Proposals to Amend the  New 
Zealand ( Maximum Residue 
Levels for Agricultural 
Compounds ) Food Notice   
New Zealand  Food Safety Discussion  Paper  No: 2021/04 
P
repared for public consultation  
By New Zealand Food Safety  
I
SBN No: 978 -1-99-100352 -2 (online)  
ISSN No: 2624- 0157 (online)  
1 O
ctober 2021 
 
 
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   
i Contents  Page 
 
1 Submissions  1 
2 Introduction  2 
2.1 Estab lishing  Maximum Residue Levels  2 
2.2 Summary of Proposed Amendments  5 
3 Proposals  7 
3.1 Proposal to amend the MRLs for Fluazinam  7 
3.2 Propo sal to  amend the MRLs fo r Mand estrob in 8 
3.3 Proposal to amend the MRLs for Pyriofenone  9 
3.4 Proposal to amend the entry for active ingredients that are foods or permitted food additives in 
Sched ule 2  11 
3.5 Propo sal to  amend the entry for microb ial active ing red ients in Schedule 2  11 
3.6 Proposal to amend the entry for plant extracts (unrefined) in Schedule 2  12 
3.7 Proposal to add an entry for zeolites to Schedule 3  14 
3.8 Proposal to remove the entry for medroxyprogesterone acetate and add an entry for 
progesterone to Schedule 3  15 
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  1 1 Submissions  
New Zealand 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.  
 
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.  
 
On balance, do you oppose any of the commodity MRLs or exemptions proposed for 
this compound?  
 
Do you oppose a  MRL  or exemption  being set at all  for this compound or for a 
commodity? 
 
If a MRL  or exemption  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?  
 
Submissions close at 5pm on 30 November  2021.  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 wi ll 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.  
 
  
2 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  2 Introduction 
Agricultural compounds are natural or synthetic substances  used in the management of 
plants and animals, and include veterinary medicines, fertilisers, and pesticides ( e.g. 
fungicides, herbicides,  and insecticides). Growers and farmers use agricultural compounds to 
manage disease in animals and crops, protect the food supply, and maximise the quantity 
and quality of the food they grow.  
Use of these agricultural compounds can leave residues in the food from those crops and 
animals that must be managed. To ensure only the appropriate amount of agricultural 
compounds  are used to achieve their intended purpose, a set of principles and methods 
known as good agricultural practice (GAP) are utilised. GAP covers the production of safe 
and good quality horticultural and animal products.  
GAP is established for each agricultural compound by evaluating public health, crop safety, animal health and safety, and occupational and environmental safety considerations for the 
range of treatments and use patterns. This involves determining the administration and 
application rates and r anges necessary for an agricultural compound to achieve its intended 
effects, while leaving the smallest amount of residue practicable without compromising that efficacy.  
Once the GAP has been established for a use for an agricultural compound, the residues 
resulting from its use up to the highest authorised dose or application rate is then used to 
establish maximum residue levels (MRLs) in food commodities from crops and animals 
associated with that use. The MRLs are then compared against the health- based guidance 
value in an evaluation commonly referred to as the dietary exposure (or dietary risk) assessment. This is 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 diffe r 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 
Phytos anitary Measures (the SPS Agreement) the proposed MRLs will be 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  
MRLs are set out in the New Zealand (Maximum Residue Levels for Agricultural 
Compounds) Food Notice. This Notice is amended regularly  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 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 MRL Food Notice, with the final dec ision on any 
changes to the Notice resting with the Director -General of MPI. The Food Notice is issued 
under section 405 of the Food Act 2014. When setting or amending MRLs, the Director -
General must take into account:   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  3 • 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 standards that apply 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.  
The requirements for the content of the MRL Food Notice ar e set out in Part 6 of the Food 
Regulations 2015, allowing for the promulgation of MRLs for agricultural compounds as well 
as the promulgation of exemptions from compliance with MRLs. In addition to establishing 
the requirements for domestically produced f oods, Part 6 of the Food Regulations also 
outlines the residue level compliance requirements for imported foods. Clause 144 states 
that food must contain residues of agricultural compounds:  
- no greater than the MRLs specified for that food in a notice set under the Food Act 2014 (section (1)(a)); or  
- the default MRL of 0.1 mg/kg (section (1)(c)); or  
- for imported food, the current editions of either the Maximum Residue Limits (MRLs) and Extraneous Maximum Residue Limits (EMRLs) for Pesticides (Codex Pesticide s 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)).  
 
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 SPS Agreement are met.  
On the whole, the Regulations allow for the management of residues in all foods consumed in New Zealand.  
2.1.1 National Estimated Dietary Intake  
The chronic dietary exposure to a substance is estimated by the NEDI calculation, encompassing all authorised uses of the agricultural compound, and using food consumption 
data based upon the 1997 National Nutritional Survey for adults and the 1995 National 
Nutrition Survey of Australia,  for children. The NEDI 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 potential chronic 
exposure to toxi cologically relevant residues in all food derived from crops/livestock treated 
with the agricultural compound according to the authorised GAP use.  
The possible implications for consumer health are considered during the toxicological and dietary risk assessments, by comparing the NEDI with a Health Based Guidance Value (HBGV). Provided the estimated dietary exposure of all toxicologically relevant residue 
components in all fresh and processed food is less than the HBGV, the use of an agricultural 
compound ac cording to GAP is unlikely to pose a health risk to consumers.  
2.1.2 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  
4 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  through a very similar scientific process. HBGVs are reported as milligrams of compound per 
kilogram bodyweight per day (mg/kg bw/d).  
A PDE (food) is a v alue 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 (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 (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.  
As required by the HSNO Act in New Zealand, 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 estimated dietary exposure is compared with the ADI, set by the 
WHO/FAO joint expert committees, the Australian Pesticides and Veterinary Medicines 
Authority (APVMA), the European Food Safety Authority (EFSA), or another regulatory authority. If none of these are available, the HBGV used will be a New Zealand Food Safety -
determined ADI.   
2.1.3 International MRLs and Trade  
Where MRLs are being set, t he “Relevant International MRLs” table listed in each entry is a 
summary of the MRLs set by Codex and a selection of other international regulatory bodies 
reviewed to evaluate trade risk. For animal commodities, the MRLs set by Australia, Canada, 
China, Co dex, the European Union, Japan, and the USA are reviewed and compared; for 
horticultural commodities, MRLs set by Codex and Australia are reviewed and compared. Other international MRLs are reviewed and reported in the table if there is a particular trade 
risk to be considered for those regions. If 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 internati onal MRLs” section of the 
proposal entry.  
Where MRL exemptions are proposed, the proposed exemptions from compliance with a MRL have been thoroughly assessed in accordance with international methodologies 
published by the Organisation for Economic Cooperat ion and Development (OECD), 
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), or FAO. Each proposal includes a discussion of the 
rationale behind the considerations for exemption,  and a discussion of the assessed risks. 
New Zealand Food Safety has evaluated the potential food safety and dietary intake risks 
associated with promulgating an exemption and have determined that MRLs are not required 
to manage compliance to GAP or food s afety risk.  
2.1.4 Agricultural Compounds for Which No Maximum Residue Level Applies   
There are some agricultural compounds for which it has been determined that their use in 
crops or animals does not require management through the application of a MRL.  This may 
be because there are no residues present due to the compound being eliminated quickly or 
not being absorbed by the treated crop or animal, or because there is no food safety or trade 
risk associated with the residues that are present. Clause 141 of the Food Regulations allow  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  5 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 Food Notice, respectively.  
Agricu ltural chemicals and veterinary medicines being considered for  listing as compounds 
for which no MRL applies undergo scientific assessment of their use in the target crop or 
species  similar to t hat conducted for ot her compounds  to characterise their residu e profiles 
and the potential risks posed to public health and trade.  This may include an assessment of 
dietary exposure when considered necessary to fully assess the risks. When the outcome of 
that assessment is a determination that a MRL is not required, the compound is listed in 
Schedules 2 or 3 with conditions on their use to ensure the listing applies only to the 
situations that have been evaluated. If a compound listed in Schedules 2 or 3 is used in a 
way that does not meet the specified condition, the default MRL will apply to food derived 
from treated plants or animals.  
2.2 SUMMARY OF PROPOSED AMENDMENTS  
The proposed MRLs have been thoroughly assessed 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. Information on the technical assessment of each proposal is included in this document (refer section 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 relevant authorities (e.g. Australia, Canada, China, EU, Japan, USA)  
 
Where an existing entry is proposed for revision, new or revised MRLs are highlighted in bold 
print, and MRLs proposed for revocation are identified using a strikethrough.  
MPI has reviewed the estimated dietary exposure assessments associated with all 
authorised and proposed uses according to what has been established as GAP for New 
Zealand, compared them with the appropriate HBGV (the PDE
(food) or an ADI), and has 
concluded that residues arising from these uses are unlikely to present any public health or 
food safety concerns.  
2.2.1 Amendments to Schedule 1: New  and Amended MRLs  
MPI proposes to add new MRLs to the Food Notice, and/or amend the existing entries , for 
the following compounds:  
• Fluazinam: 0.01(*) mg/kg in apples  
• Mandestrobin: 0.0 1(*) mg/kg in potatoes  
• Pyriofenone: 0.01(*) mg/kg in apples and 0.05 mg/kg in grapes  
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.   
6 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  2.2.2 Amendment to Schedule 2 : Agricultural Chemi cals for which No Maximum Residue Level 
Applies  
• MPI proposes to amend the following entries in Schedule 2:  
o The entry for active ingredients that are foods or permitted food additives, to 
revise the wording of the substance description for clarity;  
o the entry for microbial active ingredients, to revise the wording to ensure the 
listing manages the associated risk  without being unnecessarily restrictive; 
and 
o the entry for plant extracts (unrefined), to add three additional species to the list of plants from which extracts are derived that do not require the application 
of a MRL.  
2.2.3 Amendment to Schedule 3: Veterinary Medicines for which No Maximum Residue Level 
Applies  
• MPI proposes to add a new entry for zeolite to the schedule for veterinary medicines 
for which no MRL applies. The compound would not require compliance to a MRL 
when used in cattle as a calcium binder t o reduce the risk of milk fever and in food-
producing species as a mycotoxin binder.  
• MPI proposes to remove the entry for medroxyprogesterone acetate for intravaginal 
use in sheep, and replace it with one for progesterone for intravaginal use in sheep 
and cattle. Intravaginal p rogesterone is used in cattle and sheep to manage fertility 
status and anoestrus , and would not require compliance with a MRL when used in 
this manner.   
 
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  7 3 Proposals  
3.1 PROPOSAL TO AMEND THE MRLS FOR FLUAZINAM  
It is proposed that MRLs for fluazinam  are amended to establish a MRL to support the GAP 
use of the compound on apples.   
The revised 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)  
Fluazinam  79622 -59-6 Fluazinam  Apples  
Brassica vegetables  
Grapes  
Onions  
Potatoes  
Tomatoes   0.01(*) 
0.02(*) 
1 
0.02 
0.02(*)  
0.02(*)  
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.1.1 Amendment Rationale  
The MRL is being proposed to support the use of fluazinam  for the control of blackspot  on 
apples in accordance with the use pattern and withholding period that are proposed as GAP 
for New Zealand.   
3.1.2 Good Agricultural Practice  
Fluazinam  is a broad- spectrum pyridine  fungicide which acts by inhibiting spore germination, 
hyphal penetration, and organism growth. It is currently used in New Zealand on grapes to 
control downy mildew, Phomopsis  leafspot, and Botrytis , in potatoes to control blight, 
Sclerotinia, and powdery scab, in tomatoes to control Botrytis, Sclerotinia, and late blight, and 
in vegetable brassicas to control clubroot .  
The GAP use of fluazinam o n apples is up to two foliar application s at a maximum rate of  
420g ai/h a from tight cluster up until king fruit have reached 30 mm in size, with a 7- 14 day 
interval between applications. This use attracts a withholding period of 70 days, with a 
restriction that fluazinam is not to be applied after king fruit have reached 30 mm in size and 
not less than 70 days before harvest. Although livestock may be grazed in treated orchards, 
a livestock withhol ding period was not considered necessary to manage animal transfer 
residues  given the low potential for exposure to grazing animals .  
3.1.3 Residue Information 
The residue data for the use of fluazinam on apples  are sufficient to conclude that, when 
applied according to the proposed GAP use pattern, residues of fluazinam should not exceed 
the limit of quantification ( 0.01 mg/kg) . The current residue definition of ‘fluazinam ’ has been 
determined to be appropriate to apply to apples for both GAP  compliance and dietary intake 
assessment  as per the other crop commodities in which it is used.  
The potential for agricultural chemical residues to transfer to a nimal  commodities was 
considered for this use because animals may be grazed in apple orchards.  After a review of 
available data characterising the potential for fluazinam residues to transfer to animal 
commodities through grazing, i t was determined that animal commodity MRLs were not 
required due to the negligible residue profile in treated orchards and  the lack of detectable 
residues  in any animal commodities from exposed livestock.     
8 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  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 profile expected in food from  all foods treated with or exposed to 
fluazinam when used according to GAP, including the negligible residues expected in animal 
commodities,  the NEDI is estimated to total less than 11% of the HBGV . 
New Zealand Food Safety  has therefore determined that the use of  fluazinam on apples , 
when use according to the GAP specified above, is unlikely to pose any health risks from 
authorised use.   
3.1.5 Relevant International MRLs 
Authority                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Pome fruits  0.01 
There is no Codex MRL for fluazinam in apples.  
3.2 PROPOSAL TO AMEND THE MRLS FOR MANDESTROBIN  
It is proposed that MRLs for mandestrobin are amended to establish a MRL to support the 
GAP use of the compound on potatoes .  
The revised 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)  
Mandestrobin  173662 -97-0 Mandestrobin  Beans (with pods)  
Bulb onions  
Head lettuce  
Leafy lettuce  
Potatoes  0.7 
0.01(*)  
1.5 
10 
0.01(*)  
(*) 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 mandestrobin  on potatoes  for the control of 
early blight in accordance with t he use pattern and withholding period that are proposed as 
GAP for New Zealand.   
3.2.2 Good Agricultural Practice  
Mandestrobin is a systemic strobilurin  fungicide which acts by inhibiting mitochondria l 
respiration and disrupting the production of ATP in the fungal organism. It is currently used in 
New Zealand on beans and lettuce for the control of Sclerotinia, and on bulb onions for the 
control of white rot and downy mildew.    
The GAP use of mandestrobin on potatoes  is 375g ai/ha for a maximum of two applications 
at 7-10 day intervals. This use attracts a withholding period of seven  days.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  9 3.2.3 Residue Information 
The residue data for the use of mandestrobin on potatoes  are sufficient to conclude that, 
when applied according to the proposed GAP use pattern, residues of mandestrobin  should 
not exceed the limit of quantification ( 0.01 mg/kg) . The current residue definition of 
‘mandestrobin’  has been determined to be appropr iate to apply to potatoes  for both GAP  
compliance and dietary intake assessment  as per the other crop commodities in which it is 
used.  
Animal residue transfer information was not required or assessed for the use of 
mandestrobin in potatoes  as they are not  considered a primary feed commodity in New 
Zealand.   
3.2.4 Dietary Risk Assessment  
The HBGV  of 0.133 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residue profile expected in food from  all horticultural crops treated with 
mandestrobin including potatoes , the NEDI is estimated to total less than 1% of the HBGV . 
New Zealand Food Safety  has therefore determined that the use of  mandestrobin on 
potatoes , when use according to the GAP specified above, is unlikely to pose any health 
risks from authorised use.   
3.2.5 Relevant International MRLs 
There are no Codex  or Australian  MRL s for mandestrobin in potatoes.   
3.3 PROPOSAL TO AMEND THE MRLS FOR PYRIOFENONE  
It is proposed tha t MRLs for pyriofenone are amended to establish MRLs to support the GAP 
use of the compound on apples  and grapes .  
The revised 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)  
Pyriofenone 688046 -61-9 Pyriofenone Apples  
Fruiting vegetables 
(cucurbits)  
Grapes  0.01(*)  
 0.2 
0.05 
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.3.1 Amendment Rationale  
The MRL is being proposed to support the use of pyriofenone for the control of powdery 
mildew o n apples and grapevines in acc ordance with the use pattern and withholding period s 
that are proposed as GAP for New Zealand.   
3.3.2 Good Agricultural Practice  
Pyriofenone  is a benzoylpyridine  fungicide which acts by inhibiting actin/myosin/fimbrin 
function to disrupt hyphal  growth in the ta rget organism.  It is currently used in New Zeala nd for 
the control of powdery mildew on cucurbits.    
10 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  The GAP use of pyriofenone on apples and grapes is a maximum of two applications of 9 
gai/100L to the point of runoff at 10- 14 day intervals. In grapes, this use attracts a restriction 
that it is applied up to pre- bunch closure, and a withholding period of at least 65 days before 
harvest; in apples,  the use of pyriofenone  attracts a withholding period of 65 days.  
Because livestock may be grazed in treated orchards and vineyards, GAP for pyriofenone 
also includes a pre -slaughter interval of two months and a restriction that stock are not to be 
grazed within treated vineyards or orchards until after harvest. With these controls in place, 
the residue profile in exposed animals was negligible and thereby did not require the 
establishment of animal commodity MRLs.  
3.3.3 Residue Information 
The residue data for the use of pyriofenone on apples  and grapes are sufficient to conclude 
that, when applied according to the proposed GAP use pattern, residues of pyriofenone  
should not exceed the limit of quantification (0.01 mg/kg)  in apples or 0.05 mg/kg in grapes . 
The current residue definition of ‘fluazinam ’ has been determined to be appropriate to apply 
to apples and grapes for both GAP  compliance and dietary intake assessment  as per the 
other crop commodities in which it is used.  
The potential for agricultural chemical residues to transfer to animal commodities was  
considered for this use because animals may be grazed in apple orchards and vineyards. As 
described above, the residue data confirmed that with the application of the pre- slaughter 
interval and grazing restrictions considered part of GAP for pyriofenone,  residues in animal 
commodities  were negligible. It was therefore determined that animal commodity MRLs were 
not required for these uses.    
3.3.4 Dietary Risk Assessment  
The HBGV  of 0.05  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 
pyriofenone when used according to GAP , including the negligible residues  expected in 
animal commodities, the NEDI is estimated to total less than 0.3% of the HBGV . 
New Zealand Food Safety  has therefore determined that the use of  pyriofenone on apples  
and grapes , when use according to the GAP specified above, is unlikely to pose any health 
risks from authorised use.   
3.3.5 Relevant International MRLs 
Authority                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Dried grapes  
Grapes  2 
0.5 
Codex  Dried grapes  
Small fruit vine climbing  2.5 
0.8 
 
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  11 3.4 PROPOSAL TO AMEND THE ENTRY FOR ACTIVE INGREDIENTS THAT ARE 
FOODS OR PERMITTED FOOD ADDITIVES IN SCHEDULE 2  
It is proposed that the description of the substance in column 1 of the entry for active 
ingredients that are foods or permitted food additives  in Schedule 2 is amended to clarify the 
intent of the entry. The entry will be revised to remove the “and/or” part of the substance description, to ensure it is understood that either classification as a novel food as per section 1.1.2 in the Australia New Zealand Food Standards Code or identification of the active ingredient as one that deviates from the common physiochemical range or has undergone 
refinement will mean the compound attracts compliance with a MRL. Only those foods or permitted food additives that do conform to either of these classifications can be considered compounds for which MRLs do not apply.   
The proposed revised entry in Schedule 2 will read as follows:  
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 either  of the 
following apply :  
 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 
phys icoch emical range, or has 
undergone refining to a level 
exceeding that accepted as 
common for the food.  n/a  Used as an agricultural compound  
3.5 PROPOSAL TO AMEND THE ENTRY FOR MICROBIAL ACTIVE INGREDIENTS 
IN SCHEDULE 2  
It is proposed that  the description of the substance in column 1 of the entry for microbial 
active ingredients in Schedule 2 is amended to better reflect the use of these compounds in 
crops . The entry will be revised to extend the exemption to allow  quantifiable residues to be 
present at  over background levels, providing that the levels are not  considered to be a 
dietary intake concern.  
The existing exemption wording is difficult to comply with for any microbial active ingredient 
(MAI) which has quantifiable metabolites when applied close to harvest, even where the 
metabolite is non- pathogenic or non- toxic to humans . This ha s the consequence of restricting 
exemptions to MAIs with quantifiable metabolites to those with earlier application timings. 
Howe ver, GAP for MAIs commonly involves application close to harvest as part of an 
Integrated Pest Management programme. Th e revised  wording will allow MAIs with  
12 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  quantifiable metabolites to be exempt when used closer to harvest, providing the residue 
levels are not considered to be a dietary intake concern.  
The current scope, exclusion and condition will remain unchanged.  
The proposed revised  entry in Schedule 2 will read as follows:  
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 organisms (either viable or 
non-viable), organism organelles, 
organism metabolites, organism 
spores, or occlusion bodies.)  
 
This exemption 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 exemption applies when the 
Microbial Active Ingredient  leaves 
no residues of the parent 
organism, its metabolites or 
toxins on the treated crop at levels that are considered a 
dietary intake concern.   
 
This exemption 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 intended for use 
as an agricultural chemical.  
3.6 PROPOSAL TO AMEND THE ENTRY FOR PLANT EXTRACTS (UNREFINED)  IN 
SCHEDULE 2  
It is proposed that  Beta vulgaris  (sugar  beet, beetroot, and chard) , Undaria pinnatifida 
(Wakame  or edible seaweed), and Ribes nigrum  (Blackcurrant ) are added to the list of plants 
from which extracts can be considered compounds for which no MRL applies.  The entry 
concerns the use of plant extracts as compound intended for use as an agricultural chemical, rather than as a food commodity.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  13 It is considered that because these plants are edible commodities in their own right , residues 
from their use as agricultural  chemicals are unlikely to present a concern for human health 
requiring management through the application of a MRL.  As such,  it is proposed that these 
plants are added to the list of species from which extracts may be derived for use as  
agricultural chemicals to which no MRL applies.  
   
14 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  The proposed revised  entry in Schedule 2 will read as follows:  
Substance  CAS#  Condition  
Plant extracts (unrefined)  n/a  Except where listed in Schedule 1 of this Notice:  
Where the extract is in a product registered under the 
Agricultural Compounds and Veterinary Medicines Act 
1997 and intended for use as an agricultural chemical, 
and;  
Where the extract is derived from plants of the following species:  
Beta vulgaris (Sugar beet, beetroot, and chard)  
Camellia sinesis (Tea)  
Clitorea ternatea (Butterfly Pea)  
Fallopia sachalinensis (Giant knotweed)  
Melaleuca alternifolia (Tea Tree)  
Optuntia linheimeri (Texas prickly pear)  
Quercus falcate (Southern red oak)  Rhus aromatica (Fragrant sumac)  
Ribes nigrum (Blackcurrant)  
Rhizophoria mangle (Red mangrove)  
Undaria pinnatifida (Wakame)  
 
3.7 PROPOSAL TO  ADD AN ENTRY FOR ZEOLITES TO  SCHEDULE 3  
It is proposed that zeolites, including both naturally occurring and synthetically manufactured substances, are added to Schedule 3 of the notice to identify these compounds as veterinary 
medicines to which no MRL applies.  The zeolites are a group of hydra ted crystalline alumino-
silicate compounds containing exchangeable cations of group lA and lIA elements such as 
sodium, potassium, magnesium and calcium. These compounds are used in veterinary medicine as calcium binder s administered orally to cattle to reduce the risk of hypocalcaemia 
(milk fever) around the time of calving, and as gastrointestinal adsorbent s administered orally 
to bind mycotoxin s to prevent mycotoxicosis in food -producing species.  
When administered to food- producing animals, absorption of the aluminium component is 
minimal (<1%) and rapidly eliminated by the kidneys, with  no residues expected in edible 
tissues. Administration of zeolites to lactating cattle for the prevention of hypocalcaemia , 
result ed in aluminium milk residues that were not greater than the aluminium levels present 
in the normal diet . 
It is therefore concluded that the use of zeolites for the binding of ingested mycotoxins in food- producing animals and for the management of hypocalcaemia in lactating dairy cattle do 
not present  residue levels requiring management through the application of MRLs. As such, 
these compounds can be listed in Schedule 3 as veterinary medicines for which no MRL 
applies , with a condition that no MRL applies when the compound is administered orall y to 
food- producing species for the purposes of calcium binding or mycotoxin binding . 
The proposed new entry in Schedule 3 will read as follows:  
Substance  CAS#  Condition  
Zeolites  n/a When  used in  food- producing animals  as an orally 
administered calcium binder or mycotoxin binder   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  15 3.8 PROPOSAL TO REMOVE THE ENTRY FOR MEDROXYPROGESTERONE 
ACETATE AND ADD AN ENTRY FOR PROGESTERONE TO SCHEDULE 3  
It is proposed that  the entry for medroxyprogesterone acetate for intravaginal use in sheep in 
Schedule 3 is removed, and a new entry for progesterone for intravaginal use in sheep and 
cattle is added. Medroxyprogesterone acetate was used to manage anoestrus and fertility 
status by the administration of an intravaginal implant impregnated with the compound, but is no longer registered for use in New Zealand. The Schedule 3 entry for  medroxyprogesterone 
acetate is therefore no longer required.  
Current GAP for the management of reproductive cycles and fertility status in cattle and 
sheep is the use of progesterone -based intravaginal implants . This use can be expected to 
produce progesterone residues at levels similar to normal physiological levels, and therefore 
does not require a MRL to manage GAP or food safety. As such, it is proposed that 
progesterone is included in Schedule 3 as a veterinary medicine for which no MRL applies, with a condition that no MRL applies when the compound is used intravaginally in cattle and sheep.  
The Schedule 3 entry to be removed is the following:  
Substance  CAS#  Condition  
Medroxyprogesterone  acetate  71-58-9 For intravaginal use in sheep  
 
The proposed new entry in Schedule 3 will read as follows:  
Substance  CAS#  Condition  
Progesterone  57-83-0 For intravaginal use in cattle and sheep