A European parliament vote on the REACH chemicals legislation last week struck a balance between health, the environment and industry after months of intense debate.
The Parliament plenary sealed a compromise on the registration aspects of REACH, struck the previous week between the three main political formations, the centre-right EPP-ED, the socialists (PES) and the liberals (ALDE).
"The European Parliament has responded to some of the fears of the Europeans, ensuring competitive jobs together with a high level of protection of health and the environment," said Parliament's President Josep Borrell.
The agreed legislation will now undergo a Competitiveness Council debate scheduled for 28 November 2005, and it is hoped a common position will be achieved by the end of the year.
However, this may have become unrealistic when MEPs backed to the "substitution principle," which requires companies to replace dangerous chemicals 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 be found was the endorsement of the Environment Committee's approach towards authorisation, which is based on registering the most dangerous chemicals, and those used in the largest quantities, first and limiting authorisations to a maximum period of five years at a time to allow continuous consideration of available substitutes.
Additionally, the new German government, which is to be sworn in on 22 November, has asked for more time to read the dossier.
The legislation, which has wide implications for industry competitiveness and innovation on the one hand, and health and the environment on the other, has been one of the most complex issues the Parliament has ever had to consider.
In-PharmaTehnologist.com outlines the agreed legislation for registration, which only applies to existing substances - new substances will continue to be required to provide full safety data for all quantities.
All of the 30,000 chemicals in questions will still need to be registered, but chemicals manufactured or imported in volumes of 1-10 tonnes will be exempt from undergoing health and safety tests - this may apply to up to two-thirds of all chemicals.
Substances of high concern and substances dangerous to human health or environment, which are used in consumer products, will, however, have to provide full sets of safety data.
A new European Chemicals Agency, based in Helsinki, will decide which of these chemicals used in low volumes are risky enough to have to pass through the testing procedure.
The possibility was also introduced of allowing companies to omit certain tests ("waiving") for substances produced/imported between 10-100 tonnes when this is justified on the basis of certain criteria (yet to be determined by the Commission).
However, the possibility of making additional tests, if this appears necessary, was also introduced.
The "One Substance, One Registration" (OSOR) approach was agreed upon, to minimise costs, with an opt-out in specific conditions where it can be justified.
Helpdesks and additional guidance and tools will be provided to meet the obligations of the regulation.
All the above compromises are aimed to cater for the concerns of small and medium businesses (SMEs) that fear they could be driven out of business because of the high administrative costs that REACH is expected to entail.
The legislation does still maintain, in all cases, however, the "burden of proof" on industry to make available information on the hazards, risks, and risk reduction measures for chemicals.
The EP endorsed by a narrow margin a slightly revised version of the approach to "substances in articles" adopted by the Environment Committee, which stipulates equal treatment of imported articles to those produced in the EU, through simple notification requirements for articles containing substances listed as being of very high concern, and by equal application of authorisation.
"The vote had been very positive, it had strengthened the balance of the regulation," said rapporteur, Guido Sacconi.