BfRshort forGerman Federal Institute for Risk Assessment FAQ, 7 July 2016
3-monochloropropanediol (3-MCPD), 2-monochloropropanediol (2-MCPD) and their fatty acid esters as well as glycidyl fatty acid esters are process contaminants in foods that have the potential to be harmful to health and are therefore undesirable in foods.
Since 3-MCPD fatty acid esters were detected in refined vegetable fats for the first time in 2007, the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) has assessed the health risks of these process contaminants in foods multiple times, most recently in 2012. The European Food Safety Authority (EFSAshort forEuropean Food Safety Authority) has now assessed possible risks to human health of 2-MCPD, 3-MCPD and their fatty acid esters, as well as of glycidyl fatty acid esters, in foods. During this process, EFSAshort forEuropean Food Safety Authority documented analytical data on the occurrence of these process contaminants in foods from a total of 23 EU member states (collected between 2009 and 2015) and performed an exposureExposureTo glossary assessment for different groups of the population. In its expert report, EFSAshort forEuropean Food Safety Authority identified potential health risks from fatty esters of 3-MCPD, 2-MCPD and glycidol in foods in particular for younger age groups of the population.
Frequently asked questions regarding the contamination of foods with 3-MCPD, 2-MCPD and glycidyl fatty acid esters
3-monochloropropanediol (3-MCPD) und 2-monochloropropanediol (2-MCPD) belong to the chemical group of chloropropanols. What is characteristic for this group of substances is that they possess the basic structure of glycerol in which a hydroxyl group is replaced by a chlorine atom. In 3-MCPD, the chlorine atom is in position 3, in 2-MCPD in position 2. The fatty acid esters consist of the chloropropanol esterified with one or two fatty acid esters (monoesters and diesters).
Glycidol has the same basic glycerol structure as the chloropropanols but possesses an epoxide structure. Accordingly glycidyl fatty acid esters are compounds consisting of glycidol esterified with a fatty acid.
The effects of 2-MCPD and its fatty acid esters on the organism have not yet been investigated, and as a result no toxicological studies are currently available that are suitable for the derivation of a health based reference value within the context of risk assessment. What are above all necessary, therefore, are long-term studies and studies on possible mechanisms of the toxicity of 2-MCPD and its fatty acid esters.
The situation is different in the case of 3-MCPD and its fatty acid esters. A study on bioavailability in rats showed that 3-MCPD fatty acid esters are almost completely hydrolysed during digestion in the intestine with the release of 3-MCPD. In long-term toxicological studies, administration of 3-MCPD to laboratory animals led to an increase in the cell count (hyperplasia) in the renal tubules as the most sensitive endpoint. Higher doses triggered benign tumours in the treated animals. No genotoxic effect was observed. It can therefore be assumed that the tumours observed in the animal study only occur above a certain threshold value.
The compounds have been detected in refined edible oils and edible fats as well as in foods manufactured from these oils and fats, such as margarine, bakery and pastry products, deep-fried products and various snack products as well as infant formula and follow-up formula.
The most recent collection of concentration data in foods can be found in the 2016 report of EFSAshort forEuropean Food Safety Authority. This report documents a total of 7,175 analycal data sets on the occurrence of these process contaminants in foods from a total of 23 EU member states (collected between 2009 and 2015). In order to improve the data basis for exposure estimates for Germany, the BfRshort forGerman Federal Institute for Risk Assessment has initiated a project for the measurement of concentrations of fatty acid esters of 3-MCPD, 2-MCPD and glycidol in foods.
The composition of infant formula is tailored to the specific needs of children in the first months of life. These formula products are made using individual components in line with the latest scientific knowledge on nutrient requirements. Refined vegetable fats have long been used to provide the fat content for these products. The fact that 3-monochloropropanediol (3-MCPD), 2-monochloropropanediol (2-MCPD) and glycidyl fatty acid esters have been detected in these fats means that these substances are also present in infant formula.
The higher exposure of formula-fed infants to fatty acid esters of 3-MCPD, 2-MCPD and glycidol only became known a few years ago, but has probably existed for decades. To date, there are no indications that children fed with industrially produced baby milk might have suffered damage to their health due to the intake of the aforementioned fatty acid esters. In the opinion of the BfRshort forGerman Federal Institute for Risk Assessment, therefore, the probability that the current exposure levels of formula-fed infants will result in health impairments is low, particularly as the activities of authorities and industry are currently showing the first signs of success in the endeavour to reduce the concentrations of these fatty acid esters.
When infants are not breastfed, there is basically no alternative to industrially produced infant formula. It is the only way to ensure optimum nutrition if mothers do not breastfeed. The BfRshort forGerman Federal Institute for Risk Assessment therefore emphatically advises parents to continue to feed their babies with the products made specifically for this purpose where necessary, as these products contain the right mix of nutrients that are essential for babies.
This text version is a translation of the original German text which is the only legally binding version.