18.8.2023
EN
Official Journal of the European Union
C 290/11
The above interpretation of the interface between the Cosmetics Regulation and the REACH Regulation is currently under scrutiny by the General Court in two cases brought against ECHA.
A registrant challenges the obligation to perform animal testing, requested by ECHA in dossier evaluation decisions under the REACH Regulation.
The judgments are expected in the course of 2023 and may have consequences for the current interpretation underlying the Commission’s response to this ECI.
Case T-655/20 and Case T-656/20 (Symrise v ECHA) The applicants apply for annulment of two decisions of the Board of Appeal of ECHA.
In these decisions, the Board of Appeal had confirmed the ECHA’s request for certain tests involving animal testing for chemicals that are solely used in cosmetics.
Among other pleas, the applicant, supported by NGOs and companies active in the production of cosmetics, claims that by requesting tests on vertebrate animals for the assessment of the risks to workers’ health, and by failing to take account of the safety of the substance as assessed under the Cosmetics Regulation into account, ECHA committed a manifest error of assessment and misinterpreted the REACH Regulation.
3.2.
Objective 2: Transform EU chemicals legislation
The ECI calls on the Commission to transform EU chemicals legislation and to ensure that human health and the environment are protected by managing chemicals without adding of new animal testing requirements.
The initiative requests under objective 2 to put in place concrete steps to develop, validate, and implement human-relevant, non-animal approaches for the identification of toxic chemicals.
It asks to commit to a full transition away from animal testing, ensure an uptake of non-animal methods that is aligned between all relevant regulatory agencies with administrative responsibility for chemicals, biocides, plant protection products, pharmaceuticals, and other products and to adapt regulatory frameworks to ensure a rapid uptake of NAMs.
It further requests to ensure that test requirement deadlines are not applied at the expense of scientific rigour or human and environmental safety by allowing a default fallback to reliance on unreliable tests on animals.
In essence, the objectives of the initiative correspond to putting in place a strategy or roadmap for a transition away from animal testing.
Points mentioned under objective 2, which have been further detailed in a meeting with the Commission on 17 March 2023, appear to partly overlap with those under objective 3 asking to ‘plot a roadmap’ and further to prioritise the funding for developing and validating non-animal methods, also for regulatory purposes, and to coordinate the uptake of the methods.
In particular, the request for concrete steps in objective 2 corresponds to setting up a roadmap towards phasing out animal testing for chemical safety assessments.
Response to Objective 2: A roadmap towards ultimately phasing out animal testing for chemical safety assessments The Commission will immediately launch the work to develop a roadmap that will outline milestones and specific actions, to be implemented in the short to longer term, to reduce animal testing and that would be pre-requisites for a transition towards an animal-free regulatory system under relevant pieces of chemical legislation (e.g. REACH, Biocidal Product Regulation, Plant Protection Products Regulation and human and veterinary medicines).
Core of the roadmap will be to analyse and to describe the necessary steps to replace animal testing in pieces of legislation that currently require animal testing for chemical safety assessments.
The roadmap will outline the path to expand and accelerate the development, validation and implementation of non-animal methods as well as means to facilitate their uptake across legislations.
The Commission intends to discuss with Member States and stakeholders elements of the roadmap at a workshop in the second half of 2023 and to present the progress made at a second workshop in the second half of 2024.
It is intended to finalise the work on the roadmap in the first quarter of the term of the next Commission.
When drawing up the roadmap, the Commission will work closely with its agencies, the Member States and relevant stakeholders from NGOs, industry and research.
The roadmap’s development will be supported by assessments that were carried out by the Joint Research Centre, EFSA’s work on non-animal approaches, the EFSA roadmap and the expertise of ECHA, EFSA and EMA.