REASONED OPINION

APPROVED: 6 November 2015 PUBLISHED: 26 November 2015

doi:10.2903/j.efsa.2015.4311

Modification of the existing maximum residue level

(MRL) for bromoxynil in chives
European Food Safety Authority (EFSA)
Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS)
Belgium compiled an application to modify the existing maximum residue level (MRL) for the active
substance bromoxynil in chives. The EMS drafted an evaluation report in accordance with Article 8 of
Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to
EFSA. The intended northern Europe (NEU) use on chives is adequately supported by residue data
and a MRL proposal of 0.08 mg/kg can be derived by extrapolation from trials conducted on spring
onions. Based on the risk assessment results, EFSA concludes that the proposed use of bromoxynil on
chives will not result in a consumer exposure exceeding the toxicological reference values and
therefore is unlikely to pose a consumer health risk.
© European Food Safety Authority, 2015

Keywords: bromoxynil, chives, MRL application, consumer risk assessment

Requestor: European Commission

Question number: EFSA-Q-2015-00491
Correspondence: [email protected]

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Modification of existing MRL for bromoxynil in chives

Suggested citation: EFSA (European Food Safety Authority), 2015. Reasoned opinion on the
modification of the existing maximum residue level (MRL) for bromoxynil in chives. EFSA Journal
2015;13(11):4311, 18 pp. doi:10.2903/j.efsa.2015.4311
ISSN: 1831-4732
© European Food Safety Authority, 2015
Reproduction is authorised provided the source is acknowledged.

The EFSA Journal is a publication of the European Food

Safety Authority, an agency of the European Union.

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Modification of existing MRL for bromoxynil in chives

Summary
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS)
Belgium compiled an application to modify the existing maximum residue level (MRL) for the active
substance bromoxynil in chives. Belgium drafted an evaluation report in accordance with Article 8 of
Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to
the European Food Safety Authority (EFSA) on 2 September 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment
report (DAR) prepared under Council Directive 91/414/EEC, the Commission review report on
bromoxynil and the conclusions from EFSA reasoned opinion on the review of the existing maximum
residue levels for bromoxynil.
The toxicological profile of bromoxynil was assessed in the framework of the peer review under
Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of
0.01 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.04 mg/kg bw.
The metabolism of bromoxynil in primary crops was investigated following foliar application on
cereal/grass (wheat, maize, alfalfa) and the pulses/oilseeds crop groups (cotton). The peer review
considered alfalfa to cover a third crop group and proposed the residue definition for the risk
assessment and enforcement in all plant commodities as ‘bromoxynil’. The Article 12 MRL review
agreed with this proposal and the residue definition in Regulation (EC) No 396/2005 was set as
‘bromoxynil and its salts, expressed as bromoxynil’. There are adequate analytical methods available
to control bromoxynil residues in chives according to the existing enforcement residue definition.
EFSA concludes that the submitted supervised residue trials on spring onions are sufficient to derive a
MRL proposal of 0.08 mg/kg, extrapolated to chives.
Specific studies investigating the nature and magnitude of bromoxynil residues under processing are
not required due to low residues in raw commodity. Bromoxynil degrades rapidly in the soil and
therefore bromoxynil residues are not expected to occur at relevant levels in rotational crops.
Bromoxynil residues in livestock were not assessed as chives are not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake
Model (PRIMo). EFSA updated the consumer risks assessment conducted in the framework of the
Article 12 MRL review, taking into account the median (STMR) and highest (HR) residue levels derived
for chives from the residue trials conducted on spring onions. The highest calculated chronic intake
accounted for 7% of the ADI (WHO Cluster B). The contribution of residues in chives to the total
consumer exposure was below 0.1% of the ADI. An acute consumer risk was not identified in relation
to the MRL proposal for chives (0.02% of the ARfD).
EFSA concludes that the intended use of bromoxynil on chives will not result in a consumer exposure
exceeding the toxicological reference values and therefore is unlikely to pose a health risk to
consumers.
EFSA proposes to amend the existing MRL as reported in the summary table below.

Code(a) Commodity Existing Proposed Comment/Justification

EU MRL EU MRL
(mg/kg) (mg/kg)

Enforcement residue definition: Bromoxynil and its salts, expressed as bromoxynil

0256020 Chives 0.02* 0.08 NEU (outdoor). Extrapolation from residue
trails on spring onions
(a): Commodity code number according to Annex I of Regulation (EC) No 396/2005
(*): indicates that the MRL is set at the limit of analytical quantification (LOQ)

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Modification of existing MRL for bromoxynil in chives

Table of contents

Abstract .........................................................................................................................................1
Summary .......................................................................................................................................3
Background....................................................................................................................................5
The active substance and its use pattern .........................................................................................5
Assessment ....................................................................................................................................6
1. Method of analysis ..............................................................................................................6
1.1. Methods for enforcement of residues in food of plant origin ...................................................6
1.2. Methods for enforcement of residues in food of animal origin ................................................7
2. Mammalian toxicology .........................................................................................................7
3. Residues.............................................................................................................................7
3.1. Nature and magnitude of residues in plant ...........................................................................7
3.1.1. Primary crops .....................................................................................................................7
3.1.2. Rotational crops ................................................................................................................ 10
3.2. Nature and magnitude of residues in livestock .................................................................... 10
4. Consumer risk assessment ................................................................................................. 10
Conclusions and recommendations ................................................................................................ 11
References ................................................................................................................................... 12
Abbreviations ............................................................................................................................... 13
Appendix A – Good Agricultural Practice (GAPs) .......................................................................... 15
Appendix B – Pesticide Residue Intake Model (PRIMo) ................................................................ 16
Appendix C – Used compound code(s) ....................................................................................... 18

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Modification of existing MRL for bromoxynil in chives

Background
Regulation (EC) No 396/20051 establishes the rules governing the setting of pesticide maximum
residue levels (MRLs) at European Union (EU) level. Article 6 of the Regulation lays down that any
party having a legitimate interest or requesting an authorisation for the use of a plant protection
product in accordance with Council Directive 91/414/EEC,2 repealed by Regulation (EC) No
1107/2009,3 shall submit to a Member State, when appropriate, an application to modify a MRL in
accordance with the provisions of Article 7 of the Regulation.
Belgium,4 hereafter referred to as the evaluating Member State (EMS), compiled an application to
modify the existing MRL for the bromoxynil in chives. This application was notified to the European
Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated in
accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to
the European Commission and to EFSA on 2 September 2015. The application was included in the
EFSA Register of Questions with the reference number EFSA-Q-2015-00491 and the following subject:
Bromoxynil: Application to modify MRL in chives
Belgium proposed to raise the existing MRL of bromoxynil in chives from the limit of quantification of
0.02 mg/kg to 0.05 or 0.08 or 0.10 mg/kg. EFSA proceeded with the assessment of the application
and the evaluation report as required by Article 10 of the Regulation.
In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation
report submitted by the EMS, provide a reasoned opinion on the risks to the consumer associated with
the application.
In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as
possible and at the latest within three months (which may be extended to six months if more detailed
evaluations need to be carried out) from the date of receipt of the application. If EFSA requests
supplementary information, the time limit laid down shall be suspended until that information has
been provided.

The active substance and its use pattern

Bromoxynil is the ISO common name for 3,5-dibromo-4-hydroxybenzonitrile (IUPAC). Although the
active substance is defined as the phenol compound, it may be used in formulated products under
different salt or ester forms (i.e. bromoxynil heptanoate, bromoxynil octanoate or bromoxynil-
potassium). The chemical structure of the active substance and related compounds is reported in
Appendix C.
Bromoxynil phenol (here after bromoxynil) was evaluated in the framework of Directive 91/414/EEC
with France designated as the rapporteur Member State (RMS). It was included in Annex I of this
Directive by Directive 2004/58/EC5 which entered into force on 1 March 2015 for use as herbicide
only. In accordance with Commission Regulation (EU) No 540/2011 6 bromoxynil is approved under
Regulation (EC) No 1107/2009, repealing Council Directive 91/414/EEC.
The representative uses supported for the peer review process involved a single early growth-stage
foliar spray application on winter and spring cereals and maize. The draft assessment report (DAR)
was not peer reviewed by EFSA and therefore no EFSA conclusion is available. However, the review of

1
Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of
pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.03.2005,
p. 1–16.
2
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230,
19.08.1991, p. 1–32.
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. OJ L 309, 24.11.2009,
p. 1–50.
4
Belgium, FPS Health, Food chain safety and Environment DG4, Place Victor Horta 40, Box 10, 1060, Brussels, Belgium
5
Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to include alpha-cypermethrin,
benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as active substance. OJ L 120, 24.4.2004, p.26-29.
6
Commission Implementing Regulation (EU) No 540/2011 of 23 May 2011 implementing Regulation (EC) No 1107/2009 of the
European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.06.2011, p. 1–186.

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Modification of existing MRL for bromoxynil in chives

existing MRLs of bromoxynil according to Article 12 of Regulation (EC) No 396/2005 (here after Article
12 MRL review) has been finalized and an EFSA opinion has been issued (EFSA, 2012).
The EU MRLs for bromoxynil are established in Annex II of Regulation (EC) No 396/2005. The MRL
changes that were reported in the EU legislation since the entry into force of the regulation are
summarised in Table 1.
Table 1: Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005

Procedure(a) Considered by Regulation Remarks

Art. 12 (EFSA, 2012) Regulation 1146/2014 Review of the existing MRLs

(a): Art. 12: Review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005

Codex maximum residue limit (Codex MRL, CXLs) are not established for bromoxynil. The details of
the intended GAP for bromoxynil in Belgium on chives are given in Appendix A.

Assessment
EFSA bases its assessment on the evaluation report submitted by the EMS (Belgium, 2015), the DAR
(and its addendum) prepared under Directive 91/414/EEC (France, 2000, 2001), the Commission
review report on bromoxynil (European Commission, 2004) and the conclusions from EFSA reasoned
opinion on the review of the MRLs for bromoxynil (EFSA, 2012). The assessment is performed in
accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation
of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 7 and the currently
applicable guidance documents relevant for the consumer risk assessment of pesticide residues
(European Commission, 1996, 1997a–g, 2000, 2010a, b, 2011; OECD, 2011).

1. Method of analysis

1.1. Methods for enforcement of residues in food of plant origin

Analytical methods for the determination of bromoxynil residues in plant commodities were assessed
during the peer review under Directive 91/414/EEC (France, 2000) and in the Article 12 MRL review
(EFSA, 2012). The current enforcement residue definition in Regulation (EC) No 396/2005 is
established as ‘bromoxynil and its salts, expressed as bromoxynil’.
During the peer review various analytical methods using GC-ECD were evaluated for the determination
of bromoxynil methyl ester (bromoxynil octanoate), bromoxynil and certain metabolites with an LOQ
of 0.02 to 0.1 mg/kg in dry/starch content commodities (cereal grain) and certain forage crops (straw
and silage) (France, 2000). These methods include a hydrolysis step converting all esters to
bromoxynil prior to analysis.

In the framework of the Article 12 MRL review a method using LC-MS/MS quantification (and ILV) was
submitted and evaluated for the determination of bromoxynil esters (bromoxynil octanoate) and
bromoxynil with an LOQ of 0.01 mg/kg in high water (tomatoes), dry/starch (wheat grain), high acid
(citrus) and high oil (oilseed rape) content commodities (EFSA, 2012). This method includes a
hydrolysis step converting all esters to bromoxynil prior to analysis. The esters of bromoxynil,
however, are rapidly hydrolysed in plants (EFSA, 2012).
The multi-residue QuEChERS method in combination with HPLC-MS/MS was also concluded to be
sufficiently validated to analyse bromoxynil with an LOQ of 0.002 to 0.01 mg/kg in high water, high
acid content and in dry commodities (EFSA, 2012). However, this method does not include a
hydrolysis step and is therefore not expected to include esters of bromoxynil.
It is concluded that there are adequate analytical methods available to control bromoxynil residues in
chives (high water content commodity) according to the existing enforcement residue definition.

7
Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L
155, 11.06.2011, p. 127–175.

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Modification of existing MRL for bromoxynil in chives

1.2. Methods for enforcement of residues in food of animal origin

Analytical methods for the determination of bromoxynil residues in food of animal origin are not
assessed in the current application, since chives are normally not fed to livestock.

2. Mammalian toxicology
The toxicological profile of the active substance bromoxynil was assessed in the framework of the
peer review under Directive 91/414/EEC and toxicological reference values were established by the
European Commission (Table 2).
Table 2: Overview of the toxicological reference values

Source Year Value Study Safety factor

Bromoxynil octanoate and heptanoate
ADI EC 2004 0.01 mg/kg bw per day 18 month mouse study 100
ARfD EC 2004 0.04 mg/kg bw Teratogenicity study 100

3. Residues

3.1. Nature and magnitude of residues in plant

3.1.1. Primary crops

3.1.1.1. Nature of residues

In the framework of the peer review under Directive 91/414/EEC, the metabolism of bromoxynil in
primary crops was investigated in the cereal/grass (wheat, maize, alfalfa) and pulses/oilseeds crop
groups (cotton), using foliar application of 14C-bromoxynil octanoate labelled on the phenyl ring or in
the cyano group (France, 2000). An overview of the available metabolism studies is presented in
Table 3.
Table 3: Summary of available metabolism studies in plants

Crop Crops Application Sampling(a) Comments

group (day, DAT)
Cereal Wheat Foliar (brush; 1 × 1100 g/ha) 0, 3, 7, 14, 28 DAT Foliar deposit
/Grass Foliar (syringe or brush; 1× 1100-1650 7, 14, 21, 28 DAT by brush or
g/ha) microsyringe
Foliar (syringe or brush; 1× 1650-2200 82, 125 DAT
g/ha)
Foliar (syringe or brush; 1× 1100 g/ha) 14 DAT
Alfalfa Foliar (syringe; 1× rate not stated) 0, 2, 5, 12, 21 DAT
Foliar (1× 1260 g/ha) 0, 30 DAT Foliar spraying
Maize Foliar (1× 330 g/ha) 9, 66 DAT application
Pulses Cotton Foliar (1× 830 g/ha) 87 DAT
/Oilseeds Cotton (GM) Foliar (1× 4200 g/ha) 87 DAT
(a): DAT, days after treatment.

The detailed results of the metabolism studies are reported in the previously issued EFSA reasoned
opinion on the Article 12 MRL review (EFSA, 2012). Total radioactive residues (TRRs) in edible plant
parts were consistently very low with bromoxynil identified as the main component of residues in
conventional crops. Occasionally, small amounts of bromoxynil ester were also detected. Other
metabolites were found in very small percentages of the total extractable residues. In genetically
modified cotton, the main component of residues was identified as 3,5-dibromo-4-hydroxybenzoic acid
(approximately 50% of TRR).

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Modification of existing MRL for bromoxynil in chives

During the peer review alfalfa was considered sufficient to cover a third crop group and the residue
definition for the risk assessment and enforcement in all plant commodities was proposed as
‘bromoxynil’. The Article 12 MRL review agreed with the proposals of the peer review. Consequently,
the residue definition which formerly included esters, was modified by Commission Regulation
1146/20148 to ‘bromoxynil and its salts, expressed as bromoxynil’.
For the uses on chives EFSA concludes that the metabolism of bromoxynil is sufficiently addressed and
the residue definitions for enforcement and risk assessment agreed during the peer review are
applicable.

3.1.1.2. Magnitude of residues

In support of the MRL application, the EMS submitted four residue trials on spring onions which were
already evaluated in the framework of the Article 12 MRL review. An extrapolation of residue data
from spring opinions to chives was proposed by the EMS (Belgium, 2015).
The four residue trials on spring onion were performed in Germany in 2004. In two trials bromoxynil
was applied twice, but as residues at harvest were below the LOQ, these trials were accepted. The
data are sufficient to derive a MRL proposal of 0.08 mg/kg on spring onions, extrapolated to chives.
The results of the residue trials, the related risk assessment input values (highest residue, median
residue) and the MRL proposal is summarised in Table 4.
The stability of bromoxynil residues in plant matrices under storage conditions prior to analysis was
assessed during the peer review under Directive 91/414/EEC (France, 2000). The storage stability of
bromoxynil was demonstrated for a period of 12 months at -23 °C in high water (garlic, onion, sweet
corn, grass), high oil (cotton, alfalfa, flax seeds) and dry/starch content commodities (barley, wheat,
sorghum, maize) (France, 2000). As the trial samples were stored for a maximum period of 10 months
under conditions for which integrity of the samples was demonstrated, it is concluded that the residue
data are valid with regard to storage stability.
According to the EMS, the analytical method used to analyse the residue trial samples has been
sufficiently validated and was proven to be fit for the purpose (Belgium, 2015).
EFSA concludes that the data are sufficient to derive the following MRL proposal:
– 0.08 mg/kg chives in NEU (extrapolation from trials on spring onions)

8
Commission Regulation (EU) No 1146/2014 of 23 October 2014 amending Annexes II, III, IV and V to Regulation (EC) No
396/2005 of the European Parliament and of the Council as regards maximum residue levels for anthraquinone, benfluralin,
bentazone, bromoxynil, chlorothalonil, famoxadone, imazamox, methyl bromide, propanil and sulphuric acid in or on certain
products. OJ L 308, 29.10.2014, p.3-60.

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Modification of existing MRL for bromoxynil in chives

Table 4: Overview of the available residues trials data

Crop Region/ Residue levels observed in Recommendations/comments(c) MRL HR(d) STMR(e)
(GAPs) Indoor(a) the supervised residue proposal (mg/kg) (mg/kg)
trials(b) (mg/kg) (mg/kg)
Spring onion NEU 2× <0.01; <0.01; 0.04 Underlined values: Trials overdosed (conducted with two 0.08 0.04 0.01
(1× 250 g/ha, applications at 225 to 240 g/ha) but accepted for MRL calculation
PHI 28 d) since resulted with residues at harvest below the LOQ.
MRLOECD: 0.078/0.08

Extrapolation to chives
(a): NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non-EU trials.
(b): Individual residue levels considered for MRL calculation are reported in ascending order
(c): Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values)
(d): HR: Highest residue level according to the residue definition for risk assessment.
(e): STMR: Median residue level according to residue definition for risk assessment.

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3.1.1.3. Effect of industrial processing and/or household preparation

As residues of bromoxynil are not expected to exceed 0.1 mg/kg in chives, there is currently no need
to investigate the effect of industrial and/or household processing on the nature and magnitude of
bromoxynil residues (EC, 1997d).

3.1.2. Rotational crops

Chives can be grown in rotation with other plants and therefore the possible occurrence of residues in
succeeding crops resulting from the use on primary crops has to be assessed. The soil degradation
studies demonstrated that the degradation rate of bromoxynil would be below the trigger value of
100 days (France, 2000; EFSA, 2012). Thus, further studies on rotational crops are not required (EC,
1997) and significant residues are not expected to occur in rotational crops following the use of
bromoxynil on chives according to the intended GAP.

3.2. Nature and magnitude of residues in livestock

As chives and their by-products are not normally fed to livestock, the nature and magnitude of
bromoxynil residues in livestock was not assessed in the framework of this application (EC, 1996).

4. Consumer risk assessment

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake
Model (PRIMo). This exposure assessment model contains the relevant European food consumption
data for different sub-groups of the EU population9 (EFSA, 2007).
For the chronic consumer exposure assessment, EFSA updated the evaluation conducted in the
framework of the Article 12 review (EFSA, 2012) with the median residue level (STMR) derived for
chives from the residue trials conducted on spring onions (see Table 4). Therefore this assessment
considers only the crop commodities for which GAPs were reported in the framework of the Article 12
MRL review.
The acute exposure assessment was performed only with regard to chives, assuming the consumption
of a large portion of the food item as reported in the national food surveys and that it contained
residues at the highest residue level (HR) as observed in supervised field trials (see Table 4). A
variability factor accounting for the inhomogeneous distribution on the individual items consumed was
included in the calculation, when required (EFSA, 2007).
The input values used for the dietary exposure calculation are summarised in Table 5.
Table 5: Input values for the consumer dietary exposure assessment

Commodity Chronic exposure assessment Acute exposure assessment

Input Comment Input Comment
(mg/kg) (mg/kg)
Risk assessment residue definition: Bromoxynil and its salts, expressed as bromoxynil
Chives 0.01 STMR spring onions (Table 4) 0.04 HR spring onions (Table 4)
Other plant and See Table 4-1 in Reasoned opinion on Acute risk assessment undertaken only
animal commodities Article 12 MRL review (EFSA, 2012) with regard to chives

The estimated exposure was then compared with the toxicological reference values derived for
bromoxynil (see Table 2). The results of the intake calculation are presented in Appendix B of this
reasoned opinion.
The total calculated chronic intake accounted for up to 7% of the ADI (WHO, Cluster B). The
contribution of residues in chives to the total consumer exposure was below 0.1% of the ADI.

9
The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22
national diets collected from MS surveys plus 1 regional and 4 cluster diets from the WHO GEMS Food database; for the acute
exposure assessment the most critical large portion consumption data from 19 national diets collected from MS surveys is
used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007).

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Modification of existing MRL for bromoxynil in chives

An acute consumer risk was not identified in relation to the MRL proposal for chives (0.02% of the
ARfD).
EFSA concludes that the intended use of bromoxynil on chives will not result in a consumer exposure
exceeding the toxicological reference values and therefore is unlikely to pose a consumers health risk.

Conclusions and recommendations

The information submitted was sufficient to propose the MRL as summarised in the table below:

Code(a) Commodity Existing Proposed Comment/Justification

EU MRL EU MRL
(mg/kg) (mg/kg)

Enforcement residue definition: Bromoxynil and its salts, expressed as bromoxynil

0256020 Chives 0.02* 0.08 NEU (outdoor). Extrapolation from trials on spring
onions
(a): Commodity code number according to Annex I of Regulation (EC) No 396/2005
(*): indicates that the MRL is set at the limit of analytical quantification (LOQ)

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References
Belgium, 2015. Evaluation report on the modification of MRLs for bromoxynil in chives prepared by the
evaluating Member State Belgium under Article 8 of Regulation (EC) No 396/2005, 6 July 2015, pp.
12.
European Commission, 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4.
European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3.
European Commission, 1997b. Appendix B. General recommendations for the design, preparation and
realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of
Council Directive 90/642/EEC. 7029/VI/95-rev.6.
European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops.
7524/VI/95-rev.2.
European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5.
European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals.
7030/VI/95-rev.3.
European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5.
European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals.
7039/VI/95.
European Commission, 2000. Residue analytical methods. For pre-registration data requirement for
Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SANCO/3029/99-
rev.4.
European Commission, 2004. Review report for the active substance bromoxynil. Finalised in the
Standing Committee on the Food Chain and Animal Health at its meeting on 13 February 2004 in
view of the inclusion of bromoxynil in Annex I of Council Directive 91/414/EEC. SANCO/4347/2000-
Final, 13 February 2004, 104 pp.
European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue
Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain
and Animal Health at its meeting of 23–24 March 2010.
European Commission, 2010b. Residue analytical methods. For post-registration control.
SANCO/825/00-rev.8.1.
European Commission, 2011. Appendix D. Guidelines on comparability, extrapolation, group
tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9.
EFSA (European Food Safety Authority), 2007. Reasoned opinion on the potential chronic and acute
risk to consumers health arising from proposed temporary EU MRLs. The EFSA Journal 2007, 32r,
1-1141. doi:10.2903/j.efsa.2007.32r
EFSA (European Food Safety Authority), 2012. Reasoned opinion on the review of the existing
maximum residue levels (MRLs) for bromoxynil according to Article 12 of Regulation (EC) No
396/2005. EFSA Journal 2012;10(8):2861, 41 pp. doi:102903/j.efsa.2012.2861
France, 2000. Draft assessment report on the active substance bromoxynil prepared by the rapporteur
Member State France in the framework of Council Directive 91/414/EEC, February 2000. Available
online: www.efsa.europa.eu
France, 2001. Addendum to the draft assessment report on the active substance bromoxynil prepared
by the rapporteur Member State France in the framework of Council Directive 91/414/EEC.
Available online: www.efsa.europa.eu
OECD (Organisation for Economic Co-operation and Development), 2011. OECD MRL calculator:
spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide
Publications/Publications on Pesticide Residues. Available online: http://www.oecd.org

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Abbreviations
a.s. active substance
ADI acceptable daily intake
ARfD acute reference dose
BBCH growth stages of mono- and dicotyledonous plants
bw body weight
CAC Codex Alimentarius Commission
CF conversion factor for enforcement to risk assessment residue definition
CXL Codex maximum residue limit (Codex MRL)
DAR draft assessment report
DAT days after treatment
DT90 period required for 90% dissipation (define method of estimation)
ECD electron capture detector
EFSA European Food Safety Authority
EMS evaluating Member State
GAP good agricultural practice
GC gas chromatography
GM genetically modified
HPLC high performance liquid chromatography
HR highest residue
ILV independent laboratory validation
ISO International Organisation for Standardisation
IUPAC International Union of Pure and Applied Chemistry
LOQ limit of quantification
MRL maximum residue level
MS Member States
MS/MS tandem mass spectrometry detector
NEU northern Europe
OECD Organisation for Economic Co-operation and Development
PHI pre-harvest interval
PRIMo (EFSA) Pesticide Residues Intake Model
QuEChERS
RD residue definition
RMS rapporteur Member State
SC suspension concentrate
STMR supervised trials median residue
TMDI theoretical maximum daily intake
TRR total radioactive residue

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WHO World Health Organization

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Appendix A – Good Agricultural Practice (GAPs)

F Formulation Application Application rate per treatment
MS or Pest or
Crop G Number Interval PHI
NEU/SEU group of Growth g/hL Water Remarks
and/or or type conc. Method g/ha (days) (m)
or pests stage & min-max min- L/ha
situation(a) I (d-f)
a.s.(i) kind(f-h) min-max min-max (l)
Country (b) controlled(c) season(j) (k) max min-max
NEU 250
Chives F Annual dicots SC Spray BBCH 11-16 1 250 28
(Belgium) g/L

Remarks:
(a) For crops, EU or other classifications, e.g. Codex, should be used; where relevant, the (i) g/kg or µg/L
usage situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (Meier U, 2001. Growth Stages of mono- and
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) dicotyledonous plants. BBCH Monograph, 2nd Ed., Federal Biological Research Centre of
(c) e.g. biting and sucking insects, soil-born insects, foliar fungi, weeds Agriculture and Forestry, Braunschweig, Germany, 2001), including where relevant,
(d) e.g. wettable powder (WP), water soluble granule (WG) information on season at time of application
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (k) The minimum and maximum number of application possible under practical conditions of
(f) all abbreviations must be explained use must be provided
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (l) PHI - minimum pre-harvest interval
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants. (m) Remarks may include: Extent of use/economic importance/restrictions
type of equipment used must be indicated

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Appendix B – Pesticide Residue Intake Model (PRIMo)

Prepare workbook for refined

bromoxynil calculations
Status of the active substance: Included Code no.
LOQ (mg/kg bw): proposed LOQ:
Toxicological end points
ADI (mg/kg bw/day): 0,01 ARfD (mg/kg bw): 0,04 Undo refined calculations
Source of ADI: EC Source of ARfD: EC
Year of evaluation: 2004 Year of evaluation: 2004

Chronic risk assessment - refined calculations

TMDI (range) in % of ADI
minimum - maximum
7
No of diets exceeding ADI: ---
Highest calculated Highest contributor 2nd contributor to 3rd contributor to pTMRLs at
TMDI values in % to MS diet Commodity / MS diet Commodity / MS diet Commodity / LOQ
of ADI MS Diet (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI)
7 WHO Cluster diet B 4,3 Wheat 1,2 Maize 0,4 Bovine: Meat
7 NL child 2,9 Milk and milk products: Cattle 2,4 Wheat 0,8 Swine: Meat
6 DK child 2,8 Wheat 2,2 Rye 0,3 Bovine: Liver
5 ES child 2,2 Wheat 1,2 Milk and milk products: Cattle 0,7 Bovine: Meat
5 WHO cluster diet D 3,3 Wheat 0,5 Milk and milk products: Cattle 0,3 Bovine: Meat
5 IE adult 1,1 Maize 1,1 Maize 0,6 Barley
5 DE child 2,1 Wheat 1,4 Milk and milk products: Cattle 0,4 Rye
4 WHO Cluster diet F 1,8 Wheat 0,6 Swine: Meat 0,4 Bovine: Meat
4 WHO cluster diet E 2,0 Wheat 0,4 Barley 0,4 Bovine: Meat
4 WHO regional European diet 1,5 Wheat 0,6 Swine: Meat 0,5 Bovine: Meat
3 FR infant 2,6 Milk and milk products: Cattle 0,4 Wheat 0,3 Bovine: Meat
3 IT kids/toddler 3,3 Wheat 0,0 Maize 0,0 Onions
3 SE general population 90th percentile 1,6 Wheat 1,2 Milk and milk products: Cattle 0,1 Rye
3 NL general 1,0 Wheat 0,7 Milk and milk products: Cattle 0,5 Swine: Meat
3 ES adult 1,2 Wheat 0,5 Milk and milk products: Cattle 0,4 Bovine: Meat
2 FR all population 1,6 Wheat 0,3 Milk and milk products: Cattle 0,3 Bovine: Meat
2 PT General population 2,0 Wheat 0,2 Maize 0,1 Rye
2 LT adult 0,5 Rye 0,5 Wheat 0,5 Swine: Meat
2 UK Infant 1,3 Wheat 0,5 Maize 0,2 Bovine: Liver
2 FR toddler 1,3 Wheat 0,7 Bovine: Meat 0,2 Swine: Meat
2 UK Toddler 2,0 Wheat 0,1 Bovine: Liver 0,0 Oats
2 IT adult 2,1 Wheat 0,0 Onions 0,0 Maize
2 DK adult 1,0 Wheat 0,3 Rye 0,3 Bovine: Meat
1 UK vegetarian 1,0 Wheat 0,0 Oats 0,0 Onions
1 UK Adult 0,8 Wheat 0,0 Bovine: Liver 0,0 Onions
1 FI adult 0,5 Wheat 0,3 Rye 0,0 Oats
0 PL general population 0,0 Onions 0,0 Leek 0,0 Maize

Conclusion:
The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.
A long-term intake of residues of bromoxynil is unlikely to present a public health concern.

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Acute risk assessment /children - refined calculations Acute risk assessment / adults / general population - refined calculations

The acute risk assessment is based on the ARfD.

For each commodity the calculation is based on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the critical consumption. If no data on the unit weight was available from that MS an average
European unit weight was used for the IESTI calculation.
In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce a variability factor of 5 was used.
In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation was performed with a variabilty factor of 3.
Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % of the ARfD.
Unprocessed commodities

No of commodities for which ARfD/ADI No of commodities for which No of commodities for which No of commodities for which ARfD/ADI is
is exceeded (IESTI 1): --- ARfD/ADI is exceeded (IESTI 2): --- ARfD/ADI is exceeded (IESTI 1): --- exceeded (IESTI 2): ---

IESTI 1 *) **) IESTI 2 *) **) IESTI 1 *) **) IESTI 2 *) **)

pTMRL/ pTMRL/ pTMRL/ pTMRL/
Highest % of threshold MRL Highest % of threshold MRL Highest % of threshold MRL Highest % of threshold MRL
ARfD/ADI Commodities (mg/kg) ARfD/ADI Commodities (mg/kg) ARfD/ADI Commodities (mg/kg) ARfD/ADI Commodities (mg/kg)
0,02 Chives 0,04 / - 0,0 Chives 0,04 / - 0,0 Chives 0,04 / - 0,0 Chives 0,04 / -

No of critical MRLs (IESTI 1) --- No of critical MRLs (IESTI 2) ---

Processed commodities

No of commodities for which ARfD/ADI No of commodities for which

is exceeded: --- ARfD/ADI is exceeded: ---
***) ***)
pTMRL/ pTMRL/
Highest % of Processed threshold MRL Highest % of Processed threshold MRL
ARfD/ADI commodities (mg/kg) ARfD/ADI commodities (mg/kg)

*) The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% of ARfD are reported.
**) pTMRL: provisional temporary MRL
***) pTMRL: provisional temporary MRL for unprocessed commodity

Conclusion:
For bromoxynil IESTI 1 and IESTI 2 were calculated for food commodities for which pTMRLs were submitted and for which consumption data are available.
No exceedance of the ARfD/ADI was identified for any unprocessed commodity.

For processed commodities, no exceedance of the ARfD/ADI was identified.

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Appendix C – Used compound code(s)

Code/Trivial name Chemical name Structural formula(a)

bromoxynil 3,5-dibromo-4-hydroxybenzonitrile Br
bromoxynil-phenol
HO N

Br
Br
Bromoxynil- 2,6-dibromo-4-cyanophenyl
O
heptanoate heptanoate
CH 3(CH 2) 5 C O CN
6

Br
Br
Bromoxynil octanoate 2,6-dibromo-4-cyanophenyl
O
octanoate
CH3 (CH2 )6 C O CN

Br
3,5-dibromo-4-
hydroxybenzoic acid

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