Biocides (Amendment) (No. 2) Regulations, 2012

L.N. 270 of 2012

PESTICIDES CONTROL ACT

(CAP. 430)

Biocides (Amendment) (No. 2) 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:-

The title of these regulations is the Biocides (Amendment) Citation.

(No. 2) Regulations, 2012, and these regulations shall be read and

construed as one with the Biocides Regulations, hereinafter referred S.L. 430.03

to as "the principal regulations".

Part A of Schedule I to the principal regulations shall be Amends

substituted by the following

"PART A

List of Active Substances with Requirements Agreed At Community Level

for Inclusion in Biocidal Products

No

Common

IUPAC

Minimum

Date of

Deadline

Expiry

Prod

Specific provisions (*)

Name

Name

purity of

inclusion

for

date of

uct

Identifica

the active

complian

inclusion

type

-tion

substance

ce with

Numbers

in

the

Article

biocidal

16(3)

product

(except

as placed

for

on

the

products

market

containin

g more

than one

active

substanc

e,

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

substanc

es)

sulfurylflu

sulfuryl

> 994 g/

1 January

31 De-

31 De-

Member States shall ensure

oride

difluoride

kg

cember

cember

that authorizations are

EC No

subject to the following

220-281-

conditions

CAS

(1) the product may only

No: 2699-

be sold to and used by

79-8

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

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).

dichloflua

N-

> 96% w/

Member States shall ensure

nid

(Dichloro

March

February

February

that authorizations are

w

fluoromet

subject to the following

hylthio)-

conditions

N′,N′-

(1) Products authorised for

dimethyl-

industrial

and/or

N-

professional use must be

phenylsul

used with appropriate

famide

personal

protective

EC No

equipment.

214-118-

(2) In view of the risks

CAS

identified for the soil

No: 1085-

compartment appropriate

98-9

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.

clothianidi

(E)-1-(2-

950 g/kg

When

assessing,

in

Chloro-

February

January

January

accordance with Article 5

n

1,3-

and Annex VI, the

thiazol-5-

application for authoriz-

ylmethyl)

ation of a product, Member

-3-

States shall assess those

methyl-2-

use / exposure scenarios

Nitroguan

and/or populations that

idine EC

have

not

been

No: 433-

representatively addressed

460-1

in the Community level

CAS No

risk assessment and that

210880-

may be exposed to the

92-5

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.

Difethialo

3-[3-(4′-

976 g/kg

In view of the fact that the

ne

bromo[1,

Novembe

October

October

active

substance

1′bipheny

r2009

characteristics render it

l]-4-yl)-

poten-tially

persistent,

1,2,3,4-

liable to bioaccumulate and

tetrahydro

toxic, or very persistent

naphth-1-

and

very

liable

to

yl]-4-

bioaccumulate, the active

hydroxy-

substance is to be subject

2H-1-

to a comparative risk

benzothio

assessment in accordance

pyran-2-

with

the

second

one EC

subparagraph of Article

No: n/a

10(5) (i) of Directive 98/8/

CAS No

EC before its inclusion in

104653-

this Annex is renewed.

34-1

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

phenoxyb

February

January

January

accordance with Article 5

enzyl-2-

and Annex VI, the

(4-

application

for

ethoxyph

authorisation of a product,

enyl)-2-

Member States shall access

methylpro

those use and/or exposure

pylether

scenarios

and/or

EC No

populations that have not

407-980-

been

representatively

CAS

addressed

in

the

No

Community level risk

80844-

assessment and that may be

07-1

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.

tebuconaz

1-(4-

950 g/kg

Member States shall ensure

ole

chlorophe

April

March

March

that authorizations are

nyl)-4,4-

subject to the following

dimethyl-

conditions

3-(1,2,4-

In view of the risks

triazol-1-

identified for the soil and

ylmethyl)

aquatic

compartments

pentan-3-

appropriate risk mitigation

ol EC No

measures must be taken to

403-640-

protect

those

com-

CAS

partments. In particular,

No

labels and/or safety data

107534-

sheets

of

products

96-3

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.

carbondio

carbon

990 ml/l

When

assessing

the

xide

dioxide

Novembe

October

October

application

for

EC No

r2009

authorization of a product

204-696-

in accordance with Article

CAS

5 and Annex VI, Member

No: 124-

States shall assess, when

38-9

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.

propicona

1-[[2-

930 g/kg

Member States shall ensure

zole

(2,4-

April

March

March

that authorizations are

dichlorop

subject to the following

henyl)-4-

conditions

propyl-

In view of the assumptions

1,3-

made during the risk

dioxolan-

assessment,

products

2-

authorised for industrial

yl]methyl

and/or professional use,

]-1H-

must

be

used

with

1,2,4-

appropriate

personal

triazole

protective

equipment,

EC No

unless

it

can

be

262-104-

demonstrated

in

the

CAS

application for product

No

authorisation that risks to

60207-

industrial

and/or

90-1

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.

Difenacou

3-(3-

960 g/kg

In view of the fact that the

biphenyl-

April

March

March

active

substance

m

4-yl-

characteristics render it

1,2,3,4-

potentially

persistent,

tetrahydro

liable to bioaccumulate and

-1-

toxic, or very persistent

naphthyl)

and

very

liable

to

-4-

bioaccumulate, the active

hydroxyc

substance is to be subject

oumarin

to a comparative risk

EC No

assessment in accordance

259-978-

with

the

second

CAS

subparagraph of Article

No

10(5)(i) of Directive 98/8/

56073-

EC before its inclusion in

07-5

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

Cyclohex

977 g/kg

July

30 June

30 June

When

assessing

the

ylhydroxy

application

for

diazene1-

authorization of a product

oxide,

in accordance with Article

potassium

5 and Annex VI, Member

salt EC

States shall assess, when

No: n/a

relevant for the particular

CAS No

product, the populations

66603-

that may be exposed to the

10-9

product and the use or

(This

exposure scenarios that

entry also

have

not

been

covers

representatively addressed

thehydrat

at the Community level

ed forms

risk assessment. Member

of

K-

States shall ensure that

HDO)

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

July

30 June

30 June

Member States shall ensure

propynyl

that authorisations are

butylcarb

subject to the following

amate EC

conditions

No: 259-

In view of the assumptions

627-5

made during the risk

CAS No

assessment,

products

55406-

authorised for industrial

53-6

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.

Chloropha

Chloroph

978 g/kg

July

30 June

30 June

In view of the identified

cinone

acinone

risks

for

non-target

EC No

animals,

the

active

223-003-

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.

Thiabenda

2-thiazol-

985 g/kg

July

30 June

30 June

Member States shall ensure

zole

4-yl-1H-

that authorizations are

benzoimi

subject to the following

dazole EC

conditions

No: 205-

In view of the assumptions

725-8

made during the risk

CAS No

assessment,

products

148-79-8

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.

thiametho

thiametho

980 g/kg

July

30 June

30 June

Member States shall ensure

xam

xam EC

that authorizations are

No: 428-

subject to the following

650-4

conditions

CAS No

In view of the assumptions

153719-

made during the risk

23-4

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.

alphachlor

(R)-1,2-

825 g/kg

July

30 June

30 June

When

assessing

the

alose

O-(2.2,2-

application

for

Trichloro

authorization of a product

ethyliden

in accordance with Article

e)-α-D-

5 and Annex VI, Member

glucofura

States shall assess, when

nose

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.

brodifacou

3-[3-(4’-

950 g/kg

In view of the fact that the

bromobip

February

January

January

active

substance

m

henyl-4-

characteristics render it

yl)-

potentially

persistent,

1,2,3,4-

liable to bioaccumulate and

tetrahydro

toxic, or very persistent

-1-

and

very

liable

to

napthyl]-

bioaccumulate, the active

4-

substance is to be subject

hydroxyc

to a comparative risk

oumarin

assessment in accordance

EC No

with

the

second

259-980-

subparagraph of Article

CAS

10(5)(i) of Directive 98/8/

No

EC before its inclusion in

56073-

this Annex is renewed.

10-0

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.

bromadiol

3-[3-(4’-

969 g/kg

July

30 June

30 June

In view of the fact that the

one

Bromo[1,

active

substance

1’-

characteristics render it

biphenyl]

potentially

persistent,

-4-yl)-3-

liable to bioaccumulate and

hydroxy-

toxic, or very persistent

1-

and

very

liable

to

phenylpro

bioaccumulate, the active

pyl]-4-

substance is to be subject

hydroxy-

to a comparative risk

2H-1-

assessment in accordance

benzopyr

with

the

second

an-2-one

subparagraph of Article

EC No

10(5) (i) of Directive 98/8/

249-205-

EC before its inclusion in

CAS

this Annex is renewed.

No

Member States shall ensure

28772-

that authorizations are

56-7

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.

Thiaclopri

(Z)-3-(6-

975 g/kg

n/a

When

assessing

the

chloro-3-

January

Decemb

application

for

d

pyridylme

er

authorization of a product

thyl)-1,3-

in accordance with Article

thiazolidi

5 and Annex VI, Member

n-2-

States shall assess, when

ylidenecy

relevant for the particular

anamide

product, the populations

EC No: n/

that may be exposed to the

a

CAS

product and the use or

No

exposure scenarios that

111988-

have

not

been

49-9

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.

Indoxacar

Reaction

796 g/kg

n/a

When

assessing

the

b(enantio

mass of

January

Decemb

application

for

mericreact

methyl(S)

er 2019

authorization of a product

ionmass

-

and

in accordance with Article

S:R75:25)

methyl(R)

5 and Annex VI, Member

-7-chloro-

States shall assess, when

2.3,4a,5-

relevant for the particular

tetrahydro

product, the populations

-2-

that may be exposed to the

[methoxy

product and the use or

carbonyl-

exposure scenarios that

(4-

have

not

been

trifluorom

representatively addressed

ethoxyph

at the Community level

enyl)carb

risk assessment.

amoyl]ind

When granting product

eno[1,2-

authorisation,

Member

e][1.3,4]o

States shall assess the risks

xadiazine

and subsequently ensure

that appropriate

-

4acarbox

ylate

(This

entrycove

rs

the

75:25

reactionm

ass of the

S and R

enantiom

ers)EC

No: n/a

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.

aluminium

aluminiu

830 g/kg

When

assessing

the

phosphide

Septemb

August

August

application

for

m

releasingp

phosphide

er2011

authorization of a product

hosphine

EC No

in accordance with Article

244-088-

5 and Annex VI, Member

CAS

States shall assess, when

No

relevant for the particular

20859-

product, the populations

73-8

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).

fenpropim

(+/-)-cis-

930 g/kg

July

30 June

30 June

When

assessing

the

orph

4-[3-(p-

application

for

tert-

authorization of a product

butylphen

in accordance with Article

yl)-2-

5 and Annex VI, Member

methylpro

States shall assess, when

pyl]-2,6-

relevant for the particular

dimethyl

product, the populations

morpholi

that may be exposed to the

ne

EC

product and the use or

No: 266-

exposure scenarios that

719-9

have

not

been

CAS No

representatively addressed

67564-

at the Community level

91-4

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

990 g/kg

When

assessing

the

EC No

Septemb

August

August

application

for

233-139-

er 2011

authorization of a product

CAS

in accordance with Article

No

5 and Annex VI, Member

10043-

States shall assess, when

35-3

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

Diboron

975 g/kg

When

assessing

the

oxide

trioxide

Septemb

August

August

application

for

EC No

er2011

authorization of a product

215-125-

in accordance with Article

CAS

5 and Annex VI, Member

No: 1303-

States shall assess, when

86-2

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 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.

disodiumt

disodium

990 g/kg

When

assessing

the

etraborate

tetraborat

Septemb

August

August

application

for

e EC No

er2011

authorization of a product

215-540-

in accordance with Article

CAS

5 and Annex VI, Member

No

States shall assess, when

(anhydrou

relevant for the particular

s): 1330-

product, the populations

43-4 CAS

that may be exposed to the

No

product and the use or

(pentahyd

exposure scenarios that

rate):1226

have

not

been

7-73-1

representatively addressed

CAS No

at the Community level

(decahydr

risk assessment.

ate):1303-

When granting product

96-4

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.

disodiumo

disodium

975 g/kg

Se

When

assessing

the

ctaboratete

octaborat

ptember2

August

August

application

for

trahydrate

authorization of a product

e

tetrahydra

in accordance with Article

teEC No

5 and Annex VI, Member

234-541-

States shall assess, when

CAS

relevant for the particular

No

product, the populations

12280-

that may be exposed to the

03-4

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.

Magnesiu

Trimagne

880 g/kg

When

assessing

the

mphosphi

sium

February

January

January

application

for

dereleasin

diphosphi

authorization of a product

deEC No

in accordance with Article

g

phosphine

235-023-

5 and Annex VI, Member

CAS

States shall assess, when

No

relevant for the particular

12057-

product, those uses or

74-8

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 18 of Regulation

(EC) No 396/2005 of the

European Parliament and

of the Council (OJ L 70,

16.3.2005, p. 1).

Nitrogen

Nitrogen

999 g/kg

When

assessing

the

EC No

Septemb

August

August

application

for

231-783-

er2011

authorization of a product

CAS

in accordance with Article

No: 7727-

5 and Annex VI, Member

37-9

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.

Coumatetr

Coumatet

980 g/kg

July

30 June

30 June

In view of the

alyl

ralyl EC

identified risks for non-

No: 227-

target animals, the active

424-0

substance shall be subject

CAS No

to a comparative risk

5836-29-

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.

tolylfluani

Dichloro-

960 g/kg

Products shall

N-

October

Septemb

Septemb

not be authorised for the in

d

[(dimethy

er 2013

er2021

situ treatment of wood

lamino)su

outdoors or for wood that

lphonyl]fl

will

be

exposed to

uoro-N-

weathering.

(p-

Member States shall ensure

tolyl)met

that authorizations are

hanesulph

subject to the following

enamide

conditions

EC No

1. In view of the

211-986-

assumptions made during

CAS

the

risk

assessment,

No: 731-

products authorised for

27-1

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

Acrylalde

913 g/kg

Not

When

assessing

the

hyde EC

Septemb

applicabl

August

application for authoriz-

No: 203-

er 2010

ation of a product in

e

453-4

accordance with Article 5

CAS No

and Annex VI, Member

107-02-8

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.

Flocoumaf

4-

955 g/kg

In view of the fact that the

en

hydroxy-

October

Septemb

Septemb

active

substance

3-

er 2013

er2016

characteristics render it

[(1RS,3R

potentially

persistent,

S;1RS,3R

liable to bioaccumulate and

S)-

toxic, or very persistent

1,2,3,4-

and

very

liable

to

tetrahydro

bioaccumulate, the active

-3-[4-(4-

substance is to be subject

trifluorom

to a comparative risk

ethylbenz

assessment in accordance

yloxy)phe

with

the

second

nyl]-1-

subparagraph of Article

naphthyl]

10(5)(i) of Directive 98/8/

coumarin

EC before its inclusion in

EC

No

this Annex is renewed.

421-960-

Member States shall ensure

CAS

that authorizations are

No

subject to the following

90035-

conditions

08-8

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-

990 g/kg

The active substance shall

hydroxy-

February

January

January

be subject to a comparative

3-(3-oxo-

risk

assessment

in

1-

accordance with the second

phenylbut

subparagraph of Article

yl)coumar

10(5)(i) of Directive 98/8/

in EC No

EC before its inclusion in

201-377-

this Annex is renewed.

CAS

Member States shall ensure

No: 81-

that authorisations are

81-2

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.

Warfarins

Sodium

910 g/kg

The active substance shall

odium

2-oxo-3-

February

January

January

be subject to a comparative

(3-oxo-1-

risk

assessment

in

phenylbut

accordance with the second

yl)chrome

subparagraph of Article

n-4-olate

10(5)(i) of Directive 98/8/

EC No

EC before its inclusion in

204-929-

this Annex is renewed.

CAS

Member States shall ensure

No: 129-

that authorizations are

06-6

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

Tetrahydr

960 g/kg

1 August

31 July

31 July

When

assessing

the

o-3,5-

application

for

dimethyl-

authorisation of a product

1,3,5-

in accordance with Article

thiadiazin

5 and Annex VI, Member

e-2-thione

States shall assess, when

EC No

relevant for the particular

208-576-

product, those uses or

CAS

exposure scenarios and

No: 533-

those

risks

to

74-4

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-

N,N-

970 g/kg

1 August

31 July

31 July

Member States shall ensure

diethyl-

diethyl-

that authorisations are

meta-

m-

subject to the following

toluamide

toluamide

conditions

EC No

1. primary exposure of

205-149-

humans shall be minimized

CAS

by

considering

and

No: 134-

applying appropriate risk

62-3

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.

Metofluthr

RTZ

The

May

Not

30 April

When

assessing

the

in

isomer

active

applicabl

application

for

2,3,5,6-

substance

authorisation of a product

e

tetrafluor

shall

in accordance with Article

o-4-

comply

5 and Annex VI, Member

(methoxy

with both

States shall assess, when

methyl)be

the

relevant for the particular

nzyl-

following

product, those uses or

(1R,3R)-

minimum

exposure scenarios and

2,2-

purities

those

risks

to

dimethyl-

RTZ

compartments

and

3-

(Z)-

isomer

populations that have not

(prop-1-

754 g/kg

been

representatively

enyl)cycl

Sum of

addressed in the European

opropane

all

level risk assessment.

carboxyla

isomers

te

930 g/kg

EC No

n.a. CAS

No

240494-

71-7 Sum

of

all

isomers

2,3,5,6-

tetrafluor

o-4-

(methoxy

methyl)be

nzyl

(EZ)-

(1RS,3RS

;1SR,3SR

)-

2,2-

dimethyl-

3-prop-1-

enylcyclo

propaneca

rboxylate

EC No

n.a. CAS

No

240494-

70-6

Spinosad

EC No

850 g/kg

When

assessing

the

434-300-

Novembe

October

October

application

for

r 2012

authorisation of a product

CAS No

in accordance with Article

168316-

5 and Annex VI, Member

95-8

States shall assess, when

Spinosad

relevant for the particular

is

a

product, those uses or

mixture

exposure scenarios and

of 50-95

those

risks

to

compartments

and

%

spinosyn

populations that have not

A and 5-

been

representatively

%

addressed in the EU level

spinosyn

risk assessment.

D.

Member States shall ensure

Spinosyn

that authorisations are

subject to the following

A

(2R,3aS,5

conditions

aR,5bS,9

Authorisations shall be

S,13S,14

subject to appropriate risk

R,16aS,1

mitigation measures. In

6bR)-2-

particular,

products

[(6-

authorised for professional

deoxy-

use by spraying shall be

2,3,4-tri-

used with appropriate

O-

personal

protective

methyl-α-

equipment, unless it can be

L-

demonstrated

in

the

mannopyr

application for product

anosyl)ox

authorisation that risks to

y]-

13-

professional users can be

[[(2R,5S,

reduced to an acceptable

6R)-5-

level by others means.

(dimethyl

For products containing

amino)tet

spinosad that may lead to

rahydro-

residues in food or feed,

6-

Member States shall verify

methyl-

the need to set new and/or

2H-

amended

existing

pyran-2-

maximum residue levels

yl]oxy]-9-

(MRLs)

according

to

ethyl-

Regulation (EC) No 470/

2,3,3a,5a,

2009 and/or Regulation

5b,6,9,10,

(EC) No 396/2005, and

11,12,13,

take any appropriate risk

14,16a,16

mitigation

measures

b-

ensuring that the applicable

tetradecah

MRLs are not exceeded.

ydro-14-

methyl-

1H-as-

indaceno[

3,2-

d]oxacycl

ododecin-

7,15-

dione

CAS No

131929-

60-7

Spinosyn

D

(2S,3aR,5

aS,5bS,9S

,13S,14R,

16aS,16b

S)-2-[(6-

deoxy-

2,3,4-tri-

O-

methyl-α-

L-

mannopyr

dimethyl-

1H-as-

indaceno[

3,2-

d]oxacycl

ododecin-

7,15-

dione

CAS No

131929-

63-0

Bifenthrin

IUPAC

911 g/kg

When

assessing

the

name: 2-

February

January

January

application

for

methylbip

authorisation of a product

henyl-3-

in accordance with Article

ylmethyl

5 and Annex VI, Member

(1RS)-

States shall assess, when

cis-3-

relevant for the particular

[(Z)-2-

product, those uses or

chloro-

exposure scenarios and

3,3,3-

those

risks

to

trifluorop

environmental

comp-

rop-1-

artments and populations

enyl]-2,2-

that have not been

dimethylc

representatively add-ressed

yclopropa

in the Union level risk

necarbox

assessment.

ylate EC

Member States shall ensure

No: n.a.

that authorisations are

CAS No

subject to the following

82657-

conditions

04-3

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

When

assessing

the

tetradeca-

Tetradeca

February

January

January

application

for

9,

12-

-9,

12-

authorisation of a product

dienyl

dien-1-yl

in accordance with Article

acetate

acetate

5 and Annex VI, Member

EC No

States shall assess, when

n.a.

relevant for the particular

CAS No

product, those uses or

30507-

exposure scenarios and

70-1

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.

Fenoxycar

IUPAC

960 g/kg

When

assessing

the

name

February

January

January

application

for

b

Ethyl [2-

authorisation of a product

(4-

in accordance with Article

phenoxyp

5 and Annex VI, Member

henoxy)

States shall assess, when

ethyl]carb

relevant for the particular

amate

product, those uses or

EC No

exposure scenarios and

276-696-

those

risks

to

environmental

com-

CAS No

partments and populations

72490-

that have not been

01-8

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

896 g/kg

When

assessing

the

acid,

name

February

January

January

application

for

Pelargonic

Nonanoic

authorisation of a product

acid

acid

in accordance with Article

EC No

5 and Annex VI, Member

203-931-

States shall assess, when

relevant for the particular

CAS No

product, those uses or

112-05-0

exposure scenarios and

those

risks

to

en-

vironmental compartments

and populations that have

not been representatively

addressed in Union level

risk assessment.

imidaclopr

(2E)-1-

970 g/kg

When

assessing

the

id

[(6-

July 2013

June

June

application

for

chloropyr

authorisation of a product

idin- 3-

in accordance with Article

yl)methyl

5 and Annex VI, Member

]-N-

States shall assess, when

nitroimid

relevant for the particular

azolidin-

product, those uses or

2-imine

exposure scenarios and

EC No

those risks to human

428-040-

populations and to environ-

CAS

mental compart-ments that

No

have not been representati-

138261-

vely addressed in the

41-3

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

Abamecti

The

When

assessing

the

n is a

active

July 2013

June

June

application

for

mixture

substance

authorisation of a product

of

shall

in accordance with Article

avermecti

comply

5 and Annex VI, Member

n B 1a

with all

States shall assess, when

and

the

relevant for the particular

avermecti

following

product, those uses or

n B 1b

purities

exposure scenarios and

Abamecti

Abamecti

those risks to human

n: IUPAC

n

populations

and

to

name: n.a.

minimum

environmental

EC No

900 g/kg

compartments that have not

Avermecti

n.a. CAS

been

representatively

n B 1a

No

addressed in the Union

71751-

minimum

level risk assessment.

41-2

830 g/kg

Products applied in such a

Avermecti

Avermecti

way that emission to a

n B 1a

n B 1b

sewage treatment plant

IUPAC

maximum

cannot be prevented shall

name

80 g/kg

not be authorised for those

(10E,14E,

application rates for which

16E,22Z)

the Union level risk

assessment

showed

-

(1R,4S,5'

unacceptable risks, unless

S,6S,6'R,

data

are

submitted

8R,12S,1

demonstrating that the

3S,20R,2

product will meet the

1R, 24S)-

requirements of Article 5

6'- [(S)-

and Annex VI, if necessary

secbutyl]-

by the application of

21,24-

appropriate risk mitigation

dihydroxy

measures. Authorisations

shall

be

subject

to

-

5',11,13,2

appropriate risk mitigation

2-

measures. In particular,

tetrameth

appropriate risk mitigation

yl-2-oxo-

measures shall be taken to

3,7,19-

minimise the potential

trioxatetra

exposure of infants and

cyclo[15.

children.

6.1.1 4,8

.0

20,24]pen

tacosa-

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-

hexopyra

nosyl)- 3-

O-

methyl-α-

L-

arabinohe

xopyrano

side

EC No

265-610-

CAS

No

65195-

55-3

Avermecti

n B 1b

IUPAC

name

(10E,14E,

16E,22Z)

-

(1R,4S,5'

S,6S,6'R,

8R,12S,1

3S,20R,2

1R,24S)-

21,24-

dihydroxy

-6'- 2- e

EC

isopropyl-

5',11,13,2

2-

tetrameth

yl-2-oxo-

3,7,19-

trioxatetra

cyclo[15.

6.1.1 4,8

.0

20,24]pen

tacosa-

10,14,16,

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-

hexopyra

nosyl)- 3-

O-

methyl-α-

L-

arabinohe

xopyrano

sid No

265-611-

CAS

No

65195-

56-4

4,5-

4,5-

950 g/kg

When

assessing

the

Dichloro-

Dichloro-

July 2013

June

June

application

for

2- octyl-

2-

authorisation of a product

2H-

octylisoth

in accordance with Article

isothiazol-

iazol-

5 and Annex VI, Member

3- one

3(2 H )-

States shall assess, when

one EC

relevant for the particular

No: 264-

product, those uses or

843-8

exposure scenarios and

CAS No

those risks to human

64359-

populations

and

to

81-5

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

Grade B

Biocidal products con-

EC No

or Grade

May

April

April

taining creosote may only

232-287-

be authorised for uses

C

CAS

creosote

where the authorising

No: 8001-

as

Member State, based on an

58-9

specified

analysis regarding the

in

technical and economic

European

feasibility of substitution

Standard

which it shall request from

EN

the applicant, as well as on

13991:20

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

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 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

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/

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.

When

assessing

the

Bacillus

No

30 Sep-

30 Sep-

Not

application

for

Appli-

thurin-

relevant

October

tember

tember

authorisation of a product

cable

giensis

impuri-

in accordance with Article

subsp.

ties

5 and Annex VI, Member

israelen-

States shall assess, where

sis

relevant for the particular

Serotype

product, those uses or

exposure scenarios and

H14,

those risks to human

Strain

populations

and

to

AM65-52

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

israelensis

subsp.

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.

fipronil

(±)-5-

g/

1 Octo-

30 Sep-

Only professional use

amino-

kg

ber

tember

Sep-

indoors by application in

1-(2,6-

tember

locations

normally

dichloro

inaccessible

after

-α,α,α,-

application to man and

trifluoro

domestic animals has been

-p-

addressed in the Union

tolyl)-4-

level risk assessment.

trifluoro

When

assessing

the

methyls

application

for

ulfinylp

authorisation of a product

yrazole-

in accordance with Article

3-

5 and Annex VI, Member

carbonit

States shall assess, where

rile

relevant for the particular

(1:1)

product, those uses or

EC No

exposure scenarios and

424-

those risks to human

610-5

populations

and

to

CAS

environmental

No

compartments that have

120068-

not been representatively

37-3

addressed in the Union

level risk assessment.

lambda-

Reactio

g/

When

assessing

the

cyhaloth

n mass

kg

October

Septem

Septem

application

for

rin

of (R)-

ber

ber

authorisation of a product

α-

in accordance with Article

cyano-

5 and Annex VI, Member

3-

States shall assess, where

phenox

relevant for the particular

ybenzyl

product, those uses or

(1S,3S)-

exposure scenarios and

3-[(Z)-

those risks to human

2-

populations

and

to

chloro-

environmental

3,3,3-

compartments that have

trifluoro

not been representatively

pro-

addressed in the Union

penyl]-

level risk assessment.

2,2-

Products applied in such a

dimethy

way that emission to a

lcyclopr

sewage treatment plant

opaneca

cannot be prevented shall

rboxylat

not be authorised, unless

e

and

data

are

submitted

(S)-α-

demonstrating that the

cyano-

product will meet the

3-

requirements of Article 5

phenox

and

Annex

VI,

if

ybenzyl

necessary

by

the

(1R,3R)

application of appropriate

-3-[(Z)-

risk mitigation measures.

2-

Products authorised for

chloro-

professional use shall be

3,3,3-

used with appropriate

trifluoro

personal

protective

propeny

equipment, unless it can

l]-2,2-

be demonstrated in the

dimethy

application for product

lcyclopr

authorisation that risks to

opaneca

professional users can be

rboxylat

reduced to an acceptable

e (1:1)

level by other means. For

CAS-

products

containing

No

lambda-cyhalothrin that

91465-

may lead to residues in

08-6 EC

food or feed, Member

No

States shall verify the need

415-

to set new or to amend

130-7

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.

delta-

(S)-α-

g/

30 Sep-

When

assessing

the

methrin

cyano-

kg

October

tember

Sep-

application

for

3-

tember

authorisation of a product

phenox

in accordance with Article

ybenzyl

5 and Annex VI, Member

(1R,3R)

States shall assess, where

-3-(2,2-

relevant for the particular

dibromo

product, those uses or

vinyl)-

exposure scenarios and

2,2-

those risks to human

dimethy

populations

and

to

lcyclopr

environmental

opane

compartments that have

carboxy

not been representatively

late

addressed in the Union

CAS-

level risk assessment.

No

Products shall not be

52918-

authorised for indoor

63-5 EC

treatments resulting in

No

sewage treatment plant

258-

emissions of the scale for

256-6

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. ".

€6.12