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Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title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European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)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

[F4 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).]

[F52 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.]

[F63 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.]

[F74 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.]

[F85 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.]

[F96 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.]

[F107 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.]

[F11 990 ml/l 1 November 2012 31 October 2014 31 October 2022 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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the European 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.

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

(1)

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

(2)

Appropriate measures to protect operators shall be taken to ensure minimum risk, including the availability of personal protective equipment if necessary.

(3)

Appropriate measures shall be taken to protect bystanders, such as exclusion from the treatment area during fumigation.]

[F128 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.]

[F139 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.]

[F1410 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.]

[F1511 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.]

[F1612 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.]

[F1713 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.]

[F1814 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.]

[F1915 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.]

[F2016 brodifacoum

3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydro-1-napthyl]-4-hydroxycoumarin

EC No: 259-980-5

CAS No: 56073-10-0

950 g/kg 1 February 2012 31 January 2014 31 January 2017 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.]

[F2117 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.]

[F2218 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.]

[F2319 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.]

[F2420 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.]

[F25 830 g/kg 1 February 2012 31 January 2014 31 January 2022 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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the Union level risk assessment. In particular, where relevant, Member States shall assess outdoor use.

When granting product authorisation, Member States shall ensure that adequate residue trials are provided to allow consumer risk assessment and that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

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

(1) Products shall only be supplied to and used by specifically trained professionals in the form of ready-for-use products.

(2) In view of the risks identified for operators, appropriate risk mitigation measures must be applied. Those include, amongst others, the use of appropriate personal and respiratory protective equipment, the use of applicators and the presentation of the product in a form designed to reduce the exposure of operators to an acceptable level. For indoor use, those include also the protection of operators and workers during fumigation, the protection of workers at re-entry (after fumigation period) and the protection of bystanders against leaking of gas.

(3) For products containing aluminium phosphide that may lead to residues in food or feed, labels and/or safety data sheets for authorised products must contain instructions for use, such as the adherence to waiting periods, which ensure compliance with the provisions laid down in Article 18 of Regulation (EC) No 396/2005 of the European Parliament and of the Council ( OJ L 70, 16.3.2005, p. 1 ).]

[F2621 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.]

[F2722 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.]

[F2823 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.]

[F2924 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.]

[F3025 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.]

[F3126 Magnesium phosphide releasing phosphine

Trimagnesium diphosphide

EC No: 235-023-7

CAS No: 12057-74-8

880 g/kg 1 February 2012 31 January 2014 31 January 2022 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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the Union level risk assessment. In particular, where relevant, Member States shall assess outdoor use.

When granting product authorisation, Member States shall ensure that adequate residue trials are provided to allow consumer risk assessment and that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

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

(1)

Products shall only be supplied to and used by specifically trained professionals in the form of ready-for-use products.

(2)

In view of the risks identified for operators, appropriate risk mitigation measures must be applied. Those include, amongst others, the use of appropriate personal and respiratory protective equipment, the use of applicators and the presentation of the product in a form designed to reduce the exposure of operators to an acceptable level. For indoor use, those include also the protection of operators and workers during fumigation, the protection of workers at re-entry (after fumigation period) and the protection of bystanders against leaking of gas.

(3)

For products containing magnesium phosphide that may lead to residues in food or feed, labels and/or safety data sheets for authorised products must contain instructions for use, such as the adherence to waiting periods, which ensure compliance with the provisions laid down in Article 18 of Regulation (EC) No 396/2005 of the European Parliament and of the Council ( OJ L 70, 16.3.2005, p. 1 ).]

[F3227 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.]

[F3328 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.]

[F3429 tolylfluanid

Dichloro-N-[(dimethylamino)sulphonyl]fluoro-N-(p-tolyl)methanesulphenamide

EC No: 211-986-9

CAS No: 731-27-1

960 g/kg 1 October 2011 30 September 2013 30 September 2021 8

Products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering.

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 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 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 or professional 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.]

[F3530 Acrolein

Acrylaldehyde

EC No: 203-453-4

CAS No: 107-02-8

913 g/kg 1 September 2010 Not applicable 31 August 2020 12

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where 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 Union level risk assessment.

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

(1)

Waste waters containing acrolein shall be monitored prior to discharge, unless it can be demonstrated that risks for the environment can be reduced by other means. Where necessary in view of the risks to marine environment, waste waters shall be held in suitable tanks or reservoirs or appropriately treated before discharge.

(2)

Products authorised for industrial and/or professional use shall be used with appropriate personal protective equipment, and safe operational procedures shall be established, 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.]

[F3631 Flocoumafen

4-hydroxy-3-[(1 RS ,3 RS ;1 RS ,3 RS )-1,2,3,4-tetrahydro-3-[4-(4-trifluoromethylbenzyloxy)phenyl]-1-naphthyl]coumarin

EC No 421-960-0

CAS No 90035-08-8

955 g/kg 1 October 2011 30 September 2013 30 September 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 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. Those 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.]

[F3732 Warfarin

(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin

EC No: 201-377-6

CAS No: 81-81-2

990 g/kg 1 February 2012 31 January 2014 31 January 2017 14

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 shall not exceed 790 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 and 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 possibility of 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.]

[F3833 Warfarin sodium

Sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate

EC No: 204-929-4

CAS No: 129-06-6

910 g/kg 1 February 2012 31 January 2014 31 January 2017 14

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 shall not exceed 790 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 and 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 possibility of 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.]

[F3934 Dazomet

Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione

EC No: 208-576-7

CAS No: 533-74-4

960 g/kg 1 August 2012 31 July 2014 31 July 2022 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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the EU level risk assessment. In particular, where relevant, Member States shall assess any other use than professional use outdoors for the remedial treatment of wooden poles by insertion of granules.

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

Products authorised for industrial and/or professional use shall 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.]

[F4035 N,N-diethyl-meta-toluamide

N,N-diethyl-m-toluamide

EC No: 205-149-7

CAS No: 134-62-3

970 g/kg 1 August 2012 31 July 2014 31 July 2022 19

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

(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)

labels on products intended for application on human skin, hair or clothing shall indicate that the product is intended only for restricted use on children between two and twelve years old, and that it is not intended for use on children less than two years old, unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI without such measures;

(3)

products must contain deterrents for ingestion.]

[F4136 Metofluthrin
  • RTZ isomer:

    2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl-(1R,3R)-2,2-dimethyl-3-(Z)-(prop-1-enyl)cyclopropanecarboxylate

    EC No: n.a.

    CAS No: 240494-71-7

  • Sum of all isomers:

    2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1SR,3SR)-2,2-dimethyl-3-prop-1-enylcyclopropanecarboxylate

    EC No: n.a.

    CAS No: 240494-70-6

The active substance shall comply with both the following minimum purities:

  • RTZ isomer:

    754 g/kg

  • Sum of all isomers:

    930 g/kg

1 May 2011 Not applicable 30 April 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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the European level risk assessment.]
[F4237 Spinosad

EC No: 434-300-1

CAS No: 168316-95-8

Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D.

Spinosyn A

(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-60-7

Spinosyn D

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-63-0

850 g/kg 1 November 2012 31 October 2014 31 October 2022 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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the EU level risk assessment.

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

  • Authorisations shall be subject to appropriate risk mitigation measures. In particular, products authorised for professional use by spraying shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by others means.

  • For products containing spinosad that may lead to residues in food or feed, Member States shall verify the need to set new and/or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 and/or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.]

[F4338 Bifenthrin

IUPAC name: 2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

EC No: n.a.

CAS No: 82657-04-3

911 g/kg 1 February 2013 31 January 2015 31 January 2023 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, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed in the Union level risk assessment.

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

  • Products shall be authorised only for industrial or professional use, unless it is demonstrated in the application for product authorisation that risks to non-professional users can be reduced to acceptable levels in accordance with Article 5 and Annex VI.

  • Products authorised for industrial 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 or professional users can be reduced to an acceptable level by other means.

  • Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding, 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.

  • Products shall not be authorised for the in situ treatment of wood outdoors, or for treatment of wood that will be either continually exposed to the weather or protected from the weather but subject to frequent wetting, unless data have been submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F4439 (Z,E)-tetradeca-9,12-dienyl acetate

(9Z,12E)-Tetradeca-9,12-dien-1-yl acetate

EC No: n.a.

CAS No: 30507-70-1

977 g/kg 1 February 2013 31 January 2015 31 January 2023 19

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, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed in Union level risk assessment.

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

  • Labels for biocidal products containing (Z,E)-tetradeca-9,12-dienyl acetate shall indicate that those products shall not be used in spaces where un-packaged food or feed is kept.]

[F4540 Fenoxycarb
  • IUPAC name: Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate

  • EC No: 276-696-7

  • CAS No: 72490-01-8

960 g/kg 1 February 2013 31 January 2015 31 January 2023 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, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed in the Union level risk assessment.

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

  • Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding under roof, 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.

  • Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above water, unless data is submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F4641 Nonanoic acid, Pelargonic acid
  • IUPAC name: Nonanoic acid

  • EC No: 203-931-2

  • CAS No: 112-05-0

896 g/kg 1 February 2013 31 January 2015 31 January 2023 19 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, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed in Union level risk assessment.]
[F4742 imidacloprid

(2E)-1-[(6-chloropyridin-3-yl)methyl]-N-nitroimidazolidin-2-imine

EC No: 428-040-8

CAS No: 138261-41-3

970 g/kg 1 July 2013 30 June 2015 30 June 2023 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, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products shall not be authorised for uses in animal housings where emission to a sewage treatment plant or direct emission to surface water cannot be prevented, unless data is submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Authorisations shall be subject to appropriate risk mitigation measures. In particular, appropriate risk mitigation measures shall be taken to minimise the potential exposure of infants and children.

For products containing imidacloprid that may lead to residues in food or feed, Member States shall verify the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.]

[F4843 Abamectin

Abamectin is a mixture of avermectin B 1a and avermectin B 1b

  • Abamectin:

    • IUPAC name: n.a.

    • EC No: n.a.

    • CAS No: 71751-41-2

  • Avermectin B 1a :

    • IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-6'-[(S)-secbutyl]-21,24-dihydroxy-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside

    • EC No: 265-610-3

    • CAS No: 65195-55-3

  • Avermectin B 1b :

    • IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6'-isopropyl-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside

    • EC No: 265-611-9

    • CAS No: 65195-56-4

The active substance shall comply with all the following purities:

  • Abamectin:

    minimum 900 g/kg

  • Avermectin B 1a :

    minimum 830 g/kg

  • Avermectin B 1b :

    maximum 80 g/kg

1 July 2013 30 June 2015 30 June 2023 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, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products applied in such a way that emission to a sewage treatment plant cannot be prevented shall not be authorised for those application rates for which the Union level risk assessment showed unacceptable risks, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Authorisations shall be subject to appropriate risk mitigation measures. In particular, appropriate risk mitigation measures shall be taken to minimise the potential exposure of infants and children.]

[F4944 4,5-Dichloro-2-octyl-2H-isothiazol-3-one

4,5-Dichloro-2-octylisothiazol-3(2 H )-one

EC No: 264-843-8

CAS No: 64359-81-5

950 g/kg 1 July 2013 30 June 2015 30 June 2023 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, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products shall not be authorised for treatment of wood that will be continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water, unless data have been submitted demonstrating 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)

for products authorised for industrial or professional use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means;

(2)

labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing under roof, 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.]

[F345 Creosote

Creosote

EC No: 232-287-5

CAS No: 8001-58-9

Grade B or Grade C creosote as specified in European Standard EN 13991:2003 1 May 2013 30 April 2015 30 April 2018 8

Biocidal products containing creosote may only be authorised for uses where the authorising Member State, based on an analysis regarding the technical and economic feasibility of substitution which it shall request from the applicant, as well as on any other information available to it, concludes that no appropriate alternatives are available. Those Member States authorising such products in their territory shall no later than 31 July 2016 submit a report to the Commission justifying their conclusion that there are no appropriate alternatives and indicating how the development of alternatives is promoted. The Commission will make these reports publicly available.

The active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) before its inclusion in this Annex is renewed.

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed at the Union level risk assessment.

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

(1)

Creosote may only be used under the conditions mentioned in point 2 of the second column of entry No 31 in Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC b .

(2)

Creosote shall not be used for the treatment of wood intended for those uses referred to in point 3 of the second column of entry No 31 in Annex XVII to Regulation (EC) No 1907/2006.

(3)

Appropriate risk mitigation measures shall be taken to protect workers, including down-stream users, from exposure during treatment and handling of treated wood in compliance with Regulation (EC) No 1907/2006 and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) c .

(4)

Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber must 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 must be collected for reuse or disposal.]

[F5046 Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 Not applicable No relevant impurities 1 October 2013 30 September 2015 30 September 2023 18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

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

For products containing Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.]

[F5147 fipronil

(±)-5-amino-1-(2,6-dichloro-α,α,α,-trifluoro-p-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile (1:1)

EC No: 424-610-5

CAS No: 120068-37-3

950 g/kg 1 October 2013 30 September 2015 30 September 2023 18 Only professional use indoors by application in locations normally inaccessible after application to man and domestic animals has been addressed in the Union level risk assessment. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.]
[F5248 lambda-cyhalothrin

Reaction mass of (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate (1:1)

CAS-No: 91465-08-6

EC No: 415-130-7

900 g/kg 1 October 2013 30 September 2015 30 September 2023 18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products applied in such a way that emission to a sewage treatment plant cannot be prevented shall not be authorised, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

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

For products containing lambda-cyhalothrin that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.]

[F5349 deltamethrin

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate

CAS-No: 52918-63-5

EC No: 258-256-6

985 g/kg 1 October 2013 30 September 2015 30 September 2023 18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products shall not be authorised for indoor treatments resulting in sewage treatment plant emissions of the scale for which the Union level risk assessment showed unacceptable risks, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.]

[F5450 Copper hydroxide

Copper (II) hydroxide

EC No: 243-815-9

CAS No: 20427-59-2

965  g/kg 1 February 2014 31 January 2016 31 January 2024 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

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

(1)

Products shall not be authorised for application by dipping, unless data have been submitted in the application for product authorisation demonstrating that that application meets the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

(2)

For products authorised for industrial use, safe operational procedures shall be established, and products shall 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.

(3)

Labels and, where provided, safety data sheets of products authorised shall indicate 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.

(4)

Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above 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 mitigation measures.

51 Copper (II) oxide

Copper (II) oxide

EC No: 215-269-1

CAS No: 1317-38-0

976  g/kg 1 February 2014 31 January 2016 31 January 2024 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

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

(1)

For products authorised for industrial use, safe operational procedures shall be established, and products shall 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)

Labels and, where provided, safety data sheets of products authorised shall indicate 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.

(3)

Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above water or for the treatment of wood in contact with fresh 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 mitigation measures.

52 Basic copper carbonate

Copper(II) carbonate-copper(II) hydroxide (1:1)

EC No: 235-113-6

CAS No: 12069-69-1

957  g/kg 1 February 2014 31 January 2016 31 January 2024 8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

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

(1)

Products shall not be authorised for application by dipping, unless data have been submitted in the application for product authorisation demonstrating that that application meets the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

(2)

For products authorised for industrial use, safe operational procedures shall be established, and products shall 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.

(3)

Labels and, where provided, safety data sheets of products authorised shall indicate 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.

(4)

Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above water, or for the treatment of wood in direct contact with fresh 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 mitigation measures.]

[F5553 bendiocarb

2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate

CAS-No: 22781-23-3

EC No: 245-216-8

970  g/kg 1 February 2014 31 January 2016 31 January 2024 18

The Union level risk assessment did not address all potential uses, but concerned, for example, application by professionals only, and excluded contact with feed or food and direct application on soil. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

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

  • Products shall not be used for the treatment of surfaces that are prone to frequent wet cleaning, other than crack and crevice or spot treatment, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

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

  • Where relevant, measures shall be taken to prevent foraging bees from gaining access to treated nests by removing the combs or blocking the nest entrances.]

[F5654 methyl nonyl ketone

Undecan-2-one

CAS No: 112-12-9

EC No: 203-937-5

975  g/kg 1 May 2014 30 April 2016 30 April 2024 19 The Union level risk assessment was based on indoor use by non-professional users. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.]
[F5755 margosa extract

IUPAC name: Not applicable

CAS-No: 84696-25-3

EC No: 283-644-7

Description: margosa extract from the kernels of Azadirachta indica extracted with water and further processed with organic solvents

1 000  g/kg 1 May 2014 30 April 2016 30 April 2024 18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Member States shall ensure that authorisations are subject to appropriate risk mitigation measures for the protection of surface water, sediment and non-target arthropods.]

[F5856 Hydrochloric acid

Hydrochloric acid

CAS No: not applicable

EC No: 231-595-7

999  g/kg 1 May 2014 30 April 2016 30 April 2024 2

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Member States shall ensure that authorisations of products for non-professional use are subject to the packaging being designed to minimise user exposure, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.]

[F5957 flufenoxuron

1-[4-(2-chloro-alpha,alpha,alpha-trifluoro-para-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea

EC No: 417-680-3

CAS No: 101463-69-8

960  g/kg 1 February 2014 31 January 2016 31 January 2017 8

Flufenoxuron 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.

The Union level risk assessment addressed treatment of wood which will not be used in animal housing or come into contact with food or feed. Products shall not be authorised for uses or exposure scenarios that have not been representatively addressed in the Union level risk assessment.

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

(1)

Products shall only be used for treatment of wood intended for indoor use.

(2)

For products authorised for industrial or professional use safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

(3)

Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of authorised products shall indicate 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.]

Textual Amendments

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