This content is current only at the time of printing. This document was printed on 30 March 2017. A current copy is located at http://apvma.gov.au/node/26336
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Globally harmonized system of classification and labelling
GHS implications for agvet chemical products
The work health and safety legislation requires that, from 1 January 2017, all agvet chemical products be labelled in accordance with the Globally Harmonized System of Classification and Labelling (GHS). This includes statements relating to the intrinsic hazards of the product, in addition to relevant label particulars required by the APVMA.
Safe Work Australia has agreed that the obligation to have GHS label statements will not be required for agvet chemical products that have been manufactured up to and including 31 December 2016. Any product manufactured after this date will require appropriate GHS label statements.
GHS label content
The APVMA does not approve GHS label content. The GHS content must be placed in a separate box on the market label and not included with the APVMA approved content. GHS content must also not obscure any approved APVMA label content.
GHS content falls into the same category as any other information required to be added to a market label for an agvet chemical product under any other regulatory framework. For example, requirements for transport and other safety information are placed in a separate box on the label.
The labelling codes for both agricultural and veterinary chemical products provide guidance on placement of content that is not approved or required by the APVMA.
GHS requirements specific to veterinary chemical products
The majority of veterinary chemical products must be manufactured in accordance with the Code of Good Manufacturing Practice (the GMP Code). Under the GMP Code, labelling of chemical products is a step of manufacture, therefore the market label that contains APVMA approved content must be put on the product in a manufacturing site that holds a GMP licence issued by the APVMA.
For veterinary chemical products, where companies determine they need to add statements to their market label to meet GHS requirements after the product has left the GMP licenced site of manufacture, the following guidance applies:
- if an additional label containing statements/content solely related to GHS requirements is added to blank space on the product container, the additional label does not have to be added to the product container in a GMP licenced manufacturing site
- if the market label containing the APVMA approved label content is being replaced (removed or over-stickered), this needs to occur in a GMP licenced site of manufacture
- this is important to ensure APVMA approved label content is accurately transferred to any new label, including the instructions for use, product expiry and batch numbering
- any replacement of market labels including APVMA approved label content outside a GMP licenced manufacturing site will not meet the requirements outlined in APVMA legislation.
The APVMA will take a risk-based approach to any compliance activities related to labelling requirements under the agvet legislation.
GHS requirements for agricultural chemical products
Labels for agricultural chemical products are not subject to the same GMP restrictions, therefore holders of agricultural chemical products can replace the market label containing the additional GHS content in any location.
Exemptions from GHS requirements for agvet chemical products
Safe Work Australia has published guidance material that outlines exemptions from GHS requirements for agvet chemical products:
- GHS statements do not have to be added to the market labels for agvet chemical products where the statements are inconsistent with, or duplicate, APVMA approved label statements
- pictograms under GHS are not required to be added to market labels for agvet chemical products
- veterinary chemical products do not require GHS statements where they are listed under Schedule 4 (if they are supplied in a form and packaging consistent with direct administration to animals) or Schedule 8 of the Poisons Standard
- agvet chemical products manufactured on or before 31 December 2016 are not required to include GHS statements on their market labels.
For advice on these exemptions, as well as additional elements to labels, agvet registration holders should contact Safe Work Australia or their state and territory work health and safety authority.
About the Globally Harmonized System (GHS)
GHS is a single internationally agreed system of chemical classification and hazard communication through labelling and safety data sheets.
Most Australian states and territories have implemented work health and safety legislation based on the model Work Health and Safety Act 2011 and the model Work Health and Safety Regulations 2011. This legislation now covers the adoption of GHS.
The GHS requirements do not impact on the label content approved by the APVMA, however, statements to meet GHS requirements may need to be added to the market label of a product.
More information and guidance on the implementation of the model Work Health and Safety Act 2011, the model Work Health and Safety Regulations 2011 and the Globally Harmonized System of Classification and Labelling is available from:
- Safe Work Australia—www.SafeworkAustralia.gov.au
- State and territory work health and safety authority in your state or territory.