EU Dietary Intake Estimates - Focus on Enzymes - March 2016

www.intertek.com1
EU Dietary Intake
Estimates – Focus on
Enzymes
Danika Martyn, PhD
Scientific & Regulatory Consultant,
Food & Nutrition Group, Intertek Scientific & Regulatory
Consultancy, U.K.

www.intertek.com2
What is dietary exposure assessment?
“ ’Tis the dose that makes the poison ”
-Paracelsus
Anything when consumed in sufficient quantities can be toxic
Exposure = Amount food consumed * Amount component in food
(mg/kg bw/day) (kgfood/kg bw/day) (mg/kgfood)
Enzymes

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Typical approach to estimating exposure
1. Screening methods
• Makes broad assumptions on food and beverage consumption and proportion of
foods containing compound
2. National dietary survey summary statistics
• Provide mean and upper percentile exposure estimations
• Presentation for food categories; entire population or fixed population groups;
including body weight data
3. Individual food consumption data
• Provide distribution of exposure estimates
• Presentation for individual foods; allows calculation for population group of
interest; individual body weight data
• Probabilistic assessments - use of market share, brand loyalty etc.

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Enzymes Additives Novel Foods Flavourings
Budget method with no
factors
• Simple
FAIM
• Simple
• Provides % breakdown by
food group
FAIM (?)
• Simple
• Provides % breakdown by
food group
Added Portion
Exposure Techniques
• Simple – standard
portion sizes provided
A: EFSA Comprehensive
• User-friendly format
B: Budget method with
specific factors
• Data may be available
from literature
EFSA Comprehensive
• Provides intake values per
survey, per age group, on
an absolute and body
weight basis
EFSA Comprehensive
• Provides intake values per
survey, per age group, on
an absolute and body
weight basis
Individual Food Consumption Data (e.g., NDNS)
• Distribution of intakes
• Most realistic estimate
• Not dependant on summary statistics and assumptions re heavy level intakes

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Enzymes Additives Novel Foods Flavourings
Budget method with no
factors
• Unrealistic
FAIM
• Broad categories results
in overestimation
FAIM (?)
• Novel ingredient are rarely
intended for use in
categories FCS
Added Portion
Exposure Techniques
• No further refinement
available
A: EFSA Comprehensive
• Difficult for applicant to
obtain information
required for use
• Requires assumptions to
be made
• Resource intensive
B: Budget method with
specific factors
• Case-by-case – no
guidance
EFSA Comprehensive
• Summary statistics
be made
• Range must be
presented per age group
EFSA Comprehensive
• Summary statistics
be made
• Range must be presented
per age group
Individual Food Consumption Data (e.g., NDNS)
• Require input regarding use level of product in final foods – issue for enzymes (as per
Comprehensive)

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Enzymes
Food Enzyme: “means a product obtained from plants, animals or
micro-organisms or products thereof including a product obtained by
a fermentation process using micro-organisms:
i. containing one or more enzymes capable of catalyzing a specific
biochemical reaction; and
ii. added to food for a technological purpose at any stage of the
manufacturing, processing, preparation, treatment, packaging,
transport or storage of foods;”
Regulation (EC) No. 1332/2008

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Basic considerations
• “Food enzymes” are in most cases not a pure isolated
enzyme – exposure must be calculated on the basis of the
“total organic solids”
• Food enzymes are generally added on the basis of their
activity. Thus the lower the activity, the more TOS is
added
• Enzyme exposures should be expressed as mg/kg
bodyweight/day considering the lowest activity level (i.e.
highest TOS)
• EFSA has identified a margin of exposure of 3001
1 Factor 10 for inter-species difference, factor 10 for
intra-species difference and factor 3 for the
extrapolation from short-term studies to chronic studies
(EFSA Scientific Committee, 2012)

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EFSA Safety Evaluation of Food Additives
Critical issues of risk assessment:
• The source
• The food enzyme
• Intended and unintended reaction products
• The dietary exposure of the consumer
Depends on the residual concentration of the food enzyme(s) and other
constituents of the food enzyme in the foods at the time of consumption and the
amount and frequency of their consumption
1 http://www.efsa.europa.eu/en/efsajournal/pub/1305

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Dietary Exposure
“Potential human exposure to the food enzyme and to any other constituent or by-
product of concern should be assessed considering all proposed uses. A
conservative technique such as the “budget method” (Hansen, 1966; Hansen
1979; Douglass et al., 1997; European Commission 1998; FAO/WHO 2008)
should be used to assess potential dietary exposure in a standard adult of 60 kg
body weight consuming large amounts of the categories of foods and beverages
for which use levels have been proposed, assuming that they always contain the
food enzyme at its proposed upper use level. If needed, the technique should be
adapted to consider the potential higher consumption per kg body weight of
these foods and beverages in children. All assumptions and data used for the
dietary exposure assessment should be clearly described and justified.
In case the use of the food enzyme is proposed for products specifically designed
for infants (0-12 months) or young children (12-36 months) as defined in the
Commission Directive 2006/141/EC, ad hoc conservative exposure estimates
must be produced taking specifically into account these population groups.”

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Budget Method
Assumptions:
• Food and non-milk beverage intake (0.05 kg and 0.1 L per kg bw/day)
• Percentage of foods and beverages that are processed (~50%)
• Percentage of processed foods and beverages containing the food additive
(~25-50%)
Consumption
of Foods and
Beverages
(kg/kg bw/day)
Consumption
of Foods and
Beverages
for 70-kg
adult1
(kg/day)
Percentage
of
Processed
Products
(%)
Percentage of
Processed
Products
Containing
Additive (%)
Consumption
of Foods and
Beverages
Containing
Additive
(kg/day)
Solid foods 0.05 3.5 50 50 0.875
Non-Milk
Beverages
0.10 7.0 50 50 1.75
Total 2.625
1 http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2579.pdf

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Issues with approach
1. Budget method assumptions (or standard factors) not
validated for enzymes
• Additives have a technological function in the final food
2. Missing data on residual levels in foodstuffs as
consumed
• Use levels often presented for substrate – requires
information on conversion factors (‘substrate’ to ‘product’)
• No information on use level of ‘product’ in final foods and
beverages

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EFSA Draft Statement
Draft Statement published1
Info session held2
‘Traditional’ budget method not suitable for enzymes and
there needs to be guidance on refinements steps
New tiered approach proposed:
• Tier 1: Budget method without standard factors
• Tier 2A: EFSA Comprehensive Database
• Tier 2B: Budget method with specific factors
1 http://www.efsa.europa.eu/sites/default/files/consultation/160216.pdf
2 http://www.efsa.europa.eu/en/events/event/160203#documents

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EFSA Proposed Tier 1
Budget method without standard
factors

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Tier 1: Budget method without standard factors
Consumption
of Foods and
Beverages
Processed
with Enzyme
(kg/kg
bw/day)
Consumption
of Foods and
Beverages for
70-kg adult
Processed
with Enzyme
(kg/day)
Percentage
of Processed
Products (%)
Percentage of
Processed
Products
Containing
Additive (%)
Consumption
of Foods and
Beverages
Containing
Additive
(kg/day)
Solid foods 0.05 3.5 50 50 0.875
Non-Milk
Beverages
0.10 7.0 50 50 1.75
Total 10.5 2.625

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Considerations
Removal of standard factors:
• Results in intake levels that are highly unrealistic –
10.5 kg of foods and beverages per day processed
with enzyme
• Food enzymes are processing aids – therefore some
factor to account for proportion of foods/beverages
that are processed
• No factor for ingredients
Dossiers submitted may have an exposure level
which is 4- to 6- times higher than the level estimated
using the suggested approach

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EFSA Proposed Tier 2A
EFSA Comprehensive Database
(Nutrition Surveys)

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Tier 2A: EFSA Comprehensive Database
• Database of summary statistics based on survey data
from EU Member States
• Apply concentration of food enzyme to FoodEx categories
• Calculate upper percentile for total population
• Tiered approach recommended
FoodEx Level 1 Milk and dairy products
FoodEx Level 4 Acidophilus milk

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Considerations
Comprehensive Database1 is user-friendly…
1 http://www.efsa.europa.eu/en/food-consumption/comprehensive-database

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Considerations

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Considerations
Comprehensive Database1 is user-friendly, however
points such as:
1. Calculation of upper percentiles
• Need to consider trends of intake (food groups which may
be consumed together)
• EFSA Guidance document2
2. Selection of suitable food groups
need to be considered carefully, particularly at lower
(more refined) FoodEx levels
1 http://www.efsa.europa.eu/en/food-consumption/comprehensive-database
2 http://www.efsa.europa.eu/en/efsajournal/pub/2097

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Considerations
• Difficulty in obtaining all required data to conduct assessment
• However, allows “educated overestimates” the levels of consumption
are likely to be far more realistic than Proposed Tier 1
Activity of
enzyme
TOS of
enzyme
Conversion rate
to ingredient
Maximum level
of ingredient in
final food
Enzyme Producer
× ×
Ingredient
Producer × × ×
Final food
Producer × × ×
Applicant

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EFSA Proposed Tier 2B
Adjusted Budget Method with
Specific Factors

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Tier 2B: Budget method with specific factors
Proposed for use when it is not possible to obtain information
necessary to conduct the EFSA Comprehensive
Activity of
enzyme
TOS of
enzyme
Conversion rate
to ingredient
Maximum level
of ingredient in
final food
Enzyme Producer
× ×
Ingredient
Producer × × ×
Food Producer
× × ×
Applicant

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Tier 2B: Budget method with specific factors
‘Adjusted’ budget method
Case-by-case basis
• Comprehensive Database
• Literature
• Food industry
Consumption
of Foods and
Beverages
(kg/kg bw/day)
Consumption
of Foods and
Beverages
for 70-kg
adult (kg/day)
Percentage
of
Processed
Products
(%)
Percentage of
Processed
Products
Containing
Enzyme (%)
Consumption
of Foods and
Beverages
Containing
Enzyme
(kg/day)
Solid foods 0.05 3.5 ? ? ?
Non-Milk
Beverages
0.10 7.0 ? ? ?
Total ?

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Considerations
• Alternative when information is not available
• Not based on actual consumption data
• Burdensome
• Case-by-case – difficult for applicants to ensure
robustness of approach
• Submit without assurance whether approach is
acceptable?
• Will EFSA perform own assessment and result in an
MOE below 300?

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Next Steps?

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Next Steps for Process
• Finalise statement after public consultation (deadline: 31/03/2016)
• Requests for data
• Preparation of a FAIM-like tool?
• Mutually-exclusive food categories? Case-by-case
Activity of
enzyme
TOS of
enzyme
Conversion rate
to ingredient
Maximum level
of ingredient in
final food
Enzyme Producer
× ×
Ingredient
Producer × × ×
Food Producer
× × ×

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Conclusions
In order to conduct exposure assessments, information on final
concentration of TOS in foods as consumed is needed and it is not
always easy to get. Thus there will always need to be assumptions made
EFSA’s current guidance for enzymes intakes is based on the ‘traditional’
Budget Method that assumes ~2.6 kg of foods and beverages per day
contain enzyme
Proposed Tier 1 ~quadruples that
Proposed Tier 2A will probably provide a much more accurate
overestimation but requires a lot of information
Proposed Tier 2B is suitable if there is no way to get information on the
final applications, but still requires considerable input, and has a lot of
uncertainties
A 300-fold safety factor is required when compared against the safety
level

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Thank you!
danika.martyn@intertek.com
www.intertek.com/food/consulting
Danika Martyn, PhD
Scientific & Regulatory Consultant, Food & Nutrition
Group, Intertek Scientific & Regulatory Consultancy, U.K.

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EU Dietary Intake Estimates - Focus on Enzymes - March 2016

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EU Dietary Intake Estimates - Focus on Enzymes - March 2016