Deficiencies in the current Regulations have been recognised by both industry and government for a number of years. The delay in a review of the Regulations has been partly due to uncertainty about the extent its scope. There has never been a ‘best time’ to propose change without other factors raising issues that would also impact on the Regulations.
However, with the signing of the agreement between Australia and New Zealand on the joint regulatory scheme for therapeutic products, the impetus to review the Regulations has become more pressing. This is because those dietary supplements that are to be considered and treated as complementary medicines will transfer from the Regulations to provisions under the joint scheme.
This discussion paper, therefore, assumes that, in the main, these products will be identified and that in due course a transitional process will be proposed and consulted on for this transfer: This paper focuses on two key areas:
- How to identify and deal with products currently covered by the Regulations but which align more closely with fortified food-type products rather than therapeutic-type products.
- Changes that should be made to the Regulations that should apply during any transitional period.
Part one of this paper deals with the definition of foods and the fortified food-type products/ therapeutic-type products interface. It proposes criteria to assist in separating fortified food-type products from therapeutic-type products with the intention that those products not covered by the joint therapeutic scheme should be managed within the food supply. In many respects, the requirements applying to foods are more comprehensive than currently apply to dietary supplements; the implicit question is: why should products sold alongside food not be treated as food? Options are presented for addressing this question within a regulatory framework.
Part two of this paper considers amendments that should be made to the Regulations as an interim measure until decisions on future regulatory coverage are made. The changes proposed in this paper are intended to complement decisions taken about dietary supplements, while recognising the importance and value to industry and consumers of making some changes to have effect sooner rather than later. There are two distinct aspects to part two:
I. To amend the Regulations to reflect recent developments in terms of upper fortification levels of specific products and permitted sweeteners; and
II. To mandate allergen labelling and labelling in English to address significant health and safety requirements applying to foods that are not currently featured in the Regulations. By ensuring ingredient listing is in English, consumers can be alerted to the product mix and to any health warnings that might be included. While allergen labelling focuses on assisting a particular sub-population, it is nevertheless a significant health and safety feature of food labelling that should also apply explicitly to dietary supplements.
Contents
Executive summary
1 Background
The Regulations
Policy for the joint food standards system
International approaches to food-medicines regulation
The Trans-Tasman Mutual Recognition Arrangement
Part One
2 Dietary supplements and developments at the food-medicines interface
Overview
Changes to medicines law
Classifying dietary supplements as foods or medicine
- 1. Purpose of the product
2. Composition of the product
3. Form of the product
4. Presentation of the product
5. Effects – what happens after you consume it?
6. Law
7. Other external reference factors
8. Use patterns.
9. Other factors that stakeholders consider relevant
3 Fortified foods regulated as dietary supplements: Options for future regulations
Overview
Should these products be regulated as foods?
Regulatory best practice and risk-based methodology
Australia New Zealand Food Regulation Ministerial Council (ANZFRMC)
Regulating fortified products currently sold as dietary supplements as foods in the future:
Arguments for and against
Regulatory options for fortified foods currently regulated as dietary supplements
Preferred regulatory option
Part Two
4 Proposed changes to levels and substances permitted under the Regulations
Overview
5 Proposed change to maximum daily dose for folic acid supplements
- Criteria for assessing the proposed change
Public health and safety
Impact on Industry
Health claims
Proposed Change to Maximum Daily Dose for Vitamin B12 Supplements
- Criteria for assessing the proposed change
Public health and safety
Impact on industry
Harmonisation with Australia
Proposed change to Regulation 16: Artificial sweeteners
- Requirements for use of sweeteners in foods
Requirements for use of artificial sweeteners in dietary supplements
Requirements for the use of sweeteners in medicines
Criteria for assessing the proposed change
Public health and safety
Impact on industry
Harmonisation with Australia
6 Proposed amendments to mandate allergen labelling and labelling in English
A: Allergen labelling
- What is a food allergy?
Standard 1.2.3, Clause 4 - Mandatory declaration of certain substances in food
B: Labelling in English
- Standard 1.2.9 – Legibility Requirements
Criteria for assessing the proposed change (allergen labelling and labelling in English)
Public health and safety
Consumers
Industry
Harmonisation with Australia
Annex 1: Glossary
Annex 2: The Regulations (as amended in 1986)
Annex 3
- Definitions of Dietary Supplements
Annex 4: International definitions and provisions relating to dietary supplements
- The Codex Alimentarius Commission (Codex)
Australia
Canada
United States
UK
EU
Annex 5 : Proposed changes to the food-medicine interface
Annex 6: Health claims for folate-containing dietary supplements
Annex 7: Risk assessment –folic acid
- The nutrient –folate and folic acid
Recommended intakes
Current intakes
Risks associated with high intakes of folic acid
Safe upper limits for folate
United States
Risk assessment
Other life stage groups
Intake assessment
UK
Establishment of a guidance level
- Australia
Folate and children
Relevance for New Zealand population
Risk management and communication on folic acid
Monitoring and surveillance of folic acid
Benefits of increasing the daily dose of folic acid in dietary supplements
Annex 8: Risk assessment – vitamin B12
- The nutrient: Vitamin B12
Recommended intakes of vitamin B12
Current intakes of vitamin B12
Risks associated with high levels of vitamin B12
Safe upper limits for vitamin B12
United States
UK
- Australia
Relevance for the New Zealand population
Risk management and communication around vitamin B12
Monitoring and surveillance of vitamin B12
References for Vitamin B12:
Annex 9: Recommended dietary intakes used in New Zealand
Annex 10: Summary of discussion paper questions
- Your views?
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