Taiwan Amends the List of Prohibited Ingredients in Cosmetics
On 13th December 2023, Taiwan Food and Drug Administration (TFDA) introduced draft amendments to the List of Prohibited Ingredients in Cosmetics. These amendments were finalised on 21st March 2024, and the majority of them are set to take effect on 1st January 2025.
The amendment includes:
Updates the regulation of two ingredients:
- Cells, tissues, or products of human origin: Companies or individuals reviewed and approved by the central competent authority are not restricted.
- Zirconium and its compounds: Zirconium lakes, salts, pigments used as colourants in cosmetics, and other specified ingredients are not restricted.
The addition of 9 prohibited substances:
- Aminocaproic acid（INN）and its salts
- 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC)
- 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol)
- 3-Chloro-2,6-Dihydroxy-4-methylbenzaldehyde (chloroatranol)
- Perfluorooctane sulfonic acid; heptadecafluorooctane-1- sulfonic acid [1], Potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate [2], Diethanolamine perfluorooctane sulfonate [3], Ammonium perfluorooctane sulfonate; Ammonium heptadecafluorooctanesulfonate [4], Lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate [5]
- Ammonium pentadecafluorooctanoate
- Perfluorooctanoic acid
- Nonadecafluorodecanoic acid [1], Ammonium nonadecafluorodecanoate [2], Sodium nonadecafluorodecanoate [3]
- Perfluorononan-1-oic acid [1], and its sodium [2], and ammonium [3] salts
Sephora Launches Two Global Sustainability Seals
This week, at the ChangeNow summit in Paris Sephora announced the launch of their two global sustainability seals:
- Clean at Sephora; &
- Planet Aware at Sephora.
The aim is to increase Sephora’s transparency and standardisation across its stores globally. The seals are due to be introduced in April in an effort to harmonise Sephora’s environmental commitment and formulation communications globally.
The seals took over two years to develop with input from collaborating with external environmental and scientific exports. They are designed to encourage beauty brands towards more responsible product development and transparency, with criteria set for ingredients, sourcing, packaging, and corporate commitments.
The seals build on Sephora’s sustainability efforts which began in 2018. Sephora’s seals have been known locally in the US, Europe and other regions but Sephora recognised a need for global harmonisation across its stores. It will also lead to a significant increase in its sustainable product offering.
The seals will be introduced in phases across North America, Europe, the U.K., the Middle East, Brazil, Mexico, and are planned for China by 2025.
US: California - Reporting Requirements for Additional EU Allergens Postponed to align with EU deadlines
On 27th March 2024, the California Department of Public Health (CDPH) announced that their Reportable Ingredients List (RIL) has been updated to align transition periods for reporting additional EU allergens with the EU. Under the Cosmetic Fragrance and Flavour Ingredient Right to Know Act (CFFIRKA) or SB312 as it is more commonly known, a manufacturer of a cosmetic product sold in the State of California shall report a list of each fragrance allergen included in Annex III of the EU Cosmetics Regulation No. 1223/2009 to CDPH no later than the timelines required under the EU law.
As a reminder the deadlines in the EU are as follows:
- 31st July 2026 - after this date no stock shall be manufactured without being compliant to the EU Extended Allergens Regulation
- 31st July 2028 - after this date no stock shall be sold on the EU market without being compliant to the EU Extended Allergens Regulation
If manufacturers choose to do so, they may report extended fragrance allergens at any time before the above deadlines. CFFIRKA does not require to label allergens on pack.
South Korea’s Ministry of Food and Drug Safety (MFDS) announces three main initiatives for the cosmetics industry in 2024
The South Korean Ministry of Food and Drug Safety (MFDS) announced three main initiatives for the cosmetics industry in 2024. The aim is to echo international standards and promote industrial growth through safety management.
- Implementation of a proactive safety network based on science:
Establishing cosmetics safety assessment for echoing the global market and supporting cosmetic exports:
- Expansion of the East Asia Cosmetics Beauty Forum;
- Enhanced provision of global regulatory information for the domestic cosmetics industry; and
- Enhancement of industry competitiveness through the establishment of the cosmetics safety assessment system.
Ensuring consumer safety by strengthening distributed cosmetics’ safety and quality:
- Promotion of ingredient evaluation based on domestic and international research data and regulatory trends;
- Improvement of the reliability of private human application testing institutions for cosmetics by adopting autonomous management; and
- Quality inspection of cosmetics and education on the safe use of cosmetics for consumers.
- Implementation of safety & welfare that allows everyone to enjoy at any time
Introducing cosmetic e-labeling to improve product labelling and advertising:
- Implementation of the "Cosmetics e-label pilot project" to conserve resources and improve cosmetic label’s readability; and
- Optimization of the labelling items on the external packaging of cosmetics.
Enhancing the management of customised cosmetics for safety consumption:
- Classification of eyelash perm products as cosmetics; and
- Improvement of labelling and documentation requirements for small-volume cosmetics.
- Innovation of Regulation
Operating communication platform "Jump Up K-Cosmetic" for regulatory improvement and industry support:
- Operation of five subcommittees: System, Safety, Standards and Evaluations, Manufacturing and Quality, Qualifications and Education, with participation of government, industry, and relevant agencies (approximately 80 members);
- Addition of a Task Force for labelling and advertising;
- Promotion of regulatory improvement tasks;
- Allowance of hair dye products applied through automated devices;
- Autonomy of credible standards for various certification institutions involved in labelling and advertising;
- Establishment of a new application process for lifting the ban on prohibited ingredients;
- Permission for cosmetics (shampoo, conditioner, body wash, liquid soap) refill stores without the presence of a manufacturing manager.
One noteworthy initiative is the cosmetics safety assessment system, which marks a shift from a government-centric approach merely outlining prohibited and restricted ingredients, to a framework highlighting the voluntary accountability of businesses.
The implementation direction involves companies presenting evidence of their cosmetics' safety, maintaining relevant data, and receiving assistance from government-assigned technology and evaluation personnel. The Ministry of Food and Drug Safety (MFDS) plans to gather and develop safety assessment data for each ingredient, disseminating it to cosmetic firms through a unified government platform. Moreover, MFDS aims to conduct training programs to nurture specialised professionals and release instructional materials.
MFDS also aims to establish a roadmap for the new system, develop standards for selecting products covered by the scheme, and offer a comprehensive support plan.
EU: Tea Tree Oil facing a ban in cosmetic products
The European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) have published their final opinion on Tea Tree Oil. The RAC opinion confirms that tea tree will be classified as a CMR 1B (reprotox) under the EU Classification, Labelling and Packaging (CLP) Regulation. Therefore, it will be part of the 23rd Adaptation to Technical Progress (ATP) to EU CLP.
Substances classed as CMRs are banned for use in cosmetic products, unless industry applies for an exemption by demonstrating safe use according to specific criteria. CMR class 1A & 1B must fulfil the following conditions within Article 15(2) before being allowed to be used in cosmetic products:
(a) they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
(b) there are no suitable alternative substances available, as documented in an analysis of alternatives;
(c) the application is made for a particular use of the product category with a known exposure; and
(d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.
It is thought that industry is preparing a defence but this does not mean the defence will be successful so it is likely the ban will take place. In the UK, tea tree oil is not currently going through the GB CLP mandatory classification process so the ban will not apply in the UK unless HSE decides to review this substance.
