Proposals to Amend the  New 
Zealand ( Maximum Residue 
Levels for Agricultural 
Compounds ) Food Notice   
 
New Zealand  Food Safety Discussion  Paper  No: 2021/04 
 
  
Prepared for public consultation  
By New Zealand Food Safety  
 
 ISBN No: 978 -1-99-100352 -2 (online)  
ISSN No: 2624- 0157 (online)  
 
  
 
April 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 Background  2 
2.2 Summary of Proposed Amendments  4 
3 Proposals  7 
3.1 Proposal to amend terminology in the Notice  7 
3.2 Proposal to amend the MRLs for amoxicillin  7 
3.3 Proposal to amend the MRLs for ampicillin  9 
3.4 Proposal to set MRLs for benzylpenicillins  11 
3.5 Proposal to amend the MRLs for cefquinome  13 
3.6 Propo sal to  set MRLs f or clavulanic acid 14 
3.7 Proposal to amend the MRLs for clomazone  16 
3.8 Pr oposal to set MRLs for  cloxacillin  17 
3.9 Proposal to set MRLs for erythromycin  19 
3.10  Propo sal to  set MRLs fo r ethof umesate 20 
3.11  Proposal to amend the MRLs for fludioxonil  21 
3.12  Proposal to amend the MRLs for lasalocid 23 
3.13  Propo sal to  set MRLs fo r metobromuron  24 
3.14  Proposal to set MRLs for pydiflumetofen  25 
3.15  Proposal to amend the MRLs for tilmicosin  27 
3.16  Proposal to amend the MRLs for tulathromycin  29 
3.17  Pr oposal to set MRLs for  tylosin  32 
3.18  Propo sal to  exemp t cod  liver o il f rom comp liance with a MRL in Sched ule 3 34 
3.19  Proposal to e xemp t smectite clays f rom comp liance with a MRL in Sched ule 3  34 
   
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 11 June 2021. Y our comments should be sent to: 
MRL Amendments  
New Zealand Food Safety  
Minist ry for Primary Industries  
PO Box 2526 Wellington 6140 
Email: MaximumResidueLevels@mpi.govt.nz . 
Please include your name and address on your submission. If you are making comments on behalf of an organisation, also include your title and the name of the organisation.  
Please make sure your comments can be clearly read, as a number of copies of your submission may be made.  
 
The Official Information Act  
The Official Information Act 1982 (the OIA) states that information is to be made available 
unless there are grounds for withholding it. The grounds for withholding information are outlined in the OIA.  Submitters may wish to indicate any grounds for withholding information contained in their submission.  Reasons for withholding information could include that 
information is commercially sensitive or that the submitters wish personal information such 
as names or contact details to be withheld.  MPI will take such indications into account when 
determining whether  to release information.  Any decision to withhold information requested 
under the OIA may be reviewed by the Ombudsman.  
 
  
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 ranges 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 differ from those established overseas for a similar use because their GAP 
may be different.  However, as noted below, imported food can also comply with Codex MRLs.  
To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures  (the SPS Agreement)  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 BACKGROUND  
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 decision 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 are 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 foods, 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 Limit s 
(MRLs) and Extraneous Maximum Residue Limits (EMRLs) for Pesticides (Codex Pesticides Residues in Food Online Database), or the Maximum Residue Limits for Veterinary Drugs in Food (Codex Veterinary Drug Residue in Food Online 
Database) (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 toxicologically 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 according 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 value determined by a toxicological evaluation by the New Zealand 
Environmental Protection Authority ( NZ EPA) as part of its responsibility for managing public 
health under the Hazardous Substances and New Organisms Act 1996 (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, the “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, Codex, 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 international 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 methodol ogies 
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. 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 safety risk.  
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  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  5 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:  
• Amoxicillin: 0.05 mg/kg in mammalian fat, 0.05 mg/kg in mammalian meat, 0.05 
mg/kg in mammalian offal, and 0.004 mg/kg in milk.  
• Ampicillin: 0.05 mg/kg in cattle fat, 0.05 mg/kg in cattle meat, 0.05 mg/kg in cattle offal, and 0.004 mg/kg in milk.  
• Benzylpenicillins: 0.05 mg/kg in mammalian fat, 0.05 mg/kg in mammalian meat, 0.05 
mg/kg in mammalian offal, and 0.004 mg/kg in milk.  
• Cefquinome: 0.02 mg/kg in cattle milk.  
• Clavulanic acid: 0.1 mg/kg in cattle fat, 0.1 mg/kg in cattle meat, 0.1 mg/kg in cattle 
offal, and 0.05(*) mg/kg in cattle milk.  
• Clomazone: 0.05(*) in winter squash.  
• Cloxacillin: 0.05 mg/kg in cattle fat, 0.1 mg/kg in cattle kidney, 0.05 mg/kg in cattle 
liver, 0.05 mg/kg in cattle meat, and 0.03 mg/kg in milk.   
• Erythromycin: 0.05 mg/kg in eggs, 0.1 mg/kg in poultry fat, 0.1 mg/kg in poultry meat, 
and 0.1 mg/kg in poultry offal.  
• Ethofumesate: 0.01(*) mg/kg in onions, bulb.  
• Fludioxonil: 0.02 mg/kg in mammalian fat, 0.05 mg/kg in mammalian kidney, 0.05 
mg/kg in mammalian liver, 0.01(*) mg/kg in mammalian meat, and 0.01(*) mg/kg in milk.  
• Lasalocid: 0.15 mg/kg in eggs.  
• Metobromuron: 0.01(*) mg/kg in potatoes.   
6 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  • Pydiflumetofen: 0.2 mg/kg in grapes, 0.03 mg/kg in mammalian fat, 0.01(*) mg/kg in 
mammalian meat, 0.03 mg/kg in mammalian offal, 0.02 mg/kg in milk, and 0.01(*) mg/kg in potatoes.  
• Tilmicosin: 0.05 mg/kg in cattle fat, 0.05 mg/kg in cattle meat, 0.3 mg/kg in cattle 
kidney, 1 mg/kg in cattle liver, 0.05 mg/kg in sheep fat, 0.05 mg/kg in sheep meat, 0.3 
mg/kg in sheep kidney, 1 mg/kg in sheep liver, and 0.05 mg/kg in milk.  
• Tulathromycin: 0.1 mg/kg in milk.  
• Tylosin: 0.1 mg/kg in cattle fat, 0.1 mg/kg in cattle meat, 0.1 mg/kg in cattle offal, 0.3 
mg/kg in eggs, 0.1 mg/kg in goat fat, 0.1 mg/kg in goat meat, 0.1 mg/kg in goat offal, 0.05(*) mg/kg milk, 0.1 mg/kg in pig fat, 0.1 mg/kg in pig meat, 0.1 mg/kg in pig offal, 0.1 mg/kg in poultry fat, 0.1 mg/kg in poultry meat, 0.1 mg/kg in poultry offal, 0.1 mg/kg in sheep fat, 0.1 mg/kg in sheep meat, and 0.1 mg/kg in sheep offal.  
 (*) indicates that the maximum residue level has been set at or about the limit of an alytical 
quantification.  
2.2.2 Amendment to Schedule 3: Exemptions from Maximum Residue Levels for Veterinary 
Medicines 
• MPI proposes to add an exemption for cod liver oil when used as a topical treatment 
for foot rot.  
• MPI proposed to add an exemption for smectite clays when used for the purpose of 
binding mycotoxins in food- producing animals.  
2.2.3 Other Amendments to the Notice  
• MPI also proposes to amend the Schedule headings for Schedules 2 and 3 to better 
reflect the wording in the Food Regulations under which the N otice is set.  
   
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 TERMINOLOGY IN THE N OTICE  
It is proposed that the Notice is amended to change the headings to Schedules 2 and 3.  The 
heading for Schedule 2 will be changed from “Exemptions from Maximum Residue Levels for 
Agricultural Chemicals” to “Agricultural Chemicals for which No Maximum Residue Level Applies”. Similarly, the heading for Schedule 3 will be changed from “Exemptions from 
Maximum Residue Levels for Veterinary Medicines” to “Veterinary Medicines for which No Maximum Residue Level Applies.”  
These changes are being proposed to more closely align the language in the Notice with that 
used in the Food Regulations  2015 under which the Notice is set. This change does not 
impact the function or scope of either Schedule or its use and will not change any of the 
entries within the Schedules .  
3.2 PROPOSAL TO AMEND THE MRLS FOR AMOXICILLIN  
It is proposed that the Notice entry for amoxicillin is amended to better support the GAP use of the compound in food- producing animals.  
The revised entry for amoxicillin in Schedule 1 of the Notice will read as follows. Changes are shown in bold:  
Compound 
Common Name  CAS#  Residue to which the maximum residue  level  
applies  Food Maximum  Residue 
Level (mg/kg)  
Amoxicillin  26787 -78-0 Amoxicillin  Mammalian fat  
Mammalian meat  
Mammalian offal  
Milk 0.05 
0.05 
0.05 
0.004  
3.2.1 Amendment Rationale  
The new and amended MRLs are being proposed to support the use of a moxicillin in cattle, 
pigs, and sheep in accordance with the dose rates and use patterns considered as GAP in 
New Zealand. The changes to the existing ‘meat’ and ‘edible offal’ MRLs to ‘mammalian fat,’ 
‘mammalian meat, ’ and ‘mammalian offal’ MRLs are being proposed to more accurately and 
clearly represent New Zealand food commodities; the MRLs themselves remain unchanged. The new milk MRL is being proposed to support GAP in lactating animals as the compound is approved for use in dairy  animals.  
The promulgation of these MRLs is an outcome of a review of all existing approved uses for 
veterinary medicines containing antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.  
3.2.2 Good Agric ultural Practice 
Amoxicillin is a penicillin antibiotic used for the treatment of bacterial infections either as a 
sole therapeutic active ingredient or in combination with clavulanic acid in companion and 
food- producing animals.  Oral liquid, oral tablet, injectable, and intramammary formulations 
are registered in New Zealand for use in companion animals, horses, cattle, sheep, and pigs.  
Amoxicillin dose rates for the oral and injectable formulations range between 7 mg/kg and 15 
mg/kg, while intramammary treatment is administered at 200mg amoxicillin per quarter. Meat and milk withholding periods  vary depending on the dose rate administered to each species  
8 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  and class , and with periods set at  between four and 28 days for meat and between 36 hours 
and 35 days for milk . 
3.2.3 Residue Information 
The residue data for the use of a moxicillin in food -producing species  are sufficient to 
conclude that, when administered as per existing  GAP use patterns and complying with the 
applicable withholding periods , residues  can be expected to remain below 0.05 mg/kg in all 
tissue commodities  and below  0.004 mg/kg in milk.  The residue profile of amoxicillin does  not 
differ significantly when administered as a sole active ingredient or in combination with 
clavulanic acid. This conclusion is based on a review of existing data on file for the registered products and all publicly available data and information relevant to GAP in New Zealand.   
The existing residue definition of ‘amoxicillin’ is considered appropriate for both GAP compliance and dietary intake for all commodities including milk.
 
3.2.4 Dietary Risk Assessment  
The HBGV of 0. 1 mg/kg bw/d, and the stated dietary intake residue definition,  are considered 
appropriate for use in the dietary intake assessment. Based on the residue profile expected 
in food from animals treated with amoxicillin,  the NEDI is estimated to total less than 0. 15% 
of the HBGV.   
MPI has therefore determined that amoxicillin , when used according to the GAP specified 
above, is unlikely to pose any health risks from authorised use.  
3.2.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle milk  
Edible offal (mammalian)  
Meat (mammalian)  
Sheep milk  0.01 
0.01 
0.01 
0.01 
Canada  Pig k idney, liver, muscle, skin and fat  0.01 
China Mammalian muscle  
Mammalian fat  
Mammalian liver  
Mammalian kidney  
Milk 0.05 
0.05 
0.05 
0.05 
0.004  
Codex  Cattle fat, liver, kidney, and muscle  
Cattle milk  
Pig fat/skin, liver, kidney, and muscle  
Sheep fat, liver, kidney, and muscle 
Sheep milk  0.05 
0.004  
0.05 
0.05 
0.004  
EU Edible tissues  
Milk 0.05 
0.004  
Japan Mammalian muscle  
Mammalian fat  
Mammalian liver  
Mammalian kidney  
Mammalian edible offal  
Milk 0.05 
0.05 
0.05 
0.05 
0.05 
0.004  
United States  Cattle fat, kidney, liver , muscle, milk  0.01  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  9 3.3 PROPOSAL TO AMEND THE MRLS FOR AMPICILLIN    
It is proposed that the Notice entry for am picillin  is amended to better support the GAP use of 
the compound in cattle . 
The revised entry for am picillin  in Schedule 1 of the Notice will read as follows. Changes are 
shown in bold:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food Maximum Residue 
Level (mg/kg)  
Ampicillin  69-53-4 and 
7177- 48-2 Ampicillin  Cattle  fat 
Cattle  meat  
Cattle  offal  
Cattl e Milk 0.05 
0.05 
0.05 
0.004  
3.3.1 Amendment Rationale  
The new and amended MRLs are being proposed to support the use of am picillin  in cattle  in 
accordance with the dose rates and use patterns considered as GAP in New Zealand. The 
changes to the existing ‘meat’ and ‘edible offal’ MRLs to ‘ cattle  meat,’ and ‘ cattle  offal’ MRLs 
are being proposed to more accurately and clearly represent New Zealand food commodities  
since the compound is only approved for use in cattle; th e MRLs themselves remain 
unchanged. The new milk MRL is being proposed to support  the GAP use of ampicillin in 
lactating dairy cattle . 
The promulgation of these MRLs is  an outcome of a review of all existing approved uses for 
veterinary medicines containing antibiotic compounds to ensure their use conforms with the 
expectations of GAP and prudent use.  
 
3.3.2 Good Agricultural Practice  
Ampicillin  is a penicillin antibiotic used in combination with cloxacillin for the treatment  and 
prevention of mastitis in dairy cattle during the dry (non- lactating) period. The compound is 
approved for use exclusively in intramammary preparations for dry dairy cattle and  is 
administered at doses of either 250mg or 300mg per quarter at the end of lactation.  This use 
attracts a meat  withholding period of 21 or 30 days, depending on the dose administered and 
the individual product’s dose rate, formulation pharmacokinetics, and residue profile . 
Intramammary treatments used in the dry period attract a two- part milk withholding period to 
manage residues depletion over the entire lactation cycle, with different periods set for the 
pre-calving interval (from treatment to calving), and from the onset of lactation (from calving 
onwards) . The use of ampicillin as a dry cow  treatment  attracts milk withholding periods of 
either 30 days pre- calving plus eight milkings post -calving , or 49 days pre- calving plus eight 
milkings post -calving.  
When an animal calves before the pre- calving period has elapsed, the entire withholding 
period must be observed before milk can be collected. For example, if a cow calves 45 days 
after treatment with a product attracting a milk withholding period of 49 days plus eight 
milkings, milk must be withheld for the four days remaining in the pre-calvi ng period plus an 
additional eight milkings  before it can enter the food chain. Like the meat withholding periods, 
the milk withholding periods are assigned based on each individual products’ use and residue profile.   
10 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.3.3 Residue Information 
The residue data for the use of am picillin in lactating  cattle  are sufficient to conclude that, 
when administered as per existing GAP use patterns and complying with the applicable 
withholding periods, residues can be expected to remain below 0.05 mg/kg in all tissue commodi ties and below  0.004 mg/kg in milk. This conclusion is based on a review of existing 
data on file for the registered products and all publicly available data and information relevant to GAP in New Zealand.   
The existing residue definition of ‘ampicillin’ is considered appropriate for both GAP compliance and dietary intake for all commodities including milk.
 
3.3.4 Dietary Risk Assessment  
The HBGV of 0. 003 mg/kg bw/d, and the stated dietary intake residue definition,  are 
considered appropriate for use in the dietary intake assessment. Based on the residue profile expected in food from cattle  treated with ampicillin , the NEDI is estimated to total less than  
4% of the HBGV.
  
MPI has therefore determined that am picillin , when used according to the GAP specified 
above, is unlikely to pose any health risks from authorised use.  
3.3.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle milk 0.01 
Canada  Fat, kidney, liver, muscle, and milk of cattle 0.01 
China Mammalian muscle  
Mammalian fat  
Mammalian liver  
Mammalian kidney  
Milk 0.05 
0.05 
0.05 
0.05 
0.004  
European Union Edible tissues  
Milk 0.05 
0.004  
Japan Cattle  muscle  
Cattle  fat 
Cattle liver  
Cattle  kidney  
Cattle  edible offal  
Milk 0.03 
0.03 
0.04 
0.03 
0.04 
0.02 
United States  Cattle fat, kidney, liver, muscle, milk  0.01 
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  11 3.4 PROPOSAL TO S ET MRLS FOR BENZYLPENICILLIN S  
It is proposed that MRLs are set for benzylpenicillin to support the GAP use of penethamate 
hydriodide, penicillin G benzathine, and penicillin G procaine as veterinary medicines.  
There is currently no entry for benzylpenicillin in the Notice  and therefore the default MRL 
applies . The new entry in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue  level  
applies  Food Maximum Residue 
Level (mg/kg)  
Benzylpenicillin s 
(includes 
penethamate hydriodide, 
penicillin G 
benzathine, and penicillin G 
procaine)  808-71-9, 
54-35-3, 
1538- 09-6, 
and  
6130- 64-9 Benzylpenicillin  Mammalian fat  
Mammalian meat   
Mammalian offal 
Milk   0.05 
0.05 
0.05 
0.004 
Separate entries for penethamate hydriodide (CAS number 808- 71-9), penicillin G 
benzathine (CAS number 1538- 09-6), and penicillin G procaine (CAS numbers 54- 35-3 and 
6130- 64-9) will be added to the Notice to reference back to the benzylpenicillin entry to avoid 
confusion. These reference entries will read:  
Penethamate 
hydriodide  808-71-9 See Benzylpenicillin s. 
 
Penicillin G benzathine  1538- 09-6 See Benzylpenicillin s. 
 
Penicillin G procaine  54-35-3 and 
6130- 64-9 See Benzylpenicillin s. 
3.4.1 Amendment Rationale  
The new MRLs are being proposed to support the use of the benzylpenicillins penethamate 
hydriodide, penicillin G benzathine, and penicillin G procaine in food- producing animals  in 
accordance with the dose rates and use patterns considered as GAP in New Zea land. The 
promulgation of these MRLs  is an outcome of a review of all existing approved uses for 
veterinary medicines containing antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.  
3.4.2 Good Agricultural Practice  
Penethamate hydriodide, penicillin G benzathine, and penicillin G procaine are 
benzylpenicillins  belong ing to the penicillin class of antibiotics . Penicillin G benzathine is 
benzylpenicillin combined with benzathine as a stabiliser, and penethamate hydriodide is a 
prodrug which is rapidly converted to benzylpenicillin after administration . Penicillin G 
procaine is a 1:1 combination of benzylpenicillin and procaine, with the former providing 
antimicrobial activity and the latter being a local anaesthetic. As per the approach of other regulatory authorities including Codex, MRLs specific to the procaine portion of penicillin G procaine is not required.  
The benzylpenicillins are used for the treatment of Gram -positive bacterial infections in cattle, 
sheep, horses , pigs, and companion animals, as well as the treatment of mastitis by 
intramammary administration in lactating dairy cattle. Meat and milk withholding periods vary  
12 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  depending on the dose rate administered to each species and class, and range between 
three days and 91 days for meat and between 48 hours and 35 days for milk . 
3.4.3 Residue Information 
The residue data for the use of the benzylpenicillins are  sufficient to conclude that, when 
applied as per the proposed GAP use patterns and complying with the applicable withholding 
periods, residues of these compounds  should not exceed 0.0 5 mg/kg in mammalian fat, 
meat, and offal, and 0.004 mg/kg in milk. These revised MRLs are based on residue data 
and information characterising the use of penethamate hydriodide, penicillin G benzathine, and penicillin G procaine in all approved food- producing species, either alone or in 
combination.  
The common residue definition of ‘benzylpenicillin’ applies to all three compounds  for both 
GAP compliance and dietary intake, and is consistent with the Codex approach for this group.  
3.4.4 Dietary Risk Assessment  
The HBGV of 0.03 mg/kg bw/d, and the stated dietary intake residue defi nition , are 
considered appropriate for use in the dietary intake assessment. The total NEDI from the use 
of all benzylpenicillins in  food from  animal s treated with these compounds  is estimated to 
total less than 1.4% of the HBGV.  
MPI has therefore determined that the additional use of benzylpenicillins, when that use is according to the GAP specified above, is unlikely to pose any health risks from authorised 
use. 
3.4.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia   
[Benzyl G p enicillin ] Mammalian meat  
Mammalian edible offal  
Milks  0.06 
0.06 
0.0015  
Australia  
[Procaine penicillin ] Mammalian meat  
Mammalian edible offal  
Milks  0.1 
0.1 
0.0025  
Canada   
[Penicillin G ] Cattle fat , meat, kidney, and liver  
Pig fat , meat, kidney, and liver  
Sheep fat, meat, kidney, and liver  
Milk 0.05 
0.05 
0.05 
0.01 
China  
[Benzylpenicillin / Procaine 
benzylpenicillin]  Cattle kidney , liver, and muscle  
Cattle milk  
Pig kidney , liver, and muscle   0.05 
0.004  
0.05 
Codex  
[Benzylpenicillin / Procaine 
benzylpenicillin]  Cattle kidney , liver, and muscle  
Cattle milk  
Pig kidney , liver, and muscle   0.05 
0.004 
0.05 
European Union 
[Benzylpenicillin  and 
penethamate]  All food producing species: muscle, fat, liver, and kidney 
All food producing species: milk  0.05 
0.004  
Japan 
[Benzylpenicillin]  Cattle  and pig  muscle  and fat  
Other terrestrial mammal muscle and fat  
Cattle and pig liver  and kidney  
Other terrestrial mammals, liver  and kidney  
Cattle and pig edible offal  
Other terrestrial mammals, edible offal  
Milk 0.05 
0.003  
0.05 
0.003  
0.05 
0.003  
0.004  
United States  
[Penicillin]  Cattle fat, kidney, liver, and muscle  0.05  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  13 3.5 PROPOSAL TO AMEND THE MRLS FOR CEFQUINOME   
It is proposed that the Notice entry for cefquinome is amended to establish a  revised MRL for 
the compound in milk . 
The revised entry for cefquinome in Schedule 1 of the Notice will read as follows. Changes 
are shown in bold:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food Maximum Residue 
Level (mg/kg)  
Cefquinome 84957 -30-2 Cefquinome Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  
Cattle milk  
Pig fat  
Pig kidney  
Pig liver  
Pig meat  0.05 
0.2 
0.1 
0.05 
0.02 
0.05 
0.2 
0.1 
0.05 
3.5.1 Amendment Rationale  
The revised MRL is being proposed to align with that established by overseas markets to 
better support the GAP use of the compound while facilitat ing trade in accordance with the 
use considered as GAP in New Zealand. The amendment of the cattle milk MRL is an 
outcome of a review of all existing approved uses for veterinary medicines containing 
antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.  
3.5.2 Good Agricultural Practice  
Cefquinome is a fourth generation cephalosporin antibiotic used for the treatment of 
respiratory disease, digital dermatitis and acute interdigital necrobacillosis  in cattle at a dose 
rate of 1 mg cefquinome/kg bodyweight, and to treat mastitis in cattle  either with a 1 mg/kg 
injection or by intramammary infusion of 75 mg cefquinome per infected quarter . Cefquinome 
is also used to treat respiratory infections and Mastitis -Metritis -Agalactia syndrome in pigs  at 
a dose rate of 1- 2 mg cefquinome per kg bodyweight . These uses attract withholding periods 
of five days for cattle meat, two days for pig meat, and 24 hours for milk after injectable 
administration, and two days for meat and 96 hours for milk from cattle treated by 
intramammary administration.   
3.5.3 Residue Information 
The residue data for the use of cefquinome in cattle and pigs ar e sufficient to conclude that, 
when used according to the established GAP and observing the applicable withholding 
periods , residues of cefquinome should not exceed the applicable MRLs including the 
proposed 0.02 mg/kg MRL in milk.  
The existing residue definition of ‘cefquinome’ is considered appropriate for both GAP 
compliance and dietary intake for all commodities including milk.  
3.5.4 Dietary Risk Assessment  
The HBGV  of 0.0019 mg/kg bw/d,  and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment.  Based on the residue profile 
expected in food from animals treated with cefquinome, the NEDI is estimated to total less 
than 11.2% of the HBGV.   
14 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  MPI has therefore determined that the use of cefquinom e in cattle and pigs, when use 
according to the GAP specified above, is unlikely to pose any health risks from authorised 
use.  
3.5.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
China Cattle/Swine muscle  
Cattle/Swine fat  
Cattle/Swine liver  
Cattle/Swine kidney  
Cattle milk  0.05 
0.05 
0.1 
0.2 
0.02 
European Union Bovine and porcine muscle  
Bovine and porcine fat  
Bovine and porcine liver  
Bovine and porcine kidney  
Bovine m ilk 0.05 
0.05 
0.1 
0.2 
0.02 
Japan Cattle muscle  
Pig muscle  
Cattle fat 
Pig fat  
Cattle liver  
Pig liver  
Cattle kidney  
Pig kidney  
Cattle edible offal  
Pig edible offal  
Milk  0.02 
0.05 
0.02 
0.05 
0.02 
0.1 
0.02 
0.2 
0.02 
0.2 
0.02 
3.6 PROPOSAL TO SET MRLS FOR CLAVULANIC ACID   
It is proposed that MRLs are set for clavulanic acid  to support the GAP use of the compound 
as a veterinary medicine.  
There is currently no entry for clavulanic acid  in the Notice and therefore the default MRL 
applies . The new entry in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue t o which the 
maximum residue level 
applies  Food Maximum Residue 
Level (mg/kg)  
Clavulanic acid  58001 -44-8 Clavulanic acid  Cattle  fat 
Cattle  meat  
Cattle offal  
Cattle milk 0.1 
0.1 
0.1 
0.05(*) 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.6.1 Amendment Rationale  
Clavulanic acid has been used in New Zealand as a veterinary medicine for several years, 
with its  use in cattle being subject to compliance with the New Zealand default MRL of 0.1 
mg/kg. The new MRLs are being proposed to provide transparency for , and support the use 
of, clavulanic acid  in cattle in accordance with the dose rates and use patterns considered as 
GAP in New Zealand.  
The promulgation of these MRLs are the result of a review of all existing approved uses for 
veterinary medicines containing antibiotic compounds to ensure their use conforms with the 
expectations of GAP and prudent use.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  15 3.6.2 Good Agricultural Practice  
Clavulanic acid is a β -lactamase inhibitor always used in combination with amoxicillin to 
extend that antibiotic’s therapeutic spectrum. It is approved for  oral or parenteral  use in 
companion animals and cattle to potentiate amoxicillin’s  treatment of bacterial infections at a 
dose range of 1.75- 2.5 mg/kg , and for intramammary administration to lactating cattle for the 
treatment of mastitis  at a dose rate of 50 mg clavulanic acid per infected quarter. The 
withholding periods applicable to clavulanic -acid-containing products are driven by the 
residues of its co -formulant amoxicillin, and  vary depending on dose rate, administration 
route, and class. The withholding periods applicable to amoxicillin are between four and 28 
days for m eat, and between 36 hours and 35 days for milk.  
3.6.3 Residue Information 
The residue data for the use of clavulanic acid  in cattle are sufficient to conclude that, when 
administered as per existing  GAP use patterns and complying with the applicable withholding 
periods, residues can be expected to remain below 0.1 mg/kg in all tissues and 0.05 mg/kg in 
milk. The highest administered dose rate, 50mg clavulanic acid per infected quarter by 
intramammary infusion, results in residues less than 0.05 mg/kg by  48 hours post- treatment .  
Data characterising parenteral and oral administration of the compound at lower rates  (up to 
2.5 mg/kg)  confirmed rapid elimination within the withholding periods assigned to New 
Zealand registered amoxicillin/clavulanic acid veterinary medi cines. These conclusion s are  
based on a review of existing data on file for the registered products and all publicly available data and information relevant to GAP in New Zealand.   
The parent compound ‘ clavulanic acid ’ is considered the most appropriate marker residue for 
both GAP compliance and dietary intake.   
3.6.4 Dietary Risk Assessment  
The HBGV  of 0.005 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment. Based on the residue profile 
expected in food from  cattle  treated with clavulanic acid , the NEDI is estimated to total less 
than 8.1% of the HBGV.   
MPI has therefore determined that  clavulanic acid,  when used according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.  
3.6.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle meat , edible offal, and milk  0.01 
European Union                  Cattle fat  and muscle   
Cattle liver  
Cattle kidney  
Cattle milk  
Pig fat/skin  and muscle  
Pig liver  
Pig kidney                              0.1 
0.2 
0.4 
0.2 
0.1 
0.2 
0.4 
Japan                           Cattle  and pig  fat and muscle  
Cattle  and pig  liver 
Cattle and pig kidney  
Cattle edible offal  
Pig edible offal  
Milk                                        0.05 
0.1 
0.2 
0.1 
0.05 
0.05  
16 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.7 PROPOSAL TO AMEND THE MRLS FOR CLOMAZONE  
It is proposed that the Notice entry for clomazone is  amended to amend the MRL for ‘squash’ 
to ‘winter squash’ to align with the approved uses of this compound. This is because there 
are currently no approved uses of clomazone in summer squash crops.  
The revised entry for clomazone in Schedule 1 of the Notice will read as follows. Changes 
are shown in bold:  
Compound 
Common Name  CAS#  Residue to which the maximum residue level applies  Food Maximum Residue 
Level (mg/kg)  
Clomazone 81777 -89-1 Clomazone Beans  
Brassica vegetables  Carrots  
Potatoes  
Pumpkin  
Winter squash  0.05(*)  
0.01(*)  
0.02  
0.05(*)  
0.05(*)  
0.05(*)  
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.7.1 Amendment Rationale  
The change from ‘squash’ to ‘winter squash’ is intended to more accurately align with the 
approved uses of this compound, which do not currently include summer squash varieties. The MRL value remains unchanged. The proposed MRLs will manage the use of the 
compound when used in winter squash in accordance with the use pattern currently 
accepted as GAP in New Zealand.  
3.7.2 Good Agricultural Practice  
The GAP use of clomazone remains unchanged. Clomazone is a pre- emergent 
isoxazolidinone systemic herbicide, taken up by plant roots and shoots and moves into the xylem, inhibiting carotenoid synthesis. GAP in winter squash and pumpkins is currently accepted as one application of up to 200 gai/ha, applied immediately after sowing. This use attracts a restriction that th e compound is only to be used at the pre- crop and weed 
emergence period. When used according to GAP, clomazone residues  are not expected to 
be found at quantifiable levels  in the harvested crop.  
3.7.3 Residue Information 
The residue data for the use of  clomazone in winter squash are sufficient to conclude that, 
when applied as per the proposed GAP use pattern, residues of parent clomazone are not 
expected in winter squash and should not exceed the limit of analytical quantification (0.05 
mg/kg).  
Animal commodity MRLs were not considered as winter squash is  not a primary animal feed.  
3.7.4 Dietary Risk Assessment  
The HBGV of 0.015 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment. Based on the residue profile 
expected in food from crops treated with clomazone, the NEDI is estimated to total less than 
0.9% of the HBGV.   
MPI has therefore  confirms that the  continued  use of clomazone, when use according to the 
GAP specified above, is unlikely to pose any health risks from authorised use.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  17 3.7.5 Relevant International MRLs 
There are no MRLs established by either Codex or Australia for clomazone in winter squash.  
3.8 PROPOSAL TO SET  MRLS FOR CLOXACILLIN   
It is proposed that MRLs are set for cl oxacillin  to support the GAP use of the compound as a 
veterinary medicine.  
There is currently no entry for cl oxacillin  in the Notice and therefore the default MRL applies . 
The new entry in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue level 
applies  Food Maximum Residue 
Level (mg/kg)  
Cloxacillin  61-72-3 Cloxacillin  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  
Cattle m ilk 0.05 
0.1 
0.05 0.05 
0.03 
3.8.1 Amendment Rationale  
Cloxacillin has been used in New Zealand as a veterinary medicine for several years, with its 
use in food- producing species being subject to compliance with the New Zealand default 
MRL of 0.1 mg/kg. The new MRLs are being proposed to provide transparency for and 
support the use of cloxacillin in cattle in accordance with the dose rates and use patterns considered as GAP in New Zealand.   
The promulgation of these MRLs are the result of a review of all existing approved uses for veterinary medicines containing antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.  
3.8.2 Good Agricultural Practice  
Cloxacillin is a semi- synthetic antibiotic in the penicillin class, primarily used to treat mastitis 
in lactating cattle and to t reat and prevent mastitis in cattle during the dry period. In lactating 
animals, cloxacillin is administered  by intramammary infusion to the infected quarter for up to 
six treatments once a day,  a use that attracts milk withholding periods of up to 96 hours after 
the last treatment and a meat withholding period of three days.  
For animals in the non- lactating or dry period, cloxacillin is administered alone or in 
combination with ampicillin  at the end of the lactation period.  The dry period use attract s milk 
withholding periods of up to 35 days pre- calving plus eight milkings post calving for the 
cloxacillin products, and up to 49 days pre- calving plus eight milkings post -calving  for the 
cloxacillin/ampicillin products.  When an animal calves before the pre- calving period has 
elapsed, the entire withholding period must be observed before milk can be collected. For 
example, if a cow calves 45 days after treatment with a product attracting a milk withholding 
period of 49 days plus eight milkings, milk must be withheld for the four days remaining in the pre-calving period plus an additional eight milkings before it can enter the food chain.  
Products used in the dry period attract meat withholding periods of up to 30 days.  
There is also one New Zealand product containing cloxacillin that is approved for use as a 
topical eye ointment in cattle, sheep, horses, and companion animals  for the treatment of 
bacterial keratoconjunctivitis . Because the dose of cloxacillin administered by topical ocular 
application is s mall and does not get systemically absorbed, it is used in food- producing 
animals without attracting a withholding period.  
18 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.8.3 Residue Information 
The residue data for the use of  cloxacillin, alone or in combination with ampicillin, are 
sufficient to establish MRLs for the use patterns and withholding periods considered GAP in 
New Zealand. When used according to GAP, and complying with the applicable withholding 
periods, cloxacillin residues will remain less than 0.05 mg/kg in liver, meat, and fat, less than 0.1 mg/kg in kidney, and less than 0.03 mg/kg in milk.  A residue definition of ‘cloxacillin’ has 
been determined to be appropriate to manage New Zealand GAP compliance and dietary intake in accordance with the residue definitions established by overseas authorities.  
Although the topical use of cloxacillin is approved in sheep and horses, residue data has confirmed that thi s does not result in detectable residues in any commodity when used 
according to New Zealand GAP. As such, it has been determined that it is not necessary to 
establish commodity specific  MRLs for foods  derived from sheep and horses . 
A residue definition of ‘cloxacillin’ is considered appropriate for both GAP compliance and dietary intake for all commodities including milk.  
3.8.4 Dietary Risk Assessment  
The HBGV  of 0.1 mg/kg bw/d, and the stated dietary intake residue definition, are  consid ered 
appropriate for use in the dietary intake assessment.  Based on the residue profile expected 
in food from  animals treated with cloxacillin , the NEDI is estimated to total less than 0.3% of 
the HBGV.  
MPI has therefore determined that the use of cloxacillin , when use alone or in combination 
with ampicillin according to the GAP specified above, is unlikely to pose any health risks from 
authorised use.   
3.8.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle milk  0.01 
Canada  Fat of cattle  
Kidney of cattle 
Liver of cattle 
Muscle of cattle                                                                                       0.01 
0.01 
0.01 
0.01 
European Union   Muscle  
Fat 
Liver  
Kidney  
Milk     0.3 
0.3 
0.3 
0.3 
0.03 
Japan  Cattle muscle  
Cattle fat 
Cattle liver  
Cattle kidney  
Cattle edible offal  
Milk                                                                 0.04 
0.04 
0.04 
0.04 
0.04 
0.02 
United States  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle muscle  
Cattle milk  0.01 
0.01 
0.01 
0.01 
0.01  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  19 3.9 PROPOSAL TO SET  MRLS FOR  ERYTHROMYCIN   
It is proposed that MRLs are set for erythromycin to support the GAP use of the compound in 
poultry.  
There is currently no entry for erythromycin in the Notice and therefore the default MRL 
applies . The new entry in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food Maximum Residue 
Level (mg/kg)  
Erythromycin  114-07-8 Erythromycin A  Eggs  
Poultry fat  
Poultry meat  
Poultry offal  0.05 
0.1 
0.1 
0.1 
3.9.1 Amendment Rationale  
The MRLs are being proposed to support the continued GAP use of erythromycin in poultry 
in accordance with the use patterns considered GAP in New Zealand. The promulgation of 
these MRLs are the result of a review of all existing approved uses for  veterinary medicines 
containing antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.   
3.9.2 Good Agricultural Practice  
Erythromycin is a macrolide antibiotic  which acts by inhibiting protein synthesis and thereby 
cell growth by binding bacterial ribosomes . It is approved for use in New Zealand under 
veterinary authorisation for the treatment of respiratory disease in poultry at dose rates of 15-20 mg/kg. This use attracts a meat withholding period of three days and an egg withholding period of three days . 
3.9.3 Residue Information 
The residue data for the use of  erythromycin in poultry  are sufficient to conclude that, when 
used according to the use pattern and withholding periods considered GAP in New Zealand, 
residues of erythromycin A are not expected to exceed 0.05 mg/kg in eggs or 0.1 mg/kg in all other tissues. This conclusion is based on a review of existing data on file for the registered products and all publicly available data and information relevant to GAP in New Zealand.   
The residue definition of ‘erythromycin A’ is considered appropriate for both GAP compliance 
and dietary intake assessment.    
3.9.4 Dietary Risk Assessment  
The HBGV  of 0.0025 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment.  Based on the residue profile 
expected i n food from poultry treated with erythromycin, the NEDI is estimated to total less 
than 17% of the HBGV.  
MPI has therefore determined that the use of erythromycin in poultry, when use d according 
to the GAP specified above, is unlikely to pose any health risks from authorised use.   
   
20 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.9.5 Relevant International MRLs 
Country                                                          Food  Maximum Residue 
Level (mg/kg)  
Australia  Poultry meat                              
Poultry, edible offal of  0.3            
0.3 
Canada  Kidney , liver, muscle, skin, and fat  of chickens  
Kidney, liver muscle, skin, and fat of  turkeys       0.125  
0.125  
China  Chicken  muscle, fat, liver, and kidney  
Turkey muscle, fat, liver, and kidney  
Chicken egg 0.1 
0.1 
0.05 
Codex  Chicken  kidney, liver, fat, and muscle  
Turkey kidney, liver fat, and muscle  
Chicken eggs  0.1 
0.1 
0.05 
European Union  Muscle , fat, liver, and kidney  
Eggs  0.2 
0.15 
Japan  Muscle, fat, liver, kidney, and edible offal of c hicken and other poultry  
Eggs of c hicken s and other poultry  0.1 
0.05 
United States  Chicken fat, kidney liver, muscle, and skin  
Turkey fat, kidney, liver, muscle, and skin 
Chicken and turkey egg s 0.125  
0.125  
0.025  
3.10 PROPOSAL TO SET MRLS FOR ETHOFUMESATE  
It is proposed that an MRL is set for ethofumesate to support the GAP use of the compound 
on bulb onions.  
There is currently no entry for ethofumesate in the Notice. The new entry in Schedule 1 of 
the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum resid ue limit applies  Food Maximum Residue 
Level (mg/kg)  
Ethofumesate  26225 -79-6 Ethofumesate  Onions, bulb  0.01(*)  
  (*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.10.1 Amendment Rationale  
The MRL is being proposed to support an expansion of the use of ethofumesate to include 
bulb onions. The proposed MRL will manage the use of the compound in the crop bulb 
onions in accordance with the use pattern and withholding period that are proposed as  GAP 
in New Zealand.  
3.10.2 Good Agricultural Practice  
Ethofumesate belongs to the benzofuranyl alkylsulfonate group of herbicides u sed to 
manage broadleaf weeds and grass weeds  in arable crops . The proposed use for 
ethofumesate in bulb onions is  for application at a rate of 450- 600 gai/ha to onions from 1st 
true leaf onwards at 7 - to14-day intervals, with a m aximum of 3 applications per crop.  This 
use attracts a withholding period of 90 days. 
3.10.3  Residue Information 
The residue data for the use of ethofumesate are sufficient to conclude that, when applied 
according to the proposed GAP use pattern, quantifiable residues of ethofumesate are not 
expected in bulb onions. The residue definition of ‘ ethofumesate’ remains ap propriate for 
plant commodities for GAP compliance and dietary intake assessment.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  21 Animal  commodity MRLs are not  required as a result of the proposed use,  as bulb onions  are 
not considered to be a primary animal feed in New Zealand.  
3.10.4 Dietary Risk Assessmen t 
The HBGV of 0.15 mg/kg bw/day was considered appropriate for use in the assessment.  
Based on the residue profile expected in food from crops treated with ethofumesate the NEDI 
is est imated to total less than 0.1 % of the HBGV  for the average New Zealand adult.  
New Zealand Food Safety  has therefore determined that the use of  ethofumesate, when 
used according to the GAP specified above, is unlikely to pose any health risks from 
authorised use.   
3.10.5 Relevant International MRLs 
Authority                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Bulb vegetables                         0.1(*)  
There are no MRLs set by Codex for ethofumesate in bulb onions.  
3.11 PROPOSAL TO AMEND THE MRLS FOR FLUDIOXONIL  
It is proposed that the Notice entry for fludioxonil is amended to set MRLs in animal 
commodities  to manage residues  arising from  leaf plucking and vineyard grazing practices.  
The revised entry for fludioxonil in Schedule 1 of the Notice will read as follows. Changes are 
shown in bold:  
Compound 
Common Name  CAS#  Residue to which the maximum 
residue level applies  Food Maximum Residue 
Level (mg/kg)  
Fludioxonil  131341 -86-1 Plant Commodities: Fludioxonil  
Animal Commodities: Sum of 
fludioxonil and metabolites determined as 2,2 -
difluorobenzo[1,1]dioxole -4-
carboxylic acid, expressed as fludioxonil Blackcurrants  
Blueberries  
Bulb onions  
Grapes  
Kumara  
Mammalian fat  
Mammalian kidney  
Mammalian liver  
Mammalian meat  
Milk  
Pineapples  
Strawberries  0.8 
0.5 
0.01(*)  
1 
10 
0.02 
0.05 
0.05 
0.01(*)  
0.01(*)  
7 
1 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.11.1 Amendment Rationale  
The MRLs are being proposed to support the practice of leaf plucking and grazing by sheep 
in vineyards. The proposed MRLs will manage the residues in sheep when exposed to 
fludioxonil  used in accordance with the use pattern proposed as GAP for vineyard treatment 
in Ne w Zealand.   
22 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.11.2 Good Agricultural Practice  
Fludioxonil is a non- systemic phenylpyrrole fungicide, with long residual activity and limited 
uptake into plant tissues. The mode of action is inhibition of conidia germination, and to a lesser 
extent, germ tube and mycelial growth inhibition.  
Fludioxonil is currently used in grapes, either alone or in combination with fluazinam or 
cyproconazole, with  label claims in NZ for use on grapes  up to 21- 28 days before harvest.   
The proposed new use in grapes is one foliar application of 25 g ai/hL up to 80% cap- fall, as 
a high- volume spray (or an equivalent rate/ha as a concentrate spray)  in combination with 
pydiflumetofen. This use also allows for the practice of  leaf plucking  by sheep to  thin the 
leaves around the bunches,  and grazing of interrow grass, with sheep introduced into treated 
vineyards immediately after spraying. This practice attracts a two -month slaughter interval  for 
exposed sheep, during which they must be placed on grazing free of any residues (“clean 
feed”).   
3.11.3 Residue Information 
The residue data for the use of fludioxonil  are sufficient to conclude that, when applied 
according to the proposed GAP use pattern, residues of fludioxonil should not exceed the current 1 mg/kg MRL in gra pes. The current residue definition of ‘fludioxonil’ remains 
appropriate for plant commodities (for both GAP  compliance and dietary intake assessment).  
Animal metabolism and feeding study data characterising the residue transfer potential to animal commodities following exposure to fludioxonil. These data are sufficient to conclude that use of the compound on grapes and subsequent vineyard grazing and leaf plucking practices will not result in residues above the proposed animal commodity MRLs. The proposed residue definitions applicable in New Zealand for animal commodities align with 
those established by Codex: the sum of fludioxonil and metabolites determined as 2,2-
difluorobenzo[1,1]dioxole-4- carboxylic acid, expressed as fludioxonil  for both GAP 
compliance and dietary intake.  
3.11.4 Dietary Risk Assessment  
The HBGV  of 0.0165 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residue profile expected in food from  horticultural crops treated with fludioxonil 
and animal commodities from sheep exposed to fludioxonil, the NEDI is estimated to total 
less than  13% of  the HBGV . 
New Zealand Food Safety  has therefore determined that the use of fludioxonil, when use 
according to the GAP specified above, is unlikely to pose any health risks from authorised 
use.  
3.11.5 Relevant International MRLs 
Authority                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Grapes  
Edible offal (mammalian)  
Meat (mammalian)  
Milks  2 
0.1 
0.05 
0.05 
Canada  Kidney, liver, and fat of cattle and sheep  
Meat of cattle and sheep 
Milk 0.05 
0.01 
0.01 
  
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  23 Authority                                                        Food  Maximum Residue  
Level (mg/kg)  
Codex  Grapes  
Edible offal (mammalian)  
Mammalian fats (except milk fats)  
Meat (from mammals other than marine mammals)  
Milks  2 
0.1 
0.02 
0.02 
0.04 
EU Bovine and ovine muscle  
Bovine and ovine fat  
Bovine and ovine liver  
Bovine and ovine kidney  
Bovine and ovine edible offals (other than liver and kidney)  
Milk 0.04 
0.02 
0.2 
0.2 
0.1 
0.04 
Japan Mammalian muscle  
Mammalian fat  
Mammalian liver 
Mammalian kidney  
Mammalian edible offal  
Milk 0.01 
0.05 
0.05 
0.05 0.05 
0.01 
United States  Cattle byproducts, fat, kidney, and liver  
Cattle meat  
Milk 
Sheep byproducts,  fat, kidney, liver , and meat  0.05 
0.01 
0.01 
0.01 
3.12 PROPOSAL TO AMEND THE MRLS FOR LASALOCID    
It is proposed that the Notice entry for lasalocid  is amended to set  a MRL  for eggs  to support 
the GAP use of the compound. 
The revised entry for lasalocid  in Schedule 1 of the Notice will read as follows. Changes are 
shown in bold:  
Compound 
Common Name CAS#  Residue to which the 
maximum residue level applies  Food Maximum Residue 
Level (mg/kg)  
Lasalocid  (or 
its sodium salt) 25999 -31-9 or 
25999 -20-6 Lasalo cid as free acid  Edible offal of poultry  
Eggs  
Poultry fat  
Poultry meat  5 
0.15 
0.2 
0.2 
3.12.1 Amendment Rationale  
The MRL is being proposed to better support the use patterns approved as GAP in New 
Zealand, which include the treatment of replacement layer pullets . The other changes to the 
entry are to add the CAS number specific to lasalocid sodium, and to adjust wording in the 
common name and residue definition for clarity.  
3.12.2  Good Agricultural Practice  
Lasalocid is a divalent  polyether ionophore antiprotozoal compound, which acts by inducing 
osmotic lysis of coccidial cells. It is used for the prevention of coccidiosis caused by Eimeria 
species in broiler chickens, turkeys, and replacement layer and breeder pullets  at a dose of 
75 to 125 mg lasalocid/kg feed. For broiler  chickens and turkeys, treatment is administered 
continuously in the feed; for replacement layer and broiler breeder pullets, treatment is administered for 1- 2 weeks, and is discontinued at least 14 days before the onset of egg lay.   
24 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  The use of lasalocid i n broiler chickens and turkey s attract s a nil meat withholding period, 
and the replacement layer pullet use attracts a 14-day egg withholding period to enforce 
GAP.  
3.12.3 Residue Information 
The residue data for the use of  lasalocid in chickens are  sufficient  to conclude that, when 
used according to the existing  GAP use pattern and conforming to the applicable withholding 
period, residues of lasalocid can be expected to conform to a MRL of  0.15 mg/kg in eggs.  
The GAP compliance and residue dietary intake definitions, ‘lasalocid as the free acid’ , will 
remain unchanged.  
3.12.4 Dietary Risk Assessment  
The HBGV  of 0.005 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary int ake assessment.  Based on the residue profile 
expected in food from poultry treated with lasalocid,  the NEDI is estimated to total less than 
21% of the HBGV.  
MPI has therefore determined that the use of  lasalocid in poultry, when use according to the 
GAP specified above, is unlikely to pose any health risks from authorised use.   
3.12.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Eggs  0.05 
EU Eggs  0.15 
Japan Chicken eggs  0.2 
Singapore Eggs  0.15 
3.13 PROPOSAL TO SET MRLS FOR METOBROMURON  
It is proposed that  an MRL is set for metobromuron to support the GAP use of the compound 
on potatoes.  
There is currently no entry for metobromuron in the Notice. The new entry in Schedule 1 of 
the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Residue 
Level (mg/kg)  
Metobromuron  3060 -89-7 4-bromophenylurea  Potatoes  0.01(*)  
  (*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.13.1 Amendment Rationale  
The MRL is being proposed to support the use of the novel active ingredient metobromuron 
in potatoes.  The proposed MRL will manage the use of the compound in potatoes in 
accordance with the use pattern and withholding period that are proposed as GAP in New 
Zealand.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  25 3.13.2 Good Agricultural Practice  
Metobromuron is a pre- emergent urea herbicide, which is taken up by roots and acts by 
inhibi ting photosynthesis. The proposed use in New Zealand is as a herbicide in potatoes, 
applied at a rate of 1.5- 2 kg ai/ha as a single pre- emergence spray to soil at last ridging. This 
use attracts a withholding period of ‘Before crop emergence’ . 
3.13.3  Residue Information 
The residue data for the use of metobromuron are sufficient to conclude that, when applied 
according to the proposed GAP use pattern, quantifiable residues of metobromuron  are not 
expected in potato tubers  at harvest. A residue definition of ‘ 4-bromophenylurea ’ has been 
proposed for  plant commodities for GAP compliance. For dietary intake assessment in plant 
commodities , the proposed residue definition is the ‘sum of parent  metobromuron, 
desmethoxy - metobromuron, desmethyl - metobromuron and 4-bromophenylurea ’, with 
residues being measured as 4- bromophenylurea and expressed as metobromuron (using a 
conversion factor of 3.4).  
Animal  commodity MRLs are not  required to support  the proposed use as potatoes  are not 
considered to be a primary animal feed in New Zeal and.  
3.13.4 Dietary Risk Assessment  
The HBGV  of 0.021 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the assessment. Based on the residue profile expected in 
food from crops treated with metobromuron, the NEDI  is estimated to total less than 0.2% of 
the HBGV.  
New Zealand Food Safety  has therefore determined that the use of metobromuron, when 
use according to the GAP specified above, is unlikely to pose any health risks from 
authorised use.   
3.13.5 Relevant International MRLs 
There are no MRLs set by Codex or Australia for metobromuron in potatoes. 
3.14 PROPOSAL TO SET MRLS FOR PYDIFLUMETOFEN   
It is proposed that  MRLs are set for pydiflumetofen to support the GAP use of the compound 
on grapes and potatoes.  
There is currently no entry for pydiflumetofen in the Notice. The new entry in Schedule 1 of 
the Notice will read:  
Compound 
Common Name  CAS#  Residu e to which the 
maximum residue limit 
applies  Food Maximum Residue 
Level (mg/kg)  
Pydiflumetofen  1228284 -64-7 Pydiflumetofen  
 Grapes  
Mammalian fat  
Mammalian meat  
Mammalian offal 
Milk 
Potatoes  0.2 
0.03 
0.01(*) 
0.03 
0.02 
0.01(*)  
  (*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.   
26 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.14.1 Amendment Rationale  
The MRLs are being proposed to support the use of the compound pydiflumetofen in grapes 
for powdery mildew and B otrytis  control, and in potatoes for early blight control  in accordance 
with the  use pattern and withholding period s that are proposed as GAP in New Zealand. The 
proposed MRLs will manage the use of the compound in grapes and potatoes, and residues 
in animal commodities resulting from the practice of  introducing sheep for  leaf plucking and 
grazing in vineyards . 
3.14.2 Good Agricultural Practice  
Pydiflumetofen is a carboxamide succinate dehydrogenase inhibitor (SDHI) fungicide with 
protectant activity against a range of fungal diseases. It is a 50:50 mixture of R - and S - 
enantiomers, both being biologically active.  
The compound is used to control early blight in potatoes  with the application of three foliar  
sprays of 50 gai/ha at 7- to 14-day intervals, or 75 gai/ha at 14- 21 days intervals, as part of a 
full season protectant programme. The withholding period applied to this use is 14 days. It is 
also currently approved for use at a  maximum of two applications of 4 g ai/100 L for powdery 
mildew control on grapes, applied before the start of flowering, at a 14- to 21-day interval. The 
withholding period applied to this use is “Do not apply after flowering has commenced”.  
The proposed new use pattern is a single application of  15 gai/hL for control of Botrytis 
cinerea in grapes, in combination with fludioxonil. The proposed withholding period  in grapes 
of “up to 80% capfall”  reflects this use and is considered to be Good Agricultural Practice for 
vineyard treatment. When used in vineyards, the use patterns allow for the practice of  leaf 
plucking  by sheep to  thin leaves around the bunches, and for grazing of interrow grass . This 
practice attracts a two -month slaughter interval for exposed sheep, during which they must 
be placed on grazing free of any residues (“clean feed”). This applies to both the powdery 
mildew and Botrytis  control uses.  
3.14.3 Residue Information 
The residue data for the use of pydiflumetofen are sufficient to conclude that, when applied 
according to the proposed GAP use pattern, residues of pydiflumetofen should not exceed 
0.2 mg/kg in grapes . In potatoes used according to the proposed GAP use pat tern, 
measurable residues of pydiflumetofen are not expected in tubers (or any processed commodities) from treated crops. The residue definition of ‘pydiflumetofen’  is appropriate for 
plant commodities (for both GAP  compliance and dietary intake assessment).  
Animal metabolism and feeding study data characterising the residue transfer potential to animal commodities following exposure to pydiflumetofen are sufficient to conclude that use 
of the compound on grapes and subsequent vineyard grazing and leaf plucking practices will not result in residues above the proposed animal commodity MRLs.  
The proposed residue definitions applicable in New Zealand align with those established by 
Codex . For GAP compliance in both plant and animal commodities, and for dietar y intake 
estimation in plant commodities, the residue definition is proposed to be pydiflumetofen. For 
dietary intake estimation in animal commodities, the proposed residue definitions  are: the 
sum of pydiflumetofen, 2,4,6- TCP and its conjugates, and 3- (difluoromethyl) -N-methoxy -1-
methyl -N-[1-methyl -2-(2,4,6 -trichloro -3-hydroxy - phenyl) ethyl]pyrazole-4- carboxamide 
(SYN547897) and its conjugates, expressed as pydiflumetofen for liver and kidney;  and the 
sum of pydiflumetofen and 2,4,6- TCP and its conjugates, expressed as pydiflumetofen,  for all 
other animal commodities.  
The potato use will have no impact on animal commodity residues,  as potatoes  are not 
considered to be a primary animal feed in New Z ealand.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  27 3.14.4 Dietary Risk Assessment  
The HBGV  of 0.06 mg/kg bw/d, and the stated dietary intake residue definitions, are  
considered appropriate for use in the assessment. Based on the residue profile expected in 
food from  horticultural crops treated with pydiflumetofen and animal commodities from sheep 
exposed to pydiflumetofen,  the NEDI is estimated to total less than 0.8% of the HBGV . 
New Zealand Food Safety  has therefore determined that the use of pydiflumetofen, when 
use according to the GAP specified above, is unlikely to pose any health risks from 
authorised use.   
3.14.5 Relevant International MRLs 
Authority                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Grapes  
Root and tuber vegetables  2 
0.05 
Canada  Fat of sheep and cattle  
Meat byproducts of sheep  and cattle 
Meat of cattle  and shee p 
Milk 0.03 
0.03 
0.01 
0.03 
Codex  Small fruit vine climbing  1.5 
Japan Mammalian muscle  
Mammalian fat  
Mammalian liver  
Mammalian kidney  
Mammalian edible offal  
Milk 0.01 
0.03 
0.03 
0.03 
0.03 
0.03 
United States  Cattle by products, fat, kidney, and liver  
Sheep by products, fat, kidney, and liver  
Cattle and sheep meat  
Milk  0.03 
0.03 
0.01 
0.03 
3.15 PROPOSAL TO AMEND THE MRLS FOR TILMICOSIN  
It is proposed that the Notice entry for tilmicosin  is amended to set MRLs to support the 
existing  GAP use s of the compound in cattle and sheep.  
The revised entry for t ilmicosin  in Schedule 1 of the Notice will read as follows. Changes are 
shown in bold:  
Compound 
Common Name CAS#  Residue to which the 
maximum residue level applies  Food Maximum Residue 
Level (mg/kg)  
Tilmicosin  108050 -54-0 Tilmicosin  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  
Milk 
Sheep fat  
Sheep kidney  
Sheep liver  
Sheep meat  
Pig fat  
Pig kidney  
Pig liver  
Pig meat   0.05 
0.3 
1 
0.05 
0.05 
0.05 
0.3 
1 
0.05 
0.1 
1 1.5 
0.1  
28 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.15.1 Amendment Rationale  
The MRLs are being proposed to support the continued GAP use of tilmicosin in cattle, 
sheep, and pigs in accordance with the use patterns considered GAP in New Zealand. The promulgation of these MRLs are the result of a review of all existing approved uses  for 
veterinary medicines containing antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.  
3.15.2 Good Agricultural Practice  
Tilmicosin is a macrolide antibiotic which acts by inhibiting protein synthesis and cell growth by binding to bacterial ribosomes. It is approved for use in New Zealand under veterinary authorisation for the treatment bovine respiratory disease (BRD) in cattle, the treatment of footrot  in sheep, and the treatment of pneumonia in pigs.  Tilmicosin is used at a dose rate of 
10 mg/kg in cattle, 5 mg/kg in sheep, and 8- 24 mg/kg in pigs. The withholding periods 
applicable to these uses are 28 days and 42 days for meat from cattle and sheep, 
respectively, 14 days for meat from pigs, and 35 days for milk from cattle and sheep.   
3.15.3 Residue Information 
The residue data for the use of tilmicosin in the approved target species are sufficient to conclude that, when used according to the use patterns and observing the withholding 
periods considered GAP in New Zealand, residues of tilmicosin  are not expected to exceed 
the proposed MRLs in commodities derived from cattle and sheep including milk. The MRLs 
applicable to pig- derived commodities will remain unchanged from those already established 
for tilmicosin at levels that align with MRLs established by Codex. Th ese conclusion s are  
based on a review of existing data on file for the registered products and all publicly available data and information relevant to GAP in New  Zealand.   
The residue definition of ‘ tilmicosin ’ is considered appropriate to apply to all animal 
commodities for both GAP compliance and dietary intake assessment .    
3.15.4 Dietary Risk Assessment  
The HBGV  of 0.00 2 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment. Based on the residue profile expected in food from animals treated with tilmicosin, the NEDI is estimated to total less than 
22% of the HBGV.  
MPI has therefore determined that the use of tilmicosin , when use according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.
  
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  29 3.15.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle and pig meat  
Cattle  and pig, edible offal of  0.05 
1 
Canada  Fat and muscle of cattle  
Kidney  and liver  of cattle  
Fat and muscle of sheep 
Kidney and liver of sheep 
Kidney of swine  
Liver of swine  
Muscle , skin, and fat  of swine  0.1 
1 
0.1 
1 1 1.5 
0.1 
China Cattle and sheep muscle  
Cattle and sheep fat  
Cattle and sheep liver  
Cattle and sheep kidney  
Pig muscle  and fat  
Pig liver  
Pig kidney  
Milk 0.1 
0.1 
1 
0.3 
0.1 
1.5 
1 
0.05 
Codex  Cattle muscle and fat                         
Cattle liver  
Cattle kidney  
Pig muscle and fat  
Pig liver  
Pig kidney  
Sheep muscle and fat  
Sheep liver  
Sheep kidney  0.1 
1 
0.3 
0.1 
1.5 
1 0.1 
1 
0.3 
EU Mammalian muscle  
Mammalian fat  
Mammalian liver  and kidney  
Milk  0.05 
0.05 
1 
0.05 
Japan Cattle, pig, and sheep  muscle  
Cattle, pig, and sheep fat 
Cattle  and sheep liver  
Pig liver  
Cattle  and sheep kidney  
Pig kidney  
Cattle  edible offal  
Sheep edible offal  
Pig edible offal  
Milk 0.1 
0.1 
1 1.5 
0.3 
1 0.5 
0.3 
1 
0.05 
United States  Cattle and sheep liver 
Cattle and sheep muscle  
Pig liver  
Pig muscle  1.2 
0.1 
7.5 
0.1 
3.16 PROPOSAL TO AMEND THE MRLS FOR TULATHROMYCIN  
It is proposed that the Notice entry for tulathromycin is amended to set MRLs to support the 
existing GAP use of the compound in cattle.  
   
30 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  The revised entry for tilmicosin in Schedule 1 of the Notice will read as follows. Changes are 
shown in bold:  
Compound 
Common 
Name CAS#  Residue to which the 
maximum residue level applies  Food Maximum Residue 
Level (mg/kg)  
Tulathromycin  217500 -96-4  
 Sum of residues converted to  
(2R,3S,4R,5R,8R,10R,11R,12S, 13S,14R) -2-ethyl-3,4,10,13 -
tetrahydroxy -3,5,8,10,12,14 -
hexamethyl -11-[[3,4,6 -trideoxy -
3(dimethylamino) -β-D-xylo-
hexopyranosyl]oxy] -1-oxa- 6-
azacyclopentadecan- 15-one, 
expressed as t ulathromycin 
equivalents  Cattle fat  
Cattle kidney  Cattle liver  
Cattle me at  
Milk  
Pig fat/skin  
Pig kidney  
Pig liver  
Pig meat  
Sheep fat  
Sheep liver  
Sheep kidney  
Sheep meat  0.1  
3  
3  
0.1  
0.1 
0.3  
3  
2  
0.5  
0.25  
5.4  
1.8  
0.45  
3.16.1 Amendment Rationale  
Tulathromycin has been used in New Zealand as a veterinary medicine for several years, 
with its use in cattle being subject to compliance with established MRLs for tissue commodities and the New Zealand default MRL of 0.1 mg/kg for milk. The new MRL  is being 
proposed to provide transparency for and support the use of tulathromycin in cattle in 
accordance with the dose rates and use patterns considered as GAP in New Zealand. All other MRLs will remain unchanged.  
The promulgation of this  MRL is  an outcome of a review of all existing approved uses for 
veterinary medicines containing antibiotic compounds to ensure their use conforms with the expectations of GAP and prudent use.  
3.16.2 Good Agricultural Practice  
Tulathromycin is a macrolide antibiotic which , like other macrolides,  acts by inhibiting protein 
synthesis and cell growth by binding to bacterial ribosomes. It has been approved for use in 
New Zealand since 2013 in cattle , sheep,  and pigs , for the treatment of respiratory disease 
and infectious bovine keratoconjunctivitis in cattle, respiratory disease in pigs, and footrot in sheep. The compound is used at a dose rate of 2.5 mg/kg in cattle, and 2.5 mg/kg in pigs  
and sheep, and  attracts withholding periods of 35 days for meat and 70 days for milk in 
cattle, 14 days for meat in pigs, and 21 days for meat in sheep.  
Tulathromycin is not approved for use in sheep producing or intending to produce milk for 
human consumption.      
3.16.3 Residue Information 
The residue data for the use of tulathromycin in the approved target species and 
commodities are sufficient to conclude that, when used according to the use patterns and 
observing the withholding periods considered GAP in New Zealand, residues are not expected to exceed the existing and proposed MRLs  in animal commodities.  Milk is currently 
expected to conform to a MRL of 0.1 mg/kg (the default MRL), so setting a MRL for it in 
Schedule 1 reflects the existing expectation as dictated by residue data. It is noted that the 
70-day cattle milk withholding period applied to tulathromycin will mean the compound is 
effectively excluded for use in cattle producing milk for human consumption.  
The residue definition  has been slightly revised from ‘ (2R,3S,4R,5R,8R,10R,11R,12S, 
13S,14R) -2-ethyl-3,4,10,13- tetrahydroxy -3,5,8,10,12,14 -hexamethyl -11-[[3,4,6 -trideoxy - 
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  31 3(dimethylamino) -β-D-xylo-hexopyranosyl]oxy]-1- oxa- 6-azacyclopentadecan- 15-one 
Expressed as: tulathromycin equivalents ’ to ‘sum of residues converted to  
(2R,3S,4R,5R,8R, 10R,11R,12S, 13S,14R) -2-ethyl-3,4,10,13- tetrahydroxy -3,5,8,10,12,14 -
hexamethyl -11-[[3,4,6 -trideoxy -3(dimethylamino) -β-D-xylo- hexopyranosyl]oxy] -1-oxa- 6-
azacyclopentadecan -15-one, expressed as tulathromycin equivalents ’. This change is to 
reflect that definition captures the sum of metabolites  that may be hydrolysed to that 
compound, aligning it with overseas definitions. This definition is considered appropriate for 
both GAP compliance and dietary intake.  
The change to the end of the definition is a  minor administrative change only, to link the 
‘expressed as’ portion to the rest of the definition.  
3.16.4 Dietary Risk Assessment  
The HBGV  of 0.05 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment. Based on the residue profile 
expected in food from animals treated with tulathromycin , the NEDI is estimated to total less 
than 3% of the HBGV.  
MPI has therefore determined that the use of tulathromycin , when use according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.   
3.16.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle  fat and muscle  
Cattle kidney  
Cattle liver  
Pig fat/skin  
Pig muscle  
Pig kidney  
Pig liver  0.1 
1 
3 0.3 
0.5 
3 
2 
Canada  Kidney of cattle  
Liver of cattle 
Muscle of cattle  
Kidney of swine  
Liver of swine  
Muscle of swine  4 
2 1 
5 
4 
1.5 
EU Bovine muscle  
Bovine fat  
Bovine liver  
Bovine kidney  
Porcine muscle 
Porcine skin + fat  
Porcine liver  
Porcine kidney  0.3 
0.2 
4.5 
3 
0.8 
0.3 
4 
8 
Japan Cattle muscle  
Pig muscle  
Cattle fat 
Pig fat  
Cattle liver  
Pig liver  
Cattle kidney  
Pig kidney  
Cattle edible offal  
Pig edible offal  0.3 
2 
0.2 
0.3 
5 4 
3 
9 3 
5 
United States  Cattle liver  
Swine kidney  5.5 
15  
32 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.17 PROPOSAL TO  SET MRLS FOR TYLOSIN  
It is proposed that MRLs are set for tylosin to support the GAP use of the compound in food-
producing animals.  
There is currently no entry for tylosin in the Notice and therefore the default MRL applies . 
The new entry in Schedule 1 of the Notice will read:  
Compound 
Common 
Name CAS#  Residue to which the 
maximum residue level applies  Food Maximum Residue 
Level (mg/kg)  
Tylosin  1401-69-0 Tylosin A  Cattle fat  
Cattle meat  
Cattle offal  
Eggs  
Goat fat  
Goat meat  
Goat offal  
Milk 
Pig fat  
Pig meat  
Pig offal  
Poultry fat  
Poultry meat  
Poultry offal  
Sheep fat  
Sheep meat  
Sheep offal  0.1 
0.1 
0.1 
0.3 
0.1 
0.1 
0.1 
0.05(*) 
0.1 
0.1 
0.1 
0.1 
0.1 
0.1 
0.1 
0.1 
0.1 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.17.1 Amendment Rationale  
The MRLs are being proposed to support the continued GAP use of tylosin in cattle, goats, 
sheep, pigs, and poultry, in accordance with the use patterns considered GAP in New 
Zealand. The promulgation of these MRLs  is an outcome of a review of all existing approved 
uses for veterinary medicines containing antibiotic compounds to ensure their use conforms 
with the expectations of GAP and prudent  use.  
3.17.2 Good Agricultural Practice  
Tylosin is a macrolide antibiotic which , like other m acrolides,  acts by inhibiting protein 
synthesis and cell growth by binding to bacterial ribosomes. It has been approved for use in New Zealand under veterinary authorisation for many years i n cattle, goats, sheep, pigs, and 
poultry , for the treatment of a number of clinically significant bacterial respiratory and 
gastrointestinal diseases .  
The compound is administered as a parenteral injectable treatment in all species except 
poultry at doses between 5 mg/kg and 10 mg/kg for up to five days ; administered v ia water to  
pigs and poultry at 100 mg/L drinking water and up to 500 mg/L drinking water, respectively; 
and administered via feed to beef cattle (up to 90 mg/head/day), pigs  (up to 100 ppm), and 
poultry (most commonly up to 100 ppm ).  
The residue profile of tylosin varies between target species, method of administration, and dose rates, but meat from treated animals attract withholding periods up to 28 days, milk from treated animals attract withholding periods up to 35 days, and eggs from treated layer 
hens do not require a withholding period.      
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  33 3.17.3 Residue Information 
The residue data for the use of tylosin  in the approved target species  and commodities  are 
sufficient to conclude that, when used according to the use patterns and observing the 
withho lding periods considered GAP in New Zealand, residues of  tylosin A  are not expected 
to exceed the proposed MRLs in animal commodities. This conclusion is based on a review 
of existing data on file for the registered products and all publicly available data  and 
information relevant to GAP in New Zealand.   
The residue definition of ‘ Tylosin A ’ is considered appropriate to apply to all animal 
commodities for both GAP compliance and dietary intake assessment.    
3.17.4 Dietary Risk Assessment  
The HBGV  of 0.03 mg/kg bw/d, and the stated dietary intake residue definition, are  
considered appropriate for use in the dietary intake assessment. Based on the residue profile expected in food from animals treated with tylosin, the NEDI is estimated to total less than 
3% of the HBGV.  
MPI has therefore determined that the use of tylosin , when use according to the GAP 
specified above, is unlikely to pose any health risks from authorised use.
  
3.17.5 Relevant International MRLs 
Country                                                        Food  Maximum Residue  
Level (mg/kg)  
Australia  Cattle meat  and edible offal  
Eggs  
Milk 
Pig fat  
Pig meat  and edible offal  
Poultry fats  
Poultry meat  and edible offal  0.1 
0.2 
0.05 
0.1 
0.2 
0.1 
0.2 
Canada  Fat, kidney, liver, and muscle  of cattle  
Kidney , liver, muscle, skin, and fat  of chickens  
Kidney , liver, muscle, skin, and fat of swine  
Kidney , liver, muscle, skin, and fat  of turkeys  0.2 
0.2 
0.2 
0.2 
Codex  Cattle liver , fat, muscle, and kidney  
Cattle  milk 
Chicken liver, muscle , kidney, fat and skin  
Chicken eggs  
Pig liver, fat, muscle, and kidney  
Sheep liver , muscle, and kidney  0.1 
0.1 
0.1 
0.3 
0.1 
0.1 
EU Bovine muscle, fat, liver, and kidney  
Bovine milk  
Porcine muscle, skin + fat, liver, and kidney  
Poultry muscle, skin + fat, liver, kidney  
Poultry eggs   0.1 
0.05 
0.1 
0.1 
0.2 
Japan Cattle, pig, and other terrestrial mammal muscle  
Cattle, pig, and other terrestrial mammal fat  
Cattle, pig, and other terrestrial mammal liver  
Cattle, pig, and other terrestrial mammal kidney  
Cattle, pig, and other terrestrial mammal edible offal  
Milk 
Chicken muscle, fat, liver, kidney, and edible offal  
Chicken eggs  0.1 
0.1 
0.1 
0.1 
0.1 
0.1 
0.1 
0.3 
United States  Cattle fat, kidney, liver, and muscle  
Chicken and turkey fat, kidney, liver, and muscle 
Chicken and turkey eggs  
Swine fat, kidney, liver, and muscle  0.2 
0.2 
0.2 
0.2  
34 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.18 PROPOSAL TO EXEMPT COD LIVER OIL FROM COMPLIANCE WITH  A MRL  IN 
SCHEDULE 3  
It is proposed that  cod liver oil is exempt from compliance with an MRL by amendment to 
Schedule 3 of the Notice when it is used as a  topical antifungal and antibacterial treatment. 
The compound is an extract comprised of the omega -3 fatty acids eicosapentaenoic acid 
(EPA) and docosahexaenoic acid (DHA)  as well as vitamins A and D. It  is commonly used as 
a human dietary supplement.  
When used as a  veterinary medicine, cod liver oil is applied as a topical spray with very little 
potential for systemic absorption and therefore not expected to result in residues in animal 
commodities. While there are dosing limits when consumed as a dietary supplement, the 
levels of cod liver oil and its components present in treated animals would not approach 
these levels and therefore not pose any food safety  risks.  
The proposed entry in Schedule 3 will read as follows :  
Substance  CAS#  Condition  
Cod liver oil 8001 -69-2 When  used as a  topical antifungal or antibacterial 
treatment  
3.19 PROPOSAL TO EXEMPT SMECTITE CLAYS FROM COMPLIANCE WITH A MRL  
IN SCHEDULE 3  
It is proposed that smectite clays are exempt from compliance with an MRL by amendment to Schedule 3 of the Notice. The exemption will attract a condition that it is only exempt from MRL compliance when used as a mycotoxin binder in food- produci ng animals.  
Smectite clays are phyllosilicate  compounds  comprised of montmorillonite in varying 
quantities, in addition to other mineral compounds and various elemental constituents. These clays are used in food- producing animals as gastrointestinal adsorbents , primarily for the 
binding of fungal toxins for the prevention of mycotoxicosis. Smectite clays possess no pharmacological activity and are not systemically adsorbed and are therefore not expected to 
cause residues in treated animals.  
Bentonite, one of the most commonly used smectite clays,  is recognised as GRAS under 
21CFR582.1155 when used in accordance with good manufacturing or feeding practice.   It is 
also included on the FDA approved inactive ingredient register and is approved for inclusi on 
in tablets at up to 355mg.   Given the term bentonite is widely used in literature without 
specificity it is considered that the GRAS status applies equally to all clays in the smectite 
group.  
As naturally mined substances, smectite clays have the potential to contain heavy metals and dioxins.  These contaminants are managed as part of the registration process for 
veterinary medicines  like mycotoxin binders, and therefore do not preclude the promulgation 
of an exemption. 
The proposed entry in Schedule 3 will read as follows:  
Substance  CAS#  Condition  
Smectite clays n/a When used for the purpose of binding  mycotoxin s in 
food- producing animals