The EU Cosmetics Regulation provides strict rules and ingredients guidelines for safe use including harmful chemicals that are prohibited and how much of an ingredient can be used in a specific procurement. Many brands that are based outside of the EU often encounter hardship due to stricter regulations when penetrating the new market.
Here is what you need to know before marketing your cosmetics products in the EU in accordance with the regulations.
The EU Cosmetics Regulation urges all cosmetics brands to manufacture all products ensuring high-quality standards and following Good Manufacturing Practices (GMP). The five main pillars (5 P’s) of Good Manufacturing Practices (GMP) are people, premises, processes, products, and procedures. GMP system was developed to reduce the pharmaceutical and safety risks of the product.
Maintaining your product database helps you organize your brand and ensure all products meet the regulatory requirements. It is required to keep information about your products for a minimum of 10 years after the production.
Your product information file (PIF) should include:
- Description of your product
- Safety assurance report of your product
- Manufacturing process information and GMP compliance
- All information on product testing including animal testing
The European Cosmetics Directive Annex II list has over 2,000 ingredients banned to this day. In March 2022, they announced 23 more ingredients are banned. With regulations changing frequently, it is crucial to stay up-to-date with the most recent changes to maintain your product ingredients’ safety and ensure your customers the safety of your products.
List of 23 newly banned ingredients:
Zinc Pyrithione, Butylphenyl Methylpropional (Lilial), Bis(α,α-dimethylbenzyl) peroxide, Imiprothrin, Hymexazol, Hymexazol, Dichlorodioctylstannane, Iprovalicarb, Penflufen, Methylolacrylamide, Flurochloridone, Sodium N-(hydroxymethyl)glycinate, 2-methoxyethyl acrylate, Diisooctyl phthalate, 2,2-bis(bromomethyl) propane-1,3-diol, Paclobutrazol, Paclobutrazol, Ipconazole, Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene, Dioctyltin dilaurate and stannane, Tris (2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, Tris (2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, Silicon carbide fibers, Fluxapyroxad
Visit the European Chemicals Agency website to access the full list of banned ingredients in the EU.
The EU has requirements for listing ingredients on cosmetics products. The product’s name and labeling should reflect its nature.
Information to include in the label:
- Your brand name and function
- Product function with the exception of products with distinctive function by design (i.e. nail polish)
- Ingredients list
- Expiration date
- Country of origin
- Product content measure
- Precautions for use
- Contact point information
Marketing Your Products
The EU requires assurance of safety or the product safety report prior to marketing or advertising your products as a necessary step. The assurance of safety includes the overall safety of your products including information about the ingredients and the manufacturer or the distributor in the EU. Another important step to take before marketing your product is to notify the EU directly. This step is called submitting pre-market notification and can be done via the Cosmetic product notification portal (CPNP).