Proposals to Amend the  
New Zealand ( Maximum Residue 
Levels for Agricultural 
Compounds ) Food Notice  
 
New Z ealand Food Safety Discussion  Paper  No: 2022/01 
 
  
Prepared for public consultation  
By New Zealand Food Safety  
 
 ISBN No: 978 -1-99-102651 -4 (online)  
ISSN No: 2624- 0157 (online)  
 
 
 
 
21 March  2022 
 
 
Disclaimer  
 
While every effort has been made to ensure the information in this publication is accurate, the  
Ministry for Primary Industries  does not accept any responsibility or liability for error of fact, omission, 
interpretation or opinion that may be present, nor for the consequences of any decisions based on this 
information.  
 
This publication is available on the Ministry for Primary Industries  website at  
http://www.mpi.govt.nz/news -and-resources/publications/   
  
© Crown Copyright - Ministry for Primary Industries   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  1 Contents  Page 
 
1 Request for submissions  2 
2 Introduction  3 
2.1 Estab lishing  Maximum Residue Levels  3 
2.2 Summary of Proposed Amendments  7 
3 Proposals  9 
3.1 Proposal to set MRLs for fenpyroximate  9 
3.2 Proposal to amend the MRLs for fludioxonil  10 
3.3 Proposal to set MRLs for fluensulfone  10 
3.4 Propo sal to  amend  the MRL fo r fluop yram  12 
3.5 Pr oposa l to se t MRL s for  pre dnisolone  13 
3.6 Proposal to add an entry for follicle stimulating hormone (FSH) to Schedule 3  165 
3.7 Proposal to add an entry for melatonin to Schedule 3  165 
 
   
2 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  1 Request for s ubmissions  
New Zeala nd Food Safety  invites public comment on this discussion document, which 
outlines proposals to amend the New Zealand (Maximum Residue Levels for Agricultural 
Compounds) Food Notice (Notice) . 
 
For each compound  you are commenting on, please clearly answer the following questions. 
Any additional comment is welcome, along with supporting discussion, and data or examples 
to illustrate particular points.  
 
Do you oppose a  MRL  in Schedule 1  or listing in Schedule 3 being set or deleted at all  
for this compound or for a commodity? 
 
If a MRL  in Schedule 1  or listing in Schedule 3  is to be set for this compound for the 
commodity, do you disagree with the level s or conditions  proposed? If so, why do you 
disagree?  
 
On balance, do you oppose any of the commodity MRLs in Schedule 1 or details of the  
listing in Schedule s 3 proposed for this compound?  
 
 
Submissions close at 5pm on 19 May 2022 . Your comments should be sent to:  
MRL Amendments  
New Zealand Food Safety  
Ministry for Primary Industries  
PO Box 2526 Wellington 6140 
Email: MaximumResidueLevels@mpi.govt.nz . 
Please include your name and address on your submission. If you are making comments on 
behalf of an organisation, also include your title and the name of the organisation.  
Please make sure your comments can be clearly read, as a number of copies of your 
submission may be made.  
 
The Official Information Act  
The Official Information Act 1982 (the OIA) states that information is to be made available 
unless there are grounds for withholding it. The grounds for withholding information are outlined in the OIA.  Submitters may wish to indicate any grounds for withholding information contained in their submission.  Reasons for withholding information could include that information is commercially sensitive or that the submitters wish personal information such as names or contact details to be withheld.  MPI will take such indications into account when 
determining whether  to release information.  Any decision to withhold information requested 
under the OIA may be reviewed by the Ombudsman.  
 
  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  3 2 Introduction 
Agricultural compounds are natural or synthetic substances used in the direct  management 
of plants and animals, and incl ude all agricultural chemicals (e.g. fungicides, herbicides,  and 
insecticides) , veterinary medicines, a nd other compounds used to maintain plant and animal 
health and productivity.  Growers and farmers use these agricultural compounds to manage 
disease in animals and crops, protect the food supply, and maximise the quantity and quality 
of the food they grow.  
Agricultural compound use can leave residues in the food harvested from treated crops and 
animals. To manage these residues, it is important to ensure that only the appropriate amount of an agricultural compound is used to achieve its  intended purpose and leave the 
smallest amount of residue practicable without compromising the compound’s efficacy. The set of principles and methods used to manage that bal ance is known as good agricultural 
practice (GAP ). These principles apply to the production of safe and good quality 
horticultural , agricultural,  and animal products.  Maximum residue levels (MRLs) are then 
established for each compound/food commodity combination by evaluating the residues left in food commodities as a result of the highest authorised GAP use  (the ‘critical GAP’) .  This 
value is compared against the hea lth-based guidance value before a maximum level of 
agricultural compound residue allowable in that food commodity  is set . How the MRLs are 
determined, and how they are used once they have been set, are explained in more detail below.   
MRLs are the maximum  legal levels for residues of agricultural compounds permitted in food 
for sale in New Zealand. They are established based on domestic uses of a particular compound, and are used to monitor GAP compliance in New Zealand while ensuring food safety. Because they are based on New Zealand authorised uses according to domestic 
GAP, MRLs may differ from those established overseas for a similar use because their GAP 
may be different.  However, as noted below, imported food can also comply with Codex MRLs.  
To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement) , proposals for new and amended MRLs are 
notified to the World Trade Organization. Any country may choose to comment if they believe 
a proposed MRL represents a barrier to their trade.  
2.1 ESTABLISHING MAXIMUM RESIDUE LEVELS  
2.1.1 Regulatory Structure  
Maximum residue levels are the maximum legal levels of agricultural compound residues permitted in food for sale in New Zealand, and are set out in the New Zealand (Maximum 
Residue Levels for Agricultural Compounds) Food Notice. This Notice is updated up to four times a year to reflect changes in the use of agricultural compounds in the production of food. The current Notice is available from the Ministry for Primary Industries (MPI) New 
Zealand Food Safety website at: https://www.mpi.govt.nz/dmsdocument/19550 -maximum-
residue- levels -for-agricultural -compounds .  
New Zealand Food Safety administers the Notice, with the final decision on any changes to the Notice resting with the Director -General of MPI. The Notice is issued under section 405 
of the Food Act 2014. When setting or amending MRLs, the Director -General must follow, as 
far as practicable, international best practice on dietary intake assessment and setting of 
maximum residue levels.  The requirements for the content of the Notice are set out in Part 6  
4 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  of the Food Regulations 2015  (the Food Regulations) , allowing for the setting  of MRLs for 
agricultural compounds a s well as specifying compounds to which no MRL applies .  
In addition to establishing the requirements for domestically produced foods, Part 6 of the 
Food Regulations  also outlines the residue level compliance requirements for imported 
foods. The following provisions of r egulation 144 state that a person must not sell food 
containing  residues of an agricultural compound unless one of the following applies : 
- the residue level of the agricultural compound does not exceed the MRLs 
specified for that food in a notice set under the Food Act 2014 ( regulation 
144(1)(a)); or 
- the residue level of the agricultural compound does not exceed the default MRL of 
0.1 mg/kg ( regulation  144(1)(c)) , and there is no MRL otherwise specified in the 
notice; or  
- for imported food, the residue level of the agricultural compound does not exceed 
MRLs specified in the current editions of either the Maximum Residue Limits 
(MRLs) and Extraneous Maximum Residue Limits (EMRLs) for Pesticides (Codex 
Pesticides Residues in Food Online Database), or the Maximum Residue Limits 
for Veterinary Drugs in Food (Codex Veterinary Drug Residue in Food Online 
Database) ( regulation 144(1)(d)).  
The regulations allow for New Zealand Food Safety to set MRLs for imported food 
commodities when such l evels are required. As imported food commodities can comply with 
either a Codex MRL or a MRL established in the Notice, New Zealand’s obligations under the 
SPS Agreement  are met.  
On the whole, the Food Regulations allow for the management of residues in all foods 
consumed in New Zealand.  
2.1.2 Determining Maximum Residue Levels  
The first step in determining MRLs for an agricultural compound is establishing GAP for the use of the compound in the target species or crop. New Zealand Food Safety establishes 
GAP by evaluating public health, crop safety, animal health and safety, occupational , and 
environmental safety considerations for the range of treatments and use patterns  approved 
and proposed for each compound. Once GAP has been established for an agricultural 
compound, the residues resulting from the highest authorised dose or application rate  and 
use pattern,  which is likely to give rise to the highest residues  (the ‘critical GAP’)  is then used 
to determine the maximum residue levels (MRLs) in food commodities from  treated  crops 
and animals that will ensure conformance to New Zealand GAP .  
Although the primary function of MRLs is to ensure conformance with established New 
Zealand GAP, the MRLs also play a role in managing dietary exposure and risks to trade in food commodities. To ensure the MRLs w ill effectively manage residues related t o those 
risks, a national estimated daily intake or NEDI calculation is conducted to evaluate 
consumption risk  and a  review of all international MRLs for the compound/commodity 
combinations being considered is completed to evaluate trade risk. If it is found that the MRL 
being considered may pose a food safety or trade risk,  the proposed MRL is not progressed.   
Where it has been determined that MRLs can be set, those MRLs are proposed for inclusion in the Notice. Animal commodity MRLs will be proposed for t he species in which a veterinary 
medicine is approved for use. MRLs may be proposed for a specific species (e.g. cattle, 
chicken) or a species group (e.g. mammalian, poultry) depending on the residue and 
metabolism  profile of the agricultural compound being considered. Where an agricultural 
chemical is used on a crop from which both food and feed commodities are derived, MRLs 
will be proposed for both the crop intended for human consumption and animal commodities  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  5 for th e species or species group to which the feed commodity is fed. If an agricultural 
chemical is only used on an animal feed commodity such as pasture from which there are no 
foods harvested for human consumption, only animal commodity MRLs will be proposed.   
2.1.3 Estimat ing Chronic Dietary Exposure   
National estimated daily intake 
The objective of the estimated chronic dietary exposure is to determine whether residues in 
food commodities will pose an unacceptable risk to consumers as a result of the authorised 
use of an agricultural compound according to established GAP. This exposure is estimated 
by calculating the national estimated daily intake  (NEDI ) in accordance with Guidelines for 
predicting dietary intake of pesticide residues (revised) [World Health Organization, 1997] . 
The N EDI calculation  uses  the total residues in food derived f rom all New Zealand authorised 
uses of an agricultural compound,  including all toxicologically significant residues,  and 
regional dietary consumption data derived from the 1997 National Nutritional Survey for 
adults and the 1995 National Nutrition Survey of Australia for children. The calculated NEDI 
is then compared with the  health based guidance value (HBGV)  associated with the 
compound; if the total residues derived from all uses of the agricultural compound is estimated to be less than the HBGV, the dietary exposure is unlikely to pose a health risk to cons umers.   
Health Based Guidance Values  
The HBGV used in determining the estimated dietary exposure may be either a Potential 
Daily Exposure (food) (PDE (food)) or an Acceptable Daily Intake (ADI). The ADI and PDE (food) 
are largely equivalent as they are determined using the same set of toxicology data and 
through a very similar scientific proces s. Both values are reported as milligrams of compound 
per kilogram bodyweight per day (mg/kg bw/d).  
A PDE (food) is a value determined by a toxicological evaluation by the New Zealand 
Environmental Protection Authority ( NZ EPA) as part of its responsibility for managing public 
health under the Hazardous Substances and New Organisms Act 1996.  A PDE (food) gives the 
potential daily exposure to a substance that  a person may  be subject to via food, and is the 
food- specific part of a set of values for different exposure pathways comprising the NZ EPA’s 
assessment of acceptable daily exposure (ADE) for an agricultural compound.  
An ADI is defined by the World Health Organization (WHO) as “the daily intake which, during 
an entire lifetime, appears to be without appreciable risk on the basis of all the known facts at 
the time”. “Without appreciable risk” has been further defined as: “the practical certainty that 
injury will not re sult even after a lifetime of exposure”. ADIs are established by the WHO and 
Food and Agriculture Organization (FAO) of the United Nations joint expert committees, which are made up of toxicologists and residue specialists. The ADI information from these joint committees also feeds into the Codex Alimentarius Commission (Codex), which sets 
international MRLs.  
New Zealand Food Safety  uses the PDE
(food) set by the NZ EPA as the HBGV for the 
estimation of dietary exposure when one is available. If there is no PDE (food), the NEDI  is 
compared with an  ADI set by the WHO/FAO joint expert committees, the Australian 
Pesticides and Veterinary Medicines Authority, the European Food Safety Authority, or 
another regulatory authority. If none of these are available, the HBGV used will be a New 
Zealand Food Safety -determined ADI.    
6 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  2.1.4 International MRLs and Trade  
Because  New Zealand MRLs are based on domestic GAP, they may differ from th e MRLs  
established overseas  for the use of the same compound in the same target species or crop if 
the GAP us ed to set those MRLs are different . To ensure the New Zealand MRLs will not 
unduly impact trade, the MRLs set by Codex and a selection of other international regulatory 
bodies  are reviewed to evaluate trade risk.  
For animal commodities, the MRLs set by Australia, Canada, China, Codex, the European Union, Japan, and the U nited States  are reviewed and compared; for horticultural 
commodities, MRLs set by Codex and Australia are reviewed and compared. Other 
international MRLs are also reviewed and compared if there is a particular trade risk to be 
considered for those regions.   
Where there are international M RLs to be considered in the trade assessment  for the 
proposal , these are included in a table in the “Relevant International MRLs” section of each 
proposal entry. This table includes all MRLs for the agric ultural compound/ food commodit y 
combinations for whi ch new or amended New Zealand MRLs are being proposed; 
international MRLs for other commodities for which New Zealand MRLs already exist are not 
included. If there are no MRLs set by an international authority for a particular 
compound/commodity combination, the authority is not listed in the table.  
2.1.5 Agricultural Compounds for Which No Maximum Residue Level Applies   
Not all agricultural compounds require a n MRL to manage their use in crops or animals . This 
may be because there are no residues present due to the properties of the compound such 
as rapid elimination from the plant, animal, or their environment,  or because there are no 
food safety or trade risk s associated with the residues that are present. Regulation 141 of the 
Food Regulations allow s for the listing of specified compounds that fit these criteria as 
agricultural chemicals or veterinary medicines for which no MRL applies. These compounds 
are listed in Schedule 2 and Schedule 3 of the Notic e, respectively , and the conditions of 
listing can be set  for a particular use, a particular animal or crop, or general use as an 
agricultural chemical or veterinary medicine.  
Agricultural chemicals and veterinary medicines being considered for  listing as  compounds 
for which no MRL applies undergo a similar scientific assessment of their use as that 
undertaken for MRL assessment. This assessment is done in accordance with international 
methodologies published by the Organisation for Economic Cooperation and Development 
(OECD), International Cooperation on Harmonisation of Technical Requirements for 
Registration of Veterinary Medicinal Products (VICH), or FAO. It includes establishing the 
GAP use of the compound, the relevant metabolism and residue information, and the 
potential risks posed to public health and trade.  The assessment may also include an 
assessment of dietary exposure when considered necessary to ful ly assess the risks.  
Where New Zealand Food Safety has determined that a n MRL is not required, the compound 
is proposed for list ing in Schedule 2 (for agricultural chemicals)  or Schedule 3 (for veterinary 
medicines) with conditions on their use to ensure the listing applies only to those situations 
that have been evaluated. If a compound listed in Schedule 2 or 3 is used in a way that does 
not meet the specified condition, the default MRL applies  to food derived from treated plants  
or animals. Each proposa l for inclusion in Schedule 2 or 3 includes a discussion of the 
rationale behind the considerations for listing , and a discussion of the assessed risks  and 
proposed conditions .   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  7 2.2 SUMMARY OF PROPOSED AMENDMENTS  
The proposed MRLs have been thoroughly assessed in accordance with international 
methodologies published by the O ECD, VICH, or FAO . Information on the technical 
assessment of each proposal is included in this document (refer section 3) and covers:  
• the new or amended entry proposed for inclusion in the Notice;  
• the rationale  for the new entry or amendment being proposed;  
• New Zealand good agricultural practice for the compound and target crop or species ; 
• the relevant residues information used in determining the proposed MRLs ; 
• a summary of the dietary risk  and public health assessment ; and 
• the MRLs set by Codex and other authorities (e.g. Australia, Canada, China, EU, 
Japan, USA)  relevant to the new or amended entry.  
Where an existing entry is proposed for revision, new or revis ed entry content is listed in bold 
print, and content proposed for removal is  identified by a strikethrough.  
The MRL compliance and dietary risk assessment residue definitions are included in the 
residues information section of the proposal . The HBGV used to compare to the NEDI 
calculation and determine the potential public health risk is included in the dietary risk and 
public health assessment section of the proposal .  
2.2.1 Amendments to Schedule 1 : Maximum Residue Levels for Agricultural Compounds  
MPI proposes to make the following changes to Schedule 1 of the Notice : 
• The addition of new entries in the Notice for the following compounds:  
 
- Fenpyroximate, to set a MRL of 0.1 mg/kg for pome fruits ; 
 
- Fluensulfone, to set MRLs at 0.6 mg/kg for carrots, 0.6 mg/kg for parsnips, 
and 0.4 mg/kg for t uberous and corm vegetables (Subgroup 16B)  
 
- Prednisolone, to set MRLs at 0.004 mg/kg for cattle fat, 0.01 mg/kg for cattle 
kidney, 0.01 mg/kg for cattle liver, 0.004 mg/kg for cattle meat, 0.004 mg/kg for goat fat, 0.01 mg/kg for goat kidney, 0.01 mg/kg for goat liver, 0.004 mg/kg 
for goat meat, 0.004 mg/kg for horse fat, 0.01 mg/kg for horse kidney, 0.01 
mg/kg for horse liver, 0.004 mg/kg for horse meat, and 0.006 mg/kg for milk.  
• The amendment of the exis ting entr y in the Notice for the following compounds : 
- Fludioxonil , to add a MRL of 0.01(*) mg/kg for potatoes.   
- Fluopyram, to amend the MRL of 0.01(*) mg/kg to 0.07 mg/kg for bulb onions.  
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
2.2.2 Amendment s to Schedule 3: Veterinary Medicines for which No Maximum Residue Level 
Applies  
• MPI proposes to add a new entry for follicle stimulating hormone (FSH)  to the 
schedule for veterinary medicines for which no MRL applies. FSH  would not require 
compliance to a n MRL when used to manage reproduction in ruminants .  
8 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  • MPI proposes to add a new entry for melatonin to the schedule for veterinary 
medicines for which no MRL applies.  Melatonin would not require compliance to a n 
MRL when used to manage reproduction in sheep, deer and goats .  
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  9 3 Proposals  
3.1 PROPOSAL TO SET MRLS FOR F ENPYROXIMATE   
It is proposed that MRLs are set for fenpyroximate  to support the GAP use of the compound 
on pome fruits.   
There is currently no entry for fenpyroximate  in the Notice and therefore the default MRL 
applies . The new entry in Schedule 1 of the Notice will rea d: 
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food  Maximum Residue 
Level (mg/kg)  
Fenpyroximate  134098 -61-6 Fenpyroximate  Pome fruits  0.1 
3.1.1 Amendment Rationale  
Fenpyroximate has been used in New Zealand for the control of European red mite and two-
spotted mite on pome fruit  since  1994, with the use subject to compliance with the New 
Zealand default MRL of 0.1 mg/kg. The new entry is proposed to reflect the residue level in 
accordance with the use pattern considered as GAP in New Zealand.  There are no other 
approved uses for fenpyroximate.  
 
3.1.2 Good Agricultural Practice  
Fenpyroximate is a pyrazole non-systemic miticide which acts on larvae, nymphs and adults 
of mites, mainly by c ontact and ingestion, and with some moulting inhibitory activity on larvae .  
There are currently two registered products containing the active ingredient fenpyroximate in 
New Zealand, both for the control of European red mite and two- spotted mite on pome f ruits. 
The GAP use is for one application of 2.5 gai/100L water, in either November -December or 
during January. A withholding period of 14 days is considered to be GAP for pome fruit.  
3.1.3 Residue Information 
The residue data for the use of fenpyroxi mate  on pome fruit  are sufficient to conclude that, 
when applied according to the proposed GAP use pattern, residues of fenpyroximate should 
not exceed 0.1 mg/kg.  The current residue definition of ‘fenpyroximate’ ha s been determined 
to be appropriate to apply to plant commodities for both GAP compliance and dietary intake assessment.   
3.1.4 Dietary Risk Assessment  
The HBGV  of 0.01 mg/kg bw/ d was considered appropriate for use in the assessment.  
Based on the residue profil e expected in food from  all foods treated with or exposed to 
fenpyroximate when used according to GAP, including the negligible residues expected in 
animal commodities,  the NEDI is estimated to total less than 3% of the HBGV.  
New Zealand Food Safety  has therefore determined that the use of  fenpyroximate on pome 
fruit, when used according to the GAP specified above, is unlikely to pose any health risks 
from authorised use.    
10 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  3.1.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue Level 
(mg/kg)  
Codex  Pome fruit  0.3 
Australia  Apple 
Pear  0.3 
0.3 
3.2 PROPOSAL TO AMEND THE MRLS FOR F LUDIOXONIL  
It is proposed that  the Notice entry for fludioxonil is amended to support the GAP use of the 
compound as a seed treatment for p otatoes . 
The revised entry in Schedule 1 of the Notice will read: 
Compound Common 
Name CAS#  Residue to which the maximum residue limit 
applies  Food Maximum 
Residue Level 
(mg/kg)  
Fludioxonil   131341 -86-1 Fludioxonil  Blackcurrants  
Blueberries  
Bulb onions  
Grapes  
Kumara  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Mammalian meat  
Milk 
Pineapples  
Potatoes  
Strawberries  0.8 
0.5 
0.01(*)  
1 10 
0.02 
0.05 
0.05 
0.01(*)  
0.01(*)  
7 0.01(*)  
1 
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.2.1 Amendment Rationale  
The MRL is being proposed to support the use of fludioxonil in potato seed tubers for the 
control of seed- borne diseases  in accordance with the use pattern and withholding period 
that is currently accepted as  GAP for New Zealand. The use for control of seed- borne fungal 
diseases when used as a seed treatment in potato has been approved in New Zealand for 
many years, with its use being subject to compliance with the New Zealand default MRL of 
0.1 mg/kg.  The new  MRL in potato is being proposed to better reflect the residue level in 
accordance with the use pattern considered as GAP in New Zealand.  
3.2.2 Good Agricultural Practice  
Fludioxonil is a phenylpyrrole fungicide. It is non-systemic with long residual activity and 
limited uptake into the plant tissues. Activity is by the inhibition of conidia germination and, to 
a lesser extent, the germ tube and mycelial growth inhibition.  The use for control of seed-
borne diseases Rhizoctonia solani (stem canker and black scurf) and silver scurf when used 
as a seed treatment in potato has been approved in New Zealand since 1999. 
Good agricultural practice for control of seed- borne diseases in potato is  one application of 
25 gai / tonne seed in a maximum of 2.75 L water/tonne.  Application is made as a spray to 
seed tubers before planting, ensuring complete coverage of the tubers. A withholding period is not required when used as directed.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  11 3.2.3 Residue Information 
The residue data for the use of fludioxonil on potato are sufficient to conclude that, when 
applied according to the proposed GAP use pattern, residues of fludioxonil should not 
exceed the limit of quantification (0.01 mg/kg). The current residue definition of ‘fludioxonil’ has been determined to be appropriate to apply to p otatoes for both GAP compliance and 
dietary intake assessment as per the other plant  commodities in which it is used.  
3.2.4 Dietary Risk Assessment  
The HBGV  of 0.0165 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residue profile expected in food from all foods treated with or exposed to 
fludioxonil  when used according to GAP, the NEDI is estimated to total less than 12%  of the 
HBGV.  
New Zealand Food Safety  has therefore determined that the use of  fludioxonil  on potato,  
when use according to the GAP specified above, is unlikely to pose any health risks from 
authorised use.   
3.2.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue Level 
(mg/kg)  
Codex  Potato  5 
Australia  Potato  0.03 
3.3 PROPOSAL TO SET MRLS FOR F LUENSULFONE   
It is proposed that MRLs are set for fluensulfone to support the GAP use of the compound in 
carrot, kūmara/sweet potato, parsnip and potato . 
There is currently no entry for fluensulfone in the Notice. The new entry in Schedule 1 of the 
Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit 
applies  Food Maximum Residue 
Level (mg/kg)  
Fluensulfone  318290 -98-1 Sum of fluensulfone and 
3,4,4 -trifluorobut -3-ene-1-
sulfonic acid (BSA), expressed as fluensulfone 
equivalents  Carrots  
Parsnips Tuberous and corm 
vegetables  
 0.6 
0.6 
0.4 
3.3.1 Amendment Rationale  
The MRL is being proposed to support use of the new active ingredient fluensulfone to 
control nematodes in c arrot, kūmara/sweet potato, parsnip, and potato. The proposed MRL 
will manage the use of the compound in c arrot, kūmara /sweet potato, parsnip, and potato es 
in accordance with the use patterns  and withholding periods that are proposed as GAP in 
New Zealand.   
12 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  3.3.2 Good Agricultural Practice  
Fluensulfone is a nematicide from the fluoroalkenyl thioether chemical group that acts as a 
metabolic inhibitor in the pathway that the plant parasitic nematode uses to access its energy 
reserves. The proposed use for fluensulfone is as a single application pre- emergence of 1.92 
- 3.84 kgai/ha in a minimum of 200L water/ha, applied evenly to soil and incorporated to a 
depth of 15- 20 cm, a minimum of 3 days prior to sowing or planting.  This use has a 
Withholding Period of “Do not use on varieties maturing earlier than 80 days after planting”. The following plant back restrictions are also proposed:  
 
CROP  PLANT -BACK INTERVAL  
Carrots, kūmara/sweet potato, parsnip, potato  No restriction  
Cereals for animal forage (greenfeed)  120 days  
Cereals for grain; pasture  180 days  
Lettuce  180 days  
All other crops  270 days  
 
3.3.3 Residue Information 
Plant metabolism data have been provided for fluensulfone which show a similar metabolic 
pathway in crops either directly planted into treated soil, or subsequently planted as 
rotational crops. Fluensulfone is largely converted into thiazole sulfonic acid (TSA) and 
butene sulfonic acid (BSA) .  
The following r esidue definitions are considered to be appropriate: ‘Sum of fluensulfone and 
3,4,4 -trifluorobut -3-ene-1-sulfonic acid (BSA), expressed as fluensulfone equivalents’ for 
GAP- compliance in pla nt commodities; and ‘fluensulfone’ for dietary intake risk estimation in 
plant commodities.  
The residue definition proposed for GAP -compliance and dietary intake risk estimation in 
animal commodities is ‘fluensulfone’.  
Residue data for the use of fluensulfone are sufficient to conclude that, when applied 
according to the proposed GAP use pattern, residues of up to 0.4 mg/kg fluensulfone 
equivalents are expected in potatoes and sweet potatoes (and by extrapolation in other 
tuberous and corm vegetables included in subgroup 16B of the Codex Classification of 
Foods and Animal Feeds), and up to 0.6 mg/kg in carrots (and by extrapolation in parsnips). Residues of fluensulfone equivalents are not expected to occur over the default MRL of 0.1 
mg/kg in rotational crops planted subsequently, when the relevant plant back interval is 
applied.  
Animal  commodity MRLs are not  required  as a result of the proposed use,  as carrot, 
kūmara/sweet potato, parsnip, and potato  are not considered to be a primary animal feed in 
New Zealand. No detectable parent fluensulfone residues are expected in any animal feed 
commodity from rotational crops. 
 
 
3.3.4 Dietary Risk Assessment  
The HBGV of 0.0105 mg/kg bw/day was considered appropriate for use in the assessment.  
Based on the residue profile expected in food from crops treated with fluensulfone, the NEDI 
is est imated to total less than 0.7 % of the HBGV  for the average New Zealand adult.  
New Zealand Food Safety  has therefore determined that the use of  fluen sulfone , when used 
according to the GAP specified above, is unlikely to pose any health risks from authorised 
use.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  13 3.3.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue Level 
(mg/kg)  
Codex  Carrot  
Parsnip  
Potato  
Root and tuber vegetables  (not specified elsewhere)  
Sweet potato  4 
4 
0.8 
3 
0.8 
Australia  Root and tuber vegetables  2 
3.4 PROPOSAL TO AMEND MRLS FOR FLUOPYRAM  
 
It is proposed that  the Notice entry for fluopyram is amended to support the GAP use of the 
compound as a fungicide on bulb onions . 
The revised entry in Schedule 1 of the Notice will read: 
Compound Common 
Name CAS#  Residue to which the 
maximum residue limit 
applies  Food Maximum 
Residue Level 
(mg/kg)  
Fluopyram  658066 -35-4 Plant commodities: 
Fluopyram  
 
Animal commodities: Sum of 
fluopyram  and 2 -
(trifluoromethyl) benzamide, 
expressed as fluopyram  Bulb onions  
Cereal grains  
Carrots  
Eggs  
Fruiting vegetables (except cucurbits) 
Grapes  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Mammalian meat  
Milk  
Parsnips  
Stone fruits  0.07 
0.01(*)  
0.2 
0.3 
1.0 
 0.05 
0.5 
0.7 
3 
0.5 
0.3 
0.2 
0.7 
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.4.1 Amendment Rationale  
The MRL is being proposed to support the use of flu opyram  in bulb onions  for the control of 
white rot  in accordance with the use pattern and withholding period that is currently accepted 
as GAP for New Zealand. The use for control of white rot in bulb onions has been approved 
in New Zealand for many years, in combination with triadimenol. The use is currently  subject 
to compliance with an  MRL of 0. 01(*) mg/kg  as residues were estimated to be below 
quantifiable levels at harvest. However, recent information has been received which indicates 
that low quantifiable levels are present when used in accordance with GAP, possibly due to uptake from previously treated soil . The new MRL in bulb onions  is being proposed to better 
reflect the residue level in accordance with the use pattern considered as GAP in New 
Zealand.  
3.4.2 Good Agricultural Practice  
Fluopyram is a non- systemic phenylpyrrole fungicide, with long residual activity and limited 
uptake into plant tissues . The mode of action is inhibition of conidia germination, and to a 
lesser extent, germ tube and mycelial growth inhibition. It is currently used for control of white rot in bulb onions, suppression of root knot nematodes in carrots and parsnips, and in co- 
14 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  formulations with cyprodinil or fluazinam for use in grapes, blackcurrants, blueberries, and 
strawberries. For the current use in bulb onions, the compound is applied at a rate of 250 
gai/ha , co-formulated with 250 gai/ha triadimenol, as  a broadcast spray  with the first 
application at 100- 150 Onion White Rot Degree Days (approx 4- 8 weeks after sowing) , and a 
second a month later. This use pattern has an associated withholding period of 7 0 days.  
3.4.3 Residue Information 
The original residue data for the use of f luopyram  in bulb onions indicated that, when applied 
according to the GAP use pattern, quantifiable residues of fluopyram  are not expected in 
bulb onions. However, new information suggests that low, but quantifiable, fluopyram residue 
levels have been found when used according to the GAP use pattern, which  should not 
exceed 0.07 mg/kg in bulb onions. The proposed MRL aligns with Codex. The current 
residue definition of ‘ fluopyram ’ remains appropriate for plant commodities for GAP 
compliance, with ‘fluopyram+benzamide’ for dietary intake assessment . Current animal 
tissue MRLs are not affected as bulb onions  are not considered to be a primary animal feed.  
3.4.4 Dietary Risk Assessment  
The HBGV  of 0.0084 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residue profile expected in food from crops treated with fluopyram  the NEDI is 
estimated to total less than 43 % of the HBGV . 
MPI has therefore determined that the use of  fluopyram , when use according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.   
3.4.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue Level 
(mg/kg)  
Codex  Onion, bulb 0.07 
Australia  All other foods  0.2 
 
3.5 PROPOSAL TO SET MRLS FOR P REDNISOLONE   
It is proposed that MRLs are set for prednisolone  to support the GAP use of the compound 
as a veterinary medicine.  
There is currently no entry for prednisolone in the Notice and therefore the default MRL 
applies . The new entry in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food Maximum Residue 
Level (mg/kg)  
Prednisolone  50-24-8 Prednisolone  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  
Goat  fat 
Goat  kidney  
Goat  liver 
Goat meat  
Horse  fat 
Horse  kidney  0.004 
0.01 
0.01 
0.004 
0.004 
0.01 
0.01 
0.004  
0.004  
0.01  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  15 Horse  liver 
Horse  meat  
Milk 0.01 
0.004  
0.006  
3.5.1 Amendment Rationale  
Prednisolone has been used in New Zealand as a veterinary medicine for several years, with 
its use in food- producing species being subject to compliance with the New Zealand default 
MRL of 0.1 mg/kg. The new MRLs are being proposed to better reflect the residue levels 
expected with the use of prednisolone in cattle , goats, and horses  in accordance with the 
dose rates and use patterns considered as GAP in New Zealand.   
3.5.2 Good Agricultural Practice  
Prednisolone is a synthetic glucocorticosteroid used in veterinary medicine to treat 
inflammation associated with allergic reactions and bacterial infections. In New Zealand, most veterinary medicines containing prednisolone are antibiotic formulations used to treat 
mastitis in lactating dairy cattle by int ramammary infusion into the infected quarter for three to 
five consecutive treatments. Additional prednisolone -based treatments registered for use in 
food- producing species include a topical ointment intended for the treatment of 
dermatological infections,  and an oral granule product intended for the management of 
inflammatory conditions in horses at doses of 0.5- 2 mg/kg for up to three weeks to manage 
chronic allergic and non- infectious respiratory inflammatory disease.  
All but the oral granule product for horses are co -formulated with antibiotic compounds, with 
the antibiotic compounds dictating the withholding periods associated with treatment.  
3.5.3 Residue Information 
The residue data for the use of prednisolone, alone or in combination with antibiotic therapy , 
are sufficient to establish MRLs for the use patterns and withholding periods considered GAP 
in New Zealand. When used according to GAP, and complying with the applicable withholding periods, prednisolone depletes rapidly and is often less than the limit of 
quantification at the point where the antibiotic compound is compliant with its respective 
MRLs. As such, it can be expected that prednisolone residues will remain less than 0.0 04 
mg/kg in meat and fat, 0.01 mg/kg in liver and kidney, and 0.006 mg/kg in milk after all uses. A residue definition of ‘ prednisolone’ has been determined to be appropriate to manage New 
Zealand GAP compliance and dietary intake in accordance with the residue definitions 
established by overseas authorities.  
3.5.4 Dietary Risk Assessment  
The HBGV  of 0.0002 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment. Based on the residue profile 
expected in food from  animals treated with prednisolone, the NEDI is estimated to total less 
than 16.4% of the HBGV.  
MPI has therefore determined that the use of prednisolone  according to the authorised uses 
established as  GAP is unlikely to pose any health risks.   
3.5.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
European Union  Bovine  muscle  
Bovine f at 
Bovine l iver 
Bovine k idney  0.004 
0.004  
0.01 
0.01  
16 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  Milk 
Equine muscle  
Equine fat  
Equine liver  
Equine kidney      0.006 
0.004  
0.008  
0.006  
0.015  
Japan  Cattle , muscle  
Other terrestrial mammals, muscle 
Cattle , fat 
Other terrestrial mammals, fat  
Cattle , liver 
Other terrestrial mammals, liver  
Cattle , kidney  
Other terrestrial mammals, kidney  
Cattle edible offal  
Other terrestrial mammals, offal  
Milk                                                                 0.004 
0.001  
0.004 
0.001  
0.01 
0.001  
0.01 
0.001  
0.01 
0.001 
0.006 
3.6 PROPOSAL TO ADD AN ENTRY FOR F OLLICLE STIMULATING HORMONE 
(FSH)  TO SCHEDULE 3  
It is proposed that follicle stimulating hormone (FSH) is  added to Schedule 3 of the N otice to 
identify these compounds as veterinary medicines for  which no MRL applies. FSH is a 
naturally occurring gonadotropin hormone which regulates ovarian maturation a nd the 
reproductive cycle in mammals. As a veterinary medicine, FSH is used in cattle, sheep, and 
goat reproductive management to increase ovulation rates.   
When administered to ruminants  as a veterinary medicine,  the introduced FSH is 
indistinguishable from the endogenous ly-released  compound and rapidly eliminate d within 
hours. In addition, assessments of the use of FSH as a veterinary medicine conducted by 
international authorities such as the European Food Safety Authority  (EFSA)  have 
determined that MRLs are not required to manage residues. As such, the use of FSH  is not 
expected to pose risks to either food safety or trade when used as a veterinary medicine and 
can therefore be listed in Schedule 3 as veterinary medicines  for which no MRL applies . The 
condition of exemption will reflect  the use of the compound as a zootechnical agent to 
manage reproduction in food- producing species.  
The proposed new entry in Schedule 3 will read as follows:  
Substance  CAS#  Condition  
Follicle stimulating hormone 
(FSH)  9002 -68-0 When used to manage reproduction in ruminants  
3.7 PROPOSAL TO  ADD AN ENTRY FOR M ELATONIN  TO SCHEDULE 3  
It is proposed that  melatonin is added to Schedule 3 of the N otice to identify  it as a veterinary 
medicine for which no MRL applies.  Melatonin is a naturally occurring hormone released by 
the pineal gland which regulates day -night perception and, in sheep,  deer, and goats,  
seasonal reproductive cycles. When administered as a vet erinary medicine, melatonin is 
used to increase  reproductive performance in sheep by altering the reproductive seasonal 
rhythm and extending the breeding season. Like FSH, administered melatonin is 
indistinguishable from endogenous melatonin and is eliminated quickly . It has been 
determined by the EFSA and other overseas authorities not to require a MRL.  
It is therefore proposed that melatonin is added to Schedule 3 as follows:    
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  17 Substance  CAS#  Condition  
Melatonin                                                                                                                                                                                                                                                                                                                                                                                             73-31-4 When  used to manage reproduction in sheep, deer, 
and goats