Brussels, 29/10/2003 (Agence Europe) - This Wednesday, after five years work and intense talks, the Commission presented its proposal for a framework regulation to regulate the registration, evaluation and authorisation of chemical products in the European Union. This draft regulation, named Reach aims to reform EU policy on chemical products to overcome the failures seen in the present legislation, complex and ineffective, since most the chemical substances already on the market have not be evaluated, which would create an enormous deficit in information on the dangers that they present for public health and the environment.
The proposed regulation is a remodelled version of the draft the Commission publish on the internet last May, complemented with the results from an independent impact assessment of the reform concluding the direct costs for industry of EUR 2.3 billion over 11 years, or 10 billion less than initial estimates (see EUROPE of 17 October, p. 10). In the Commission's mind, the aim of the remodelling was to lighten the bureaucratic burden and the cost of the Reach system in order not to block European competitiveness and innovation, in accordance with the conclusions of the last European Council. It wanted to do this while preserving the new system's objectives of protecting public health and the environment, as wanted by consumer protection and environmental organisations. Let us recall that the estimated benefits from this proposal in terms of the health economy as estimated at EUR 50 billion over thirty years.
The new system increases industry's responsibility by reversing the burden of proof. It will be for manufacturer to prove the safety of their products (and not for public authorities to check that the products are safe) and to undertake the necessary tests. For lack of which, the products may not me marketed.
Accordingly, Reach will make the registration of all chemical substances produced or imported in quantities above 1 ton per year and per producer obligatory, with the exception of certain intermediary substances, polymers and a few chemical products subject to different Community legislation.
Manufacturers and importers of these substances will be forced to provide all the necessary data relating to the properties, uses and precautions for use of the chemical products.
The crucial data relating to safety and the use of chemical products will be passed on through the supply chain, in order for the processing industry to be able to use these substances without endangering worker and consumer health and without risk for the environment.
A chemical product agency would be entrusted with managing the database, with receiving the registration dossiers and with providing confidential information to the public.
Evaluation will be required for the products that seem to present a risk to human health or the environment.
All the substances classified as highly concerning - carcinogenic, mutagenic or reprotoxic, persistent bioaccumulative and toxic substances (PBT) and highly persistent and very bioaccumulative substances - would be forcibly submitted to the Commission's prior authorisation procedure, in view of specific uses.
During a joint press conference, Margot Wallström, Environment Commissioner and Erkki Liikanen, Industry Commissioner, both felt that this proposal was balanced as it was respectful of the interests defended by both of their portfolios.
Margot Wallström underlined that the text had received the College's full support and would be published on the Internet as quickly as possible. This proposal answers the growing concerns over the impact of products on health and the environment. The growing number of cancers and allergies, and the presence of chemical substances that accumulate in the human body, while some of them have been illegal for several years, is enough to justify it, she declared.
According to the Commissioner, this new legislation is also required due to the impressive increase in the production of chemical products that has risen from 1 million tonnes in the 1930s to 400 million tonnes today. However, only 3% of these substances produced in quantities above 1,000 tonnes per year are presently evaluated. The present system is based on an artificial distinction between older products (marketed before 1981: ed.) and new products (marketed after 1981). It is inefficient and too slow. More than 100,000 chemical products can be marketed without evaluation, thus more easily than recent and sometimes less dangerous products.
In ten years, only eleven assessments have been carried out. The obligation for testing new substances that start with the production of 10 kg, hampers innovation". Ms Wallström considers that the Reach system is balanced because it reconciles, "the demands of a modern society that need chemical products and the needs to master the risks". She indicated that standard tests would be developed to replace the tests that are currently carried out "in the dark". A total of 30,000 substances will be tested and animal experiments will be limited by the pooling of experiment results to avoid duplications. She declared that, "the approach decided on rests on two principles: no data, no market. Reach will be in the service of a policy that will replace the most dangerous products with safer products. Erkki Liikanenen considered that this reform was the greatest challenge ever confronted by the Commission for implementing its sustainable development strategy, by respecting the economic, social and environmental pillars. "That's the proposal on which we have done the most work. It is going to replace forty directives, he said. Pointing our that the chemical industry represented 2 million jobs in Europe and a trade surplus of EUR 60 bn, as well as it bringing an important contribution to all sectors, he underlined the importance of preserving the competitive advantages of this sector. He thinks that the proposal will improve conditions for innovation, not only because it takes the threshold of the current 10 kg up to 1 tonne but also because it extends the trial period for R&D laboratories (currently 6 years as opposed to 10 years, indeed 15 years for pharmaceutical products) by increasing the registration level for substances for research and also because it encourages industrial strategies that are environmentally friendly. "Of course this reform has a cost. But we have made enormous efforts to reduce the estimated cost by 80%", he declared, adding that "a workshop on assessing the impact of Reach, where all issues are covered", will take place. In the meantime, the Commission will work in partnership with industry to test how the system works , he explained.
Environmental NGOs (BEE, WWF, Greenpeace and consumer defecne organisation (BEUC) are not happy that the proposal, according to them, is too attentive to industry, particularly in that it allows it extended use of hazardous substances in products that are currently consumed, even when alternative solutions are safer and available. Eurogroup for Animal Welfare is disappointed by the proposal as it does not guarantee animal experiments to be kept to the minimum. The UEAPME reiterates its worry about the cost and impact on downstream industrial sectors but is happy that the Ecofin Council requested an additional impact study. EUROPE will return to this subject.