Regulatory round-up: Oral supplement ruling, formula health risk and inaccurate vitamin A labelling

By Will Chu

- Last updated on GMT


Related tags Regulation Efsa ANSES CAFIA

November’s regulatory news round-up kicks off with France’s National Agency for Food Safety, Environment and Labor (ANSES) concluding a hypokalaemia case was likely due to the ‘misuse’ of an oral nutritional supplement.

The agency refers to the case​ in which a 10-year-old child was fed almost exclusively with a supplement intended for adults.

Since 2015, the child consumed four 200 millilitre (mL) bottles daily of a high energy supplement for adults, eating very little solid or liquid food, apart from the supplement.

“They are intended to be consumed in addition to and at a distance from usual meals,”​ says the notification. “They can, under certain conditions, be taken during a meal.”

“The Agency reminds everyone that these nutritional preparations intend to cover insufficient or incomplete daily energy and protein requirements. They cannot constitute an exclusive contribution.”

Having been admitted to hospital with a potassium level of 2.7 millimols per litre (mmol / L) (standard: 3.50-5.10 mmol/L) a complementary potassium intake is introduced raising the serum potassium level to at 3.6 mmol/L.  Supplementation with calcium and vitamins are also introduced.

“In general, the Agency advises consumers to report to a health professional any adverse effects arising from the consumption of an oral nutrition supplements or foodstuffs intended for special medical purposes (DADFMS).”

“The Agency reminds health professionals of the importance of reporting adverse reaction cases that they suspect to be related to their consumption and to declare them to the nutrivigilance system.”

Possible hydrocarbon health risk

Meanwhile The European Food Safety Agency (EFSA) provides their assessment​ of a possible public health risk due to infant formula contamination following detection of mineral oil aromatic hydrocarbons (MOAH).

The discovery, found in infant and follow‐on formula batches in France, Germany and the Netherlands, meant Member States (MS) had to analyse these batches and to investigate possible contamination sources.

EFSA were called upon to perform a rapid assessment on the health risks related to the presence of MOAH in infant and follow‐on formula.

Concern is heightened after findings from the Agency’s opinion of June 2012 identify mineral oil hydrocarbons as a potential health concern.

For the current assessment, EFSA says it received only limited occurrence data from two MS (Austria and Germany), in addition to the data published by foodwatch and data from Specialised Nutrition Europe.

EFSA also reports that quantified MOAH levels were in the range 0.2‐3 milligrams per kilogram (mg/kg).

However, due to the complex analytical methods, the Agency are uncertain on the reported levels used to estimate exposure to MOAH for infants and toddlers.

Higher levels were estimated for infants, ranging from 0.8 to 44.6 and from 1.7 to 78.8 micrograms per kilogram body weight (μg/kg bw) per day for average and 95th percentile of exposure, respectively.

“No information on the absence of genotoxic and carcinogenic 3‐7 ring polycyclic aromatic compounds (3‐7 PAC) in the samples analysed was made available to EFSA,”​ says the Agency.

“Therefore the estimated exposure for infants and toddlers is of possible concern for human health.

“This assessment relies on occurrence data made available up to 14 November 2019. Analysis of further samples by MS is ongoing and an update of the assessment will be considered upon availability of additional data.”

Incorrect labelling

Goldim Family in Diet slimming product
Czech firm Goldim and its recalled product 'Family In Diet.'©Goldim

Finally, Czech authorities move to ban a slimming preparation containing lower vitamin content than is claimed on the label.

The Czech Agriculture and Food Inspection Authority (CAFIA) orders​ Czech company GOLDIM to stop selling a non-compliant foodstuff offered as a food substitution for weight control.

The product, ‘Family In Diet' ​(vanilla flavour) is available in 750 ml containers, and marked as ‘lot L68’ with a best before date of ‘30/11/2019.

“The producer indicates on the label that vitamin A content was 1100 micrograms per 100g (μg/100g) of the foodstuff.

“However, laboratory analysis confirms the presence of vitamin A amounts to 50 μg/100g only. Information on the labelling misled consumers as regards the real content of vitamin A.

“The inspected person failed to comply with requirements laid down by European Regulation No. 1169/2011,” ​adds the Authority.

“For that reason CAFIA orders Goldim to stop selling the non-compliant lot in question and inform customers. CAFIA will initiate an administrative procedure on imposition of a fine with the inspected person.”

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