The entry into force of the European Regulation on cosmetic products [1] in July 2013 has focused much of the discussions of the 9th Congress of the Perfumes and Cosmetics "Regulatory Issues" organized by the Cosmetic Valley and Chartres Métropole. Among the 468 people gathered for the occasion, there were many representatives of SMEs, rather unanimous on one point: the term may seem quite far away, but given the importance of the task at hand, time is running out!

Time and money

Admittedly, from REACH to the new Regulation on cosmetic products through the CLP [2] (for Classification, Labelling and Packaging of substances and mixtures) Regulation, the scope of the issues discussed at the Congress was impressive and the stacking of legislations could be bewildering. But "we must be careful not to pave the way of anti regulation speeches," tempers Anne Dux, Director of Scientific and Regulatory Affairs at the Federation of Beauty Enterprises (FEBEA). "Both REACH and the CLP regulation are quite old already. Moreover, SMEs in our industry hardly have to deal with REACH. They are a bit more concerned by the CLP Regulation, for the protection of their employees. However, their main concern remains the cosmetics regulation, and in our opinion, they are not yet ready," she adds.

One explanation for the late departure of companies is the fact that several parts of the new regulatory framework have been detailed quite late. But according to Jean-Marc Giroux, president of COSMED, "all companies will comply with their obligations." However, the representative of the association of the French cosmetics SMEs, tells the main problem is about resources of time and money to allocate for this purpose. "We do not deny the interest of the cosmetics Regulations, nor its benefits to consumers and even businesses, but the financial resources to devote to this implementation are very important."

An analysis that shares the FEBEA which calculated that in order to be ready in July 2013, each company must allocate "the equivalent of a full-time job every 75 formulas".

In any case, in such a context, the French decision to tax its cosmetics industry falls rather bad.

Key steps

Nevertheless, the good organization of the transition period is probably as important as the allocation of resources. "It is important not to be mistaken in priorities, stresses Anne Dux, we find that firms tend to address the notification first, but it’s really the last thing to do.

The priorities are, by decreasing order:

- To check that its production complies with the good manufacturing practices, and therefore to audit suppliers, when one do not produce itself,
- To organize the cosmeto-vigilance system. "And that also affects SMEs. To say that one has no problems is not an answer since, as long as one is not well organized to see something, it may never see anything," insists the Director of Scientific and Regulatory Affairs of FEBEA. "We are organising a free and open information session on this subject, on 30 January 2012."
- To check all contracts with partners in order to ensure they comply with the requirements of the Regulation. For contracts with manufacturers, these include provisions relating to good practices. For contracts with distributors, the cosmetic-vigilance clauses are the most important.
- Then we can begin the updating of the product information package, knowing that on this issue final guidelines are in draft form and still have to be published by the European Commission.

The latter step is probably the one where SMEs may face the greatest difficulties. "In our view, the main problem for SMEs is that they will be confronted with complex technical issues, including in the toxicological field. They will need advices from experts who will be less and less available, and they will have obtain information that suppliers may be reluctant to provide," said Pierre Perrier, co-founder of Essential Consulting.

To help companies in this stage, the FEBEA provides a diagnostic service in order to prepare the transition of product information packages. "We send a person within the company, a specialist who identifies the key issues of each information package," adds Anne Dux.

For its part, COSMED will launch its Guide of the Schedule 1, in January, a 150-page handbook designed to help businesses get their records in compliance with the new requirements.

According to the FEBEA, resources to allocate at this step correspond to the equivalent of one-week full-time job per product information package.

Once all these steps completed, and only then, it is possible to make the notification through the web portal set up by the European Commission for this purpose. Notifying a product, is also committing on its comply with the new regulations. The portal set up by the European Commission will be available from January 11, 2012. And between 500,000 and 700,000 notifications are expected by July 2013.