EU Scientific Committee warns on the impossibility to assess the risk of nanomaterials in cosmetics

Clashing provisions

Cosmetics manufacturers may find themselves at an impasse when they seek to comply with two apparently clashing requirements in the cosmetics legislation.

Indeed, the EU’s Cosmetics Directive [1], which will be replaced by the EU’s Cosmetics Regulation [2] as of July 11, 2013, has been phasing out animal testing progressively. Testing finished cosmetic products on animals has been prohibited in the European Union (EU) since 2004, as with animal testing of ingredients since 2009. In addition to these, after March 2009 there has been a marketing ban on selling cosmetic products within the EU containing ingredients that have been tested on animals after this date, irrespective of the place of testing. However, some very complex tests [3] remain exempted from these various prohibitions until a full marketing ban comes into force in March 2013.

In parallel, article 16 of the Cosmetics Regulation will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials.

Unfortunately, validated alternative methods that can be used to replace animal tests are only available for conventional substances, and not for nanomaterials. “This poses an insurmountable obstacle to the safety assessment of cosmetic nanomaterials, and further research work is needed in this area,” says the SCCS in a recently published Guidance on the Safety Assessment of Nanomaterials [4].

Nanomaterials need special considerations

The publication of this Guidance is aimed at providing scientific and technical information to cosmetics companies in order to comply with the requirements for safety assessment of nanomaterials intended for use their products.

The document highlights that in view of the possible distinct properties, interactions, and/or effects that may differ from conventional form of the same materials, the safety assessment of nanomaterials requires special considerations.

The SCCS considers that in the absence of a sufficient knowledgebase on nanomaterial properties, behaviour, and effects a category approach to risk assessment is currently not feasible, and risk assessment of each nanomaterial needs to be carried out on a case-by-case basis. Material characterisation appears as the first step and as an essential requirement of risk assessment. Then the SCCS suggests the process should be driven by considerations of exposure. Eventually, where application of a nanomaterial containing cosmetic product can lead to systemic exposure, data on toxicological evaluation will be required.

It is precisely at this step that the current lack of alternative methods that are specifically validated for nanomaterials, combined with a complete ban on in vivo testing of cosmetic ingredients and products in 2013 “poses an obstacle to the risk assessment of cosmetic ingredients in general, and ingredients in nanomaterial form in particular,” says the SCCS.

The Committee also insists on the fact that the field of nanomaterial risk assessment is still evolving and that its opinion is based on the currently available knowledge. “The guidance may therefore be revised in the light of new scientific knowledge in the future.”