Safety Testing for REACH Compliance
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 was 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 culminated on 31st May 2018 for chemicals manufactured or imported in the 1-10 annual tonnage band – a category that includes most cosmetic ingredients.
REACH is applicable to all industry sectors. If you’re a manufacturer, importer or user of substances in the EU, they must legally be REACH registered. However, in many cases the registration is handled by a SIEF (Substance Information Exchange Forum.) This is a consortium of stakeholders for the substance, designed to share data and costs and to avoid the duplication of tests. Non-members can purchase data from SIEFs.
HOW WE CAN HELP YOU WITH REACH COMPLIANCE
REACH registration is a complex process that should be handled by a qualified regulatory professional. Often, existing safety data is available and may be enough to satisfy the information requirements. The regulation supports the use of a variety of animal-free approaches including computer modelling, in vitro testing and read-across of historical data (in vivo or in vitro) from similar substances. If there are data gaps, new testing might be needed – these tests should be performed in a GLP accredited lab.
There are 6 human health endpoints listed in annex VII of REACH – we’ve listed them here along with how we can help:
|OECD TG 431||Skin corrosion||Human skin model||More info >|
|OECD TG 439||Skin irritation||Human skin model||More info >|
|OECD TG 492||Eye irritation||Human cornea model||More info >|
|OECD TG 442c||Skin sensitisation||Direct Peptide Reactivity Assay (DPRA)||More info >|
|OECD TG 442d||Skin sensitisation||KeratinoSens™||More info >|
|OECD TG 442e||Skin sensitisation||Human Cell Line Activation Test (h¬-CLAT)||More info >|
|n/a||Acute toxicity||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.||More info >|
|n/a||Genotoxicity||We don’t 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 and can be used as part of a Weight of Evidence approach.||More info >|
Please note that for other Annexes of REACH, covering chemicals used at higher tonnage bands, there are currently no regulatory in vitro tests available for some of the required endpoints such as repeat dose / chronic exposure and reproductive toxicity. There are several initiatives underway across industry to address these endpoints without using animals.
If you’re uncertain about the best approach to ensure REACH compliance for your substances, we partner with professional regulatory consultancies who can help you formulate the best strategy to fit your needs. Please get in touch to ask for advice.
REACH AND THE COSMETICS REGULATION
There’s been a lot of debate in the cosmetics industry about REACH compliance and how it fits with the European animal testing ban, which has been in force as part of the Cosmetics Regulation 1223/2009 since 2013.
Essentially, it states that no cosmetic products containing ingredients that have been tested on animals since the ban can be sold or marketed in Europe. REACH makes provision for the safety of cosmetic ingredients to be assessed using animal-free approaches, but there are some caveats. These include testing that may be considered essential to protect the safety of manufacturing workers, who need to handle chemicals in a neat or highly concentrated form.
In our experience, a variety of approaches are adopted throughout the industry in Europe and beyond, with many companies avoiding the need for any animal testing using Weight of Evidence approaches. We recommend seeking regulatory advice to develop an animal-free testing strategy that supports your needs.
Ask us a question