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Since an evaluation of large databases including REACH registered data is showing cumulative risk levels exceeding a risk characterization ratio (RCR) of 1, the adoption of the mixture assessment concept is proposed as a pragmatic and precautious default assumption. The risk management tool MAF should be applied in the CSR, when a specific risk assessment considering all (relevant) substances, to which human populations and the environment are exposed, is not possible.

A default MAF of 5 is proposed, which should be applied to substances registered at ≥1,000 t/y (covering >99.8% of total tonnage registered), and which should also be utilized to establish DMELs (Derived Minimal Effect Levels) for non-threshold carcinogens and mutagens without new animal tests. The MAF will be relevant for eco- and toxicological risk assessment. A derogation from the default MAF is possible if a specific risk assessment is carried out and documented. The respective clause of the REACH regulation Article 138 will be reviewed.