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| Addition
of vitamins and minerals and of certain other substances to foods |
CFG
06/04
Comments by Foodaware
on the Proposal for a Regulation of the European Parliament and of
the Council on the addition of vitamins and minerals and of certain
other substances to foods (COM (2003) 671 final)
Introduction
Background – General Comments
Specific Issues – Addition of Vitamins
and Minerals
Specific Issues – Addition of
certain other substances
Detailed Comments on the Text of the
Regulation
Members welcome the opportunity to comment on this important area
of food policy where industry practice is developing rapidly and there
is a significant risk of over-consumption of some nutrients, which
can be toxic if consumed to excess.
Introduction
Foodaware welcomes the proposal to harmonise national rules regarding
the voluntary addition of vitamins and minerals to foods by establishing
a positive list and introducing labelling requirements. The draft
Regulation also prohibits fortification of fresh, non-processed produce
and alcoholic beverages which we also support. The draft proposal
is clearly written and the case for regulation effectively argued.
Background – General Comments
We agree that for the time being it should be possible for Member
States to retain national provisions for mandatory fortification where
this is justified on public health grounds by reference to scientific
analysis. However, we consider that the Commission should establish
a timetable for reviewing the ongoing justification for national mandatory
rules. In the UK, for example, rules governing the mandatory addition
of nutrients to margarine and flour were introduced in the post war
period to prevent deficiency diseases. It is questionable whether
the justification for fortification remains valid today when food
supply is plentiful and the majority of the population is adequately
nourished. We would encourage you to put forward proposals regarding
the conditions under which compulsory fortification should be permissible
as soon as practicable. We note that the present proposal does not
cover those nutrients that are allowed in products for particular
nutritional purposes and regulated under the PARNUTS Directive.
We accept that the voluntary addition of vitamins and minerals, for
example, in breakfast cereals, flour and margarine can add significantly
to the intake of essential nutrients and reduce the risk of deficiency.
They are of particular value where specific population groups have
low nutrient status. There is, however, considerable variation between
individuals and Member States suggesting that the general fortification
of foods may be both undesirable and unnecessary. Voluntary fortification
should not conflict with or jeopardise national nutrition policies
and non fortified food should be available for those who wish it.
We are also concerned about the potential for some people to consume
excessive amounts, at a time when deficiency diseases in the EU are
rare, and tend to be confined to specific population groups and those
with medical conditions. Thus, while we do not favour a ban on the
voluntary addition of essential nutrients to food, we believe that
their application should be controlled and that the levels of consumption
within the population should be monitored. Where nutrients are added,
any claims should make clear the importance of a balanced and varied
diet. This is not currently included in the proposal. Food suppliers
should not be permitted to create an image that fortified foods are
better, healthier or otherwise superior than fresh, unprocessed and
traditional foods which have not been supplemented.
Specific Issues – Addition of Vitamins
and Minerals
Safety : We are pleased that the Commission (Para 11) acknowledges
the risk to consumer health from proliferation of fortified foods.
The argument, however, that liberal fortification regimes in some
countries have not led to an explosion in the market in fortified
food does not justify the industry being given a free hand to determine
the nutrients which may be added and the quantities. If the Commission
wishes to protect public health, it must as proposed, specify a positive
list, then monitor the rate and nature of changes in the food supplied
and consumed to ensure that acute health effects or long term damage
do not occur. The Commission considers monitoring to be a matter for
Member States and the proposal allows them to establish notification
systems in addition to food intake surveys and other means of monitoring.
The Commission states that data collection should be given priority,
but gives no commitment about its role in gathering information on
relevant indicators. A more specific commitment is necessary to ensure
systems in Member States are adequate to allow the position in the
EU to be monitored.
Claims : The proposal acknowledges that Consumer organisations
consider that products that do not have a ‘desirable nutrient
profile, such as sweets, high salt and high fat snacks or high fat
and sugar biscuits and cakes should not be allowed to be fortified.
We strongly support this view. Fortification of food is heavily influenced
by marketing considerations. The ability for manufacturers to make
a claim is likely to be a major driver for the introduction of new
forms of fortification, with potential consumer benefit a secondary
consideration. Food suppliers should not be permitted to create (or
suggest, for instance with pictures) that fortified foods are better,
more healthy or otherwise superior than fresh, unprocessed and traditional
foodds which have not been supplemented. The use of fortification
must not be permitted to give a positive image to foods that contain
high levels of sugar, fat and salt, and the regulation on health claims
should be rigorously applied to ensure consumers are not misled.
We also agree with the Commission’s view that vitamins and minerals
should not be added to fresh fruit, vegetables, meat poultry, fish
and alcoholic drinks but regret that it is not proposing a similar
restriction for other foods such as dairy products (e.g milk, cream,
yoghurt, butter, cheese and eggs). We recommend that nutritional criteria
be drawn up for foods that are not allowed to be fortified in Europe
taking account of developments in Australia, New Zealand and the USA.
We are also concerned that the addition of vitamins and minerals to
foods should not encourage poor dietary practice, but should be carried
out in the context of an overall healthy diet to which reference should
be made on the label.
Labelling : Informative labelling is the key to consumer choice,
and accurate labelling where products are fortified is essential if
consumers are not to be misled. We agree that all fortified
products should carry comprehensive nutrition labelling but should
also include information on the importance of a balanced diet with
warnings about the risk of consuming too much. We believe that the
way nutrition information is given on labels could be improved and
would like consideration to be given to declaring the level of nutrients
in a product in absolute numbers and as a percentage of the appropriate
dietary reference value. To avoid confusing consumers, fortified foods
intended for the general population should not carry medical information
relevant only for specific at-risk groups. Where particular population
groups require supplementation for reasons associated with their medical
or nutritional status, this should be addressed through ‘PARNUTS’
of medical channels and not through generalised labelling.
Information : Educational initiatives to promote good diet
are supported by Foodaware and we appreciate the Commission’s
endorsement of more nutrition education. However, it is also important
that the forthcoming legislation on claims is applied and rigorously
enforced so that suppliers do not benefit inappropriately from claims
which may be relevant to very few amongst the people consuming the
product and are therefore misleading and inaccurate for many. (Paras
17/18) Information leaflets need to give guidance to encourage people
to take care when mixing fortified foods with food supplements to
avoid the risk of over-consumption. There may also be a case for other
types of information to be provided by industry or food regulators,
such as ‘average diets contain sufficient X; this product is
only necessary if the diet is deficient or restricted’ so as
not to mislead the public.
Conditions of Use : The Commission acknowledges the importance
of establishing upper limits for the addition of vitamins and minerals
to ensure total intakes of individual substances within the general
population remain safe. We strongly support the development of positive
lists and conditions of use, and endorse the Commission’s proposal
that these be subject to safety assessment by the EFSA, SCF and other
authoritative independent bodies. It is not acceptable for the safety
limits and the foods to which particular nutrients can be added to
be determined by a Regulatory Committee without proper consultation
after this ‘framework’ regulation is adopted. These levels
are important for public health and the proposed limits should be
subject to an open consultation. The scientific risk assessments and
the process for setting conditions of use must gain wide agreement
from all stakeholders including consumer groups. We fear that this
will not be achieved unless the whole process is open and transparent.
Specific Issues - Addition of Certain other substances
The Regulation may apply to substances other than vitamins and minerals
that are added to food but it is unclear what the Commission has in
mind. No substances are listed and it appears as a generic provision.
We would want substances such as amino acids, fatty acids, flavanoids
and phyto-oestrogens to be brought within this provision and would
like the Commission to establish a timetable for their inclusion.
Might this also apply to the addition of certain types of bacteria
and other probiotics?
Foodaware supports the establishment of a web-based Register of the
substances which may be added to particular foods and the maximum
and minimum quantities permitted. We remain most concerned, however,
that there should be extensive discussion with stakeholders, including
consumers, to determine which substances should be included on this
list and the conditions of use to be applied.
Detailed Comments on the Text of the Regulation
Article 6 : Purity criteria
We support the provision for purity criteria to be established by
the Regulatory Committee procedure, by reference to existing Community
legislation or as specified by international bodies where there are
no precedents within EU law.
Article 7 : Maximum and Minimum Amounts
We support the setting of maximum and minimum limits following scientific
risk assessment, taking account of the safety of the relevant nutrient,
varying degrees of sensitivity of different consumers and the intake
from all dietary sources. We particularly welcome the proposal that
the total amount of the vitamin or mineral present in the food as
sold should not exceed the maximum amounts set. This should restrict,
or indeed prohibit, the industry practice of formulating products
with more than the declared amount of vitamin or mineral to ensure
that there is sufficient throughout the shelf life (over-aging[1].
We welcome the inclusion of reference intakes when setting maximum
levels in Article 7.3
Article 7.5 is unclear about how ‘a significant amount’
should be defined. Minimum levels to ensure benefit should be set,
but will depend on assessment of the bio-availability of the nutrient
in question. Consumers buying fortified foods would be misled if the
amount available were too low to have an effect on dietary intake.
Minimum limits are of particular importance when the product’s
formulation is linked to a nutrient claim. Such limits should be based
on independent scientific judgement such as that of the SCF or EFSA.
Foodaware strongly supports an open and transparent approach to the
setting of safety levels for substances added to food. We are therefore
disappointed that the safety limits and conditions of use will be
set through a regulatory committee procedure. Maximum and minimum
limits should be based entirely on recommendations from an independent
body such as the EFSA, which should also keep the risk assessments
under review. We also want provision for a precautionary approach
to be adopted where there is uncertainty.
Article 11 - Substances under Community scrutiny
It is not clear whether substances included under this article may
continue to be used pending investigation, or whether they must be
removed if the possibility of harmful effects have been identified
in a substance currently permitted. Article 10 seems only to prohibit
their continued use if the substance has been added in excessive quantities
likely to have a harmful effect on health.
Article 17 - Monitoring
This article is particularly weak. There is no obligation on either
a Member State or the Commission to monitor the development of the
market in fortified products. This article merely provides for a Member
State to require notification of the placing of such products on the
market if it so wishes. We have previously called for additional surveys
to be carried out to establish baseline data on diets and nutrient
intake for all Member States, including vulnerable population sub-groups.
The available data continues to be patchy and of varying quality.
Article 18 – Evaluation
We support the commitment to evaluate the impact of this regulation
but suggest that the article should be more specific and oblige Member
States to supply information on the results of monitoring activity
to the Commission.
March 2004
1 'Safe Upper Limits for
Vitamins and Minerals’ Expert Group on Vitamins and Minerals,
May 2003
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