Assessment of one published review on health risks associated with phosphate additives in food

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(11):3444 [27 pp.].
doi
10.2903/j.efsa.2013.3444
Acknowledgements

EFSA wishes to thank the Food Ingredients and Packaging Unit for the preparatory work on this scientific output and the members of the Panel on Food Additives and Nutrient Sources added to Food: Ursula Gundert-Remy and Jürgen König and EFSA Staff: Georges Kass, Camilla Smeraldi and Gabriele Zancanaro for the support provided to this scientific output.

Contact
Type
Statement of EFSA
On request from
European Commission
Question Number
EFSA-Q-2013-00311
Approved
24 ottobre 2013
Published
13 novembre 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to undertake a scientific assessment of the concerns raised in a scientific article that suggested an association between high intake of phosphates as food additives and increased cardiovascular risk in the general population. The publication assessed is a narrative review summarising the latest evidence from observational studies on a possible association between elevated serum phosphate levels and an increased risk of cardiovascular disease and overall mortality in the general population. In their review, the authors also present some considerations on the metabolism of inorganic phosphate, the latest insights into the hormonal mechanisms that are involved in its homeostasis and possible explanations for its role in vascular calcification. The authors reported that intake of phosphate as a food additive, especially through consumption of processed and ready-to-eat food, is of particular concern. EFSA assessed this published review and concluded that, owing to the intrinsic limitations of the non-interventional design of the studies included, it is not possible to make causal inferences for serum phosphate levels and the observed adverse effects. In addition, from the evidence reviewed it is not clear whether the increased cardiovascular risk observed in these observational studies is attributable to differences in the dietary intake of phosphorus in general or in the form of phosphate additives and serum phosphate levels. As set out by Regulation (EU) No 257/2010, phosphates for use as food additives will be re-evaluated by EFSA with high priority by 31 December 2018. In the context of this re-evaluation all relevant toxicological information will be collated and evaluated. A dedicated call for data aimed at gathering information on usage levels of phosphates in food will be launched in preparation for the re-evaluation.

Summary

The European Food Safety Authority was asked by the European Commission to undertake a scientific assessment of the concerns raised in the scientific article “Phosphate additives in food: a health risk”, by Ritz et al., published in 2012 which suggested an association between high intake of phosphates as food additives and increased cardiovascular risk in the general population.

In their review article, Ritz et al. (2012) present the latest evidence from observational studies showing a possible association between elevated serum phosphate concentration and an increased risk of cardiovascular disease and overall mortality in the general population. The authors also discuss the metabolism of inorganic phosphate and the hormonal systems that regulate its homeostasis and present possible explanations for an involvement of phosphate in vascular calcification. The intake of phosphate through consumption of processed and ready-to-eat foods is hypothesised by the authors to be of particular concern for the whole population, as recent studies have shown that it may be much higher than previously estimated. In the light of the potential harmful effects associated with excessive phosphate consumption, in their conclusions, the authors call for a labelling requirement to be introduced for foods with added phosphates.

An association between elevated serum phosphate levels and cardiovascular morbidity and mortality in patients with chronic kidney disease has long been known.

Recent observational studies in individuals with normal renal function have also shown a correlation between serum phosphorus levels and increased risk of cardiovascular disease in the general population, and of all-cause mortality in subjects with a prior history of myocardial infarction. Owing to the intrinsic limitations of the non-interventional design of these cross sectional studies, it is not possible to make causal inferences for serum phosphate (and calcium) levels and the observed adverse effects.

In addition, some studies have been published showing inconsistent or contrasting findings. In this statement, as well as in the published literature, these have been reported in a narrative format. Ideally a meta-analysis of a systematic review of the available literature could help in interpreting these findings.

Phosphoric acid and phosphates (E 338–341; E 343) and polyphosphates (E 450–452) are food additives authorised, for several technological purposes, in a large number of foodstuffs. These additives were evaluated by the Scientific Committee for Food (SCF) in 1991, when the maximum tolerable daily intake (MTDI) of 70 mg/kg, previously proposed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and expressed as phosphorus, was endorsed.

As phosphoric acid and phosphates (E 338–341; E 343) and polyphosphates (E 450–452) as food additives were already permitted in the European Union before 20 January 2009, they are included in the programme for the re-evaluation of food additives set up under the Regulation (EU) No 257/2010 and EFSA has to complete the assessment of this group of food additives with high priority by 31 December 2018. In this context, all relevant and most up-to-date scientific evidence on their toxicity will be collated and evaluated. Given that some of the published studies have shown inconsistent or contrasting results regarding the possible health risks associated with serum phosphate levels, a meta-analysis of a systematic review of the available literature should be performed.

In order to allow completion of the re-evaluation of phosphoric acid, phosphates, di-, tri- and polyphosphates (E 338–341; E 343 and E 450–452) for use as food additives within the set deadline, data relevant for the estimation of the human exposure to the relevant food additives should be submitted by the interested parties to EFSA. To this end a dedicated call for data aimed at gathering information on usage levels will be launched, in addition to the previous call for scientific data on miscellaneous food additives published by EFSA in 2012.

Keywords
phosphates, polyphosphates, phosphorus, food additives, cardiovascular disease
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Number of Pages
27