Environment, Public Health & Food Safety

Chemicals

After several years of debate, the European Union has overhauled its regulatory régime toward chemicals. The proposal for the Registration, Evaluation and Authorisation of Chemicals (REACH) was approved by the European Parliament on 13th December 2006 and by the Council of Ministers on 18th December 2006. The regulation came into force in April 2007.

REACH provides a new, coherent system to identify the risks of chemicals and manage risks. John Bowis was involved in the final round of negotiations to find a compromise agreement.

Background:

The old regulatory regime was inadequate, as chemicals that were on the market prior to 1981 had not undergone any systematic risk assessment, whereas most chemicals put on the market since 1981 had to be notified and tested. This had the perverse effect of encouraging the continued use of old untested chemical. Only about 3,000 new chemicals were put on the market between 1981 and 2007. The authorities were able to single out chemicals of concern for risk assessment but this was both random and slow.

REACH provides a single, coherent, integrated system of Registration, Evaluation and Authorisation, replacing over 40 existing Directives and Regulations. Under REACH companies that manufacture or import more than one tonne of a chemical substance per year are required to register it in a central database. Safety information on substances has to be provided to a Chemicals Agency so that the burden of proof for ensuring the safety of chemicals is placed on industry instead of the public authorities. Information on chemicals is passed down the production chain for the benefit of manufacturers, retailers and consumers.

First Reading:

At First Reading, the European Parliament made the bureaucracy associated with the original REACH proposal less burdensome, by targeting information requirements for registration, providing for ‘One Substance One Registration’, basing registration phases on risk, facilitating information in the supply chain to downstream users, assigning the EU Agency with responsibility for evaluating dossiers and strengthening its role in substance evaluation, encouraging substitution of safer alternatives and minimising animal testing.

Animal Testing:

The Conservatives supported improvements to the Regulation that reduced the need for animal tests, through requirements for data sharing between companies (to avoid duplication of tests) and by supporting the funding, development and validation of alternative test methods.

Authorisation and Substitution:

The vast majority of chemicals only need to be registered. In evaluating the dossiers submitted, the Chemicals Agency is able to identify the substances that need further examination, with a rolling programme of evaluations. At the end of the process, the chemicals of the highest concern need an authorisation for their use. These include those that are carcinogenic, mutagenic or toxic to reproduction (CMRs), persistent, bio-accumulative and toxic (PBTs) or very persistent and very bio-accumulative (vPvBs), as well as other substances identified as having serious and irreversible effects to humans and the environment.

At the authorisation stage there is an opportunity to substitute the most dangerous chemicals with safer alternatives where they exist. The Conservatives pressed for a stronger substitution principle than that proposed by the Council. In the final compromise agreement (reached on 30th November after intense negotiations), substitution plans were made mandatory, i.e. if a suitable alternative exists the applicant company must submit a substitution plan with a programme of actions to substitute the dangerous substance. If there is no safer alternative at the time of the application, the company must submit a research plan into possible substitutes.