It would be hard to miss this very newsworthy and obvious acronym published everywhere during the past several months, but unless you’re immersed in its impact on the European cosmetic industry, REACH may appear as yet another complex program with many unanswered questions. In fact, even the experts will agree that this enormous chemical initiative, while highly structured, still leaves many technical and economic uncertainties./
Safety and Usage Legislation
REACH is a comprehensive program for the registration, evaluation and authorization of chemicals, negotiated by the European Parliament and signed into law by the European Council of Ministers on December 18, 2006. The 800-page document, including annexes and supplemental guidances on implementation (ec.europa.eu/enterprise/reach/index_en.htm), will replace approximately 40 pieces of existing chemical legislation with a system intended to control and manage both new and existing chemicals throughout the supply chain. While finished cosmetic product safety and ingredient usage are already regulated and controlled via the 7th Amendment to the Cosmetic Directive (76/768/EEC), the REACH initiative addresses both the safety and long-term environmental impact of the ingredients used in cosmetics, as well as packaging.
REACH is based upon one principle: safety. It requires manufacturers, importers and downstream users to assure that chemical substances are inherently safe for consumer product use, occupational exposure and long-term environmental impact. It also admonishes the “no data, no market” rule and further imposes the “precautionary principal,” where additional data and definitive action are required when uncertainty is identified.
There are requirements to register all substances used in a product, evaluate the safety dossiers and the chemical substances, authorize the specific uses of very high concern substances and restrict usage of certain chemicals with documented safety concerns.
REACH goes into effect on June 1, 2007, with enforcement responsibility assigned to a new European Chemicals Agency (ECHA) to be established in Helsinki, Finland. There are extensive details yet to be addressed by the ECHA, so the forms, fees and basic refinements to many of the stated requirements of REACH must still be developed and published in the months ahead. Over the next 11 years, approximately 30,000 currently used chemical substances must be registered according to the established timetable.
REACH regulations have already had a broad effect on the industry because reporting requirements apply to all manufacturers in the EU, European importers and downstream users. The suppliers of chemical substances and those who use them to manufacture or blend products are subject to stringent reporting obligations when the annual average quantity of a single substance (based on a three year average) exceeds one metric ton for that manufacturer or importer. Other categories are scheduled for earlier registration, based upon higher tonnage and where greater safety concerns are warranted.
For most reporting companies, there is a benefit to using the pre-registration process because it will delay the date for registration and submission of a full Chemical Safety Report (CSR) beyond December 2008, or any other date imposed based upon tonnage.
Furthermore, it will allow participation in a consortium called Substance Information Exchange Forums (SIEFS), which will be created to collect and coordinate data and share the cost of required safety substantiation to satisfy concerns raised by the ECHA and required by the safety classification assigned to a given substance. The window for pre-registration is open June 1–December 1, 2008.
Pre-registration information must include the substance identity—including chemical name, CAS number, EINECS number, the anticipated deadline for actual registration, and the European registrant’s name, address and contact information. The pre-registration submission option has been strongly endorsed by industry experts close to the REACH activity, particularly because pre-registration past the six-month window is prohibited.
Once the pre-registration process has been completed, the ECHA will publish a list of the pre-registered substances, which can be used for the formation of SIEFS and the subsequent participation of companies’ representatives or chemical suppliers. For downstream users, it will be imperative to assure suppliers participation based upon chemical usage and quantity purchased. At present, it appears that the reporting company, individual or representative must be located in Europe. Alternatively, if your supplier is unable to participate in the REACH pre-registration for your ingredient, you will be obliged to negotiate or seek a new source if you intend to ship products or materials into the EU.
Registration is a more formal and demanding process, and it, too, will follow a schedule and structure based on REACH Implementation Project guidelines—also known as RIPs. Submissions will be accepted from European companies or European representatives and must include a technical dossier with the full identity of the substance, its manufacture and intended use, as well as other specific information required by the annexes.
Additionally, the required CSR must include formal hazard assessments, exposure assessments and risk characterizations for both human health and environmental impact. Details will be provided in the REACH implementation guidelines. CSR preparation must be coordinated via the assigned SIEF, with funding arranged and assessed proportionally from participating companies or parties. These contributions are compulsory in order to do business in the EU.
Based upon the average annual tonnage for each individual substance used, there are scheduled dates for the required registration and submission of technical dossiers and chemical safety reports. If the substance has been pre-registered, the closing date is November 30, 2010, for Category I or II CMRs (carcinogens, mutagens or reproductive toxicants). These materials are banned from cosmetic use but could, perhaps, be required as a starting ingredient for a given raw material generation process or synthesis. Other substances used at more than 1,000 tons per year also fall under this deadline. May 31, 2013, is the deadline for substances used at an average of 100–999 tons per year, and May 31, 2018, for substances used at one to 99 tons per year.
The intent of REACH is to identify substances that pose a high safety risk for humans or potentially detrimental environmental impact—certainly a continuing objective for the cosmetic industry as well. Substitution plans would be required for chemicals that fall into certain classes such as:
- CMRs, Category I or II
- Persistent and Bioaccumulative and Toxic (PBT)
- Very Persistent and Very Bioaccumulative and Toxic (vPvBT)
- Substances of equivalent concern
Refinement and interpretation of these potential classifications will be made by the European Chemical Agency at a future date.
The best way to prepare your company is with a comprehensive chemical inventory of substances used for products or materials being exported to Europe that addresses the specific identity, CAS and EINECS numbers, and quantity information for each. Next, contact suppliers and identify their plans for pre-registration, so they can coordinate with others in their supply base and determine their ability and willingness to comply with REACH requirements. If they are unable to provide a commitment, you may be obliged to seek other alternatives to support future European business.
REACH is complex, and there are numerous questions yet to be answered. The review and interpretation of existing legislation, as well as input from various contributors to the REACH negotiations over the last six years, is helpful—but not always definitive. Information about the forms for pre-registration and registration, and potential cost assessments will follow once the ECHA has been staffed and trained. Additional details and clarifications are also expected after a European Commission workshop to be held in Bonn, Germany, this month.
There are many conditions and considerations that will affect your compliance with REACH, and while it would be impossible to address all of them here, I can say, having attended and participated in several seminars during the past six months, that the complexity of the program and the unanswered issues still cause experts to walk cautiously through the process. However, the overall goals and objectives of REACH are commendable, and the benefits can only be realized by active and attentive participation with appropriate planning.