The withholding period is the minimum period that should elapse between the last administration or application of a veterinary chemical product (including treated feed) and the slaughter, collection or harvesting for human consumption or use of the animal commodity. It is required to avoid unacceptable residues of veterinary chemical products and/or their metabolites in animal commodities.
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If ‘Withholding period’ statements are required on a label, they must be the next item following the ‘Directions for use’ section and preceded by the following heading:
WITHHOLDING PERIODS
The heading must be in capital sans-serif boldfaced letters. For print size and style requirements, refer to the Printing and legibility requirements.
Withholding periods statements should appear in sans-serif bold type and lower case, except for those statements that should appear in upper case (see example below). For print size and style requirements, refer to the Printing and legibility requirements.
DO NOT USE
- Where there is more than one withholding period, each one should be preceded by an appropriate descriptor and appear on a separate line. For example:
WITHHOLDING PERIODS:
MEAT: [appropriate statement(s)]
MILK: [appropriate statement(s)]
EGGS: [appropriate statement(s)]
- Where a product can be used in, or on more than one species and/or by more than one route of administration and the withholding periods are different, these differences should be clearly indicated on the label. For example:
WITHHOLDING PERIODS:
MEAT: Cattle - [appropriate statement(s)]
Sheep - [appropriate statement(s)]
MILK: Cattle - [appropriate statement(s)]
Sheep - [appropriate statement(s)]
- Where no time is required for a withholding period, the following statement should be shown on the label:
WITHHOLDING PERIODS: [commodity] Zero (0) days
- When a withholding period cannot be established for an animal producing a specified commodity, a ‘Restraints’ statement must appear on the label. The ‘Restraints’ statement should appear under the 'Restraints' subheading in the 'Directions for use' section. It is not necessary to also include the restraint under the ‘Withholding periods’ heading.
- For prescription products, the prescribing veterinarian should be made aware that any variation to the registered use pattern (under veterinary prescribing rights) may require a different withholding period. If required, this must appear as the last statement under the ‘Withholding periods’ heading. For example:
Any variation by the prescribing veterinarian to the approved use pattern, may require an extended withholding period.
7.1. Statements required for food-producing species
Depending on the species of animal, more than one commodity may be produced. For example, statements may be required for the meat alone, or for meat and/or milk or eggs. Table 1 lists species and their relevant commodities that may require statements.
|
Species |
Commodity requiring statement |
|---|---|
|
Cattle |
Meat and milk |
|
Sheep |
Meat and milk |
|
Goats |
Meat and milk |
|
Poultry |
Meat and eggs |
|
Pigs |
Meat |
|
Aquatic species |
Meat |
|
Rabbits |
Meat |
|
Bees |
Honey |
Note: Meat also includes offal.
Minor species are also required to carry appropriate statements. Appropriate statements for each type of commodity are listed below.
7.1.1. Meat
All products for use in, or on meat-producing species of animals (for example, cattle, sheep, goats, poultry, pigs, aquatic species and rabbits) are required to carry an appropriate ‘Withholding period’ statement for meat, unless a restraint statement is included for that particular animal species.
The following ‘Withholding period’ statement examples should be used:
MEAT: DO NOT USE less than [x] days before slaughter for human consumption.
REMOVE ALL MEDICATED FEED/WATER [x] days before slaughter for human consumption.
When harvesting aquatic species for slaughter, degree days should be used. For example, 500 degree days = 50 days at 10˚C water temperature or 25 days at 20˚C water temperature. The following ‘Withholding period’ statement should be used:
DO NOT USE less than [x] degree days before harvesting [fish/abalone/etc.] for human consumption
7.1.2. Milk
7.1.2.1. Non-intramammary products
All products for use in, or on animals from which milk may be used or processed for human consumption are required to carry an appropriate 'Withholding period' statement, unless a restraint statement is included for that particular animal species.
The following 'Withholding period' statement examples should be used:
7.1.2.1.1. Cows
Milk collected from cows within [x] hours ([x] milkings) following treatment MUST NOT BE USED or processed for human consumption, or fed to bobby calves
7.1.2.1.2. Other milk producing species
Milk collected from [animal species] within [x] hours ([x] milkings) following treatment MUST NOT BE USED or processed for human consumption
7.1.2.2. Intramammary products
Products for use in lactating cows should use the following statement:
Milk collected from cows within [x] hours ([y] milkings) following treatment MUST NOT BE USED or processed for human consumption, or fed to bobby calves
Products for use in dry cows should use the following statement:
DO NOT USE in lactating cows or within [x] days of calving. After calving, colostrum or milk from treated dry cows MUST NOT BE USED or processed for human consumption for [y] hours ([z] milkings). If premature or unscheduled calving occurs, consult the prescribing veterinarian for advice on handling milk for bobby calves
7.1.3. Eggs
All products for use in, or on birds from which eggs may be used or processed for human consumption are required to carry an appropriate 'Withholding period' statement unless a restraint statement is included.
Producers cannot usually implement a withholding period other than a zero day withholding period. Where a zero day withholding period is established, the following statement applies:
EGGS: Zero (0) days
If a withholding period can be established for eggs, the following example should be used:
EGGS: Eggs collected within [x] days following treatment MUST NOT BE USED or processed for human consumption
7.1.4. Honey and other bee products
All products for use in, or on bees or beehives that produce honey or bee by-products (including comb honey, royal jelly and propolis) for human consumption or processing are required to carry an appropriate ‘Withholding period’ statement, unless a restraint statement is included. ‘Withholding period’ statements for honey are based on honey residues data generated with treated bees or beehives.
Where the use of products in, or on bees or beehives is permitted, you should use one of the following ‘Withholding period’ statements:
HONEY: Honey collected from hives within [x] hours ([y] days) following treatment must not be used or processed for human consumption
HONEY: Zero (0) days
7.2. Statements required for fibre-producing species
The following ‘Wool Harvesting Interval’ statements are required for the wool of sheep and the fibre (for example, mohair) of goats, alpacas and llamas.
WOOL/FIBRE HARVESTING INTERVAL: WOOL/FIBRE: DO NOT USE less than [x] days/weeks/months before shearing/fibre collection
7.3. Statements required for horses
Although horses are not currently defined as a food-producing animal, horse products are required to carry a ‘Withholding period’ statement for meat, unless a restraint statement is included for horses.
The inclusion of this statement is particularly important for products not used in other meat-producing species. For products that are also used in species other than horses, the statement should begin with:
MEAT WITHHOLDING PERIOD (HORSES):
A ‘Withholding Period’ does not refer to a withdrawal period required by the relevant racing or performance authorities to ensure horses are presented for competition drug-free. This information should appear under the 'General directions' subheading under the ‘Directions for use’.
The options for this statement are:
- for products where there are no residue concerns, for example:
- products where the residues are identical to or indistinguishable from natural food components, or are otherwise of no toxicological significance
- most vaccines (unless otherwise directed by the APVMA)
- many nutritional and general healthcare products – including most stockfoods, vitamins, mineral or amino acid supplements, electrolyte supplements, hoof and coat care products, grooming aids, rubefacients, liniments or poultices, skin emollients, antiseptics or astringents (provided they do not contain prescription drugs or unless otherwise directed by the APVMA) – a withholding period is not required and the following statement should be used:
WITHHOLDING PERIODS: Zero (0) days
- for other products that are registered for use in food-producing animals, a ‘Withholding period’ statement may be set on data or argument. If scientific data or argument is not presented to establish a withholding period then a conservative default period will be used with the following statement:
DO NOT USE less than [x] days before slaughter for human consumption
A default period of 28 days will be used where the withholding period for all the food-producing animals on the label is less than or equal to 7 days. A default period of 60 days will be used where the withholding period for all the food-producing animals on the label is between 7 and 28 days.