Agricultural and Veterinary Chemicals Code Ingredient Determination 2015

Constituent. The instrument uses “constituent” to refer to any chemical substance listed in the Schedule. A constituent may be a single chemical compound, a mixture (e.g., tocopherol‑rich extracts of natural origin), or a class of substances (e.g., “all colouring agents permitted for colouring foodstuffs” under the Food Standards Code). The interpretation clause at section 4(2) provides that a reference to a salt, without specifying hydration level, includes all hydrated forms. This avoids ambiguity and prevents the need to list every possible hydrate separately.

Authorisation. Authorisation under this instrument is not the same as product registration. It is a declaration that the constituent may be used for the stated functional purpose in any substance or mixture. The instrument does not set maximum concentration limits, purity specifications, or conditions of use beyond the purpose limitation. Those details would need to be addressed elsewhere in the product registration process or in other provisions of the AgVet Code. Authorisation is a permissive status: it removes a prohibition on using the constituent without further approval. It does not create a positive right to market a product containing the constituent; product registration must still be obtained.

Purpose set out in the heading. Each Part of the Schedule has a heading that defines the functional category (e.g., PART 1,ANTIOXIDANTS). The instrument authorises use of the listed constituents “for the purpose or purposes set out in the heading”. This means that an antioxidant listed in Part 1 cannot automatically be used as a preservative unless it also appears in Part 3. A manufacturer who uses a Part 1 constituent as a preservative would be relying on the determination incorrectly. The heading thus functions as a use‑limitation. This is a significant design feature: it prevents cross‑category misuse while still allowing broad pre‑approval within each category.

Schedule. The Schedule is an integral part of the instrument. It is not a standalone list; it is incorporated by clause 5. The Schedule is divided into ten Parts, and within each Part, constituents are listed by name. Some entries are specific chemical names; others are generic (e.g., “Vegetable oils” in Part 7). The use of generic categories creates flexibility but also uncertainty about which specific oils are covered. The instrument does not define “vegetable oils” further, so a manufacturer would need to rely on common usage and perhaps other regulatory definitions.

Reference to the Food Standards Code. For colourants (Part 2) and flavouring substances (Part 10), the instrument incorporates the Food Standards Code as a dynamic reference. This means that any future amendment to the Food Standards Code that adds or removes a permitted colouring agent automatically affects the scope of this determination. Manufacturers must monitor changes to the Food Standards Code to know whether a colourant remains authorised. This is a technique that reduces the need for frequent amendments to this instrument but shifts the compliance burden onto industry to track external standards.

The instrument primarily affects manufacturers of agricultural and veterinary chemical products who formulate products such as pesticides, herbicides, fungicides, veterinary medicines, feed additives, and stock treatments. For these businesses, the determination provides a list of ingredients that can be used without seeking individual pre‑approval from the APVMA. This reduces the time and cost of product development and registration, particularly for minor formulation changes that involve swapping one approved excipient for another. Small and medium‑sized enterprises that lack dedicated regulatory affairs teams are likely to benefit most, because they can rely on the pre‑approved list rather than commissioning toxicological dossiers for each ingredient. Larger manufacturers may also benefit but may have already secured their own approvals for proprietary ingredients.

Suppliers of raw ingredients are indirectly affected. A supplier whose ingredient is listed in the Schedule gains a competitive advantage: customers can use it without further approval. Conversely, a supplier whose ingredient is not listed faces a barrier: potential customers must seek separate approval or use a listed alternative. This creates an incentive for suppliers to petition the APVMA to add new ingredients to the list, which may be a nontrivial process requiring data submission.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the regulator that maintains and enforces the instrument. The APVMA must ensure the list remains current, safe, and aligned with scientific evidence. Adding or removing ingredients requires an amendment to the instrument, which is a legislative instrument subject to parliamentary scrutiny and disallowance. The APVMA also must deal with the consequences of the dynamic incorporation of the Food Standards Code.

Downstream users - farmers, veterinarians, pest control operators, and animal owners - are affected only to the extent that product formulations change. If a manufacturer replaces one listed ingredient with another, the product’s efficacy and safety profile may shift. However, the instrument does not directly govern end‑user conduct; that is handled by product labels and permits.

State and territory regulators may be affected because the AgVet Code is a Commonwealth‑state cooperative scheme. The instrument is made under Commonwealth regulations, but state and territory laws adopt the Code. A pre‑approved ingredient list reduces the need for state‑by‑state assessment of individual ingredients.

The instrument itself imposes no positive duties on any person. It is entirely permissive. The right it creates is the right to use the listed constituent for the stated purpose in a substance or mixture without needing additional approval under item 8 of the table at subclause 5(3) of Schedule 3AA to the Regulations. This is a significant right because it removes what would otherwise be a prohibition or a requirement for a separate approval.

However, this right is conditional on the constituent being used “for the purpose or purposes set out in the heading”. A manufacturer that uses a listed constituent for a different purpose (e.g., using a Part 1 antioxidant as a preservative) cannot rely on the determination and may be in breach of the AgVet Code if the constituent is not otherwise approved. Therefore, the instrument creates an implicit duty on manufacturers to correctly classify the functional role of the constituent in their formulation.

The instrument does not address concentration limits, purity standards, or residue tolerances. Those remain to be dealt with under other provisions of the AgVet Code or under the Agricultural and Veterinary Chemicals (Administration) Act 1992. For example, a constituent may be authorised under this instrument, but if its use results in residues that exceed maximum residue limits set by Food Standards Australia New Zealand, the product may still be non‑compliant. The manufacturer’s right to use the ingredient is subject to all other applicable laws.

Similarly, the instrument does not grant any right to make false or misleading claims about the ingredient. The constituent’s authorisation does not imply endorsement of efficacy or safety for any particular claim; those must be supported by data and approved by the APVMA during product registration.

Third parties - such as competitors or consumer groups - have no direct right under this instrument. They cannot challenge the inclusion of a constituent in the Schedule except through judicial review of the instrument itself or through a merits review of a registration decision that relies on the instrument.

The instrument contains no penalty provisions. Any enforcement action for non‑compliance would be taken under the principal legislation: the Agricultural and Veterinary Chemicals Code Act 1994 and the Regulations. The most relevant offences would be for selling or using a chemical product that contains a constituent not authorised for that purpose. For example, if a product contains a constituent that is not listed in the Schedule and has not otherwise been approved, the product may be considered unregistered or its use may contravene a condition of registration. Penalties for such offences can include fines, injunctions, and in serious cases, criminal liability.

The APVMA is the enforcement body. It can investigate complaints, audit product formulations, and require manufacturers to demonstrate that each constituent is authorised. The instrument would serve as a defence: if a manufacturer can show that the constituent is listed in the relevant Part and used for the stated purpose, no offence is committed regarding the authorisation of that particular ingredient.

Strict liability may apply to some offences under the AgVet Code. The instrument does not alter that. A manufacturer who inadvertently uses a constituent that is not listed or uses a listed constituent for a non‑listed purpose may still be liable even if the mistake was unintentional.

The instrument may also be relevant to prosecutions for false or misleading representations. If a product label claims that all ingredients are approved, and a constituent is not authorised under the instrument, that claim could be false. Therefore, even though the instrument itself does not create penalties, it underpins the regulatory status of ingredients, and misrepresentation about that status can attract penalties under fair trading laws or the AgVet Code.

Compliance monitoring by the APVMA may include random testing of product formulations. If a non‑listed constituent is detected, the manufacturer may face enforcement action. The existence of the positive list simplifies enforcement: the regulator only needs to check whether a constituent appears on the list; it does not need to evaluate the safety of the constituent de novo each time.

This instrument is a legislative instrument made under the Agricultural and Veterinary Chemicals Code Regulations 1995, which themselves are made under the Agricultural and Veterinary Chemicals Code Act 1994. It forms part of a broader regulatory framework for agricultural and veterinary chemicals. The instrument does not operate in isolation; it must be read together with the principal Act, the Regulations, and any other determinations made under the Regulations.

Relationship with the Food Standards Code. Two Parts of the Schedule incorporate by reference the Food Standards Code (as defined in the National Food Authority Act 1991). Part 2 (Colourants) includes “All colouring agents permitted for colouring foodstuffs, being Colouring agents not otherwise specified in this Part, as described in the Food Standards Code”. Part 10 (Flavours) includes a similar reference for flavour and aromatic substances. This means that changes to the Food Standards Code automatically affect the scope of this determination. Manufacturers must monitor the Food Standards Code to ensure continued compliance. This incorporation is efficient but creates a risk of regulatory creep: if the Food Standards Code expands the list of permitted colourants, those new colourants become automatically authorised under this determination, possibly without a dedicated safety assessment by the APVMA. Conversely, if the Food Standards Code removes a colourant, it ceases to be authorised under this instrument.

Interaction with state and territory laws. The AgVet Code is adopted in each state and territory through mirror legislation. This instrument, being made under Commonwealth regulations, applies in all jurisdictions as a matter of Commonwealth law. However, states and territories may have additional requirements for the use of chemical products, such as requirements for record‑keeping, notification, or environmental management. This instrument does not override those state laws; it only addresses the authorisation of constituents under the AgVet Code.

Interaction with work health and safety laws. The instrument does not affect obligations under the Work Health and Safety Act 2011 (CWI) or equivalent state laws. An ingredient may be authorised under this determination but still be subject to hazardous chemical regulations under the Model Work Health and Safety Regulations, including labelling, safety data sheets, and exposure limits.

Interaction with environmental laws. Use of a constituent authorised under this instrument remains subject to environmental protection laws, such as the Environment Protection and Biodiversity Conservation Act 1999 (CWI) and state environmental laws. The instrument does not grant any immunity from environmental liability.

Interaction with food safety and residue standards. As noted, the instrument does not set maximum residue limits for veterinary medicines or agricultural chemicals. Those limits are set by Food Standards Australia New Zealand under the Food Standards Code and enforced under state food laws. A product containing a listed constituent may still breach residue limits if the ingredient does not degrade as expected.

The instrument was made on 3 June 2015 by the then Chief Executive Officer of the APVMA, Kareena Arthy. It commenced on the day after it was registered on the Federal Register of Legislation. The source provided does not reveal any subsequent amendments. However, as a legislative instrument under the Legislation Act 2003, it is subject to ongoing management by the APVMA. The APVMA has the power to amend the instrument under the same clause 9 of Division 3.3 of Part 3 of Schedule 3AA to the Regulations. Amending the Schedule would require a new determination, which would be a legislative instrument subject to tabling, disallowance, and sunsetting.

Given the dynamic incorporation of the Food Standards Code for colourants and flavours, the instrument is effectively amended without a formal instrument whenever the Food Standards Code changes. This is an unusual feature: the instrument’s content changes automatically through external reference. The Legislation Act 2003 does not require that such changes be published as separate instruments, but the APVMA should keep a consolidated version. Practitioners should not rely solely on the original 2015 list; they must check the current state of the Food Standards Code for Parts 2 and 10.

The instrument is also subject to the 10‑year sunsetting cycle under the Legislation Act 2003. It would have been originally scheduled for repeal in 2025 unless reviewed and remade. (As of the time of writing, sunsetting dates may have been affected by legislative amendments extending sunset periods.) If the instrument is not reviewed and remade, it ceases to have effect. A manufacturer relying on the list would need to monitor the sunsetting status.

There is no evidence in the source of any consultation process, explanatory statement, or regulatory impact analysis. The instrument appears to be a straightforward codification of existing practice or a consolidation of earlier approvals.

The source contains no reference to any litigation concerning this instrument. Given its technical nature and limited scope, it is unlikely to have been the subject of judicial review or court proceedings. Challenges would most likely arise in the context of a dispute over product registration or enforcement action, where the validity of the determination is an issue. For example, a manufacturer might argue that the APVMA acted beyond power in including or excluding a particular constituent, or that the instrument is invalid because it does not comply with the Regulations. Alternatively, a competitor might challenge a product registration on the basis that the product contains a constituent not authorised by the determination.

Because the instrument is a legislative instrument, it could be challenged under administrative law principles, such as unreasonableness, error of law, or lack of procedural fairness (though the instrument is legislative, not administrative, so the grounds are limited). There is no record in the source of any such challenge.

The incorporation of the Food Standards Code by reference could give rise to litigation if the Food Standards Code is amended in a way that creates unforeseen consequences. For instance, if the Food Standards Code permits a new colourant that later proves harmful in agvet formulations, a manufacturer might argue that the APVMA should have specifically assessed it before it became automatically authorised. However, that would be a challenge to the instrument’s design, not its application.

The instrument itself does not create rights that are directly justiciable; it is more likely to be considered as part of the regulatory matrix in a broader dispute. For example, in a prosecution for selling an unregistered product, the defendant might raise the instrument as a defence that the ingredient was authorised. The court would then have to interpret the instrument: e.g., whether an ingredient falls within a listed generic category, or whether the purpose for which it was used matches the heading.

Overall, litigation risk is low, but not zero. The main practical litigation risk is for the APVMA if it refuses to add a new ingredient to the list; a supplier might seek judicial review of that refusal.

Purpose mismatch is the most common trap. A constituent listed in Part 1 (Antioxidants) is authorised only as an antioxidant. Using that same chemical as a preservative is not authorised by this instrument, even if the chemical could function as a preservative. The manufacturer must check that the listed purpose matches the intended role. If not, separate approval is required. This is easy to overlook, especially when a chemical has multiple functions.

Generic categories create ambiguity. For example, Part 7 includes “Vegetable oils”. Which oils? The instrument does not define “vegetable”. Coconut oil? Soybean oil? Essential oils? A manufacturer should either confirm that the specific oil falls within the meaning of “vegetable oil” in the relevant regulatory context or seek guidance from the APVMA. The same applies to “Edible grains and their processing by‑products” in Part 8. Over‑interpretation could lead to using an ingredient that is not actually authorised.

Dynamic reference to the Food Standards Code means the list can change without notice. A colourant that was permitted when the instrument was made may be removed from the Food Standards Code years later. The instrument would then no longer authorise that colourant, but a manufacturer might still be using it, unaware of the change. Regular tracking of Food Standards Code amendments is essential.

Hydrated forms are included, but not other derivatives. Section 4(2) includes all hydrated forms of a salt. However, it does not include other derivatives such as esters, salts of different acids, or complexes. For example, “sodium propionate” is listed in Part 3; “potassium propionate” is also separately listed. If only “sodium propionate” were listed, the instrument would not authorise “calcium propionate” (which is separately listed). So manufacturers cannot assume that listing one salt covers all salts.

The instrument does not set purity or impurity limits. A manufacturer cannot assume that any commercial grade of a listed constituent is acceptable. The APVMA may still require that the constituent meet certain specifications during product registration (e.g., heavy metal limits). Using a technical grade that contains impurities could lead to the product being considered not compliant.

No grandfathering for existing products that used a constituent that is later removed from the list. If the APVMA amends the instrument to remove a constituent (or the Food Standards Code changes), manufacturers may need to reformulate or seek transitional approvals. The instrument does not contain a savings provision.

The instrument is not a substitute for product registration. Some manufacturers mistakenly think that if all ingredients are listed, no further approval is needed. Not so. The product itself must still be registered, and the APVMA will assess the overall formulation, including efficacy, safety, and labelling. The instrument only exempts the ingredient from a separate approval step.

To safely rely on this determination, a manufacturer should take the following steps:

1. Identify the functional purpose of each ingredient in the product. Determine whether the ingredient is acting as an antioxidant, colourant, preservative, binder, acidity regulator, emulsifier, dust suppressant, diluent/carrier, deodoriser, or flavour/flavour enhancer. The functional role must be genuine; cosmetic reclassification to fit a listed category is not permitted.

2. Check the relevant Part of the Schedule. Locate the Part that corresponds to that functional purpose. Verify that the specific chemical name appears in that Part. If the chemical is listed under a different Part, it is not authorised for the intended function. If the chemical is not listed at all, separate approval is required.

3. Pay attention to generic entries and by‑reference categories. For items like “Vegetable oils” (Part 7) or “All colouring agents permitted for colouring foodstuffs” (Part 2), confirm that the specific ingredient falls within the generic description. For colourants and flavours, check the current version of the Food Standards Code to see if the ingredient is permitted there. Do not rely on an older version of the Food Standards Code.

4. Consider whether the ingredient is used in a salt form. If the ingredient is listed as a salt, note that hydrated forms are included. But if the ingredient is listed as a free acid or base, and you are using a salt, that salt is not automatically authorised unless also listed. Check the Schedule for the specific salt.

5. Review other applicable requirements. The instrument does not cover concentration limits, purity specifications, or residue tolerances. Ensure that the product as a whole meets all other regulatory requirements under the AgVet Code, including any conditions of registration. Also ensure compliance with work health and safety, environmental, and food safety laws.

6. Keep a record of reliance. Maintain documentation showing that the ingredient was listed in the relevant Part at the time of use. This is important in case the Schedule is later amended or if the Food Standards Code changes. A screenshot of the determination as at the date of formulation could be useful.

7. Monitor amendments and sunsetting. The instrument is subject to amendment. Subscribe to APVMA updates or regularly check the Federal Register of Legislation for new versions. Also be aware of the sunsetting date; if the instrument is about to expire, engage with the APVMA review process or seek transitional approvals.

8. If an ingredient is not listed, do not use it unless otherwise approved. Do not assume that because it is similar to a listed ingredient, it is covered. The list is exhaustive for the purposes for which it provides authorisation. Using a non‑listed ingredient may result in the product being considered unregistered and may attract penalties.

9. For new ingredients not listed, petition the APVMA to add them. This would require submitting safety and efficacy data. The APVMA has the power to amend the instrument. A successful petition can benefit the entire industry.

10. Seek legal or regulatory advice when in doubt. The instrument is concise, but its interaction with the broader regulatory framework is complex. When there is uncertainty about whether a particular use is authorised, it is prudent to seek a written ruling from the APVMA or a legal opinion.