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Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

6 Articles / Provisions · Malta
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Statutory Text (6 Articles)

Malta Government Gazette — Legal Notice 2019 319 · Government Gazette Of Malta No. 20,300– 26.11.2019 — Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

L.N. 319 of 2019

PESTICIDES CONTROL ACT

(CAP. 430)

Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

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

Pesticides Control Act, the Minister responsible for the Environment,

Sustainable Development and Climate Change, in consultation with

the Minister for Health, has made the following regulations:-

Malta Government Gazette — Legal Notice 2019 319 · Government Gazette Of Malta No. 20,300– 26.11.2019 — Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

The title of these regulations is the Sustainable Use of Title.

Pesticides (Amendment No 2) Regulations, 2019 and these regulations

shall be read and construed as one with the Sustainable Use of S.L. 430.08.

Pesticides Regulations, hereinafter referred to as "the principal

regulations".

Malta Government Gazette — Legal Notice 2019 319 · Government Gazette Of Malta No. 20,300– 26.11.2019 — Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

Sub-regulation (2) of regulation 1 of the principal Amends

regulation 1 of

regulations shall be substituted by the following

the principal

regulations.

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

Directive 2009/128/EC of the European Parliament and of the

Council of 21 October 2009 establishing a framework for

Community action to achieve the sustainable use of pesticides

and Commission Directive (EU) 2019/782 of 15 May 2019

amending Directive 2009/128/EC of the European Parliament

and of the Council as regards the establishment of harmonised

risk indicators.".

Malta Government Gazette — Legal Notice 2019 319 · Government Gazette Of Malta No. 20,300– 26.11.2019 — Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

Sub-regulation (1) of regulation 14 of the principal Amends

regulation 14 of

regulations shall be substituted by the following

the principal

regulations.

"(1) Harmonised risk indicators as established in Schedule

IV shall be made use of, provided that the Director may continue

to use existing national indicators or adopt other appropriate

indicators in addition to the harmonised ones.".

Malta Government Gazette — Legal Notice 2019 319 · Government Gazette Of Malta No. 20,300– 26.11.2019 — Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

Immediately after regulation 14 of the principal regulations Adds new

regulation 14A

there shall be added the following new regulation

to the principal

regulations.

" Director shall

Malta Government Gazette — Legal Notice 2019 319 · Government Gazette Of Malta No. 20,300– 26.11.2019 — Sustainable Use of Pesticides (Amendment No 2) Regulations, 2019

The

Director

shall

request

request

information as information related to quantities of substances

contained in pesticides placed on the market or

deemed

necessary.

other information as deemed necessary to

achieve the objectives of these regulations.".

5. Schedule IV of the principal regulations shall be substituted Substitutes

Schedule IV of

by the following

the principal

regulations.

"Schedule IV

SECTION 1

Harmonised Risk Indicators

The harmonised risk indicators are listed in Sections

2 and 3 of this Schedule

SECTION 2

Harmonised Risk Indicator 1: Hazard-based Harmonised Risk Indicator based

on the quantities of active substances placed on the market in plant protection

products under Regulation (EC) No 1107/2009

1. This indicator shall be based on statistics on the quantities of active substances

placed on the market in plant protection products under Regulation (EC) No

1107/2009, provided to the Commission (Eurostat) under Annex I (Statistics on

the placing on the market of pesticides) of Regulation (EC) No 1185/2009.

Those data are categorised into 4 Groups, which are divided into 7 Categories.

2. The following general rules shall apply for the calculation of Harmonised Risk

Indicator 1

(a)

the Harmonised Risk Indicator 1 shall be calculated on the basis of

the categorisation of active substances into the 4 Groups and 7

Categories set out in Table 1;

(b)

the active substances in Group 1 (categories A and B) shall be

those listed in Part D of the Annex to Commission Implementing

Regulation (EU) No 540/2011;

(c)

the active substances in Group 2 (categories C and D) shall be

those listed in Parts A and B of the Annex to Implementing

Regulation (EU) No 540/2011;

(d)

the active substances in Group 3 (categories E and F) shall be

those listed in Part E of the Annex to Implementing Regulation

(EU) No 540/2011;

(e)

the active substances in Group 4 (category G) shall be those not

approved under Regulation (EC) No 1107/2009, and therefore not

listed in the Annex to Implementing Regulation (EU) No 540/

2011;

(f)

the weightings in row (vi) in Table 1 shall apply.

3. Harmonised Risk Indicator 1 shall be calculated by multiplying the annual

quantities of active substances placed on the market for each Group in Table 1

by the relevant hazard weighting set out in Row (vi), followed by the

aggregation of the results of these calculations.

4. The quantities of active substances placed on the market for each Group and

Category in Table 1 may be calculated.

Table 1

Categorisation of active substances and hazard weightings for the purpose

of calculating Harmonised Risk Indicator 1

Row

Groups

(i)

Low-risk active substances

Active substances approved

Active substances approved or

Active

which are approved or

or deemed to be approved

deemed to be approved under

substances

deemed to be approved

under Regulation (EC) No

Article 24 of Regulation (EC) No

which are not

under Article 22 of

1107/2009, and not falling

1107/2009, which are candidates

approved under

Regulation (EC) No 1107/

in other categories, and

for substitution, and which are

Regulation (EC)

2009, and which are listed

which are listed in Parts A

listed in Part E of the Annex to

No 1107/2009,

in Part D of the Annex to

and B of the Annex to

Implementing Regulation (EU) No

and therefore

Implementing Regulation

Implementing Regulation

540/2011

which are not

(EU) No 540/2011

(EU) No 540/2011

listed in the

Annex to

Implementing

Regulation (EU)

No 540/2011

(ii)

Categories

(iii)

A

B

C

D

E

F

G

(iv)

Micro-

Chemical

Micro-

Chemical

Which are not

Which are

organisms

active

organisms

active

classified as

classified as

substances

substances

Carcinogenic

Carcinogenic

Category 1A or

Category 1A or

1B

1B

and/or

and/or

Toxic for

Toxic for

Reproduction

Reproduction

Category 1A or

Category 1A or

1B

1B

and/or

and/or

Endocrine

Endocrine

disruptors

disruptors,

where

exposure of

humans is

negligible

(v)

Hazard Weightings applicable to quantities of active substances placed on the market in products authorised under

Regulation (EC) No 1107/2009

(vi)

5. The baseline for Harmonised Risk Indicator 1 shall be set at 100 and is equal to

the average result of the above calculation for the period 2011-2013.

6. The result of Harmonised Risk Indicator 1 shall be expressed by reference to

the baseline.

7. It shall be the duty of The Authority to calculate and publish the Harmonised

Risk Indicator 1 in accordance with Article 15(2) and 15(4) of Directive 2009/

128/EC for each calendar year and at the latest 20 months after the end of the

year for which the Harmonised Risk Indicator 1 is being calculated.

SECTION 3

Harmonised Risk Indicator 2: Harmonised Risk Indicator based on

the number of authorisations granted under

Article 53 of Regulation (EC) No 1107/2009

1. This indicator shall be based on the number of authorisations granted for plant

protection products under Article 53 of Regulation (EC) No 1107/2009 as

communicated to the Commission in accordance with Article 53(1) of that

Regulation. Those data are categorised into 4 Groups, which are divided into 7

Categories.

2. The following general rules shall apply for the calculation of the Harmonised

Risk Indicator 2

(a)

the Harmonised Risk Indicator 2 shall be based on the number of

authorisations granted under Article 53 of Regulation (EC) No

1107/2009. It shall be calculated on the basis of the categorisation

of active substances into the 4 Groups and 7 Categories set out in

Table 2 of this Section;

(b)

the active substances in Group 1 (categories A and B) are listed in

Part D of the Annex to Implementing Regulation (EU) No 540/

2011;

(c)

the active substances in Group 2 (categories C and D) are those

listed in Parts A and B of the Annex to Implementing Regulation

(EU) No 540/2011;

(d)

the active substances in Group 3 (categories E and F) shall be

those listed in Part E of the Annex to Implementing Regulation

(EU) No 540/2011;

(e)

the active substances in Group 4 (category G) shall be those not

approved under Regulation (EC) No 1107/2009, and therefore not

listed in the Annex to Implementing Regulation (EU) No 540/

2011;

(f)

the weightings in row (vi) in Table 2 of this Section shall apply.

3. The Harmonised Risk Indicator 2 shall be calculated by multiplying the

number of authorisations granted for plant protection products under Article 53

of Regulation (EC) No 1107/2009 for each Group in Table 2 by the relevant

hazard weighting set out in Row (vi), followed by the aggregation of the results

of these calculations.

Table 2

Categorisation of active substances and hazard weightings for the purpose of

calculating Harmonised Risk Indicator 2

Row

Groups

(i)

Low-risk active substances

Active substances approved

Active substances approved or

Active

which are approved or

or deemed to be approved

deemed to be approved under

substances

deemed to be approved

under Regulation (EC) No

Article 24 of Regulation (EC) No

which are not

under Article 22 of

1107/2009, and not falling

1107/2009, which are candidates

approved under

Regulation (EC) No 1107/

in other categories, and

for substitution, and which are

Regulation (EC)

2009, and which are listed

which are listed in Parts A

listed in Part E of the Annex to

No 1107/2009,

in Part D of the Annex to

and B of the Annex to

Implementing Regulation (EU)

and therefore

Implementing Regulation

Implementing Regulation

No 540/2011

which are not

(EU) No 540/2011

(EU) No 540/2011

listed in the

Annex to

Implementing

Regulation (EU)

No 540/2011

(ii)

Categories

(iii)

A

B

C

D

E

F

G

(iv)

Micro-

Chemical

Micro-

Chemical

Which are not

Which are

organisms

active

organisms

active

classified as

classified as

substances

substances

Carcinogenic

Carcinogenic

Category 1A

Category 1A

or 1B

or 1B

and/or

and/or

Toxic for

Toxic for

Reproduction

Reproduction

Category 1A

Category 1A

or 1B

or 1B

and/or

and/or

Endocrine

Endocrine

disruptors

disruptors

where

exposure of

humans is

negligible

(v)

Hazard Weightings applicable to the number of authorisations granted under Article 53 of Regulation (EC) No 1107/

(vi)

4. The baseline for Harmonised Risk Indicator 2 shall be set at 100 and is equal to

the average result of the above calculation for the period 2011-2013.

5. The result of the Harmonised Risk Indicator 2 shall be expressed by reference

to the baseline.

6. It shall be the duty of The Authority to calculate and publish the Harmonised

Risk Indicator 2 in accordance with Article 15(2) and 15(4) of Directive 2009/

128/EC for each calendar year and at the latest 20 months after the end of the

year for which Harmonised Risk Indicator 2 is being calculated.".

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