A new EU regulation that came into effect recently brought about some significant changes in the world of cosmetics. The cosmetics market, consisting of around 500 million consumers, will be served by a single, harmonised piece of legislation that is directly applicable in all the member states of the EU, a major upgrade from the previous Cosmetics Directive replaced by the new regulation.

The regulation focuses primarily on consumer and health protection. There is a new emphasis on giving consumers’ health a uniform level of protection through appropriate monitoring of the composition and labelling of products and by providing for the assessment of product safety.

The changes brought into effect through this regulation represent a significant tightening of the rules governing the manufacture, promotion and sale of cosmetics. All cosmetic products placed on the market of the EU are now obliged to comply with the new European cosmetics regulations.

New responsibilities are placed on producers established within the EU, importers of products manufactured outside the EU, and distributors that market cosmetics. These persons are duty-bound to oversee and ensure compliance with the obligations emanating from the cosmetics regulation and for this purpose they must set in place a monitoring system for a period of three years from the date on which the batch of cosmetic product is made available.

The regulation assigns new duties to manufacturers, notably among which are the obligation to have product traceability by keeping records on the supply chain, and to withdraw a product from the market in case of non-compliance. They must also refrain from making products available where they have reason to believe that they are not in conformity with the regulation. In the event of non-compliance, the responsible person or distributor is required to inform the competent national authority of the market in which the product was made available for sale, giving details of the non-compliance and of the corrective measures taken.

In order to ban a product that raises safety concerns, the national authority does not need to prove that it poses a specific danger to consumer health. These responsible persons are now liable to prove the safety of a cosmetic product if concerns are raised.

Unlike its predecessor, the regulation falls short of defining what a cosmetic is. Undoubtedly this is due to the fact that the European Commission (EC) had no intention of limiting the definition of cosmetics, especially given that innovative products hit the market constantly. Generally cosmetics include not just make-up, perfumes and aftershaves, but also products which are vital for the health and well-being of consumers such as sunscreen, toothpaste and cleansing products. The EC is empowered to define a cosmetic through the issue of a guidance note, and it therefore remains to be seen whether the Commission will opt for regulatory action to assist regulators and operators in determining whether a product falls under the definition of a cosmetic.

Information-keeping requirements have been bolstered, as the regulation requires product information to be kept by a responsible person for a period of 10 years following the date on which the last batch of the cosmetic product is released.

Specific requirements around product claims in advertising of cosmetic products have been introduced. The cosmetics regulation now requires that product claims are not used to imply that these products have characteristics or functions which they actually do not have. Therefore, consumers must be informed where claimed functions are disputed or not scientifically verified. It is now also illegal to make claims that denigrate safe and legal ingredients.

Labelling requirements are also introduced. Containers or packaging must bear information that is indelible, legible and visible. This information must invariably include the details of the responsible person, the country of origin for imported products, the weight or volume of the content at the time of packaging, a use-by date, precautions for use, the batch number of manufacture or the reference for identifying the cosmetic product and the list of ingredients. This information must be presented in a language to be determined by the member state where the product is made available to the end user.

In addition, the cosmetics regulation imposes a ban on marketing of cosmetic products in the EU whose ingredients have been tested on animals. Animal testing must be replaced by alternative methods that will henceforth be used to estimate the safety of cosmetic products.

This regulation focuses on strengthening safety standards and giving consumers greater confidence in the cosmetic products they purchase.

Through the regulation, cosmetic products on shop shelves could now be said to be regulated on a level comparable to that of pharmaceutical products.

jgrech@demarcoassociates.com

Josette Grech is an associate with Guido de Marco & Associates and heads its European Law division.

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