Titanium Dioxide, Climbazole and a new preservative

From November 27^th, 2019, the changes introduced in Annex VI and V of the Regulation 1223/2009 have obliged us. What substances do they concern? You already know from the title 😉 And what exactly are these changes? I invite you to read below article.

Titanium Dioxide (nano)

We’ll start with Titanium Dioxide. It is a well-known UV filter used in cosmetics, belonging to the group of physical (mineral) filters. This substance is included in the Annex VI of the Regulation 1223/2009, in the list of UV filters allowed for use in cosmetic products – position 27: Titanium Dioxide and 27a: Titanium Dioxide (nano). The nano form is allowed to be used in cosmetics at a maximum concentration up to 25 % and is subjected to many other restrictions, including its purity, particle size, photostability, moreover, it cannot be used in products that create inhalation exposure. The Regulation also indicates which substances can be used for coating of nano-Titanium Dioxide, including such as: silica, alumina, stearic acid, glycerin and dimethicone. The Scientific Committee on Consumer Safety (SCCS) in the opinion no. SCCS/1580/16 confirmed the safety of subsequent substances coating titanium dioxide nanoparticles, or actually their combinations. Hence, Commission Regulation (EU) No 2019/1857/ EU of November 6^th, 2019 introduced a provision in the conditions of use of nano-Titanium Dioxide by adding the following combinations of coating substances:

Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %,
Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products),
Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %.

The significant oral toxicity of manganese dioxide and the potential risk of its harmful effects after ingestion were also taken into account in the SCCS opinion mentioned above. Therefore, sunscreen face products containing nano-Titanium Dioxide together with a combination of alumina and manganese dioxide coatings should contain a warning: Not to be used on the lips.

The above-described changes to the Regulation 1223/2009 regarding nano-Titanium Dioxide have been in force from November 27^th, 2019.

Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1857&from=EN

Link to the website with the SCCS opinion: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_202.pdf

Climbazole

Another change concerns the preservative Climbazole – 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one. This substance is on the list of allowed preservatives (Annex V) of the Regulation 1223/2009 and takes the position 32. The only condition for using this preservative until now was its maximum concentration in the ready for use preparation of 0.5 %. The change introduced on the basis of SCCS/1506/13, SCCS/1590/17, SCCS/1600/18 opinions and the Commission Regulation (EU) No 2019/698/EU of 30^th April 2019 specifies more precisely the conditions for using Climbazole as a preservative, divided into individual product categories. Thus, this preservative can be used in the following cosmetic preparations:

hair lotions – maximum concentration: 0.2 %,
face creams – maximum concentration: 0.2 %,
foot care products – maximum concentration: 0.2 %,
rinse-off shampoos – maximum concentration: 0.5 %.

Apart from the preservative effect, Climbazole is also used as the active ingredient in anti-dandruff shampoos. Hence the presence of this substance in the Annex III of Regulation 1223/2009 – the list of substances which cosmetic products must not contain except subject to the restrictions laid down (position 310). In accordance with an earlier amendment imposed by the Regulation 2019/698/EU, the restrictions on the use of Climbazole described in the Annex III apply to its use in rinse-off anti-dandruff shampoos up to a maximum concentration of 2 %.

From November 27^th, 2019, cosmetic products containing Climbazole that do not meet the above requirements shall not be placed on the market in the European Union. However, from February 27^th, 2020, these cosmetics cannot be made available on the EU market at all, in other words – they must be withdrawn from the market.

Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0698&from=EN

Link to the website with SCCS opinions: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_120.pdf https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_212.pdf https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_220.pdf

A new preservative

Last but not least, a curiosity – the family of preservatives has increased 😉 From now, Annex V will include a new preservative – 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one, INCI name: Hydroxyethoxyphenyl Butanone (HEPB). This substance will take the next – 60^th position in the list of allowed preservatives. In addition to the preservative effect, HEPB also has skin conditioning properties. The SCCS Committee in its opinion No. SCCS/1582/16 confirmed the safety of this preservative using in cosmetics at the maximum concentration of 0.7 %. And this concentration will now appear in the Annex V, under position 60^th. However, further research is needed regarding eye irritation potential of this substance.

The described change has been introduced by the Commission Regulation (EU) No 2019/1858 of November 6^th, 2019, effectively from November 27^th, 2019.

Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1858&from=EN

Link to the website with the SCCS opinion: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_203.pdf

Finally, I have to admit that I am happy with the last one change. In the times of “free froms”, when preservatives have poor reputation, a run of misfortune of parabens and phenoxyethanol, the list of allowed preservatives likely will be drastically shortened, which will certainly have a negative impact on the cosmetics sector. That is even better that the new preservative appears in Annex V 🙂 I am very curious how HEPB will get on the market, and you?

Titanium Dioxide, Climbazole and a new preservative Read More »

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.

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

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 26 to 82 – longer list of allergens? Read More »

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.

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).

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

Marketing declarations of cosmetics – restrictions Read More »

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