UK Seeks Industry Expertise on Nanomaterials
The UK's Office for Product Safety and Standards (OPSS) has issued two "calls for data" on nanomaterials used in cosmetics and the safety of cosmetic chemicals. To ensure the ongoing safety of consumers the OPSS invites interested parties, including academia and manufacturers of cosmetic products to share scientific information on safety assessments.
Seven cosmetic nanomaterials are of particular interest, including surface functionalised variants, alloys or other related variants, namely, platinum, copper, silver, colloidal silver, gold, colloidal gold, gold thioethylamino hyaluronic acid, lithium magnesium sodium silicate and hydroxyapatite (nano).
The deadline for submission of these materials is 22 December 2023.
Silica and its variants, such as hydrated silica, silica silylate, and silica dimethyl silylate, are also of interest. Interested parties should submit data by 27 June 2025.
Data submitted should include the findings from the Scientific Committee on Consumer Safety (SCCS) Guidance on the Safety Assessment of Nanomaterials in Cosmetics, Guidance for the Testing of Cosmetic Ingredients in their evaluation.
ECHA Public Consultation
The ECHA has announced public consultations on the following proposals for harmonised classification and labelling:
- 4,4'-methylenediphenol; bisphenol F (EC: 210-658-2; CAS: 620-92-8). Chemical registered under REACH. Health hazard class open for commenting.
Submission deadline: 29 September 2023.
- bronopol; 2-bromo-2-nitropropane-1,3-diol (EC: 200-143-0; CAS: 52-51-7). Biocide active substance. All hazard classes open for commenting.
Submission deadline: 29 September 2023.
- 2-(4-tert-butylbenzyl) propionaldehyde (EC: 201-289-8; CAS: 80-54-6) 4-tert-butylbenzoic acid (EC: 202-696-3; CAS: 98-73-7); 3-(4-tert-butylphenyl)propionaldehyde (EC: 242-016-2; CAS:18127-01-0); 4-tert-butyltoluene (EC: 202-675-9; CAS: 98-51-1); 4-tert- butylbenzaldehyde (EC: 213-367-9; CAS: 939-97-9); methyl 4-tert-butylbenzoate (EC: 247- 768-5; CAS: 26537-19-9). Chemicals registered under REACH. Health hazard class open for commenting.
Submission deadline: 22 September 2023
- p-cymene; 1-isopropyl-4-methylbenzene (EC: 202-796-7; CAS: 99-87-6); 3-p-cumenyl-2-methylpropionaldehyde; 2-methyl-3-(4-isopropylphenyl)propanal (EC: 203-161-7; CAS: 103- 95-7); 3-(p-cumenyl)propionaldehyde3-(4-isopropylphenyl)propanal (EC: 231-885-3; CAS:7775-00-0); 4-isopropylbenzaldehyde; cuminic aldehyde (EC: 204-516-9; CAS: 122-03-2); 4-isopropylbenzoic acid; cuminic acid (EC: 208-642-5; CAS: 536-66-3). Chemicals registered under REACH. Health hazard class open for commenting.
Submission deadline: 22 September 2023
UK businesses are strongly encouraged to share any relevant information. Scientific and technical information should be submitted directly to the ECHA using their webform.
Comments will be made public on the ECHA website.
Indonesia Amends Required Documents for Product Information File (PIF)
On 2 August, the Indonesian Food and Drug Supervisory Agency (BPOM) finalised and implemented the Guidelines for Product Information File (PIF).
The Guidelines were developed to assist cosmetics companies compiling the PIF and provide guidance to BPOM officials during PIF reviews. A brief overview of the requirements can be found below.
The Guidelines categorise documents to be included in the PIF into four types, providing explicit standards these types must adhere to.
- Administrative Documents
For imported cosmetics:
- A copy of the agency appointment letter
- A copy of the contract between cosmetic company and product notifier
- Certificate of Free Sale
- GMP certificate
- Statement letter of lawful directors and/or leaders
For domestic cosmetics:
- Business registration number
- GMP certificate
- Licence agreement between brand owner and product notifier
- Cosmetic product licence
- Statement letter of lawful directors and/or leaders
- Cosmetic Ingredient Quality and Safety
Quality data:
- The specification of each ingredient and quality specification certificate i.e. a certificate of analysis
- Analytical methods used for specification
- The manufacturing process
Safety data:
- Data from suppliers
- Published data or reports from scientific committees i.e. ASEAN Cosmetic Scientific Body or the EU Scientific Committee on Consumer Safety (SCCS)
- Empirical evidence
- Cosmetic Product Quality Data
- The INCI name, function and concentration of the all ingredients used in the finished product
- A summary of the manufacturing process, including information about quality control and the batch numbering system
- Cosmetic specifications including contamination control and ingredients purity
- Stability Data
- Safety and Efficacy Data
- Product safety assessment report based on ingredients, chemical structure and exposure level
- CV of technical responsible person or safety assessor
- Adverse reaction monitoring reports
- Signed efficacy evaluation report including supporting data
- A copy of the labelling on the primary and secondary packaging
The Guidelines revises the retention time of the PIF to a minimum of one year after the expiration date of the last cosmetic produced or imported. PIF version history must be documented and incorporated into the PIF.
EU Active Substances Expiry Dates Postponed
The following active substance expiry dates have been postponed whilst the renewal evaluation is completed in the EU
- 2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1SR,3SR)- 2,2-dimethyl-3-prop-1-enylcyclopropanecarboxylate (Metofluthrin) (CAS 240494-71-7 EC n/a) in product type 18
From 31 October 2023 to 31 October 2024
- Reaction mass of (R)-α-cyano- 3-phenoxybenzyl (1S,3S)-3-[(Z)-2- chloro-3,3,3-trifluoropro-penyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3- trifluoropropenyl]-2,2- dimethylcyclopropanecarboxylate (1:1) (lambda-cyhalothrin) (CAS 91465-08-6 EC 415-130-7) in product type 18
From 30 September 2023 to 31 March 2026
- (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2- dimethylcyclopropanecarboxylate (Deltamethrin) (CAS 52918-63-5 EC 258-256-6) in product type 18
From 30 September 2023 to 31 March 2026
- Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 (CAS n/a EC n/a) inproduct type(s) 18
From 30 September 2023 to 31 March 2026
Suppliers wishing to market new biocidal products containing these active substances can apply for EU BPR product authorisation.
China to Develop Toothpaste Efficacy Evaluation Standards
On 8 August, China’s National Institute for Food and Drug Control issued an announcement detailing plans to formulate the following toothpaste efficacy evaluation standards:
- Efficacy Evaluation of Toothpaste: General Principles
- Efficacy Evaluation of Toothpaste: Anti-caries
- Efficacy Evaluation of Toothpaste: Control of Dental Plaque
- Efficacy Evaluation of Toothpaste: Anti-dentin Hypersensitivity
- Efficacy Evaluation of Toothpaste: Gum Problems Alleviation
The standards will serve as a foundation for evaluating toothpaste efficacy.
Toothpastes marketed in China must comply with the Administrative Measures on Toothpaste by 1 December 2023. The Measures require toothpaste notifiers to publish research data, literature or product efficacy evaluation summary substantiating any product claims made. The efficacy evaluation summary should include test methods, items, institutions and conclusions.
Toothpaste manufacturers are encouraged to review their labels, and ensure no efficacy claims have been made without a scientific basis.
