www.euractiv.com September 15, 2005 Background: The proposal to register and control some 30,000 chemical substances in the EU, known as REACH, is entering a decisive voting phase in Parliament this autumn (EurActiv, 5 August 2005). The proposal would require health and environmental assessments for more than 30,000 chemicals and substances. It proposes reversing the burden of proof from the authorities to the companies instead of the opposite as is now the case. In future, the idea is that companies would have to provide health and safety data for each one of these products or substances. Issues: The UK Presidency has circulated the outlines of a compromise proposal on the draft REACH legislation on chemicals that it hopes could lead to an early political agreement at a ministers' meeting scheduled on 28-29 November. At a press briefing on 15 September, the UK Presidency said the proposed deal would allow exemptions to the scope of the legislation to exclude waste, certain recycled materials, metal ores and ore concentrates. An earlier British-Hungarian proposal to allow businesses to share data for registering chemicals substances in a consortium -- the so- called One Substance One Registration (OSOR) proposal -- would be the key to the whole system. The mandatory sharing of data submitted by companies in a consortium under an updated version of OSOR would be the general rule, the UK Presidency told the press on 15 September. But there would be mechanisms and safeguards to protect the confidentiality of data that are highly sensitive for the protection of business secrets and intellectual property. For instance, information such as the specific usage of a substance submitted for registration or the production process needed to manufacture it would not be required. However, other companies in the consortium would have a right to voice disagreement and ask the agency to assess whether the data should be shared or not. In such cases, characteristics such as hazard or flammability would be compelling arguments for the agency to impose mandatory sharing, the UK Presidency indicated. An industry request for an opt-out allowing a company to go it alone and register a product separately to bypass consortium and keep its data secret was ruled out as such. In another key proposal, the Presidency suggested lighter data requirements for chemicals produced or imported in small volumes (1-10 ton range) based on the so-called Maltese-Slovenian proposal. However, the proposed compromise would make it simpler, the UK Presidency said. For these chemicals, companies would be allowed to submit only their available data to the agency unless some simple criteria highlight them as being of very high concern (such as persistent, bioaccumulative and toxic substances -- PBTs). Three additional safety tests -- acute toxicity, biodegradability and algal toxicity -- have been added "to ensure an adequate assessment of the risks can be made". The UK Presidency admitted that this provision would apply to around 20,000 chemical substances out of the 30,000 that are to be tested under REACH but pointed out that it would probably be much less in terms of volumes. As was suggested by MEP Guido Sacconi, the risk-based approach was generally strengthened by adding substances identified as potentially Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) to the first three-year registration phase - along with the high tonnage. However, this would only apply to chemicals imported or produced over one tonne per year (around 100-200 substances, according to the UK Presidency). Finally, it is proposed that information on risk and hazard is passed up and down the supply chain, to ensure that substances are handled safely. The information should also "certainly" be made available at the request of consumer organisations, the UK Presidency indicated. Furthermore, in order to avoid loopholes in the system, the agency would submit registered substances to a regular review and monitoring. Positions: Reacting to the outcome of votes in EP committees that took place this week (EurActiv, 15 Sept. 2005), the European Chemical Industry Council (CEFIC) said the REACH proposal was "making a step in the right direction". "The risk-based approach is taken into account better than in the Commission's proposal, and the role of the Central Agency has been strengthened," it notes. However, CEFIC believes the proposal could be further refined by applying the risk-based approach "throughout the process, notably in the authorisation and restriction of chemicals". The European SME organisation UEAPME hailed the UK Presidency compromise proposal on mandatory data sharing. "Introducing the compulsory sharing of all data, as the UK Presidency has proposed, will help overcome" problems for downstream users of chemicals, UEAPME said in a statement. According to the Wall Street Journal Europe, the US Chamber of Commerce is planning to mount a legal challenge against the REACH legislation after its final adoption. The American business lobby claims that the new EU law will "disrupt international trade and supply change and greatly increase costs". Latest & next steps: RELATED * Chemicals Policy review (REACH) * 4 October: Environment Committee vote on REACH * 16 November: Likely date for vote in Parliament plenary, Strasbourg Links Official Documents DG Enterprise: The new EU chemicals legislation -- REACH DG Environment: REACH Governments UK Presidency: UK Presidency Compromise REACH Text [summary paper only, not an official text] (Sept. 2005) UK DEFRA: Future EU Chemicals Policy UK DEFRA: One Substance, One Registration: a joint proposal from Hungary and the UK EU Actors positions European Chemical Industry Council (CEFIC): Outcome of votes in European Parliament Committees is a step in the right direction for REACH (15 Sept. 2005) UEAPME: Chemicals law moving in the right direction (15 Sept. 2005) WWF / FoE / EPHA: IMCO and ITRE votes fatally undermine REACH (13 Sept. 2005) Related Documents Two EP committees streamline EU chemicals law (15 September 2005) MEP: Do not expect a major swing on REACH (14 September 2005) Key lawmaker ready for compromise on REACH (13 September 2005) Chemicals found in babies heat up REACH debate (09 September 2005) Chemicals debate coming to the boil in the autumn (05 August 2005) Copyright EurActiv 2000-2005