Review of REACH Annex IV – Establishing the minimum risk of a substance based on its intrinsic properties

Registration is the main mechanism in REACH that ensures the safety of substances. However, some substances are exempted from Registration, such as those included in Annex IV. Annex IV lists substances that are exempted from Registration on the basis that ‘sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties’. As part of the follow up to the co-decision process on REACH, the Commission was mandated to review Annex IV. To enable consideration of whether additional substances should be added to Annex IV and whether substances currently in the Annex should remain, the Commission, together with stakeholders, operationalised the core concepts of minimum risk and sufficient information in the form of criteria. These criteria consider the intrinsic properties of the substance and are based on the classification criteria in Annex VI of Directive 67/548/EEC but were set at a level ‘well below’ the classification criteria to correspond with a minimum risk level. As a result of the review, Annex IV has been recently amended. This paper looks at how the agreed criteria demonstrate minimum risk and concludes that, although developed in the frame of REACH registration, they could be more widely used in the sound management of chemicals.