Contents lists available at ScienceDirect Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph Impact of REACH legislation on the production and importation of CMR (carcinogen, mutagen and reproductive) and explosive chemicals in Italy from 2011 to 2015 Marco Marzo a,* , Caterina Leone a , Cosimo Toma a , Alessandra Roncaglioni a , Stefano Gianazzi b , Ralf Knauf c , Emilio Benfenati a a Laboratory of Environmental Chemistry and Toxicology, Department of Environmental Health Sciences, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, 20156, Milano, Italy b Ticass S.c.r.l., Genova, Italy c Centro REACH S.r.l., Milano, Italy ARTICLE INFO Keywords: REACH regulation Carcinogen Mutagen and reproductive toxicity Explosivity Italian chemical market ABSTRACT On 1 June 2007, the European Commission issued the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) to protect both the environment and human health. We analyzed the impact of REACH in the Italian market considering the presence of chemicals, their diversity, importation and production during the period 2011–2015, with particular attention to products with toxic or explosive properties. There was a re- duction of the chemicals on the market, in terms of tons but also the absolute numbers of types of compounds. The production reduction was particularly noticeable for explosive chemicals: -14.7%. CMR products did not show any statistically significant reduction in term of tons: -2.3%. 1. Introduction On 1 June 2007, the European Commission issued Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) with the aim to protect both the environment and human health and to make European industry in- novative and more competitive. The REACH Regulation affects not only the chemical industry as producers but also a large number of others such as 1) importers of chemicals, mixtures and products; 2) down- stream users managing or handling chemicals; 3) the overall population and the environment in general (Understanding REACH, 2018). The fact that there have long been substances with very limited information on human health and environmental impact on the European market led the legislators to develop a strategy to ensure higher levels of safety and to set out principles that in fact have completely changed the ap- proach to importation, production and use of chemicals. One of the basic criteria of REACH is the precautionary principle: manufacturers and importers of chemicals have to demonstrate that their substances do not pose any risk to the environment and to human health before they can be placed on the market (Leinen, 2012). The REACH Regulation shifted the “burden of proof” from authorities to companies, which have now to prove the safety in manufacturing and use of substances and report detailed information on risk management in their supply chains. Another key principle is “extended producer responsibility” (EPR). According to the Organisation for Economic Co-operation and Development (OECD) definition, EPR is “an environmental policy ap- proach in which a producer's responsibility for a product is extended to the post-consumer stage of a product's life cycle”. So manufacturers and importers have to communicate and report in their registration dossiers all relevant properties (physico-chemical properties, toxicological properties, etc.) for the substances they intend to introduce (or in- troduced before the REACH Regulation came into force) onto the market in order to ensure that users apply the correct risk management measures when they manage such chemicals (OECD, 2001). A third principle is the “authorization and restriction” of dangerous substances, that guarantees stricter rules in production and importation of sub- stances of very high concern (SVHC) (Arfaoui et al., 2014). To achieve a gradual transition the Regulation sets three registra- tion deadlines for various categories: (i) substances manufactured or imported at 1000 tons or more per year; carcinogenic, mutagenic or toxic to reproduction (CMR) substances above one ton a year; and substances dangerous for https://doi.org/10.1016/j.yrtph.2018.11.013 Received 15 June 2018; Received in revised form 19 November 2018; Accepted 23 November 2018 * Corresponding author. IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, 20156 Milano, Italy. Tel.: +39 02 3901 4396. E-mail address: Marco.marzo@marionegri.it (M. Marzo). Regulatory Toxicology and Pharmacology 101 (2019) 166–171 Available online 28 November 2018 0273-2300/ © 2018 Elsevier Inc. All rights reserved. T