for any further clarification.
Dr. Blanca Serrano
Secretary General of ECETOC
Read full response16 Aug 2022
ECETOC welcomes the opportunity to comment on this initiative, which would be a key step in the implementation of the “One Substance-One Assessment” action from the Chemical Strategy for Sustainability (CSS).
Below you will find highlighted comments, more details can be found in the attachment.
LEGISLATIVE PROPOSAL ON DATA ACCESS
The use of a harmonised tool is positive. The use of IUCLID would be the logical choice, a full revaluation of the tool should be carried out. Among the issues that need to be addressed are the shortcomings in data structure and issues with automatic data import/export.
The governance of IUCLID should be revised. We support a cooperative approach with stakeholders from industry and academia to steward tool developments . Any revisions or new versions of the tool should be consistent, independently of the sector or Agency that is carrying it out.
REMOVE LEGISLATIVE OBSTACLES FOR DATA RE-USE
ECETOC supports the re-use of data by the different EU Agencies. We support alignment between different EU bodies and duty holders and the use of common vocabularies and dictionaries, which would facilitate a common understanding.
When sharing information among different agencies the highest level of confidentiality needs to be respected. Highest confidentiality needs to be given to studies during an approval process, i.e. before a candidate product is subject to regulation.
Data should be connected to purpose. The creation of massive databases should be avoided as having access to more information could be counterproductive if the massive amount of data complicates evaluation.
DATA DISSEMINATION
ECETOC agrees that data shared in an open platform can have a very positive impact, e.g. improving read across. However, adequate consideration should be given to Confidential Business Information and IP of such studies.
In order for the data dissemination to work is the necessary to consider alignment of the transparency and dissemination requirements from the different sectorial legislations.
Only interpreted data should be published and made publicly available to avoid misinterpretation of complex studies.
We strongly encourage a clear definition on what information needs to be provided and will be made publicly available, to avoid misuse of resources for storing data and putting an unnecessary burden on the notifiers/registrants.
We would also like to encourage considerations of improved opportunities for read-across given the significant amount of information available in submitted dossier, but sparsely available to individual companies.
DATA GENERATION
ECETOC supports the implementation of a data generation mechanism for well-defined use-cases. It should be used whenever an added value of the commissioned studies can be proven. The use of the mechanism should never stand in conflict with the overarching principle defined in the REACH-Regulation that it is the role of the industry to prove that their products are safely produced and placed on the market.
Studies must be conducted in the relevant form of the substance, i.e. the form available in the market to ensure that data generated is suitable for use in environmental and human health risk assessment.
The selection of the Contract Research Organisation (CRO)/Testing facility is also critical, adequate expertise and understanding of the material being tested will be key for good quality results.
NOTIFICATION OF STUDIES
ECETOC agrees in principle to a notification system for studies. We strongly encourage the EU Commission to build on the lessons learned from food regulation. The notification has to be fit for purpose and in line with established chemical regulations, the scope must be clear and the limits defined. Special consideration should be given to a well-defined integration of notification and dossier processes to limit administrative overhead. In the notification process confidentiality of R&D data must always be ensured.
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