New ban of ingredients in cosmetics by the European Commission

The European Union has probably the most stringent and protective laws for cosmetics in the world. Ingredients used in cosmetics are regulated by law and those of questionable safety are carefully assessed by the Scientific Committee on Consumer Safety at the European Commission (SCCS). Information on substances is regularly updated and takes into account new data resulting from the progress of toxicological studies. The results of the evaluation by the SCCS Committee are the basis for the restrictions on the use of the substance.

Recently, the European Commission has extended its list of prohibited carcinogenic, mutagenic or toxic for reproduction (CMR) chemicals in cosmetics as a result of an opinion published by the Scientific Committee on Consumer Safety (SCCS) and other interested parties on the matter. 

You can read more below on several ingredients that have been banned in cosmetics recently. 

1. Butylphenyl Methylpropional (Lilial) – banned from the 1st of March 2022

The substance 2-(4-tert-Butylbenzyl)propionaldehyde (BMHCA, Lysmeral, Lilial) CAS No. 80-54-6 with INCI name Butylphenyl methylpropional is a fragrance ingredient used in many compounds for cosmetic products as well as in non-cosmetic products. Currently, it is included in Annex III to the EU Cosmetics Regulation and must be mentioned in the list of ingredients when its concentration exceeds 0,001% in leave-on products and 0,1% in rinse-off products.

In May 2020, the European Commission published the Commission Delegated Regulation No. 2020/1182, regarding the classification, labelling and packaging of substances and mixtures (amendment to CLP Regulation (EC) No. 1272/2008). In accordance with this amendment to the CLP Regulation, Butylphenyl Methylpropional is now classified as Repr. 1B (toxic to reproduction – CMR 1B), applying from 1st of March 2022.

According to the EU Regulation 1223/2009, the use of substances classified as CMR under the CLP Regulation is banned. Therefore, on the 3rd of November 2021, the European Commission published the Omnibus Act IV – Regulation (EU) 2021/1902 that aims at including in Annex II to the European Cosmetic Regulation substances that have been recently classified as CMR.

As stated in the Regulation (EU) 2021/1902, Butylphenyl Methylpropional (Lilial) is prohibited in cosmetic products. The ban has applied from March 1, 2022 and it affected not only new products but also cosmetics already on shelves on the EU market that will need to be withdrawn. 

You might have seen appear a lot of “scary” posts on the internet recently about Lilial (Butylphenyl Methylpropional), but don’t panic just yet! Together with each ingredient ban, the news often breaks out about the ingredient in question demonizing it. However, we believe it is necessary to temper things because the legislation at the present time already makes it possible to ensure a very high level of consumer safety. The fact that toxicology is a science foreign to most of the population makes it more complicated for people to feel the nuances on the scale of toxicity. To understand why the European Commission takes the decision to regulate an ingredient or even ban it, it is not enough to stick only to the final decision on the legal act, even if it is supreme and that each must obey it scrupulously. Indeed, behind each provision there is a process that involves a number of institutions that assess the safety of a given substance based on all existing data and in case of uncertainty or lack of data, they always make the more restrictive decision, which sometimes amounts to putting ingredients that are not really harmful in the prohibited substances.

The end goal is of course to protect the consumer. That is why Europe is considered the safest market in the world for consumers and that regulators from many other regions of the world take their inspiration from.

Whether a substance (also classified as hazardous) poses a real risk to health is determined by the risk assessment : a procedure that follows at least 50 years of development in modern toxicology. During this process, it can happen that a substance classified as carcinogenic, mutagenic or toxic to reproduction turns out to be safe in some applications. Why? Because whether a substance is a poison or not is determined by the dose – amount, method of application.

A risk assessment of Lillial (Butylphenyl Methylpropional) or in other words the development of a safety assessment dossier would require carrying out tests on animals that are prohibited in the cosmetics industry. As it is not allowed to carry out those tests, it is therefore impossible to have a proof of the safety of the substance and that explains why the Commission had to introduce a ban since the safety data were not available.

2. Zinc Pyrithione – banned from the 1st of March 2022

Zinc Pyrithione is an aromatic zinc compound used as an antidandruff, antiseborrhoeic, hair conditioning agent and preservative in cosmetics and personal care products. Moreover, Zinc Pyrithione enhances the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. It also helps to control dandruff, seborrheic dermatitis, and psoriasis. 

This compound has been used for more than 60 years as an anti-dandruff agent and until now, it was listed in Annexes III and V to the EU Cosmetics Regulation. It was allowed to be used:

  • In Leave-on hair products at maximum concentration of 0,1% when it is not used as a preservative (annex III)
  • In rinse-off hair products at a maximum concentration of 1,0% when used as a preservative 
  • In rinse-off other products at a maximum concentration of 0,5% when used as a preservative

In May 2020, the European Commission published the Commission Delegated Regulation No. 2020/1182, regarding the classification, labelling and packaging of substances and mixtures (amendment to CLP Regulation (EC) No. 1272/2008). In accordance with this amendment to the CLP Regulation, Zinc Pyrithione is now classified as CMR Repr. 1B. (Toxic for Reproduction). On 11th of April 2019, a request was submitted to keep using it as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1% by way of exception.

According to Article 15.2 of the EU Cosmetic Regulation, the use of CMR 1B substances in cosmetic products may be exceptionally permitted if:

  1. they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1); 
  2. there are no suitable alternative substances available, as documented in an analysis of alternatives; 
  3. the application is made for a particular use of the product category with a known exposure; and (
  4. d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.

In view of the above, CMR substances of category 1A or 1B may be used in cosmetic products on an exceptional basis when all conditions are met, including conditions under which no suitable alternative substance is available, as documented in an analysis of alternatives. However, it has not been established that there are no suitable alternative substances available with regard to anti-dandruff ingredients in rinse-off hair products.

Therefore, on the 3rd of November 2021, the European Commission published the Omnibus Act IV – Regulation (EU) 2021/1902 that aims at including in Annex II to the European Cosmetic Regulation substances that have been recently classified as CMR.

As stated in the Regulation (EU) 2021/1902, Zinc Pyrithione is prohibited in cosmetic products. The ban has applied from the 1st of March 2022 and it affected not only new products but also cosmetics already on shelves on the EU market that will need to be withdrawn. 

3. Other substances – banned from the 1st of March 2022

In addition to Lilial and Zinc Pyrithione, Omnibus IV has established that the following substances should be added to Annex II to the EU Cosmetics Regulation:

  • Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1);
  • Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane;
  • Dioctyltin dilaurate and stannane, dioctyl-, bis (coco acyloxy) derivs;
  • Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene;
  • Ipconazole;
  • Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme;
  • Paclobutrazol;
  • 2,2-bis(bromomethyl) propane-1,3-diol;
  • Diisooctyl phthalate;
  • 2-methoxyethyl acrylate;
  • Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate];
  • Flurochloridone;
  • 3-(difluoromethyl)-1- methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad;
  • N-(hydroxymethyl)acrylamide; methylolacrylamide;
  • 5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2′- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen;
  • Iprovalicarb;
  • Dichlorodioctylstannane;
  • Mesotrione;
  • Hymexazol;
  • Imiprothrin;
  • Bis(α,α-dimethylbenzyl) peroxide.
4. Methyl-N-methylanthranilate (M-N-MA) – banned in sunscreen products and products marketed for exposure to natural or artificial UV light from the 21st of November 2022

Methyl-N-methylanthranilate (M-N-MA) is a methyl ester formed by the condensation of the carboxyl group of N-methylanthranilic acid with methanol. In cosmetics, it acts as a fragrance component. It is used in pure fragrance compositions, shampoos, soaps and many other types of cosmetics. Until now, M-N-MA has not been subject to any prohibition or restrictions of use under Regulation (EC) No 1223/2009.

On the 1st of February 2022, in the Official Journal of the European Union, Commission Regulation (EU) 2022/135 of the 31st of January 2022 amending Regulation (EC) 1223/2009 of the European Parliament and of the Council as regards the use of the substance Methyl-N-methylanthranilate in cosmetic products was published.

Methyl-N-methylanthranilate has been included in the annex III – List of substances which cosmetic products must not contain except subject to the restrictions laid down.

According to the Commission Regulation (EU) 2022/135, Methyl-N-methylanthranilate can only be used in:

  1. Leave-on products, in maximum concentration in ready for use preparation 0,1%
  2. Rinse-off products, in maximum concentration in ready for use preparation 0,2%.

Moreover, Methyl-N-methylanthranilate is banned to be used in sunscreen products and products marketed for exposure to natural or artificial UV light.

Other conditions for using Methyl-N-methylanthranilate in leave-on and rinse-off products are as follow: 

  1. Do not use with nitrosating agents
  2. Maximum nitrosamine content: 50 μg/kg
  3. Keep in nitrite-free containers. 

The following transition period has been concluded:

  • From the 21st of August 2022 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. 
  • From the 21st of November 2022 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
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