Since July 2013, Regulation (EC) No 1223/2009 on Cosmetic Products of the EU has been fully implemented and represents a modern regulatory framework grounded on state of the art of cosmetic science and product technology. It is structured in regulatory modules, which include the safety assessment and the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), Responsible Person (RP), label information, cosmetovigilance, substance regulations, claims, etc. The legislator's existing goal is assurance of the safety for the ingredients and for the cosmetics products in use of consumers. 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.
During the workshop the provisions depicted as regulatory modules will be presented and explained. On the basis of the knowledge gained from this introduction, alleys towards compliance will be depicted which will use practical examples and experiences made while having performed the necessary compliance steps before marketing of cosmetics products in the European Union.
Why should you attend: The European Cosmetics Products Regulation (EC) 1223/2009 (CPR) represents a newly recasted piece of legislation, fully implemented since July 2013, and putting in place demanding provisions for those seeking compliance. Affected by the challenges of meeting compliance are the players in the world's biggest cosmetic market, the European Union's internal market, as such similarly EU and non-EU manufactures of cosmetics as well as the suppliers of cosmetic ingredients requested to provide data on their chemicals.
Provisions of the CPR are formulated as modules and these include substance regulations, product information file, labeling, cosmetovigilance, claims, notification, responsible person, etc. Compliance with these modules requires know-how, diligence and ongoing adjustment to state of the art of knowledge and documentation. In this format, the EU Regulation represents not only the entry requirements for marketing of cosmetic product in the European Union; however, it represents as well a model framework for many national legislators worldwide. These legislators often either adopt certain of the modules or the structure of the Regulation in full, respectively of its predecessor legislation, the Cosmetics Directive. Therefore, skills to comply with the EU's CPR support and supply a background for attempting compliance with other regulatory frameworks.
The seemingly hardest module of the CPR is the safety assessment, requiring extensive skills in various science areas, such as toxicology, chemistry, cosmetology, microbiology, etc., as well as the knowledge in regulatory affairs and compliance management. Further difficulties with the EU's legal provisions arose from the final implementation of the animal testing ban in March 2013. In consequence, sometimes contradictory requirements arise from different sector legislation or from the requests in various legislative areas worldwide prior to marketing. Additionally, validated alternative tests are not available for all toxicological endpoints required to be assessed within the safety assessment and the Cosmetic Product Safety Report. Therefore, manufacturers are placed in an extremely complicated regulatory and scientific environment for meeting the compliance needs in general and especially for introducing new ingredients.
Areas Covered in the Session: