Regulatory Toxicology in the European Union
CHAPTER 10: REACH
Published:21 Feb 2018
REACH was introduced in the European Union (EU) to strengthen controls on the use of industrial chemicals and to protect human and environmental health. REACH obliges companies manufacturing or importing chemical substances in quantities of one tonne per annum or more to submit a registration dossier to the European Chemicals Agency. The registration dossier must contain toxicological information on the chemical, the extent of which is dependent on the quantity in which it is manufactured or exported. Although the REACH Regulation states that performing new studies in vertebrate animals must be a ‘last resort’, its introduction caused concern within the chemical industry due to the extent of testing required and the associated costs. The toxicological data requirements and potential testing strategies are discussed, together with ‘non-testing’ options such as in vitro methods, data waiving and read-across, in line with recent changes to the guidance on testing.