Evaluation of 3-MCPD esters – EFSA's position

Evaluation of 3-MCPD esters
EFSA’s position
Dr Claudia Heppner
Head of the Unit on Contaminants in the Food Chain
3-MCPD esters in Food Products
ILSI Europe Workshop in association with the European Commission (EC)
Brussels, 5-65
6 February 2009
1

3-Monochloro-propane-1,2-diol
(3-MCPD)
3-MCPD
• Is not a new contaminant but known since decades.
• Belongs together with 1,3-dichloro-2-propanol to a
group of chemical contaminants known as
chloropropanols.
• Is formed when chloride ions react with lipid
compounds in foods subject to high temperatures
during food processing, cooking and storage.
• Highest levels have been found in chemically
hydrolysed vegetable proteins and initially it was
thought it mainly occurs in spicy sauces e.g. soy
sauce.
• Later confirmed to occur also in other foods e.g. bread
and toast, and smoked products.
2

EU exposure – 3-MCPD
• Within a SCOOP-task data on the levels of 3-MCPD and
related substances in foodstuffs were available in 2004.
• The main contributors of 3-MCPD to dietary intake were
soy sauce and soy-sauce based products, and bread
and noodles. The latter two due to high consumption
rather then high levels of 3-MCPD present in these
foods.
3

TDI – 3-MCPD
• The Scientific Committee on Food established a tolerable
daily intake (TDI) of 2 µg/kg body weight (b.w.) in 2001
based on a carcinogenicity study in rats with a LOAEL of 1.1
mg /kg b.w. for kidney hyperplasia and by applying an
uncertainty factor of 500.
• The Joint FAO/WHO Expert Committee on Food Additives
(JECFA) established a provisional maximum tolerable daily
intake (PMTDI) of 2 µg/kg b.w. in 2001.
• In 2006 the JECFA noted that no new pivotal studies had
become available, and retained the PMTDI for 3-MCPD.
The JECAF noted that 3-MCPD esters had been reported in
foods, but there were insufficient data to evaluate their
intake or toxicological significance.
4

EU legislation
Regulatory limits 3-MCPD3
Maximum level = 20 µg/kg
(hydrolysed vegetable protein and soy sauce)
(Commission Regulation No 1881/2006)
5

Request to EFSA in 2008
EUROPEAN
COMMISSION
REQUEST for a STATEMENT
Meeting of the Codex
Committee on Contaminants
in Food, April’08.
Discussions at the Codex
Alimentarius to propose for 3-
MCPD higher maximum levels
of 0.4 mg/kg for liquid
condiments
Findings in Germany on high
levels of 3-MCPD esters in
edible refined plant oils and
fats, such as margarine, and
infant formula in Dec 2007
Scientific Panel on Contaminants
in the Food chain (CONTAM)
Preparing EC position on 3-MCPD in liquid
condiments containing acid-HVP.

Request to EFSA in 2008
• EFSA was asked to take into account the
recently issued opinion from the German
Bundesinstitut für Risikobewertung (BfR) on 3-
MCPD esters and recently published scientific
literature.
7

CONTAM statement 3-MCPD 3
esters
Question No EFSA-Q-2008-258
Adopted on 28 th March, 2008
• The CONTAM Panel noted that since there are no
toxicological data on 3-MCPD esters, the German BfR
based its recent risk assessment on toxicological data on
3-MCPD, under the assumption that 100% of 3-MCPD is
released from its esters.
• The CONTAM Panel agreed with this assumption.
• CONTAM Panel would welcome kinetic studies with 3-
MCPD esters to gain further information on the timecourse
and site of the release of 3-MCPD from its esters
in vivo.
8

Risk assessment needs
• Occurrence data on 3-MCPD esters (such as mono and
diesters) in food items, particularly infant formula in
different EU Member States.
• Validation of findings on 3-MCPD esters in animal
products (e.g. goat milk) and human milk.
• Toxicity studies for 3-MCPD ester.
• Data from kinetic studies with 3-MCPD esters in order to
re-assess the risk characterisation.
9

Statement of the Scientific Panel on Contaminants in the Food chain on a request
from the European Commission related to 3-MCPD ester.
http://www.efsa.europa.eu/cs/BlobServer/Statement/contam_statement_3-
MCPD_en.pdf?ssbinary=true
SCIENTIFIC PANEL MEMBERS
Jan Alexander, Guðjón Atli Auðunsson, Diane Benford, Andrew Cockburn, Jean-
Pierre Cravedi, Eugenia Dogliotti, Alessandro di Domenico, Maria Luisa Fernández- Cruz,
Johanna Fink-Gremmels, Peter Fürst, Corrado Galli, Philippe Greandjean, Jadwiga Gzyl,
Gerhard Heinemeyer, Niklas Johansson, Antonio Mutti, Josef Schlatter, Rolaf van Leeuwen,
Carlos van Peteghem, Philippe Verger.
10

Thanks for your attention!
☺
11