Statement concerning the review of the approval of the active substance pirimicarb

European Food Safety Authority (EFSA)

doi:10.2903/j.efsa.2023.7807

. 2023 Feb 16;21(2):e07807. doi: 10.2903/j.efsa.2023.7807

Statement concerning the review of the approval of the active substance pirimicarb

European Food Safety Authority (EFSA)^✉

PMCID: PMC9933487 PMID: 36818643

Abstract

On 26 August 2022, the European Commission asked EFSA to provide scientific and technical assistance according to Article 21(2) of Regulation (EC) No 1107/2009 concerning the review of the approval of the active substance pirimicarb and to deliver a statement on whether the applicable approval criteria may still be considered fulfilled, taking into consideration the information submitted by the applicant and the assessment of the rapporteur Member State, Sweden and, where applicable, the results of a discussion with experts from Member States. The current statement contains a summary of the main findings of the assessment of the risks to consumers from the exposure to metabolites of pirimicarb through dietary intake, the risks to human health through non‐dietary exposure and the acute risk to birds from the representative uses of pirimicarb assessed for the first approval and additionally, from the representative uses as submitted as part of the renewal of approval. Concerns are reported where identified.

Keywords: pirimicarb, peer review, risk assessment, pesticide, insecticide, genotoxicity of metabolites, dietary and non‐dietary exposure

Summary

Pirimicarb is deemed to have been approved on 1 February 2007 under Regulation (EC) No 1107/2009 by Commission Directive 2006/39/EC, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulations (EU) No 541/2011, 2021/566 and 2022/378.

An application for the renewal of the approval of pirimicarb was submitted to the original rapporteur Member State (RMS), the United Kingdom, and the co‐rapporteur Member State, Sweden, in accordance with Commission Implementing Regulation (EU) No 844/2012. Following the departure of the United Kingdom from the EU, Sweden was designated as RMS. The peer review process of the renewal assessment remains ongoing. In accordance with Article 13(3a) of Commission Implementing Regulation (EU) No 844/2012, EFSA requested further information related to the implementation of the scientific criteria for the determination of endocrine‐disrupting (ED) properties introduced by Regulation (EU) No 2018/605.

The RMS subsequently informed the European Commission that during the peer review process concerns have been identified about the genotoxicity of some metabolites of pirimicarb to which consumers may be exposed through dietary intake, and for some metabolites, a conclusion on general toxicity could not be made. Furthermore, following an exchange with EFSA, it also became apparent that for some of the representative uses of pirimicarb, non‐dietary exposure exceeds the reference values established during the peer review. In addition, an acceptable acute risk to birds could not be demonstrated for any of the representative field uses.

Given those concerns, there are indications that pirimicarb may no longer satisfy the approval criteria in Article 4 of Regulation (EC) No 1107/2009.

Therefore, pursuant to Article 21(1) of Regulation (EC) No 1107/2009, the European Commission informed the applicant about the concerns and invited it to provide comments or information. The applicant submitted further information in January 2022, which has been evaluated by the designated RMS after Brexit, Sweden, who submitted its evaluation to the European Commission and EFSA on 16 June 2022.

In accordance with Article 21(2) of Regulation (EC) No 1107/2009, in August 2022, EFSA was requested to provide scientific and technical assistance concerning the review of the approval of the active substance pirimicarb and to deliver a statement on whether the applicable approval criteria may still be considered fulfilled, taking into consideration the information submitted by the applicant and the assessment of the RMS and, where applicable, the results of a discussion with experts from Member States. Specifically, EFSA was requested to consider (i) the risks to consumers from the exposure to metabolites of pirimicarb through dietary intake, (ii) the risks to human health through non‐dietary exposure and (iii) the acute risk to birds from the representative uses of pirimicarb assessed for the first approval and additionally, from the representative uses reflecting the currently authorised uses as submitted as part of the renewal of approval. The following conclusions are derived.

As regards the dietary exposure, the consumer risk assessment for none of the uses proposed under the renewal of the approval could be finalised due to insufficient data to address the genotoxic potential of the metabolites R34885, R31805, R16210, R34865 and R406405 and general toxicity of R406405, found relevant in plant and/or in livestock. Furthermore, no sufficient trials were available in primary and rotational crops to investigate the magnitude of residues. As regards the representative uses for the first approval, the consumer risk assessment could also not be finalised in view of the outstanding data from the renewal of the approval with impact on the consumer risk assessment.

As regards the human health assessment through non‐dietary exposure, no risks were identified for the existing uses on wheat crops assessed for the first approval and for the renewal uses on wheat crops, sugar beet crops, and ornamentals in greenhouse (in case of downward spraying) when appropriate risk mitigation measures are adopted, while risks were identified for the use on ornamentals in greenhouse (in case of upward spraying) for operators, bystanders and residents. As regards the acute risk to birds, low acute risk to birds could be concluded for the representative greenhouse uses in ornamentals in permanent structures, whereas high risk was indicated for all uses in wheat (from the first approval and renewal of approval), the uses in sugar beet and eventual uses in ornamentals in non‐permanent greenhouses.

1. Introduction

Pirimicarb is deemed to have been approved on 1 February 2007 under Regulation (EC) No 1107/20091 by Commission Directive 2006/39/EC2, in accordance with Commission Implementing Regulation (EU) No 540/20113, as amended by Commission Implementing Regulations (EU) No 541/20114, 2021/5665 and 2022/3786.

The RMS subsequently informed the European Commission that during the peer review process, concerns have been identified about the genotoxicity of some metabolites of pirimicarb to which consumers may be exposed through dietary intake, and for some metabolites, a conclusion on general toxicity could not be made. EFSA had already asked the applicant (Syngenta) to provide additional information on those metabolites during the renewal peer review, in accordance with Article 13(3) of Implementing Regulation (EU) No 844/2012; however, concerns remained or cannot be excluded following evaluation of the additional information provided and following expert discussion.

Furthermore, following an exchange with EFSA, it also became apparent that for some of the representative uses of pirimicarb, non‐dietary exposure exceeds the reference values established during the peer review. In addition, an acceptable acute risk to birds could not be demonstrated for any of the representative field uses.

Given those concerns, there are indications that pirimicarb may no longer satisfy the approval criteria in Article 4 of Regulation (EC) No 1107/2009.

On 26 August 2022, EFSA was requested by the European Commission to provide scientific and technical assistance concerning the review of the approval of the active substance pirimicarb and to deliver a statement on whether the applicable approval criteria may still be considered fulfilled, taking into consideration the information submitted by the applicant and the assessment of the RMS and, where applicable, the results of a discussion with experts from Member States, within 3 months following such consultations have been completed or once EFSA receives the updated assessment by the RMS following those consultations, if such update is needed.

More specifically, EFSA was requested to consider (i) the risks to consumers from the exposure to metabolites of pirimicarb through dietary intake, (ii) the risks to human health through non‐dietary exposure and (iii) the acute risk to birds from the representative uses of pirimicarb assessed for the first approval and additionally, from the representative uses reflecting the currently authorised uses as submitted as part of the renewal of approval (see Appendix A).

Based on that mandate, an expert consultation was organised in September 2022 and subsequently, following receipt of the revised assessment from the RMS, EFSA prepared a draft statement in October 2022 which was circulated to all Member States for commenting via a written procedure.

A key supporting document to this statement is the peer review report (EFSA, 2022a), which is a compilation of the documentation developed to evaluate and address all issues raised in the course of the peer review of the renewal of the active substance pirimicarb, from the initial commenting phase to the preparation of this statement. For reasons of completeness and transparency, the peer review report comprises all background documents, which were developed and finalised during the ongoing renewal process up to the production of the present statement and relate to all sections of the risk assessment, as follows:

the comments received on the RAR;
the reporting table (13 July 2018);
the reports of the scientific consultation with Member State experts (where relevant);
the comments received on the assessment of the additional information (where relevant);
the comments received on the draft EFSA statement.

Given the importance of the RAR, including its revisions prepared in the context of the renewal up to the production of the present statement (United Kingdom/Sweden, 2022) as well as the stand‐alone addendum prepared in the context of the Art 21 review (Sweden, 2022), and the peer review report, all these documents are considered as background documents to this statement and thus are made publicly available.

It is recommended that this statement and its background documents would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information on which this statement is based.

1.1. Terms of Reference as provided by the requestor

In accordance with Article 21(2) of Regulation (EC) No 1107/2009, on 26 August 2022, EFSA was mandated by the European Commission to provide scientific and technical assistance concerning the review of the approval of the active substance pirimicarb and to deliver a statement on whether the applicable approval criteria may still be considered fulfilled, taking into consideration the information submitted by the applicant and the assessment of the RMS and, where applicable, the results of a discussion with experts from Member States.

Specifically, EFSA was requested to consider the following aspects for the representative uses of pirimicarb assessed for the first approval (European Commission, 2006) and for the representative uses reflecting the currently authorised uses, as submitted as part of the renewal of approval:

the risks to consumers from the exposure to metabolites of pirimicarb through dietary intake;
the risks to human health through non‐dietary exposure;
the acute risk to birds.

Given the need for discussion of some aspects with experts from Member States, the outcome of which could be relevant for the assessment, EFSA was requested to provide its scientific assistance in the form of a statement within a 3‐month time period starting once such consultations have been completed or once EFSA received the updated assessment by the RMS following those consultations, if such update was needed. An updated assessment after the expert consultation was provided by the RMS on 3 October 2022 (Sweden, 2022).

Following request from the European Commission in accordance with Article 21(1) of Regulation (EC) No 1107/2009, the applicant submitted to EFSA and all Member States the information it provided to the Commission and the RMS in January 2022.

The active substance and the formulation for representative uses

Pirimicarb is the ISO common name for 2‐(dimethylamino)‐5,6‐dimethylpyrimidin‐4‐yl dimethylcarbamate (IUPAC).

The formulation for representative uses for the evaluation of the first approval and renewal of approval was ‘Pirimor’, a water dispersible granule (WG) containing 500 g/kg pirimicarb.

The representative uses evaluated were foliar spray applications on wheat (winter and summer), sugar beet and ornamentals (pot plants, permanent greenhouse7) for control of aphids. Full details of the good agricultural practice (GAPs) can be found in Appendix A.

2. Assessment

2.1. Toxicological reference values of pirimicarb and assessment of metabolites

The toxicological reference values of pirimicarb were discussed at the Pesticides Peer Review Experts' Meetings 190 in January 2019 and PREV 07 in June 2019 in the context of the renewal process, and at the Experts' Teleconference 89 in September 2022 in the context of the review under Article 21 of Regulation (EC) No 1107/2009.

Based on the available data in June 2019, the experts8 agreed to increase the uncertainty factors (UF) for the derivation of the toxicological reference values, in order to account for the lack of specific data addressing the sensitivity of pup to acetylcholinesterase (AChE) inhibition. The resulting acceptable daily intake (ADI) and acceptable operator exposure level (AOEL) are 0.007 mg/kg body weight (bw) per day, based on the no‐observed adverse effect level (NOAEL) of 3.5 mg/kg bw per day from the 1‐year dog study supported by the 2‐year rat study, and applying an overall UF of 500 (and no correction of the AOEL for oral absorption). The resulting acute reference dose (ARfD) and acute acceptable operator exposure level (AAOEL) are 0.01 mg/kg bw, based on the NOAEL of 10 mg/kg bw from the acute neurotoxicity study, and applying an overall UF of 1,000.

As part of the additional information submitted by the applicant in January 2022, new in vitro data for AChE enzyme inhibition and in vivo data with pirimicarb were assessed by the RMS (Sweden, 2022) and discussed by the experts.9 These data were concluded as supplementary, and insufficient to justify the removal of the extra uncertainty factors. Consequently, for the derivation of the toxicological reference values, the experts confirmed the applicability of an increased UF in order to take into account for the lack of specific data addressing the sensitivity of pups to AChE inhibition.

The toxicological profile of the metabolites of pirimicarb was discussed at the Pesticides Peer Review Experts' Meeting 190 in January 2019 and at the Pesticides Peer Review Experts' Teleconference 89 in September 2022. The discussion in the second experts' teleconference 89 was based on the additional information and assessment provided by the applicant for the metabolites R34885, R31680, R31805, R34865, R406405 and R16210.

For the metabolite R34836 10, the majority of the experts agreed that it was unlikely to be genotoxic (by read across from the parent), and that the reference values of pirimicarb could be applied for the consumer risk assessment.

For the metabolite R34885, three new genotoxicity tests were provided. The negative results in the in vitro mammalian cell gene mutation test and in the in vitro micronucleus test were not considered sufficient to address the mutagenic potential based on the equivocal results in the Ames test (data gap).

For the metabolite R31680, the three new genotoxicity tests (Ames, in vitro mammalian cell gene mutation test, in vitro micronucleus test) were all negative. R31680 is therefore considered unlikely to be genotoxic, and confirmed to be of lower systemic toxicity than the parent compound based on acute toxicity results.

For the metabolite R31805, positive results had been observed in the in vitro mouse lymphoma assay. The negative results in the new in vitro mammalian cell gene mutation test, submitted instead of an in vivo Comet assay (as agreed during the peer review) were considered insufficient to conclude on the genotoxicity potential (mutagenic endpoint) of the metabolite (data gap).

For the metabolite R34865, positive results had been observed in the in vitro mouse lymphoma assay. The negative results in the new in vitro mammalian cell gene mutation test, submitted instead of an in vivo Comet assay (as agreed during the peer review ¹⁰ ) were considered insufficient to conclude on the genotoxicity potential (mutagenic endpoint) of the metabolite (data gap). Pending on the outcome of the genotoxicity assessment, the toxicological reference values agreed during the peer review could be applied.

For the metabolite R16210, as no data have been made available, the assessment of its genotoxic potential cannot be concluded (data gap).

For the metabolite R406405, as no experimental data have been made available and the applicability of the read across for genotoxicity (from the metabolites R31805 and R34865) could not be agreed, ¹⁰ both the genotoxic and general toxicity assessment cannot be concluded (data gap).

2.2. Risks to consumers from the exposure to metabolites of pirimicarb through dietary intake

The assessment in this section is based on the following guidance documents: OECD (2009, 2011), European Commission (2011) and JMPR (2004, 2007).

Pirimicarb was discussed at the Pesticides Peer Review Experts' meeting 191 in January–February 2019 in the context of the renewal process.

To address the mandate, the representative uses in wheat evaluated for the first approval (European Commission, 2006) was considered for the consumer dietary risk assessment. Under the peer review process for renewal, the representative uses in wheat, sugar beet and ornamentals were assessed for the consumer risk assessment via dietary intake (see relevant GAPs in the Appendix A).

In the context of the current mandate, the applicant did not provide new data in the Residue section compared to the data submitted in the framework of the renewal process.

The available primary crops metabolism studies in lettuce, potatoes, apples and wheat by foliar application on pyrimidine ring showed that pirimicarb was the major residue in lettuce, apple fruits and wheat grain and in limited amount in potatoes (1.7% TRR). Metabolite R34836 was found in significant amounts in lettuce (21% TRR) while in the rest of the crops, it was below 10% TRR. Although metabolites R34885 and R31805 in most of the investigated crops were recovered at levels below 10% TRR, the absolute amount was found to be relevant (0.14 mg/kg and 1 mg/kg in lettuce respectively); metabolite R34865 was found up to 0.72 mg/kg in lettuce only. Metabolite R16210 was recovered at 32% TRR in potato tubers although the total radioactivity of residues in potato tubers was very low (0.04 mg/kg). It was noted that the genotoxic profile of R16210 was not resolved (see Section 2.1).

In the two rotational crops metabolism studies conducted in lettuce, radish, wheat and millet, similar metabolic patterns were observed as in primary crops. Pirimicarb was recovered in radish roots (up to 20% TRR) but also in the other crops in limited amounts. Metabolites R34836, R31805, R34865 and R34885 were recovered in relevant amounts either in relative or in absolute amounts of TRR in most of the crops (e.g. 0.13 mg/kg in radish leaves for R34865). It is also noted from the data submitted under the renewal that R31805, R34865 and R34885 are persistent compounds in soil.

During the renewal peer review process, two rotational crops field trials conducted in the US at sufficiently high concentration (i.e. 2,240 g/ha) were submitted; they cover the application rate and the soil plateau concentration of pirimicarb. In those trials, only pirimicarb, R34836 and R238177 were analysed, and the results confirmed the occurrence of pirimicarb and R34836 residues in rotational crops. Metabolites R31805, R34865 and R34885 were not investigated in the field rotational crops studies, although, based on the results from the metabolism studies and in view of their persistency in soil, residues are expected in rotational crops. Consequently, a data gap was identified during the expert's meeting11 for sufficient rotational field trials analysed for parent and metabolites: R31805, R34865, R34836 and R34885. It is also noted that the genotoxic profile of several metabolites R31805, R34865 and R34885 was not complete (see Section 2.1). Considering all the above information from the plant metabolism studies, the outstanding data in field rotational trials and the outcome from the mammalian toxicology section, the risk assessment residue definition is proposed as sum of pirimicarb and R34836, expressed as pirimicarb. This proposal is provisional pending the submission of the additional toxicological data needed in mammalian toxicology for the above‐mentioned metabolites and the additional rotational crop trials.

As regards the livestock assessment studies, four metabolism studies were submitted in laying hens and lactating goats. In laying hens, pirimicarb was extensively metabolised to R34865 (up to 48% TRRs in eggs white) and R31680 (up to 50% TRR in muscle). In ruminants, R34865, R31680, R406405 were found in milk up to 29%, 16% and 16% TRR, respectively. It is highlighted that the genotoxic potential of R34865 and R406405 cannot be excluded (see Section 2.1). Considering the occurrence of R406405 in milk and pending its genotoxicity profile, its inclusion in the risk assessment residue definition should be reconsidered. Currently, the residue definition for the risk assessment in ruminants provisionally includes residues of R34865 and R31680, expressed as pirimicarb. It is noted that the fate of R34836 in animal matrices was not investigated although triggered for ruminants only by the representative uses assessed under the renewal. Therefore, information on the fate of R34836 in ruminants needs to be provided (data gap). Further to that, the investigation of R34836 in poultry is not needed, since the metabolism studies conducted with pirimicarb were highly overdosed and residues > 0.01 mg/kg are not expected in poultry matrices. The risk assessment residue definition in poultry is proposed as pirimicarb by default.

Field trials to support the representative uses under renewal were sufficient only for wheat grain. For the wheat straw, only six trials were submitted for Northern Europe (NEU) use, thus two additional GAP compliant trials are needed (data gap). No residue trials were submitted for sugar beet leaves to support the representative use in NEU and need to be provided (data gap).

The stability of pirimicarb residues and R34836 was demonstrated in several commodities up to 18 months when the samples are stored at least at −15°C. Although storage stability data were provided in cabbage and lettuce (high water content), the sugar beet leaves cannot be considered as covered by available data since the stability of residues should be demonstrated in three different crops with high water content to cover the whole group of commodities (data gap).

An indicative consumer risk assessment for the representative uses as part of the renewal was conducted by using the toxicological reference values, ADI of 0.007 mg/kg bw per day and the ARfD of 0.01 mg/kg bw derived during the renewal peer review process, the available residue trials on wheat, sugar beet and leaves by using the PRIMo rev. 3.1. The chronic exposure (TMDI) resulted in maximum 7% of the ADI (GEMs/Food G06 diet),12 while the acute intake (IESTI) was 11% of the ARfD (NL adults). However, the overall consumer risk assessment cannot be finalised for all the uses due to the non‐finalised risk assessment residue definitions in plant and livestock, the outstanding data in primary and rotational crops and the lack of conclusion on the genotoxic potential of R31805, R34885, R34865, R406405 and R16210 and lack of data on general toxicity on R406405 (see Section 2.1). Regarding the representative use on ornamentals in greenhouse, although they are not foodstuff, they could be grown in rotation with other food crops. Thus, the consumer exposure via dietary intake cannot be excluded for the ornamentals use that leads to the consumer risk assessment not finalised also for ornamentals.

An indicative consumer risk assessment was conducted also for the uses evaluated under the first approval with PRIMo rev. 3.1 and the toxicological reference values of ADI of 0.007 mg/kg bw per day and ARfD of 0.01 mg/kg bw derived during the peer review process for renewal, and the results from the residue trials in wheat grain. The chronic exposure (TMDI) resulted in maximum 6% of the ADI (GEMs/Food G06 diet), while the acute intake (IESTI) was 9% of the ARfD (UK children). However, also for these uses, the consumer risk assessment could not be finalised considering the lack of conclusion on the genotoxic potential of R31805, R34885, R34865, R406405 and R16210 and lack of data on general toxicity on R406405, found in relevant amounts in plant and animal commodities.

2.3. Risks to human health through non‐dietary exposure

The non‐dietary exposure assessment of pirimicarb was discussed at the Pesticides Peer Review Experts' Teleconference 89 in September 2022, based on the following guidance documents: EFSA, 2014b, EFSA PPR Panel, 2017 and EFSA, 2022b.

With regard to dermal absorption (DA), the agreed values during the peer review meeting13 were 1% for the undiluted formulation and 14% for the dilution of 0.4 g a.s./L, based on experimental data and applicable to the uses of the existing approval (wheat). Pro‐rata corrections were agreed for the different spray concentrations in the renewal uses, including 19% for the use on winter wheat (0.3 g/L), 18% for the use on summer wheat (0.31 g/L), 15% for the use on sugar beet (0.375 g/L) and 22% for the use on ornamentals (0.25 g/L).

Based on two dislodgeable foliar residue (DFR) trials on indoor ornamentals, a refined DFR value of 1.74 μg/cm²/kg a.s./ha has been agreed for the use on ornamentals, and a refined DT ₅₀ value of 4.65 days was concluded as applicable to pirimicarb for all uses.

2.3.1. Operator exposure

For the existing uses on wheat crops from the first approval, the predicted systemic exposure estimates using the EFSA calculator (EFSA, 2014b) are below the (A)AOEL with the use of drift reduction nozzles and appropriate personal protective equipment (PPE) (i.e. workwear and gloves during mixing, loading and application).

For the renewal uses on winter wheat, summer wheat and sugar beet crops, the predicted systemic exposure estimates using the EFSA calculator (EFSA, 2014b) are below the (A)AOEL with the use of drift reduction nozzles and appropriate PPE (i.e. workwear and gloves during mixing, loading and application).

For the renewal use on ornamentals in greenhouses, the predicted systemic exposure estimates using the new EFSA calculator (EFSA, 2022b) are above the AAOEL for upward spraying (high ornamentals, e.g. on shelves or staggered plant pots), and below the (A)AOEL for downward spraying (low ornamentals), considering appropriate PPE and respiratory protective equipment (RPE).

It is noted that the number of applications has no impact on the predicted exposure estimates for the operators, and that exposure estimates for use in greenhouses are for closed permanent structures (it is considered that non‐permanent greenhouses would be closed during the application of the product; therefore, operator exposure for permanent structures would also apply).

An overview of the risk assessment for operators can be found in Table 1, while detailed results are provided in Appendix B.1.

Table 1.

Risk assessment (RA) for the operators

Pirimor WG – Representative uses from the existing approval (European Commission, 2006) Model: EFSA 2015 (last version of calculator from EFSA 2014b)
Use: Wheat, Southern EU, outdoor use, 0.21 kg a.s. per ha
Application method	PPE/RPE ^*	Short‐term RA (%AOEL)	Acute RA (%AAOEL)
Vehicle‐mounted, downward spray	Workwear (Ww)	93	419
	Ww + gloves + RPE (MLA^**)	10	114
	Ww + gloves (MLA^**) + drift reduction	21	52
Use: Wheat, Northern EU, outdoor use, 0.15 kg a.s. per ha
Vehicle‐mounted, downward spray	Workwear (Ww)	71	336
	Ww + gloves + RPE (MLA^**)	8	108
	Ww + gloves (MLA^**) + drift reduction	18	51
Pirimor WG – Representative uses from the renewal process Model: EFSA (2015) for outdoor uses (last version of calculator from EFSA, 2014b) and EFSA, 2022b for indoor uses (ornamentals)
Use: Winter wheat, outdoor use, 0.12 kg a.s. per ha
Vehicle‐mounted, downward spray	Workwear (Ww)	71	363
	Ww + gloves + RPE (MLA^**)	9	140
	Ww + gloves (MLA^**) + drift reduction	17	50
Use: Summer (spring) wheat, outdoor use, 0.125 kg a.s. per ha
Vehicle‐mounted, downward spray	Workwear (Ww)	71	358
	Ww + gloves + RPE (MLA^**)	9	133
	Ww + gloves (MLA^**) + drift reduction	17	50
Use: sugar beet, outdoor use, 0.15 kg a.s. per ha
Vehicle‐mounted, downward spray	Workwear (Ww)	74	353
	Ww + gloves + RPE (MLA^**)	9	115
	Ww + gloves (MLA^**) + drift reduction	18	50
Use: Low ornamentals (pot plants), greenhouse, 0.3 kg a.s. per ha Input parameters: normal crop density
Hand‐held application, downward spray	Workwear (Ww)	94	> 100
Hand‐held application, downward spray	Ww + gloves (MLA^**)	< 94	45
Use: High ornamentals (pot plants), greenhouse, 0.3 kg a.s. per ha Input parameters: normal crop density
Hand‐held application, upward spray	Ww + gloves + RPE (MLA^**)	> 100	> 100
Trolley application, upward spray	Ww + gloves (MLA^**)	87	> 100
Trolley application, upward spray	Ww + gloves + RPE (MLA^**)	< 87	> 100

Pirimor WG – Representative uses from the existing approval (European Commission, 2006) Model: EFSA (2015) (last version of calculator from EFSA, 2014b)
Use: Wheat, Southern EU, outdoor use, 2 × 0.21 kg a.s. per ha Input parameters: 7‐day interval between applications, DT₅₀ 4.65 days
Worker task	PPE	%AOEL
Inspection	Ww	80
Use: Wheat, Northern EU, outdoor use, 2 × 0.15 kg a.s. per ha Input parameters: 7‐day interval between applications
Inspection	Ww	57
Pirimor WG – Representative uses from the renewal process Model: EFSA (2015) (last version of calculator from EFSA, 2014b) and also EFSA, 2022b for the ornamentals
Use: Winter wheat, outdoor use, 1 × 0.12 kg a.s. per ha, Input parameters: DT₅₀ 4.65 days
Inspection	Ww	46
Use: Summer (spring) wheat, outdoor use, 2 × 0.125 kg a.s. per ha Input parameters: 14‐day interval between applications, DT₅₀ 4.65 days
Inspection	Ww	51
Use: Sugar beet, outdoor use, 1 × 0.15 kg a.s. per ha Input parameters: DT₅₀ 4.65 days
Inspection	Ww	45
Use: Low/high ornamentals (pot plants), greenhouse, 3 × 0.3 kg a.s. per ha Input parameters: 7‐day interval between applications, DT₅₀ 4.65 days, DFR 1.74 μg/cm²/kg as/ha
Cutting and harvesting activities^*	Ww + gloves	> 500
Cutting and harvesting activities^ (DAA^* 0) (DAA^*** 12)	Ww + gloves	> 500 < 100
Inspection and maintenance (8 h)^ (DAA^* 0) (DAA^*** 10)	Ww + gloves	413 < 100
Inspection and irrigation (2 h)^ (DAA^* 0) (DAA^*** 1)	Ww + gloves	103 < 100
Use: Low/high ornamentals (pot plants), greenhouse, 1 × 0.3 kg a.s. per ha Input parameters: DT₅₀ 4.65 days, DFR 1.74 μg/cm²/kg as/ha
Cutting and harvesting activities^*	Ww + gloves	364
Cutting and harvesting activities^ (DAA^* 0) (DAA^*** 9)	Ww + gloves	366 < 100
Inspection and maintenance (8 h)^ (DAA^* 0) (DAA^*** 8)	Ww + gloves	282 < 100
Inspection and irrigation (2 h)^ (DAA^* 0)	Ww	79
Use: Low/high ornamentals (pot plants), greenhouse, 3 × 0.3 kg a.s. per ha Input parameters: 14‐day interval between applications, DT₅₀ 4.65 days, DFR 1.74 μg/cm²/kg as/ha
Inspection and maintenance (8 h)^ (DAA^* 0) (DAA^*** 8)	Ww + gloves	320 < 100
Inspection and irrigation (2 h)^ (DAA^* 0)	Ww	90

Pirimor WG – Representative uses from the existing approval (European Commission, 2006) Model: EFSA (2015)^*
Use: Wheat, Southern EU, outdoor use, 2 × 0.21 kg a.s. per ha Input parameters: 7‐day interval between applications, DT₅₀ 4.65 days, drift reduction
Category	% (A)AOEL by exposure pathway
	Drift	Vapour	Deposits	Re‐entry	All (mean)
Bystander child/adult	45/12	11/2	12/4	67/37	–
Resident child/adult	28/7	15/3	6/2	96/53	112/50
Input parameters: 14‐day interval between applications, DT₅₀ 4.65 days, drift reduction, buffer zone 10 m
Bystander child/adult	24/5	11/2	2/0.8	56/31	–
Resident child/adult	16/3	15/3	1/0.4	80/44	88/40
Input parameters: 1 application, DT₅₀ 4.65 days, drift reduction, buffer zone 10 m
Bystander child/adult	24/5	11/2	2/0.7	50/28	–
Resident child/adult	16/3	15/3	1/0.3	71/39	81/37
Use: Wheat, Northern EU, outdoor use, 2 × 0.15 kg a.s. per ha Input parameters: 7‐day interval between applications, DT₅₀ 4.65 days, drift reduction
Bystander child/adult	32/9	11/2	8/3	48/27	–
Resident child/adult	20/5	15/3	4/1	68/38	84/37
Pirimor WG – Representative uses from the renewal process Model: EFSA (2015)^* and also EFSA, 2022b for the ornamentals
Use: Winter wheat, outdoor use, 1 × 0.12 kg a.s. per ha Input parameters: DT₅₀ 4.65 days, drift reduction
Bystander child/adult	47/13	11/2	6/2	38/21	–
Resident child/adult	29/7	15/3	3/1	55/31	77/32
Use: Summer (spring) wheat, outdoor use, 2 × 0.125 kg a.s. per ha Input parameters: 14‐day interval between applications, DT₅₀ 4.65 days, drift reduction
Bystander child/adult	46/12	11/2	7/3	43/24	–
Resident child/adult	29/7	15/3	3/1	61/34	82/34
Use: Sugar beet, outdoor use, 1 × 0.15 kg a.s. per ha, Input parameters: DT₅₀ 4.65 days, drift reduction
Bystander child/adult	46/12	11/2	7/2	38/21	–
Resident child/adult	29/7	15/3	3/1	54/30	77/31
Use: Low ornamentals (pot plants), greenhouse, 3 × 0.3 kg a.s. per ha (EFSA calculator 2022b) Input parameters: 7‐day interval between applications, DFR 1.74 μg/cm² foliage per kg a.s./ha, DT₅₀ 4.65 days
Bystander child/adult	101/27	8/2.7	26/10	–	–
Resident child/adult	64/15	11/4	13/5	–	56/14
Input parameters: 7‐day interval between applications, DFR 1.74 μg/cm² foliage per kg a.s./ha, DT₅₀ 4.65 days, buffer zone 5 m
Bystander child/adult	66/13	8/2.7	11/4	–	–
Resident child/adult	43/8	11/4	5/2	–	39/9
Use: High ornamentals (pot plants), greenhouse, 3 × 0.3 kg a.s. per ha (EFSA calculator 2022b) Input parameters: 7‐day interval between applications, DFR 1.74 μg/cm² foliage per kg a.s./ha, DT₅₀ 4.65 days
Bystander child/adult	526/291	8/2.7	11/4	–	–
Resident child/adult	328/182	11/4	7/3	–	232/125
Input parameters: 7‐day interval between applications, DFR 1.74 μg/cm² foliage per kg a.s./ha, DT₅₀ 4.65 days, buffer zone 10 m
Bystander child/adult	526/291	8/2.7	4/1.5	–	–
Resident child/adult	328/182	11/4	2/1	–	229/123
Use: High ornamentals (pot plants), greenhouse, 1 × 0.3 kg a.s. per ha (EFSA calculator 2022b) Input parameters: DFR 1.74 μg/cm² foliage per kg a.s./ha, DT₅₀ 4.65 days, buffer zone 10 m
Bystander child/adult	526/291	8/2.7	2.6/1	–	–
Resident child/adult	328/182	11/4	1.6/0.6	–	228/123

	Crop	Application rate (g a.s./ha)	MAF	Indicator species	Shortcut value	DDD (mg a.s./kg bw)	LD₅₀ (mg/kg bw)	TER ^(a)
Existing approval (European Commission, 2006)	Wheat	2 × 210 ^(b)	1.4	Small omnivorous bird	158.8	46.69	20.9	0.4
		1 × 210	1.0			33.35		0.6
		2 × 150 ^(b)	1.4			33.35		0.6
		1 × 150	1.0			23.82		0.9
Renewal of approval	Winter wheat	1 × 120	1.0			19.06		1.1
	Summer (Spring) wheat	2 × 125 ^(c)	1.2			23.82		0.9
	Summer (Spring) wheat	1 × 125	1.0			19.85		1.0
	Sugar beet	1 × 150	1.0			23.82		0.9
	Ornamentals (pot plants) ^(d)	3 × 300	2.0	Small insectivorous bird	46.8	28.08		0.7

	Crop	Application rate (g a.s./ha)	BBCH	MAF₉₀	Generic focal species	SV₉₀	DDD (mg a.s./kg bw)	LD₅₀ (mg/kg bw)	TER ^(a)
Existing approval (European Commission (2006)	Wheat ^(b)	2 × 210	65–85	1.4	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	2.12	20.9	9.9
		2 × 210	65–85	1.4	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	16.93		1.2
		1 × 210	65–85	1.0	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	1.51		13.8
		1 × 210	65–85	1.0	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	12.10		1.7
		2 × 150	65–85	1.4	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	1.51		13.8
		2 × 150	65–85	1.4	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	12.10		1.7
		1 × 150	65–85	1.0	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	1.08		19.4
		1 × 150	65–85	1.0	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	8.64		2.4
Renewal of approval	Winter wheat	1 × 120	51–89	1.0	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	0.86		24.2
	Winter wheat	1 × 120	51–89	1.0	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	6.91		3.0
	Summer (Spring) wheat ^(c)	2 × 125	51–89	1.2	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	1.08		19.4
		2 × 125	51–89	1.2	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	8.64		2.4
		1 × 125	51–89	1.0	Small omnivorous bird ‘lark’ (BBCH ≥ 40)	7.2	0.90		23.2
		1 × 125	51–89	1.0	Small insectivorous bird ‘passerine’ (BBCH 71–89)	57.6	7.20		2.9
	Sugar beet	1 × 150	12–49	1.0	Small insectivorous bird ‘wagtail’ (BBCH 10–19)	10.9	1.64		12.8
					Small insectivorous bird ‘wagtail’ (BBCH 20–49)	7.7	1.16		18.1
					Small insectivorous bird ‘wagtail’ (BBCH 20–49)	25.2	3.78		5.5
					Small omnivorous bird ‘lark’ (BBCH 10–19)	24.0	3.60		5.8
					Small granivorous bird ‘finch’ (BBCH 30–49)	24.7	3.71		5.6
	Ornamentals (pot plants) ^(d)	1 × 300	12–92	1	Small insectivorous bird ‘tit’	46.8	14.04		1.5
		1 × 300		1	Small insectivorous/worm feeding species ‘thrush’	7.4	2.22		9.4
		2 × 300		1.6	Small insectivorous bird ‘tit’	46.8	22.46		0.9
		2 × 300		1.6	Small insectivorous/worm feeding species ‘thrush’	7.4	3.55		5.9
		3 × 300		2.0	Small insectivorous bird ‘tit’	46.8	28.08		0.7
		3 × 300		2.0	Small insectivorous/worm feeding species ‘thrush’	7.4	4.44		4.7

	Crop (Regulatory zone)	Application rate (g a.s./ha)	BBCH	Risk ^(a)
Existing approval in European Commission (2006)	Wheat (SEU)	2 × 210	65–85	High
	Wheat (SEU)	1 × 210	65–85	High
	Wheat (NEU)	2 × 150	65–85	High
	Wheat (NEU)	1 × 150	65–85	High
Renewal of approval	Winter wheat (All zones)	1 × 120	51–89	High
	Summer (Spring) wheat (All zones)	2 × 125	51–89	High
	Summer (Spring) wheat (All zones)	1 × 125	51–89	High
	Sugar beet (SEU)	1 × 150 ^(b)	12–49	High
	Ornamentals (pot plants) (All zones)	1 × 300	12–92	High
		2 × 300		High
		3 × 300		High

Representative use ^(a)		Existing approval in European Commission (2006)				Renewal of approval
		Wheat (SEU) 2 × 210	Wheat (SEU) 1 × 210	Wheat (NEU) 2 × 150	Wheat (NEU) 1 × 150	Winter wheat 1 × 120	Summer (Spring) wheat 1 × 125	Summer (Spring) wheat 2 × 125	Sugar beet 1 × 150	Ornamentals (pot plants) 1–3 × 300	Ornamentals (pot plants) 1 × 300	Ornamentals (pot plants) 2 × 300	Ornamentals (pot plants) 3 × 300
		Field use	Field use	Field use	Field use	Field use	Field use	Field use	Field use	Green house (non‐permanent structures)	Greenhouse use (permanent structures)	Greenhouse use (permanent structures)	Greenhouse use (permanent structures)
Operator risk	Risk identified									X ^(b)	X ^(b)	X ^(b)	X ^(b)
Operator risk	Assessment not finalised
Worker risk	Risk identified
Worker risk	Assessment not finalised
Resident/bystander risk	Risk identified									X ^(b)	X ^(b)	X ^(b)	X ^(b)
Resident/bystander risk	Assessment not finalised
Consumer risk	Risk identified
Consumer risk	Assessment not finalised	X	X	X	X	X	X	X	X	X ^(c)	X ^(c)	X ^(c)	X ^(c)
Acute risk to birds	Risk identified	X	X	X	X	X	X	X	X	X
Acute risk to birds	Assessment not finalised

Crop and/or situation ^(a)	Member State or Country	Product name	F G or I ^(b)	Pests or Group of pests controlled ^(c)	Preparation		Application				Application rate per treatment			PHI (days) ^(m)	Remarks
Crop and/or situation ^(a)	Member State or Country	Product name	F G or I ^(b)	Pests or Group of pests controlled ^(c)	Type ^(d–f)	Conc. a.s. ⁽ⁱ⁾	Method kind ^(f) , ^(g) , ^(h)	range of growth stages & season ^(j)	number min–max ^(k)	Interval between application (min)	kg a.s/hL min–max ^(l)	Water L/ha min–max	kg a.s./ha min–max ^(l)	PHI (days) ^(m)	Remarks
Winter Wheat	EU	Pirimor	F	Aphids	WG	500	Foliar spray	BBCH 51–89	1	N/A	0.03–0.08	150–400	0.12	28
Summer (spring) wheat	EU	Pirimor	F	Aphids	WG	500	Foliar spray	BBCH 51–89	1–2	N/A	0.031–0.083	150–400	0.125	28
Sugar beet	EU	Pirimor	F	Aphids	WG	500	Foliar spray	BBCH 12–49	1	N/A	0.0375–0.1	150–400	0.15	21
Ornamentals (pot plants)	EU	Pirimor	G^*	Aphids	WG	500	Foliar spray	BBCH 12–92	1–3	7–14	0.025–0.15	200–1,200	0.3	N/A

Model data	Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL
Low ornamentals/Indoor/Downward spraying/Manual‐hand held/75th percentileCrop density: Normal
Pirimicarb	Number of applications and application rate: 3 × 0.3 kg a.s./ha; Dermal absorption (concentrate): 1%; Dermal absorption (in‐use dilution): 22%
Pirimicarb	M/L: Workwear App: Workwear	0.007	94.2

Model data	Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL
High ornamentals/Indoor/Upward spraying/Manual‐hand held/75th percentile Crop density: Normal
Pirimicarb	Number of applications and application rate: 3 × 0.3 kg a.s./ha; Dermal absorption (concentrate): 1%; Dermal absorption (in‐use dilution): 22%
Pirimicarb	M/L: Workwear + Protected hands + FP2, P2 and similar App: Workwear + Protected hands + FP2, P2 and similar	0.02	No safe use!

Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL	Re‐entry restriction [days]
Cutting, sorting, bundling, carrying/harvesting, including cutting and bundling/indoor; Work rate: 8 h/day; interval: 7 days; body weight: 60 kg; TC (potential): 14000 cm²/h; TC (workwear (arms, body and legs covered)): 5000 cm²/h; TC (workwear (arms, body and legs covered) and gloves): 1400 cm²/h; TC (gloves): NA cm²/h; TSF: 0.1 mg a.s./h/kg a.s./ha
Pirimicarb (refined DFR & DT ₅₀ foliar)	Number of applications & application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22%; DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀ foliar: 4.65 days; DT₅₀ air: 30 days; DT₅₀ soil: 30 days
Potential	0.3	4,592	26
Workwear	0.1	1,678	20
Workwear and gloves	0.04	513	12
Hands covered, no workwear

Model data	Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL
Season: Not relevant; Buffer zone: 2–3 m Interval between treatments: 7 days Minimum volume of water: 200 l
Pirimicarb (refined DFR & DT ₅₀ )	Number of applications and application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22%; DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀: 4.65 days
Resident child Body weight: 10 kg	Drift (75th perc.)	0.004	64
	Vapour (75th perc.)	0.0008	11.4
	Deposits (75th perc.)	0.0009	12.7
	Re‐entry (75th perc.)
	Sum (mean)	0.004	55.7
Resident adult Body weight: 60 kg	Drift (75th perc.)	0.001	15.2
	Vapour (75th perc.)	0.0003	3.9
	Deposits (75th perc.)	0.0003	4.8
	Re‐entry (75th perc.)
	Sum (mean)	0.001	14.4

Model data	Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL
Season: Not relevant; buffer zone: 5 m; interval between treatments: 7 days; minimum volume of water: 200 l
Pirimicarb (refined DFR & DT ₅₀ )	Number of applications and application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22%; DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀: 4.65 days
Resident child Body weight: 10 kg	Drift (75th perc.)	0.003	42.7
	Vapour (75th perc.)	0.0008	11.4
	Deposits (75th perc.)	0.0004	5.2
	Re‐entry (75th perc.)
	Sum (mean)	0.003	38.8
Resident adult body weight: 60 kg	Drift (75th perc.)	0.0005	7.8
	Vapour (75th perc.)	0.0003	3.9
	Deposits (75th perc.)	0.0001	2
	Re‐entry (75th perc.)
	Sum (mean)	0.0006	9.3

Model data	Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL
Season: Not relevant; buffer zone: 5 m; interval between treatments: 7 days; minimum volume of water: 200 l
Pirimicarb (refined DFR & DT ₅₀ )	Number of applications and application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22%; DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀: 4.65 days
Resident child Body weight: 10 kg	Drift (75th perc.)	0.02	328
	Vapour (75th perc.)	0.0008	11.4
	Deposits (75th perc.)	0.0005	7
	Re‐entry (75th perc.)
	Sum (mean)	0.02	232
Resident adult Body weight: 60 kg	Drift (75th perc.)	0.01	182
	Vapour (75th perc.)	0.0003	3.9
	Deposits (75th perc.)	0.0002	2.6
	Re‐entry (75th perc.)
	Sum (mean)	0.009	125

Model data	Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL
Season: Not relevant; buffer zone: 10 m; interval between treatments: 7 days; minimum volume of water: 200 l
Pirimicarb (refined DFR & DT ₅₀ )	Number of applications and application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22%; DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀: 4.65 days
Resident child Body weight: 10 kg	Drift (75th perc.)	0.02	328
	Vapour (75th perc.)	0.0008	11.4
	Deposits (75th perc.)	0.0002	2.3
	Re‐entry (75th perc.)
	Sum (mean)	0.02	229
Resident adult Body weight: 60 kg	Drift (75th perc.)	0.01	182
	Vapour (75th perc.)	0.0003	3.9
	Deposits (75th perc.)	6 e‐05	0.9
	Re‐entry (75th perc.)
	Sum (mean)	0.009	123

Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL	Re‐entry restriction [days]
Inspection, irrigation/general maintenance/indoor; work rate: 8 h/day; interval: 7 days; body weight: 60 kg; TC (potential): 12500 cm²/h; TC (workwear (arms, body and legs covered)): 1400 cm²/h; TC (workwear (arms, body and legs covered) and gloves): 1250 cm²/h; TC (gloves): NA cm²/h; TSF: 0.01 mg a.s./h/kg a.s./ha
Pirimicarb (refined DFR & DT ₅₀ foliar)	Number of applications & application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22% DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀ foliar: 4.65 days DT₅₀ air: 30 days; DT₅₀ soil: 30 days
Potential	0.3	4,055	25
Workwear	0.03	461	11
Workwear and gloves	0.03	413	10
Hands covered, no workwear

Level of PPE	Total absorbed dose [mg/kg bw per day]	% of systemic AOEL	Re‐entry restriction [days]
Inspection, irrigation/inspection, watering/indoor; work rate: 2 h/day; interval: 7 days; body weight: 60 kg; TC (potential): 12500 cm²/h; TC (workwear (arms, body and legs covered)): 1400 cm²/h; TC (workwear (arms, body and legs covered) and gloves): 1250 cm²/h; TC (gloves): NA cm²/h; TSF: 0.01 mg a.s./h/kg a.s./ha
Pirimicarb (refined DFR & DT ₅₀ foliar)	Number of applications & application rate: 3 × 0.3 kg a.s./ha; dermal absorption: 22%; DFR: 1.74 μg/cm² foliage per kg a.s./ha; DT₅₀ foliar: 4.65 days; DT₅₀ air: 30 days; DT₅₀ soil: 30 days
Potential	0.07	1,014	16
Workwear	0.008	115	1
Workwear and gloves	0.007	103	1
Hands covered, no workwear

Code/trivial name ^(a)	IUPAC name/SMILES notation/InChiKey ^(b)	Structural formula ^(c)
Pirimicarb	2‐(dimethylamino)‐5,6‐dimethylpyrimidin‐4‐yl dimethylcarbamate Cc1nc(nc(OC(=O)N(C)C)c1C)N(C)C YFGYUFNIOHWBOB‐UHFFFAOYSA‐N
R34885	5,6‐dimethyl‐2‐(N‐methylformamido)pyrimidin‐4‐yl dimethylcarbamate Cc1nc(nc(OC(=O)N(C)C)c1C)N(C)C=O GDEAMEURJBBCOQ‐UHFFFAOYSA‐N
R31680	2‐amino‐5,6‐dimethylpyrimidin‐4‐ol Cc1c(O)nc(N)nc1C APWRLAZEMYLHKZ‐UHFFFAOYSA‐N
R31805	2‐(dimethylamino)‐5,6‐dimethylpyrimidin‐4‐ol Cc1nc(nc(O)c1C)N(C)C MUEHLDAHWSCFAG‐UHFFFAOYSA‐N
R34865	5,6‐dimethyl‐2‐(methylamino)pyrimidin‐4‐ol Cc1nc(NC)nc(O)c1C IFOLNWVBRSCJOJ‐UHFFFAOYSA‐N
R16210	N,N‐dimethylguanidine N=C(N)N(C)C SWSQBOPZIKWTGO‐UHFFFAOYSA‐N
R406405	5‐(hydroxymethyl)‐6‐methyl‐2‐(methylamino)pyrimidin‐4‐ol Cc1nc(NC)nc(O)c1CO NTGVGPFDHAOUOY‐UHFFFAOYSA‐N
R34836	5,6‐dimethyl‐2‐(methylamino)pyrimidin‐4‐yl dimethylcarbamate Cc1nc(NC)nc(OC(=O)N(C)C)c1C GTKRZJVAXAQBMB‐UHFFFAOYSA‐N
R238177	2‐(dimethylamino)‐6‐(hydroxymethyl)‐5‐methylpyrimidin‐4‐yl dimethylcarbamate CN(C)c1nc(CO)c(C)c(OC(=O)N(C)C)n1 YLZGFEXCEZDUAQ‐UHFFFAOYSA‐N

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Statement concerning the review of the approval of the active substance pirimicarb

Abstract

Summary

1. Introduction

1.1. Terms of Reference as provided by the requestor

2. Assessment

2.1. Toxicological reference values of pirimicarb and assessment of metabolites

2.2. Risks to consumers from the exposure to metabolites of pirimicarb through dietary intake

2.3. Risks to human health through non‐dietary exposure

2.3.1. Operator exposure

Table 1.

2.3.2. Worker exposure

Table 2.

2.3.3. Bystander and resident exposure

Table 3.

2.4. Acute risk to birds

Table 4.

Table 5.

Table 6.

3. Conclusions

Table 7.

Abbreviations

Appendix A – List of representative uses considered in the assessment as requested in the mandate

Appendix B – Non‐dietary exposure estimates, detailed calculations

B.1 OPERATOR

B.1.1 Existing approval – Use on wheat (Southern Europe)

B.1.2 Existing approval – Use on wheat (Northern Europe)

B.1.3 Renewal – Use on winter wheat

B.1.4 Renewal – Use on summer wheat

B.1.5 Renewal – Use on sugar beet

B.1.6 Renewal – Use on ornamentals (greenhouse)

B.2 WORKER

B.2.1 Existing approval – Use on wheat (Southern Europe)

B.2.2 Existing approval – Use on wheat (Northern Europe)

B.2.3 Renewal – Use on winter wheat

B.2.4 Renewal – Use on summer wheat

B.2.5 Renewal – Use on sugar beet

B.2.6 Renewal – Use on ornamentals (greenhouse)

B.3 RESIDENT

B.3.1 Existing approval – Use on wheat (Southern Europe)

B.3.2 Existing approval – Use on wheat (Northern Europe)

B.3.3 Renewal – Use on winter wheat

B.3.4 Renewal – Use on summer wheat

B.3.5 Renewal – Use on sugar beet

B.3.6 Renewal – Use on ornamentals (greenhouse)

B.4 BYSTANDER

B.4.1 Existing approval – Use on wheat (Southern Europe)

B.4.2 Existing approval – Use on wheat (Northern Europe)

B.4.3 Renewal – Use on winter wheat

B.4.4 Renewal – Use on summer wheat

B.4.5 Renewal – Use on sugar beet

B.4.6 Renewal – Use on ornamentals (greenhouse)

Appendix C – Higher tier acute risk assessment to birds for the representative field uses of pirimicarb under evaluation following EFSA (2009) and using updated residue unit dose and deposition values

Appendix D – PRIMo 3.1

D.1 PRIMo calculation for the representative uses assessed under the renewal process

D.2 PRIMo calculation for the representative uses assessed under the first approval

Appendix E – Used compound codes

Notes

References

ACTIONS

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