Skin sensitization testing is a major gap for many companies addressing the 2018 REACH substance registration deadline. Join us for a Q&A session with our Covance experts as we review REACH requirements and focus on a better solution for skin sensitization studies: in vitro assays as new alternatives to animal testing.
Q: What do REACH regulations hope to achieve?
A: The European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) places responsibility on companies to assess and manage risks posed by chemicals. They also have to provide appropriate safety information to users. The first purpose is to ensure protection of human health and the environment. Next, the regulation promotes using alternatives to animal test methods. Third, it seeks free circulation of substances to the market, with enhanced competitiveness and innovation.
Q: What is the deadline for REACH chemical testing?
A: You must register your chemicals or substances, with a complete dossier of testing and support data, by May 2018. Consider your timeline as you plan your testing program as many other companies are also looking for resources to meet the deadline.
Q: How far-reaching is the effect of REACH?
A: Any chemical or substance being imported to or directed within the European Union (EU) must meet testing requirements. This includes chemicals used in industry/manufacturing, cosmetics, agriculture and more.
Q: What happens if I miss the May 2018 REACH deadline?
A: If your products are not registered on time, you will not be able to commercialize or transport them through the EU. This could have a negative impact on your sales, so it is best to plan ahead and begin testing today.
Q: What tests are required for my chemicals or substances?
A: REACH legislation is split into several Annexes depending on the production tonnage of the chemical. For 2018, it is the lowest (1-10 tonnes) which incorporates:
- Skin corrosion/irritation
- Serious eye damage/eye irritation
- Acute dermal and oral toxicity
- Skin sensitization
In our experience working with EU chemical providers, we see that skin sensitization testing represents the greatest gap in testing to meet the May 2018 REACH deadline. The recent amendment to Annex VII and revision of ECHA Guidance Document Chapter R.7a (December 2016) added in vitro data as the default source for skin sensitization testing (skin/eye corrosion/irritation had already been amended previously). The good news? We have these three skin sensitization assays available for you to use, as well as the others listed above.
Q: Why are there new, alternative methods for testing?
A: Refinement, reduction or replacement (3Rs) of animals in testing is not only an international goal but a practice we are passionate about. From its inception, the REACH regulation desired in vitro data where possible and this stance has been strengthened by the 2016 amendment. In vitro data for certain endpoints are now the expected source for submissions if existing historical data sources or (Q)SAR data are not sufficient. In vitro, in chemico and in silico testing methods are now available for appropriate REACH studies. Make sure to select an experienced research partner with validated options for these assays.
Q: How many of the new tests will we need to complete?
A: As part of the Organization for Economic Cooperation and Development (OECD) integrated approach to testing and assessment (IATA), multiple in vitro assays must be available to support the replacement of in vivo assays. All relevant information, including physio-chemical, in silico and analogue chemical information form part of an integrated weight-of-evidence assessment. If in silico and analogue information are insufficient to predict sensitizing potential, you may need to combine information from multiple in vitro assays to make a decision.
Q: Can we determine potency classifications?
A: Although a specific in vitro test for potency is not yet accepted at the regulatory level, combining data from several assays may help you sub-categorize substances into Category 1A (strong/extreme) or Category 1B (moderate) classifications. Until this situation changes, the local lymph node assay (LLNA) is also available when regulatory requirements specify a measure of potency.
Q: What is an acceptable turnaround time for these studies?
A: Experimental data should typically be available after only three weeks with study reports typically available in about two months. Some studies can be performed in parallel to help save you time.
Q: When should we begin our testing program for REACH compliance?
A: We advise that you don’t delay – start developing your testing programme today to achieve regulatory compliance in May 2018. This will alleviate bottlenecks in your testing strategies and increase your opportunity to continue on schedule to market and transport your products in the EU.
About the authors: Ms. Henderson and Dr. Kidd have extensive experience in in vitro toxicology/ alternative methods. Mr Rothwell has extensive cell culture and flow cytometry experience. The team has most recently validated three in vitro assays for skin sensitization:
- Direct Peptide Reactivity Assay (DPRA)
- ARE-Nrf2 Luciferase Test Method (KeratinoSens™)
- human Cell Line Activation Test (h-CLAT)