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REACH—The Essential Guide
Posted: June 16, 2008
page 4 of 6
Once the full scope of REACH has been understood, it is essential to assess the implications for product portfolios. A key consideration will be the potential need for reformulation; some substances may become unavailable if suppliers are unable to comply with the regulation.
Treatt’s range of products, for example, can be divided into three groups: essential oils and extracts, aroma chemicals and blends (or preparations as they are described in REACH). Each will be treated differently under REACH regulation.
Essential oils and extracts: By far the most complicated category, essential oils and extracts are referred to as Natural Complex Substances (NCS) within the industry or Substances of Unknown or Variable composition (UVCBs) under REACH. Many of these substances are imported into the EU in quantities greater than one tonne per year. The challenge for this category is that many of these substances have been used for hundreds of years, and as a result are generally recognized as safe. This means that the necessary test data has never been generated. Therefore, many companies possess the physico-chemical data but lack testing facilities to produce the required human and environmental exposure data. The European Flavor & Fragrance Association and the European Federation of Essential Oils have formulated a plan to assist the industry in preparing for the registration of Natural Complex Substances. This is primarily through the formation of pre-consortia which preempt the substance information exchange forum described in the regulation. For the highest priority aroma chemicals and naturals, namely those requiring registration in 2010, this process has already started.
Aroma chemicals: Aroma chemicals can be considered ‘well defined substances’—substances with a defined qualitative and quantitative composition that can be sufficiently identified based on the required identification parameters. Initial assessments have indicated that for importers and distributors of these substances, like Treatt, much of the required data is already available or will become available through data sharing. However, assessment of volumes and supply lines will be necessary to determine which substances importers will need to register.
Preparations or blends: Although preparations or blends do not need to be registered under REACH, companies must record the substances in these preparations that are present in quantities greater than one tonne per year.