REACH Dossier Updates: EU States Propose Implementing Regulation
Along with Norway, three member states of the EU, France, Netherlands, and Hungary, have called for regular, obligatory updates of REACH dossiers and argued strongly for an implementing regulation. They formulated their position in special papers submitted after a discussion of 5 of the 16 REACH review actions at the June meeting of Competent Authorities for REACH and CLP (CARACAL). They argue that the proposal would not define any new obligations, but simply explain the existing ones. The central point is to clarify the conditions set forth in Article 22.
The article states that after each registration, the registrant is responsible, “on his own initiative” and “without undue delay”, for updating the registration based on relevant new information and to transmit the information to the agency. Nevertheless, the text clearly leaves room for interpretation, so that many companies update their registrations only after an express request from the ECHA.
According to the argument made by France, companies should be obligated to review their registrations from time to time. Companies should be able to document the performance of a routine review in IUCLID in cases where an update is unnecessary. Along with France, the other three member states regard an implementing regulation as the pragmatic solution.
The four countries are not alone in their concern. Both industry associations, the Downstream Users of Chemicals Coordination Group (DUCC) and Eurometaux, support mandatory updates according to Article 22. For example, Eurometaux calls for a “clear and systematic process” for updating dossiers. The association also suggested a checklist that could help companies in consortiums determine when an update is necessary. Sample items in the checklist include:
- Substance identity profiles (for new registrants)
- Hazard profiles and classifications for humans and the environment
- New scientific findings that lead to changes in classification, safety data sheets, and chemical safety reports
The executive director of the ECHA, Bjorn Hansen, has also identified Article 22 as a weakness. In a speech at the REACH Review Conference in June, he admitted that REACH is weak in terms relation to registration updates. As early as September 2017, a report sponsored and published by the agency stated that new regulatory measures must ensure that updates occur at regular intervals – every three years, for example.
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