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The New EU Chemicals Policy – REACH

The European Commission adopted proposals in October 2003 to establish a new system to regulate the manufacture, import and use of chemical substances - called REACH (Registration, Evaluation and Authorisation of Chemicals). The EC has adopted this strategy because it considers that there is insufficient information about the effects of the majority of existing chemicals used by industry on human health and the environment.

REACH is the biggest and most complex of European legislation that the EC has ever undertaken and creates a new responsibility for all companies. It replaces over 40 existing Directives and Regulations and will have a massive impact on the chemical industry. The legislation is expected to be agreed by Member States by the end of this year and to come into force in April 2007. The new regime will create a new European Chemicals Agency (ECHA) to be set up in Helsinki, Finland, and be operational by April 2008 to manage the scientific, technical and administrative aspects of the REACH Regulation, including a new central database, IUCLID 5, for managing hazard data on chemical substances and to report to the authorities.

REACH will replace all existing chemicals' legislation, including CHIP, cosmetics and biocides legislation. The system requires manufacturers and importers of substances to submit a registration to the Agency for each substance manufactured or imported in the EU in quantities of one tonne or above per year, based on a phased-in period of 11 years. Failure to register means that the substance is not allowed to be manufactured or imported.

Companies that produce and import chemicals (Upstream Users) are required to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. The safety information will be passed down the supply chain to Downstream Users (DU), who are required to consider the safety of their uses of substances, based primarily on information from their suppliers, and to apply appropriate risk management measures. DU will need to ensure they get the information they need in the well ­established and familiar format of the safety data sheet (SDS), that will be carried over to the REACH Regulation. The information in the SDS will be improved and extended as a result of the registrations under the new system.

The Commission is currently preparing technical guidance documents for industry and authorities to assist them in the implementation of REACH. The work is done in the framework of so-called REACH Implementation Projects, or RIPs. These are divided into 13 sub-projects covering the main processes and requirements of REACH.

In order to assist and update industry on the progress of RIP 3 - Development of Guidance for Industry - the Commission and industry jointly organised an information and awareness workshop in Brussels on 25 September 2006. Places were limited to 400 throughout the whole of Europe, and the ATC applied for and was granted a place on behalf of our specialist industry.

The programme focused on the needs of organisations and companies, especially SMEs in chemicals and downstream industries. Although the Commission tried to assure delegates that animal testing would be a last resort, there is no doubt that new animal tests will be compulsory across Europe. Indeed they have been estimated by the Commission itself to potentially involve millions of animals. The ATC has strongly opposed animal testing in all its responses to the REACH consultation documents.

Essential oils do not fit into the proposed definition of a chemical substance or a preparation, because when they are produced they naturally contain a mixture of chemical substances and their composition will vary from batch to batch and from crop to crop. Consequently, they cannot be standardised easily and they have not been subjected to the full range of safety tests required by the regulations, many of which require animal testing. As a result the regulations will require that the safety of an essential oil is determined by reference to the safety of all of its components. This is a task that is totally impractical to perform and will need to be reviewed each year as the composition changes. The European Federation of Essential Oils (EFEO) and ATC believe this to be totally unworkable and unnecessary.

Consequently, EFEO prepared a Position Paper and Proposed Amerndments to the draft REACH Regulations that were circulated to MEPs by both EFEO and ATC last year. As a consequence of EFEO's heavy lobbying efforts four amendments relating to substances of botanical origin and their exclusion from REACH, were tabled at the First Reading vote on 17 November last year. With over 1,000 amendments to the REACH proposal to vote or amendments were divided into blocks. Unfortunately EFEO's ammendments failed. probably as victims of the block voting system. although the European Council added recitals in its position asking 'the Member States, the Agency and all interested parties to take full account of the results of the REACH Implementation Projects (RlPs), in particular with regard to the registration of naturally occurring substances.' So essential oils are in REACH under category NCS - Natural Complex Substances - and the main concern is now to get a special (softer) treatment as to the registration of our products.

This article was published on Tuesday 01 January, 2008.
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