One submitter sought clarification on whether chewing gum (0.2% residual sugars) fortified with calcium to a level of 10% of the RDI would be eligible to make a general level health claim under the proposed Standard 1.2.7. Another submitter recommended that the health claims framework be finalised prior to the consideration of this Application. The regulation of health claims is not within the scope of this Application. Under Proposal P293 it has been proposed that all health claims must be substantiated to a certain level of evidence and in accordance with certain principles. FSANZ considers that this framework will adequately address the substantiation of health claims made in regard to calcium-fortified chewing gum (0.2% residual sugars). FSANZ will ensure that the qualifying criteria for general level health claims for calcium-fortified chewing gum (0.2% residual sugars) are consistent with the criteria for nutrition claims in relation to releasable calcium. 9.4.4
Advisory statements
One submitter to the Initial Assessment Report suggested that an advisory statement that reflects the dietary guidelines with respect to sources of calcium should be provided on labels, so that consumers are not misled by claims which equate the nutritional benefits of calcium-fortified chewing gum (0.2% residual sugars) with dairy foods. FSANZ recommends that such an advisory statement will not be prescribed. An advisory statement is only required when the general public or a sub-population are exposed to a significant potential risk to health but the risk is not life threatening, or when guidance about the use of a food is needed to protect public health and safety. As reported in the risk assessment, there is only a small risk that some consumers may replace calcium-rich foods with the proposed product, and this is unlikely to cause any dietary inadequacies of other nutrients. Also, in accordance with the wording conditions proposed under Proposal P293, all health claims must be presented in the appropriate dietary context and must make reference to a variety of foods (with the exception of small packages). 9.5
Enforcement
The proposed approach that calcium claims for calcium-fortified chewing gum (0.2% residual sugars) are based on the amount of calcium released during 20 minutes of chewing is different to that taken for other fortified foods. For this reason, a different approach to assess compliance with the Code will be required. As the calcium content of calcium-fortified chewing gum (0.2% residual sugars) will differ depending on the form of calcium used, assessing the product’s calcium content alone will not verify the validity of the claim(s) made. Additional information on the amount of calcium released from the chewing gum during 20 minutes will be required. Enforcement agencies may experience difficulties gathering the addition information on the amount of calcium released from the product. For this reason, it is proposed that the manufacturer must hold information to substantiate the amount of calcium released from their product during 20 minutes of chewing, and provide this to enforcement agencies on request. It can reasonably be assumed that this requirement will not place additional burden on the manufacturer, as the relevant analytical tests should have been conducted to determine the claim stated on the food package.
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