FoodDrinkEurope Internal Survey on the
EU Guidance on Tolerances and Rounding Rules
Note: Thank you for answering as many questions as possible to enhance the quality of the survey’s results. As a
minimum, the questions in bold should be answered.
Any information submitted will be kept confidential.
Data will be treated anonymously during the overall process of data collection and analysis.
Responses to be sent by 7 January 2014
(c.gubbiotti@fooddrinkeurope.eu)
Avenue des Nerviens, 9-31 - 1040 Brussels - BELGIUM - Tel. +32 2 514 11 11 - Fax. +32 2 511 29 05
info@fooddrinkeurope.eu - www.fooddrinkeurope.eu
Copyright FoodDrinkEurope aisbl; photocopying or electronic copying is illegal.
A- General Information on the company and its activities
Type of industry: Large / Medium / Small / Micro
Company category Employees Turnover or Balance sheet total
Large
> 250
> € 50 m
> € 43 m
Medium-sized
< 250
≤ € 50 m
≤ € 43 m
Small
< 50
≤ € 10 m
≤ € 10 m
Micro
< 10
≤€2m
≤€2m
: ………………………………………………..
Which are the main food categories in which your company is currently active? ………………………………………………..
Do you use nutrition and/or health claims on some of your products (If yes, estimate if possible the % of products having at least 1 claim)?
………………………………………………..
Do you add vitamins and/or minerals to the foods you are producing (If yes, estimate if possible the % of products having at least 1 added
micronutrient)? ………………………………………………..
From which Member State(s) is your company reporting for the purposes of answering this questionnaire?
.........................................................................................................................................
Are your foods mainly marketed on the national market or are they also exported to other countries? Precise to which countries/regional area if
possible (e.g. national market, Internal market (EU), third countries etc) ………………………………………………..
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B- Questions related to the EU Guidance on Tolerances and Rounding Rules – General questions
1. Are you aware that the European Commission has issued a
Guidance document on Tolerances and Rounding Rules?
(Please indicate your answer by means of an “X”)
2. If yes, how have you been informed of the existence of this
guidance document?
(Please indicate your answer by means of an “X”)
o
o
YES
NO
o
o
o
o
o
o
Via national authorities
Via the European Commission
By FoodDrinkEurope
By other trade associations
By colleagues
Other (specify): ………………………………….
3. As far as you are aware, are the control authorities of the
o YES
country(ies) from where you are reporting
informing
o NO
companies about the EU Guidance on Tolerances and
Additional comments/information:
Rounding Rules?
………………………………………………
(Please indicate your answer by means of an “X”)
………………………………………………
………………………………………………
4. As far as you are aware, have competent authorities in the
o YES
country(ies) from where you are reporting
started
o NO
implementing the EU Guidance on Tolerances and Rounding
Additional comments/information:
Rules?
………………………………………………
(Please indicate your answer by means of an “X”)
………………………………………………
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………………………………………………
5. In case you are aware of this new Guidance document, have
you started implementing it?
(Please indicate your answer by means of an “X”)
o
o
YES
NO
Additional comments/information:
………………………………………………
………………………………………………
………………………………………………
6. If you have not started implementing the guidance yet, could
you explain why?
…………………………………………………………………………………………
7. If you have not started implementing the Guidance yet, when
will your company start?
……………………..…………………………………………………………………
8. In your opinion, how much time is necessary to adapt to the
new guidance requirements? Do you think the transition
period foreseen in the Guidance document (until 13
December 2014 the latest) for adapting to the new rules is
sufficient? (If not, indicate why and which date you propose)
…………………………………………………………………………………………
9. Which impact has the Guidance on your current practices?
…………………………………………………………………………………………
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C- Questions related to the EU Guidance on Tolerances and Rounding Rules – questions concerning the Guidance’s content
10. Within your company, which method(s) are you applying for
calculating the average amount of foods’ nutrients that will
be labelled in the nutrition declaration?
(Please indicate your answer by means of an “X”)
o A
11. Could you indicate if you identify one/more of these
problems/difficulties arising from the guidance document?
(Please indicate your answer by means of an “X”)
o
Analysis of the foods
Please indicate which % of the product portfolio (roughly):
…………………………
o
A calculation from the known or actual average values of ingredient
used
Please indicate which % of the product portfolio (roughly):
…………………………
o
A calculation from generally established and accepted data
Please indicate which % of the products portfolio (roughly):
…………………………
 General difficulty in understanding the Guidance document
 Complexity due to the co-existence of different tables/calculation
methods depending on whether claims are made on the foods and on
whether vitamins and/or minerals are added to foods
 Complexity due to the fact that different thresholds are set for the same
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nutrient, depending on its content in the food
 Complexity due to the existence of relative and absolute limits for the
same nutrient
 Complexity due to the fact that macronutrients are not grouped
 Too tight tolerances values for some nutrients
 Problems arising from the inclusion of the measurement uncertainty(MU):
o the inclusion of MU make the tolerance ranges
too tight
o the measurement uncertainty may vary
from one laboratory to another, as different
analytical methods are used
o lack of knowledge / lack of reporting of the measurement
uncertainty in the reports from the laboratories
o lack of a EU-wide definition of measurement
uncertainty
o Others (specify)
 The application of one-side tolerances is not coherent with the declaration
of an average value, as the measurement uncertainty is not enough to
cover the statistical distribution of values around the average value
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 Problems created by the fact that the EU Guidance does not address
adequately:
o The choice between the three methods that can be
applied for calculating the average amount of the
nutrient that will be labelled in the nutrition declaration
o The natural high variation of some nutrients,
including seasonality
o The particular high degradation rates of
nutrients in some food matrices
o The particular high analytical variability of
nutrients in a specific food matrix
o The particular low homogeneity of a
product leading to particular high variation
of nutrient content in a product that is not
offset by the sampling procedure
o Any other problems encountered? .............................
 Applying the rounding rules (possibly detail why)
12. How does your company understand and apply the notion of
measurement uncertainty to be applied as per the EU
………………………………………………………..
Guidance on Tolerances and Rounding Rules?
7/11
13. What are (if any) the tests that your company has already carried out according to the new EU Guidance on Tolerances and Rounding Rules?
In case your company has not started testing the new Guidance, please, specify this and, if possible, assess the new rules on the basis of “old”
analysis data in order to fill in the table.
Food category (please, use the food Nutrient
categories
listed
in
Reg.
1333/2008/EC)
Number of analyses carried out
Consolidation
results:
%
of
products having at least 1
parameter out of tolerances range
14. Have you identified “particular nutrients” which are systematically out of the tolerance range (if so, please provide any details)?
……………………………………………………………………………………………………………………………………………
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15. Concrete examples of cases of nutrients which are found to be out of the ranges of tolerances as established in the EU Guidance (please fill out
the table below):
Category of
Nutrient Declared
products
value
(where possible,
please use the
food categories
listed in Reg.
1333/2008/EC)
Example:
Flavoured drink
(category
14.1.4)
Example:
Breakfast
cereals
(category 06.3)
Vitamin
C
13 mg/
100ml
Fiber
5g/100g
Which method
from Question
n. 13 is your
company using
for calculating
the
average
amount
of
foods’ nutrients
that will be
labelled in the
nutrition
declaration?
Value from
ingredients
minus shelf-life
losses
Claim and/or
addition
of
vitamin/miner
al?
Which
Measurement
section
of uncertainty
the
EU applied by the
Guidance
company
applies?
Yes, the claim
“source of
vitamin C” is
made
Section 5.3
Official
database
Contains 5g
fiber
Section 5.4
How do you
evaluate
that
the
values are
not in the
tolerance
range
Amount of
the
deviation
from
the
tolerance
range (%)
Main
reasons
why
the
value
is
found to
be out of
the range
of
tolerances
-20% +20%
Analysis at
production
20mg
instead of
max 18 mg
+- 30%
Analysis
+10%
Ingredients
variability
for their
levels in
vitamin C
Analytical
variability
for fiber
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16. Which actions do you plan for the above products being out of the
tolerances range?
……………………………………………………………………………………………………….
17. Has your company reformulated and/or is planning to reformulate
products that are out of the tolerance ranges as defined in the EU
Guidance?
……………………………………………………………………………………………………….
18. In cases of a positive answer to the above question (question n. 17),
can you estimate how many products have already been
reformulated and/or will be reformulated (% of the product ……………………………………………………………………………………………...
portfolio)
19. In cases where you are exporting your products to other countries,
have you experienced any difficulties due, e.g., to the fact that
national authorities are applying different rules for tolerances in the
importing countries?
……………………………………………………………………………………………………….
20. Do you think modifications should be made to the EU Guidance on
Tolerances and Rounding Rules? If yes, which?
……………………………………………………………………………………………………….
21. Please give the economic/financial impact of implementing the
new guidance for your company (total salary cost of staff involved
in the implementation of the new Guidance, analytical extra-costs,
reformulation of some foods in order to meet the tolerance levels
established in the guidance, etc.) from January 2013.
………………………………………………………………………………………………………..
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