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Fatty Acid Esters of 3-MCPD in
Food


7 Nov 2012




             1
3-Monochloropropane-1,2-diol (3-
        MCPD)
           3-MCPD
               is a type of process contaminant

                    produced naturally in foods during food
                     manufacturing, cooking, and other processing
                     activities such as deep frying and roasting

                    It occurs in foods in its free form as well as in the
                     bound form (fatty acid esters)

                    Much of the 3-MCPD found in foods is present
                     as 3-MCPD fatty acid esters (3-MCPD esters)
                     and 3-MCPD esters are found in a wide range
                     of food
3-MCPD fatty acid esters is a source of previously not recognized 3-MCPD

                                        2
3-Monochloropropane-1,2-diol (3-
         MCPD)

            Two joint projects with Consumer Council
                3-MCPD in Soy Sauce Products; conducted in
                 2002/03
                3-MCPD in Condiments and Sauces; conducted
free
                 in 2003/04
3-MCPD
            A RA study conducted in 2007
                 “Dietary Exposure to Chloropropanols of
                 Secondary School Students”

             Determine the level of the bound 3-MCPD
             (3-MCPD fatty acid esters) instead in this study


                                      3
Occurrence of 3-MCPD esters
   The exact mechanism on the formation of 3-MCPD
    fatty acid esters is still unknown

   There is currently lack of data about 3-MCPD fatty
    acid esters in foodstuffs at international scene

   Formed when fat- and salt-containing foods are
    processed at high temperatures during
    production

   High concentrations found in refined vegetable
    oils and fats, and in milk powder for infants in
    some overseas studies



                          4
Occurrence of 3-MCPD esters
          ILSI Europe Workshop in 2009


               " Although there is a lack of data about 3-
                MCPD esters for many foodstuffs, it is obvious
                that thermally processed foods and refined
                fats and oils (as such or as a component of
                other foodstuffs) are the most significant
                sources of 3-MCPD esters for consumers. In
                particular, refined palm oil in different kinds
                of foodstuffs is responsible for a significant
                part of the exposure."


* Workshop on 5-6 February 2009
                                  5
Toxicology of 3-MCPD esters

   There is currently an information gap on 3-
    MCPD fatty acid esters internationally
       the metabolic pathways and toxicological
        properties of the intact 3-MCPD esters

   The Joint Food and Agriculture Organization
    (FAO) / World Health Organization (WHO)
    Expert Committee on Food Additives (JECFA)
       noted that 3-MCPD esters had been reported in
        foods, but there were insufficient data to
        evaluate their intake or toxicological significance


                             6
Toxicology of 3-MCPD esters

   In 2010, the Codex Committee on
    Contaminants in Foods (CCCF)

       included 3-MCPD fatty acid esters in
        the priority list for evaluation by
        JECFA for toxicological assessment
        and exposure assessment




                      7
Toxicology of 3-MCPD esters

   The primary toxicological concern is the potential
    release of the toxic 3-MCPD in vivo during
    digestion in the gastrointestinal tract

   Adverse effects of 3-MCPD
       affect the kidney, the central nervous system and the
        male reproductive system of rats

       The International Agency for Research on Cancer
        (IARC) classified 3-MCPD as Group 2B agent (Possibly
        carcinogenic to humans)
           there is sufficient evidence showing that 3-MCPD is
            carcinogenic to experimental animals
           no data is currently available for the carcinogenicity
            of 3-MCPD in humans.
                              8
Objectives
   The Centre for Food Safety (CFS), as a
    World Health Organization (WHO)
    Collaborating Centre for Risk Analysis of
    Chemicals in Food , conducted the study
    with a view to
       giving WHO an overview of the level of fatty
        acid esters of 3-MCPD in foods in Hong Kong


       assessing the potential health risk posed to the
        local population



                           9
Scope
   Ranges of products which reported having
    higher level of fatty acid esters of 3-MCPD

       Refined oils and fat & fat and salt containing
        products
       foodstuffs involving thermal processing e.g.
        baking, roasting, frying, deep frying etc.
       Sample: 300 individual samples




                          10
Laboratory analysis
   Laboratory analyses were conducted by
    the Food Research Laboratory (FRL) of the
    CFS

   The concentration of 3-MCPD fatty acid
    esters in samples are expressed as 3-
    MCPD

   The limits of detection (LOD) varied
    among different food categories (ranged
    1 – 20 µg/kg )

                    11
Data analysis
   Safety reference value

       JECFA established a provisional maximum
        tolerable daily intake (PMTDI) of 2 µg/kg
        bw in 2001 for 3-MCPD

       No safety reference value for its esters




                       12
Data analysis
   Assumption:
       Since primary toxicological concern is the
        potential release of the toxic 3-MCPD in vivo
        during digestion in the gastrointestinal tract

       Assumed 100% of 3-MCPD was released from its
        fatty acid esters by hydrolysis in the digestive
        system in adults, (having noted that this
        assumption may overestimate the actual 3-MCPD
        exposures)

       this approach was agreed by European Food
        Safety Authority (EFSA)

                         13
Data analysis
   Estimate dietary exposure
       Substance Level X Food Consumption Amount
       1/2 LOD was assigned to the ND samples for the
        calculation of mean levels of 3-MCPD fatty acid
        esters

   Food Consumption data
      Hong Kong Population-based Food Consumption
       Survey 2005-2007 (the Survey)
       For fats and oils consumption data
          The survey
          HK Edible Oil Association (2007)



                          14
3-MCPD fatty acid esters levels
in different food groups




                15
3-MCPD fatty acid esters levels
     in different vegetable oils
             Oils             Number of    3-MCPD fatty acid esters level (μg/kg),
                                Samples            expressed as 3-MCPD

                                              Mean          Minimum – Maximum

          Peanut oil             3             570                500 - 650

          Canola oil             3             110                100 - 130

           Corn oil              3             280                120 - 470

           Olive oil             3             390                250 - 640

        Grape seed oil           3            1180                390 - 2500

     Extra virgin olive oil      1              10                   ND

• Local levels ranged 100 - 2500 μg/kg (except extra virgin olive oil)
• Reported levels in other countries <200 – 21500 μg/kg
                                      16
Adult’s dietary exposure to 3-MCPD
   fatty acid esters

         The estimated dietary exposure to 3-
          MCPD from its fatty acid esters

            average adult consumers
                0.20 μg/kg bw/day
                (10% of the PMTDI of 3-MCPD)

            high (95th percentile) adult consumers
                0.53 μg/kg bw/day
                (26 % of the PMTDI of 3-MCPD)
Assuming that 100% of 3-MCPD was released from its fatty acid
esters, the results suggested that both average and high consumers
were unlikely to experience major toxicological effects of 3-MCPD.
                                17
Adult’s dietary exposure to 3-MCPD fatty
acid esters from different food groups




    *average exposure and percentage of PMTDI values below 10 have
    been rounded to one significant figure and values equal to or above
                                       18
    10 have been rounded to two significant figures
Consumption amount of fats and oils

     Local Fats and Oils consumption data for food
      items in this study (all respondents)
        Average consumer: 2.67 grams per day

     Data from the HK Edible Oil Association in 2007
       consumption per capita was 11.22 kg per
        annum (about 30.74 grams per day)


    about 11.5-folds higher



                         19
Adult’s dietary exposure to 3-MCPD fatty
acid esters from different food groups




                                                    150                  8




*average exposure and percentage of PMTDI values below 10 have been rounded to one significant
                                          20
figure and values equal to or above 10 have been rounded to two significant figures
Comparison on dietary exposure to
free 3-MCPD and its esters

     Previous CFS study results on free 3-
      MCPD

         Average consumer (secondary school
          student)
             0.063 – 0.150 μg/kg bw/day
             (3- 8% PMTDI of 3-MCPD)
         High consumer (secondary school student)
             0.152 – 0.300 μg/kg bw/day
             (8 – 15% PMTDI of 3-MCPD)




                          21
Comparison on dietary exposure to
free 3-MCPD and its esters

    The estimated dietary exposure to 3-
     MCPD from its fatty acid esters in this
     study

        average adult consumers
            0.20 μg/kg bw/day
            (10% of the PMTDI of 3-MCPD)

        high (95th percentile) adult consumers
            0.53 μg/kg bw/day
            (26 % of the PMTDI of 3-MCPD)



                         22
Limitation
   Limited laboratory resources
       Focused on local food items reported more
        likely to contain higher amount of 3-MCPD
        fatty acid esters

   Information gaps on 3-MCPD fatty acid
    esters
       Formation mechanism
       Occurrence in food
       Analytical method
       Potential toxicological properties of intact 3-
        MCPD esters
       Metabolic pathway such as degree of
        hydrolysis during digestion etc.
                           23
Conclusion

   Average and high consumers were
    unlikely to experience major
    toxicological effects of 3-MCPD




                 24
Recommendation

   By virtue of the dietary exposure to 3-
    MCPD fatty acid esters in adults alone,
       the findings of the current study did not provide
        sufficient justifications to warrant changes to the
        basic dietary advice on healthy eating
       to maintain a balanced and varied diet which
        includes a wide variety of fruits and vegetables

   Refined oil is one of the major sources of 3-MCPD
    fatty acid esters
       may reduce consumption of fats and oils to further
        reduce the exposure to 3-MCPD fatty acid esters


                           25
Recommendation
    Members of the food trade are
        advised to find ways to reduce the levels of
         3-MCPD fatty acid esters in refined fats and
         oils while not impairing the quality of their
         products

       The methods may include
         removal of precursors from the raw material
          e.g. remove chloride by washing,
         optimisation of the oil refining process and
         removal of 3-MCPD-esters from the product
    All these possibilities needed to be assessed in the future

                            26
End




      27

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HK Fatty Acid Esters of 3 MCPD in Food 2012

  • 1. Fatty Acid Esters of 3-MCPD in Food 7 Nov 2012 1
  • 2. 3-Monochloropropane-1,2-diol (3- MCPD)  3-MCPD  is a type of process contaminant  produced naturally in foods during food manufacturing, cooking, and other processing activities such as deep frying and roasting  It occurs in foods in its free form as well as in the bound form (fatty acid esters)  Much of the 3-MCPD found in foods is present as 3-MCPD fatty acid esters (3-MCPD esters) and 3-MCPD esters are found in a wide range of food 3-MCPD fatty acid esters is a source of previously not recognized 3-MCPD 2
  • 3. 3-Monochloropropane-1,2-diol (3- MCPD)  Two joint projects with Consumer Council  3-MCPD in Soy Sauce Products; conducted in 2002/03  3-MCPD in Condiments and Sauces; conducted free in 2003/04 3-MCPD  A RA study conducted in 2007  “Dietary Exposure to Chloropropanols of Secondary School Students” Determine the level of the bound 3-MCPD (3-MCPD fatty acid esters) instead in this study 3
  • 4. Occurrence of 3-MCPD esters  The exact mechanism on the formation of 3-MCPD fatty acid esters is still unknown  There is currently lack of data about 3-MCPD fatty acid esters in foodstuffs at international scene  Formed when fat- and salt-containing foods are processed at high temperatures during production  High concentrations found in refined vegetable oils and fats, and in milk powder for infants in some overseas studies 4
  • 5. Occurrence of 3-MCPD esters  ILSI Europe Workshop in 2009  " Although there is a lack of data about 3- MCPD esters for many foodstuffs, it is obvious that thermally processed foods and refined fats and oils (as such or as a component of other foodstuffs) are the most significant sources of 3-MCPD esters for consumers. In particular, refined palm oil in different kinds of foodstuffs is responsible for a significant part of the exposure." * Workshop on 5-6 February 2009 5
  • 6. Toxicology of 3-MCPD esters  There is currently an information gap on 3- MCPD fatty acid esters internationally  the metabolic pathways and toxicological properties of the intact 3-MCPD esters  The Joint Food and Agriculture Organization (FAO) / World Health Organization (WHO) Expert Committee on Food Additives (JECFA)  noted that 3-MCPD esters had been reported in foods, but there were insufficient data to evaluate their intake or toxicological significance 6
  • 7. Toxicology of 3-MCPD esters  In 2010, the Codex Committee on Contaminants in Foods (CCCF)  included 3-MCPD fatty acid esters in the priority list for evaluation by JECFA for toxicological assessment and exposure assessment 7
  • 8. Toxicology of 3-MCPD esters  The primary toxicological concern is the potential release of the toxic 3-MCPD in vivo during digestion in the gastrointestinal tract  Adverse effects of 3-MCPD  affect the kidney, the central nervous system and the male reproductive system of rats  The International Agency for Research on Cancer (IARC) classified 3-MCPD as Group 2B agent (Possibly carcinogenic to humans)  there is sufficient evidence showing that 3-MCPD is carcinogenic to experimental animals  no data is currently available for the carcinogenicity of 3-MCPD in humans. 8
  • 9. Objectives  The Centre for Food Safety (CFS), as a World Health Organization (WHO) Collaborating Centre for Risk Analysis of Chemicals in Food , conducted the study with a view to  giving WHO an overview of the level of fatty acid esters of 3-MCPD in foods in Hong Kong  assessing the potential health risk posed to the local population 9
  • 10. Scope  Ranges of products which reported having higher level of fatty acid esters of 3-MCPD  Refined oils and fat & fat and salt containing products  foodstuffs involving thermal processing e.g. baking, roasting, frying, deep frying etc.  Sample: 300 individual samples 10
  • 11. Laboratory analysis  Laboratory analyses were conducted by the Food Research Laboratory (FRL) of the CFS  The concentration of 3-MCPD fatty acid esters in samples are expressed as 3- MCPD  The limits of detection (LOD) varied among different food categories (ranged 1 – 20 µg/kg ) 11
  • 12. Data analysis  Safety reference value  JECFA established a provisional maximum tolerable daily intake (PMTDI) of 2 µg/kg bw in 2001 for 3-MCPD  No safety reference value for its esters 12
  • 13. Data analysis  Assumption:  Since primary toxicological concern is the potential release of the toxic 3-MCPD in vivo during digestion in the gastrointestinal tract  Assumed 100% of 3-MCPD was released from its fatty acid esters by hydrolysis in the digestive system in adults, (having noted that this assumption may overestimate the actual 3-MCPD exposures)  this approach was agreed by European Food Safety Authority (EFSA) 13
  • 14. Data analysis  Estimate dietary exposure  Substance Level X Food Consumption Amount  1/2 LOD was assigned to the ND samples for the calculation of mean levels of 3-MCPD fatty acid esters  Food Consumption data  Hong Kong Population-based Food Consumption Survey 2005-2007 (the Survey)  For fats and oils consumption data  The survey  HK Edible Oil Association (2007) 14
  • 15. 3-MCPD fatty acid esters levels in different food groups 15
  • 16. 3-MCPD fatty acid esters levels in different vegetable oils Oils Number of 3-MCPD fatty acid esters level (μg/kg), Samples expressed as 3-MCPD Mean Minimum – Maximum Peanut oil 3 570 500 - 650 Canola oil 3 110 100 - 130 Corn oil 3 280 120 - 470 Olive oil 3 390 250 - 640 Grape seed oil 3 1180 390 - 2500 Extra virgin olive oil 1 10 ND • Local levels ranged 100 - 2500 μg/kg (except extra virgin olive oil) • Reported levels in other countries <200 – 21500 μg/kg 16
  • 17. Adult’s dietary exposure to 3-MCPD fatty acid esters  The estimated dietary exposure to 3- MCPD from its fatty acid esters  average adult consumers  0.20 μg/kg bw/day  (10% of the PMTDI of 3-MCPD)  high (95th percentile) adult consumers  0.53 μg/kg bw/day  (26 % of the PMTDI of 3-MCPD) Assuming that 100% of 3-MCPD was released from its fatty acid esters, the results suggested that both average and high consumers were unlikely to experience major toxicological effects of 3-MCPD. 17
  • 18. Adult’s dietary exposure to 3-MCPD fatty acid esters from different food groups *average exposure and percentage of PMTDI values below 10 have been rounded to one significant figure and values equal to or above 18 10 have been rounded to two significant figures
  • 19. Consumption amount of fats and oils  Local Fats and Oils consumption data for food items in this study (all respondents)  Average consumer: 2.67 grams per day  Data from the HK Edible Oil Association in 2007  consumption per capita was 11.22 kg per annum (about 30.74 grams per day)  about 11.5-folds higher 19
  • 20. Adult’s dietary exposure to 3-MCPD fatty acid esters from different food groups 150 8 *average exposure and percentage of PMTDI values below 10 have been rounded to one significant 20 figure and values equal to or above 10 have been rounded to two significant figures
  • 21. Comparison on dietary exposure to free 3-MCPD and its esters  Previous CFS study results on free 3- MCPD  Average consumer (secondary school student)  0.063 – 0.150 μg/kg bw/day  (3- 8% PMTDI of 3-MCPD)  High consumer (secondary school student)  0.152 – 0.300 μg/kg bw/day  (8 – 15% PMTDI of 3-MCPD) 21
  • 22. Comparison on dietary exposure to free 3-MCPD and its esters  The estimated dietary exposure to 3- MCPD from its fatty acid esters in this study  average adult consumers  0.20 μg/kg bw/day  (10% of the PMTDI of 3-MCPD)  high (95th percentile) adult consumers  0.53 μg/kg bw/day  (26 % of the PMTDI of 3-MCPD) 22
  • 23. Limitation  Limited laboratory resources  Focused on local food items reported more likely to contain higher amount of 3-MCPD fatty acid esters  Information gaps on 3-MCPD fatty acid esters  Formation mechanism  Occurrence in food  Analytical method  Potential toxicological properties of intact 3- MCPD esters  Metabolic pathway such as degree of hydrolysis during digestion etc. 23
  • 24. Conclusion  Average and high consumers were unlikely to experience major toxicological effects of 3-MCPD 24
  • 25. Recommendation  By virtue of the dietary exposure to 3- MCPD fatty acid esters in adults alone,  the findings of the current study did not provide sufficient justifications to warrant changes to the basic dietary advice on healthy eating  to maintain a balanced and varied diet which includes a wide variety of fruits and vegetables  Refined oil is one of the major sources of 3-MCPD fatty acid esters  may reduce consumption of fats and oils to further reduce the exposure to 3-MCPD fatty acid esters 25
  • 26. Recommendation  Members of the food trade are  advised to find ways to reduce the levels of 3-MCPD fatty acid esters in refined fats and oils while not impairing the quality of their products  The methods may include  removal of precursors from the raw material e.g. remove chloride by washing,  optimisation of the oil refining process and  removal of 3-MCPD-esters from the product All these possibilities needed to be assessed in the future 26
  • 27. End 27