November Regulatory Updates

PVC additives and microparticle releases:

• The European Chemicals Agency (ECHA) has conducted a thorough investigation into the risks associated with certain additives used in polyvinyl chloride (PVC) plastics. Key findings from this investigation, which examined 63 different PVC additives such as plasticisers, heat stabilisers, and flame retardants, indicate that regulatory action is necessary to mitigate the associated risks. The concerns primarily focus on:

1. Plasticisers, especially certain ortho-phthalates, which are harmful to reproduction.
2. Heat stabilising organotins, like DOTE, which may cause developmental and reproductive harm.
3. Flame retardants, with recommendations for reducing emissions aligning with ECHA’s Regulatory Strategy for Flame Retardants.
4. Minimising the emission of PVC microparticles, especially at recycling facilities and landfills. These microparticles not only contribute to plastic pollution but also contain harmful additives.

• However, the risks from PVC resin in its current usage and handling, particularly concerning worker and environmental safety, are deemed to be adequately controlled through existing operational conditions and safety measures in companies.
• ECHA’s findings have been forwarded to the European Commission for further evaluation. The Commission will determine the necessity of a formal request for ECHA to prepare a REACH restriction proposal. This investigation aligns with the broader objectives of the EU’s Plastics Strategy and its commitment to reducing plastic pollution under the United Nation’s Environment Programme (UNEP).

Cosmetics:

• The European Commission has tasked its Scientific Committee on Consumer Safety (SCCS) with evaluating the safety of silver in cosmetic products. This assessment is crucial as silver, often used as a colorant in products like eye shadows and nail polishes, was previously labeled by ECHA’s Risk Assessment Committee as potentially toxic for reproduction and possibly affecting the nervous system.
• Under current regulations, substances identified as carcinogens, mutagens, or reproductive toxicants (category 2) are generally prohibited in cosmetics. However, exceptions can be made if the SCCS deems them safe at specific concentrations. The Commission is seeking guidance on whether micron-sized silver particles are safe in rinse-off cosmetics at a maximum concentration of 0.2%, and 0.3% in leave-on products.
• Additionally, the SCCS has been asked to reevaluate the safety of nano-hydroxyapatite, particularly in oral products like toothpaste and mouthwash. This request follows new industry evidence suggesting its safety at higher concentrations than previously approved. The SCCS’s last opinion, issued in March, considered nano-hydroxyapatite safe up to 10% in toothpaste and 0.465% in mouthwash, specifically for rod-shaped particles with a certain aspect ratio.
• The Commission is now inquiring whether concentrations of up to 29.5% in toothpaste and 10% in mouthwash are safe. These assessments by the SCCS will play a vital role in guiding the Commission’s decisions on setting safe limits for these substances in various consumer products.

Medical Devices:

• The NGO Health Care Without Harm (HCWH) has expressed strong disapproval of the European Commission’s decision to extend the REACH authorisation deadline for bis(2-ethylhexyl) phthalate (DEHP) in medical devices. This extension, from November 2023 to January 2029, allows more time for the industry to adapt to the medical devices regulation (MDR) and prevents potential shortages of critical medical equipment.
• HCWH criticizes the decision, citing risks to patient health, particularly for vulnerable groups like neonates and infants. The NGO emphasizes that safer alternatives to PVC, which often contains DEHP, exist for most medical applications. They advocate for the elimination of hazardous chemicals from healthcare plastics, arguing for safer materials to protect global patient health.
• The European Commission has been criticized in recent years for its authorization of DEHP, which is known to be reprotoxic and an endocrine disruptor. The substance was added to REACH Annex XIV in 2011 due to these concerns.

Flame retardants:

• The European Commission has proposed a revision to the EU’s regulation on persistent organic pollutants (POPs), targeting the brominated flame retardant hexabromocyclododecane (HBCDD). This draft delegated regulation aims to reduce the unintentional trace contaminant (UTC) limit for HBCDD from 100mg/kg (0.01% by weight) to 75mg/kg in substances, mixtures, or articles, including those used in flame-retarded articles.
• This amendment is currently open for public consultation until 26 December. HBCDD, known for its persistent, bioaccumulative, and toxic (PBT) properties, is listed in Annex I of the EU POPs regulation, which adheres to the Stockholm Convention. It is also on the REACH candidate list and is subject to authorisation.
• HBCDD has been predominantly used as a flame retardant in polystyrene insulation materials and has applications in textiles, packaging material, and high-impact polystyrene (HIPS) for electrical and electronic uses. The EU has largely phased out the production, marketing, and use of HBCDD, and specific exemptions under the Stockholm Convention expired in November 2019.
• The proposed amendment maintains the 100mg/kg limit only for HBCDD used in recycled polystyrene in the production of expanded and extruded polystyrene insulation materials for buildings or civil engineering works. This revised UTC value, along with the exception, will undergo a review by 1 January 2026, focusing on technical and scientific information, particularly regarding analytical methods and limitations.
• This move follows a decision last year by the European Parliament and Council of Ministers to lower the permissible limit of HBCDD in waste.