EU/UK Regulatory Updates: ECHA, CBD, Animal Testing Bans

Read this article and more in the September 2023 digital magazine.

In this month’s regulatory update, scrutiny over ingredients under REACH (Registration, Evaluation and Authorization of Chemicals), CLP (Classification, Labeling and Packaging) and the Cosmetics Regulation continues apace on either side of the English Channel. In addition, notices to the World Trade Organization of annex changes, CBD calls for data and position papers/rulings, green claims and animal testing bans are also action items. Following is a summary.

ECHA Ingredient Updates

The European Chemicals Agency (ECHA) has made several moves in terms of classification and labeling of ingredients. These include:

• Harmonized Classification and Labeling: New Intentions
• Diacetone alcohol
• No entry in EU Cosmetic Products Regulation (CPR)
• Proposed CMR (reprotoxic)
• Harmonized Classification and Labeling: Dossier Submitted
• Carvone
• No entry in CPR
• CMR 2 (reprotoxic)
  
  
• Sodium EDTMP
• No entry in CPR
• CMR 1B (carcinogen)
  
  
• Potassium EDTMP
• No entry in CPR
• CMR 1B (carcinogen)
• Substances of Very High Concern (SVHC) Classification and Authorization
• Glutaral
• Recommended for Authorization
• Respiratory sensitizer
• Draft REACH Restriction
• Microplastics
• Restriction voted 26.04.23

Note that during the same period, there have been no updates for harmonized classification or labeling or SVHC in the UK.

EU WTO Notifications

The European Union (EU) Commission has notified to the World Trade Organization (WTO) a draft regulation on nine cosmetic ingredients that will amend the Annexes to the EU Cosmetic Products Regulation (CPR).¹ The comment period for this notification is open for 60 days from the date of notification. The draft regulation² and its Annex will introduce the following bans and restrictions, and will enter into force on the day of publication in the Official Journal of the European Union.

Annex II change (banned substances): 4-Methylbenzylidene camphor (4-MBC) will be added to Annex II of the EU CPR and therefore be banned from use in cosmetic products. The transition period is 12 months for placing on the market and 24 months for making available (off shelf).

Annex III changes (restricted substances):

• Genistein and daidzein will be added to Annex III of the CPR and therefore be restricted for use at 0.007% and 0.02%, respectively. The transition period is nine months for placing on the market and 18 months for making available (off shelf).
• Kojic acid will be added to Annex III of the CPR and therefore be restricted for use at 1% in face and hand products. The transition period is nine months for placing on the market and 18 months for making available (off shelf).
• Retinol, retinyl acetate and retinyl palmitate (vitamin A) will be added to Annex III of the CPR and therefore be restricted for use at 0.05% retinol equivalent in body lotions and 0.3% retinol equivalent in other leave-on and rinse-off products. Products must have this warning on the label: Contains vitamin A-related compounds, which contribute to your daily intake of Vitamin A. The transition period is 18 months for placing on the market and 36 months for making available (off shelf).
• Alpha-arbutin will be added to Annex III of the CPR and therefore be restricted for use at 2% in face creams and 0.5% in body lotions. Hydroquinone levels shall remain as low as possible in formulations containing alpha-arbutin and shall not be higher than the unavoidable trace level. The transition period is nine months for placing on the market and 18 months for making available (off shelf).
• Arbutin will be added to Annex III of the CPR and therefore be restricted for use at 7% in face creams. Hydroquinone levels shall remain as low as possible in formulations containing arbutin and shall not be higher than the unavoidable trace level. The transition period is nine months for placing on the market and 18 months for making available (off shelf).

Annex V changes (list of preservatives permitted for use in cosmetics):

• Triclocarban’s entry is updated and therefore ingredient use will be restricted as a preservative at 0.2% in all cosmetic products (except mouthwash). Purity criteria are: 3,3',4,4'-tetrachloroazobenzene ≤ 1 ppm and 3,3',4,4'-tetrachloroazoxybenzene ≤ 1 ppm. This use is prohibited in toothpaste intended for children under six years of age. For toothpaste containing triclocarban, the following labeling is obligatory: Not to be used for children under 6 years of age. For uses other than as a preservative, see Annex III entry 100.
• Triclosan’s entry is updated and therefore ingredient use will be restricted as a preservative at 0.3% in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders, blemish concealers and nail products for cleaning the fingernails and toenails before the application of artificial nail systems. This use is prohibited in toothpastes intended for children under 3 years of age. For toothpaste containing triclosan, the following labeling is obligatory: Not to be used for children under 3 years of age. The transition period is nine months for placing on the market and 18 months for making available (off shelf).

Annex II changes: The European Commission (EC)³ also notified a draft regulation to the WTO that will ban or restrict a number of nanomaterials. These will be added to Annex II of the EU CPR:

• Styrene/acrylates copolymer (nano) and 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), acetyl tetrapeptide-17 colloidal platinum (nano).

Annex III changes: Hydroxyapatite will be added to Annex III of the CPR and therefore be restricted for use at 10.0% in toothpastes and 0.465% in mouthwashes. This use is prohibited in applications that may lead to exposure of the end-user’s lungs by inhalation.

Only nanomaterials with the following characteristics are allowed: composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio of less than three, and the remaining 4.2% have an aspect ratio not exceeding 4.9; and not coated or surface modified. The transition period is nine months for placing on the market and 18 months for making available (off shelf).

Once entered into force, all of these provisions will apply in the EU and Northern Ireland. They will not apply in Great Britain (England, Scotland and Wales).

UK WTO Notifications

The UK’s Office for Product Safety and Standards (OPSS, the regulator for cosmetic products) has notified⁴ to the WTO a regulation⁵ updating the following annexes to the UK Cosmetics Regulation (UKCR). The notification is open for comment for 60 days from the day of the notification.

Annex III (restricted substances): 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 or products marketed for exposure to natural or artificial UV light; and
• 0.2% in rinse-off products.
• Also, in both product types, the ingredient cannot be used with nitrosating agents, the maximum nitrosamine content must be 50 μg/kg and MNM-containing products must be kept in nitrite-free containers.

The provision implements an opinion⁶ from the Scientific Advisory Group on Consumer Safety (SAG-CS). The deadline for placing on the market is July 6, 2024; 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): The UV filter bis-(diethylamino hydroxybenzoyl benzoyl) piperazine (HAA299) and its nano form are allowed for use in cosmetic products under the following conditions:

• HAA299 at 10%; in the case of combined non-nano and nano forms, the sum must not exceed 10%; and
• HAA299 (nano) at 10% with specific characteristics of the nanomaterial being: purity ≥ 97%; median particle size D50 (50% of the number below this diameter), ≥ 50 nm of number size distribution; not to be used in applications that may lead to the exposure of the end user’s lungs by inhalation. Again, in the case of combined non-nano and nano forms, the sum must not exceed 10%.

This provision implements an opinion from SAG-CS and applied as of July 28, 2023.⁷

CBD Updates

EU call for data: In June 2023, the EC called for data on the safety of cannabidiol (CBD) in cosmetic products. The deadline for feedback is Sept. 30, 2024.⁸ This call covers not only data on the safety of CBD in pure form, but also as an extract that may contain contaminants of other cannabinoids, including trans-Δ⁹- tetrahydrocannabinol (THC or delta-9-THC), at trace levels. The data submitted will be used to prepare a mandate for the Scientific Committee on Consumer Safety (SCCS) to produce an opinion on the safe use of this ingredient in cosmetic products.

UK – updated CTPA position paper on CBD: The Cosmetic, Toiletry and Perfumery Association (CTPA) issued its position paper on CBD in 2019. Given developments on the topic, the position was reviewed and updated to reflect UK law. The document⁹ has been updated with:

• The addition of relevant guidance published by the Home Office on the topic;
• A fact sheet¹⁰ on drug licensing for cannabis, CBD and other cannabinoids; and
• Guidance¹¹ on analytical limits for controlled cannabinoids in products containing CBD, which includes cosmetic products.

ASA ruling on CBD in skin care: There is also some scrutiny on CBD-related claims in the UK. In April 2023, the Advertising Standards Authority (ASA) upheld a ruling against social media and website advertisements for a CBD skin care range that made both explicit and implicit medicinal claims for an unlicensed product.¹² The social media advert stated the product “targets areas of pain,” which the ASA determined the consumer would understand to mean the creams could relieve pain. The product website also mentioned ongoing research into CBD to help with illnesses, which the ASA ruled implied CBD was being considered for treating the outlined medical conditions.

Taken together, the ASA determined these to be medicinal claims. And the Committees of Advertising Practice (CAP)¹³ Code states that medicinal claims and indications may only be made for a product licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or under the auspices of the European Medicines Agency (EMA). The ASA ruled that the stated adverts must not appear again in the form raised in this case.

Green Claims

Regarding claims, I have written on several occasions about green claims for cosmetic products. In particular, I have highlighted the concern of the UK regulator the Competition and Markets Authority (CMA) and shared the CMA Green Claims Code, which is applicable for all sectors.¹⁴

The Green Claims Code provides six key principles against which any green or environmental claims should be made:

• Claims must be truthful and accurate;
• Claims must be clear and unambiguous;
• Claims must not omit or hide important information;
• Comparisons must be fair and meaningful;
• Claims must consider the full life cycle of the product or service; and
• Claims must be substantiated.

This year (2023), the CMA launched a review for some Fast Moving Consumer Goods (FMCGs); i.e., products considered by consumers to be necessities such as food, drink and household care. These include personal care products.¹⁵

Examples of what the CMA is reviewing include:

• Vague and broad statements such as sustainable, better for the environment, reduced CO₂, etc.;
• How much packaging is made of recycled material and to what extent is it recyclable;
• Ranges or selections branded as sustainable or eco-friendly that are not; and
• Narrow claims without broader context.

The CTPA’s guide to environmental and green claims has been updated to take into consideration the CMA Green Claims Code.¹⁶ It provides an overview of EU and UK requirements for environmental claims and key considerations for consumer understanding.

Animal Testing Bans

Article 18 of both the European Union cosmetic product regulation and the UK cosmetics regulation clearly sets out the strict animal testing bans for cosmetic products and their ingredients that were brought into EU law as part of the 7th amendment to the European cosmetics directive in 2003. The ban on animal testing for cosmetic products came into effect in 2004; for ingredients, in 2009.

United Kingdom: In the UK, the animal testing of cosmetic products was banned in the late 90s after a voluntary initiative by the industry that led to the withdrawal of all licenses for testing cosmetic products. The CTPA was clear that the EU CPR animal testing bans must be replicated in the new UK cosmetics laws when the UK left the EU – and they have been retained in the UK.

Conflicting regulations: Despite the strict animal testing ban for cosmetics, however, sometimes cosmetic ingredients are required to be tested to comply with other legislations, particularly REACH. For example, while consumer and professional safety are managed under cosmetic regulations, environmental and occupational (worker) safety are managed under REACH, where there is no animal testing ban in place. Therefore, the authorities responsible for REACH may request animal data for chemical registrations to prove safety for these endpoints as a last resort. They can be mandated to do this even if the ingredient is only used in cosmetics. This interface between cosmetics regulations and REACH regulations is significant to understanding the regulatory dilemmas in which cosmetics ingredient companies can find themselves.

Case in point, on May 5, 2023, the UK High Court Judicial issued a ruling¹⁷ that centred around a complaint made by the organization Cruelty Free International. The complaint claimed the UK home office had not communicated clearly its alignment with an EU court ruling in 2020.¹⁷ In this scenario, a company had challenged the ECHA on its requests for animal testing data. The EU ruling confirmed that in some cases, the chemicals used in cosmetics may require testing in animals as a last resort, to prove their safety for workers or the environment for the purposes of REACH. The UK high court ruling dismissed the complaint against the home office.

The ruling was widely reported in the media, often with misleading headlines, suggesting animal testing for cosmetic products was going to take place in the UK, which is not the case. On May 17, 2023, the UK government issued a statement explaining that no new licenses would be granted for animal testing of chemicals that are exclusively intended to be used as ingredients in cosmetics products.¹⁸ This step is to be welcomed, as it shows the UK’s commitment to animal-free chemicals safety assessment – something the industry has been working toward for many years.

European Union: In the EU, the ECHA is also considering approaches toward animal testing-free chemicals legislation, and at the end of May 2023, the agency held a workshop on New Approach Methodologies (NAMs).¹⁹ The workshop debated ways to replace the animal testing of chemicals in the context of human health and the environment, as well as how to achieve regulatory acceptance for such methodologies. The outcomes of the workshop were not available at the time of writing.

This ECHA action comes at a time of heightened NGO scrutiny of animal testing in the EU. In 2021, a European Citizens Initiative (ECI) was launched entitled, “Save Cruelty-free Cosmetics – Commit to a Europe Without Animal Testing.” It called for the cosmetics animal testing ban to be protected and strengthened – identifying the interface between REACH and the CPR as an area that needs to be addressed.²⁰

Since this ECI²¹ received the required level of support for further consideration, with more than one million signatories, the Commission held a hearing on it in May 2023. During the hearing, those supporting the initiative recommended to:

• Bring worker safety testing under the cosmetics animal testing ban;
• Include environmental toxicity under the EU CPR;
• Avoid new animal tests under REACH/CLP (Classification, Labeling and Packaging) regulations;
• Prioritize and incentivize non-animal methods for all endpoints; and
• Maintain the experience and independence of the SCCS.

It remains to be seen what the next steps will be for the ECI.

Global

In February 2023, the International Collaboration on Cosmetics Safety (ICCS)²² was launched,¹⁵ of which Cosmetics Europe, the European personal care association, and the U.S. Personal Care Products Council (PCPC) are founding members.

ICCS has a mission to advance the adoption of animal-free human and environmental safety science for cosmetics and personal care products and their ingredients. The ICCS brings together experts from cosmetics manufacturers and suppliers, industry associations and animal protection organizations to drive greater global awareness and confidence in animal-free safety science through research, education and regulatory engagement.

ICCS will collaborate with existing organizations to:

• Evaluate and further develop animal-free safety assessment approaches and demonstrate their scientific validity for human health and environmental protection;
• Share the results of these evaluation activities with regulators to inform ongoing regulatory acceptance discussions around the world; and
• Provide education and training materials to accelerate the widespread adoption of the latest animal-free safety science.

On a final note, it should be acknowledged that the cosmetics industry is a global pioneer in researching alternative test methods that do not use animals yet ensure human safety. The industry’s long-standing commitment of funding, time, resources and scientific expertise to this area has not only made it a leader in this field – it has given it a dedicated strategy for developing new testing methods.

References

1. WTO. (2023). Notification from the European Commission. Available at: https://eping.wto.org/en/Search/Index?viewData=%20G/TBT/N/EU/986
2. European Commission. (2023). Draft regulation to the European cosmetic products regulation. Available at: https://members.wto.org/crnattachments/2023/TBT/EEC/23_10130_00_e.pdf
3. WTO. (2023). Notification from the European Commission. Available at: https://epingalert.org/en/Search/Index?viewData=G%2FTBT%2FN%2FEU%2F872%2FRev.1
4. WTO. (2023). Notification from UK Department for Business and Trade (Office for Product Safety and Standards). Available at: https://eping.wto.org/en/Search/Index?viewData=%20G/TBT/N/GBR/61
5. UK Secretary of State. (2023). Draft Statutory Instrument amending The Cosmetic Products (Restriction of Chemical Substances) Regulations 2023. Available at: https://members.wto.org/crnattachments/2023/TBT/GBR/23_9344_00_e.pdf
6. UK Scientific Advisory Group on Consumer Safety (SAG-CS). (2022). Final Opinion on Methyl-N-methylanthranilate in Cosmetic Products. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1130699/sag-cs-opinion-06-methyl-n-methylanthranilate-in-cosmetic-products.pdf
7. SAG-CS. (2022). Final Opinion on HAA299 and HAA299 (nano) as UV Filters in Cosmetic Products. Available at:  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1130706/sag-cs-opinion-08-HAA299-and-HAA299-in-cosmetic-products.pdf
8. European Commission. (2023). Call for data on the safety of Cannabidiol (CBD) ingredients used in cosmetic products. Available at: https://single-market-economy.ec.europa.eu/system/files/2023-06/Final_Call%20for%20data%20CBD_10623_1.pdf
9. CTPA. (2022). The Legal Status of Cannabis and Cannabis Extracts in Finished Cosmetics in the UK. Available at: https://www.ctpa.org.uk/file.php?fileid=3422
10. UK Home Office. (2019). Drug licensing factsheet - Cannabis, CBD and other cannabinoids. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/825872/factsheet-cannabis-cbd-and-cannabinoids-2019.pdf
11. UK Government. (2021). Government chemist guidance on analytical limits for controlled cannabinoids in specified products containing cannabidiol (CBD). Available at: https://www.gov.uk/government/publications/guidance-on-analytical-limits-for-controlled-cannabinoids
12. UK Advertising Standards Authority (ASA). (2023). ASA Ruling on a Facebook post and a website for a health and beauty range. Available at: https://www.asa.org.uk/rulings/legacy-369-ltd-a23-1187936-legacy-369-ltd.html
13. UK Committees of Advertising Practice (CAP) Code of Non-broadcast Advertising and Direct & Promotional Marketing. (2014). Medicines, medical devices, health-related products and beauty products. Available at: https://www.asa.org.uk/type/capcode/code_rule/12.1.html?_vhid=BDA3D624DFB8865BE0CC38B979EC118B
14. UK Competition and Markets Authority (CMA). (2021). Green Claims Code. Available at: https://www.gov.uk/government/publications/green-claims-code-making-environmental-claims
15. CMA. (2023). CMA to scrutinize ‘green’ claims in sales of household essentials. Available at:https://www.gov.uk/government/news/cma-to-scrutinise-green-claims-in-sales-of-household-essentials
16. CTPA. (2021). Environmental and Green Claims Guidance. Available at: https://www.ctpa.org.uk/file.php?fileid=3802
17. England and Wales High Court (Administrative Court) Decisions. (2023). Ruling between Cruelty-Free International (Claimant) and UK Secretary of State for the Home Department (Defendant). Available at: https://www.bailii.org/ew/cases/EWHC/Admin/2023/1064.html
18. UK Parliament written questions, answers and statements. (2023). Statement made by UK Secretary of State for the Home Department. Available at: https://questions-statements.parliament.uk/written-statements/detail/2023-05-17/hcws779
19. European Chemicals Agency (ECHA). (2023). Workshop on new approach methodologies. Available at: https://echa.europa.eu/-/new-approach-methodologies-workshop-towards-an-animal-free-regulatory-system-for-industrial-chemicals
20. European Citizens Initiative (ECI). (2021). Save cruelty-free cosmetics – Commit to a Europe without animal testing. Available at: https://europa.eu/citizens-initiative/initiatives/details/2021/000006_en
21. European Commission. (2023). Hearing on the ‘save cruelty-free cosmetics’ ECI. Available at: https://www.europarl.europa.eu/committees/en/eci-hearing-save-cruelty-free-cosmetics-/product-details/20230524ECI00141
22. International Collaboration on Cosmetics Safety (ICCS). (2023). Available at: https://www.iccs-cosmetics.org/