This content is current only at the time of printing. This document was printed on 29 September 2016. A current copy is located at http://apvma.gov.au/node/13021
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Changes to stockfeed and petfood regulation
A number of changes to the Agvet Code Regulations commenced on 5 March 2015 to exclude certain types of animal feed for both stock and companion animals from the scope of the APVMA’s regulation.
Information for current applicants, existing registrants and GMP licence holders is provided here.
The proposed amendments
The proposed legislative amendments provide that to be excluded from registration with the 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 four 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 four 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; and
- claims: 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 manufacturing, labelling and claims requirements. The main consideration for these will be whether the ingredients meet the ingredients test.
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 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 however, evidence supporting all such claims must be available if requested.
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.
Products that have been registered with the APVMA prior to 5 March 2015 that then meet the requirements to be an excluded nutritional or digestive (END) product, will cease to be registered when the amendments commence. The APVMA product register will not be automatically updated on 5 March 2015, as we need product registrants to confirm whether their product is an END product.
Under these reforms, registrants determine whether their product/s meet the requirements to be an END product. The APVMA has updated the Registration Assessment Tool (veterinary) to assist you in determining whether your product is affected by these reforms.
The APVMA has identified some existing product registrations that we believe may be affected by these changes. We will write to these registrants asking you to review your product/s to see whether they are now END product/s.
Even if you do not receive correspondence from the APVMA regarding these changes, please ensure that you review all your current registrations for stockfeed and petfood products to determine if they are still required.
If, after reviewing the requirements for END products, you believe your product/s no longer require registration, please contact the APVMA at firstname.lastname@example.org.
Where you have an END product that no longer requires registration and it is manufactured overseas, this will be taken into account when the APVMA issues invoices for the overseas manufacturing fee for 2014–15.
The APVMA has identified a small number of current applications for product registration which are yet to be finalised and are likely to be affected by these reforms. Following commencement the APVMA will contact each applicant to confirm whether registration for the product under application will continue to be required. If registration will no longer be required the APVMA will work with you to arrange a refund for any assessments that have not commenced.
If you believe your current application will no longer be required because your product will be excluded by these changes please contact the APVMA on email@example.com.
Impact on GMP Licence Holders
If you hold an APVMA GMP licence and you only manufacture stockfeed or pet food products, you may no longer be required to maintain your licence.
Where all of a manufacturer’s products become excluded under these amendments, the manufacturer no longer requires APVMA auditing and licensing. The APVMA believes this will affect manufacturers holding a Category 4 licence or a multi-category licence which includes Category 4. Any licence holders in this position are encouraged to contact the Manufacturing Quality and Licensing Section to discuss your options. Licences will not be automatically cancelled by the APVMA.
For further information please refer to:
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, or
- an ingredient listed in the relevant APVMA legislative instrument.
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:
- 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.
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).
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.
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 and instructions for use (including period of use)
- 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.
We are also updating a number of related pages on our website and will include details here as changes are made.
In addition if you still require further assistance to determine how these reforms affect you, please contact firstname.lastname@example.org.