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Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)

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ANNEX IU.K.LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL FOR INCLUSION IN BIOCIDAL PRODUCTS

a

[F2For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm] ]

[F1No Common Name IUPAC Name Identification Numbers Minimum purity of the active substance in the biocidal product as placed on the market Date of inclusion Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) Expiry date of inclusion Product type Specific provisions a
1 sulfuryl fluoride

sulfuryl difluoride

EC No: 220-281-5

CAS No: 2699-79-8

> 994 g/kg 1 January 2009 31 December 2010 31 December 2018 8

Member States shall ensure that authorisations are subject to the following conditions:

(1)

the product may only be sold to and used by professionals trained to use it;

(2)

appropriate risk mitigation measures are included for operators and bystanders;

(3)

concentrations of sulfuryl fluoride in remote tropospheric air are monitored.

Member States shall also ensure that reports of the monitoring referred to in point (3) are transmitted by authorisation holders directly to the Commission every fifth year starting from 1 January 2009 .

[F3 994 g/kg 1 July 2011 30 June 2013 30 June 2021 18

Member States shall ensure that authorisations are subject to the following conditions:

(1)

Products shall only be sold to and used by professionals trained to use them.

(2)

Appropriate measures to protect fumigators and bystanders during fumigation and venting of treated buildings or other enclosures must be taken.

(3)

Labels and/or safety-data sheets of products shall indicate that, prior to fumigation of any enclosure, all food items must be removed.

(4)

Concentrations of sulfuryl fluoride in remote tropospheric air are monitored.

(5)

Member States shall also ensure that reports of the monitoring referred to in point (4) are transmitted by authorisation holders directly to the Commission every fifth year, starting at the latest five years after the authorisation. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m 3 of tropospheric air).]

[F42 dichlofluanid

N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide

EC No: 214-118-7

CAS No: 1085-98-9

> 96 % w/w 1 March 2009 28 February 2011 28 February 2019 8 Member States shall ensure that authorisations are subject to the following conditions:
(1)

Products authorised for industrial and/or professional use must be used with appropriate personal protective equipment.

(2)

In view of the risks identified for the soil compartment appropriate risk mitigation measures must be taken to protect that compartment.

(3)

Labels and/or safety-data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses must be collected for re-use or disposal.]

[F53 clothianidin

(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

EC No: 433-460-1

CAS No: 210880-92-5

950 g/kg 1 February 2010 31 January 2012 31 January 2020 8

When assessing, in accordance with Article 5 and Annex VI, the application for authorisation of a product, Member States shall assess those use/exposure scenarios and/or populations that have not been representatively addressed in the Community level risk assessment and that may be exposed to the product. When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks. Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

In view of the risk identified for the soil, surface water and groundwater compartments, products cannot be authorised for the treatment of wood that will be used outdoors unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses must be collected for reuse or disposal.]

[F64 Difethialone

3-[3-(4′-bromo[1,1′biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one

EC No: n/a

CAS No: 104653-34-1

976 g/kg 1 November 2009 31 October 2011 31 October 2014 14

In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

Member States shall ensure that authorisations are subject to the following conditions:

(1)

The nominal concentration of the active substance in the products shall not exceed 0,0025 % w/w and only ready-for-use baits shall be authorised.

(2)

Products shall contain an aversive agent and, where appropriate, a dye.

(3)

Products shall not be used as tracking powder.

(4)

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, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.]

[F75 etofenprox

3-phenoxybenzyl-2-(4-ethoxyphenyl)-2-methylpropylether

EC No: 407-980-2

CAS No: 80844-07-1

970 g/kg 1 February 2010 31 January 2012 31 January 2020 8

When assessing, in accordance with Article 5 and Annex VI, the application for authorisation of a product, Member States shall access those use and/or exposure scenarios and/or populations that have not been representatively addressed in the Community level risk assessment and that may be exposed to the product. When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks. Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

In view of the risk identified for workers, products cannot be used year round unless dermal absorption data is provided to demonstrate that there are no unacceptable risks from chronic exposure. In addition, products intended for industrial use must be used with appropriate personal protective equipment.]

[F86 tebuconazole

1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol

EC No: 403-640-2

CAS No: 107534-96-3

950 g/kg 1 April 2010 31 March 2012 31 March 2020 8

Member States shall ensure that authorisations are subject to the following conditions:

  • In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

  • In addition, products cannot be authorised for the in situ treatment of wood outdoors or for wood that will be in continuous contact with water unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F97 carbon dioxide

carbon dioxide

EC No: 204-696-9

CAS No: 124-38-9

990 ml/l 1 November 2009 31 October 2011 31 October 2019 14

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.]

[F108 propiconazole

1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole

EC No: 262-104-4

CAS No: 60207-90-1

930 g/kg 1 April 2010 31 March 2012 31 March 2020 8

Member States shall ensure that authorisations are subject to the following conditions:

In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

In addition, products cannot be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F119 Difenacoum

3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin

EC No: 259-978-4

CAS No: 56073-07-5

960 g/kg 1 April 2010 31 March 2012 31 March 2015 14

In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

Member States shall ensure that authorisations are subject to the following conditions:

(1)

The nominal concentration of the active substance in the products shall not exceed 75 mg/kg and only ready-for-use products shall be authorised.

(2)

Products shall contain an aversive agent and, where appropriate, a dye.

(3)

Products shall not be used as tracking powder.

(4)

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, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.]

[F1210 K-HDO

Cyclohexylhydroxydiazene 1-oxide, potassium salt

EC No: n/a

CAS No: 66603-10-9

(This entry also covers the hydrated forms of K-HDO)

977 g/kg 1 July 2010 30 June 2012 30 June 2020 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

Member States shall ensure that authorisations are subject to the following conditions:

(1)

in view of the possible risks for the environment and workers, products shall not be used in other systems than industrial, fully automated and closed ones unless the application for product authorisation demonstrates that risks can be reduced to acceptable levels in accordance with Article 5 and Annex VI;

(2)

in view of the assumptions made during the risk assessment, products must be used with appropriate personal protective equipment, unless the application for product authorisation demonstrates that risks to users can be reduced to acceptable levels by other means;

(3)

in view of the risk identified for infants, products shall not be used for the treatment of wood that may enter in direct contact with infants.]

[F1311 IPBC

3-iodo-2-propynyl butylcarbamate

EC No: 259-627-5

CAS No: 55406-53-6

980 g/kg 1 July 2010 30 June 2012 30 June 2020 8

Member States shall ensure that authorisations are subject to the following conditions:

  • In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

  • In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hardstanding to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.]

[F1412 Chlorophacinone

Chlorophacinone

EC No: 223-003-0

CAS No: 3691-35-8

978  g/kg 1 July 2011 30 June 2013 30 June 2016 14

In view of the identified risks for non-target animals, the active substance shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

Member States shall ensure that authorisations are subject to the following conditions:

1.

The nominal concentration of the active substance in products other than tracking powder shall not exceed 50 mg/kg and only ready-for use products shall be authorised.

2.

Products to be used as tracking powder shall only be placed on the market for use by trained professionals.

3.

Products shall contain an aversive agent and, where appropriate, a dye.

4.

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, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.]

[F1513 Thiabendazole

2-thiazol-4-yl-1H-benzoimidazole

EC No: 205-725-8

CAS No: 148-79-8

985 g/kg 1 July 2010 30 June 2012 30 June 2020 8

Member States shall ensure that authorisations are subject to the following conditions:

  • in view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, with respect to the double-vacuum and dipping application tasks, must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by others means.

  • In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

  • Products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F1614 thiamethoxam

thiamethoxam

EC No: 428-650-4

CAS No: 153719-23-4

980 g/kg 1 July 2010 30 June 2012 30 June 2020 8

Member States shall ensure that authorisations are subject to the following conditions:

In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

Products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data have been submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F1715 alphachloralose

(R)-1,2-O-(2.2,2-Trichloroethylidene)-α-D-glucofuranose

EC No: 240-016-7

CAS No: 15879-93-3

825  g/kg 1 July 2011 30 June 2013 30 June 2021 14

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

In particular, products cannot be authorised for outdoor use unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Member States shall ensure that authorisations are subject to the following conditions:

1.

The nominal concentration of the active substance in the products shall not exceed 40 g/kg.

2.

Products shall contain an aversive agent and a dye.

3.

Only products for use in tamper resistant and securely closed bait boxes shall be authorised.]

[F1817 bromadiolone

3-[3-(4’-Bromo[1,1’-biphenyl]-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-1-benzopyran-2-one

EC No: 249-205-9

CAS No: 28772-56-7

969  g/kg 1 July 2011 30 June 2013 30 June 2016 14

In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

Member States shall ensure that authorisations are subject to the following conditions:

1.

The nominal concentration of the active substance in the products shall not exceed 50 mg/kg and only ready-for-use products shall be authorised.

2.

Products shall contain an aversive agent and, where appropriate, a dye.

3.

Products shall not be used as tracking powder.

4.

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, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.]

[F1918 Thiacloprid

(Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide

EC No: n/a

CAS No: 111988-49-9

975 g/kg 1 January 2010 n/a 31 December 2019 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

2.

In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

3.

Products shall not be authorised for the in situ treatment of wooden structures near water, where direct losses to the aquatic compartment cannot be prevented, or for wood that will be in contact with surface water, unless data have been submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F2019 Indoxacarb (enantiomeric reaction mass S:R 75:25)

Reaction mass of methyl (S)- and methyl(R)-7-chloro-2.3,4a,5-tetrahydro-2-[methoxycarbonyl-(4-trifluoromethoxyphenyl) carbamoyl]indeno[1,2-e][1.3,4]oxadiazine-4a-carboxylate (This entry covers the 75:25 reaction mass of the S and R enantiomers)

EC No: n/a

CAS No: S-enantiomer: 173584-44-6 and R-enantiomer: 185608-75-7)

796  g/kg 1 January 2010 n/a 31 December 2019 18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

Appropriate risk mitigation measures must be taken to minimise the potential exposure of humans, of non-target species and of the aquatic environment. In particular, labels and/or safety-data sheets of products authorised shall indicate that:

1.

Products shall not be placed in areas accessible to infants, children and companion animals.

2.

Products shall be positioned away from external drains.

3.

Unused products shall be disposed of properly and not washed down the drain.

For amateur uses, only ready-to-use products shall be authorised.]

[F2120 aluminium phosphide releasing phosphine

aluminium phosphide

EC No: 244-088-0

CAS No: 20859-73-8

830  g/kg 1 September 2011 31 August 2013 31 August 2021 14

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels. In particular, products cannot be authorised for indoor use unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Member States shall ensure that authorisations are subject to the following conditions:

1.

Products shall only be sold to and used by specifically trained professionals.

2.

In view of the risks identified for operators, appropriate risk mitigation measures must be applied. These include, amongst others, the use of appropriate personal protective equipment, the use of applicators and the presentation of the product in a form designed to reduce operator exposure to an acceptable level.

3.

In view of the risks identified for terrestrial non-target species, appropriate risk reduction measures must be applied. These include, amongst others, the non-treatment of areas where other burrowing mammals than the target species are present.]

[F2221 fenpropimorph

(+/-)-cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

EC No: 266-719-9

CAS No: 67564-91-4

930  g/kg 1 July 2011 30 June 2013 30 June 2021 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

In view of the assumptions made during the risk assessment, products authorised for industrial use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial users can be reduced to an acceptable level by other means.

2.

In view of the risks identified for the soil and aquatic compartments, appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.]

[F2322 boric acid

boric acid

EC No: 233-139-2

CAS No: 10043-35-3

990  g/kg 1 September 2011 31 August 2013 31 August 2021 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.]

[F2423 boric oxide

Diboron trioxide

EC No: 215-125-8

CAS No: 1303-86-2

975  g/kg 1 September 2011 31 August 2013 31 August 2021 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.]

[F2524 disodium tetraborate

disodium tetraborate

EC No: 215-540-4

CAS No (anhydrous): 1330-43-4

CAS No (pentahydrate): 12267-73-1

CAS No (decahydrate): 1303-96-4

990  g/kg 1 September 2011 31 August 2013 31 August 2021 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.]

[F2625 disodium octaborate tetrahydrate

disodium octaborate tetrahydrate

EC No: 234-541-0

CAS No: 12280-03-4

975  g/kg 1 September 2011 31 August 2013 31 August 2021 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.]

[F2727 Nitrogen

Nitrogen

EC No: 231-783-9

CAS No: 7727-37-9

999  g/kg 1 September 2011 31 August 2013 31 August 2021 18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

Member States shall ensure that authorisations are subject to the following conditions:

1.

Products may only be sold to and used by professionals trained to use them.

2.

Safe working practices and safe systems of work must be in place to ensure minimum risk, including the availability of personal protective equipment if necessary.]

[F2828 Coumatetralyl

Coumatetralyl

EC No: 227-424-0

CAS No: 5836-29-3

980  g/kg 1 July 2011 30 June 2013 30 June 2016 14

In view of the identified risks for non-target animals, the active substance shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

Member States shall ensure that authorisations are subject to the following conditions:

1.

The nominal concentration of the active substance in products other than tracking powder shall not exceed 375 mg/kg and only ready-for use products shall be authorised.

2.

Products shall contain an aversive agent and, where appropriate, a dye.

3.

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, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.]

Textual Amendments

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