Regulation are often viewed as a four-letter word, as they can be offensive and disruptive to the way a company runs its operations. This is probably true for many cosmetics companies dealing with the upcoming amendments to the European Cosmetic Directive that will be implemented by 2013. In some ways, the directive will simplify matters by harmonizing the notification process required for cosmetic companies. Here are some of the changes the new directive will introduce:
- The Directive will introduce a homogenized notification that is valid for all 27 European countries versus having to fill out a separate notification for each individual country.
- Companies will be required to obtain GMP (good manufacturing practice) certification.
- A big change for companies, specifically U.S.-based companies will be in the matter of the responsible person. Currently, the responsible person has an address on file and is responsible for cosmetic files—safety data sheets. Several changes are happening to the responsible person clause, but specifically, U.S. companies will now have to have a responsible party in Europe if they plan to market their cosmetics overseas.
- Another matter on deck is clarification for safety report. Testing will have to be done on each individual ingredient as well as the cosmetic formulation as a whole. And even though many of these ingredients may have been used for many years, they don’t have the necessary tests and data. The toxicology assessments necessary require new alternative ways of testing, as animal testing is banned, so options such as in vitro need to be explored.
Clearly, there are many issues that will be affected by these changes, and as expected, these changes many be a bit hard to understand. In the coming months, Inside Cosmeceuticals will be featuring a series of articles by Intertek on these regulatory changes and how better to understand them.
