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EU Update—Changes with Implementation of 1223/2009
By: Chris Flower, PhD; and Emma Meredith, PhD, CTPA
Posted: March 5, 2013, from the March 2013 issue of Cosmetics & Toiletries.
Since 1976, the manufacture, marketing and import of cosmetic products in Europe have been subject to the European Cosmetics Directive 76/768/EEC. The directive is a risk-based legislation, with consumer safety as the main goal. Following seven major amendments to the directive’s text and more than 40 adaptations to its annexes, the European Commission (EC) began the process of recasting the directive into a regulation in 2007 to simplify and clarify the text. That recast resulted in the publication of the new European Cosmetics Regulation 1223/2009 in 2009, which will be referred to in the remainder of this article as the regulation.
The implementation of the new regulation is of prime importance to the cosmetics industry. Although many requirements remain the same as in the directive, there are changes that will have an impact on companies, with compliance required by July 11, 2013. Unlike the Cosmetics Directive, a regulation is directly applicable across all 27 European member states and does not require transposition into national law. As with the directive, there is no pre-market registration or certification of products, and the system of in-market control remains. The cosmetics industry should, as a whole, welcome improved and effective enforcement as it does two things: maintains a level playing field, and helps reinforce the industry’s reputation for safe products within a well-regulated framework.
The EC established working groups to provide guidance to complement the regulation in the four major areas of change: notification, safety assessment, the reporting of Serious Undesirable Effects (SUEs) and claims. Cosmetics Europe (formerly Colipa) has been a part of these working groups, and the CTPA is involved with all groups at Cosmetics Europe, working on major areas of change and guidance. The main premise of the legislation remains that only safe products may be placed on the market.
The major changes in the new regulation text include roles and responsibilities, notification, CMRs, safety assessment, nanomaterials, claims, reporting of SUEs, and a new symbol to indicate period of minimum durability. This symbol can be used if a product has a shelf life of only 30 months or less, instead of labeling that reads “best used before the end of” and requiring the consumer to calculate a date. Several of these aspects will be discussed in detail in future CTPA columns.
Roles and Responsibilities
The roles and responsibilities of the responsible person (RP), importers and distributor are clearly defined in the regulation. Some of the requirements are new, but most of them merely clarify what should have already happened. The aim is to ensure that there is traceability throughout the whole supply chain.