Request for SCCS Scientific Opinion on Citral
The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

CITRAL

Citral is a mixture of neral and geranial (monoterpene aldehydes) and is widely used as a fragrance and flavor ingredient in food, beverages and several cosmetic and household products. According to the European Cosmetics Regulation (No. 1223/2009), Citral is included in the list of substances which cosmetic products must not contain except subject to the restrictions laid down (Annex III, entry 70). The presence of this ingredient must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off formulations.

The European Commission’s Scientific Committee on Consumer Safety (SCCS) has assessed the safety of fragrance allergens in cosmetic products. The SCCS included Citral in the list of 13 allergens which are most frequently reported and well-recognized as consumer allergens.

REQUEST FOR A SCIENTIFIC OPINION ON CITRAL

The International Fragrance Association (IFRA) has developed and implemented a model for dermal sensitization quantitative risk assessment (QRA). This methodology is based on thresholds (no effect or low effect levels) established in healthy human volunteers and/or in animal experiments and a set of safety factors is applied to derive ‘acceptable exposure level’.

In 2012, it was established the International Dialogue for the Evaluation of Allergens (IDEA) with the aim of improving the risk assessment of fragrance allergens. This project reviewed uncertainty factors, introduced dermal aggregate exposure for fragrance ingredients, resulting in the QRA2 methodology. In 2018, the SCCS issued an opinion stating that it was not yet possible to use the QRA2 to establish a concentration at which induction of sensitization of fragrance is unlikely to occur.

IFRA submitted in 2021 a dossier on derived safe use levels for Citral, by applying the refined QRA2 methodology based on the induction of skin sensitization. Following the new data, the Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 is adequate to protect consumers.

Two questions are asked to the SCCS:

  • In light of the data provided and taking under consideration the derived upper safe levels using QRA2 methodology for the sensitisation endpoint, does the SCCS consider Citral safe when used as a fragrance ingredient in cosmetic products up to the maximum concentrations provided in the dossier submission?
  • Does the SCCS have any further scientific concerns with regard to the use of QRA2 to derive safe upper levels for Citral or for fragrance allergens in general?

The SCCS accepted this mandate by written procedure on 16 Febuary 2022 and a deadline of 9 months was set.

If you wish to get more information on the safety of cosmetic ingredients, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. European Commission. Request for a scientific opinion on Citral (CAS No. 5392-40-5, EC No. 226-394-6) on sensitisation endpoint. 2022.
  3. Scientific Committee on Consumer Safety (SCCS). Opinion on Fragrance allergens in cosmetic products. SCCS/1459/11. 2012.

further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »