BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol

What’s new in the near future in the cosmetics law? This time, the changes concern as many as 5 substances: BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol. If you want to know more details of the new Regulation 2022/2195 of November 10th, 2022, I invite you to read the post below.

BHT

BHT, or butylated hydroxytoluene, 2,6-di-tert-butyl-4-methylphenol, INCI name: Butylated Hydroxytoluene, is a commonly used synthetic antioxidant that helps to maintain the durability and functional properties of cosmetics.

Much has been said recently about the potential endocrine-disrupting properties of this substance. Therefore, the SCCS Committee took a closer look at BHT. In its opinion No. SCCS/1636/21, the committee concluded that BHT is a safe ingredient in cosmetics when used in the combined use of: mouthwash – with BHT content at a maximum concentration of 0.001%; toothpaste – in the maximum concentration of BHT = 0.1% and other rinse-off and leave-on products in the maximum concentration of BHT = 0.8%.
Therefore, BHT will be included in Annex III of the Cosmetics Regulation, i.e. the list of restricted substances. It will occupy the position 325 in that annex. Restrictions on the use of BHT in cosmetics will be in line with the SCCS opinion, i.e. it will be allowed to be used in:

mouthwashes – at maximum concentration = 0.001%;
toothpastes – concentration max. = 0.1%;
other leave-on and rinse-off products – up to a concentration of max. 0.8%.

Change dates? From the 1st of July 2023, cosmetic products containing BHT and not complying with the new requirements will not be allowed to be placed on the Union market. However, from January 1st, 2024, it will not be possible to make BHT products that do not meet the requirements set out in the restrictions available on the market.

Link to SCCS opinion: https://health.ec.europa.eu/system/files/2022-08/sccs_o_257.pdf

Acid Yellow 3

Acid Yellow 3 dye is another substance that will be subject to changes in the conditions of use in cosmetics. Until now, this substance was listed in item 82 of Annex IV to Regulation 1223/2009. Therefore, Acid Yellow 3 could be used as a colorant in cosmetic products without any maximum concentration.

Current data shows that Acid Yellow 3 can be safely used in non-oxidative hair dye products at concentrations on the scalp not exceeding 0.5%. This is reflected in the SCCS Opinion No. SCCS/1631/21, where it was concluded that above 0.5% this dye poses a potential risk to human health. Accordingly, Acid Yellow 3 will be included in Annex III under entry 326, where the use of this colorant in non-oxidative hair dye products will be limited to a concentration of 0.5%.

The transitional periods will be analogous to those for BHT, i.e. from July 1st, 2023 – a ban on placing on the market products that do not comply with the new requirements, and from January 1st, 2024 – a ban on making them available on the market.

Important! If this substance is used as a “standard colourant”, i.e. not in hair dyes, but e.g. in nail lacquers, Annex IV entry 82 still applies.

The SCCS opinion on Acid Yellow 3 can be found at the following link: https://health.ec.europa.eu/system/files/2022-08/sccs_o_253.pdf

Homosalate

UV filters have also been included in the new regulation. Including Homosalate – a filter that appears in the position 3 of Annex VI of the cosmetic regulation. This compound can currently be used as a sunscreen in cosmetic products at a maximum concentration of 10%.

Due to the potential endocrine-disrupting properties of Homosalate, the SCCS issued a scientific opinion No. SCCS/1622/20, in which it concluded that this filter, in currently permitted concentrations in cosmetic products, poses a potential threat to human health. The opinion describes that the use of this UV filter in cosmetics is safe for the consumer only at a maximum concentration of 0.5% in the final product.

Following the intervention of the cosmetics industry to ensure that consumers are adequately protected from the sun, the SCCS issued a further opinion SCCS/1638/21. It confirmed the safety of Homosalate at concentrations up to 7.34% when used in non-spray cream and pump spray facial products. Accordingly, the following amendments have been made to Annex VI, entry 3:

the use of Homosalate is limited to facial products only (other than spray and pump spray),
maximum allowed concentration of Homosalate in the above products = 7.34%.

Transitional periods: January 1st, 2025 – for placing products on the market and July 1st, 2025 – for making them available on the market.

SCCS opinions on Homosalate can be found at the following links:

https://health.ec.europa.eu/system/files/2022-08/sccs_o_244.pdf

https://health.ec.europa.eu/publications/scientific-advice-safety-homosalate-cas-no-118-56-9-ec-no-204-260-8-uv-filter-cosmetic-products_en

HAA299

Annex VI will also include a new UV filter – HAA299 with the INCI name: Bis-(Diethylaminohydro xybenzoyl Benzoyl) Piperazine. The SCCS submitted 2 opinions on the safety of this compound: SCCS/1533/14 and SCCS/1634/2021, with the second opinion concerning HAA299 in nano form.

Therefore, 2 new entries have been added to Annex VI:

33: Bis-(Diethylaminohydro xybenzoyl Benzoyl) Piperazine,
34: Bis-(Diethylaminohydro xybenzoyl Benzoyl) Piperazine (nano).

The maximum allowed concentration of both forms of HAA299 will be 10%, and in the case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine in the “regular” and nano form, their sum may not exceed 10%. In addition, only nanomaterials with the following properties are allowed for the nano form:

purity ≥ 97%,
median particle size D50 (50 % of the num ber below this diameter): ≥ 50 nm of number size distribution,
not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.

These changes will enter into force on December 1, 2022.

Links to SCCS opinions:

https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_159.pdf

https://health.ec.europa.eu/publications/haa299-nano_en

Resorcinol

Finally, we have an amendment on resorcinol (INCI: Resorcinol) – a substance intended for colouring hair. This compound is restricted under the entry 22 in Annex III to Regulation 1223/2009.

What is this rectification about? The warning on the use of resorcinol for dyeing eyebrows has been deleted: ‘Do not use to dye eyelashes or eyebrows’. Thus, in the row for item 22, column i (a) in the case of oxidative hair dye products, the last sentence is replaced by the following: ‘Do not use to dye eyelashes’.

The regulation will enter into force on December 1st this year.

Regulation 2022/2195 introduces a lot of changes to the cosmetics law. They concern a variety of substances used in cosmetics: the antioxidant Butylated Hydroxytoluene, Acid Yellow 3 and Resorcinol dyes, as well as 2 UV filters: Homosalate and Bis-(Diethylaminohydro xybenzoyl Benzoyl) Piperazine. Details of the new regulation can be found at the following link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R2195&from=EN

BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol Read More »

There are more novelties in the cosmetic law ahead of us. On September 15th, the Commission Regulation (EU) 2022/1531 was published, introducing the above-mentioned changes – more about them below.

Methyl salicylate

There has been a lot of hype around methyl salicylate (INCI: Methyl Salicylate) for some time. This ingredient is used in cosmetics as a fragrance ingredient, flavouring agent and soothing agent. However, studies have shown that it has the potential to be toxic to reproduction, leading to the classification of methyl salicylate as CMR (carcinogenic, mutagenic or toxic for reproduction) category 2.

The Scientific Committee on Consumer Safety (SCCS) has assessed methyl salicylate and found it safe for use in certain cosmetic products (opinion no. SCCS / 1633/21). Therefore, Methyl Salicylate was included in the Annex III of the Cosmetics Regulation, ie the list of restricted substances. So far, this substance has not been subject to any restrictions of use in cosmetics. Now, methyl salicylate will take the position 324 in the Annex III. There are 14 categories of cosmetics in which it will be possible to use this compound together with the maximum allowable concentrations. In addition, methyl salicylate will not be used in formulations for children under 6 years of age, with the exception of toothpastes. For convenience, the conditions for using salicylate in each product category are presented in the table below.

Product category	Maximum allowable concentration
Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products)	0,06%
Face makeup (except lip products, eye makeup and makeup remover)	0,05%
Eye makeup and makeup remover	0,002%
Leave-on hair products (spray/aerosol)	0,009%
Deodorant spray/aerosol	0,003%
Body lotion spray/aerosol	0,04%
Rinse-off skin products (except hand wash) and rinse-off hair products	0,06%
Hand wash	0,6%
Hydroalcoholic-based fragrances	0,6%
Lip products	0,03%
Toothpaste	2,52%
Mouthwash intended for children aged 6–10 years	0,1%
Mouthwash intended for children above 10 years of age and adults	0,6%
Mouth spray	0,65%

Corrigendum regarding sodium hydroxymethylglycinate

In Commission Regulation (EU) 2021/1902, sodium N-(hydroxymethyl)glycinate (INCI: Sodium Hydroxymethylglycinate) was incorrectly added to the list of prohibited substances in Annex II as entry 1669 to Regulation (EC) No 1223/2009. This compound is already listed in entry 51 of Annex V to the Cosmetics Regulation as ” Sodium hydroxymethylamino acetate” as a preservative allowed in cosmetic products. The substance should not be listed both as banned in Annex II and as an allowed preservative in Annex V. Therefore entry 1669 will be deleted from Annex II of the Cosmetics Regulation.

In addition, the list of permitted preservatives (Annex V), which includes Sodium Hydroxymethylglycinate, also needs to be corrected. Entry 51 in Annex V contains an error in column (b) with regard to the chemical name of the substance. The correct name for the compound is Sodium N-(hydroxymethyl)glycinate (previously it was: Sodium hydroxymethylamino acetate). The additional condition in column (h) regarding the maximum theoretical concentration of formaldehyde was also incorrectly worded: “Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0,1 % w/w“. The correct wording has now been changed to: ” Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w’“.

New banned substances

The regulation also provides the introduction of 14 new prohibited substances in Annex II. These substances were previously classified as CMRs. Annex II of the Cosmetics Regulation will already contain 1694 compounds. The new substances banned from use in cosmetics include for example:

Tetrafluoroethylene,
3-Methylpyrazole,
6,6′-Di-tert-butyl-2,2′-methylenedi-p-cresol [DBMC],
4-Methylpentan-2-one; isobutyl methyl ketone (MIBK),
Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate.

The new regulation concerning methyl salicylate and new banned substances will apply from December 17th, 2022. Cosmetic products that do not comply with the new rules will not be allowed to be made available in the supply chain from December 17 this year and will have to be withdrawn. Regarding the correction to Sodium Hydroxymethylglycinate, it will apply from the twentieth day after the publication of Regulation 2022/1531 in the Official Journal of the European Union.

Regulation 2022/1531 can be found at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1531&from=EN

The SCCS opinion on methyl salicylate can be found here: https://health.ec.europa.eu/system/files/2022-08/sccs_o_255.pdf

Methyl salicylate and other novelties in the cosmetic law Read More »

Summer is in full swing, so the perfect time to write about UV filters 🙂 We are awaiting changes in the cosmetic law regarding the use of two UV filters: Benzophenone-3 and Octocrylene. That’s not all, because the new regulations will also apply to substances that release formaldehyde. More details can be found below.

Benzophenone-3 and Octocrylene

Caution, manufacturers of sunscreen cosmetics: the conditions of using the above-mentioned UV filters are changing. On July 7th, the Commission Regulation (EU) 2022/1176 appeared, introducing changes to the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products with regard to the use of Benzophenone-3 and Octocrylene in cosmetic products. What’s going on and where do these changes come from?

It all started with concerns about the potential endocrine disrupting properties that Benzophenone-3 and Octocrylene could potentially induce. Both Benzophenone-3 and Octocrylene are included in the Annex VI (list of permitted UV filters) of the Regulation 1223/2009, in positions 4 and 10, respectively. The maximum permitted concentration of Benzophenone-3 in cosmetics was 6% so far, and 10% for Octocrylene.

Meanwhile, the Scientific Committee on Consumer Safety (SCCS) concluded in its opinion SCCS/1625/20 that Benzophenone-3 is not safe for consumers when used as a UV filter at the current maximum concentration of 6% in sunscreen products. This assessment applies to cosmetics in the form of a body cream as well as a sunscreen propellant spray or pump spray. However, the safety of using this UV filter has been confirmed up to the maximum concentration:

6% in face creams, hand creams and lipsticks (where due to the smaller application area the exposure is lower),

0.5% in cosmetic products to protect the formulation of the cosmetic,

2.2% in body creams and in propellant sprays and in pump sprays, if there is no additional use of Benzophenone-3 at a concentration of 0.5% in the same formulation in order to protect the composition of the cosmetic.

The SCCS further concluded that when Benzophenone-3 is also used at a concentration of 0.5% in the same formulation, the level of this UV filter should not exceed 1.7% in body creams and in propellant sprays and in pump sprays.

Therefore, the use of Benzophenone-3 will be limited to the maximum concentrations proposed by the SCCS. According to the new requirements, Benzophenone-3 can be used taking into account the following maximum concentrations:

6% – in face, hand and lip products, excluding propellant and pump spray products (IMPORTANT! If 0.5% Benzophenone-3 is used to protect the product formulation, the levels used as a UV filter must not exceed 5.5% – we just subtract 0.5% from the initial concentration of 6%);

2.2% – in body care products, including propellant and pump spray products (IMPORTANT! If 0.5% Benzophenone-3 is used to protect the formulation of the product, the levels used as a UV filter must not exceed 1,7%);

0.5% – in other products.

With regard to Octocrylene, SCCS issued an opinion SCCS/1627/21 confirming the safety of using this UV filter up to a maximum concentration of 10% in cosmetic products when used individually. However, for products such as a sunscreen propellant spray, Octocrylene can be considered safe up to a concentration of 9% – considering the use together with a face cream, hand cream or lipstick containing 10% of this substance.

Thus, the modification of Octocrylene conditions of use is to add a new category of cosmetics to the entry 10, Annex VI. Namely, propellant spray products were included, where the maximum allowed concentration of Octocrylene will be 9%. The use of this filter in other types of products will remain unchanged, where the max. concentration of 10% will continue apply.

With regard to the transitional periods to this regulation, we have time until: January 28th, 2023 – for placing cosmetics on the market, and until July 28th, 2023 for making them available on the market.

To learn about the new regulation, please visit the link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1176&qid=1657880385749&from=en

I would also like to refer you to the SCCS opinions: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_247.pdf

https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_249.pdf

Formaldehyde donors

One more change awaits us, related to formaldehyde donors, i.e. substances capable of releasing formaldehyde. The preamble of the Annex V to the Regulation 1223/2009 on cosmetic products will change here.

According to the new Commission Regulation (EU) 2022/1181 of 8 July 2022, the aforementioned preamble, point 2 is replaced by the following: „All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning <releases formaldehyde> where the total concentration of formaldehyde released in the finished product exceeds 0,001% (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.”.

What has changed compared to the previous preamble? The version in force so far included the requirement to apply the warning “releases formaldehyde” for 0.05% of the released formaldehyde, so this concentration has been significantly reduced. In scientific opinion No. SCCS/1632/21, the SCCS Committee concluded that the current threshold of 0.05% (500 ppm) does not sufficiently protect consumers allergic to formaldehyde. In order to protect the vast majority of these users, the current threshold for the labeling requirement has therefore been lowered to 0.001% (10 ppm).

In this case, the transition periods for adapting to the new changes are much longer: July 31, 2024 – for placing on the market and July 31, 2026 – for making the products available on the market.

You can find the link to the regulation at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1181&from=PL

And the SCCS opinion is here: https://health.ec.europa.eu/system/files/2021-05/sccs_o_254_0.pdf

To sum up, significant changes in the cosmetic law are awaiting us. The first ine concerns the new conditions of use of two UV filters: Benzophenone-3 and Octocrylene. Additional categories of cosmetics in which these filters can be used are listed, along with new maximum allowable concentrations. Another change is the lowering of the threshold for the concentration of formaldehyde released from its donors from 500 to 10 ppm in the preamble to Annex V. This is related to the requirement to display the warning “releases formaldehyde” on the labels of cosmetics where the concentration of formaldehyde released from its donors exceeds the mentioned 10 ppm.

UV filters and formaldehyde donors Read More »

Uncategorized

BHT

Acid Yellow 3

Homosalate

HAA299

Resorcinol