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.
Picture of 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

medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
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 »