MEPs have approved by a large majority (407 votes in favour, 155 against and 41 abstentions), the highly controversial REACH proposal to evaluate and possibly ban chemical products based on human health and environmental safety grounds.
The Parliament plenary sealed a political agreement struck a week before between the three main political formations, the centre-right EPP-ED, the socialists (PES) and the liberals (ALDE) (for more, see EurActiv, 8 Nov. 2005).
If backed by EU ministers later this year, it would mean that some 30,000 potentially hazardous chemicals, which have sometimes been in use for decades, will need to go through at least basic assessment before receiving authorisation. Otherwise, they could face a ban.
Substitution
However, the chances of an early agreement with EU ministers seemed to drift away when MEPs gave their backing to the so-called 'substitution principle', which requires companies to drop dangerous chemicals and replace them with safer alternatives when these are available. This provision has been fought hard by industry and has so far proved too controversial to be included in any compromise agreement in Council.
Another provision on which compromise could not previously be found concerns time-limits on authorisations, which the agency could grant for a limited period of five years.
Registration
Under the text voted on by Parliament, registration for chemicals produced or imported in smaller quantities (1 to 10 tonnes per year) is made simpler in order to meet one of the key demands of large industrial producers. Registration for existing substances (those in circulation before 1981) in this low tonnage range will be targeted at chemicals of high concern only and the safety data reduced to the basics.
MEPs however maintained the cornerstone principle of REACH which places the responsibility on companies to prove their products are safe before they are allowed onto European markets ('burden of proof').
In supporting the cross-party compromise, MEPs also confirmed the option for companies to do away with safety tests on chemicals produced or imported in larger quantities (10 to 100 tonnes a year). Waivers would be granted by the agency based on satisfactory justification of risk by the companies. The criteria for granting waivers will be defined at a later stage by the Commission within 18 months after the regulation is in force using a fast-track 'comitology' procedure.
Finally, mandatory data sharing under the One Substance, One Registration (OSOR) proposal is made more flexible with an opt-out option allowing companies to register on their own. This caters for one crucial demand from industry which called for confidentiality to be safeguarded. The agency will assess opt-outs against three criteria.



