Cosmetics Regulation (EC) No. 1223/2009 – What is Essential to Know?

The training gives an extensive overview on the regulatory framework requirements for cosmetic products in the European Economic Area (EEA) according to Regulation (EC) No 1223/2009 on cosmetic products and Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Relevant aspects of the cosmetics legislation will be translated into a reasonable and easy to use guidance. Participants will be able to apply their gained knowledge in their daily work.

Content

  • Overview on the regulatory framework of cosmetic products in the EU/EEA
  • The legal space EU/EEA
  • Competent authorities
  • Overview on the content of the Cosmetics Regulation (EC) No 1223/2009
  • Basic terms used in the Cosmetics Regulation  
  • What is a cosmetic product?
  • Definition of key terms
  • Roles exist in the supply chain (manufacturer, importer, distributor or consumer)?
  • Duties and responsibilities along the supply chain
  • The „Responsible Person”, who takes on this role and which responsibilities are associated?
  • Which duties and responsibilities apply to distributors?
  • What is a Cosmetic Product Information File (PIF) and what kind information does it comprise?
  • Safety assessment of cosmetic products
  • What is a safety report and what does it look like?
  • Which substances are prohibited and restrictions for the use in cosmetics?
  • Colorants, preservatives and UV-filters: essential criteria for use
  • Additional requirements applying to nanomaterial
  • The use of CMR substances (carcinogenic, mutagenic or toxic for reproduction)
  • Cosmetic product claims and labelling of cosmetic products
  • Which criteria apply to cosmetic product claims according to EU/EEA regulations?
  • Borderline Products: Distinction between cosmetic products and other types of products (e.g. biocides, medical devices, medicinal products, toys). What has to be kept in mind when creating product claims?
  • How is a cosmetic product to be labelled correctly?
  • Notification of cosmetic products
  • How and when does a cosmetic product have to be notified?
  • Which information has to be submitted?
  • Dealing with undesirable effects and serious undesirable effects
  • What are undesirable effects and serious undesirable effects?
  • Introduction to cosmetovigilance
  • The Five Ws: Who communicates which information in which form, when and to whom?
  • Animal testing ban for cosmetic products
  • Introduction to the animal testing ban for cosmetic products in the EU/EEA
  • Dealing with regulations which require animal testing (e.g. REACH or non-EU legislations)
Details
Target audience: 
Manufacturers and formulators, toll manufacturers, anyone involved in Regulatory Affairs, Research & Development and Safety Assessments, Safety Assessors, as well as Suppliers and Importers in the fields of Cosmetics and Personal Care
Participants: 
approx. 16
Language: 
German
Fee: 
690 Euro + 19% MwSt. = 821,10 Euro
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