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 11 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).

Contact Us

The Welby Group
Block 2, Unit 3

Whistleberry Industrial Estate
South Lanarkshire
Glasgow ML3 0ED
Tel: 01698 440230

Opening Hours
Monday - Thursday, 9am - 5pm
Friday, 9am - 4pm


ISO 9001:2008 Quality System - Our assurance to you...

The Welby Group is committed to achieving customer satisfaction through compliance with our quality management systems and by promoting the importance of this throughout the business in order to ensure the provision of products and associated services that comply with both regulatory requirements and all other customer needs and expectations.