Regulatory compliance

Our GLP-accredited laboratory provides in vitro safety data for compliance with a wide range of European and global regulations for the protection of human health.

Our clients use the data we provide in regulatory submissions for cosmetic ingredients, chemicals from a wide range of industry sectors, and finished products. Relevant regulations include:

REACH (EC 1907/2006)

We worked with a wide range of companies to assist their registration requirements for the REACH deadline on 31st May 2018 and continue to help others with the backlog that this huge project created.  We provide regulatory in vitro tests for all of the human health endpoints required under Annex VII of REACH, with the exception of acute toxicity, for which there is currently no validated in vitro test available. For this purpose, we currently offer a non-regulatory human cell based acute toxicity screen, which is internally validated for cosmetic ingredients and is being used by clients as a strategy to submit non-animal acute toxicity data as part of a weight-of-evidence approach.

Ask us about our unique animal product-free adaptations of two skin sensitisation tests (OECD TG 442d and 442e), accepted by ECHA for inclusion in REACH dossiers.

  • CLP Regulation (EC 1272/2008)
  • Biocidal Products Regulation (EC 528/2012)
  • Plant Protection Products Regulation (EC 1107/2009)
  • Cosmetics Regulation (EC 1223/2009)

We enable cosmetic companies and their ingredient suppliers to comply with the animal testing ban in Section 18 of the Cosmetics Regulation. Fully enforced from 11 March 2013, the ban covers all cosmetic products and ingredients, and includes a European marketing ban on any products or ingredients tested on animals elsewhere in the world. We not only enable compliance with the ban, but go the extra mile in completely eradicating any animal-derived components from our tests, providing additional ethical advantages to companies using XCellR8’s lab.

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