Label Approval Process
1. REQUIREMENTS OF THE AGVET CODE
Section 21 of the Agvet Code provides that if the APVMA approves a label for containers for a chemical product, it must:
- determine (if appropriate) the size and type of the label;
- give a distinguishing number to the label;
- determine the particulars that are to be contained on the label (which must include the distinguishing number, the instructions for the use of the product and any particulars that are prescribed by the regulations);
- place a label of the determined size and type, and containing the particulars mentioned in paragraph (iii), in the relevant APVMA file; and
- record in that file any conditions of the approval.
Section 28 of the Agvet Code provides that an application for a variation to the particulars of a label must be accompanied by a proposed new label.
The guiding principle throughout the label approval process is:
The label which is affixed to the marketed product must be identical to the label on the APVMA product file, except for any minor differences which are allowed under permits 6868 or 9523.
2. DEFINITIONS
Size of label
The size of the label is its dimensions in centimetres (cm) or millimetres (mm).
The dimension s of labels which have containing a number of sides to be placed on cartons, boxes or printed directly onto boxes or drums etc. are given as height x width x depth.
Type of label
The label type is determined by label details such as:
-
label layout, eg single panel, two panel, bottle-in-box, primary and measure packs, label leaflets
-
placement of label information or particulars
-
formatting including letter size, colours and inclusion of diagrams and pictures.
Draft label
Applicants must submit a label with each application. The label may be in a draft form, or it may be in a finished form ie printer’s proof label (PPL ) or marketed product label (MPL).
The draft label can be submitted as a paper print or electronically (e-label) as a PDF.
Text label (TXL)
A TXL is a text-only label printed on A4 or A3 size plain paper.
A TXL contains the particulars which will be printed on the final approved label, but a TXL is usually not of the size and type of the final approved label.
In the case of shelf registrations an applicant may provide a TXL for approval, meaning that the TXL will be the MPL.
Marketed product label (MPL)
The MPL is the label that is attached to or printed on the product container.
The MPL includes all components of the label suite, such as the immediate container label, outer container label, and leaflet.
MPLs submitted to the APVMA for approval must be in an electronic format (e-label).
Printer’s proof label (PPL)
A PPL is produced by the printer for the client to check accuracy and artwork before a print run.
PPLs are usually generated in PDF format and are usually printed on A4 or A3 paper. PPLs show colour, artwork and particulars identical to those intended to be printed on the MPL.
Label approval number (LAN)
The Agvet Code provides that all approved labels must include a distinguishing number allocated by the APVMA. This distinguishing number is termed the label approval number (LAN).
E-label
An e-label (or electronic label) is a label submitted to the APVMA in an electronic PDF format.
Approved label
This is a label that is approved by the APVMA under sections 21 and 29 of the Agvet Code and placed in the APVMA file.
3. SPECIFYING LABEL SIZE AND TYPE
When completing an application for a new product, the applicant must indicate in the application form the size and type of label that is to be approved for each pack size or pack size range.
If this information is not available at the time of making an application, the applicant must indicate this on the application form. The APVMA cannot grant label approval until the applicant has provided this information.
4. EVERY APLICATION MUST CONTAIN A LABEL
Every application for registration of a new product or to vary an existing label must include a label. The use of e-labels gives applicants the opportunity to provide the initial label not as a draft, but as an e-label of the MPL for approval, because applicants can readily make any amendments which may be required.
The APVMA will regard the label that is initially submitted in conjunction with an application as a draft label unless otherwise indicated by the applicant.
4.1. Draft label
Applicants must submit a draft label with the application. The APVMA will make deficient any applications which are submitted without a draft label.
Draft labels can be submitted as a TXL, PPL or MPL and may be submitted as a paper copy or as an e-label in PDF format.
If the draft label is submitted as a paper copy, two copies must be submitted.
4.2. Approval of the e-label of the marketed product label (MPL)
Once the APVMA product evaluator is satisfied that the text on the draft label is acceptable, the APVMA will write to the applicant requesting an e-label of the MPL.
The applicant has two months in which to submit the e-label MPL. If the APVMA has not received the e-label within two months of the letter requesting the e-label MPL, the APVMA may treat the application as having been withdrawn.
Any written request for an extension to time to submit the e-label MPL must indicate when the label will be submitted.
5. FORMAT FOR e-LABELS
E-labels must be submitted as PDF files. PDF files must be generated using Adobe Ac rob at, preferably the most recent version.
Applicants must use the PDF/A or PDF/A:Draft specification or setting.
Important: The file must not be password protected and the label must not be derived from scanning a label or another image. The submitted e-label must be text searchable.
6. SUBMITTING e-LABELS OF MPLs
Applicants must submit MPLs as an e-label, either as an attachment to an email or on a CD.
The APVMA will not usually accept the MPL in printed paper form. If the APVMA agrees to accept the MPL in printed paper form because of exceptional circumstances, the applicant must submit three copies of the MPL.
6.1. Submitting e-labels by email
The address for submitting e-labels by email is: E-labels@apvma.gov.au.
Important: DO NOT email e-labels directly to the product evaluator for the application.
DO NOT provide e-labels via email if accompanying information is also being submitted through the normal mail. In this case, submit the e-labels on a CD together with the accompanying information.
6.2. Email size limits
PDF file sizes must be kept to a minimum where possible. Emails to the APVMA cannot exceed 3Mb. If the e-label exceeds this size, the e-label must be submitted on a CD. DO NOT send several emails each containing separate components and/or pack sizes of the overall label suite.
6.3. Submitting e-labels on CD by mail
The mail address for CDs is:
Application Management & Enquiries
APVMA
PO Box 6182
KINGSTON 2604.
Ensure that CDs are clearly marked with the identity of the product, ie product name and application tracking system (ATS) number.
7. FILE NAMING PROTOCOL FOR E-LABELS
Each component of the e-label must be named according to the following protocol (where applicable):
DRAFT LABELS:
[Product name]_[Pack size]_[Component]_DRAFT_[Version].PDF
MPLs:
[Product number]_[ATS number]_[Pack size]_[Component]_MPL_[Version].PDF
Product name:
- The brief name of the product (one or two words only).
Product number:
- The unique five-digit number allocated to an approved product by the APVMA
Pack size:
-
The pack size of the label, eg 10kg, 30L
-
Labels for leaflets, measure packs or other label components that are common across a range of pack sizes do not need to include a pack size
-
If the label is a representative label covering a range of pack sizes, specify the range, eg 10–40kg, 20–30 sachets
ATS number:
-
The unique five-digit application tracking system number allocated to an application by the APVMA
Component:
-
The label suite includes the complete range of labels for a product and covers all the label components for all the various pack sizes. A label may comprise one or more different components depending on how the product is packaged. Refer to Table 1 for a list of commonly used terms for describing a label component in a file name
-
Whilst it is preferable to use the descriptive terms contained in the Ag and Vet Labelling Codes, the APVMA will accept alternative terms provided that the same term is consistently used to clearly identify all components of a label
Version:
-
The version is necessary in case changes are required during assessment. The initial submitted e-label should be marked ‘V01’, with the next submitted version becoming ‘V02’, then ‘V03’ and so on
Table 1: Terms applicants should use when describing a label component in the file name
| Term | When to use the term |
|---|---|
| Label | When the entire label is contained in a single PDF |
| Primary | When the PDF only contains the label of the primary pack |
| Immediate | When the PDF only contains the label of the immediate pack |
| Leaflet | For leaflets, booklets or similar components |
| Front and rear | When the front and rear of a label, primary pack or immediate pack are submitted separately (refer to Appendix A, Label Type A). |
| Partlabel and breakout | When overlarge labels are submitted (refer to Appendix A, Label Type C). |
7.1. Separate PDF files for each separate label component
If a label has several components, each component must be submitted as a separate PDF. This allows labels to be amended or varied by resubmitting the varied component, rather than the entire label.
7.2. Various pack sizes
If a product comprises a range of pack sizes, applicants must provide either:
- a separate label for each pack size; or
- a representative label covering a range of pack sizes (refer to paragraph 19).
7.3. Overlarge labels
All submitted e-labels must be capable of being printed onto A4 or A3 paper. If a label is larger than A3 at full size it must be reduced to fit onto A3 paper.
If any text is illegible when reduced to A3, ‘breakout’ sections must be used. Refer to Appendix A, Label Type C for details on how to display breakout sections.
IMPORTANT: Breakout areas must be clearly marked on the ‘partlabel’ component.
8. LABEL DIMENSIONS AND SCALING
All MPL e-labels must include the dimensions of the full-size printed label, printed in a text box, as part of the label PDF file, as shown below:
| File name | Refer to the file naming protocol (see paragraph 7 ) |
| Dimensions | The dimensions in cm or mm of each label component when they are printed as the full size MPL (eg primary pack = 100mm x 80mm) |
| Scale | The approximate scale (%) at which the PDF file will print onto either an A4 or an A3 page (eg This label is 75% of full size) |
| Date | Used in combination with version control (eg V01, 0107) |
This text box must be positioned beside the label graphic. No part of this text box should intrude onto any part of the actual label graphic.
9. APPROVAL OF TEXT LABELS FOR SHELF REGISTRATIONS
An applicant may submit an e-label of the TXL as the MPL for final approval. The inclusion of colours and graphics and other similar formatting is not required for the APVMA to approve a label. However, the e-label approved by the APVMA must be identical to the label (MPL) which is supplied with the product.
Once the APVMA has approved a TXL as the MPL, any subsequent variations to the label to convert it to a commercial MPL format, such as the addition of colours, logos, graphics, or other reformatting of the layout of the label, will require the submission of a Category 12 application for a label variation.
10. SUBMITTED e-LABELS MUST BE ‘CLEAN’
E-labels of MPLs submitted for approval MUST NOT contain any graphic, text or comment on the actual label, that is not meant to be part of the label, apart from the printer’s identification and the text box described in paragraph 8.
11. UNACCEPTABLE e-LABELS
e-labels must pass an initial quality check before assessment can begin. The initial check examines whether the e-label:
- is in PDF format
- applicants must not submit e-labels as Word documents because the APVMA will not convert Word documents to PDF format
- is not derived from scanning a printed label (refer to paragraph 5)
- is not password protected (refer to paragraph 5)
- is clear and readable with respect to size, font, colours
- has dimensions that are clearly indicated (refer to paragraph 8)
- does not contain any non-label matters (refer to paragraph 10)
- is complete in regard to what comprises the actual components of the complete label.
If an e-label does not pass the initial quality check, the APVMA will return the label to the applicant or approved person and request that it be rectified and resubmitted (as version V02).
Applicants must submit an acceptable e-label before technical assessment can begin.
12. THE LABEL APPROVAL NUMBER (LAN)
The Agvet Code provides that all approved labels must include a distinguishing number allocated by the APVMA. This distinguishing number is termed the label approval number (LAN) and is placed on all components of an approved label.
The LAN is preceded by ‘APVMA approval number’, or ‘APVMA’ where label space is limited.
12.1. Placing the LAN on the label
If an applicant has initially submitted a draft label, the APVMA will specify the LAN which must be placed on the e-label MPL to be submitted by the applicant for label approval.
If the applicant has initially submitted an e-label of the MPL, the APVMA will add the appropriate LAN to the e-label as part of the approval process. The applicant may then change the position, size, or print colour of the LAN without seeking further approval from the APVMA.
12.2. LAN format
The LAN differs in purpose and structure from the file naming protocol for e-labels described in paragraph 7. The LAN format is:
[Product number]/[Pack size identifier]/[Version control]
Product number:
- The unique five-digit number allocated to a product by the APVMA
Pack size identifier (PSI):
-
As the name suggests, the PSI is used to differentiate between pack sizes of the same product. The PSI may be a sequential number starting at ‘1’ or related to the actual pack sizes, eg ‘20L’ (see paragraph 13)
Version control:
- Is determined by the month and year (displayed as MMYY) in which the APVMA grants registration and/or label approval
13. PACK SIZE IDENTIFIER (PSI)
The PSI may contain characters that are whole numbers (eg 1, 2, 3), letters, or a mixture of numbers and letters. Decimal points may be used, but characters other than numbers and letters must not be used.
Letters may be upper or lower case or a mixture of both, eg ‘mL’.
For example, valid PSIs include 2, 2.5, 22.5L, 5mL, 10–20L but not 5% (however 5 percent is valid).
If the label is to cover a range of pack sizes, the PSI must include the pack size range, eg ‘1–10L’. Refer to paragraph 19 for more information on a single label for a range of pack sizes.
A product (number 56789) comprising the pack sizes 1L, 5L, 10L and 25L and approved during April 2007 could have the following LANs based on different methods used to express the PSI:
PSI based on sequential numbers:
56789/1/0407 56789/2/0407 56789/3/0407 56789/4/0407
PSI based on numbers and letters related to the pack sizes:
56789/1L/0407 56789/5L/0407 56789/10L/0407 56789/25L/0407
PSI for a label representing a range of pack size:
56789/1-5L/0407 56789/10-25L/0407 or 56789/1-25L/0407 (see paragraph 19 for information on labels for a range of pack sizes)
13.1. Products with a single pack size
If the application is for the registration of a product with a single pack size, the LAN must still include a PSI.
13.2. Applicant’s preference
Applicants may prefer a particular style of PSI and they should indicate this when submitting their application. If the applicant does not express a preference, the APVMA will allocate a PSI based on the pack size.
13.3. Product information leaflets
If a label component such as a measure pack or leaflet is used with a range of different pack sizes for a product, the LAN on the measure pack or leaflet may omit the PSI. The leaflet or measure pack is correlated to the registered product, but the same leaflet or measure pack can be used irrespective of the pack size.
If there is more than one measure pack or label leaflet, ie a different measure or leaflet is used for different pack sizes, each different measure pack or leaflet will require a different PSI to distinguish the different measure packs or leaflets.
13.4. LANs for label suites and components
A label for a product may comprise a number of components. For example, a label may comprise an inner pack or immediate container, an outer pack or primary pack and a label leaflet.
The label for a product is not complete unless all components are included when the product is marketed.
For example, the LAN as shown on each individual component of a label suite is outlined below:
Label suite |
LABEL COMPONENTS |
||||||
|---|---|---|---|---|---|---|---|
Label 1 |
= |
Inner pack |
+ |
Outer pack |
+ |
Leaflet |
|
| LAN | = |
56789/1/0407 |
56789/1/0407 |
|
56789/0407 |
||
Label 2 |
= |
immediate container |
+ |
|
Leaflet |
||
| LAN | = |
[56789/5/0407] |
[56789/0407] |
||||
Label 3 |
= |
immediate container |
+ |
primary pack |
|
(no leaflet supplied with this pack size) |
|
| LAN | = |
56789/25/0407 |
56789/25/0407 |
||||
In the above example, the label suite for product 56789 is Label 1 + Label 2 + Label 3:
Label 1 comprises an inner pack, an outer pack and a label leaflet. Label 1 is not complete unless all three components are marketed.
Likewise, Labels 2 and 3 are not complete unless they are marketed with all of their components.
When approving a label for a new product, the APVMA will allocate the same PSI to all components of a label (except for a measure pack or leaflet as outlined in paragraph 13.3).
14. VARIATIONS TO EXISTING LABELS
The APVMA will allocate a new LAN to labels which are varied after application from the registrant. Labels which have minor variations allowed by permit 6868 (refer to paragraph 20), and are therefore not varied after application from the registrant, must retain the existing LAN.
Once the APVMA has allocated a LAN to a label for a pack size for a new product, any approved variations to the label for that pack size will be allocated a new LAN.
14.1. Variation to a label component
Any variation to a label component results in the label being deemed a new label. However, if only one component of a label is varied, only this component requires a new LAN. If the applicant wishes, the other label components may retain their existing LANs.
Example: An applicant wishes to vary the outer pack component of the label, while continuing to use the existing inner pack component and leaflet. The APVMA approves the application for variation in April 2007:
Current approved label:
Label 1 (1L) LAN |
= |
Inner pack 56789/1/0406 |
+ |
Outer pack 56789/1/0406 |
+ |
Leaflet 56789/0406 |
|
¯ |
|
¯ |
|||
Varied label:
Label 1 (1L) LAN |
= |
Inner pack 56789/1/0406 |
+ |
Outer pack 56789/1/0407 |
+ |
Leaflet 56789/0406 |
In such a situation, the applicant need submit only the new or varied label component with the application.
15. REMOVAL OF A LABEL COMPONENT
Removal of any label component results in a new label and therefore a new LAN may be required. In the examples below, removal of the outer pack label results in the a label. Whether or not the label requires a new LAN depends on whether the remaining label is identical to the previously-approved component or whether there is a change in label particulars.
Example 1: An applicant wishes to remove the outer pack label and add more instructions to the existing inner pack label. The application is approved in April 2007.
Current approved label:
Label
LAN=
®Inner pack
[56789/1/0406]+
Outer pack
[56789/1/0406]
New label:
Label
LAN=
®Inner pack
[56789/1/0607]
Example 2: An applicant wishes to remove the outer pack component of the label. The existing inner pack requires NO additional instructions. The application is approved in April 2007.
In such a case the existing inner pack label can still be used. Therefore, the applicant has the option to keep the existing LAN.
Current approved label:
Label
LAN=
®Inner pack
[ 56789/1/0406]+
Outer pack
[ 56789/1/0406]
New label:
Label
LAN=
®Inner pack
[ 56789/1/0406]
16. PLASTIC BAG IN AN IMMEDIATE CONTAINER
A plastic bag containing the chemical product, which is itself contained within an immediate container, does not require a label.
17. PROMOTIONAL PACKS
Labels of promotional packs do not require approval and therefore do not require inclusion of a LAN.
18. ADDITION OF A NEW PACK SIZE
The following example is relevant for additional labels for an existing approved label suite when the only difference between the new label and the existing labels is the net contents. If additional changes are included, refer to paragraph 14.
Example: The existing label suite is:
1L
56789/1/0406
Two new pack size labels (500mL and 15L) are added to the suite and approved in April 2007.
The respective LANs for these two new labels may be 56789/4/0407 and 56789/5/0407.
The PSIs may maintain the system of using the next sequential number, ie 4 and 5, even though the practice of allocating the smallest number to the smallest pack size and so on no longer applies in this case.
Another option is to vary the type of PSI. For example, even though the existing approved labels use sequential numbers, the new pack sizes may use ‘500mL’ and ‘15L’ as their PSIs.
19. LABEL FOR A RANGE OF PACK SIZES
A label for a range of pack sizes means that a label which is attached to a container for each pack size within the range, including the smallest and largest pack size in that range is identical, apart from the net contents statement in:
- wording and instructions
- font size, format and layout including components, colours and graphics
- dimensions.
Example: An applicant intends to market a product (number 34567) in the pack sizes 1, 2, 5, 10, 15, 20, 25, 40, 50, 60, 100 and 200L. Rather than seeking label approval for the 12 different pack sizes, the applicant indicates that three labels can be submitted to cover the following sizes:
- the 5L label representing pack sizes 1 to 10L
- the 20L label representing pack sizes 15 to 60L
- the 100L label representing pack sizes 100 to 200L.
In this example, the 20L label differs from the 5L label in dimensions, ie it is larger. The 100L label is identical in dimensions to the 20L label, but contains different disposal instructions.
19.1 Permit 9523
The APVMA has issued permit 9523 (see Appendix B) which allows applicants to supply a product with a label that differs from the approved label only in relation to the net contents statement.
This permit means that registrants need not make a separate application to the APVMA to vary the approved label, where the only variation is to include a net contents statement that is within the range specified in the notice of registration or approval.
19.2 Indicating a single label for a range of pack sizes on the application form
If an applicant wants the APVMA to approve a label that can be used for a range of pack sizes in accordance with permit 9523, the applicant must indicate this on the application form.
In the section on the application form where proposed pack size(s) are indicated, the applicant must specify the range rather than listing individual pack sizes.
In the above example, the applicant would specify 1 to 10L, 15 to 60L, and 100 to 200L. The applicant must provide a three draft labels for each of the three ranges with the application.
Note: The label for each range of pack sizes must be identical in wording, instructions, format and size, and may only differ in the net contents statement.
19.3 Changes to the LAN
If an applicant wishes to use a label for a range of pack sizes, its PSI should incorporate the range of pack sizes for which that label will be used. For the example product (number 34567) the respective LANs would be:
- 5L label: 34567/1–10L/0407
- 20L label: 34567/15–60L/0407
- 100L label: 34567/100–200L/0407.
19.4 Supply of unapproved labels under permit 9523
For the example above, permit 9523 allows the registrant to supply the product with the following unapproved labels:
- a label with LAN 34567/1–10L/0407 and a net contents statement anywhere within the range 1L to 10L inclusive, provided that the label is identical to the approved 5L label apart from the net contents statement
- a label with LAN 34567/15–60L/0407 and a net contents statement anywhere within the range 15L to 60L inclusive, provided that the label is identical to the approved 20L label apart from the net contents statement
- a label with LAN 34567/100–200L/0407 and a net contents statement anywhere within the range 100L to 200L inclusive, provided that the label is identical to the approved 100L label apart from the net contents statement.
19.5 Labels outside the Specified Pack Size Range
For the example given above, the registrant may now wish to market a product with net contents of 80L. The registrant has two options:
- submit a Category 12 application to approve a separate 80L label with LAN 34567/80L/0407; or
- submit a Category 12 application to vary either the 20L or 100L labels by amending the PSI within the LAN to include the additional pack size, ie 34567/15–80L/0407 or 34567/80–200L/0407 depending on which of the representative labels is best suited to the 80L pack size.
20. PERMITS 9523 AND 6868
The APVMA has issued permits 9523 (Appendix B) and 6868 (Appendix C) so that within certain defined and limited conditions, a registered chemical product may lawfully be supplied with a label that is not identical to the approved label.
Registrants need not make application to the APVMA to vary the approved label IF the variations are within the conditions of permit 9523 or permit 6868.
If an application is made under Category 12 to vary a label and the variation is allowed under permits 9523 or 6868, the APVMA will inform the applicant that the variation may be made without application.
APPENDIX A: file names for label PDFs
LABEL TYPE A: LABEL COMPRISING MORE THAN ONE COMPONENT
Label A = A1 + A2 + A3 |
|
| Cover information: | Product number: 12345; ATS number: 67899 |
A single label for pack sizes: 10 to 100L |
|
Separate PDFs
Label A should be submitted as three separate PDF documents. The correct PDF file names are:
For the primary pack label (A1):
12345_67899_10-100L_PRIMARY_MPL_V01.PDF
For the immediate pack label (A2):
12345_67899_10-100L_IMMEDIATE_MPL_V01.PDF
For the leaflet (A3):
12345_67899_LEAFLET_MPL_V01.PDF
LABEL TYPE B: LABEL COMPRISING ONE COMPONENT, WITH A FRONT PANEL AND A REAR PANEL
| Cover information: | Product number: 12345 ; ATS number: 67899 |
Pack sizes: 10 & 20L |
Single PDF
If the applicant submits Label B as a single PDF, the correct PDF file name is:
12345_67899_10-20L_LABEL_MPL_V01.PDF
Multiple PDFs
If the applicant submits Label B as separate PDFs for the front and rear panels, the correct PDF file names are:
For the front panel (B1):
12345_67899_10-20L_FRONT_MPL_V01.PDF
For the rear panel (B2):
12345_67899_10-20L_REAR_MPL_V01.PDF
LABEL TYPE C: LARGE SINGLE COMPONENT LABELS WHERE THE PDF CONTAINS A NUMBER OF BREAKOUT AREAS
Note: This applies to overlarge labels which, when reduced in size to A3 or A4, contain text that may be too small to be legible.
| Cover information: | Product number: 12345 ; ATS number: 67899 |
Pack size: 200kg |
The entire label C and the breakout details should be submitted as separate PDFs.
The correct PDF file names are:
For Label C:
12345_67899_200_PARTLABEL_MPL_V01.PDF
For the breakout sections:
12345_67899_200_BREAKOUT1_MPL_V01.PDF
12345_67899_200_BREAKOUT2_MPL_V01.PDF
12345_67899_200_BREAKOUT3_MPL_V01.PDF
APPENDIX B: Permit 9523
APPENDIX C: Permit 6868
REVISION HISTORY
| Revision Date | Description of Revision |
|---|---|
| 1 July 2005 | First edition |
| 1 October 2005 | Second edition
|
1 April 2006 |
Third edition
|
| 1 January 2007 | Edition 3.1
|
1 July 2007 |
Edition 4
|