COMPLYING WITH EU REGULATIONS - COSMETICS
Anyone placing a cosmetic product on the EU market has to comply with the laws governing cosmetic products. It doesn’t matter if the product is to be sold, or given away for free, and it makes no difference if the producer of the cosmetic product is a large organisation or one person operating from their own home – the legislation applies to everyone equally.
Cosmetic Regulation (EC) No. 1223/2009 came into force in all 27 Member States simultaneously in July 2013.
Overview of Regulation requirements
The new Regulation requires that all producers of cosmetic products do the following:
1. Appoint a ‘Responsible Person’
2. Have a Cosmetic Product Safety Report (CPSR) produced by a qualified professional
3. Keep a detailed and up to date Product Information File (PIF)
4. Label products correctly with appropriate warnings if relevant
5. Comply with Good Manufacturing Practice
6. Register information on the Cosmetic Product Notification Portal (CPNP)
The responsible person is either the manufacturer of the product, the person a manufacturer appoints to be their agent, or the person who has commissioned products from a manufacturer.
Obligations of the Responsible Person
- Ensure compliance with the Regulation
- Take corrective measures if and when necessary
- Immediately notify details of non compliance and corrective measures taken
- Cooperate with authorities
All cosmetic products on the market in the EU have to have a Cosmetic Product Safety Report produced by a qualified Safety Assessor.
The Regulation states that any safety assessors must be…
“in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State”.
As a minimum, the PIF will usually contain the following information:
The Product Information File can be kept in any format you wish and it doesn’t have to all be in one place. However, it has to be available for inspection at one address when asked for by the competent authorities and must be kept for a period of ten years following the date that last batch was placed on the market.
- The CPSR – much of the information required for the PIF will be included in the CPSR
- A description of the cosmetic product along with the formula or recipe with percentage of each ingredient
- Safety Data Sheets for each ingredient, product specifications, and certificates of analysis (if relevant)
- File on any undesirable effects on human health resulting from the use of the product
- If effects are being claimed (for example anti-wrinkle) you need to keep proof of that effect in the file or reference the source (research data, etc).
- Suppliers of raw materials
- Data on any animal testing performed by manufacturer, agent or suppliers
- Details of packaging or containers and any artwork, labels
- Details of manufacturing process and a statement on compliance with good manufacturing practice
Cosmetic product labels must include the following:
- Name and function of the product
- An identifiable address within the EU
- Name of manufacturer or responsible person
- List of ingredients (using INCI) in descending order of weight or volume
- Any allergens in the product
- Weight or volume of the product
- Best Before Date or Period After Opening Information
- Batch Number for traceability
- Any warning statements and/or precautionary information
It is a requirement to produce your cosmetic products according to Good Manufacturing Practice.
The law doesn’t require you to be GMP certified, only to state that you are complying with a recognised industry standard.
Details of all cosmetic products on the market in the EU must be registered on the Cosmetic Product Notification Portal. More information on this can be found here CPNP FAQ
Other Useful Links and Resources
Cosing Database (COSmet INGredients)
Aromantic Challenge Test Results
Regulations - What about therapists?