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Currently, Regulation 1223/2009 requires to include 26 allergens, derived from synthetic fragrances, as well as natural essential oils and extracts, on the list of cosmetics ingredients (INCI). In practice, it means that if a given allergen exceeds 0.01% in a rinse-off cosmetic (e.g. soap, shower gel, shampoo) or 0.001% in a leave-on cosmetic (e.g. cream, lotion, tonic) then it must be listed on a cosmetic label in the INCI composition.

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The current list of 26 allergens includes:

Alpha-isomethyl Ionone

Amyl Cinnamal

Amyl Cinnamyl Alcohol

Anise Alcohol

Benzyl Alcohol

Benzyl Benzoate

Benzyl Cinnamate

Benzyl Salicylate

Butylphenyl Methylpropional

Cinnamal 

Cinnamyl Alcohol

Citral

Citronellol

Coumarin

Eugenol

Evernia Prunastri Extract

Evernia Furfuracea Extract

Farnesol

Geraniol

Hexyl Cinnamal

Hydroxycitronellal

Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (HICC)* 

Isoeugenol

Limonene

Linalool

Methyl 2-octynoate

^*From 23 August 2019 cosmetic products containing HICC shall not be placed on the Union market. From 23 August 2021 cosmetic products containing HICC shall not be made available on the Union market.

The practice described above is primarily aimed at protecting consumers and informing them about the presence of individual allergens in cosmetics. This is especially important for people who are allergic to particular fragrances. The INCI list of ingredients is also important in clinical practice in the treatment of patients who are allergic to at least one of the fragrance allergens listed.

The Scientific Committee on Consumer Safety (SCCS) in its opinion on fragrance allergens in cosmetic products (SCCS / 1459/11) stated that consumers should also be informed about additional fragrance ingredients that go beyond the aforementioned list of 26 allergens. Review of clinical and experimental data shows that there are many more fragrances than currently declared 26 allergens that are sensitizing to humans. The SCCS opinion is available at: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_073.pdf

Therefore, works are currently in progress to implement new changes to Regulation 1223/2009, namely to expand the list from 26 to 82 fragrance allergens. “New allergens” may include: Menthol, Terpineol, Linalyl Acetate, Camphor, Vanillin, Geraniol derivatives: Geranial and Geranyl Acetate, as well as well-known essential oils, such as: ylang-ylang oil (Cananga Odorata Flower Oil), cinnamon oil (Cinnamomum Zeylanicum Bark Oil), or lavender oil (Lavandula Officinalis Flower Oil). The European Commission has proposed amendments to the Annex III, which you can see at: https://ec.europa.eu/docsroom/documents/34512

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These changes can be introduced as early as 2020 or 2021. Then, cosmetics manufacturers will be obliged to modify cosmetics labels by adding more allergens to INCI compositions. Everything indicates that the lists of cosmetics ingredients will significantly increase soon or – if you prefer – they will be enriched with new allergens.

From 1 July 2019, the provisions of the Technical Document on Cosmetic Claims of the European Commission (Annex III and IV) has become applicable. The Technical Document was approved in 2014, but formally it came into force only now. It was created to describe good practices in the application of the Regulation 655/2013, and also as a tool for control authorities.

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What are the consequences of implementing the Technical Document? Particular emphasis will be placed on “free from” (Annex III) and “hypoallergenic” (Annex IV) declarations. Look at the Annex III – “Free from claims”. It prohibits the use of declarations such as “free from”, “does not contain”, “without”, which denigrates legally used ingredients. Examples?

• “Without parabens” – a flagship example of deprecating allowed preservatives. Although parabens have been thoroughly tested for their safety in cosmetics and are legally used preservatives, this claim has been commonly used so far, suggesting to consumers that they are harmful ingredients. In this case, the honesty principle of Regulation 655/2013 is violated.

• “Free from allergens” – this claim should also not be used due to the fact that in practice it is not possible to guarantee the absence of allergens in the cosmetic. Why? Because allergic reactions are such individual, thus, we can never be sure if any of the ingredients will not cause allergies in a particular person. Therefore, such a claim misleads the consumer and violates the principle of the fairness.

• “Does not contain formaldehyde” – here, in turn, we have a contradiction with the principle of the legal compliance. According to the latest changes in Regulation 1223/2009 (https://www.cosmeticscare.eu/en/amendments-to-the-regulation-1223-2009/), formaldehyde is currently on the list of prohibited ingredients. Therefore, the use of the claim “does not contain” in relation to prohibited substances is unlawful.

Another issue is the need to adapt marketing communication to the Annex IV of the Technical Document – “Hypoallergenic claim”. In this annex, we find the criteria to be met to name a cosmetic product as hypoallergenic. Therefore, such products must not contain known and potential allergens, in particular substances or mixtures: recognized as sensitizing by the Scientific Committee on Consumer Safety (SCCS), classified as sensitizing category 1 (1A, 1B) according to the criteria of the Regulation No. 1272/2008 / WE (CLP), or considered to be sensitizing according to scientific literature. The hypoallergenic declaration should be supported by appropriate evidence (e.g. dermatological tests on a group of volunteers with allergy-prone skin). It should be remembered that the term “hypoallergenic” does not guarantee complete lack of possibility of allergic reaction, so it can not be suggested in marketing communication.

Products placed on the market after 1st July 2019 should therefore comply with the requirements of the Technical Document of the European Commission. It is worth emphasizing that the cosmetics market should adapt to these changes not only in the area of ​​claims used on product labels, but also in marketing communication as a whole (e.g. advertising, descriptions on websites).

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So what about the most controversial “free from” claims? In general, the cosmetics sector should stop using such declarations, including for legally used ingredients. Because such claims have been used extensively on cosmetic labels, the question arises: what to replace them with? How to encourage the consumer to buy a cosmetic towards such restrictions? Or maybe just focus on WHAT DOES OUR COSMETIC CONTAIN, instead of what it does not contain? Emphasize the ingredients that make the product stand out instead of looking for what it lacks. Let’s change what’s negative for positive. The declaration “contains” always has a more positive effect than the claim “does not contain”.

Link to the website with the Technical Document on Cosmetic Claims: https://ec.europa.eu/docsroom/documents/24847

On June 12, Commission Regulation (EU) No 2019/831 /EU of 22 May 2019 entered into force amending Annexes II, III and V to the Regulation 1223/2009.

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What has changed?

• First of all, the Regulation takes into account compounds classified as CMR substances (carcinogenic, mutagenic or toxic to reproduction) in accordance with the Regulation No. 1272/2008 /EC (CLP) of 1st December 2018.
• In connection with the above, the list of prohibited substances in cosmetic products has significantly increased (Annex II). Formaldehyde, Dichloromethane and Quaternium-15 has appeared, among others, on the list, which were classified as CMR substances, and a number of other compounds, e.g. Methylene Glycol, Styrene, Octamethylcyclotetrasiloxane (D4) and Acetaldehyde. The previous version of the list of prohibited substances included 1384 compounds, currently we have as many as 1611 of them.
• From the Annex III (the list of substances which cosmetic products must not contain except subject to the restrictions laid down) some compounds have been deleted and transferred to the Annex II (the list of prohibited substances). Why? Because some of them have been classified as CMR substances. Taking into account this fact and other factors concerning toxicological and safety data, it was found that these compounds should be banned in cosmetic products. Among these substances, e.g. already mentioned Formaldehyde or Dichloromethane has appeared. Also Boric Acid and Tetraborates have been removed from the Annex III.
• In the Annex V (the list of allowed preservatives), similar changes have occurred as above. Previously allowed preservatives, subsequently classified as CMR substances have now been banned, therefore, they have been transferred from the Annex V to the Annex II. What are those substances? Of course, Formaldehyde, as well as Quaternium-15 and Chloroacetamide. Also Chlorophene has disappeared from the list of allowed preservatives, and the maximum allowable concentration for Polyaminopropyl biguanide has been reduced from 0.3% to 0.1% and the possibility of its use in products with inhalation exposure has been excluded.

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As you can see, there are a lot of changes. The regulation entered into force on June 12, 2019. This is the final date of withdrawal from the market of products containing ingredients added to the Annex II of the Regulation 1223/2009.

The Regulation can be read at the following link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0831&qid