On August 17，a test result of 15 infant formulas was released by Hong Kong Consumer Council. The result showed that all the products contained 3-chloro-1,2 propanediol (3-monochloropropane diol, 3-MCPD) which can damage the kidneys.

1 What is 3-MCPD?

3-MCPD is a common pollutant which was originally identified as a contaminant of acid-hydrolysed vegetable proteins and soy sauce and later found in other foods. 3-MCPD and its esters formed from glycerol or acyl glycerides with chloride ions present in food or food contact materials in the heat treatment process.

No genotoxic potential has been demonstrated in vivo for 3-MCPD，but it can damage the human reproductive system and kidney function by long-term excessive intake.

2 Current management status of 3-MCPD in various countries

China, the European Union, South Korea, etc. have established limit requirements for 3-MCPD in soy sauce and hydrolyzed vegetable protein, however, no countries or regions have set a limit on 3-MCPD in infant formula. In this article, some risk assessment data on 3-MCPD are summarized as follows:

Joint FAO/WHO Expert Committee on Food Additives (JECFA)

3-MCPD was first evaluated by the Committee at the 41st meeting of JECFA. The Committee concluded that it is an undesirable contaminant in food and expressed the opinion that its concentration in acid-hydrolysed vegetable proteins should be reduced as far as technically achievable.

It was re-evaluated by the Committee at its 57th meeting. The Committee concluded that 3-MCPD is nephrotoxic and provisional maximum tolerable daily intake (PMTDI) is 2μg/kg bw.

It was proposed at the 67th meeting in 2006 that JECFA still retains the previously determined PMTDI, given that there is no new pivotal toxicological studies.

The most recent evaluation of 3-MCPD was at the 83rd meeting in 2016. The result based on two long-term carcinogenicity studies with 3-MCPD in rats were showed that 3-MCPD has not been found to be genetically toxic, but long-term consumption may be cause fertility toxic and kidney damage. The previous PMTDI of 2 µg/kg bw for 3-MCPD was withdrawn because the study found that estimated dietary exposures to 3-MCPD for the general population, even for high consumers (up to 3.8 µg/kg bw per day), did not exceed 4 μg/kg bw. Estimates of mean dietary exposure to 3-MCPD for formula-fed infants, however, could exceed the PMTDI by up to 2.5-fold for certain countries. In the end, the meeting determined that the PMTDI of 3-MCPD was 4 μg/kg bw. PMTDI of 4 µg/kg bw for 3-MCPD and 3-MCPD esters singly or in combination was determined in this meeting.

European Food Safety Authority (EFSA)

EFSA’s expert panel on contaminants first assessed the potential risks of 3-MCPD in 2016 and set the TDI as 0.8 μg/kg bw.

EFSA reviewed its assessment after JECFA subsequently established a different safe level – tolerable daily intake or TDI. Finally, it was determined that the tolerable daily intake (TDI) of 3-MCPD was 2.0 μg/kg bw. The pollutant research group pointed out that consumption levels of 3-MCPD in food are considered safe for most consumers but there is a potential health concern among high consumers in younger age groups. In the worst case scenario, infants receiving formula only may slightly exceed the safe level.

Australia and New Zealand

In March 2020, the Food Standards Australia New Zealand (FSANZ) issued a preliminary risk assessment of 3-monochloropropanediol (3-MCPD) from infant formula. A sampling survey found that the estimated dietary exposures to 3-MCPD esters for 3 month old infants ranged between 0.93 and 3.39 μg/kg bw/day, below the PMTDI determined by JECFA, indicating that there are no public health concerns at current exposure levels.

Germany

Germany has developed a guidebook to reduce 3-MCPD and glycidyl esters in food that called ‘Toolbox for the Mitigation of 3-MCPD Esters and Glycidyl Esters in Food’, to help and ensure consumer health.

Japan

3-MCPD is banned for use in printing inks in Japan

3 Summary

Although 3-MCPD was detected in the infant formulas’ samples taken by Hong Kong Consumer Council, the daily intake of all samples did not exceed the 4 μg/kg bw set by JECFA through feeding the infant according to the recommended intake. In addition, China, the Hong Kong Special Administrative Region of China, the European Union, the Food Standards Australia New Zealand and other countries or organizations have not set the limit of 3-MCPD in their regulations. Therefore, the infant formula tested by Hong Kong Consumer Council does not mean that the product is unqualified. It’s more like a signal to consumers that ‘the more expensive the price does not mean the better’.

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