EF Cosmetics Safety

The EU Cosmetic Regulations

The EU Cosmetic Regulation 1223/2009

EU regulation EC1223/2009 came into force in July 2013 when it replaced the old EU directive EC76/768. It applies directly to all countries in the EU and EEA. The Responsible Person (usually the company address listed on the product label) is legally liable for compliance and it is recommended that people carefully read the original text of Regulation 1223/2009 on the EU website. Cosmetics Europe also have good detailed guidelines to the law on their publications page, as do the CTPA on their information page. The main aspects of compliance are as follows:

  • Manufacturing to good manufacturing practice (GMP)
  • Correct labelling of the product
  • List of ingredients on the label including allergens and colours all in EU INCI format
  • Stability and challenge testing
  • Safety assessment (CPSR)
  • PIF file (which includes the CPSR)
  • Notification on the EU cosmetic product portal CPNP
  • Adverse events log

Definition of Responsible Person (RP)

The regulation defines the Responsible Person, who must have an address in the EU and is responsible for holding all the documentation on the product, including the safety assessment in a PIF (Product Information File). They also have total legal responsibility for maintaining the PIF, for compliance of the product with the EU legislation and the annexes, and for having an effective customers complaints procedure such that adverse reactions can be recorded and investigated. They are usually the company that manufactures the cosmetic, has it manufactured, or they are the local office or agent for a manufacturer based outside the EU. If there is no local agent for a non-EU manufacturer, then the first company importing the product into the EU is usually considered the responsible person, unless they have mandated a third party company to take on the role. See our Useful information page for possible third party RP companies.

Product Information File (PIF)

The PIF contains all the documentation on the product required under the regulation, including the cosmetic product safety report. It has to be "readily available" at the EU address on the product label.

Labelling of cosmetic products

The EU Regulation also defines the correct labelling that must be used with cosmetic products. This is quite a technical exercise, especially since some suppliers don't always use correct INCI labelling and calculation of allergens can be difficult. EF Cosmetics Safety can supply a list of the correct ingredients to go on the label when ordered at the same time as the safety assessment, along with our labelling guidance document. The required warnings are listed in the safety assessment.

Good Manufacturing Practice (GMP)

GMP is about having a common-sense system of making the correct product every time without contamination or mistakes and under Regulation EC1223/2009 all cosmetic products have to be manufactured to GMP principles. It involves writing a set of procedures and keeping various simple records. In practice, there is an expectation that cosmetic companies follow the international standard ISO 22716.

Notification of products on the CPNP

All cosmetic products that are being sold must be notified on the the EU-wide Cosmetic Product Notification Portal (CPNP). First the company has to be registered on the portal - and this process can take several weeks. Once the company has been validated and receives log-on details it can then notifiy the individual products. If the product fits one of the standard frame formulations that are already in the system it can be quite quick to notify each product, but depending on the product you will be asked technical questions about e.g. CMRs, percentage essential oils, vitamin A or nanoparticles. Full instructions are on the CPNP user manual that can be downloaded off the internet.

Please email edmund@efchemicalconsulting.co.uk to find out more about our cosmetic safety assessment services, or to discuss pricing.