European Chemical Regulations

Date: 9 Jan 2009 | posted in: environment | 0 Facebooktwitterredditmail

The European Commission approved a framework for the Registration, Evaluation and Authorisation of Chemicals (REACH) (COM(03) 644 (01)) in October 2003.  Following two years of negotiation on the Commission’s original proposal and following the European Parliament’s first reading opinion, the Council reached a Common Position on June 27, 2006.

TheEuropean Commission supports achieving final agreement on REACH at Second Reading. Final adoption of the proposal is expected by the end of 2006.

If approved by the European Parliament, the proposed REACH system would overhaul the European Union’s chemical substances policy. This new EU regulation will replace 40 existing legal acts and create a single system for all chemical substances.

Thenew system, REACH, will establish an integrated system for the registration, evaluation, authorisation and restriction of chemicals. REACH will ensure that the gaps in existing information on the hazardous properties of some 30,000 chemicals are filled and that the necessary information on the safe use of substances is transmitted along the industrial supply chain leading to reduced risks for workers, for consumers, and for the environment.

REACH will reverse the burden of proof so that industry, both producers and importers of substances, rather than the public authorities, will have to assume greater responsibility for providing the necessary information and taking effective risk management measures.

Legislationenacted in 1981 (Directive 67/548) required “new substances” produced in quantities as low as 10kg (22 pounds) per year to be registered and tested for environmental and health risks. More than 100,000 "existing substances" already on the market in 1981 were not subject to the same requirements.

EU leaders have identified two major shortcomings of the 1981 approach.

  • The expense of testing new substances encourages the use of existing substances, stifling innovation. There is some evidence to validate this theory.  Existing substances account for 99 percent of the volume of synthetic chemicals.  Only about 3,000 new substances have been introduced in Europe since 1981.
  • Some grandfathered substances have been found to pose a public health danger.  For example, ethyl benzene is in many home products yet is known to cause nerve damage; heavy metals like cadmium, an ingredient in many paints, can cause lung damage and kidney disease.

Under the original proposed rules, any company that manufactures or imports more than one metric ton of an existing substance is required to register it in a central database. Registration includes information about the properties of the substance, its uses and safe ways of handling it. A new European Chemicals Agency will be responsible for reviewing registrations and providing non-confidential information to the public.

Theproposed directive does not require that each chemical be tested. Indeed, it is tailored to reduce the expense of testing (and minimize animal testing).  Each registered chemical’s dossier is examined to evaluate compliance with registration requirements and existing test data related to the substance. If a human health or environmental risk is suspected, further testing may be required. It is expected that around 80 percent of existing substances will not require more than a dossier evaluation.

Official authorization would be required to continue to use substances determined to pose serious and irreversible risks.

TheEU estimates that the cost of implementing REACH will be $3.5 to $6.5 billion over the next 15 years, but that $60 billion will be saved in chemical-related health costs. In addition, business costs will be offset by profits from new, safer alternative substances.

U.S.chemical producers and the U.S. government have lobbied against REACH, which they say will adversely affect most goods exported to the EU. The government maintains that it is a technical barrier to trade, in violation of World Trade Organization rules.

Related Rule:
In January 2003 the EU amended its Cosmetics Directive (76/768) to ban chemicals known to or suspected of causing cancer, mutation or birth defects. Since then, major cosmetics companies have reformulated their products for global, not just European, markets.

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