Here is a brief overview of how cosmetics are regulated in key regions, including the EU, Canada, Turkiye, the US, the Middle East, and China.
European Union (EU)
Regulation: Regulation (EC) No 1223/2009
In the EU, cosmetics are strictly regulated under Regulation (EC) No 1223/2009. This regulation ensures the safety of cosmetic products before they enter the market. Key requirements include:
- Product Information File (PIF): Manufacturers must maintain a PIF containing detailed product data, including a Cosmetic Product Safety Report (CPSR).
- Responsible Person (RP): An RP, based within the EU, is accountable for product compliance.
- Labelling Requirements: Required label elements should be present in the local language of the country where the product will be placed and include information such as product identity, net quantity, ingredient list and instructions for use and warnings.
- Notification: Products must be notified via the Cosmetic Products Notification Portal (CPNP) before being sold in the EU.
- Prohibited Substances: The Annex II, III, IV, V, VI of Regulation (EC) No 1223/2009 contains a is a list of banned and restricted ingredients.
United Kingdom (UK)
Regulation: UK Cosmetics Regulation 2019 (SI 2019/696)
Following Brexit, the UK no longer adheres to the EU Cosmetics Regulation. The UK Cosmetics Regulation 2019 mirrors many EU requirements but applies independently:
- Responsible Person (RP): A UK-based RP is mandatory for products sold in Great Britain (England, Scotland, Wales). For Northern Ireland, the EU’s rules still apply under the Northern Ireland Protocol.
- Notification: Products must be notified to the UK’s Submit Cosmetic Product Notification (SCPN) portal for sale in Great Britain.
- Labelling: Labels must include the RP’s UK address and required product information.
United States (U.S.)
Regulation: Federal Food, Drug, and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act (MoCRA) 2022
In the US, cosmetics are regulated by the FDA. The recent Modernization of Cosmetics Regulation Act (MoCRA) 2022 introduced significant updates to the FD&C Act:
- Product listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
- Facility Listing: Cosmetic product manufacturers and processors must register their facilities with FDA and renew their registration every two years.
- Labelling: Labels must include ingredient lists, warnings, and the manufacturer’s information.
- Good Manufacturing Practices (GMP): MoCRA requires compliance with GMP to ensure product safety.
- Adverse Event Reporting: Companies are obliged to report adverse events.
Canada
Regulation: Food and Drugs Act and Cosmetic Regulations
In Canada, cosmetics are regulated under the Food and Drugs Act and the Cosmetic Regulations.
Key points include:
- Ingredient Restrictions: A list of prohibited or restricted ingredients (Hotlist) must be adhered to.
- Notification: Cosmetic manufacturers must submit a Cosmetic Notification Form (CNF) to Health Canada within 10 days of selling the product.
- Labeling Requirements: Labels must be bilingual (English and French) and include information such as product identity, net quantity, ingredient list and instructions for use and warnings.
Turkiye
Regulation: Regulation on Cosmetic Products (Official Gazette No. 25823)
Turkey follows EU regulations closely due to its alignment with EU standards:
- Product Safety: Products must comply with safety assessments and have a Product Information File (PIF).
- Responsible Person: A locally-based RP is required.
- Notification: Products must be registered in the ÜTS (Product Tracking System) before entering the market.
- Labelling Requirements: Labels must be in Turkish and include information such as product identity, net quantity, ingredient list and instructions for use and warnings.
Middle East (GCC)
Regulation: GCC Cosmetic Technical Regulation (GSO 1943)
In Gulf Cooperation Council (GCC) countries, such as Saudi Arabia, UAE, and Qatar, cosmetics are regulated under the GCC Cosmetic Technical Regulation:
- Safety and Quality: Products must meet safety, quality, and efficacy standards similar to those in the EU.
- Labelling: Labels must be in Arabic and include an ingredient list, manufacturing date, and expiration date.
- Notification: Some countries, like Saudi Arabia, require product registration with local authorities (e.g., SFDA).
China
Regulation: Cosmetics Supervision and Administration Regulation (CSAR)
China’s cosmetics regulation is governed by the CSAR, which was updated in 2021 to strengthen safety standards:
- Pre-market Registration: Special-use cosmetics (e.g., hair dye, sunscreen) require registration with the National Medical Products Administration (NMPA).
- Filing for General Cosmetics: General-use cosmetics need to be filed but do not require registration.
- Animal Testing: Mandatory animal testing for imported cosmetics has been relaxed if certain conditions are met, promoting the acceptance of alternative testing methods.
- Labeling: Chinese labeling standards apply, requiring detailed product information.
