BIOCIDES
No shared destination
Article 5( 1) of the BPR added hazardbased exclusion criteria to risk assessment: carcinogenic, mutagenic and reprotoxic( CMR) substances, endocrine disruptors( EDs), persistent, bioaccumulative and toxic( PBT) and very persistent, very bioaccumulative( vPvB) substances. Classification is how those criteria bite.
The eCA must submit a harmonised classification and labelling( CLH) proposal no later than the assessment report where it considers a CMR criterion met and not properly addressed. Authorities no longer wait for the opinion of the Committee for Risk Assessment( RAC), since the Biocidal Products Committee( BPC) may reach its own conclusions on CMR properties and the exclusion criteria, leaving the BPC in effective control of the outcome.
It is worth spelling out what that outcome is. If the substance is found to meet an exclusion criterion, it is not approved at all, unless derogation is obtained on one of three narrow grounds: negligible risk, no suitable alternative or use essential to control a serious danger to health or the environment. A derogation is not a formality and the route to it runs through public consultation, an analysis of alternatives and a socioeconomic assessment.
Classification bites at product level too. Where the active substance is classified as CMR category 1A or 1B, or meets the ED, PBT or vPvB criteria, products containing it cannot be authorised for making available on the market for use by the general public. For a Commodity Substance sold into consumer disinfectants, that removes the market rather than just restricting it.
A harmonised classification also applies horizontally, with an impact on a variety of uses for Commodity Substances. For instance, a CMR classification can bring suitable protective equipment and changed handling, storage and transport procedures under workplace safety law, stricter operating permits under the Industrial Emissions Directive, extra labelling, record-keeping and monitoring for hazardous waste, restrictions on activities involving pregnant or breastfeeding workers and consequences under the Cosmetic Products Regulation. Most of that cost lands outside the biocides business that paid for the dossier.
The perimeter keeps widening. Scientific criteria for endocrine disruptors were set in 2017, and new hazard classes for EDs, PBT / vPvB and mobility apply from 1 May 2025, subject to transitional periods. 1 The Commission may now adopt a harmonised classification for biocidal substances on the basis of the BPC decision, without a further RAC opinion. 2
This is the alignment problem in its sharpest form. Members of a substance consortium may agree on keeping the substance for biocidal uses and still disagree fundamentally
Ethanol and formaldehyde are among the Commodity Substances subject to multiple regulatory regimes
NOV / DEC 2026 SPECCHEMONLINE. COM
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