California Updates Reportable Ingredients List
California has issued a notification of corrections to CSCP’s Reportable Ingredients List.
California’s Safe Cosmetic Program (CSCP) requires companies to report certain ingredients used in cosmetics. The purpose of the program is to collect information on hazardous and potentially hazardous ingredients in cosmetics products and make this information publicly available.
The following changes to listed ingredients have been made:
- 2-(4-tert-Butylbenzyl)propionaldehyde (CAS RN 80-54-6): Added EC Annex VI CMRs - Cat. 1B as an authoritative source and Reproductive Toxicity hazard trait. This clarifies that the ingredient, also known as Lilial and Butylphenyl methylpropional, is reportable at any concentration.
- Beta-myrcene (CAS RN 123-35-3): Added Prop 65 as an authoritative source
- Talc-based body powder (perineal use of) (CAS RN 14807-96-6): Added entry due to erroneous exclusion in previous version
- Added the following specific glycol ether entries, in addition to the existing non-specific listing of “glycol ethers”:
- 2-Butoxyethyl acetate (CAS RN 112-07-2)
- 2-(4-Methylphenoxy)ethanol (CAS RN 15149-10-7)
- 2-Phenoxyethanol (CAS RN 122-99-6)
- 2-Phenoxyethyl isobutyrate (CAS RN 103-60-6)
- 2-Phenoxyethyl propionate (CAS RN 23495-12-7)
- Diethylene glycol monobutyl ether (CAS RN 112-34-5)
- Diethylene glycol monomethyl ether (CAS RN 111-77-3)
- Diethylene glycol monoethyl ether (CAS RN 111-90-0)
- Silica, crystalline (airborne particles of respirable size) (CAS RN 14464-46-1; 14808-60-7; 15468-32-3; 7631-86-9): Combined multiple entries; added CAS numbers from authoritative sources
- Silica (CAS RN 1333-86-4): Removed incorrect CAS RN
In addition, the instructions for reporting fragrance allergens has been updated to clarify that fragrance allergens must be reported regardless of their intended purpose in the product.
SCCS Publishes Preliminary Opinion on Benzyl Salicylate
In light of data provided and concerns related to the potential endocrine disrupting properties of benzyl salicylate, the SCCS have issued the following recommendations for maximum use concentrations of benzyl salicylate in cosmetic products.
- Hydroalcoholic-based fragrances (spray and non-spray) - 4
- Rinse-off skin & hair products (except rinse off body products) - 0.5
- Rinse off body products - 1.3
- Leave on skin & hair products (non-spray/non-aerosol)(except body
lotion) - 0.5
- Leave on hair products (spray/aerosol) - 0.5
- Leave on body products (non-spray/spray/aerosol) - 0.7
- Face make-up products and make-up remover - 0.2
- Oral care - 0.004
- Deodorant products (spray/aerosol) - 0.91
The SCCS considers benzyl salicylate safe when used up to these maximum concentrations and confirms the available data provides some indications for an endocrine mode of action, but there is norevidence that this results in potential endocrine effects.
The opinion is open for comments until 24 August 2023.
Implementation Plan for New Hazard Classes
The ECHA has provided an implementation plan for the new hazard classes.
New hazard classes:
Endocrine disruption
Class code:
- ED HH Cat 1 and Cat 2
- ED ENV Cat 1 and Cat 2
Hazard statements:
- ED HH 1 EUH380 May cause endocrine disruption in humans
- ED HH 2 EUH381 Suspected of causing endocrine disruption in humans
- ED ENV 1 EUH430 May cause endocrine disruption in the environment
- ED ENV 2 EUH431 Suspected of causing endocrine disruption in the environment
Guidance currently available: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5311
Persistent, Bioaccumulative, Toxic
Class code:
- PBT, vPvB
Hazard statements:
- PBT EUH440 Accumulates in living organisms including in humans
- vPvB EUH441 Strongly accumulates in living organisms including in humans
Guidance currently available: https://echa.europa.eu/documents/10162/17235/information_requirements_part_c_en.pdf/e56a6015-807e-46eb-b808-e5a7dc9fd572?t=1498474748441
Persistent, Mobile, Toxic
Class code:
- PMT, vPvM
Hazard statements:
- PMT EUH450 Can cause long-lasting and diffuse contamination of water resources
- vPvM EUH451 Can cause very long-lasting and diffuse contamination of water resources
Revision of the CLP Guidance will take place this month. Publication of the guidance is expected by Spring 2024. Once the CLP revision is adopted, all SVHCs in the Candidate List and Active Substances for Biocides and Plant Protection Products assessed will be automatically transferred to Annex VI.
European Commission Calls for Data on CBD Safety
The European Commission is calling for data on the safety of cannabidol (CBD) in cosmetic products. The call follows France's attempt to issue a Europe-wide ban on CBD containing cosmetic products.
The ECHA has been notified of France’s intention to ask for the harmonising classification and labelling of CBA based on the “potential to cause reproductive toxicity”. If the risk assessment committee opinion falls in line with the French view, CBD will be classified as a CMR substance and banned from use in any cosmetic products on the EU Market.
Industry stakeholders are invited to submit data on the safety of CBD by 1 October 2024
China Consults on Updates to Prohibited ingredients and Toxicological Test Methods
China’s National Institute for Food and drug Control (NIFDC) has initiated a public consultation on proposed updates to the Inventory of Prohibited Ingredients for Cosmetics.
The following ingredients are proposed additions to the Inventory:
- Bimatoprost (CAS No. 155206-00-1)
- Latanoprost (CAS No. 130209-82-4)
- Tafluprost (CAS No. 209860-87-7)
- Tafluprost ethyl amide, (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-Difluoro-4-phenox y-1-buten-1-yl]-3,5-dihydroxycyclopentyl}-N-ethyl-5- heptenamide (CAS No 1185851-52-8)
- Travoprost (CAS No 157283-68-6)
The draft test methods for the toxicological test of cosmetic ingredients, listed below, have been developed for review according to OECD guidelines.
- 28-Day Inhalation Toxicity Study
- 90-Day Inhalation Toxicity Study
- Extended One-generation Reproductive Toxicity Study
- Two-generation Reproductive Toxicity
- Skin Absorption In-vivo Method
- Acute Inhalation Toxicity Acute Toxic Class Method
- U937 Cell Line Activation Test
Industry stakeholders are invited to provide feedback until 15 July 2023 by submitting an Opinion Feedback Form via email to hzpbwh@nifdc.org.cn.
South Korea to Introduce Microplastic Control Act
On 5 June, South Korea’s Environment and Labour Committee proposed to legislate the Special Act on Microplastic Reduce and Control (Act).
The act defines microplastics as solid plastic particles less than five millimetres in diameter that are insoluble in water. The Act distinguishes between microplastics that are artificially or intentionally manufactured to be utilised for specific functions, primary microplastics and those generated in the process of using plastic products, secondary microplastics.
The Act establishes the following requirements:
- Businesses are required to take necessary measures to reduce and manage the generation and emission of microplastics in all links in the reproductive chain.
- The Minister of Environment must establish and implement a comprehensive plan for microplastic management.
- Products containing primary microplastics over the safety standard are prohibited from being manufactured or imported.
- The government shall conduct microplastic research and development to prevent and manage health damage caused by microplastics.
EU Proposes 11 Changes to Use Requirements for Cosmetic Ingredients
The European Commission has proposed 11 changes to the ingredients listed in Regulation (EC) No. 1223/2009.
The draft proposes to prohibit and restrict the use of certain ingredients.
List of Prohibited Ingredients: One added
- 4-Methylbenzylidene Camphor (CAS No. 36861-47-9 / 38102-62-4)
List of Restricted Ingredients: Eight added
- Genistein (CAS No. 446-72-0) at 0.007% max concentration in all cosmetic products.
- Daidzein (CAS No. 486-68-8) at 0.02% max concentration in all cosmetic products.
- Kojic Acid (CAS No. 501-30-4) at 1% max concentration in face and had products.
- Retinol (CAS No. 11103-57-4) at 0.05% max concentration in body lotion.
- Retinyl Acetate (CAS No. 127-47-9) at 0.3% max concentration in leave on and rinse of products.
- Retinyl Palmitate (CAS No. 79-81-2) at 0.3% max concentration in leave on and rinse of products.
- Alpha-Arbutin (CAS No. 84380-01-8) at 2% max concentration in face creams.
- Alpha-Arbutin (CAS No. 84380-01-8) at 0.5% max concentration in body lotions.
- Arbutin (CAS No. 497-76-7) at 7% max concentration in face creams.
List of Permitted Preservatives: Two revised
- Triciocarban (CAS No. 101-20-2) revised to 0.2% max concentration in all cosmetic products with the exception of mouthwash. The chemical is not to be used in toothpaste intended for children under 6 years of age.
- Triclosan (CAS No. 3380-34-5) revised to 0.3% max concentration in toothpastes, soaps, shower gels, deodorants, face powders, nail products for cleaning. The chemical is not to be used in toothpaste intended for children under 6 years of age.
The draft proposal is open for comments until 7 August 2023.
Bulletin Update:
- FDA issues guidance on preventing contamination in tattoo inks: https://www.fda.gov/media/169265/download#:~:text=Food%20and%20Drug%20Administration%2C%20%E2%80%9CFDA,%2Dor%2Dselling%2Dcertain%2D
- ECHA public consultation: call for comments on the following proposal for harmonised classification and labelling (CLH): 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol (EC: 204-279-1; CAS: 118-82-1). Deadline: 31 July 2023
- The European Flavour Association (EFFA) note hydroxyacetone(CAS 116-09-6, has been self-classified as H341 (MUT 2) in the REACH dossier: https://echa.europa.eu/registration-dossier/-/registered-dossier/27189
- Deadline to submit comments on MoCRA labelling requirements, facility registration and product listing program closes 30 June 2023.
- China’s Measures for Toothpaste Supervision and Administration will be formally implemented on 1 December 2023.
