ABSTRACT
Figure 8.1 Conclusions from risk assessment of 123 high production volume chemicals acc. to the EC existing chemicals regulation 793/93 (1995-2008), data from [4].
Chemical substances and mixtures are handled at workplaces from the beginning of their lifecycle in research and development to their end in recycling and waste disposal. In the REACH regulation, “Substance” means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. “Mixture” means a mixture or solution composed of two or more substances [5]. Following this regulatory definition, nanomaterials belong to the group of substances or mixtures, too. For this reason, the regulatory framework for chemical
safety plays an important role for occupational safety and health also regarding the handling of nanomaterials. It delivers the substancerelated information for an adequate workplace risk assessment and management: knowledge on adverse effects for safety and health and corresponding data gaps, strategies for controlling the risks as well as restrictions for use. Chemical safety regulation in the EU is based on two pillars. The first is the legal framework for placing chemicals on the market, the second is built from specific provisions for occupational safety and health, consumer and environmental protection. Within the legislation for placing on the market based on article 114 of the Treaty on the Functioning of European Union (TFEU), important information is generated, gathered and bundled for hazard and risk assessment, as well as for risk management along a chemical’s life cycle (Fig. 8.2). The directive for Classification, Labeling and Packaging (CLP) and the REACH regulation describe the basic requirements for synthetic and natural chemical substances and mixtures [5, 6]. These European legislations are supplemented by bodies of rules and regulations for specific product groups like biocides, pesticides, cosmetics, pharmaceuticals, additives for food and animal feedstuff. Additionally, these regulations are more or less harmonized within the EU based on the basic idea of a common market without barriers for internal trade.
