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Beginning 11 July 2013, the new European Regulation (EC) No 1223/2009 on cosmetic products will be in effect, replacing the existing Cosmetics Directive (76/768/EEC), which was first enacted in 1976.
Unlike Directives, Regulations in the EU are immediately binding on all member states. Therefore, while the previous Cosmetics Directive had to be entered into state national law before it was effective (and thus subject to each state’s interpretation), Regulation 1223/2009 is, upon its effective date, immediately applied identically across all member states.
Key changes include:
Companies previously had to meet notification requirements for each country in which the product was placed on the market. Now, there is one electronic notification necessary through which a company must submit information prior to placing the cosmetic product on the EU market. The information you must provide includes listing the member state in which the product is to be placed on the market as well the presence of substances in the form of nanomaterials, in addition to standard notification content.
The new labeling standards require labels to include the country of origin, if imported. Otherwise, labeling, like in the Directive, is required to be in “indelible, easily legible and visible lettering,” and to include the name of the responsible entity, the use-by date, precautions for use, the batch number and the list of ingredients.
Product Safety Assessments
Responsible persons must ensure that cosmetic products undergo safety assessments prior to placing them on the market, as specified in Article 10 of the new Regulation.
Product Information File (PIF)
A product information file must be kept for 10 years following the last placement of a batch of the cosmetic product on the market. The PIF, described in Article 11, must include a description of the product, as specified, the cosmetic product safety report (established in Article 10), a description of the method of manufacturing and a statement of compliance with GMP (Article 8), proof of effect (if relevant), and data on animal testing related to the development or safety assessment of the product or ingredients, including that conducted to comply with the regulatory requirements of third countries. The PIF must also be made readily accessible to competent authorities.
Article 20 prohibits companies from labeling and advertising cosmetic products using text, names, trademarks, pictures or figurative signs that might imply that the products have characteristics or functions which they do not have. The Commission will submit a report by 11 July 2016 on the use of claims based upon the list of common criteria for claims, adopted by the Commission in consultation with the SCCS.
Regulation 1223/2009 also places responsibilities squarely on the distributors, which are defined as any part of the cosmetic supply chain other than the manufacturer or importer. Distributors must verify the labeling, language, and dates are compliant before placing a product on the market. They are also responsible to keep a product from market or remove a product from the market if they consider or have reason to believe that a cosmetic product is not in conformity with this Regulation.
Traceability of Supply Chain
Responsible persons must also, at the request of a competent authority, identify certain parties in the supply chain, specifically the distributors to whom and from whom the cosmetic product is supplied.
If a product is non-compliant, it must be withdrawn from the market or recalled unless measures are taken to render the product compliant. The national authorities may take corrective measures if the responsible person does not respond appropriately to remedy non-compliant products on the market. They may also intervene if a compliant product presents or could present a serious risk to human health.
Like in the Directive, the new Regulation uses both negative and positive lists of substances. In the Regulation, Annex II lists prohibited substances; Annex III lists restricted substances; and Annex IV, V, and VI list allowed colorants, preservatives, and UV-filters, respectively.
Many of the provisions of the new European Cosmetics Regulation will make doing business easier for companies. By having one e-notification system and a common set of rules across all member states, businesses will have more clear laws to follow when placing products on the market.
The EU Cosmetics Directive has been adopted as a legislative model in many countries around the world, which has afforded benefits to European exporters since there is less need to adapt labels and product standards. The use of negative and positive lists for restricted and approved ingredients is now a common feature in different geographic regions, with a notable exception of the U.S.
Costs to manufacturers of changing regulations include re-formulating and re-labeling, as well as a loss of sales due to delayed product launches. The decision to turn the cosmetics directive into a regulation generally has a positive impact on business since the laws are harmonized across jurisdictions, ensuring uniformity in implementation and interpretation.
Regulations 1223/2009 goes into effect on 11 July 2013, with two timing exceptions: Article 15 paragraphs 1 and 2 (CMR substances), and Articles 14 (restricted substances), 16 (nanomaterials), 31 (procedure for amending annexes), and 32 (committee procedure) went into effect on 1 December 2010; and the second section of paragraph 3 in Article 16 (relating to notification on cosmetic products containing nanomaterials that have already been placed on the market before 11 January 2013) goes into effect on 1 November 2013. The Regulation was passed in 2009.
Kirsten Wallerstedt is a Senior Regulatory Analyst with the new Supply Chain Product Compliance Solution at 3E Company. In addition to engaging suppliers to obtain and manage compliance data, the service links your products directly to news alerts that affect your products. For more information, please visit our page on Supply Chain Documentation.