Intertek's webinar, "Compliance With the New European Union Cosmetics Regulations – Are You Ready for 2013?", presented by David H. Bechtel, Ph.D., DABT, VP, New Jersey; and Andrea W. Wong, Ph.D., senior scientific & regulatory consultant, discussed what actions the cosmetic industry must take into comply with the new regulation. Inside Cosmeceuticals was able to ask Intertek a few questions in addition to the information it provided in the free webinar.
First, here's a quick recap of what's happening with Europe's regulatory landscape. The European Council Directive 76/768/EEC was originally established in 1976; since then, it has experienced several adaptations and amendments. The Cosmetic Regulation was introduced in 2009 and by 2013, all companies will need to be compliant with the new changes. The regulation is a hybrid of the adaptations and amendments that have occurred over the years and more, in a single piece of legislation.
Directive vs. Regulation
The directive was interruptive and "subjective" depending on the member state, i.e., the old directive was just a guide that every member country transposed into its national legislation making it open to interpretation; whereas the regulation is immediate and the same across all member states.
Q&A with David H. Bechtel, Ph.D., and Andrea W. Wong, Ph.D.
Q: Was this regulation introduced to homogenize standards that the directive failed to do? Or were there other motives?
Intertek: We can't really comment on the motives; however, the EU is undergoing a lot of regulatory revisions in all areas in order to come up with a unified code. We think this is in the spirit of the entire movement. Also, the original directive was established in 1976, so lots has changed—there are more member states and so much variation—we think this is an attempt to centralize everything.
Q: What is the best way for companies to ensure they are compliant with all of the changes the regulation is introducing? Where do they start?
Intertek: For our clients, we ask them for their product form, we conduct an initial screening of their ingredients and mark any red flags such as safety concerns. We help them streamline their product line, and work with them to gather safety info—Is there enough to support safety, product claims, etc.?
Overall, the industry has does a good job to ensure safety; so the likelihood of dangerous ingredients is probably minimal. The regulation is really more about the disjointed approach that's been prevalent thus far; and to create an organized, unified, single system to gather and maintain the use of ingredients in the products they occur in. It basically documents safety in a transparent manner. It also takes a look at old cosmetic ingredients that may not have been updated since the 50s or so, among other things.
Q: Is this transition as big as it appears?
Intertek: Yes, it's as big as it seems. The template context in which it's organized has not been in existence before. Products that were safe are still subject to complete reevaluation and business as usual isn't sufficient anymore. It requires a credentialed person to conduct the safety assessment, and now there is a designated responsible person.
Interek did note it's possible some companies may find when evaluating their product offerings, it's not worth repeating the study to get updated info, and they may replace that ingredient with an ingredient that has a robust safety package; or, they may revisit/reintroduce that product at a later time.
Q: How should a company designate a responsible person?
Intertek: The responsible person can be anyone; there are no specified credentials except they must accept the responsibility in writing; however, there are specified credentials outlined in the regulation for the person doing the safety assessment. The responsible person can be in-house, such as the quality assurance manager or can be outsourced to a company such as Intertek.
Q: How are nutricosmetics handled? Such as foods, beverages and dietary supplements in the cosmetic industry?
Intertek: Oral consumption so doesn't meet the requirements of the regulation, because cosmetics apply to the external parts of human body (skin) or the oral cavity; therefore they are regulated as food supplements, not cosmetics.
Q: If you could tell or emphasize one thing to cosmetic companies what would it be? What's the key, take-home message?
Intertek: Get started now! There is clearly lot of requirements and whatever you did for the directive won't be enough. This is a larger process than what's been in place; it's a more intense approach of what will be required. And, besides science, the need to have a responsible person is one of the most important changes.
Just a Few Notes:
· The distributor/finished product supplier, not the raw material or ingredient supplier, needs to designate a responsible person.
· Both U.S.-based and European-based companies are required to designate a responsible person; however, if your company is based in the United States, your responsible person has to be located in Europe.
· The requirements are not different when entering the market today versus post-2013, as the grace period is already in effect and companies will need to be compliant with the new regulation by 2013 anyway.
"In January 2012, the electronic notification process starts, so you might as well meet the directive now," Intertek added.