New information requirements for registration
On June 1, 2023, the European Chemicals Agency (ECHA) began completeness checks on REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) registration dossiers. Indeed, the REACH regulation on the registration of chemicals requires new information requirements.
The checks apply to all types of dossiers, whether they are new registrations or updates of existing dossiers. ECHA will check that dossiers comply with the new requirements.
What are the reasons for these changes?
In 2021 and 2022, many changes have been made to REACH, including the information requirements for registering chemicals under REACH. The decision was taken by the European Commission (EC), and controls are carried out by ECHA.
The changes concern :
- Substance identity: to ensure correct and consistent identification of the limit composition of a substance and its constituents and additives on the basis of the clarifications made in Annex VI.
- Standard information requirements based on Annexes VII-XI: to help registrants communicate information on effects concerning mutagenicity, degradation and aquatic toxicity based on the information requirements of Annex VII-XI. Registrants adding a new adaptation of evidence will be asked to provide arguments in favor of the approach in a more structured format.
ECHA has made available an IUCLID (International Uniform ChemicaL Information Database) validation wizard for registrants, to give them the opportunity to check their registrations before submitting them.
ECHA's objective is to control all substances registered above 1t/year by 2027, to prevent any possibility of non-conformity of chemical substances and to ensure the safety and management of chemical substances within the European Union.
ECHA has added 2 new substances to the candidate list
The candidate list of substances of very high concern (SVHC) was updated on June 14, 2023 with the addition of 2 new substances, and now includes 235 entries.
ECHA web page for revocations
ECHA has launched a web page to provide information on its REACH registration number revocation process. The agency can revoke a registration in two situations:
- If the company is no longer established in the European Economic Area (EEA)
- If the company benefits from reduced registration due to misrepresentation of its size
If ECHA decides to revoke a company's registration, the company may temporarily or permanently lose its REACH registration number. Thus, the company loses its authorization to manufacture or import its substance into the EEA.
CMR substances added to REACH restrictions list
The European Commission has added 24 new category 1A or 1B CMR (Carcinogenic, Mutagenic or Reprotoxic) substances to the REACH Annex XVII restrictions list. These include ammonium bromide, theophylline, 2-ethylhexanoic acid and its salts, and 2,4,6-tri-tert-butylphenol.
The inclusion of these substances on the REACH restriction list will lead to a ban on their marketing and use from December 1, 2023.
Non-animal test method
ECHA has published its 5th report on non-animal in vitro test methods under the REACH regulation. In this report, ECHA explains that the use of non-animal tests for alternative test methods has seen little change overall in the European Union. However, the agency has noted that in vitro studies are increasingly being used to assess the safety of chemical substances.
The concept of non-animal test methods has been gaining ground in recent years. The aim is to avoid unnecessary animal testing, by opting for alternative methods such as isolated tissues, organs or cells.
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