Proposals to Amend the New 
Zealand ( Maximum Residue 
Levels for Agricultural 
Compounds) Food Notice   
 
New Zealand Food Safety Discussion  Paper  No: 2020/ 02 
 
 
 
Prepared for public consultation 
By New Zealand Food Safety  
 
 
ISBN No: 978-1-99-001779- 7 (online)  
ISSN No: 2624- 0157 (online)  
 
 
 
 February  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 Submissi ons 1 
2 Introduction  2 
2.1 Background  2 
2.2 Summary of Proposed Amendments  4 
3 Proposals  5 
3.1 Proposal to exempt glycer ol from compliance with a MRL when used in teat sanitisers  5 
3.2 Proposal to exempt sorbitol from compliance with a MRL when used in teat sanitisers  6 
   
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 details of the exemption as proposed 
(substance or conditi on 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  3 April  2020 . Your 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 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 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 t hey 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 diet ary 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 MRL will be not ified 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 Safety website at: 
https://www.mp i.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:  
• 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 Notice •  3 • the desirability of maintaining consist ency 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 promulg ation 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 Onl ine 
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) [W orld 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 rel evant 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 scientif ic 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 facts at 
the time”. “Without appreciable risk” has been further defined as: “the practical certainty that injury will not result even after a lifetime of exposure”. ADIs are established by the WHO and 
Food and Agriculture Organization (FA O) of the United Nations joint expert committees, 
which are made up of toxicologists and residue specialists. The ADI information from these 
joint committees also feeds into the Codex Alimentarius Commission (Codex), which sets 
international MRLs.  
As requ ired 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  
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 
internati onal body or regulator is omitted from the “other international MRLs” section of the 
proposal entry.  
 
2.2 SUMMARY OF PROPOSED AMENDMENTS  
The proposed exemptions from compliance with a MRL have been thoroughly assessed in accordance with international methodolo gies 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 o f 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 that MRLs ar e not required to manage compliance to GAP or food safety 
risk. 
2.2.1 Amendments to Schedule 3: Exemptions from Maximum Residue Levels for Veterinary 
Medicines  
New Zealand Food Safety  proposes to add a new exemption for glycer ol in Schedule 3 of the 
Food Notice,  for which compliance with a maximum residue level  is not required . This 
compound is commonly used on udders of dairy animals  as an emollient  and skin conditioner  
in teat sanitisers.  
New Zealand Food Safety also proposes to add a new exemption for sorbitol in Schedule 3 
of the Food Notice, for which compliance with a maximum residue level  is not required . Like 
glycerine this compound is commonly used as an emollient and skin conditioner on dairy 
animals, and can be used with glycerine in a single teat sanitiser compound.    
New Zealand Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice •  5 3 Proposals  
3.1 PROPOSAL TO  EXEMPT GLYCER OL FROM COMPLIANCE WITH  A MRL  
It is proposed that  glycerine, when used as an emollient and skin conditioner in teat 
sanitisers appli ed to lactating dairy animals,  be exempt from compliance with an MRL by 
addition to Schedule 3 of the Notice.  Glycer ol, also called glycerine or glycerin,  is a polyol 
compound used as a food additive and in pharmaceutical preparations. In veterinary 
medici nes, glycer ol is used as a  solvent  and stabiliser  excipient in liquid formulations, and as  
an emollient and skin conditioner in teat sanitisers. Glycerol is generally recognised as safe 
as a food additive and humectant when used in accordance with good manufacturing 
practice in food manufacture and with good agricultural practice for veterinary use.  
The quantity of glycerol in milk would be limited given that teat sanitisers are diluted prior to 
use and are generally administered to dairy animals as a topical post -milking treatment in 
New Zealand. Due to this, and the recognition that the compound is internationally 
considered s afe for other food -related uses, an exemption with conditions is being proposed 
to ensure good agricultural practice without the need to apply residue limits.   
The proposed  entry in Schedule 3 will read as follows:  
Substance CAS#  Condition  
Glycerol (glycerine)  
 56-81-5 When  used topically as a skin conditioner or as an 
active ingredient in a teat sanitiser  
 
3.2 PROPOSAL TO  EXEMPT SORBITOL  FROM COMPLIANCE WITH  A MRL  
Sorbitol is also a polyol compound used in a similar manner to glycerol in veterinary 
medicines, particularly its use in dairy teat sanitisers as a skin conditioner. Sorbitol is also 
generally recognised as safe, though it is known to have gastrointestinal  effects at high 
doses. Its presence in milk through the application of teat sanitisers would be limited due to the way sanitisers are used in New Zealand. As per glycerol, an exemption for sorbitol allows 
for assurance of the good agricultural practice of  its use in teat sanitisers without the need for 
residue limits.  
The proposed  entry in Schedule 3 will read as follows:  
Substance CAS#  Condition  
Sorbitol  
 50-70-4 When  used topically as a skin conditioner or as an 
active ingredient in a teat sanitiser