#32026R0385Commission Implementing Regulation (EU) 2026/385 approving formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) as an existing active substance for biocidal products of types 2, 6, 11, 12 and 13
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This regulation approves the substance commonly known as MBO or RP 3:2 (formaldehyde released from paraformaldehyde and 2-hydroxypropylamine in 3:2 ratio) as an existing active biocidal substance despite it being classified as a Carcinogen Category 1B. It is approved for product types 2 (disinfectants), 6 (in-can preservatives), 11 (cooling system preservatives), 12 (slimicides) and 13 (metalworking fluid preservatives). Approval is granted under the derogation in Article 5(2) of the Biocidal Products Regulation because no suitable chemical or non-chemical alternatives were found after extensive assessment. The substance is restricted to specific industrial and professional uses in closed systems or controlled environments where alternatives failed due to efficacy, compatibility or hazard reasons.
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Key Changes
- Approves RP 3:2 (MBO) as active substance for PT 2, 6, 11, 12 and 13 despite Carcinogen Category 1B classification
- Approval granted under Article 5(2) derogation of Regulation (EU) No 528/2012 due to lack of alternatives
- Public consultation conducted from 5 September to 4 November 2017 on availability of alternatives
+ 3 more changes with Pro
Obligations
What this law requires
Manufacturers and formulators must restrict use of RP 3:2 (formaldehyde released from paraformaldehyde and 2-hydroxypropylamine ratio 3:2) to industrial and professional applications only in closed systems or controlled environments for product-types 2, 6, 11, 12, and 13
Biocidal product manufacturers must ensure that RP 3:2 is only used where suitable chemical or non-chemical alternatives have been documented as failing due to efficacy, compatibility, or hazard reasons
Product labels and technical documentation must clearly indicate the carcinogenic category 1B classification of RP 3:2 in accordance with Regulation (EC) No 1272/2008
For product-types 6 and 13, manufacturers must provide Tier 2 efficacy data representing real-life conditions as per the applicable guidance document on efficacy before market approval
Manufacturers must maintain and provide documentation demonstrating that no suitable alternatives exist for their specific intended use of RP 3:2