Introduction

This work is dedicated to substances and products to be used for plant and crop protection in Europe agriculture. We previously worked to characterize one side of the growing biocontrol agents’ functions, usages, and their evolution since 2011 (Robin 2019a), and during this first review, all the chemicals were untreated, even forgotten, except for the comparison in the ratio biocontrol agent vs chemicals. However, during the same time frame (2011–2022), chemicals, although new chemical active substances (AS) were still approved for this crop protection purpose, were drastically reduced in amount, consequently reducing the total number of AS, functions, and usages covered. This heavy changes in the global crop protection solutions encourage us to look also at chemical AS and to characterize their global disappearance, their impact regulatory, and technically in fields.

The evolution of AS has been conducted at various levels: their own evolution in number and their quality (chemical versus BCA AS) at entry/exit; the evolution of their regulatory status (basic substances, low-risk substances, renewal, Parts A to E of the Implementing Regulation 540/2011) (EU 2011), of their uses, functions, and the cultures covered after their approval. This evolution is guided by the active ingredient (substance) renewal (AIR) programs (from AIR-1 in 2007 to AIR-6 in 2020) managing re-evaluation of approved AS under Article 13 of Plant Protection Products (PPP) Regulation (EC) No 1107/2009 (EC 2009a) until 2028. Subsequently, the details of their category/status (i.e., as biocontrol agents or in organic production) outside PPP regulations and subordinate to the legal status. Ultimately, once used in the field, we dealt with the issue of residues via maximum residue limits (MRL), all with a view to overall monitoring developments over the past 11 years. Since June 2011, plant protection active substances (AS) are regulated within the European Union (EU) by the PPP Regulation (EC) No 1107/2009 (EC 2009a) and listed in Implementing Regulation (EU) No 540/2011 (EU 2011). 342 AS were previously approved before the entry in vigor of the new PPP Regulation but estimated to be 556 by Minor Uses facility before 2021 (Minor Uses 2020). Three hundred ninety-eight AS were listed in the first approval Part A of Regulation 540/2011. Following, between 2011 and 2018, the total number of AS increased with a steady growth up to a maximum of 502 (+ 104), then gradually reduced. This recent drastic reduction of the active substances amount is affecting not only the global net availability of the PPP panel of solutions, but also the corresponding available usages, functions, and even the diversity of the mode of action, leading to orphan uses in some cases. This decrease is caused by many factors, including the abandonment by the applicant, the voted non-renewal until their withdrawal decided by the Commission and the 27 EU Members States.

Material and methods

Legal support

European pesticides database

The raw data were retrieved from the European pesticides database. This database lists all the substances approved as well as those not approved and those where an approval is pending (EU 2022).

Directives and Regulations

Regulation (EC) No 1107/2009 (EC 2009a) is the main and original document dealing with PPP and AS (pesticides) since 2009. Implementing Regulation (EU) No 540/2011 is the main companion of the PPP regulation as regards the list of approved active substances. Following, Regulation (EC) No 396/2005 (EC 2005) is managing the rules on maximum residue levels of pesticides in or on food as well as plant and animal feed. Subsequently, all the information on one active substance is centralized on the pesticide database, including Review Reports which contain the Good Agricultural Practices (GAP) usage tables. Finally, Directive (EC) No 128/2009 (EC 2009b), the Sustainable Use of Pesticides Directive (SUD), established a regulatory framework for community action to achieve the reduction of the environmental footprint of the EU’s food system, outside the approval and registration procedure, including all relevant National Action Plans (NAP), training, sales of pesticides, information awareness-raising, pesticides storage, application and equipment (i.e., inspection of equipment in use), specific practices and uses (i.e., aerial spraying), indicators and reporting on pesticide uses, this later being updated.

The evolution of plant protection agrochemical substances panel followed using the commission implementing regulations amending the Implementing Regulation (EU) No 540/2011 (EU 2011) for withdrawal, non-renewal, and modification of end of approval dates at PPP Regulation, and was published in the European Union Official Journal. Raw data were extracted from the European Commission pesticide database rev 2.2 website (EU 2022) dealing with the Implementing Regulation (EU) No 540/2011 active substance management. Information about any other consolidated Directives was drawn from the Official Journal of the European Union. Similar follow-up is also used to assign the disappearance of substances without any implementing regulation in the case of simple end of approvals. All the information retrieved from the database rev 2.2 since 2018, affiliated regulations and corresponding Review Reports were added and updated to our previous work (Robin and Marchand 2019a), and other new calculations and statistics have been added in this work but covering the whole period since 2011.

Definitions

Active substances

Active substances (AS) are all substances (EC 2009a), including micro-organisms which have a general or specific action against harmful organisms or on plants, parts of plants, or plant products. These active substances are further classified into categories that correspond to the parts of Implementing Regulation (EU) No 540/2011 (EU 2011). All substances in Part A of Implementing Regulation (EU) No 540/2011 came directly in 2011 from previous Directive 91/414/EEC. Substances in Part B are coming from Part A via renewals or from direct approvals after 2011. Basic substances are approved according to Article 23 of Regulation (EC) No 1107/2009 and listed in Part C. Low-risk (LR) substances are approved according to Article 22 of Regulation (EC) No 1107/2009 and listed in Part D. Substances candidates for substitution (CFS) are approved according to Article 24 of Regulation (EC) No 1107/2009 and listed in Part E. These active substances meet one or more of the additional criteria laid down in point 4 of Annex II of Reg. No 1107/2009.

Agricultural uses (WHO 2022) or usages in plant protection are defined by cultivation practices and roughly managed by the couple crop vs bioagressor (insect/pathogen), linked to function, and are listed in the corresponding Good Agricultural Practices (GAP) Table in the Review Reports in the EU Pesticide database (EU 2022).

Results

Evolution of the number of active substances since 2011

Following our previous work (Robin and Marchand 2019b), new biocontrol data were implemented since 2018 to follow the evolution to exhibit the total amount of active substances. Data were concatenated for each semester between 2011 and 2021. A peak of 502 was reached in 2018, but since then only a decrease is observable. The 2019 bulge is due to the separation of the different strains of microorganisms inducing an overall artificial increase (Fig. 1).

Fig. 1
figure 1

Total amount of active substances

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This global bell curve corresponds to total amount of substances managed by semester and it is the result of the difference between approvals, withdrawals and also of the evolution of various categories of substances subject to natural end of approvals without modification of the regulation (no trace of regulations on the date of end of approval).

Alongside the classic active substances, the new regulation has created three specific categories: basic, low-risk, and substances candidate for substitution (CfS). Inherently, basic and low-risk substances are expected to increase and CfS to decrease over time. Figure 2 exhibits evolution of these three specific categories since 2011 (Romanazzi et al. 2022, Robin and Marchand 2021, Robin and Marchand 2022).

Fig. 2
figure 2

Detailed number of AS

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Regulatory repartitions of the AS

Following, the heavy modification of substances positions in the different parts (A to E) of Regulation 540/2011 is exhibited in Figs. 20 and 21. These drawings may be seen as an update of Fig. 3 in Robin and Marchand 2019a. Substances initially granted in Part A (Robin and Marchand 2019c) are only decreasing by end of approvals, non-renewals, or renewals in Parts B to E. Substances in Part B are only coming from Part A during renewals or direct approvals after 2011. Substances in Parts D and E are only coming from Parts A and B during renewals or direct approvals after 2011. Substances in Part C are only coming from direct approvals after 2011 even if the first basic substance was approved in 2014. It should be noted that a same substance can now be in two categories, basic substance and low-risk substance, such as sodium hydrogen carbonate.

Fig. 3
figure 3

Repartition of AS since 2011 in Parts of Reg 540/2011

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Figure 3 exhibits the evolution by semester of the five parts of Regulation (EU) No 540/2011 and especially shows the decrease of Part A after 2011 together with the evolution, mainly increase, of all the other parts over time.

Incoming AS, as approvals

Notwithstanding renewals, which do not affect the total number of substances, but only categories and parts of the Regulation (EU) No 540/2011, newly approved “active” substances, are exhibited in Fig. 4, with detailed status, namely, basic substances (Art. 23 of PPP Regulation) (Orçonneau et al. 2022); biocontrol agent (BCA) AS like microorganism AS and semiochemical AS; as regular AS like older substance, mainly chemical AS; low-risk AS like microorganisms and natural AS (Vekemans and Marchand 2020, EU 2021b); and chemical AS like most herbicides. No other regulatory action can make an AS appear, except for the detail of the list of substances in unit AS (which we could observe for microorganism strains of later separated in new unitarian lines in the parts of Regulation (EU) No 540/2011).

Fig. 4
figure 4

Newly approved AS

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Chemical AS (black) inputs per year are decreasing over time with even no chemical AS approved since 2019, BCA AS (hatched) approvals in are quite regular per year since 2012 but with a too low amount to overcome reduction of chemical AS (Fig. 1), and basic AS (gray) after important arrivals initially (2014–2017) are scarce since 2018.

Disappearing AS

All of the AS which have disappeared since 2011, from voluntary withdrawal, end of approval, or non-renewals, are exhibited in Fig. 5. Although withdrawals and non-renewals come from the votes of EU member states (M.S.) at the Plant Animal Feed Food (PAFF) Committee, end of approval are only dependent on the supporting company’s choices, if they are not interested in supporting the renewal (Articles 13 to 24 of PPP Reg. 1107/2009). Chemical AS are a great majority of suppressed AS compared to BCA, which are mainly removed by end of approval.

Fig. 5
figure 5

Suppressed active substances since 2011

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Chemical AS (black) are the main contributors to the decrease of total amount of AS (Fig. 1), and the impact is colossal between 2018 and 2021, but BCA AS (hatched) to some extent are also affected by the removal. Approved for 10 years in 2009, the cost for renewal is the main explanation for their abandon by applicants, before weak and narrow business due to less efficacy and the specificity of targets.

The global disappearance of AS is directly induced by the global loss of crop usages (a substance could cover several crops); these losses are exhibited in Fig. 6, whereas specific crop usages evolution is shown in Figs. 7 and 8.

Fig. 6
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Suppressed crop usages since 2011

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Fig. 7
figure 7

Evolution of crop usages

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Fig. 8
figure 8

Net positive contribution of BCA for crop usages replacement

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Chemical (black) and BCA (hatched) crop usages affected by the removal of the corresponding AS, with one AS possibly covering several usages (GAP).

Regarding affected crops by these losses of AS, specific usage modifications involved in this evolution are detailed in Fig. 6 for all AS. This evolution, mainly corresponding to overall losses of AS and crop usages, can be detailed through the all period since 2011 to better understand Figs. 1 and 2.

Evolution of main crop usages (GAP) per year between 2011 and 2022 is described in Fig. 7. A global bump style curve is observed for all crop usages, following the aspect of Fig. 1, but if some usage coverages are going back to the same level after 11 years (market gardening and arboriculture), main of the usages are decreasing, obeying the general regression of chemical substances, BCAs often having a much narrower and more specific spectrum of activity.

Suppressed crop usages are offset by approvals, unfortunately, while Chemical AS made up for losses until 2018; this has not been the case since; nevertheless, BCA are good replacement candidates for all crops (Fig. 8), with the exception of a downside for cereals and horticulture.

Figure 8 exhibits the net (approvals minus removals) contribution of BCA AS between 2011 and 2022 to increase the crop usages for PPP AS. Some contributions for certain crops are clearly important and others weak, but these results represent more the technical and regulatory possibilities than the interest or disinterest of the petitioners.

Net balance of AS

The superposition of the two preceding data sets gives the net balance of the active substances. There are two distinct periods: 2011–2017 with a slowing net growth and 2018–2021 with a net reduction between 10 and 20 substances per year, and 95 non-approved in the same period. Actual net balance and detailed amounts are exhibited in Figs. 9 and 10, whereas Fig. 11 shows the global cumulative detailed balance.

Fig. 9
figure 9

Annual net balance of active substances (ongoing for 2022)

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Fig. 10
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Detailed annual balance of active substance since 2011 (ongoing for 2022)

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Fig. 11
figure 11

Cumulative detailed balance of active substance since 2011

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Figure 9 is directly influence the shape of Fig. 1, showing an increase until 2017 then a decrease of the maximum amount AS since. The gap between the positive arrivals before 2018 and the regression since is quite sharp with a difference of c.a. − 20 between 2017 and 2018. The balance for 2022 is neutral (expected + 1), which demonstrates a stabilization of the maximum of substances towards 450. Only the ratio between chemical AS vs BCA AS, slowly increasing in favor of the BCA, may change in the future.

Although few partings are definitely planned or voted for in 2022 (included in Fig. 9), the year 2022 seems to be returning to a positive balance sheet (mainly due to BCA AS approvals). This would have the effect of stabilizing the total number of substances and increasing the percentage of BCA.

Figure 10 is similar with Fig. 9 including both data abounding the net balance with the all details (arrivals, removals) including chemical arrivals (black) and removals (grey) together with BCA arrivals (black hatched) and removals (gray hatched). This detail is eloquent in the modification of the type of substances proposed and validated as well as those of the substances remote during the two distinct periods: 2011–2017 and 2018–2022.

Figure 11 provides an overview since 2011 of all movements and balances for the two, chemical and BCA AS categories, as well as the overall and net balance over the period 2011–2022. Figure 10 displays over 11 years a net balance, including chemical arrivals (black) and removals (gray) together with BCA AS arrivals (black hatched) and removals (gray hatched) in the first column, a net balance of together with BCA AS arrivals (black hatched 68) versus chemical removals (gray − 17) in the second column and finally the global net balance (+ 58) overtime in the third column showing that only the arrivals of new BCA AS are responsible for the increase in AS between 2011 and 2022.

Usages affected by entries and exits

The uses corresponding to these approvals and departures are very different. As much as the approvals are mostly fungicides and insecticides, the disappearances correspond to fungicide, insecticide, and herbicide functions mainly covered by chemical AS since 2011.

Figure 13 provides an overview of the lost functions represented by the corresponding number of AS showing that fungicides, herbicides, and insecticides are the main lost functions linked to the removal of AS in 11 years. Other represented functions are less affected by these removals.

Figure 13 provides an overview of the functions gained in 11 years showing that fungicides and insecticides and in lesser shade herbicides are the main lost functions linked to the approval of new AS. Other represented functions were less subject to approvals.

The global evolutions of the usages corresponding to these approvals and these departures, show an increase of fungicides and insecticides, and a disappearance of herbicides.

Figure 14 clearly shows that fungicide was the main function positively affected by regulatory and herbicide the most negatively affected in 11 years, other functions being quite stable.

Some functions are deeply impacted by approvals and removals such as fungicides, insecticides, and herbicides (Figs. 12, 13), but the cumulative net variation show only a fungicide increase in a large proportion while herbicides are decreasing, whereas, strangely considering the importance of the in/out movements, all of the other functions have been quite stable during the last 11 years (Fig. 14).

Fig. 12
figure 12

Lost usages associated with active substances

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Fig. 13
figure 13

Gain of usages associated with new active substances

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Fig. 14
figure 14

Cumulative variation in usages with the evolution of active substances

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This global vision is not sufficient, however, because with regard to Figs. 15 and 16, some functions have been indeed quite stable during the last 11 years (Fig. 16), while others (Fig. 15) have undergone great changes.

Fig. 15
figure 15

Evolution of covered functions impacted by the evolution of active substances

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Fig. 16
figure 16

Evolution of covered functions globally stable with the evolution of active substances

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Figures 15 and 16 show function evolution by year. Figure 15 displays heavily impacted functions (fungicides, insecticides, and herbicides), while Fig. 16 exhibits almost stable functions in 11-year survey.

Evolution of chemical vs BCA AS

Evolution of chemical and BCA AS are described in Fig. 17 and 18. Chemical AS are following a parabolic curve, while the BCA AS increase is quite linear and is noticeable in Figs. 17 and 18. In addition, it is clear that approvals of chemical AS were massive before 2018 and have declined rapidly since.

Fig. 17
figure 17

Evolution of chemical AS

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Fig. 18
figure 18

Evolution BCA AS

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In Fig. 17, chemical AS (black line) are displayed by semester over 11 years together with its polynomial regression curve showing quite good R2 confirming the good following of the curve. Almost 30 chemical AS (net balance) are lost in this period of time. On the contrary, approvals of BCA AS are regular, and the slope is always positive although some BCA AS were removed in the meantime, mainly due to abandon by applicants during renewal.

In Fig. 18, BCA AS (black line) are displayed for each first semester of the 11 years together with its linear regression showing quite good R2 confirming the good follow-up of the curve. Almost 100 BCA AS (net balance) are gained in this period of time. An update of the figure drawn in 2019 (unpublished data) showing the co-evolution of chemical AS and BCA AS is provided in Fig. 19. The intersection of the two curves previously estimated in 2025 is now estimated to occur early in 2023!

Fig. 19
figure 19

Parallel evolution of BCA and chemical AS

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In Fig. 19, co-evolution of BCA AS (hatched line) and chemical AS (black line) are displayed for each first semester of the 11 years together with its polynomial regression curve showing quite good R2 values confirming the good following of the curves. Crossing of the two curves (50/50% BCA vs chemical AS) it now expected next year since few chemical AS are again expected to be removed and correspondingly quite few BCA AS approval are already programmed at PAFF Committee.

Impacts on environment: maximum residues limits (MRL) analysis

MRL are defined by Regulation (EC) 396/2005 divided in 3 classes accordingly to our previous work showing high differences between Annexes IV and V and similarity between Annexes II and III grouped into a single class (Charon et al. 2019, 2021). These classes are for substances without MRL (Annex VI) (Class 0), with MRL by default (V) (Class 1) and assigned MRL in Annexes II or III (Class 2). Global examination of the results displayed in 2011 (Fig. 20) and actual in 2022 (Fig. 21) shows a substantial difference between chemical and BCA AS regarding MRL distribution in the 3 classes previously described (Charon et al. 2019). Later, chemical and BCA AS are both accounting for the total amount of AS (all AS) in Figs. 20 and 21. The number of substances and corresponding percentages, for each MRL class and for each AS category (chemical, BCA, and all AS), are displayed in Figs. 20 and 21 for the beginning of the PPP Reg. in 2011 and for the actual situation in 2022.

Fig. 20
figure 20

Repartition of MRLs in 2011

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Fig. 21
figure 21

Actual repartition of MRLs in 2022

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In Fig. 20, the first column displays initial situation in 2011 for BCA AS with a majority of AS with no MRL and high number of AS with MRL by default. Column 2 on the contrary shows a high prevalence of AS with MRLs for chemical AS. Column 3 is the resulting combination of both previous columns weighted by the number of respective AS for chemical and BCA AS.

In Fig. 21, the first column displays situation in 2022 for BCA AS with a high majority of AS with no MRL (increase), a decrease of AS with MRL by default and a similar number of AS with MRL (class 2). Column 2 on the contrary shows a high prevalence of AS with MRLs for chemical AS, although a small decease is observable and the situation is better nowadays. Column 3 is the resulting combination of both previous columns weighted by the number of respective AS for chemical and BCA AS.

The evolution shows a clear improvement in the situation with a decline in the fraction of AS with MRLs vs. an increase in AS with default MLRs and AS with no MRLs, this for all AS and in all specific BCA and chemical AS categories. All categories are progressing, thereby improving the situation of the entire AS, but this impact can be clearly attributed to BCA AS amount progression with lower MRL concerns.

Co-evolution of active substance functions (BCA and chemical AS)

Following the analysis of functions loss and evolution between 2011 and 2022, and looking at the wave type of some of the curves, it was crucial to ask the questions of replacement types of lost AS. We therefore had in hand with this analytical tool the means to also answer this question. Figure 22 illustrates well the various situations encountered: general increase and for certain functions of BCA AS, replacement of chemical by BCA AS in certain cases, significant increase in BCA AS for some functions, disappearance of chemical AS in other cases.

Fig. 22
figure 22

Repartition of function between BCA and chemical AS (2022 vs 2011)

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In Fig. 22, chemical AS (black) and BCA AS (hatched) are exhibited with the sum of both and are organized by superposed function; initial 2011 situation under and 2022 situation above for each function.

Discussion

Evolution of the AS amount

The first observation from Fig. 1 that can be made is that 11 years after its creation; the global increase in the amount of AS (+ 54) is a 52% increase (451 vs 398), although the shape the curve suggests a different issue and more events behind. All these AS (all AS) are separated into 234 chemical AS (Marchand 2019) and 217 BCA AS (48%). The total amount of AS is divided into categories, as found by the PPP regulation: 66 low-risk AS, 24 basic AS, 56 candidates for substitution AS (Fig. 2) (Robin and Marchand 2021a), and 305 AS. In fact, Fig. 1 shows an increase until 2018 up to 502 AS (real) (Robin and Marchand 2019a) corresponding to a + 68% increase (+ 204 AS) followed by a decrease of 51 AS since (− 10%). Following, the repartition (Fig. 3) in the different parts of Reg. 540/2011 (A to E) are largely amplified since 2018 (Robin and Marchand 2019b, c).

Details of these entries and removals from chemical and BCA AS are exhibited in Fig. 4 for entries and in Fig. 5 for exits. It can be inferred that fewer and fewer chemical AS are being approved (in Fig. 4), with the number decreasing to zero in the last 2 years. On the other hand, suppression AS is mainly chemical AS with a strong increase since 2018 (in Fig. 5).

A different view may be taken by measuring entry and arrivals each year since 2011 to explain this global net evolution. Figure 9 exhibits the annual balance given further explanation of the visible change in the global slope evolution of curve in Fig. 1. Further details of in are shown Fig. 10 since 2011, while a global overview is later provided by Fig. 11, resuming the last 11 years AS evolution in only one figure.

Evolution of the substance categories

Although the positive slope in the first part of Fig. 1 is due to chemical and BCA AS increase, the second part of the curve with a negative slope is mainly due to the disappearance of chemical AS, as shown in Fig. 17, since the end of 2017. Figure 1 is already taken into account as expected from non-renewals and end of approvals. The second crest in 2020 is mainly due to the unitary separation of the lists of strains of microorganisms for BCA AS observable in Fig. 18. These conclusions on Fig. 1 are only decisive when observing Fig. 18 and 19 separately, when the two curves are disconnected, compared to Fig. 1. In fact, BCA AS are increasing most regularly, with 5 to 6 new AS being approved per year since 2011, noticeable with slope regression coefficient, linear on Fig. 18 and polynomial on Fig. 19. Since almost all the low-risk and basic AS are BCA AS, as described in our previous publications (Marchand 2015, Marchand 2016, Marchand 2018, Robin and Marchand 2021b, Robin and Marchand 2022, Romanazzi et al. 2022, Taylor 2022), this implies that these two categories are important providers of BCA AS, as exhibited in Fig. 2. However, since AS may gain this low-risk status when renewed, the increase of the low-risk AS (LR) curve in Fig. 2 is not directly corresponding to a contribution of new BCA AS. However, this yearly increase from 5 to 6 is largely insufficient to counter the reduction in the number of AS or to fuel ecological substitution, or to provide new solutions, because this replacement is often done from broad-spectrum substances to highly targeted AS, which is desirable but also reduces crop uses accordingly.

Finally, the global decrease of in the number of AS is predictable since very few chemical AS are expected to be approved nowadays, and it is expected that many more will be removed, especially those qualified as endocrine disruptors or in Part E of 540/2011 (Robin and Marchand 2019c), and few renewed.

Evolution of the crop usages, a global loss of covering

Active substances, chemical or BCA AS, are developed for crop protection, with each substance being qualified for one or more crops. Over the last 11 years, a global loss of crop usages is observed in Fig. 6, predominantly by the loss of chemical AS. This global loss is demonstrated in Fig. 7, showing an initial increase of all crop usages until 2018 and a rapid decrease in the last 3 years, except for arboriculture which plateaus for 7 years then decreases. The disappearance of numerous AS not only reduces the possibilities for sustainable conventional agriculture, but also increases the use of those PPP AS that are still available, increasing sometimes residue concerns for those and even sometimes create orphan uses (no more AS available for a specific usage).

Evolution of the substance functions, a global loss of covering

The important disappearance of fungicide, insecticide, and herbicide usages observable in Fig. 12 are only counter-balanced by the arrival of new fungicides and insecticides (Fig. 13). Following, herbicides were heavily penalized by the tightening of the rules for re-evaluating pesticides during their renewal, (Minor uses 2020) leading to their marked decrease, despite a notable increase in the total of AS during the same period. The cumulative net results in Fig. 14 show a net increase of fungicides and a decrease of herbicides together with a stable amount or small increase of all other uses. These global results have to be expanded regarding their evolution through years. Two cases are clearly separated in the 2011–201,818 period; the heavily impacted uses exhibited in Fig. 15, and the quite stable uses grouped in Fig. 16.

It is noticeable that not only are all functions covered by BCA AS, but also that certain functions are mainly covered by BCA AS (bactericides, acaricides, plant growth regulators (PGR) and insecticides) and finally that certain functions like attractants and elicitors are mostly covered by BCA AS. Only the herbicidal function is still mainly covered by chemical AS (Fig. 22) although the BCA AS are still in the minority of AS overall (48%).

Evolution of the substance maximum residue limits (MRL), an important change

MRLs in this study are divided into 3 classes previously described: no MRL in Annex IV of Regulation 396/2005, by default in Annex V, attributed in Annexes II or III (Charon et al. 2019). In fact, non-approved AS still own some MRL for the control of misuses, infringements on the use of pesticides and imported raw crops and foodstuffs. Co-evolution of AS and MRLs is obvious since MRLs are created or modified for an active substance and mostly disappear with its removal, many of which in are in Annex V (by default). Starting in 2011, actual values are depicted in Figs. 20 and 21, respectively. Although for chemical MRLs, repartition is quite stable through time, all AS are progressing, indeed increasing in % of no-MRL AS (from 18.5 to 38.7%) and AS with MRL by default (from 8 to 16%). This improvement is coming from the most noticeable changes from the BCA AS MRL with no-MRL progressing from 39 to 79% and the disappearance of chemical AS.

Global reduction of AS may lead to a reduction of residues in food on the one hand, boosted in this virtuous way by global reduction of residues due to global evolution of MRL in both BCA and chemical AS. On the other hand, this global decrease of number of plant protection solutions (AS, functions and crop usages) largely described in this work can cause a number of problems. As examples, the emergence of resistance due to overuse of the remaining AS may occur, the lower quality of productions due to the increase of absence of treatments (orphan uses), etc. This may lead to sales problems, including export and dissemination of new pest and diseases by contaminated plant materials. However, EU ongoing strategy still plan a drastic reduction of pesticide uses in the future.

Conclusions

Following all AS since the entry into force of Regulations EC 1107/2009 and EC 540/2011, great changes in 11 years are observed in terms of the number of AS repartition in parts, evolution of crop, function, and usages covered through this period. A bit less than 200 AS (i.e., still 50% of the AS initially granted by the new regulation) are still in Part A of 540/2011 waiting for re-evaluation although they were initially approved for 10 years. The global small increase of amount in AS (+ 14%) hides some crucial facts: the large decrease of chemical AS compensated by corresponding approvals unti l 2017 and the partial substitution of these losses by BCA AS. This tendency is going to amplify in the coming years since chemical AS are removed and have recently had trouble getting approval (i.e., 1,3-dichloropropene, chloropicrin not approved in 2022). The implementation of Regulation EC 1107/2009 triggered by Directive EC 128/2009 (EC 2009b) therefore corresponds to a deep change in crop protection, even more than what is visible by looking at the point of actual arrival compared to the starting point (Part A of Regulation EC 540/2011). Ongoing and further changes induced by these orientations and this shift towards the BCA AS in plant protection is clearly underway since low-risk and no-MRL substances are largely increasing in 2022. Furthermore, at the end of the decennial renewal, the global panel of PPP AS is expected to be again largely modified by chemicals end of life and actual significant pending BCA AS approvals from the 64 pending AS observable in the EU Pesticide database. On the other hand, as the substances are not replaced item by item, use by use, and as BCAs are usually more specialized, losses of use may occur again, potentially increasing the number of orphan uses already established. Therefore, unless there is an explosion of BCA AS in the next few years, the protection of plants and crops will have to change direction to ensure that production is maintained at the same level or even increased, with the requirements in terms of food safety. Finally, the planned reduction of pesticides in EU may trigger other ways of protecting crops (i.e., macro-organisms), together with very low concern PPP or PPP with no contact with crops (Marchand 2019), especially Low-risk AS, with no or by default MRL.