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Safety

Complying with EU Cosmetics Regulation 1223/2009

The EU cosmetics regulation 1223/2009 was first published at the beginning of 2010 but took effect on 11 July 2013.  This Regulation replaced the commonly known “Cosmetics Directive” – existing legislation 76/768EC and covers all cosmetic products available for sale in the EU.

To legally sell a cosmetic product in the EU there are five main requirements:

  • an EU address for the person legally responsible for the products
  • a valid safety assessment, called a Cosmetic Product Safety Report (CPSR)
  • correct labelling on the package
  • a completed Product Information File (PIF)
  • notification of the product to the EU authorities using the Cosmetic Products Notification Portal (CPNP).

A ‘cosmetic product’ is defined in the European Cosmetics Directive (76/768/EEC): Article 1 of 76/768/EEC

A ‘cosmetic product’ shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odours and/or protecting them or keeping them in good condition.

This definition is expanded in the UK Cosmetic Products (Safety) Regulations: Regulation 3(1) of SI 2004 No. 2152

‘Cosmetic product’ means any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view to exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping in the in good condition or correcting body odours except where such cleansing, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease.

Any claims made about a product need to be backed up and documented in the PIF.

Cosmetic Product Safety Report (CPSR)

Safety assessments under the new regulation are called the Cosmetic Product Safety Report (CPSR).  Previous assessments carried out under the old directive EC76/768 will not normally comply. All products manufactured after 11 July 2013 will require a CPSR, and it is the responsibility of the authorities (Trading Standards in the UK) to ensure that organisations comply with this law.

Variations within CPSRs

The EU Regulation makes it clear that a separate PIF file and therefore CPSR must be completed on an exact product formulation. CPSRs can normally only be done on a specific product with a product code that matches the exact formulation as documented in the PIF. Flexible assessments that small craft manufacturers have had in the past, for a range of soaps or massage oils for example, unfortunately will no longer be allowed.

Microbial Challenge Tests

Most products containing water will require a microbial challenge test under the new regulations.

Since these take between 30 – 40 days it’s a good idea to get them completed as soon as possible.  The challenge tests generally cost around £150-£250, sometimes much more, and are offered by few companies in the UK.   Oxford Biosciences offers cosmetic product challenge testing for £150 per product.  The tests are commonly referred to as Microbial Challenge Test (Challenge) and Preservative Efficacy Test (PET) but they are the same test.

The challenge test examines the antimicrobial properties of the product.  If a significant decrease or no increase in viable count of micro-organisms is seen:

  • A 2 log reduction in the microorganisms counting after 14 days compared to that at the beginning
  • A 0.5 log reduction in the microorganisms counting after 28 days compared to that after 14 days.

If a challenge test has already been done on a very similar product, for example with a different perfume, it may not be necessary to repeat it.

A standard international test method must be used such as the EP (topical products) method or the new ISO method (11930:2012).