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.

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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.

Notification

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.

Safety Assessment

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.

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