Safety assessment of cosmetics in the EU and US
July 24, 2009
Not all products have a worldwide formulation – a product’s ingredients can depend on whether you live in the EU or the US – this is due to differences in the levels of pre-market approval required by law. In terms of regulatory control, the EU is considered the most active but in many countries (including the US) products aren’t subject to any pre-market approval.
This post provides a summary of EU and US regulations used to assess the safety of cosmetic products:
Cosmetic legislation in Europe is based on the Cosmetics Directive. The EU Cosmetics Directive (76/768/EEC) was revised in January 2003 to ban 1,100 chemicals from cosmetics.
- The European Union proposing to change the way it regulates all chemicals – requiring chemical companies to test chemicals for their effect on health before they are put on the market.
- Companies are no longer allowed to sell products (in the EU) made with chemicals that are known or suspected to have negative impacts on health including: carcinogens, mutagens or reproductive toxins.
- A full technical file for a cosmetic product must be kept available for inspection by authorities at a specified EU address.
- A safety assessment of the finished cosmetic product must be performed before the product can be placed on the EU market.
- The EU Cosmetics Directive (76/768/EEC) was revised in January 2003 to ban 1,100 chemicals from cosmetics. Ingredients were reviewed for safety by SCCS (EU Scientific Committee on Consumer Products).
- In May 2009, Parliament introduced laws regulating cosmetics containing nanomaterials. Additionally, all nanomaterials in the cosmetic must be mentioned on the list of ingredients on the packaging, with the names of such ingredients followed by the word “nano” in brackets.
Cosmetics laws in the US are broken up into 3 areas:
The FDA (Food and Drug Administration) is responsible for assuring the safety of human and veterinary drugs, biological biological products, medical devices, the nations food supply, cosmetics and products that emit radiation.
- Cosmetic products and ingredients are not subject to FDA market approval before they are placed on the market.
- Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing.
- Manufacturers are not required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA. However, companies are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA’s Voluntary Cosmetic Registration Program (VCRP).
- FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA’s written request.
- The FD&C Act does not subject cosmetics to FDA premarket approval in order to be marketed legally. However, FDA collects samples for examination and analysis as part of its plant inspections, import inspections, and follow-up to complaints of adverse reactions.
- There is a list of nine cosmetic ingredients restricted or prohibited by the FDA. Nine additional cosmetic ingredients judged by the Cosmetic International Review Expert Panel not safe for use in cosmetics.
- Ingredients reviewed for safety by CIR (Cosmetic Ingredient Review Expert Panel).
In 1938, laws were passed by congress giving the FDA authority to oversee the safety of the above products.
Individual states have taken steps to assess product safety and pass state legislation.