Stockfeed and petfood products which are excluded from registration
To be excluded from registration with the Australian Pesticides and Veterinary Medicines Authority (APVMA), an animal feed product must be one that is fed to, and voluntarily consumed by, an animal and meet specified requirements in relation to ingredients, manufacturing, labelling and claims. These products are referred to as excluded nutritional or digestive (END) products.
The 4 tests for END products
To be excluded from the requirement to register your nutritional or digestive animal feed product, it must be one that is fed to, and voluntarily consumed by an animal and must meet certain requirements for ingredients, claims, labelling and manufacture. To be excluded, products must pass 4 separate tests:
- Ingredients: the product must not contain certain ingredients, such as antibiotics; and all ingredients must be on at least one of the specified list of substances that are generally recognised as safe (the ‘GRAS’ lists).
- Manufacturing systems: the product must be made to one of a number of specified quality assurance (QA) systems.
- Labelling: the label must contain specified information about the product.
- Claims: the label does not include a claim that the product treats a disease, condition or injury, unless it is supplied by or in accordance with instructions of a vet and any claim is backed up by high quality scientific evidence.
More details on these tests are outlined below.
Examples of products that are likely to be END products
The following products are likely to meet the exclusion criteria set out in the amendments, noting that these products must be fed to, and voluntarily consumed, by animals.
Direct fed microbial products
Containing microbes on the GRAS Register for Oral Nutritional Compounds and satisfying all requirements for exclusion as outlined above.
Containing enzymes on the Prescribed Standard 1.3.3 of Food Standards Code and satisfying all requirements for exclusion as outlined above.
Pre-biotic products or pro-biotic products
Not claiming to cure a disease or condition or treat and injury and satisfying all requirements for exclusion as outlined above.
Therapeutic pet food products
If the product is not claiming to cure a disease or condition and satisfies all requirements for exclusion as outlined above. Products which make claims to nutritionally manage a disease or condition will be exempted from registration provided that they are supplied by, or in accordance with the instructions of, a vet and evidence supporting all such claims is able to be substantiated using quality scientific evidence.
If the product is not claiming to cure a disease or condition and satisfies all requirements for exclusion as outlined above. Products which make therapeutic health claims will be exempted from registration however, evidence supporting all such claims must be available if requested.
For a product to be excluded from the legislation, it must not contain any of the following ingredients:
- A hormone.
- Material from a vertebrate animal (if the product is to be consumed by ruminants).
- An antibiotic listed in schedule 2, 3, 4, 7, 8, or 9 of the Poisons Standard.
- An antibiotic listed in schedule 6 of the Poisons Standard, other than as a preservative in the product.
- An ingredient listed in the relevant APVMA legislative instrument, noting the APVMA has not made any legislative instrument for this purpose.
In addition, every ingredient in the product must either be:
- a substance of plant or animal origin that is edible by an animal, including:
- an edible grain and a processing by-product of an edible grain; and
- whey powder and any other milk by-product
- listed in at least one of the following, for the purpose and in accordance with any other restrictions specified:
- Paragraph 1.3.3-4 of Standard 1.3.3 of Food Standards Code as at the date of the supply of the product
- Paragraph 1.3.1-4 of Standard 1.3.1 of Food Standards Code as at the date of the supply of the product
- a determination under section 8B of New Zealand’s Agricultural Compounds and Veterinary Medicines Act 1997 as existing on 5 March 2015 (see relevant list of determinations here)
- Annex I of the European Union Register of Feed Additives as at the date of the supply of the product (other than a category 5 substance), and a expiry date is listed for that ingredient
- Parts 573, 582 and 584 of Title 21 of the Code of Federal Regulations of the United States of America, as existing at the time of supply
- Chapter 6 of the Official Publication of the Association of American Feed Control Officials as at the date of the supply of the product
- Handbook of Pharmaceutical Excipients (for products for canine and equine only) as at the date of the supply of the product
- an ingredient determination of the APVMA as at the date of the supply of the product
- Part 1 of Schedule 4 and 5 to the Feeds Regulations 1983 of Canada as at the date of supply of the product.
If an ingredient is covered by more than one of the standards above, the most stringent one applies.
In addition, each ingredient must conform to the Australian quality standard (if any).
Note that there are limitation for the use of ingredients listed at item 4 above (see paragraph 5(4) of Division 3.2 of schedule 3AA of the Agricultural and Veterinary Chemicals Code Regulations 1995).
If a product does not make therapeutic claims it is excluded from the legislation. If the product does make a therapeutic claim it is not excluded from the legislation unless any therapeutic claims are supported by scientific evidence accessible to the supplier. The evidence should be of a standard that is suitable for publication in recognised peer-reviewed scientific journals, and should be provided to the APVMA on request. Alternatively, the product may be excluded from the legislation if it is supplied only through the treating veterinarian and where the claims are supported by the treating veterinarian.
For a product to be excluded from the legislation, the product label must contain:
- the name of the product
- signal words required by Poisons Standard
- instructions for safe handling (may be in accompanying material)
- application/dosage rate and instructions for use (including period of use) and accompanying material
- analysis of key ingredients to support claims (may be in accompanying material)
- list of ingredients (may be in accompanying material)
- batch number and expiry date (may be in accompanying material)
- name, address and phone number for a person responsible for marketing the product
- that the product is supplied by a veterinary surgeon if the product can make claims about treating a disease or injury on that basis
- information required by EU Commission Directive 2008/38/EC about treating or alleviating a disease or condition or modifying the physiology of an animal.
For a product to be excluded from the legislation, the product must be manufactured under one of the following QA systems:
- Meet the requirements of the APVMA GMP Code of Practice and manufacturing principles.
- An Australian animal feed industry code of practice (such as FeedSafe or the FIAAA CoP).
- An Australian Standard for animal feed manufacture (in particular, AS 5812-2011).
- An animal feed quality standard of the United States of America or the European Union (such as FAMI-QS).
The QA system must be appropriate for the product. For example, a stock feed QA system will not apply to a pet food, and vice versa.
You can request advice from your industry association – contact details for the FIAAA and PFIAA are on their websites.
If you require further assistance concerning END products, please contact firstname.lastname@example.org.