 
 
Proposals to Amend the New 
Zealand ( Maximum Residue 
Levels for Agricultural 
Compounds) Food Notice   
 
New Zealand Food Safety Discussion  Paper  No: 2020/ 03 
 
 
 
Prepared for public consultation 
By New Zealand Food Safety  
 
 
ISBN No: 978-1-99-001769- 8 (online)  
ISSN No: 2624- 0157 (online)  
 
 
 
 April  2020 
 
 
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  6 
3.1 Proposal to Amend the Exemption for Plant Extracts (Unrefined)  from Compliance with a MRL  6 
3.2 Proposal to Exempt Medium Chain Fatty Acids and their Mono- , Di-, and Triglycerides  from 
Compliance with a MRL  7 
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Noti ce • 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 details of the exemption as proposed 
(substance or condition of exemption) ? 
 
Do you oppose an exemption  being set at all  for this compound for the commodity? If 
so, why do you oppose it?  
 
 
Submissions close at 5pm on 16 June  2020. Y our comments should be sent to:  
 
MRL Amendments  
New Zealand Food Safety  
Ministry for Primary Industries  
PO Box 2526 
Wellington 6140 
 
Email: ACVM.Consultation@mpi.govt.nz . 
 Please include your name and address on your submission. If you are making comments on 
behalf of an organisation, also include your title and the name of 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 i nclude 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 or not 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 (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 agricultu ral 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 smal lest 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) 
asse ssment. 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 monit or 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 MRL will be notified to the 
World Trade Organization. Any country may choose to comment if they believe the proposed MRL represents a barrier to their trade.  
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 Safet y 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 M PI. 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:  
• the need to protect public health;  
• the desirability of avoiding unnecessary restrictions on trade;   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Noti ce • 3 • 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 Austr alia-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 on 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 Limits 
(MRLs) and Extraneous Maximum Residue Limits (EMRLs) for Pesticides (Codex 
Pesticides Residues in Food Online Database), or the Maximum Residue Limits 
for Veterinary Drugs in Food (Codex Veterinary Drug Residue in Food Online 
Database) (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 predi cting 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 
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 (EPA) as part of its responsibility for managing public 
health under the Hazardous Substances and New Organisms Act 1996 (the HSNO Act).  A  
4 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  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 fac ts 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 Nati ons 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 EPA as the HBGV for the estimation of dietary exposure when one is available. If 
there is no PDE (food), the estimated dietary exposure is compared with the ADI, set by the 
WHO/FAO joint expert committees, the Australian Pesticides and Veterinary Medicines Authority (APVMA), the European Food Safety Authority (EFSA), or another regulatory 
authority. If none of these are available, the HBGV used will be a New Zealand Food Safety -
determined ADI.   
2.1.3 International MRLs and Trade  
Where MRLs are being set, t he “Relevant International MRLs” table listed in each entry is a 
summary of the MRLs set by Codex and a selection of other international regulatory bodies 
reviewed to evaluate trade risk. For animal commodities, the MRLs set by Australia, Canada, 
China, 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 methodologies 
published by the Organisation for Economic Cooperation and Development (OECD), 
International Cooperation on Harmonisation of Technical Requirements for Registration of 
Veterinary Medicinal Products (VICH), or FAO. Each proposal includes a dis cussion 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 determined tha t MRLs are not required to 
manage compliance to GAP or food safety risk.  
 
2.2 SUMMARY OF PROPOSED AMENDMENTS  
2.2.1 Amendment to Schedule 2: Amendment of an E xemption from Maximum Residue Levels 
for Agricultural Chemicals 
New Zealand Food Safety  proposes to amend the existing exemption Plant Extracts 
(unrefined)  in Schedule 2 of the Food Notice, for which compliance with a maximum residue 
level is not required  for agricultural chemical compounds . This amendment will add an 
additional plant species,  Clitorea ternatea  (Butterfly P ea), to allow extracts from this plant to 
be used as an agricultural compound as an insecticide in fruit and vegetable crops  without 
the need for compliance with a MRL.   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Noti ce • 5 2.2.2 Amendment to Schedule 3: Exemptions from Maximum Residue Levels fo r Veterinary 
Medicines  
New Zealand Food Safety also proposes to add a new exemption for medium chain fatty 
acids and their mono- , di-, and triglycerides  in Schedule 3 of the Food Notice, for which 
compliance with a maximum residue level is not required for veterinary medicine compounds . 
These fatty acids are used as antimicrobials in teat sanitisers  for the prevent ion of  mastitis in 
dairy animals.     
6 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice New Zealand Food Safety  3 Proposals  
3.1 PROPOSAL TO  AMEND THE EXEMPTION FOR PLANT EXTRACTS 
(UNREFINED)  FROM COMPLIANCE WITH  A MRL  
It is proposed that the curren t list of plant species in the Plant E xtract s (unrefined) exemption 
is amended to include extracts derived from  Clitorea ternatea  (Butterfly pea).  The Clitorea 
ternatea  extract will be used as an insecticide for whitefly, thrips, aphids, scale and other 
sucking insects in a range of food and non -food producing crops . The main extract 
components , flavonoids and cyclotides , are the same or closely similar to those commonly  
found in food.   
When used according to GAP , residues from the  Clitoria ternatea extract will not occur in 
foods and animal feeds above background level s of these or similar compounds. The 
compounds in the extract are therefore  not expected to produce any toxic effects from dietary 
exposure.  
 
The entry in Schedule 2 i s proposed to be amended as follows : 
Substance CAS#                                      Condition  
Plant extracts (unrefined)  n/a  Except where listed in Schedule 1 of this Notice:  
Where the extract is in a product registered under the Agricultural Compounds and Veterinary Medicines Act 
1997 and intended for use as an agricultural chemical, 
and;  
Where the extract is derived from plants of the following species:  
Camellia sinesis (Te a)  
Fallopia sachalinensis (Giant Knotweed),  
Melaleuca alternifolia (Tea Tree)  
Optuntia linheimeri (Texas prickly pear),  
Quercus falcate (Southern red oak),  
Rhus aromatica (Fragrant S umac),  
Rhizophoria mangle (Red M angrove)  
Clitorea ternatea  (Butterf ly Pea) 
   
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Noti ce • 7 3.2 PROPOSAL TO  EXEMPT  MEDIUM CHAIN FATTY ACIDS AND T HEIR MONO -, 
DI-, AND T RIGLYCERIDES  FROM C OMPLIANCE WITH A MRL  
Medium chain fatty acids and their mono- , di-, and triglycerides, such as lactic, capric, 
caprylic, lauric, and myristic acids , are used as antimicrobial active ingredients in some teat 
sanitisers . These compounds are generally recognised as safe (GRAS) for human 
consumpti on when used as food additives; when used according to GAP, the residues 
resulting from their use as teat sani tisers can be expected to be low in milk and dairy 
products  and comparable to GRAS food additive levels.  
The promulgation of an exemption for these medium chain fatty acids will allow  for assurance 
of the ir good agricultural practice use in teat sanitisers  without the need to establish 
maximum residue levels .  
The proposed  entry in Schedule 3 will read as follows:  
Substance CAS#  Condition  
Medium chain fatty acids (C6 -
C12) and their mono- , di-, and 
triglycerides  n/a When  used as a teat sanitiser  
 