14/11/2005.

By dint of intense and complex political negotiations, Guido Sacconi (PES, Italy), rapporteur of the EP on the substance, and Harmut Nassauer (EPP-ED, Germany), rapporteur for the committee on the internal market, reached a compromise in extremis on Tuesday evening, November 8, on the most controversial aspect of the proposed regulation: the registration procedure for chemical products. The EPP-ED, PES and ALDE groups rallied to this agreement between the two rapporteurs, which bodes well for a broad majority on this point at the plenary session. "We are able to confirm that the debate at the Parliament will take place next Tuesday and the vote on Thursday. It is extremely important for the Parliament to respect the timetable already laid down and to take the responsibility incumbent upon it", Guido Sacconi told the press on Wednesday,

"The most important points of principle for the committee on the environment have been kept in place. We have made a few major concessions, it is true, but we are continuing to do our work", added Mr Sacconi.

"Overall, the compromise agrees with the result of the Council's work", said Guido Sacconi, referring in particular to the following elements:

• all substances must be pre-registered at least 18 months before they are produced. The option of extending this deadline by six months is provided for;
• the deadline for submitting data relating to substances used for R&D is extended with a view to promoting innovation;
• the principle of one substance one registration (OSOR) is kept in place, but with derogation options for multiple registrations (the idea of consortiums between businesses is no longer under discussion);
• persistent, bioaccumulative substances and those toxic to reproduction (PBT) must be registered every three years only if they are produced or imported in quantities above 100 tonnes per annum. All such substances must be registered within six years;
• the principle of categories of exposure to substances is brought in "as an additional element" determining the information to be provided throughout the chain of supply;
• a modulation of the degree of information to be provided is brought in on a case-by-case basis, depending on volume and toxicity of the substances.

For substances produced or imported in quantities between one and 10 tonnes per annum (or 20 000 of the 30 000 substances to evaluate), physical and chemical data, together with all available and relevant information for the assessment of risks, must be made available. The requirement for information will only be extended if the risk assessment justifies this.

A safety report on the substance must be drawn up if the available data or the structure of the substance points to any carcinogenic or mutagenous characteristics.

For substances produced or imported in quantities between 10 and 100 tonnes per annum (some 5000 substances), the compromise sacrifices certain tests and makes any additional study conditional upon an assessment focusing on the risk.

The doctors of medicine, who signed the Appel de Paris - an international declaration on the health dangers of chemical pollutants launched in 2004 at a UNESCO - have criticized the compromise. According to them, public health is clearly put on the back shelf in the successive changes to the initial proposal for a regulation. They deplore the fact that the alarm has not been heard.

"Three-quarters of cancers are due to mutations caused by environmental factors and one cancer out of two is linked to chemical pollution; 15% of couples are infertile and allergies affect 20% of EU citizens. Cancer patients are being treated but the environment, which is itself ill, is not being treated", commented Professor Dominique Belpomme, French cancer specialist.

The compromise has also caused anger on the part of the Greens/EFA Group and environmental NGOs who see this last change to the text before the vote at first reading as a further weakening of the proposal for regulation, denoting the unacceptable victory of industrial interests over the imperatives of health and environmental protection.

Source: Agence europe