Selling your products to the EU? You may want to read this. Companies that are currently or seeking to sell their products into the EU must now fully comply with the Regulation (EC) n° 1223/2009 as of July 2013.
 
EU regulations now require that companies have a Product Information File (PIF) for each product sold on the market and this PIF must be available to authorities at the address on the package (if requested).
 
One of the critical components of the PIF is the Cosmetic Safety Report. This report demonstrates the safety of the product, including its packaging. This means that the report must take into account impurities and chemicals prohibited in the EU that may be found in the packaging and therefore may leach into the cosmetic product.
 
This is a real challenge for the cosmetics industry as the EU currently prohibits in excess of 1,300 chemicals. In addition, EU regulations require proof that the chemicals in the product’s package does note migrate into the cosmetic product itself.
 
In order to comply with EU regulations for cosmetics packaging,finding the right laboratory to perform the necessary extractables and leachables (E&L) testing is critical. Unfortunately, there aren’t well defined test methods for E&L testing on cosmetics packaging.
 
A few organizations have stepped in to help companies satisfy this EU requirement by developing the necessary E&L test methods. For example, global public health organization NSF International has adapted test protocols used for pharmaceutical and medical device packaging and components to fit the cosmetics application. Scientists at NSF have been developing E&L test methods and testing packaging products for food, water, pharmaceutical and medical device industry for 70 years.
 
Depending on the cosmetic product type (e.g. nail polish, lotion, shampoo, etc.), different solvents are used to determine if the packaging leaches any water or lipid soluble chemicals – also called extractables – into the cosmetic product. The packaging material is exposed to these solvents under prescribed conditions that simulate real life use as well as extreme conditions that challenge the packaging. If the total extractables are not detectable, it can be concluded that there is nothing being extracted or leached into the cosmetics product. If there are extractables identified following the exposure process, NSF scientists measure the levels and composition of the leached chemicals to determine whether they are prohibited under EU cosmetic regulations.
 
The E&L test report is provided to the company to be included in their product’s Cosmetic Safety Report and provides proof that the product complies with EU packaging regulations for cosmetics.


Casey Coy has over 13 years of experience in cosmetic, dietary supplement and pharmaceutical industries with expertise in analytical testing and quality systems design and implementation. As Manager of NSF International’s Cosmetics and Personal Care Program, Casey provides advanced auditing, training, product testing and certification services that enable manufacturers to improve the quality and safety of their products and retailers to strengthen the oversight of their cosmetic and personal care suppliers.  As manager of this program, Casey works with retailers and manufacturers to develop and implement quality systems that comply with country or retailer-specific requirements, including the widely recognized Good Manufacturing Practice standard for cosmetics ISO 22716.  She also developed NSF’s cosmetic and personal care training and testing programs to verify label claims (e.g. free from chemicals of concern) or regulatory compliance (e.g. Proposition 65, EU regulations) in addition to NSF’s existing cosmetic and personal care organic (i.e. USDA and NSF/ANSI 305) certification services.