#32026R0373Commission Implementing Regulation (EU) 2026/373 approving formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) as an existing active substance for biocidal product-types 2, 11 and 13
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This regulation approves the substance commonly known as RP 1:1 (formaldehyde released from paraformaldehyde and 2-hydroxypropylamine in 1:1 ratio) as an existing active substance for use in biocidal products of types 2 (disinfectants), 11 (preservatives for liquid cooling systems), and 13 (metalworking fluid preservatives). Although the substance is classified as carcinogenic category 1B and meets the exclusion criterion under Article 5(1)(a) of the Biocidal Products Regulation, it is approved because no suitable alternatives exist and non-approval would cause disproportionate negative societal impacts compared to the controlled risks. Approval is granted only for specific industrial and professional uses with strict risk mitigation measures. The Agency could not conclude on endocrine-disrupting properties due to data gaps, but the substance is permitted under the derogation in Article 5(2)(c).
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Key Changes
- Approves RP 1:1 (formaldehyde released from paraformaldehyde + 2-hydroxypropylamine 1:1) for PT 2, 11 and 13 despite carcinogen 1B classification
- Applies derogation under Article 5(2)(c) of Regulation (EU) No 528/2012 due to lack of alternatives and disproportionate societal impact
- Limits approval to industrial/professional use only: system cleaners for metal working (PT2), closed liquid cooling systems (PT11), and metalworking/cutting fluids (PT13)
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Obligations
What this law requires
Manufacturers and distributors must only use RP 1:1 (formaldehyde released from paraformaldehyde and 2-hydroxypropylamine in 1:1 ratio) in biocidal products of product-types 2 (disinfectants), 11 (preservatives for liquid cooling systems), and 13 (metalworking fluid preservatives) as approved under this regulation
Biocidal products containing RP 1:1 must be formulated and used only for industrial and professional uses, not for consumer or household applications
Manufacturers must implement and maintain strict risk mitigation measures for all biocidal products containing RP 1:1 to address its classification as carcinogenic category 1B
For product-type 13 (metalworking fluid preservatives), manufacturers must demonstrate efficacy based on Tier 2 data representing real-life conditions in accordance with applicable efficacy guidance documents
Member States must monitor whether suitable alternatives to RP 1:1 become available and report findings to the European Chemicals Agency, as approval is contingent on the absence of suitable alternatives