European Union regulatory issues for cosmetic products - the EU Regulation 1223/2009

Tasked with regulating a huge market consisting of half a billion consumers and generating about a third of the world's total economic output; the European Union (EU) has quite an unenviable task on its hands. Cosmetic products are among the primary areas of European Union regulatory issues, because they account for a huge market.

Cosmetic products that originate in many parts of the world reach EU shores; likewise, European products also go out to the rest of the world from the European Union. EU regulatory issues for cosmetic products have a major bearing on several big and small companies. EU regulatory issues also impact and straddle several regulatory areas, because many countries make up the Union.

The EU Regulation 1223/2009 (Cosmetics Regulation)

The EU Regulation 1223/2009, which came into effect from mid-2013, is aimed at the cosmetic industry in the EU. Although a regulation with regard to cosmetics, the Directive 76/768/EC, was in effect from the mid1970's and underwent substantial changes; the EU sought to replace it with a more powerful regulation.

The need for replacing the Directive 76/768/EC with EU Regulation 1223/2009 was felt because of the many technological changes that have taken place over the past few decades, which have made a major impact on the cosmetics industry.


Highlights of the EU Regulation 1223/2009

  • The most important amendment the EU Regulation 1223/2009 has brought in is that it has proposed the introduction of a "responsible person". By this amendment, only those cosmetic products which have been overseen by what the EU terms and designates as a "responsible person" will be allowed to place a product in the market. Cosmetics manufacturers have to adhere to strict guidelines in identifying this "responsible person". The EU Regulation 1223/2009 also provides clear-cut guidelines on their roles and responsibilities
  • It fortifies cosmetic product's safety requirements
  • All the cosmetic products that get placed in the EU market get notified through a centralized notification mechanism
  • With the passage of EU Regulation 1223/2009, cosmetics manufacturers are required to adhere to specific requirements when it comes to preparing a product safety report that has to be done before they release a product into the market
  • There are now new rules by which cosmetics manufacturers have to report Serious Undesirable Effects (SUE). The "responsible person" is obliged to notify these to concerned and respective national authorities. The authorities, on their part, will collect information from sources such as health professionals, users and others to corroborate this information. They are also required to share this information with other members of the EU
  • The EU Regulation 1223/2009 also has new provisions for the use of nanomaterials that go into cosmetic products. These materials are now more clearly and explicitly authorized with regard to their use in UV-filters, preservatives and colorants
  • Notifying their products has become a lot easier for cosmetic manufacturers. They need to now to it only once through the mechanism called the EU Cosmetic Products Notification Portal (CPNP)
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