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© Food Standards Australia New Zealand 2016
While all care has been taken to ensure information is accurate, all information in this publication is only intended as a guide. It is intended to provide general information to persons in relation to food regulatory matters and the Australia New Zealand Food Standards Code. Its contents constitute general guidelines only and may be changed by FSANZ without notice at any time. It is not a substitute for legal advice. FSANZ expressly disclaims liability for any loss or damage directly or indirectly suffered by any person arising out of any errors or omissions in this Guide or any reliance in part or in full upon the contents of this Guide.
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CONTENTS
GUIDE TO SUBMITTING REQUESTS FOR MAXIMUM RESIDUE LIMIT (MRL) PROPOSALS
CONTENTS
Glossary
1. Introduction
1.1Purpose
1.2Navigating this guide
1.3What are MRLs?
1.4MRL regulatory arrangements
1.5How are MRLs amended in Standard 1.4.2?
2. FSANZ MRL harmonisation proposal process
2.1What is a harmonisation request?
2.2Overview of FSANZ MRL proposal process
2.3How are applicants informed on progress of their requests?
3. Administrative and technical information requirements
3.1 Administrative information
3.2 Requested chemical
3.3 Requested commodity
3.4 Relevant MRLs
3.5 Import data requirements
3.6 Data to support the dietary exposure assessment
ATTACHMENT 1 (see separate MS Excel file)
Harmonisation Request Template
ATTACHMENT 2: Supplementary information on the process for considering harmonisation requests
Item 1 Administrative information
Item 2The requested chemical
Item 3The requested commodity
Item 4Relevant MRLs
Item 5Import data
Item 6The dietary exposure assessment process
Glossary
Acceptable daily intake (ADI)
The ADI is the amount of anagvet chemical that may be consumed every day for an entire lifetime without causing an appreciable risk to health, expressed in milligrams per kilogram (mg/kg) of body-weight.
Acute reference dose (ARfD)
The ARfD is an estimate of the maximum amount of an agvet chemical in food or drinking water, expressed as mg/kg of body-weightthat can be ingested in one meal or one day, without appreciable health risk to the consumer, based on all the known facts at the time of the evaluation.
Administrative Assessment Report
All potential applications and proposals are subject to an Administrative Assessment by FSANZ. A reportis prepared by FSANZfollowing completion of the assessment. The main purpose of the administrative assessment is to determine whether an application should be accepted or whether a potential proposal should be prepared and, if so, the assessment procedure by which it should then be assessed under the Food Standards Australia New Zealand Act 1991 (Cth).
Agvet chemical
Agvet chemical means an agricultural chemical product or a veterinary chemical product, within the meaning of the Agvet Code.
Agvet Code
Agricultural and Veterinary Chemicals Code Act 1994 is legislation administered by the APVMA. The Agvet Code, details provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products, (and their associated labels); to issue permits and to licence the manufacture of chemical products; provides for controls to regulate the supply of chemical products; and includes provisions ensuring compliance with, and for the enforcement of, the Code.
Application
An application is lodged under section 22 of the Food Standards Australia New Zealand Act 1991 (Cth) (the FSANZ Act) for a variation to the Australia New Zealand Food Standards Code (the Code).
Applicants shouldensure their applications meet requirements laid out in the relevant guidelines in Part 3 of the FSANZ Application Handbook. Visit the FSANZ website for further information.
Approval Report
A report prepared by FSANZ in accordance with the FSANZ Act, followingthe approval of a draft variation to the Code. This report includes information about the assessment of the application or proposal and the reasons for approval.
Australia New Zealand Food Standards Code (the Code)
The Code contains food standards which have been developed, approved and gazetted by FSANZ. The Code applies to all food sold or prepared for sale in Australia and New Zealand (except where specified ‘Australia only’). Any agency, body or person can make an application to vary the Code. In accordance with State, Territory and New Zealand food legislation, it is an offence to supply food that does not comply with the Code.
FSANZ has published a revision of the Code (the revised Code) which will replace the current Code on 1 March 2016, when the current Code will be repealed. In the revised Code, the MRLs for agvet chemicals that may legitimately occur in food are listed in the table to Schedule 20—3 (S20—3). The foods and classes of foods are described in Schedule 22.
This guide refers toSchedules 20 - 22(Schedules 1 through 4 of the old Code)of Standard 1.4.2 which can be accessed through the ComLaw website.
Australian Pesticides and Veterinary Medicines Authority (APVMA)
The APVMA is an Australian government statutory authority established in 1993 to centralise the registration of all agvet chemical products in the Australian marketplace. Visit the APVMA websitefor more information.
Codex Alimentarius Commission (Codex)
The Codex Alimentarius Commission (Codex), established by the Food and Agriculture Organization (FAO) and World Health Organization (WHO) in 1963, develops harmonised international food standards, guidelines and codes of practice to protect the health of the consumers and ensure fair practices in food trade. Codex also promotes coordination of all food standards work undertaken by international governmental and non-governmental organisations. Codex has a number of relevant committees for establishing MRLs, specifically the Codex Committee on Pesticide Residues (CCPR) and Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF). Visit the Codex Alimentarius website for more information.
Dietary exposure assessment (DEA)
A dietary exposure assessment (DEA) is the process of estimating how much of an agvet chemical a population, or population sub group, may be exposed to from the diet and is usually compared to a relevant health-based guidance value. FSANZ uses internationally accepted ‘dietary modelling’ techniques to conduct dietary exposure assessments. These assessments consider the potential dietary exposure of the Australian and New Zealand populations to chemicals such as food additives, pesticidesand veterinary chemical productresidues, chemical contaminants, nutrients, food ingredients and other substances. Dietary exposure to (or intake of)agvet chemicals is estimated by combining food consumption data with agvet chemical concentration data. Visit the FSANZ website for general information and/or Attachment 2 for information on the DEA process for pesticide and veterinary chemical product residues.
Extraneous Residue Limit (ERL)
The maximum level of a residue of a chemical permitted to be present in a food and which arises from environmental sources other than the use of a chemical directly or indirectly on the food.
Food and Agriculture Organization of the United Nations (FAO)
The Food and Agriculture Organization (FAO) is an intergovernmental organization with 194 member nations, two associate members and one member organization, the European Union. The FAO employs experts to identify and work collaboratively to meet demands posed by major global trends in food, agricultural development and natural resources. The FAO jointly administers the Joint Meeting on Pesticide Residues (JMPR) and Joint Expert Committee Meeting on Food Additives (JECFA). Visit the Food and Agriculture Organization website for more information.
Food group
A food group is a collection of foods that have similar characteristics (for example ‘stone fruits’). The Codeuses the term ‘Classes of foods’ to describe food groups in Schedule 22 of Standard 1.4.2. International pesticide databases for MRL purposes are available that describe the food group and lists commodities included in each group. The commodities included within food groups may differ between international pesticide databases and Schedule 22 of Standard 1.4.2.
Good Agricultural Practice (GAP)
Good agricultural practice in the use of agvet chemicals(GAP) includes the nationally authorised safe uses of agvet chemicals under actual conditions necessary for effective pest, disease or weed control. It encompasses a range of levels of agvet chemical applications up to the highest authorised use, applied in a manner which leaves a residue which is the smallest amount practicable.
Authorised safe uses take into account public and occupational health and environmental safety considerations. Actual conditions include any stage in the production, storage, transport, distribution of food commodities and animal feed.
Harmonisation request template
This template is used by FSANZ to collect information from people making anMRL harmonisation request. This template has been designed specifically to assist FSANZ determine whether a harmonisation request should be included in a potential proposal. The template is provided as Attachment 1to this guide.
Health-based guidance values (HBGV)
For agvet chemicals, health-based guidance valuesareusually defined as the amount of an agvet chemical in food that may be consumed daily or for an entire lifetime without causing an appreciable risk to health.The ADI and ARfD are examples of HBGVs.
Highest residue (HR)
The highest residue (HR) is the highest residue (mg/kg) found in a commodity from a supervised trial that results from using the chemical according to the label directions.
Joint FAO/WHO meeting on pesticide residues (JMPR)
The "Joint Meeting on Pesticide Residues" (JMPR) is an expert ad hoc body administered jointly by the FAO and the World Health Organization. The JMPR has met annually since 1963 toreview residues and analytical aspects of the pesticides, estimate the maximum residue levels, review toxicological data and estimate acceptable daily intakes (ADIs) for humans of the pesticides under consideration.
It provides advice on the acceptable levels of agvet chemical residues in internationally traded food. The JMPR consists of experts who attend as independent internationally-recognized specialists acting in a personal capacity and not as representatives of national governments. Visit theFood and Agriculture Organization websitefor more information.
Joint FAO/WHO Expert Committee on Food Additives (JECFA)
The “Joint Committee Meeting on Food Additives” (JECFA) is an international scientific expert committee administered jointly by the Food and Agriculture Organization and the World Health Organization. It works to evaluate the safety of food additives, evaluates contaminants, naturally occurring toxicants and residues of veterinary drugs in food. Visit the World Health Organization website for more information.
Maximum residue limit (MRL)
Maximum residue limit or MRL for an agvet chemical in a food, means the amount identified in Schedule 20 for the permitted residue of that agvet chemical in that food and is expressed in milligrams per kilogram of food.
The term ‘Maximum Residue Limits’, when used in this guide has the same meaning as the terms ‘Maximum Residue Levels’ in the European Union or,in relation to crops, ‘Tolerances’ in the United States of America.
National estimate of dietary intake (NEDI)
The exposure toa chemical through the diet calculated across the population for all food commodities with an MRL for that chemical. The estimateddietary exposure derived from the DEA is compared to the relevant ADI in order to determine whether long term exposure to the chemicalis likely to be a risk to public health and safety.
National estimate of short-term intake (NESTI)
The exposure to a chemical through the diet calculated for high consumers of a food commodity that has an MRL and an ARfD. It determines short term exposure over one meal or one day. Estimated exposureis calculated for each food commodity separately and is not summed across all foods. The estimated dietary exposure is compared to the ARfD in order to determine whether short term exposures are likely to be a risk to public health and safety.
Office of Chemical Safety (OCS)
The Office of Chemical Safety is an agency of the Australian Government Department of Health, responsible for human health risk assessment policy and practice for veterinary medicines and pesticides. The OCS establishesHBGVs, including ADIs and ARfDs for agvet chemicals used on food producing crops or animals. Visit the Department of Health, Office of Chemical Safety website for more information.
Pesticide
A pesticide is any substance or mixture of substances intended for: preventing, destroying, or controlling any pest, including vectors of human or animal disease, unwanted species of plants or animals, causing harm during or otherwise interfering with the production, processing, storage, transport, or marketing of food, agricultural commodities, wood and wood products or animal feedstuffs; or substances that may be administered to animals for the control of insects, arachnids, or other pests in or on their bodies. The term includes substances intended for use as a plant growth regulator, defoliant, desiccant, or agent for thinning fruit or preventing the premature fall of fruit. Also used as substances applied to crops either before or after harvest to protect the commodity from deterioration during storage and transport (Food and Agriculture Organization of the United Nations).
Residue(s)
In this guide, the term ‘residue’ has the same meaning as that given to the term permitted residue in Standard 1.4.2. The permitted residue of an agvet chemical, means a chemical that is identified in Schedule 20 or Schedule 21 as being a permitted residue in relation to the agvet chemical.
Supervised trial median residue (STMR)
Supervised trial median residue (STMR) is the median concentration of a chemical detected from a number of analyses of residues in the food following application of the chemical according to the label directions.
World Health Organization (WHO)
The World Health Organization (WHO) is an intergovernmental organizationcomprising of employeesfrom 150 countries who direct and coordinate international health within the United Nation’s system.The WHO jointly administers the Joint Committee Meeting on Food Additives and Joint Meeting on Pesticide Residues. Visit the World Health Organization website for more information.
World Trade Organization Notification (WTO notification)
As members of the World Trade Organisation (WTO), Australia and New Zealand are obliged to notify WTO member nations where proposed mandatory regulatory measures are inconsistent with any existing or imminent international standards and the proposed measure may have a significant effect on trade. As part of the MRL harmonisation proposal, a notification to the WTO under Australia’s and New Zealand’s obligations under the WTO Technical Barriers to Trade or Application of Sanitary and Phytosanitary Measures Agreement is made to enable other WTO members to comment on the proposed amendments. The WTO regards 60 days as the minimum period for comments to be received from member nations.