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Laws and regulations

“The new European Regulation on cosmetics is going to change our way of working!” Sylvain-Romain Cotte

Dr. Sylvain-Romain Cotte, a specialist in cosmetic regulations, founder and director of SRC Consulting, is about to launch a new company, to facilitate the accomplishment of regulatory obligations but to also optimise the relationship between subcontractors and contractor.

Sylvain-Romain Cotte

Sylvain-Romain Cotte


Premium Beauty News - You are launching a new offer to help cosmetic companies meet their regulatory obligations. Is the new European Regulation going to change the situation at this level?

Sylvain-Romain Cotte - The Regulation on cosmetic products [1], which will become mandatory no later than July 11, 2013, will be introducing several new elements, with some of them having a significant impact on the businesses of companies. But mostly, it will clarify some legal points which were ambiguous or interpreted differently from one EU member state to the other. This is the case, in particular, for the notion of person responsible for placing on the market. Articles 4 and 5 of the Regulation give a very precise definition on the marketer’s mission and scope of responsibility. They also provide that the person responsible for placing on the market can be a third party specifically appointed by the manufacturer, the customer or the importer.

Our analysis is that the entry into force of the Regulation with the removing of many grey areas, will force a number of companies, including distributors, subcontractors and importers of cosmetics to change their way of working.

Premium Beauty News - Ensuring the full regulatory compliance of the company’s activity and of its products can represent a pretty heavy workload, especially for small businesses.

Sylvain-Romain Cotte - Quite true! That’s why we are offering three services through a new legal entity that we created, International Beauty Office SAS, with the aim to enable companies to focus on their core business and help them benefit from economies of scale on regulatory issues.

First service offer: the role of legal person responsible for placing on the market of products of companies that so wish. In accordance with the requirements of the Regulation, International Beauty Office ensures the full compliance of the cosmetic product vis-à-vis the European regulations and assume responsibility as such. This service is mostly intended for SMEs who do not have the possibility to set up their own regulatory service nor to ensure a constant regulatory watch, as well as for cosmetic brands located in a non-European Union member and whose importer or distributor do not wish to “endorse” the responsibility of marketer.

Second service offer: the European notification. As of 1 January 2012, companies will be able to electronically start notifying their products to the European Commission and they will need to comply with this requirement no later than July 2013. The marketers will therefore have to organize themselves to perform these procedures internally or rely on qualified service providers. They will have to collect the required data and prioritize the work, by giving priority to products which they are sure will still be on the market after July 2013 and by side-lining the ones they know will no longer be available at that date. In order to meet these confidentiality requirements, it is also a service that we offer to perform in the premises of our customers by despatching one of our staff member trained on a given period of time.

Third service offer: the electronic Product Information File (PIF). We build, manage and validate electronically our customers Product Information Files which are required by European regulations.

I also remains at the head of SRC Consulting, which still offers a set of consulting & expertise services (regulatory compliance of imported and exported products, compliance audits of industrial sites with Good Manufacturing Practices in cosmetics according to standards EN ISO 22716).

Premium Beauty News - You were mentioning economies of scale, how is this achieved concretely?
Sylvain-Romain Cotte - The core of our business is regulations, that of our customers is essentially research and development, marketing developments and the placing on the market of cosmetics. For medium-sized companies and/or third country companies who are seeking to market their products in the European Union, it is obviously preferable in terms of regulatory constraints to rely on a specialized service structure rather than internalizing all the costs.

We have also invested in the design and development of a unique software package specially intended to perform the computerized management of the cosmetic Product Information File (PIF) which is also available online if necessary on the fully secured website “DIP-online.com”. It is both an innovative and user-friendly tool based on all our know-how and operational experience. It enables the creation, management, downloading and editing a DIP through a simple process. Of course the storage, archiving and traceability of the technical data are undertaken in a fully secured and confidential manner. Depending on the customers’ choice, we can insure the validation of the DIP’s technical data or we can offer a complete full service for the DIP with its updating. For the time being, this tool is not intended for the creation of registration files of products exported outside the EU. We have developed this expert tool on European regulatory requirements. It is therefore particularly suited to the needs of operators within the European market.

In addition, we are developing partnerships on DIP Online and we are already working with other providers to offer a comprehensive range of quality services.

We plan to present our company and DIP Online in Paris early next year.

Premium Beauty News - Doesn’t the involvement of third parties like your new company, raise confidentiality issues?

Sylvain-Romain Cotte - On the contrary, it often helps to solve them! I am convinced our action will be likely to facilitate the relationship between contractors and subcontractors. We all know that customers, who need to obtain all the guarantees in terms of regulatory compliance sometimes find it difficult to collect all the legal technical information they want from their suppliers or subcontractors. The latter being legitimately concerned with preserving the confidentiality of some key information. In this context, the involvement of a third party, such as International Beauty Office SAS, which will guarantee the regulatory compliance, is likely to reassure all parties. In addition DIP-Online, our software package, makes it possible if need be, to filter in a completely transparent manner the editing of some of the DIP’s details, and this, with the contractual consent of the parties involved (client and subcontractors). Our company remaining the guarantor that all the legal information has been provided. At their request, the supervisory authorities have of course access to all the data contained in the DIP.

Interview by Vincent Gallon

Footnotes

[1] Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products

© 2011 - Premium Beauty News - www.premiumbeautynews.com
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