Biocides (Amendment) Regulations, 2013

L.N. 90 of 2013

PESTICIDES CONTROL ACT

(CAP. 430)

Biocides (Amendment) Regulations, 2013

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 Citation and

(Amendment) Regulations, 2013, and these regulations shall be read scope.

and construed as one with the Biocides Regulations, hereinafter

referred to as "the principal regulations".

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

Directive 2012/2/EU of 9 February 2012 amending Directive 98/8/

EC of the European Parliament and of the Council to include copper

(II) oxide, copper (II) hydroxide and basic copper carbonate as active

substances in Annex I thereto; Commission Directive 2012/3/EU of 9

February 2012 amending Directive 98/8/EC of the European

Parliament and of the Council to include bendiocarb as an active

substance in Annex I thereto; Commission Directive 2012/14/EU of 8

May 2012 amending Directive 98/8/EC of the European Parliament

and of the Council to include methyl nonyl ketone as an active

substance in Annex I thereto; Commission Directive 2012/15/EU of

8 May 2012 amending Directive 98/8/EC of the European Parliament

and of the Council to include margosa extract as an active substance

in Annex I thereto; Commission Directive 2012/16/EU of 10 May

2012 amending Directive 98/8/EC of the European Parliament and of

the Council to include hydrochloric acid as an active substance in

Annex I thereto; Commission Directive 2012/20/EU of 6 July 2012

amending Directive 98/8/EC of the European Parliament and of the

Council to include flufenoxuron as an active substance for product-

type 8 in Annex I thereto; Commission Directive 2012/22/EU of 22

August 2012 amending Directive 98/8/EC of the European

Parliament and of the Council to include DDACarbonate as an active

substance in Annex I thereto; Commission Directive 2012/38/EU of

23 November 2012 amending Directive 98/8/EC of the European

Parliament and of the Council to include cis-Tricos-9-ene as an active

substance in Annex I thereto; Commission Directive 2012/40/EU of

26 November 2012 correcting Annex I to Directive 98/8/EC of the

European Parliament and of the Council concerning the placing of

biocidal products on the market; Commission Directive 2012/41/EU

of 26 November 2012 amending Directive 98/8/EC of the European

Parliament and of the Council to extend the inclusion in Annex I

thereto of the active substance nonanoic acid to product type 2;

Commission Directive 2012/42/EU of 26 November 2012 amending

Directive 98/8/EC of the European Parliament and of the Council to

include hydrogen cyanide as an active substance in Annex I thereto;

and Commission Directive 2012/43/EU of 26 November 2012

amending certain headings of Annex I to Directive 98/8/EC of the

European Parliament and of the Council.

Schedule I to the principal regulations shall be amended as

follows:-

(a) In Part A thereof, immediately after item number 49 there

shall be added the following:-

"50

Copper

Copper (II)

965 g/kg

1 February

31 January

When assessing the application

hydrox

hydroxide

January

for authorisation of a product in

ide

EC No

accordance with Article 5 and

243-815-9

Annex VI, Member States shall

CAS No

assess, where relevant for the

20427-59-2

particular product, those uses or

exposure scenarios and those

risks to human populations and

to environmental compartments

that have not been

representatively addressed in

the Union level risk assessment.

Member States shall ensure that

authorisations are subject to the

following conditions

(1) Products shall not be

authorised for application by

dipping, unless data have been

submitted in the application for

product authorisation

demonstrating that that

application meets the

requirements of Article 5 and

Annex VI, if necessary by the

application of appropriate risk

mitigation measures.

(2) For products authorised for

industrial use, safe operational

procedures shall be established,

and products shall be used with

appropriate personal protective

equipment unless it can be

demonstrated in the application

for product authorization that

risks to industrial users can be

reduced to an acceptable level

by other means.

(3) Labels and, where provided,

safety data sheets of products

authorised shall indicate that

freshly treated timber shall be

stored after treatment under

shelter or on impermeable hard

standing, or both, to prevent

direct losses to soil or water,

and that any losses from the

application of the product shall

be collected for reuse or

disposal.

(4) Products shall not be

authorised for treatment of

wood that will be used in

outdoor constructions near or

above water, unless data is

submitted to demonstrate that

the product will meet the

requirements of Article 5 and

Annex VI, if necessary by the

application of appropriate

mitigation measures.

Copper

Copper (II)

976 g/kg

1 February

31 January

31 January

When assessing the application

(II)

oxide

for authorisation of a product in

Oxide

EC No

accordance with Article 5 and

215-269-1

Annex VI, Member States shall

CAS No

assess, where relevant for the

1317-38-0

particular product, those uses or

exposure scenarios and those

risks to human populations and

to environmental compartments

that have not been

representatively addressed in

the Union level risk assessment.

Member States shall ensure that

authorisations are subject to the

following conditions

(1) For products authorised for

industrial use, safe operational

procedures shall be established,

and products shall be used with

appropriate personal protective

equipment unless it can be

demonstrated in the application

for product authorisation that

risks to industrial users can be

reduced to an acceptable level

by other means.

(2) Labels and, where provided,

safety data sheets of products

authorised shall indicate that

freshly treated timber shall be

stored after treatment under

shelter or on impermeable hard

standing, or both, to prevent

direct losses to soil or water,

and that any losses from the

application of the product shall

be collected for reuse or

disposal.

(3) Products shall not be

authorised for treatment of

wood that will be used in

outdoor constructions near or

above water or for the treatment

of wood in contact with fresh

water, unless data is submitted

to demonstrate that the product

will meet the requirements of

Article 5 and Annex VI, if

necessary by the application of

appropriate mitigation

measures.

When assessing the application

Basic

Copper (II)

957 g/kg

1 February

31 January

31 January

for authorisation of a product in

copper

carbonate-

accordance with Article 5 and

carbon

copper (II)

Annex VI, Member States shall

ate

hydroxide

assess, where relevant for the

(1:1)

particular product, those uses or

EC No

exposure scenarios and those

235-113-6

risks to human populations and

CAS No

to environmental compartments

12069-69-1

that have not been

representatively addressed in

the Union level risk assessment.

Member States shall ensure that

authorisations are subject to the

following conditions

(1) Products shall not be

authorised for application by

dipping, unless data have been

submitted in the application for

product authorisation

demonstrating that that

application meets the

requirements of Article 5 and

Annex VI, if necessary by the

application of appropriate risk

mitigation measures.

(2) For products authorised for

industrial use, safe operational

procedures shall be established,

and products shall be used with

appropriate personal protective

equipment unless it can be

demonstrated in the application

for product authorization that

risks to industrial users can be

reduced to an acceptable level

by other means.

(3) Labels and, where provided,

safety data sheets of products

authorised shall indicate that

freshly treated timber shall be

stored after treatment under

shelter or on impermeable hard

standing, or both, to prevent

direct losses to soil or water,

and that any losses from the

application of the product shall

be collected for reuse or

disposal.

(4) Products shall not be

authorised for treatment of

wood that will be used in

outdoor constructions near or

above water, or for the

treatment of wood in direct

contact with fresh water, unless

data is submitted to demonstrate

that the product will meet the

requirements of Article 5 and

Annex VI, if necessary by the

application of appropriate

mitigation

Measures

The Union level risk assessment

Bendio

2,2-

970 g/kg

1 February

31 January

31 January

did not address all potential

carb

dimethyl-

uses, but concerned, for

1,3-

example, application by

benzodioxo

professionals only, and

l-4-yl

excluded contact with feed or

methylcarb

food and direct application on

amate

soil. When assessing the

CAS-No

application for authorisation of

22781-23-3

a product in accordance with

EC No

Article 5 and Annex VI,

245-216-8

Member States shall assess,

where relevant for the particular

product, those uses or exposure

scenarios and those risks to

human populations and to

environmental compartments

that have not been

representatively addressed in

the Union level risk assessment.

Member States shall ensure that

authorisations are subject to

the following conditions

Products shall not be used for

the treatment of surfaces that

are prone to frequent wet

cleaning, other than crack and

crevice or spot treatment, unless

data are submitted

demonstrating that the product

will meet the requirements of

Article 5 and Annex VI, if

necessary by the application of

appropriate risk mitigation

measures.

Products authorised for

industrial or professional use

shall be used with appropriate

personal protective equipment,

unless it can be demonstrated in

the application for product

authorisation that risks to

industrial or professional users

can be reduced to an acceptable

level by other means.

Where relevant, measures shall

be taken to prevent foraging

bees from gaining access to

treated nests by removing the

combs or blocking the nest

entrances.

Methyl

Undecan-2-

975 g/kg

1 May

30 April

30 April

The Union level risk assessment

nonyl

one

was based on indoor use by

ketone

CAS No

non-professional users. When

112-12-9

assessing the application for

EC No

authorisation of a product in

203-937-5

accordance with Article 5 and

Annex VI, Member States shall

assess, where relevant for the

particular product, those uses or

exposure scenarios and those

risks to human populations and

to environmental compartments

that have not been

representatively addressed in

the Union level risk assessment.

Margos

IUPAC

1000 g/kg

1 May

30 April

30 April

When assessing the application

a

name: Not

for authorisation of a

extract

applicable

product in accordance with

CAS-No

Article 5 and Annex VI,

84696-25-3

Member States shall assess,

EC No

where relevant for the particular

283-644-7

product, those uses or exposure

Description

scenarios and those risks to

: margosa

human populations and to

extract from

environmental compartments

the kernels

that have not been

of

representatively addressed in

Azadirachta

the Union level risk assessment.

indica

Member States shall ensure that

extracted

authorisations are subject to

with water

appropriate risk mitigation

and further

measures for the protection of

processed

surface water, sediment and

with

non-target arthropods.

organic

solvents

Hydroc

Hydrochlori

999 g/kg

1 May

30 April

30 APril

When assessing the application

hloric

c acid

for authorisation of a product in

acid

CAS No

accordance with Article 5 and

not

Annex VI, Member States shall

applicable

assess, where relevant for the

EC No

particular product, those uses or

231-595-7

exposure scenarios and those

risks to human populations and

to environmental compartments

that have not been

representatively addressed in

the Union level risk assessment.

Member States shall ensure that

authorisations of products for

non-professional use are subject

to the packaging being designed

to minimise user exposure,

unless it can be demonstrated in

the application for product

authorisation that risks for

human health can be reduced to

acceptable levels by other

means.

flufeno

1-[4-(2-

960 g/kg

1 February

31 January

31 January

Flufenoxuron shall be subject to

xuron

chloro-

a comparative risk

alpha,

assessment in accordance with

alpha,

the second subparagraph of

alpha-

Article 10(5)(i) of Directive

trifluoro-

98/8/EC before its inclusion in

para-

this Annex is renewed.

tolyloxy)-2-

The Union level risk assessment

addressed treatment of wood

fluoropheny

which will not be used in animal

l]-3-(2,6-

housing or come into contact

difluoroben

with food or feed. Products

zoyl)urea

shall not be authorised for uses

EC No

or exposure scenarios that have

417-680-3

not been representatively

CAS No

addressed in the Union level

101463-69-

risk assessment.

Member States shall ensure that

authorisations are

subject to the following

conditions

(1) Products shall only be used

for treatment of wood intended

for indoor use.

(2) For products authorised for

industrial or professional use

safe operational procedures

shall be established, and

products shall be used with

appropriate personal protective

equipment unless

it can be demonstrated in the

application for product

authorisation that risks to

industrial or professional users

can be reduced to an acceptable

level by other means

(3) Appropriate risk mitigation

measures shall be taken to

protect the soil and aquatic

compartments. In particular,

labels and, where provided,

safety data sheets of authorised

products shall

indicate that freshly treated

timber shall be stored after

treatment under shelter or on

impermeable hard standing, or

both, to prevent direct losses to

soil or water, and that any losses

from the application of the

product shall be collected for

reuse or disposal.

DDA

Reaction

Dry weight

1 February

Not

31 January

The Union level risk assessment

Carbon

mass of

740 g/kg

Applicable

did not address all

-ate

N,N-

potential uses; certain uses,

Didecyl-

such as use by non-

N,N-

professionals, were excluded.

dimethyl

When assessing the

ammonium

application for authorisation of

Carbonate

a product in

and

accordance with Article 5 and

N,N-

Annex VI, Member

Didecyl-

States shall assess, where

N,N-

relevant for the particular

dimethyl

product, those uses or exposure

ammonium

scenarios and those risks to

Bicarbonate

human populations and to

environmental compartments

EC No

that have not been

451-900-9

representatively addressed in

CAS No

the Union level risk assessment.

894406-76-

Member States shall ensure that

authorisations are

subject to the following

conditions

(1) for industrial users 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 can be

reduced to an acceptable level

by other means;

(2) labels and, where provided,

safety data sheets of products

authorised shall indicate that

industrial

application shall be conducted

within a contained area or on

impermeable hard standing with

bunding, that freshly treated

timber shall be stored after

treatment under shelter or on

impermeable hard standing, or

both, to prevent direct losses to

soil or water, and that any losses

from the application of the

product shall be collected for

reuse or disposal;

(3) products shall not be

authorised for treatment

of wood that will be in contact

with fresh water

or used for outdoor

constructions near or above

water, or for treatment by

dipping of wood that will be

continually exposed to the

weather or subject to frequent

wetting, unless data is

submitted to demonstrate that

the product will meet the

requirements of Article 5 and

Annex VI, if necessary by the

application of appropriate

mitigation measures.

cis-

cis-Tricos-

801 g/kg

The Union level risk assessment

tricos-

9-ene; (Z)-

October

September

September

did not address all potential uses

9-ene

Tricos-9-

and exposure scenarios; certain

(Musca

ene

uses and exposure scenarios,

lure)

EC No

such as outdoor use and

248-505-7

exposure of food or feed, were

CAS No

excluded. When assessing the

27519-02-4

application for authorisation of

a

product in accordance with

Article 5 and Annex VI,

Member States shall assess,

where relevant for the particular

product, those uses or exposure

scenarios and those risks to

human populations and to

environmental compartments

that have not been

representatively addressed in

the Union level risk assessment.

For products containing cis-

tricos-9-ene 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.

hydrog

hydrogen

976 g/kg

8, 14

When assessing the application

en

cyanide

October

September

September

and

for authorisation of a product in

cyanide

EC No

accordance with Article 5 and

200-821-6

Annex VI, Member States shall

CAS No

assess, where relevant for the

74-90-8

particular

product, those uses or exposure

scenarios and those risks to

human populations and to

environmental compartments

that have not been

representatively addressed in

the

Union level risk assessment.

Member States shall ensure that

authorisations of products for

use as a fumigant are subject to

the following

conditions

(1) product shall only be

supplied to and used by

professionals adequately trained

to use them;

(2) safe operational procedures

during fumigation and venting

shall be established for

operators and

bystanders;

(3) products shall be used with

adequate personal protective

equipment including, where

appropriate, self-contained

breathing apparatus and gas-

tight clothing;

(4) re-entry into fumigated

spaces shall be prohibited until

the air concentration has

reached safe levels for operators

and bystanders by ventilation;

(5) exposure during and after

ventilation shall be prevented

from exceeding safe levels for

operators and bystanders

by the establishment of a

supervised exclusion zone;

(6) prior to fumigation, any

food and any porous material

with a potential to absorb the

active substance, except

wood intended to be treated,

shall either be removed from the

space to be fumigated or

protected from absorption by

adequate means, and the space

to be fumigated shall be

protected against accidental

ignition.".

(b) In Part A thereof, items 21 and 41 shall be substituted by the following,

respectively:-

"21

Disodium

disodium

990 g/

When assessing the application

tetraborate

tetraborate

kg

September

August

August

for

EC No: 215-540-

authorization of a product in

accordance with Article 5 and

CAS No

Annex VI, Member States shall

(anhydrous)

assess, when

1330-43-4

relevant for the particular product,

CAS No

the populations that may be

(pentahydrate)

exposed to the product and the use

12179-04-3

or exposure

CAS No

scenarios that have not been

(decahydrate)

representatively addressed at the

1303-96-4

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.

Nonanoic

IUPAC name

896 g/

When assessing the application

acid,

Nonanoic

kg

February

January

January

for authorisation of a product in

Pelargonic

acid

accordance with Article 5 and

acid

EC No: 203-931-

Annex VI, Member States shall

assess, when relevant for the

CAS No: 112-05-

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.

When assessing the application

October

September

September

for authorisation of a product in

accordance with Article 5 and

Annex VI, Member States shall

assess, where relevant for the

particular

product, those uses or exposure

scenarios and those risks to

human populations and to

environmental compartments that

have not been representatively

addressed in the

Union level risk assessment.

Member States shall ensure that

authorisations of products for

non-professional use are subject

to the packaging being designed

to minimise user exposure, unless

it can be demonstrated in the

application for product

authorisation that risks for human

health can be reduced to

acceptable levels by other

means.".

(c) In Part A thereof, the first row of the Schedule containing the headings of

the table shall be substituted by the following

"No

Common

IUPAC Name

Minim

Date of

Deadline

Expiry

Product

Specific provisions (***

Name

Identification

um

inclusion

for

date of

type

Numbers

degree

complianc

inclusion

of

e with

purity

Article

of the

16(3),

active

unless

substan

one of the

ce (*)

exceptions

indicated

in the

footnote to

this

heading

applies

(**)

(*) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with

Article 11. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent

with the evaluated substance.

(**) For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the

last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before

the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1)

within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to

120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to

derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the

date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

(***) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the

Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm".

€1.26