EC Publishes SCCS Notes of Guidance for Cosmetic Ingredients
On 15 May, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation.
The Notes of Guidance are updated approximately every three years to incorporate progress in the field of testing and safety evaluation of cosmetic ingredients. The notes, aim to provide guidance to public authorities and the industry to improved harmonised compliance with current EU cosmetic legislation (Regulation (EC) No. 1223/2009)
The updates emphasise the following aspects:
- The importance of systemic literature review
- Updating animal-free alternative methods, for example NAM (New Approach Methodology)
- The importance of Adverse Outcome Pathways, Next Generation Risk Assessments, Thresholds of Toxicological Concern and Integrated Approaches to Testing and Assessment
- Updating of in silico prediction possibilities
- Exposure data reviews
- Exposure of children to different product categories according to age
- The rationale behind exposure data when considering sun protection in sunscreen products
- Human biomonitoring
- Reporting requirements for CMR substances
- Reporting requirements for endocrine active substances
Washington’s New Cosmetic Ingredient Ban
Washington State Governor Jay Inslee has signed HB 1047 into law. The law, known as the Toxic Free Cosmetics Act, has raised concerns among industry trade groups regarding the availability, pricing and sourcing of effective alternatives to targeted preservatives.
The law will prohibit the manufacture, sale or distribution of cosmetic products containing nine chemicals or chemical classes, including formaldehyde releasing agents, perfluoroalkyl and polyfluoroalkyl substances (PFAS), triclosan, methylene glycol and mercury. The ban is set to take effect from 1 January 2025.
The industry has expressed apprehension about the lack of viable substitute preservatives to effectively and affordably replace targeted formaldehyde-releasing substances. Additionally, the laws inconsistency with FDA regulations on lead levels has raised concerns.
Industry stakeholders are advised to closely monitor the developments and potential impacts of this new legislation.
South Korea's New Sunscreen Ingredient
South Korea's Ministry of Food and Drug Safety (MFDS) has announced a draft amendment to its cosmetic regulations to include Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (MCE) as an approved raw material for sunscreen products.
Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (MCE) is currently recognised as a sunscreen raw material in Europe with a maximum concentration of 3%.
The proposed restriction limit for MCE is 3%. It is prohibited in products that may be inhaled into the lungs and products containing nitrating agents.
Cosmetic manufacturers wanting to use the new ingredient must apply to the MFDS for assessment.
The MFDS said:
“After reviewing the submitted data on the safety and effectiveness of MCE, the validity of its use was recognised. Therefore, we have made an administrative Advance Notice of the draft amendment to the ‘Regulations on Cosmetc Safety Standards”
The MFDS are collecting opinions on the proposed amendment until 4 July 2023. The revision is expected to be completed this year and effective six months after the revision date.
California Public Workshop on Microplastics
The California Safer Consumer Products (SCP) Program is seeking public comment on a proposal to add microplastics to the Candidate Chemicals List.
The Candidate Chemicals List identifies chemicals that require further safety evaluation due to potential adverse impacts on human health or the environment.
Given the growing concern over the potential adverse impacts of microplastics released to the environment, The Department of Toxic Substances Control (DTSC) are proposing to add microplastics to the Candidate Chemical List to evaluate consumer products that contain or release microplastics.
The DTSC have defined microplastics as:
“Solid polymeric materials to which chemical additives or other substances may have been added, which are particles having at least three dimensions that are less than 5,000 micrometers (μm). Polymers derived in nature that have not been chemically modified (other than by hydrolysis) are excluded.”
The virtual workshop will be held on 27 June 2023, 9.00-12.00pm PT / 12.00-15.00 ET. You can also submit written comments via CalSAFER.
Adding a chemical to the Candidate Chemicals List does not create any new regulatory obligations or any new regulated entities.
UN Countries Add 3 Substances to Annex A of the Stockholm Convention
On 5 May, more than 120 countries agreed to add two plastic chemicals and one pesticide to the Annex A of the Stockholm Convention.
Annex A of the Stockholm Convention on Persistent Organic Pollutants lists specific chemicals or groups of chemicals subject to stringent control measures and ultimately targeted for global elimination due to their adverse effects on human health and the environment.
The delegates found the chemicals met the Convention criteria as persistent organic pollutants required for a global ban.
The uses and hazards of the three chemicals are:
UV-328
For use in:
- Automotive paints, coatings, sealants, adhesives, plastics and rubbers to protect materials from UV light-induced degradation or color-change
- Additives and printing inks in the plastics and rubbers for outdoor furniture, construction materials and food packaging (in non-
- food contact layer) and wood products
Dechlorane Plus
For use in:
- Flame retardant in adhesives, sealants and polymers
- Used in cables, wires and in motor vehicles
Methoxychlor
For use in:
- Pesticide used to protect crops, ornamentals, livestock, and pets against fleas, mosquitoes, cockroaches, and other insects.
- Replacements for DDT
UN Chemical Report Released
The UN's "Chemicals in Plastics: A Technical Report," released on May 3, 2023, aims to raise awareness about the often overlooked chemical-related issues associated with plastic pollution.
The report highlights the negative impacts of plastics on human health, the environment, and the need for efficient resource usage and circularity. It stresses the urgent need for action and suggests potential areas for action supported by solid scientific evidence.
The report identified Brominated and organophosphorus flame retardants as a chemical of concern in the personal care product and household industry.
