On 21 Sept. 2016, the European Commission amended skin sensitisation testing provisions under Annex VII to REACH Regulation by releasing Regulation (EU) 2016/1688.

In recent years, great progress has been made in alternatives tests to avoid animal testing or reducing repetition of already performed tests.

The amendments focus on point 8.3 of the annex, and stipulate skin sensitisation studies do not need to be carried out if the substance is:

• classified as skin corrosion (category 1); or
• a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5); or
• spontaneously flammable in air or in contact with water or moisture at room temperature.
• In vitro/in chemico tests are not needed if:
• an in vivo study is available; or
• available in vitro/in chemico test methods are not applicable or adequate for the substance.
• C&K Testing advises businesses to deal with due care.

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