• Regulatory Solutions
  • Product Safety
  • Pharmaceutical Development and Quality
  • Cosmetics


The challenges involved in the EU Cosmetics Regulation

The new EU Cosmetics Regulation No. 1223/2009 will go into full effect on July 11th 2013, and will replace the Cosmetics Directive (76/768/EEC) which ensured free circulation of cosmetic products throughout the EU, as well as a high protection of consumers. The new EU Cosmetics Regulation sets out more detailed requirements regarding the Cosmetic products and aims to harmonize  national regulations among the 27 European member states.


What are the consequences for Cosmetics companies?
Some of the major changes are the implementation of well-defined minimum requirements for cosmetic product safety reports (according to Annex I of the EU Cosmetics Regulation No. 1223/2009). Additionally, there must be a “product information file” prepared for each cosmetic product. This file has to be stored for 10 years after the product has been withdrawn from the market. And some further new details are described in the following explanation.

A “responsible person”, based in Europe, must be appointed for each marketed cosmetic product. This means e.g., if a cosmetic product is manufactured in the EU, the manufacturer is (automatically) the “responsible person”. This person is responsible for ensuring certain safety requirements, which involves for each product keeping an up-to-date  “Product Information File” readily accessible to authorities which should contain e.g.:

  • detailed description of the cosmetic product
  • cosmetic product safety report (part A: product safety information,  part B: product safety assessment)
  • manufacturing information
  • proof of the effect claimed for the cosmetic product
  • data on any animal testing (if applicable)

Then, there is a need for a system which must enable the identification, the analysis and the reporting of all serious undesirable effects of a cosmetic product to the authority. These cosmetics safety systems are usually called “cosmetovigilance systems”.
And after collection and qualification of all mandatory data to safely describe the cosmetic product according to the EU Cosmetics Regulation No. 1223/2009, these data have to be notified to the EU via the “Cosmetic Products Notification Portal” (CPNP). This applies to products that were placed on the market under the previous Cosmetic Directive and to any new cosmetic products introduced in the EU.


How can ProductLife support Cosmetics companies?

ProductLife has the expert knowledge and an expert team, who supports different Cosmetics companies also on implementing this new EU Cosmetics regulation. ProductLife can provide the following support:

  • Update of raw materials dossiers (including toxicological profile).
  • Update of cosmetic dossiers (including safety assessment).
  • Assessment and creation of the “Product Information File” and the cosmetic product safety report.
  • Notification/submission of the required information through the CPNP online portal.
  • Provision of a full certified cosmetovigilance system and related support services on an outsourcing basis.
  • Implementation of an internal cosmetovigilance system for monitoring and notify serious undesirable effects to the authorities.
  • Evaluation of claims (e.g. for Marketing).


For manufacturers and suppliers who are producing cosmetic dossiers documentation currently "in-house" and who are relying on the services of a safety assessor, the financial impact will potentially be significant in preparation for July 2013/post 2013, depending on the level of "in-house" expertise available.

ProductLife can provide services and resources at the client´s site or fully outsourced from its own sites or propose a combination of both solutions, depending on the project itself.

What are the risks for Cosmetics companies not to be compliant with the Cosmetics Regulation?

  •  Financial risk: in case a cosmetic product does not meet the new safety requirements, the national competent authority can decide to  withdraw it from the market, to recall it or to restrain its availability on the market. If the measure is justified, the EU Commission could  enforce it in every member states.
  • Legal and penalty risk: for the named responsible person.
  • Risk of damaging the corporate image: information getting public about safety noncompliance of a marketed product is able to hardly damage the brand and the global corporate image.


Latest News

ProductLife Group Expands German Operations with Acquisition of Kohne Pharma.
Read more

Wednesday 31.12.2014
11-12 February 2015, CSC Life Sciences Forum in Málaga, Spain
Read more

Tuesday 02.12.2014
2–3 December 2014, Drug Information Association 15th Conference on European Electronic Document Management (eDM), Berlin
Read more

Wednesday 19.11.2014
19-20 November 2014 Congres Parfum Cosmetiques, Chartes
Read more