NZFSA does not accept any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be present, however it may have occurred.

Website

A copy of this document can be found a t: http://www.nzfsa.govt.nz/animalproducts/index.htm

Review of Code of Practice

This code of practice will be reviewed, as necessary, by the New Zealand Food Safety

Authority. Suggestions for alterations, deletions or additions to this code of practice, should be sent, together with reasons for the change, any relevant data and contact details for the person making the suggestion, to:

Assistant Director (Production and Processing)

New Zealand Standards Group

New Zealand Food Safety Authority

P O Box 2835

Wellington

Telephone: 04 463 2500

Facsimile: 04 463 2643

Code of Practice: Processing of Bee Products

Part 1: Overview

July 2005

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Prelims

Page 4

Amendment Record

It is important that this publication is kept up-to-date by the prompt incorporation of amendments.

To update this publication when you receive an amendment, remove the appropriate outdated pages, destroy them, and replace them with the pages from the new issue.

Complete instructions will be given on the covering letter accompanying the amendment.

File the covering letter at the back of the publication and sign off and date this page.

If you have any queries, please ask your local verifier.

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No.

Date Initials Amendment

No.

Date

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2 22

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Purpose and Scope of the Code of

Practice

1 Purpose and Scope of the Code of Practice

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July 2005

This code of practice (COP) has been developed by the New Zealand Food Safety Authority

(NZFSA), in consultation with industry, to assist bee product operators meet the requirements of the Animal Products Act 1999 and produce edible bee products that are safe and suitable for their purpose. In particular, it provides guidance for meeting the requirements for the development, registration and implementation of risk management programmes (RMP).

This COP applies to businesses involved in the secondary processing of edible bee products which covers the extraction of honey; and the processing, packing and storage of honey and other edible bee products.

This COP is divided into five parts.

Part 1: Overview

Part 1 gives an overview of the whole code of practice and the requirements of the Animal

Products Act 1999. It explains the options available to operators for the development of

RMPs. It also provides links to other relevant documents published by the NZFSA.

Part 2: Good Manufacturing Practice (GMP)

Part 2 covers good manufacturing practice and process control. It sets out the regulatory requirements, and acceptable or agreed procedures for meeting the requirements of the Act, particularly the Specifications for Products Intended for Human Consumption. This will assist operators in the development and documentation of supporting systems that form part of RMPs.

Part 3: HACCP Application

Part 3 shows how the principles of Hazard Analysis and Critical Control Point (HACCP) are applied for a generic process for the extraction, processing, packing and storage of honey; and the processing of dried pollen.

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Purpose and Scope of the Code of

Practice

Part 4: Identification and Control of Risk Factors Related to Wholesomeness and

Labelling

Part 4 shows the identification of risk factors and controls related to the wholesomeness and labelling of honey and dried pollen.

Part 5: RMP Templates

Part 5 provides simple RMP templates that can be used by operators in developing their own

RMP. The templates are accompanied by a guide that explains the use and application of the templates.

Exclusions

This code of practice does not apply to primary processing of bee products. Primary processing does not require an RMP.

Primary processing of bee products includes the following activities:

•

Beehive management including the rearing of queen bees for royal jelly production

•

Collection of honey supers, temporary storage of supers prior to delivery to the extraction facility, and transport to the extraction facility

•

Scraping or collection of raw propolis from boxes or mats, bagging and storage of raw propolis, and transport to an extraction facility

•

Collection of pollen, bagging, holding in a freezer by the beekeeper, and transport to a pollen drying/processing facility

This code of practice has been developed based on New Zealand requirements only and does not cover overseas market access requirements. Exporters must ensure that they meet the overseas market access requirements relevant to their product and intended market.

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Requirements of the Animal Products

Act 1999

2 Requirements of the Animal Products Act

1999

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July 2005

The Animal Products Act 1999 is New Zealand’s legal framework for the processing of animal products. It establishes a risk management system that requires all animal products traded and used to be “fit for intended purpose”. The Act sets out the duties of the operator and the requirements related to risk management programmes (RMPs), regulated control schemes, and exporter controls.

2.1 Risk management programmes (Part 2 of the Act)

All secondary processors of bee products for human consumption that need an official assurance to export their products are required to have a documented RMP. Secondary processing includes, but is not limited to, the following operations:

• processing of honey – from receipt of honey supers, to extraction, processing, packing, and storage;

• storage of bulk honey;

• processing of dried pollen – from receipt of pollen, to drying , freezing, packing and storage;

• further processing, packing and storage of honey products (e.g. honey and fruit, honey and velvet) and other edible bee products; extraction of propolis;

• processing of wax for human consumption (e.g. wax used for comb honey foundation, cosmetics, pharmaceutical materials).

Secondary processing starts from the point when raw material (e.g. honey supers, pollen, raw propolis) is received at the premises or facility where it will be processed (e.g. extracted, dried, heated), packed or stored.

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Requirements of the Animal Products

Act 1999

All existing bee product processors that require an RMP must operate under a registered programme from 1 July 2006. Application for registration should be made at least three months before this date (i.e. by 1 April 2006 to ensure registration is in place by 1 July 2006).

2.2 Regulated control schemes (Part 3 of the Act)

A regulated control scheme is a scheme developed by the NZFSA and imposed by the

Director-General to manage risks, where:

•

RMPs would not be feasible or practicable;

• it is more efficient for the government to run the programme; or

• it is needed to meet the market access requirements of foreign governments.

At present, there are no regulated control schemes for bee product processing.

2.3 Exporter controls (Part 5 of the Act)

Exporters of bee products are required to register with the NZFSA. Exporters are responsible for exporting in accordance with the Act and, where appropriate, may be required to meet specified market access requirements of foreign governments which may be additional to the New Zealand standard.

Export requirements are excluded from this COP, as they are additional to RMP requirements. Operators need to be aware of these requirements and ensure that their documented systems include procedures and records necessary to demonstrate compliance with all relevant requirements notified in:

•

General Requirements for Export (GREX); and

•

Overseas Market Access Requirements (OMAR).

The Guide for Exporters and the Bee Products Official Assurances Guide discuss exporter requirements in more detail.

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Requirements of the Animal Products

Act 1999

2.4 Imposition of authorisations, duties and responsibilities (Part 8 of the Animal

Products Act)

The Act provides for the recognition by the NZFSA of agencies and persons to undertake certain functions and activities (e.g. evaluation and external verification) that are important to the management of RMPs. The NZFSA maintains a public register of all recognised agencies and accredited persons, which is available on the NZFSA website .

The Act imposes duties on these key persons:

• operators of RMPs (section 16 of the Act);

• exporters (section 51 of the Act);

• recognised agencies (section 106 of the Act); and

• accredited persons (section 107 of the Act).

The Act also provides for appropriate penalties to be applied when an offence occurs.

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Risk Management Programme

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3.1 What is a risk management programme?

A risk management programme (RMP) is a documented programme designed to identify and manage hazards and other risk factors in relation to the production and processing of animal material and animal products, in order to ensure that the resulting animal product is fit for intended purpose. The risk factors that need to be considered in the development of an

RMP are:

• risks from hazards to human and animal health;

• risks from false or misleading labelling; and

• risks to the wholesomeness of animal material or product.

An operator’s registered RMP will be “legally binding” so it must be developed and implemented in accordance with relevant New Zealand legislation. Overseas market access requirements and commercial quality issues are not required to be part of the risk management programme.

The Risk Management Programme Manual provides comprehensive information on the principles and components of an RMP and provides guidance for their development.

An RMP may be developed for a single business or for multiple businesses.

3.2.1 Single-business RMP (Sections 12(3) and 12(4) of the Act)

A single RMP that covers the operations of a single-business located in a single-site is the simplest form of an RMP and its use is encouraged, whenever applicable. This is likely to be the most suitable RMP configuration for majority of honey extractors and packers.

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Risk Management Programme

A business may also decide to have more than one RMP. This may be useful when the operation can be logically and clearly split by product, process or premises. For example, a single business involved in the extraction and packing of honey may wish to have two RMPs

– one covering the extraction process and the other the packing process. This arrangement can give flexibility to the operator in terms of making RMP amendments. It also allows for the suspension or deregistration of one RMP without affecting the other. However, consideration should be given to the practicality and cost of managing more than one RMP within a single business, and any market access requirements.

3.2.2 Multi-business RMP (Section 17A of the Act)

An RMP may apply to more than one business, if the Director-General approves such an arrangement for the particular business. The approval will depend on the operator being able to demonstrate that:

• the programme is appropriate to all businesses or part-businesses that it covers;

• the registered operator of the programme will have sufficient control, authority and accountability for all matters covered by the programme in relation to the other business or part-business subject to its coverage; and

• the applicant has obtained the consent or otherwise taken into account the views of any person whose business or part-business is to be covered by the programme.

An example where a multi-business RMP could apply is in a situation where the honey packer decides to include the operations of several extractors under a single RMP. In this case, the packer must have sufficient control, authority and accountability for the related activities of the extractors. The extractors must consent to this arrangement and should only supply bulk honey to the particular packer covered by the RMP.

Certain market access requirements, for example European Union (EU) listing requirements, do not allow this RMP configuration to be used. Therefore, this is not likely to be a suitable

RMP configuration for majority of honey processors.

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Risk Management Programme

3.3 Contents of a risk management programme

3.3.1 Contents

The documented RMP must include the following:

•

Good manufacturing practice

Good manufacturing practice (GMP) includes the practices and procedures designed to ensure the consistent production of products that are safe and suitable for their intended purpose, and that meet relevant regulatory requirements. It includes several interacting components such as hygienic practices, process control and quality assurance systems.

GMP is usually documented by the operator in supporting systems of their RMP.

GMP is the foundation for Hazard Analysis and Critical Control Point (HACCP) and RMPs. It may also be referred to as Good Operating Practice (as used in the NZFSA Domestic Food

Review discussion papers).

GMP for the processing of honey and other edible bee products is discussed in Part 2 of this

COP.

•

Application of HACCP principles

The operator must apply HACCP principles, as appropriate to the product and process, to ensure a systematic approach to the identification and analysis of hazards and their control.

This is covered in Part 3 of this COP.

•

Identification of other risk factors and their controls

Other risk factors related to the wholesomeness of the product and risks from misleading labelling must be identified in the RMP. The control measures for addressing the identified risk factors must also be documented in the RMP. These are presented in Part 4 of this

COP.

•

Other RMP requirements

Other RMP requirements such as business identification, operator’s details, physical boundaries, and provision for verifiers’ rights must also be documented in the RMP. These requirements are covered in the RMP templates provided in Part 5 of this COP.

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Risk Management Programme

The RMP should include the following components:

•

Operator, business and RMP identification

•

List of RMP documents

•

Management authorities and responsibilities

•

Scope

•

Animal material and animal product description

•

Process

•

Good Manufacturing Practice

•

Application of HACCP (identification, analysis and control of hazards to human or animal health)

•

Identification and control of risks to wholesomeness

•

Identification control of risks from false and misleading labelling

•

Identification and competency of responsible persons

•

Corrective action for unforeseen circumstances

•

Recall

•

Confirmation validity

•

Operator

•

Notification

•

Provision for verification activities & verifiers rights

•

Document control and requirements for records

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Development of an RMP based on an

Approved Code of Practice

4 Development of an RMP based on an

Approved Code of Practice

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July 2005

The Animal Products Amendment Act 2002 allows for an RMP to be based on a COP, a template, or a model if in the view of the Director-General it is valid and appropriate for businesses of that kind. A COP that is deemed as valid and appropriate after an assessment process carried out by the NZFSA will be formally recognised as an “approved code of practice”.

A COP is a valuable tool to use in the development of the RMP. Compliance to an approved

COP will:

• ensure that the operator complies with current best practice or acceptable industry practices and procedures;

• ensure that the operator meets the relevant regulatory requirements; and

• simplify and reduce the cost of developing and evaluating the RMP.

The applicability of the approved COP to the particular business and the degree of the operator’s compliance to the approved COP will impact on the development approach and evaluation requirements for the RMP.

4.1

COP

Businesses whose products and processes are fully covered by an approved

4.1.1 Development

When the COP fully covers the scope of the operation of a business, the simplest approach for developing an RMP is to use the appropriate RMP template provided. The RMP template is a simple form that the operator completes by filling in the required information in the appropriate boxes.

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Development of an RMP based on an

Approved Code of Practice

The requirement for the documentation of GMP supporting systems and the application of

HACCP principles in the RMP can be met by incorporating the relevant sections of the COP into the RMP by reference. This means that that the operator will only need to write very few procedures that are specific to their operation. The operator’s RMP will, therefore, consist of the completed RMP template, the relevant sections of the COP that apply to their operation, and their own written procedures.

Confirmation by the operator that the RMP meets all the legal requirements for a valid RMP and that it will conform to the approved COP will simply involve signing a declaration in the

RMP template.

Two RMP templates are provided in Part 5 of this COP. One template covers the processing of honey and dried pollen. The other template has been designed for use by beekeepers who do not extract their own honey and are only involved in the storage of bulk honey .

4.1.2 Evaluation

An RMP that is fully based on an approved COP does

not

require an evaluation prior to registration since the NZFSA has already determined that the requirements and procedures set out in the COP are valid and will deliver the relevant regulatory requirements.

Verification of the accuracy of the documented RMP and operator’s compliance to the COP will be carried out at the initial verification by the contracted verifier.

4.2 Businesses whose products or processes are not fully covered by an approved COP, or those with significant variation from the COP

4.2.1 Development

Since the COP is limited in its scope in terms of the bee products, processes and procedures it covers, some businesses will need to tailor parts of the RMP template to meet their particular process variations. Some may also need to, or want to develop their own specific

RMP.

Businesses whose products and processes are not fully covered by the COP, or who have decided to apply procedures or processing parameters that significantly differ from those given in the COP must write their own documentation for those parts of the RMP that are not covered or vary from the COP (including HACCP application and GMP procedures). The

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Development of an RMP based on an

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RMP template may still be used but the operator will need to add their own information or documents for those parts not covered by the template or COP.

The operator must be able to demonstrate the effectiveness of any alternative procedures or parameters to consistently meet all relevant regulatory requirements and produce products that are safe and suitable for their purpose. Demonstration of its effectiveness may involve the collection of evidence (e.g. data from testing or trials, published scientific information, report from an expert) by the operator for assessment of the accredited evaluator or the

NZFSA.

4.2.2 Evaluation

An RMP that is not fully covered by an approved COP or has procedures that vary from the

COP will need to be evaluated by an independent evaluator to confirm the adequacy of the

RMP. Evaluation will involve a desk-top audit of the documented RMP and may require an on-site visit of the premises before registration of the RMP.

4.3 Steps for the development, registration and implementation of an RMP

The steps for the development, registration and implementation of an RMP are summarised in Figure 1. The diagram shows the steps for two options:

•

Option 1: For businesses whose products and processes are fully covered by the COP.

•

Option 2: For businesses whose products and processes are not fully covered by the

COP, or who have decided to apply procedures or processing parameters that significantly differ from those given in the COP.

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Development of an RMP based on an

Approved Code of Practice

Figure 1. Steps for the development, registration and implementation of an RMP

Option 1

Development

•

Operator to complete RMP template and incorporate relevant parts of the COP into

RMP by reference

•

Operator to obtain confirmation letter from recognised verifying agency

Option 2

Development

•

Operator to complete RMP template and incorporate relevant parts of the COP into

RMP by reference,

and add own documents for products/processes/procedures not covered by COP; OR

Operator to develop own RMP

•

Operator to confirm effectiveness of any alternative procedures/parameters, and validity of RMP

•

Operator to sign declaration confirming validity of RMP and compliance to COP

•

Operator to obtain confirmation letter from recognised verifying agency

•

Evaluation

Operator to contract an evaluator

•

Accredited evaluator to carry out evaluation, prepare report and recommend RMP for registration

•

Registration

Operator to submit documents required for registration including RMP or

RMP outline, application form and fee to NZFSA

•

NZFSA to assess and register the RMP application

•

Implementation

Operator to notify recognised verifying agency of RMP commencement

•

Operator to implement the RMP, including operator verification

•

Accredited verifier to provide external verification

•

Operator to apply for registration of any significant amendment*

* Significant amendments will require evaluation prior to registration

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Legislation

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July 2005

This COP will assist bee product operators meet the requirements of the Animal Products

Act 1999. Operators are responsible for ensuring that they are familiar and comply with all other legislation. Operators should not rely solely on this COP to provide them with information on the legal requirements under the different legislation.

Legislation that are likely to be relevant to bee product operators include, but is not limited to, the following Acts and their associated regulations and specifications:

•

Animal Products Act 1999

•

Animal Products (Ancillary and Transitional Provisions Act) 1999

•

Agricultural Compounds and Veterinary Medicines Act 1997

•

Biosecurity Act 1993

•

Commerce Act 1986

•

Consumer Guarantees Act 1993