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.
One change is that an RP or an importer can designate another person as the RP as long as the RP formally accepts this role in writing. The person/organization accepting this mandate must be aware that as the RP, they will be responsible for all the RP duties as established in the regulation. One important point is that the RP’s name and address must be on the label.
The requirement to notify when products are placed on the market in the European Union (EU) is not new; however, the harmonization of notifications is new. The directive originally was transposed into each member state’s national law, making the notification process different in each EU country. In contrast, under the new regulation, notification will be harmonized and executed through a single electronic system called the Cosmetic Product Notification Portal (CPNP), which went live in January 2012. The CPNP allows a one-stop product notification that is valid across the whole of Europe. This will also cover the requirement to notify poison centers, another process that has been different in each member state under the directive. The RP currently has the option to notify of any new products on the market under the Cosmetics Directive or through this new system; however, by July 2013 all products on the market must be notified under the CPNP.
How a safety assessment is compiled is one of the major changes under the regulation, and safety assessment is the cornerstone to the legislation. Under the regulation, the documentation will change, requiring a Cosmetic Product Safety Report to be produced for each product. Its contents are set out in the new Annex I to the regulation.
Part A of Annex I lists the things that need to be considered by the safety assessor; essentially, this is a list of information to be gathered. Part B is the written assessment, requiring the assessor to justify why the product is safe based on the available information, and document what that information contributes to the assessment. It requires and relies on the assessor to use their professional expertise and judgment.
The objective of this change is to improve the consistency of safety assessments across Europe. However, it is important that the reasoning does not simply follow a check-box approach. It must be based on a thorough evaluation of all data using the assessor’s knowledge and expertise, taking a weight of evidence approach. The EC is in the process of writing guidelines regarding this, which are expected to be published in 2013.
There appears to be a misconception regarding the extent to which nanomaterials are used in cosmetic products, and contrary to popular belief, the use and safety of nanomaterials in cosmetic products is already covered by the Cosmetics Directive.
The regulation provides a definition of a nanomaterial, which is open to some interpretation. A cosmetics industry interpretation is available but an interpretation by the EC has not been provided. In October 2011, the EC issued its Recommendation on the Definition of a Nanomaterial. This recommendation provides a broad regulatory definition within the EU; however, the possibility for narrowing the scope under sector specific legislation can be foreseen. Therefore, it is the industry view that both the recommendation and the regulation’s definition can coexist.
The impact of the recommendation’s particle size distribution cut-off in the existing regulation definition is currently a point of discussion, as is the interpretation of the various criteria of the regulation’s definition. This does have an impact on compliance with the regulation’s requirements for notifying and labeling nanomaterials by the 2013 deadline.
From July 2013, notification of products containing certain nanomaterials is required six months prior to placing them on the market. Products already on the market as of Jan. 11, 2013, will also need to submit notification during the six month period from Jan. 11 to July 11. The regulation does clarify what nanomaterials will require notification by naming those that are exempt: those used as colorants, UV filters or preservatives, or substances listed specifically as nanomaterials in Annex III. In relation, the electronic nano-notification facility was launched in January 2013.
In the future, any ingredient present in the nano-form will have to be labeled with the word “nano” in brackets after its name in the ingredient listing. It is worth stressing that the addition of the “nano” indication is for consumer information only, and is of no relevance to safety. It is not a warning statement. This labeling requirement applies to all products on the market as of July 11, 2013.
The directive already states that the manufacturer must keep proof of the effect claimed for the cosmetic product in the Product Information File (PIF). This remains in the regulation; however, there is a new requirement allowing the EC to establish common criteria justifying the use of a claim. The EC’s approach has been to work with industry to develop general guidelines applicable to all claims—a “dos and don’ts” list—rather than a comprehensive manual or claim-by-claim approach.
Reporting of SUEs
The concept of addressing and documenting undesirable effects attributable to cosmetic products is not new. This has been a requirement since the 7th Amendment to the directive. Information on any serious undesirable effect attributable to a cosmetic product will already be kept in the PIF. The new requirement is that any SUE will have to be reported to the competent authority of the member state where the SUE occurred. Note that the incidence of serious undesirable effects attributable to cosmetic products is low. The EC will issue guidance on this process and is developing reporting forms.
The majority of the requirements in the new regulation will be implemented on July 11, 2013. Up to that date, companies can choose to comply with the directive, the regulation or a mixture of both. However, a word of warning with regard to Annexes II-VI published as part of the regulation text: these are not up-to-date and also contain many errors. CTPA recommends that the annexes to the Cosmetics Directive and its amendments are used until the EC produces a comprehensive update to the annexes of the regulation.