Retinol as cosmetic ingredient– the current status

Retinol (CAS No. 68-26-8 / 11103-57-4) has become a more and more popular ingredient for cosmetic products throughout the years, in particular in the form of crèmes, lotions and serums advertising with its “anti-aging” properties and several other benefits.

The chemical substance Retinol belongs to a group of fat-soluble vitamins known as Vitamin A, also including its esterified form (retinyl esters) and retinal. Retinol is present as nutrient in food of animal origin and contributes to important biological functions in the human body, for example in reproduction and development, cell growth, etc. Retinol and its esters are also used as a dietary supplement, in particular to prevent or treat Vitamin A deficiency[1] [2].

For the use as cosmetic ingredient, the opinion SCCS/1576/16[3] published by the Scientific Committee on Consumer Safety (SCCS) indicates the safe use in cosmetics with 0.3 % in face creams, hand creams and rinse-off products. Furthermore, a maximum concentration of 0.05 % in body lotions is considered safe. At the time of the study, these concentrations represented “standard” amounts of Retinol used for cosmetic products in the EU. The European Commission meanwhile requested a revision of this Opinion which the SCCS accepted in written on 8 March 2021 [4]

For safety assessments according to the European Cosmetics Regulation 1223/2009[5], the current scientific knowledge about cosmetic ingredients and its effects on the human body represents the actual basis of knowledge. Specific knowledge was even implemented into the Regulation (and earlier Directive) in the form of maximum concentrations, warnings to be indicated in the labels, etc. (Annexes III-VI), up to complete bans of specific substances (Annex II).

Due the high number of new ingredients for cosmetics alongside with new and revised studies for already established ones, many aspects are still under investigation and have not yet lead to actual legal rules. For many popular ingredients, the opinion papers published by the SCCS remain the only reliable information for safety aspects in the scope of cosmetics. This also applies for Retinol.

For cosmetic products using higher concentrations of Retinol (often 1%, available up to 3%), proofs for safe use of higher Retinol concentrations must be provided before the product is made available on the market, considering Article 3 of the Cosmetics Regulation and the general precautionary principle.

Due to the lack of data, cosmetic products using higher amounts of retinol will therefore likely not be considered safe by EU authorities and national institutes. For examples, the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) issued a statement back in 2014, recommending to limit the concentration of vitamin A for face and hand care and not using it at all in lip and body care products[6].

The lack of data does of course not necessarily mean that higher concentrations of Retinol are per se not safe. Products using high Retinol concentrations may be evaluated more positive considering the values for systemic exposure given in the opinion SCCS/1576/16.

Also, for informing customers about potential overuse of Retinol, claims indicating to “not use other cosmetics containing Retinol” or “not use together with other cosmetic products containing Vitamin A” can be often found on products on the market.

However, as long as verified data is not available for concentrations higher than 0.3 %, the safety of those products cannot be definitely proven on a solid scientific basis and within the scope of Article 3.

[1] https://www.drugs.com/monograph/vitamin-a.html

[2] https://ods.od.nih.gov/factsheets/VitaminA-HealthProfessional/

[3] https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_199.pdf

[4] https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs2016_q_052.pdf

[5] https://eur-lex.europa.eu/legal-content/de/ALL/?uri=CELEX:32009R1223

[6] https://www.bfr.bund.de/cm/343/vitamin-a-aufnahme-ueber-kosmetische-mittel-sollte-begrenzt-werden.pdf



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