The EU Chemicals Policy (REACH)
REACH (Registration Evaluation and Authorisation of Chemicals) is a new European Union (EU) regulatory system for the safety testing of chemicals. REACH will harmonise regulation of chemicals within the EU by bringing each country's different legislation into one comprehensive document.
The main aim of REACH is to pass the ‘burden of proof’ from the regulatory bodies to the Chemicals Industry, so that companies must evaluate the safety of substances they produce and show how any risks to humans and/or the environment can be satisfactorily managed.
Chemicals developed prior to a change in EU legislation in 1981 have not undergone full safety testing and a number have subsequently been a cause for concern, such as phthalates and brominated flame retardants. REACH will only apply to chemicals produced in quantities greater than 1 tonne per year (around 30,000 substances) and the higher the production tonnage the more testing will be required.
All manufacturers and importers have to register the chemicals they produce with a central Agency who enforce the legislation. The original REACH proposals were not well received. The European Commission (EC) proposed the use of animal tests to fulfil almost all the testing requirements and made little effort to recommend the use or development of alternative, non-animal tests.
FRAME, and other animal welfare organisations, had concerns about the number of animals that would be required. Estimates ranged from a few million to 40 million animals. They have campaigned tirelessly to make sure that as few animals as possible will end up being used. When REACH was first proposed, there was little detail on how animal testing should be minimised, but now the reduction, refinement and replacement of animal testing is promoted throughout the document.
The final REACH legislation was adopted in December 2006 and entered into force on 1 June 2007 with the first registrations being accepted on 1 June 2008.
FRAME has always believed that the REACH system was needed to ensure greater protection of humans, wildlife and the environment, but considered the original proposals to be ill conceived and unlikely to achieve their purpose.
Our campaign to make REACH more workable included a number of suggestions, some of which have been adopted.
Suggestion: The EU should only require the testing of substances for which there is adequate evidence that significant human exposure is likely.
Outcome: It was agreed that certain categories of testing may be omitted, based on exposure scenarios. This applies to all substances produced above 100 tonnes per year and to repeat-dose and reproductive testing for substances produced in quantities between 10 and 100 tonnes per year.
The EC is to adopt criteria defining what constitutes adequate justification for exposure-based waiving. Adequate justification and documentation must be provided before a test may be waived, including:
- The type of environmental compartment
- The human populations exposed
- The risk management measures
- The routes of exposure
- The duration and frequency of exposure
- Protection of animal lives
Testing on existing substances produced in quantities between 1 and 10 tonnes is to be greatly reduced, with only those substances where there is cause for concern requiring new tests.
Suggestion:The EU should ensure that any requirements for animal tests at the registration stage are scientifically justified and involve the use of the minimum number of animals and the lowest level of animal suffering.
Outcomes: Registrants must submit a proposal for any new animal testing required for substances produced in quantities of 100 tonnes or more. All interested parties to have 45 days to comment on the proposals.
It is now specified that data on test substances should be generated whenever possible by means other than animal tests. Test methods are to be reviewed regularly to reduce the number of animals required and to make sure refinement measures are implemented wherever possible.
Suggestion: The EU should insist on the use of validated non-animal approaches, as and when they become available.
Outcome: The final legislation states that the EC shall make proposals to amend the regulation as soon as possible after a new test method or reviewed test method is adopted.
Suggestion: The EU should develop clear procedures, guidelines and incentives to promote data sharing by industry, in order to avoid unnecessary testing.
Outcome: The ‘one substance, one registration’ concept was adopted to prevent duplication of studies. Sharing animal data is to be mandatory with specific opt-out clauses for non-animal data allowed to protect commercially sensitive information. Incentives were also agreed to ensure the workability of data sharing:
• The cost of any animal testing will be shared between all interested parties and will be fair, transparent and non-discriminatory.
• Animal and non-animal data, submitted in the framework of a registration, will be freely available 12 years after its submission to the Agency to any other registrant or potential registrant.
• Any information which could prevent the use of animals must be made available; this includes data from substances no longer produced or imported, which must be kept for a period of at least 10 years.
• Failure to make available animal data, or other information to prevent animal testing, will result in the forfeiture of the right to register the substance.
• Failure to pay a share of the costs of animal testing will result in the forfeiture of the right to register a substance.
Suggestion: There should be a new initiative for funding and co-ordination of research aimed specifically at developing and validating new non-animal approaches to safety assessment.
Outcome: The Chemicals Agency is to produce a report for the EC on the progress made on development, validation and legal acceptance of non-animal test methods and the use of such methods in intelligent stepwise risk assessment every 3 years, with the first report scheduled for June 2011. Also, the Agency will produce a report for the EC on the amount and distribution of funding for alternative test methods every 5 years, with the first report due in June 2012.
• We are still campaigning to make more use of integrated/intelligent testing strategies which have the potential to minimise the use of animals further by making maximum use of non-animal approaches to toxicity testing and risk assessment, including the use of existing data, computer predictions and in vitro tests.
• We are also lobbying the OECD (Organisation for Economic Cooperation and Development) who publish the test guidelines used by the chemicals industry. We have recently reviewed these guidelines and found that some methods are unnecessary and others urgently require updating to include modern techniques to improve the scientific and animal welfare aspects of the procedures involved.
Recent FRAME publications
Combes, R. (2007). Why ‘Suitable’ In Vitro Methods, as Defined in the Final EU REACH Legislation, are an Inappropriate Basis for Risk Assessment. ATLA 35, 289-293.
Grindon, C. (2007). The New EU REACH Regulation Has Finally Been Adopted: Is This the End of the Campaign Trail… or Just the Beginning? ATLA 35, 239-242.
Grindon, C., Combes, R., Cronin, M.T.D., Roberts, D.W. & Garrod, J.F. (2006). Integrated Testing Strategies for Use in the EU REACH System. ATLA 34, 407-427.
Grindon, C. & Combes. R. (2006). Introduction to the EU REACH Legislation. ATLA 34, Suppl. 1, 5-10.
Grindon, C., Combes, R., Cronin, M.T.D., Roberts, D.W. & Garrod, J. (2006). A review of the Status of Alternative Approaches to Animal Testing and the Development of Integrated Testing Strategies for Assessing the Toxicity of Chemicals under REACH – A Summary of a DEFRA-funded Project Conducted by Liverpool John Moores University and FRAME. ATLA 34, Suppl. 1, 149-158.
Grindon, C., Bhogal, N., Combes, R., Balls, M. (2005). The scientific, animal welfare and regulatory implications of the EU REACH system for chemical safety. TOPRA Regulatory Rapporteur 2, No. 4, 16-22.