24 March, 2009
After having been approved, the Directive was amended 55 times. Further, (as for all the Directives) it was understood quite differently by the different Member-States when they transposed it in their own legal system. At the end, the regulations on cosmetic products seemed neither similar nor even at least consistent. To overcome these increasingly obvious drawbacks that the ‘Cosmetics Directive’ will be replaced by the new European Regulation. The main advantage is that the full overhaul makes it possible to include all the successive amendments within one sole document, which eases understanding. Further, a Regulation being applicable as it is (without transposition), its provisions could be understood exactly the same way in all the European countries.
Basic Rules Unchanged
The new document is based on the same guidelines as in the previous Directive: what is a cosmetic product, the principle that it shall not be detrimental to the human health, the programming of the total ban of animal tests; the good practices of manufacture are mandatory;health authorities shall have access to the product information file; annexes listing forbidden ingredients or those subject to restrictions for use. All these requirements are still written, sometimes completed with new or clearer requirements.
Further, the text gives clues to ensure a higher level of safety of cosmetic products.
Exemptions to the ban of CMR substances (Cancerogenic, Mutagen or Toxic for the reproduction substances) will be granted only for specific uses and not for cosmetic products at large, and after an advice by the SCCP (Scientific Committee for Consumer Products).
Substances disturbing the endocrine system will draw a specific attention, first by defining criteria agreed upon by the Community or at the international level to allow for their identification, to ease revision of regulations that deal with them.
The Members of Parliament have also given the definition of ‘counterfeit cosmetic product’ and harmonized the definition of ‘serious undesirable effect’ with the definitions currently used by the World Health Organization (WHO) and the International Conference on Harmonization (CIH).
Nanomaterials for the first time in Regulations
Though having been used for a long time in cosmetic products, nanomaterials are mentioned for the first time in the texts which govern cosmetic products. Defined as ‘nonsoluble materials or bio-persistants’ sized between 1 and 100 nm (a nanometer is one billionth of a meter), from now on, due to this size, they are officially seen as having special properties that can make them a source of specific risks.
Their presence must be declared to the European Commission, which can ask for an evaluation of the SCCP. Moreover, in the future, a speciic labelling will be mandatory: any ingredient used as a nanomaterial shall be listed in the list of ingredients, the prefix ‘nano’ preceding the name of the ingredient.
An increased Transparency
Besides additional requirements in the text about the files of the products, their content and their availability to the health authorities and the explicit request that Member States carry out on their territory improved controls aimed at ensuring that cosmetics meet regulations, the European Parliament also targeted the allegations carried on labels or mentioned in advertisements:they must not claim for ‘characteristics or functions which they do not have’. Criteria for use must be defined, and controls further reinforced.
The text must now be published in the Official Journal after translation in the various languages of the Community (which can take several months), then be enforced within a time sufficient for the different partners involved to adapt to the new requirements…a process which could last until 2013 for the first consequences.