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Welcome
22 March 2005
Open letter to Members of Parliament
REACH Chemicals Regulation – Risk Assessment and Safety Testing Protocols
On behalf of Animal Defenders International, The Lord Dowding Fund for Humane Research and National Anti-Vivisection Society, I am pleased to present our suggestions for a scientifically robust testing and risk assessment strategy for REACH, the new chemicals regulation proposed by the European Commission.
Our strategy is uses advanced techniques to deliver the aims of REACH – protection of humans and the environment, it would:-
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remove animal testing protocols from REACH and implement our technologically and scientifically advanced strategy;
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set deadlines for validation and implementation of non-animal methods;
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an immediate fast-screening strategy facilitates removal of dangerous chemicals from the market, to be replaced by greener alternatives;
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avoid problems of data sharing. We have suggested a workable approach to the problem of data sharing in our proposal, where initial screening for the first 3-year phase would benefit from, but not require data sharing.
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Set up a comprehensive database of all known chemicals in products, with contributions from companies, government laboratories, contract research laboratories, academia, environmental monitoring agencies, green/animal groups, consumer groups, with controlled public access;
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set up a system of incentives to encourage companies to share data by charging a fee for anyone who wants to use their data. Companies would therefore be encouraged to share data on chemicals that they do not intend to register, as well as those scheduled for registration under REACH;
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Mandatory data sharing with substance registration: Currently, REACH allows companies to avoid data sharing – each company undertakes a separate registration for the same substance, so a company that is last to register can avoid sharing data.
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Expand ECVAM (European Centre for the Validation of Alternative Methods), so that it can work to achieve the aims of REACH. (NB: The total cost of REACH to industry has been put by the UK government at between £1,240,735,000 and £4,643,745,914 over 11 years. By comparison, the EU allocated €26 million to ECVAM over 4 years).
One Substance One Registration: The UK and Hungarian governments have proposed that there should be one registration for each substance. This would make it compulsory for groups of companies forming consortia to apply for one chemical registration; it also avoids the risk of duplication of testing. We support this proposal.
The programme of animal testing that has been proposed is hugely costly, both financially and in terms of animals’ lives.
The UK’s Royal Commission on Environmental Pollution (RCEP) has said of REACH: “The infeasibility of carrying on with traditional approaches for hazard and risk assessment and not exploiting fully new technologies and advances in computational assessment techniques are serious failings.
“Current approaches to assessing and managing risks of chemicals in the environment are cumbersome, unsound and rely heavily on animal testing. A new paradigm is needed.”
The RCEP’s criticisms of the REACH testing strategy are summarised as:-
- It is time-consuming, expensive, and unlikely to achieve its aims.
- Animal testing will delay the proper assessment of potentially lethal chemicals while cumbersome testing protocols are carried out.
- It is not realistic to expect a comprehensive risk assessment to be carried out on all the tens of thousands of chemicals currently on the market, in the timescale provided.
- Instead the RCEP recommends an initial computer-based screening which will facilitate a preliminary risk assessment of all the chemicals on the market so that the investigation of chemicals that are already of concern can be prioritised.
- RCEP suggested that the UK Government should press for an EU-wide initiative to promote in vitro and computer techniques, due to their efficiency and relevance.
Animal tests are expensive. On the assumption that in the region of 20% of the REACH bill will be borne by the UK, one estimate puts the cost of REACH to UK industry at between £250,000,000 and £930,000,000 and another has put the cost of testing at 60% of the overall figure. This means that the testing cost for the UK alone would be in the order of £150,000,000-£560,000,000.
The animal tests outlined in the REACH proposals are cumbersome, outdated and inappropriate to the task. By contrast, new techniques for example using cell lines expressing enzymes can be used to determine metabolites (a process crucial in the determination of toxicity) so that 200 chemicals a month can be screened.
The attached briefing paper containing full details of our proposal has been sent to your colleagues in the European Parliament. We hope that you can support the sensible approach that we have put forward to remove the animal testing protocols from REACH, which is vital for both people and the environment. It will also save money for industry. Please help by applying pressure on the UK Government to insist on a non-animal testing strategy for REACH.
Thank you for your time and consideration.
Yours faithfully,
Jan Creamer
Chief Executive
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