Brussels, 04/05/2005 (Agence Europe) - The guidelines of German MEP Hartmut Nassauer (EPP-ED), rapporteur for the parliamentary committee on the internal market and consumer protection, for the future European chemicals policy are complete. His report on the proposed REACH regulation (registration, evaluation and limited authorisation of chemicals) will be presented to the committee on 24 May, with a view to its adoption no later than July. With his contribution to work on this in the parliament, headed up by the committee on the environment (rapporteur: Guido Sacconi, PES, Italy), Hartmut Nassauer aims mainly to remedy what he sees as the main weakness of the text, which has been on the table since October 2003: the emphasis on the quantity of the chemicals produced or imported every year as an element requiring registration and the degree of requirement for data to be supplied by the producers/importers/users for the assessment of the substances- a requirement which is in proportion to the level of annual tonnage, but entirely independent of the effective risks presented by these substances to health and the environment. “The bureaucratic burden, the unsuitability and the disproportionate cost of such a system, particularly for SMEs”, have long been criticised by the rapporteur (EUROPE 8869). Presenting the outlines of his report to the press on Wednesday, he hoped to show that the time had come for constructive proposals not calling the objectives of REACH into question, or the principle of registration, but the method.
“Registration is the key element for the functioning of the internal market. What I propose are elements to add to the Commission's proposal with categories of use for the chemicals and categories of exposure to these substances to concentrate on”, said Hartmut Nassauer. There will be three categories of use: industrial, commercial and private. The categories of exposure will determine the conditions under which human beings or the environment enter into contact with these substances (oral, cutaneous or inhalation exposure for humans, by the soil, air or water for the environment), and will be clarified by short- or long-term exposure criteria.
It is on the basis of these categories that the risks could be assessed and producers or importers called upon to provide the required registration data, i.e. relevant information on the risks identified. On the basis of these effective risk criteria, the Nassauer report proposes the following system:
- concomitant pre-registration of all substances: the notification of all substances in a register held by the future chemicals agency would be the first obligatory stage in the eighteen months following the entry into force of the REACH regulation (this pre-registration would contain a small amount of information on each substance). A producer or importer could ask for information on these substances earmarked for registration at any point and be put in contact with registration candidates in order to create consortia to share costs between several producers.
- the establishment of a dossier containing key obligatory information for all substances produced or imported in quantities of over a tonne per year, within three and a half years. These data would be relative to the tests recommended by the European Commission (annex V of the regulation), to which the rapporteur is proposing to add a test on acute toxicity and one on the biodegradability of the substances. “These data would be obligatory and sufficient for all substances. These additional data would be called for only in matters relating to exposure and use categories of substances”, the rapporteur observed.
- the chemicals agency would draw up an order of priority to be observed in the registration of substances, “which would allow the potential risk of a substance to be taken much more into account and the highest-risk substances to be dealt with first”.
The rapporteur proposes that all substances that are carcinogenic, mutagenic or harmful to reproduction (CMR) and all substances produced or imported in quantities greater than 1,000 tonnes a year be registered within five years. The other substances would be assessed within seven, eight or nine years, depending on the risk, so that after eleven years (a deadline which fits in perfectly with the overall timetable put forward by the European Commission), the 30,000 substances targeted by REACH would be registered (17,000 produced in quantities of between 1 and 10 tonnes and 13,000 in quantities ranging from ten tonnes to upwards of 1,000 tonnes a year).
The taxes paid to the chemicals agency for the registration of substances would not be required for those produced or imported in quantities between one tonne and a hundred tonnes a year, which would reduce the burden on SMEs. Hartmut Nassauer also hopes to exclude from REACH all chemicals already governed by specific legislation, such as medicines, construction products, cosmetics and biocides.