Review of Commission Implementing Regulation (EU) 2026/373
This regulation approves the use of RP 1:1, a substance releasing formaldehyde, in specific biocidal products (types 2, 11, and 13). Despite being classified as a carcinogen, its use is deemed necessary due to the lack of alternatives and socio-economic importance. However, its use is subject to strict conditions outlined in the Annex, including minimizing exposure to humans, animals, and the environment. The substance can only be used in industrial or professional settings for metalworking systems, liquid cooling systems, and metalworking fluids. The regulation also restricts the placing on the market of treated articles to those using RP 1:1 in these specified applications and requires specific labeling according to Regulation (EU) No 528/2012. Furthermore, RP 1:1 is identified as a candidate for substitution, encouraging the search for safer alternatives. Each Member State must also assess whether the socio-economic benefits outweigh the risks.
Review of Commission Implementing Regulation (EU) 2026/372
This regulation extends the approval periods for 29 active substances used in plant protection products. The extensions vary from 12 to 42 months depending on the substance. The extensions allow farmers to continue using these substances while the European Food Safety Authority (EFSA) and the Commission finalize their risk assessments and decisions on renewal.
Review of Commission Implementing Regulation (EU) 2026/386
This regulation authorizes defatted rapeseed powder as a novel food for use in various food products and food supplements. It grants NapiFeryn BioTech Sp. z o.o. exclusive rights to market the product for five years, protecting their scientific data. The regulation includes specific labeling requirements regarding potential allergic reactions (especially for mustard allergies) and restrictions on its consumption with other foods containing the powder, as well as age restrictions. It also details specifications for the powder’s composition, heavy metal limits, and microbiological criteria.
Review of Commission Implementing Regulation (EU) 2026/385
This regulation approves RP 3:2 (another formaldehyde-releasing substance) for use in biocidal products, specifically disinfectants, in-can preservatives, preservatives for liquid-cooling systems, slimicides, and metalworking-fluid preservatives (product types 2, 6, 11, 12, and 13). Despite being a category 1B carcinogen, its use is approved under strict conditions for five years due to the disproportionate negative impacts of its non-approval. The regulation specifies that each Member State must assess whether the non-approval of RP 3:2 would have a disproportionate negative impact on society compared to the risks associated with its use. Its approved uses include metal working systems, preservation of fuels, closed liquid cooling systems, slime control in offshore oil installations, and metalworking fluids. Strict measures to minimize exposure are also mandated.
Review of each of legal acts published today:
Commission Implementing Regulation (EU) 2026/373 of 20 February 2026 approving formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) as an existing active substance for use in biocidal products of product-types 2, 11 and 13 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This Commission Implementing Regulation (EU) 2026/373 approves formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1), also known as RP 1:1, as an existing active substance for use in biocidal products of product-types 2, 11, and 13. This approval is in accordance with Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products. The regulation acknowledges that RP 1:1 meets the exclusion criterion as a carcinogenic substance but its use is still necessary due to the lack of suitable alternatives and its socio-economic importance. The approval is subject to specific conditions to minimize risks to human and animal health and the environment.
The regulation consists of two articles and an annex. Article 1 states that RP 1:1 is approved for use in biocidal products of product-types 2, 11, and 13, subject to the conditions in the annex. Article 2 specifies that the regulation will enter into force twenty days after its publication in the Official Journal of the European Union. The annex details the specific conditions for the approval of RP 1:1, including the minimum degree of purity, the expiry date of the approval (May 31, 2032), and specific conditions for each product type (2, 11, and 13). These conditions include the need for product assessments to pay attention to exposures, risks, and efficacy, and that products may only be authorized in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied.
The most important provisions of this act are those listed in the Annex.
* **Conditions for Use:** The approval is specifically for industrial or professional use as a system cleaner for metal working systems (product-type 2), for preservation of liquid cooling and processing systems in closed systems (product-type 11), and for the preservation of metal working or cutting fluids (product-type 13).
* **Risk Mitigation:** The use of biocidal products containing RP 1:1 must be subject to measures that minimize exposure to humans, animals, and the environment.
* **Treated Articles:** The placing on the market of treated articles is restricted to those where RP 1:1 has been used in the specified applications (metal working systems, liquid cooling systems, and metal working fluids).
* **Labeling Requirements:** The person responsible for placing treated articles on the market must ensure that the label provides the information listed in Article 58(3) of Regulation (EU) No 528/2012.
* **Candidate for Substitution:** RP 1:1 is identified as a candidate for substitution, meaning that efforts should be made to find safer alternatives.
* **National Assessment:** Product assessments must evaluate whether the condition set out in Article 5(2)(c) of Regulation (EU) No 528/2012 is satisfied in each Member State, ensuring that the socio-economic benefits outweigh the risks.
Commission Implementing Regulation (EU) 2026/372 of 20 February 2026 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1-naphthylacetamide, 1-naphthylacetic acid, 6-benzyladenine, aluminium sulfate, boscalid, dodine, esfenvalerate, eugenol, fenpyroximate, fluazifop-P, fluazinam, fluometuron, fluopyram, flutolanil, geraniol, malathion, penoxsulam, pinoxaden, prohexadione, proquinazid, prosulfuron, pyrethrins, pyridaben, pyrimethanil, sintofen, spiroxamine, sulphur and thymol
This Commission Implementing Regulation (EU) 2026/372 extends the approval periods for several active substances used in plant protection products. This extension is necessary because the renewal assessment procedures for these substances have not been completed yet. The regulation ensures that farmers and other users can continue to use these substances while the assessments are finalized.
The regulation amends the Annex to Implementing Regulation (EU) No 540/2011, which lists approved active substances. The amendment involves updating the expiration dates for the approval of 29 active substances. These substances include 1-decanol, 1-naphthylacetamide, boscalid, dodine, esfenvalerate, eugenol, fenpyroximate, fluazinam, fluazifop-P, fluometuron, fluopyram, flutolanil, geraniol, malathion, penoxsulam, pinoxaden, prohexadione, proquinazid, prosulfuron, pyrethrins, pyridaben, pyrimethanil, sintofen, spiroxamine, sulphur, thymol, 6-benzyladenine, aluminium sulfate, 1-naphthylacetic acid. The extension periods vary depending on the substance and the stage of the renewal process, ranging from 12 to 42 months.
The most important provision of this regulation is the extension of the approval periods for the listed active substances, as detailed in the Annex. For example, the approval for pyrimethanil is extended to June 30, 2027, while the approval for boscalid is extended to March 31, 2028. These extensions allow for the continued use of these substances in plant protection products while the European Food Safety Authority (EFSA) and the Commission finalize their risk assessments and decisions on renewal.
Commission Implementing Regulation (EU) 2026/386 of 20 February 2026 authorising the placing on the market of defatted rapeseed powder as a novel food and amending Implementing Regulation (EU) 2017/2470
This is a description of Commission Implementing Regulation (EU) 2026/386, which authorises the placing on the market of defatted rapeseed powder as a novel food and amends Implementing Regulation (EU) 2017/2470. The regulation allows the use of defatted rapeseed powder in various food products, including bakery goods, cereals, pasta, drinks, and food supplements, under specific conditions. It also grants exclusive rights to NapiFeryn BioTech Sp. z o.o. for placing this novel food on the market for five years, protecting the scientific data they provided. The regulation includes specific labelling requirements to inform consumers about potential allergic reactions and restrictions on simultaneous consumption with other foods containing the powder.
The structure of the act is as follows:
– It consists of a preamble that outlines the reasons and legal basis for the regulation, referring to Regulation (EU) 2015/2283 on novel foods.
– Article 1 authorises the placing on the market of defatted rapeseed powder within the Union and amends Implementing Regulation (EU) 2017/2470 to include it in the Union list of novel foods.
– Article 2 grants exclusive rights to NapiFeryn BioTech Sp. z o.o. to place the novel food on the market for five years, with exceptions for subsequent authorisations based on different data.
– Article 3 protects the scientific data provided by NapiFeryn BioTech Sp. z o.o. for five years, preventing its use by subsequent applicants without their agreement.
– Article 4 specifies the date of entry into force of the regulation.
– The annex amends Implementing Regulation (EU) 2017/2470 by adding defatted rapeseed powder to the list of authorised novel foods, including conditions of use, labelling requirements, and specifications.
The main provisions of the act include:
– Authorisation of defatted rapeseed powder as a novel food for use in a variety of food products and food supplements, with specified maximum levels.
– A five-year period of exclusive rights for NapiFeryn BioTech Sp. z o.o. to place the product on the market, protecting their scientific data.
– Specific labelling requirements to inform consumers about potential allergic reactions (especially for those allergic to mustard) and restrictions on simultaneous consumption with other foods containing the powder, as well as age restrictions.
– Detailed specifications for the defatted rapeseed powder, including composition, heavy metal limits, residual solvent limits, and microbiological criteria.
Commission Implementing Regulation (EU) 2026/385 of 20 February 2026 approving formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) as an existing active substance for use in biocidal products of product-types 2, 6, 11, 12 and 13 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This Commission Implementing Regulation (EU) 2026/385 approves formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2), also known as RP 3:2, as an existing active substance for use in specific types of biocidal products. These product types include disinfectants, in-can preservatives, preservatives for liquid-cooling and processing systems, slimicides, and metalworking-fluid preservatives. The regulation acknowledges that RP 3:2 meets an exclusion criterion due to its classification as a category 1B carcinogen, but its use is still approved under strict conditions because its non-approval would have disproportionate negative impacts on society. The approval is valid for a limited period of five years and is subject to specific conditions to minimize risks to human health and the environment.
The regulation consists of two articles and an annex. Article 1 states that Formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) is approved as an active substance for use in biocidal products of product-types 2, 6, 11, 12 and 13, subject to the conditions set out in the Annex. Article 2 defines the date of entry into force of the regulation. The Annex specifies the conditions for the approval of RP 3:2 for each product type (2, 6, 11, 12, and 13), including requirements for product assessment, restrictions on use to Member States where the benefits outweigh the risks, measures to minimize exposure, and specific instructions for labeling treated articles.
The most important provisions of this act are those listed in the Annex. They define the specific conditions under which RP 3:2 can be used in biocidal products. These conditions include that products containing RP 3:2 may only be authorized for use in Member States where the condition set out in Article 5(2), first subparagraph, point (c), of Regulation (EU) No 528/2012 is satisfied. This means that each Member State must evaluate whether the non-approval of RP 3:2 would have a disproportionate negative impact on society compared to the risks associated with its use. The Annex also specifies the uses for which RP 3:2 is approved, such as system cleaner formulations for metal working systems, preservation of fuels, preservation of liquid cooling and processing systems (in closed systems only), prevention or control of slime growth in offshore oil industry installations, and preservation of metal working or cutting fluids.
