The Commission proposal for a revision of the REACH regulation is expected in the first quarter of 2023. Although the final content of the proposal remains unknown, the Commission has already addressed several aspects of the review through discussion documents exchanged with the CARACAL working group of competent authorities of the Member States.
One of the papers addresses a proposal to substantially increase information requirements in the 1-10 tonne band by merging REACH Annexes VII and VIII, while also incorporating new adaptations and additional data requirements for all quantity bands.
Revised information requirements under consideration
As already announced in its Chemicals Strategy for Sustainability, the Commission intends to considerably strengthen the information requirements of REACH. This will be a direct result of two things: 1) expansion of testing in the context of new polymer registration requirements; and 2) increased testing for certain hazards in ALL quantity bands, including carcinogenicity, neurotoxicity, immunotoxicity and endocrine disruption. The main elements are described below.
Increased data requirements for substances in the 1-10 tonnage band
The data requirements for the 1-10 tonne band (Annex VII REACH) currently include only three vertebrate studies and do not require a chemical safety assessment or a chemical safety report. The 10-100 tonne band (Appendix VIII) further includes data on nanoforms (which are often difficult to collect for all grades) and several complementary studies on vertebrates, including repeat dose toxicity and screening on the reprotox criterion. A chemical safety assessment is required. After the merger of annexes VII and VIII of REACH, all these data will also be required for the tonnage band 1-10 tonnes.
New Approach Methodologies (NAM)
In parallel, the Commission is also considering the inclusion of New Approach Methodologies (NAMs) in Annex XI of REACH to become further adaptations to standard testing requirements (i.e. alternatives to testing animal). NAMs include various test methods such as in silico and in chemico approaches, new test tools, as well as some “conventional” methods that aim to improve the understanding of toxic effects.
Five options considered regarding UAMs
The Commission presented five options for the review. The options diverge mainly on the role of NAMs. Either they will only be used as an additional adaptation to avoid animal testing (essentially, as a screening tool), or they will serve as additional data needed to improve existing data, or both. The earliest option would, however, reduce the amount of information available at a later stage for classification and labeling as a hazard, a classification still largely based on animal testing.
Given this need for information, option 1B, presented as the most “extreme” by the Commission, relies on UAMs in addition to existing sources of information rather than on adaptations. They would be used for ADME studies (Absorption, Distribution, Metabolism and Excretion) and critical risks (including endocrine disruption, immune toxicity, respiratory sensitization, neurotoxicity, bioaccumulation in aquatic species). They would also be used to supplement information from traditional repeated dose toxicity studies and to support grouping.
We can expect a substantial increase in REACH information requirements, especially for the lower tonnage band. However, all tonnage bands will be affected with regard to the upcoming registration of polymers and with regard to the tests that will be required on the new parameters of neurotoxicity, immunotoxicity and endocrine disruption. The role that will be assigned to the NAMs will be decisive in determining the extent of this increase and the possible adaptations.
 REGULATION (EC) N° 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the registration, evaluation, authorization and restriction of chemical substances (REACH)