Cosmetic Safety Regulations


  • Welby Healthcare Ltd complies with the regulations as laid down in EU Regulation No 1223/2009.
  • The products we offer as standard stock formulations comply with regulations.
  • Customised formulations will require safety assessments.

It is important that anyone who seeks to put cosmetics on the market knows their obligations to comply with EU Regulation No 1223/2009.

The information below is taken from the official EU website guidelines and provides links to more information you will need. It will help you to understand the background and what you have to do to comply.

What is a cosmetic product?

Any substance or preparation intended to be placed in contact with the various external parts of the human body with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours, protecting them, or keeping them in good condition.

Every cosmetic product placed on the market requires a safety assessment carried out by a suitably European qualified professional. The assessment will form part of the product information pack which should also include details of the qualitative and quantitative composition of the product, specifications of raw materials and finished products and the purity and microbiological controls, details methods of manufacture in accordance with good manufacturing practice, data on undesirable effects on human health, and where appropriate, proof of any claimed effect.


On 11th July 2013 the new EU Regulation 1223/2009 Cosmetics Regulation- came into force strengthening the safety of cosmetic products and streamlining the framework for all operators in the sector. The Regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality. The Cosmetics Regulation, adopted in 2009, replaces Directive 76/768/EC that was adopted in 1976 and has been substantially revised on no less than 7 occasions.

The most significant changes introduced by the Cosmetics Regulation include:


  • Strengthened safety requirements for cosmetic products
  • Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.
  • Introduction of the notion of ‘responsible person’

Only cosmetic products for which a legal or natural person is designated within the EU as “responsible person” can be placed on the market. The new Cosmetics Regulation allows the precise identification of who the responsible person is and clearly outlines the obligations.

Centralised notification of all cosmetic products placed on the EU market

Manufacturer will need to notify its product only once – via the EU Cosmetic Products Notification Portal (CPNP).