24 March 2022, the European Commission published Regulation (EU) 477/2022, formalising important changes to Annexes from VI to X of the REACH Regulation.
These annexes set out the minimum information that registrants are required to submit in their registration dossiers (broken down by tonnage bands) and give to the Chemical Agency the possibility of requesting additional experimental tests and information in the dossiers.
The main requirements introduced or amended by the EU Commission in the various annexes are listed below. Most of the concepts and requirements that have been standardised were already defined in the ECHA guidelines or were methods/operations/requirements of ECHA's practice to an expert further evaluation.
- Only Representatives (OR) (ref. Annex VI): obligation to provide information on EXTRA-EU suppliers for whom they are representatives
- Submission of information on substances subject to registration (ref. Annex VI):
- obligation for member registrants to describe the composition, nano-form or set of similar nano-forms related to the information submitted by the lead registrant.
- clarification of requirements for reporting constituents, impurities and additives for substances of unknown or variable composition, products of complex reactions or biological materials (UVCB)
- definition of the qualitative and quantitative analytical information useful for identification of the substance to be registered (data from UV, IR, NMR, MS or diffraction analysis);
- obligation to include a description of analytical methods or experimental protocols justifying the interpretation of the experimental data obtained.
- - Reproductive and developmental toxicity studies (ref. Annexes VII; VIII; IX; X):
- defining the animal species to be evaluated (rat)
- establishing the routes of exposure to the substance under investigation according to its physical state: oral route for solid and liquid substances; inhalation route for gaseous substances.
- choosing of a different species or route of administration other than those just mentioned (e.g. rabbit and dermal route) can only be made after a justification relevant to the case.
- Long-term aquatic toxicity studies and degradation and bioaccumulation studies (ref. Annexes VIII; IX; X):
- Introduction of the possibility for the Chemical Agency to require or propose long-term aquatic toxicity studies for registrants if the relevant short-term toxicity tests are insufficient for an adequate chemical safety assessment.
- information on degradation and bioaccumulation may be requested by the Chemical Agency or proposed by registrants if it is necessary to investigate PBT or vPvB properties of the substance under investigation.
Before this update, these kinds of studies were the prerogative of the higher tonnage bands (Annexes IX-X) whereas now the Agency's request for their integration is extended to Annex VIII.
All the new features and changes made to these annexes give more flexibility to registrants that want to propose new tests, but also give the Chemical Agency broad power to require them.
This possibility will have a major impact on registrants who can share the payment of tests required and conducted by lead registrants, and on keeping updated their registration files.
ECHA is updating its guide and will publish advice on requirements for registrants in the second half of 2022.
Source: European Commission