The last EU Regulation on cosmetic products (Regulation No. 1223 of the European Parliament and of the Council of 30 November 2009, published on the Official Journal of the European Union on 22 December 2009 – the “Regulation”) will enter into force on 11 July 2013. The new Regulation harmonizes the rules in the Community regulating manufacture, packaging, distribution and marketing of cosmetic products.
A few provisions of the Regulation entered already into force:
- articles 15.1 e 15.2 (and other related provisions to the extent they are necessary to implement the said articles), prohibiting the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances), entered into force on December 1, 2010;
- article 16.3 (sub-paragraph 2), regarding mandatory notifications in case of products already on the market containing nanomaterials, applicable since 11 January 2013, and;
- some provisions on animal testing, prohibited since 11 March 2013 (see art. 18 of the Regulation).
The Regulation is directly applicable and binding in all Member States. It repeals Directive 76/768/EEC (the “Directive”), implemented in Italy by Legislative Decree No. 713/1996. Most significantly, the replacement of the directive with a regulation has an harmonization effect within Member States, as the legal instrument of the regulation, needing no implementation by Member States, excludes risks of delays and of addition of diverging adoption measures.
The Regulation expressly aims at simplifying procedures and terminology, thereby reducing administrative burden and ambiguities, to the benefit of manufacturing and marketing of cosmetic products within the Community. Moreover, the Regulation strengthens the safety framework and in-market control, with a view to ensuring a high level of protection of end users’ health.
- RESPONSIBLE PERSON
Together with some provisions which are more technical in nature (use of certain ingredients, hazardous properties of certain substances, etc.), one of the most important principles set forth in the Regulation is the key role attributed to the so called “Responsible Person”, who substitutes the role of the “technical manager” already identified in the legislation presently in force in Italy (Leg. Decree 713/1996). Indeed, according to art. 4, the Regulation expressly envisages that only those cosmetic products for which a legal or natural person is designated within the Community as “responsible person” shall be placed on the market, and that the “responsible person” shall, for each cosmetic product placed on the market “ensure compliance with the relevant obligations set out in the Regulation”.
The Responsible Person shall be either the manufacturer, the importer or the distributor of the cosmetic product depending on how the product is actually placed on the market (e.g., whether the production is within or outside the Community, whether the product is distributed in the market under the distributor name, etc.), as better provided by art. 4. If the role of responsible person is vested either in the producer or the importer, they may designate a person established within the Community as the responsible person to act on their behalf, upon the condition that such person is designated by written mandate and expressly accepts it in writing. In this regard, new business opportunities, focused on the offering of specialized consultancy by legal or natural persons to cosmetic companies could be envisaged.
- DUTIES OF THE REPONSIBLE PERSON AND PRE-MARKET SAFETY REQUIREMENTS
The main duty of the responsible person is to guarantee the safety of the cosmetic products and ensure the conformity of the same to the Regulation, and more generally, to good manufacturing practices (GMP); compliance with the same is now expressly provided for by art. 8 of the Regulation.
In order to better guarantee safety, the Regulation imposes upon the responsible person the obligation to ensure that the cosmetic product has undergone a specific safety assessment before being placed on the market. The safety assessment has to be carried out by a professional assessor, having adequate training and expertise and having of specific requirements as indicated in art. 10.2 of the Regulation, and the relevant conclusions have to be incorporated in a specific product safety report to be drafted in accordance with Annex I to the Regulation.
The cosmetic product safety report shall constitute an integral part of the product information file that will be kept by the responsible person for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. The responsible person shall always make the product information file accessible to the competent authorities and consumers, although the latter may have access to essential information only, as long as it is not covered by confidentiality. As a matter of fact, the Regulation pursues consumers’ health protection also providing for extensive information requirements upon the responsible person.
Prior to placing the product on the market, the responsible person shall also proceed with the notification -which becomes centralized and has to be submitted by electronic means- of the main information relevant to the product, among which the presence of substances in the form of nanomaterials.
The distributor, upon which certain notification obligations are also provided for, is required to comply, in line with the provisions of the Directive No. 2001/95 (implemented in Italy by the Consumer Code), with a general obligation of due care, which translates into specific duties to control labeling, safety in the transport and storage of products.
- POST MARKET SURVEILLANCE
The “cosmetovigilance” system is implemented by the introduction of the obligation, upon the responsible person, to notify all serious undesirable effects caused by the cosmetic product to the competent authority of the Member State where the serious undesirable effect occurred (art.23). The notification shall include the identification of the product concerned and the indication of the corrective measures taken, if any.
In the event of serious risks for human health, the responsible person shall take any appropriate measures to address such risk, including the withdrawal of the product from the market or the recall. In this regard, the definitions of withdrawal and recall have been introduced in order to distinguish: the measures aimed at preventing the making available on the market of a cosmetic product (withdrawal), and the ones aimed at achieving of the return of a product already made available to a end user (recall).
In accordance with the provisions of the above-mentioned Directive No. 2001/95, the participation to the in-market surveillance is not requested to the responsible person only but to the distributor as well. The distributor is obliged to cooperate with the responsible person as well as the competent authorities.
- CRITICAL REMARKS
In conclusion, the Regulation harmonizes, clarifies and strengthens the safety rules, controls and responsibility for manufacturing, marketing and sale of cosmetic products, rules which were basically already in place in Italy.
However the Legal Framework as resulting from the Regulation appears per se insufficient to ensure safety of products and protect consumers uniformly and comprehensively in the Community.
When it comes to the sanctioning system, it should be kept in mind that the Regulation calls upon Member States to lay down the provisions on penalties for infringement of the Regulation.
Until these sanctions are not in place, the effectiveness of the new Regulation’s provisions may result limited, at least when it comes to provisions not already included in the previous legal framework, the infringement of which cannot be punished on the basis of the sanctioning system already in place (enacted in Italy by Law No. 713/1986 and other laws such as the Consumer Code, etc.).
Thereafter, this may lead to diverging sanctioning systems, since the identification of the sanctions is left to each Member State.
Furthermore, with regard to the protection of consumers, it is necessary to address the serious and spreading issue of counterfeit products, which represents a considerable percentage of the world market in many sectors, including that of cosmetic products. Within the cosmetic sector, trade union organizations point out a significant diffusion of the phenomenon both with regard to high level products (suffice it e.g., to look at parallel trade and e-commerce of many articles) and fast-moving consumer goods, which are used on a day-by-day basis and are less expensive.
Clearly enough, the provisions of the Regulation may hardly have an effect on this issue. The Regulation ensures transparency as well as more and more accurate controls by the competent authorities in cooperation with the responsible persons and distributors over the manufacturing and marketing process. On the contrary, ad hoc instruments directly and immediately available to consumers in case of counterfeit goods are missing in the legislation, as consumers protection is left to the surveillance and sanctioning powers of the competent authorities.
To effectively achieve consumers protection the legislation should provide also appropriate instruments leading to a higher degree of awareness among consumers – who are the target of all those practices that put at risk human health –, thereby discouraging them to buy counterfeit products. In Italy, in this perspective, some initiatives such as the issuance and circulation of specific information documents are being taken by the Italian Ministry of Health and the Italian Ministry of Economic Development, together with the professional associations.