BHT and Acid Yellow 3
As of January 1, 2024, cosmetics that do not meet the latest restrictions on BHT and Acid Yellow 3 cannot be made available on the EU market anymore. These restrictions were stipulated in the Commission Regulation (EU) 2022/2195 of November 2022 and provided the following restrictions:
BHT (Butylated Hydroxytoluene; CAS No. 128-37-0)
- Mouthwash products, up to 0.001%
- Toothpastes, up to 0.1%
- Other leave-on and rinse-off products, up to 0.8%.
Acid Yellow 3 (CAS No. 38615-46-2)
- Limited to non-oxidative hair dye products at a maximum concentration of 0.5%. Any other use not explicitly regulated will not be allowed.
International Fragrance Association (IFRA) Standards
In the 51st Amendment to the IFRA Standards there were some updates to the IFRA standards, with:
- 1 new IFRA Restriction Specification Standard
- 32 new IFRA Restriction Standards based on dermal sensitization and systemic toxicity
- 11 new IFRA Restriction Standards to control potential dermal sensitization effects solely based on QRA2
- 2 new IFRA Restriction Standards for which risk management is based on Systemic Toxicity (TTC)
- 1 new IFRA Restriction Standard due to potential of depigmentation
- 1 new IFRA Prohibition Standard due to potential genotoxicity effects
And also some Revised IFRA Standards:
- 7 Revised IFRA Restriction Standards to control potential dermal sensitization effects for which the systemic toxicity endpoints have now also been evaluated
- 1 Revised IFRA Restriction Standard based on new dermal sensitization data
- 1 Revised IFRA Restriction Standard based on phototoxicity and systemic toxicity
- 2 Revised IFRA Restriction Standards based on systemic toxicity
Regarding new creations, the restrictions will enter into force on 30 March 2024. As for existing creations, the prohibitions and restrictions will only enter into force on 30 July 2024.
New regulation 2023/988 on General Product Safety (GPSR)
From December 13, 2024 the new Regulation (EU) 2023/988 on General Product Safety (GPSR) will be fully enforced in all EU Member States.
The GPSR modernises the EU general product safety framework and address the new challenges posed to product safety by the digitalisation of economies, aiming to strengthen the protection of consumers while enhancing the functioning of the EU internal market.
The GPSR applies to non-food products (for which there is no specific directive or regulation) and to all sales channels, providing a safety net for products or risks not regulated in other EU legislation. It requires that all consumer products on the EU markets are safe and it establishes specific obligations for businesses to ensure it.
Talc, Heliotropine and Potassium Caroate
On 12 June 2023, the European Chemicals Agency (ECHA) launched three consultations on proposals for harmonised classification and labelling of Talc (Carc. 2), Heliotropine (Repr. 1B) and Potassium Caroate (Skin. Corr. 1).
Depending on the outcome of the ECHA’s Risk Assessment Committee (RAC) opinions regarding the proposed new harmonized classification and labelling, the future use of Talc and Heliotropine in cosmetic products may be at risk.
According to the EU Cosmetics Regulation No. 1223/2009, cosmetic ingredients classified as CMR (Carcinogenic, Mutagenic, Toxic to Reproduction) of categories 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, shall be prohibited. Additionally, cosmetic ingredients classified as CMR substances in category 2 may also face prohibition, unless they have undergone evaluation by the Scientific Committee on Consumer Safety (SCCS) within the new classification framework and have been deemed safe for use in cosmetic products.
Legal deadline for RAC opinions adoption:
- Talc – 04 december 2024
- Heliotropine – 24 October 2024
- Potassium Caroate – 20 November 2024
New Labelling for formaldehyde releasers
On July 8th, the European Commission published the Commission Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009.
This Commission Regulation concluded that the formaldehyde threshold should be decreased as proposed by the SCCS.
As previously announced, Point 2 of the preamble of Annex V to Regulation 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.
However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026.”
European regulation on deforestation-free products
On 29 June 2023, the Regulation on deforestation-free products entered into force. This Regulation defines a product as deforestation-free when the product itself, its ingredients or its derivatives were not produced on land subject to deforestation or forest degradation after the cut-off date of 31 December 2020. The products most affected by this regulation include: cocoa, coffee, soy, palm oil, wood, rubber and cattle.
As of 29 June 2023, operators and traders will have 18 months to implement the new rules (until 30 December 2024). Micro and small enterprises will enjoy a longer adaptation period, as well as other specific provisions.
When the new rules enter into force, all relevant companies, including cosmetic companies that place on the EU market or export from it palm oil, cattle, soy, coffee, cocoa, timber, and rubber as well as derived products, have to put together a due diligence statement proving that their supply chains are deforestation-free.
Companies will also be required to collect precise geographical information on the farmland where the commodities that they source have been grown so that these commodities can be checked for compliance.
Updates to UK cosmetics regulation – Methyl-N-methylanthranilate
Regarding updates to the UK cosmetics regulation, it’s important to note that Cosmetic products containing Methyl-N-methylanthranilate, not in accordance with the new restrictions cannot be placed on the market on or after 6 July 2024.
The fragrance ingredient, Methyl-N-methylanthranilate, is included in Annex III/321 (list of substances which cosmetic products must not contain except subject to the restrictions laid down)
- 0.1% max. in leave-on products but not to be used in sunscreen products and products intended for exposure to natural or artificial UV light.
- 0.2% max. in rinse-off products.
- In both cases: Do not use with nitrosating agents. Maximum nitrosamine content: 50 µg/kg. Keep in nitrite-free containers.
A transition provision will allow them to be made available until 6 July 2026 (sell-off), after which any supply will be unlawful.
REFERENCES
- Commission Regulation (EU) 2022/2195 of 10 November 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and HAA299 in cosmetic products and correcting that Regulation as regards the use of Resorcinol in cosmetic products.
- The International Fragrance Association (IFRA) – Notification of the 51st Amendment to the IFRA Standards, 30 June 2023
- European Commission – General Product Safety Regulation (EU) 2023/988
- European Chemicals Agency (ECHA) – Registry of CLH intentions until outcome
- Comission Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009
- Regulation (EU) 2023/1115 of the European Parliament and of the Counci of 31 May 2023 on the making available on the Union market and the export from the Union of certain commodities and products associated with deforestation and forest degradation and repealing Regulation (EU) No 995/2010
- UK Statutory Instrument No. 764 – Consumer Protection – The Cosmetic Products (Restriction of Chemical Substances) Regulations 2023
