APPLICATION A424 - fortification of foods with calcium
18 December 2002
DRAFT ASSESSMENT REPORT
DEADLINE FOR PUBLIC SUBMISSIONSto the Authority in relation to this matter: 12 February 2003 (See “Invitation for Public Submissions” for details)
Full Report [ 486kb ]
Executive Summary and Statement of Reasons
Food Standards Australia New Zealand (FSANZ, formerly ANZFA) received an application from Food Liaison Pty Ltd on behalf of Arnott’s Biscuits Limited and Nutrinova Pty Ltd to amend Standard 1.3.2 – Vitamins and Minerals, of the joint Australia New Zealand Food Standards Code (the Code), to permit the addition of calcium to fruit and vegetable juices, fruit and vegetable drinks, fruit cordial, soups and crispbread/cracker type biscuits.
A total of 28 submissions were received in response to the Initial Assessment Report. The Australia New Zealand Food Authority (ANZFA) to FSANZ transitional requirements for an application at full (draft) assessment stage have been followed and no additional submissions have been received.
Vitamins or minerals are not permitted to be added to [general-purpose] foods unless the addition of that vitamin or mineral is specifically permitted in Standard 1.3.2 – Vitamins and Minerals and the vitamin or mineral is in a permitted form as specified in the Schedule to Standard 1.1.1 of the Code. There is not currently any permission for the addition of calcium to any of the food products requested by the applicant.
To determine whether the Code should be amended to permit the voluntary fortification of the food products requested in the application with calcium. Any such amendment would need to be consistent with the objectives set out in section 10 of the FSANZ Act.
Regulatory principles for the voluntary vitamin and mineral addition to general purpose foods were developed by ANZFA previously and were derived from the Codex General Principles for the Addition of Essential Nutrients to Foods (Codex General Principles) developed by the Codex Alimentarius Commission.
FSANZ has recently clarified and elaborated the regulatory principles for addition of vitamins and minerals to foods. This clarification and elaboration was undertaken in order to:
- provide a basis for decision making in relation to relevant applications until such time as the Australia and New Zealand Food Regulation Ministerial Council (ANZFRMC) develops policy on the matter; and
- respond to calls from submitters for a review of the regulatory principles (and Standard 1.3.2) in order to address the perceived inequity of vitamin and mineral permissions.
This application has been assessed against the (clarified and elaborated) regulatory principles for addition of vitamins and minerals to foods.
Issues considered in the Draft Assessment include (with consideration of the dietary intake assessment): the eligibility of the nutrient for voluntary fortification; the eligibility of the foods proposed for fortification; an assessment of the risk of excess calcium intake; an assessment of the risk of nutrient deficits or imbalances; a consideration of potential effectiveness; and consideration of risk management strategies in relation to addressing the inappropriate consumption of calcium-fortified food products.
There are two options for addressing this Application:
Option 1 – No approval. Maintain the status quo by not amending the Code to approve the voluntary addition of calcium to the food products requested by the Applicant.
Option 2 – Approval. Amend the Code, as requested by the applicant, and approve the voluntary addition of calcium to the food products requested by the Applicant.
The conclusion of the impact analysis is thatOption 2, approval of the application, is the preferred option taking into account the dietary intake assessment, matters raised by submitters and the Regulatory Impact Statement (RIS). Some of the specific considerations in reaching this conclusion were as follows:
- There are benefits to consumers of additional and/or alternative food sources of calcium.
- Dietary intake assessment indicates that there is very little risk of excess consumption of calcium under Option 2.
- The potential exists to improve the calcium intake of population subgroups with current intakes assessed as inadequate. This potential benefit is estimated to outweigh any risks associated with inappropriate use of the calcium-fortified products.
A total of 28 submissions were received in response to the Initial Assessment Report released in December 2001. Of these submissions, 12 submitters unconditionally supported Option 2 and 8 submitters opposed the application in its entirety. Other submitters either: supported limited permissions (variation of Option 2); declined to support either option; or thought the application should not be assessed in isolation of a review of Standard 1.3.2 – Vitamins and Minerals, and the regulatory principles underpinning the Standard.
Conclusion and Statement of Reasons
FSANZ recommends the approval of the application to permit the voluntary addition of calcium to fruit and/or vegetable juices, fruit and/or vegetable drinks, fruit cordial, soups and crispbread/cracker-type biscuits for the following reasons:
- Calcium is considered to be potentially eligible for voluntary fortification (subject to risk assessment) because, in accordance with the regulatory principles for the addition of vitamins and minerals to foods, more than one population subgroup in both Australia and New Zealand has a customary intake below 30% of the Estimated Average Requirement (EAR) based on National Nutrition Surveys.
- All foods requested by the applicant are considered to be eligible for voluntary fortification (subject to risk assessment) since the food categories are consistent with general dietary guidance.
- The dietary intake assessment estimates that there would be negligible risk of excess calcium intake based on the addition of calcium at the levels requested to all the proposed foods.
- The addition of calcium to all the proposed foods has the potential to increase the calcium intake for the population or subgroups of the population with a current intake assessed as inadequate. However, this potential benefit depends on the extent to which this permission to voluntarily add calcium is taken up by industry.
- Permission for the voluntary fortification of the proposed foods with calcium would provide consumers with additional and/or alternative food sources of calcium.
It is recommended that all food categories requested by the applicant be granted a permission to voluntarily add calcium to a level that allows a ‘good source’ content claim (at least 25% of the Recommended Dietary Intake (RDI) per reference quantity) to be made.
The proposed drafting for an amendment to Standard 1.3.2 – Vitamins and Minerals, is at Attachment 1 of the Draft Assessment Report.
Full Report [ 486kb ]