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
Date: 2003-11-10
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, inorganic chemical product, vitamin

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 10.11.2003
COM(2003) 671 final

2003/0262 (COD)

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

(presented by the Commission)

EXPLANATORY MEMORANDUM

EXECUTIVE SUMMARY

The proposed Regulation aims to harmonise divergent national rules concerning the addition
of  vitamins  and  minerals  and  of  certain  other  substances  to  foods  in  order  to  ensure  a  high
level of consumer protection and the free circulation of goods within the Community.

The proposed Regulation

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

defines the purposes for which vitamins and minerals are allowed to be added

lists  in  Annex  I  the  vitamins  and  minerals  that  may  be  added  and  in  Annex  II  the
vitamin  preparations  and  mineral  salts  that  may  be  used  and  refers  to  their  purity
criteria

provides  for  certain  restrictions  regarding  the  foods  to  which  vitamins  and  minerals
may be added

set the  criteria  for the  establishment  of  maximum  levels  of  vitamins  and  minerals  in
foods  through  the  procedure  of  the  Standing  Committee  on  the  Food  Chain  and
Animal Health

provides for the setting of minimum levels of vitamins and minerals to be established
through  the  procedure  of  the  Standing  Committee  on  the  Food  Chain  and  Animal
Health

provides  for  appropriate  specific  rules  on  labelling,  presentation  and  advertising  of
products to which vitamins and minerals have been added in addition or by derogation
to other such horizontal rules applicable to all foods

enables Member States to require the notification of the marketing of these products in
order to facilitate their monitoring

Finally,  the  proposed  Regulation  provides  the  basis  for  scrutinising  and,  where  necessary,
regulating the addition of certain substances, other than vitamins and minerals, to foods.

INTRODUCTION

1.

In  its  White  Paper  on  Food  Safety,  the  Commission  announced  that  it  would  put
forward a proposal for harmonising rules on the addition of nutrients to food in the
European Union (Action no. 61). It is widely recognised today that relevant national
rules vary widely and very often result in obstacles to intra-community trade in such
products. Therefore it is necessary to harmonise these rules in order to facilitate the
free  circulation  of  these  products  within  the  Community.  At  the  same  time
harmonisation  would  ensure  a  high  level  of  consumer  protection  across  the
Community in general and notably ensure that products concerned do not present any
risk for public health.

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3.

4.

BACKGROUND

Addition  of  nutrients  is  generally  practised  by  manufactures  either  voluntarily  or
because  it  is  compulsory  under  national  or  Community  rules.  Thus,  addition  of
vitamins  and/or  minerals  is  compulsory  for  a  number  of  foods  for  particular
nutritional  uses  (dietetic  foods)  by  Community  law.  At  national  level,  in  some
Member States, the addition of vitamins and/or minerals is mandatory in margarine
(Vitamins A and D), flour (B complex vitamins, iron, and calcium), and salt (iodine).
These national rules are dictated by public health considerations that are relevant to
national  or  regional  level  and  the  rationale  for  their  mandatory  nature  cannot  be
applied at Community level. Therefore, this proposed Regulation does not affect the
existing Community rules on addition of nutrients and is not intended to harmonise
existing  national  rules  on  compulsory  addition  of  nutrients  to  foods  at  this  stage,
although  the  possibility  of  adopting  harmonised  specific  rules  on  the  compulsory
addition  of  certain  nutrients  to  certain  foods  or  food  categories  should  not  be
excluded.  This  proposal  aims  to  harmonise  the  rules  on  the  voluntary  addition  of
nutrients  in  the  European  Union.  The  nutrients  most  commonly  added  to  foods  for
the  purposes  mentioned  above  are  vitamins  and  minerals.  For  this  reason  it  is
considered  appropriate  for  this  proposed  Regulation  to  cover  only  the  addition  of
vitamins  and  minerals  to  foods.  Some  other  nutrients  are  specifically  allowed  by
Community  legislation  to  be  added  to  foods  for  particular  nutritional  uses  (dietetic
foods). Thus amino acids may be added to foods such as infant formulae and follow-
on  formulae  based  on  soya  for  improving  the  quality  of  the  protein.  Certain  fatty
acids  also  are  added  to  such  products  for  satisfying  the  particular  nutritional
requirements  of  the  persons  for  whom  they  are  intended.  However,  as  said  above,
rules concerning such products are not the subject of this proposed Regulation.

Vitamins and minerals are added to food for three purposes. Firstly, for restoring in
the  final  product  offered  to  the  consumer  the  amount  of  nutrient(s)  lost  during  the
various stages of the storage, handling and manufacturing of foods. Such losses are
very  often  inevitable  and  may  occur  even  when  the  latest  state  of  the  art  in
manufacturing  process  is  applied.  Secondly,  for  producing  substitute  foods  that
resembles  common  food  in appearance, organoleptic properties  and  nutritive  value.
The most well-known of such products is margarine, which was originally produced
as  a  substitute  to  butter.  Thirdly,  vitamins  and  minerals  are  added  to  foods  for  the
purpose of fortifying or enriching foods with them, irrespective of whether or not the
nutrients are originally present in the food.

As  already  mentioned,  national  rules  on  the  voluntary  addition  of  vitamins  and
minerals vary widely. For example addition is allowed without any restrictions in one
Member State provided the food is not posing any risk to health while in another the
addition is only allowed if it could be demonstrated that there was a nutritional need
for the addition of the nutrient. In between, some Member States allow the addition
of vitamins and minerals specified in a list but allow different maximum levels to be
present in the food. Yet some others prohibit the addition of a few specific vitamins.
This is the result of a differing appreciation of the various arguments that are being
considered  when  regulating  their  addition  to  foods.  Food  has  two  basic  functions.
One  is  to  provide  pleasure  and  the  other  is  to  provide  nutrition,  that  is  all  the
necessary  elements  for  growth,  development  and  maintenance  of  a  healthy  life.  In
addition, food must be safe. Most would agree that in the context of the addition of
vitamins and  minerals  for  the  purposes  outlined  above,  products  to  which  vitamins

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6.

7.

and minerals are added should offer to consumers a plausible beneficial nutritional or
physiological effect and should be safe when consumed as part of a varied diet.

European Union citizens in general have at their disposal a variety of safe  foods  at
affordable  prices.  Ideally,  they  should  be  able  to  choose  a  diet  that  provides  all
necessary  nutrients  in  adequate  quantities  according  to  their  individual  needs.
However,  many  studies  have  demonstrated  that  all  individuals  do  not  achieve  this
ideal situation across the European Union. This may be due to a variety of reasons.
Changes  to  economic  and  social  situations,  such  as  an  increased  proportion  of
working  women  and  changes  in  family  structures,  affect  food  purchasing,  meal
preparation  and  the  number  and  nature  of  meals  eaten  at  home.  The  application  of
technological  progress,  both  at  work  and  at  home,  and  changes  to  other  life-style
factors have contributed to changing dietary needs, in particular a reduction in energy
requirements.  For  example,  the  UK  National  Food  Survey  of  1998  showed  that  in
UK households there has been a 30% decline in the average energy intakes of adults,
from  2700  calories  in  1960  to  1800  calories  in  1998.  As  a  result  substantial
modifications of eating habits and dietary behaviour have occurred that would place
substantial  importance  on  the  micronutrient  density  (amount  of  vitamins  and
minerals  per  given  amount  of  energy)  of  individual  foods  and  overall  diets.  In
addition,  scientific  progress  has  led  to  a  reappraisal  of  dietary  needs  for  certain
nutrients because their effect on specific conditions or diseases has been established
or because the baseline that determines need is moving from preventing deficiencies
towards ensuring optimal health.

It is widely recognised that different groups of the population may be affected. The
report  of  the  Scientific  Co-operation  (SCOOP)  task  No.  7.1.1.,  published  in  April
1997,  on  the  scientific  considerations  for  the  development  of  measures  on  the
addition of vitamins and minerals to foods states: “The results suggest that for almost
all vitamins, minerals and trace elements there exist one or more population groups
with  intakes  below  nationally  recommended  levels.  However,  some  nutrients  are
mentioned  more  often  than  others:  iron,  iodine  and  vitamins  B2,  B6  and  D”.  The
population  groups  may  include  adolescents  or  children,  particularly  “picky”  ones,
women,  women  during  the  periconceptual  period,  the  elderly,  people  on  a  diet  for
losing  weight,  people  on  vegetarian  diets,  an  increasing  number  of  people  having
allergies to foods, persons  eating  a high proportion  of  “fast foods”  or  “junk  foods”
and  others.  The  combinations  of  the  specific  groups  of  the  population  and  the
nutrients for which the intake may be deficient vary  from one Member State of the
Community to another.

Foods  to  which  vitamins  and  minerals  have  been  added  voluntarily  can  make  a
contribution,  sometimes  significant,  to  achieving  adequate  intakes  of  them  and
consequently  reducing  the  risk  of  deficiencies.  It  is  estimated  that  in  general
margarine and spreadable fats to which vitamin A and D are added, voluntarily in the
great  majority  of  the  Member  States,  contribute  about  20%  of  the  Population
Reference Intake (PRI) of vitamin A intake and about 30% of the PRI of vitamin D
intake  for  very  important  groups  of  the  EU  population.  Fortified  breakfast  cereals
have become, in the 1990s, the principal source of iron in young children’s diets in
the UK, replacing meat that was the principle source in the 1950s. The same products
can also contribute 20% of vitamin D intake and about 20% of intakes of B vitamins
in the diets of children. Fortified fruit juices contribute to the calcium and Vitamin C
intakes  of  German  adolescents.  Therefore,  in  general,  the  availability  and
consumption of these foods can make a significant contribution to nutrient intakes.

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9.

10.

SPECIFIC ISSUES OF THE PROPOSAL

ADDITION OF VITAMINS AND MINERALS

At  international  level  General  Principles  for  the  addition  of  essential  nutrients  to
foods  were  adopted  by  the  Codex  Alimentarius  in  1987.  These  General  Principles
provide  definitions  for  the  three  cases  of  addition  of  nutrients  to  foods  mentioned
above,  namely  restoration,  nutritional  equivalence  of  substitute  foods  and
fortification or enrichment. The Codex definitions in the first two cases remain valid
to a large extent today and could be therefore included in this proposed Regulation.
The  definition  of  fortification  merits  more  careful  consideration  in  the  context  of
European Community legislation on the subject.

The  Codex  General  Principles,  according  to  the  definition  of  fortification,  would
allow  addition  of  nutrients  to  foods  "for  the  purpose  of  preventing  or  correcting  a
demonstrated deficiency of one or more nutrients in the population or specific groups
of the population". This is a definition that was adopted fifteen years ago having in
mind the nutritional situation worldwide at the time. It gives emphasis to preventing
or correcting a demonstrated deficiency of a vitamin or a mineral, a situation that was
likely to occur, particularly in developing countries. This definition would result in a
restrictive  regime  of  fortification  and  would  be  difficult  to  retain  for  the  European
Community for a number of reasons. Nutrient deficiencies for specific vitamins and
minerals  demonstrated  by  agreed  clinical  symptoms  or  other  biomarkers  are  very
few, if any, in the European Community today. They would not concern the whole of
the EC population but rather specific groups which would not necessarily exist or be
the  same  in  all  the  Member  States.  Therefore,  acceptance  of  fortification  only  for
such restricted purposes would eliminate the basis for harmonising the EC  rules  on
voluntary addition of nutrients to foods and give reason to those advocating that rules
for  the  addition  of  nutrients  to  foods,  voluntary  or  mandatory,  should  remain  the
responsibility of national authorities.

On the other hand, intakes below the recommended intakes for various vitamins and
minerals, as defined at national level, have been reported in many Member States for
different  groups  of  the  population  as  mentioned  above.  Various  physiological
parameters  indicate  a  poor  nutritional  status  for  them  too.  Changes  taking  place  in
food  habits  may  also  indicate  risk  for  insufficient  intakes  as  mentioned  in  point  5.
These indicators of "deficiencies" of vitamins and minerals should therefore be taken
into account today. This would be supported by the Codex General Principles which,
in  the  case  of  fortification  programs,  accepts  that  a  demonstration  of  the  need  for
increasing intakes  “may be in the form  of  actual  clinical or subclinical  evidence of
deficiency,  estimates  indicating  low  levels  of  intake  of  nutrients  or  possible
deficiencies  likely  to  develop  because  of  changes  taking  place  in  food  habits”.
Further, it is very important to take note of the evolution of scientific thinking with
regard to recommended intakes. In the very recent past these would aim to cover the
needs  of  the  vast  majority  of  the  population  in  order  to  avoid  deficiencies.  Today
more recent recommendations from scientific bodies of Member States and of third
countries are aimed at providing intakes that would contribute to "optimal health" for
the population. These take into account evolving scientific knowledge on the role and
the  beneficial  effects  of  certain  vitamins  and  minerals  on  certain  physiological
processes and conditions. It is true that many of the beneficial relationships between
vitamin and mineral intakes and health are put forward as plausible benefits based on
scientific evidence rather than proof. But many would point out that proof may take

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12.

yet some time. Thus although evidence about the relationship between folic acid and
neural  tube  defects  existed  for  some  time,  proof  came  only  a  few  years  ago.
Selenium  was  shown  to  be  essential  in  animals  in  1958  whilst  it  was  accepted  as
essential to humans in 1980 and similar stories can be told for zinc and chromium.
There have been reports about boron, silicon, molybdenum, tin, vanadium and other
trace elements having a function in animals but because there are no deficiencies or
reduced biochemical activity demonstrated in humans the potential beneficial effects
of their intake for man remain very much in doubt.

The  above  arguments,  which  would  be  in  favour  of  a  less  strict  approach  on  the
addition  of vitamins and  minerals to foods, are often  countered  by  arguments  as  to
the potential risks that such an approach may entail. Such risks could be the result of
two  possible  effects  of  fortification.  First,  it  is  feared  that  voluntary  fortification
practised by the manufacturers in a liberal environment would result in a substantial
proliferation of fortified foods. These could progressively replace non-fortified foods
in  the  diet  and  thus  result  in  excessive  intakes  of  certain  nutrients  that  would
represent  a risk to  the  health  of  consumers.  This  is  a  legitimate  concern.  However,
evidence  from  Member  States  and  third  countries,  where  voluntary  fortification  is
allowed  without  many  or  any  restrictions,  show  that  the  feared  proliferation  of
fortified  foods  has  been  fairly  limited.  Today  in  these  countries,  according  to  data
provided  by  the  manufacturers,  such  foods  represent  1-6%  of  the  food  supply,  a
percentage that has remained stable in recent years. In any case, there are measures
to  be  adopted  that  would  avoid  risks  of  excess  consumption  of  vitamins  and
minerals.  Therefore,  prohibiting  or  severely  restricting  fortification  to  avoid  risk  of
excess consumption of vitamins and minerals would be considered a disproportionate
measure to take at European Community level.

Another  serious  concern  is  that  the  proliferation  of  fortified  foods  may  undermine
consumer  knowledge  of  basic  nutritional  principles  and  perception  of  foods.  Some
national  authorities  and  consumer  organisations  claim  that  after  substantial  efforts
they  have  succeeded  in  educating  consumers  about  the  nutritional  value  of  the
different foods and the importance of having a varied diet for ensuring the necessary
intakes of the essential nutrients. Fortification could result in diminishing the current
importance,  in  consumers’  minds,  of  certain  categories  of  foods  such  as  fruits,
vegetables, dairy products and red meat as sources of vitamins and minerals. People
could  turn  to  fortified  foods  for  their  vitamin  and  mineral  intakes,  change  their
dietary patterns and thus jeopardise good dietary habits. This, it is feared, could have
a detrimental effect on the quantity, quality and  ratio of  intakes  of certain  nutrients
and  other  substances,  such  as  fibre,  protein,  fat  and  carbohydrate,  and  constitute  a
long-term risk for the population. This is also a legitimate concern which, however,
at this stage is based on a hypothesis for  future  market evolution,  supported  by  the
observation that often the fortification of foods is used as a promotional tool by the
manufacturers.  It  is  not  supported  by  any  evidence  for  such  adverse  effects  in  any
Community  Member  State  or  third  countries  having  experience  with  voluntary
addition  of  nutrients.  Therefore,  again,  there  are  measures  that  can  be  taken  which
would be more proportionate than a prohibition or severe restriction of fortification.

13.

Instead of severe restrictions on fortification across the board some would advocate
selective  restrictions  on  the  foods  or  categories  of  foods  that  can  be  fortified.
Practices  in  some  third  countries  are  cited  as  examples.  Thus  the  USA  Food  and
Drug  Administration  "does  not  encourage  indiscriminate  addition  of  nutrients  to
foods,  nor  does  it  consider  it  appropriate  to  fortify  fresh  produce;  meat,  poultry  or

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fish products; sugars or snack foods such as candies and carbonated beverages". The
Australia and New Zealand regulatory principles for voluntary  addition  of  vitamins
and minerals to general foods allow the addition "to some basic foods providing the
vitamin or mineral is present in the nutrient profile, prior to processing, of a closely
associated  reference  food  in  the  food  group  to  which  the  basic  food  belongs".
However  they  allow  the  addition  of  some  nutrients  to  certain  categories  of  foods,
even if the criteria are not met, where such additions are historically established (e.g.
calcium  and  vitamin  C  added  to  breakfast  cereals).  They  also  set  certain  specific
"nutritional  quality"  limits  for  allowing  some  categories  of  foods  to  be  fortified
(biscuits  containing  up  to  200  g/kg  fat  and  not  more  than  50g/kg  sugar).  Health
Canada,  in  policy  recommendations  on  the  addition  of  vitamins  and  minerals  to
foods, put forward in 1999 for public comment, suggested criteria for selecting foods
to which vitamins and minerals should be allowed to be added. Such foods would be
those that provide 10 % or more of the Canadian recommended nutrient intake for at
least  one  nutrient  and  that  would  not  contain  "disqualifying"  nutrient  levels
(proposed for total fats, saturates and trans fatty acids, and sodium). However it was
recognised that  "foods  of  low nutritional  value  and  foods  with  high  levels  of  those
nutrients  for  which  reduced  intake  is  desirable  could  also  be  potential  vehicles  for
reaching  specific  groups  in  certain  circumstances  (e.g.  fruit-flavoured  drinks  and
whole  milk)".  On  the  basis  of  the  comments  received,  Health  Canada  revised  the
policy recommendations and put them forward again for further comment. In the new
recommendations, among other, the amount of total fat as a “disqualifying” nutrient
level  has  been  dropped.  No  rules  have  yet  been  adopted  by  Canada  following  the
publication of the above policy document.

Consumer organisations in the European Community consider that products that do
not have a "desirable" nutrient profile, such as candies, high salt and high fat snacks
or high fat and sugar biscuits and cakes should not be allowed to be fortified. Such
foods, they consider, would become more attractive because of their fortification and
they would be consumed in greater quantities by many consumers who are currently
eating  them  in  moderation.  This,  they  consider,  would  have  a  more  immediate
negative effect in the dietary habits of certain particularly vulnerable sections of the
population,  like  children  and  adolescents.  This  view  is  shared  by  a  number  of
Member  States.  This  argument  has  been  taken  into  consideration  in  the  proposed
rules regarding nutrition and health  claim made  for foods.  The nutrient profile of a
food  is  proposed  to  be  a  criterion  for  allowing  a  food  to  bear  claims.  In  the  vast
majority  of  cases  manufacturers  that  add  vitamins  and  minerals  to  foods  wish  to
make  a  claim  about  that  addition.  Preventing  such  a  claim  for  a  food  will  be
dissuasive for such addition to be effected. It is therefore not necessary to establish
nutrient profiles also as a criterion for the foods to which the addition of vitamins and
minerals should be allowed.

Restrictions to add vitamins and minerals only to foods that originally contain them
is  strongly  contested  because  such  a  criterion  would  unnecessarily  deprive  certain
groups  of  the  population  of  valuable  intakes  of  some  nutrients.  For  example,
consumption of fruit juices or fruit-flavoured soft drinks fortified with calcium may
contribute  to  reaching  desirable  levels  of  calcium  intakes  by  persons  who  cannot
drink milk for physiological, taste or social reasons. Cultural and culinary traditions
in the different Member States would further complicate the choice of different foods
or  groups  of  foods  as  appropriate  or  inappropriate  for  fortification.  The  exception
would be alcoholic beverages. Given the efforts made against alcohol abuse, addition

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of  vitamins  and  minerals  to  these  products  should  be  prohibited  as  is  proposed  to
prohibit  any  claims  for  them.  It  should  also  be  clear  that  the  above  considerations
apply to manufactured foods and that vitamins and minerals should not be added to
fresh and non-transformed produce such as fruits, vegetables, meat, poultry, fish etc
in order to preserve the original content  of these nutrients and  avoid  any confusion
for the consumer.

It  is  worth  mentioning  a  few  other  points  that  would  be  relevant  for  the  complete
consideration of the issue. Consumers are becoming more and more conscious about
the  relationship  between  nutrition  in  general  and  intakes  of  certain  nutrients  in
particular  and  health.  Therefore,  rightly  or  wrongly,  they  are  increasingly  seeking
products  to  which  vitamins  and  minerals  have  been  added.  As  mentioned  in  the
Nordic Council of Ministers report on the Addition of Nutrients to Foods, in a study
conducted in the Nordic countries on behalf of a food company, 78% of consumers
in those countries believed that consumers should have the possibility and choice to
buy foods fortified with vitamins and minerals although not as many would choose
the fortified version (only 33% would choose it). The above figures indicate that it is
important  for  consumers  to  have  choice  between  fortified  and  non-fortified  foods.
Therefore,  all  those  concerned  should  ensure  that  allowing  voluntary  fortification
should  not  lead  to  the  disappearance  of  the  non-fortified  versions  from  the  mass
distribution chain. This will be a substantial responsibility of the food industry who,
on the other hand, requests that the rules on the addition of vitamins and minerals to
foods are not unduly restrictive. This would enable it to develop innovative products,
beneficial for the consumers, and remain competitive not only at the Community and
wider European level but also worldwide. This will be of particular importance now
that  the  obligation  has  been  established,  through  the  recently  adopted  general
principles and requirements of food law, that food exported from the Community for
placing on the market of a third country shall comply with the relevant requirements
of Community law.

Given  the  modification  of  nutrient  content  through  the  addition  of  vitamins  and
minerals, the information for the consumer about the overall nutritional profile of the
product  could  be  improved  through  the  labelling.  Thus  nutrition  labelling  should
become  mandatory  for  all  foods  to  which  vitamins  and  minerals  are  added  on  a
voluntary basis. It should also be complete in order to give a better overall picture of
the  food.  Specific  statements  relevant  to  the  importance  of  a  diversified  diet  can
serve  to  remind  and  reinforce  consumer  knowledge  on  this  specific  point.  As  said
above, the issue of claims made for fortified products is very important. Claims can
give  an  improved  image  to  fortified  foods  and  hence  their  potential  value  as  a
promotional tool is considerable. Proposals for the harmonisation of claims for foods
in  general  are  being  put  forward  by  the  Commission  in  parallel  with  the  present
proposal  on  the  addition  of  vitamins  and  minerals  to  foods.  Appropriate  control  of
relevant  claims  would  be  another  measure  for  controlling  the  impact  of  fortified
foods  on  the  choices  of  consumers.  In  parallel  efforts  to  inform  and  educate
consumers on nutritional issues and the importance of good dietary habits for better
health and overall well-being should be maintained and, where possible, reinforced.

18.

However, there should be vigilance regarding the evolution of the situation once the
harmonised rules begin to apply in the European Community. In order to identify any
adverse  developments  that  may  appear  to  occur  and  take  the  necessary  action  to
prevent  or  minimise  them  Member  State  authorities  should  be  able  to  monitor  the
marketing of products to which vitamins and minerals are added as best they can. For

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this  reason  they  should  be  able,  if  they  consider  it  necessary,  to  require  those
responsible for the marketing of these products to notify their marketing. It is up to
the  Member  States  to  decide  whether  existing  means  of  monitoring,  for  example
regular food intake surveys or other, are sufficient or whether notification should be
required for  the  purpose of monitoring.  Authorities, scientific bodies and  interested
stakeholders  should  co-operate  as  much  as  possible  in  order  to  best  gather  data
concerning  food  intakes  that  are  comparable  across  the  European  Community,
identify  intakes  of  foods  to  which  vitamins  and  minerals  have  been  added  and
estimate with the best possible accuracy the intake of these nutrients. In addition, the
gathering  of  data  on  relevant  indicators  should  be  given  priority  at  national  and  at
European  Community  level.  The  Commission  should  proceed,  after  a  reasonable
period following the effective application of the adopted rules, to analyse and report
on  their  effect  on  the  issues  mentioned  above  and  any  others  that  may  become
relevant and to propose any appropriate measures that may be deemed necessary.

As said before, it is necessary to adopt measures to ensure that there will be no risk
from excessive consumption of nutrients from a varied diet that includes also foods
to  which  vitamins  and  minerals  have  been  added.  It  is  well  known  that  excessive
intakes  of  some  vitamins  and  minerals  would  present  greater  risks  to  public  health
than  others.  A  classification  to  categories  according  to  the  potential  risk  has  been
proposed  by  the  Nordic  Nutrition  Recommendations,  the  French  Food  Safety
Authority  and  other  scientific  sources  and  they  tend  to  coincide.  The  Scientific
Committee  for  Food  (SCF),  following  a  request  from  the  Commission,  established
upper  safe  levels  for  a  number  of  vitamins  and  minerals  based  on  scientific  risk
assessment. The European Food Safety Authority that took over the advisory role on
scientific  matters  from  the  SCF  will  complete  this  task  for  the  remaining  vitamins
and minerals. On the basis of these upper levels and taking into account certain other
parameters, maximum  levels of vitamins and minerals in foods  to  which  they  have
been added should be set in order to ensure  that the consumption of these foods in
the context of a diversified diet will not result in any risk for the consumer. Therefore
intakes from all potential food sources, including those naturally present in foods and
food supplements, should be taken into account. These maximum levels should also
take  into  account  the  use  of  some  vitamins  or  minerals  as  food  additives  and
flavourings.  It should be noted,  however,  that  it  is  not  possible  to  fortify  all  foods.
This  may  be  due  to  technological  reasons  that  render  addition  of  vitamins  and
minerals impossible or would result in  products that would  not  be  appealing  to  the
consumer because of the resulting taste, colour, odour or consistency. For others the
costs  involved  would  be  dissuasive.  The  population  reference  intakes  or  safe  and
adequate intakes established by the Scientific Committee for Food in 1992 and, more
recently,  by  other  authoritative  scientific  bodies  should  also  be  given  due
consideration.

20.

For  some  vitamins  and  minerals  the  amounts  that  could  be  permitted  to  be  added,
potentially  to  a  wide  range  of  foods,  would  be  limited  by  safety  considerations.
Allowing  their  addition  to  all  foods,  on  the  basis  of  energy  (calorie)  content  or
specific  quantity  of  weight  or  volume,  could  result  in  allowing  only  insignificant
amounts  to  be  added  in  the  different  foods.  This  would  be  misleading  for  the
consumer  and  jeopardise  the  nutritional  value  of  some  traditional  substitute  foods
(e.g. margarine) or others that have become an important part of certain meals (e.g.
breakfast cereals). It might be therefore necessary in such cases to preferentially limit
the  addition  of  a  certain  vitamin  or  mineral  to  only  one  or  a  few  products  or

9

categories of products, taking into account the importance of their contribution to the
intake  of  the  vitamin  or  mineral  by  the  population.  In  this  context  another  useful
criterion would be the nutrient profile of the food that is proposed to be  a criterion
for  allowing  a  food  to  make  nutrition  and  health  claims  in  the  relevant  proposed
Regulation under discussion in the European Parliament and the Council. Given the
technical and complex nature of setting these maximum levels it is appropriate that
they should be adopted through the procedure of the Regulatory Committee when all
the technical and scientific data become available.

ADDITION OF CERTAIN OTHER SUBSTANCES

In recent years we note the increasing appearance in the composition and labelling of
foods of substances or ingredients other than vitamins and minerals that are used in
an “innovative” way. The majority of these substances or ingredients are used on the
basis  of  adequate  scientific  data  supporting  a  demonstrated  or  plausible  beneficial
effect and have permitted the food industry to put forward innovative products for an
increasingly  health  conscious  and  demanding  consumer.  The  use  of  certain
substances  or  ingredients  though  is  increasingly  cause  for  concern.  This  is  largely
due to the absence of sufficient scientific data to demonstrate that their use in large
quantities,  often  far in  excess of  the  quantities  in  which  these  substances  would  be
ingested  with  a  normal  diet,  do  not  pose  any  risks  to  health.  Because  of  their
presence  in  foods  or  their  use  as  food  ingredients  prior  to  the  entry  into  force  of
Regulation (EC) 258/97 of  the European Parliament and of the Council concerning
novel foods and novel food ingredients these substances or ingredients would not fall
under  the  scope  of  that  Regulation.  Sometimes  their  use  and  presentation  in  the
labelling  may  lead to  questions  as  to  whether  they  should  be  treated  as  ingredients
used in the manufacture of foods or whether they should be considered as “added”.
Irrespective of the answer to this question, it would be opportune to regulate the safe
use of such substances or ingredients, and where necessary prohibit their use, under
this proposed Regulation.

For  the  sake  of  transparency  a  Community  Register  on  addition  of  vitamins  and
minerals and of certain other substances to foods shall be established and regularly
updated. It shall include information regarding vitamins and minerals and the vitamin
formulations  and  mineral  salts  that  may  be  added  to  foods  and  the  maximum  and
minimum  amounts  permitted  and  information  regarding  the  mandatory  addition  of
vitamins  and  minerals  in  Member  States,  as  the  case  may  be.  It  shall  also  include
information on the status of substances other than vitamins and minerals and, where
necessary, ingredients containing them mentioned in point 21.

21.

22.

23.

There are no budgetary implications for the Commission.

–  The  above-mentioned  « Register »  will  be  established  as  a  section  of  DG

SANCO’s Web-site, using existing budgetary and human resources

–  The  regulatory  committee  mentioned  in  Article  16  is  the  existing  Standing
Committee on the Food Chain and Animal  Health  instituted  by Regulation (EC)
No 178/2002 ; decisions under this Proposal will be dealt with by the Section on
General  Food  Law  of  the  Committee,  which  currently  meets  6  times  a  year ;
implementation of  this  proposal  will  not  result  in  more  meetings  of  this  Section
being organised

10

24.

25.

–  The management of the Community procedures foreseen in this proposal will not
require  additional  staffing  as  current  infringement  procedures  should  be
significantly reduced.

CONSULTATION

In  preparing  this  proposal  the  Commission  considered  carefully  relevant  rules  that
are applicable or are under preparation in third countries. It also took into account the
relevant  Codex  Guidelines.  The  Commission  consulted  extensively  with  Member
States and interested stakeholders. To that effect a preliminary draft of the measures
to be proposed was discussed with stakeholders in July of 2000 and with the Member
States in September 2000. This initial consultation highlighted the wish of Member
States and of the stakeholders to harmonise the rules in this area, the similarities with
certain  issues  included  in  the  proposal  concerning  food  supplements  that  was
discussed at the time by the European Parliament and the Council and the strong link
that the proposal on the addition of vitamins and minerals to foods should have with
the proposal on nutrition and health claims made on foods also under elaboration at
the  time.  Following  the  adoption  of  Directive  2002/46/EC  of  the  European
Parliament and of the Council on food supplements and taking into account progress
in the preparation of the proposals on claims an updated draft proposal was prepared
and  discussed  in  February  2003  with  the  stakeholders  and  in  March  2003  with  the
Member  States.  The  various  views  expressed  on  the  individual  issues  that  are
covered  by  the  proposal  have  been  considered  very  carefully.  The  positions  and
arguments put forward are reflected in this explanatory note although not necessarily
attributed to specific interested parties.

CONCLUSION

In  conclusion,  the  proposed  rules  would  contribute  to  a  high  level  of  protection  of
human life and health and promote the protection of consumer interests by ensuring
that the marketed foods to which vitamins and minerals are added or in which certain
ingredients are used, are safe and labelled in an adequate and clear manner, allowing
consumers  to  make  informed  choices.  Thus  they  would  be  in  line  with  the  general
principles and requirements of food law as stipulated in Articles 5-8 of the recently
adopted  Regulation  (EC)  178/2002  of  the  European  Parliament  and  of  the  Council
and with Article 153 of the Treaty. They would also take into account the importance
for  the  food  industry  to  have  a  regulatory  environment  that  will  allow  them  to
innovate and remain competitive at Community and international level. Finally, they
would allow monitoring and the possibility to take action if a risk to health or other
consumer interests was to appear.

11

2003/0262 (COD)

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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
95 thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1)

(2)

(3)

(4)

There  is  a  wide  range  of  nutrients  and  other  ingredients  that  might  be  used  in  food
manufacturing,  including,  but  not  limited  to,  vitamins,  minerals  including  trace
elements, amino acids,  essential fatty  acids, fibre and many  others. Their  addition to
foods  is  regulated  in  Member  States  by  differing  national  rules  that  impede  the  free
movement of these products, create unequal conditions of competition, and thus have a
direct  impact  on  the  functioning  of  the  internal  market.  It  is  therefore  necessary  to
adopt  Community rules harmonising  national  provisions  which  relate  to  the  addition
of vitamins and minerals and of certain other substances to foods.

In  accordance  with  the  principle  of  proportionality,  as  set  out  in  Article  5  of  the
Treaty, this Regulation confines itself to those measures which are necessary in order
to  achieve  the  internal  market  objectives  pursued,  taking  as  a  base  a  high  level  of
consumer protection.

This Regulation restricts itself  in regulating the addition of  vitamins  and  minerals  to
foods and the use of  certain  other substances or  ingredients  containing them that  are
added  to  foods  or  used  in  the  manufacture  of  foods  at  conditions  that  result  in  the
ingestion of amounts greatly exceeding those reasonably expected to be ingested under
normal conditions of consumption of a balanced and varied diet.

Some Member States require the mandatory addition of some vitamins and minerals to
certain ordinary foods, for reasons dictated by public health considerations. These may
be  pertinent  at  national  or  even  regional  level  and  as  such  would  not  support  today

1

2

OJ
OJ

12

                                                
(5)

(6)

(7)

(8)

(9)

harmonisation of the mandatory addition of nutrients across the Community. However,
if and when this became appropriate, such provisions could be adopted at Community
level.  Meanwhile,  it  would  be  useful  that  information  on  such  national  measures  be
compiled.

Vitamins  and  minerals  may  be  added  to  foods  voluntarily  by  food  manufacturers  or
must  be  added  as  nutritional  substances  as  provided  by  specific  Community
legislation.  They  may  also  be  added  for  technological  purposes  as  additives,
colourings,  flavourings or  other  such  uses  including  authorised  oenological  practices
and  processes  provided  by  relevant  Community  legislation.  This  Regulation  shall
apply without prejudice to the specific Community rules concerning addition to or use
of vitamins and  minerals in  specific  products or  groups of  products or  their  addition
for purposes other than those covered by this Regulation.

Given that detailed rules on food supplements containing vitamins and minerals have
been adopted by Directive 2002/46/EC of the European Parliament and of the Council
of  10  June  2002  on  the  approximation  of  the  laws  of  the  Member  States  relating  to
food  supplements3,  provisions  of  this  Regulation  regarding  vitamins  and  minerals
should not apply to food supplements.

Voluntary addition  of  vitamins  and  minerals  to  food  is  carried  out  by  manufacturers
for  three  purposes:  for  restoration  of  the  vitamin  or  mineral  levels  reduced  during
processing  of  foods,  ensuring  nutritional  equivalence  of  products  replacing  common
foods in the diet and for fortifying or enriching foods with vitamins or minerals they
do not usually contain or contain at lower levels.

An  adequate  and  varied  diet  can,  under  normal  circumstances,  provide  all  necessary
nutrients  for  normal  development  and  maintenance  of  a  healthy  life  in  quantities  as
those established and recommended by generally acceptable scientific data. However,
surveys  show  that  this  ideal  situation  is  not  being  achieved  for  all  vitamins  and
minerals and by all  groups of the population  across the  Community.  Foods to  which
vitamins and minerals have been added appear to contribute a non-negligible amount
of  these  nutrients  and  as  such  may  be  considered  to  make  a  positive  contribution  to
overall intakes.

At international level Codex Alimentarius adopted in 1987 General Principles for the
addition of nutrients, including vitamins and minerals, to foods. Due consideration is
given  to  the  definitions  included  therein  for  “restoration”,  “nutritional  equivalence”,
and “substitute food”. The Codex definition for “fortification” or “enrichment” allows
the  addition  of  nutrients  to  food  for  the  purpose  of  preventing  or  correcting  a
deficiency of one or more nutrients in the population or specific population groups that
can be demonstrated by existing scientific evidence or indicated by estimated nutrient
intakes due to changing dietary habits.

(10)

Some nutrient  deficiencies,  although  not  very  frequent,  can  be  demonstrated  to  exist
today  in  the  Community.  Changes  in  the  socio-economic  situation  prevailing  in  the
Community  and  the  life  styles  of  different  groups  of  the  population  have  led  to
different nutritional requirements and to changing dietary habits. This in turn has led
to changes in the energy and nutrient requirements of various groups of the population

3

OJ L 183, 12.7.2002, p. 51

13

                                                
and to intakes of certain vitamins and minerals for these groups that would be below
those  recommended  in  different  Member  States.  In  addition,  progress  in  scientific
knowledge indicates that intakes of some nutrients for maintaining optimal health and
well being could be higher than those currently recommended. Taking into account the
above  it  is  considered  that  in  Community  rules  the  definition  on  fortification  should
include  but  also  be  extended  beyond  what  is  provided  in  the  relevant  Codex
Alimentarius General Principles.

(11) Only  vitamins and minerals normally  found  in and consumed  as part of the diet  and
considered  essential  nutrients  should  be  allowed  to  be  added  in  foods  although  this
does not mean that their addition therein is necessary. Controversy as to the identity of
these essential nutrients that could potentially arise should be avoided. Therefore it is
appropriate to establish a positive list of these vitamins and minerals.

(12)

(13)

(14)

The chemical substances used as sources of vitamins and minerals to be added to food
should be safe and also be bio-available i.e. available to be used by the body. For this
reason a positive list of these substances should also be established. Such substances
that have been approved by the Scientific Committee for Food (opinion expressed on
12 May 1999), on the basis of the above criteria of safety and bioavailability, and can
be used in the manufacture of foods intended for infants and young children, in other
foods  for  particular  nutritional  uses  or  in  food  supplements  should  appear  in  this
positive list.

In order to keep up  with  scientific  and  technological  developments  it is important to
revise  the  above  lists  promptly,  when  necessary.  Such  revisions  would  be
implementing measures of technical nature and their  adoption should be  entrusted to
the Commission in order to simplify and expedite the procedure.

Food  to  which  vitamins  and  minerals  are  added  are  in  most  cases  promoted  by
manufacturers  and  may  be  perceived  by  consumers  as  products  having  a  nutritional,
physiological  or  other  health  advantage  over  similar  or  other  products  without  such
nutrients  added.  This  may  induce  consumer  choices  that  may  be  otherwise
undesirable. To counter this potential undesirable effect, it is considered appropriate to
impose some restrictions to the products to which vitamins and minerals can be added,
in  addition  to  those  that  would  result  naturally  from  technological  considerations  or
become necessary for safety reasons when maximum limits of vitamins and minerals
in such products are set. The content in the product of certain substances, like alcohol,
would,  in  this  context,  be  an  appropriate  criterion  for  not  allowing  vitamins  and
minerals to be added to it. In order to avoid any confusion for the consumer as to the
natural  nutritional  value  of  fresh  foods,  vitamins  and  minerals  should  also  not  be
allowed to be added to them.

(15)

For  vitamins  and  minerals  excessive  intakes  may  result  in  adverse  effects  and
therefore necessitate the setting of maximum safe levels for them when they are added
to  foods,  as  the  case  may  be.  These  levels  must  ensure  that  the  normal  use  of  the
products, under the instructions of use provided by the manufacturer and in the context
of  a  diversified  diet,  will  be  safe  for  the  consumer.  Therefore  they  should  be  total
maximum safe levels of the vitamins and minerals present in the food naturally and/or
added to the food for whatever purpose, including for technological uses.

(16)

For  that  reason  these  maximum  levels  and  any  other  conditions  restricting  their
addition to foods, where necessary, should be adopted taking into account their upper

14

safe  levels  established  by  scientific  risk  assessment  based  on  generally  acceptable
scientific data and their potential intake from other foods. Due account should also be
taken  of  the  population  reference  intakes  of  vitamins  and  minerals.  Where  it  is
necessary,  for  certain  vitamins  and  minerals,  to  establish  restrictions  regarding  the
foods to which they can be added, priority should be given according to the purpose of
the addition and the contribution of the food to the overall diet.

(17) Minimum  amounts  of  vitamins  and  minerals  added  for  the  purpose  of  restoration  or
for  nutritional  equivalence  of  substitute  foods  would  depend  on  the  levels  in  the
unprocessed  food  or  the  food  being  substituted.  However,  their  addition  for  the
purpose of fortification should result in a minimum amount being present in the food.
Otherwise the presence of too small and insignificant amounts in these fortified foods
would  not  offer  any  benefit  to  consumers  and  would  be  misleading.  The  same
principle  underlines  the  requirement  that  these  nutrients  should  be  present  in  a
significant  amount  in  the  food  in  order  to  be  allowed  to  be  declared  in  nutrition
labelling.  Therefore  it  would  be  appropriate  that  the  minimum  amounts  of  vitamins
and  minerals  in  foods  resulting  from  fortification  should  be  the  same  as  those
significant  amounts  that  should  be  present  for  those  nutrients  to  be  declared  in
nutrition labelling.

(18)

The adoption of maximum levels and any conditions of use based on the application of
the principles and criteria stipulated in this Regulation and the adoption of minimum
levels would be implementing measures of technical nature and their adoption should
be entrusted to the Commission in order to simplify and expedite the procedure.

(19) General labelling provisions and definitions are contained in Directive 2000/13/EC of
the European Parliament and of the Council of 20 March 2000 on the approximation
of the laws of the Member States relating to the labelling, presentation and advertising
of  foodstuffs4  as  amended  by  Directive  2001/101/EC.  This  Regulation  should
therefore  be  confined  to  the  necessary  additional  provisions.  Those  additional
provisions  should  also  apply  without  prejudice  to  Regulation  (EC)  No  ../..  of  the
European Parliament and of the Council of ……. On nutrition and health claims made
on foods5

(20) Given  the  nutritional  importance  of  products  to  which  vitamins  and  minerals  have
been added and their potential impact on dietary habits and overall nutrient intakes the
consumer  should  be  able  to  evaluate  their  global  nutritional  quality.  Therefore,
nutrition labelling, by derogation to Article 2 of Council Directive 90/496/EEC of 24
September 1990 on nutrition labelling for foodstuffs6, should be compulsory.

(21) A  normal  and  varied  diet  contains  many  ingredients  which  in  turn  contain  many
substances. The intake of these substances or ingredients resulting  from  their normal
and traditional use in current diets would not cause concern and does not  need to be
regulated. Some substances other than vitamins and minerals or ingredients containing
them are added to foods as extracts or concentrates and may result in intakes that are
significantly higher than those that could be ingested through eating an adequate and
varied diet. The safety of such practices is in some cases seriously contested and the

4

5

6

OJ L 109, 6.5.2000, p. 29
OJ […]
OJ L 276, 6.10.1990, p. 40

15

                                                
benefits are unclear; therefore they should be regulated. It is appropriate, in such cases,
that  food  operators,  responsible  for  the  safety  of  the  food  products  they  place  in  the
market, assume the burden of proof of the safety of them.

(22) Given  the  particular  nature  of  foods  to  which  vitamins  and  minerals  are  added,
additional means to those usually available to monitoring bodies should be available in
order to facilitate efficient monitoring of those products.

(23)

The measures necessary for the implementation of this Regulation should be adopted
in accordance with Council Decision 1999/468/EC of 28  June 1999  laying  down the
procedures for the exercise of implementing powers conferred to the Commission7.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.

2.

3.

This Regulation is intended to harmonise the provisions laid down by law, regulation
or  administrative  action  in  Member  States  which  relate  to  the  addition  of  vitamins
and minerals and of certain other substances to foods, with the purpose of ensuring
the  effective  functioning  of  the  internal  market  whilst  providing  a  high  level  of
consumer protection.

The provisions of this Regulation regarding vitamins and minerals shall not apply to
food supplements covered by Directive 2002/46/EC.

This Regulation shall apply without prejudice:

(a)

(b)

(c)

(d)

to specific provisions laid down in Community legislation concerning foods for
particular  nutritional  uses  and,  in  the  absence  of  specific  provisions,
compositional  requirements  of  such  products  rendered  necessary  by  the
particular nutritional requirements of the persons for whom they are intended;

to  specific  provisions  laid  down  in  Community  legislation  concerning  novel
foods and novel food ingredients;

to  specific  provisions  laid  down  in  Community  legislation  concerning  food
additives and flavourings;

to  specific  provisions  laid  down  in  Community  legislation  concerning
authorised oenological practices and processes.

7

OJ L 184, 17.7.1999, p.23

16

                                                
Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1)

(2)

(3)

(4)

“restoration”  means  the  addition  to  a  food  of  vitamins  and  minerals  which  are  lost
during  the  course  of  good  manufacturing  practice,  or  during  normal  storage  and
handling procedures, in amounts which will result in the presence in the food of the
levels of the  vitamins  and  minerals present  in  the edible  portion of the  food  before
processing, storage or handling;

“nutritional equivalence” means being of similar nutritive value in terms of quantity
and bio-availability of vitamins and minerals;

“substitute  food”  is  a  food  which  is  designed  to  resemble  a  common  food  in
appearance,  texture, flavour and odour and is intended to be used  as  a  complete  or
partial replacement for the food it resembles;

“fortification”  or  “enrichment”  means  the  addition  of  one  or  more  vitamins  and/or
minerals to a food whether or not it is usually contained in the food in order to take
into account:

(a)

(b)

a  deficiency  of  one  or  more  vitamins  and/or  minerals  in  the  population  or
specific population groups that can be demonstrated by clinical or sub-clinical
evidence  of  deficiency  or  indicated  by  estimated  low  levels  of  intake  of
nutrients or,

the potential to improve the nutritional status of the population and/or correct
possible deficiencies in dietary intakes of vitamins or minerals due to changes
in dietary habits or,

(c)

evolving  generally  accepted  scientific  knowledge  on  the  role  of  vitamins  and
minerals in nutrition and consequent effects on health;

(5)

“Authority”  means  the  European  Food  Safety  Authority  as  set  by  Regulation  (EC)
No 178/2002 of the European Parliament and the Council.

CHAPTER II

ADDITION OF VITAMINS AND MINERALS

Article 3

Conditions for the addition of vitamins and minerals

1.

2.

Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II may
be added to foods subject to the rules laid down in this Regulation.

Vitamins and minerals may be added to foods only for the purpose of:

(a)

restoration and/or,

(b)

nutritional equivalence of substitute foods and/or,

(c)

fortification or enrichment.

17

3.

4.

Implementing rules for the addition of vitamins and minerals to foods for the purpose
of  restoration  and  nutritional  equivalence  of  substitute  foods  may  be  adopted,  as
necessary, in accordance with the procedure referred to in Article 16(2).

Modifications  to  the lists referred  to in paragraph 1  shall be  adopted  in accordance
with the procedure referred to in Article 16(2).

Article 4

Transitional measures

By way of derogation from Article 3 paragraph 1 and until (seven  years from the entry into
force of this Regulation), Member States may allow in their territory the use of vitamins and
minerals not listed in Annex I, or in forms not listed in Annex II, provided that:

a)

b)

the substance in question is used for addition to foods marketed in the Community on
the date of entry into force of this Regulation,

the  European  Food  Safety  Authority  has  not  given  an  unfavourable  opinion  in
respect  of  the  use  of  that  substance,  or  its  use  in  that  form,  in  the  manufacture  of
food,  on  the  basis  of  a  dossier  supporting  use  of  the  substance  in  question  to  be
submitted to the Commission by the Member State not later than  (three  years from
the entry into force of this Regulation).

Member  States  may,  in  compliance  with  the  rules  of  the  Treaty,  continue  to  apply
existing  national  restrictions  or  bans  on  trade  in  foods  to  which  vitamins  and
minerals not included in the list in Annex I or in the forms not listed in Annex II are
added.

Article 5

Restrictions on the addition of vitamins and minerals

Vitamins and minerals may not be added to:

a)

b)

1.

fresh  non-processed  produce, including, but not  limited  to,  fruits,  vegetables,  meat,
poultry and fish;

beverages containing more than 1.2% by volume of alcohol.

Additional foods or categories of foods to which vitamins and minerals may not be
added  may  be  determined  in  accordance  with  the  procedure  laid  down  in  Article
16(2) and in the light of scientific evidence.

Article 6

Purity criteria

The purity  criteria for substances  listed in Annex II shall  be  adopted  in  accordance
with the procedure referred to in Article 16(2), except where they apply pursuant to
paragraph 2.

18

2.

3.

1.

2.

3.

4.

Purity criteria for substances listed in Annex II, specified by Community legislation
for their use in the manufacture of foodstuffs for purposes other than those covered
by this Regulation, shall apply.

For those substances listed in Annex II for which purity criteria are not specified by
Community  legislation,  and  until  such  specifications  are  adopted,  generally
acceptable  purity  criteria  recommended  by  international  bodies  shall  be  applicable
and national rules setting stricter purity criteria may be maintained.

Article 7

Maximum and minimum amounts

When a vitamin or a mineral is added to foods for the purposes specified in Article
3(2), the total amount of the vitamin or mineral present, for whatever purpose, in the
food  as  sold  shall  not  exceed  amounts  that  shall  be  set.  For  concentrated  and
dehydrated products the maximum amounts that shall be set shall be those present in
the  foods  when  prepared  for  consumption  according  to  the  manufacturers
instructions.

The  maximum  amounts  of  vitamins  and  minerals  referred  to  in  the  first  sub-
paragraph  and  any  conditions  restricting  or  prohibiting  the  addition  of  a  specific
vitamin or mineral to a food or a  category  of foods shall  be adopted in accordance
with the procedure referred to in Article 16(2).

The maximum amounts referred to in paragraph 1  shall be  set taking  the  following
into account:

a)

upper  safe  levels  of  vitamins  and  minerals  established  by  scientific  risk
assessment  based  on  generally  acceptable  scientific  data,  taking  into  account,
as appropriate, the varying degrees of sensitivity of different consumer groups;

b)

intakes of vitamins and minerals from other dietary sources

When the maximum levels referred to in paragraph 1 are set, due account should also
be taken of reference intakes of vitamins and minerals for the population.

When  the  maximum  levels  referred  to  in  paragraph  1  are  set  for  vitamins  and
minerals whose reference intakes for the population are close to the upper safe levels,
the following will also be taken into account, as necessary:

a)

b)

c)

the  requirements  for  addition  of  certain  vitamins  or  minerals  to  foods  for  the
purpose  of  restoration  and/or  for  the  purpose  of  nutritional  equivalence  of
substitute foods;

the contribution of individual products to the overall diet of the population in
general or of sub-groups of the population.

the nutrient profile of the product  established  as foreseen by Regulation (EC)
No ../2003 on nutrition and health claims made on foods.

5.

The addition of a vitamin or a mineral to food for the purpose of  fortification shall
result in the presence of this vitamin or mineral in the food in  at  least  a significant

19

amount  as  this  is  defined  in  the  Annex  of  Directive  90/496/EEC.  The  minimum
amounts,  including  any  lower  amounts,  by  derogation  to  the  significant  amounts
mentioned  above,  for  specific  foods  or  categories  of  foods  shall  be  adopted  in
accordance with the procedure referred to in Article 16(2).

Article 8

Labelling, presentation and advertising

The labelling, presentation and advertising of foods to which vitamins and minerals
have been added  shall  not  include  any  mention  stating  or  implying  that  a  balanced
and varied diet cannot provide appropriate quantities of nutrients. Where appropriate
a  derogation  concerning  a  specific  nutrient  may  be  adopted  in  accordance  with  the
procedure referred to in Article 16(2).

The labelling, presentation and advertising of foods to which vitamins and minerals
have been added shall not mislead or deceive the consumer as to the nutritional merit
of the food that may result from the addition of these nutrients.

The labelling of products to which vitamins and minerals have been added may bear
a  statement  indicating  such  addition  under  the  conditions  laid  down  in  Regulation
(EC) No …/2003 on nutrition and health claims made on foods.

Nutrition labelling of products to which vitamins and minerals have been added and
covered by this Regulation shall be compulsory. The information to be provided shall
consist of that specified in Article 4, paragraph 1, Group 2 of that Directive and of
the total amounts present of the vitamins and minerals added to the food.

This Article shall apply without prejudice to Directive 2000/13/EC, Regulation (EC)
No  ../2003  on  nutrition  and  health  claims  made  on  foods,  and  other  provisions  of
food law applicable to specified categories of foods.

Rules  for  implementing  this  Article  may  be  specified  in  accordance  with  the
procedure referred to in Article 16(2).

Article 9

Mandatory addition of vitamins and minerals

Community  provisions  applicable  to  specified  foods  or  categories  of  foods  may
provide for the mandatory addition of vitamins and  minerals. Such provisions shall
otherwise  conform with the provisions laid down  in this  Regulation  unless  specific
derogations are provided.

Where there are no Community provisions, Member States may make provisions for
the mandatory addition of vitamins and minerals to specified foods or categories of
foods, in accordance with the procedure laid down in Article 14.

Within six months from the entry into force of this Regulation, Member States shall
inform the Commission of existing relevant national provisions.

1.

2.

3.

4.

5.

6.

1.

2.

20

CHAPTER III

ADDITION OF CERTAIN OTHER SUBSTANCES

Article 10

Restricted and prohibited substances

Where  a  substance,  or  an  ingredient  containing  a  substance  other  than  vitamins  or
minerals,  is  added  to  foods  or  used  in  the  manufacture  of  foods  at  conditions  that
would  result  in  the  ingestion  of  amounts  of  this  substance  greatly  exceeding  those
reasonably  expected  to  be  ingested  under  normal  conditions  of  consumption  of  a
balanced  and  varied  diet,  and  where,  following  in  each  case  an  assessment  of
available  information  by  the  Authority,  a  harmful  effect  on  health  resulting  from
such  use  has  been  identified,  the  substance  and/or  the  ingredient  containing  the
substance,  where  necessary,  shall,  in  accordance  with  the  procedure  referred  to  in
Article 16(2):

(a)

(b)

either be placed in Annex III, Part A and its addition to foods or its use in the
manufacture of foods shall be prohibited;

or  be  placed  in  Annex  III,  Part  B  and  its  addition  to  foods  or  its  use  in  the
manufacture  of  foods  shall  only  be  allowed  under  the  conditions  specified
therein.

Community provisions applicable to specified foods may provide for restrictions or
prohibitions  on  the  use  of  certain  substances  in  addition  to  those  laid  down  in  this
Regulation.  Where  there  are  no  Community  provisions,  Member  States  may  make
provision for such prohibitions or restrictions, in accordance with the procedure laid
down in Article 14.

Article 11

Substances under Community scrutiny

Where  a  substance,  or  an  ingredient  containing  a  substance  other  than  vitamins  or
minerals,  is  added  to  foods  or  used  in  the  manufacture  of  foods  at  conditions  that
would  result  in  the  ingestion  of  amounts  of  this  substance  greatly  exceeding  those
reasonably  expected  to  be  ingested  under  normal  conditions  of  consumption  of  a
balanced  and  varied  diet,  and  where,  following  in  each  case  an  assessment  of
available  information  by  the  Authority,  the  possibility  of  harmful  effects  on  health
resulting from such use is identified but scientific uncertainty persists, the substance
shall be placed in Annex III, Part C, in accordance with the procedure referred to in
Article 16(2).

Food business operators, or any other interested parties, may at any time submit for
evaluation  to  the  Authority,  a  file  containing  the  scientific  data  demonstrating  the
safety of a substance listed in Annex III, Part C under the conditions of its use in a
food or in a category of foods and explaining the purpose of that use.

1.

2.

1.

2.

21

3.

1.

2.

Within four years  from the date a substance has been listed in Annex  III, Part C, a
decision shall be taken, in accordance with the procedure referred to in Article 16(2)
and  taking  into  account  the  opinion  of  the  Authority  on  any  files  submitted  for
evaluation  as  mentioned  in  paragraph  2,  to  generally  allow  the  use  of  a  substance
listed in Annex III, Part C or to list it in Annex III, Part A or B, as appropriate.

CHAPTER IV

GENERAL AND FINAL PROVISIONS

Article 12

Community Register

The Commission shall establish and maintain a Community Register on addition of
vitamins and minerals and of certain other substances to foods, hereinafter referred to
as 'the Register'.

The Register shall include the following:

a)

b)

c)

d)

e)

f)

The  vitamins  and  minerals  which  may  be  added  to  foods  in  accordance  with
Annex I.

The vitamin formulations and mineral substances which may be added to foods
in accordance with Annex II.

The maximum and minimum amounts of vitamins and minerals which may be
added to foods set in accordance with Article 7.

The  information  regarding  mandatory  addition  of  vitamins  and  minerals
referred to in Article 9.

The substances for which dossiers have been submitted as provided in Article 4
first paragraph, point (b).

Information about the substances referred to in  Annex  III  and the  reasons for
their inclusion therein.

3.

The Register shall be made available to the public.

Article 13

National provisions

Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may
not restrict or forbid trade in foods which comply with this Regulation and Community acts
adopted  for  its  implementation  by  the  application  of  non-harmonised  national  provisions
governing the addition of vitamins and minerals to foods.

22

1.

2.

3.

4.

1.

2.

3.

1.

Article 14

Notification procedure

Where reference is made to this Article, the procedure laid down in paragraphs 2, 3
and 4 shall apply.

If a Member State considers it necessary to adopt new legislation, it shall notify the
Commission  and  the  other  Member  States  of  the  envisaged  measures  and  give  the
reasons justifying them.

The  Commission  shall  consult  the  Standing  Committee  on  the  Food  Chain  and
Animal  Health  instituted  by  Article  58  (1)  of  Regulation  (EC)  No  178/2002,  if  it
considers such consultation to be useful or if a Member  State so requests  and shall
give an opinion on the envisaged measures.

The Member State concerned may take the envisaged measures only six months after
the  notification  referred  to  in  paragraph  2,  and  provided  that  the  Commission's
opinion is not negative.

If  the Commission’s  opinion  is  negative, it  shall  determine,  in  accordance  with  the
procedure referred to in Article 16(2) and before the expiry of the period referred to
in the first subparagraph of this paragraph, whether the envisaged measures may be
implemented.  The  Commission  may  require  certain  amendments  to  be  made  to  the
envisaged measure.

Article 15

Safeguard measures

Where a Member State has serious grounds for considering that a product endangers
human  health  though  it  complies  with  this  Regulation,  that  Member  State  may
temporarily  suspend  or  restrict  application  of  the  provisions  in  question  within  its
territory.

It  shall  immediately  inform  the  other  Member  States  and  the  Commission  thereof
and give reasons for its Decision.

In  accordance  with  the  procedure  referred  to  in  Article  16(2),  a  decision  shall  be
taken, where appropriate after obtaining an opinion from the Authority.

The Commission may initiate this procedure on its own initiative.

The  Member  State  referred  to  in  paragraph  1  may  maintain  the  suspension  or
restriction until the decision referred to in paragraph 2 has been notified to it.

Article 16

Committee procedure

The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal  Health  instituted  by  Article  58  (1)  of  Regulation  (EC)  No  178/2002,
hereafter referred to as the “Committee”.

23

2.

reference 

Where 
this  paragraph,  Articles  5  and  7  of
Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8
thereof.

is  made 

to 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 17

Monitoring

To facilitate efficient monitoring of foods to which vitamins and minerals have been added,
and of foods containing substances listed in Annex III, Part B and Part C, Member States may
require the manufacturer or the person placing such  foods on the market in their territory to
notify the competent authority of that placing on the market by forwarding it a model of the
label used for the product.

Article 18

Evaluation

By  …  at  the  latest  [first  day  of  sixth  month  following  date  of  publication  +  6  years],  the
Commission shall submit to the European Parliament and the Council a report on the effects
of implementing this Regulation, in particular concerning the evolution of the market of foods
to which vitamins and minerals have been added, their consumption, nutrient intakes for the
population  and  changes  in  dietary  habits,  accompanied  by  any  proposals  for  amendment  to
this Regulation which the Commission deems necessary. In this context Member States shall
provide  the  necessary  relevant  information  to  the  Commission  by  [first  day  of  sixth  month
following date of publication + 5 years]

Article 19

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.

It shall apply from [first day of sixth month following publication].

Foods placed on the market or labelled prior to [first day of sixth month following publication
] which do not comply with this Regulation may be marketed until [last day of the seventeenth
month following publication].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

24

ANNEX I

Vitamins and minerals which may be added to foods

1.

VITAMINS

Vitamin A
Vitamin D
Vitamin E
Vitamin K
Vitamin B1
Vitamin B2
Niacin
Pantothenic acid
Vitamin B6
Folic acid
Vitamin B12
Biotin
Vitamin C

2.

MINERALS

Calcium
Magnesium
Iron
Copper
Iodine
Zinc
Manganese
Sodium
Potassium
Selenium
Chromium
Molybdenum
Fluoride
Chloride
Phosphorus

25

ANNEX II

Vitamin formulations and mineral substances which may be added to foods

1.

VITAMINS FORMULATIONS

VITAMIN A

- retinol
- retinyl acetate
- retinyl palmitate
- beta-carotene

VITAMIN D

- cholecalciferol
- ergocalciferol

VITAMIN E

- D-alpha-tocopherol
- DL-alpha-tocopherol
- D-alpha-tocopheryl acetate
- DL-alpha-tocopheryl acetate
- D-alpha-tocopheryl acid succinate

VITAMIN K

- phylloquinone (phytomenadione)

VITAMIN B1

- thiamin hydrochloride
- thiamin mononitrate

VITAMIN B2

- riboflavin
- riboflavin 5'-phosphate, sodium

NIACIN

- nicotinic acid
- nicotinamide

PANTOTHENIC ACID

- D-pantothenate, calcium
- D-pantothenate, sodium
- dexpanthenol

VITAMIN B6

- pyridoxine hydrochloride
- pyridoxine 5'-phosphate
- pyridoxine dipalmitate

FOLIC ACID

- pteroylmonoglutamic acid

26

VITAMIN B12

- cyanocobalamin
- hydroxocobalamin

BIOTIN

- D-biotin

VITAMIN C

- L-ascorbic acid
- sodium-L-ascorbate
- calcium-L-ascorbate
- potassium-L-ascorbate
- L-ascorbyl 6-palmitate

27

Minerals substances

calcium carbonate
calcium chloride
calcium salts of citric acid
calcium gluconate
calcium glycerophosphate
calcium lactate
calcium salts of orthophosphoric acid
calcium hydroxide
calcium oxide
magnesium acetate
magnesium carbonate
magnesium chloride
magnesium salts of citric acid
magnesium gluconate
magnesium glycerophosphate
magnesium salts of orthophosphoric acid
magnesium lactate
magnesium hydroxide
magnesium oxide
magnesium sulphate
ferrous carbonate
ferrous citrate
ferric ammonium citrate
ferrous gluconate
ferrous fumarate
ferric sodium diphosphate
ferrous lactate
ferrous sulphate
ferric diphosphate (ferric pyrophosphate)
ferric saccharate
elemental iron (carbonyl + electrolytic + hydrogen reduced)
cupric carbonate
cupric citrate
cupric gluconate
cupric sulphate
copper lysine complex
sodium iodide
sodium iodate
potassium iodide
potassium iodate
zinc acetate
zinc chloride
zinc citrate
zinc gluconate
zinc lactate
zinc oxide
zinc carbonate
zinc sulphate
manganese carbonate

28

manganese chloride
manganese citrate
manganese gluconate
manganese glycerophosphate
manganese sulphate
sodium bicarbonate
sodium carbonate
sodium chloride
sodium citrate
sodium gluconate
sodium lactate
sodium hydroxide
sodium salts of orthophosphoric acid
potassium bicarbonate
potassium carbonate
potassium chloride
potassium citrate
potassium gluconate
potassium glycerophosphate
potassium lactate
potassium hydroxide
potassium salts of orthophosphoric acid
sodium selenate
sodium hydrogen selenite
sodium selenite
chromium (III) chloride and its hexahydrate
chromium (III) sulphate and its hexahydrate
ammonium molybdate (molybdenum (VI) )
sodium molybdate (molybdenum (VI) )
potassium fluoride
sodium fluoride

29

ANNEX III

Substances and whose use in foods is prohibited or subject to conditions

Part A - Prohibited substances

Part B – Restricted substances

Part C - Substances under Community scrutiny

30

BASIC IMPACT ASSESSMENT STATEMENT

Draft 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.

1.

WHAT PROBLEM THE POLICY/PROPOSAL IS EXPECTED TO TACKLE ?

Nutrients and other substances are often added to foods voluntarily in order to restore what is
lost during processing, to produce foods that would be nutritionally equivalent to an important
food item or to enrich foods with particular nutrients or other substances having a nutritional
or  physiological  effect.  The  nutrients  most  commonly  added  to  foods  for  the  purposes
mentioned above are vitamins and minerals.

The practice of adding vitamins and minerals has attracted attention in recent years because of
the increasing scientific evidence of the relationship between diet and health. Manufacturers
have  developed  more  products  to  which  vitamins  and  minerals  are  added  and  they  tend  to
promote those as products that would confer a health benefit to consumers. This has lead to
increasing concern of authorities regarding the practice and its consequences for public health
and to attempts to regulate it by a number of Member States at he national level. It is widely
recognised today that relevant national rules vary widely and very often result in obstacles to
intra-community trade in such products. Some of these national rules have been considered by
the Commission as contrary to the provisions of the Treaty and have resulted in a number of
cases currently in front of the European Court. Therefore, it is necessary to harmonise these
rules. In its White Paper on Food Safety (COM (1999) 719, adopted on 12 January 2000) the
Commission  announced  that  it  would  put  forward  a  proposal  for  harmonising  rules  on  the
addition of nutrients to food in the European Union (Action no. 61).

In  addition,  in  recent  years  we  note  the  increasing  appearance  in  the  composition  and
labelling of foods of substances or ingredients other than vitamins and minerals that are used
in  an  “innovative”  way.  The  use  of  certain  such  substances  or  ingredients  is  increasingly
cause for concern from the public health point of view. This is largely due to the absence of
sufficient scientific data to demonstrate that their use in large quantities, often far in excess of
the  quantities  in  which  these  substances  would  be  ingested  with  a  normal  diet,  do  not  pose
any risks to health. Again attitudes and rules to such practices vary in the different Member
States resulting in obvious problems for the free circulation of products. Member States have
asked with insistence the Commission to act on this issue.

2.

WHAT MAIN OBJECTIVE IS THE POLICY/PROPOSAL SUPPOSED TO REACH?

The overall policy objectives of the proposal are the basic objectives of food law, namely:

(cid:1)  to contribute to a high level of protection of human health and promote the protection of

consumer interests

(cid:1)  to improve the free movement of goods within the internal market

(cid:1)  to  increase  legal  security  for  operators  and  through  proportionate  measures,  promote

innovation

31

(cid:1)  to ensure fair competition in the area of foods

The proposed rules would contribute to a high level of protection of human life and health and
promote  the  protection  of  consumer  interests  by  ensuring  that  the  marketed  foods  to  which
vitamins and minerals are added or in which certain ingredients are used, are safe and labelled
in an adequate and  clear manner,  allowing  consumers  to make  informed choices. Thus they
would  be  in  line  with  the  general  principles  and  requirements  of  food  law  as  stipulated  in
Articles  5-8  of  the  recently  adopted  Regulation  (EC)  178/2002  of  the  European  Parliament
and of the Council and with Article 153 of the Treaty.

The  importance  of  improving  the  functioning  of  the  internal  market  for  the  products
concerned is obvious. The proposed rules take also into account the importance for the food
industry  to  have  a  regulatory  environment  that  will  allow  them  to  innovate  and  remain
competitive at Community and international level. Finally, they would allow monitoring and
the possibility to take action if a risk to health or other consumer interests was to appear.

3.

WHAT ARE THE MAIN POLICY OPTIONS AVAILABLE TO REACH THE OBJECTIVE?

The  issues  arising  in  the  case  of  addition  of  vitamins  and  minerals  and  of  certain  other
substances to foods concern from the one hand the functioning of the internal market but also
the protection of public health. The latter is the main reason put forward by certain Member
States  for  taking  certain  measures  which,  however,  the  Commission  has  considered  as
contrary to the provisions of the  Treaty.  However, the issues concerning  public health  were
mostly  relevant  to  all  EU  citizens.  Therefore,  their  regulation  could  not  be  considered  as  a
matter of subsidiarity and be left to the Member States.

Some of the issues to be regulated are real issues of safety of the products. As examples can
be cited the vitamin and mineral substances to be used in the manufacture of these products,
that  need  to  be  selected  on  the  basis  of  opinions  of  the  scientific  advisory  bodies  (the
Scientific  Committee  for  Food  in  the  past  and  the  European  Food  Safety  Authority  in  the
future) and the maximum levels for certain vitamins and minerals that need to be set again on
the basis of scientific advice. The promotion of voluntary Codes of practice by the industry or
the adoption of non binding Community measures were, therefore, not a viable option.

The nature of the rules was appropriate for them to be tackled through a Regulation.

4.

WHAT  ARE  THE  IMPACTS  –  POSITIVE  AND  NEGATIVE  –  EXPECTED  FROM  THE
DIFFERENT OPTIONS IDENTIFIED?

There  are  two  important  elements  to  bear  in  mind  when  considering  the  impact  of  the
proposed  rules  on  the  addition  of  vitamins  and  minerals  and  of  certain  other  substances  to
foods. First, the addition of these substances is practised on a voluntary basis, that is, no such
addition  is  imposed  on  the  food  manufacturers.  Second,  products  to  which  the  nutrients  or
other  substances in  question are added  are  perceived  by  the  consumer  and  promoted  by  the
manufacturers as of “better” nutritional quality and as conferring certain benefits to those who
consume them and as such constitute a developing and promising segment.

Bearing  the  above  in  mind  it  can  be  said  that  the  proposed  rules  will  have  a  substantial
positive impact both for the economic operators concerned and for consumers. Manufactures
will not only benefit from the establishment of common rules in the relevant area which will
facilitate  the  free  circulation  of  the  products  but  will  benefit  from  the  opening  of  certain

32

national markets which currently are severely restricted by very strict national rules.  In fact,
the food industry is a strong supporter of harmonising this area. The benefits are likely to be
felt by both the big companies and the small and medium enterprises.

Consumers  are  becoming  increasingly  conscious  of  the  important  relationship  between  diet
and health and are very much attracted by products to which vitamins and minerals and other
substances are added. The proposed Regulation will ensure that the products when consumed
under normal conditions and as part of a varied diet will pose no risk to public health, an issue
closely  related  to  the  setting  of  maximum  levels  for  certain  vitamins  and  minerals  in  such
products. The rules  relating to specific labelling  requirements will ensure that  the  consumer
disposes  of  adequate  and  appropriate  information  that  will  help  him/her  to  make  informed
choices among these products. Consumer organisations are also in favour of this Regulation
for this reason.

There are some restrictions concerning certain foods to which vitamins and minerals may be
added that may be perceived as having a negative impact for some operators. Such restrictions
are  based  on  health  considerations  like  the  increasing  incidence  of  obesity  and  of  other
chronic diseases for which diet is emerging as a very important factor. However, they concern
a  very  limited  number  of  products  to  which  vitamins  and  minerals  are  added  today.  Food
manufacturers,  as  important  players  in  the  shaping  of  dietary  habits  for  the  population,  are
aware  of  their  responsibilities  and  the  role  they  are  expected  to  play  in  promoting  health
through improved dietary choices and they are expected to adapt accordingly without serious
consequences.  In  any  case  the  great  majority  of  the  products  marketed  today  are  thriving
without any added vitamins and minerals.

There are no particular effects that can be expected for Candidate Countries. The rules would
not be contrary to existing Codex Alimentarius Guidelines and, therefore, are not expected to
pose  any  problem  at  international  level.  It  should  also  be  noted  that  that  important  trading
partners like the USA, Canada and Australia/New Zealand are either having or are consulting
on similar rules or recommendations.

5.

HOW  TO  MONITOR  AND  EVALUATE  THE  RESULTS  AND  IMPACTS  OF  THE  PROPOSAL
AFTER IMPLEMENTATION?

One particular concern from the public health point of view is the effect of the  rules  on the
availability of foods to which vitamins and minerals and  certain other substances have been
added. This is expected to increase in particular in those Member States where national rules
were  particularly  restrictive.  Many  Member  States  requested  the  possibility  to  monitor
consequences  for  the  ingested  amounts  of  certain  vitamins  and  minerals  and  also  for  the
variation in consumer habits, that may result from the penetration in the market of more such
products, through the notification of these products to the competent authorities when they are
placed  on  the  market.  Such  a  notification  has  been  foreseen.  It  is  a  simple  notification  that
announces the marketing of the product and includes a model of the label of the product and
as such does not constitute a burden for the economic operators.

6.

WHAT ACTIONS ARE EXPECTED TO FOLLOW-UP?

There has been  extensive  consultation  with  Member  States  and  interested  stakeholders  over
the past year in preparing the proposed Regulation through specifically organised meeting and
subsequent submission of written comments. The different views and suggestions have been

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taken  on  board  to  the  extent  possible  and  necessary  to  produce  a  balanced  proposal.  An
extended assessment on this proposal is not recommended.

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