Label content

This labelling code explains the information that must be placed on labels for veterinary products if they are to meet the legislative requirements, and provides examples of acceptable wording for certain statements where specific words are not mandated by the legislation.

Where the term 'must' is used, it is a legal requirement that labels comply with this provision. This labelling code also provides advice on how the requirement might be met, under the sub-heading ‘Guidance notes’. The notes are not mandatory. They are words that have previously been considered by the APVMA and are likely to be able to be accepted as suitable without an in-depth assessment. Any variation from these words would need some justification and may require submission and evaluation of supporting information or argument. 

The specific wording required to be included on a particular product label will be determined by the APVMA during evaluation of the application for approval of the label or variation of the approved label.

Specific requirements over and above the minimum requirements for placement and legibility of the particulars are also provided in this requirement.

Some variations to these requirements apply to certain classes of products. Therefore, specific information is provided for:

1. Signal heading

1.1. Signal words

If the product contains a substance that is classified as a scheduled poison in the current Poisons Standard, the label must include any signal words relating to the schedule in which that substance is included. Appropriate signal words for veterinary chemical products containing scheduled poisons are as follows:

  • Schedule 4: PRESCRIPTION ANIMAL REMEDY
  • Schedule 5: CAUTION
  • Schedule 6: POISON
  • Schedule 7: DANGEROUS POISON
  • Schedule 8: CONTROLLED DRUG.

If the product label is required to include signal words, they must be:

  • on the first line of the main label, with nothing other than a class label written on that line as specified in the Australian Code for the Transport of Dangerous Goods by Road or Rail (ADG Code). Note that for a Schedule 5 poison only, a statement of the principal hazard of the poison may be written on that line.
  • in bold-face, sans-serif capital letters of uniform thickness
  • in a letter size that is at least half the height of the largest letter or numeral on the label, provided that this is greater than 1.5 mm. However, the size need not be larger than 6 mm on labels for containers of nominal capacity of 2 L or less, or larger than 15 mm for larger containers. If the label includes a single large letter or numeral as part of the product name that is larger than other lettering on the label or is an affix forming part of the trade name, do not take this into account when determining the largest letter size.

For a Schedule 8 poison, the cautionary statement is also required:

POSSESSION WITHOUT AUTHORITY ILLEGAL

This statement must be written:

  • on a separate line or lines immediately below the signal words
  • in bold-face, sans-serif capital letters of uniform thickness
  • in letters that are at least four-tenths the height of the letters used for the signal words
  • on a single line, with no other statement written on the same line.

1.1.1. Other cautionary words or phrases

1.1.1.1. Keep out of reach of children

If the product contains a substance that is classified as a poison in the current Poisons Standard, the following statement must be included on the label as part of the signal heading:

KEEP OUT OF REACH OF CHILDREN

Where this statement is required on the label as part of the signal heading, it must be:

  • immediately below the signal word(s), with nothing, other than a class label—as specified in the ADG Code—written on that line
  • in bold-face, sans-serif capital letters of uniform thickness
  • in letters that are at least four-tenths the height of the letters used for the signal words, provided that these are larger than 1.5 mm.

For products that do not contain scheduled substances, this statement must not appear in the signal heading; however, you may incorporate it with the storage instructions.

1.1.1.2. Read safety directions before opening or using

Either of the following statements must be included whenever safety directions are shown on the label:

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

READ SAFETY DIRECTIONS

This requirement applies to products that do not require any other signal heading (that is, they are not scheduled substances) but are required to include safety directions.

If this statement is required on the product label, it must:

  • be on a separate line immediately below the cautionary statement ‘Keep out of reach of children’, or
  • placed immediately below other cautionary statements that are required to be on the line immediately below ‘Keep out of reach of children’
  • have no other statement on the same line, other than a class label, as specified in the ADG Code
  • be in bold-face, sans-serif capital letters of uniform thickness
  • be in letters that are at least four-tenths the height of the letters used for the signal words (provided that these are larger than 1.5 mm).

If this statement is required for products that do not contain any scheduled substances, it must be the first line of the signal heading.

1.1.1.3. For animal treatment only

The following statement is required as part of the signal heading of all veterinary chemical products:

FOR ANIMAL TREATMENT ONLY

This statement must be placed immediately below any required other signal words, expressions or statements as follows:

  • on a separate line, either
    • immediately below the cautionary statement ‘Read safety directions before opening or using’ or ‘Read safety directions’
    • if these statements are not required, immediately below ‘Keep out of reach of children’
    • if other cautionary statements are required to be on the line immediately below ‘Keep out of reach of children’, immediately below those statements
  • with no other statement on the same line, other than a class label, as specified in the ADG Code
  • in bold-face, sans-serif capital letters of uniform thickness
  • in letters that are at least two-tenths the height of the letters used for the signal words (provided that these are larger than 1.5 mm)
  • for products that do not contain any scheduled substances, and the ‘Read safety directions before opening or using’ is not required, this statement must be the first line of the signal heading.

Although this statement must be included as part of the signal heading of all veterinary chemical products, it must not be used for products that are not medicinal, or do not contain scheduled substances, such as food and food supplements, as these products are not regarded as being for treatment of animals.

1.1.1.4. Other cautionary words and statements

Other words and cautionary statements may be required in the signal headings, depending on the types of constituents in a particular product. These statements will be determined by us on a case-by-case basis during product evaluation and, if the application is granted, they will become part of the approved particulars for the product.

2. Product name

The label must include the name of the chemical product. This does not have to be the same as the distinguishing name recorded in the APVMA register for the chemical product.

The product name must be:

  • positioned between the signal heading and the ‘Active constituent’ statement on the main panel of the label
  • the most prominent wording in that section of the label
  • written as a single expression.

2.1. Guidance notes

Please keep in mind the following advice when deciding on a product name:

  • the product name should be distinctive. It must not be misleading, confusing or inconsistent with other label instructions or be easily confused with other registered product names. It is your responsibility to ensure that the product name is sufficiently unique as to not cause confusion in the market place
  • the name should describe the physical form and route of administration and, possibly, its intended purpose (for example, oral powder, feed additive, oily injection, inhalant, tablet, spray-on, dip, oral paste, dip and spray, pessary, injectable suspension, oral suspension)
  • a simple approach is to use a trade name (if applicable), followed by the brief description. Where the product name is not distinctive, such as a generic active constituent, the company name could, for example, be incorporated into the product name to distinguish it from other products having similar names
  • products for over-the-counter sale are normally named according to their purpose; for example ‘pour-on worm treatment for sheep and goats’. The product name should be distinctive, descriptive and concise
  • it is not necessary to detail a medicinal claim in a product name where this is given in an abbreviated statement of claim elsewhere on the main panel of the label
  • when numbers are used as part of the product name, they should relate to the level or concentration of the active constituent in the product, and be expressed in metric units (not percentages) or as otherwise determined by the APVMA. Exceptions we permit may include references to dose rates in relation to weights of target animals in the product name, (for example, TICKEX 20, where a unit of the product was the dose for a 20 kg dog or 5 IN 1 for multivalent vaccines)
  • we may approve the word ‘plus’ in a name when another active constituent is added to a currently registered product to extend the medicinal claim. In this instance, the name of the new active constituent or class of constituent should be listed after the word ‘plus’. Note that we would not normally approve the word ‘plus’ in a name in any other circumstances.

3. Constituent statements

3.1. ‘Active constituent’ statement

The label must contain the name and proportion of each active constituent in the product.

The active constituents are the substances that are primarily responsible for the biological activity or other effect identifying the product as a veterinary chemical product. This biological activity, or other effect, together with the proposed uses, makes the product a veterinary chemical product.

The concentration and name of all active constituents in the product must be shown immediately below the product name on the main panel of the label, parallel to other printed matter on the label. The label should not include on the same lines other wording that is not associated with the ‘Active constituent’ statement.

The concentration of the active constituent must be clearly stated in front of the name of the constituent.

These statements must be:

  • in bold-face, sans-serif letters of uniform thickness
  • in letters that are at least 1.5mm in height.

Where two or more active constituents are present in the end-use product, the following conditions apply:

  • the active constituents must be shown in descending order of concentration (highest to lowest)
  • when solvents, synergists or other scheduled ingredients are present, even when present at higher levels than the active constituents, they must be shown after the main active constituents.

The following statement must also be included on labels for products containing organophosphate or carbamate compounds:

anticholinesterase compound

Where this statement is required on labels, it must appear immediately below, following or beside the ‘Active constituent’ statement for each active constituent with anticholinesterase activity.

Note that the use of the following heading is optional:

ACTIVE CONSTITUENTS

3.2. Synergists

The label must contain the name and proportion of any constituent that has synergistic activity in the product.

Synergists are constituents that, on their own may not be known to be biologically active for the particular use described, but their inclusion may result in a synergistic effect with the active constituents, so that the product may not be as effective without them.

The concentration and name of any synergistic constituents must:

  • be preceded by the subheading:

Also contains:

  • be placed immediately below the ‘Active constituent’ statement and parallel to other printed matter on the label
  • have immediately following or beside the ingredient statement the word:

(synergist)

3.3. Other scheduled constituents

The label must:

  • contain the name and proportion of any solvent or any other constituent in the product that is a scheduled medicine or poison in the current Poisons Standard
  • contain the concentration and name of any other scheduled constituents—these must be placed immediately below the ‘Active constituent’ statement and parallel to other printed matter on the label and be preceded by the subheading:

Also contains:

  • if the constituent is a solvent, it must have immediately following or beside the constituent statement, the word:

(solvent)

Note: The subheading is not considered appropriate for unscheduled non-active constituents or food constituents to supplement diets where levels may be low—such as vitamins, minerals or amino acids fed at normal dietary levels. However, these ingredients may be included under the following subheading on the ancillary panel:

Other ingredients:

Appropriate use of ‘Also contains:’ statements is determined by the APVMA on a case-by-case basis.

3.4. Guidance notes

Please keep in mind the following advice when creating constituent statements.

3.4.1. Name of constituents

The name for scheduled constituents should be the name specified in the current Poisons Standard.

If a poison schedule does not apply, the preferred name for constituents is:

  • the name in the Therapeutic Goods Administration (TGA) approved terminology for medicines, which is the Australian approved name (AAN)
  • the name, not including synonyms by which the constituent is described in; for example, the British pharmacopoeia, the British pharmaceutical codex, the Australian pharmaceutical formulary and handbook, or the British pharmacopoeia (veterinary), the European pharmacopoeia, or the United States pharmacopeia
  • the name approved by Standards Australia
  • the name given by the International Organisation for Standardisation
  • the name given by the British Standards Institution
  • the accepted scientific name (in the Chemical Abstracts or International Union of Pure and Applied Chemistry) or the name descriptive of the true nature and origin of the constituent.

3.4.2. Expression of quantities

The quantity for the constituents should be expressed in metric terms according to the formulation.

All units of mass or volume should be written in full or represented by their correct symbols such as gram or g, litre or L, for example:

  • gram/litre or g/L for large volume liquid preparations (1 litre or more)
  • gram/kilogram or g/kg for large volume solid preparations such as premixes
  • milligram/millilitre or mg/mL for injectable preparations and small volume liquids (less than 1 litre)
  • milligram/gram or mg/g for small volume solid or semi-solid preparations
  • gram/kilogram or g/kg for aerosol preparations
  • µg should be used as the abbreviation of microgram.

Expressions for a product packed in discrete dosage units or for small volume liquids (10 mL or less) include:

each tablet/capsule/caplet contains [x] mg (active constituent)
each mL contains [x] mg (active constituent).

International units, or potency units, may be applicable to some preparations such as antibiotics, sera and biologicals, but only if preparations cannot be described as above.

Vitamins A and D should be expressed in International Units (IU) while other vitamins are to be expressed in metric units.

The ‘Active constituent’ statement for direct-fed microbials should read as:

Contains a source of live (viable) naturally occurring microorganisms

This should then be followed by a listing of each of the microorganisms and their quantities, such as colony-forming units per gram (CFU/g).

Salts or esters of active constituents that are used in a formulation should indicate the amount of active moiety present and nominate the salt or ester present, for example:

110 mg/mL hydroxyprogesterone hexanoate (equivalent to 100 mg/mL hydroxyprogesterone)
100 mg/mL hydroxyprogesterone (as the hexanoate)

Solvents should be given as:

Solvent: [x] g/L or liquid hydrocarbons
Solvent: [x] g/L or toluene

3.4.3. Format for constituents of mixtures

Active constituents should be shown in a column or sequence in descending order, based on the concentration of each active constituent present in the product.

Where synergists are present, they should be shown after the main active constituent(s) even when at a higher concentration than the active constituent(s).

Where scheduled non-active constituents are present, they should be shown after the active constituent(s) (and synergists, if applicable) even when at a higher concentration than the active constituent(s)/synergist(s).

Vitamin and mineral preparations should have the ingredients listed in the following order:

  • fat-soluble vitamins
  • water-soluble vitamins
  • minerals
  • antioxidants
  • other ingredients.

4. Statement of claims for use

The label must include a statement of the claims (indications) for use that have been approved for the product. The indications for effective use of a product are determined by the APVMA on a case-by-case basis during product evaluation.

The claims or indications for use must be positioned immediately beneath the active constituent statements, on the main panel of the label. If the required detailed statement of indications does not fit in this position, a suitable summary statement must appear on the main panel and a full detailed indications statement must appear immediately above the ‘Directions for use’ on the ancillary panel.

4.1. Guidance notes

Please keep in mind the following advice when creating a ‘Claims for use’ statement.

  • where it is known, the class or group (by mode of action) of the active constituents must be identified
  • for prescription-only products, the class or level of permitted prescribing should be stated as follows:
    • when the level of permitted prescribing is either for use by or under supervision of a registered veterinarian, either of the following statements should appear as the first (and possibly only) indication statement on the main panel of the label:

      For use only by a registered veterinarian

      For use only by or under supervision of a registered veterinarian

    • when it is permitted to dispense the product, the following statement should appear as the first statement of indications on the main panel of the label:

      For use by or under direction of a registered veterinarian

      and this statement should also appear immediately above the ‘Directions for use’ heading (see below) on the ancillary label panel:

      Use as directed by prescribing veterinarian

  • all labels should have accurate and moderately worded claim(s). The claim(s) should not imply excessive efficacy or make a comparison with other competing products
  • the name(s) of the intended target species (for example, dog, cat, horse, sheep) should be included in the statement of claims on the main panel
  • the disease, condition or other pharmacological or physiological effect in each target animal species, and (where applicable) in each class of animal, must be clearly stated. Claims must be directly related to the parameters measured in the pivotal target animal efficacy trials you submitted for registration
  • the Linnaean binomial (scientific name, bracketed and in italics or underlined) and common name used in Australia of each pest, parasite or disease organism for which an effect is claimed should be included in the ‘Claims for use’ statement. The Linnaean binomial is optional in the abbreviated claim if included in the extended claim on the ancillary panel or on the leaflet (where space is limiting)
  • labels of parasiticides and antimicrobials must also include a resistance warning statement
  • important restrictions, limitations, contra-indications or warning statements that affect the use of the product can also be repeated in the ‘Statement of claims’ on the main panel.

5. ‘Net contents’ statement

The label must state the net contents of the container of the product.

The ‘Net contents’ statement must be positioned immediately beneath the ‘Statement of claims’ or ‘Summary of claims’ statement on the main panel of the label.

5.1. Guidance notes

Please keep in mind the following advice when creating a ‘Net contents’ statement.

  • the heading ‘Contents’ is optional
  • in accordance with the requirements of the National Measurement Act 1960 and its regulations, units of mass or volume must be metric, and be written in full or represented by their correct symbols:
    • liquids must be expressed by reference to volume, usually as:

      [x] mL (millilitre/s) or L (litre/s)

    • solids, semi-solids, pastes or aerosols must be expressed by reference to mass, usually as:

      [x] g (gram/s) or kg (kilogram/s)

    • products containing discrete dosage units, like tablets or syringes must be shown as the number of units; for example:

      [x] tablets or [x] x 1 mL syringes

  • when the product is a non-prescription veterinary product that consists of discrete dosage units or an immediate container that is not the primary pack, it is illegal to supply these containers without the primary pack (including the leaflet or insert to which the primary pack refers, if applicable). The ‘Net contents’ statement must contain either of the following words:

    It is illegal to sell individual [container/unit] separately

    Illegal to sell [container/unit] separately

6. Directions for use

The label must include adequate directions for use of the product. Directions for safe and effective use for a product are determined by the APVMA on a case-by-case basis during product evaluation.

The directions-for-use section of a label, when required, must be placed below the following heading on the ancillary label panel:

DIRECTIONS FOR USE

Immediately below this, the section must be divided (in the order shown below) into the following subsections:

Restraints

Contraindications

Precautions

Side effects/Adverse reactions

Dosage and administration

General directions [including a general limitation statement for ectoparasiticides and advice on avoiding the development of resistance].

7. Restraints

A restraint is an absolute limitation or restriction placed on the use of the product. The limitation is required to manage a risk associated with the use of the product that may be necessary for human safety, public health or environmental protection (for example, issues related to residues, antibiotic resistance) and that has been determined during product evaluation. ‘Restraints’ statements that relate to a withholding period must also be included.

If ‘Restraints’ statements are required on a label, they must be the first item in the ‘Directions for use’ section; and be preceded by a subheading:

Restraints

Each separate ‘Restraints’ statement must commence on a new line.

7.1. Guidance notes

Please keep in mind the following advice when creating a ‘Restraints’ statement.

  • ‘Restraints’ statements must begin with text such as:

    DO NOT USE
    NOT TO BE USED
    USE ONLY

  • for all products intended for intravenous administration or stomach tubing (excluding Schedule 4 or Schedule 8 products) or any other products as directed by the APVMA, the following statement should appear immediately below the ‘Directions for use’ heading:

    FOR USE ONLY BY OR UNDER the direction of a registered veterinary surgeon

  • when the chemical or product is not for use in food—or fibre-producing species of animals, the restraint following statement should appear:

    DO NOT USE in food-producing species of animals

  • antibiotics for ornamental fish should have the following ‘Restraints’ statement:

    DO NOT USE in fish intended for human consumption.

7.2. Re-treatment interval

A re-treatment interval is a restraint that must be included on the label of products used in or on food-producing animals where a repeat dosage regimen can be reasonably expected, even if a repeat dosage regimen is not specified on the label. The re-treatment interval will be determined by the APVMA during evaluation of the product. The statement should appear in bold-face font.

Example of a statement for the re-treatment interval:

Re-treatment interval: DO NOT re-treat animals for [x] days after last treatment

8. Contraindications

Contraindications indicate when the product should never be given or is generally not indicated if there are safety issues for the target animal. They are normally used when there is evidence that toxicity will occur in a particular situation or physiological state or in an off-label animal species. If ‘Contraindications’ statements are required on a label, they must be preceded by a subheading:

Contraindications

8.1. Guidance notes

Please keep in mind the following advice when creating a ‘Contraindications’ statement:

  • a ‘Contraindications’ statement must begin with text such as:

    This product should not be used (or is not recommended/intended for use, or is contraindicated for use) in [species (or species with a particular disease/condition)]

  • ‘Contraindications’ statements are relevant where test results or adverse experience reports for the product demonstrate an adverse effect
  • ‘Contraindications’ statements should be grouped according to outcome, and should explain the mechanism of action (where known).

9. Precautions

‘Precautions’ statements aim to minimise health risks to target animals from approved use(s) of a product. They are normally used when there is insufficient evidence to demonstrate safety in a particular situation or physiological state.

If ‘Precautions’ statements are required on a label, they must be preceded by the subheading:

Precautions

9.1. Guidance notes

Please keep in mind the following advice when creating a precautions statement.

  • a ‘Precautions’ statement must begin with text such as:

    Use with caution
    Check [xxx] before using

  • statements regarding incompatibilities must be included as precautions
  • ‘Precautions’ statements are relevant where test results for the product are not available for all physiological situations (for example, a pregnant or lactating female, a foetus or neonate and/or an aged animal)
  • ‘Precautions’ statements should be grouped according to outcome, and should explain the mechanism of action (where known).

10. Side effects

Statements on side effects or adverse drug reactions alert the end users of effects that may occur in the target animal from approved use(s) of a product (such as anaphylaxis). These statements should indicate the severity, clinical importance and treatment of the effects. You could also include statements on how to avoid, recognise and treat overdosage under this heading.

If ‘Side effects’ statements are required on a label, they must be preceded by the subheading:

Side effects

11. Dosage and administration

Dosage and administration includes instructions on:

  • the specific dose rate (for example, [x] mg of active constituent/kg body weight of animal)
  • the general dose rate or inclusion rate (for example, [x] mL of product/10 kg body weight or [y] kg of product/tonne of feed) for each species
  • the method and route of administration
  • the frequency of dosing
  • the duration of treatment
  • any special instructions relating to dosage and administration.

All units of mass or volume must be stated in metric units and, where abbreviated, must be represented by their correct symbols.

The statement on dosage and administration is always required on a label, and must be preceded by the subheading:

Dosage and administration

Where applicable, the relevant mixing directions and in-use shelf life statements must also appear under this subheading.

11.1. Guidance notes

Please keep in mind the following advice when creating a ‘Dosage and administration’ statement.

  • relevant mixing directions and in-use shelf life statements should be given first in bold type; for example:

    Shake well before use

    Use all product within 24 hours of mixing

    Use the contents within 24 hours of first broaching of the vial. Discard the unused portion

  • special instructions may include dosage adjustment in renal or liver disease or concomitant disease, maximum tolerated daily dose, maximum dose for an entire course of therapy, monitoring advice and other information (for example, relating to administration with food).

12. General directions

General directions include any other instructions or advice about safe and effective use of the product not included elsewhere on the product label. Examples include statements on the general limitation for ectoparasiticides, antibiotic and anthelmintic resistance, non-prescription injectable product warning, performance animal withholding period, and on compatibility for mixing a product with other products.

If any other directions are required on a label, they must be the last item in the ‘Directions for use’ section and be preceded by a subheading:

General directions

12.1. Guidance notes

Please keep in mind the following advice when creating a ‘General directions’ statement.

  • the general limitation statement must be printed in bold-face and sans-serif capital letters of not less than 2 mm in height. This statement should appear below the ‘General directions’ heading or under a ‘Directions for use’ table, but above the ‘Withholding period’ statement. For example, the general limitation statement for ectoparasiticides is:

    NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION

  • products that may be used in performance animals may carry the following statement printed in bold-face and sans-serif letters of not less than 1.5 mm in height:

    If used in performance animals, the regulations of the relevant authorities regarding medication should be observed

  • for advice on non-prescription injectable preparations likely to be used in food producing animals, see the requirements for non-prescription injectable products
  • compatibility statements require evaluation and approval before addition to the label.

13. ‘Withholding period’ statements

The label must include ‘Withholding period’ statements that are required to avoid unacceptable residues of veterinary chemical products and/or their metabolites in animal produce and food for humans. ‘Withholding period’ statements for a product are determined by the APVMA during product evaluation.

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. Any ‘Restraints’ statement that restricts or limits the use due to residue concerns must also be included.

If ‘Withholding period’ statements are required on a label, they must be:

  • the next item following the directions for use section required above
  • preceded by the following heading in capital bold-faced letters of not less than 1.5 mm in height:

    WITHHOLDING PERIODS

13.1. Guidance notes

Please keep in mind the following advice when creating a ‘Withholding period’ statement.

  • withholding periods should appear in bold type and lowercase, except where the following special text is required to be inserted:

    DO NOT USE

  • a ‘Restraints’ statement is used when a withholding period has not been set. This means that the product has a limited or restricted use in animals that are producing a specified commodity. The ‘Restraints’ statement should appear in bold-faced type immediately after the ‘Directions for use’ heading under the ‘Restraints’ subheading. It is not necessary to also include the restraint under the ‘Withholding periods’ heading
  • where there is more than one withholding period, each one should appear on a separate line. For example:

    WITHHOLDING PERIODS:
    MEAT: [appropriate statement(s)]
    MILK: [appropriate statement(s)]

  • where a product can be used in, or on, more than one species or by more than one route of administration and the withholding periods are different, these differences should be clearly indicated on the label
  • where no withholding period is required, the following statement should be shown on the label:

    WITHHOLDING PERIODS: Zero (0) days

  • for prescription products, the prescribing veterinarian should be made aware that the registered withholding periods are based on the registered use pattern, and that any increase to dose, frequency, or duration, or any variation to route of administration (under vets prescribing rights) would require a different withholding period.

13.2. 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 (as well as fibre). Table 1 lists the species and the relevant commodity requiring statements.

Table 1: Commodities requiring Withholding period 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.

13.2.1. Meat

13.2.1.1. Ruminants, poultry, pigs and others (including aquatic species, rabbits)

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 one of the ‘Withholding period’ statements for meat.

The following ‘Withholding period’ statement 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

For rabbits, where a withholding period is not established, a ‘Restraint’ statement such as the following should be used.

DO NOT USE [in/on] rabbits that may be used or processed for human consumption

13.2.2. Milk

13.2.2.1. Non-intramammary products

‘Withholding period’ statements for milk are to be based on residue data for lactating animals.

All products for use in or on cattle, sheep and goats from which milk or milk products may be used for human consumption are required to carry an appropriate ‘Residue’ statement such as:

Milk collected from [cows/ewes/does] within [x] hours ([x] milkings) following treatment MUST NOT BE USED or processed for human consumption, or fed to bobby calves

Where a withholding period is not established, you should use a ‘Restraints’ statement such as the following:

DO NOT USE [in/on] [cows/ewes/does] which are producing or may in the future produce milk that may be used or processed for human consumption

Depending on residue data available, one of the following ‘Restraints’ statements may be used instead of the one stated above:

DO NOT USE [in/on] lactating or pregnant [cows/ewes/does] where milk may be used or processed for human consumption

DO NOT USE [in/on] lactating [cows/ewes/does] or within [x] days of [calving/lambing/kidding] where milk may be used or processed for human consumption

DO NOT USE [in/on] lactating [cows/ewes/does] where milk may be used or processed for human consumption

13.2.3. 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 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

13.2.4. Eggs

Statements are required on all products for use in, or on, female poultry from which eggs or egg products may be used or processed for human consumption.

Practically, producers cannot implement a withholding period other than a ‘nil’ withholding period. The following statement applies:

EGGS: Zero (0) days

If a ‘nil’ withholding period cannot be set, the following ‘Restraints’ statement is required:

DO NOT USE [in/on] birds which are producing or may in the future produce eggs or egg products which may be used or processed for human consumption

Depending on residue data available, one of the following ‘Restraints’ statements may be used instead of the one given above:

DO NOT USE [in/on] birds during lay where eggs or egg products which may be used or processed for human consumption

DO NOT USE [in/on] birds during laying or within [x] days of laying where eggs or egg products may be used or processed for human consumption or processing. If laying takes place within [x] days, those eggs or egg products must not be used processed for human consumption

13.2.5. Honey

All products for use in, or on, bees or bee hives 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 residue statement. ‘Withholding period’ statements for honey are based on honey residues data generated with treated bees or bee hives.

Where the use of products in, or on, bees or bee hives 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.

Where use in, or on, bees or bee hives is not permitted, you should use a ‘Restraints’ statement such as the following:

HONEY: DO NOT USE [in/on] bees or hives which are producing or may in the future produce honey for human consumption or processing.

Where available residues data indicate that residues preferentially partition into bee by-product fractions (for example, wax), the following ‘Restraints’ statement may be appropriate:

[COMB HONEY/PROPOLIS/ROYAL JELLY]: DO NOT make [comb honey/propolis/royal jelly] from treated bees or hives available for human consumption.

13.2.6. Statements required for fibre producing species

The following ‘Withholding period’ statements are required for the wool of sheep, and the fibre (for example, mohair) of goats, alpacas and llamas.

WITHHOLDING PERIOD—WOOL/FIBRE: DO NOT USE less than [x] days/weeks/months before shearing or fibre collection

‘Withholding period’ statements for meat and milk are also required for these species.

13.3. Statements required for horses

Although horses are not currently defined as a food-producing animal, horse products require a ‘Withholding period’ statement for meat to appear on the product label. The statement should begin with:

MEAT WITHHOLDING PERIOD (HORSES):

The inclusion of this header is particularly important for products not used in other meat-producing species. The ‘Withholding period’ statement for meat for horses shows the minimum period that should elapse between the last treatment and slaughter for human consumption and not the withdrawal period required by the relevant racing authorities to ensure that racehorses are presented for competition drug-free, which appears in the general directions under the ‘Directions for use’ heading.

The options for this statement are:

  • for products containing:
    • synthetic pyrethroids, aminoglycoside antibiotics or non-steroidal anti-inflammatory drugs (unless residue data are available to support a withholding period)
    • substances having a thyrostatic, oestrogenic, androgenic, gestagenic, somatotrophic or beta-agonistic action
    • substances that are not approved for use in food producing animals (unless residue data are available to support a withholding period), the following ‘Restraints’ statement is required. The ‘Restraints’ statement should be located after the ‘Directions for use’ heading under the ‘Restraints’ subheading:

      DO NOT USE [in/on] horses that may be used for human consumption

  • 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 of the food producing animals on the label is less than or equal to seven days. A default period of 60 days will be used where the withholding period for all of the food producing animals on the label is between seven and 28 days. Otherwise the following ‘Restraints’ statement is required:

DO NOT USE [in/on] horses that may be used for human consumption

14. Trade advice

The label must include any export slaughter, collection or harvest interval statement or trade advice that is required to avoid unacceptable residues of veterinary medicines and their metabolites in animals or produce that may be exported, where those residues have the potential to unduly prejudice Australian trade. All products for use in or on cattle, sheep and pigs require ‘Trade advice’ statements. ‘Trade advice’ statements for a product are determined by the APVMA during product evaluation.

If ‘Trade advice’ statements are required on a label, they must be:

  • the next item following the withholding periods section required above
  • preceded by either of the following headings, as appropriate:

    TRADE ADVICE—Export Slaughter Interval

    TRADE ADVICE—Export Collection/Harvest Interval

  • printed in bold type and lowercase, except where text such as the following must be inserted:

    DO NOT USE

14.1. Examples of ‘Trade advice’ statements for meat commodities

Where an export slaughter interval (ESI) has been established for the product:

EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than [x] days before slaughter for export. Before using this product, confirm the current ESI from [registration holder/distributor name] on [insert telephone contact number] or the APVMA website (www.apvma.gov.au/residues)

Where the ESI is zero days:

EXPORT SLAUGHTER INTERVAL (ESI): Zero (0) days. Before using this product, confirm the current ESI from the [registration holder/distributor name] on [telephone contact number] or the APVMA website (www.apvma.gov.au/residues)

Where an ESI has not been established for the product:

EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for this product. Note—observing the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice should be sought from [registration holder/distributor name] on [telephone contact number] before using this product.

15. Safety directions

The label must include safety directions that relate to safety in handling, mixing and using of the product from the First aid instruction and safety directions (FAISD) handbook: handbook of first aid instructions, safety directions, warning statements and general safety precautions for agricultural and veterinary chemicals, published by the APVMA. Safety directions are product-specific and apply regardless of scheduling considerations related to the product. ‘Safety directions’ statements for a product are determined by the APVMA during product evaluation.

Safety directions are statements included on product labels that specify human hazards, precautions and instructions for handling, mixing and using the product safely.

If ‘Safety directions’ statements are required on a label, they must be:

  • the next item following the sections required above
  • preceded by the following heading and written in capital, bold-faced letters of not less than 1.5 mm in height):

    SAFETY DIRECTIONS

15.1. Guidance notes

Please keep in mind the following advice when creating a ‘Safety directions’ statement:

  • statements should be in clear letters of not less than 1.5 mm in height to enable users to readily locate and read them. They should be clearly separated from the rest of the information on the label
  • where safety directions are required, the appropriate signal heading should also be included on the label
  • safety directions may be required even if the active constituent is exempt from poisons scheduling.

16. First aid instructions

The label must include first aid instructions from the FAISD handbook: handbook of first aid instructions, safety directions, warning statements and general safety precautions for agricultural and veterinary chemicals, published by the Department of Health. First aid instructions are substance-specific.

First aid instruction ‘a’ (see below) should appear on the label of all agricultural and veterinary chemical products unless replaced by instruction ‘i’.

Other substance-specific standard statements in the FAISD handbook apply only to substances in agricultural and veterinary chemical products registered by the APVMA when present in concentrations at which they would be scheduled as poisons. ‘First aid’ statements for a product are determined by the APVMA during product evaluation.

First aid instructions specify the initial action to be taken to counteract the effects of exposure to the product. The instructions may include decontamination measures, administration of antidotes or medical treatment advice.

‘First aid’ statements must be:

  • the next item following the sections required above
  • preceded by the following heading, written in capital, bold-faced letters of not less than 1.5 mm in height:

    FIRST AID

16.1. Guidance notes

Please keep in mind the following advice when creating a ‘First aid’ statement:

  • statement ‘a’:

    If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126, New Zealand 0800 764 766

  • statement ‘i’:

    If poisoning occurs, get to a doctor or hospital quickly.

17. Additional user safety information

Statements additional to those listed as mandatory in the FAISD handbook may be included on the label, provided they are reasonable and do not contradict the mandatory statements. These statements may be determined during product evaluation or may be proposed by an applicant to manage a specific user exposure risk.

If required, statements must be clearly identified as separate to the first aid and safety directions above, and the following heading must precede them:

ADDITIONAL USER SAFETY INFORMATION

For hazardous substances, ‘Additional user safety information’ statements may include reference to the safety data sheet (SDS) and/or where to get a copy of the full SDS. Reference to obtaining a safety data sheet for the product is not a relevant label particular. It is nevertheless encouraged, to ensure that users are aware of their obligations under relevant state or territory occupational health and safety legislation. When an SDS is required to be obtained under that legislation, product labels may refer users to the SDS by including a statement such as the following:

Additional information is listed in the safety data sheet.

17.1. Guidance notes

Please keep in mind the following advice when creating an ‘Additional user safety information’ statement:

  • it is your responsibility to determine if you need to include a reference to an SDS
  • labelling requirements under Work Health and Safety Regulations must be included in a separate panel. See 25. Other label information.

18. Environmental protection statements

The label must include suitable instructions about the proper method to dispose of used product and any other statements required to manage risk to the environment. ‘Environmental protection’ statements are those relating to the protection of wildlife, fish, crustaceans and the environment. These statements are determined by APVMA during product evaluation.

If ‘Environmental protection’ statements are required on a label, you must precede them with the heading:

ENVIRONMENTAL PROTECTION

18.1. Guidance note

An example of an ‘Environmental protection’ statement is:

Do not contaminate dams, rivers, streams or other waterways with the chemical or used container.

19. Disposal statements

You must include suitable instructions about the proper method of disposing of containers and any unused product on the label. These statements are determined by the APVMA during product evaluation.

The following heading must precede an appropriate ‘Disposal’ statement:

DISPOSAL

‘Disposal’ statements provide advice on the appropriate method to dispose of unused chemical and used containers. Inappropriate disposal of product containers can present a hazard to the environment and human safety. Consumers should be offered sufficient guidance for disposal of small or large containers and single-use product containers.

19.1. Guidance notes

The following statements should be used as guidance.

19.1.1. Small containers (less than or equal to 1 L or 1 kg)

These are example statements for small containers.

19.1.1.1. Live vaccine containers

Dispose of vial/container in a designated and appropriately labelled biologicals container.

19.1.1.2. Aerosol cans

Aerosols should be completely emptied before disposal. Place empty can in household rubbish. Do not puncture or incinerate.

19.1.1.3. Other small containers (less than or equal to 1L or 1kg)

Dispose of container by wrapping with paper and putting in garbage.

19.1.1.4. Disposal of sharps

Where a disposable sharp is distributed with a product or is expected to be used with a product, and sales of the product are not restricted to veterinarians, the following additional statement is recommended: Discarded needles/sharps should immediately be placed in a designated and appropriately labelled ‘sharps’ container.

19.1.2. Large containers (greater than 1 L or 1 kg)

These are example statements for large containers.

19.1.2.1. Metal drums and plastic containers

Triple-rinse container into the medicated water, dip, drench, etc. Do not dispose of undiluted chemicals on-site. If recycling, replace cap and return clean container to recycler or designated collection point. If not recycling, break, crush, or puncture container and deliver to an approved waste management facility. If an approved waste management facility is not available, bury the broken, crushed or punctured containers 500 mm below the surface in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and tree roots, in compliance with relevant local, state or territory government regulations. Do not burn empty containers or product.

In the case of drenches in metal or plastic containers that are not diluted, the following statement should replace the first sentence above. In some instances additional wording may be required:

Triple-rinse container and dispose of rinsate in compliance with relevant local, state or territory government regulations.

19.1.2.2. DrumMUSTER-eligible containers

For containers eligible for drumMUSTER the following statement may be used in place of, or in addition to, the second sentence (recycling statement) above:

If the container has the drumMUSTER logo visible, and has been thoroughly cleaned and dried, and is free of any visible residues, it can be recycled at any drumMUSTER collection or similar container management program site. The cap should not be replaced, but may be recycled separately with the container.

19.1.3. Plastic bags

Single-rinse or shake container into the medicated feed, water, dip, drench, etc. Do not dispose of undiluted chemicals on-site. Puncture bag and deliver to an approved waste management facility. If an approved waste management facility is not available, bury the container 500 mm below the surface in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and tree roots, in compliance with relevant local, state or territory government regulations. Do not burn empty containers or product.

19.1.4. Paper or cardboard containers and paper material bags

Shake container into medicated feed, water, dip, drench, etc. Do not dispose of undiluted chemicals on-site. Break, crush, or puncture container and deliver to an approved waste management facility. If an approved waste management facility is not available, bury the punctured containers 500 mm below the surface in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and tree roots, in compliance with relevant local, state or territory government regulations. Do not burn empty containers or product.

20. Storage statements

You must include suitable instructions on storage of the product on the label. These statements are determined during product evaluation by the APVMA and reflect the conditions studied during the generation of stability data. The following heading must precede the appropriate ‘Storage’ statement:

STORAGE

‘Storage’ statements are instructions on appropriate temperatures, light and environmental conditions for storage of product, as determined by stability studies.

The statement:

KEEP OUT OF REACH OF CHILDREN

may also be shown here, as well as in the signal heading if it is required there.

One of the following standard statements may be appropriate:

Store below -18 ˚C (deep freeze)

Store in liquid nitrogen or ‘dry ice’ and alcohol

Store below -5 ˚C (freeze)

Store between 2 ˚C and 8 ˚C (refrigerate, do not freeze)

Store below 8 ˚C (refrigerate)

Store below 25 ˚C (air conditioning)

Store below 30 ˚C (room temperature)

Storage conditions specifying temperatures over 30 ˚C or below -18 ˚C may be allowed, subject to submission and review of stability data.

The APVMA may require other storage instructions, for example:

Store in a dry place, keep container closed, protect from light

21. Name and address of person primarily responsible for marketing the product

The label must contain the name and address of the person who is primarily responsible for marketing the product. The address shown must be a street address (not a post office box) in Australia and an emergency contact telephone number (NOT just ‘000’) must also be included.

This statement may be qualified by, for example, the words:

Packed for

Distributed by

Licensed to

Manufactured by

Sold by

Holders need to be careful that the wording chosen does not infer that the product is manufactured in Australia if this is not the case. The Competition and Consumer Act 2010 establishes rules about making false and misleading representations. Further information can be obtained from the Australian Competition and Consumer Commission.

Holders should also note that the Commerce (Trade Descriptions) Act 1905, administered by the Australian Customs and Border Protection Service, establishes rules for the labelling of imported goods that relate to the country of origin.

You may also show other information on labels, including details of branch offices, local agents or distributors, phone numbers and web addresses. These details will not be checked for approval by the APVMA.

22. APVMA label approval number

The label must contain the distinguishing number of the label for the product. This is a number unique to each label that is allocated by the APVMA. The number must not be written or displayed in any way that implies that the APVMA recommends, warrants or guarantees the use of the product. This would include using letters that are large in comparison with others on the label or prefixing the statement with words that imply that the APVMA recommends, warrants or guarantees the use of the product.

The unique number, allocated by the APVMA, must be included at the bottom of either the main panel or the ancillary panel of an approved label, and must be preceded by either of the following statements (depending on label space):

APVMA Approval No.:

APVMA:

23. Expiry date and date of manufacture of the product

The expiry date of a product must be determined for all veterinary medicines. These dates are determined by the APVMA on a case-by-case basis during product evaluation and they must be shown on the label, or be suitably affixed to the label or container, before containers of the product are released for supply.

The expiry date is the date (month and year) after which the product must not be used. Show the expiry date in such a way that the meaning is clear, for example:

DEC16

12/16

Expiry dates must be preceded by either of the statements:

Expiry Date

Expiry

or by a suitable prefix:

EXP

(E)

The appropriate expiry date must be printed adjacent to the expression or prefix, to ensure that it is not confused with any other numerical codes that may also be on the label.

The date of manufacture may also be included on the label for these products and should immediately follow the expiry date. When the date of manufacture does appear, it must be preceded by either of the statements:

Date of Manufacture

DOM

The appropriate date of manufacture must be printed adjacent to this expression or prefix, to ensure that it is not confused with any other numerical codes that may also be on the label.

24. Batch number

The label must state the batch number for the product. This must be shown on the label or be suitably affixed to the label or the container before containers of the product are released for supply.

The batch number is the number or letters, or a combination of numbers and letters, in English, by which the manufacturer uniquely identifies each production batch. It enables the tracing of a particular batch from manufacture through distribution to end-use.

A batch number must be preceded by either of the statements:

Batch Number

Batch

or a suitable prefix:

BN

(B)

The appropriate batch number must be printed adjacent to this expression or prefix, to ensure that it is not confused with any other numerical codes.

24.1. Guidance note

Please keep in mind the following advice when adding an expiry date or a batch number statement.

The batch number and expiry date should appear together and be grouped together with the APVMA approval number. When they do not appear in this actual position the information must be easy to find. Appropriate wording to specify the actual position would be:

For batch and expiry see [xxx]

25. Other label information

Other information to meet the requirements of other regulators—such as emergency and transport advice and hazard symbols, warranty statements or disclaimers, as well as logos such as drumMUSTER and barcodes—may be included on the label, provided they are shown in a distinct panel or clearly delineated box, and not incorporated under the same headings as the APVMA-required directions or instructions approved by the APVMA. This additional information should not be supplied to the APVMA as part of label approval as it does not constitute relevant particulars.

Some of the other information will be assessed and approved by the APVMA, including company-chosen statements such as other ingredients, typical analysis and other human safety advice.

Emergency and transport advice on steps to be taken in the case of leakage, spillage or fire should be included on the label when required under the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG Code).

Emergency information statements should include the information required by the ADG code, or its successor, which is incorporated into relevant state legislation. The information should be included on the label in a clearly defined emergency information panel or box.

If the product is classified as a hazardous chemical under the Work Health and Safety Regulations there are likely to be labelling requirements in those regulations. You should make inquiries about these requirements with Safe Work Australia or state or territory workplace health and safety agencies. Any required statements must be shown in a distinct panel or clearly delineated box. This information does not constitute a relevant particular and must not be incorporated amongst the APVMA-required safety directions or other instructions approved by the APVMA.

Note that it is the responsibility of the applicant to meet these requirements. However, the information will not be assessed or approved as part of the APVMA’s approval process. Please make sure that the other label information must not be contrary to the relevant label particulars that are approved by the APVMA and that these are placed in such a way as not to interfere with the layout and presentation requirements in this code.

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