Date: May 2018
The European Food Safety Agency (EFSA) has published its risk analysis for 2-MCPD and 3-MCPD fatty acid esters, glycidyl fatty acid esters and free 3- and 2-MCPD in foodstuffs (EFSA Journal 2016; 14(5):4426).
In creating their risk analysis, the EFSA drew on 7,175 pieces of content data from the year 2009. This came from EU member states, the Joint Research Centre – Institute for Reference Materials and Measurements (JRC-IRMM), the German Federal Institute for Risk Analysis (BfR) and three commercial associations.
The results of animal studies were used to establish the health risks posed by 2-MCPD, 3-MCPD, their esters and glycidyl fatty acid esters. The EFSA assumes that in the human organism, the three esters are completely split into the free compounds, and that the toxicological observations only relate to these free compounds. In doing so, the EFSA confirmed 3-MCPD’s toxicity to the kidneys and testicles. On the basis of the results of a study from 2008, the EFSA has recalculated and reduced the tolerable daily intake (TDI) of 3-MCPD from 2 µg/kg of body weight to 0.8 µg/kg body weight. Furthermore, this new TDI is a group TDI, which applies to the total of 3-MCPD and its esters (calculated as free 3-MCPD).
No risk analysis could be carried out for 2-MCPD and its esters due to the inadequate toxicological data. Accordingly, no toxicological thresholds were also determined. The EFSA assumes that, due to the structural differences, the effect mechanism of 2-MCPD is different to that of 3-MCPD. In animal studies, 2-MCPD did not display toxicity to kidneys.
With regard to the glycidyl fatty acid ester, the EFSA confirmed that the free compound glycidol is a genotoxic carcinogen. For such compounds, the EFSA currently uses the ‘margin of exposure (MoE)’ concept for characterising the risk. In the case of glycidol, the EFSA assumes that an MoE of 25,000 and above does not present a health risk. On this basis, looking at all age groups, it has been established that ‘younger normal eaters’ and ‘heavy eaters’ in all age groups ingest potentially worrying amounts of glycidyl fatty acid esters.
The EFSA recommends carrying out further scientific studies to close the gaps in existing knowledge.
The JECFA (Joint FAO/WHO Expert Committee on Food Additives) also evaluated 3-MCPD fatty acid esters and glycidyl fatty acid esters in Rome for the first time during their meeting from November 8-17, 2016. As a result, they determined a new TDI for 3-MCPD, as did the EFSA in its scientific opinion issued in May, 2016. Like the EFSA, the JECFA determined a group TDI (here: PMTDI) for the sum total of free 3-MCPD and its esters, expressed as free 3-MCPD. In contrast to EFSA, which had reduced the previous TDI from 2.0 μg/kg of body weight to 0.8 μg/kg of body weight, the JECFA raised the TDI from 2.0 to 4.0 μg/kg of body weight.
Due to the differing results of the risk assessment authorities, the European Commission has asked the EFSA to review the TDI of 0.8 μg/kg of body weight which it had derived. The EFSA has accepted this mandate and agreed to the TDI review. The results of the review are currently expected in June, 2017.
There are maximum amounts of permitted 3-MCPD in foodstuffs and additives. The Contaminants Directive EC 1881/2006 sets out a threshold of 20 µg/kg for hydrolysed soya protein and soya sauce.
For glycerine as an additive, the maximum amount of free 3-MCPD has been set at 0.1 mg/kg (Directive EC 231/2012).
There are no legal regulations for 3-MCPD esters, 2-MCPD and glycidol and their esters. The ALARA principle (‘As low as reasonably achievable’) applies.