Legislation to reform chemical regulation enacted

Tranche 1 of the Better Regulation reforms

First published 29 July 2010

The Agricultural and Veterinary Chemicals Code Amendment Act 2010 contains five amendments to the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994. These measures are now in effect, and cover:

Labels

On 15 July 2010 legislation was enacted which has changed the way APVMA approves labels. The legislative changes operate in conjunction with new regulations, which have been developed by the Department of Agriculture, Fisheries and Forestry (DAFF) and are now in force. The purpose of this document is to clarify the operation of these arrangements. The APVMA will publish new requirements and guidance documents in the near future.

The effect of the changes is that the APVMA is no longer required to assess elements of an agvet product label such as colour, presentation, logos, marketing information, warranty and other company information. The legislation limits the APVMA’s consideration to only those matters prescribed in the legislation and regulations (the ‘relevant particulars’). These essentially relate to the assessment of whether labels have adequate instructions for the safe and effective handling and use of a product.

The legislation establishes that the Agricultural and Veterinary Chemicals Code Regulations 1995 (the regulations) may impose statutory conditions on label approval with which registrants must comply. Parameters for label size, type and format are now governed by these statutory conditions of label approval.

The following information and FAQs are provided to guide applicants in regards to the processing and approval of labels until new requirements and guidance documents are published. This information will be updated as required.

The label instructions and other particulars (the ‘relevant particulars’) assessed by the APVMA include information that identifies the product, how it is to be used, stored and disposed, and what to do in case of poisoning, as well as other information set out in the legislation and regulations. From this point forward the APVMA will use the term Relevant Label Particulars (RLPs) when referring to the instructions and particulars it approves. When the APVMA approves a label, it now only approves these RLPs.

When registering a product or approving a label, the APVMA will issue the applicant a notice containing any conditions of label approval that are additional to the standard statutory conditions. With the notice will be the label containing the RLPs that have been approved and the approval number. The applicant has the responsibility to ensure that the Marketed Product Labels (MPLs) placed on containers for the product contain the approved RLPs and comply with any conditions of label approval.

The objective and intent of the new arrangements is set out in the Revised Explanatory Memorandum to the Amendment Bill which is available from the Parliament of Australia website (www.aph.gov.au).

Does the APVMA still approve a label?

Yes. The legislation still requires the APVMA to approve a label. However, the approved label means only the approved instructions and particulars that comprise the RLPs. All other elements of a label such as colour, presentation, logos, marketing information, warranty and other company information will not be assessed or covered by the approval itself. However as previously noted these things will be governed by conditions to which the approval will be subject.

The APVMA will continue to publish the form of the label it approves to InfoPest for publication. As such the label available through PUBCRIS will differ in appearance to the MPL affixed to containers in the marketplace. As noted above it is the applicant's responsibility to ensure that MPLs placed on containers for the product contain the approved RLPs and comply with any conditions of label approval.

What are the Relevant Label Particulars (RLPs)

The RLPs include information on the label that identifies the product, how it is to be used, stored and disposed, and what to do in case of poisoning, as well as other information set out in the legislation and regulations.

A list of the RLPs for agricultural and veterinary chemical products, as currently set out in the legislation and regulations, is provided in Appendix I and Appendix II respectively. Specific details as to the content for each of the RLPs can be obtained from Chapter 2 in the respective Agricultural and Veterinary Chemical Labelling Codes.

Can I change my MPL without needing approval?

Yes, for certain changes. Applicants will only need to apply for a label variation where the change involves varying an approved RLP.

Applicants can change MPLs in regards to label layout, graphics, font size, colours, logos, marketing and other information without seeking APVMA approval, provided the variation complies with the relevant conditions of label approval and does not result in the addition of material that is contrary to the RLPs (see below).

The conditions of label approval require that all MPLs must comply with parameters for label size, type and format and legibility (see below). In the interim period until new requirements and guidance documents are published, the parameters that apply are those set out in the respective Agricultural and Veterinary Chemical Labelling Codes.

Do all the approved RLPs need to be included on the MPL?

Yes. As discussed above, under the new arrangements the approved label is the approved instructions and particulars that comprise the RLPs. The legislation stipulates that a registered chemical product may only be supplied if the label attached to the container states the relevant particulars (the RLPs) and does not contain any information that is contrary to the relevant particulars. As such all the approved RLPs must be included on the MPL.

The APVMA may only approve complete sets of RLPs for each product. Where different disposal instructions are required for the different pack sizes in which the product may be supplied (for example 20L as opposed to 1000L), the RLPs proposed to the APVMA for approval must specify which disposal instructions apply to which pack size. The APVMA will approve those disposal instructions on that basis. Only those disposal instructions relevant to the pack size should be displayed on the final MPL that is affixed to the containers for that pack size that are supplied to the market. All other approved RLPs, including all instructions for use, warnings, precautions and other particulars, must be included on the MPL.

Functional differences in labels for a product to account for things such as different home garden and commercial labelling will be dealt with via the approval of a separate set of RLPs.

What conditions of label approval apply to my label?

For label approvals granted after 15 July 2010 (when the changes took effect) conditions of approval imposed by the APVMA will be shown on the Approval Notice. These labels are also subject to any statutory conditions that are prescribed.

For labels approved prior to 15 July 2010 the Amendment Act contains provisions applying the new arrangements, including the statutory conditions, to those existing approvals.

The statutory conditions that apply to label approvals are prescribed in Subdivision 2.1.6 of the Regulations (see particularly Regulations 18B to 18I (external site)). That Subdivision also prescribes requirements for retention of labels and the provision of copies to the APVMA where requested.

Registrants must observe all relevant conditions when preparing MPLs as the approval is granted subject to those conditions. As the APVMA no longer assesses or approves MPLs it is beyond its scope of operation to advise registrants on whether their MPLs comply with the conditions of label approval in its pre-market assessment. This is the registrant’s responsibility. However the APVMA will check MPLs at retail outlets and through targeted audits (see below).

What sorts of label content may be considered contrary to the RLPs?

It is an offence to supply an MPL that contains content that is contrary to the approved RLPs, or that otherwise negates or minimises the significance or effect of an RLP. In general the APVMA will consider contrary content to be any information that contradicts any RLP, confuses or affects the meaning of any RLP, or otherwise directly or indirectly provides instruction for the handling or use of the product in a manner which is inconsistent with that for which it has been approved.

A specific area in which registrants may need to exercise care in regards to contrary content is when compiling harmonised labels for use in Australian and New Zealand markets. These may contain both Australian RLPs and New Zealand specific classification, approval and contact details as required by the Agricultural Chemicals and Veterinary Medicines (ACVM) group of the New Zealand Food Safety Authority (NZFSA). Such information must continue to be included in a New Zealand section or box that is prefixed by words such as ‘In New Zealand’ or alike to clearly identify that content as applying only in New Zealand. However use patterns (claims), instructions, recommendations and warnings (including withholding periods where relevant) which differ from the approved Australian RLPs will be considered to be content that is contrary to the approved RLPs where such content directly or impliedly instructs the handling or use of the product in Australia in a manner that may pose risk beyond that which has been assessed and determined to be acceptable for the Australian circumstance (for example use at a higher rate or observance of a shorter withholding period). Inconsistencies in such information have the potential to cause confusion amongst users and may contribute to the misuse of chemical products.

Do the existing Labelling Codes still apply?

Yes. In the interim period until new requirements and guidance documents are published, the existing Labelling Codes will continue to apply in regards to acceptable label instructions (RLPs), label content, the placement and formatting of text, as well as font sizing requirements.

Future requirements and guidance documents will include a Labelling Standard consolidating requirements for RLPs, label layout and legibility, as well as best practice principles for labelling. The requirements of such a standard will essentially be the same as those of the existing Labelling Codes. Additional supporting or requirement-clarifying material may be included covering matters such as label legibility, but such material would be largely identical to that previously proposed and consulted on in relation to the APVMA’s label reform proposal that was published in April, prior to the legislative amendments. When the APVMA develops a Labelling Standard chemical industry stakeholders will be informed well in advance of its implementation and consultation will be conducted on its usability.

Will I need to keep a copy of the MPL?

Yes. You should keep a copy in secure custody as you may be required to give it to the APVMA upon request. As noted above the statutory conditions of approval prescribe requirements for retention of labels and the provision of copies to the APVMA where requested.

Will APVMA check MPLs at retail outlets?

Yes. The APVMA will be auditing MPLs at retail outlets to ensure applicants are complying with new legislative requirements and arrangements. In cases of non-compliance, the legislation includes penalties of $33000 for an individual and $165000 for a company for each offence.

Non-compliance with the conditions of label approval may also result in the label approval being suspended or cancelled and necessitate a recall of the affected products from the marketplace.

Initially, the APVMA will work with industry to ensure compliance with the new requirements, however deliberate breaches will be treated very seriously. From 1 January 2011 onwards, breaches of these provisions will be managed in the same way as other comparable compliance issues.

What happens to my current application and submitted labels?

If the submitted labels (text drafts or MPLs) include adequate RLPs (i.e. label instructions) you do not need to do anything further. The APVMA will allocate an approval number and approve the label. You will be forwarded a copy of the approved label and a notice containing the conditions of label approval. As indicated above, this label approval is only for the RLPs.

If the submitted label requires a change or correction to a RLP, the APVMA will forward a letter detailing all required changes. Applicants will be required to resubmit corrected labels, which can be either text labels or MPLs in paper or electronic forms.

What do I do if I have an MPL request letter?

The APVMA has systematically examined all applications where, under the previous approval arrangements, applicants have been required to make certain changes to the labels and/or resubmit an MPL label version to see if the application can be progressed with the already provided label.

Applicants who received an MPL request letter under the previous approval arrangements have been notified by the APVMA whether their application can be progressed with the label already provided or whether label changes are still required. If the latter is the case, the APVMA specified the necessary changes to RLPs that were required for the label to be approved.

What type of label must applicants submit with an application?

As previously stated, the APVMA will publish new requirements and guidance documents in the near future. In the interim period applicants are required to continue the process of submitting a text draft label with their application. The APVMA will only assess the RLPs contained on the draft label. The APVMA will no longer require applicants to submit MPLs prior to granting registration or approval.

What format will be used for the label approval number?

The format for label approval numbers that will be used under the new arrangements is ‘product number / application number’. In the interim period the APVMA will continue to process MPLs received before the amendments took effect that contain all the required RLPs if they utilise the previous label approval number format, including pack size identifiers. However for all other applications the new format will apply.

Applicants should not propose label approval numbers on any labels submitted to the APVMA with new applications.

As noted above, under the new arrangements the APVMA may only approve complete sets of RLPs for each product. As such in the majority of circumstances there will only be need for one label approval number for each product for all most new applications.

Labels affixed to containers in the marketplace (MPLs) must bear the approval number that was given to the label at the time it was approved by the APVMA. This number is shown in the notice of approval for the label.

I have an application with the APVMA – when should I print MPLs?

Applicants with an application for label approval or variation under APVMA consideration should not have the labels with which the product is intended to be marketed (MPLs) printed until they receive the notice of approval from the APVMA. If the APVMA identifies very minor typographical errors in the RLPs proposed for approval it may rectify those manually in order for the application to be finalised as quickly as possible. The applicant will be advised of any such minor changes in correspondence accompanying the notice of approval.

If an applicant prints MPLs before the notice is received they may find that those labels do not match the approved RLPs. It is an offence to supply a product to the marketplace bearing a label that does not state the RLPs that were approved for the product.

What do the legislative changes mean for chemicals under review?

Under the new legislative arrangements, outcomes of a chemical review that involve changes to RLPs on a product can be more readily implemented. The APVMA will issue instructions detailing what changes must be incorporated into the approved RLPs for affected products. The APVMA can finalise a review without requiring applicants to submit new labels. The onus will be on applicants to ensure all new RLPs are incorporated onto their MPLs.

Trade Issues

The new labelling provisions relating to trade align the statutory definition of adequate instructions with the statutory tests against which applications for registration as well as chemical reviews must be considered. Trade issues will be considered when determining whether labels instructions are adequate. Label instructions must include appropriate information to mitigate potential trade risks associated with the use of the product. For example, the RLPs may include export withholding periods or export slaughter intervals if necessary to mitigate trade risk. This is essentially no different than the current situation.

How will the change affect chemical review?

The inclusion of trade issues in the determination of whether a label contains adequate instructions allows the APVMA to review a product label directly when significant trade concerns arise. The APVMA will be able to address a trade concern by reviewing the label instructions rather than the previous approach of having to reconsider the product registration.

Approved Persons

Applicants, that are companies incorporated in Australia, will no longer be required to advise the APVMA which individuals in the company are authorised to contact the APVMA about the application. While the APVMA will continue to address correspondence to the nominated contact person, it will expect that any correspondence it receives on the company’s letterhead, or from an email address in that company, has been authorised to be sent by the company.

What about overseas applicants?

There is no change to the current arrangements. An applicant that does not reside in Australia or a company that is not incorporated in Australia will still be required to nominate an Australia-based agent or person to act on their behalf and advise the APVMA of that person’s nomination. The APVMA will send correspondence to the Australia -based agent.

How does APVMA safeguard against unauthorised persons?

The APVMA sends all correspondence (post and email) to the contact person specified in the application. Emails containing Commercially Confidential Information (CCI) may only be sent via secure email. The APVMA will only accept correspondence for the application if it is on appropriate letterhead or from the recognised email address.

APVMA will only discuss application details over the phone with a nominated contact person for that application. The unauthorised use of company letterhead and the making of similar false representations is fraud and is dealt with by legislation other than the Agvet legislation.

Permits

The legislative amendment formalises the process whereby the APVMA may seek comment from the manufacturers of the chemical products that are proposed for use under a minor use or emergency permit.

Minor Product Variations

The new legislation establishes a mechanism whereby applicants can apply to the APVMA through a simplified application process when they with to make specified low risk variations to their registered agvet products. Before these legislative provisions can be given effect, the APVMA must develop a Legislative Instrument that describes the types of variations to be covered by the process.

Where can I obtain more information about these changes?

Updates on the legislative changes will be published at www.apvma.gov.au/legislation.
Enquiries can be sent to pesticides@apvma.gov.au or 02 6210 4748 or vetmedicines@apvma.gov.au 02 6210 4789. If a number of enquiries are for the same issue, the APVMA will update this page with relevant questions and answers.

Appendix I

Relevant label particulars (Agricultural Chemical Products)

  • Signal heading.
  • Product name.
  • The active constituent statement including proportion and name of each active constituent, solvent/s (if scheduled), other constituent/s (if scheduled) and ‘anticholinesterase compound’ statement (if applicable).
  • Mode of action identification symbol.
  • Statement of claims for use.
  • Restricted chemical product statement.
  • The net contents of the product.
  • The name and address of registrant, formulator or distributor.
  • Directions for use including:
    • Restraints;
    • Spray drift restraints;
    • Directions for Use or directions;
    • “Not to be used…..” statement;
    • Other limitations and prohibitions;
    • Withholding periods;
    • Trade advice including Export Slaughter Intervals (ESIs).
  • General instructions.
  • Resistance warning statements.
  • Precaution statements.
  • Re-entry periods.
  • Protection statements, including:
    • Protection of crops, native and other vegetation;
    • Protection of livestock;
    • Protection of wildlife, fish, crustaceans and environment.
  • Storage and disposal instructions.
  • Safety Directions.
  • First Aid Instructions.
  • Approval number.
  • Measure pack statement.

Appendix II

Relevant label particulars (Veterinary Chemical Products)

  • Signal heading.
  • Product name.
  • The active constituent statement including proportion and name of each active constituent, solvent/s (if scheduled), other constituent/s (if scheduled) and ‘anticholinesterase compound’ statement (if applicable).
  • Statement of claims for use.
  • The net contents of the product.
  • The name and address of registrant, formulator or distributor.
  • Directions for use including:
    • Restraints
    • Contraindications
    • Precautions
    • Side Effects or Adverse Reactions
    • Dosage and Administration
    • General directions
    • Resistance warning statements
    • Other limitations
    • Withholding periods
    • Trade advice including Export Slaughter Intervals (ESIs).
  • Safety Directions
  • First Aid Instructions
  • Other instructions (e.g. Additional user safety information, HGP palpable marker statement).
  • Re-handling periods.
  • Environmental statements
  • Storage
  • Disposal instructions
  • Approval number.
Last updated on 22 December, 2011

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