New Substances Banned in EU Cosmetics from 1st September 2025.
The European Commission has proposed an amendment to Regulation (EC) No 1223/2009, which focuses on prohibiting the use of certain carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in cosmetic products. This amendment will align with Delegated Regulation (EU) 2024/197, set to take effect on 1st September 2025. The Delegated Regulation (EU) 2024/1973, will enforce the ban on substances classified under CMR categories by the European Chemicals Agency (ECHA). These categories indicate the level of evidence for their harmful properties:
- Category 1A: Known to have carcinogenic, mutagenic, or reproductive toxicity effects.
- Category 1B: Presumed to have carcinogenic, mutagenic, or reproductive toxicity effects.
- Category 2: Suspected to have carcinogenic, mutagenic, or reproductive toxicity effects.
Affected substances include:
- Trimethylbenzoyl Diphenylphosphine Oxide: Previously allowed in artificial nail systems at a concentration of up to 5%, this substance will now be prohibited due to its classification as a category 1B reproductive toxicant.
- Cymoxanil: Already listed in Annex II as prohibited, its entry will be updated to include additional chemical names and CAS numbers for clarity and legal certainty
- Additional CMR substances not previously listed will be added to the prohibited substances list in Annex II of Regulation (EC) No 1223/2009.
Substances currently in use under certain conditions will either be removed from the list of allowed substances or their usage conditions will be amended accordingly. Manufacturers and distributors must ensure compliance by the effective date to avoid market disruptions.
This regulatory update underscores the EU's commitment to consumer safety and the responsible use of chemicals in cosmetics. Companies within the cosmetic industry will need to review their product formulations and supply chains to ensure they meet the new standards by September 2025. This might involve reformulating products, sourcing alternative ingredients, or even discontinuing certain products.
For those seeking further details on these changes, the full list of substances, official documentation and guidelines can be accessed through the European Commission's publications.
Halal Cosmetics: Growing Demand and Regulatory Changes.
Halal cosmetics are experiencing a surge in global demand, driven by increasing consumer awareness of ethical and clean beauty products. Halal, an Arabic term meaning "permissible," refers to products that comply with Islamic law, particularly in terms of ingredients and manufacturing processes.
Halal cosmetics must not contain any ingredients derived from haram (forbidden) sources, such as pigs, carnivorous animals, or alcohol. The entire production process, from sourcing to manufacturing and packaging, must adhere to Islamic guidelines to ensure purity and cleanliness. This includes avoiding cross-contamination with non-halal substances and ensuring ethical treatment of workers and animals.
The halal cosmetics market is expanding rapidly, with significant growth observed in regions such as Southeast Asia, the Middle East, and North Africa. Consumers are increasingly seeking products that align with their religious beliefs and ethical values. Additionally, non-Muslim consumers are drawn to halal products for their perceived purity and natural composition.
Regulatory Developments:
Vietnam is taking proactive steps to regulate halal products and services, reflecting the increasing demand and importance of halal certification. On June 25th 2024, Vietnam’s Ministry of Science and Technology (MOST) announced the drafting of a "Decree on the Management of Halal Products and Services." This decree aims to standardise the halal certification process and ensure compliance with international standards, facilitating the growth of the halal industry in Vietnam.
The Indonesian Halal Product Assurance Organising Agency (BPJPH) recently reinforced the need for clear labelling of non-halal products. According to BPJPH guidelines, non-halal products must have distinct markings on their packaging, ensuring consumers are well-informed about the nature of the products they purchase. This includes clear text or imagery indicating the presence of non-halal ingredients such as pork.
While the halal cosmetics market offers significant growth opportunities, it also presents challenges. Companies must navigate complex certification processes and ensure compliance with diverse regional standards. Collaboration with local certification bodies and a deep understanding of halal requirements are essential for success in this market.
Halal cosmetics represent a dynamic and rapidly growing sector within the beauty industry. With increasing consumer demand and evolving regulatory frameworks, such as the new decree in Vietnam, the market is poised for continued expansion. Companies that prioritise compliance with halal standards and ethical practices are well-positioned to capitalise on this burgeoning market.
UK's Alignment with the 14th and 15th ATP in the CLP Regulation.
The UK is making significant strides towards aligning with the 14th and 15th Adaptations to Technical Progress (ATP) under the Classification, Labelling, and Packaging (CLP) Regulation. This effort marks a crucial step in ensuring harmonisation with European Union standards despite Brexit.
The CLP Regulation, essential for the safe handling and labelling of chemicals and mixtures, undergoes periodic updates through ATPs. The 14th and 15th ATPs introduce revised classifications for various substances, addressing their hazardous properties and updating labelling requirements accordingly.
The UK's commitment to adopting these ATPs underscores its dedication to maintaining high standards of chemical safety and regulatory compliance post-Brexit. By aligning closely with EU regulations, the UK aims to facilitate seamless trade and ensure consistency in hazard communication across borders.
These updates are pivotal for industries dealing with chemicals, as compliance ensures safety in handling and transport, enhances consumer protection, and supports environmental stewardship.
For further details on the implementation timeline and specific changes introduced by the 14th and 15th ATPs, refer to the official CLP Regulation updates and guidance provided by relevant regulatory bodies.
MoCRA Registration Deadline Passes.
The deadline for cosmetic product manufacturers to comply with the new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has officially passed. Cosmetic manufacturers and distributors operating in the United States were required to ensure that their facilities were registered with the FDA and that all marketed cosmetic products were listed with the agency by 1st July 2024. This regulatory measure aimed to enhance transparency and regulatory oversight within the cosmetic sector, ensuring consumer safety and product quality.
Leading up to the enforcement date, the FDA provided guidance and resources to assist in how to comply with the updated regulations. This included detailed instructions on how to register facilities and list products using the FDA's electronic submission systems.
The compliance deadline represented a critical juncture for the cosmetic industry, prompting companies to review their operations and ensure alignment with the FDA's updated requirements. By meeting these obligations, businesses aimed to maintain their market presence and uphold consumer trust in the safety and integrity of their cosmetic products.
Moving forward, ongoing compliance with FDA regulations remains essential for companies such annual updates, including details of any product discontinuation and registration renewal every two years. The enforcement of facility registration and product listing requirements signifies a proactive step towards ensuring that cosmetic products marketed in the United States meet stringent safety standards and regulatory scrutiny.
A Recent Update to Endocrine Disruptor (ED) Lists in June 2024.
In June 2024, significant updates were made to the Endocrine Disruptor (ED) lists in the European Union, reflecting changes in regulations concerning chemicals suspected or identified to disrupt the hormonal system. The primary goal of edlists.org is to enhance transparency, coherence, and consistency across EU legislative frameworks concerning EDs. By consolidating this information into two main lists (List I and II), aligned with regulations such as REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals; (EC) 1907/2006), BPR (Biocidal Products Regulation; (EU) 528/2012, and (EU) 2017/2100), PPPR (Plant Protection Products Regulation; (EC) 1107/2009, and (EU) 2018/605), and CR (Cosmetic Products Regulation; (EC) 1223/2009), the website facilitates easier access to crucial data for regulatory compliance and decision-making.
List I Updates: Several substances have been added to List I following the legal adoption of proposals identifying them as endocrine disruptors:
- Propiconazole
- Cyanamide
- DBNPA
- Asulam
- Benthiavalicarb
- Dimethomorph
- Metiram
- Mepanipyrim
- Clofentezine
- Triflusulfuron-methyl
List II Updates: The following substances have been newly added to List II with specific regulatory intentions:
- Sodium Fluoride: ED HH CLH intention submitted
- 3-aminopropyldiethylamine: ED HH CLH intention submitted
- Mono- and di-phthalate esters with linear and/or branched alkyl moieties: ED HH and ENV CLH intention submitted
- Tris(4-nonylphenyl, branched) phosphite: SVHC ED ENV intention submitted
Substances removed or with altered regulatory statuses include:
- 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]: SVHC ED intention no longer available
- Thiophanate-methyl: Concluded ED in EFSA opinion, not yet legally adopted
- 4,4'-isopropylidenedi-2,6-xylol
- 4,4'-isopropylidenebis[2-allylphenol]
- 2,4,6-tribromophenol
- 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bisethyl diacetate
- (1-methylethylidene)bis(4,1-phenyleneoxy-3,1-propanediyl) bismethacrylate
- Tris[2-chloro-1-(chloromethyl)ethyl] phosphate: Withdrawn from CoRAP
- 4-tert-butylphenol: REACH substance evaluation concluded ED ENV + ED HH unresolved, already on List I
- 2-Ethylhexyl trans-4-methoxycinnamate: Substance evaluation concluded, ED inconclusive
- Benzophenone-4: SCCS evaluation finalised
- Butylparaben: SCCS evaluation finalised, still on List I
- Benzyl salicylate: SCCS evaluation finalised
List III Updates: Denmark has added the following substance to List III due to its evaluation as an ED for Human Health (HH):
- Reaction products of phosphoryl trichloride and 2-methyloxirane (TCPP).
