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International Food Risk Analysis Journal
Food Risk Analysis Communication
Issued By Health Canada’s Food Directorate
Proposed Approach to Setting Maximum Levels for Vitamins, Mineral Nutrients,
and Amino Acids in Beverages, Beverage Mixes and Concentrates, Powders, Bars
and Confectionaries Eligible for a Temporary Marketing Authorization in Canada
Chantal Martineau1, Jennifer Barber1, Jesse Bertinato1, Steve Brooks1, Eunice Chao1, Janice
Daoust1, Nora Lee1, Lindsay Lukeman1, Robin J. Marles1 and Natasha Hinkson1
1 Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch, Health Canada
Health Canada’s Food Directorate is making available this paper, following an internal peer review by Food Directorate
scientific and regulatory experts, to seek comments from peer scientists, regulators and stakeholders prior to finalization.
This paper is open for comment commencing June 2, 2014 and closing on August 2, 2014 (60 calendar days). Only
comments of a scientific nature will be considered in developing the final version of this document. Authors will strive to
document how the various comments received, when deemed relevant, were considered in amending this document and in
shaping the final version that will be published.
Comments may be submitted in writing by regular mail or electronically at the address indicated below. If you are submitting
your comments electronically, please use the phrase “Setting of Vitamin, Mineral Nutrients and Amino Acids Maximum
Levels” in the subject box of your email.
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E-mail: [email protected]
© 2014 Health Canada. Licensee InTech. This is an open access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.
1. Introduction
In recent years, a number of food products containing
added vitamins, mineral nutrients and amino acids not in
compliance with the Food and Drug Regulations (FDR)
were introduced into the Canadian marketplace as
natural health products (NHPs) through the early
implementation of the Natural Health Products Regulations.
These were mainly beverages and a small number of
other food formats.
Health Canada has determined, based on public
perception, history of use, product representation to
consumers and product format, in accordance with the
classification guidance outlined on its website (Health
Canada, 2013) that many of these products fit the
definition of a food and are therefore more appropriately
regulated under the food regulatory framework. In
contrast, Natural Health Products encompass products
more commonly sold in dosage forms such as pills,
capsules and tinctures.
Int Food
RiskDaoust,
Anal J, 2014,
4:3
Chantal Martineau, Jennifer Barber, Jesse Bertinato, Steve Brooks, Eunice Chao,
Janice
Nora Lee,
Lindsay Lukeman, Robin J. Marles and Natasha Hinkson: Food Risk Analysis Communication
1
As a result, these products were transitioned from the
natural health products regulatory framework to the food
regulatory framework in 2012. The nature of these food
products challenges the traditional premise of food
regulations, which has been based on a model of food
consumption generally without conditions (ad libitum).
While there appear to be no immediate safety concerns
with these products, there remain a number of
outstanding data and information gaps in order to inform
potential regulatory requirements under the FDR for
these products and to appropriately manage any
potential health risk associated with their consumption.
Examples of data gaps include, but are not limited to,
consumption patterns in the dietary context as food and
the effectiveness of labelling as a risk mitigation tool. As a
result, Temporary Marketing Authorizations (TMAs), a
food regulatory tool in Canada (The Minister of Justice,
2014), have been issued to allow market access to safe
products for the purpose of gathering in-market data to
inform appropriate regulatory amendments.
These products are subject to all of the requirements
applicable to food products, including the provisions of
the Food and Drugs Act and its Regulations and the
Consumer Packaging and Labelling Act and its Regulations,
except for those requirements of the Food and Drug
Regulations which have been exempted as set out in a
Temporary Marketing Authorization Letter.
product’s label. Setting maximum levels for the purpose
of issuing TMAs will also improve predictability of access
to the Canadian market, during the TMA eligibility
period.
It is important to note that these proposed maximum
levels may be subject to change once data gathered
during the TMA period is analyzed. Therefore, the
proposed levels should not be construed as final
regulatory requirements for these products.
2. Proposed Approach to Setting Maximum Levels for
Vitamins, Mineral Nutrients, and Amino Acids
Health Canada’s Food Directorate used a risk-based
approach to set the proposed maximum levels of addition
supporting the issuance of TMAs. The levels are not
related to nutritional requirements and they are not
intended as recommended levels for addition.
It is important to note that the nutrients listed and their
maximum levels are subject to change based on future
review as new evidence becomes available. The proposed
approach was followed for nutrients that are in products
for which manufacturers are seeking access to the
Canadian market or that are already available. The
addition of other nutrients will be subject to case-by-case
analysis in order to set such maximum levels.
3. Determining Maximum Levels per Serving
Health Canada is developing additional requirements for
these types of products to alert the consumer to their
uniqueness and to help reduce the potential risks
associated with their inappropriate consumption. These
include compositional and labelling requirements.
With regards to compositional requirements, Health
Canada is proposing to set maximum levels for the
addition of vitamins, mineral nutrients and amino acids.
This report describes the scientific and risk analysis
approach followed by scientists and standard setters in
Heath Canada’s Food Directorate for setting maximum
levels for the addition of vitamins, mineral nutrients and
amino acids in beverages, beverage mixes and
concentrates, bars and confectionaries that will be
permitted for the purposes of issuing TMAs for eligible
products. TMAs will be valid for a number of years to
enable Heath Canada to collect data to estimate actual
consumption of these products and better determine
nutrient exposure. The research conducted through the
TMA period is expected to help estimate the usual and
upper levels of intake of these products in order to
understand their impact on intakes of vitamins, mineral
nutrients and amino acids by the Canadian population, as
well as the effectiveness of cautionary statements on the
2
Int Food Risk Anal J, 2014, 4:3
The main goal of the proposed approach to establishing
maximum levels for vitamins, mineral nutrients and
amino acids is to help ensure that their addition to the
foods receiving TMAs does not contribute to excessive
intakes.
A general approach was developed for vitamins and mineral
1
nutrients with a Tolerable Upper Intake Level (UL)
established by the Institute of Medicine (IOM). For the
general approach, maximum levels were determined by
adding the 95th percentile of daily dietary intake from
Canadian Community Health Survey (Health Canada et al.,
2009), unless otherwise noted, to the estimated intake from
2
supplements , and subtracting this total from the UL. This
provided a maximum daily intake that could be permitted
for these foods for each nutrient. This was then divided by
1 A Tolerable Upper Intake Level (UL) is the highest level of
continuing daily nutrient intake that is likely to pose no risk of
adverse health effects in almost all individuals in the life-stage
group for which it has been designed (IOM, 2006).
2 An assumed value for Canadian supplement intake has been
estimated by determining the highest level of each nutrient
found in the top 5 selling multivitamin/mineral supplements for
children and adults currently marketed in Canada, based on an
AC Nielsen market survey (Nielsen Market Track, 2012).
five to allow for the possibility that consumers might have
up to 5 servings of these food products in a day.
The 95th percentile of dietary intake was selected as a
reference value in order to address potential health risks
from overconsumption in agreement with the approach for
the safe addition of vitamins and minerals to foods
recommended by Flynn et al. (2003) and Rasmussen et al.
(2006). To ensure safe intakes from added nutrients, it is
necessary to take into account individuals who already
consume high levels of nutrients from foods. Thus, the 95th
percentile represents individuals who have intakes
considerably above the population mean, i.e., those in the
top 5% of consumption for each nutrient (Flynn et al., 2003).
In the case of a few nutrients (folic acid, nicotinic acid,
iodine and iron) with a UL, the general approach
described above was not used because an overriding
issue was identified to justify the decision not to permit
their addition to foods eligible for TMAs. Elevated
physiological status in certain segments of the Canadian
population was used to justify the decision for folic acid
and iodine. In the case of nicotinic acid, because of the
potential for flushing associated with this form of the
nutrient, it is recommended that the niacinamide form be
used as a source of niacin. It is also proposed that iron not
be permitted for TMA products as it can be a hazard for
those with undiagnosed hemochromatosis.
Where there was no UL or other information was
determined more appropriate (niacinamide and vitamin
E), different approaches were adopted depending on the
nutrient.
The maximum levels per serving are meant to apply to
the declared nutrient amount and include both naturally
occurring and added amounts.
4. Setting Maximum Levels by Target Population
and Risk Categories
In the case of many nutrients, the proposed approach
described below differentiates between foods intended
for the general population (i.e., including children) and
those intended for adults only. In particular, for certain
nutrients with a UL1, more than one maximum level has
been set to account for this difference as ULs for children
are generally lower than ULs for adults. It is proposed
that a food permitted to use levels above those for the
general population but below the maximum levels
specified for adults only be clearly labelled with the
cautionary statement “For adults only”.
Vitamins and mineral nutrients are not all equal with
respect to the human body’s ability to metabolize and
eliminate excess intake. Some are so efficiently handled
that no adverse effects have been associated with excess
intake from food or supplements, although this does not
mean that there is no potential for adverse effects
resulting from high intakes. In some cases the majority of
Canadian consumers already consume as much as or
more than the UL, so additional food sources of intake
are not advisable. Other vitamins and mineral nutrients
have well known toxicity in excess, either to all
consumers or to particular at-risk subpopulations. Since
maximum levels thus cannot be set for vitamin and
mineral nutrients as a single group, nutrients have been
classified into five categories based on risk and intended
target population. The five tables below provide
information on:
1) Vitamins or Mineral Nutrients not Acceptable for
Addition
2) Vitamins or Mineral Nutrients only Permitted to be
Added to Products Targeted to Adults
3) Vitamins or Mineral Nutrients with a Different
Maximum Level for Products Targeted to Adults and
to the General Population
4) Vitamins or Mineral Nutrients with Only One
Maximum Level Set for All Populations
5) Vitamins for which No Maximum Level has been Set
at this Time.
4.1 Vitamins or Mineral Nutrients not Acceptable for Addition
Certain nutrients have the potential for considerable risk
for the general population, for children or for a specific
vulnerable population. Table 1 includes nutrients not
permitted to be added to TMA products and the rationale
for the proposed approach.
4.2 Vitamins or Mineral Nutrients only Permitted to be added
to Products Targeted to Adults
It is recommended that nutrients listed in Table 2 be
permitted to be added to products targeted to adults only
because of the risk of exceeding the UL for these nutrients
in children. These nutrients are therefore not permitted to
be added to products targeted to the general population.
Under the proposed approach, products containing these
nutrients will be required to have an indication “For
adults only” on their label.
Vitamin A (retinol)
It is recommended that Vitamin A in the form of retinol
and its derivatives (e.g., retinyl acetate, retinyl palmitate)
not be permitted for addition to products targeted to the
general population because, based on nutrient intake data
(Health Canada et al., 2009), the 95th percentile of food
intake is above the UL for children 4-8 years of age. The
adverse effect associated with exceeding the UL is liver
toxicity (IOM, 2001).
Chantal Martineau, Jennifer Barber, Jesse Bertinato, Steve Brooks, Eunice Chao, Janice Daoust, Nora Lee,
Lindsay Lukeman, Robin J. Marles and Natasha Hinkson: Food Risk Analysis Communication
3
Nutrient
Folic acid1
Reason
A large proportion (53-73%) of the Canadian population has blood values associated with intakes above
the UL (MacFarlane et al., 2011). Adverse effects associated with exceeding the UL is masking and
potentially delaying diagnosis of vitamin B12 deficiency.
Nicotinic acid1
Has known side effect and niacinamide can be used more safely in foods. Adverse effects associated
with exceeding the UL is flushing of the skin.
Calcium
The 95th percentile of combined food and supplement intake exceeds the UL for females 51-70 years of
age (Health Canada et al., 2009). Adverse effects associated with exceeding the UL is kidney stones.
Manganese2
The 95th percentile of combined food and supplement intake exceeds the UL for children 4-8 years of age
and for adults. Adverse effects associated with exceeding the UL is neurotoxicity.
Vitamin K
Hazard for those on blood thinning medications.
Iodine1
The 95th percentile of estimated intake3 exceeds the UL for children 4-8 years of age and for adults.
Adverse effects associated with exceeding the UL is thyroid dysfunction.
Iron1
Hazard for those with undiagnosed hemochromatosis. Hereditary hemochromatosis is an inherited
disorder of iron metabolism which affects 1 in every 200–300 individuals of Northern European descent
(Lyon, 2001).
1The general approach to determine maximum level for nutrients with a UL was not used in the case of this nutrient due to an
overriding issue as stated in the 2nd column.
2 Canadian intake data not available; therefore, U.S. intake data from the Total Diet Study was used to calculate maximum level (IOM, 2001).
3 Daily iodine intake was estimated using urinary iodine concentrations from Canadian Health Measures Survey: Cycle 1 Data Tables
(Statistics Canada, 2013).
Table 1. Vitamins or Mineral Nutrients not Acceptable for Addition
Nutrient
Vitamin A [retinol and its
derivatives (e.g., retinyl acetate,
retinyl palmitate]
Zinc
Maximum Level
(per serving)
125 µg
0.4 mg
Table 2. Vitamins or Mineral Nutrients only Permitted to be
Added to Products Targeted to Adults
Zinc
It is recommended that zinc not be permitted to be added
to products targeted to the general population because,
based on nutrient intake data (Health Canada et al., 2009),
the 95th percentile of food intake is above the UL for
children 4-8 years of age. The adverse effect associated
with exceeding the UL is reduction of copper status
(IOM, 2001).
4.3 Vitamin or Mineral Nutrients with a Different
Maximum Level for Products Targeted to Adults
and to the General Population
For the group of nutrients with a UL listed in Table 3,
different maximum levels have been recommended for
products intended for the general population (i.e.,
including children) and those intended for adults only.
To set the maximum level for products targeted to the
general population, the UL for the most vulnerable
population was used, which was 4-8 year olds in the
majority of cases. The maximum level for adults was set
using the UL for the most vulnerable adult group. For
products to be permitted to contain the maximum levels
that are specified for adults only, they must have an
indication “For adults only” on their label.
4
Int Food Risk Anal J, 2014, 4:3
Nutrient
Population1
Maximum Level
(per serving)
Choline2
General Population
54 mg
Adults Only
492 mg
Niacinamide3
General Population
34 mg
Adults Only
158 mg
Vitamin B6
General Population
7 mg
Adults Only
18 mg
Vitamin C
General Population
66 mg
Adults Only
305 mg
Vitamin D
General Population
11 µg
Adults Only
13 µg
Copper4
General Population
342 µg
Adults Only
1070 µg
Magnesium
General Population
12 mg
Adults Only
57 mg
Molybdenum5
General Population
80 µg
Adults Only
351 µg
Selenium6
General Population
6 µg
Adults Only
23 µg
1 For products to be permitted to use the maximum levels that
are specified for adults only they must have an indication “For
adults only” on their label.
2 Canadian intake data not available; therefore, intake estimated
from the Dietary Reference Intake Report (IOM, 1998).
3 The maximum level was calculated using the UL from the
European Commission Scientific Committee on Food as opposed
to the IOM UL.
4 Canadian intake data not available; therefore, U.S. intake data from
National Health and Nutrition Examination Survey III (NHANES
III) was used to calculate the maximum level (IOM, 2001).
5Canadian intake data not available; therefore, intake was
estimated from the Dietary Reference Intake Report (IOM, 2001).
6Canadian intake data not available; therefore, U.S. intake data
from NHANES III was used to calculate the maximum level
(IOM, 2000).
Table 3. Vitamin or Mineral Nutrients with a Different
Maximum Level for Products Targeted to Adults and to the
General Population
4.4 Vitamins or Mineral Nutrients with One Maximum
Level Set for All Populations
For the nutrients in this group, only one maximum level
was set for each nutrient for all population groups. In all
cases except for phosphorus, a value other than the IOM
UL was used to set the level, because in some cases the
IOM has not set a UL or even where there was such a UL,
new information relative to toxicity has emerged since the
publication of the IOM report.
•
•
Nutrient
Beta-carotene
Maximum Level (per serving)
1040 µg
•
Vitamin E
5 mg
Chromium(III)1
30 µg
•
Phosphorous
185 mg
Potassium
300 mg
Chromium (VI) is a form of chromium that is not permitted for
addition to foods. It is found in the environment as a chemical
by-product and has been shown to be carcinogenic when inhaled
(IOM, 2001).
1
Table 4. Vitamins or Mineral Nutrients with One Maximum
Level Set for All Products
Details on setting maximum levels for nutrients listed in
Table 4
Beta-Carotene
The IOM did not set a UL for beta-carotene due to
insufficient data (IOM, 2000). The maximum level was
derived using the United Kingdom Expert Group on
Vitamins and Minerals Safe Upper Level for daily
consumption of supplemental beta-carotene over a lifetime (7000 µg/d) (Expert Group on Vitamins and
Minerals, 2003) and subtracting the estimated
consumption from supplements (1800 µg/d) to derive a
value of 5200 µg/d. This value was then divided by five to
arrive at a maximum level of 1040 µg/serving.
Vitamin E
The IOM set the adult UL at 1000 mg alpha-tocopherol
(AT) (which applies to supplements, fortified foods, or a
combination of the two) based on the potential for
haemorrhagic effects (IOM, 2000). However, since the
publication of that report, a number of other studies have
cast doubt on the safety of vitamin E in certain vulnerable
subpopulations at intakes below the UL.
Health Canada Food Directorate’s proposed approach to
set a maximum level for Vitamin E followed the rationale
described below.
• A Lowest Observed Adverse Effect Level (LOAEL)
of 180 mg AT/d (400 IU “synthetic” or 268 IU
“natural” vitamin E) (PEN, 2013) was determined
based on two clinical trials which found that
supplemental vitamin E may increase the risk of
prostate cancer and second primary cancer in
healthy older (≥ 50 years of age) men and patients
undergoing radiation therapy, respectively (Klein et
al., 2011); (Bairati et al., 2005).
An uncertainty factor of 3 was applied for the
extrapolation of the LOAEL of 180 mg AT to reach a
No Observed Adverse Effect Level (NOAEL)
(Expert Group on Vitamins and Minerals, 2003)
equalling 60 mg;
The safe upper level for daily consumption of
vitamin E added to foods is therefore taken to be 60
mg AT/d;
The Canadian consumption from supplements was
estimated to be equal to 34 mg AT/d;
The estimated Canadian consumption from
supplements (34 mg AT/d) was subtracted from the
safe upper level for daily consumption in foods (60
mg AT/d) to derive a value of 26 mg AT/d. This
value was divided by five to arrive at a maximum
level of 5 mg/serving (after rounding).
It is important to note that dietary vitamin E was not
subtracted from the safe upper level as it has not been
linked to adverse outcomes. Current fortification levels in
the general food supply are limited. A separate maximum
level was not set for children since the maximum was
based on adverse effects in adult subpopulations.
Chromium
The IOM did not set a UL for chromium (IOM, 2001). The
European Food Safety Authority (EFSA) Panel on Food
Additives and Nutrient Sources added to Food concluded
that the safety of chromium(III) as a nutrient added to
foods for particular nutritional uses and foods intended
for the general population (including food supplements)
is not of concern, provided that the intake of
chromium(III) from these sources does not exceed 250
µg/d, the value established by the World Health
Organization for supplemental intake of chromium(III)
that should not be exceeded (EFSA, 2010; World Health
Organization, 1996).
The highest level of chromium(III) found in the top 5
selling multivitamin/mineral supplements for adults
currently marketed in Canada (100 µg/d) was subtracted
from the maximum level for chromium(III) (250 µg/d)
established by the WHO and EFSA. This maximum value
per day (150 µg) was divided by five to arrive at a
maximum level of 30 µg/serving.
Phosphorus
The IOM UL was used to set the maximum level (IOM,
1997) but given that the most vulnerable group was adult
males older than 70 years of age, only one level was set.
The same method was used as other nutrients with a UL
by adding the 95th percentile of daily dietary intake to the
estimated intake from supplements, and subtracting this
total from the UL and dividing by 5.
Chantal Martineau, Jennifer Barber, Jesse Bertinato, Steve Brooks, Eunice Chao, Janice Daoust, Nora Lee,
Lindsay Lukeman, Robin J. Marles and Natasha Hinkson: Food Risk Analysis Communication
5
Potassium
Certain medications and medical conditions can decrease
renal excretion of potassium and predispose individuals
to hyperkalemia (Bakris et al., 2013). Although the IOM
has not determined a UL for potassium (IOM, 2006), the
maximum level for potassium was established to protect
vulnerable individuals from hyperkalemia. Intake above
1500 mg from these products was deemed inappropriate
because vulnerable individuals on a low potassium diet
are often instructed to consume no more than 1500–2700
mg potassium/d (Bakris et al., 2013). Also, vulnerable
individuals on a low potassium diet may not be
counselled currently to avoid potassium-fortified foods.
Limiting the amount of potassium that can be added to
these products to 300 mg per serving (1500 mg/d ÷ 5
servings) provides a measure of protection in the event
that these individuals choose to consume these products,
unaware of the added level of potassium.
4.5 Vitamins for which No Maximum Level will
be Set at this Time
Table 5 includes nutrients with no UL for which no
maximum levels have been proposed. The absence of a
UL for these nutrients means that there is either no
adverse effects that have been associated with high
intakes or data on adverse effects were not considered
sufficient for derivation of a threshold (IOM, 2006). Even
if no maximum levels are being proposed for these
nutrients, the acceptability of any levels above those
found in currently marketed products will be assessed by
Health Canada.
•
•
•
The 5th percentile of dietary intake was selected as a
reference value because for amino acids, the greatest risk
appears to be from a negative effect on protein quality
among those consumers who have a low dietary intake of
protein, rather than a risk from overconsumption
associated with toxicity as is the case for vitamins and
minerals. The concern is that adding individual amino
acids to these products may cause a decrease in protein
quality of the diets, particularly for individuals with an
already low intake of protein or intake of poor quality
protein.
Amino Acid
Maximum Level
(per serving)
Alanine
67 mg
Arginine
78 mg
Aspartic Acid + Asparagine1
115 mg
Cysteine + Cystine1
16 mg
Glutamic Acid + Glutamine1
340 mg
58 mg
Nutrient
Population
Glycine
Thiamine
General Population
Histidine
46 mg
Riboflavin
General Population
Isoleucine
71 mg
Vitamin B12
General Population
Pantothenic Acid
General Population
Leucine
124 mg
Biotin
General Population
Lysine
105 mg
Methionine
36 mg
Phenylalanine
72 mg
Proline
122 mg
Table 5. Vitamins for which No Maximum Levels will be Set at
this Time
5. Proposed Maximum Levels for Amino Acids
The IOM has not established ULs for amino acids (IOM,
2006) and neither has any other food safety or nutrition
authoritative body. Therefore a conservative approach
was developed based on potential adverse effects on
dietary protein quality in vulnerable populations that
may result from consuming high amounts of single
amino acids rather than whole proteins.
The proposed approach to establish maximum levels for
amino acids (Table 6) followed the rationale described
below:
6
A daily maximum level of each amino acid was
determined such that intake from these products
would not exceed 20% of the total daily intake of
each amino acid for individuals at the 5th percentile
of dietary intake (Health Canada et al., 2009).
Each daily maximum level was divided by five
assuming people might consume up to 5 servings of
these products in a day.
For all amino acids only one level was proposed,
which applies to the general population given that
the most vulnerable group was adult females >70
years of age.
Int Food Risk Anal J, 2014, 4:3
Serine
Taurine
71 mg
2
Threonine
600 mg
56 mg
Tryptophan
17 mg
Tyrosine
58 mg
Valine
79 mg
The maximum level applies to both forms of the amino acid
combined
2Taurine is often considered an amino acid but it is actually a 2aminoethanesulfonic acid
1
Table 6. Maximum Levels of Addition for Amino Acids for the
General Population
In addition, the risks associated with some amino acids as
separate food ingredients are not the same as for amino
acids that are components of protein because the human
body regulates the breakdown of proteins into their
constituent amino acids in a manner that helps to ensure
there will not be an excess of any individual amino acid
in the bloodstream.
Taurine
There is insufficient information to establish a UL for
taurine. Based on published clinical trials and supported
by animal studies, a Highest Observed Intake approach
established an Observed Safe Level of 3 g/d of taurine as
a daily maximum level of supplemental intake (Shao,
2008). This amount was divided by five, based on the
assumption that people might consume up to 5 servings
of these products in a day, which resulted in a maximum
level for taurine of 600 mg per serving, applicable to the
general population.
6. Conclusion
This paper attempts to present a risk-based approach to
set maximum levels for the addition of vitamins, mineral
nutrients and amino acids to foods that are intended to be
consumed as a vehicle of nutrient supplementation.
The approach proposed is limited by data gaps related to
the consumption patterns of these foods with added
nutrients by different subsets of the population. The
approach was also challenged by the uncertainty related
to the way these products would be represented to
consumers and therefore the consumers’ ability to
distinguish them from their equivalent that are not
intended as a vehicle for nutrient supplementation.
Where risks were clearly identified or uncertainties
deemed important, a conservative approach was
followed to set proposed maximum levels for addition of
these nutrients. The proposed levels will be thoroughly
re-examined upon collection of additional data
characterizing Canadians’ consumption of foods and
beverages intended to be used as a vehicle for
supplementation or “supplemented foods”.
Information and data related to the effectiveness of
labelling as a measure to alert consumers to the
exceptional nature of these products and their
differentiation
from
their
“non-supplemented”
equivalent will also support the evaluation of the
proposed risk management approach. This may in turn
impact the proposed composition requirements for
nutrients discussed in this paper. The temporary
marketing authorization of selected products, satisfying
to provisional formulation and labelling requirements,
with a data collection obligation to fill some of the
knowledge gaps on consumption information and
consumers’ reaction will be an avenue used by Health
Canada’s Food Directorate to support the re-evaluation of
the current proposed approach.
7. References
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Nabid, F. Brochet, J. P. Mercier, B. Têtu, F. Harel, B.
Abdous, E. Vigneault, S. Vass, P. Vecchio and J. Roy,
“Randomized trial of antioxidant vitamins to prevent
acute adverse effects of radiation therapy in head
and neck cancer patients.” Journal of Clinical
Oncology, vol. 23, no. 24, pp. 5805 – 5813 (2005).
[2] G. L. Bakris and B. Olendzki, “Patient information:
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2014 Jan 31]. Available from:
http://www.uptodate.com/contents/low-potassiumdiet-beyond-the-basics?source=related_link, (2013).
[3] EFSA Panel on Food Additives and Nutrient Sources
added to Food, “Scientific Opinion on the safety of
trivalent chromium as a nutrient added for
nutritional purposes to foodstuffs for particular
nutritional uses and foods intended for the general
population (including food supplement).” European
Food Safety Authority Journal, vol. 8, no. 12, pp. 1882 –
1927 (2010).
[4] Expert Group on Vitamins and Minerals, “Safe Upper
Levels for Vitamins and Minerals,” [accessed on: 2014
Jan 31]. Available from:
http://cot.food.gov.uk/pdfs/vitmin2003.pdf, (2003).
[5] A. Flynn, O. Moreiras, P. Stehle, R. J. Fletcher and D.
J .G. Müller, “Vitamins and minerals: A model for
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[6] Health
Canada,
“Authorized
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