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Call for data on the ingredients ‘alpha and beta arbutin’ under Regulation (EC) 1223/2009

Policy fields

Internal market and industry, public health

Target

Any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned, relevant industry and consumers associations.

Period of consultation

27 July 2020 to 27 April 2021

Request

The Commission would like to invite any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned, relevant industry and consumers associations to submit any information relevant to the safety assessment of

  1.  ‘alpha-arbutin/α-arbutin’ (INCI Name: Alpha-Arbutin, Chemical name: 4-Hydroxyphenyl-alpha-D-glucopyranoside, CAS No 84380-01-8, EC No. 617-561-8), and
  2.  ‘beta arbutin/β-arbutin’ (INCI Name: Arbutin, Chemical name: 4-Hydroxyphenyl-b-D-glucopyranosideCAS No 497-76-7, EC No. 207-850-3)

Action proposed by the Commission 

The Commission has concerns on the potential use of alpha and beta arbutin in cosmetic products, because of inconsistencies and data gaps concerning their safety assessment that were not addressed under previous submissions (SCCS/1550/15 on β-arbutin and SCCS/1552/15 on α-arbutin).

To mandate the SCCS on the safety of alpha and beta arbutin, we invite interested parties to submit, following the requirements described below, any relevant scientific information on the safety of the following chemicals in cosmetic products 

  • 'alpha-arbutin' (Chemical name: 4-Hydroxyphenyl-alpha-D-glucopyranoside, CAS No 84380-01-8, EC No. 617-561-8), and
  • 'beta-arbutin' (Chemical name: 4-Hydroxyphenyl-β-D-glucopyranosideCAS No 497-76-7, EC No. 207-850-3)

Requirements

Please submit, in particular, data regarding all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products and/or an indication on the suggested safe concentration limits for these ingredients. More specifically, the points of highest importance are

  1. stability of alpha and beta arbutin as such, and in final formulations
    a. temperature, light and storage conditions, with a particular focus on pH
    b. amount of hydroquinone (HQ) as a contaminant in the cosmetic formulation when used, and not only under storage conditions
  2. dermal absorption of alpha and beta arbutin
  3. release rate of HQ, in particular, the biotransformation rate of alpha and beta arbutin to HQ in vivo; taking enzymatic activity of human skin and bacterial enzymes into consideration (e.g. demonstrated by suitable human-relevant in vitro conditions)
  4. data (if available) on aggregate exposure for cosmetic products that contain alpha and/or beta arbutin in face creams and body lotions

Interested parties are requested to provide their input together with

a) the attached template (template for submitting input – checklists)
b) a table of contents
c) numbered references

Data submitted should be in line with the SCCS ‘notes of guidance’ (testing of cosmetic ingredients and their safety evaluation - 10th revision).

How to submit your contribution

Submit any data and/or information via email to GROW-D4@ec.europa.eu with the reference: ‘Call for data on Ingredients: alpha and beta arbutin’ by 27 April 2021 at the latest.

Background

α-arbutin (INCI name: Alpha-Arbutin, Chemical name: 4-Hydroxyphenyl-alpha-D-glucopyranoside, CAS No 84380-01-8, EC No. 617-561-8) and the structurally related compound (optical isomer) β-arbutin (INCI Name: Arbutin, Chemical name: 4-Hydroxyphenyl-b-D-glucopyranosideCAS No 497-76-7, EC No. 207-850-3) are similar cosmetic ingredients currently not regulated under the Cosmetic Regulation (EC) No. 1223/2009. Among the reported functions for both α- and β-arbutin are antioxidant, skin bleaching and skin conditioning.

The safety of α-arbutin and β-arbutin has been previously assessed in the SCCS/1552/15 and SCCS/1550/15, respectively. Their effects could be attributed to the fact that they are hydrolysed to hydroquinone (HQ). Hydroquinone (CAS No. 123-31-9) is listed in entry 1339 of Annex II to the Cosmetic Regulation. This means that it is prohibited as a cosmetic ingredient except for entry 14 in Annex III (restricting its use to professionals in artificial nail systems with a maximum concentration up to 0.02% in the finished product).

In the relevant SCCS Opinions (SCCS/1552/15 and SCCS/1550/15), the SCCS concluded that 

  1. the use of α-arbutin in cosmetic products is safe for consumers when its concentration is up to 2% in face creams and up to 0.5 % in body lotions
  2. the use of β-arbutin in cosmetic products is safe for consumers when its concentration is up to 7% in face creams, provided that the contamination of hydroquinone in the cosmetic formulations remain below 1 ppm

Nevertheless, the SCCS highlighted in both opinions that potential combined use of hydroquinone releasing substances in cosmetic products has not been evaluated. 

During previous discussions within the working group on cosmetic products, concerns were raised on the HQ content, its release, as well as on the aggregate exposure from cosmetic products containing α-arbutin and/or β-arbutin. This led to additional consultation with the SCCS and resulted in the identification of several issues in the previous submissions. Notably, the stability and dermal absorption of α-arbutin and/or β-arbutin, the release rate of HQ and the aggregate exposure calculation from cosmetics exposure.

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