The greatest challenge involved in REACH (Registration, Evaluation and Authorisation of Chemicals) was deciding how to strike the right balance between the obligations to be imposed on industry and the need to protect health and the environment. On 13 September the Committees on Industry and the Internal Market had indicated that they would like the burden on industry to be substantially eased. Without neglecting this aspect, the Environment Committee voted to place the emphasis on the health and environmental requirements which provide the justification for this future legislation, while accepting numerous amendments tabled by the nine other committees asked for opinions.(*)
The duty of care
The Environment Committee adopted as a general principle the duty of care of businesses - i.e. the duty to avoid placing on the market products which endanger health or the environment. Producers will be required to prevent, limit and even remedy any adverse effects. They will also be required to inform downstream users of risks automatically and free of charge, a detailed procedure being laid down for this purpose, so that those users can choose less harmful substances. Consumers and workers should also have access to this information. However, the duty to inform and prevent should not burden small and medium-sized firms with excessive red tape, and, where appropriate, such businesses should be able to receive aid.
Disagreements about registration
REACH requires producers to register chemicals and to supply information about their properties. This is the aspect of the regulation which has the most serious implications for business and also has given rise to most controversy among MEPs. The Environment Committee was able to arrive at a compromise which secured the support of a majority within the committee, although Members of the EPP-ED group did not endorse it.
The committee suggests that the requirements concerning the information to be supplied to the future European Chemicals Agency on substances produced in quantities between 1 and 10 tonnes be eased. But this concession is not an invitation to cheat, as the Agency will be required to perform checks (on at least 10% of cases) and could withdraw registrations if the rules are evaded. In addition, proper chemical safety assessment reports will still be required where more than 1 tonne is produced.
The Committees on Industry (opinion by Lena EK - ALDE, SE) and the Internal Market (opinion by Hartmut Nassauer - EPP-ED, DE), which are closely involved in consideration of this legislation (under the 'enhanced cooperation' procedure provided for by Rule 47 of the EP's Rules of Procedure) tabled a series of amendments on this aspect, which, like the amendments tabled by the Environment Committee, will be put to the vote directly in plenary in mid-November. The Committee on the Internal Market, in particular, wished to ease the information requirements where the quantity produced was less than 100 tonnes, rather than 10 tonnes.
The Environment Committee, for its part, wishes substances contained in articles to be notified to the Agency if their concentration exceeds 1% and when the possibility of a hazard to the environment or health cannot be excluded. It suggests that a 'quality mark' be placed on articles manufactured in accordance with the REACH Regulation.
The Environment Committee has added various entries to the list of products exempt from registration, particularly minerals, foods, polymers and substances for use in product and process orientated research and development (PPORD). However, these exemptions must not lead to discrimination between products and substances manufactured in the EU and those which are imported.
One substance, one registration
In order to ease the burden on businesses, REACH allows them the option of forming consortia for the purpose of submitting data to the Agency jointly. In the same spirit and in accordance with the principle, 'one substance, one registration' (OSOR), various amendments adopted by the Environment Committee reinforce the obligation on businesses to exchange non-confidential data among themselves (in order to avoid duplication of applications). Exemptions would be possible for the purpose of protecting confidential information, but these must be granted by the Agency and on no account could the exemptions apply to data concerning tests on animals. The Agency would be required to publish a list of the substances already registered in order to make life easier for businesses and again to avoid duplication.
Reducing experiments on animals
Members considered that, where the required data necessitate experiments, they must primarily be carried out 'in vitro'. If alternatives to experiments on animals exist, their use should be compulsory. Businesses would also be required to communicate to the Agency all results of experiments on animals and all information which could make it possible to avoid experiments on animals, on pain of forfeiting their rights to registration. Members also suggest that the Sixth Framework Programme of Research should include encouragement for research into alternative methods and that the European Centre for the Validation of Alternative Methods (ECVAM) should be consulted before any experiment is performed.
The Agency is at the heart of the system
While Members are divided in their opinions regarding registration procedures, they are more unanimous about the 'evaluation' component of REACH and the central role to be played by the future European Chemicals Agency, which will be set up under the regulation and be based in Helsinki. On these points, the Environment Committee accepted many of the amendments suggested, in particular, by the Committees on Industry and the Internal Market.
In order to avoid confusion and duplication between the authorities of the Member States, and with the aim of promoting confidence, it is felt that the Agency should be 'in charge of the overall management of the REACH process': this applies both to the evaluations and to the granting of registration and authorisations. The Agency would of course be assisted by a network of national bodies, but the Agency itself would decide the priorities for evaluations and draw up annual plans. Many amendments are concerned with the evaluation procedures, the composition and functioning of the Agency and the principle that it is to be independent and its work transparent, as well as laying down appeal procedures.
Authorisations to be temporary and revisable
One of the main aims of REACH is to encourage the replacement of the most hazardous substances (those which are carcinogenic, mutagenic, toxic to reproduction or bioaccumulative). On the basis of the precautionary principle and the substitution principle, the Environment Committee wishes to make the provisions in the package more stringent. In its opinion, authorisations should be granted only for a maximum of 5 years in order to encourage the development of alternative methods and substances. These authorisations would be open to revision at any time, particularly if new scientific data necessitate urgent measures.
Hazardous substances should be authorised only where no alternative exists and on condition that measures are taken to limit the risks of exposure, particularly of those who are vulnerable, and provided that the social and economic benefits outweigh the risks to health and the environment. To the list of the substances most hazardous to health Members added ingredients added to tobacco products and sensitisers (substances which cause allergies).
