Label presentation and layout

The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, stipulates that, for a label for a container for a chemical product to meet the labelling criteria and be approved, the label must contain adequate instructions relating to specified matters (as are appropriate), including any matters prescribed by the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations). Among other things, a label must comply with the requirements of the Labelling Standard or, if there is no Labelling Standard, the Agricultural or Veterinary Labelling Codes made by the APVMA, as in force from time to time.

Where the term 'must' is used, it is a legal requirement that labels comply with this provision. The Labelling Code also contains some additional guidance on how labels may be structured and presented, where terms such as 'may' and 'should' are used.

The following sections set out requirements of the Veterinary Labelling Code and some guidance on:

  • what information is required on labels and what should be avoided
  • label layout
  • printing and legibility requirements.

1. Information required on labels

The Agvet Code stipulates that a label must contain adequate instructions relating to such of the following as are appropriate:

  • the circumstances in which the product should be used
  • how the product should be used
  • the times when the product should be used
  • the frequency of the use of the product
  • the duration of the withholding period after the use of the product
  • the disposal of the product when it is no longer required
  • the disposal of the product’s containers
  • the safe handling of the product and first aid in the event of an accident caused by the handling of the product
  • any matters prescribed by the Agvet Code Regulations, which include:
    • the duration of any treatment when using the product
    • the prevention of undue prejudice to trade or commerce between Australia and places outside Australia
    • the appropriate signal words (if any) required by the current Poisons Standard
    • the storage of containers for the product
    • any other matter determined by the APVMA CEO.

1.1. Legislative compliance

The label must also comply with any the particulars prescribed by the Agvet Code Regulations that are appropriate to be contained on the label. The following particulars are prescribed:

  • the appropriate signal words required by the current Poisons Standard
  • the name of the chemical product
  • the name of each active constituent in the product
  • the proportion of each active constituent in the product
  • the name of each constituent for the product that is:
    • not an active constituent, and
    • classified as a poison in the current Poisons Standard
  • the proportion of each constituent that is:
    • not an active constituent, and
    • classified as a poison in the current Poisons Standard
  • the net contents of the product
  • other particulars determined by the APVMA CEO.

The ‘relevant particulars’ in relation to the approval of a label, as defined in the Agvet Code, include the adequate instructions and prescribed particulars specified above.

The label must also comply with any conditions of the approval imposed by the APVMA. Among other things, a label must comply with the requirements of the Labelling Standard or, if there is no Labelling Standard, the Agricultural or Veterinary Labelling Codes made by the APVMA, as in force from time to time.

The Veterinary Labelling Code also includes requirements relating to certain additional information on the label, its layout, presentation, printing and legibility. These requirements must be met for the label to comply with the conditions of approval of the label.

1.2. Additional information

Labels may also include:

  • information needed to meet the requirements of other regulators; for example, reference to safety data sheet and transport emergency information
  • other company chosen statements, such as warranty statements, disclaimers regarding liability, logos such as drumMUSTER and barcodes
  • other information that is not contrary to the label’s relevant particulars or the requirements of the Agvet Code and the Agvet Code Regulations.

This additional information must be placed in such a way as to enable compliance with the layout requirements of this Labelling Code. It will not be assessed as part of the APVMA’s label approval process and does not need to be supplied to the APVMA for the purposes of label approval.

1.3. Terms to be avoided

According to the Agvet Code, a label must not include any statement or expression that expressly or impliedly claims—irrespective of how the claim is stated—that:

  • the APVMA recommends the use of the product
  • the APVMA guarantees, warrants or assures the safety or efficacy of a product, or
  • the product is natural, organic, safe, harmless, non-toxic, non-poisonous, non-injurious or environmentally friendly without qualification, or with a qualification that is not acceptable to the APVMA.

In addition, advertising statements are not permitted on labels. This includes cross-references to other products. An exception to cross-references to other products may be for compatibility purposes or pest or disease management where specific approval has been obtained from the APVMA. The name of a product not registered for use in a state or territory is not acceptable on a label for use in that state or territory.

The information on a label should avoid using certain terms and making claims that cannot be substantiated (see Tables 1 and 2).

Table 1: Examples of terms to be avoided
Category Examples of terms to be avoided
Superlatives and comparatives the best, better, the most effective, superior control, super, top, best, highly, complete, extra, quality, care, essential, elite, premium, enhance, organic, advance
Imprecise words and phrases booster (except vaccines), conditioner (except as coat conditioner), improver, tonic, pep, constitution, worms
Multiple meanings liver tablets, lamb paste, kidney mixture, fly dust
Table 2: Examples of phrases that must be qualified
Conditions of use Examples of phrases to be qualified

Natural origin claims

These terms, and similar words, can only be used when all product constituents are of natural origin
natural, naturally derived, nature’s way
New product claims

plus

new, improved (use is limited to six months after first sales of a product or new formulation and is not permitted in a product’s name)

Australian-made claims

Relevant consumer affairs and trade practices authorities should be contacted for information about the valid use of these claims
Australian made, Made in Australia, Australian owned, Australian based and owned

1.4. Use of logos and pictures

Logos must not interfere with the required label information. Labels must not include logos that:

  • contain letters or words that are superlatives or comparatives
  • make a claim regarding product safety or efficacy, or
  • make a promotional or marketing inference or statement.

Logos and pictures should be pertinent to the product, and not confuse, mislead, be deceptive, or reduce the readability of the label. If a label features a non-target species used as either a background graphic or logo, it should show enough information or instructions on the label to clearly indicate the species for which the product is intended.

All words, symbols and numbers that appear between FOR ANIMAL TREATMENT ONLY and the ‘Active constituent’ statement are considered to be the name of the product.

Company logos containing representations of animals that are not included in the claim for the product or other pictures should be located next to the registration holder or distributor name and address—in other words, well separated from the claim and product name. The size and prominence of such a logo should not diminish the prominence of the product name or claims for use.

If a logo containing a registered trade name is used as part of the label name of a product, the inclusion of this trade name is acceptable, provided all other labelling requirements stated in this publication are met.

An Australian-made logo or graphic (for example, Australian flag, kangaroo, koala) that implies a product is Australian may appear on a label in a position that does not interfere with the label’s function. This does not represent approval for the use or the accuracy of such claims. Relevant consumer affairs and trade practices authorities should be contacted for information about the valid use of these claims.

1.5. Pack sizes

A single product may be registered with several pack sizes, provided it is the same product (that is, it has the same formulation, specifications). In general, the product will have the same immediate container packaging material and shelf life, but we will consider these on a case-by-case basis. The product will have the same relevant particulars, except that the different pack sizes will have different net contents of the containers and possibly different ‘Disposal’ statements relevant to the pack size.

However, related veterinary chemical products that have different dosage masses or different concentrations cannot be registered as different pack sizes, and must be registered as separate products. This is because they have different pharmaceutical properties that may result in different stability, different efficacy and safety profiles, and different label instructions to ensure the safe and effective use of the product. The packs containing different dosage masses or different concentrations should be easily recognised and differentiated, to avoid inadvertent over-dosing or under-dosing.

Refer to the requirements for labelling for professional packs of oral non-prescription products for more details.

1.6. Promotional, display and shipper packs

Promotional, display and shipper packs are defined as:

outer packaging containing one or more registered products used to promote, display or protect the products or the special deal for the purchaser in the form of a price discount, a free bonus pack or a gift.

They may also contain unregistered products or gifts. Generally, these packs are discarded prior to, or once a product is supplied or sold, except in the case of the gift being a reusable container such as an esky. The promotional, display or shipper packaging should not obscure the approved label information.

The pack itself does not require approval as a primary pack if:

  • the chemical products inside the pack are registered and have labels that contain all the relevant particulars
  • the wording on the promotional, shipper or display pack does not include any registration information (claims, instructions, warnings, etc.), other than the product name, pack size or sizes, company name and any transport information required under other legislation.

The packs may also contain words such as Gift Pack, Starter Pack, and Combination Pack.

2. Label layout

Although the APVMA no longer approves the final form of the label when finalising a registration or variation application, the Agvet Code provides that we may subsequently request the registration holder to provide us with a copy of the marketed product label. The registration holder is responsible for conversion of the approved relevant particulars into the marketed product label.

In the next two sections we provide guidance on the placement of information on labels and any layout requirements and details of label printing and colour requirements to ensure labels are legible. This information is provided for:

The size and type of container determines the space available for labelling and, therefore, the format or layout of a label and the space available for each item on the label. More space and a larger typeface should be allocated for key information.

Space must be allowed for items such as barcodes and hazard symbols and care taken to ensure that:

  • the legislative requirements for relevant poisons are not contravened
  • the information of greatest importance to the user of the product is not difficult to read.

2.1. Non-prescription products

2.1.1. Primary pack—main panel

Table 1 shows the type of information that must be shown on a primary pack. The relevant particulars must be shown on the main panel of the primary pack label in the following order and be visible at all times without the need to open packaging or leaflets.

Table 1: Non-prescription products—information that must appear on the main panel of a primary pack
Required information Order of appearance on label
Signal headings 1
Product name 2
‘Active constituent’ statement (and, where applicable, ‘Also contains’ statement) 3
Statement of claims for use  4 (at least in summary form)
‘Net contents’ statement  5

When the product 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 (and the leaflet or insert where the primary pack refers to one). In this case, the ‘Net contents’ statement must contain either of the following statements:

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

Illegal to sell [container/unit] separately [where space is limited]

2.1.2. Primary pack—ancillary panels

Table 2 shows the type of information that must be shown on the ancillary panels of a primary pack. All indications and instructions for use, including any restrictions or limitations, must be visible at all times without the need to open the packaging or read leaflets or inserts.

When there is no user information leaflet or insert included in, or attached to, the primary pack, the following particulars, when required, must appear on the ancillary panels of the primary pack label, in the order shown in Table 2.

If there is a user information leaflet or insert included in, or attached to, the primary pack, and where space is limited, the particulars appearing on the ancillary panels of the primary pack label may be reduced (see minimum required information column in Table 2). When they are reduced, the following statement must be inserted above the ‘Directions for use’ heading:

Read the [enclosed/attached] leaflet/insert for full instructions

Table 2: Non-prescription products—information that must appear on the ancillary panel of a primary pack
Required information Minimum required information (on reduced labels) Order of appearance on label
Complete statement of claims (indications) for use (where summarised on the main panel) Complete statement of claims (indications) for use (where summarised on the main panel) 1

The directions for use section of a label, divided into the following subsections and expressed in this order:

  • Restraints
  • Contraindications
  • Precautions
  • Side effects/adverse reactions
  • Dosage and administration1
  • General directions
  • Withholding periods1
  • Trade advice1
  • Safety directions
  • First aid instructions
  • Additional user safety information (where appropriate)
  • ‘Environmental protection’ statement
  • ‘Disposal’ statement
  • ‘Storage’ statement

The directions for use section of a label divided into the following subsections and expressed in this order:

  • Restraints
  • Contraindications
  • Dosage and administration1
  • Withholding periods1
  • Trade advice1
  • Safety directions
  • First aid instructions
  • ‘Environmental protection’ statement
  • ‘Disposal’ statement
  • ‘Storage’ statement
2

The following details must also appear below the items listed above, unless they appear on the main panel away from the items required there:

  • name and address of the person primarily responsible for marketing the product
  • APVMA label approval number
  • expiry date
  • batch number

The following details must also appear below the items listed above, unless they appear on the main panel away from the items required there:

  • name and address of the person primarily responsible for marketing the product
  • APVMA label approval number
  • expiry date
  • batch number
3

May be abbreviated where it appears in full on the leaflet or insert.

2.1.3. Immediate container

The immediate container is the container that is in direct contact with the agvet chemical product.

  • When the immediate container is the primary pack—it must carry the same information in the same layout and format as required on the main and ancillary panels of the primary pack label. 

    If the container that is in direct contact with the product is a bag in a box, and the bag is firmly attached inside the box, and cannot easily be removed, it is considered as part of the box, and does not require separate labelling. If however the bag is not stuck inside the box, it needs to be labelled as an immediate container, with the box as the primary pack.

  • When the immediate container is not the primary pack, it must carry the same information in the same layout and format as required on the main panels of the primary pack label, but where space is limited, it may have reduced information on the ancillary panels (see Table 3 below).
  • When labels are reduced, either of the following statements, as appropriate, must be inserted above the ‘Directions for use’ heading:

Read the outer pack/carton for full instructions

Read the [enclosed/attached] leaflet/insert for full instructions

Table 3: Non-prescription products—minimum information that must appear on the ancillary panels of the immediate container label
Required information Order of appearance on label
Indications for use1 1

The directions for use section of a label divided into the following subsections and expressed in this order:

  • Restraints
  • Contraindications
  • Dosage and administration1
  • Withholding periods1
  • Trade advice1
  • Safety directions
  • First aid instructions1
  • ‘Environmental protection’ statement
  • ‘Storage’ statement
2

The following details must also appear on the ancillary panels of the immediate container below the items listed above, unless they appear on the main panel away from the items required there:

  • name and address of the person primarily responsible for marketing the product
  • APVMA label approval number
  • expiry date
  • batch number
3

These statements may be abbreviated where they appear in full on the leaflet or insert.

Products containing discrete dosage units or packed in very small immediate containers—for example, foils or blister packs containing tablets or capsules; or syringes, ampoules, vials or tubes containing less than 5 mL or 5 g—when packed inside a primary pack that has all the required instructions for primary packs above may have the instructions that appear on the immediate container label further reduced (see Table 4).

Table 4: Non-prescription products—minimum reduced information for very small containers or discrete doses packed inside a primary pack
Required informtion Order of appearance on label
FOR ANIMAL TREATMENT ONLY  
  • distinguishing words of product name1
  • ‘active constituent’ statement
  • contents (not needed for foils and blisters)
  • name and address of the person primarily responsible for marketing the product
  • expiry date
  • batch number
 

Where a distinguishing word is used for several products—for example, for different target animal species or different concentrations of active constituent—each will need to be distinguished by identifying the species or concentration. This information should appear at least once on every strip of foil or blister pack enclosed within a primary pack, and more frequently on packs that are scored for sub-division.

2.1.4. Leaflets 

When a leaflet or insert is included in, or attached to, the primary pack, it must include all of the information in the same layout and format as required on the main and ancillary panels of the primary pack label that do not contain a leaflet or insert, except for:

  • expiry date
  • batch number.

If the leaflet is used as a common leaflet with other similar products, all product names, active constituent names and concentrations or strengths, and all APVMA numbers need to appear on it.

If a zip-seal label is attached to an immediate container that is also the primary pack, it may require certain information to be repeated so that, when it is folded, the necessary information is still visible at all times.

2.2. Prescription products

Prescription-only products may be approved for use by, under supervision of, or under direction of, a registered veterinarian.

Under state and territory prescribing laws, it is the responsibility of the prescribing veterinarian to give adequate instruction to their client on the safe and effective use of a prescription-only veterinary product when dispensing it. This is usually done after a diagnosis is made or as part of a treatment trial, so the specific indication, appropriate dose, frequency and duration of treatment have already been determined. The states and territories generally require these instructions to be in writing, particularly for the treatment of food-producing animal species.

The prescribing laws also require, among other things, the label to contain the name and contact details of the prescribing veterinarian and date of the prescription. As with prescription products for humans, this is usually done by sticking a personalised veterinary practice label over the product label, being careful not to obscure any of the details on the main panel, or any of the label instructions the veterinarian wishes to be available as part of their written instructions.

Space should therefore be allowed on some part of the product label for a personalised veterinary practice label. Most products will have space for this on a panel of the primary pack; however, very small containers may need to have this space on a specific user information leaflet or insert.

2.2.1. Primary pack—main panel

The mandatory layout and placement requirements for the relevant particulars for non-prescription veterinary products on the main panel of the primary pack also apply to prescription veterinary products, with the following exception:

  • The statement of the registered indications for use of a product on the main panel of the primary pack label is not mandatory, although, if known, the class or group (by mode of action) of the active constituents should be identified, and the class or level of permitted prescribing should be stated.

Note: If the product is a prescription veterinary product that consists of discrete dosage units or has an immediate container that is not the primary pack, the ‘Net contents’ statement on the main panel of the primary pack label is not normally required to mention that the container or units must not be sold separately.

2.2.1.1. Primary pack—ancillary panels

The mandatory layout and placement requirements for the particulars for non-prescription veterinary products on the ancillary panels of the primary pack also apply to prescription veterinary products, with the following exceptions:

  • When the full particulars are contained in a user information leaflet or insert, the following statement must appear immediately above the ‘Directions for use’ heading,

Read the [enclosed/attached] leaflet/insert for full instructions

  • When it is permitted to dispense the product, the statement must also appear immediately above the ‘Directions for use’ heading,

Use as directed by prescribing veterinarian.

In the latter case, the particulars appearing on the ancillary panels of the primary pack label may be reduced as required as shown in Table 5.

Space should be made available on an ancillary panel for the personalised practice label of the prescribing veterinarian.

Table 5: Prescription products—minimum requirements for ancillary panels of primary pack
Required information Order of appearance on label

The directions for use section of a label with the following subsection:

  • restraints
  • dosage1
  • withholding periods1
  • trade advice1
  • safety directions
  • first aid instructions
1

Additional details2

  • name and address of the person primarily responsible for marketing the product
  • APVMA approval number
  • expiry date
  • batch number
na

These statements may be able to be abbreviated where they appear in full on the leaflet or insert. 

These details must also be placed on the ancillary panels of the primary pack, below the items listed above, unless they appear on the main panel away from the items required there.

2.2.2. Immediate container

The mandatory layout and placement requirements on the immediate container for prescription veterinary products are the same as for the primary pack.

Products containing discrete dosage units or in very small immediate containers—for example, foils or blister packs containing tablets or capsules; or syringes, ampoules, vials or tubes containing less than 5 mL or 5 g—when packed inside a primary pack that has all the required instructions for primary packs above, may have the instructions that appear on the immediate container label further reduced (see Table 6).

Table 6: Prescription products—minimum reduced information for very small containers or discrete doses packed inside a primary pack
Required information Order of appearance on label
FOR ANIMAL TREATMENT ONLY 1
  • distinguishing words of product name
  • ‘Active constituent’ statement
  • contents (not needed for foils and blisters)
  • name and address of the person primarily responsible for marketing the product
  • expiry date
  • batch number
2

2.2.3. Leaflet or insert

Leaflets or inserts are almost always included with prescription products. The mandatory layout and placement requirements on the leaflet or insert for non-prescription veterinary products also apply to prescription veterinary products.

Note: If it is required by the APVMA, or requested by the applicant and permitted by APVMA, that detailed clinical or pharmacological information be included on a label to help the prescribing veterinarian understand the type of drug or the trial work carried out during the registration process, this should appear on a separate professional leaflet or insert. This will avoid unnecessary clutter or confusion with the end-user instructions that the prescribing veterinarian may wish to give the animal owner or carer.

3. Printing and legibility requirements

The label instructions required by the APVMA, and any other information relevant to the handling or use of the chemical product contained on a label, must be legible to the average person using their normal reading aids (for example, glasses) if required, in good natural light conditions (320 lux). If the product is primarily for use indoors (for example, household products), the label must be legible using incandescent lighting of the type used in the average household (160 lux).

Any words required on labels must be printed on the outside face of the label or container and be in the English language.

When printed for attachment to containers of agricultural and veterinary chemical products registered under the Agvet Code, labels must adhere to requirements for:

  • attachment method
  • print size and style
  • typeface
  • print quality
  • colour.

3.1. Attachment method

Every label for a product must be printed on, or securely attached to, the outside of the container or pack of the product. Leaflets or booklets, if used, should be attached to the container in plastic pockets or other suitable secure holding methods.

A print size of 2 mm or greater should be used unless label space is limited. Larger print sizes are more readable by users and other persons dealing with the chemical. This facilitates the clear communication of warnings and instructions and contributes to the safe handling and use of the chemical.

If label space is limited (for example, on very small immediate containers), a minimum letter height of 1.5 mm (6 point type) may be used on the ancillary panel. This means that:

  • letters with ascenders or descenders, such as b, f, g, h, l, t, are to be a minimum of 1.5 mm in height
  • letters without ascenders or descenders, such as a, e, i, o, u, m, r, are to be a minimum of 1 mm in height.

This minimum print size should only be used on the ancillary panel where space is limited.

3.3. Typeface

Typefaces chosen for labels need to be clear and simple. Complicated or decorative fonts can be difficult to read and should be avoided. Bodies of text should not be in all capitals or italics, unless specifically required. Closely-spaced, condensed or widely-spaced lettering should be avoided. Bold text can be used for emphasis, in addition to where it is required. Where bold text is used, registration holders must ensure the type does not become so thick that it reduces the white spaces within characters.

Printing must be clear and crisp, and free from blurring or other distortion. Printing must be sufficiently durable so as not to fade, run, smudge or otherwise lose legibility during reasonable handling and storage for at least the stated shelf life of the products.

3.5. Colour

The colour of the printed letters must be distinctly contrasted to the background colours—use light-coloured text on dark background and dark text on light background. Well-contrasted colours with widely differing hues and an appreciable difference in value should be used; avoid using strongly saturated colour pairs for text and background.

There must be a luminance contrast of at least 30 per cent between letters and background. (Australian Standard AS1428.1, particularly Appendix D, provides further details on luminance contrast).

Text printed directly over pictorial or multicoloured backgrounds may be difficult to read and should be avoided. A plain screen, preferably white, may be used beneath the letters to improve legibility in these situations.

Colour blindness affects a significant number of people in the community—between 5 to 10 per cent of males and around 0.5 per cent of females. These people usually have difficulty with the colours green, yellow, orange and red, so this should be taken into account when choosing label colours for critical information. In particular, avoid red print on green background or the reverse. Do not use red, green, brown, grey and purple next to each other or on top of each other.

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