EU Cosmetic Ingredient Glossary

EU and UK Regulatory updates January 2023

1) Lilial ingredient ban comes into force in the UK

Cosmetics containing perfume allergen lilial (Butylphenyl methylpropional) are no longer allowed to be sold in the UK.

The ‘making available on the market’ deadline for products containing the fragrance ingredient was 15 December 2022. The ‘placing on the market’ deadline was two months earlier, on 15 October 2022.

The lilial ban has been in force in the EU and Northern Ireland since 1 March 2022.

2) Titanium Dioxide’s CMR classification (CLP regulation) cancelled

Titanium Dioxide (TiO2) in the form of some powders is no longer considered as a carcinogenic compound via inhalation in the European Union.

Titanium dioxide is currently classified as a CMR 2 by inhalation under the EU Classification, Labelling and Packaging (CLP) Regulation.  This classification applies to mixtures in powder form containing 1% or more titanium dioxide which is in the form of, or incorporated in, particles with aerodynamic diameter ≤ 10 µm.  This classification was published as part of the 14th ATP to CLP. The latter was then included in the 3rd CMR Omnibus Regulation and implemented under the EU Cosmetics Regulation.

The European Court of Justice has recently announced the cancellation of the CLP regulation on harmonised classification and labelling of titanium dioxide as a CMR 2 by inhalation in the form of some powders. The judgement can be found here: https://curia.europa.eu/jcms/upload/docs/application/pdf/2022-11/cp220190en.pdf

The exact consequences of this action are currently still uncertain, and we need to wait for the EU to officially annul the mentioned regulation.

​​3) Final SCCS Opinion on Triclocarban and Triclosan

Back in November 2022, the SCCS published the final opinion on triclocarban and triclosan (https://health.ec.europa.eu/publications/safety-triclocarban-and-triclosan-substances-potential-endocrine-disrupting-properties-cosmetic_en=). The SCCS concluded that:

  1. Triclocarban is safe:
  • as a preservative in dermally applied cosmetic product up to a maximum concentration of 2% for both children (0.5-18 years) and adults, when used individually or in combination.
  • In addition to the above function, the use of triclocarban is also safe up to a maximum concentration of 1.5% in rinse-off product when used individually or in combination for both children (0.5-18 years) and adults.

However, the use of triclocarban to a maximum concentration of 0.2% in mouthwash is not safe for adults and children and in toothpaste is not safe for children below 6 years old.

The assessment does not include exposure of babies through wipes.

  1. Triclosan is safe:
  • as a preservative in dermally applied cosmetic product (as per entry 25 of Annex V of the EU Cosmetic Products Regulation) at 3% except for body lotions, when used individually or in combination, for both adults and children (0.5-18 years);
  • as a preservative in toothpaste at the concentration of 3% when used individually for both adults and children (0.5-18 years) but it is not safe when used in combinations for children below 3 years old.
  • For adults as a preservative in mouthwash at the concentration of 2% when used individually but not when used in combination. For children and adolescents, it is not safe at 0.2%, even when used individually.

The SCCS did not include the assessment on the use of triclocarban and triclosan together in a single product.

4) Draft SCCS Opinion on Hydroxyapatite (nano)

On 11 January 2023, the SCCS published a draft opinion on the use of Hydroxyapatite (nano) in cosmetic products (https://health.ec.europa.eu/system/files/2023-01/sccs_o_269.pdf).

This draft opinion is a follow up to a previous final opinion, which was published in 2021 and could not conclude on the safety of this ingredients due to a lack of data on genotoxicity.

In this draft opinion, the SCCS concludes that hydroxyapatite (nano) is safe up to a maximum concentration of:

  • up to 10% in toothpaste, and
  • up to 0.465% in mouthwash

This conclusion only applies to the hydroxyapatite (nano) with the following characteristics:

  • composed of rod-shapes particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9;
  • the particles are not coated or surface modified.

The opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles and it is also not applicable to sprayable products (e.g. breath sprays).

5) US’ Modernization of Cosmetics Regulation Act

On 29 December 2022, the US President signed into law the Consolidated Appropriations Act 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), a long-awaited reform of the US cosmetics regulation.

You can read more about this on our separate blog.