Active Substance(S) Proposed for Inclusion in Annex I of the Biocidal Products Directive
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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 you have any other comments on the proposed approval of these active substances, please list them here.
Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance1 Biphenyl-2-ol IUPAC Name: 995 g/kg 1st July 2017 1 The product assessment shall pay particular attention to the exposures, the ortho-phenylphenol 30 June 2027 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 EC No: 201-993-5 active substance. CAS No: 90-43-7 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.
2 The authorisations of biocidal products are subject to the following
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 16(2) of Directive 98/8/EC or 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. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance condition: For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. 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 The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for the surface water, sediment and soil compartments, biocidal products shall not be authorised for large scale disinfection, unless it can be demonstrated that risks can be reduced to an acceptable level. (3) 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 or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (4) Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of biphenyl-2-ol into food or it has been established pursuant to that Regulation that such limits are not necessary. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance
The product assessment shall pay particular attention to the exposures, the 6 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.
The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for the aquatic compartment, biocidal products shall not be authorised for the preservation of washing and cleaning fluids and other detergents for professional use, unless it can be demonstrated that risks can be reduced to an acceptable level. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for 13 authorisation, but not addressed in the Union level risk assessment of the active substance.
The authorisations of biocidal products are subject to the following condition: For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance C(M)IT/MIT Reaction mass of 5- 579 g/kg 1 July 2017 2 The product assessment shall pay particular attention to the exposures, the (3:1) chloro-2-methyl-2h- (theoritical 30 June 2027 risks and the efficacy linked to any uses covered by an application for isothiazol-3-one and 2- calculated authorisation, but not addressed in the Union level risk assessment of the methyl-2h-isothiazol-3- dry weight). active substance. one (3:1) EC No: n.a. The active The authorisations of biocidal products are subject to the following CAS No: 55965-84-9 substance is condition: manufacture For professional users, safe operational procedures and appropriate d as a organisational measures shall be established. Products shall be used with technical appropriate personal protective equipment where exposure cannot be reduced concentrate to an acceptable level by other means. (TK) with different The placing on the market of treated articles is subject to the following solvents and condition: stabilizers. The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
The product assessment shall pay particular attention to the exposures, the 4 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. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance The authorisations of biocidal products are subject to the following conditions: (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for professional users, biocidal products shall only be loaded by automated systems, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (3) 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 Council2 or Regulation (EC) No 396/2005 of the European Parliament and of the Council3 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (4) Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of C(M)IT/MIT (3:1) into food or it has been established pursuant to that Regulation that such limits are not necessary.
The placing on the market of treated articles is subject to the following 2 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). 3 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). Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance condition: The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
6 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.
The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks to the environment, biocidal products shall not be used to preserve pulp and paper processing fluids, unless it can be demonstrated that risks can be reduced to an acceptable level.
The placing on the market of treated articles is subject to the following conditions: (1) In view of the risks identified for human health, mixtures treated with or incorporating C(M)IT/MIT (3:1) and placed on the market for use by the general public shall not contain C(M)IT/MIT (3:1) at a concentration triggering classification as skin sensitizer, unless exposure can be avoided by other means than the wearing of personal protective equipment. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance (2) In view of the risks identified for human health, liquid detergents treated with or incorporating C(M)IT/MIT (3:1) and placed on the market for use by professional users shall not contain C(M)IT/MIT (3:1) at a concentration triggering classification as skin sensitizer, unless exposure can be avoided by other means than the wearing of personal protective equipment. (3) In view of the risks identified for human health, mixtures treated with or incorporating C(M)IT/MIT (3:1), other than liquid detergents, and placed on the market for use by professional users shall not contain C(M)IT/MIT (3:1) at a concentration triggering classification as skin sensitizer, unless exposure can be avoided, including by the wearing of personal protective equipment. (4) The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
The product assessment shall pay particular attention to the exposures, the 11 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.
The authorisations of biocidal products are subject to the following conditions: (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance (2) In view of the risks identified for the environment, products shall not be authorized for the preservation of photographic processing liquid, of wood treatment solution and for the use in large open recirculating cooling systems unless it can be demonstrated at that risks can be reduced to an acceptable level. (3) In view of risks identified for the environment, and unless it can be demonstrated that risks can be reduced to an acceptable level, labels and, where provided, safety data sheet of products shall indicate that: a. For uses in small open recirculating cooling systems, risk mitigation measures shall be in place to reduce the direct contamination of terrestrial compartment via air deposition. b. For uses other than those specified under condition (2), release of waste water from the facilities shall be directed to a sewage treatment plant.
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
The product assessment shall pay particular attention to the exposures, the 12 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.
The authorisations of biocidal products are subject to the following conditions: Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for the environment, products shall not be authorised for use in off-shore installations, unless it can be demonstrated that risks can be reduced to an acceptable level. (3) In view of the risks identified for human health, labels or safety data sheets of products authorised for off-shore installations shall indicate that drilling mud shall not contain CMIT/MIT (3:1) at a concentration triggering classification as skin sensitizer, unless safe operational procedures and appropriate organisational measures can be established for workers. (4) In view of the risks identified for the environment, labels or safety data sheets of products authorised for use in paper mills shall indicate the need for an appropriate dilution of the industrial release from the facilities into the watercourse after mechanical/chemical treatment or after treatment in a sewage treatement plant, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance 13 authorisation, but not addressed in the Union level risk assessment of the active substance.
The authorisations of biocidal products are subject to the following conditions: (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for professional users, loading of the products into metalworking fluids shall be semi-automated or automated, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (3) In view of the risks identified for professional users, labels and, where provided, safety data sheets shall indicate that the products shall not be used in metal working fluids at a concentration triggering classification as skin sensitizer, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance st PHMB (1600; IUPAC Name: 956 g/kg 1 July 2017 2 PHMB (1600; 1.8) is considered a candidate for substitution in accordance th 1.8) CoPoly(bisiminoimido (calculated 30 June 2024 with Article 10(1)(d) of Regulation (EU) No 528/2012. (polyhexamethyle carbonyl, dry weight ne biguanide hexamethylene specification The product assessment shall pay particular attention to the exposures, the hydrochloride hydrochloride), ). risks and the efficacy linked to any uses covered by an application for with a mean (iminoimidocarbonyl, authorisation, but not addressed in the Union level risk assessment of the number-average hexamethylene The active active substance. molecular weight hydrochloride) substance as (Mn) of 1600 and manufacture a mean The authorisations of biocidal products are subject to the following EC No: n.a. d is an conditions: polydispersity aqueous CAS No: 27083-27-8 (1) For industrial or professional users, safe operational procedures and (PDI) of 1.8) solution of and 32289-58-0 appropriate organisational measures shall be established. Products 20% w/w of shall be used with appropriate personal protective equipment where PHMB exposure cannot be reduced to an acceptable level by other means. (1600; 1.8) (2) In view of the risks identified for human health and the environment, products shall not be authorised for the treatment of swimming pools, unless it can be demonstrated that risks can be reduced to an acceptable level. (3) In view of the risks identified for human health and the environment, products shall not be authorised for disinfection of medical equipment by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level. (4) In view of the risks identified for human health, ready-to-use wipes shall not be authorised for non-professionals, unless it can be Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance demonstrated that risks can be reduced to an acceptable level. (5) In view of the risks identified for human health, labels, and where provided, safety data sheets of ready-to-use wipes shall indicate that the use is restricted to areas not accessible to general public, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1600; 1.8) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
3 PHMB (1600; 1.8) is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012.
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.
The authorisations of biocidal products are subject to the following conditions: Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance (5) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (6) In view of the risks identified for human health, products shall not be authorised for disinfection of equipment by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level. In addition, in case products are authorised, in view of the risks identified for the environment, labels, and where provided, safety data sheets shall indicate that no release to sewage treatment plants shall be allowed, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (7) In view of the risks identified for human health, labels, and where provided, safety data sheets of ready-to-use wipes shall indicate that the use is restricted to areas not accessible to the general public, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (8) 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 Council4 or Regulation (EC) No 396/2005 of the European Parliament and of the Council5 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
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). Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1600; 1.8) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
11 PHMB (1600; 1.8) is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012.
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.
The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for human health, labels and, where provided, safety data sheets shall indicate that loading of product into the cooling system shall be automated, that the pump shall be rinsed before cleaning and that appropriate personal protective equipment shall be worn during the cleaning phase, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. (3) In view of the risks identified for water, sediments and soil, labels and, where provided, safety data sheets shall indicate that disposal of preserved liquids following drainage of the closed recirculating system Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance shall be handled as hazardous waste, unless it can be demonstrated at product authorisation that risks to the environment can be reduced to an acceptable level by other means.
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1600; 1.8) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. st PHMB (1600; IUPAC Name: 956 g/kg 1 July 2017 4 PHMB (1600; 1.8) is considered a candidate for substitution in accordance th 1.8) CoPoly(bisiminoimido (calculated 30 June 2027 with Article 10(1)(d) of Regulation (EU) No 528/2012. (polyhexamethyle carbonyl, dry weight ne biguanide hexamethylene specification The product assessment shall pay particular attention to the exposures, the hydrochloride hydrochloride), ). risks and the efficacy linked to any uses covered by an application for with a mean (iminoimidocarbonyl, authorisation, but not addressed in the Union level risk assessment of the number-average hexamethylene The active active substance. molecular weight hydrochloride) substance as (Mn) of 1600 and manufacture a mean The authorisations of biocidal products are subject to the following EC No: n.a. d is an conditions: polydispersity aqueous CAS No: 27083-27-8 1 For professional users, safe operational procedures and (PDI) of 1.8) solution of and 32289-58-0 appropriate organisational measures shall be established. 20% w/w of Products shall be used with appropriate personal protective PHMB equipment where exposure cannot be reduced to an acceptable (1600; 1.8) level by other means. 2 In view of the risks identified for human health and the aquatic and soil compartments, products shall not be authorised for use as disinfectant of utensils by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level. Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance 3 In view of the risks identified for human health and the aquatic compartment, products shall not be authorised for surface disinfection by mopping, unless it can be demonstrated that risks can be reduced to an acceptable level. 4 In view of the risks identified for human health, labels, and where provided, safety data sheets of ready-to-use wipes shall indicate that the use is restricted to areas not accessible to the general public, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. 5 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 Council6 or Regulation (EC) No 396/2005 of the European Parliament and of the Council7 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 6 Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of PHMB (1600; 1.8) into food or it has been established pursuant to that Regulation that such limits are not necessary.
The placing on the market of treated articles is subject to the following condition:
6 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). 7 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). Common name IUPAC Name & Minimum Date of approval Product Specific provisions Identification purity of and expiry date type Numbers active (PT) substance The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1600; 1.8) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.