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| Fortified
foods: the addition of vitamins and minerals to foods |
CFG
03/03
Comments by UK
voluntary, statutory and professional organisations concerned with
the effects of EU policies and proposals on UK consumers
Introduction
Conclusions and recommendations
Background
Scientific, legislative and policy considerations
Specific considerations
Labelling issues
1. INTRODUCTION
The addition of nutrients to foods is common practice and has long
been used for the purpose of restoration, standardisation, ensuring
the nutritional equivalence of substitute foods, and for fortification
or enrichment.
The addition of nutrients to food is a subject of considerable debate
within the European Union. This debate is fuelled by the different
degrees of acceptance of fortification within Member States, and by
the different regulations across the EU. Although the aim of the
different approaches in Member States is to protect and promote good
public health, these differences have created confusion for consumers
and have restricted free trade.
We therefore welcome the Commission's attempt to introduce legislation
to control the sale and marketing of fortified foods. The primary
objective of this legislation must be to ensure consumer safety although,
at the same time, it must also ensure that consumers are not misled
and are given adequate information to be able to make informed choices
about their diet.
2. CONCLUSIONS AND RECOMMENDATIONS
Mandatory fortification
We consider voluntary fortification should not conflict with, or jeopardise,
national nutrition policies.
Scope
We recommends that, in cases where novel food legislation does not
apply, the Commission should extend the scope of the Directive to
cover the many other nutrients and bioactive substances added to foods
(including, but not limited to, amino acids, fatty acids, flavanoids
and phytooestrogens). We recommend that the Commission establish a
timetable to do this as soon as practicable.
Non-fortified foods
We agree that consumers must be able to choose whether or not to buy
fortified foods and calls for measures to ensure that a full choice
of original, non-fortified foods remains freely available.
Foods to which nutrients may be added
We recommend that foods high in fat, added sugar, and salt, low in
fibre or otherwise "unhealthy" for consumers should not
be fortified. Nutritional criteria for foods that may not be fortified
should be developed.
Positive Lists
We strongly support the development of positive lists for all substances
used in fortified foods. We recommend that substances on positive
lists must have been subject to prior safety evaluation by independent
experts, such as the EU Scientific Committee on Food (SCF).
Purity Criteria
We consider that, in the short term, the Commission may need to set
general purity criteria in the form of maximum levels of specific
contaminants, such as heavy metals, and establish a programme to identify
the risks and set more detailed criteria across the market.
Limits
We support the setting of maximum limits for vitamins and minerals
in fortified foods in conjunction with appropriate scientific risk
assessments carried out by independent experts (e.g. the SCF or UK
Expert Group). We consider that the same principles should, in due
course, be used to set maximum limits for all other substances used
in food foods to ensure the same degree of safety as applied to vitamins
and minerals.
We recommend that the whole process used to set maximum limits, including
the scientific risk assessment, must be made open and transparent
and must gain the wide agreement of stakeholders, including consumer
groups.
We recommend that a consistent approach to the safety evaluation of
nutrients should be established: where there is uncertainty in the
science or a lack of knowledge, a precautionary approach should be
adopted.
We recommend that the workings of both the SCF and the UK Expert Group
should be made more open and transparent and that there should be
effective co-ordination, and co-operation, between both committees
to avoid wasting resources.
We recommend that the SCF be given a clear responsibility for the
determination of the EU research programme on vitamin and mineral
safety and, in doing so, it should take full account of relevant national
research programmes (e.g. the UK Expert Group's research programme).
We strongly support the proposal that maximum limits for vitamins
and minerals in fortified food take account of all other sources of
intake from the daily diet. We have previously called for additional
surveys to be carried out to establish baseline data on diets and
nutrient intake for all EU Member States, including any sub-groups
of the population within each country. Significant differences continue
to exist in the availability of such data for each Member State.
Where such data is unavailable, a precautionary approach to setting
maximum limits should be taken.
We welcome the proposal to take nutritional need into account when
setting maximum limits for those vitamins and minerals which have
a narrow margin of safety between Dietary Reference Value (DRV) and
upper safe intake level.
We welcome the proposal to set minimum limits for vitamins and minerals
in fortified foods. Such limits should be set by an independent committee,
such as the SCF, that would also be responsible for identifying and
reviewing the justification for nutrient-related claims to protect
consumers from being misled.
Notification and monitoring
We strongly support the principle of notification as we consider it
will help to control the placing of products on the market and their
subsequent monitoring.
We consider monitoring is essential to assess the long-term health
effects from the use of fortified foods. Any adverse data from these
monitoring programmes must then be reported back to independent scientific
committees, such as the SCF, who should keep risk assessments under
review.
Labelling issues
We consider that the voluntary addition of specific nutrients to a
food may mislead consumers about that food's overall nutrient content.
We therefore recommend that fortified foods should be required to
give a full label description of their nutritional profile as well
as their ingredients.
We support the proposal for specific nutritional labelling that would
declare the level of nutrients in a product in absolute numbers and
as a percentage of the appropriate Dietary Reference Value. In addition,
we consider a study should be carried out to establish the most useful
way for consumers to understand such information on labels.
We consider that health claims should not be permitted. However,
should they be allowed, health claims should be regulated at EU level
to ensure consistency across the single market and to provide a basis
for enforcement. We consider that full substantiation of claims and
pre-market approval by an independent committee, such as the SCF,
should be a requirement.
We are opposed to the use of implied claims.
We consider that where specific population subgroups require supplementation
for particular reasons associated with their medical or nutritional
status, this should be addressed through 'PARNUTS' or medical channels
and not through generalised food labelling.
3. BACKGROUND
While the addition of nutrients for the purposes of restoration, standardisation
and substitution is generally acknowledged, there is less agreement
over the role of fortification/enrichment. The 1987 Codex Alimentarius
General Principles for the addition of nutrients to foods only allows
fortification for the purpose of preventing or correcting a demonstrated
deficiency of one or more nutrients in the population or specific
population groups. However the current draft proposal from the Commission
argues that, based on the nutritional status of the population, the
dietary habits and the socio-economic situation prevailing in the
Community, this definition is restrictive and outdated. The Commission
proposes to extend legitimate purposes of fortification to cover both
possible deficiencies in dietary intakes of nutrients, due to changes
in dietary habits, and evolving generally accepted scientific knowledge
on the role of nutrients in health. This more liberal interpretation
of fortification, foregoing the requirement to prevent or correct
a demonstrable deficiency, reflects the current practice in Member
States where voluntary addition of nutrients is allowed (e.g. the
UK, Holland and Germany).
An increasing number of fortified foods are becoming available on
the European market. As consumers have become more aware of the benefits
of a healthy diet, food manufacturers have increasingly fortified
foods with vitamins, minerals or other substances such as herbal extracts.
Continued innovation by the food industry has lead to the production
of foods with added functional ingredients that manufacturers claim
can help to develop and maintain optimal health - so called 'functional
foods'. These developments are currently not specifically regulated
and there is a pressing need to introduce legislative control into
the market place.
4. SCIENTIFIC, LEGISLATIVE AND POLICY CONSIDERATIONS
Mandatory fortification
Population groups within Member States have different diets and different
intakes of nutrients, and consequently different needs for supplementary
nutrients. We recognise that the variation in statutory additions
of nutrients (whether for restoration or fortification) between Member
States and their basis in relation to national public health are unlikely
to be applicable throughout the Community. It should be possible
for Member States to retain such national provisions if they are made
on public health grounds and where there is clear scientific justification.
We welcome the fact that the Commission's proposals do not affect
national provisions for mandatory fortification. Voluntary fortification
should not conflict with, or jeopardise, such national nutrition policies.
Scope
The Commission intends to restrict the scope of the proposed Directive,
in the first instance, to vitamins and minerals. We welcome this
as a first step. However, food manufacturers are increasingly adding
many other nutrients and bioactive substances to foods to gain marketing
advantage including, but not limited to, amino acids, fatty acids,
flavanoids and phytooestrogens. In cases where novel food legislation
does not apply, We recommend that the Commission introduces similar
proposals to bring such practices under harmonised regulatory control
and should establish a timetable to do this as soon as practicable.
Non-fortified foods
We agree that consumers must be able to choose whether or not to buy
fortified foods and should not be obliged to do so. If necessary,
adequate measures must therefore be taken to ensure that a full choice
of original, non-fortified foods remain freely available for consumers
who prefer to buy them.
5. SPECIFIC CONSIDERATIONS
Foods to which nutrients may be added
Lack of vitamins and minerals in a diet is often a symptom of overall
poor nutrition, usually the result of a diet containing too much fat,
too little fibre, little variety and not enough fruit and vegetables.
A healthy balanced diet is widely regarded as one based on a high
consumption of cereals, fruit and vegetables and a moderate consumption
of meat and dairy products.
Among consumers there is likely to be some differences of view as
to the value of the restoration and fortification of foods with added
nutrients within the context of a healthy balanced diet. We consider
that fortifying food is not the way to improve inadequate diets.
There is a body of opinion concerned that a proliferation of foods
with added nutrients would make it increasingly difficult for consumers
to choose a balanced diet. There is a danger that consumers may wrongly
believe that fortified foods can substitute for a healthy balanced
diet. As many fortified foods are marketed for young children, there
is a particular risk that parents will be led to believe that such
products are especially healthy when this is not necessarily the case.
In Europe the consumption of too much food energy is much more common
than under nutrition. Excessive fat intake is a particular concern.
For this reason we recommend that unhealthy food products that are
high in fat, salt, and added sugar should not be fortified. The addition
of vitamins and minerals to foods should not encourage poor dietary
practice and should be carried out in the context of an overall healthy
diet. Some countries (eg Australia, New Zealand and the USA) define
nutritional profiles for foods that can be fortified due to the potential
for random fortification to create nutrient imbalances in the food
supply and for consumers to be misled by unregulated claims. The
US FDA considers it "inappropriate to fortify fresh produce;
meat, poultry, or fish products; sugars; or snack foods such as candies
and carbonated beverages." We recommend that nutritional criteria,
applicable to Europe, be developed for foods that may not be fortified.
Such foods could be defined using generally accepted nutritional principles,
for example, those used by some UK retailers to label "healthy"
foods, or based on specifications used in other countries if appropriate.
At present there is an imbalance between, on the one hand, the marketing
of fortified foods and, on the other, promotion of a healthy diet
through nutritional education programmes which is misleading to consumers.
We recommend that nutritional education at both national and European
level should promote healthy eating habits. Such programs should
ensure that consumers are made aware that fortified foods cannot replace
a balanced and healthy diet. There is also a need to ensure that
labelling and advertising of products is not misleading and does not
conflict with, or undermine, nutritional education messages. Such
labelling should make clear the distinction between products that
have been fortified and products in which nutrients lost in processing
have been restored.
Positive lists
We strongly support the development of positive lists for vitamins
and minerals that may be used in fortified foods. Positive lists
should, in due course, be extended to cover all other substances that
may be used to fortify foods. We consider that positive lists specifying
appropriate sources of these substances must also be developed in
order to avoid any confusion. We recommend that substances on positive
lists must have been subject to prior safety evaluation by independent
experts, such as the EU Scientific Committee on Food (SCF).
Purity criteria
We strongly agree that purity criteria must also be established for
all substances used to fortify foods (initially vitamins and minerals)
to safeguard purity of such substances. Producers must be required
to produce evidence that they have taken seriously their duty to produce
a safe product. Purity criteria would need to include information
on the nature of the raw materials used, method of processing, impurities
that may be present, limits on the level of contaminants, natural
toxicants and microbiological standards. Where possible toxicological
safety tests must be conducted on raw material that complies with
the purity criteria. Given the size of this task, in the short term,
general purity criteria could be established in the form of maximum
levels for specific contaminants, such as heavy metals, and a programme
established to identify the risks and set more detailed criteria across
the market.
Safety of fortified food - maximum limits for addition of vitamins
and minerals to fortified foods.
Transparency
We consider some of the main issues of concern relate to the need
for safety to be openly demonstrated in a transparent way for fortified
foods. This is essential to ensure consumer confidence in the product.
The whole process used to set maximum limits, including the scientific
risk assessment and any other principles adopted, must be made open
and transparent and must gain the wide agreement of stakeholders,
including consumer groups.
Risk assessment and maximum limits
For some nutrients, such as Vitamins A or B6, there is clear evidence
of adverse physiological effects when taken at high doses. For other
nutrients, there is little or no evidence of adverse effects at present.
However, the long-term consumption of high doses (at and above the
Recommended Daily Allowance) of nutrients is a relatively recent phenomenon
and little is known about any resulting adverse effects. It should
not be assumed that consumption at these levels is safe. Foodaware:
the Consumers Food Group has called for a structured approach to studying
these issues, involving both nutritionists and pharmacologists, and
therefore supports the efforts of the SCF and the UK Expert Group
on Vitamins and Minerals to establish upper safe levels of intake
by a thorough risk assessment including toxicological and human data.
We support the setting of maximum limits for vitamins and minerals
in fortified foods in conjunction with appropriate scientific risk
assessments establishing upper safe levels carried out by independent
experts, such as the SCF or the UK Expert Group. We consider that
maximum limits should also be set for other substances used to fortify
foods in due course. Maximum limits should equate to the amount of
the product that would generally be consumed in one day.
The risk assessment process itself is fundamentally important. We
recommend that a consistent approach to the safety evaluation of nutrients
must be established. Where there is uncertainty in the science or
a lack of knowledge, we consider it essential for a precautionary
approach to be adopted. The wide variation in individual's dietary
requirements and the limited information regarding likely effects
of long-term consumption of high levels of many nutrients (as this
is a relatively recent phenomenon) are two very important sources
of uncertainty that must be taken into account. The upper safe intake
level must also take into account the toxicity of substances in combination,
due to adverse interactions, as well as individual toxicity.
We consider that there is a lack of clarity about the work being done
by the SCF in this field and a potential lack of co-ordination between
it and the UK Expert Group. We are particularly concerned about a
lack of co-ordination between the separate research programmes on
vitamin and mineral safety conducted at EU and national level. We
recommend that the workings of both the EU and the UK committee be
made more open and transparent and that there be effective co-ordination
and co-operation between both committees to avoid wasting resources.
We are concerned by the perceived lack of influence that the SCF has
in determining the content of the EU research programme on vitamin
and mineral safety. We therefore recommend that the SCF be given
a clear responsibility for the determination of this research programme
and, in doing so, it should take full account of relevant national
research programmes (e.g. the UK Expert Group's research programme).
We consider that there may be a need for the risk assessment to advise
both manufacturers and consumers how to respect upper safe levels
of intake when choosing foods in the diet.
Taking account of intakes from all other dietary sources, we strongly
support the proposal for maximum limits for these substances in food
supplements to take into account of all other sources of intake.
In order to evaluate fully the dietary intakes of vitamins and minerals
it is important to consider intakes from food supplements in addition
to natural sources. It is recognised that the data available on intake
varies significantly between Member States and between individuals
within any population. The former Consumers in Europe Group (CEG)
called for surveys of food intake to be established on a community-wide
basis to identify baseline data on diets and nutrient intake for all
EU Member States, including any sub-groups of the population within
each country. Significant differences continue to exist in the availability
and comparability of such data for each Member State. Where such data
is unavailable, a precautionary approach to setting maximum limits
should be taken.
It has not been made clear how the different national diets and nutritional
status of different populations and individuals across the community
will be taken into account. It is therefore unclear how a single
set of maximum limits can be appropriate for consumers of all ages
in Member States with very different dietary intakes and requirements.
Nutritional need
Foodaware considers that nutritional need should be taken into account
when setting maximum limits for those vitamins and minerals which
have a narrow margin of safety between Dietary Reference Value (DRV)
and upper safe intake level.
Minimum limits
We welcome the proposal to set minimum limits for vitamins and minerals
in fortified foods. In this respect it is important that the bioavailability
of nutrients is also assessed. Consumers buying food supplements
would be misled if the amount of the available nutrient were to be
too low to have an effect on dietary intake. Minimum limits are therefore
of particular importance when linked to claims made for a product
based on their nutrient content. We consider that such limits should
be drawn up by an independent scientific committee, such as the SCF,
that would also be responsible for identifying and reviewing the justification
for nutrient-related claims, based on the most up-to-date research.
Notification & Monitoring
We strongly support the principle of notification as we consider it
will help to control the placing of products on the market and their
subsequent monitoring.
We consider monitoring essential to assess the long-term health effects
from the use of fortified foods. Any adverse data from these monitoring
programmes must then be reported back to independent scientific committees,
such as the SCF, who should keep risk assessments under review.
6. LABELLING ISSUES
General labelling provisions
Alongside safety, the other main issue of consumer concern is that
of information and labelling. Consumers who choose fortified foods
are likely to be taking a specific interest in their health and physical
well being, but may not necessarily be well informed about appropriate
intake levels.
We support the proposed application of general labelling provisions
to fortified foods. We consider that the voluntary addition of specific
nutrients to a food may mislead consumers about that food's overall
nutrient content. We therefore recommend that fortified foods should
be required to give a full label description of their nutritional
profile as well as their ingredients. The level of nutrients in a
product should be declared in absolute numbers and as a percentage
of the Recommended Daily Allowance. This information and its presentation
must be standardised to allow consumers to be able to compare different
products. We suggest that there should be a study to establish the
most useful way for consumers to understand nutritional information
on labels.
In general, consumers would not expect to see specific warnings or
instructions on use of fortified foods and maximum levels of vitamins
and minerals should be set such that safe intake levels will not be
exceeded. However, guidance about taking care when mixing with food
supplements and warnings for specific groups of the population, should
be included if appropriate. There may also be a case for other types
of general information, such as 'average diets in the UK contain sufficient
X, this product is only necessary if the diet is deficient or restricted'.
Claims
As stated in CEG's response to the Commission's Green Paper on Food
Law, Foodaware considers that nutritional and health claims should
be regulated at EU level, to ensure consistency across the Single
Market and to provide a basis for enforcement.
CEG called for greater control over the use of claims made about foodstuffs,
particularly fortified foods and food supplements, for many years.
As the number and range of claims has grown consumers can be left
increasingly confused and without sufficient information to assess
these objectively. Current legislation is inadequate to deal with
the range of claims currently being made about foodstuffs.
Food claims can have a significant impact on the purchasing decisions
of consumers. Ideally, we consider that such messages should be limited
to objective, measurable aspects of a food which enable consumers
to make up their own minds about the health value of a food. Nutrition
claims should be clearly defined in terms of the quantitative level
of the nutrient present, be consistent between products and be meaningful
to consumers.
In relation to health claims, we consider that health claims are hard
to justify for individual foods and that any potentially useful educational
role they might have will be heavily outweighed by their potential
to confuse and mislead consumers. Ideally such claims should not
be allowed. Instead, consumers should be encouraged to achieve dietary
change by the provision of clear, accurate, simple and comprehensive
nutrition information and education - rather than through marketing
claims. However, if a decision is taken to permit health claims then
we consider that this should only be under very limited and strict
conditions. These should include full substantiation of any claims
made and pre-market approval.
We are opposed to the use of implied claims, for instance via product
packaging and product names, which cannot be controlled in this way
and can cause confusion.
We agree that it is important to disseminate information regarding
a generally accepted need for supplementation of the diet to meet
the medical needs of specific groups of people. However, we consider
that this is an area where it is important to make the distinction
between medicinal use and food use (e.g. folic acid and iron supplementation
for pregnant women or the need for psoriasis sufferers taking high
dose Vitamin A medication to avoid Vitamin A-containing supplements).
In order to avoid confusing consumers fortified foods intended for
consumption by the general population should not carry information
on the label addressing the medical needs of specific at-risk groups.
We consider that where particular population subgroups require supplementation
for particular reasons associated with their medical or nutritional
status, this should be addressed through 'PARNUTS' or medical channels
and not through generalised food labelling.
July 2001
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