Jean-Jacques Bourgois is the president and main technical expert of Biorius, an international consultancy in technical and regulatory matters for the cosmetic sector. He is a member of the Board of the Royal Belgian Cosmetic Chemists Society and a certified consultant in industrial politics for the Walloon region of Belgium.
Biorius will be holding a workshop at in-cosmetics Asia 2010 on exporting products to the EU. Personal Care editor, Richard Scott, spoke to Jean-Jacques Bourgois to find out more.
As a technical and regulatory consultant, Jean-Jacques Bourgois founded Safe Biocare in 2000 and co-founded Biorius in 2008. He also provides his expertise to the US professional association “Independent Cosmetics Manufacturers and Distributors”. In addition he is a researcher in the field of bacterial bioluminescence and a college professor of organic chemistry, microbiology and quality control of cosmetics. Starting out as a researcher in the toxicology of heavy metals for the European Community, he served as an international associate expert and plant genetic resources scientist for the Food and Agriculture Organization of the United Nations (FAO). He was awarded a master’s degree in botany and holds a Safety Assessor Certificate from the Free University of Brussels (VUB) in Belgium. He also participated in a number of scientific meetings and specialised courses in quality audits, REACH, regulatory compliance and hazard communication. He has published several scientific articles in botany, microbiology and toxicology.
PC: What are the key elements to understand about exporting a product to the EU?
JJB: In order to be placed on the EU market, a cosmetic product must follow a very specific process. The Cosmetics Directive is the main regulatory framework for the placing of cosmetic products on the community market, according to which no pre-market authorisation is required to put cosmetics on the European market. However, the manufacturer or importer has to ensure the safety of the cosmetic product placed on the community market. To this end, a “safety-file” which includes an assessment of the safety of the product for human health, among other things, has to be kept readily accessible for control purposes to the competent authorities concerned. In addition, each product has to be notified to the competent authority in the member state where the product is manufactured or first imported (cf. Art. 7a Cosmetics Directive).
PC: In terms of restrictions, what areas need specific attention?
JJB: The Cosmetics Directive contains lists of substances which are either prohibited (Annex II) or subject to other restrictions, for example, concentration limits (Annex III). It also includes “positive lists” indicating that only substances listed in Annex IV (colourants), Annex VI (preservatives), and in Annex VII (UV-filters) can be used in cosmetics. In addition, a cosmetic product must meet important requirements with regard to animal testing. The Cosmetics Directive foresees a regulatory framework with the aim of phasing out animal testing. It establishes a prohibition to test finished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the European Community, finished cosmetic products and ingredients included in cosmetic products which were tested on animals (marketing ban). The testing ban on finished cosmetic products has applied since 11 September 2004 and the testing ban on ingredients or combination of ingredients has applied since 11 March 2009. The testing ban applies irrespective of whether or not alternative methods are available. The marketing ban has applied since 11 March 2009 for all human health effects with the exception of repeateddose toxicity, reproductive toxicity and toxicokinetics. For these specific health effects, the marketing ban will apply step by step as soon as alternative methods are validated and adopted in EU legislation with due regard to the OECD validation process, but with a maximum cut-off date of 10 years after entry into force of the Directive, i.e., 11 March 2013, irrespective of the availability of alternative non-animal tests.
PC: How could this effect imported products?
JJB: In the absence of alternative test methods, results of animal tests performed before 11 March 2009 can still be used in order to prove the safety of the cosmetic product placed on the Community market. Many cosmetic ingredients are manufactured in Asia and happen to be cheaper because of lower labour costs, thus offering competitive prices. Nevertheless, finished products are usually not exported to EU countries, Japan and the US because quality and safety criteria do not meet EU, US and Japanese requirements.
PC: What does the future hold?
JJB: The Commission proposed to simplify the Cosmetics Directive in the form of a recast, i.e. a legislative technique which enables to codify a legislative text and its amendments and to introduce substantive improvements. On 30 November 2009, the new Cosmetic Products Regulation, EU Regulation 1223/2009, was adopted replacing the Cosmetics Directive.
PC: What is the main benefit of the new regulation?
JJB: With the new Cosmetics Regulation, Europe now has a robust, internationally recognised regime, which reinforces product safety, taking into consideration the latest technological developments, including the possible use of nanomaterials.
PC: And have there been any drawbacks recognised yet?
JJB: Most of the provisions of this new regulation will be applicable as from 11 July 2013. The ban and the strict regime aiming to phase out animal testing were not modified. All cosmetic companies worldwide will have to comply with the new regulation, which won’t allow any exceptions.
PC: Biorius is taking a workshop on the exporting of products to the EU. What will the workshop cover?
JJB: The workshop will cover all aspects of the new EU Cosmetics Regulation and will focus on the specific issues Asian exporters must address, especially the quality and safety of the products (GMP standards and safety information file). This workshop will include a special emphasis on new EU recast’s provisions, built on four main axes. Firstly, an in-depth study of ISO 22716:2007 (Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices) that gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality aspects of the product. Secondly, guidance in compiling the Product Information File. Thirdly, the status and function of the “responsible person”, and finally, nanomaterials. A round table about the specific needs of the participants will also be organised.
For more information about the workshop at in-cosmetics Asia, visit www.in-cosmeticsasia.com/education
