Sustainable Use of Pesticides (Amendment) Regulations, 2019 (L.N. 319 of 2019)

VERZJONI ELETTRONIKA 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: B 2357 1. 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.os. Pesticides Regulations, hereinafter referred to as "the principal regulations". 2. Sub-regulation (2) of regulation 1 of the principal Amends regulations shall be substituted by the following: regulation 1 of the principal "(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.". regulations. 3. Sub-regulation (1) of regulation 14 of the principal Amends 1 • 1 1 1 b b • d b h ;:- 1 1 • regulation 14 of regu at10ns S la e SU Stltute Y t e 10 0Wmg: the principal regulations. "(l) Ha1111onised 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.". 4. Immediately after regulation 14 of the principal regulations Adds new h 1 11 b dd d h "' 11 · 1 · regulation 14A t ere s1a ea e t e 10 owmg new regu at10n: totheprincipal regulations. "Director shall 14A. The Director shall request ;~t:i:~tion as information related to quantities of substances deemed contained in pesticides placed on the market or necessruy. other info1111ation as deemed necessary to achieve the objectives of these regulations." . 5. Schedule IV of the principal regulations shall be substituted by the following: Substitutes Schedule IV of the principal regulations. B 2358 VERZJONI ELETTRONIKA "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. Ham1onised 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. VERZJONI ELETTRONIKA B 2359 4. The quantities of active substances placed on the market for each Group and Category in Table 1 may be calculated. Table I Categorisation of active substances and hazard weightings for the purpose of calculating Harmonised Risk Indicator 1 Row Groups 1 2 3 4 (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 I 107/2009, and not falling I I 07 /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 Aunex to and B of the Allllex to Implementing Regulation (EU) No and therefore Implementing Regulation Implementing Regulation 540/201 1 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 orgamsms active classified as: classified as: substances substances Carcinogenic Carcinogenic Category 1 A or Category IA or 1B 1B and/or and/or Toxic for Toxic for Reproduction Reproduction Category IA or Category IA or 1B 1B and/or and/or Endocrine Endocrine disrupt ors disrupt ors, 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) 1 8 16 64 5. The baseline for Harn1onised Risk Indicator 1 shall be set at 100 and is equal to the average result of the above calculation for the period 2011-2013. VERZJONI ELETTRONIKA B 2360 6. The result of Hannonised 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 Ham1onised Risk Indicator 2: (a) the Ham1onised 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; VERZJONI ELETTRONIKA 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 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 1 2 3 4 (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 I I 07 / 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 oftheAll!lex to Implementing Regulation (EU) and therefore Implementing Regulation Implementing Regulation No 540/2011 which are not (EU) No 540/201 I (EU) No 540/2011 listed in the Annex to Implementing Regulation (EU) No 540/201 I (ii) Categories (iii) A B C D E F G (iv) Micro- Chemical Micro- Chemical \Vhich are not Which are organisms active organisms active classified as: classified as: substances substances Carcinogenic Carcinogenic Category IA Category IA or 1B or 1B and/or and/or Toxic for Toxic for Reproduction Reproduction Category IA Category IA or 1B or 1B and/or and/or Endocrine Endocrine disruptors disrupt ors 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) I 8 16 64 VERZJONI ELETTRONIKA B 2362 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 Ham1onised 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.". Ippubblikat mid-Dipartiment tal-Infonnazzjoni (doi.govm t) - Valletta - Published by the Departme11t of Information (doi.gav.mt) - Valletta Mitbugb ft-Istamper ija tal-Gvern fuq karta FSC - Pri11ted at the Government Printing Press 011 FSC certified paper PrezliPrice €0.54