Article 1
Open ↗The approval of bromadiolone as an active substance for use in biocidal products of product-type 14 is renewed, subject to the specifications and conditions set out in the Annex.
Source
Commission Implementing Regulation (EU) 2017/1380 of 25 July 2017 renewing the approval of bromadiolone as an active substance for use in biocidal products of product-type 14 (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/1380 of 25 July 2017 renewing the approval of bromadiolone as an active substance for use in biocidal products of product-type 14 (Text with EEA relevance. )
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Expiry date of approval Product type Specific conditions Bromadiolone IUPAC Name: 3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin EC No: 249-205-9 CAS No: 28772-56-7 969 g/kg 30 June 2024 14 Bromadiolone is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012. The authorisations of biocidal products are subject to the following general conditions: (1) the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied; (2) products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied; (3) the nominal concentration of bromadiolone in the products shall not exceed 50 mg/kg; (4) products shall contain an aversive agent and a dye; (5) products shall not be authorised in the form of tracking powder; (6) products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals; (7) only ready-to-use products shall be authorised; (8) primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category; (9) dead bodies and uneaten bait shall be disposed of in accordance with local requirements. The method of disposal shall be described specifically in the summary of the product characteristics of the national authorisation and be reflected on the product label. In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions: (1) products shall only be authorised for use in tamper-resistant bait stations; (2) products shall only be supplied with a maximum quantity of bait per pack of: (a) for products against mice only: (i) for grain, pellet or paste baits: 50 g; (ii) for wax block baits: 100 g; (b) for products against rats only, or mice and rats: (i) for grain, pellet or paste baits: 150 g; (ii) for wax block baits: 300 g; (3) products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings; (4) products against Mus musculus shall only be authorised for use indoors; (5) products shall not be authorised for use in permanent or pulse baiting treatments; (6) persons making products available on the market shall ensure that the products are accompanied by information on the risks associated with anticoagulant rodenticides in general, measures to limit their use to the minimum necessary and appropriate precautionary steps to be taken; (7) products in the form of loose bait formulations, such as grain or pellets, shall only be authorised in formulations that are supplied in sachets or other packaging to reduce exposure to humans and the environment. In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions: (1) products shall not be authorised for use in sewers, open area or waste dumps; (2) products shall not be authorised for use in permanent or pulse baiting treatments; (3) products shall only be authorised for use in tamper-resistant bait stations; (4) persons making products for professional users available on the market shall make sure that these products are not supplied to the general public. In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions: (1) products may be authorised for use in sewers, open area or waste dumps; (2) products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations; (3) products shall not be authorised for use in pulse baiting treatments; (4) products may only be authorised for use in permanent baiting treatments at those sites with a high potential for reinvasion when other methods of control have proven insufficient; (5) persons making products for trained professional users available on the market shall make sure that the products are not supplied to other persons than trained professionals. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Other acts of the same type
Regulation (EU) 2018/825 of the European Parliament and of the Council of 30 May 2018 amending Regulation (EU) 2016/1036 on protection against dumped imports from countries not members of the European Union and Regulation (EU) 2016/1037 on protection against subsidised imports from countries not members of the European UnionRegulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (Text with EEA relevance)Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (Text with EEA relevance)Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (Text with EEA relevance.)Commission Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’ (Text with EEA relevance. )Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance. )Commission Implementing Regulation (EU) 2018/783 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance imidacloprid (Text with EEA relevance. )Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin (Text with EEA relevance. )Commission Implementing Regulation (EU) 2018/785 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance thiamethoxam (Text with EEA relevance. )Council Implementing Regulation (EU) 2018/774 of 28 May 2018 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in SyriaCommission Implementing Regulation (EU) 2018/775 of 28 May 2018 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food (Text with EEA relevance. )
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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