SCCS Revision of the Opinion on Vitamin A
Vitamin A is not currently included in the Annexes of the European Cosmetics Regulation (Regulation (EC) No 1223/2009). The SCCS published the preliminary version of its revision of the scientific opinion on Vitamin A (retinol, retinyl palmitate and retinyl acetate). The deadline for comments was set at 7 February.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

VITAMIN A AND ITS SAFETY

Vitamin A constitutes a group of lipid-soluble compounds including retinol, retinyl palmitate, retinyl acetate, retinyl linoleate and retinal. Vitamin A is a micronutrient essential for most mammalian species. According to CosIng database, retinol, retinyl palmitate and retinyl acetate are used as a skin conditioning agents in cosmetics and personal care products.

A safety dossier was submitted by Cosmetics Europe in 2012, with the aim to support the continuous use of Vitamin A in cosmetic products. It relates to the use of retinol, retinyl palmitate and retinyl acetate as cosmetic ingredients at maximum use concentrations of 0.05% RE in body lotions, 0.3% RE in hand and face creams as well as in other leave-on or rinse-off products. The Norwegian risk assessment of the use of Vitamin A (retinol and retinyl esters) was received by the European Commission in 2013.

The Commission asked the opinion of the European Medicine Agency (EMA) to exclude the possibility that, at maximum use concentrations of 0.05% RE in body lotions, 0.3% RE in hand and face creams as well as in other leave-on or rinse-off products, Vitamin A could be considered a medicinal product instead of a cosmetic product. EMA considered that “locally applied products containing Vitamin A at the maximum concentrations of 0.05% (retinol equivalents) in body lotions, 0.3% (retinol equivalents) in hand and face creams as well as in other leave-on or rinse-off products, are not considered to be medicinal products by virtue of their function“.

In 2016, the European Commission’s Scientific Committee on Consumer Safety (SCCS) issued an opinion on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate). The teratogenic potential of Vitamin A and effects on liver and local skin effects were considered the most critical toxicological endpoints.

The SCCS concluded that Vitamin A (retinol, retinyl palmitate and retinyl acetate) at a maximum concentration of 0.05% (of retinol equivalent) in body lotions is per se safe. The SCCS also considered that Vitamin A at a maximum concentration of 0.3% in hand cream, face cream and in rinse-off products per se is safe. Baby skin care products containing Vitamin A (like body lotions and creams) were considered safe for 1-3 year old children by the SCCS.

Exposure to Vitamin A from sunscreen products, the derivatives retinyl linoleate and retinal, exposure to Vitamin A from sources other than cosmetic products, were not included or taken into in the SCCS opinion. The SCCS recognized that population’s overall exposure to Vitamin A can be significantly higher, especially because diet (followed by supplements and cosmetics) represents the most important source of Vitamin A in the population.

REVISION OF THE SCIENTIFIC OPINION ON VITAMIN A

The European Commission received additional information on a recent study, which evaluated the aggregated exposure to Vitamin A from cosmetics, diet and food supplements and the contribution of cosmetic products among the overall/total exposure to Vitamin A. The Commission requested a revision of the opinion on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) issued in 2016 by the SCCS

The SCCS has issued a preliminary version of the requested revision. On this revision, the SCCS stated that “Vitamin A in cosmetics at the specified concentrations is safe”.

Although cosmetics alone do not exceed the upper limit allocated to Vitamin A, cosmetics containing Vitamin A may be of concern for consumers with the highest exposure (contribution from food and food supplements) because it may exceed the recommended upper limit of daily intake.

The SCCS considers that it is beyond its scope to suggest maximum concentration limits that take into account contributions from other sources (e.g., food, food supplements, etc.).

The SCCS preliminary version of the revision of the scientific opinion on Vitamin A is open for comments until 7 February 2022.

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. Scientific Committee on Consumer Safety (SCCS). Revision of the scientific Opinion (SCCS)1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate). SCCS/1639/21. 2021
  3. Scientific Committee on Consumer Safety (SCCS). Opinion on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate). SCCS/1576/16. 2016

further
reading

parfum_fragrance_allergen_1
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »