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Advice to advertisers and publishers
| Note - see Operational Notice on Complaints about advertising |
Before an agricultural or veterinary chemical product can be legally imported, supplied, sold, used, promoted or advertised in Australia, theAPVMA must register it. Part of the APVMA's role and responsibility is to monitor and enforce compliance of agricultural and veterinary chemical products in the market place.
Each year the APVMA receives many complaints about advertising and promotional material for agricultural and veterinary chemical products that do not comply with the requirements of the Agricultural and Veterinary Chemicals Code (Agvet Codes) and the Agricultural and Veterinary Chemicals Code Regulations (Agvet Code Regulations).
This information provides a guide to advertisers and publishers in relation to their obligations in complying with legislated requirements for the advertisement and promotion of agricultural and veterinary chemical products.
1. Who is liable for the promotion and advertising of unregistered agricultural and veterinary chemical products and unapproved active constituents?
Sections 84, 88 and 89 of the Agvet Codes define the responsibilities
of persons, including publishers and advertisers in relation to the
promotion and advertising of agricultural and veterinary chemical products
and active constituents. Obligations under the Agvet Codes extend not
only to the person who commissions an advertisement, but also to the
publisher of that advertisement.
In accordance with section 84 of the Agvet Codes, persons must
not make any claim, or permit any claim to be made in respect of a registered
chemical product that is not consistent with the approved label for
that product. In certain limited circumstances (for example, where the
particular claim has been exempted by the APVMA or where a person is
authorised to make such a claim by way of an approved APVMA Permit)
a claim may be made that is not consistent with the approved label.
A maximum penalty of $30,000 (for an individual), and $150,000 (for
a company), may be imposed for each offence under section 84
of the Agvet Codes.
Section 88 of the Agvet Codes relates to the publication of notices which offer to sell or invite to buy an unregistered agricultural or veterinary chemical product or unapproved actives. Section 89 of the Agvet Codes deals with certain prohibited statements that cannot be published in an advertisement or promotional materials. These include such things as information that is false or misleading, statements that suggest or claim that the APVMA or other State or Commonwealth government agency recommends the use of the chemical product, or that the APVMA guarantees, warrants or assures its safety or efficacy. Certain exemptions apply to both section 88 and 89 of the Agvet Codes. A maximum penalty of $3,000 (for an individual) and $15,000 (for a company) may be imposed for each offence under these sections.
3. Which products require registration by the APVMA?
The Agvet Codes and Agvet Code Regulations legally define which products
constitute an agricultural or veterinary chemical product and those
that do not.
The full definition of both agricultural and veterinary chemical products can be found in sections 4 and 5 of the Agvet Codes and regulations 7 and 8 Agvet Code Regulations, respectively. Reference should be made to these definitions if there is any doubt about the requirement for registration of a particular product.
In accordance with these definitions a product can be considered an agricultural or veterinary chemical product in one or more of the following ways;
- because the product is a substance or mixture of substances that is declared by the Agvet Code Regulations to come within, or are excluded from the definition of an agricultural or veterinary chemical product;
- because of what the product is and what it contains, irrespective of any claims made about its effect (i.e. because of its formulation); or
- because of the represented effect of the product (i.e. claims made about the product).
Products captured within these definitions must be registered with the APVMA and are subject to certain requirements when they are being advertised or promoted.
4. How do I identify registered products?
Registered products can be identified by a unique APVMA approval number,
which should appear on the product label. If it doesn't, the product
may still be registered. The requirement for the inclusion of an APVMA
approval number commenced in 1995 and does not apply retrospectively
to product labels approved before this time. Consequently, labels of
registered products approved before 1995 may not include the APVMA approval
number.
It is possible to check if a particular product is registered by searching the APVMA product registration database (PUBCRIS) on line at www.apvma.gov.au.
A publisher should take all reasonable steps to ensure that advertising or promotional material they are to publish complies with the Agvet Codes. A publisher may request that the advertiser provide evidence that the chemical product is registered, or does not require registration by the APVMA before publishing the advertisement or promotional material. Alternatively a publisher may request the person placing the advertisement, state in writing that they are aware of the requirements of the Agvet Codes and that the material provided is not in breach of the codes.
5. Do I need to include an approval number in the advertisement or promotional material?
No. It is not a requirement that the APVMA approval number of a product
appears in the advertising or promotional material. The approval number
may be included at the discretion of the advertiser and/or publisher.
All claims made about a registered chemical product, must be consistent
with the instructions on the approved label, unless the APVMA has exempted
such a statement or where the APVMA has issued a permit to allow such
a statement.
Information on the approved label includes instructions that relate to the circumstances in which a product may be used, how the product may be used, stored, disposed of, as well as information that relates to the safe use and handling of the product. Advertising or promotion of a registered product for a purpose that is not consistent with the approved label, or with claims that are false or misleading, is an offence under the Agvet Codes.
7. Are some statements prohibited even when agricultural or veterinary chemical product is registered?
Yes. The publication of certain statements about chemical products are
prohibited under section 89 of the Agvet Codes. Such statements
include;
- False or misleading information.
- Claims that either state or imply that the APVMA guarantees, warrants or assures the safety or efficacy of a chemical product.
- Statements which expressly or impliedly claim (however the claim is stated), without any qualification or with a qualification that, in the APVMA's opinion, is unjustified, to the effect that a chemical product is natural, organic, safe, harmless, non-toxic, non-poisonous, non-injurious or environmentally-friendly.
- Claims, which either state or imply that the APVMA or any Commonwealth, State, or Territory Department recommends the use of a chemical product.
- Claims which either state or imply that a chemical product has a particular quality, based on qualities which are prescribed for that type of product in the Agvet Code Regulations.
In general, the APVMA and its employees are not authorised to, and will not, give any "approval" or advice about whether or not a particular advertising or promotional claim would give rise to breach of any of these provisions of the Agvet Codes and Agvet Code Regulations. Persons responsible for the advertisement and publishing should seek their own legal advices on these matters.
8. Can testimonials be used in advertising and promotional material?
Yes. Testimonials can be used for the advertising and promotion of a
registered product where the information in that testimonial is consistent
with the approved label of that product. Statements or claims made in
a testimonial for the promotion of a registered chemical product that
are not consistent with the approved label of that product is an offence
under the Agvet Codes. Similarly, where a product does not require registration,
persons responsible for the advertisement and promotion of such products
should ensure that any testimonial used in association with such a product
does not bring the product under the definition of an agricultural or
veterinary chemical product, hence requiring that product to be registered.
A person is not prevented from making or reporting a statement about
a chemical product, which is not consistent with the information on
the approved product label where such statements are made or reported
in scientific papers, literature or reports, presentations, conferences,
seminars, meetings or discussion concerning the product. In these circumstances,
statements must be based on published data in a reputable refereed scientific
journal or is based on material of a standard publishable in such a
journal. Persons wishing to publish or present such information should
refer to section 89 of the Agvet Codes and regulation 43
of the Agvet Code Regulations. Information reported in these circumstances
must not be used for the purpose of advertising or promoting
the product for supply or inviting offers to buy in situations that
are not consistent with the approved label.
Yes. The promotion of agricultural and veterinary chemicals prior to
registration is permissible only in circumstances where an application
for the approval of the active constituent or registration of the product
has been lodged and accepted by the APVMA. The promotional material
must clearly state that the active constituent is not an approved active,
or the product is not registered, but an application for approval or
registration has been lodged with the APVMA. An advertisement or promotional
material that offers to sell or invites the making of offers to buy
an active constituent that is not approved or a chemical product that
is not registered (where approval and registration are required, respectively)
is an offence under section 88 of the Agvet Codes.
It is possible for a statement or claim to bring a product under the definition of an agricultural or veterinary chemical product. In conjunction with the definitions of an agricultural or veterinary chemical product outlined earlier, the Agvet Code Regulations provide further clarification about which products do, and do not constitute an agricultural or veterinary chemical product. According to the definition of agricultural or veterinary chemical product, a product may require registration on the basis of its represented effect (i.e. if the claims, including a purpose or a claim that may be inferred from the product name are consistent with the definitions in the Agvet Codes, the product must be registered).
12. How can products that are declared not to be agricultural or veterinary chemical products be advertised or promoted?When advertising or promoting products that do not require registration, all claims should be carefully considered to ensure the represented effect of the product does not bring it within the definition of an agricultural or veterinary chemical product. The represented effect of a chemical product may be stated or inferred from the product name, by the claims made on the product label or in advertising and promotional material associated with the product.
Examples of products that are declared not to be agricultural chemical products under the Agvet Code Regulations and may not require registration include:
- mould inhibitors used in the manufacture of paper, glue, plywood, carpets or any surface coating (including paint), where the manufactured product is not claimed to have any pesticide effect;
- any soil ameliorant, conditioner or fertiliser if the product is not claimed to have any effect as a regulator of plant growth;
- any disinfectant, mould inhibitor, air freshener or sanitiser presented, promoted or sold by retailers for domestic use (with the exception of sanitisers for use in swimming pools or spas).
Examples of products that are declared not to be veterinary chemical products under the Agvet Code Regulations and may not require registration include;
- medicated premixes and medicated stock foods where the container is labelled in accordance with the directions on the approved label for the registered chemical product that is incorporated into the premix or stockfeed;
- non-medicated blocks and licks, premixes, and stockfeed supplements where the only claim on the label (and therefore the only claim permissible on promotional material for those products) consists of the words "to supplement diets where levels may be low" or wording to that effect;
- pet foods making 'maintenance of health' or 'reduction of risk of a condition or disease' may be exempt from registration, provided the constituents they contain do not meet the definition of an active constituent.
Any therapeutic, performance or productivity claim that is made or implied in relation to these products will require that product to be registered.
Persons responsible for the advertising and promotion of a product that may be declared not to be an agricultural or veterinary chemical product should consult the Agvet Code Regulations to ensure that promotion is compliant with the law. A series of guidelines relating to the registration of the above-mentioned classes of veterinary chemical products are available from the Veterinary Medicines Division Contact Officer on (02) 6272 3744.
13. Where can I get more information?
A complete copy of the Agvet Codes and Agvet Code Regulations, can be
obtained from the Australian Government Shop (Ausinfo) or via the links
on the APVMA website - seehttp://www.apvma.gov.au/about_us/legislat.shtml
If you would like to know more please contact us.
Postal Address
Manager, Compliance
APVMA
PO Box 6182
Kingston ACT 2604
(02) 6210 4700
Fax(02) 6210 4813
http: www.apvma.gov.au