Cosmetics (Europe)

On 30 November 2009 the new Cosmetic Products Regulation (EU Regulation 1223/2009) was adopted and replaces the Cosmetics Directive.  This regulation reinforces product safety taking into account the latest technological developments (including the possible use of nanomaterials).  Most of the provision of this new regulation will apply as from 11 July 2013.

** Important **

As from 11 July 2013:
All existing Safety Assessments must be in the new format which includes more data from the Product Information Pack (PIP) particularly adverse event data.  Therefore, all PIPs must be updated by 11 July 2013.

Existing assessors who are experienced and qualified Chartered Chemists can continue to undertake Safety Assessments after this date.  Anyone new taking on this role (i.e. as a new career) must be a qualified scientist – pharmacology, medical, toxicologist or similar.

There will be a central 'clearing house' for cosmetics for all Member States so as to harmonise the regulations across Europe.  The guidelines to comply with this central 'clearing house' have yet to be issued.

Current Key Requirements

Responsible Person (RP)
If a company has an EU distributor then it is usual for this distributor to take on the role of "Responsible Person (RP)".  The RP's company is responsible for the importation and marketing of the products.  Their name and address must be included on the packaging and, in the UK, they must ensure the completed Product Information Pack (PIP) is made available to Trading Standards within three days of it being requested.

Note: The RP doesn't necessarily have to hold the PIP.  This can be held in confidence by Global Regulatory Services or a nominated professional.

Other responsibilities for the RP include:

• ensuring the PIP is kept up-to-date,
• reporting significant adverse events,
• running a public recall (should that ever be required), and
• registering the product before import.

Compliance with other legislation
Cosmetics may also be subject to:

• Weights and Measures legislation
• Protection from Misleading Advertising
• REACH (Registration, Evaluation, Authorisation and restriction of CHemicals)
• Packaging and Labelling requirements
• Permitted/restricted ingredients (including ozone-depleting substances)

European Safety Assessments
Compliant safety assessments are mandatory before the product is placed on the market.  Global Regulatory Services is happy to provide their cosmetic clients with the expertise of a cosmetic specialist who, on average, can assess and provide the required certification within a two week period.  This assumes data is readily available and is of good quality.

Please contact us with your specific regulatory compliance requirements.