Biocides (Amendment) Regulations, 2012

L.N. 128 of 2012

PESTICIDES CONTROL ACT

(CAP. 430)

Biocides (Amendment) Regulations, 2012

IN exercise of the powers conferred by articles 4 and 5 of the

Pesticides Control Act, the Minister for Resources and Rural Affairs,

in consultation with the Prime Minister and with the Ministers

responsible for Health and the Environment, has made the following

regulations:-

(1) The title of these regulations is the Biocides

(Amendment) Regulations, 2012 and they shall be read and construed

as one with Biocides Regulations, hereinafter referred to as "the

principal regulations".

(2) The scope of these regulations is to transpose Commission

Directive 2011/71/EU of 26 July 2011 amending Directive 98/8/EC

of the European Parliament and of the Council to include creosote as

an active substance in Annex I thereto.

Part A of Schedule I to the principal regulations shall be

substituted as follows:-

"SCHEDULE I

PART A

List of Active Substances with Requirements Agreed At

Community Level for Inclusion in Biocidal Products

No

Common

IUPAC Name

Minimu

Date of

Deadline

Expiry

Product

Specific provisions (*)

Name

Identification

m purity

inclusion

for

date of

type

Numbers

of the

compliance

inclusion

active

with Article

substance

16(3)

in the

(except for

biocidal

products

product

containing

as placed

more than

on the

one active

market

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)

sulfurylfluor

sulfuryl

> 994 g/

Member States shall

ide

difluoride EC

kg

January

December

December

ensure that authorizations

No: 220-281-5

are

subject

to

the

CAS No: 2699-

following conditions

79-8

(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.

994 g/kg

1 July

30 June

30 June

Member States shall

ensure that authorizations

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 authorization 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/m3 of

tropospheric air).

dichlofluani

N-

> 96% w/

Member States shall

d

(Dichlorofluoro

w

March

February

February

ensure that authorizations

methylthio)-

are

subject

to

the

N′,N′-dimethyl-

following conditions

N-

phenylsulfamide

(1) Products authorised

EC No: 214-118-

for

industrial

and/or

7 CAS No: 1085-

professional use must be

98-9

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.

clothianidin

(E)-1-(2-Chloro-

950 g/kg

When

assessing,

in

1,3-thiazol-5-

February

January

January

accordance with Article 5

ylmethyl)-3-

and Annex VI, the

methyl-2-

application for authoriz-

Nitroguanidine

ation of a product,

EC No: 433-460-

Member States shall

1 CAS No

assess those use /

210880-92-5

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 de-monstrates

that risks can be reduced

to acceptable levels.

Member States shall

ensure that authorizations

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.

Difethialone

3-[3-(4′-

976 g/kg

In view of the fact that the

bromo[1,1′biphe

November

October

October

active

substance

nyl]-4-yl)-

characteristics render it

1,2,3,4-

potentially

persistent,

tetrahydronaphth

liable to bioaccumulate

-1-yl]-4-

and toxic, or very

hydroxy-2H-1-

persistent and very liable

benzothiopyran-

to bioaccumulate, the

2-one EC No: n/a

active substance is to be

CAS No

subject to a comparative

104653-34-1

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 authorizations

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.

etofenprox

3-

970 g/kg

When

assessing,

in

phenoxybenzyl-

February

January

January

accordance with Article 5

2-(4-

and Annex VI, the

ethoxyphenyl)-2-

application

for

methylpropyleth

authorisation of a product,

er EC No: 407-

Member States shall

980-2 CAS No

access those use and/or

80844-07-1

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 authorizations

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.

tebuconazol

1-(4-

950 g/kg

Member States shall

e

chlorophenyl)-

April

March

March

ensure that authorizations

4,4-dimethyl-3-

are

subject

to

the

(1,2,4-triazol-1-

following conditions

ylmethyl)pentan-

In view of the risks

3-ol EC No: 403-

identified for the soil and

640-2 CAS No

aquatic

compartments

107534-96-3

appropriate risk mitigation

measures must be taken to

protect

those

com-

partments. 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.

carbondioxi

carbon dioxide

990 ml/l

When

assessing

the

de

EC No: 204-696-

November

October

October

application

for

9 CAS No: 124-

authorization of a product

38-9

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.

propiconazol

1-[[2-(2,4-

930 g/kg

Member States shall

e

dichlorophenyl)-

April

March

March

ensure that authorizations

4-propyl-1,3-

are

subject

to

the

dioxolan-2-

following conditions

yl]methyl]-1H-

In

view

of

the

1,2,4-triazole EC

assumptions made during

No: 262-104-4

the

risk

assessment,

CAS No: 60207-

products authorised for

90-1

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

com-

partments. In particular,

labels and/or safety data

sheets

of

products

authorized 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.

Difenacoum

3-(3-biphenyl-4-

960 g/kg

In view of the fact that the

yl-1,2,3,4-

April

March

March

active

substance

tetrahydro-1-

characteristics render it

naphthyl)-4-

potentially

persistent,

hydroxycoumari

liable to bioaccumulate

n EC No: 259-

and toxic, or very

978-4 CAS No

persistent and very liable

56073-07-5

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 authorizations

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.

K-HDO

Cyclohexylhydro

977 g/kg

1 July

30 June

30 June

When

assessing

the

xydiazene1-

application

for

oxide, potassium

authorization of a product

salt EC No: n/a

in accordance with Article

CAS No: 66603-

5 and Annex VI, Member

10-9 (This entry

States shall assess, when

also covers

relevant for the particular

thehydrated

product, the populations

forms of K-

that may be exposed to the

HDO)

product and the use or

exposure scenarios that

have

not

been

representatively addressed

at the Community level

risk assessment. Member

States shall ensure that

authorizations 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.

IPBC

3-iodo-2-

980 g/kg

1 July

30 June

30 June

Member States shall

propynyl

ensure that authorisations

butylcarbamate

are

subject

to

the

EC No: 259-627-

following conditions

5 CAS No

In

view

of

the

55406-53-6

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.

Chlorophaci

Chlorophacinone

978 g/kg

1 July

30 June

30 June

In view of the identified

none

EC No: 223-003-

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 authorizations

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.

Products shall contain

an aversive agent and,

where appropriate, a dye.

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.

Thiabendazo

2-thiazol-4-yl-

985 g/kg

1 July

30 June

30 June

Member States shall

le

1H-

ensure that authorizations

benzoimidazole

are

subject

to

the

EC No: 205-725-

following conditions

8 CAS No: 148-

79-8

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

authorization 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 authorized 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.

thiamethoxa

thiamethoxam

980 g/kg

1 July

30 June

30 June

Member States shall

m

EC No: 428-650-

ensure that authorizations

4 CAS No

are

subject

to

the

153719-23-4

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 part=-

icular, labels and/or safety

data sheets of products

authorized 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.

alphachloral

(R)-1,2-O-(2.2,2-

825 g/kg

1 July

30 June

30 June

When

assessing

the

ose

Trichloroethylid

application

for

ene)-α-D-

authorization of a product

glucofuranose

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 authorizations

are

subject

to

the

following conditions

1. The nominal concent-

ration 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.

brodifacoum

3-[3-(4’-

950 g/kg

In view of the fact that the

bromobiphenyl-

February

January

January

active

substance

4-yl)-1,2,3,4-

characteristics render it

tetrahydro-1-

potentially

persistent,

napthyl]-4-

liable to bioaccumulate

hydroxycoumari

and toxic, or very

n EC No: 259-

persistent and very liable

980-5 CAS No

to

56073-10-0

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 authorizations

are

subject

to

the

following conditions

1. The nominal concent-

ration 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.

bromadiolon

3-[3-(4’-

969 g/kg

1 July

30 June

30 June

In view of the fact that the

e

Bromo[1,1’-

active

substance

biphenyl]-4-yl)-

characteristics render it

3-hydroxy-1-

potentially

persistent,

phenylpropyl]-4-

liable to bioaccumulate

hydroxy-2H-1-

and toxic, or very

benzopyran-2-

persistent and very liable

one EC No: 249-

to bioaccumulate, the

205-9 CAS No

active substance is to be

28772-56-7

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 authorizations

are

subject

to

the

following conditions

1. The nominal concent-

ration 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.

Thiacloprid

(Z)-3-(6-chloro-

975 g/kg

n/a

When

assessing

the

3-

January

December

application

for

pyridylmethyl)-

authorization of a product

1,3-thiazolidin-

in accordance with Article

2-

5 and Annex VI, Member

ylidenecyanamid

States shall

e EC No: n/a

assess, when relevant for

CAS No

the particular product, the

111988-49-9

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 authorizations

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 equip-

ment, unless it can be

demonstrated

in

the

application for product

authorization that risks to

industrial and/or profes-

sional 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.

Indoxacarb(

Reaction mass of

796 g/kg

n/a

When

assessing

the

enantiomeric

methyl(S)- and

January

December

application

for

reactionmass

methyl(R)-7-

authorization of a product

S:R75:25)

chloro-2.3,4a,5-

in accordance with Article

tetrahydro-2-

5 and Annex VI, Member

[methoxycarbon

States shall

yl-(4-

assess, when relevant for

trifluoromethoxy

the particular product, the

phenyl)carbamo

populations that may be

yl]indeno[1,2-

exposed to the product

e][1.3,4]oxadiazi

and the use or exposure

ne-4acarboxylate

scenarios that have not

(This

been

representatively

entrycovers the

addressed

at

the

75:25

Community level risk

reactionmass of

assessment.

the S and R

When granting product

enantiomers)EC

authorisation,

Member

No: n/a

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 authorizations

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 authorized

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.

aluminiump

aluminium

830 g/kg

When

assessing

the

hosphiderele

phosphide EC

September

August

August

application

for

asingphosph

No: 244-088-0

authorization of a product

ine

CAS No: 20859-

in accordance with Article

73-8

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 authorizations

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.

830 g/kg

When

assessing

the

February

January

January

application

for

authorization 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 authorizations

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 authorized 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,

3.2005, p. 1).

fenpropimor

(+/-)-cis-4-[3-(p-

930 g/kg

1 July

30 June

30 June

When

assessing

the

ph

tert-

application

for

butylphenyl)-2-

authorization of a product

methylpropyl]-

in accordance with Article

2,6-

5 and Annex VI, Member

dimethylmorphol

States shall assess, when

ine EC No: 266-

relevant for the particular

719-9 CAS No

product, the populations

67564-91-4

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 authorizations

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 demon-strated 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 compart-

ments. 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.

boric acid

boric acid EC

990 g/kg

When

assessing

the

No: 233-139-2

September

August

August

application

for

CAS No: 10043-

authorization of a product

35-3

in accordance with Article

5 and Annex VI, Member

States shall assess, when

relevant for the particular

product, he 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 authorizations

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 demonst-

rated 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 authorized 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.

boric oxide

Diboron trioxide

975 g/kg

When

assessing

the

EC No: 215-125-

September

August

August

application

for

8 CAS No: 1303-

authorization of a product

86-2

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.

Prduct authorisation can

only be granted where the

application demonstrates

that risks can be reduced

to acceptable levels.

Member States shall

ensure that authorizations

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 demons-

trated 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,

pro-ducts 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 author-ised 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.

disodiumtetr

disodium

990 g/kg

When

assessing

the

aborate

tetraborate EC

September

August

August

application

for

No: 215-540-4

authorization of a product

CAS No

in accordance with Article

(anhydrous)

5 and

1330-43-4 CAS

Annex VI, Member States

No

shall

assess,

when

(pentahydrate):1

relevant for the particular

2267-73-1 CAS

product, the populations

No

that may be exposed to the

(decahydrate):13

product and the use or

03-96-4

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.

disodiumoct

disodium

975 g/kg

When

assessing

the

aboratetetrah

octaborate

September

August

August

application

for

ydrate

tetrahydrateEC

authorization of a product

No: 234-541-0

in accordance with Article

CAS No: 12280-

5 and Annex VI, Member

03-4

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 authorizations

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 authorized 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.

Magnesiump

Trimagnesium

880 g/kg

When

assessing

the

hosphiderele

diphosphideEC

February

January

January

application

for

asing

No: 235-023-7

authorization of a product

phosphine

CAS No: 12057-

in accordance with Article

74-8

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 authorizations

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

of

Regulation (EC) No 396/

2005 of the European

Parliament and of the

Council (OJ L 70,

16.3.2005, p. 1).

Nitrogen

Nitrogen EC No

999 g/kg

When

assessing

the

231-783-9 CAS

September

August

August

application

for

No: 7727-37-9

authorization 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.

Product authorisation can

only be granted where the

application demonstrates

that risks can be reduced

to acceptable levels.

Member States shall

ensure that authorizations

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.

Coumatetral

Coumatetralyl

980 g/kg

1 July

30 June

30 June

In view of the identified

yl

EC No: 227-424-

risks

for

non-target

0 CAS No: 5836-

animals,

the

active

29-3

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 authorizations

are

subject

to

the

following conditions

1. The nominal concent-

ration 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.

tolylfluanid

Dichloro-N-

960 g/kg

Products shall not be

[(dimethylamino

October

September

September

authorised for the in situ

)sulphonyl]fluor

treatment

of

wood

o-N-(p-

outdoors or for wood that

tolyl)methanesul

will be exposed to

phenamide EC

weathering.

No: 211-986-9

CAS No: 731-

Member States shall

27-1

ensure that authorizations

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 demonst-

rated in the application for

product authorization 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 compart-

ments. 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.

Acrolein

Acrylaldehyde

913 g/kg

Not

31 August

When

assessing

the

EC No: 203-453-

September

applicable

application for authoriz-

4 CAS No: 107-

ation of a product in

02-8

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 repres-

entatively 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 profes-

sional 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 profes-

sional users can be

reduced to an acceptable

level by others means.

Flocoumafe

4-hydroxy-3-

955 g/kg

In view of the fact that the

n

[(1RS,3RS;1RS,

October

September

September

active

substance

3RS)-1,2,3,4-

characteristics render it

tetrahydro-3-[4-

potentially

persistent,

(4-

liable to bioaccumulate

trifluoromethylb

and toxic, or very

enzyloxy)phenyl

persistent and very liable

]-1-

to bioaccumulate, the

naphthyl]coumar

active substance is to be

in EC No 421-

subject to a comparative

960-0 CAS No

risk

assessment

in

90035-08-8

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 authorizations

are

subject

to

the

following conditions

1. The nominal concentr-

ation 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 approp-

riate 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.

Warfarin

(RS)-4-hydroxy-

990 g/kg

The active substance shall

3-(3-oxo-1-

February

January

January

be

subject

to

a

phenylbutyl)cou

comparative

risk

marin EC No

assessment in accordance

201-377-6 CAS

with

the

second

No: 81-81-2

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 concent-

ration 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.

Warfarinsod

Sodium 2-oxo-3-

910 g/kg

The active substance shall

ium

(3-oxo-1-

February

January

January

be

subject

to

a

phenylbutyl)chro

comparative

risk

men-4-olate EC

assessment in accordance

No: 204-929-4

with

the

second

CAS No: 129-

subparagraph of Article

06-6

10(5)

(i) of Directive 98/8/EC

before its inclusion in this

Annex is renewed.

Member States shall

ensure that authorizations

are

subject

to

the

following conditions

1. the nominal concent-

ration 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.

Dazomet

Tetrahydro-3,5-

960 g/kg

1 August

31 July

31 July

When

assessing

the

dimethyl- 1,3,5-

application

for

thiadiazine-2-

authorisation of a product

thione EC No

in accordance with Article

208-576-7 CAS

5 and Annex VI, Member

No: 533-74-4

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.

N,N-diethyl-

N,N-diethyl-m-

970 g/kg

1 August

31 July

31 July

Member States shall

meta-

toluamide EC

ensure that authorisations

toluamide

No: 205-149-7

are

subject

to

the

CAS No: 134-

following conditions

62-3

1. primary exposure of

humans

shall

be

minimized by considering

and applying appropriate

risk mitigation measures,

including, where applic-

able, 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.

Metofluthrin

RTZ isomer

The

1 May

Not

30 April

When

assessing

the

2,3,5,6-

active

applicable

application

for

tetrafluoro-4-

substance

authorisation of a product

(methoxymethyl)

shall

in accordance with Article

benzyl-(1R,3R)-

comply

5 and Annex VI, Member

2,2-dimethyl-3-

with both

States shall assess, when

(Z)-(prop-1-

the

relevant for the particular

enyl)cyclopropa

following

product, those uses or

necarboxylate

minimum

exposure scenarios and

EC No: n.a.

purities

those

risks

to

CAS No

RTZ

compartments

and

240494-71-7

isomer

populations that have not

Sum of all

754 g/kg

been

representatively

isomers

Sum of

addressed in the European

2,3,5,6-

all

level risk assessment.

tetrafluoro-4-

isomers

(methoxymethyl)

930 g/kg

benzyl (EZ)-

(1RS,3RS;1SR,3

SR)- 2,2-

dimethyl-3-prop-

1-

enylcyclopropan

ecarboxylate

EC No: n.a.

CAS No

240494-70-6

Spinosad

EC No: 434-300-

850 g/kg

31 October

When

assessing

the

November

October

application

for

CAS No

authorisation of a product

168316-95-8

in accordance with Article

Spinosad is a

5 and Annex VI, Member

mixture of 50-95

States shall assess, when

% spinosyn A

relevant for the particular

and 5-50 %

product, those uses or

spinosyn D.

exposure scenarios and

Spinosyn A

those

risks

to

(2R,3aS,5aR,5bS

compartments

and

,9S,13S,14R,16a

populations that have not

S,16bR)-2-[(6-

been

representatively

deoxy-2,3,4-tri-

addressed in the EU level

O- methyl-α-L-

risk assessment.

mannopyranosyl

)oxy]- 13-

Member States shall

[[(2R,5S,6R)-5-

ensure that authorisations

(dimethylamino)

are

subject

to

the

tetrahydro-6-

following conditions

methyl-2H-

pyran-2-yl]oxy]-

Authorisations shall be

9-ethyl-

subject to appropriate risk

2,3,3a,5a,5b,6,9,

mitigation measures. In

10,11,12,13,14,1

particular,

products

6a,16b-

authorised

for

tetradecahydro-

professional

use

by

14-methyl- 1H-

spraying shall be used

as-indaceno[3,2-

with appropriate personal

d]oxacyclododec

protective

equipment,

in-7,15-dione

unless

it

can

be

CAS No

demonstrated

in

the

131929-60-7

application for product

Spinosyn D

authorisation that risks to

(2S,3aR,5aS,5bS

professional users can be

,9S,13S,14R,16a

reduced to an acceptable

S,16bS)-2-[(6-

level by others means.

deoxy-2,3,4-tri-

O- methyl-α-L-

For products containing

mannopyranosyl

spinosad that may lead to

)oxy]- 13-

residues in food or feed,

[[(2R,5S,6R)-5-

Member States shall

(dimethylamino)

verify the need to set new

tetrahydro-6-

and/or amended existing

methyl-2H-

maximum residue levels

pyran-2-yl]oxy]-

(MRLs) according to

9-ethyl-

Regulation (EC) No 470/

2,3,3a,5a,5b,6,9,

2009 and/or Regulation

10,11,12,13,14,1

(EC) No 396/2005, and

6a,16b-

take any appropriate risk

tetradecahydro-

mitigation

measures

4,14- dimethyl-

ensuring

that

the

1H-as-

applicable MRLs are not

indaceno[3,2-

exceeded.

d]oxacyclododec

in-7,15-dione

CAS No

131929-63-0

Bifenthrin

IUPAC name: 2-

911 g/kg

When

assessing

the

methylbiphenyl-

February

January

January

application for auth-

3-ylmethyl

orisation of a product in

(1RS)-cis-3-[(Z)-

accordance with Article 5

2-chloro- 3,3,3-

and Annex VI, Member

trifluoroprop-1-

States shall assess, when

enyl]-2,2-

relevant for the particular

dimethylcyclopr

product, those uses or

opanecarboxylat

exposure scenarios and

e

those

risks

to

EC No: n.a.

environmental

comp-

CAS No: 82657-

artments and populations

04-3

that have not been

representatively

add-

ressed 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 dem-

onstrated

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 prot-

ective 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 mit-

igation measures shall be

taken to protect the soil

and

aquatic

comp-

artments. 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 hard-

standing, or both, to

prevent direct losses to

soil or water, and that any

losses from the ap-

plication 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 exp-osed to

the weather or protected

from the weather but

subject

to

frequent

wetting, unless data have

been submitted dem-

onstrating that the product

will meet the requirements

of Article 5 and Annex

VI, if necessary by the

app-lication of appropriate

risk mitigation measures.

(Z,E)-

(9Z,12E)-

977 g/kg

1 February

31 January

When

assessing

the

tetradeca-9,

Tetradeca-9, 12-

January

application

for

12-dienyl

dien-1-yl acetate

authorisation of a product

acetate

EC No: n.a.

in accordance with Article

CAS No: 30507-

5 and Annex VI, Member

70-1

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.

Fenoxycarb

IUPAC name

960 g/kg

When

assessing

the

Ethyl [2-(4-

February

January

January

application

for

phenoxyphenoxy

authorisation of a product

)

in accordance with Article

ethyl]carbamate

5 and Annex VI, Member

EC No: 276-696-

States shall assess, when

relevant for the particular

CAS No: 72490-

product, those uses or

01-8

exposure scenarios and

those

risks

to

environmental

com-

partments 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 mit-

igation measures shall be

taken to protect the soil

and

aquatic

comp-

artments. 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 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.

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.

Nonanoic

IUPAC name

896 g/kg

When

assessing

the

acid,

Nonanoic acid

February

January

January

application

for

Pelargonic

EC No: 203-931-

authorisation of a product

acid

in accordance with Article

CAS No: 112-

5 and Annex VI, Member

05-0

States shall assess, when

relevant for the particular

product, those uses or

exposure scenarios and

those

risks

to

en-

vironmental

compartments

and

populations that have not

been

representatively

addressed in Union level

risk assessment.

imidacloprid

(2E)-1-[(6-

970 g/kg

When

assessing

the

chloropyridin- 3-

July 2013

June 2015

June 2023

application

for

yl)methyl]-N-

authorisation of a product

nitroimidazolidin

in accordance with Article

-2-imine EC No

5 and Annex VI, Member

428-040-8 CAS

States shall assess, when

No: 138261-41-3

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.

Abamectin

Abamectin is a

The

When

assessing

the

mixture of

active

July 2013

June 2015

June 2023

application

for

avermectin B 1a

substance

authorisation of a product

and avermectin

shall

in accordance with Article

B 1b Abamectin

comply

5 and Annex VI, Member

IUPAC name

with all

States shall assess, when

n.a. EC No: n.a.

the

relevant for the particular

CAS No: 71751-

following

product, those uses or

41-2 Avermectin

purities

exposure scenarios and

B 1a : IUPAC

those risks to human

Abamecti

name

populations

and

to

n

(10E,14E,16E,22

minimum

environmental

Z)-

900 g/kg

compartments that have

(1R,4S,5'S,6S,6'

not been representatively

Avermect

R,8R,12S,13S,20

addressed in the Union

in B 1a

R,21R,24S)-6'-

minimum

level risk assessment.

[(S)-secbutyl]-

830 g/kg

Products applied in such a

21,24-

way that emission to a

Avermect

dihydroxy-

sewage treatment plant

in B 1b

5',11,13,22-

maximu

cannot be prevented shall

tetramethyl-2-

m 80 g/

not be authorised for those

oxo-3,7,19-

kg

application rates for which

trioxatetracyclo[

the Union level risk

15.6.1.1 4,8 .0

assessment

showed

20,24]pentacosa-

unacceptable risks, unless

10,14,16,22-

data

are

submitted

tetraene-6-spiro-

demonstrating that the

2'-(5',6'- dihydro-

product will meet the

2'H-pyran)-12-yl

requirements of Article 5

2,6-dideoxy-4-

and

Annex

VI,

if

O-(2,6- dideoxy-

necessary

by

the

3-O-methyl-α-L-

application of appropriate

arabino-

risk mitigation measures.

hexopyranosyl)-

Authorisations shall be

3-O-methyl-α-L-

subject to appropriate risk

arabinohexopyra

mitigation measures. In

noside

particular, appropriate risk

EC No: 265-610-

mitigation measures shall

3 CAS No

be taken to minimise the

65195-55-3

potential exposure of

infants and children.

Avermectin B 1b

: IUPAC name

(10E,14E,16E,22

Z)-

(1R,4S,5'S,6S,6'

R,8R,12S,13S,20

R,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-

arabinohexopyra

noside EC No

265-611-9 CAS

No: 65195-56-4

4,5-

4,5-Dichloro-2-

950 g/kg

When

assessing

the

Dichloro-2-

octylisothiazol-

July 2013

June 2015

June 2023

application

for

octyl-2H-

3(2H)-one EC

authorisation of a product

isothiazol-3-

No: 264-843-8

in accordance with Article

one

CAS No: 64359-

5 and Annex VI, Member

81-5

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.

Creosote

Creosote EC No

Grade B

Biocidal products con-

232-287-5 CAS

or Grade

May 2013

April 2015

April

taining creosote may only

No: 8001-58-9

C

be authorised for uses

creosote

where the authorising

as

Member State, based on

specified

an analysis regarding the

in

technical and economic

European

feasibility of substitution

Standard

which it shall request from

EN

the applicant, as well as

13991:20

on any other information

available to it, concludes

that

no

appropriate

alternatives are available.

Those Member States

auth-orising 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 alt-

ernatives and indicating

how the development of

alter-natives is promoted.

The Commission will

make

these

reports

publicly available. The

active substance is to be

subject to a comparative

risk assessment in ac-

cordance with the second

subparagraph of Article

10(5)(i)

before

its

inclusion in this Annex is

renewed. When assessing

the application for auth-

orisation 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 env-iron-

mental 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 foll-

owing 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 con-

cerning 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 (1 ). (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.

EN L 195/50 Official

Journal of the European

Union 27.7.2011

(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) (2 ). (4)

Appropriate

risk

mitigation measures shall

be taken to protect the soil

and

aquatic

com-

partments. 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 collect ed

”.

for reuse or disposal.

€4.14