3-MCPD in Infant Formula Linked to Cancer: European Union First to Respond

3-MCPD (3-monochloropropane-1,2-diol or 3-chloropropane-1,2-diol) is an organic chemical compound which is carcinogenic and highly suspected to be genotoxic in humans, has male anti-fertility effects, and is a chemical byproduct which may be formed in foods. In genetics, genotoxicity describes the property of chemical agents that damages the genetic information within a cell causing mutations, which may lead to cancer. It is primarily created in foods by protein hydrolysis, the breakdown process of protein into smaller peptides and free amino acids. Chloride can react with the glycerol to produce 3-MCPD. Protein hydrolysis can be used to modify the allergenic properties of infant formula. The size of cow milk proteins in the formula and the milk becomes more suitable for consumption by babies.

The presence of 3-MCPD in foods was detected more than 35 years ago. Since 1998, many regulatory agencies recommended that 3-MCPD not exceed 0.01 to 1 ppm in acid hydrolyzed protein products.

“We have set a tolerable daily intake (TDI) of 0.8 micrograms per kilogram of body weight per day (µg/kg bw/day) for 3-MCPD and its fatty acid esters based on evidence linking this substance to organ damage in animal tests,” explained Dr Knutsen of the European Food Safety Authority.

In 2001, the United Kingdom Food Standards Agency (FSA) found in tests of various sauces that 22% of samples contained 3-MCPD at levels considerably higher than those deemed safe by the European Union. About two-thirds of these samples also contained a second chloropropanol which experts advise should not be present at any levels in food. Both chemicals have the potential to cause cancer and the Agency recommended that the affected products be withdrawn from shelves and avoided.

In November of 2008, Britain's Food Standards Agency reported a wide range of household name food products from sliced bread to crackers, beef burgers and cheese with 3-MCPD above safe limits. Relatively high levels of the chemical were found in majority of brands. The highest levels of 3-MCPD found in a non-soy sauce product was crackers. The highest level of 3-MCPD was found in soy sauce was 700 times higher.

In 2008, the FDA issued a guidance level for 3-MCPD in acid-hydrolyzed protein. The agency noted that 3-MCPD, one member of chloropropanol classification of compounds, is a substance produced during acid hydrolysis and heat treatment of proteins. In its guidance document, the agency established an upper limit of 1 ppm of 3-MCPD in ingredients, such as hydrolyzed vegetable protein. These limits were based on several two-year animal studies with 3-MCPD at high doses rats presented renal carcinomas. However as recent as 2013, according to the agency, there was insufficient data to assess the potential toxicity of 3-MCPD among humans.

In March of 2016, the European Food Standards Authority (EFSA) issued a report warning about the health consequences of co-contaminants created during the processing and refining of edible oils. EFSA specifically identified 3-MCPD (3-monochloropropane1,2 diol), which is classified as a possible human carcinogen. The EFSA report sheds new light on levels for contaminants known to be present in all refined vegetable oils, the same oils used in infant formulas.

Dr Helle Knutsen, Chair of the CONTAM Panel, said: “There is sufficient evidence that glycidol is genotoxic and carcinogenic... The exposure to babies consuming solely infant formula is a particular concern as this is up to ten times what would be considered of low concern for public health.”

But for 1,3-DCP, a byproduct of 3-MCPD, there is no standard to meet as it is unregulated. According to research, it could cause cancer and mutations.

Edible oil producers know that their success depends on consumers’ trust that the oils they buy are healthy and safe. Awareness of this issue is imperative while the EFSA report may prompt alternative production of safe and high-quality foods. European brands of infant formula have already changed their production methods many years ago to reduce or eliminate entirely 3-MCPD according to European standards, otherwise they would not be certified.

  • We understand the problem, but relevant toxicity or toxicokinetic data among humans do not exist. There is not any direct evidence that current 3-MCPD levels in foods and at their typical consumption amounts, trigger adverse health effects. Thus, advisement is based on limited animal studies (among rats, not mice) and projected exposure among humans of various population or age groups.

  • There is a need to carefully evaluate each step and identify the conditions under which the contaminants, such as 3-MCPD are generated. There are some data, for example, that indicate the timing of the harvest and pressing, as well as processing temperature, significantly can affect the generation and subsequent levels of these contaminants.

  • Several investigators have noted toxicological data gaps and call for further research. Thus, there is a need for additional research that assesses potential causes and effects of 3-MCPD on human health when consumed as typical levels over a lifespan.

  • This is an expensive, industry-wide concern. Retrofitting to change the refining process would be extremely expensive.

  • We need to balance concerns with health potential. Some companies continue to use the protein hydrolyzation method but modify methods to lower contaminants to meet standards. The best quality oils are processed using molecular distillation processes. This process has the advantages of avoiding the problem of toxicity that occurs in techniques that use solvents as the separating agent, and also of minimizing losses due to thermal decomposition. The levels of 3-MCPD are almost non-existent in such products. European manufacturers have embraced such changes to meet standards.

  • The implications may extend beyond oil processing. There is some evidence that repeated heating of oils, such as in a quick-service environment, may accelerate or enhance the amount of co-contaminants in these food components. The end-users would need to be educated on safer use guidelines, including monitoring and changing their oil based on the potential adverse threshold levels of these compounds.

This issue is as much about what we do not know, as it is about what we do know. As research continues to elucidate the composition of 3-MCPD and its potential health effects, there may one day be a 3-MCPD alarm. Thus, it is important to be pragmatic in our approach to this issue.

While this report has received limited media attention, the food industry should be aware of the issue and be pragmatic in its reaction.

The science of food and related areas of research continue to improve our understanding of food ingredients and their impact on health. Food processing and regulatory guidelines are constantly evolving. Just as the change from thermal to non-thermal processing has created significant opportunities for many food types, I suspect that similar processing advances will materialize relative to edible oils. We may be on the cusp of the next generation of edible oil processing.

http://www.ctahr.hawaii.edu/oc/freepubs/pdf/FST-1.pdf <- Important
http://www.foodnavigator.com/Policy/EFSA-highlights-high-levels-of-suspected-carcinogen-in-baby-formula <- Important
http://www.foodingredientsfirst.com/news/Stepan-Technology-Addresses-Suspected-Carcinogens-in-Infant-Formula?type=article <- Important