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, operationalized 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.
Blainey
Mark
M
Policy Analysis and Chemical Evaluation (PACE) SPRL, Haneveldlaan 23, 1850 Grimbergen, Belgium. mark.blainey@pacesprl.eu
Avila
Cristina de
Cd
van der Zandt
Peter
P
D004781:Environmental Exposure / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D015386:Hazardous Substances / Q000145:classification / Q000633:toxicity*; D006801:Humans; D021281:Quantitative Structure-Activity Relationship; D018570:Risk Assessment / Q000592:standards*; D020711:Threshold Limit Values
D015386:Hazardous Substances