Cosmetics: regulatory context

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To place your cosmetic products on the European market, you must comply with the requirements of Regulation (EC) No.1223/2009, which superseded the Cosmetics Directive 76/768/EEC on 11/07/2013.

The implementation of Regulation (EC) No.1223/2009 aims to ensure a high level of consumer health protection, simplify and harmonise the declaration procedures, clarify the responsibilities, guarantee product traceability and promote and monitor their marketing within the European market. On top of that, the adoption of these new requirements in the form of a Regulation also guarantees that the legal provisions are implemented simultaneously across the European Community.

The main new features of Regulation (EC) No.1223/2009 compared to Directive 76/768/EEC concern:

  • The creation of the status of Responsible Person,
  • Changes to the contents of the Product Information File (PIF): raw materials, packaging, human health safety, cosmetovigilance, GMP, etc.,
  • Changes to the safety assessment format,
  • An approach per ingredient (margin of safety),
  • Arrangements for hazardous substances (CMR, nanomaterials, endocrine disruptors, etc.),
  • CPNP electronic notification of a cosmetic product prior its marketing, which among other things means that the formulas are automatically submitted to the antipoison centres for emergency medical treatment,
  • A reinforced and harmonised cosmetovigilance system,
  • Compulsory traceability (PIF keep for 10 years after last batch placed on the market),
  • Sanctions specified in local law, with reinforcement of the competent authorities of the European Union Member States.

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