REACH Update: The European Union Tightens Restrictions on Silicones D5 and D6 in Cosmetic Products.
The European Union has introduced further restrictions on the use of silicones D5 (Decamethylcyclopentasiloxane) and D6 (Dodecamethylcyclohexasiloxane) in cosmetic products, effective from 6th June 2027 following a 3-year transition period. These amendments to the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulations are part of ongoing efforts to address the environmental concerns associated with these substances. Both D5 and D6 are cyclic volatile methylsiloxanes (cVMS) widely used in personal care products for their smoothing and conditioning properties. However, they have been identified as persistent, bioaccumulative, and toxic (PBT) substances, posing significant risks to aquatic life and the environment.
The new restrictions limit the concentration of D5 and D6 to 0.1% by weight in both rinse-off and leave-on cosmetic products. This move follows extensive scientific evaluation by the European Chemicals Agency (ECHA) and reflects growing awareness of the need to reduce the environmental footprint of cosmetic ingredients.
It is important to note that D4 (octamethylcyclotetrasiloxane) is listed in Annex II of the EU Cosmetics Regulation, which is the catalogue of substances prohibited for use in cosmetics. Consequently, the new REACH restrictions on D4 will not impact cosmetic products, as its use is already banned within the EU.
Manufacturers are now tasked with reformulating their products to meet the new requirements. This involves not only reducing the levels of D5 and D6 but also finding suitable alternatives that do not compromise product performance. The transition period until June 2027 allows companies to adapt their formulations and update their product information on the Cosmetic Products Notification Portal (CPNP).
In addition to reformulation, manufacturers must ensure accurate labelling and documentation to demonstrate compliance with the updated regulations. Failure to comply could result in significant penalties and market access restrictions within the EU.
Detailed information on these regulatory changes and their implications for the cosmetics industry can be found in the Commission Regulation (EU) 2024/1328.
The Environmental Protection Agency Designates Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as CERCLA Hazardous Substances.
The United States Environmental Protection Agency (EPA) has officially designated perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). CERCLA addresses site-specific contamination, providing broad discretion for the EPA to respond to releases. The statute enables cost recovery from responsible parties, ensuring they fund or conduct necessary clean-up actions.
The rule, effective from 8th July, 2024, facilitates quicker and more effective responses to contamination, helping reduce health risks for affected communities. Signification action has been taken to bolster the protection of public health and the environment by mandating stringent requirements for reporting, investigating, and remediating contamination involving these "forever chemicals".
PFOA and PFOS are part of a larger group of per- and polyfluoroalkyl substances (PFAS) that are characterised by their persistence in the environment and potential adverse health effects. These chemicals have been widely used in various industrial applications and consumer products, including non-stick cookware, water-repellent clothing, and firefighting foams. Their extensive use has led to widespread contamination of water sources and soil, prompting growing concern among regulatory agencies and the public.
These substances can accumulate in the body, posing health risks such as cancer, liver damage, and developmental issues. The aim is to mitigate these risks by enabling earlier action and comprehensive clean-up efforts.
Under the new rule, any significant release of PFOA and PFOS into the environment that meets or exceeds the reportable quantity within a 24-hour period, must be promptly reported to federal, state, and local authorities. This reporting requirement is crucial for ensuring timely and effective responses to contamination incidents, minimising potential exposure to these harmful substances. Designation does not automatically impose liability but allows the EPA to hold polluters accountable.
Furthermore, federal facilities are now required to address contamination on their properties, providing notice about the storage, release, or disposal of these substances when transferring or selling property - ensuring that clean-up efforts are transparent and that the entities responsible for pollution bear the costs of remediation.
The EPA's decision to list PFOA and PFOS as hazardous substances under CERCLA is a pivotal step in addressing the challenges posed by PFAS contamination. This designation empowers the EPA and other regulatory bodies to enforce comprehensive clean-up efforts, thereby mitigating the risks these chemicals pose to communities and ecosystems. By holding polluters accountable, the rule ensures that the polluters, rather than taxpayers, bear the costs of clean-up and promotes greater environmental stewardship and public health protection. The rule does not mandate specific disposal methods for PFOA or PFOS waste.
The EPA's initiative aligns with broader efforts to tackle PFAS pollution at national and international levels. As scientific understanding of these substances evolves, regulatory frameworks continue to adapt, aiming to safeguard the environment and public health from the long-term impacts of persistent chemical contaminants.
For further information, visit the EPA's official page on the designation.
Amendments to Canada’s Cosmetic Ingredient Hotlist.
Health Canada revised the Cosmetic Ingredient Hotlist on May 17th 2024, with the following amendments:
Ingredients Added to the Hotlist:
Basic Green 4: Included in the list of prohibited substances.
Benzophenone: Present on the restricted substances list with a maximum concentration of 3%.
p-Chloro-m-cresol: Restricted with a maximum concentration of 1% and is not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, nose or mouth.
Solvent violet 13 - Restricted to 0.3% in cosmetic products.
Amendments to Existing Items on the Hotlist:
Dialkanolamines / Secondary Amines: Now includes secondary alkyl- and alkanolamines and their salts.
Alpha-hydroxy Acids: Clarified to include polyhydroxy acids and bionic acids with alpha-hydroxyl groups, and their salts. The maximum concentration allowed for consumer use has been raised from 10% to 18%. Additionally, there have been updates to labelling requirements to include warnings, cautionary statements, and specific directions for safe use.
Hydroquinone: Restrictions have expanded permitted nail product categories to include products for consumer use and increased the maximum allowable concentration for these products. A combined limit when both p-hydroxyanisole and hydroquinone are present in a nail product has also been implemented.
p-Hydroxyanisole: If hydroquinone and p-hydroxyanisole are used in the same nail product product, the total concentration of the 2 ingredients may not exceed 0.1% - with additional warning and labelling requirements.
Talc: Amended labelling requirements and warnings to help reduce inhalation exposure to talc in cosmetics.
UK Draft of Packing and Packaging Waste Regulations Sent to the European Union and World Trade Organisation.
The draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 were submitted to the European Union earlier this month and labelling requirements have been notified to the World Trade Organisation.
This comes as a milestone introduction for the packaging Extended Producer Responsibility (EPR) legislation, which is expected to be presented to the UK Parliament later this year, aiming to take effect 1st January 2025. Producers must report the amount of packaging they place on the market for the period of January-December 2024. Reporting will be used to calculate producer fees and reimburse local authorities for managing packaging waste from April 2025 to March 2026.
Based on feedback from the packaging EPR consultation, the Producer Responsibility Obligations (Packaging and Packaging Waste) regulations have been updated to include:
- The addition of recycling targets for 2025-2030.
- A provision that if a Deposit Return Scheme (DRS) has not been established by 1st January 2028, producers of drinks containers made of PET plastic, aluminium, and steel will be subject to the full range of Extended Producer Responsibility (pEPR) obligations until a DRS is operational for these materials.
- Amendments to the labelling provisions so that all labelling obligations will now take effect on 1st April 2027.
- Removal of provisions regarding binned waste and litter payments, which will now be addressed through separate regulation.
- A requirement for the Scheme Administrator (SA) to provide guidance on the methodology used and factors considered in assessing net efficient disposal costs and effectiveness.
- A revision of the household packaging definition to broaden the criteria, allowing certain packaging to be exempt from being classified as household packaging, and therefore exempt from disposal cost fees.
The products covered include:
- Plastic items for transporting or packing goods, such as stoppers, lids, caps, and other closures.
- Packaging made from paper and cardboard.
- Glass containers, including carboys, bottles, flasks, jars, pots, phials, ampoules, and other goods conveyance or packing containers, as well as preserving jars, stoppers, lids, and other closures.
- Sacks and bags for packing goods, made from various textile materials.
- Stoppers, caps, and lids, including crown corks, screw caps, pouring stoppers, capsules for bottles, threaded bungs, bung covers, seals, and other packing accessories.
The full draft for the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 can be found here
