by Annelie Struessmann, PhD, CONUSBAT, Aachen, Germany
Editor’s Note: This edition of C&T Today, we welcome a new exclusive monthly feature, the “REACH Update,” by Annelie Struessmann, PhD. REACH legislation is continually evolving and it effects are only beginning to be realized. This column has been added to keep formulators, chemists and R&D managers updated of changes occurring in the legislation, and how those changes affect them. This column will also provide useful advice explaining how to comply. In addition to this e-newsletter column, Struessmann will field reader questions in a new online feature and her updates, as well as portions of the Q&A, will appear monthly in Cosmetics & Toiletries magazine, beginning in January 2008. Please help us welcome Annelie Struessmann, PhD, to the lineup.
An Introduction: How REACH Affects Cosmetics and Personal Care Manufacturers
REACH basically applies to all chemicals manufactured or marketed in the European Union (EU), including process chemicals as well as ingredients in consumer products or additives. Some exemptions apply and are specified in the REACH regulation.
However, ingredients in cosmetics and personal care are subject to almost all provisions of REACH. Cosmetics and toiletries are considered as preparations under REACH and each individual substance of a preparation has to be registered, either by the substance manufacturer or by the importer of the substance or of the preparation. The threshold for registration is 1 ton per year.
Substances that have been registered by the manufacturer or by an importer do not need to be registered again by a downstream user that mixes them into a preparation. Therefore, for a producer of a cosmetics and personal care product that is located in the EU, usually no obligation arises to register the ingredients used in the products; if it does arise, the producer is a direct importer of the ingredients from a country outside the EU.
The situation is most often different when cosmetics and personal care products are manufactured outside of the EU and meant to be imported into the EU markets. In some cases, registration may have been completed by an upstream manufacturer; e.g., the ingredients are imported from Europe, and are re-exported as a part of the consumer product. If the ingredients are not registered, and when exceeding the threshold quantity, the importer of the consumer products into the EU is responsible for the registration. Importer here means any natural or legal person established within the community who is responsible for the import.
All manufacturers of substances or preparations, including cosmetics and personal care, which are located outside the EU and export into the EU can nominate an “only” representative located within the EU to fulfill all registration requirements. This only representative will have to comply with all obligations of importers under the registration title of REACH. In the above example, the importer would be considered a downstream user.
One exemption exists for cosmetics and personal care chemicals under REACH--Title IV does not apply to cosmetic products. This title specifies the provisions for information down the supply chain. In other words, this exception for cosmetics and personal care means that a safety data sheet, as specified by the REACH regulation, does not need to be provided to the users of cosmetics and personal care products, which are the consumers.
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• Producers of cosmetics and personal care products located in the EU are usually downstream users and have no obligations to register ingredients under REACH
• Producers of cosmetics and personal care products located outside the EU have no obligations to register
• It is the importer of the products into the EU who has to register the individual ingredients when present in quantities of 1 ton or more per year, and when not yet registered by an upstream manufacturer
• The noncommunity manufacturer can nominate an “only” representative to fulfill all obligations of an importer under REACH
• In case of the nomination of an “only” representative, the importer is considered a downstream user
Further Useful Information: The European Chemicals Agency (ECHA) offers a Web site with several helpful tools for everyone affected by REACH. Since June, various REACH Guidance Documents have been published.
Competent Authorities (CA) and Help Desks: Each EU member state has to appoint a competent authority or competent authorities with responsibly for performing the tasks under REACH in cooperation with the European Commission and the ECHA. Also, member dtates have to establish national help desks to provide advice to manufacturers, importers, downstream users, etc:
About the Author
Since 2003, Annelie Struessmann, PhD, has been the Technical Director with CONUS Business, Advice & Training (CONUSBAT) (Aachen, Germany and Laren, Netherlands). With responsibility for the areas of cosmetics and personal care, detergents and household cleaners, fragrances, food and nutrition, and pharmaceuticals, Struessmann has more than 20 years of industry experiences in regulatory affairs and product safety, application and product R&D and technical marketing.
Prior to CONUSBAT, she worked in various managerial functions with global companies at international locations, such as: International Flavors & Fragrances in the Netherlands, Akzo Nobel Chemicals in the United States and Germany, Rewo Chemicals (Evonic) and DHW Rodleben in Germany. Her responsibilities included the introduction of quality standards (ISO 9000s, HACCP, GMP, and kosher certification) and the membership function at trade associations’ sector groups: CEFIC/APAG, VCI, and Tegewa.
Representing CONUSBAT, her major responsibilities cover REACH issues. She acts as “only representative” for noncommunity manufactures and performs online courses for the international specialty chemicals industry and related consumer product industries.
Her educational background includes a masters degree in chemistry and a bachelor of science degree in food chemistry from the Technical University RWTH Aachen, Germany. In addition, she received a doctorate in biopolymer chemistry from the German Wool Research Institute (DWI) in Aachen. Her research projects included cooperations with Schwarzkopf/Germany and Clairol/Stamford-USA. From Clairol she was awarded the company’s prestigious Gelb Foundation Fellowship.