EFSA increases safe levels for contaminant 3-MCPD

A contaminant found in refined vegetable oils and fats, 3-MCPD esters form from chlorinated substances during the refining process.

In 2016, an EFSA opinion warned that ) ​3-monochloropropanediol (3-MCPD) could pose risks to kidneys and male reproductive system. It also warned that glycidyl fatty acid esters (GE) are genotoxic and carcinogenic but could not conclude on possible risks of 2-MCPD because of insufficient data.

It also warned that babies are exposed to almost ten times the acceptable level​​ of GE due to the use of fats, particularly palm oil, in infant formula.

However, this update, published yesterday in the EFSA online journal​​, is for 3-MCPD and its esters only. It was made using the same evidence as the previous opinion but using an updated scientific method.

EFSA reiterated that its previous assessment on GE has not changed.

It has increased the 2016 TDI for 3-MCPD from 0.8 µg per kilo body weight to 2.0. This is two and a half times greater than the previous amount but still half the 4.0 µg/kilo/body limit set by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

EFSA's new TDI of 2 μg is “considered protective​” for renal health and male fertility, it said, and adults will not exceed the level.

However, it added: “A slight exceedance of the TDI was observed in the high consumers of the younger age groups and in particular for the scenarios on infants receiving formula only.”​

This updated review found evidence for reduced sperm motility and reduced male fecundity in rats that were exposed to more than 1 mg of 3-MCPD per kilo body weight per day over a short period of time.

When the scientists looked at higher doses given over a longer period of time, they found lower sperm counts and histopathological (tissue) changes in the testis and epididymis. Links have also been found between 3-MCPD intake and kidney tubular hyperplasia.

Professor Christer Hogstrand, who chaired the scientific group that developed both the 2016 opinion and the update, said: “EFSA decided to review its assessment after the UN’s JECFA subsequently established a different safe level (TDI). ​In the meantime EFSA updated the method we used to calculate our previous TDI – what’s called the benchmark dose (BMD) approach.​

“We checked again the data concerning effects on development and reproduction, particularly on male fertility as these were highlighted by JECFA. ​We calculated the levels at which possible adverse effects on the kidney and on male fertility could occur. The updated TDI is protective for both types of effects​.”

Why do EFSA and JECFA have different levels?

A statement issued by the Authority explained that while EFSA and JECFA based their evaluations on the same toxicological data, they used different benchmark dose modelling techniques.

“Despite these technical differences, both bodies came to the same overall conclusions on the possible adverse effects of 3-MCPD and the level of concern for public health,”​ the EFSA statement read.

FEDIOL: Mitigation is complex

The president of FEDIOL, the trade group that represents the interests of EU vegetable oil and proteinmeal suppliers and manufacturers, Henri Rieux said the opinion was important for the ongoing risk management discussions.

“Mitigation of 3-MCPD esters is particularly complex​,” Rieux said. ”It requires an ​integrated approach including preventive measures in the country of origin and processing ​changes, whilst at the same time maintaining other safety and quality parameters and ​meeting customer and consumer demands.”​

Recommendations

The EFSA opinion called for: 

• In-vitro​ studies to compare the effects on human and rat sperm.

• Human pharmacokinetics studies in particular multiple doses across a substantial time frame.

• Epidemiological studies to gather human data.

• More data on the effects of long-term exposure on fertility and on developmental, neurodevelopmental and juvenile toxicity.