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Essential Oils & REACH
Posted: December 22, 2006
The European Council has adopted the new European chemicals policy -- REACH (the Registration, Evaluation and Authorization of Chemicals) -- on December 18, 2006. After publication in the official journal of the EU, the new regulation will enter into force on June 1, 2007. Recently, the JOSHE Committee, FMA Scientific Affairs Committee and FEMA Regulatory Affairs Committee sent out a letter with some provisions in REACH regarding essential oils. They are:
- All chemical substances, including essential oils will be covered under the scope of the regulation with the exception of substances under customs supervision, traded in transit or temporarily stored in a free zone or free warehouse for re-export.
- Substances used for a variety of applications will be excluded from the obligation to register. Essential oils used in medicinal products for human or vetinary use, in food, including as a food additive and as a flavoring for food and in feeding stuff, including feed additives and in animal nutrition, will not be subject to registration.
- Essential oils imported or produced for use in fragrance and cosmetics, including oral care and detergent products, will need to be registered with the new European Chemicals Bureau to be based in Helsinki, Finland. Following the principle of "No data, no market" there will be no production, import or placing on the market without registration. This applies to all essential oils manufactured or imported in an individual quantity of one ton or more per year.
- Data requirements will depend on the individual production or import quantity per year. Increasing data requirements will apply to tonnage ranges of 1-10, 10-100, 100-1,000 tons and above. These requirements are outlined in Annexes VII through X of the REACH regulation.
- For essential oils in a tonnage range between 1 and 10 tons per year, a chemical safety assessment and a chemical safety report are not required. This provision may be reconsidered by the EU Commission 12 years after entry into force of the regulation and years after entry into force in the case of CMR substances. At that stage, the obligation to present chemical safety assessments and reports might also be extended to substances/essential oils not yet subject to registration obligations.