Occupational Toxicology and Occupational Hygiene within the European Union (EU) Chemicals Regulation

The purpose of this chapter is to discuss the interplay between the disciplines of toxicology and occupational (or industrial) hygiene in understanding and controlling the hazards and risks to health posed by chemicals, in an occupational setting. Ten years ago, the chapter ‘Industrial Toxicology and Hygiene’, produced for the second edition of General and Applied Toxicology, offered a perspective on the main approaches, roles and responsibilities that, in a regulatory context, had held for a considerable period of time within chemical legislation. This updated chapter is written from within the European Union (EU) at a time when it is embarking on a new era of chemicals legislation that promises to change things profoundly. On 1 June 2007 the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation came into force in the EU. This legislation changes the nature and balance of roles between industry and regulatory authorities—and modifies the conventional approaches to, and interplay between, toxicology and occupational hygiene—in regulating industrial and commercial chemicals within the EU. In its information requirements for registration purposes, REACH creates a tension between desires to improve the extent and quality of data available on chemicals, but also to minimize experimental animal testing. In relation to toxicology, this poses challenges to all concerned. REACH removes the distinction and associated data-expectation requirements between ‘new’ and ‘existing’ substances within the EU. REACH also expands and reinforces the ‘customer care’ principle that suppliers of chemicals take responsibility for understanding the uses to which their chemicals are to be put and specifying the risk management measures that should be followed in such uses. This will be a big challenge to the occupational hygiene profession. And all of this also comes at a time when the EU is in the process of adopting the globally harmonized system (GHS) of classification and labelling (C&L) of chemicals, which will modify the EU C&L system that has operated for the previous several decades. So it is a time of change—and no one is quite sure how things will work out in the next 10 years. This chapter attempts to portray how these recent developments build on, or change, what has gone before, and discusses some of the key issues that are ahead for the toxicology and occupational-hygiene fields, operating in this new regulatory context. Keywords: occupational toxicology; occupational hygiene; REACH; regulatory toxicology; risk assessment; classification and labelling; occupational exposure limits; OELs; epigenetics