NEW CONCEPTS FOR LABELS

The current APVMA labelling codes for agricultural and veterinary chemical products were published in 1997 and are based on labelling principles that have applied for many years. The APVMA has received feedback from users, chemical manufacturers and regulators that many aspects of the current guidelines for labelling need revision.

The APVMA has established a working group, including some members of the Registration Liaison Committee, that has been working on revision of the principles for labelling of agricultural and veterinary chemicals.

The working group has developed three key labelling principles that should apply to labels. These are that:

1. Information relating to the key risks be grouped and arranged in a set order.

2. Important use restriction statements be prominently shown and be based on information presented to the APVMA which demonstrates that the aspect of use that is to be restricted is either known to, or can be reasonably expected to, cause an adverse effect to third parties, ie with respect to trade, public health, or the environment.

3. Instructions on labels must be clearly worded so that statements that are warnings to users of possible adverse outcomes, or advice to achieve best results, are not restricted by directive “do not” statements.

The working group has focussed initially on agricultural chemical products and has developed a “concept label” based on the above principles. The group has then applied these principles to five actual product labels to provide illustrations of how the revised labels would look. These products represent five of the major classes of agricultural chemical products. It is hoped that these example labels will facilitate comment on the proposed changes. Note that these labels have been changed by the working group (with the permission of registrants) and that they do not necessarily reflect the views of the companies that market the products and do not replace current approved labels.

These principles have been based largely on the views of regulators and the APVMA now seeks inputs from chemical users, marketers, manufacturers and other interested persons to ensure that the proposed new principles meet the needs of all these parties as far as possible.

The details of the example labels and a link to the actual approved label for each product are given below.

Product type	Example label	Current label, product no.
Broadacre herbicide	Sprayseed	46516
Broadacre insecticide	Lannate L	47336
Horticultural product	Regent 200 SC	46793
Soil fumigant	Telone	52475
Pest control operator product	Cislin	32223

The concept label that outlines the proposed new principles is available.

The working group has yet to apply these principles to veterinary products or to certain special classes of agricultural chemicals, such as home garden products, aerosols, marine antifoulants and others. There are also specific wording requirements (such as withholding period statements, container disposal statements, bee hazard warnings) that need further development and the working group continues to work on these.

The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is an international system for classifying substances and mixtures according to their health, environmental and physical hazards and providing harmonised hazard communication elements, including requirements for labelling and safety data sheets. Implementation of the GHS in Australia could impact on APVMA data requirements and assessments and on product labelling. The APVMA is working with other Government agencies on the adoption of GHS, including how it might apply to agvet chemicals and when it might come into force. The proposed new labelling principles do not include possible requirements from the GHS at this stage.