Active substance(s) proposed for approval under the EU Biocidal Products Regulation
1. Are any of the active substances in the table below and/or biocidal products containing them currently on the UK market? (NB: You do not need to tell us about any active substances or biocidal products approved under the Control of Pesticides Regulations, as we will already be aware of these)
2. If yes, can you provide details of what these actives/products are, and the level of distribution in the UK?
3. Do you foresee any problems with the specific provisions relating to the Approval of the active substance(s)? Please give details.
4. Are any of these active substances and/or biocidal products currently on the EU market other than the UK? Please give details.
5. If youhave any other comments on the proposed approval of these active substances, please list them here.
Common name / IUPAC Name & Identification Numbers / Minimum purity of active substance[1] / Date of approval and expiry date / Product type (PT) / Specific provisions[2]Cyproconazole / IUPAC Name :
(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
EC n° : N/A
CAS n° : 94361-06-5
Cyproconazole has two diastereomers.
Diastereomer A: enantiomeric pair, where the 3-hydroxy group and the 2-hydrogen are located on the same side (2S, 3S and 2R, 3R).
Diastereomer B: enantiomeric pair, where the 3-hydroxy group and 2-hydrogens are located on opposite sides (2R, 3S and 2S, 3R).
Technical cyproconazole is ca. 1:1 mixture of the two diasteriomers, each of which is exactly a 1:1 mixture of the enantiomers. / 940 g/kg
Cyproconazole has two diastereomers.
(Diastereoisomer A: 430 – 500 g/kg,
Diastereoisomer B: 470 – 550 g/kg). / 1 November 2015 - 31 October 2018 / PT 8 / Cyproconazole is considered a candidate for substitution in accordance with Article10(1)(a) and (d) of Regulation (EU) No528/2012.
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.
Authorisations are subject to the following conditions:
(1)For industrial users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.
(2)Products shall not be authorised for industrial use by double vaccum impregnation, unless data is submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures.
(3)Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular :
a. Labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.
b. Products shall not be authorised for industrial treatment of wood that will be exposed to weathering, or for treatment of wood that will be used for outdoor constructions, unless data is submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures.
Synthetic amorphous silicon dioxide, as a nanomaterial according to the definition set out in Article 3(1)(z) of Regulation (EU) No 528/2012. / IUPAC Name :
Silicon dioxide
EC n° : 231-545-4
CAS n° : 112926-00-8
Synthetic amorphous silicon dioxide in the form of stable aggregated particules of particle size > 1µm, with primary particules of nanosize. / 800 g/kg / 1 November 2015 – 31 October 2025 / PT 18 / 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.
Structural characteristics[3]
- Primary particle size < 25nm
- Volume specific surface area > 600 m²/cm3
Transfluthrin / IUPAC Name :
2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
or
2,3,5,6-tetrafluorobenzyl (1R)-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
EC n° : 405-060-5
CAS n° :1187712-89-3 / 960 g/kg of 1R trans configuration / 1 November 2015 – 31 October 2025 / PT 18 / 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.
Authorisations are subject to the following condition :
In the view of the risks for water, sediment and soil compartments, transfluthrin shall not be used in battery-operated fan vaporisers or insecticidal coils unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.
Ethyl butylacetylaminopropionate / IUPAC Name :
3-(N-acetyl-N-butyl)aminopropionic acid ethyl ester
EC n° : 257-835-0
CAS n° : 52304-36-6 / 980 g/kg / 1 November 2015 – 31 October 2025 / PT 19 / 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.
Authorisations are subject to the following condition :
(1)Primary exposure of humans shall be minimized by considering and applying appropriate risk mitigation measures, including, where applicable, instructions for the amount and frequency of application of the product on human skin.
(2) Products must contain deterrents for ingestion.
Lauric acid / IUPAC Name :
Dodecanoic acid
EC n° : 205-582-1
CAS n° : 143-07-7 / 980 g/kg / 1 November 2015 – 31 October 2025 / PT 19 / 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.
4,5-Dichloro-2-octyl-2H-isothiazol-3-one / IUPAC Name :
4,5-Dichloro-2-octylisothiazol-3(2H)-one
EC n° : 264-843-8
CAS n° : 64359-81-5 / 950 g/kg / 1 January 2016 – 31 December 2025 / PT 21 / 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.
Authorisations are subject to the following conditions:
(1)For industrial or professional users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.
(2)Products authorised for non-professional users shall be sold with the appropriate protective gloves. Labels and, where provided, instructions for use shall indicate whether other personal protective equipments shall be used.
(3)Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area and on impermeable hard standing with bunding to prevent direct losses and minimize emissions to the environment, and that any losses or waste containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one shall be collected for reuse or disposal.
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council[4] or Regulation (EC) No 396/2005 of the European Parliament and of the Council[5] shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
[1]The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
[2]For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website:
[3]The structural characteristics indicated in this column were the ones of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012.
[4]Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
[5]Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).