As we approach the end of the year, this article looks ahead to the anticipated changes in 2025-2026 to the status of ingredients in both the European Union and Great Britain.
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As we approach the end of the year, this article looks ahead to the anticipated changes in 2025-2026 to the status of ingredients in both the European Union and Great Britain.
EU Nanomaterial Bans, Restrictions
A number of regulations have been published in 2024 by the European Commission in its Official Journal regarding ingredients in nano form.
Nanomaterial bans: Regulation 2024/858 on nanomaterials adds the following nanomaterials to Annex II of the EU Cosmetic Products Regulation EC 1223/2009 (CPR), therefore banning them for use in cosmetic products:
- Styrene/acrylates copolymer (nano), sodium styrene/acrylates copolymer (nano)
- Copper (nano), colloidal copper (nano)
- Colloidal silver (nano)
- Gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano), acetyl heptapeptide-9 colloidal gold (nano)
- Platinum (nano), colloidal platinum (nano) and acetyl tetrapeptide-17 colloidal platinum (nano).
The “placing on the market” deadline is Feb. 1, 2025, while the “making available on the market” (off shelf) deadline is Nov. 1, 2025.
Nano-hydroxyapatite restrictions: In addition, nano-hydroxyapatite is added to Annex III of the EU CPR and therefore restricted for use under specific conditions, outlined as follows.
- Hydroxyapatite (nano) is permitted in toothpaste at 10% and in mouthwashes at 0.465%, given the below characterization restrictions. It is not permitted in applications that may lead to exposure of the end user’s lungs by inhalation.
- Only nanomaterials having the following characteristics are allowed:
- Composed of rod-shaped 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 and
- The particles are not coated or surface modified.
The placing on the market in this case is Feb. 1, 2025, and the making available on the market (off shelf) deadline is Nov. 1, 2025.
EU CPR Ingredient Annex Amendments, Bans
Regulation 2022/2195 dated Nov. 10, 2022, amended the following annexes to the CPR.
Annex III now includes the below entries:
- Acid yellow 3 is restricted for use in non-oxidative hair dye products at 0.5% (entry 82 of Annex IV still applies if the ingredient is used as a colorant). The placing on the market deadline for non-oxidative hair dyes containing this ingredient was July 1, 2023, and the making available on the market deadline (off-shelf) was Jan. 1, 2024.
- Resorcinol, entry 22, is corrected in column i(a) by changing the last sentence from “Do not use to dye eyelashes or eyebrows” to “Do not use to dye eyelashes.”
Annex VI is amended as below:
- Homosalate is allowed for use at 7.34% in face products, with the exception of propellent spray products. The placing on the market deadline is Jan. 1, 2025, and the making available on the market (off-shelf) deadline is July 1, 2025.
- Bis-(diethylaminohydroxybenzoyl benzoyl) piperazine is included for use as a UV filter in cosmetic products at 10%, both in the non-nano and nano forms. The nanoform is only allowed for purity ≥ 97%, with a median particle size D50 (50% of the number below this diameter) ≥ 50 nm of number size distribution. Furthermore, the nano form cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation. In case of combined use of both the non-nano and nano forms, the sum concentration shall not exceed 10%.
Regulation 2024/996 amended the following annexes to the CPR as outlined below.
Annex II is amended as follows:
- The UV filter 4-methylbenzylidene camphor is added to Annex II, and therefore banned from use in cosmetic products. The placing on the market deadline is May 1, 2025 and the making available (off-shelf) deadline is May 1, 2026.
Annex III is amended as below:
- Retinol, retinyl acetate, retinyl palmitate can be used in body lotions at a maximum concentration of retinol equivalent (RE) of 0.05% and other leave-on and rinse-off products at a maximum concentration of RE of 0.3%. These cosmetic products must be labeled with the warning: “Contains Vitamin A. Consider your daily intake before use.” The placing on the market deadline is Nov. 1, 2025 and the making available (off-shelf) deadline is May 1, 2027.
- Genistein can be used in cosmetic products at a maximum concentration of 0.007%. The placing on the market deadline is Feb. 1, 2025; the making available (off-shelf) deadline is Nov. 1, 2025.
- Daidzein can be used in cosmetic products at a maximum concentration of 0.02%. The placing on the market deadline is Feb. 1, 2025, while the making available (off-shelf) deadline is Nov. 1, 2025.
- Kojic acid can be used in face and hand cosmetic products at a maximum concentration of 1%. The placing on the market deadline is Feb. 1, 2025 and the making available (off-shelf) deadline is Nov. 1, 2025.
- Alpha arbutin can be used in face cream at a maximum concentration of 2%, and body lotion at a maximum concentration of 0.5%. Furthermore, hydroquinone levels shall remain as low as possible in formulations containing alpha-arbutin and shall not be higher than the unavoidable trace level. The placing on the market deadline is Feb. 1, 2025, and the making available (off-shelf) deadline is Nov. 1, 2025.
- Arbutin can be used in face cream at a maximum concentration of 7% but again, hydroquinone levels must remain as low as possible in formulations containing arbutin and must not be higher than the unavoidable trace level. The placing on the market deadline is Feb. 1, 2025. The making available (off-shelf) deadline is Nov. 1, 2025.
Annex V is amended as follows:
- Triclocarban can be used in all cosmetic products with the exception of mouthwash at a maximum concentration of 0.2%. Purity criteria include the presence of 3,3',4,4'-tetrachloroazobenzene at ≤ 1 ppm and 3,3',4,4'-tetrachloroazoxybenzene at ≤ 1 ppm. This ingredient cannot to be used in toothpaste intended for children under six years of age. Therefore, toothpaste containing triclocarban must have the following warning: “Not to be used for children under 6 years of age.”
- Triclosan can be used in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealers, products for cleaning the fingernails and toenails before the application of artificial nail systems at a maximum concentration of 0.3%. This ingredient cannot to be used in toothpaste intended for children under three years of age. Therefore, toothpaste containing triclocarban must have the following warning: “Not to be used for children under three years of age.”
The placing on the market deadline for both ingredients is Dec. 31, 2024, and the making available (off-shelf) deadline is Oct. 31, 2025.
EU Labeling Change: Formaldehyde-Releasing Preservatives
Annex V of the EU CPR lists the substances that may be used as preservatives in cosmetic products. Some Annex V preservatives release a very small amount of formaldehyde within the product to protect against microbial growth.
Point 2 of the Annex V preamble requires: All finished products containing substances in this Annex and which release formaldehyde must be labeled with the warning: “contains formaldehyde” where the concentration of formaldehyde in the finished product exceeds 0.05%.
An opinion from the Scientific Committee on Consumer Safety (SCCS), the EU’s independent scientific committee, in May 2021, recommended that the labelling concentration be reduced from 0.05% to 0.001%.
In 2022, the European Commission published Regulation (EU) 2022/1181 on the labelling requirements for cosmetic products containing formaldehyde-releasing preservatives. The regulation amends the preamble to Annex V of the CPR, to provide for: All finished cosmetic products containing formaldehyde-releasing preservatives to be labeled 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.
The deadlines for compliance were/are: July 31, 2024, for placing on the market and July 31, 2026, for making available on the market (off-shelf).
EU Labeling Change: Additional Fragrance Allergens
In July 2023, the European Commission published Regulation (EU) 2023/1545 updating the labeling requirements for fragrance allergens by adding 80 to the list.3 The transition periods are July 31, 2026, for placing on the market and July 31, 2028, for making available on the market (off-shelf).
Cosmetics Europe (CE, the European personal care association) is working on an extensive guidance to help companies comply with these requirements; in particular, the use of the grouping name. This legislation applies in the EU and Northern Ireland only. It will not apply in Great Britain.
EU: 21st ATP to the CLP Regulation
In January 2024, the European Commission published in the Official Journal the 21st Adaptation to Technical Process (ATP) to the Classification, Labeling and Packaging (CLP) Regulation. The regulation entered into force on Jan. 25, 2024, and will apply from Sept. 1, 2025.
The EU CLP aims to ensure a high level of protection of health and the environment, as well as the free movement of substances, mixtures and articles. The CLP Regulation is based on the United Nations’ Globally Harmonized System (GHS). It applies to all EU Member States, European Economic Area (EEA) countries and Northern Ireland (in accordance with the Windsor Framework).
The CLP requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package chemicals appropriately before placing them on the market. It applies to all substances and mixtures irrespective of the volume supplied.
Finished cosmetic products (i.e., ready for sale to the consumer) are exempt from the requirements of the CLP Regulation. However, cosmetic ingredients as raw materials or cosmetic mixtures (such as the bulk of a cosmetic that is not in the finished state) fall under the remit of the CLP Regulation; the European Chemical Agency (ECHA) regulates and enforces the CLP Regulation.
The 21st ATP amends Annex VI of the EU CLP Regulation, adding more mandatory harmonized classifications of chemicals. The amendments contain new carcinogenic, mutagenic and reprotoxic (CMR) classifications relating to the below cosmetic ingredients.
- Dimethyltolylamine, carcinogenic 1B – no annex entry in EU Cosmetic Products Regulation (CPR),
- Diuron (ISO), carcinogen 1B – already banned from use in cosmetics in the EU, as included in Annex II entry 1058 of the CPR,
- Trimethylbenzoyl diphenylphosphine oxide, reprotoxic 1B – found in Annex III entry 311 of the CPR and
- Cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide, reprotoxic 2 – already banned from use in cosmetics in the EU, as included in Annex II entry 1580 of the CPR.
Since these ingredients were not defended by industry, the European Commission will include these substances in Annex II (prohibited substances) of the EU CPR via the seventh CMR Omnibus Regulation. The making available (off-shelf) deadline for products containing these substances will be 18 months after publication of the 21st ATP to CLP.
The 21st ATP to the EU CLP will not automatically be included within the Great Britain (GB) CLP Regulation. To be included within GB CLP, it must first undergo independent scientific scrutiny in the UK.
UK Annex Updates to the UKCR Notified to WTO
In 2023, the Office for Product Safety and Standards (OPSS, the UK regulator for cosmetic products) notified to the World Trade Organization (WTO) a regulation updating the annexes to the UK Cosmetics Regulation (UKCR). Below are the changes to be implemented in Great Britain.
Annex III (list of restricted substances) outlines:
- Methyl-Nmethylanthranilate (MNM) is allowed for use in cosmetic products at 0.1% in leave-on products, although the ingredient cannot be used in sunscreen products and products marketed for exposure to natural or artificial UV light;
- MNM is allowed at 0.2% in rinse-off products; and
- In both product types, MNM cannot be used with nitrosating agents and the maximum nitrosamine content must be 50 μg/kg; the product also must be stored in nitrite-free containers.
This provision implements an opinion from the Scientific Advisory Group on Consumer Safety (SAG-CS) – the UK’s independent scientific committee. The deadline for placing on the market was July 6, 2024, and the deadline for making available on the market (off-shelf) is July 6, 2026.
Annex VI (list of UV filters permitted for use in cosmetics), following an opinion from the SAG-CE, specifies the UV filter Bis-(Diethylami nohydroxybenzoyl Benzoyl) Piperazine (HAA299) and its nano form are allowed for use in cosmetic products under the below conditions:
- HAA299 at 10%, and in the case of combined non-nano and nano forms, the sum must not exceed 10%; and
- HAA299 (nano) at 10% with the following specific characteristics of the nanomaterial: purity ≥ 97% and the median particle size D50 (50% of the number below this diameter) at ≥ 50 nm of number size distribution. It is also not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. In case of combined non-nano and nano forms, the sum must not exceed 10%.
This provision was effective as of July 28, 2023.
UK on Butylated Hydroxytoluene (BHT)
In April 2024, the OPSS published the Statutory Instrument 2024 No. 455 updating Annex III of the UK Cosmetics Regulation. The amendment restricts the use of butylated hydroxytoluene (BHT) in cosmetic products under the following conditions:
- in toothpaste at a maximum of 0.1%;
- in mouthwash at a maximum of 0.001%;
- in leave-on oral care products at a maximum of 0.001%; and
- in other leave-on and rinse-off products a maximum of 0.8%.
The placing on the market deadline is Feb. 24, 2025, and the making available (off-shelf) deadline is June 24, 2025.
GB Mandatory Classification List (MCL) Notified to WTO
Substances and mixtures placed on the GB market must be classified and labeled in line with the GB Classification, Labeling and Packaging (CLP) Regulation, wherein there are two types of classifications: mandatory classification and self-classification.
Mandatory classification has been made legally binding within GB. It is equivalent to the harmonized classifications that exist under the EU CLP. The mandatory classifications and the accompanying hazard labelling (MCL) are listed in the GB mandatory classification and labelling list (GB MCL list). Where a substance has an MCL for some or all hazard classes, suppliers to the GB market must apply it.
In 2023, the UK government notified to the WTO the proposed amendments to the GB MCL, which will introduce new mandatory classifications under the GB CLP for a number of substances. Below is a list of substances that have an INCI name and may therefore be used as cosmetic ingredients that have a proposed CMR classification. Only the CMR mandatory classification would trigger Article 15 of the UKCR, where the ingredient would need to be banned or restricted for use.
- Methylene di-t-butylcresol (CMR 1B) will be added to Annex II of the UKCR,
- Methyl salicylate (CMR 2) will be defended for continued use by the UK cosmetics industry and the ingredient may be added to Annex III of the UKCR,
- Methyl isobutyl ketone (MIBK) (CMR 2) will be added to Annex II of the UKCR,
- Benzophenone (CMR 1B) will be added to Annex II of the UKCR,
- Theophylline (CMR 1B) will be added to Annex II of the UKCR,
- Trimethylolpropane triacrylate (CMR 2) will be added to Annex II of the UKCR,
- Melamine (CMR 2) will be added to Annex II of the UKCR and
- Margosa (Azadirachta indica) extract (CMR 2) will be added to Annex II of the UKCR
The application date for mandatory classifications is scheduled for the fourth quarter of this year (2024).
GB Mandatory Classification List: Ingredient Additions
In 2024, the UK Health and Safety Executive (HSE) added a number of chemical substances to the GB MCL. This introduces new mandatory classifications under Article 37 of the GB CLP Regulation for these substances.
Below is a list of substances that have INCI names and may therefore be used as cosmetic ingredients that have a proposed CMR classification, triggering Article 15 of the UKCR.
- 2-ethylhexanoic acid and its salts: reprotoxic 1B, of which
- 2-ethylhexanoic acid is already found in Annex II of the UKCR (entry 1024) and it is already banned from use in cosmetics;
- 2-ethylhexanoic acid nickel salt is already found in Annex II of the UKCR (entry 1460) and it is already banned from use in cosmetics;
- 2-ethylhexanoic acid zinc salt (INCI: Zinc Ethylhexanoate) does not have an entry in the UKCR and may therefore be used as a cosmetic ingredient. This ingredient is therefore expected to be banned for use in cosmetics and added to Annex II of the UKCR.
- Dimethyltolylamine, carcinogenic 1B – no Annex entry in UKCR. This ingredient is therefore expected to be banned for use in cosmetics and added to Annex II of the UKCR.
The application date for harmonized classifications is Sept. 2, 2025.
For any bans or restrictions to be implemented under the UKCR, the OPSS must publish a Statutory Instrument adding the substances to Annex II of the UKCR. Possible transition periods will be established through the corresponding annex amendment. However, according to the CMR process, it is expected that the placing on the market deadline will be Sept. 2, 2025, and the making available on the market deadline will be six months later; but deadlines can only be confirmed when OPSS publishes the Statutory Instrument.
Tracking Ingredient Status Divergence Between the EU and UK
It is inevitable that there will be some divergence between the EU and UK on ingredient issues, as processes and priorities differ between the two regions. In order to help with this, the Cosmetic, Toiletry and Perfumery Association (CTPA) has created a “divergence table,” aiming to address the points of divergence between the annexes of the EU CPR and the UKCR. The table is available as a downloadable PDF.1 The CTPA updates this table as, and when, the two markets implement different rules.
Ecodesign for Sustainable Products Regulation (ESPR)
Most readers have heard about the Ecodesign for Sustainable Products Regulation (ESPR), which is part of the European Green Deal. It requires products to be made more durable, reliable, reusable, upgradeable and reparable; easier to maintain, refurbish and recycle; and to be more energy and resource efficient. In addition, it has been proposed that all regulated products should have Digital Product Passports (DPPs), which would allow for the tracking of substances of concern along the supply chain and make it easier to repair or recycle products.
The ESPR, Regulation (EU) 2024/1781, has now been published in the Official Journal of the European Union and entered into force on July 18, 2024. It sets out ecodesign requirements for certain product groups and introduces DPPs as well as provisions on the destruction of unsold consumer products; additional aspects of these are provided below.
Cosmetic products have not been prioritized in the first working plan. However, it is expected that they will be listed as a product group for the second working plan. The product groups that have been prioritized for the first working plan, to be adopted by April 19, 2025, are:
- iron, steel and aluminium,
- textiles and furniture,
- tires,
- detergents,
- paints,
- lubricants,
- chemicals,
- energy-related products for which ecodesign requirements are to be set for the first time, or for which existing measures adopted pursuant to Directive 2009/125/EC are to be reviewed under this Regulation, and
- information and communication technology products and other electronics.
Ecodesign requirements: The European Commission will adopt delegated acts to supplement the Regulation by setting ecodesign requirements. Where relevant to the product group concerned, the ecodesign requirements may include the following aspects:
- durability, reliability, reusability, recyclability, upgradability and repairability,
- the presence of substances of concern,
- energy, water and resource use and efficiency,
- recycled content, recyclability, remanufacturing, maintenance and refurbishment,
- environmental impacts, including carbon footprint and environment footprint and
- expected generation of waste.
DPPs: Chapter III of the ESPR sets out the DPP, a digital identity card for products, components and materials, which will store relevant information regarding the product’s environmental and sustainability credentials. The intention is to make it easier for consumers, manufacturers and authorities to make more informed decisions related to sustainability, circularity and regulatory compliance.
Information to be included in the DPP will be product-specific and identified by the European Commission, taking into account the nature of the product and its market. This information can include:
- the product’s technical performance,
- materials and their origins,
- repair activities,
- recycling capabilities and
- lifecycle environmental impacts.
Destruction of unsold consumer products: The ESPR is also tackling the destruction of unsold consumer products. Annex VII to the regulation provides a list of product categories for which the destruction of unsold consumer products shall be prohibited. At present, cosmetic products are not listed in Annex VII; however, the European Commission is empowered to adopt delegated acts to amend the annex and add new products.
Estimated timeline for cosmetics: As mentioned, cosmetic products are not included in the first phase of the ESPR and there is not yet any official information about when the second stage will begin. Cosmetics Europe, the European personal care association, has previously estimated the following timeline for a delegated act on cosmetic products:
- Commission work to begin near the end of 2026,
- with adoption near the end of 2027 and
- entry into force in mid-2029.
Elections, Implications and Conclusions
This is a historic year in terms of elections. According to King’s College London,2 my alma mater, more than 50 countries are holding significant elections during 2024, including the European Union, the UK, the USA, India and South Africa; 1.5 billion people around the world will have had the opportunity to vote this year.
In June 2024, EU citizens voted for a new European Parliament and a new European Commission was established. On July 4, 2024, the UK went to the polls and at the time of writing this, we are still awaiting the U.S. election.
Trade associations are vital in ensuring that the voice of the industries they represent is heard, and this is even more important at the time of a new government. The CTPA is already engaging with the new UK government, and Cosmetics Europe is continuing its active advocacy at an EU level. The Personal Care Products Council will also likely continue its public affairs work in the lead-up to and after the U.S. election.
I feel 2024 has gone in a bit of a blur but so much has happened and many significant events and changes have taken place. We look forward to 2025 with eager anticipation – and certainty that the year will not be a boring one.
References
1. CTPA. (Accessed 2024, Sep 25). UK cosmetics regulations and amendments. Available at:
https://www.ctpa.org.uk/uk-cosmetic-regulations-amendments
2. King’s College London. (2024). Poll to poll 2024: A year of elections around the world. Available at: https://www.kcl.ac.uk/poll-to-poll-2024
3. Journal of the European Union. (2023). Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1545