According to article 138 of Regulation (EC) No 1907/2006 (REACH), by 1 June 2014, the Commission shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment-CSA (and to document it in a chemical safety report-CSR) to CMR (Carcinogenic, Mutagenic and Reprotoxic) substances not covered by this obligation because they are subject to registration but manufactured or imported in quantities of less than 10 tonnes per year.
That assessment shall consider the following:
- the costs for manufacturers and importers of drawing up the chemical safety reports;
- the distribution of costs between actors in the supply chain and the downstream user;
- the benefits for human health and the environment.
The costs taken into account were related to the hazard assessment, PBT(Persistent, Bioaccumulative and Toxic) assessment, exposure assessment and risk characterisation. About hazard and PBT assessment, it’s pointed out that no extension of the Annex VII data requirements can be foreseen besides the CSA request for 1-10 registrants. Therefore, the costs for those two points were considered as negligible, even considering that DNEL/PNEC (Derived No Level Effect/Predicted No-Effect Concentrations) are information which can be easily extrapolated from disseminated data and public documents. Moreover, data protection of twelve years is going to expire for most data, under REACH Regulation.
The larger part of the costs should be afforded for exposure assessment and risk characterization by manufacturers and/or importers. In particular, the average costs are estimated to be 5.250,00€ per use (considering both human health and environmental exposure assessment) for substances registered at 1-10 tonnes only. Alternatively, the costs should be lower for 1-10 tonnes substances also registered at higher tonnages. The document also considers the cost for DU communication and eSDS drafting. Overall, the average cost of a CSA per substance is estimated to be slightly less than 17.000,00€.
Information from the REACH Registration database reveals that a total of 929 companies would be affected by a new requirement to produce a CSA for 1-10 tonnes CMRs across 1 653 dossiers (of which 983 were submitted in 2010). According to the Commission, it is noteworthy as well that 90% of large companies are importers and/or only representatives, and that pure manufacturers represent only 7%. Therefore, large importers and only representatives would bear most of the costs above.
The whole picture entails a combined cost for manufacturers, importers (MIs) and downstream users (DUs), of less than € 5 million , with DUs bearing slightly more than a third of them, the large majority of costs (64%) being on the side of MIs.
On the basis of this cost estimate, it was calculated that if the fact of having MIs performing the CSA/CSR provides a break-even value of a minimum of 1.261,00€ per downstream user, the measure can be considered economically justified. This value needs to be compared to the cost a downstream user incurs today for complying with parallel legislation (i.e. Worker Health and Safety Legislation, Product Safety Requirements and Waste Legislation) in the absence of a CSA/CSR for 1-10 tonnes CMRs, which is estimated to be € 1 500 (lower bound). This comparison would confirm that the measure is economically justified.
In addition, benefits are also expected for human health and the environment, as of all 294 1-10 tonnes CMR substances (registered at this tonnage band and higher), 163 are carcinogenic, 45 substances are mutagenic and 167 substances are toxic for reproduction. Due to upgraded risk management measures, the extension of the requirements is expected to lead to benefits in terms of reduced morbidity.
According to the Commission, the introduction of a CSA/CSR requirement for the MIs for all 1-10 tonnes CMR substances seems justified, even if only considering the quantifiable costs and the unquantified benefits. It seems therefore highly recommendable to extend the obligation to develop a CSA/CSR to 1-10 tonnes CMR 1A/1B substances.
Reference: European Commission