Proposals to Amend  the Maximum 
Residue Levels for Agricultural 
Compounds Food Notice 2017  
 
MPI Discussion Paper No: 2017/34 
 
 
 
Prepared by the Systems Audit, Assurance and Monitoring 
Directorate of the Ministry for Primary Industries   
 
ISBN No: 978 -1-77665 -737-7 (online)  
ISSN No: 2253 -3907 (online)  
 
 
 
December  2017  
 
 
 
Disclaimer  
 
While e very 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.  
 
Requests for further copies should be directed to:  
 
Publications Logistics Officer  
Ministry for Primary Industries  
PO Box 2526  
WELLINGTON 6140  
 
Email: brand@mpi.govt.nz  
Telephone: 0800 00 83 33  
Facsimile: 04 -894 03 00 
 
This publication is also available on the Ministry for Primary Industries website at  
http://www.mpi.govt.nz/news -and-resources/publications/  
 
© Crown Copyright - Ministry for Prim ary Industries  
 
 
 
 
 
  
  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   1  
 
Contents  Page 
 
1 Submissions  2 
2 Introduction  3 
2.1 Background  3 
2.2 Summary of Proposed Amendment s 5 
3 Proposals  7 
3.1 Proposal  to add a definition for 'active ingredient' to Part 1 of the  Notice  7 
3.2 Proposal to amend MRLs for chlormequat  7 
3.3 Proposal to amend MRLs for fluopyram  9 
3.4 Proposal to set MRLs for fluralaner  11 
3.5 Proposal to amend MRLs for fluxapyroxad  12 
3.6 Proposal to amend MRLs for halofuginone  14 
3.7 Proposal to amend  MRLs for lignocaine  16 
3.8 Proposal to set MRLs for oxathiapiprolin  18 
3.9 Proposal to amend MRLs for trifloxystrobin  19 
3.10 Proposal  to except active ingredients that are foods or food additives from compliance 
with a MRL  21 
3.11 Proposal to amend the exception s for Iron -EDTA complex  and Iron Phosphate  22 
3.12 Proposal  to amend the exception for microbial active ingredients   
 with a MRL  22 
  
   
2  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  1 Submissions  
The Ministry for Primary Industries (MPI) invites public comment on this discussion 
document, which outlines proposals to amend the New Zealand (Maximum Residue Levels  
for Agricultural Compounds) Food Notice . 
 
 
For each compound  you are commenting on, please c learly answer the following qu estions. 
Any additional comment is welcome, along with supporting discussion,  and data or examples 
to illustrate partic ular points.  
 
On balance, do you oppose any of the commodity MRLs proposed for this compound?  
 
Do you oppose an MRL being set at all  for this compound for the commodity?  
 
If an MRL is to be set for this compound for the commodity, do you disagree with the 
particular level proposed?  If so, why do you disagree?  
 
Submissions close at 5pm on  29 January 2018 .  Your comments should be sent to:  
 
MRL Amendments  
ACVM Programmes and Appraisals  
MPI Systems Audit, Assurance and Monitoring Directorate  
PO Box 2526  
Wellington 6140  
 
Email: ACVM.Consultation@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 th e 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 ther e 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 th at 
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 or not to release information.  Any decision to  withhold information 
requested under the OIA may be reviewed by the Ombudsman.  
   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   3 2 Introduction  
Maximum residue l evels (MRLs) are the maximum legal levels  for residues of agricultural 
compounds and veterinary medicines in food for sale in New Zealand. MRLs are primarily a 
tool for monitoring the use of agricultural compounds in accordance with good agricultural 
practice (GAP). GAP is not explicitly defined or regulated, but is the generally accepted 
means for producing safe primary produce in a particular location while taking account of 
climate, pests or diseases and other environmental factors. The New Zealand MRLs are 
established  based on domestic use of a particular compound, and are used to monitor GAP 
in New Zealand. Because they are based on use patterns, conditions, and animal or plant 
management needs here in New Zealand, they may differ from MRLs established overseas 
for a similar use.  As imported food commodities can comply with either a Codex MRL or a 
MRL established in the MRL Food Notice,  New Zealand’s obligations  under the Agreement 
on the Application of Sanitary and Phytosanitary Measures  are met.  
 
MRLs are used to minimise risks to public he alth by ensuring that chemical residues in food 
are as low as practicable, without compromising the ability of the chemical to successfully do 
what is intended.  
 
 
2.1 BACKGROUND  
MRLs are set out in the New Zealand (Maximum Residue Levels for Agricultural 
Compo unds) Food Notice . The MRL Food Notice is  amended a number of times each year 
to reflect changes in the use of agricultural compounds in the production of food. The MRL 
Food Notice is  available from the Ministry fo r Primary Industries (MPI) Food S afety web site 
at: http://mpi.govt.nz/document -vault/11329 .  
 
MPI administers the MRL Food Notice , with the final decision on any changes to the Notice  
resting with the  Director -General  of MPI.  The Food Notice is issued under sections 405 and 
406(1) of the Food Act 2014. When setting or amending MRLs, the Director -General mu st 
take into account:  
 the need to protect public health;  
 the desirability of avoiding unnecessary restrictions on trade;  
 the desirability of maintaining consistency between New Zealand ’s food standards 
and those applying internationally;  
 New Zealand ’s obligations under any relevant international treaty, agreement, 
convention, or protocol, and, in particular, under the Australia -New Zealand Joint 
Food Standards Agreement; and  
 such other matters as appropriate.  
 
Once the  amended  MRL Food Notice  is in place, official chemical residue monitoring 
programmes are reviewed and are amended as necessary.  
 
Possible implications for public health are considered during the toxicological and dietary risk 
assessments, by comparing the estimated dietary intake with a Health Based Guidance 
Value (HBGV). This 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 
process.  The HBGV is 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 Environmental 
Protection Authority (EPA) as part of its responsibility for managing public health under the  
4  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  Hazardous Substances and New Organisms Act 1996 (the HSNO Act).  A PDE (food) gives the 
potential daily exposure a person may be subject to from a substance, via food.  
 
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 result even after a lifetime of exposure”. ADIs are established by the WHO and 
Food and Agriculture Organization (FA O) 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.  An ADI m ay also occasionally be set in New Zealand by the EPA. Where 
an EPA-determined or an  internationally -determined ADI is not available, an ADI may be 
calculated by MPI to quantify  the dietary exposure risk.  
 
As required by the HSNO Act in New Zealand, MPI uses the PDE (food) set by the EPA as the 
HBGV for the estimation of dietary intake when one is  available. Where there is no PDE (food), 
the estimated dietary intake is compared with the  ADI, set by the EPA, the WHO/FAO joint 
expert committees, the Austr alian Pesticides and Veterinary Medicines Authority (APVMA), 
or the European Food Safety Authority (EFSA). If none of these are available, the HBGV 
used will be the MPI -determined ADI.   
 
The chronic dietary exposure to a substance is estimated by the Nati onal Estimated Dietary 
Intake (NEDI) calculation, encompassing all registered uses of the chemical and food 
consumption data based upon the 1997 National Nutritional Survey for adults and the 1995 
National Nutrition Survey of Australia, for children. The N EDI calculation is made in 
accordance with Guidelines for predicting dietary intake of pesticide residues (revised) 
[World Health Organization, 1997]. The NEDI calculation provides an estimation of the 
portion of the  PDE (food) or ADI that can be expected f rom consumption of food containing 
residues complying with existing and proposed MRLs to determine whether the chronic 
dietary exposure risk is acceptable  
 
Clause 144 of the Food Regulations 2015 states that imported food must contain residues of 
agricultu ral compounds no greater than the MRLs specified for that food in a notice set under 
the Food Act 2014 (section (1)(a)), the default MRL of 0.1 mg/kg (section (1)(c)), or the 
current editions of either the Maximum Residue Limits (MRLs) and Extraneous Maxim um 
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) (section (1)(d)).  
 
The “other  international MRLs ” listed in each entry is a summary of the MRLs set by Codex 
and other internationally regulatory bodies. For animal commodities, MRLs set by our major 
trading partners (Australia, Canada, China, Codex, the European Union, Japan, and the  
United States) are reviewed and compared; for horticultural commodities, only MRLs set by 
Codex and Australia are reviewed and compared  unless there is a particular trade reason to 
include other regions . Other international MRLs are reviewed and reported if there is a 
particular trade risk to be considered. Where a particular international body or regulator does 
not have MRLs set for the species or crop for which a New Zealand MRL is being proposed, 
that international body or regulator is omitted from the “other international MRLs” section of 
the entry.  
  
To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and 
Phytosanitary Measures the proposed MRL will be notified to the World Trade Organization. 
Any country may choose to comment if they believe the proposed MRL represents a barrier 
to their trade.  
  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   5 2.2 SUMMARY OF PROPOSED AMENDMENT S 
The proposed MRLs have been thoroughly assessed in accordance with international 
methodologies such as those utilised by the expert committees advising Codex. Information 
on the technical assessment of each proposal is included in this document (refer sect ion 3) 
and covers:  
 
 rationale;  
 chemical information;  
 good agricultural practice;  
 residues information;  
 dietary risk assessment;  
 toxicological/public health assessment; and  
 MRLs set by Codex and other authorities . 
 
Where an existing entry has been r evised to propose new or amended MRLs , the changes 
can be identified in the proposed revised entries as highlighted in bold print.  
 
MPI reviewed the estimated dietary exposure assessments for the application of the 
proposals in this discussion paper and compared  them with the appropriate HBGV  (the 
PDE (food ) or an ADI). MPI has determined that the residues associated with the proposed 
MRLs do not present any public health or food  safety concerns.  
2.2.1 Amendment to Part 1 of the Notice  
 
MPI proposes to add a defi nition of ‘active ingredient’ to section 1.2 of Part 1: Requirements 
in the Notice.  
2.2.2 Amendment s to Schedule 1: New and Amended  MRLs  
MPI proposes to add the following new MRLs to the MRL Notice and/or amend the existing 
entries for certain compounds : 
 
 Chlormequat: 1 mg/kg in barley.  
 Fluopyram: 0.7 mg/kg in stonefruit.  
 Fluralaner: 1.3 mg/kg in chicken eggs, 0.65 mg/kg in chicken fat/skin, 0.42 mg/kg in 
chicken kidney, 0.65 mg/kg in chicken liver, and 0.065 mg/kg in chicken meat.  
 Fluxapyroxad: 0.01(*) mg/ kg in stonefruit, and 0.01(*) mg/kg in winter squash.  
 Halofuginone: 0.02 mg/kg in chicken fat/skin, 0.2 mg/kg in chicken kidney, 0.3 mg/kg 
in chicken liver, and 0.01 mg/kg in chicken meat.  
 Lignocaine: 5 mg/kg in deer velvet.  
 Oxathiapiprolin: 0.01(*) mg/k g in bulb onions.  
 Trifloxystrobin: 0.03 mg/kg in stonefruit.  
 
Note: (*) indicates that the maximum residue level has been set at or about the limit of analytical 
quantification.   
6  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  2.2.3 Amendment s to Schedule 2: New and Amended Exceptions from Maximum Residue 
Levels  for Agricultural Chemicals  
MPI proposes  to add an exception from Maximum Residue Levels for Agricultural Chemicals 
(Schedule 2)  for active ingredients that are foods  or food additive s when used as an 
agricultural chemical . 
The new exception will mak e three of the current entries in Schedule 2 redundant, as they 
are classed as foods used as active ingredients. They are:  
 Canola oil  
 Fish oil (food grade)  
 Soya bean oil  
Discussion of the removal of these redundant entries is included in section 3 .13 of this 
proposal document.  
In addition to the new exceptions to this schedule, MPI proposes to amend the entr ies in 
Schedule 2 for microbial active ingredients , to better define the se substance s and their 
condition of exception , and for iron -EDTA complex  and iron phosphate , to extend the scope 
of an exception to  encompass  elemental iron.  
2.2.4 Amendment s to Schedule 3: Exceptions from Maximum Residue Levels for Veterinary 
Medicines  
There are no amendments proposed for Schedule 3 of the Notice.    
   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   7 3 Proposals  
3.1 PROPOSAL TO ADD A DEFINITION FOR  ‘ACTIVE INGREDIENT ’ TO PART 1 OF 
THE NOTICE  
It is proposed that a definition for ‘active ingredient’ is added to section 1.2 of the Food 
Notice.  
The schedules for exceptions from maximum residue levels use the term ‘active ingredient’ in 
establishing the substance definition and/or the conditions of exception for certain entries. 
The current definitions section of the Notice (section 1.2) in the requirements states that all 
terms used in the Notice are defined in the Food Ac t 2014 or the Food Regulations 2015. It 
has been noted that ‘active ingredient’ is not defined in either of these references.  
Section 1.2 currently states:  
 
(1) All terms used in this Part of this Notice and that are defined in the Food Act 2014 
(the Act) or the Food Regulations 2015, but not defined in this Part of this Notice, 
have the same meaning as in that Act or Regulations.  
  
 
The revised section will read:  
 
(1) All terms used in this Part of this Notice and that are defined in the Food Act 2014 
(the Act) o r the Food Regulations 2015, but not defined in this Part of this Notice, 
have the same meaning as in that Act or Regulations.  
 
(2) In this Notice,  active ingredient  has the same meaning as defined in Regulation 
3 of the Agricultural Compounds and Veterinary Medicines (Exemptions and 
Prohibited Substances) Regulations 2011.  
 
This will provide a definition of the term ‘active  ingredient’ and align with one already present 
in a relevant piece of legislation.  
3.2 PROPOSAL TO AMEND THE MRL S FOR CHLORMEQUAT  
It is proposed that MRLs for chlormequat  are amended to support the GAP use of the 
compound on barley.  
The current entry for chlormequat  in Sc hedule 1 of the Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Chlormequat  7003 -89-6 Chlormequat cation  Oats  
Wheat  5 
1 
 
   
8  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  The revised entry for chlormequat  in Schedule1 of the  Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Chlormequat  999-81-5 Chlormequat cation  Oats  
Wheat  
Barley  5 
1 
1 
3.2.1.1   Amendment Rationale  
The MRL is being  proposed to support a new use for  chlormequat  on barley  in accordance 
with the application rates and withholding periods that are proposed as GAP in New Zealand.  
This amendment will also include correction  of the CAS number listed in the Notice . 
 
3.2.2 Chemical Information  
Common name of compound  Chlormequat  
Use of compound  Plant Growth Regulator  
Chemical Abstract Services (CAS) Registry number  999-81-5 
Type of compound  Quaternary ammonium compounds  
Administration method  Spray  
3.2.2.1  Good Agricultural Practice  
The proposed use of chlormequat is as a plant growth regulator, in combination with either a 
chlorethephon/mepiquat -chloride  combination , or trinexapac -ethyl, to control height growth in 
barley. Chlormequat is to be applied in a single application  with a maximum rate of 1.5 kg  
active ingredient ( ai)/ha at G rowth Stage BBCH 30-32 (the start of stem elongation) . This use 
will attract a livestock withholding period of  42 days from the last application.   
3.2.2.2  Residue Information  
The residue data for the use of chlormequat in barley  demonstrated that , when applied as 
per the proposed use pattern , chlormequat residues did not exceed 0.92 mg/kg in barley 
grain in any of the trial work conducted. The proposed  MRL of 1 mg/kg is therefo re sufficient  
to support GAP  when used on barley .  
Data was also reviewed to support this use with respect to animal grazing. The trial work 
conducted confirmed that residues remained below the limit of quantification (0.01 mg/kg) in 
all animal commodities when a 42-day livestock withholding period is observed. It has 
therefore been concluded that animal commodity MRLs are not re quired at this time to 
manage the potential for transfer residues.  The default MRL of 0.1 mg/kg will apply to all 
animal commodities.  
3.2.2.3   Dietary Risk Assessment  
The HBGV  of 0.0 7 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the r esidues of chlormequat expected in food from crops treated according to 
existing and proposed GAP uses, the  NEDI for chlormequat is equivalent to less than 10% of 
the HBGV.  
3.2.2.4   Toxicological/Public Health Assessment  
It has b een determined that the use of chlormequat in barley , according to the GAP specified 
above, is unlikely to pose any health risks from authorised use .   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   9 3.2.2.5  Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Wheat  
Barley  5 
T2 
Codex  Oats  
Wheat  
Barley  10 
3 
2 
3.3 PROPOSAL TO AMEND THE MRLS FOR FLUOPYRAM  
It is proposed that MRLs fo r fluopyram are amended to support the GAP use of the 
compound on stonefruit.  
The current entry for fluopyram  in Sc hedule 1 of the Notice is:  
Compound 
Common Name  CAS#  Residue to which the  maximum 
residue limit applies  Food  Maximum Permitted 
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 meat  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Milk 0.01(*)  
0.01(*)  
0.2 
0.3 
1 
 
0.05 
0.5 
0.5 
0.7 
3 
0.3 
 
The revised entry for fluopyram in Schedule1 of the  Notice will read:  
Compound 
Common  Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
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 meat  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Milk 
Stonefruit  0.01(*)  
0.01(*)  
0.2 
0.3 
1 
 
0.05 
0.5 
0.5 
0.7 
3 
0.3 
0.7 
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.3.1.1   Amendment Rationale  
The MRL is  being  propos ed to support a new use for fluopyram on stonefruit  in accordance 
with the application rates and withholding periods that are propose d as GAP in New Zealand.  
 
   
10  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  3.3.2 Chemical Information  
Common name of compound  Fluopyram  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  658066 -35-4 
Type of compound  Pyridinyl ethylbenzamide  
Administration method  Spray  
3.3.2.1  Good Agricultural Practice  
The proposed use of flu opyram  (concurrently with trifloxystrobin) is to control brown  rot in 
stonefruit by applying 125 gai/ha over flowering or in the pre-harvest  period . The use of this 
compound is limited to  a maximum of two consec utive applications  with a retreatment 
interval of 7 days , and a maximum of  three applications per season. This use will attract a 
withholding period that limits application to no closer  than one day before harvest .  
3.3.2.2  Residue Information  
The residue data for  the use of fluopyram on stonefruit demonstrated that when applied as 
per the proposed use pattern and  observing  a withholding period of one day, residues  of 
fluopyram in the treated fruit did not exceed  0.6 mg/kg. The proposed MRL of 0.7 mg/kg is 
therefore  sufficient to support GAP when used on stonefruit .  
Data w as also reviewed  to support this use with respect to orchard treatment and animal 
grazing. The existing MRLs, and the current controls on the use of fluopyram related to 
animal consumption  (i.e. an established two -month clean feed period), are sufficient to 
manage the potential for animal transfer residues. The current MRLs in animal commodities 
will remain unchanged.  
3.3.2.3   Dietary Risk Assessment  
The HBGV  of 0.0 084 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues of fluopyram expected in food from crops treated according to existing 
and proposed GAP uses, the  NEDI for flu opyram  is equivalent to less than 5 0% of the 
HBGV.  
3.3.2.4   Toxicological/Public Health Assessment  
It has been determined that the use of flu opyram in stonefruit , according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.  
3.3.2.5  Other International MRLs  
Country  Food  Maximum Residue Li mit 
(mg/kg)  
Australia  Cherries  
Stone fruits (except cherries)  3 
2 
Codex  Cherries (includes all 
commodities in this 
subgroup)  
Peaches  (includes all 
commodities in this 
subgroup ) 
Plums (including prunes) 
(includes all commodities in 
this subgroup)  0.7 
 
 
1 
 
 
0.5 
 
  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   11 3.4 PROPOSAL  TO SET  MRLS FOR FLURALANER  
It is proposed that MRLs are  set for fluralaner to support the GAP use of the compound in 
chickens .  
There is currently no entry for fluralaner  in Schedule 1 of the Notice . 
 
The new  entry for fluralaner  in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted  
Residue Level (mg/kg)  
Fluralaner  864731 -61-3 Fluralaner  Chicken eggs  
Chicken fat/skin 
Chicken kidney  
Chicken liver  
Chicken meat  1 
0.6 
0.4 
0.6 
0.06 
3.4.1 MRL Promulgation  Rationale  
The MRL s are being  proposed to support a new use for flu ralaner on chickens in accordance 
with use  rates and withholding periods that are proposed as GAP in New Zealand.  
3.4.2 Chemical Information  
Common name of compound  Fluralaner  
Use of compound  Ectoparasiticide  
Chemical Abstract Services (CAS) Registry number  864731 -61-3 
Type of compound  Isoxazoline  
Administration method  Oral (in water)  
3.4.2.1  Good Agricultural Practice  
The proposed use of flu ralaner is for the treatment and control of Dermanyssus gallinae 
(poultry red mite) in chickens. Use of this compound is limited to two doses of 0.5 mg 
fluralaner/kg bodyweight administered one week apart, in the drinking water of breeder and 
layer hens on ly (not broiler chickens). Use of the compound will attract a meat withholding 
period of 14 days; no egg withholding period is required.   
3.4.2.2  Residue Information  
The MRLs proposed for fluralaner in New Zealand align with those set for the compound in 
the EU. Residue data for the use of f luralaner in chickens  demonstrated that when applied as 
per the proposed use pattern , residues were found to be less than the proposed MRLs in all 
tissues by 14 days : 0.06 mg/kg in muscle, 0.5 mg/kg in liver, 0.4 mg/kg in kidne y, and 0.6 
mg/kg in skin and fat . In addition, r esidues in eggs did not exceed 0.9 mg/kg at any point in 
the egg residue trials, confirming that the use pattern considered to be GAP in New Zealand 
will conform to the proposed MRL at all times without the n eed for an egg withholding period. 
The proposed MRLs are therefore  sufficient  to support GAP when used in chickens.  
3.4.2.3  Dietary Risk Assessment  
The HBGV  of 0.0 1 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues of fluralan er expected in  edible tissues from chicken s treated 
according to  the proposed GAP uses, and the residues in eggs from treated chickens, the 
NEDI for f luralaner  is equivalent to less than 7% of the HBGV.  
3.4.2.4   Toxicological/Public Health Assessment  
It has been determined that the use of f luralaner in layer chickens , according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.   
12  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  3.4.2.5  Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
EU Muscle  
Skin and fat in natural 
proportions  
Liver  
Kidney  
Eggs  0.065  
0.65 
 
0.65 
0.42 
1.3 
3.5 PROPOSAL TO AMEND THE MRLS FOR FLUXAPYROXAD  
It is proposed that MRLs for fluxapyroxad are amended to support the GAP use of the 
compound on stonefruit  and winter squash . 
The current entry for fluxapyroxad  in Sc hedule 1 of the Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Fluxapyroxad  907204 -31-3 Fluxapyroxad  Apples  
Barley grain  
Bulb vegetables  
Edible offal  
Mammalian fat  
Mammalian meat  
Milk 
Pears  
Wheat grain  0.02 
0.3 
0.2 
0.03 
0.05 
0.01(*)  
0.005  
0.02 
0.1 
 
The revised entry for fluxapyroxad  in Schedule1 of the  Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Fluxapyroxad  907204 -31-3 Fluxapyroxad  Apples  
Barley grain  
Bulb vegetables  
Edible offal  
Mammalian fat  
Mammalian meat  
Milk 
Pears  
Stonefruit  
Wheat grain  
Winter squash  0.02 
0.3 
0.2 
0.03 
0.05 
0.01(*)  
0.005  
0.02 
0.01(*)  
0.1 
0.01(*)  
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.5.1.1   Amendment Rationale  
The new MRL s are proposed to support  new use s for fluxapyroxad on stonefruit and winter 
squash in accordance with application rates and withholding periods that are proposed as 
GAP for these crops in New Zealand.  
3.5.2 Chemical Information  
Common name of compound  Fluxapyroxad  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  907204 -31-3 
Type of compound  Pyrazole -carboxamide  
Administration method  Spray   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   13 3.5.2.1  Good Agricultural Practice  
The proposed use of fluxapyroxad on stonefruit is for the  control of fungal diseases  at an 
application rate of 6.25 gai/100L  (between 62.5 and 187.5 gai/ha, dependent on tree height)  
from early flowering to the onset of shuck fall . The compound is to be applied at an interval of 
5-11 days when conditions favour disease , and not more than twice in succession  or three 
sprays per season , with the last application no later than the onset of shuck fall (BBCH 72) . 
Stock must not be allowed to graze treated orchards until after harvest, in lieu of withholding 
periods.   
The proposed use of fluxapyroxad on winter squash is for the contro l of powdery mildew at 
an application rate of 60  gai/ha at the first sign of disease or when plants begin to run , with a 
maximum of 2 applications per season . Application is to occur  alternatively with other 
fungicides . This use  will attract a withholding period of 21 days from the last application.   
3.5.2.2  Residue Information  
The residue data for the use of fluxapyroxad on stonefruit  demonstrated that when applied as 
per the proposed use pattern and all restrictions on timing and applications are observed, 
residues of fluxapyroxad in fruit at harvest were below 0.01 mg/kg. The proposed MRL of 
0.01 mg/kg  (at or about the limit of analy tical quantification ) is therefore sufficient to support 
GAP for fluxapyroxad on stonefruit.  
The residue data for the use of fluxapyroxad on winter squash  demonstrated that when 
applied according to the proposed GAP , residues of fluxapyroxad in the treated  squash  were 
less than 0.01 mg/kg. The proposed MRL of 0. 01 mg/kg (at or about the limit of analytical 
quantification ) is therefore  sufficient  to support GAP  for fluxapyroxad on winter squash . 
Data were  also reviewed to support this use with respect to orchard treatment and animal 
grazing. The existing MRLs, and the controls on the use of fluxapyroxad related to animal 
consumption (i.e. prohibition on animals grazing treated orchards until after harvest), are 
sufficient to manage the potential for animal  transfer residues. The current MRLs in animal 
commodities will remain unchanged.  
 
3.5.2.3  Dietary Risk Assessment  
The HBGV  of 0.014 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues of fluxapyroxad expected in food from crops  treated according to 
existing and proposed GAP uses, the  NEDI for fluxapyroxad is equivalent to less than 5% of 
the HBGV.  
3.5.2.4   Toxicological/Public Health Assessment  
It has been determined t hat the use of fluxapyroxad in stonefruit and winter squash , 
according to the GAP specified above, is unlikely to pose any health risks from authorised 
use.  
   
14  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  3.5.2.5  Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  All other foods  
[specific MRLs are only set 
for animal products, wheat, 
barley, and barley bran ] 0.1 
Codex  Cherries (includes all 
commodities in this 
subgroup)  
Fruiting vegetables, 
cucurbits  
Peaches (including 
nectarine and apricots) 
(includes all commodities in 
this subgroup)  
Plums (including prunes) 
(includes al l commoditi es in 
this subgroup)  3 
 
 
0.6 
 
1.5 
 
 
 
1.5 
 
 
3.6 PROPOSAL TO AMEND THE MRLS FOR HALOFUGINONE  
It is proposed that MRLs for halofuginone  are amended to suppo rt the GAP use of the 
compound i n chickens . 
The current entry for halofuginone  in Sc hedule 1 of the Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Halofuginone  55837 -20-2 Halofuginone  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  0.02 
0.03 
0.03 
0.01 
 
The revised entry for halofuginone  in Schedule1 of the  Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Halofuginone  55837 -20-2 Halofuginone  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  
Chicken fat /skin 
Chicken kidney  
Chicken liver  
Chicken meat  0.02 
0.03 
0.03 
0.01 
0.02 
0.2 
0.3 
0.01 
3.6.1.1  Amendment Rationale  
The new MRL s are  proposed to support a new use for halofuginone in chickens  in 
accordance with the application rates and withholding periods that are proposed as GAP in 
New Zealand.  
 
   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   15 3.6.2 Chemical Information  
Common name of compound  Halofuginone  
Use of compound  Coccidiostat  
Chemical Abstract Services (CAS) Registry number  55837 -20-2 
Type of compound  Quinazolinone alkaloid  
Administration method  Oral 
3.6.2.1  Good Agricultural Practice  
The proposed use of  halofuginone is to prevent  and control  coccidiosis in broiler chickens 
with a n administration rate of 3 g halofuginone /tonne of feed fed continuously. This use will 
attract a meat withholding period of two days from cessation of treatment.   
An egg withholding period is not required for this product because the proposed use is 
restricted to broiler chickens only.  
3.6.2.2  Residue  Information  
The residue data for  the use of halofuginone in chickens  demonstrated that when used as 
per the proposed use pattern and observing a withholding period of two days, residues were 
less than 0.23 mg/kg in liver, less than 0.15 mg/kg in kidney, l ess than 0.02 mg/kg in skin 
and fat, and less than 0.005 mg/kg in muscle. The MRLs are proposed to support GAP, and 
to help facilitate trade with most of our major trading partners.  
No data was provided or evaluated for residues in eggs as the proposed us e of halofuginone 
is restricted to broiler chickens only.  
3.6.2.3   Dietary Risk Assessment  
The HBGV  of 0.0 003 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues of halofuginone expected in food from animals  treated according to 
existing and proposed GAP uses, the  NEDI for halofuginone  is equivalent to less than 14% 
of the HBGV.  
3.6.2.4   Toxicological/Public Health Assessment  
It has been determined that the use of halofuginone in chickens , according to the GAP 
specif ied above, is  unlikely to pose any health risks from  authorised use .  
   
16  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  3.6.2.5  Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Edible offal of poultry  
Meat, poultry  1 
0.05 
Canada  Kidney, Chickens  
Liver, Chickens  
Muscle, Chickens  
Skin and fat, Chickens  0.02 
0.06 
0.01 
0.02 
China Chicken/Turkey muscle  
Chicken/Turkey skin with fat  
Chicken/Turkey liver  0.1 
0.2 
0.13 
Japan  Edible offal, chicken  
Fat, chicken  
Kidney, chicken  
Liver, chicken  
Muscle, chicken  1 
0.01 
1 
0.4 
0.01 
United States  Liver, broilers  
Muscle, broilers  
Skin with fat, broilers  0.3 
0.1 
0.2 
Taiwan  Chicken fat (skin)  
Liver, Chicken  
Muscle, Chicken  0.2 
0.3 
0.1 
3.7 PROPOSAL TO AMEND THE MRLS FOR LIGNOCAINE  
It is proposed that MRLs for lignocaine  are amended to support the GAP use of the 
compound in velvet removal in deer . 
The current entry for lignocaine  in Schedule 1 of the Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Lignocaine 
(lidocaine)  137-58-6 Sum of:  Lignocaine and 2,6 -
dimethylaniline  
Expressed as : 2,6-dimethylaniline  Deer velvet  0.1 
 
The revised entry for  lignocaine  in Schedule1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Lignocaine  
(Lidocaine)  137-58-6 Sum of:  Lignocaine and 2,6 -
dimethylaniline  
Expressed as : 2,6-dimethylaniline  Deer velvet  5 
3.7.1.1  Amendment Rationale  
The amended  MRL  is proposed after a review of new information  on lignocaine.  This review 
confirmed the existing MRL was not fit for purpose to manage lignocaine residues in deer 
velvet when the compound was used according to established GAP in New Zealand .  
   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   17 3.7.2 Chemical In formation  
Common name of compound  Lignocaine  
Use of compound  Anaesthetic  
Chemical Abstract Services (CAS) Registry number  137-58-6 
Type of compound  Amide  
Administration method  Injection as a local anaesthetic  
3.7.2.1  Good Agricultural Practice  
There is no change to GAP for lignocaine as previously established. Current GAP for the use 
of lignocaine in deer for the purposes of harvest ing velvet requires  the application of a 
tourniquet . This is followed by administering lignocaine as a local anaesthetic (ring block 
technique) at a rate of 20 mg lignocaine per centimetre  of antler pedicle circumference, at the 
base of the antler between the top of the head and the tourniquet.  This use  does not attract 
the nee d for a withholding period for lignocaine  in the harvested velvet .  
3.7.2.2  Residue Information  
New and existing residue data , as well as residue data obtained as part of the National 
Chemical Residues Programme (NCRP),  were reviewed to determine if the existing M RL for 
lignocaine remained fit for purpose. It was determined that there was a degree of variability in 
velvet residues due to variations in tourniquet application and harvest techniques . This 
variability changed the residue profile for lignocaine even whe n GAP  was adhered to . These 
variations were not represented in the original data set on which the current MRL was set, 
but has become apparent with the evaluation of a much larger data set.  
When all data is taken into account, it was determined that when l ignocaine is used as per 
established GAP, lignocaine residues were less than 4.5 mg/kg in 98% of velvet samples 
assayed. The revised MRL of 5 mg/kg is therefore proposed to support GAP for velvet 
harvesting while providing a more realistic representation o f post -treatment residues.  
It is noted that part of GAP for velvet harvest is the concurrent use of xylazine for sedation of 
the animal prior to administration of the local anaesthetic. Residues for xylazine, and the 
metabolite shared between both compoun ds 2,6 -dimethylaniline, were also evaluated as part 
of the review. It was determined that the current xylazine MRL is still fit for purpose for 
managing the GAP use of that compound, and does not require amendment.  
3.7.2.3  Dietary Risk Assessment  
The HBGV  of 0.021 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues of lignocaine expected in food from animals treated according to 
existing and proposed GAP uses, the  NEDI for lignocaine  is equivalent to less than 35% of 
the HBGV , and the NEDI for total 2,6 -dimethylaniline from both lignocaine and xylazine is 
equivalent to less than 40% of the HBGV .  
3.7.2.4   Toxicological/Public Health Assessment  
It has been determined that the use of lignocaine in the harvesting of velvet  according to the 
GAP specified above,  and accounting for the inherent variability associated with the 
procedure,  is unlikely to pose any health risks from authorised use.   
3.7.2.5  Other International MRLs  
There are no international MRLs for lignocaine (or lidocaine) in deer velvet.    
18  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  3.8 PROPOSAL TO SET MRLS  FOR OXATHIAPIPROLIN   
It is proposed t hat MRLs are set for oxathiapiprolin  to support the GAP use of the compound 
on onions .  
There is no current entry for oxathiapiprolin  in Schedule 1 of the Notice . 
The new  entry for oxathiapiprolin  in Schedule  1 of the Notice  will read: 
Compound 
Common 
Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted  
Residue Level (mg/kg)  
Oxathiapiprolin  1003318 -67-9 Oxathiapiprolin  Bulb onions  0.01(*)  
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.8.1 MRL Promulgation  Rationale  
The proposed MRL  is the result of the registration of a new product containing a new active 
ingredient for use as a fungicide on onions . It will manage the use of oxathiapiprolin  in 
accordance with the application rates and withholding periods that are considered GAP in 
New Zealand.  
3.8.2 Chemical Information  
Common name of compound  Oxathiapiprolin  
Use of compound  Fungicide  
Chemical Abstract  Services (CAS) Registry number  1003318 -67-9 
Type of compound  Piperidinyl thiazole isoxazoline  
Administration method  Spray  
3.8.3 Good Agricultural Practice  
Oxathiapiprolin  is used as a preventative fungicide in bulb onions for the control of downy 
mildew. The first treatment is applied at a rate of 35gai/ha before infection is evident, then 
again 10 days later. Use of oxathiapiprolin attracts a withholding period of 14 days.  
3.8.4 Residue Information  
The residue data  for the use of oxathiapiprolin on onions as per the residue definition  
demonstrated that when applied as per the proposed use pattern and observing the 14-day 
withholding period, residues of oxathiapiprolin in the onions at harvest  were below the limit of 
quantification (0.01 mg/kg) .  The MRL is therefore proposed to be set at 0.01 mg/kg to 
support GAP in New Zealand.  
An animal transfer residue assessment was not required in this case due to the inclusion of a 
label statement preven ting the grazing or feeding of livestock after application of  the 
compound. The default MRL of 0.1 mg/kg will apply to all animal commodities.  
 
3.8.5 Dietary Risk Assessment  
The HBGV of 0. 7 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues of oxathiapiprolin expected in food from crops treated according to 
proposed GAP uses, the NEDI for oxathiapiprolin is equivalent to less than 1 % of the HBGV.  
3.8.6 Toxicological/Public Health Assessment  
It has been determined that the use of oxathiapiprolin on bulb onions , in accordance with the 
GAP specified above, is unlikely to pose any health risks from  authorised use .  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   19 3.8.7 Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Onio n, Bulb  0.02 
Codex  Onion, Bulb  0.04 
3.9 PROPOSAL TO AMEND THE  MRLS FOR TRIFLOXYSTROBIN   
It is proposed that MRLs are amended  for trifloxystrobin  to support  the GAP use  of the 
compound on stonefruit . 
The current entry for trifloxystrobin in Sch edule 1  of the Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Trifloxystrobin  141517 -21-7 Sum of : Trifloxystrobin and its free acid 
metabolite.  
 
Expressed As: Trifloxystrobin 
equivalents  
 Cereal grains  
Citrus fruits (except 
Clementine and Satsuma 
mandarins)  
Cucurbits (inedible peel)  
Grapes  
Kiwifruit  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Mammalian meat  
Mandarins (Clementine and 
Satsuma)  
Pome fruits  
Stone fruits (except cherries)  0.05(*)  
0.3 
 
 
0.02(*)  
0.02(*)  
0.02(*)  
0.05 
0.04 
0.05 
0.05 
0.02(*)  
 
0.02(*)  
0.02(*)  
 
 
The proposed  entry for t rifloxystrobin  in Sc hedule 1  of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Trifloxystrobin  141517 -21-7 Sum of : trifloxystrobin and its free acid 
metabolite.  
 
Expressed As: Trifloxystrobin 
equivalents  
 Cereal grains  
Citrus fruits (except 
Clementine and Satsuma 
mandarins)  
Cucurbits (inedible  peel)  
Grapes  
Kiwifruit  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Mammalian meat  
Mandarins (Clementine and 
Satsuma)  
Pome fruits  
Stone fruits 0.05(*)  
0.3 
 
 
0.02(*)  
0.02(*)  
0.02(*)  
0.05 
0.04 
0.05 
0.05 
0.02(*)  
 
0.02(*)  
0.3 
 
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
  
3.9.1 Amendment Rationale  
The new MRL is proposed to support a new use for trifloxystrobin on stonefruit in accordance 
with the application rates and withholding periods that are proposed as GAP in New Zealand.  
20  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  When considering the revised MRL for stone  fruits, it was determined that it was also 
appropriate to apply the proposed MRL to cherries.  The current exclusion of cherries from 
the stone  fruits is no longer required, and will be removed.   
3.9.2 Chemical Information  
Common name of compound  Trifloxystrobin  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  14151721 -7 
Type of compound  Strobilurin  
Administration method  Spray  
3.9.2.1  Good Agricultural Practice  
The proposed use of  trifloxystrobin (co -formulated with flu opyram) is to control brown rot in 
stonefruit by applying 125 gai/ ha over flowering or pre -harvest . The use of this compound is 
limited to  a minimum of seven days between applications, a maximum of two consecutive 
applications , and a maximum of  three applications per season. This use will attract a 
withholding period that limits application to no later than one day  before harvest.  
3.9.2.2  Residue Information  
The residue data for the use of trifloxystrobin on stonefruit as per the residue definition  
demonstrated that when applied as per the proposed use pattern and  observing  a 
withholding period of one day, residues  in the treated fruit at harvest did not exceed  0.2 
mg/kg. The MRL of 0. 3 mg/kg is therefore proposed to support GAP.   
Data w as also reviewed to support this use with respect to orchard treatment and animal 
grazing. The existing MRLs, and the current contr ols on the use of trifloxystrobin related to 
animal consumption (i.e. an established two -month clean feed period), are sufficient to 
manage the potential for animal transfer residues. The current MRLs in animal commodities 
will remain unchanged.  
3.9.2.3   Dietary R isk Assessment  
The HBGV  of 0.0 4 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP, the  NEDI for trifloxystrobin  is equivalent to less than 10% of the HBGV.  
3.9.2.4   Toxicological/Public Health Assessment  
It has been determined that the use of trifloxystrobin in stone  fruit, according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.  
3.9.2.5  Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Stone fruits  5 
Codex  Stone fruits  3 
   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   21 3.10 PROPOSAL TO EXCEPT A CTIVE INGREDIENTS TH AT ARE FOODS OR FOOD  
ADDITIVES FROM COMPL IANCE WITH A  MRL  
It is proposed that an exception from compliance with an MRL is established for all active 
ingredients that ar e foods  or food additives when used as an agricultural compound. The 
residues risk associated with these kinds of compounds is negligible when the proposed 
condition is met because as a food, as defined under the Food Act, the residue risk in the 
commodities from  which the food is derived has already been mitigated by compliance with 
the Act.  
There is currently no entry in Schedule 2 for active ingredients that are foods  or food 
additives as a group.   
 
The proposed entry in Schedule 2 will read:  
Substance  CAS#  Condition  
Active ingredients that are foods 
or permitted food additives 
when the treated commodity at 
sale will be compliant with the 
Australia New Zealand Food 
Standards Code.  
 
Except where:  
 
The food is deemed a novel 
food as defined in section 1.1.2 
of the Australia New Zealand 
Food Standards Code;  
 
And/or;  
 
The composition of the active 
ingredient deviates from the 
physicochemical  range, or has 
undergone refining to a level 
exceeding that, accepted as 
common for the food.  n/a Used as an agricultural compound.  
 
Promulgation of this exception will result in the revocation of the following exceptions, as they 
will now fall under the o verarching exception for foods  and food additive s used as active 
ingredients:  
 
Substance  CAS#  Condition  
Canola oil  120962 -03-0 Used as an insecticide  
Fish oil (food grade)  n/a Used on food producing plant species  
Soya bean oil  8001 -22-7 Used as a fungicide  
 
These exceptions will be removed from Schedule 2 when the new exception is promulgated.  
  
22  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries  3.11 PROPOSAL TO  AMEND THE  EXCEPT ION FOR IRON -EDTA COMPLEX  AND 
IRON PHOSPHATE  
It is proposed that the exception s from compliance with an MRL for  iron-EDTA complex and 
iron phosphate are removed and replaced with a new exception for elemental iron, iron 
complexes, and iron  salts.  
 
The current entries in Schedule 2 of the Notice are:  
Substance  CAS#  Condition  
Iron-EDTA Comple x 15275 -07-7 When used in pellet form as a molluscicide  
and 
 
Substance  CAS#  Condition  
Iron phosphate  10045 -86-0 When used in pellet form as a molluscicide  
 
The proposed entry in Schedule 2 will read:  
Substance  CAS#  Condition  
Elemental iron, iron complexes, and iron 
salts n/a When used in pellet form as a molluscicide  
 
 
On review of the previously promulgated exception s, it was determined that the scope of the 
exception s were too narrow relative to the risk profile of elemental iron and other iron salts 
used as molluscicide . It has been determined that removal of these entries and the 
promulgation of a new exception is more appropriate to allow for other forms of iron to be 
used as molluscicides. Although the scope of the substance has changed, it is considered 
that the condition specifying its use pattern is sufficient  to manage the associated  risks; 
residues associated with iron -containing  compounds used in any other form than in a pellet, 
or for any other reason other than as a molluscicide, will be subject to the applicable MRL or 
default MRL.  
3.12 PROPOSAL TO  AMEND THE  EXCEPT ION FOR MICROBIAL AC TIVE 
INGREDIENTS   
It is proposed that the excep tion from compliance with an MRL for microbial active 
ingredients is revised to better define substance s to and conditions under which this 
exception applies .   
 
   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017   23 The current entry in Schedule 2 of the Notice is :  
Substance  CAS#  Condition  
Microbial Active Ingredients (any 
organism classified as a 
microorganism including but not 
limited to bacteria, protozoa, fungi 
and viruses, or the genetically 
modified or naturally occurring 
mutants of any of these 
microorganisms. This includes 
whole orga nisms (either viable or 
non-viable), organism organelles, 
organism metabolites, organism 
spores, or occlusion bodies.)  
 
Does not include metabolites 
produced by a microorganism that 
have been isolated as an 
independent active ingredient.  
. n/a Except where otherwise stated in 
this Notice:  
 where the Microbial Active 
Ingredient is the active 
ingredient in an agricultural 
compound registered under 
the Agricultural Compounds 
and Veterinary Medicines Act 
1997 and intended for use as 
an agricultural chemical ; and  
 
 where the Microbial Active 
Ingredient leaves no 
quantifiable residue of toxins 
or metabolites exceeding that 
of expected background 
levels; and  
 
 where the Microbial Active 
Ingredient has been 
determined to be non -
pathogenic or non -toxic to 
humans.  
   
The proposed entry in Schedule 2 will read:  
Substance  CAS#  Condition  
Microbial Active Ingredients (any 
organism classified as a 
microorganism including but not 
limited to bacteria, protozoa, fungi 
and viruses, or the genetically 
modified or naturally occurring 
mutants of any of these 
microorganisms. This includes 
whole orga nisms (either viable or 
non-viable), organism organelles, 
organism metabolites, organism 
spores, or occlusion bodies.)  
This exception applies when the 
Microbial Active Ingredient:  
 leaves no quantifiable residue 
of toxins or metabolites 
exceeding that of expected 
background levels; and  
 is non-pathogenic or non -toxic 
to humans.  
This exception does not include 
metabolites produced by a 
microorganism that have been 
isolated as an independent active 
ingredient.  
 n/a When used as the active 
ingredient in an agricultural 
compound registered under the 
Agricultural Compounds and 
Veterinary Medicines Act 1997, 
and is intended for use as an 
agricultural chemical.  
  
24  Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2017  Ministry for Primary Industries   
 
On review of the previously promulgated exception, it was determined that the aspects of the 
conditions of exception for these compounds were actually defining the substance itself. The 
entry has therefore been revised to retain the condition that the compound is used as an 
agricultural chemical in the condition , and move the second and third bullet point of that 
previously promulgated as the condition to the definition of the substance.  
 
The intent of the exception as a whole, and the compounds which are captured by it, are not 
affected by these changes.