Parliament adopted the compromise it negotiated with Council on the new regulation for chemicals, REACH, which will oblige producers to register all those chemical substances produced or imported above a total quantity of 1 tonne per year. Registration will affect about 30,000 substances. For more hazardous substances, producers will have to submit a substitution plan to replace them with safer alternatives.
When no alternative exists, producers will have to present a research plan aimed at finding one. The compromise package agreed with the Council and tabled by 4 political groups (EPP-ED, PES, ALDE and UEN), was approved with 529 in favour, 98 against and 24 abstentions.
The regulation will enter into force progressively from June 2007, and the registration process will take 11 years to be completed. The calendar for registration depends on the risk of the substance and the quantity produced. All covered substances will have to be registered by 2018. REACH also creates a new Chemicals Agency, to be based in Helsinki, which will be responsible for the authorisation process.
Registration will affect about 30,000 substances. The calendar for registration depends on the risk of the substance and the quantity produced. All covered substances will have to be registered by 2018.
European Parliament President Josep Borrell commenting on the EP adoption of REACH said: "This vote, on one of the most complex texts in the history of the EU, sets up an essential piece of legislation to protect public health and the environment from the risks of chemical substances, without threatening European competitiveness. It offers EU citizens true protection against the multitude of toxic substances in everyday life in Europe."
The issues at second reading
- Authorisation of hazardous substances
For the most dangerous substances, there will be an obligation for producers to submit a substitution plan to replace them with safer alternatives. Where no alternative exists, producers will have to present a research and development plan aimed at finding one. Under a review clause, it will be decided after six years, on the basis of the latest scientific data, whether endocrine disruptors should be included in a list of substances which can only be authorised in the light of an analysis of their socio-economic costs and benefits. A clause was agreed to review after six years, on the basis of the latest scientific data, the inclusion of these substances among those which can only be authorised in the light of an analysis of the socio-economic costs and benefits.
- Registration of substances
The Commission must decide in 12 years' time whether or not to recommend extending the requirement for chemical safety reports for substances produced or imported in amounts of less than 10 tonnes per year. This deadline was shortened to seven years for cancerous or mutagenic substances or those toxic to reproduction. The intellectual property provisions were strengthened, with data protection extended from three to six years.
- Duty of care
As MEPs wanted, the "duty of care" principle will be enshrined in the regulation. It will be in a recital stipulating that the manufacturing, import or placing on the market of substances must be done prudently and responsibly, to ensure that, under reasonably foreseeable circumstances, human health or the environment are not adversely affected. This will involve collecting all necessary information on the substances in question and relaying all recommendations about risk management along the distribution chain.
- Evaluation of substances
Parliament will appoint two members of the Helsinki-based European Chemicals Agency and the Executive Director will have to undergo a hearing with MEPs before his/her appointment is confirmed. However, Parliament's demands for guarantees of the independence of the agency's members vis-à-vis industry and the publication of declarations of interest were not accepted.
- Communication of information
A clause was added on the duty to inform the public about dangerous substances contained in products. The distribution chain, including consumers who request it, must be informed of the presence of any chemical in an amount greater than 0.1% of the total product weight. The Commission must consider the possibility of establishing a European quality mark for chemical products.
