While in the European market in reference to cosmetic products is regulated and harmonized by the Cosmetics Directive 76/768/EEC and the NEW Cosmetic Regulation EC 1223/2009, the regulatory framework in the USA has not been as comprehensive and stringent till today.
The current US law in effect is from 1938 and has not been amended ever since, therefore, a shift in the US cosmetic policy is indispensable. In light of the ongoing product safety concerns within the ‘self-regulated’ US Cosmetic industry, The Safe Cosmetics Act of 2011 was introduced on June 24th, 2011 to United States House of Representatives.
The first and foremost objective of this new Act is to eliminate the harmful chemicals from cosmetic products and require companies to fully disclose their product ingredients for the very first time. The most important features of the SCA is to reduce the loopholes deriving from its outdated status and to give the FDA the authority to see that personal care products are free of harmful ingredients.
The focus of the Safe Cosmetic Act H.R.2359 is the following highlights:
- Mandatory registration (similar to the Cosmetic Notification practiced in Europe) for cosmetic manufacturers & packagers, whose annual sales receipts exceed $2 million. There is expected to be a registration fee for manufactures, whose gross receipts or sales of products is more than $10 million;
- New labeling requirement, that entails listing the name of every and each ingredients, including the contaminants and nanomaterials (similar to EU labeling requirements);
- The Secretary of Health and Human Services is required to establish Good Manufacturing Practices (GMPs) for cosmetic ingredients (that was established in Europe by the presumption of conformity with GMP by the EN/ISO 22716);
- Manufacturers shall submit all data and information on their products (incl. functions, physical, chemical, toxicological properties, exposure, results of safety tests – very similar to the elements of the EU Product Information File );
- The Secretary shall group the ingredients as a) prohibited & restricted, b) safe without limits and c) priority assessment lists;
- Allows manufacturers to use supplier safety assessments to certify ingredient safety (very similar to the EU requirement of a Safety Assessment by of the EC 1223/2009, Annex I, Part B);
- All non-confidential information must be publicly available;
- Manufacturers are required to minimize animal testing, therefore, within one year after the date of the enactment of this Bill the Secretary shall publish a list of Alternative Testing Methods; (similar to the EU marketing Ban on Animal Testing)
- Establishing an Interagency Council on Cosmetic Safety that will enable information sharing and promoting collaboration among agencies and institutions;
- Requires the Secretary of Labor to promulgate an occupational safety and health standard relating to cosmetics for professional use.
As per today, the Safety Cosmetic Act of 2011 is still not enforced. At the moment, it is at the Committees’ level for investigation and revision; therefore, it is only the first step towards a legal regulatory framework.
None the less, it shows a first step towards a real and more stringent regulatory approach towards Cosmetics in the US alongside first interesting touching points between the European Cosmetic Regulation EC 1223/2009 and the new US Cosmetic Laws (such as: GMP, Pre-Market Registration/Notification, Safety Assessment, Labeling Requirements, Full Product specifications and the address to the issue of animal testing).
In light of the ongoing product safety concerns within the “self-regulated” US Cosmetic industry, The Safe Cosmetics Act of 2011 was introduced on June 24th, 2011 to United States House of Representatives.
The costs may seem daunting to US Cosmetic companies on the forefront of passing the Safe Cosmetics Act; however, more extensive testing should undoubtedly increase US Manufacturers international desirability and/or lead time in entering global markets, this is especially applicable to the European Union which is very structured in it safety requirements.