This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/10631
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Animal feed products
Animal feed materials and ingredients generally do not require registration by the APVMA if they meet the following requirements:
- they are fed as part of the normal diet of an animal
- they are intended solely for nutritional purposes and are only represented as being suitable and used to help maintain natural or normal health, production, or performance
- they do not contain medications or other active constituents
- they do not make any health, production or performance claim.
Although the APVMA does not regulate feed materials and ingredients, we do regulate feed medications, supplements and additives—unless they have been specifically excluded in the Agvet Code Regulations.
Animal feed products fall into the following categories: some are specifically exempt from requiring registration; others require registration.
Following are descriptions of the requirements for:
1. Non-medicated feed products
Non-medicated feed, feed premixes and feed ingredients fed as part of the normal diet of an animal, that are represented only as being suitable and used to help maintain natural or normal health, production, or performance, and that are intended solely for nutritional purposes, do not require registration.
Feed products must look, smell and taste like feed, be freely consumed as part of the animal’s natural feed intake, and must not make any representation or claim on their label or other promotional material.
They should not be represented as containing any active constituents on their labels or promotional material, and their label should contain a statement such as ‘animal feed/premix/ingredient’. They should clearly state the feed ingredients they contain.
They should not use the heading ‘for animal treatment only’ but may use the statement ‘for animal consumption only’ to identify them as an animal product but differentiate them from veterinary products or medicines used for animal treatment.
Examples of animal feed products that do not require registration include:
- whole unprocessed plant material fed as part of the normal diet of an animal, which is only represented as being suitable and used to help maintain natural or normal health, production, or performance
- inactivated fermentation by-products that do not contain any viable fermentation organisms (although they may contain minute levels of specified permissible contaminant microorganisms) or any other active substances (such as enzymes) when added to animal feed as a feed ingredient, and when represented only as being a source of nutrient to help maintain natural microbial activity (which allows ruminant animals to consume and digest more dry feed)
- psyllium husk and other cereal bran (including rice bran) when added to animal feed as a food-fibre bulking agent to stimulate gastrointestinal tract activity, when represented only as being suitable to help avoid the accumulation of faeces or sand, and provided no mention is made of specific ingredients (such as oryzanol) or the prevention or treatment of any disease or condition (such as impaction or colic)
- cold-pressed vegetable oil (including flaxseed and rice bran oil) when added to animal feed as a source of energy, and represented only as containing the oil with no mention of specific ingredients (such as oryzanol or omega fatty acids), and only as being suitable to help provide additional energy without any mention of any specific disease or condition or any other claim (such as appetite stimulant)
- colostrum when fed to an animal as a source of nutrients and when represented only as containing the colostrum or milk with no mention of specific ingredients (such as antibodies), and only as being suitable to help provide additional nutrients with no mention of any specific disease or condition (such as hyperimmunised or the immune system)
- urea and nitrate salts (such as calcium nitrate) when added to animal feed as a feed ingredient, and when represented only as being a source of non-protein nitrogen to help maintain natural microbial activity, which allows ruminant animals to consume and digest more dry feed
- whole unprocessed animal tissue such as bovine trachea containing glycoaminoglycans, fed to animals for the purpose of balancing the diet and providing normal levels of nutrients, with no associated claims, when glycoaminoglycan ingredients are not mentioned on the label, and the levels are below that which would yield eight milligrams per kilogram of bodyweight per day of glycoaminoglycans when consumed according to recommended feeding rates. The APVMA will accept levels determined according to Blumenkrantz N and G Asboe-Hansen (1973)Analytical biochemistry 54: 484–89 for these purposes. Although the APVMA does not regulate whole unprocessed animal tissue, these products may be subject to regulation by other authorities.
Read Animal feed products that do not require registration—acceptable nutritional messages for examples of the type of nutritional messages that can be used with animal feed products without the need for them to be registered.
2. Feed supplements
The APVMA regulates feed supplements unless they have been specifically excluded from requiring registration.
Nutritional supplement products, including premixes, blocks and licks (provided they are not medicated) are specifically excluded from requiring registration provided that:
- they are presented in whole food or in a food premix or as a block or a lick for voluntary ingestion, or they are presented with directions to administer in the feed for voluntary ingestion (as opposed to being administered in water or as a paste or drench, or by stomach tube)
- they are represented only as being suitable ‘to supplement diets where levels may be low’, or words to that effect.
To be excluded from registration, the feed supplements must be freely consumed as part of the animal’s natural feed intake and they must not make any representation or claim on their label or other promotional material. They should not be represented as containing any active constituents on their labels or promotional material, and their label should contain a statement such as ‘Nutritional supplement product for inclusion in animal’s feed. Product has no therapeutic effect’. The label should also clearly state the ingredients the product contains, as well as the inclusion rate, expressed as a quantity per kilogram of feed (not per kilogram of animal body weight). The words ‘dose’, ‘dose rate’, ‘dosage’, ‘administration‘ and so on should not be used on product labels or promotional material as feed supplements by definition are not administered or dosed. The heading ‘for animal treatment only’ should not be used; instead the statement ‘for animal consumption only’ may be used to identify it as an animal product but differentiate it from medicines that are used for animal treatment. Products that are not clearly identified as feed supplements may require registration.
Examples of excluded nutritional supplements are vitamins, minerals, amino acids and fatty acids that are essential for the maintenance of life, that are fed to rather than administered to animals, and that comply with all of the above requirements.
Any supplements that do not comply with all of the above requirements and any supplements represented as being suitable for, used for, or capable of curing a condition or disease, will require registration as complementary animal health products (or in some cases as pharmaceutical products). Registration is required on the basis that the supplements will be used for the purpose of curing a condition or disease—even when the condition or disease is a direct result of the low levels of that particular nutrient.
Examples of complementary animal health products that claim to cure a condition or disease and not provided by a veterinarian and require registration include:
- veterinary herbal remedies
- other naturally derived veterinary remedies, for example marine extracts such as green-lipped mussel or shark cartilage (but not products such as naturally derived antimicrobials, hormones and vaccines)
- veterinary nutraceutical products such as oral vitamins, minerals, amino acids and fatty acids, and other nutrients or food-based derivatives such as glycoaminoglycans when used at daily doses higher than the normal daily nutritional requirement
- veterinary therapeutic diets
- veterinary probiotics (directly-fed microbials)
- veterinary prebiotics and enzyme products
- veterinary homeopathic remedies.
Read Excluded feed supplements that do not require registration—acceptable nutritional messages for examples of the type of nutritional messages that can be used with animal nutritional supplements without the need for them to be registered.
Confusion often arises with supplements that are capable of performing several functions depending on dose, form and route of administration.
Vitamin E is an example of a supplement with this potential for confusion. When added to animal feed ‘to supplement diets where levels may be low’, it is an excluded feed supplement. However, when added to animal feed to cure a non-specific disease or condition that occurred as a result of a deficiency in the diet, it is a complementary animal health product, and when added to animal feed to cure white muscle disease in lambs or tying-up in horses, it is a pharmaceutical veterinary medicine.
3. Feed additives
The APVMA regulates feed additives unless they have been specifically excluded.
Substances that are added to animal feed that are not feed or nutritional ingredients or veterinary medicinal constituents are called ‘non-active constituents’. These additives do not require registration provided they are listed in the Animal Feed Reform 2014 or Excluded stockfood non-active constituents order and are used for the purposes listed and at concentrations consistent with the purpose listed in the order.
Animal feed additives that are not recognised feed ingredients or excluded feed supplements and that do not comply with the above requirement, or are represented as being suitable for, used for, or capable of curing a disease or condition and not supplied by a veterinarian will require registration.
4. Medicated feed products
The APVMA regulates feed medications unless they have been specifically excluded.
If a registered veterinary medicine is incorporated in an animal feed or feed premix then that medicated feed or premix is not a veterinary medicine and does not require APVMA registration, provided that the registered veterinary medicine is incorporated in the feed or feed premix at a rate of use that is in accordance with the rate of use shown on the approved label for the registered product, and that the medicated feed or premix is labelled in accordance with the instructions on the approved label for the registered product.
In order for a label for a medicated feed or premix to be labelled in accordance with the instructions on the approved label, the medicated feed or premix label must include all of the following matters:
- the name of the registered product incorporated into the medicated feed or premix
- the active constituent in the registered product incorporated into the feed or premix
- all relevant directions for use extrapolated as necessary from the registered product label to ensure correct dosing, or otherwise as prescribed by a veterinary surgeon
- all restraints, warnings and contra-indications
- the withholding period from the approved label or as prescribed by a veterinary surgeon
- any export slaughter interval information contained on an approved label.
Any claims made for the medicated feed or premix must be consistent with the approved label claims of the registered product.
The dilution of the registered product into the feed or feed premix should be in accordance with the label instructions and take into account the signal headings and the first aid instructions and safety directions required on the final stockfeed consistent with the cut-off limits in the current Poisons standard.
To be excluded from registration, medicated feed products must not be administered to animals but must be freely consumed as part of the animal’s natural feed intake. They should use the heading ‘for animal treatment only’ and the heading ‘active constituents’ on their labels or promotional material. They should clearly identify themselves as a medicated feed or feed premix with a label statement such as ‘medicated animal feed (or feed premix)’.
Products that do not comply with the above requirements will require registration.
5. Products excluded by the 2015 stock and pet food reforms
Reforms came into effect on 5 March 2015 which exclude certain animal feeds, for both stock and companion animals, from the scope of the APVMA’s regulation. These products, which are referred to as ‘excluded nutritional or digestive products’, will not require registration.
These changes have been added at Division 3.2 of Part 3 of Schedule 3AA to the Agricultural and Veterinary Chemicals Code Regulations 1995.
To be excluded under the 2015 reforms, an animal feed product must be one that is fed to, and voluntarily consumed by an animal and must meet certain requirements for ingredients, claims, labelling and manufacture. These requirements are summarised below. You can also use the Registration self-assessment tool (veterinary) for guidance on whether an animal feed requires registration.
Certain stockfeed and pet food products will be excluded from the scope of APVMA regulation, and will therefore no longer need APVMA registration. To be excluded, products must pass four different 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 systems
- labelling: the label must contain specified information about the product
- claims: unless the product is only sold through veterinarians, any claim that the product treats a disease, condition or injury must be backed up by high quality scientific evidence, accessible to the supplier.
Products that are already registered should, as a general rule, already meet the last 3 (b-d) of the above requirements. The main consideration for these will be whether the ingredients meet the ingredients test.
5.2. Ingredients requirements
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.
- 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:
- Para 3(a)-C) of Standard 1.3.3 of Food Standards Code.
- Clause 11, or Schedule 3 or 4 of Standard 1.3.1 of Food Standards Code.
- a determination under section 8B of New Zealand’s Agricultural Compounds and Veterinary Medicines Act the GRAS Register for Oral Nutritional Compounds, as published at 1 January 2015.
- Annex I of the European Union Register of Feed Additives (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.
- Handbook of Pharmaceutical Excipients (for products for canine and equine only).
- An ingredient determination of the APVMA.
In addition, each ingredient must conform to the Australian quality standard (if any) or the strictest relevant standard in the lists above. The strictest standard is the first-mentioned in the list above.
5.3. Claims requirements
For a product to be excluded from the legislation, any therapeutic claims made on the product label or in advertising or other publicity must be 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 supplied only through the treating veterinarian, where the claims are supported by the treating veterinarian.
5.4. Labelling requirements
For a product to be excluded from the legislation, the product label must contain:
- Name of product.
- Signal words required by Poisons Standard.
- Instructions for safe handling (may be in accompanying material).
- Application/dosage rate..
- 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.
5.5. Manufacturing requirements
For a product to be excluded from the legislation, the product must be manufactured under one of the following QA systems:
- APVMA Good Manufacturing Practice.
- 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.