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Approved Maintenance Compounds (Non-Dairy) Manual

3 Compounds that Require Specific Approval

Amendment 0

July 2007

3.1 Application Procedure for Gaining Chemical Approval

When a compound requires a specific approval an individual compound specific approval is required. The only exception to this is where compounds can be grouped on the basis that the ingredients remain the same for all compounds in that group and only the percentages vary e.g. oils where the percentages of ingredients are altered to change the viscosity. In these cases one application can cover a group of compounds.

When one compound formulation is marketed under a number of product names or distributors a separate application must be made for each individual product.

When submitting an application the following are required to be supplied:

• Application form;

• Product label (or a copy);

• Product information sheet, where the product label does not include directions for use;

• Assessment fee;

• Sample, if requested by NZFSA.

3.1.1 Application Form

The applicant, usually either a manufacturer or distributor, must submit an application on the ‘Application Form: Approval / Re-approval of Maintenance Compound’ form provided in the appendix to this Part.

The following information is required to be provided on the form:

a. Applicant’s details including an email address if possible;

b. Product trade name as it appears, or will appear, on the label.

Note: this will be used on the approval letter and in the approval database;

c. Product composition data for each ingredient, including the:

• chemical name, this should follow the listing in the Merck Index, British Pharmacopoeia, Martindale - The Extra Pharmacopoeia etc.;

• Chemical Abstracts Service (CAS) number;

• trade name where applicable;

• manufacturer;

• percentage in the complete formulation. The percentage provided must either be the exact figure or a small range. For example where a cleaner contains 20% sodium hydroxide the content may be shown as 18-22%. Providing broad ranges (e.g. <10%, 10 – 50%), as used on material safety data sheets (MSDS), is not acceptable;

• Colour Index Reference, in the case of dyes.

Note: the full formulation is required to enable the correct decision to be made and to ensure appropriate action is taken when a compound is used incorrectly or in the case of an adverse advent;

d. Description of the nature of the compound (e.g. cleaner, detergent, lubricant).

This description only provides an indication of the nature of the compound, it does not control how it may be used. NZFSA will assign a description, from a standardised list, which best reflects the nature of the compound;

e. Approval code requested.

The approval code provides the conditions under which the compound may be used;

f. Disinfectant for foot-and-mouth disease responses details, optional.

Information relating to listing of disinfectants suitable for use in foot-and-mouth disease emergencies may be included in the application provided the compounds meet the criteria in section 4 of this part;

g. Declaration.

The declaration must be signed.

3.1.2 Product Label (or a copy)

This must include precautionary statements for the safe handling and storage of the compound.

Previously samples were required and when commercial samples (e.g. grease cartridges, aerosol cans) were supplied the label on the sample was sufficient to meet this requirement. As samples are no longer required, except where specifically requested by NZFSA, a product label must be supplied.

3.1.3 Product Information Sheet

A product information sheet must be submitted with the application if the product label does not include adequate directions as to how the compound should be used.

3.1.4 Assessment Fee

The prescribed fee, as indicated on the application form, must accompany the application.

3.1.5 Sample

Samples are no longer required to be supplied with applications. Where an applicant continues to supply samples, NZFSA reserves the right to either:

• Charge the applicant for disposal of the samples prior to assessing the applications; or

• Decline the applications.

The New Zealand Food Safety Authority reserves the right to request that a sample be submitted to assist in the assessment of the application. Where a sample is requested, and unless otherwise instructed, a 200 ml or 200 g securely stopped and wrapped sample will need to be supplied. The sender and content details (e.g. an external packing slip) must be clearly visible on the outside of the packaging.

The nature of the compound will be considered when determining whether it is appropriate to supply a sample. In general, samples will not be requested for compounds:

• that are toxic by inhalation; or

• with a flashpoint below 60 ºC; or

• containing the following chemicals at or above the stated concentrations:

• Hydrogen fluoride/ Hydrofluoric acid (at any concentration);

• Hydrochloric acid (≥500g/l or if free chlorine gas is likely);

• Sodium Hydroxide (≥750g/l);

• Formaldehyde (≥50g/l);

• Hydrogen Peroxide/Peracetic acid (≥500g/l);

• Potassium Hydroxide (≥750g/l); or

• In the case of insecticides, vertebrate toxins, aromatic hydrocarbons, if there are any major risks associated with the compound. Where there are any major risks associated with the compound these must be highlighted on the supplied sample and in a covering letter and the samples must be packaged in an appropriate and secure manner, preferably double packaged.

If any supplied samples do not meet the required safety requirements and may place NZFSA staff at risk, the application will not be assessed until another sample that meets the safety requirements is supplied. NZFSA reserves the right to charge the applicant for disposal of the inappropriately packaged sample.

Where a sample is considered necessary to assist in the assessment of the application but the nature of the compound prevents its supply NZFSA will consider alternative means.

3.1.6 Submitting the Application

The completed and signed application form along with the:

• Product label (or a copy);

• Product information sheet, where the product label does not include directions;

• Assessment fee;

• Sample, if requested by NZFSA.

Must be sent to:

Approved Maintenance Compounds
C/o Advisor (Operations)
Agricultural Compounds and Veterinary Medicines (ACVM) Group
New Zealand Food Safety Authority
South Tower
86 Jervois Quay
PO Box 2835
Wellington

3.2 Electronic Applications

Applications may be submitted electronically with prior approval from NZFSA.

All the required information, as per standard applications, must be supplied when making the application including payment of the assessment fee.

3.3 Trial Approvals

NZFSA reserves the right to grant trial approvals. These approvals are issued on an infrequent basis and generally when an applicant has a new maintenance compound that they wish to trial in a processing environment to confirm its efficacy etc. Conditions that are generally imposed include directions for use, limitation to a small number of processing facilities and a limited time approval. The assessment fee, if any, is determined on a case-by-case basis.

3.4 Compounds with Same Formulations / Groups of Similar Compounds

Compounds are individually approved except where compounds can be grouped on the basis that the ingredients remain the same for all compounds in that group and only the percentages vary e.g. oils where the percentages of ingredients are altered to change the viscosity. In these cases one application can cover the group of compounds.

When one compound formulation is marketed under a number of product names or distributors a separate application must be made for each individual product.

3.5 Permitted Approval Statement

Approval holders are permitted to include a statement on the label to the effect that the product is approved for use in premises processing all animal product except dairy, operating under the Animal Products Act regime. Any statement made, however, must include the approval code and must be limited to the following option unless otherwise specified in the approval:

NZFSA Approved <code> (All animal product except dairy).

Note: The previously used approval statement MAF Approved <code> (Fish Game Meat) was not to be used after 31 October 2004.

The label statement must be acceptable to NZFSA and must not be misleading. If for any reason the approval becomes void any labels with an approval statement can no longer be used without removing or covering the approval statement otherwise all label stocks must be destroyed. Stocks of product which exist after the date of withdrawal of the approval and which contain label statements to the effect that a product has NZFSA or MAF approval may not be sold to any person without removing or covering the approval statement.

3.6 Confidentiality

NZFSA regards all information supplied in respect of any application for compound approval as confidential. No information will be supplied to any other person or company without the written authority of the supplier of the information. In the event of any change of ownership of companies or franchises the vendor must notify NZFSA of the change and authorise any disclosures of information relevant to the transaction.

3.7 Application Process

3.7.1 Assessment Timeframes

NZFSA aim to process new applications within 10 working days of receipt and re-approvals within 20 working days of receipt, where all the necessary information is supplied. This does not include any time spent waiting for a response from an applicant where clarification has been requested.

Where information e.g. confidential formulation is to be supplied separately by a third party the applicant must ensure this information is provided promptly and indicate, at the time of submitting the application, when this information will be provided. It is the applicant’s responsibility to ensure this timeframe is met. Failure to supply this information within the stated deadline will result in NZFSA declining the application.

3.7.2 Incomplete Applications

NZFSA will automatically decline incomplete applications except for cases where there third party information e.g. confidential formulation information is pending, as described above.

3.7.3 Deficient Applications

Where NZFSA receives a complete application but deficiencies are found during the assessment the application may be automatically declined. However, dependent on the nature of the deficiencies NZFSA may send one request for further information to the applicant. This will have a specified timeframe by when this information must be provided. If the information is not provided in the specified timeframe, the application will be declined.

3.8 Letter of Approval

Once satisfied that the compound is suitable for approval the NZFSA will issue a letter of approval. This approval will then be added to the database of all individually approved maintenance compounds. Until this occurs the approval letter may be used as evidence that the compound is approved.

The approval remains valid until 31 October following the 5-year anniversary of the letter of approval.

3.9 Re-approval of Approved Maintenance Chemicals

Re-approval is the responsibility of the approval holder. However, NZFSA will endeavour to issue a reminder letter notifying that compounds are due for revalidation.

The applicant must submit an application on the ‘Application Form: Approval / Re-approval of Maintenance Compound’ form, provided in the appendix to this Part, by the date stated in the letter of notification. Failure to do so will result in removal of the compound from the list of approved maintenance compounds.

The notification letter will be sent to the named company and to the address listed in NZFSA records. NZFSA accepts no responsibility to verify proprietorship of products where this is different from NZFSA records.

The procedure for re-approval approved maintenance compounds is as described above for initial applications with the exception of a reduced fee. For a compound to continue to appear as a foot-and-mouth disease disinfectant this section must be completed. This is necessary to ensure that the information published in the foot-and-mouth disease list is as current as possible.

3.10 Changes to be Notified

Changes to the approved compound name or the approval holder are to be notified to the Advisor (Operations). This notification must include a copy of the updated label, where relevant, and confirmation that there has been no change to the formulation. Where the existing product and trade name is to remain approved a new approval is required for the new compound.

Changes to the approved compound formulation are also required to be notified to the Advisor (Operations). In this case the formulation will need to be assessed to ensure that it is still appropriate for the current approval code. NZFSA reserves the right to charge the applicant for this assessment.

Failure to give notice of changes will void the approval.

3.11 Advertising

The approval must not be used as a Ministry of Agriculture and Forestry (MAF) or New Zealand Food Safety Authority (NZFSA) endorsement of any claim made for the product by the manufacturer.