Four years of the EU’s Cosmetics Product Regulation

[John Robinson]

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it took off. It was also considered extremely significant because it suggested a regulatory framework that was in alignment with the most modern technologies and methods available during the present times.

Some of the regulatory modules which are structured into the EU’s Cosmetics Product Regulation include important elements aimed at ensuring safety of cosmetic products and accountability from manufacturers, and include points such as:

o  Cosmetic Product Safety Report (CPSR)

o  Product Information File (PIF)

o  Responsible Person (RP)

o  Label information

o  Cosmetovigilance

o  Substance regulations

o  Claims, etc.

Compliance with the safety regulations set out in EU’s Cosmetics Pr... is mandatory. This, though, is not easy, considering the severe clauses that the regulation has for ensuring compliance. These are the reasons for which compliance with the EU’s Cosmetics Product Regulation is challenging:

-       In-market control is assigned to EU Member State competent authorities

-       The flow of information between countries is interlinked by the Cosmetic Product Notification Portal (CPNP), which is fed with the information by the demand for pre-market notification of cosmetic products and by ongoing cosmetovigilance procedures put in place with the respective provisions in the CPR

-       The central role in cosmetovigilance applies to the Responsible Person while the access to manufacturers and responsible persons is assured by product labeling provisions

-       EU and non-EU manufactures of cosmetics as well, as the suppliers of cosmetic ingredients, are required to provide data on their chemicals

-       Compliance with the modules requires know-how, diligence and ongoing adjustment to state of the art of knowledge and documentation.

More challenges

In addition, the EU’s Cosmetics Product Regulation presents more challenges for manufacturers of cosmetic products that want to market to any of the countries of the EU:

The EU’s Cosmetics Product Regulation is so expansive that it represents not only the entry requirements for marketing of cosmetics product in the European Union; but is a model framework for many national legislations worldwide. These legislators are given the choice of either adopting a few parts of the EU’s Cosmetics Product Regulation’s modules, or the structure of the Regulation of its predecessor legislation, the Cosmetics Directive, in full. Therefore, companies need to have the knowledge and the skills needed for complying both with the EU’s Cosmetics Product Regulation and other regulatory frameworks.

There is yet another challenge to implementing the EU’s Cosmetics Product Regulation: The safety assessment. Complying with this part of the EU’s Cosmetics Product Regulation requires extensive knowledge and skill of a host of subjects and issues such as toxicology, chemistry, cosmetology and microbiology, apart from that of regulatory affairs and compliance management. This already tough provision has been made even tougher with the final implementation of the ban on animal testing that the EU introduced in March 2013,

As a result of this ban, considerable confusion abounds about the interpretation of the compliance regulations in the various agencies and sectors that the compliance process has to pass through. If alternative tests are carried out, they are not available for all toxicological endpoints that need assessment as part of the EU’s Cosmetics Product Regulation.

Clearing the confusions

This makes compliance with the EU’s Cosmetics Product Regulation as difficult and complicated as one can imagine. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer clarity on the provisions of the EU’s Cosmetics Product Regulation. The complicated parts of the regulation, namely the regulatory modules, will be given a clearer understanding.

The Director of this two-day seminar is Dr. Annelie Struessmann, who is the Technical & Regulatory Director with CONUSBAT Regulatory Services, a provider of internationalization compliance services for Cosmetics, Personal Care, Fine Chemicals and Borderline Industries.

To gain better understanding of this regulation, please visit Four years of the EU’s Cosmetics Product Regulation to enroll. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

At this session, Dr. Struessmann will explain the provisions of the regulatory modules and supplement this with a description of the latest developments and research results. She will use these to show pathways towards compliance, at which she will use practical examples and experiences gained in the course of performing the necessary compliance steps before and while marketing of cosmetics products in the EU.