Regulatory News

The European Chemicals Agency (ECHA) has opened public consultations on selected biocidal active substances that may be identified as Candidates for Substitution (CfS) and/or substances meeting exclusion criteria under the EU Biocidal Products Regulation (EU) No 528/2012.

The consultations invite stakeholders to submit technical, scientific, and socio-economic information to support regulatory decisions on:

  • Whether the substances should continue to be approved
  • Whether derogations from exclusion criteria may be justified
  • The availability, feasibility, and performance of safer alternatives

Regulatory Background

Candidates for Substitution – Article 10 (BPR)

A biocidal active substance may be identified as a Candidate for Substitution if it:

  • Possesses hazardous intrinsic properties (e.g. CMR, PBT, vPvB)
  • Has a significantly lower acceptable exposure threshold
  • Is associated with critical human health or environmental effects
  • Has safer alternatives available

Such substances are subject to comparative assessment during product authorisation.

Exclusion Criteria – Article 5(1) (BPR)

Substances with the following hazard profiles are normally not eligible for approval:

  • Carcinogenic, Mutagenic or Reprotoxic (CMR)
  • Endocrine disruptors
  • Persistent, Bioaccumulative and Toxic (PBT)
  • Very Persistent and very Bioaccumulative (vPvB)
Derogations – Article 5(2) (BPR)

Despite meeting exclusion criteria, substances may still be approved for limited uses if:

  • Exposure risks are negligible under realistic conditions of use
  • The substance is essential to prevent danger to human or animal health or the environment
  • Non-approval would lead to a disproportionate negative societal impact
  • No suitable alternatives are available

Ongoing Public Consultations

Substance Name Product Type(s) (PT) Regulatory Status under BPR Key Hazard / Concern Consultation Focus Consultation Deadline
Formaldehyde (released from paraformaldehyde and benzyl alcohol reaction products) PT 06 (Preservatives for products during storage) Candidate for Substitution (Art. 10) + Meets Exclusion Criteria (Art. 5(1)) Carcinogenic properties
  • Risk & exposure assessment
  • Availability of safer alternatives
  • Socio-economic justification
  • Derogation eligibility (Art. 5(2))
 26 January 2026
Silver Nitrate PT 1, 4, 5, 9 Candidate for Substitution (Art. 10) + Meets Exclusion Criteria (Art. 5(1)) Environmental & human health concerns
  • Comparative assessment of alternatives
  • Essential use claims
  • Derogation justification
 23 January 2026
Imidacloprid PT 18 (Insecticides, acaricides) Candidate for Substitution (Art. 10) High toxicity to non-target organisms
  • Availability and feasibility of alternatives
  • Comparative risk assessment
  • Continued need for specific uses
 09 February 2026
Tebuconazole Multiple PTs (fungicidal uses) Candidate for Substitution (Art. 10) + Potential Derogation (Art. 5(2)) Reproductive toxicity concerns
  • Risk vs benefit assessment
  • Availability of alternatives
  • Socio-economic impact
  • Derogation conditions
 13 February 2026

What Stakeholders Are Expected to Submit?

ECHA encourages stakeholders to provide:

  • Hazard and risk data reflecting real-world use scenarios
  • Information on alternatives, including performance and comparative risks
  • Socio-economic impact assessments
  • Use-specific information, such as closed systems or critical applications
  • Evidence supporting derogation conditions under Article 5(2)
  • Non-confidential submissions are strongly encouraged to support transparent and informed regulatory decision-making.

Impact on Industry

  • May affect approval or renewal of biocidal active substances
  • Can trigger comparative assessments and substitution obligations
  • Impacts product formulations, authorisations, and EU market access
  • Drives innovation toward safer alternatives
  • Relevant for manufacturers, importers, downstream users, and authorisation holders

Recommended Next Steps

  • Review whether your products contain the listed substances
  • Assess the availability and feasibility of alternatives
  • Submit relevant technical or socio-economic data before consultation deadlines
  • Monitor ECHA opinions and subsequent European Commission decisions

Source: Consultations on potential candidates

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