This article was published in the September 2010 issue of the European Product Liability Review and in the October 2010 issue of the Journal des Sociétés (in French).
Directive 76/768/EEC on cosmetic products3 has been the cornerstone of cosmetic law for more than thirty years. Its longevity is explained by the fact that it has been amended more than fifty times in order to adjust to scientific innovations in this constantly evolving sector. However, these numerous amendments resulted in a hardly understandable text, at the origin of incoherent national transpositions, complicating the work of more than 3,000 manufacturers.
This context explains that the adoption of Regulation 1223/2009 on cosmetic products4 on 30 November 2009 has been welcomed by the manufacturers of the sector as well as by national authorities. The objective of the European authorities was clear and simple: to redraft the legislation in order to simplify it and enable its consistent application throughout the European Union5. The choice of adopting a Regulation rather than a new Directive and the statement made by Mr Verheugen, vice-president of the European Commission responsible for enterprise and industry, clearly prove this intention: "The law on cosmetics is a good example of an EU legislation “ripe” for simplification. Working with 27 different transposition texts gives rise to unnecessary costs and work for the cosmetics industry. With today’s proposal, we will be able to improve product safety while reducing administrative costs by replacing a superfluous legislation"6. This approach is all the more justified since the European Union is the world leader in this sector and generates in this respect more than 65 billion Euros and 350,000 jobs. It can also be explained by the fact that cosmetic products directly affect the consumer's health and well-being.
Consumer safety, product traceability and the transparency of their composition thus became the major objectives of this new Regulation that substantially amends the existing rules and give rise, in the absence of European Commission guidelines, to numerous questions from cosmetic manufacturers. The latter must, indeed, get ready for the entry into force of such text, which main part will become effective as from 11 July 2013. For this purpose, cosmetic manufacturers will have to closely cooperate with national authorities (in France, in particular with the Afssaps7) that have been asked to encourage cosmetic manufacturers to already start to enforce this new text.
The impact of this Regulation and its limits still being unclear, this article intends to list the main new ideas implemented in order to achieve the three abovementioned goals.
REINFORCED CONSUMER SAFETY
Consumer safety was of course one of the objectives of Directive 76/768/EEC. The Regulation, by adding a certain number of new requirements or specifying the existing ones, has set it as its first objective, providing, in its Recital 4, for the need to ensure "a high level of protection of human health".
Clarification of the information to be mentioned in the cosmetic products safety assessment
Pursuant to Directive 76/768/EEC, before placing a product on the market, it was necessary to carry out an "assessment of the safety for human health of the finished product"8. However, the information to be mentioned in this assessment had not been specified, such that the safety assessment never played the significant role that it was supposed to play9.
Regulation 1223/2009 overcomes this problem and lays down, in its Annex I, a mandatory non-restrictive list of the information that must be mentioned in the "safety report".
This report shall include two parts that will require very close cooperation between the manufacturers of the finished products and their subcontractors, including the manufacturers of ingredients that will suddenly be subject to an increasing number of formalities, which manufacturers generally tend to avoid:
- a part relating to "cosmetic product safety information" that shall include the following elements: quantitative and qualitative composition of the cosmetic product, physical/chemical characteristics, stability of the cosmetic product, microbiological quality, impurities, traces, information about the packaging material, normal and reasonably foreseeable use, data relating to the exposure to the cosmetic product or to the substances contained in the cosmetic product, toxicological profile of the substances, undesirable effects and serious undesirable effects as well as any relevant information, and
- a part entitled "cosmetic product safety assessment" that shall be in line with the content of the first part and reflect any risk on the labelling, by means of instructions or precautions of use.
The controlled use of certain CMR substances
CMR substances (Carcinogenic, Mutagenic or toxic for Reproduction) are currently classified in three categories (1, 2 and 3) depending on the level of certainty of their carcinogenic, mutagenic or toxic for reproduction properties.
Pursuant to Directive 76/768/EEC, CMR substances of category 1 (substances known to be carcinogenic/mutagenic/toxic for human reproduction) and CMR substances of category 2 (substances that should be regarded as CMR substances of category 1 as there is a strong presumption that human exposure may result in the development of the indicated effects) are quite simply prohibited. On the contrary, CMR substances of category 3 (substances which cause concern for man owing to carcinogenic/mutagenic/toxic effects) may be used if they have been found acceptable for use in cosmetic products10 after assessment by the Scientific Committee on Consumer Safety (SCCS).
The new Regulation slightly amended this pattern since it authorises, exceptionally, the use of certain CMR substances of category 1A or 1B11, if several conditions are met, namely12:
- these substances comply with the general principles and requirements of food law,
- there are no suitable alternative substances available,
- the application is made for a particular use of the product category with a known exposure,
- they have been assessed and found safe by the SCCS.
Due to this open door to use CMR substances some may have feared a "step backwards"13 with respect to consumer protection but the rationale of this exemption is legitimate: to put an end to an inexplicable imbalance between the regime of cosmetics and food legislation that admitted, on the contrary, the use of these substances upon certain conditions. The European Commission decided that these new rules shall benefit from an early entry into force on 1st December 201014. Manufacturers will have to ensure that their products, which contain such substances, meet all the requirements of the Regulation in order for them to protect themselves from any controls carried out by national authorities that may, in this case, be even more vigilant and interventionist.
TRACEABILITY AND MARKET SURVEILLANCE
As mentioned in Recital 12 of the Regulation, "an efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators". New definitions are introduced in this respect, manufacturers now having to designate their importer, the responsible person and their distributors, and each of them will have different responsibilities.
Identification of a "responsible person"
Identifying a responsible person is a crucial point which has the attention of all the professionals of the cosmetic industry. Article 4 of Regulation 1223/2009 now provides that, "only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market".
- To determine who the "responsible person" is, the Regulation sets forth several presumptions but leaves a lot of room for interpretation. Thus, the manufacturer established in the European Union is presumed to be the responsible person if the product is manufactured in the EU and not intended to be exported and then re-imported. If, on the contrary, the product is imported, the importer will be the responsible person. All these rules are only valid in the absence of express identification of a person established in the EU by means of a written mandate accepted by the latter.
- The obligations imposed on the responsible person are numerous since he/she must guarantee that the cosmetic product for which he/she is responsible complies with the safety requirements provided for by the Regulation. To this end, the responsible person will gather all the necessary information on the product (namely the safety report) in order to be able to inform the consumer as well as the relevant authorities of each Member State. This responsible person shall thus become the only contact within the European Union.
- If the identification of this person is already a delicate subject, numerous closely related questions arise such as the guarantee of the confidentiality of the composition and trade secrets that the subcontractors will not always want to share the transfer of liability in the event of non-conformity of an ingredient and the safety assessor's role. These questions are so sensitive that a new profession has come into existence in this sector: companies whose purpose will be to be the "responsible person" for the manufacturers.
Creating a central reporting system for cosmetic products
One of the other new ideas that will impact the cosmetic sector is the implementation of a unique and central reporting system for cosmetic products, which replaces the former system whereby the relevant authority of the Member State was informed of the place where the product was manufactured or first imported15.
From now on, before a cosmetic product is placed on the market, the responsible person will have to "report" it, i.e. inform the European Commission through an electronic interface that would be handled by the latter. The gathered information will then be communicated to the relevant authorities in each Member State, to poison control centres and assimilated entities. The Regulation does not specify, however, if the consumer will have access to this portal, as it is currently the case with respect to the Community Rapid Information System for defective products implemented by the Directive on general product safety16 (RAPEX).
Such portal should be effective on 11 January 201217. In other words, as from such date and until 11 July 2013, both reporting systems mentioned above should coexist.
As well as improving consumer safety through controls before the introduction of the products on the European market, the authors of the Regulation wished to reinforce the consumer information requirements to enable them to choose their products freely. Labelling transparency is thus clearly required in this text, with respect to the price-quality-quantity ratio as well as the product composition18.
Indication of nanomaterials in the list of ingredients
This new Regulation on cosmetics reinforces the legal regime of nanomaterials.
- The Regulation gives a uniform definition of a "nanomaterial": it means "an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm"19.
- The Regulation defines a nanomaterial as an ingredient that shall be expressly mentioned in the list of ingredients. Article 19 thus provides that "all ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets".
This new regulation shall also benefit from an early entry into force on 11 January 201320 and meets the national and European public authorities' intention to identify nanomaterials in order to protect consumers from the potentially harmful effects of these materials. The launch of a campaign to identify nanomaterials in consumer products in March 2010 by the French Agency for Environmental and Occupational Health Safety (Afsset) is the most recent example21.
New labelling requirements
The labelling requirements relating to the packaging of a cosmetic product are not fundamentally different between the Regulation and the Directive22, even though there are a few exceptions that should be highlighted.
- The name of the responsible person shall replace the name of the manufacturer or the person in charge of introducing the cosmetic product on the market. His/her address shall also be mentioned on the product in order to enable the consumers and the authorities to locate the cosmetic file.
- A new pictogram has been created to indicate the date of minimum durability, i.e. the "date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3"23. This pictogram represents an hourglass (figure 1). Should the product be stable for more than 30 months, this pictogram will be replaced by the open cream jar pictogram, which already existed under the Directive (figure 2).
French authorities are already starting to ask manufacturers who place cosmetic products on the French market to apply the new Regulation 1223/2009 in order for them to be fully ready for 2013. Even if such a step often creates confusion in the manufacturers and distributors' minds as to whether what the French Authorities are asking them to do is compulsory, it is a straightforward message that French Authorities are planning to enforce the Regulation as soon as it comes into force. It is therefore recommended that companies start analysing this Regulation in depth and adapt their chain of production and supply accordingly, as well as their contracts with their sub-contractors and suppliers.