Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods
Date: 2003-07-16
Institutions: European Commission
Subjects: approximation of laws, consumer information, consumer protection, foodstuff, labelling

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.7.2003
COM(2003) 424 final

2003/0165 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on nutrition and health claims made on foods

(presented by the Commission)

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EXPLANATORY MEMORANDUM

INTRODUCTION

The  European  Community  has  adopted  detailed  rules  on  labelling1  and  nutrition
labelling2  of  foods.  With  regard  to  claims  there  is  the  basic  provision  that  claims
should  not  mislead  the  consumer.  Furthermore,  Article  2  (1)  (b)  of  Directive
2000/13/EC  on  the  labelling,  presentation  and  advertising  of  foods,  prohibits  the
attribution of preventing, treating and curing properties to foods. Proper enforcement
of  these  general  provisions  would  go  a  long  way  to  prevent  abuse  in  this  area.
However,  Member  States  and  stakeholders  have  pointed  out  that  these  general
principles are open  to  different interpretations and therefore are not satisfactory for
dealing  with  some  specific  claims.  Very  recently,  in  case  C-221/00,  Austria  v
Commission,  the  European  Court  of  Justice  interpreted  the  existing  labelling
Directive as banning all health claims relating to human diseases. In the light of the
technological  innovation  in  the  food  sector  and  the  demand  from  consumers  and
industry alike it is proposed to set a new legislative framework on the use of claims.
The  proposed  Regulation  would  allow  health  claims  under  strict  conditions  and
following an independent scientific assessment and Community authorisation.

In view of the proliferation of the number and type of claims appearing on the labels
of foods and in the absence of specific provisions at European level, some Member
States  have  adopted  legislation  and  other  measures  to  regulate  their  use.  This  has
resulted  in  different  approaches  and  in  numerous  discrepancies  both  regarding  the
definition of the terms used and the conditions warranting the use of claims.  These
discrepancies can act as barriers to guaranteeing a high level of consumer and public
health protection, and can constitute obstacles to the free movement of foods and the
proper functioning of the internal market. For these reasons, harmonisation of rules
on claims at Community level is being advocated.

In its White Paper on Food Safety, the Commission proposed to consider whether to
introduce  into  Community  legislation  specific  provisions  to  govern  “nutrition
claims” (claims describing the presence, absence or level of a nutrient contained in a
foodstuff, or its value compared to similar products) and “functional claims” (claims
related  to  the  beneficial  effects  of  a  nutrient  on  certain  normal  bodily  functions).
[Paragraph 101, Action n° 65].

In  order  to  gather  comments  and  specific  suggestions  on  these  claims,  the
Commission services prepared a Discussion Paper (SANCO/1341/2001), which was
published on the Commission’s website in May 2001. The paper outlined the issues
that needed to be considered in future legislation and invited comments. On the issue
of  health  claims,  the  Discussion  Paper  announced  a  separate  discussion  at  a  later
stage.

The Commission services received comments from more than 90 stakeholders, which
have  also  been  published  on  the  website.  Some  Member  States  and  many

Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  relating  to  the  labelling,
presentation and advertising of foodstuffs, OJ L 109 p.29 of 6.5.2000.
Council Directive 90/496/EEC on nutrition labelling of foodstuffs, OJ L 276 p. 40 of 6.10.1990.

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stakeholders, including consumers and industry, expressed their regret that so-called
“health  claims”  were  not  addressed  and  requested  that  all  types  of  claims  be
regulated at Community level, since these “health claims” are already found on the
market  and  are  posing  problems.  In  response  to  the  comments  received,  the
Commission prepared this proposal in order to define and set conditions for nutrition
and “health” claims in one single legislative proposal.

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The main objectives of this proposal are the following:

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to achieve a high level of consumer protection by providing further voluntary
information, beyond the mandatory information foreseen by EU legislation;

to improve the free movement of goods within the internal market;

to increase legal security for economic operators; and

to ensure fair competition in the area of foods;

to promote and protect innovation in the area of foods.

This  proposal  covers  nutrition  and  health  claims  used  in  the  labelling,  presentation
and advertising of foods. Only nutrition and health claims that are in conformity with
the  provisions  of this Regulation will  be  allowed on  the  labelling,  presentation  and
advertising  of  foods  placed  on  the  market  within  the  Community  and  delivered  as
such to the final consumer.

BACKGROUND

As food production has become more and more complex, consumers are increasingly
interested in the information appearing on food labels. They have also become more
interested  in  their  diet,  its  relationship  to  health,  and,  more  generally,  the
composition  of  foods  that  they  are  selecting.  For  these  reasons  it  is  important  that
information  about  foods  and  their  nutritional  value  appearing  on  the  labelling  and
used for their presentation, marketing and advertising should be  clear,  accurate  and
meaningful.

The food industry has responded to the increased interest of consumers in nutrition
by  providing  nutrition  labelling  on  many  foods  and  by  highlighting  the  nutritional
value  of  products  through  claims  in  their  labelling,  presentation  and  advertising.
Some  would  argue  that  this  evolution  could  be  considered  as  a  positive  one  for
providing  relevant  information  to  the  consumer.  It  also  provides  an  opportunity  to
use claims as a marketing tool.

At  international  level,  General  Guidelines  on  the  use  of  claims  were  adopted  by
Codex  Alimentarius  in  1979,  and  revised  in  1991.  These  General  Guidelines  are
based  on  the  following  two  principles.  Firstly,  no  food  should  be  described  or
presented in a manner that is false, misleading or deceptive, or that is likely to create
an erroneous impression regarding its character in any respect; secondly, the person
marketing  the  food  should  be  able  to  justify  the  claim  made.  These  General
Guidelines also describe those claims made on foods that should be prohibited, such
as:  claims  that  cannot  be  substantiated,  claims  implying  that  a  balanced  diet  or

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ordinary foods cannot supply adequate amounts of all nutrients, and claims as to the
suitability of a food for use in prevention, treatment or cure of a human disease.

More  specifically,  Guidelines  for  the  use  of  nutrition  claims  have  been  adopted  by
Codex  Alimentarius  since  1997.  These  Guidelines  provide  definitions  for  “nutrient
content claim” (for  example:  low  fat,  source  of  calcium),  “comparative  claim”  (for
example: reduced fat, increased calcium) and “nutrient function claim” (for example:
calcium  aids  in  the  development  of  strong  bones  and  teeth),  as  well  as  for  the
conditions  warranting  these  claims.  Initially,  health  claims  were  included  in  these
Guidelines;  however,  discussions  on  this  type  of  claims  proved  to  be  much  more
difficult and controversial, and it was only  in May this  year (2003) that  definitions
and conditions for health claims have been  agreed  within the  Codex  Committee  on
Food labelling (CCFL) and should be finalised and adopted later this year.

SPECIFIC ISSUES OF THE PROPOSAL

In  addition  to the definition of “nutrients” which  covers  the  calorific  value  and  the
“traditional”  nutrients  (protein,  carbohydrate,  fat,  fibre,  sodium,  vitamins  and
minerals),  it  is  proposed  to  cover  also  “other  substances  with  a  nutritional  or
physiological  effect”  (for  example,  antioxidants,  probiotic  bacteria).  Many  claims
concerning  these  “other  substances”  are  already  in  use  on  many  products  on  the
Community market. Not including these “other substances” would mean that claims
relating  to  them  would  not  fall  under  any  legislation  or  would  be  regulated  by
differing national rules that may  impede the free movement  of goods  and that may
not ensure an equal and high level of consumer protection throughout the EU.

Some consumer organisations in the European Union consider that products that do
not  have  a  "desirable"  nutritional  profile,  such  as  candies,  high  salt  and  high  fat
snacks or high fat and sugar biscuits and cakes should not be allowed to bear claims.
For  example,  a  “low  fat”  claim  should  only  be  allowed  if  the  product  does  not
contain high quantities of sugar or salt; or a “high calcium” claim should not be used
on a  product  with  a  high  fat content.  They  consider that such foods would become
more attractive because of the way in which they will be labelled and advertised and
many consumers that are currently eating them in moderation would consume them
in  greater  quantities.  This,  they  believe,  would  have  a  more  immediate  negative
effect  on  the  dietary  habits  of  certain  particularly  vulnerable  sections  of  the
population, like children and adolescents. This view is also shared by some Member
States.

Although based on understandable  concerns  and  important arguments,  a  number  of
scientific  and  policy  arguments  could  challenge  such  restrictions.  The  concept  of
prohibiting  the  use  of  claims  on  certain  foods  on  the  basis  of  their  "nutritional
profile"  is  contrary  to  the  basic  principle  in  nutrition  that  there  are  no  "good"  and
"bad"  foods  but  rather  "good"  and  "bad"  diets.  Nutritional  advice  certainly
recommends  judicious  food  choices  and  moderation  in  consumption  of  certain
products but accepts that, in a long-term varied diet,  all foods could  be included in
appropriate  frequency  and  quantities.  This  argument,  although  scientifically  valid,
should  be considered in the  appropriate  context.  Foods  baring  claims  are  presented
by the food operators as products whose consumption would provide a benefit, that is
as  “good”  or  “better”  products.  In  most  cases,  influenced  by  the  promotional
campaigns, consumers perceive them as such. This potential bias should be avoided

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in  order  to  prevent  the  negative  effects  mentioned  in  point  13.  Therefore  some
restrictions on the use of claims on foods based on their nutritional profile should be
foreseen.  In  particular,  the  amount  of  total  fat,  saturates,  trans  fatty  acids,  sugars,
sodium or salt, at variable levels, are commonly cited as criteria for the "nutritional
profile"  of  products.  Scientific  research  identifies  an  association  between  the  high
consumption  of  these  nutrients  and  some  chronic  diseases,  such  as  cardiovascular
disease,  diabetes,  several  types  of  cancer,  obesity,  osteoporosis  and  dental  disease.
More  complicated  schemes  involving  many  more  parameters  may  be  under  study.
But all these proposals  are  currently  far  from meeting with  the required consensus.
Therefore it would be appropriate that such criteria and any relevant exceptions that
should apply in the Community be adopted after careful and adequate consideration
of the matter but within reasonably short time limits.

In  the  Council  Conclusions  of  5  June  2001  on  a  Community  strategy  to  reduce
alcohol  related  harm3  it  is  emphasised  that  alcohol  is  one  of  the  key  health
determinants in the European Community and that scientific work has clearly shown
that high consumption of alcohol in the population substantially increases the risk of
alcohol-related  morbidity  and  of  all-cause  mortality.  Furthermore,  there  is  concern
about the way in which alcoholic beverages are designed and promoted to appeal in
particular to children and adolescents. This concern has been emphasised in Council
Recommendation  of  5  June  2001  on  the  drinking  of  alcohol  by  young  people4.
Therefore, it is appropriate to envisage the prohibition of nutrition and health claims
on alcoholic  beverages  and to envisage that, if  necessary,  appropriate  decisions  are
taken,  following  the  Committee  procedures,  for  other  foods  or  food  categories  for
which current dietary advice would not normally promote their consumption.

In  view  of  the  above  and  given  the  positive  image  conferred  on  foods  bearing
nutrition and/or health claims, the information for the consumer about the nutritional
profile  of  the  product  could  be  improved  through  the  labelling.  Thus  nutrition
labelling should become mandatory for all foods bearing nutrition and health claims.
For  all  health  claims  it  should  also  be  complete  in  order  to  give  a  better  overall
picture of the food. Furthermore specific statements relevant to the importance of a
diversified  diet  can  serve  to  remind  and  reinforce  consumer  knowledge  on  this
specific  point.  In  addition,  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.

A  very  important  aspect  is  the  actual  communication  and  presentation  of  claims  in
respect of food products. It is often argued that the information provided on foods is
not always well understood by consumers. Therefore, ways in which information is
communicated have to be considered very carefully. A claim that is not understood is
completely  useless  while  a  claim  that  is  misunderstood  could  even  be  misleading.
Consumer understanding of claims is essential and there have been discussions about
the  'representative'  or  'average'  consumer  to  whom  these  claims  should  be
understandable. The term 'average consumer' used in the proposal  has  already  been
developed  by  the  European  Court  of  Justice  in  a  number  of  cases  (C-315/92,  C-
470/93, C-313/94, C-210/96, C-303-/97). The actual wording, logos and images used

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OJ C 175, 20.6.2001, p. 1
OJ L 161, 16.6.2001, p. 38

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to  state  or  imply  a  claim  and  product  endorsements  all  play  important  roles  in  the
way claims are perceived and understood by the consumer.

Some claims may be misleading due to the way in which they are expressed, even if
they are factually true. For example, claims stating that a product is “90%  fat-free”
may indeed be true, but they imply that a the product has a low fat content while it
actually  contains  10%  fat  which,  for  the  majority  of  products,  is  not  a  low  fat
content.  A  survey  carried  out  by  the  Consumers’  Association  (UK)5  in  April  2000
revealed that  most people could not tell which was  the  healthiest  option  between  a
“low fat” product, a “reduced fat” product and a “90% fat-free” product. More than
half the people thought that the "90% fat-free” product contains the least fat, in fact it
has  the  most.  Therefore  it  is  proposed  to  prohibit  the  use  of  such  claims.
Furthermore,  there  may  be  cases  of  truthful  but  highly  specialised  claims;  for
example  “folate  may  help  normalise  plasma  homocystine  levels”.  This  claim  may
indeed  be  true,  the  product  may  contain  bio-available  folate  and  in  quantities  to
achieve the claimed effect, but hardly anyone would understand the claim. It should
therefore  be  ensured  that  complicated  specialised  claims  that  turn  out  to  be
meaningless to consumers are not used.

Many  claims  already  found  on  the  market  make  reference  to  general,  non-specific
benefits  and  to  general  wellbeing.  For  example:  “excellent  for  your  organism”,
“reinforces  the  body’s  resistance”,  “helps  your  body  resist  stress”,  “purifies  your
organism”, “has a positive effect on your wellbeing”, “ has an harmonising effect on
your metabolism”, “helps keep your body feeling good”, “preserves  youth”, etc; all
currently  found  on  foods  sold  within  the  Community.  Not  only  are  these  claims
vague and often meaningless, but also they are not verifiable. Therefore, they should
not be allowed.

There are many factors, other than dietary ones, that can influence psychological and
behavioural functions. Communication on these functions is thus very complex and it
is  difficult  to  convey  a  comprehensive,  truthful  and  meaningful  message  in  a  short
claim to be used in the labelling and advertising of foods. Furthermore, many abuses
of  these  claims  are  currently  found  on  the  market  and  “intellectual  vitamins”  for
“good  memory  and  concentration”  and  for  “better  results  in  your  exams”  easily
deceive and misinform consumers. Therefore, it is deemed appropriate not to allow
the use of such claims.

Directive  96/8/EC  on  foods  intended  for  use  in  energy-restricted  diets  for  weight
reduction6,  prohibits  in  the  labelling,  presentation  and  advertising  of  products
covered by the Directive and especially designed for weight control, any reference to
the rate or amount of weight loss which may result from their use, or to a reduction
in the sense of hunger or an increase in the  sense of satiety. A  growing  number  of
foods  not  especially  designed  for  weight  control  are  marketed  using  the  above-
mentioned references and referring to the property of reducing the  available energy
from the diet, for example “halves/reduces your calories intake”, as well as numerous
references  to  presumed  slimming  properties.  It  is  therefore  justified  that  such
references should also be prohibited for all foods.

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"Which", April 2000, Consumers' Association (UK)
OJ L, 55, 6.3.1996, p. 22

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NUTRITION CLAIMS

In order to present consumers and industry with clear benchmarks concerning the use
of nutrition claims, clear and simple rules should be set. At international level Codex
Alimentarius has developed guidelines for the most commonly used nutrition claims
(such  as  “low”,  “rich”,  “light”,  etc.).  Similar  criteria  also  exist  in  some  Member
States.  The  Annex  to  this  proposal  provides  a  list  of  nutrition  claims  and  their
specific conditions of use. This Annex takes into account existing provisions of some
the  Codex  Alimentarius  guidelines,  and  some  Community
Member  States, 
provisions.  In  order  to  revise  and  adapt  the  Annex  promptly,  when  necessary,
modifications  to  this  Annex  should  be  adopted  though  the  Committee  procedure
referred to in Article 23.

The  possibility  of  using  the  claim  “low  fat”  for  spreadable  fats  provided  in
Regulation (EC) 2991/94 will be adapted to the provisions of this Regulation at the
earliest opportunity.

For comparative claims, such as “increased” or “reduced”, one would ask compared
to  what.  It  is  therefore  necessary  that  the  products  being  compared  are  clearly
identified to the final consumer. The comparison shall be made between foods of the
same  category,  taking  into  consideration  a  range  of  foods  of  that  category  and
including  other  brands.  The  difference  in  the  quantity  of  a  nutrient  and/or  energy
value should be stated and the comparison should relate to the same quantity of food.
These provisions are deemed necessary in order to avoid biased comparisons

HEALTH CLAIMS

There  are  a  number  of  claims  that  are  generally  known  under  the  broad  term  of
“health claims” which would describe a relationship between a category of food, or a
food or one of its constituents and health.

Directive 2000/13/EC on labelling, presentation and advertising of foods specifically
prohibits  attributing  to  foods  any  properties  of  prevention,  treatment  or  cure  of  a
human  disease,  or  any  reference  to  such  properties.  Furthermore,  this  Directive
requires  the  setting  of  a  list  of  claims  referring  to  the  above-mentioned  properties
which  must  at  all  events  be  prohibited  or  restricted.  Furthermore,  the  recent  Court
judgement  (ECJ  case  C-221/00)  interpreted  the  existing  Directive  as  banning  all
health claims relating to human diseases. However, it has to be considered whether
this  total  prohibition  is  still  adapted  to  the  advances  of  research,  science  and  food
technology, as well as to consumers expectations. This proposal for a Regulation on
the  use  of  claims  maintains  the  prohibition  on  claims  referring  to  the  prevention,
treatment  or  cure  of  a  human  disease,  however  a  difference  between  “prevention”
and “reduction of a disease risk factor” is made and a derogation is provided. Indeed,
it  is  acknowledged  that  diet  and  certain  foods  can  make  important  contributions  to
the support and maintenance of health, and that diet and certain foods can play a role
in the management of certain disease risk factors.

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The  European  Parliament  Resolution  of  March  1998  on  the  Green  Paper  on  the
General Principles of Food Law in the European Union7 called on the Commission to

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OJ C104, 6.4.1998, p. 60

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propose legislation on food claims to ensure that “health claims are only authorised if
they are tested and confirmed by an independent body within the European Union”.
It also called on the Commission to continue to ban the use of claims referring to the
suitability of a food to treat, cure or prevent a disease, though claims referring to the
reduction of the risk of disease should be allowed “if they are based on sufficient and
recognised scientific findings and if they are tested and confirmed by an independent
body within the European Union”. Furthermore, the European Parliament Resolution
of  June  2001  on  the  White  Paper  on  Food  Safety8  called  on  the  Commission  to
address “enhanced function claims and disease reduction claims” and to consider this
as  a  priority  for  legislation.  In  this  proposal,  heath  claims  include  the  above-
mentioned sub-categories of claims requested by the European Parliament, as well as
those claims describing a well-established and  generally  accepted  role  of a nutrient
or  other  substance  in  growth,  development  and  normal  functions  of  the  body.  It  is
essential  to  bear  in  mind  that  a  varied  and  balanced  diet  is  a  prerequisite  for  good
health and single products have a relative importance in the context of the total diet,
and  that  diet  is  one  of  the  many  factors  influencing  the  onset  of  certain  human
diseases.  Other  factors  such  as  age,  genetic  predisposition,  the  level  of  physical
activity,  the  use  of  tobacco  (and  other  drugs/medicines),  environmental  exposure,
stress  may  all  influence  the  onset  of  human  diseases.  Hence,  the  choice  to  require
clear and honest labelling mentions on foods bearing health claims and in particular
claims related to the reduction of a risk of a human disease.

A study9 carried out on food shoppers in the US in 1997 showed that consumers were
less  likely  to  read  the  nutritional  declaration  when  the  pack  was  labelled  with  a
health claim. Furthermore, consumers ascribed other health-related advantages to the
food than those that were claimed. The study concluded that the results raised doubts
about  the  investigation’s  assumptions  concerning  the  purpose  and  value  of  health
claims in helping the consumer to a healthy diet.  Many  would argue that  there  is a
great risk that health claims are not easy to understand and utilise correctly, with the
consequence that the consumer will not achieve the result(s) wanted. Thus there is a
great risk that health claims will confuse and mislead the consumer and will not help
the  consumer  choose  a  healthy  diet,  will  not  strengthen  dietary  and  nutritional
information and will not help promote nutrition policy goals. These were indeed the
conclusions of a recently published report of the Nordic Council of Ministers10 on the
evaluation of health claims from a nutritional perspective. However, the report also
concludes that health claims should be consistently regulated in order for the claims
to promote nutrition policy goals, be truthful, scientifically-based, clear, reliable and
of help to the consumer in choosing a healthy diet. This is what the proposal aims to
achieve.

Health  claims  should  therefore  only  be  approved  for  use  on  the  labelling,
presentation  and  advertising  of  foods  on  the  Community  market  after  a  scientific
evaluation of the highest possible standard. In order to ensure harmonised scientific
assessment  of  these  claims,  the  European  Food  Safety  Authority  (EFSA)  hereafter
called the "Authority" should carry out such assessments. In this context it is worth
mentioning that the European Commission has funded valuable projects such as the

OJ C 197, 12.7.2001, p. 203
Levy et al.: Consumer Impacts of Health Claims. An experimental study, January 1997.
Evaluation of health claims from a nutritional perspective, TemaNord 2001: 537, Council of Ministers,
Copenhagen 2001

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Concerted  Action  PASSCLAIM  aiming  at  setting  principles  for  assessing  the
scientific support of health claims,  and  that this considerable work should be taken
into account when assessing claims. As stated above, the communication of claims to
the  final  consumer  is  a  very  important  aspect.  Therefore,  in  order  to  ensure  that
health  claims  are  truthful,  clear  and  reliable,  in  its  opinion  the  Authority,  and  the
subsequent authorisation procedure, should also take into account the wording of the
claims assessed. The scientific  assessment  should  be followed  by  a  decision by  the
Commission, under a regulatory procedure. In summary, the authorisation procedure
laid down in the proposed Regulation is as follows:

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The applicant will submit an application to the Authority;

The Authority will give an opinion within 3 months;

The Authority will forward its opinion to the Commission, the Member States
and  the  applicant,  and  will  make  its  opinion  public.  The  public  may  make
comments to the Commission;

The Commission will prepare a draft decision within 3 months of receipt of the
opinion of the Authority;

The Commission will inform the applicant of the final decision taken. The final
decision  will  be  published  on  the  Official  Journal  of  the  European
Communities;

– 

A summary of the final decision will also be included in the “Register”.

The  3  months  time-limit  for  the  Commission  to  prepare  a  draft  Decision  is  an
indication  of  the  maximum  time  allowed  for  completing  this  step.  In  practice,  the
average time  actually  needed should  be  lower. The  evaluation  of the application of
the Regulation foreseen in Article 25 of the proposal will provide an opportunity to
in particular revisit this matter.

Being  based  on  long-established  and  non-controversial  science,  health  claims  that
describe the role of a nutrient or other substance in growth, development and normal
physiological functions of the body shall undergo a different type of assessment and
approval prior to their use in the labelling, presentation and advertising of foods. It is
therefore proposed to adopt a list of permitted claims describing the role of a nutrient
or other substance in growth, development and normal physiological functions of the
body  following  the  opinion  of  the  Authority.  The  compilation  and  adoption  of  this
list  of  health  claims  shall  be  done  within  a  3-year  period.  In  the  meantime,  it  is
however  necessary  to  provide  the  possibility  for  national  authorities  to  apply
safeguard  measures  in  order  to  verify  the  scientific  substantiation  of  these  claims
and/or their conformity with the provisions laid down in this Regulation, and, where
necessary, to temporarily suspend the use of such claims and refer the matter to the
Community. The valuable work carried out in the Consensus Document on Scientific
Concepts  of  Functional  Foods  in  Europe,  prepared  in  the  context  of  the
Commission’s Concerted Action on Functional Food Science in Europe (FUFOSE),
shall be take into account in the compilation of this list.

30.

31.

For  the  sake  of  transparency  and  in  order  to  avoid  the  repetition  of  applications  of
health claims that have already been assessed and  for those health claims  that have

9

gone  through  the  Community  procedure,  a  “Register”  of  such  claims  shall  be
established and regularly updated.

32.

There are no budgetary implications for the Commission.

– 

– 

– 

The above-mentionned  « Register »  will be established  as a  section of

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

The  regulatory  committee  mentionned  in  Article  23  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.

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

 4.

33.

CONCLUSION

The  proposed  rules  would  contribute  to  a  high  level  of  protection  of  human  health
and  promote  the  protection  of  consumer  interests  by  ensuring  that  foods  bearing
nutrition  and  health  claims  are  labelled  and  advertised  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 Council11 and with Article 153 of the Treaty. The proposed rules 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.

11

OJ L 31, 1.2.2002, p. 1

10

                                                
2003/0165 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on nutrition and health claims made on foods

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 Commission12,

Having regard to the opinion of the European Economic and Social Committee13,

Acting in accordance with the procedure laid down in Article 251 of the Treaty14,

Whereas:

(1)

(2)

(3)

There is an increasing number of foods labelled and advertised in the Community with
nutrition and health claims. In order to ensure a high level of protection for consumers
and to facilitate their choice, products put on the market must be safe and adequately
labelled.

Differences between national provisions relating to such claims may impede the  free
movement  of  foods, and create unequal conditions of  competition.  They  thus  have  a
direct  impact  on  the  functioning  of  the  internal  market.  It  is  therefore  necessary  to
adopt Community rules on the use of nutrition and health claims on foods.

General  labelling  provisions  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
foodstuffs15,  as  amended  by  Commission  Directive  2001/101/EC16.  Directive
2000/13/EC  generally  prohibits  the  use  of  information  that  would  mislead  the
purchaser  or  attribute  medicinal  properties  to  food.  This  Regulation  should
complement  the  general  principles  laid down in Directive  2000/13/EC and  lay  down
specific provisions concerning the use of nutrition and health claims concerning foods
to be delivered as such to the consumer.

(4)

At international level Codex Alimentarius has adopted General Guidelines on Claims
in 1991 and Guidelines for the Use of Nutrition Claims in 1997. An amendment to the

12

13

14

15

16

OJ C,, p..
OJ C , , p. .
OJ C , , p. .
OJ L109, 6.5.2000, p. 29.
OJ L 310, 28.11.2001, p.19.

11

                                                
(5)

(6)

(7)

(8)

(9)

latter will soon be adopted by the Codex Commission. That amendment concerns the
inclusion of Health Claims in the 1997 Guidelines. Due consideration is given to the
definitions and conditions set in the Codex Guidelines.

There  is  a  wide  range  of  nutrients  and  other  substances  with  a  nutritional  or
physiological  effect  that  might  be  present  in  a  food  and  be  the  subject  of  a  claim.
Therefore,  general  principles  applicable  to  all  claims  made  on  foods  should  be
established in order to ensure a high level of consumer protection, give the consumer
the necessary information to  make  choices in full knowledge of the  facts,  as  well  as
creating equal conditions of competition for the food industry.

Foods promoted with claims may be perceived by consumers as having a nutritional,
physiological  or  other  health  advantage  over  similar  or  other  products  without  such
nutrients  added.  This  may  encourage  consumers  to  make  choices,  which  directly
influence their total intake of individual nutrients or other substances in a way which
would run counter to scientific advice. To counter this potential undesirable effect, it is
appropriate  to  impose  certain  restrictions  as  regards  the  products  bearing  claims.  In
this  context,  factors  such  as  the  presence  of  certain  substances  such  as  the  alcohol
content of the product or the nutrient profile of the product are appropriate criteria for
determining whether the product can bear claims.

The establishment of a nutrient profile may take into account the content of different
nutrients and substances with a nutritional or physiological effect,  in particular those
such  as  fat,  saturated  fat,  trans-fatty  acids,  salt/sodium  and  sugars  whose  excessive
intakes  in  the  overall  diet  are  not  recommended  and  those  such  as  poly-  and
monounsaturated  fats,  available  carbohydrates  other  than  sugars,  vitamins,  minerals,
protein  and  fibre.  When  setting  the  nutritional  profiles,  the  different  categories  of
foods  and  the  place  and  role  of  these  foods  in  the  overall  diet  shall  be  taken  into
account.  Exemptions  to  respect  established  nutrient  profiles  may  be  necessary  for
certain foods or categories of foods depending on their role and importance in the diet
of the population. These would be complex technical exercises and the adoption of the
relevant measures should be entrusted to the Commission.

There  is  a  wide  variety  of  claims  currently  used  in  the  labelling  and  advertising  of
foods  in  some Member States  relating  to substances  that  have  not  been  shown  to  be
beneficial  or  for  which  at  present  there  is  not  sufficient  scientific  agreement.  It  is
necessary to ensure that the substances for which a claim is made have been shown to
have a beneficial nutritional or physiological effect.

In order to ensure that the claims made are truthful, it is necessary that the substance
that  is  the  subject  of  the  claim  is  present  in  the  final  product  in  quantities  that  are
sufficient, or that the substance is absent or present in suitably reduced quantities, to
produce the nutritional or physiological effect claimed. The substance should  also be
available  to  be  used  by  the  body.  In  addition,  a  significant  amount  of  the  substance
producing  the  claimed  nutritional  or  physiological  effect  should  be  provided  by  a
quantity of the food that can reasonably be expected to be consumed.

(10)

It is important that claims on foods can be understood by the average consumer.

(11)

Scientific substantiation should be the main aspect to be taken into account for the use
of  nutrition  and  health  claims  and  the  food  business  operators  using  claims  should
justify them.

12

(12) Given  the  positive  image  conferred  to  foods  bearing  nutrition  and  health  claims  and
the  potential  impact  these  foods  may  have  on  dietary  habits  and  overall  nutrient
intakes,  the  consumer  should  be  able  to  evaluate  their  global  nutritional  quality.
Therefore,  nutrition  labelling  should  be  compulsory  and  should  be  extensive  on  all
foods bearing health claims..

(13) A list of permitted nutrition claims and their specific conditions of use should also be
created  based  on  the  conditions  for  the  use  of  such  claims  that  have  been  agreed  at
national  or  international  level  and  laid  down  in  Community  legislation.  That  list
should be regularly updated. Furthermore, for comparative claims it is necessary that
the products being compared should be clearly identified to the final consumer.

(14) Health  claims  should  only  be  authorised  for  use  on  the  Community  market  after  a
scientific assessment  of  the  highest possible  standard.  In order  to  ensure  harmonised
scientific  assessment  of  these  claims,  the  European  Food  Safety  Authority  should
carry out such assessments.

(15)

There are many factors, other than dietary ones, that can influence psychological and
behavioural functions. Communication on these functions is thus very complex and it
is  difficult  to  convey  a  comprehensive,  truthful  and  meaningful  message  in  a  short
claim to be used in the labelling and advertising of foods. Therefore, it is appropriate
to prohibit the use of psychological and behavioural claims.

(16) Commission  Directive  96/8/EC  of  26  February  1996  on  foods  intended  for  use  in
energy-restricted  diets  for  weight  reduction17  prohibits,  in  the  labelling,  presentation
and  advertising  of  products  covered  by  that  Directive,  any  reference  to  the  rate  or
amount of weight loss which may result from their use, or to a reduction in the sense
of  hunger  or  an  increase  in  the  sense  of  satiety.  A  growing  number  of  foods  not
specifically  designed  for  weight  control  are  marketed  with  the  use  of  the  such
references  and  reference  to  the  product's  ability  to  reduce  the  available  energy  from
the diet. It is therefore appropriate to prohibit references to such properties in respect
of all foods.

(17) Health  claims  that  describe  the  roles  of  nutrients  or  other  substances  in  growth,
development  and  normal  physiological  functions  of  the  body,  based  on  long-
established  and  non-controversial  science,  should  undergo  a  different  type  of
assessment  and  authorisation.  It  is  therefore  necessary  to  adopt  a  list  of  permitted
claims describing the role of a nutrient or other substance.

(18)

In order to keep up with scientific and technological developments, that list should be
revised promptly whenever necessary. Such revisions are implementing measures of a
technical nature and their adoption should be entrusted to the Commission in order to
simplify and expedite the procedure.

(19) A varied and balanced diet is a prerequisite for good health and single products have a
relative  importance  in  the  context  of  the  total  diet,  and  that  diet  is  one  of  the  many
factors  influencing  the  onset  of  certain  human  diseases.  Other  factors  such  as  age,
genetic predisposition, the level of physical activity, the consumption of tobacco and
other drugs, environmental exposure and stress may all influence the onset of human

17

OJ L 55, 6.3.1996, p. 22.

13

                                                
(20)

(21)

(22)

(23)

(24)

diseases.  Specific  labelling  requirements  should  therefore  apply  in  respect  of  claims
relating to the reduction of a disease risk.

In  order  to  ensure  that  health  claims  are  truthful,  clear,  reliable  and  useful  to  the
consumer in choosing a healthy diet, the wording and the presentation of health claims
should  be  taken  into  account  in  the  opinion  of  the  Authority  and  in  the  subsequent
authorisation procedure.

In some cases, scientific risk assessment alone cannot provide all the information  on
which a risk management decision should be based. Other legitimate factors relevant
to the matter under consideration should therefore be taken into account.

For the sake of transparency and in order to avoid multiple applications in respect of
claims,  which  have  already  been  assessed,  a  Register  of  such  claims  should  be
established.

In  order  to  keep  up  with  scientific  and  technological  developments,  the  Register
should  be  revised  promptly,  whenever  necessary.  Such  revisions  are  implementing
measures  of  a  technical  nature  and  their  adoption  should  be  entrusted  to  the
Commission in order to simplify and expedite the procedure.

In  order  to  stimulate  research  and  development  within  the  agri-food  industry,  it  is
appropriate to protect the investment made by innovators in gathering the information
and  data  supporting  an  application  under  this  Regulation.  This  protection  should
however be limited in time in order to avoid the unnecessary repetition of studies and
trials.

(25) Given the particular nature of foods bearing claims, additional means to those usually
available  to  monitoring  bodies  should  be  available  in  order  to  facilitate  efficient
monitoring of those products.

(26) A  transitional  period  is  necessary  to  enable  food  business  operators  to  adapt  to  the

requirements of this Regulation.

(27)

Since  the  objectives  of  the  proposed  action  cannot  be  sufficiently  achieved  by  the
Member  States  and  can  therefore  be  better  achieved  at  Community  level,  the
Community  may  adopt  measures,  in  accordance  with  the  principle  of  subsidiarity  as
set out in Article 5 of the Treaty. In accordance with the principle of proportionality,
as set out in that Article, this Regulation does not go beyond what is necessary in order
to achieve those objectives.

(28)

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 on the Commission18.

18

OJ L 184, 17.7.1999, p. 23.

14

                                                
HAVE ADOPTED THIS REGULATION:

CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1
Subject matter and scope

1.

2.

3.

4.

This Regulation is intended to harmonise the provisions laid down by law, regulation
or administrative action in Member States which relate to nutrition and health claims
in order to ensure the effective functioning of the internal market whilst providing a
high level of consumer protection.

This  Regulation  shall  apply  to  nutrition  and  health  claims  in  the  labelling,
presentation and advertising of foods to be delivered as such to the final consumer. It
shall  also  apply  to  foods  intended  for  supply  to  restaurants,  hospitals,  schools,
canteens and similar mass caterers.

Nutrition and health claims not complying with this Regulation shall be considered
as misleading advertising within the meaning of Council Directive 84/450/EEC19.

This  Regulation  shall  apply  without  prejudice  to  specific  provisions  concerning
foods for particular nutritional uses laid down in Community legislation.

Article 2
Definitions

For  the  purposes  of  this  Regulation,  the  definitions  of  “food”,  “food  business  operator”,
“placing on the market”, and  “final consumer” set  out in Articles 2, 3(3), 3(8) and 3(18) of
Regulation (EC) No 178/2002 of the European Parliament and of the Council20 shall apply.

The following definitions shall also apply:

(1)

(2)

(3)

(4)

19

20

“claim”  means  any  message  or  representation,  which  is  not  mandatory  under
Community  or  national  legislation,  including  pictorial,  graphic  or  symbolic
representation,  which  states,  suggests  or  implies  that  a  food  has  particular
characteristics;

“nutrient”  means  protein,  carbohydrate,  fat,  fibre,  sodium,  vitamins  and  minerals
listed in the Annex to Directive 90/496/EEC, and substances, which belong to or are
components of one of those categories;

“other  substance”  means  a  substance  other  than  a  nutrient  that  has  a  nutritional  or
physiological effect;

“nutrition claim” means any claim which states, suggests or implies that a food has
particular nutrition properties due to:

OJ L250, 19.9.1984, p.17.
OL L 31, 1.2.2002, p. 1.

15

                                                
(a)

the energy (calorific value) it

– 

– 

– 

provides,

provides at a reduced or increased rate, or

does not provide, and/or

(b)

the nutrients or other substances it

– 

– 

– 

contains,

contains in reduced or increased proportions, or

does not contain;

(5)

(6)

(7)

(8)

“health  claim”  means  any  claim  that  states,  suggests  or  implies  that  a  relationship
exists between a food category, a food or one of its constituents and health;

“reduction  of  disease  risk  claim”  means  any  health  claim  that  states,  suggests  or
implies  that  the  consumption  of  a  food  category,  a  food  or  one  of  its  constituents
significantly reduces a risk factor in the development of a human disease;

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

“average  consumer”  means  the  consumer  who  is  reasonably  well  informed  and
reasonably observant and circumspect.

CHAPTER II
GENERAL PRINCIPLES

Article 3
General principles for all claims

Nutrition and health claims may only be used in the labelling, presentation and advertising of
foods  placed  on  the  market  in  the  Community  if  they  comply  with  the  provisions  of  this
Regulation.

Without prejudice to Directives 2000/13/EC and 84/450/EEC, the use of nutrition and health
claims shall not:

(a) 

be false or misleading;

(b) 

(c) 

give rise to doubt about the safety  and/or the nutritional adequacy of
other foods;

state  or  imply  that  a  balanced  and  varied  diet  cannot  provide
appropriate quantities of nutrients in general;

16

(d) 

refer  to  changes  in  bodily  functions  in  improper  or  alarming  terms
symbolic
either 
representations;

through  pictorial,  graphic  or 

textually  or 

Article 4
Restrictions on the use of nutrition and health claims

1.

Within  18  months  from  the  adoption  of  this  Regulation,  the  Commission  shall,  in
accordance with the procedure laid down in Article 23 (2) establish specific nutrient
profiles  which  food  or  certain  categories  of  foods  must  respect  in  order  to  bear
nutrition or health claims.

The nutrient profiles shall be established, in particular, by reference to the  amounts
of the following nutrients present in the food:

(a) 

fat, saturated fatty acids, trans-fatty acids

(b) 

sugars

(c) 

salt/sodium.

The nutrient profiles shall be based on scientific knowledge about diet, and nutrition,
and their relationship to health and, in particular, on the role of nutrients  and other
substances  with  a  nutritional  or  physiological  effect  on  chronic  diseases.  In  setting
the  nutritional  profiles,  the  Commission  shall  seek  the  advice  of  the  Authority  and
carry out  consultations  with  interested  parties, in particular food  business  operators
and consumer groups.

Exemptions  and updates to take into account  relevant  scientific  developments  shall
be adopted in accordance with the procedure referred to in Article 23 (2).

2.

By way of derogation from paragraph 1, nutrition claims referring to the reduction in
the  amounts  of  fat,  saturated  fatty  acids,  trans-fatty  acids  and  sugars,  salt/sodium,
shall  be  allowed,  provided  they  comply  with  the  conditions  laid  down  in  this
Regulation.

3.

Beverages containing more than 1.2% by volume of alcohol shall not bear:

(a) 

health claims;

(b) 

nutritional  claims, other than those, which refer to  a  reduction in the
alcohol or energy content.

4.

Other foods or  categories of foods than those  referred to in paragraph 3,  for  which
nutrition  or  health  claims  are  to  be  restricted  or  prohibited  may  be  determined  in
accordance  with  the  procedure  referred  to  in  Article  23(2)  and  in  the  light  of
scientific evidence.

17

Article 5
General conditions

1.

The  use  of  nutrition  and  health  claims  shall  only  be  permitted  if  the  following
conditions are fulfilled:

(a)

the presence, absence or reduced content of the substance in respect of which
the  claim  is  made  has  been  shown  to  have  a  beneficial  nutritional  or
physiological effect, as established by generally accepted scientific data;

(b)

the substance for which the claim is made :

(i)

(ii)

is  contained  in  the  final  product  in  a  significant  quantity  as  defined  in
Community  legislation  or,  where  such  rules  do  not  exist,  in  a  quantity
that  will  produce  the  nutritional  or  physiological  effect  claimed  as
established by generally accepted scientific data; or

is  not  present  or  is  present  in  a  reduced  quantity  that  will  produce  the
nutritional  or  physiological  effect  claimed  as  established  by  generally
accepted scientific data;

(c) where applicable, the substance for which the claim is made is in a form that is

available to be used by the body;

(d)

the  quantity  of  the  product  that  can  reasonably  be  expected  to  be  consumed
provides  a significant quantity  of the substance  to  which the  claim relates, as
defined  in  Community  legislation  or,  where  such  rules  do  not  exist,  in  a
significant  quantity  that  will  produce  the  nutritional  or  physiological  effect
claimed as established by generally accepted scientific data;

(e)

compliance with the specific conditions set out in Chapter III or Chapter IV as
appropriate.

The  use  of  nutrition  and  health  claims  shall  only  be  permitted  if  the  average
consumer  can  be  expected  to  understand  the  beneficial  effects  as  expressed  in  the
claim.

Nutrition  and  health  claims  shall  refer  to  the  food  ready  for  consumption  in
accordance with the manufacturer's instructions.

Article 6
Scientific substantiation for claims

Nutrition and health claims shall be based on and substantiated by generally accepted
scientific data.

A food business operator making a nutrition or health claim shall justify the use of
the claim.

The  competent  authorities  of  the  Member  States  may  request  a  food  business
operator or a person placing a product on the market to produce the scientific work
and the data establishing compliance with this Regulation.

18

2.

3.

1.

2.

3.

Article 7
Nutrition information

Where a nutrition or health claim is made, with the exception of generic advertising, nutrition
information shall be provided in accordance with Directive 90/496/EEC.

For health claims, the information to be provided shall consist of information in Group 2 as
defined in Article 4 (1) of Directive 90/496/EEC.

In addition and as the case may be, the amount(s) of the substance(s) to which a nutrition or
health  claim  relates  that  does  not  appear  in  the  nutrition  labelling  shall  also  be  stated  in
proximity to the nutrition information.

CHAPTER III
NUTRITION CLAIMS

Article 8
Specific conditions

1.

2.

1.

2.

Nutrition  claims  shall  only  be  permitted  if  they  are  in  conformity  with  this
Regulation and comply with the conditions set out in the Annex.

Amendments  to  the  Annex  shall  be  adopted  in  accordance  with  the  procedure
referred  to  in  Article  23(2)  and,  where  appropriate,  after  consulting  the  European
Food Safety Authority.

Article 9
Comparative claims

Without  prejudice  to  Directive  84/450/EEC,  a  nutrition  claim  which  compares  the
quantity  of  a  nutrient  and/or  the  energy  value  of  a  food  with  foods  of  the  same
category shall only be made if the foods being compared are easily identified by the
average  consumer  or  clearly  indicated.  The  difference  in  the  quantity  of  a  nutrient
and/or the energy value shall be stated and the  comparison shall  relate  to  the  same
quantity of food.

Comparative nutrition claims shall compare the composition of the food in question
with a range of foods of the same category, which do not have a composition which
allows them to bear a claim, including foods of other brands.

19

CHAPTER IV
HEALTH CLAIMS

Article 10
Specific Conditions

1.

2.

Health  claims  shall  be  permitted  if  they  comply  with  the  general  requirements  in
Chapter  II  and  the  specific  requirements  in  this  Chapter  and  are  authorised  in
accordance with this Regulation.

Health claims shall only be permitted if the following information is included on the
label:

(a) 

(b) 

(c) 

(d) 

a statement indicating the importance of a balanced diet and a healthy
lifestyle;

the quantity of the food and pattern of consumption required to obtain
the claimed beneficial effect;

where appropriate, a statement addressed to persons who should avoid
using the food;

where  appropriate, a warning not to  exceed  quantities  of  the  product
that may represent a risk to health.

Article 11
Implied health claims

1.

The following implied health claims shall not be allowed:

(a) 

(b) 

(c) 

(d) 

claims  which  make  reference  to  general,  non-specific  benefits  of  the
nutrient or food for overall good health, well-being;

claims  which  make  reference  to  psychological  and  behavioural
functions;

without prejudice to Directive  96/8/EC claims which make reference
to slimming or weight control, or to the rate or amount of weight loss
which  may  result  from  their  use  or  to  a  reduction  in  the  sense  of
hunger or an increase in the sense of satiety or to the reduction of the
available energy from the diet;

claims which make reference to the advice of doctors or other health
professionals,  or  their  professional  associations,  or  charities,  or
suggest that health could be affected by not consuming the food.

2.

Where  appropriate,  the  Commission  having  first  consulted  the  Authority  shall
publish detailed guidelines for the implementation of this article.

20

1.

2.

3.

1.

2.

1.

Article 12
Health claims describing a generally accepted role of a nutrient or other substance

By  way  of  derogation  from  Article  10  (1),  health  claims  describing  the  role  of  a
nutrient or of another substance in growth, development and the normal functions of
the body, which are based on generally accepted scientific data and well understood
by the average consumer, may be made if they are included in the list provided for in
paragraph 2.

Member  States  shall  provide  the  Commission  with  lists  of  claims  as  referred  to  in
paragraph 1 by … at the latest [last day of the month of adoption of this Regulation +
1 year].

After consulting the Authority, the Commission shall adopt, in accordance with the
procedure referred to in Article 23, a Community list of permitted claims as referred
to  in  paragraph  1,  describing  the  role  of  a  nutrient  or  other  substance  in  growth,
development  and  normal  functions  of  the  body  by  …  at  the  latest  [last  day  of  the
month of adoption of this Regulation + 3 years]

Modifications to the list shall be adopted in accordance with the procedure  referred
to  in  Article  23,  on  the  Commission's  own  initiative  or  following  a  request  by  a
Member State.

From  the  date  of  entry  into  force  of  this  Regulation  until  the  adoption  of  the  list
referred  to  in  the  second  paragraph  of  paragraph  2,  health  claims  as  referred  to  in
paragraph  1  may  be  made  under  the  responsibility  of  business  operators  provided
that they are in accordance with this Regulation and with existing national provisions
applicable to them, and without prejudice to the adoption of safeguard measures as
referred to in Article 22.

Article 13
Reduction of disease risk claims

By  way  of  derogation  from  Article  2  (1)  of  Directive  2000/13/EC,  reduction  of
disease risk claims may be made where they have been authorised in accordance with
this Regulation.

In addition to the general requirements laid down in this Regulation and the specific
requirements of paragraph 1, for reduction of disease risk claims the label shall also
bear a statement indicating that diseases have multiple risk factors and that altering
one of these risk factors may or may not have a beneficial effect.

Article 14
Application for authorisation

To  obtain  the  authorisation  referred  to  in  Article  10  (1),  an  application  shall  be
submitted to the Authority.

The Authority:

21

(a) 

(b) 

(c) 

shall acknowledge receipt of an application in writing within 14 days
of its receipt. The acknowledgement shall state the date  of  receipt of
the application;

shall inform without delay the Member States and the Commission of
the application and shall make the application and any supplementary
information supplied by the applicant available to them;

shall  make  the  summary  of  the  dossier  referred  to  in  paragraph  3(f)
available to the public.

2.

The application shall be accompanied by the following particulars and documents:

(a) 

the name and address of the applicant;

(b) 

(c) 

(d) 

(e) 

the food or the category of food in respect of which the health claim is
to be made and its particular characteristics;

a copy of the  studies which have  been  carried out with regard  to  the
health  claim  including,  where  available,  independent,  peer-reviewed
studies, which have been carried out and any other material which is
available to demonstrate that it complies with the criteria provided for
in this Regulation;

a  copy  of  other  scientific  studies  which  are  relevant  to  that  health
claim;

a proposal for the wording, in all Community languages, of the health
claim for which authorisation is sought including, as the case may be,
specific conditions for use;

(f) 

a summary of the dossier.

3.

4.

1.

2

3.

Implementing rules for the application of this Article, including rules concerning the
preparation  and  presentation  of  the  application  shall  be  established  in  accordance
with the procedure referred to in Article 23 (2), after consultation of the Authority.

Before the date of application of this Regulation, the Authority shall publish detailed
guidance to assist applicants in the preparation and the presentation of applications.

Article 15
Opinion of the Authority

In  giving its opinion, the Authority shall endeavour  to respect a time limit  of three
months  from  the  date  of  receipt  of  a  valid  application.  That  time  limit  shall  be
extended  where  the  Authority  seeks  supplementary  information  from  the  applicant
pursuant to paragraph 2.

The  Authority  may,  where  appropriate,  request  the  applicant  to  supplement  the
particulars accompanying the application within a specified time limit.

In order to prepare its opinion, the Authority shall verify:

22

(a) 

(b) 

(c) 

that  the  proposed  wording  of  the  health  claim  is  substantiated  by
scientific data;

that  the  wording  of  the  heath  claim  complies  with  the  criteria  laid
down in this Regulation;

that  the  proposed  wording  of  the  health  claim  is  understandable  and
meaningful to the consumer.

4.

In the event of an opinion in favour of approving the health claim, the opinion shall
include the following particulars:

(a) 

the name and address of the applicant;

(b) 

(c) 

(d) 

the designation of the food or category of food in respect of which a
claim is to be used and its particular characteristics;

the  recommended  wording,  in  all  Community  languages,  of  the
proposed health claim;

where  necessary,  conditions  of  use  of  the  food  and/or  an  additional
statement  or  warning  that  should  accompany  the  health  claim  on  the
label and advertising.

The Authority shall forward its opinion to the Commission, the Member States and
the  applicant,  including  a  report  describing  its  assessment  of  the  health  claim  and
stating the reasons for its opinion.

The  Authority  in  accordance  with  Article  38(1)  of  Regulation  (EC)  No  178/2002
shall make its opinion public.

The  public  may  submit  comments  to  the  Commission  within  30  days  from  such
publication.

Article 16
Community Authorisation

Within three months of receipt of the opinion of the Authority, the Commission shall
submit  to  the  Committee  referred  to  in  Article  23(1)  a  draft  of  the  decision  to  be
taken in respect of the application, taking into account the opinion of the Authority,
any  relevant  provisions  of  Community  law  and  other  legitimate  factors  relevant  to
the matter under  consideration.  Where the  draft Decision is  not  in  accordance  with
the  opinion  of  the  Authority,  the  Commission  shall  provide  an  explanation  for  the
differences.

Any  draft  decision  which  envisages  the  granting  of  authorisation  shall  include  the
particulars referred to in Article 15(4) and the name of the authorisation-holder

A final decision on the application shall be adopted in accordance with the procedure
referred to in Article 23(2).

5.

6.

1.

2.

3.

23

4.

5.

1.

2.

3.

1.

2.

The Commission shall without delay inform the applicant of the decision taken and
publish details of the decision in the Official Journal of the European Union.

The granting of authorisation shall not lessen the general civil and criminal liability
of any food operator in respect of the food concerned.

Article 17
Modification, suspension and revocation of authorisations

The authorisation-holder may, in accordance with the procedure laid down in Article
14, apply for a modification of an existing authorisation.

On  its  own  initiative  or  following  a  request  from  a  Member  State  or  from  the
Commission, the Authority shall issue an opinion on whether a decision for the use
of a health claim continues to meet the conditions laid down in this Regulation.

It  shall  forthwith  transmit  its  opinion  to  the  Commission,  the  authorisation–holder
and  the  Member  States.  The  Authority,  in  accordance  with  Article  38(1)  of
Regulation (EC) No 178/2002, shall make its opinion public.

The  public  may  submit  comments  to  the  Commission  within  30  days  of  such
publication.

The Commission shall examine the opinion of the Authority as soon as possible. If
appropriate, the authorisation shall be modified, suspended or revoked in accordance
with the procedure laid down in Article 16.

CHAPTER V
GENERAL AND FINAL PROVISIONS

Article 18
Community Register

The Commission shall establish and maintain a Community Register of nutrition and
health claims made on food, hereinafter referred to as ‘the Register’.

The Register shall include the following:

(a) 

(b) 

the nutrition claims and the conditions applying to them as set out in
the Annex;

the  authorised  health  claims  and  the  conditions  applying  to  them
provided for in Articles 13(2), 17(2), 19 (1) and (2), 21(2) and 22(2);

(c) 

a list of rejected health claims.

Health  claims  authorised  on  the  basis  of  proprietary  data  shall  be  placed  on  a
separate Annex to the Register with the following information:

24

(1) 

(2) 

(3)

the  date  the  Commission  authorised  the  health  claim  and  the  name  of  the
original applicant that was granted authorisation;

that  the  Commission  authorised  the  health  claim  on  the  basis  of  proprietary
data;

that the health claim is restricted for use unless a subsequent applicant obtains
authorisation  for  the  claim  without  reference  to  the  proprietary  data  of  the
original applicant

3.

The Register shall be made available to the public.

Article 19

Data protection

1.

2.

The  scientific  data  and  other  information  in  the  application  dossier  required  under
Article 14 (2) may not be used for the benefit of a subsequent applicant for a period
of  seven  years  from  the  date  of  authorisation,  unless  the  subsequent  applicant  has
agreed with the prior applicant that such data and information may be used, where:

(a) 

(b) 

(c) 

the  scientific  data  and  other  information  has  been  designated  as
proprietary by the prior applicant at the time the prior application was
made; and,

the prior applicant had exclusive right of reference to the  proprietary
data at the time the prior application was made; and,

the health claim could not have been approved without the submission
of the proprietary data by the prior applicant.

Until  the  end  of  the  seven  years  period  specified  in  paragraph  1,  no  subsequent
applicant  shall  have  the  right  to  refer  to  data  designated  as  proprietary  by  a  prior
applicant  unless  and  until  the  Commission  takes  a  decision  on  whether  an
authorisation  could  be  or  could  have  been  granted  without  the  submission  of  data
designated as proprietary by the prior applicant.

Article 20
National provisions

Without  prejudice  to  the  Treaty,  in  particular  Articles  28  and  30  thereof,  Member
States may not restrict or forbid trade in or advertising of foods which comply with
this Regulation by the application of non-harmonised national provisions governing
claims made on certain foods or on foods in general.

Article 21
Notification procedure

1.

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

25

2.

3.

4.

1.

2.

3.

1.

2.

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
(hereinafter  referred  to  as  the  “Committee”)  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 six months after the
notification referred to in paragraph 2, 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 23(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 22
Safeguard measures

Where  a  Member  State  has  serious  grounds  for  considering  that  a  claim  does  not
comply  with  this  Regulation,  or  that  the  scientific  substantiation  provided  for  in
Article 7 is insufficient, that Member State may temporarily suspend the use of that
claim within its territory.

It shall inform the other Member States and the Commission and give reasons for the
suspension.

In  accordance  with  the  procedure  referred  to  in  Article  23(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 until the
decision referred to in paragraph 2 has been notified to it.

Article 23
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”.

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.

26

Article 24
Monitoring

To facilitate efficient monitoring of foods bearing nutrition or health claims, 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 25
Evaluation

By  …  at  the  latest  [last  day  of  the  fifth  month  following  date  of  adoption  +  6  years],  the
Commission  shall  submit  to  the  European  Parliament  and  to  the  Council  a  report  on  the
application of this Regulation, in particular on the evolution of the market of foods in respect
of  which  nutrition  or  health  claims  are  made,  together  with  a  proposal  for  amendments  if
necessary.

Article 26
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 the sixth month following publication].

Foods  placed  on  the  market  or  labelled  prior  to  that  date  which  do  not  comply  with  this
Regulation may be marketed until [last day of the eleventh 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

27

ANNEX

Nutrition claims and conditions applying to them

LOW ENERGY

A claim that a food is low in energy, and any claim likely to have the same meaning for the
consumer, may only be made where the product contains less than 40 kcal (170 kJ)/100g and
less than 20kcal (80kJ)/100ml.

In the case of foods naturally low in energy, the term “naturally” may be used as a prefix to
this claim.

ENERGY-REDUCED

A claim that a food is energy-reduced, and any claim likely to have the same meaning for the
consumer,  may  only  be  made  where  the  energy  value  is  reduced  by  at  least  30%,  with  an
indication of the characteristic(s), which make(s) the food reduced in its total energy value.

ENERGY-FREE

A  claim  that  a  food  is  energy-free,  and  any  claim  likely  to  have  the  same  meaning  for  the
consumer, may only be made where the product contains less than 4kcal (17kJ)/100ml.

In the case of foods energy-free, the term “naturally” may be used as a prefix to this claim.

LOW FAT

A  claim  that  a  food  is  low  in  fat,  and  any  claim  likely  to  have  the  same  meaning  for  the
consumer, may only be made where the product contains no more than 3g of fat per 100g or
1.5g of fat per 100ml (1.8g of fat per 100 ml for semi-skimmed milk).

In the case of foods naturally low in fat, the term “naturally” may be used as a prefix to this
claim.

FAT-FREE

A  claim  that  a  food  is  fat-free,  and  any  claim  likely  to  have  the  same  meaning  for  the
consumer, may only be made where the product contains no more than 0.5g of fat per 100g or
100ml. However, claims expressed as “X% fat-free” shall be prohibited.

In  the  case  of  foods  naturally  fat-free,  the  term  “naturally”  may  be  used  as  a  prefix  to  this
claim.

LOW SATURATED FAT

A claim that a food is low in saturated fat, and any claim likely to have the same meaning for
the consumer, may only be made where the product contains no more than 1.5g of saturates
per 100g for solids or, 0.75g of saturates per 100ml for liquids and in either case saturated fat
must not provide more than 10% of energy.

In the case of foods naturally low in saturated fat, the term “naturally” may be used as a prefix
to this claim.

28

SATURATED FAT -FREE

A  claim  that  a  food  does  not  contain  saturated  fat,  and  any  claim  likely  to  have  the  same
meaning for the consumer, may only be made where the product contains no more than 0.1g
of saturated fat per 100g or 100ml.

In the case of foods naturally saturated fat-free, the term “naturally” may be used as a prefix
to this claim.

LOW SUGARS

A claim that a food is low in sugars, and any claim likely to have the same meaning for the
consumer, may only be made where the product contains no more than 5g of sugars per 100g
or 100ml.

In the case of foods naturally low in sugars, the term “naturally” may be used as a prefix to
this claim.

SUGARS-FREE

A  claim  that  a  food  is  sugars-free,  and  any  claim  likely  to  have  the  same  meaning  for  the
consumer,  may  only  be  made  where  the  product  contains  no  more  than  0.5g  of  sugars  per
100g or 100ml.

In the case of foods naturally sugars-free, the term “naturally” may be used as a prefix to this
claim.

WITH NO ADDED SUGARS

A claim stating that sugar has not been added to a food, and any claim likely to have the same
meaning for the consumer, may only be made where the product does not contain any added
mono- or disaccharides or any other food used for its sweetening properties.

LOW SODIUM / SALT

A claim that a food is low in sodium, and any claim likely to have the same meaning for the
consumer, may only be made where the product contains no more than 0.12g of sodium, or
the equivalent value for salt, per 100g or per 100ml.

In the case of foods naturally low in sodium, the term “naturally” may be used as a prefix to
this claim.

VERY LOW SODIUM / SALT

A claim that a food is very low in sodium, and any claim likely to have the same meaning for
the consumer, may only be made where the product contains no more than 0.04g of sodium,
or the equivalent value for salt, per 100g or per 100 ml.

In  the  case  of  foods  naturally  very  low  in  sodium,  the  term  “naturally”  may  be  used  as  a
prefix to this claim.

29

SODIUM-FREE or SALT-FREE

A  claim  that  a  food  is  sodium-free,  and  any  claim  likely  to  have  the  same  meaning  for  the
consumer, may only be made where the product contains no more than 0.005g of sodium, or
the equivalent value for salt, per 100g.

In the case of foods naturally sodium-free, the term “naturally” may be used as a prefix to this
claim.

SOURCE OF FIBRE

A claim that a food is a source of fibre, and any claim likely to have the same meaning for the
consumer, may only be made where the  product  contains  at least 3g  of fibre per  100g or at
least 1.5g of fibre per 100kcal.

In the case of foods that are naturally sources of fibre, the term “naturally” may be used as a
prefix to this claim.

HIGH FIBRE

A claim that a food is high in fibre,  and any claim likely to have the same meaning  for the
consumer, may only be made where the  product  contains at least 6g of fibre per 100g or at
least 3g of fibre per 100kcal.

In the case of foods naturally high in fibre, the term “naturally” may be used as a prefix to this
claim.

SOURCE OF PROTEIN

A claim that a food is a source of protein, and any claim likely to have the same meaning for
the  consumer,  may  only  be  made  where  at  least  12%  of  the  energy  value  of  the  food  is
provided by protein.

In the case of foods that are naturally sources of protein, the term “naturally” may be used as a
prefix to this claim.

HIGH PROTEIN

A claim that a food is high in protein, and any claim likely to have the same meaning for the
consumer, may only be made where at least 20% of the energy value of the food is provided
by protein.

In the case of foods naturally high in protein, the term “naturally” may be used as a prefix to
this claim.

NATURAL SOURCE OF VITAMINS AND/OR MINERALS

A claim that a food is a natural source  of  vitamins and/or minerals, and any claim  likely to
have the same meaning for the consumer, may only  be  made  where  the  product  contains  at
least 15% of the recommended daily  allowance specified in the Annex of Council Directive
90/496/EEC per 100 g or 100 ml.

30

ENRICHED OR FORTIFIED IN VITAMINS AND/OR MINERALS

A claim that a food is enriched or fortified in vitamins and/or minerals, and any claim likely
to have the same meaning for the  consumer, may only  be  made where  the product  contains
the  vitamins  and/or  minerals  in  at  least  a  significant  amount  as  defined  in  the  Annex  of
Directive 90/496/EEC.

HIGH VITAMINS AND/OR MINERALS

A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same
meaning for the  consumer, may only be made where the  product contains  at  least  twice the
value of “source of vitamins and minerals”.

In case of foods naturally high in vitamins and/or minerals, the term “naturally” may be used
as a prefix to this claim.

CONTAINS (NAME OF THE NUTRIENT OR OTHER SUBSTANCE)

A claim that a food contains a nutrient or another substance, or any claim likely to have the
same meaning for the consumer, may only be made where the product complies with all the
applicable provisions of this Regulation.

In  the  case  of  foods  that  naturally  contain  the  named  nutrient  or  other  substance,  the  term
“naturally” may be used as a prefix to this claim.

INCREASED (NAME OF THE MACRONUTRIENT)

A claim stating that the  content  in  one or more  nutrients has been increased,  and any claim
likely  to  have  the  same  meaning  for  the  consumer,  may  only  be  made  where  the  product
meets  the  conditions  for  the  claim  “source  of”  and  the  increase  in  content  is  at  least  30%
compared to a similar product.

REDUCED (NAME OF THE NUTRIENT)

A  claim  stating  that  the  content  in  one  or  more  nutrients  has  been  reduced,  and  any  claim
likely to have the same meaning for the consumer, may only be made where the reduction in
content is at least 30% compared to a similar product, except for micronutrients where a 10%
difference in the reference values as set in Council Directive 90/496/EEC shall be acceptable

LIGHT/LITE

A  claim  stating  that  a  product  is  “light”  or  “lite”,  and  any  claim  likely  to  have  the  same
meaning  for  the  consumer,  shall  follow  the  same  conditions  as  those  set  for  the  term
“reduced”; the claim shall also be accompanied by an indication of the characteristic(s) which
make the food “light” or “lite”.

31

IMPACT ASSESSMENT FORM

Draft Proposal for a Regulation of the European Parliament and of the Council on
Nutrition Claims and Health Claims Made on Foods

1.

PROBLEM IDENTIFICATION

As  food  production  has  become  more  and  more  complex,  consumers  are  increasingly
interested  in  the  information  appearing  on  food  labels.  They  have  also  become  more
interested  in  their  diet,  its  relationship  to  health,  and,  more  generally,  the  composition  of
foods  that  they  are  selecting.  For  these  reasons  it  is  important  that  information  about  foods
and  their  nutritional  value  appearing  on  the  labelling  and  used  for  their  presentation,
marketing and advertising should be clear, accurate and meaningful.

The  food  industry  has  responded  to  the  increased  interest  of  consumers  in  nutrition  by
providing  nutrition  labelling  on  many  foods  and  by  highlighting  the  nutritional  value  of
products  through  claims  in  their  labelling,  presentation  and  advertising.  Some  would  argue
that this evolution could be considered as a positive one for providing relevant information to
the consumer. It also provides an opportunity to use claims as a marketing tool.

The European Community has adopted detailed rules on labelling (Directive 2000/13/EC) and
nutrition labelling (Directive 90/496/EEC) of foods. However, this is not the case with some
specific claims. In view of the proliferation of the number and type of claims appearing on the
labels  of  foods  and  in  the  absence  of  specific  provisions  at  European  level,  some  Member
States  have  adopted  legislation  and  other  measures  to  regulate  the  use  of  claims.  This  has
resulted in differences in approaches, definition of terms used and the conditions of the use of
claims. These discrepancies can act as barriers to guaranteeing a high level of consumer and
public health protection, and can constitute obstacles to the free movement of  foods and the
proper functioning of the internal market. For these reasons, harmonisation of rules on claims
at Community level is being advocated.

The provisions in the  proposal  aim  at  regulating  specific  claims that are  not covered by the
Community rules on labelling.

2.

OBJECTIVE OF THE PROPOSAL

The overall policy objective in terms of expected impacts is:

(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 economic operators

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

The proposed rules ensures that foods bearing nutrition claims and health claims are labelled
and  advertised  in  a  truthful  and  meaningful  manner.  By  adopting  rules  that  regulate  the
information  about  the  foodstuffs  and  their  nutritional  value  appearing  on  the  label,  the

32

consumers will be able to make informed and meaningful choices. This also contributes to a
higher level of protection of human health. Appropriate labelling can indeed point consumers
in  the  right  direction  towards  adopting  a  healthy  diet,  and  facilitate  positive  and  informed
choice.  Through  education,  information,  health  promotion  initiatives,  as  well  as  through
appropriate  legislation  we  can  act  to  help  diminish  the  health  risk  factors  affecting  the
European public and improve overall quality of life.

Improving  public  health  of  the  European  community  is  a  shared  responsibility  of  the  EU
institutions  and  Member  States.  This  regulatory  proposal  will  provide  an  important  and
necessary  foundation;  and  the  implementation  of  effective  educational  programmes  is  also
required  in  order  to  foster  positive  behavioural  change,  not  only  related  to  diet  but  also  to
physical activity and other lifestyle factors.

The  proposed  rules  also  take  into  account  the  importance  for  the  food  industry  to  have  a
regulatory  environment  thereby  allowing  them  to  innovate  and  remain  competitive  at
Community and international level. This also gives the economic operators legal security and
a more predictable environment.

3.

POLICY OPTIONS

The basic approach suggested in order to reach the above-mentioned objectives is to improve
and harmonise Community  legislation on  specific claims by introducing the proposed  rules.
Only nutrition and health claims that are in conformity with the proposed provisions will be
allowed on the  labelling,  presentation  and  advertising  of  foods  placed  on  the  market  within
the Community.

The  proposed  provisions  provide  for  further  voluntary  information  when  making  claims,
beyond the mandatory information foreseen by EU legislation. The only other policy option
therefore is not to provide for any rules on claims and leave the market unregulated.

In  terms  of  respecting  the  principles  of  subsidiarity  and  proportionality,  the  proposed  rules
aim at harmonising an area hitherto unregulated area by the Community and Member States.
The  planned  proposal  has  the  additional  value  for  each  Member  State  of  laying  down
provisions  for  common  definitions  and  principles  of  claims.  This  will  aid  in  achieving  the
objective  of  harmonisation  of  rules  as  well  as  confer  the  competency  of  establishing  the
conformity  of  claims  and  the  functioning  of  the  provisions  to  the  Member  States.  Lack  of
Community  regulation  would,  on  the  other  hand,  constitute  a  barrier  to  trade  for  Member
States and industry alike, hamper the functioning on the internal market and act as a barrier to
guaranteeing a high level of consumer and public health protection.

The  proposed  rules  are  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.

4.

IMPACTS – POSITIVE AND NEGATIVE

The proposed provisions only apply when giving voluntary information (claim) in addition to
what  is  deemed  mandatory  by  existing  Community  legislation.  It  follows  from  this  that  the
proposal will not have an impact on economic operators if they do not provide any additional
information on the label, presentation and advertising of foods. Only when doing so, will the
proposed rules apply.

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It  is  expected  that  the  current  proposal  will  to  a  great  extent  benefit  the  consumer.  By
allowing  for  clearer  legislation  on  which  claims  are  admissible  and  under  which  conditions
they can be made, the actual communication and the presentation of claims is expected to be
more understandable for consumers and will avoid misleading them. It is also expected that it
will  have  the  benefit  of  educating  the  consumer  thereby  rendering  the  consumer  capable  of
making better choices towards healthier dietary patterns.

It  is  also  expected  that  economic  operators  should  benefit  from  a  more  secure  legal
environment  in  which  to  operate  if  the  proposed  rules  are  adopted.  The  rules  for  making  a
nutrition claim will be the same for all economic operators and only those health claims that
are scientifically based and meaningful to the consumer will be allowed.

However,  by  not  providing  for  the  proposed  rules  the  consumer  will  still  be  faced  with  an
unregulated  market  in  which  claims  are  potentially  presented  in  a  manner  that  is  false,
misleading  or  deceptive  and  that  may  be  unsubstantiated.  In  the  long-term,  consuming
products that  falsely attribute  certain nutritional and/or health advantages may  have  adverse
effects on the health of the consumer and reduce consumer confidence in food products.

5.

FOLLOW-UP

Consultations  with  Member  States  and  stakeholders  on  a  discussion  paper  and  later  on  a
preliminary draft proposal have been held.

The  Commission  services  prepared  a  discussion  paper  that  was  published  on  the
Commission’s  website  in  May  2001.  More  than  90  stakeholders  gave  their  comments  and
these  were  published  on  the  SANCO  website.  In  July  2002,  a  meeting  was  held  with  the
stakeholders and one with Member States allowing for further consultation on a preliminary
draft  proposal.  On  the  basis  of  the  comments  received,  the  Commission  has  prepared  this
legislative  proposal  in  order  to  define  and  set  conditions  for  nutrition  claims  and  health
claims.

An  extended  assessment  on  this  proposal  is  not  recommended  as  the  proposal  has  already
been  subject  to  extensive  consultation  with  Member  States  and  stakeholders.  Their  opinion
has  been  taken  into  account  and  is  reflected  in  the  proposal.  Moreover,  the  proposed
provisions  only  pertain  to  voluntary  additional  information  (claims)  made  by  the  food
producer. Further consultation is not planned.

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