U.S. and EU Cosmetics Regulation
The United States (U.S.) and European Union (EU) share a common goal of ensuring the safety of cosmetics for consumers through rigorous science-based regulation. The manner by which each regulates the safety of cosmetics is quite similar.
In the United States, the cosmetics industry is regulated by the U.S. Food and Drug Administration (FDA), which has broad regulatory authority under the Food, Drug and Cosmetic Act. Under the EU Commission, Regulation (EC) No. 1223/2009 is the key European legislation governing finished cosmetics products in the EU. The European Union’s framework of chemical and cosmetics regulations are binding on all Member States Regulations and are enforced at the national level. Each country in the EU has a competent authority that is responsible for upholding compliance. As demonstrated by the following table, consumers in both parts of the world can feel confident that their cosmetics products are safe.
IS THE ASSURANCE OF SAFETY REQUIRED FOR THE PRODUCT’S INTENDED USE PRIOR TO MARKETING?
U.S. | Yes, proof of the safety of the cosmetics product and each of its ingredients is a responsibility of the manufacturer or its distributor in the U.S.
EU | Yes, proof of the safety of the cosmetics product and each of its ingredients is a responsibility of the manufacturer or its distributor in the EU. The safety assessor report is a key part of the manufacturer’s technical dossier mentioned below.
ARE THERE REQUIREMENTS FOR PRE-MARKET PRODUCT APPROVAL BY A REGULATORY AGENCY?
U.S. | No. With the exception of color additives, no pre-market approval is needed for cosmetics.
EU | No. With the exception of color additives, sunscreen active ingredients, and preservatives no pre-market approval is needed for cosmetics.
IS THERE SAFETY/TECHNICAL INFORMATION AVAILABLE TO REGULATORY AUTHORITIES?
U.S. | Under FDA’s Voluntary Cosmetic Reporting Program (VCRP), manufacturers are encouraged to:
- Register their manufacturing sites;
- Register their products and ingredients; and
- Report any health-related consumer comments (e.g., allergy reactions).
Industry voluntarily complies with these requests as part of its trade association (Personal Care Product Council) Consumer Commitment Code.
- Part of that code states that a company should maintain a safety information summary of ingredient and product safety information and other technical information on formula composition, manufacturing process, health-related consumer comments, etc.
- Any information in that safety/technical summary should be made available for inspection by FDA when there is a legitimate and specific safety concern or question related to a product, or ingredient in a product.
EU | In the EU, a full technical dossier on the cosmetic product must be kept available for inspection upon request of the local authorities. The technical file includes:
- Information is submitted through the Cosmetic Products Notification Portal (CPNP) and includes detailed product information regarding formula, manufacturing, safety assessment, labeling, and contact information.
- Regulation (EU) No. 655/2013 lists common criteria for claims and product information file must prove the claimed effects for the cosmetics product.
- Adverse experiences must be kept available for inspection by the competent authorities. Poison control centers have information available on standard formulations for medical emergency treatment.
- Some EU authorities accept the use of frame formulations for the purpose of simplifying notification and inspection requirements.
HOW ARE THE REGULATIONS ENFORCED?
U.S. | The FDA can inspect cosmetics manufacturing plants or offices at any time without notice. Inspections occur on a routine basis and when necessary in cases where safety is questioned.
FDA also has broad authority to:
- Ban or restrict cosmetics ingredients for safety reasons;
- Mandate cosmetics warning labels;
- Inspect cosmetics manufacturing facilities;
- Issue warning letters;
- Seize illegal products;
- Prohibit and stop unlawful activities;
- Prosecute violators; and
- Work with companies to implement product recalls.
EU | Each Member State appoints a competent authority to enforce the legislation in its country and to cooperate with each other and the EU Commission.
The EU Commission is responsible for driving consistency in the way the EU legislation is enforced.
ARE INGREDIENT SAFETY REVIEWS BY INDEPENDENT SCIENTIFIC BODIES PART OF COSMETICS SAFETY ASSURANCE PROCESS?
U.S. | Yes, by the Cosmetic Ingredient Review Expert Panel (CIR).
The CIR Expert Panel has reviewed (as of December 2014) 3,591 of the most commonly used cosmetic ingredients and classified them as:
- Safe as used (1,660)
- Safe with specific qualifications (1,810)
- Insufficient data to determine safety (13)
- Not safe for use in cosmetics (11)
- Use in cosmetics not supported (37)
- No cosmetic use ingredients (60)
CIR’s safety opinions are published in peer-reviewed scientific literature (International Journal of Toxicology) and are publically available on its website.
EU | Yes, by the EU Scientific Committee on Consumer Safety (SCCS).
SCCS is responsible for reviewing all cosmetics ingredients that are forwarded to them by the EU for consideration and declaring safe usage levels or none at all.
SCCS’s safety opinions are published and publicly available on its website.
ARE THERE INGREDIENTS THAT ARE BANNED FROM USE IN COSMETICS/PERSONAL CARE PRODUCTS?
U.S. | Yes, the U.S. FDA regulations list ingredients that may not be used in cosmetics/personal care products.
- There are nine cosmetics ingredients restricted or prohibited by the FDA.
- Eleven additional cosmetics ingredients have been judged by the Cosmetic Ingredient Review Expert Panel (CIR) as not safe for use in cosmetics.
- The International Fragrance Association (IFRA) also establishes safety standards for fragrance materials. The IFRA standards amount to 174 substances which have been either banned or restricted in their use in fragrance products.
EU | Yes, the European Union regulations list ingredients which may not be used in cosmetics/personal care products.
- The European Cosmetics Directive Annex II list has 1,378 banned substances; however, 80% of those ingredients have not been used and never would be used as a cosmetics ingredient. The few on that list actually used in the US have been reviewed by other experts who find that the materials may be safely used for cosmetics products. The difference in ingredients between the U.S. and European are minor and subject to legitimate disagreement among experts.
ARE THERE REQUIREMENTS TO LIST INGREDIENTS ON THE PRODUCT LABEL?
U.S. | Yes, both the U.S. and European Union have requirements for listing ingredients on cosmetics and personal care products. However, with regard to flavor and fragrance, ingredients need only be listed as “flavor” or “fragrance” on the label.
EU | Yes, both the U.S. and European Union have requirements for listing ingredients on cosmetics and personal care products. However, with regard to flavor and fragrance, ingredients need only be listed as “flavor” or “fragrance” on the label with the exception of the 26 specific perfume ingredients which must be included in the ingredient list.
HOW ARE SUNSCREENS REGULATED?
U.S. | Products with claims on the prevention or treatment of disease or for affecting a structure or function of the body, like sunscreens, are considered drugs in the US. and are regulated as Over-the-Counter (OTC) drugs.
EU | While sunscreens are an OTC drug in the U.S., they are considered cosmetics in the EU. However, UV Filters do require pre-market approval.