Registration, evaluation, authorisation and restriction of chemicals (REACH); European Chemicals Agency  
2003/0256(COD) - 10/10/2006  

 The committee adopted the report by Guido SACCONI (PES, IT) amending, under the 2nd reading of the codecision procedure, the Council's common position on the REACH proposal. Members in the committee decided by a large majority (42 votes to 12, with 6 abstentions) to take a tougher line than the Council. They called for the most hazardous substances to be substituted wherever possible and also stressed the duty of care principle, the need for a compulsory safety assessment for chemical products in amounts of less than 10 tonnes and the need to promote alternatives to animal testing. The key amendments were as follows:

- Substitution: reaffirming the position adopted by Parliament at 1st reading, the committee argued that substances which cause cancer, reproduction problems or persistent problems in the human body should not be authorised unless three conditions are met: if "suitable alternative substances or technologies do not exist", if "it is demonstrated that the social or economic advantages outweigh the risks" of these substances to human health or the environment, or if the risk is "adequately controlled". Moreover, the authorisation given for the use of a substance should be limited to a five year period;

- Duty of care: the committee stipulated that the REACH regulation should be implemented "in accordance with the duty of care" and having due regard for the obligations entered into by the EU and its Member States under international trade agreements, in particular within the WTO. This means that manufacturers, importers and downstream users of chemicals must make "every effort that may reasonably be required" to prevent, limit or remedy any adverse effects on the environment or human health and must provide adequate information about any risks and, where appropriate, provide technical assistance;

- Chemical safety assessment: the committee felt that basic safety data, in the form of a chemical safety report assessing both hazard and exposure, should be provided for all chemicals subject to registration, and not just for substances manufactured or imported in quantities of 10 tonnes or more per year, as proposed by the Council;

- Alternatives to animal testing: the REACH regulation should promote tests that do not use animals. In addition, the Commission and the Member States and companies should allocate more resources to devising, validating and adopting tests not carried out using animals. However, MEPs did not want any of the fees paid to the new agency to be used for this purpose. The European Centre for the Validation of Alternative Methods should be consulted on testing proposals that include animal tests;

- Aid for small firms: to make it easier to apply the regulation, the committee called on the EU to provide aid and support for small and medium-sized firms. The Member States were also urged to adopt special assistance measures to enable these companies to carry out the tests needed to collect the information required under the regulation and to put in place a comprehensive support network in cooperation with the Commission;

- European Chemicals Agency: a number of amendments sought to beef up the role and involvement of Parliament in the governing bodies of the Agency, which will be based in Helsinki: two MEPs should sit on the Management Board; the list of candidates for the board, drawn up by the Commission, should be sent to Parliament, which would then have three months to deliver its opinion; the nominee for Executive Director of the agency should undergo a hearing before being appointed by Parliament; members of the board, the Director and the Agency's experts should each year make a declaration of their financial interests, so as to guarantee the Agency's independence;

- European label: lastly, the committee wanted the Commission to put forward a legislative proposal on the creation of a European quality mark for articles which comply with the requirements of the regulation throughout their production process.