REACH (EC 1907/2006) refers to the Registration, Evaluation, Authorisation and restriction of CHemicals and is the EU’s primary regulation to ensure that all chemicals are adequately assessed for their impact on human health and the environment.
Enforcement of REACH has been phased in over almost a decade, with staged deadlines based on the annual tonnage of a given chemical collectively manufactured or imported into Europe by all users. This huge undertaking culminates in a final deadline on 31st May 2018 for chemicals manufactured or imported in the 1-10 annual tonnage band – a category that includes the vast majority of cosmetic ingredients. After this date, any chemical not having a REACH registration number cannot legally be sold within the EU.
Regulatory in vitro tests are provided by XCellR8 for 4 out of the 6 human health endpoints listed in Annex VII of REACH:
- Direct Peptide Reactivity Assay (DPRA) (OECD TG 442c)
- KeratinoSens™ (OECD TG 442d)
- Human Cell Line activation Test (h-CLAT) (OECD TG 442e)
In addition, we provide a human cell based screen for acute toxicity, for which there is currently no regulatory in vitro option. This is being used by clients to provide supporting data for REACH submissions as part of a weight-of-evidence approach, enabling them, where possible, to avoid the need for testing on animals.
Please note that we do not currently provide the regulatory in vitro genotoxicity tests (Ames Test, Micronucleus Test, Chromosome Aberration Test) because all 3 require the use of animal-derived components and would contravene our commitment to a fully animal product-free testing strategy. Instead we provide a human cell based screen (BlueScreen™ Animal-Free) – a non-regulatory screen that detects all major classes of genotoxin.