Summary –

Legal assessment Article 15 Cosmetics Regulation

Substances classified as Category 1 or 2 carcinogenic, mutagenic or reprotoxic (CMR) under the CLP Regulation are, as a rule, prohibited for use in cosmetic products. This ban is laid down in Article 15 of the Cosmetics Regulation (the "CMR Ban").

A CMR 2substance may be used only if a risk assessment by the Scientific Committee on Consumer Safety (SCCS) shows that the substance can be used safely in cosmetic products (Article 15.1).

A CMR 1 substance may be used in cosmetics only exceptionally provided they fulfil all of the conditions listed in Article 15.2.

The EU Commission takes the view that the CMR Ban applies automatically from the date of application of the CLP classification of the substance concerned, irrespectively of whether the substance is listed in the Annexes of the Cosmetics Regulation or not. The EU Commission considers that Article 15 does not require it to take any action to implement the CMR Ban, i.e. it considers it is not required to amend the Annexes to the Cosmetics Regulation in order to de-list previously approved substances or amend the entry of restricted substances on the grounds that the CMR Ban applies automatically overriding any positive (or otherwise inconsistent) listing of the substance by the Cosmetics Regulation.

Cosmetics Europe, on the basis of advice by outside legal counsel, considers that the EU Commission's approach is incorrect, based on the following arguments:

  • The CMR Ban does not apply automatically, but requires in each case a specific implementation, either by banning the substance for use in cosmetics altogether (by listing it in Annex II of the Cosmetics Regulation) or by granting an exemption under Article 15.1 or Article 15.2 in case of safe cosmetic use, which in itself require a substance-specific implementation in the Annexes.Support for this reading comes in the first place from the text itself of Article 15. The plural wording "to these ends" in Article 15.1 can only be understood as referring to both the ban and the possible exemption for safe use of CMR2 substances. Similarly, the expression "In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation" in Article 15.2 makes clear that implementation is needed to make the ban and the exceptional exemption for CMR1 substances effective. Secondly, this reading is in line with the remaining provisions of the Cosmetics Regulation and the overall principle of risk assessment underlying the entire Cosmetics Regulation.
  • Industry needs to have legal certainty since having both a positive listing and a CMR classification of the same substance may cause confusion as to whether the substance may continue to be used in cosmetics.
  • Industry should be given the opportunity to defend the safe use of the classified substance and apply for an exemption, without the substance being banned (and included in Annex II to the Cosmetics Regulation) pending the risk assessment by SCCS.
  • The Cosmetics Regulation has the status as a sector-specific regime as opposed to the CLP Regulation which is a general regime applicable across numerous industries and products. As such, the sector-specific regime for cosmetic products prevails over the general rules of the CLP Regulation in accordance with the well-established principle "lexspecialisderogatlegigenerali".

Specifically on the application of the 15-months limit

The EU Commission services have argued that the 15-month deadline is the cut-off date by which an Article 15 exemption process should have been initiated and that, failure to do so, would mean that it becomes impossible to apply for an Article 15 exemption at a later stage.

Arguably, this view is incorrect for the following reasons:

First, the 15-month deadline is imposed on the EU Commission ("the Commission shall amend") and not on industry. No provision in the Cosmetics Regulation prevents an applicant from requesting an exemption at any time following the CMR classification. This is so in particular where new scientific information becomes available which justifies a re-evaluation of the substance or where no commercial interest to obtain an exemption existed previously.

Second, the 'one shot or out' exemption process advocated by the EU Commission is excessively strict and unjustifiably interferes with undertakings' freedom to conduct a business. It is also inconsistent with the well-established principle that decisions by the EU Commission in areas involving the assessment of complex and evolving scientific and technical facts are to be taken on the basis of the latest available scientific data. This is precisely why recital 32 of the Cosmetics Regulation states that "substances should be continuously reviewed by the SCCS.

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