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Proposed Changes to the Regulation of Dietary Supplements

7 Proposed Complementary Food Regulations

7.1 Interpretation

The following terms are used in this discussion document and have the meanings specified:

• a ‘complementary food’ is a product that is presented as a food, or to be consumed as a food that has had substances added, for the purpose of providing a nutritional and/or health benefit to supplement the diet for which there is currently no appropriate permission in the Code and has not been assessed as unsafe by a competent authority (NZFSA, Food Standards Australia New Zealand (FSANZ), third country or international body)

• an ‘appropriate permission’ means that the compositional requirements of the Code can be met without substantially altering the nature or function of the food. The purpose of defining this term is to ensure alignment with the Code occurs to the maximum extent possible

• intoxicating has the Concise Oxford Dictionary 10th Edition meaning of intoxicate: 1 (of an alcoholic drink or a drug) cause (someone) to lose control of their faculties. 2 excite or exhilarate.

7.2 Purpose

The purpose of the Proposed Regulations would be to provide regulatory coverage for food-type dietary supplements for which there are currently no appropriate permissions in the Code. As there is consumer support for food-type dietary supplements and as many of these foods have been available for some time without causing safety concerns, it is necessary to ensure there is a suitable regulatory environment to allow the continued sale and manufacture of these products.

It is also important to align food-type dietary supplements with the requirements of the Code so that products can move into the Code as appropriate permissions (see meaning below) become available. For this reason it is proposed to incorporate some standards from the Code into the Complementary Food Regulations. Other than the standards incorporated by reference, the Code in general, however, will not apply to complementary foods.

7.3 Scope

The scope of the proposed regulations would be defined by inclusions and exclusions. The scope reflects the intention of the Proposed Regulations to align complementary foods with the Code where appropriate. The scope would exclude those products that should be regulated under therapeutic products legislation.

In cases where the regulatory status of a product is in doubt, a panel comprising food and therapeutic experts would make an assessment.

7.4 Inclusions

Food products that do not meet the requirements of the Code may be a complementary food if the following factors are met:

• appropriate standards in the Code that will provide appropriate permissions are under development and/or amendment by FSANZ; or

• appropriate standards in the Code that will provide appropriate permissions are to be developed or amended but are awaiting Food Regulation Policy Guidelines; or

• the product was being legally sold as a food-type dietary supplement in New Zealand under the Regulations immediately prior to the amendment of the Regulations.

Examples of food products that may be included are health bars/yoghurts with added vitamins or minerals that are outside the current permissions in Standard 1.3.2 in the Code or bioactive substances that are not expressly permitted (and are not prohibited) in the Code. While work continues on the policy on the addition of some these substances, an appropriate permission is not available in the Code.

Some sports foods that have significantly higher levels of vitamins, minerals or amino acids than those permitted in the Code under standard 2.9.4 or that have bioactive substances added that are not permitted in standard 2.9.4. As reformulation would substantially alter the nature or function of the food there is no appropriate permission in the Code.

7.5 Exclusions

Food products that will not be assessed as a complementary food are:

• food products that are marketed as having a therapeutic use or purpose⁷

• products determined by therapeutic product regulators as having a therapeutic use or purpose

• food products and/or food products containing substances or levels of substances that are unsafe as assessed by a competent authority (NZFSA, FSANZ, third country or international body)

• food products for which there are appropriate permissions under the Code that could be applied. Examples of food products that might meet the definition of having an appropriate permission available under the Code would be sports foods where the vitamin and mineral content exceeds the permitted level in Standard 2.9.4 by a small amount (e.g. permitted level is 22 mcg and product level is 23 mcg)

• food products containing substances that are regulated, listed or scheduled as medicines or drugs scheduled under the Medicines Act 1981 or under the Misuse of Drugs Act 1975

• food products containing intoxicating substances for which there is no explicit permission under the Code

There can be significant risks associated with intoxicating substances. Products containing these substances, such as alcohol are generally regulated to minimise those risks. In the Code, there is a standard for the use of kava which recognises that it is culturally important that kava be available but there are risks associated with its use and the standard seeks to minimise potential harm arising from misuse. The labelling provisions of this standard apply in New Zealand.

There will be some products that fall at the interface between food and medicine. A brief description of the criteria that may be used to consider the regulatory status of such products is provided (Part 9 of this paper) to allow stakeholders an opportunity to assess a product’s likely regulatory coverage as a complementary food under the Proposed Regulations or a complementary medicine under amended Regulations (and later under therapeutic product legislation).

How should these inclusions and exclusions apply to imported foods?

Are these exclusions/inclusions appropriate and why or why not?

Are there any other exclusions/inclusions that apply and why?

7.6 Empowering Act: explicit reference to the Food Act

Regulations established under the Food Act, including the Dietary Supplements Regulations, are subject to the provisions of the Act unless specifically excluded. Consideration needs to be given to whether explicit reference to relevant provisions and obligations under the Act should be made in the Proposed Regulations for the purposes of clarity. In particular these would include:

• Food Hygiene Regulations (1974). These regulations are made under the requirements of the Health Act (1956) and the Food Act (1981) and cover hygiene standards in food premises and manufacturing conditions

• Food Act (1981) Section 11O. Contravention of food standards (all foods must comply with the applicable food standards); section 9 General Prohibition on sales of food that do not comply with a standard prescribed under regulations made under the Act or by any food standard.

7.7 Composition, Labelling and Safety

The intention of the Proposal is that the minimum composition, labelling and safety standards as set out in the Code are required to be met for complementary foods. This is consistent with the public health and safety objectives in the Food Act. In addition to the Code permissions, this proposal would provide for the addition to food of substances for which there is currently no appropriate permission under the Code.

The full text of the Code can be found at http://www.foodstandards.gov.au/thecode. Standards that are considered to be relevant have been listed here for discussion purposes.

7.7.1 Technological Food Additives

The Code defines food additives as:

“any substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which is intentionally added to a food to achieve one or more of the technological functions specified in Schedule 5 of Standard.1.3.1 (eg, sweeteners, preservatives and thickeners). It or its by-products may remain in the food”.

Other additives used for technological purposes include processing aids set out in Standard 1.3.3.

As raised in the 2004 consultation process, the permissions in the Regulations for use of food additives are outdated. This proposal would allow technological food additives as permitted in the Code to be used in complementary foods for the same purposes as those permitted in the Code.

The relevant food additive standards from the Code are listed below:

Standard 1.3.1	Food additives
Standard 1.3.3	Processing aids

7.7.2 Vitamins, Minerals and Nutritive Substances

Currently the Code has standards for vitamins and minerals in prescribed forms (Standard 1.1.1) that may be added at restricted levels in specified foods (Standard1.3.2). Safety assessments, including the impact of dietary exposure, have been undertaken by FSANZ for this standard.

What level of evidence of safety, if any, should be provided for complementary foods that contain these vitamins and minerals that exceed the limits permitted in the Code or vitamins and minerals and other substances that are not currently addressed in the Code?

Should manufacturers be required to hold this evidence and, if necessary, use warning labels or advisory statements? Examples of evidence could include: history of use; peer reviewed journal citations; approved standards from overseas competent authorities recognised as equivalent (eg EU).

Would these sources be adequate? What other sources of evidence could be considered?

7.7.3 Labelling

In addition to protecting public health and safety, labelling is used to provide consumer information.

Currently dietary supplements must be labelled “Dietary Supplement”. Under this proposal complementary foods would be required to be labelled with the words “Complementary Food”.

Mandatory labelling requirements would include:

• the words “Complementary Food” in a prominent place on the label

• allergens must be labelled if an allergen is present as per the Code requirements

• all labels must be in English

• gene technology and irradiated foods must be labelled as required by the Code

The relevant labelling standards from the Code are listed below:

Standard 1.1A.4	Transitional standard for the labelling of pollen and royal jelly
Standard 1.2.1	Application of labelling and other information requirements
Standard 1.2.2	Food identification requirements
Standard 1.2.3	Mandatory warning and advisory statements and declarations
Standard 1.2.4	Labelling of ingredients
Standard 1.2.5	Date marking of packaged food
Standard 1.2.7	Representations about food (Proposed health claims)
Standard 1.2.8	Nutrition information requirements
Standard 1.2.9	Legibility requirements
Standard 1.2.10	Characterising ingredients and components of food

Note: there are also labelling requirements for specific standards in Part 2 of the Code, Food Product Standards.

Where a complementary food is standardised under Part 2 of the Code, other than for the feature that makes it a complementary food (eg, added vitamins or minerals) any labelling that would apply under Part 2 for that food would apply. Similarly any mandatory warning and advisory statements under Standard 1.2.3 would apply. For example the labelling of juice blends under Standard 2.6.1 clause 3; or alcoholic beverages under Standard 2.7.1.

7.7.4 Safety

Standard 1.6.1

Microbiological limits for food

This standard lists the maximum permissible levels of foodborne micro-organisms that pose a risk to human health in nominated foods, or classes of foods.

Standard 1.4.1

Contaminants and natural toxicants

This standard sets out the maximum levels of specified metal and non-metal contaminants and natural toxicants in nominated foods.

Standard 1.3.4

Identity and purity

This standard ensures that substances that are permitted to be added to food meet appropriate specifications for identity and purity of food additives, processing aids, vitamins and minerals and other added nutrients.

Standard 1.4.3

Articles and materials in contact with food

This standard provides permission for articles and materials to be in contact with food. It sets out maximum levels for a number of metal and non-metal contaminants and natural toxicants that may be present in food as a result of contact with the articles and materials regulated in the standard.

Is there any reason/circumstance why complementary foods should not be required to meet the requirements of these safety standards?

7.7.5 Pre-Market Assessment

Standard 1.5.1

Novel Foods

This standard regulates the sale of novel food and novel food ingredients. The purpose of the standard is to ensure that non-traditional foods which have features or characteristics which raise safety concerns will undergo a risk-based safety assessment before they are offered for retail for direct consumption in New Zealand and/or Australia.

Standard 1.5.2

Food produced using gene technology

This standard addresses health and safety requirements regulating the sale of food produced using gene technology, other than additives and processing aids. It also specifies labelling and other information requirements for foods, including food additives and processing aids using gene technology.

Standard 1.5.3

Irradiation of food

This standard prohibits the irradiation of food, or ingredients or components of food, unless a specific permission is given. It also sets out permitted sources of radiation, requires the keeping of certain records in relation to the irradiation of food, and requires the labelling of food which has been irradiated.

7.7.6 Prohibited and restricted substances

A list of prohibited substances and restricted substances would be maintained via a schedule in the Proposed Regulations, with provision for emergency updates. This list will include restrictions and conditions of use based on assessments (eg, for the safe level of nutrients). It will also include the relevant standard from the Code which is listed below:

Standard 1.4.4

Prohibited and Restricted plants and fungi

7.8 Quality Assurance

Food sold in New Zealand must meet basic standards. Systems to ensure that these standards have been met are usually based on a variety of management plans such as Food Safety Programmes (FSP), Risk Management Programmes (RMP) etc, covered by the Food Regulations. Consultation on the national application of such plans has occurred under the Domestic Food Review. It is proposed that manufacturers and suppliers of food-type dietary supplements will be required to have a Food Control Plan or equivalent⁸.

Currently, for exported product, official assurances are given for animal material in dietary supplements under the Animal Products Act (1999) if required by the importing country. This facility will remain under the Proposed Regulations for complementary foods.

7.8.1 Sanctions and Compliance

The principles described in the Domestic Food Review underpinning enforcement apply to all foods including complementary foods. These are:

• Principle 1: The compliance and sanctions regime will be seamless and coherent and will apply regulatory and non-regulatory provisions consistently and equitably across all food sectors

• Principle 2: Persons have responsibility to ensure they understand and implement the requirements of current food safety and suitability legislation

• Principle 3: The range of tools available to manage and prevent non-compliance will be flexible and extensive and will comprise options for both non-regulatory and regulatory intervention

• Principle 4: The Regulator will apply a set of assessment criteria to measure the seriousness of the non-compliance and thus the appropriate response

• Principle 5: An incremental scale of sanctions will be applied consistently and equitably across all food legislation.

The responsibilities and liabilities are described in the Food Act. As well as the prohibition on the sale of food that does not comply with the prescribed standard or regulation under section 9, there is a general obligation that food should be safe and suitable. Relevant legislation such as obligations under the Food Hygiene Regulations for the registration of premises apply, as do requirements under other relevant legislation such as the Animal Products Act (1999) and consumer legislation such as the Fair Trading Act 1986.

7.9 Transitional Provisions

NZFSA is aware that for many products, no delay will be necessary in the uptake of the Proposed Regulations. For others, however, it will be necessary to provide time to allow for labelling and composition changes to meet the requirements of the Proposed Regulations.

Following analysis of the submissions, a decision will be made regarding changes to the way food-type dietary supplements are regulated. A transition paper will then be prepared to consider the implementation issues. This will include timeframes and other requirements such as safety assessments.

Is 12 or 18 months a reasonable transition time to accommodate changes to labelling and composition for products currently being sold as food-type dietary supplements?

⁷ See http://www.anztpa.org/ (the Agreement) for definition of “therapeutic product” and “therapeutic use”.

⁸ see the Domestic Food Review position Paper found at: http://www.nzfsa.govt.nz/policy-law/projects/domestic-food-review/index.htm