Regulatory Assessment of Respirable Crystalline Silica in Europe: REACH, GHS, CLP, and Carcinogen Directive

摘要

Since the International Agency for Research on Cancer (IARC) has classified crystalline silica (quartz and cristobalite) dust as a group 1 carcinogen in 2009, new studies and reviews on respirable crystalline silica (RCS) have been published. Evidence has been obtained in scientific literature that RCS toxicity is variable; in particular, the carcinogenic potency does not express in all industrial circumstances and in any case is secondary to fi-brosis. In light of the implementation of the Globally Harmonized System (GHS) in Europe, the European Industrial Minerals Association (IMA-Europe) submitted a group notification for RCS with the classification Specific Target Organ Toxicity Repeated Exposure Category 1 (STOT RE 1) for silicosis. Consequently, generic cut-off values for hazard classification and labelling apply for products containing RCS in amounts ＞ 1 % (STOT RE 2) and ＞ 10 % (STOT RE 1), respectively. This triggers the need for a method to quantify the amount of RCS in a bulk material for classification and labelling purposes. The Metrology Working group of IMA-Europe has therefore developed the so-called SWeRF method (size-weighted relevant fine fraction), which is currently being dealt with in the European Committee for Standardization (CEN). In light of the possible setting of an EU limit value for respirable crystalline silica, the latest toxicological and epidemiological findings on exposure to RCS, as well as socio-economic assessments, provide important new information.