May Regulatory Updates


European Commission Extends Biocides Review Program

Program Extension:

The European Commission has officially extended the biocides review program with a delegated regulation published on May 22. The new deadline for completing the review of existing active substances is December 31, 2030.

Public Consultation:

The extension was supported by a public consultation, which closed in December and saw no opposition to the new deadline. However, there were comments requesting the postponement of the 2025 hard stop for data protection submitted under the program.

Measures for Progress:

To expedite substance assessments, several measures will accompany the extension. Notably, companies must submit all missing data on the endocrine-disrupting properties of biocidal active substances by the end of 2026, or their dossier will be rejected. This requirement has raised concerns within the industry.

Regulation Enforcement:

The delegated regulation cementing the review program extension will enter into force on June 11.


BPR Approvals Extended for Insecticide and Disinfectant

Extended Approvals:

The European Commission has extended the approval of two biocidal active substances and one disinfectant product.

Substances Affected:

  • Cis-tricos-9-ene: Used in repellents and attractants (product-type 19).
  • Hexaflumuron: Used in insecticides, acaricides, and products to control other arthropods (product-type 18).

Reason for Extension: The approvals for these substances are set to expire before a renewal decision is made. Since this delay is beyond the applicants’ control, the EU executive agreed to extend the approvals until March 31, 2027.

Disinfectant Product Extension:

  • Raidox 35%: Used to disinfect internal surfaces of hospital isolators for preparing sterile injectables.
    • Luxembourg’s environment agency requested this extension, citing that Raidox 35% is the only effective disinfectant for isolators. Without it, public health could be at risk.
    • The previous authorisation expired on February 21. The Commission retroactively extended it until August 25, 2025.



European Commission Adopts Cyclosiloxanes Restriction

SVHCs D4, D5, and D6 Restricted:

The European Commission has adopted a restriction on the use and market placement of three cyclosiloxanes (D4, D5, and D6) due to environmental risks. These substances are used in producing silicone rubbers, gels, and resins for various sectors, including cosmetics, cleaning products, healthcare, and construction.

Restriction Details:

From June 6, 2026, D4, D5, and D6 cannot be used or marketed as substances on their own or in mixtures at concentrations of 0.1% or higher. However, deferrals for some uses extend the restriction from 2027 to 2034. There are also derogations for specific uses, such as adhesion, sealing, gluing, casting, protective coatings, and medical devices.

Background and Opposition:

The restriction follows the targeted EU restriction of D4 and D5 in wash-off cosmetics since February 2020. Identified as substances of very high concern (SVHCs) in 2018, D4, D5, and D6 have persistent, bioaccumulative, and toxic (PBT), and very persistent and very bioaccumulative (vPvB) properties.

Industry Response:

The Global Silicones Council (GSC) and member companies have opposed the restrictions, including legal action against the European Commission and ECHA. However, in November, the European Court of Justice dismissed all industry pleas.

Future Actions:

The Commission plans to nominate these substances as persistent organic pollutants (POPs) under the Stockholm Convention, facing continued industry opposition. In the US, the EPA’s TSCA risk evaluation for D4, initiated in 2020, remains incomplete, while states like Washington and Vermont are considering measures for the substances.



NGO Advises Avoiding Toothpaste with Triclosan, Parabens, or Titanium Dioxide

Health Concerns: NGO CHEM Trust recommends avoiding toothpaste and personal care products containing triclosan, parabens, or titanium dioxide. Instead, consumers should opt for products with the EU Ecolabel.

Danish Test Results:

  • The Danish Consumer Council’s Think Chemicals initiative tested 31 fluoride toothpastes.
  • Five toothpastes received the lowest chemical rating due to suspected endocrine-disrupting chemicals (EDCs) like parabens, triclosan, and methyl salicylate. These brands are:
    • Denivit anti-stain intense toothpaste
    • G.U.M. paroex toothpaste
    • Parodol fluor toothpaste
    • Pierrot ultrafresh dental gel
    • Sence coolmint toothpaste

Titanium Dioxide Concerns:

  • Eleven toothpastes contained titanium dioxide, which is banned as a food additive in the EU but permitted in personal care products, despite potential ingestion.

Best and Worst Ratings:

  • Ten toothpastes received the best rating for not containing harmful chemicals.
  • The five lowest-rated brands did not respond to requests for comments.

Regulatory Insights: CHEM Trust highlights that current regulations do not adequately protect against the combined exposure effects of these chemicals. To earn the EU Ecolabel, products must be free from hazardous substances or mixtures.

Additional Findings: A separate Danish project recently identified menthol, widely used in toothpaste and mouthwash, as a priority substance for potential regulatory action due to evidence of endocrine disruption.