[Regulatory Update] EU Adopts Roadmap for Phasing Out Animal Testing in Chemical Assessment — Concrete Plan for Transition to Alternative Methods
The methodology for assessing chemical safety itself may change over the medium to long term. Chemical manufacturers and testing institutions need to look ahead not only to research and development of alternative methods such as in vitro and in silico approaches, but also to their regulatory acceptability; the key point here is not "animal testing has been banned", but that a roadmap has been adopted for a phased transformation of assessment methodology across the entire regulatory system.
Related Regulation Information
EU REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals)
The REACH Regulation (Regulation (EC) No 1907/2006) is a comprehensive EU regulatory framework covering all chemical substances manufactured or imported within the EU in quantities of one tonne or more per year, aimed at protecting human health and the environment while maintaining the competitiveness of the EU's chemical industry. It requires companies to identify and register information on chemical hazards, and functions as the central pillar of chemical substance control across GRI's chemical-related regulations, including the CLP Regulation, ESPR, the EU Battery Regulation, and the F-Gas Regulation. REACH operates through five pillars: registration (requiring companies that manufacture or import one tonne or more of a chemical substance per year to register its safety information with ECHA); evaluation (the process by which ECHA and member state authorities scrutinize the quality and consistency of registration data along with safety assessment data); authorisation (a system prohibiting the use or placing on the market of substances of very high concern identified as posing particularly high risk, unless individually authorized by the European Commission); restriction (measures limiting or banning the use or placing on the market of specific hazardous substances, for specific uses or entirely); and the obligation to communicate information through the supply chain for substances listed on the Candidate List of substances of very high concern (SVHCs).
See this regulation's full analysis (timeline & business impact)💡 The overview and schedule for the regulation related to this article can also be found on the Regulatory Gateway Database page.