UGAL – 39/09 – 3

CIRCULAR N. 39 / 09

To all UGAL member organisations

01.12.2009
MH/DL

SUBJECT: New Regulation on cosmetic products

Dear Sir / Madam,

On 20thNovember the Council adopted the new legal framework applicable to cosmetics in the EU internal market. This Regulation ([1]) replaces Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.

Cosmetic products include make-up products, soaps, bath and shower preparations (salts, foams, oils and gels), perfumes, depilatories, deodorants, hair products (lotions, powders, shampoos, creams and lacquers), creams and emulsions for the skin, face masks, tinted bases, shaving products, lip-sticks and tooth-paste.

 This new Regulation limits the responsibilities of the various operators and in particular, stipulates those of the distributor.

I.Differentiated responsibility

In terms of the responsibility of business operators for the products and the information shown on them, the European legislator is following the approach introduced in Decision 768/2008 on a common framework the marketing of products ([2]).

For the record, this is the Decision into which UGAL successfully introduced the principle of limiting the retailer’s responsibility to mere verification of the presence of statements such as the name and address of the producer / importer as well as the batch number on the product. Then, UGAL emphasised that it must be specified that, when the product is put onto the market by the producer, the market concerned is the European market([3]).

Consequently, this Regulation differentiates the responsibilities and obligations which are incumbent on the responsible person and distributors.

Responsible person

  • In order to clarify the responsibilities, each cosmetic must be associated with a responsible person, established within the Community. For products manufactured in the Community, this person will be the manufacturer established in the Community. However, this manufacturer may designate as the responsible person, via a written mandate, any other person established in the Community, who accepts that mandate in writing. For an imported cosmetic, each importer is the responsible person for the specific cosmetic that it places on the market.
  • The responsible person warrants, for each cosmetic placed on the market, conformity with the applicable obligations imposed in this Regulation. "Placing on the market", in the terms of this text, means making a cosmetic available on the Community market for the first time".

 Obligations of distributors

  • In the context of their business activities when they make a cosmetic available on the market, distributors act with the diligence required in relation to the obligations that apply to them. By "making available on the market", the Regulation means "any supply of a cosmetic intended to be distributed, consumed or used on the Community market in the context of a commercial activity, in exchange for payment or free of charge".
  • Before making a cosmetic available on the market, distributors are bound to check that the labelling mentions the following information:

-the name or company name and the address of the responsibleperson;

-the batch number or the reference enabling identification of the cosmetic;

-the list of ingredients.

-In addition, distributors are obliged to check that the language requirements of the Regulation have been met and that the minimum durability date has not been exceeded.

  • When the distributors consider or have reason to believe that a cosmetic does not conform to the requirements laid down by this Regulation, they may only make this product available on the market after it has been brought into conformity with the applicable requirements. Likewise, where they consider or have reason to believe that a cosmetic that they have made available on the market is not in conformity with this Regulation, they must ensure that the necessary corrective measures are taken to bring this product into conformity, or withdraw it or recall it, as the case may be.
  • Furthermore, if the cosmetic poses a risk to human health, distributors shall immediately inform the responsible person and the relevant national authorities in the Member States where they have made the product available, by providing details in particular about the non-conformity and corrective measures adopted.
  • The distributors make sure, when a product is subject to their responsibility, that the storage or transport conditions do not compromise its conformity with the requirements provided by under this Regulation.

These obligations and responsibilities of business operators represent a major change compared with the previous Directive which did not deal with these aspects.

Consequently, the Member States remained free to decide for themselves who should be held responsible for the information and labelling with regard to cosmetics.

For the commerce sector, although there is now a clear obligation to verify the presence of some statements, this new Regulation provides greater legal certainty. It will protect distributors from the practices of national authorities aimed at imposing on them obligations which henceforth will be incumbent on the producer.

II.Other new features

Among the other new features, the main on misleading claims in advertising and on the labels of cosmetics. The European Commission is charged with drawing up an action plan relating to claims on cosmetics, and to define priorities in order to determine the common criteria justifying the use of a claim.

The Regulation also introduces a safety evaluation procedure for all products containing nanomaterials. That could even go as far as a ban in the event of a risk to human health. Any ingredient in the form of a nanomaterial should be clearly indicated as such in the list of ingredients on the label.

The use of substances that are carcinogenic, mutagenic or toxic to reproduction – CMR – is prohibited by the Regulation, apart from exceptional cases and subject to very strict conditions.

III.Application

The Regulation will enter into force 20 days after it is published in the OJ and will apply 42months later

-except the provisions relating to CMR substances which will apply from 1stDecember 2010

-and the provisions relating to nanomaterials which will apply 3 years after the Regulation enters into force.

We remain at your disposal for any question you may have.

Yours faithfully,

Denis LABATUT

Secretary General

([1]) Not yet published in the Official Journal of the European Union (OJ). The UGAL member organisations will be informed as soon as the Regulation is published.

([2]) Decision No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC, OJ L218 of 13.08.2008, page 82

([3]) This decision includes the list of definitions and obligations of business operators which must be met both by the current legislation and by future Community texts in the non-food sector.