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The regulatory landscape of the personal care and cosmetic industry is ever changing, as it is a global network of legislation, certifications and standards, and more. To help the industry understand and navigate through the regulatory world, Inside Cosmeceuticals' blog—Regulatory Rundown—will feature monthly insights from industry insiders on all matters legal.

Cosmetics Frame Formulations in the EU

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by Emilie Cornillot

When the Cosmetic Products Regulation EU 1223/2009 comes into force on July 11, 2013, one significant change will be the use of frame formulations for the notification of cosmetic product information. Frame formulations are used to assist poison centers in administering the correct treatment in the event of accident, such as a child ingesting shampoo.

The definition of a frame formulation can be found in article 2 of Regulation EU 1223/2009: "Frame formulation means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress."

What is the purpose of the frame formulation?

Frame formulations were developed by the cosmetics industry and the European Association of Poison Centres and Clinical Toxicologists (EAPCCT) as a simple system that prevents the need for detailed paperwork for cosmetic products. The U.K. Cosmetic, Toiletry and Perfumery Trade Association (CTPA) and National Poisons Information Service (London) built a system upon which frame formulations are based. Products that fit within a specific frame formulation are required to only include basic information to European authorities.

The frame formulation system mitigates the need for the party responsible for the cosmetic product to submit the quantitative and qualitative formulation that consists of a list of categories and functions of ingredients, the maximum concentration present in the cosmetic product and indicates the exact concentration of additional substances.

Colipa (The European Cosmetics Association) is currently working on a frame formulation booklet. To date, there are more than 100 frame formulations for the following cosmetics categories:

  1. Skin Care
  2. Skin Cleansing
  3. Hair Removal
  4. Bleach For Body Hair
  5. Correction Of Body Odor and/or Perspiration
  6. Shaving Products
  7. Makeup
  8. Perfumes
  9. Sun Products And Self-Tanning Products
  10. Hair and Scalp Care Products
  11. Hair Coloring Products
  12. Hair Styling Products
  13. Nail Varnish And Remover
  14. Nail Care
  15. Tooth Care
  16. Mouth Wash/Breath Spray

With new innovations introduced to the cosmetics industry on an almost daily basis, the list of frame formulation is not exhaustive and can be adapted regularly to technical and scientific progress.

Frame formulations are not an obligation, if you prefer you can:

  • Submit the complete qualitative and quantitative formulation, including the percentage of each ingredient of the formulation. You can upload documentation directly or complete line-by-line on the system the name of ingredient and associated percentages.
  • Use a formulation with ranges that are predefined on the system.

The frame formulation was established by COLIPA in close collaboration with the European association of poison control centers in order to guarantee prompt and appropriate medical treatment in the event of an accident.

In addition, the EU Cosmetic Regulation has introduced the concept of “Notification" (article 13). This e-notification via an IT system will replace the notification requirements in each individual EU member country where the cosmetic product is placed on the market. This notification system was made available on 11th January 2012.

In conclusion, the frame formulation allows you to save time and avoid submitting the complete formulation of your product.

Emilie Cornillot is the health care and beauty product project manager at Intertek, a worldwide group of testing laboratories for the textile, footwear, toys, petroleum and chemicals industries. Cornillot has served as a cosmetics and cosmetotextiles project manager at Intertek since 2008. As an expert in EU regulation regarding cosmetics, she provides technical and regulatory support for cosmetics industry customers, including global retailers. She earned her master’s degree in chemistry with a specialization in flavors, fragrances and cosmetics from the University of le Havre and a bachelor's degree in chemistry from the University of Rouen.

 

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