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The unmissable event of this year
Tuesday, November 28, 2017Regulation

QRA 2: Opinion of the SCCS

© CosmeticOBS-L'Observatoire des Cosmétiques

The SCCS has just published its Opinion on the relevance of the model for dermal sensitisation by a fragrance ingredient quantitative risk assessment (QRA 2). This Opinion is opened to comments until January 22, 2018.

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Background

Skin sensitisation is induced by exposure to certain chemicals and might lead to allergy contact dermatitis.
A model for dermal sensitisation quantitative risk assessment (QRA) had been developed and implemented by the International Fragrance Association (IFRA).
The International Dialogue for the Evaluation of Allergens (IDEA) project was established to improve the risk assessment of fragrance allergens through the collaboration of academia and industry scientists together with clinicians. The IDEA project has worked on the development of the QRA. This new quantitative risk assessment methodology was named QRA 2. The consolidated QRA 2 was successively submitted to the Commission services in October 2016.

For full background information, see the article
Aluminium, HEMA, QRA 2: three requests for Opinion to SCCS of 13 March 2017

Opinion

 1. In light of the methodology provided, does the SCCS consider QRA 2 adequate to establish a concentration at which induction of sensitisation by a fragrance ingredient unlikely to occur?

It is not yet possible to establish a concentration at which induction of sensitisation of fragrance is unlikely to occur. This is because further scientific rationale behind QRA 2 still needs to be provided. Several aspects of the methodology are not clear and need …

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