An understanding of the EC 1223/2009

[Roger Steven]

The European Cosmetics Products Regulation (EC) 1223/2009 (CPR), which became fully operational from July 2013, is a game changer in many ways, as it is considered a most contemporary regulatory framework concerning state-of-the-art of cosmetic science and product technology.

It sets out vastly harsher conditions for compliance of cosmetic products that are manufactured or sold in the EU, comprising of over half a billion people. The changes suggested by this legislation are of a deep nature and affect many of the manufacturers and suppliers of cosmetic ingredients, who are now requested to provide data on their chemicals.

Provisions of the 1223/2009, which are now formulated as modules; straddle a large area of activities such as:

o  Substance regulations

o  Product information file

o  Labeling

o  Cosmetovigilance

o  Claims

o  Notification

o  Responsible person, etc.

A lot of knowledge relating to know-how, diligence and ongoing adjustment to state-of-the-art knowledge and documentation has to go into meeting compliance with these modules. Any organization in the cosmetics business has to be completely aware of the workings of these regulations if it has to sell its product successfully to the world’s largest cosmetics market.

An understanding of this most important legislation will be the learning a webinar from MentorHealth, a leading provider of professional trainings for the healthcare industry, will offer. Dr. Annelie Struessmann, who is Technical Director with CONUSBAT, will be the speaker at this webinar. To gain the benefit of her in-depth knowledge of this subject, please register for this event by logging on to http://www.mentorhealth.com/control/w_product/~product_id=800868LIV....

The toughest parts of the module

The safety assessment is considered the hardest module of the CPR, requiring as it does extensive skills in various science areas, such as toxicology, chemistry, cosmetology, microbiology, etc., as well as the knowledge in regulatory affairs and compliance management.

The animal testing ban of March 2013 further complicated the EU's legal provisions. It resulted in the following situations, which went on to further befuddle the regulatory and scientific environment for manufacturers in meeting the compliance needs in general and especially for introducing new ingredients:

-       Sometimes contradictory requirements emanate from different sector legislations or from the requests in various legislative areas worldwide prior to marketing;

-       Validated alternative tests are not available for all toxicological endpoints required to be assessed within the safety assessment and the Cosmetic Product Safety Report.

The modules contained in the 1223/2009 represent the entry requirements for marketing of cosmetic products in the whole of the European Union, inclusive of its Member States’ national legislators. These legislators often either adopt certain of the modules or the structure of the Regulation, in full, of its predecessor legislation, the Cosmetics Directive. This makes the knowledge of how to comply with the 1223/2009 all the more necessary.

Other important provisions

In order to ensure the safety of the ingredients and of the cosmetics products in use of consumers; the 1223/2009 assigns in-market control 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. While the Responsible Person is assigned the central role in cosmetovigilance; the product labeling provisions guarantees access to manufacturers and Responsible Persons.

Annelie will present and explain the provisions of the 1223/2009 depicted as regulatory modules. Building on this, she will lead participants towards pathways of compliance using practical examples and experiences.

Annelie will cover the following areas at this webinar:

o  Animal Testing Ban

o  Roles & Responsibilities in the Supply Chain

o  Product Information File (PIF)

o  Safety Assessment

o  Criteria for Claims

o  Cosmetovigilance

o  Substance Regulations

o  Product Labeling

o  Borderline Legislation