Brussels, 09/11/2005 (Agence Europe) - The proposed European legislation on the registration, evaluation and limited authorisation of chemical products (REACH) is starting to see the light at the end of the tunnel. 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, which is behind the request to postpone the vote at first reading of the Parliament on this dossier, reached a compromise in extremis on Tuesday evening, 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, visibly delighted that the Council "is not the only one to do its legislative work" (the UK Presidency has also presented an amended version of its September compromise). "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. Talks are set to continue on Wednesday evening to ensure that the amendments to be made to "other important chapters", such as the authorisation for particularly dangerous substances which are likely to be withdrawn from the market in the light of risk assessment tests, and the promotion of substitute products, are as clear and precise as possible.
"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. It will be up to the Commission to define this "adequate justification", 18 months after the entry into force of REACH, by a procedure of comitology.
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.
Hartmut Nassauer welcomed this progress towards the practical ability and efficiency of REACH. He feels that it is of particular importance for SMEs and downstream users that the information to be made available on the substances throughout the chain of supply is based on categories of use and exposure, rather than on the basis of individual applications.
Professors of medicine and MEPs in favour of very strict REACH leap to the defence of public health imperatives
On Tuesday at the EP alongside MEPs of every political leaning, professors of medicine leapt to the defence of a very rigorous REACH legislation, in order to stress the very serious threat that chemical products represent for the health of EU citizens. They called on political decision-makers to assume their responsibilities. Just a few days from the plenary debate on the proposed REACH regulation, these health professionals explained to the press how mistaken they felt it was to close one's eyes to the danger to future generations and reproduction to ignore the link between exposure to cocktails of chemical products and cancer, fertility problems and allergies from which the citizens of Europe suffer - especially children - to a growing and ever-more alarming extent. In their view, public health is clearly put on the back shelf in the successive changes to the initial proposal for a regulation, to their great regret and their deep concern. These 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 seminar, deplore the fact that the alarm has not been heard. Marie Anne Isler Béguin, French Green member, said before making way for speeches by the doctors that “tempers are heating up and stances are getting confused. We need you, the medical corps, to explain to us why we should not give way to the temptation of bending to the industry. It is urgent for public health to take the political decision that is needed”.
“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”, Professor Dominique Belpomme, French cancer specialist and President of the ARTAC (Association pour la recherché thérapeutique anti-cancéreuse) who initiated the Appel de Paris, commented, recalling three articles in the declaration: 1) - the development of many current diseases is consecutive to the worsening of the environment; 2) chemical pollution is a serious threat for children and for Man's survival; 3) our health, that of our children and that of future generations being in danger, it is the human race that is also in danger. Professor Belpomme recommends: - making the principle of substitution a compulsory option for chemical products of great concern (CMR, tPtB, PBT, endocrine disruptors); - testing as a priority all molecules that are presumed toxic(CMR) but still on the market; - strengthening the registration and assessment of substances produced in small volumes calling for a report on the consequent chemical safety of such products.
“Thirty percent of the population suffer from illnesses linked to environmental causes and 4-9% of the population have severe illnesses caused by the environment in which they live. When it comes to human beings, there is little or no information concerning the 99% of chemical products on the market”, said Dr Peter Ohnsorge, German otolaryngologist and allergologist specialised in environmental medicine and director of the European Academy for Environmental medicine. He went on to warn that doctors need more information concerning the danger of chemical cocktails to which patients are exposed. Otherwise, they cannot care for the ill and have no possibility of prevention. This is the only way to deal with chronic illnesses in the future, he said, given the indigence of health systems in Europe.
Dr Louis-Jean Calloch, Chair of the Committee on Preventive Medicine and the Environment at the Standing Committee of European Doctors requested that an impartial analysis be made of the scientific causal link between illnesses and CMR substances. He urged for there to be a diploma in environmental medicine and for a strong REACH programme.
Belgian Liberal MEP Frédérique Ries, who sees a powerful REACH legislation as providing a golden opportunity to reconcile Europe and its half a billion citizens, recalled that the health industry has already been largely heard as the proposal on the table is a “light version of REACH”, compared to the initial text. She warned that, either we yield part of the industry to temptation, or we remain ambitious and demanding when it comes to protection of health and the environment, like the Parliament's committee on the environment. Given such stakes, the traditional right/left division is not what is important, in her view, but rather the past and the future, a life choice, a choice of what one wants to leave to one's children. She went on to add: “We cannot allow ourselves to be less ambitious than the British Presidency's compromise. The battle continues. It will be violent at the Parliament in Strasbourg next week unless some (Ed.: the EPP-ED Group) manage to obtain deferral of the vote”. This hypothesis has now been dismissed.