Anne Dux, Director of Scientific and Regulatory Affairs, FEBEA
“The countdown has started,” says Anne Dux, Director of Scientific and Regulatory Affairs, at the French Federation of beauty enterprises (FEBEA). “There are 676 working days before the mandatory implementation of the cosmetics regulation. For a catalogue featuring 50 products, this means that we need to upgrade a file produced every 13.5 days. Those waiting for the 1st January 2013 to get on with the task will have only two days per product! And there are many other items to address.”
Actually, the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products will come into full force on July 13, 2013. The consequences of the text on the producers and marketers of cosmetic products are far from negligible. There are four main levels of impact said Anne Dux: on the catalogue of raw materials, on the production, on cosmetics information files and on the placement on the marketing.
Priority to raw materials
“It’s really the priority for companies. On the one hand, there is a lot of work to do. And on the other hand, this work can be started immediately, unlike the update of the cosmetics information file for which some key elements are still missing,” says Anne Dux.
The Regulation lays down several new requirements on raw materials, particularly for the notification of products containing nanomaterials and the defence of substances classified as CMR [1] class 1A and class 1B from 1 by December 2010. Furthermore, REACH is complicating things. It’s true that the cosmetics industry is largely a downstream user, which is not responsible for the registration of substances. But the downside of this situation is that the cosmetics industry does not decide what substances must be defended or eventually abandoned.
It is important, therefore, to organize a careful monitoring on the raw materials catalogue, considering that the most sensitive ones are those that are used in many formulas. The purpose of such a monitoring is to gather the data that is necessary to update the cosmetics information file, as well as to monitor the behaviour of suppliers and to anticipate the substitutions that would appear necessary.
Impact on production
As far as production is concerned, the new Regulation on cosmetics makes clear requirements: respect of good manufacturing practices (GMP) for cosmetics, as specified in the standard ISO 22716, and formalization of the contractual relationship with suppliers, subcontractors and outsourcers.
Demonstrating GMP compliance may require applying for a third party certification, which implies of course quite a long preparation.
Update of cosmetic information files
The regulations significantly strengthen the requirements for assessing the safety of cosmetic products. However, these new requirements shall be specified by guidelines published by the European Commission. This publication is expected in the first quarter of 2011 and in the meantime, says Anne Dux, it is difficult to move forward on this issue.
However, companies of the beauty industry can immediately organize the mandatory cosmetovigilance scheme. Indeed, they will have to gather all available data on the undesirable effects, including serious undesirable effects, in the report on the cosmetic products safety. “But this raises the issue of imputability,” said Anne Dux. Namely it is the question of determining to what extent an undesirable effect is really caused by the use of a cosmetic product. To this end, Afssaps and Colipa have developed common imputabilty method.
Impact on placement on the market
Article 13 of the new Regulation 1223/2009 provides that before placing a cosmetic on the market with several pieces of information must be notify to the European Commission. The electronic portal allowing to fulfil this formality should be online from January 11, 2012, and a beta version will be put into test in the first quarter of 2011.
Finally, the new regulations also require to review contractual relationships with distributors.
