Plans to Increase Data Requirements for REACH Registration, Including Significant Increase at the 1-10 Ton/Year Level, and Adoption of New Approach Methodologies
The Commission’s proposal for a revision of the REACH Regulation is expected in the first quarter of 2023. While the final content of the proposal remains unknown, the Commission has already addressed several aspects of the revision by way of discussion papers exchanged with the Member States’ competent authorities working group CARACAL.
One of the papers is addressing a proposed substantial increase of the 1-10 tons band information requirements by merging Annexes VII and VIII REACH, while also integrating new adaptations and additional data requirements for all tonnage bands.
Revised information requirements under consideration
As already announced in its Chemicals Strategy for Sustainability, the Commission intends to substantially reinforce REACH information requirements. This will come as a direct consequence of two elements: 1) the expansion of testing in the context of the new polymer registration requirements; and 2) increased testing for certain hazards at ALL tonnage bands, including carcinogenicity, neurotoxicity, immunotoxicity, and endocrine disruption. The main elements are described below.
Increase of data requirements for substances in 1-10 tonnage band
Data requirements for 1-10 tons band (Annex VII REACH) currently only include three vertebrate studies and do not require chemical safety assessment and the chemical safety report. The 10-100 tons band (Annex VIII) includes, in addition, data on nanoforms (which are often difficult to gather for all grades) and several additional vertebrate studies, including repeated dose toxicity and screening on the reprotox endpoint. A chemical safety assessment is required. After merging Annexes VII and VIII REACH, all these data will also be required for 1-10 tons tonnage band.
New Approach Methodologies (NAMs)
In parallel, the Commission also envisages the inclusion of New Approach Methodologies (NAMs) into Annex XI REACH to become new adaptations to the standard testing requirements (i.e., alternatives to animal testing). The NAMs include various testing methods such as in silico and in chemico approaches, new testing tools, as well as some “conventional” methods that aim to improve understanding of toxic effects.
Five options under consideration regarding NAMs
The Commission has presented five options for the revision. The options diverge mainly on the role of the NAMs. Either they will only be used as an additional adaptation to avoid animal testing (basically, as a screening tool), or they will serve as additional data required to improve the existing data, or both. The earliest option would however reduce the amount of information available at a later stage for classification and labelling as hazard a classification remains largely based on animal testing.
Taking into account this need for information, Option 1B, presented as the most “extreme” by the Commission, relies on NAMs as a complement to existing sources of information instead of adaptations. They would be used for ADME (Absorption, Distribution, Metabolism and Excretion) studies and critical hazards (including endocrine disruption, immune toxicity, respiratory sensitization, neurotoxicity, bioaccumulation in aquatic species). They would additionally be used to supplement information from traditional repeat dose toxicity studies and support grouping.
We can expect a substantial increase in REACH information requirements, especially for the lowest tonnage band. However, all tonnage bands will be affected in respect to the upcoming registration of polymers and with respect to the testing that will be required on new endpoints neurotoxicity, immunotoxicity, and endocrine disruption. The role that will be attributed to the NAMs will be the key in establishing the extent of this increase and possible adaptations.
 REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
 CARACAL CA/09/2022