B 2357
B 2357
L.N. 319 of 2019
PESTICIDES CONTROL ACT
(CAP. 430)
Sustainable Use of Pesticides (Am endment No 2) Regulations, 201 9
IN EXERCISE of the powers conferred by articles 4 and 5 of the
Pesticides Control Act, the Mi nister responsible for the Enviro nment,
Sustainable Development and Climate Change, in consultation wit h
the Minister for Health, has ma de the following regulations:-
Title.
S.L. 430.08.1. The title of these regulations is the Sustainable Use of
Pesticides (Amendment No 2) Regulations, 2019 and these regulat ions
shall be read and construed as one with the Sustainable Use of
Pesticides Regulations, hereinafter referred to as "the princip al
regulations".
Amends 
regulation 1 of 
the principal regulations.2. Sub-regulation (2) of regulation 1 of the principal
regulations shall be substituted by the following:
"(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 Parliamentand of the Council as regards th e establishment of harmonised
risk indicators.".
Amends 
regulation 14 of 
the principal regulations.3. Sub-regulation (1) of regulation 14 of the principal
regulations shall be substituted by the following: 
"(1) Harmonised risk indicators as established in Schedule
IV shall be made use of, provided that the Director may continu e
to use existing national indicators or adopt other appropriate
indicators in addition to the harmonised ones.".
Adds new 
regulation 14A to the principal 
regulations. 4. Immediately after regulation 14 of the principal regulations
there shall be added the following new regulation:
Substitutes 
Schedule IV of the principal 
regulations. 5. Schedule IV of the principal regulations shall be substituted
by the following:"Director shall 
request 
information as 
deemed 
necessary.14A. The Director shall request
information related to quantities of substances
contained in pesticides placed on the market or
other information as deemed necessary toachieve the objectives of these regulations.".
VERŻJONI ELETTRONIKA
B 2358
B 2358
"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 genera l rules shall apply for the calculation o f Harmonised Risk
Indicator 1:
(a) the Harmonised Risk Indicator 1 shall be calculated on the b asis 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 notlisted 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.
VERŻJONI ELETTRONIKA
B 2359
B 2359
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 acti ve substances and hazard weightings for the purpose 
of calculating Harmonised Risk Indicator 1
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.Row Groups
1 2 3 4
(i) Low-risk active substances 
which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed 
in Part D of the Annex to 
Implementing Regulation (EU) No 540/2011Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A 
and B of the Annex to 
Implementing Regulation (EU) No 540/2011Active substances approved or deemed to be approved under Article 24 of Regulation (EC) No 1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to 
Implementing Regulation (EU) No 
540/2011Active substances which are not approved under Regulation (EC) No 1107/2009, 
and therefore 
which are not listed in the Annex to Implementing Regulation (EU) No 540/2011
(ii) Categories
(iii) A B C D E F G
(iv) Micro-organisms Chemical active substancesMicro-organisms Chemical active substancesWhich are not classified as:Carcinogenic Category 1A or 1Band/or
Toxic for 
Reproduction Category 1A or 1Band/orEndocrine disruptorsWhich are classified as:Carcinogenic Category 1A or 1Band/or
Toxic for 
Reproduction Category 1A or 1Band/orEndocrine disruptors, 
where 
exposure of humans is negligible
(v) Hazard Weightings applicable to quantities of active substances placed on the market in pr oducts authorised under 
Regulation (EC) No 1107/2009
(vi) 1 8 16 64
VERŻJONI ELETTRONIKA
B 2360
B 2360
6. The result of Harmonised Risk Indicator 1 shall be expressed by reference to
the baseline.
7. It shall be the duty of The A uthority 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 calcula ted.
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 7Categories.
2. The following general rules shall apply for the calculation o f 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 categoris ation
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 li sted 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 notlisted in the Annex to Implementing Regulation (EU) No 540/
2011;
VERŻJONI ELETTRONIKA
B 2361
B 2361
(f) the weightings in row (vi) in Table 2 of this Section shall apply.
3. The Harmonised Risk Indicator 2 shall be calculated by multip lying 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
1 2 3 4
(i) Low-risk active substances 
which are approved or 
deemed to be approved 
under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011Active substances approved or deemed to be approved 
under Regulation (EC) No 
1107/2009, and  not falling 
in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011Active substances approved or deemed to be approved under 
Article 24 of Regulation (EC) No 
1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011Active substances 
which are not 
approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the 
Annex to 
Implementing Regulation (EU) No 540/2011
(ii) Categories
(iii) A B C D E F G
(iv) Micro-
organismsChemical active 
substancesMicro-
organismsChemical active 
substancesWhich are not 
classified as:
Carcinogenic Category 1A or 1Band/orToxic for Reproduction 
Category 1A 
or 1Band/orEndocrine disruptorsWhich are 
classified as:
Carcinogenic Category 1A or 1Band/orToxic for Reproduction 
Category 1A 
or 1Band/orEndocrine disruptors where exposure of 
humans is 
negligible
(v) Hazard Weightings applicable to the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009
(vi) 1 8 16 64
VERŻJONI ELETTRONIKA
B 2362
_________________________________________________________________________________________________________________________
Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta
Mitbugħ fl-Istamperija tal-Gvern fuq karta FSC — Printed at the Government Printing Press on FSC certified paper
Prezz/Price
€0.54B 2362
4. The baseline for Harmonised Ri sk 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 A uthority 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. ".
VERŻJONI ELETTRONIKA