Brussels, 13/09/2005 (Agence Europe) - The British EU Council Presidency has tabled a proposal for a compromise on the proposed REACH Regulation (registration, evaluation and limited authorisation of chemical products), on which it hopes it will be able to reconcile protection of the environment, human health and the imperative of preserving the competitiveness of European industry. The compromise aims to represent a balanced consideration of the views expressed by Member States and amendments have also been included to take into account the recommendations from the Strategic Partnership on REACH Testing (SPORT). Published the day before the two decisive votes at the European Parliament on the REACH proposal (the Industry Committee took a stance at first reading on Tuesday, and the Internal Market Committee will do so on Wednesday), the compromise also aims to facilitate the follow-up of work on a particularly complex and voluminous text, which was the subject of around 5,000 parliamentary amendments.
The main innovation of compromise is on simplification on the registration procedure for chemical substances produced or imported in low tonnage volumes (between 1 and 10 tonnes annually), according to the proposal by Malta and Slovenia. The manufacturers or importers of such substances would simply be under an obligation to submit data available on such substances except when these substances have been identified as presenting a potential risk. In such cases, the manufacturer or importer should submit key data as required under Annex IV of the Regulation, to which are added a test for acute toxicity, biodegradation and algal toxicity. The cost of these additional tests will be minimal, the Presidency states. Such simplification answers the concern that a registration system should be established to provide all the information required for evaluation of the risks linked to the use of substances while avoiding data that is not useful being provided by the companies.
In order to reduce the cost of registration, the principle of “one substance, one registration” (OSOR), which guarantees that the burden is shared, has been introduced. It will make it an obligation for companies that register their substances to share information and results of animal testing, in line with the European Commission's proposals.
The text also provides for the trade secret to be guaranteed (any information on the use of substances, for example, will remain confidential and companies are not compelled to share information on this subject).
The Presidency has also strengthened the overall risk-based approach to REACH by proposing that substances which are identified as potentially Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) based on existing classification criteria, be registered in the first phase along with high tonnage substances and substances toxic to human and reproductive health (CMRs).
Before the vote by the European Parliament's committee on the internal market, Alexander Lambsdorff (ALDE, Germany) welcomed this attempt at a compromise. In a press release, he considers that the Council document takes on board the essential elements of the balanced European Parliament position. It guarantees a high level of protection while alleviating the burden for SMEs - in line with the two main objectives followed by the Liberals during consultations.
Although registration procedure should be applied to all substances produced or imported in volumes of over one tonne per year, the Presidency compromise suggests exemption from the scope of REACH of waste and certain recycled material, as well as mineral ores.
For chemical substances contained in products and intended for release, these will be subject to registration obligation. Substances contained in imported products or incorporated in articles for usage not foreseen by the initial registration, European importers and producers would have to notify them to the authorities only if the product contains a substance which, above a minimum concentration, causes serious concern (whether or not the substance is to be released).
The Presidency compromise is similar in places to the guidelines voted by the industry committee (Rapporteur Lena Ek, ALDE, Sweden) apart from the fact that the amendments of compromise adopted by a large majority (43 for, 4 against) by the EPP-ED, PES and ALDE are still more in favour of industry (greater simplification of registration procedure, no compulsory sharing of data, no additional toxicity testing, and more exemptions) - to the great disappointment of the Greens/EFA Group and defence and environment organisations. EUROPE will come back to this in a later issue.