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INFORMATION SHEET
Number 11/01 February
2001
Food Standards Agency UK - SURVEY OF 3-MONOCHLOROPROPANE-1,2-DIOL
(3-MCPD) IN FOOD INGREDIENTS
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Introduction
Key Facts
Summary
Background
Sampling
Methodology
Results
Interpretation
Conclusions
References
Further Information
Annexes
Introduction
The results of two surveys commissioned by the FSA into
levels of 3-MCPD found in food and food ingredients were published on 1 February.
The majority of samples in both surveys did not contain quantifiable levels of
3-MCPD. Where 3-MPCD was detected it was not at levels that would give cause for
concern and there is no need for consumers to change their diet. Recent toxicological
studies are currently being evaluated and the FSA will inform consumers if the
advice changes.
3-MCPD is a chemical contaminant that can form during food
processing and scientific studies have shown that it can cause cancer in animals.
Until recently, EU and UK expert committees considered 3-MPCD
to be genotoxic and the Food Advisory Committee (FAC) had advised that levels
should be ‘undetectable.’ UK expert committees have concluded in recent studies
that 3-MCPD is not genotoxic and, as a result, the FAC have now advised that levels
be reduced to the lowest technologically possible in all foods.
For the food survey, 300 retail samples were analysed, including
cereal-based products, soups, meat and dairy products. Of these, 70 per cent did
not contain quantifiable levels. The highest levels found were low (0.13mg per
kg) – in cream crackers. The food groups identified as most likely to contain
3-MCPD include biscuits, bread and cooked/cured fish and meat.
Also analysed were 63 food ingredients, including caramels,
meat/yeast/malt extracts and breadcrumbs. There were no quantifiable levels of
3-MCPD in 78 per cent of these samples. The highest level measured was 0.49 mg/kg.
This is higher than the levels in the food survey, but generally these ingredients
constitute less than 2 per cent of the final food product. Even for ingredients
such as malt flour and breadcrumbs, which could constitute up to 10 per cent,
it is still not a cause for concern at the levels found in this survey.
To generate further information that will help reduce 3-MCPD
levels, the Agency is funding a comprehensive project on the origin and formation
of 3-MCPD. A further survey on soy sauces is also currently being carried out
and the results will be available in the next few months.
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- 3-monochloropropane-1,2-diol (3-MCPD) is one of a group
of chemical contaminants known as chloropropanols. It has been found to occur
at low levels in many foods and food ingredients as a result of processing or
storage conditions.
- 3-MCPD is a known carcinogen in animals, but recent studies
suggest that it is not genotoxic in-vivo. Further evaluation by expert
committees may permit a limit of exposure to be set.
- 63 samples of food ingredients available in the UK were
analysed in this survey.
- 78 per cent of the food ingredients analysed in this survey
did not contain quantifiable levels of 3-MCPD.
- At this stage, there is no need for consumers to change
their diets as a result of these findings. Action is being taken to generate more
information to further reduce exposure.
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A survey of 3-monochloropropane-1,2-diol (3-MCPD) in a range
of food ingredients available in the UK has been completed. The samples were analysed
by RHM Technology Ltd (RHM) using a validated method of analysis with a limit
of quantification of 0.01 mg/kg. The survey assessed the progress made by manufacturers
to reduce concentrations of 3-MCPD in food ingredients as requested by the Food
Advisory Committee (FAC).1
63 samples of food ingredients available in the UK were analysed in this survey;
including caramels, gelatines, enzyme hydrolysed vegetable proteins (HVPs), meat
extracts, yeast extracts, modified starches, malts, malt flours, malt extracts
and breadcrumbs. 3-MCPD was not quantified in 78 per cent (49/63) of the samples
analysed in this survey. The highest level was 0.49 mg/kg for a modified starch
(maize yellow dextrin), which is no longer produced in the UK.
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3-MCPD is one of a group of chemical contaminants known as
chloropropanols. 3-MCPD was originally identified as a contaminant of the savoury
ingredient acid-hydrolysed vegetable protein (acid-HVP),2 which is produced using hydrochloric acid. In acid-HVP,
components of fats and oils in the starting materials are chlorinated at high
temperature to form chloropropanols. 3-MCPD has since been found to occur at low
levels in several foods and food ingredients,3-5 though the origin and formation of 3-MCPD in these
is not yet fully understood. In addition to the research being sponsored by industry,
the Agency also intends to address this problem and has recently commissioned
a comprehensive research project that is to start shortly.
In 1994, following a review of the available data, the EC Scientific Committee
for Food (SCF) concluded that "3-MCPD should be regarded as a genotoxic carcinogen."6
In line with the SCF's opinion, the FAC recommended in 1996 that "within
18 months, the food industry should take all the steps necessary to ensure that
3-MCPD cannot be found in any food or ingredients, regardless of the method of
manufacture, when using a validated method of analysis capable of measuring down
to 10ppb, the lowest level of detection currently achievable."7 Industry has endeavoured to meet the Committee's advice
through individual and concerted effort and investment.
In 1999, following earlier surveys of 3-MCPD in the savoury food ingredient acid-HVP4
and in soy sauce and similar products,5 and supported
by information from the industry, the FAC recognised the difficulty of attaining
such low levels in food ingredients. They subsequently revised their advice and
recommended7 that industry continue to take all steps possible to
ensure that 3-MCPD is undetectable in foods and where technologically feasible
in food ingredients as well.
In October 2000, the Committee on Mutagenicity of Chemicals in Food, Consumer
Products and the Environment (COM) considered 3-MCPD in light of two new toxicological
studies, with the following outcome:
"The Committee concluded that both the rat bone-marrow micronucleus test
and the rat liver UDS test had been carried out to an acceptable standard and
were negative. Thus the additional information recommended by the COM as being
necessary to provide adequate reassurance that the mutagenic activity seen in-vitro
was not expressed in-vivo had now been provided.
The Committee agreed that the major urinary metabolite beta-chlorolactic acid
in rats was formed by oxidation of 3-MCPD and that the two new mutagenicity studies
supported the view that reactive metabolites if formed did not produce genotoxicity
in-vivo.
The Committee concluded that 3-MCPD can be regarded as having no significant genotoxic
potential in-vivo."8
The FAC's considered the COM's new opinion at its meeting in October 2000 and
issued the following advice:
"Previous advice from the Committee on Mutagenicity (COM) and the Committee
on Carcinogenicity (COC) concluded that 3-MPCD has shown mutagenic potential in-vitro
and carcinogenicity in the rat, but that it was not possible to draw firm conclusions
on the mechanism of carcinogenicity. New toxicological studies have been reviewed
by the COM who have revised their advice and stated that 3-MCPD can be regarded
as having no significant genotoxic potential in-vivo. Nevertheless it is
still a carcinogen in animals. The data on 3-MCPD is to be reviewed by the COC
and by international committees and it is anticipated that this will lead to the
establishment of a tolerable daily intake (TDI). Until these considerations have
been completed, the Committee advises industry that they should continue to take
all steps necessary to reduce concentrations of 3-MCPD in foods and food ingredients
to the lowest technologically achievable."9
Following the deliberations of the COM, the Committee on Carcinogenicity (COC)
re-considered its advice and issued a comprehensive statement in December 2000.
It concluded that:
"3-MCPD was unlikely to present a carcinogenic risk to man, provided the
exposure was 1000 times lower than the no observed effect level (NOEL) of 1.1
mg/kg body weight/day for tumourigenicity."10
The data, statements and conclusions of the COM and COC will be reviewed by the
SCF and by the Joint Food and Agriculture Organization of the United Nations/World
Health Organization Expert Committee on Food Additives (JECFA) in 2001. It is
anticipated that this will lead to a TDI being identified by the end of 2001.
The survey described here was conducted to assess the levels of 3-MCPD in food
ingredients. The Food Standards Agency has also conducted a survey of the levels
of 3-MCPD in foods; this is to be reported concurrently with these results.
The ingredients studied in this survey are used at a range of levels in a variety
of foods (Table 1). The levels quoted in Table
1 are only a guide since actual levels depend on the purpose for which the
ingredient is being used and the nature of the food product. Usage levels of malts
varies with the colour of the malt, with the darkest malts being used at much
lower levels than white malts. Table 2 shows the recommended
usage levels (i.e. typical dilution) for different types of malts in beers.
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The food ingredients studied included those where 3-MCPD had
been detected in the past and/or where acid or heat treatment was involved in
their processing. 63 samples of malts and malt products (malt flours, malt extracts
and a malted product), breadcrumbs (toasted and baked), enzyme HVPs, meat extracts,
yeast extracts, modified starches, caramels and gelatines were obtained from UK
food companies, ingredient suppliers and manufacturers between October 1999 and
March 2000.
In August 1999, companies were invited to provide details of the ingredients which
they were currently using, supplying or manufacturing and of which they could
provide samples of a batch from the previous twelve months. Where different companies
reported the use of the same brand of ingredient/supplier combination, no more
than one sample of that product was included. 55 samples were selected to cover
a wide range of ingredients. Samples provided were of 'pure' products, which contained
only the ingredient of interest rather than being present as a small percentage
such as in flavouring blends. The Brewers and Licensed Retailers Association (BLRA)
arranged for 8 samples of white and speciality dark malts to be provided for inclusion
in the survey.
Samples were stored in accordance with the manufacturer's specification. Samples
for any necessary future analysis were retained as required by the current guidelines
for planning and reporting surveys.11
Analyses were carried out using a validated and accredited
gas chromatographic method12 (GC-MS) for the determination
of 3-MCPD with a limit of quantification of 0.01 mg/kg. Samples found to have
quantifiable levels of 3-MCPD were reanalysed. Internal standards of deuterated
3-MCPD (d7-3-MCPD) and 2-MCPD (d7-2-MCPD)13,14
were added to a known amount of sample followed by saline solution and the mixture
blended to a homogenous consistency.
After sonication or centrifugation, depending on sample type, the sample was thoroughly
mixed with diatomaceous earth. This mixture was transferred to a glass chromatography
column and the non-polar components eluted using diethyl ether. The sample extract
was concentrated under rotary evaporation to a small volume. A portion of the
extract was then derivatised using n-heptafluorobutyrlimidazole. The derivatised
sample was analysed by gas chromatography/mass spectrometry with selected ion
monitoring.
Samples were analysed in batches comprising 10 samples, a sodium chloride solution
blank sample, an in-house reference sample and/or a spiked sample at 0.050 mg/kg.
The in-house reference materials used were coloured malts, breadcrumbs and soy
sauce. Calibration standards were run with each batch of samples. Details of this
quality assurance procedure are given in Annex 2.
The breadcrumb samples were processed in a blender and grain samples were milled
before analysis.
The uncertainty measurement of the reported results was estimated as described
in Annex 3.
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3-MCPD was not quantified in 49 of the 63 (78 per cent) food
ingredients samples using a method with a limit of quantification of 0.010 mg/kg
(Figure 1). The limit of quantification is the level
at which the analytical methodology has confidence in the result; it is always
greater than the limit of detection. For any analytical method each result reported
is the best estimate for that sample, it is always qualified by the measurement
uncertainty, e.g. x mg/kg plus or minus y mg/kg.
3-MCPD was not found any of the samples of yeast extracts, caramels or gelatines.
3-MCPD was quantified in 1 of the 6 samples of breadcrumbs, 1 of the 3 samples
of enzyme HVPs, 1 of the 5 samples of meat extracts and 2 of the 7 samples of
modified starches (Table 3). 3-MCPD was quantified in
9 of the 24 samples of malts and malt-based ingredients (Table 4).
The highest level of 3-MCPD found in this survey was 0.49 mg/kg for a modified
starch (maize yellow dextrin).
All results are reported for the samples as they were received, i.e. with the
same moisture content. All the results above 0.01 mg/kg were confirmed by a duplicate
analysis. The reported levels are the average of the duplicate analyses.
The FAC considered the results of this work in light of the latest toxicological
advice and made the following statement:
"The Committee commends the research and action which industry has already
undertaken and encourages the continuation of this work with the aim of reducing
concentrations of 3-MCPD to the lowest technologically achievable in all foods.
The situation should be reviewed once the SCF and JECFA have considered whether
it is possible to set a Tolerable Daily Intake for this contamination."
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The origin and formation of 3-MCPD is not yet fully understood.
The Agency has recently commissioned a research project to address this problem.
The results from this survey will help to identify foods and processes that will
need to be considered as part of this work.
The highest level found was in a modified starch, which was withdrawn from sale
to the food industry in 1999, as the method used to manufacture this starch could
not be adapted to reduce the level of 3-MCPD in the final product. The British
Starch Industry Association has confirmed that this method is no longer used to
manufacture this or any other food ingredient.
High levels of 3-MCPD were also found in the speciality dark malts, malt flours
and malt extracts (Table 2). Although the brewing industry
has conducted research into the formation of 3-MCPD, the process by which 3-MCPD
is formed during the application of heat to the grain is still not yet fully understood.
Many of the ingredients analysed in this survey are used in small amounts in foods
(up to 2 per cent of food). Even at the highest level of 3-MCPD quantified in
samples of ingredients in this survey the contribution of any such individual
ingredient to levels of 3-MCPD in the final foodstuff would not be significant.
However some ingredients, such as malt flours constitute larger proportions of
the final food (up to 10 per cent). Levels of 3-MCPD in such ingredients may thus
make a significant contribution to the level of 3-MCPD in the final foodstuff.
The results confirm that 3-MCPD is present in a range of food
ingredients. 3-MCPD was not detected in the yeast extracts, caramels or gelatines.
The mechanism of 3-MCPD formation is not fully understood. The Agency has commissioned
a comprehensive research project, due to start in April 2001, which will address
this and other issues. The results of this survey, together with the results of
the survey of 3-MCPD in selected food groups, will help to inform this work. The
Food Standards Agency and industry continue to work towards a reduction in levels
of 3-MCPD in food.
Summary of Units
Milligram (mg): one thousandth of a gram
Kilogram (kg): one thousand grams
Milligrams per kilogram (mg/kg)
ppb: parts per billion
m/z: mass/charge
1. Food Advisory Committee.
Recent developments on 3-monochloropropane-1,2-diol (3-MCPD) in food and food
ingredients, Press Release 5/99, 1999.
2. Velisek, J. D., Davidek, J., Kubelka,
V., Janicek, G., Svobodova, Z and Simicova, Z. New Chlorine Containing Organic
Compounds in Protein Hydrolysates. Journal of Agricultural and Food Chemistry
1980, 28, 1142-44.
3. Collier, P. D., Cromie, D. D. O. and Davies,
A. P. Mechanism of formation of chloropropanols present in protein hydrolysates.
Journal of the American Oil Chemists Society, 1991, 68, 785-790.
4. Survey of 3-monochloropropane-1,2-diol
(3-MCPD) in acid-hydrolysed vegetable protein. Food
Surveillance Information Sheet no. 181, 1999.
5. Survey of 3-monochloropropane-1,2-diol
(3-MCPD) in soy sauce and similar products. Food
Surveillance Information Sheet no. 187, 1999.
6. European Commission Opinion on 3-monochloropropanediol
(3-MCPD), expressed on 16 December 1994. Reports of the Scientific Committee for
Food. Food Science and Techniques, Thirty-sixth Series, 1995, 31-33.
7. Food Advisory Committee, Update on chloropropanols
present in protein hydrolysates, Press Release 13/96, 1996.
8. http://www.doh.gov.uk/mcpd2.htm
9. http://www.foodstandards.gov.gsi.uk/committee/
fac/Summary.htm
10. http://www.doh.gov.uk/mcpd1.htm
11. http://www.foodstandards.gov.uk/maff/archive/food
/foodsaft.htm
12. Determination of 3-monochloropropane-1,2-diol
in food and food ingredients using mass spectrometric detection: Collaborative
trial. CSL Report FD 97/95.
13. Hamlet, C. G. and Sutton P. G. Determination
of the Chloropropanols 3-MCPD and 2-MCPD in hydrolysed vegetable proteins and
seasonings by gas chromatography/ion trap tandem spectrometry. Rapid Communications
in Mass Spectrometry, 1997, 11, 1417-1424.
14. Hamlet, C. G. Analytical methods for
the determination of 3-MCPD and 2-MCPD in hydrolysed vegetable protein, seasonings
and food products u sing gas chromatography/ion trap tandem mass spectrometry.
Food Additives and Contaminants, 1998, 15, 451-465
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Mrs Sue Johns
Food Standards Agency
Contaminants Division
PO Box 31037
Room 210, Ergon House
17 Smith Square
London SW1P 3WG
Tel: +44 (0) 20 7238 6772
Fax: +44 (0) 20 7238 5331
E-mail: sue.johns@foodstandards.gsi.gov.uk
A full report of this survey is held in the Library at
Nobel House, 17 Smith Square, London, SW1P 3JR; Tel: +44 (0) 20 7238 6575. If
you would like to consult a copy, please contact the Library giving at least 24
hours notice or, alternatively, copies can be obtained from the Library; a charge
will be made to cover photocopying and postage.
Further copies of this Information Sheet can be obtained from:
Food Standards Agency
Information Centre
PO Box 31037
Room 303b, Ergon House
17 Smith Square
London SW1P 3WG
Tel: + 44 (0) 20 7238 6223
Fax: + 44 (0) 20 7238 6330
Email: information.centre@foodstandards.gsi.gov.uk
Copies of the statements from the Committee on Mutagenicity of Chemicals in Food,
Consumer Products and the Environment and the Committee on Carcinogenicity of
Chemicals in Food, Consumer Products and the Environment the can be obtained from:
Khandu Mistry
Room 692D Skipton House
80 London Road
London SE1 6LH
Tel: +44 (0) 20 7972 5020
Fax: +44 (0) 20 7972 5156
Email: Khandu.Mistry@doh.gsi.gov.uk
Further information on the work of the Food Advisory Committee (FAC) can be obtained
from:
Mr John Caseley
FAC Secretariat
PO Box 31037
Room 224, Ergon House
17 Smith Square
London SW1P 3WG
Tel: + 44 (0) 20 7238 6267
Fax: + 44 (0) 20 7238 6263
Email: john.caseley@foodstandards.gsi.gov.uk
These pages were last updated on 31 January 2001.
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