New EU Active Substance Approval Decision
The EU BPR has approved the active substance/product type combination:
- Reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and related compounds in product types 2 and 4.
Suppliers must apply for EU BPR product authorisation by 1 February 2025 to continue supplying these products in Northern Ireland. New products may not be supplied in Northern Ireland until product authorisation is granted.
Suppliers may need to apply for technical equivalence. Suppliers that have not demonstrated technical equivalence for their manufacturing source will not be granted product authorisation.
Argentina Prohibits Three Substances in Personal Care Products
Argentina's National Administration of Food and Drugs (ANMAT) has implemented Provision 5978/2023, which bans three specific substances from personal care products. These substances are:
- -4-Amino-3-hydroxytoluene, 1,2,4-Trihydroxybenzene,
- 2-[(4-amino-2-nitrophenyl)-amino]-
- Benzoic acid
The European Union's Scientific Committee on Consumer Safety (SCCS) has previously reviewed these substances in the context of hair and eyelash dyes and found them to be genotoxic and mutagenic, making their use in cosmetics unsafe. Drawing on this scientific evidence, the European Commission amended Annex II of Regulation No. 1223/2009 to restrict the use of these compounds in cosmetics.
ANMAT has adopted a similar stance based on the EU's findings, thereby prohibiting these substances in Argentina. Companies that produce or import cosmetic products containing these banned chemicals have until November 2, 2023, to make necessary revisions, change formulations, and update labelling. Non-compliance may result in penalties as stipulated by local laws. Provision 5978/2023 came into force upon its publication in the Official Gazette and must be submitted to various authorities, including the National Directorate of the Official Registry and the Argentine Chamber of the Industry of Personal Hygiene, Cosmetics, and Perfumery Products.
US CPSC Request for Information on PFAS
The US Consumer Product Safety Commission (CPSC) seeks information on per- and polyfluoroalkyl substances (PFAS) in consumer products and potential health impacts. Stakeholders, including consumers, manufacturers, and researchers, are invited to provide insights on PFAS presence, human exposure, and potential health effects. The comment period is open until 20 November 2023.
All submissions must include the agency name and docket number. CPSC may post all comments without change, including any personal identifiers, contact information, or other personal information provided.
Comments may be submitted here.
US Proposes Trichloroethylene (TCE) Ban
On 23 October, the U.S. Environmental Protection Agency (EPA) introduced a significant proposal to ban the use of trichloroethylene (TCE) due to its severe health risks, including cancer, neurotoxicity, and reproductive toxicity. TCE is commonly found in cleaning products, degreasers, and various industrial applications. The proposal under the Toxic Substances Control Act aims to prohibit TCE for most uses within a year, protecting workers and communities. Strict worker protection measures are also enforced for specific applications. The EPA is seeking public input for 45 days, promoting public health and a cleaner environment.
India Unveils Chemical Inventory Platform
The Department of Chemicals and Petrochemicals (DCPC), Government of India, is launching the Indian Chemical Inventory through the ChemIndia platform.
This initiative aims to gather comprehensive data on the chemical and petrochemical industry, including production, capacity, exports, imports, and chemical properties. The database includes additional qualifiers like CAS and IUPAC names for import-export data. This project empowers industries by providing real-time data collection, analysis, and storage, significantly reducing manual processes' costs and administrative burden. The Indian Chemical Inventory enhances data processing capabilities, encourages collaboration, and promotes informed decision-making and strategic planning.
ECHA to Prepare Restriction Proposal on Chromium (VI) Substances
The European Chemicals Agency (ECHA) has been tasked by the European Commission to create a restriction proposal targeting at least two Chromium (VI) substances due to their carcinogenic nature. The proposal aims to enhance safety for workers and the environment.
There are 11 entries for Cr (VI) substances (entries 16-22 and 28-31) on the REACH Authorisation List. These substances are classified as carcinogenic (1A or 1B) and exposure to them poses a risk to both workers and the general population when exposed via the environment.
The proposed restriction will cover at least the following two Cr(VI) substances:
- Chromium trioxide (CrO3) - Annex XIV entry 16
This particular Cr(VI) substance is responsible for the majority of applications for authorisation.
- Chromic acid (H2Cr2O4) - Annex XIV entry 17
The substances are commonly used in surface finishing processes.
ECHA will submit the proposal by 4 October 2024. The Commission expects that a restriction could be adopted approximately 3 years after the receipt of the mandate by ECHA.
Compliance Date for Poison Centre Notifications Approaching
Importers and downstream users of industrial-use-only mixtures must prepare for the upcoming compliance date on 1 January 2024. From this date, all poison centre notifications (PCNs) must meet harmonised information requirements as specified in Annex VIII of the CLP Regulation. Industrial-use-only mixtures are exclusively used within industrial premises and include products like automotive paints.
There will be a one-year transitional period. Notifications for existing mixtures will remain valid until 1 January 2025. The harmonised information includes full chemical composition, toxicological information, product details, and the unique formula identifier (UFI). Industrial use mixtures can use a "limited submission" option with certain safety protocols.
Industrial-use-only mixtures are used exclusively within industrial premises and remain inaccessible to both consumers and professionals, whether in their final product form or through any dilution achieved by reformulation, such as mixtures within mixtures (MiM).
PCNs can be prepared and submitted to the European Chemicals Agency (ECHA) using the International Uniform Chemical Information Database (IUCLID). More information is available on the ECHA Poison Centre Website: https://poisoncentres.echa.europa.eu/.
AICIS Annual Declaration Deadline Approaching
The deadline for submitting the annual declaration to the Australian Industrial Chemicals Introduction Scheme (AICIS) is fast approaching. This annual declaration requirement encompasses all chemical introductions, and it's crucial to remember that it applies to all categories and quantities. The period under review extends from 1 September 2022, to 31 August 2023.
The content of the annual declaration should include details regarding the introduction categories of chemicals that were imported or manufactured during the registration year. Additionally, it's imperative to declare that all introductions were carried out in accordance with sections 25 to 30 of the Industrial Chemicals Act 2019. It's worth noting that an agent or consultant cannot submit the annual declaration on behalf of a company.
Furthermore, it's important to be aware that specific post-introduction declarations are required for chemicals categorised as very low risk for human health and the environment. A separate declaration is mandated for polymers of low concern (PLCs) introduced during the registration year, and another separate declaration is required for low-concern biopolymers introduced during the same period.
The submission deadline for this annual declaration is 30 November 2023.
Redefinition of an Active Substance
Under Annex II of Delegated Regulation (EU) No. 106/2014 the following active substances was defined as:
- Didecylmethylpoly(oxyethyl)ammonium propionate referred to with its chemical name ‘poly(oxy-1,2-ethanediyl), α-[2-(didecylmethylammonio)ethyl]- ω-hydroxy-, propanoate (salt) (Bardap 26)’(CAS 94667-33-1 EC n/a) in product type 8
Following an evaluation of product types 2 and 4, it was concluded that, although the composition and reference specification with the product type 8 assessment and approval, the assigned name was not appropriate. A decision was made to redefine the active substance to:
- Reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl)-N-methylammonium propionate (CAS n/a EC n/a) in product type 8
The new identity must be adopted, impacting product types 2, 4, and 10. Suppliers of biocidal products containing the redefined active substance should apply for authorization before supplying new products in Northern Ireland.
