Report from the Commission to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements SEC(2008)2976 SEC(2008)2977
Date: 2008-12-05
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuffs legislation, inorganic chemical product, vitamin

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.12.2008 
COM(2008) 824 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

on the use of substances other than vitamins and minerals in food supplements 

SEC(2008)2976 

SEC(2008)2977 

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TABLE OF CONTENTS 

1. 

2. 

Characteristics of the market for food supplements containing substances other than 
vitamins and minerals .................................................................................................. 4 

The existing regulatory framework.............................................................................. 4 

2.1. 

Horizontal Community legislation............................................................................... 4 

2.1.1.  How the products concerned are classified in Community legislation ........................ 4 

2.1.2.  Food safety legislation ................................................................................................. 6 

2.2. 

2.3. 

3. 

4. 

National legislation ...................................................................................................... 9 

Mutual recognition ....................................................................................................... 9 

Available scientific information................................................................................. 10 

Conclusions ................................................................................................................ 11 

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INTRODUCTION 
Directive 2002/46/EC1 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  supplements  partially 
harmonises the rules applicable to the placing of food supplements on the market. 

The  scope  of  the  Directive  covers  all  food  supplements,  with  certain  requirements  –  in 
particular  those  concerning  labelling  information  –  applying  to  all  food  supplements, 
regardless of their composition. 

However, only the rules applicable to the use of vitamins and minerals in the manufacture of 
food supplements are laid down in the Directive. The use of substances other than vitamins or 
minerals in the manufacture of food supplements therefore continues to be subject to the rules 
in  force  in  national  legislation,  where  relevant,  which  apply  within  the  framework  of 
Articles 28 to 30 of the EC Treaty, without prejudice to any Community provisions of general 
application which may also concern them. 

These principles are mentioned in Recital 8 of the Directive, which states that specific rules 
concerning nutrients, other than vitamins and minerals, or other substances with a nutritional 
or physiological effect used as ingredients of food supplements should be laid down at a later 
stage. 

It  is  also  stated  that,  in  any  event,  such  rules  cannot  be  laid  down  until  adequate  and 
appropriate scientific data become available. In view of this, Article 4(8) of the Directive lays 
down that the Commission shall submit to the European Parliament and the Council a report 
on the advisability of establishing specific rules, including, where appropriate, positive lists, 
on categories of nutrients or of substances with a nutritional or physiological effect other than 
vitamins and minerals. 

The  present  report  follows  on  from  that  provision  and,  in  accordance  with  the  instructions 
outlined in the Directive and referred to above, will examine the issues concerning both the 
necessity and feasibility of the specific rules in question. 

In order to clarify matters properly and to set out the necessary information for drawing up the 
conclusions to this report, the Commission believes it is worthwhile to first describe: 

– 

– 

– 

the characteristics and prospects of the market for the products concerned; 

the existing regulatory framework; 

the status of the available scientific information. 

1 

OJ L 183, 12.7.2002, pp. 51-57. 

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1. 

CHARACTERISTICS  OF  THE  MARKET  FOR  FOOD  SUPPLEMENTS  CONTAINING 
SUBSTANCES OTHER THAN VITAMINS AND MINERALS 

Unlike  the  market  for  food  supplements  containing  vitamins  and  minerals,  which 
appears  relatively  homogeneous,  the  market  for  food  supplements  containing  other 
substances is characterised by its variety. 
A study of the Community market for food supplements2 containing substances other 
than vitamins or minerals gives rise to the following observations: 

• 

• 

the Community market for such products is extremely varied, both as regards 
the substances used and from one Member State to another; 

the  market  share  of  products  containing  vitamins  and  minerals  and  that  of 
products containing other substances are almost identical. 

Prospects for growth are strongest in the Member States where consumption is still 
relatively low. 

In  some  Member  States,  there  is  a  well  established  tradition  of  using  certain 
substances,  while  these  same  substances  are  practically  absent  in  other  Member 
States. 

More detailed information on the European food supplement market can be found in 
the  Commission’s  working  document  on  the  characteristics  and  prospects  of  the 
market for food supplements containing substances other than vitamins and minerals. 

2. 

THE EXISTING REGULATORY FRAMEWORK 

It  must  be  stressed  that  the  substances  in  question  are  already  covered  by  various 
Community legislative texts of general application, or which are applicable to certain 
categories of product, particularly as regards food safety. 

Since Community law does not include specific provisions on the use of substances 
other  than  vitamins  or  minerals  in  food  supplements,  the  free  movement  of  such 
products is governed by Articles 28 to 30 of the EC Treaty and can thus be subject to 
national restrictions or bans within the limits laid down by Article 30.  

2.1. 

Horizontal Community legislation 

2.1.1.  How the products concerned are classified in Community legislation 

Food  supplements  containing  substances  other  than  vitamins  or  minerals  are 
foodstuffs  within  the  meaning  of  Article  2  of  Regulation  (EC)  No  178/2002  of  the 
European  Parliament  and  of  the  Council3,  which  states  that  “foodstuff”  (or  “food”) 
means  any  substance  or  product,  whether  processed,  partially  processed  or 
unprocessed, intended to be, or reasonably expected to be ingested by humans. 

The  aforementioned  Article  2  explicitly  excludes  from  the  definition  of  foodstuff  a 
series  of  product  categories,  including  medicinal  products  within  the  meaning  of 

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Source “The use of substances with nutritional or physiological effect other than vitamins and minerals 
in food supplements”, European Advisory Services (EAS), 2007. 
OJ L 31, 1.2.2002, pp. 1-24. 

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Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council4  on  the 
Community code relating to medicinal products for human use. 

With regard to food supplements, and in particular those containing substances other 
than  vitamins  or  minerals,  a  certain  number  of  borderline  cases  have  given  rise,  or 
could give rise, to situations where a given product is authorised for marketing as a 
food  in  some  Member  States,  while  the  same  product  is  classified  as  a  medicinal 
product in other Member States.  

It  should  also  be  pointed  out  that  some  substances,  in  particular  certain  herbal 
extracts,  are  used  both  in  food  supplements  and  for  manufacturing  proprietary 
medicinal  products,  in  particular  traditional  herbal  medicinal  products.  Such 
difficulties  must  be  dealt  with  on  a  case-by-case  basis,  since  the  legislation  on 
medicinal  products  lays  down  rules  and  procedures  for  the  placing  of  medicinal 
products on the market and provides for marketing authorisation to be issued by the 
Member  States’  competent  authority  or,  for  certain  types  of  medicinal  product,  at 
Community level.  

For  traditional  herbal  medicinal  products,  a  so-called  simplified  registration 
procedure is provided for by Directive 2004/24/EC of the European Parliament and 
of the Council5 amending Directive 2001/83/EC on the Community code relating to 
medicinal products for human use. 

In  this  context,  the  Court  of  Justice  has  stated  on  several  occasions  that  so  long  as 
harmonisation  of  the  measures  necessary  to  ensure  the  protection  of  health  is  not 
more complete, it is difficult to avoid the existence of differences between Member 
States in the classification of products as medicinal products or foodstuffs. Thus, the 
fact that a product is classified as a foodstuff in another Member State cannot prevent 
it from being classified as a medicinal product in the Member State of importation, if 
it displays the characteristics of such a product. 

Correspondingly,  the  Court  also  concluded  long  ago  that  a  product  which  satisfies 
the  definition  of  “medicinal  product”  within  the  meaning  of  Directive  2001/83/EC 
must  be  held  to  be  a  medicinal  product  and  be  made  subject  to  the  corresponding 
rules even if it comes within the scope of other, less stringent Community rules (see 
paragraphs 37 and 38 of case C-319/05 of 15 November 2007). 

This  principle  also  figures  in  the  legislation  itself,  since  Article  2(2)  of  Directive 
2001/83/EC,  as  amended  by  Directive  2004/27/EC6,  lays  down  that,  in  cases  of 
doubt, where, taking into account all its characteristics, a product may fall within the 
definition of a “medicinal product” and within the definition of a product covered by 
other Community legislation, the provisions of the legislation on medicinal products 
shall apply. 

As  a  result,  the  provisions  of  the  legislation  applicable  to  medicinal  products  will 
apply  to  a  product  which  fulfils  the  definition  of  food  supplement,  as  laid  down  in 
Article 2(a)  of  Directive  2002/46/EC,  but  which,  at  the  same  time,  taking  into 
account all its characteristics, may also fall within one of the definitions of medicinal 
product  contained  in  Article  1  of  Directive  2001/83/EC,  which  defines  medicinal 
products with reference to both their presentation and their function. 

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OJ L 311, 28.11.2001, pp. 67-128. 
OJ L 136, 30.4.2004, pp. 85-90. 
OJ L 136, 30.4.2004, pp. 34-57. 

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With regard to the definition of medicinal product by presentation, “any substance or 
combination of substances presented as having properties for treating or preventing 
disease in human beings” must be classified as a medicinal product. 

As  regards  the  definition  of  medicinal  product  by  function,  “any  substance  or 
combination  of  substances  which  may  be  used  in  or  administered  to  human  beings 
either  with  a  view  to  restoring,  correcting  or  modifying  physiological  functions  by 
exerting  a  pharmacological,  immunological  or  metabolic  action,  or  to  making  a 
medical diagnosis” must be classified as a medicinal product. 

On  first  examination,  this  definition  could  be  understood  as  potentially  applying  to 
certain  foodstuffs,  particularly  food  supplements,  which  constitute  a  concentrated 
source of substances having a physiological effect. 

However,  the  Court  of  Justice  ruled  that  this  definition  of  medicinal  product  by 
function  should  be  interpreted  restrictively,  since  it  is  designed  to  cover  only 
products  whose  pharmacological  properties  have  been  scientifically  observed,  and 
not substances which, while having an effect on the human body, do not significantly 
affect the metabolism and thus do not strictly modify the way in which it functions 
(see paragraphs 60 to 65 of the aforementioned case C-319/05). 

By  contrast,  according  to  settled  case  law,  the  definition  of  medicinal  product  by 
presentation is subject to broad interpretation, so as to avoid consumers being misled 
by improper presentation. 

Accordingly,  it  is  more  specifically  as  regards  presentation  that  some  food 
supplements  are  liable  to  fall  within  the  definition  of  medicinal  product.  It  will  be 
possible to significantly reduce this risk of a conflict of classification by applying the 
rules on health claims concerning foodstuffs (see section 2.1.2(c) below). 

2.1.2.  Food safety legislation 

As  foodstuffs,  food  supplements,  including  those  containing  substances  other  than 
vitamins and minerals, are covered by legislative texts of general application in the 
area  of  food  safety  legislation,  some  of  which  were  adopted  or  entered  into  force 
subsequent  to  the  adoption  of  Directive  2002/46/EC.  Taken  together,  these 
provisions  constitute  a  substantial  framework  in  relation  to  the  movement  of  the 
products in question on the Community market consistent with the requirements of 
food safety. 

a) 

Regulation (EC) No 178/2002 

Regulation  (EC)  No  178/2002  lays  down  the  general  legal  framework  and 
requirements  of  food  law  and  the  procedures  applicable  in  the  area  of  food 
safety. 

It also established the European Food Safety Authority (EFSA). 

As such, this Regulation has a very wide scope, covering not only any product 
included  in  the  definition  of  “foodstuff”  (see  section  2.2.1.),  but  also  any 
substance  introduced  into  the  food  chain  for  the  purposes  of  manufacturing  a 
foodstuff, irrespective of the existence of specific provisions applicable to that 
substance.  Accordingly,  all  the  relevant  provisions  of  Regulation  (EC) 
No 178/2002  apply  directly  to  the  substances  involved  in  the  manufacture  of 
food supplements. 

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In  this  connection,  mention  can  be  made  of  the  ban  on  the  placing  on  the 
market  of  products  which  are  injurious  to  health  or  unfit  for  human 
consumption  (Article 14), 
the  primary  responsibility  of  food  business 
operations  to  ensure  that  products  comply  with  food  law  (Article  17),  their 
obligation  to  put  in  place  a  product  traceability  system  (Article  18)  and  their 
obligation  to  be  able  to  immediately  initiate  procedures  to  withdraw 
non-compliant products from the market and inform the competent authorities 
in such cases (Article 19). 

It  is  important  to  note  that  Article  14(9)  of  the  Regulation  lays  down  that, 
“where  there  are  no  specific  Community  provisions,  food  shall  be  deemed  to 
be safe when it conforms to the specific provisions of national food law of the 
Member  State  in  whose  territory  the  food  is  marketed,  such  provisions  being 
drawn up and applied without prejudice to the Treaty, in particular Articles 28 
and 30 thereof”. 

b)  Regulation (EC) No 258/977 on Novel Foods 

The  objective  of  this  Regulation  is  to  make  subject  to  an  authorisation 
procedure,  and  thus  to  a  safety  assessment,  all  foods  and  food  ingredients 
covered  by  its  scope,  i.e.  those  covered  by  the  definition  of  “novel  food”  or 
“novel  ingredient”,  which,  within  the  meaning  of  the  Regulation,  covers  all 
foods and food ingredients which had not been used for human consumption to 
a significant degree within the Community prior to the entry into force of the 
Regulation. 

This  definition  covers  foods  and  food  ingredients  with  a  new  or  intentionally 
modified  primary  molecular  structure,  those  consisting  of  or  isolated  from 
micro-organisms, fungi or algae, those consisting of or isolated from plants and 
food ingredients isolated from animals obtained by non-traditional propagating 
or breeding practices. 

The production process is also covered if it gives rise to significant changes in 
the composition or structure of the foods or food ingredients which affect their 
nutritional value, metabolism or level of undesirable substances. 

In  order  to  facilitate  the  provision  of  information  to  operators  concerning  the 
scope of these definitions, and in particular the concept of “consumption to a 
significant degree”, the Commission recently drew up and published a “Novel 
Food  Catalogue”8.  This  is  a  non-exhaustive  database,  the  aim  of  which  is  to 
provide  an  initial  indication  as  to  whether  a  given  product  is  “novel”  with 
reference to the criterion mentioned above. The catalogue will be updated on a 
regular basis. 

In the context of this report, it is also relevant to stress that, in view of the food 
safety objective of Regulation (EC) No 258/97, the concept of “novel food” is 
broadly  interpreted.  This  explains  how  a  plant  extract  which  was  not  on  the 
Community  market,  or  not  produced,  as  at  the  date  of  entry  into  force  of  the 
Regulation, will, in principle, be considered a “novel ingredient”, even though 
the plant from which it is extracted would not be considered “novel”. 

7 
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OJ L 43, 14.2.1997, pp. 1-6. 
http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/index.cfm 

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This Regulation, which was recently the subject of a proposal9 for revision, is 
thus an important factor in the issue dealt with in this  report, since it permits 
the  safety  assessment  and  free  movement  of  any  “novel  substance”  used  in 
food supplements or as a food supplement. 
Regulation (EC) No 1924/200610 on nutrition and health claims 

c) 

This  Regulation  lays  down  the  conditions  for  the  use  of  nutrition  and  health 
claims on food packaging. While the Regulation has been in force since 1 July 
2007, it necessarily includes a transitional period for the circulation of products 
which were on the market when it entered into force but do not comply with its 
provisions.  Furthermore,  several  implementing  measures  are  being  prepared. 
This  Regulation  is  very  important  for  the  food  supplement  sector,  in  which 
claims, and in particular health claims, are a favoured means of communication 
with consumers. 

The decisive criterion for use of a health claim is that the health effect claimed 
in  relation  to  a  nutrient  or  substance  must  absolutely  be  based  on  scientific 
evidence. It can thus be expected that the legal framework applicable to health 
claims  will  ultimately  constitute,  directly  or  indirectly,  an  element  of 
harmonisation  of  the  substances  enjoying  mutual  recognition  by  the  Member 
States, for which these claims will be authorised at the Community level. 

Moreover,  as  suggested  at  the  end  of  section  2.1.1.,  health  claims  authorised 
pursuant to Regulation (EC) No 1924/2006 will constitute a presumption that 
the product to which they refer belongs in the category of foodstuffs, thereby 
reducing  the  risk  of  conflicts  of  classification.  Indeed,  function  claims  and 
reduction of disease risk claims clearly establish that the product to which they 
refer  is  not  liable  to  fall  within  the  definition  of  medicinal  product  by 
presentation.  However,  they  will  not  make  it  possible  to  completely  exclude 
the risk of conflict of classification in cases where it could be claimed that the 
product concerned is liable to fall within the definition of medicinal product by 
function. 

d)  Regulation (EC) No 1925/200611 on the addition of vitamins and minerals and 

of certain other substances to foods 

to 

not 

food 

shall 

apply 

This  Regulation,  which  has  been  in  force  since  1  July  2007  subject  to  a 
transitional  period,  concerns  all  foodstuffs,  including  food  supplements. 
However,  it  is  specifically  stated  that  the  provisions  regarding  vitamins  and 
by 
minerals 
Directive 2002/46/EC.  The  definition  in  Article  1  implies,  therefore,  that  the 
provisions concerning other substances shall apply to all foodstuffs, including 
food  supplements.  With  regard  to  these  other  substances,  Regulation  (EC) 
No 1925/2006  does  not  contain  a  list  of  authorised  substances.  Instead  it 
establishes,  in  Article  8,  a  procedure  to  be  used  in  cases  where  a  substance 
other than vitamins or minerals, or an ingredient containing a substance other 
than  vitamins  or  minerals,  is  added  to  foods  or  used  in  the  manufacture  of 
foods  under  conditions  that  would  result  in  the  ingestion  of  amounts  of  this 

supplements 

covered 

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COM/2007/0872 final - COD 2008/0002 
OJ L 12, 18.1.2007, pp. 3-18. 
OJ L 404, 30.12.2006, pp. 26-38. 

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substance  greatly  exceeding  those  reasonably  expected  to  be  ingested  under 
normal conditions of consumption of a balanced and varied diet and/or would 
otherwise represent a potential risk to consumers. 

In such cases, on its own initiative or on the basis of information provided by 
the  Member  States,  the  Commission  may  take  a  decision,  following  an 
assessment of available information by the European Food Safety Authority, to 
include the substance in Annex III to the Regulation. 

Annex III, which does not currently include any substances, as the procedure 
under Article 8 has not yet been used, will make it possible to draw up a list of 
substances  whose  use  in  foods  is  prohibited,  restricted  or  under  Community 
scrutiny.  

Any decision to place a substance in one of these three headings will thus be 
taken  on  the  basis  of  the  results  of  an  assessment  of  the  available  scientific 
information,  having  regard  only  to  the  safety  of  the  substances  concerned  in 
food.  With  regard  to  substances  other  than  vitamins  or  minerals  added  to 
foodstuffs,  including  food  supplements,  or  used  in  the  manufacture  of 
foodstuffs,  the  procedure  described  above  constitutes,  on  first  examination,  a 
safety  net  as  regards  health  protection  and  can  allow,  with  a  precautionary 
approach,  harmonisation  of  the  possibilities  or  conditions  of  use  of  a  certain 
number of substances. 

This  procedure  can  be  used  on  a  case-by-case  basis,  provided  that  the 
conditions laid down in Article 8(1), referred to above, have been met. 

2.2. 

National legislation 

A  large  majority  of  the  Member  States  have  drawn  up  positive  or  negative  lists  of 
substances other than vitamins and minerals which can be used in food supplements.  

In  some  cases,  use  of  the  substances  in  question  is  subject  to  compliance  with 
technical  conditions,  such  as  maximum  limits,  type  of  extract  or  combination  of 
ingredients.  Furthermore,  entry  of  new  substances  onto  these  lists  is  liable  to  be 
subject to an assessment. 

2.3.  Mutual recognition 

Mutual  recognition  remains  an  important  tool  for  ensuring  the  free  movement  of 
products, including foodstuffs, on the Community market.  

As  already  stated  in  section  2.1.2.,  Article  14(9)  of  Regulation  (EC)  No  178/2002 
lays  down  that,  where  there  are  no  specific  Community  provisions,  food  shall  be 
deemed to be safe when it conforms to specific national provisions, without prejudice 
to the Treaty, in particular Articles 28 and 30 thereof. 

Mutual  recognition  is  not  free  from  the  risk  that  technical  obstacles  to  the  free 
movement of the products concerned can be maintained or created. 

However, these risks should be put into perspective, in that the Court of Justice, as 
part of its judicial supervision, has set precise limits within which the Member States 
may  validly  exempt  themselves  from  mutual  recognition  by  availing  themselves  of 
Article 30 EC, including in the area of foodstuffs. 

Accordingly, the Court frequently reiterates that, it is for the Member States, in the 
absence of harmonisation and to the extent that uncertainties continue to exist in the 
current state of scientific research, to decide on their intended level of protection of 

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human health and life and on whether to require prior authorisation for the marketing 
of foodstuffs, always taking into account the requirements of the free movement of 
goods within the Community. 

However, in exercising their discretion relating to the protection of public health, the 
Member States must comply with the principle of proportionality. The means which 
they  choose  must  therefore  be  confined  to  what  is  actually  necessary  to  ensure  the 
safeguarding  of  public  health;  they  must  be  proportional  to  the  objective  thus 
pursued, which could not have been attained by measures which are less restrictive 
of intra-Community trade. 

Furthermore, since Article 30 EC provides for an exception, to be interpreted strictly, 
to the  rule  of  free  movement of goods within the Community, it is for the national 
authorities which invoke it to show in each case, in the light of national nutritional 
habits and in the light of the results of international scientific research, that their rules 
are necessary to give effective protection to the interests referred to in that provision 
and, in particular, that the marketing of the products in question poses a real risk for 
public  health  (see,  most  recently,  paragraphs  86  to  88  of  the  judgment  in  the 
aforementioned case C-319/05, Commission v Germany).  

In  other  words,  the  Member  States  are  entitled  to  invoke  the  need  to  protect  the 
interests  referred  to  in  Article  30  EC,  including  health  protection,  only  when  the 
conditions laid down by the Court and referred to above have been met, and to the 
extent  that  there  is  no  harmonised  Community  legislation  capable  of  protecting  the 
same interests. 

In this context, it should be stressed that, with effect from 13 May 2009, refusals of 
mutual  recognition  will  be  subject  to  the  conditions  laid  down  in  Regulation  (EC) 
No 764/200812 of the European Parliament and of the Council of 9 July 2008 laying 
down  procedures  relating  to  the  application  of  certain  national  technical  rules  to 
products  lawfully  marketed  in  another  Member  State  and  repealing  Decision 
No 3052/95/EC of the European Parliament and the Council establishing a procedure 
for the exchange of information on national measures derogating from the principle 
of the free movement of goods within the Community. 

3. 

AVAILABLE SCIENTIFIC INFORMATION 

With  regard  to  scientific  information,  a  distinction  should  be  drawn  between 
substances  of  vegetable  origin  (plants  or  plant  extracts)  and  other  categories  of 
substance. Scientific assessments have been, or are being, carried out for a significant 
number of substances other than those of vegetable origin, within the framework of 
the legislation on foodstuffs for particular nutritional uses. This is the case for some 
amino  acids  and  other  substances,  a  list  of  which  features  in  the  Annex  to 
Commission  Directive  2001/15/EC13  on  substances  that  may  be  added  for  specific 
nutritional purposes in foods for particular nutritional uses. 

With regard to substances of vegetable origin, work is ongoing at the European Food 
Safety Authority14 and the Council of Europe’s Nutrition Committee15. 

12 
13 
14 

OJ L 218, 13.8.2008, pp. 21-29. 
OJ L 52, 22.2.2001, pp. 19-25. 
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178717026833.htm 

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However, it should be pointed out that this work is more specifically concerned with 
methodology and not with assessing the safety of substances of vegetable origin. 

The Commission believes that this high-quality work will make new tools available 
to the Member States, thereby facilitating consensus building in relation to the proper 
approach  to  be  taken  for  each  product.  It  will  also  be  a  benchmark  for  the  Court’s 
analysis, in the light of the aforementioned articles of the Treaty.  

A brief description of the ongoing work at the European Food Safety Authority and 
the  Council  of  Europe’s  Nutrition  Committee  is  available  in  the  Commission’s 
working  document  on  the  available  scientific  information  concerning  the  use  of 
substances other than vitamins and minerals in food supplements. 

4. 

CONCLUSIONS 

Considering  all  the  issues  described  and  analysed  in  this  report,  the  Commission 
concludes  that  laying  down  specific  rules  applicable  to  substances  other  than 
vitamins and minerals for use in food supplements is not justified. 

Moreover,  the  Commission  doubts  the  feasibility  of  such  a  measure,  which,  in  any 
case, is not necessary in the short term. 

a) 

Feasibility. 

Unlike vitamins and minerals, the use of which is fairly similar throughout the 
Member  States,  the  other  substances  correspond  to  very  varied  consumption 
habits.  Moreover,  given  the  available  scientific  information,  which  is 
essentially  limited  to  substances  that  may  be  added  for  specific  nutritional 
purposes to foods for particular nutritional uses, the Commission believes that 
a  proposal  for  harmonisation  in  this  area  could  only  be  limited  to  some 
substances, thus restricting its usefulness.  

Taking  account,  also,  of  the  scientific  and  methodological  difficulties  which 
would  have  to  be  overcome,  the  Commission  believes  that  the  prospect  of 
extending  Directive  2002/46/EC  to  substances  other  than  vitamins  and 
minerals  could  only  be  envisaged  in  the  light  of  the  experience  gained  when 
the rules on the use of vitamins and minerals were being laid down, bearing in 
mind that these rules still need to be supplemented by laying down maximum 
quantities in accordance with Article 5 of the Directive. 

b)  Necessity. 

Reference has been made in this report to existing instruments, in particular the 
recently  adopted  legislation  on  the  enrichment  of  foodstuffs  with  vitamins, 
minerals  and  other  substances  and  that  on  nutritional  and  health  claims.  This 
suggests that the possibilities or conditions of use of the substances in question 
in  foodstuffs,  including  food  supplements,  or  their  prohibition,  can  undergo 
harmonisation  over  time  in  the  framework  of  the  procedures  provided  for  in 
those instruments. In this connection, the Commission would refer in particular 
to  the  procedure  laid  down  in  Article  8  to  Regulation  (EC)  No  1925/2006, 
which allows a substance to be placed under scrutiny for a given period if the 

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available  scientific  information  is  insufficient.  The  Commission  believes  that 
this type of procedure is particularly well suited to plants and plant extracts, for 
which  sufficient  and  appropriate  scientific  data  are  not  always  available,  and 
for which the safety assessment methodology is still being developed. 

Furthermore,  the  legislation  on  novel  foods  is  another  factor  likely  to 
contribute to such harmonisation, within the limits of its specific scope. 

Lastly, the Commission would point out that, in general terms, despite certain 
limitations,  mutual  recognition  is  a  useful  instrument  for  facilitating  the  free 
movement of the products concerned.  

To  conclude,  the  Commission  believes  that  the  Community  legal  instruments 
described in this report already constitute a sufficient legislative framework for 
regulating  this  area  and  does  not  consider  it  opportune  to  lay  down  specific 
rules for substances other than vitamins or minerals for use in foodstuffs. 

However,  since  substances  other  than  vitamins  or  minerals,  including 
substances derived from plants, are now being added to ordinary foodstuffs and 
not only to food supplements, the Commission does not rule out the possibility, 
at  a  later  state,  of  carrying  out  a  supplementary  analysis  to  this  report, 
examining the conditions for  the addition of these substances to foodstuffs in 
general. 

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