Background

Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides (SUD) as transposed in Subsidiary Legislation 430.08 entitled Sustainable Use of Pesticides Regulations, 2011 (Legal Notice 489 of 2011) of the Laws of Malta, requires the establishment and calculation of Harmonised Risk Indicators (HRIs) by using statistical data collected in accordance with the Community Legislation concerning the statistics on plant protection products together with relevant data.

These HRIs are necessary to measure progress in meeting the objective of the SUD in the reduction of risks for pesticide use for human health and the environment.

In 2019, Directive (EU) 2019/782 was adopted to establish a method of calculation of HRIs with the intention to estimate the trends in risk resulting from pesticide use. Directive (EU) 2019/782 amends Annex VI of the SUD and is transposed in national legislation.

Further details on the establishment of HRIs can be found here.

Sales of Pesticides in Malta

Data on pesticides is collected annually in accordance with Regulation (EC) No 1185/2009 concerning statistics on pesticides which establishes a common framework for the systematic production of community statistics on the placing on the market and use of those pesticides. The competent authority responsible for the reporting of such data is the National Statistics Office of Malta (NSO), in fulfilment of the obligations of this regulation, data on sales of authorised PPPs is collected on an annual basis from all recognised importers and is transmitted to Eurostat.

The data collected at Eurostat was used to calculate the HRI reflecting volumes of plant protection products placed on the market annually in Malta, in accordance with the method of calculation provided in Directive (EU) 2019/782. Eurostat data on the sales of pesticides in Malta may be found here.

Harmonised Risk Indicators

Risk indicators are the result of a method of calculation that can be used to evaluate risk of pesticides on human health or the environment. Directive (EU) 2019/782, as transposed in national legislation supports a harmonised way how the indicators can be calculated.

Two HRIs are calculated: HRI1 and HRI2.

Harmonised Risk Indicator 1 (HRI1)

HRI1 is calculated from the quantities of pesticide active substances placed on the market which are submitted to Eurostat on an annual basis. A weighting factor is applied based on the information and the classification of the active substance in the pesticide in accordance with Regulation (EC) 1107/2009. HRI1 is calculated on the basis of the categorisation of active substances into groups and categories.

Four main groups are outlined based on the information on whether the active substance is low risk, a candidate for substitution or other active substances, while seven categories are outlined to further subdivide the groups. Categorisation of active substances is updated annually by the European Commission to take into account new approvals and/or other changes such as changes in classification. The trend lines outlined in this report take into account any updates to categories effective during the reporting period.

The baseline considered for the calculations concerning HRI1 is set at 100 and equal to the average value reflective of the quantities of pesticide active substances placed on the market for the first three years of data i.e. the period of 2011 to 2013. Thus, the total volume placed on the market annually is expressed as an index in relation to 100.

The trend line for HRI1, as depicted in Figure 1, retains a mild fluctuation throughout the first 5 years of data. A decline in volume, lower than the initial reporting value for commencement of the reporting period, is depicted beyond 2015 to 2019, reflecting a reduction in quantities of plant protection products placed on the market and use in these years.  There was however a slight increase for 2020.  This trend line can be correlated to the trend lines for each of the four groups as depicted in Figure 2 and categories as depicted in Figure 3. 

Figure 1. HRI1 trend line for the years 2011-2020 for Malta reflecting the volume of plant protection products placed on the market annually[1].

Group 1 represents the approved active substances classified as low risk under Reg 1107/2009[2]. In order to enhance the authorisation of such group of substances, fees for the authorisation of products containing low risk active substances have been reduced. This measure is intended to incentivise availability of low risk active substances, on the Maltese market. Group 2 is further subdivided into Categories A (Micro-organisms) and B (Chemical active substances). 

Group 2 represents the approved active substances under Reg 1107/2009[3] which do not fall under any particular category. Group 2 is further subdivided into Categories C (Micro-organisms) and D (Chemical active substances). The overall weighted trendline for sale volumes for this group of active substances fluctuates mildly throughout the reporting period to a subtle decline by end 2019 with a sharp increase in 2020 (Figure 2).

Group 3 represents the approved active substances which are classified as candidates for substitution. There has been a considerable decrease in the sales of active substances falling under this groups during the period covering 2015-2017 and remains relatively stable until 2020. Group 3 is further subdivided into Categories E and F representing different categories for candidates of substitution.

Group 4 represents the group of active substances which are not approved under Reg 1107/2009³. Sale volumes for this group of active substances portrays a steady decline throughout the reporting period. Group 4 substances are categorised under Category G. A grace period applies for sale and use of products which contain active substances whose authorisation has been withdraw or are non-renewed in line with the provisions of Reg 1007/2009.

Figure 2. Trend line for the years 2011-2020 for Malta reflecting the volume of plant protection products placed on the market annually by active substance grouping[4].

  2 – Group 2; 3- Group 3; 4 – Group 4[5].

Figure 3. Trend line for the years 2011-2020 for Malta reflecting the volume of plant protection products placed on the market annually by active substance category[6].

 C - Category – C; D - Category – D; E - Category – E; F - Category – F; G - Category – G[7].

The trend lines for the Categories (Figure 3) are concordant with those of the Groups (Figure 2) as outlined above. A sharp increase in volume for Category C, which corresponds to authorised plant protection products containing micro-organisms as the approved active substance is depicted. The use of biological pesticides is incentivised through the measures outlined in the Rural Development Programme (National) from Malta covering the period 2014-2020 supporting the encouragement of the implementation of Integrated Pest Management (IPM) and alternative approaches to reduce the dependency on the use of pesticides and the promotion of IPM and alternative low-pesticide input pest management as outlined in the National Action Plan for the Sustainable Use of Pesticides for Malta covering the period 2019-2023 (NAP).  

Harmonised Risk Indicator 2 (HRI2)

HRI2 is calculated based on the number of emergency authorisations granted for active substances annually. A weighting factor is applied based on the information and the categorisation of the active substance in the pesticide in accordance with Regulation (EC) 1107/2009. The baseline considered for the calculations concerning HRI2 is also set at 100 and equal to the average value of emergency authorisations for the first three years of data i.e. the period of 2011 to 2013. Thus, the total number of authorisations annually are expressed as an index in relation to 100.

The number of emergency authorisations granted annually in Malta is low and ranges from no authorisations as in the case for year 2012, 2019 and 2020 up to a maximum of three authorisation as in the case of 2017 and 2018, throughout the covering period of 2011 - 2020. The emergency authorisations were granted for limited and controlled use in cases where the situation could not be controlled by other reasonable means and no alterative authorised plant protection products were available to deal with the pest inline with the provisions of Reg 1107/2009⁸.

 Figure 4. HRI2 trend line for the years 2011-2020 for Malta reflecting the number of emergency authorisations granted annually.

Trends, practices and items for Malta, in the use of certain active substances

Trending for the covering period 2011-2020, depicts an increased trend in the use of microorganism active substances containing authorised products in Malta. The use of biological pesticides is incentivised through the measures outlined in the Rural Development Programme (National) from Malta covering the period 2014-2020 supporting the encouragement of the implementation of Integrated Pest Management (IPM) and alternative approaches to reduce the dependency on the use of pesticides and the promotion of IPM and alternative low-pesticide input pest management as outlined in the National Action Plan for the Sustainable Use of Pesticides for Malta covering the period 2019-2023.

The trend line for Group 2 and 4 active substance containing products is declining reflecting an overall reduction in quantities of plant protection products containing these active substances grouping placed on the market in Malta during the reporting period. There is a marked reduction in group 4 substances from 2014 to 2020.

The use of low-risk plant protection products remains low for Malta. In order to enhance the authorisation of such group of substances, fees for the authorisation of products containing low risk active substances have been reduced. This measure is intended to incentivise availability of low risk active substances, on the Maltese market.

The number of emergency authorisations granted annually in Malta remains low during the reporting period, ranging from no authorisations as in the case for year 2012, 2019 and 2020 and up to a maximum of three authorisation as in the case of 2017 and 2018. The emergency authorisations were granted for limited and controlled use in cases where the situation could not be controlled by other reasonable means and no alterative authorised plant protection products were available to deal with the pest in-line with the provisions of Reg 1107/2009⁸inline with the provisions of Reg 1107/2009⁸.

[1] The data collected annually in accordance with Regulation (EC) No 1185/2009 concerning statistics on pesticides which establishes a common framework for the systematic production of community statistics on the placing on the market and use of those pesticides, transmitted to Eurostat, was used to calculate the HRI reflecting volumes of plant protection products placed on the market annually in Malta, in accordance to the method of collection provide in Directive (EU) 2019/782.

[2] Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

[3] Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

[4] The data collected annually in accordance with Regulation (EC) No 1185/2009 concerning statistics on pesticides which establishes a common framework for the systematic production of community statistics on the placing on the market and use of those pesticides, transmitted to Eurostat, was used to calculate the HRI reflecting volumes of plant protection products placed on the market annually in Malta, in accordance to the method of collection provide in Directive (EU) 2019/782.

[5] No/insufficient data is available to calculate values for Group 1 for MT

[6] The data collected annually in accordance with Regulation (EC) No 1185/2009 concerning statistics on pesticides which establishes a common framework for the systematic production of community statistics on the placing on the market and use of those pesticides, transmitted to Eurostat, was used to calculate the HRI reflecting volumes of plant protection products placed on the market annually in Malta, in accordance to the method of collection provide in Directive (EU) 2019/782.

[7] No/insufficient data is available to calculate values for Categories A and B for MT