Proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC {SEC(2006)1042} {SEC(2006)1043}
Date: 2006-07-28
Institutions: European Commission
Subjects: approximation of laws, consumer information, consumer protection, flavouring, food additive, foodstuff, foodstuffs legislation, labelling

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.7.2006 
COM(2006) 427 final 

2006/0147 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on flavourings and certain food ingredients with flavouring properties for use in and on 
foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) 
No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC 

{SEC(2006)1042} 
{SEC(2006)1043} 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1)  CONTEXT OF THE PROPOSAL 

• 

Grounds for and objectives of the proposal 

Council Directive 88/388/EEC, sets out the definition of flavourings, general 
rules  for  their  use,  requirements  for  labelling  and  maximum  levels  for 
substances which raise concern for human health. It provides that Community 
Legislation  relating  to  flavourings  should  take  account  primarily  of  human 
health requirements.  

The  Directive  needs  to  be  substantially  amended,  to  take  into  account 
technological  and  scientific  developments  in  the  area  of  flavourings.  In 
addition, as a result of the adoption of Regulation (EC) No 178/2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the 
European  Food  Safety  Authority  (EFSA)  and  laying  down  procedures  in 
matters of food safety, certain provisions need to be adapted and others need 
to be newly introduced.  

In the interest of clarity and efficiency Directive 88/388/EEC is replaced by 
the present proposal.  

A  proposal  for  a  new  Regulation  on  Flavourings  and  food  ingredients  with 
flavouring properties, as part of the package on Food Improvement Agents, is 
included in the Commission Legislative Working Programme of 2005.  

• 

General context 

Article 1 of Directive 88/388/EEC restricts its scope to flavourings. However, 
through Article 4 (c), maximum levels for certain undesirable substances are 
established  in  foods  which  contain  flavourings  and  food  ingredients  with 
flavouring  properties.  Member  States  apply 
levels 
differently: some apply them to foods which contain only flavourings; others 
apply them to foods which contain both flavourings and food ingredients with 
flavouring properties. 

these  maximum 

The  maximum  levels  should  also  be  adapted  to  take  into  account the recent 
scientific opinions of EFSA.  

The  Committee  of  Experts  on  Flavouring  Substances  of  the  Council  of 
Europe  has  proposed  conditions  for  production  of  process  flavourings  and 
maximum levels for certain undesirable substances. 

The  use  of  the  term  'natural-identical'  is  considered  confusing  by  the 
consumer. In addition consumers request to be informed about the source of 
the  natural  flavourings.  The  use  of  the  term  'natural'  should  be  restricted  to 
flavourings  which  are  exclusively  obtained  from  natural  flavouring 
substances  and/or  flavouring  preparations.  Consumers  must  be  informed  if 
the smoky taste of food is due to the presence of smoke flavourings.  

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The  proposal  is  presented  in  a  package  of  "Food  Improvement  Agents", 
together  with  Regulations  on  food  additives,  food  enzymes  on  an  uniform 
procedure for their authorisation.  

• 

Existing provisions in the area of the proposal 

Council Directive 88/388/EEC of 22 June 1988 on the approximation of the 
laws  of  the  Member  States  relating  to  flavourings  for  use  in  foods  and  to 
source  materials  for  their  production  establishes  the  general  principles 
applicable to flavourings for use in foods: 

– 

– 

– 

– 

It provides definitions for flavourings, flavouring substances, flavouring 
preparations, process flavourings and smoke flavourings; 

It  restricts  the  addition  and  the  presence  of  certain  toxicologically 
relevant  substances  in  flavourings  and/or  foods  to  which  flavourings 
and food ingredients with flavouring properties have been added; 

It provides rules for the labelling of flavourings which are intended for 
sale  as  such  to  food  manufacturers  and  for  sale  as  such  to  final 
consumers. 

It  requests  the  adoption  of  more  specific  provisions  on  flavouring 
sources, flavouring substances, process flavourings, smoke flavourings 
and production methods as well as on additives, solvents and processing 
aids used for flavourings, methods of analysis and sampling as well as 
purity and microbiological criteria. 

As  a  consequence  of  the  last  indent,  the  following  legislation  has  been 
adopted: 

1.  A  procedure  for  the  establishment  of  a  positive  list  of  flavouring 
substances  for  use  in  and  on  foods  has  been  adopted  as  European 
Parliament and Council Regulation (EC) No 2232/96. The positive list 
should be adopted by July 2005. 

2. 

Regulation (EC) N 2065/2003 of the European Parliament and Council 
Regulation  of  10  November  2003  on  smoke  flavourings  used  or 
intended for use in or on foods. 

3.  Directive 2003/114/EC of the European Parliament and of the Council 
of  22  December  2003  amending  Directive  95/2/EC  on  food  additives 
other than colours and sweeteners. 

• 

Consistency with other policies 

The policy objectives to be met are: 

– 

– 

the protection of human health and consumers' interests 

To  create  a  clear  framework  that  allows  innovation  and  enables  new 

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technological developments, so that European industry can maintain its 
leaderships position in the area of flavourings 

As a consequence these objectives will contribute to the strategic objectives 
of  the  Commission  as  set  out  in  the  Lisbon  Strategy,  the  Commission  five 
year  plan  and  the  Commissions  White  paper  of  Food  Safety  published  in 
2000. 

2)  CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

• 

Consultation of interested parties 

Consultation  methods,  main  sectors  targeted  and  general  profile  of 
respondents. 

The  opinion  of  Member  States  and  stakeholders  was  assessed  through 
consultations  at  different  working  groups  and  during  bilateral  contacts  were 
working documents were discussed.  

In  addition  a  questionnaire  was  circulated  to  question  the  different 
stakeholder 

Among stakeholder organisations involved : 

BEUC (The European Consumers' Organisation) 

CAOBISCO  (Association  of  the  Chocolate,  Biscuit  and  Confectionery 
Industries of the EU) 

CEPS  (Comité  Vins,  Confédération  Européenne  des  Producteurs  de 
Spiritueux) 

CIAA (Confederation of the food and drink industries of the EU) 

EACGI (European Association of the Chewing Gum Industry) 

EDA (European Dairy Association) 

EFFA (European Flavour and Fragrance Association) 

EHGA (European Herb Grower Association) 

EHIA (European Herbal Infusion Association) 

ESA (European Spice Association) 

FIC Europe (European Condiment Association) 

SFMA (Smoke Flavourings Manufacturers Association)  

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Summary of responses and how they have been taken into account. 

After each consultation, comments have been considered and texts have been 
adapted.  General  consensus  exists  on  the  proposal.  The  responses  following 
the final consultations are summarised: 

1. 

Clarification of the scope.  

There  is  general  agreement  that  the  discrepancies  between  Member 
states will be avoided. 

2.  Definitions of flavourings 

2.1  Restriction of the use of the term natural 

There  is  no  unanimity  about  the impact  of  the  new  definition  of 
flavouring  substances  which  no  longer  makes  a  distinction 
between natural identical and artificial flavouring substances.  

The arguments in favour are: it avoids confusion; it reserves the 
term  natural  to  products  that  really  are  natural;  there  is  no 
toxicological  basis  to  make  this  difference  and  it  is  an  extra 
administrative  burden.  The  deletion  of  this  term  will  simplify 
legislation.  

The  arguments  not  in  favour  relate  especially  to  the  fact  that 
vertical  legislation  which  does  not  allow  artificial  flavouring  in 
certain food categories will need to be amended. 

2.2 

Introduction of the category "Other flavourings" 

Companies  that  are  developing  new  flavourings  are  in  favour  of 
this  category  as  it  gives  the  opportunity  to  develop  new 
flavourings that are not covered by the other definitions.  

Consumer  organisations  are  in  favour  because  it  creates  more 
transparency and it assures safety protection.  

3.  New provisions for labelling 

3.1  Labelling costs 

The possible impact of the new provisions is considered limited. 
The introduction of a transitional period can limit possible costs.  

3.2  Consumer information 

Members States as well as the Consumer organisations are of the 
opinion  that  the  proposal  will  lead  to  better  information  for  the 
consumer about the nature of the flavourings used.  

The  food  industry  and  especially  the  trade  associations  are  less 

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enthusiastic or are even against this new provision for labelling.  

4.  Maximum levels for substances of toxicological concern 

The controls by the Member States will be more efficient as they will 
focus on foodstuffs who contribute the most to the intake of substances 
of  toxicological  concern  and  no  longer  to  foodstuffs  and  beverages  in 
general  

5.  Monitoring of intake 

Member  States  are  concerned  that  for  the  monitoring  of  intake  of  the 
substances  listed  in  annex  II  and  substances  for  which  restrictions  of 
use are laid down, extra resources will be needed.  

• 

• 

Collection and use of expertise 

There was no need for external expertise. 

Impact assessment 

The  impacts  expected  on  the  different  option  concern  Economic  and  Social 
aspects.  Environmental  impacts  are  not  expected  from  the  different  options 
considered. 

1.  No action 

1.1  Economic impact 

The economic situation will become negative: 

New technological developments are not encouraged. . 

Clear  provisions  that  take  into  account  the  latest  scientific  and 
technological  developments  are  needed  in  order  to  avoid  trade 
barriers with third countries.  

European  industry  could  loose  its  leading  position  on  the  global 
market. 

1.2  Social impact 

The health of the consumers is not well protected because: 

Maximum  levels  of  substances  of  toxicological  concern  do  not 
take into account the latest scientific opinions.  

Maximum  levels  of  substances  of  toxicological  concern  in  food 
and beverages in general do not allow for a risk based control.  

The  consumers  request  for  more  informative  labelling  is  not 
fulfilled.  

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2.  Non legislative action 

2.1  Economic impact 

At the moment we are in a situation where there is legislation on 
flavourings. Guidelines can not overrule existing legislation. This 
could  lead  to  contradictory  and  confusing  situation  for  the 
industry with as a consequence negative economic impact. 

2.2  Social impact 

Guidelines could be in contradiction with existing legislation and 
are therefore not the most efficient way to protect the health of the 
consumer.  

An  unclear  legal  situation  will  result  in  loss  of  consumer 
confidence about the use of flavourings. 

3.  Deregulation of flavouring legislation 

3.1  Economic impact 

This could lead to the situation that each Member State makes its 
own  implementing  rules.  Since  the  risks  perception  could  be 
different  between  the  Member  States  this  would  result  in 
ineffective functioning of the internal market.  

3.2  Social impact 

Differences  in  approach  between  Member  States  for  safety 
assessment  will  lead  to  a  confusing  situation  for  the  consumers, 
with  different  levels  of  protection  and  a  loss  of  confidence  in 
certain Member States and in the internal market. 

4.  Amending Council Directive 88/388/EEC 

4.1  Economic impact 

The  introduction  of  the  necessary  amendments  in  the  actual 
Directive would have a beneficial economic impact as explained 
in 5.  

Changes  to  the  annexes  I  and  II  and  other  provisions  for  the 
protection  of  public  health  and  trade  would  still  need  to  be 
introduced  via  co-decision.  A  more  efficient  authorisation 
procedure  is  however  needed  for  the  management  of  a  positive 
list containing about 2600 flavouring substances to be used in and 
on food.  

The  amount  of  changes  necessary  could  lead  to  unclear 
legislation. 

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4.2  Social impact 

Positive  impacts  on  public  health  are  expected  due  to  a 
comprehensive system for safety evaluation of flavourings, to the 
adaptation  of  maximum  levels  of  substances  of  toxicological 
concern to the latest scientific opinion and by allowing controls of 
those substances to foods of highest risk.  

5. 

Proposal for a new Regulation.  

5.1  Economic impact 

5.1.1  Impact on administrative requirements imposed on business 

The elimination of the distinction between Natural Identical 
and  Artificial  flavouring  substances,  both  chemically 
synthesized,  will  result  in  less  administrative  requirements 
by harmonising the provisions in all Member States.  

Additional  efforts  will  be  needed  to  comply  with  the 
changes  proposed  for  the  labelling  of  flavourings.  These 
will  however  be  temporarily,  until  the  labels  have  been 
brought  in  line  with  the  new  requirements.  Moreover,  the 
efforts  are  limited  compared  to the additional transparency 
acquired and judged positive by the consumer.  

In  order  to  limit  efforts  and  costs  involved,  a  transitional 
period  for  adaptation  to  new  labelling  requirements  is 
proposed.  

5.1.2  Impact on innovation and research 

The  specific  provisions  for  use  and  authorisation  of 
flavourings clarify when the safety of flavouring needs to be 
evaluated.  Certain  flavourings  are  by  definition  exempt  of 
evaluation.  This  will  allow  industry  to  more  correctly 
estimate the development costs of new flavourings.  

The proposal also specifies what kind of preparations can be 
accepted  in  order  to  allow  labelling  as  natural.  This  is 
important  for  the  further  development  and  production  of 
new natural flavourings.  

The  introduction  of  the  category  "other  flavouring"  is 
considered  positive  for  innovation  and  research.  If  new 
categories  of  flavourings  are  developed,  they  can  be 
authorised as long as their safety has been evaluated.  

5.1.3  Impact on households 

The  consumer  will  be  better  informed  about  the  nature  of 

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the flavourings present in the food. 

It  is  not  expected  that  the  proposed  Regulation  will  affect 
the prices of foodstuffs. 

5.1.4  Impact on third countries and international relations 

This  proposal  will  further  harmonise  the  legislation  on 
flavourings and will create a uniform market within the EU 
and predictability to importers. 

The  harmonisation  of  the  legislation  on  flavourings  will 
place  the  European  Union  in  a  better  position  when 
negotiating  with  third  countries  about  the  introduction  of 
flavourings in the Codex Alimentarius system. 

The  European  Community  will  be  able  to  maintain  its 
leading position as producer and developer of flavourings  

5.1.5  Impact on public Authorities 

The controls by the Member States will be more efficient as 
they will focus on foodstuffs who contribute the most to the 
intake of substances of toxicological concern. 

National  legislation  will  have  to  be  adapted  in  those 
countries where certain food categories exist to which only 
natural  or  natural  identical  flavouring  substances  may  be 
added.  This  simplification  will  however  lead  to  less 
administrative requirements. .  

Member  States  are  concerned  that  for  the  monitoring  of 
intake of the substances listed in annex II and substances for 
which restrictions of use are laid down, extra resources will 
be  needed.  This  is  however  essential  to  assure  that  the 
regulation  will  be  effective  for  the  protection  consumers 
health.  

Members States  did not provide us with information about 
resources needed. The impact for the specific monitoring of 
intake  of  flavourings  can  significantly  be  reduced  by 
organising  this  monitoring  together  with  the  monitoring  of 
intake  of  additives  that  is  already  requested  by  EU 
legislation.  

5.2  Social Impact 

Positive  impacts  on  public  health  are  expected  due  to  a 
comprehensive  system  of  safety  evaluation  of  flavourings  at 
Community level. 

Control of the limits for substances of toxicological concern will 

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focus  on  foods  of  highest  risk  resulting  in  a  more  efficient 
protection of the health of the consumers.  

The conclusions of the monitoring of intake can be used to adapt 
legislation  when  it  would  appear  that  the  intake  is  of  safety 
concern 

The  Commission  carried  out  an  impact  assessment  listed  in  the  Work 
on 
Programme, 
http://ec.europa.eu/food/food/chemicalsafety/additives/index_en.htm. 

accessible 

whose 

report 

is 

3)  LEGAL ELEMENTS OF THE PROPOSAL 

• 

Summary of the proposed action 

• 

• 

The  Regulation  will  better  ensure  the  effective  functioning  of  the  internal 
market in relation to flavourings used or intended for use in or on foods and 
certain  food  ingredients  with  flavouring  properties,  it  will  provide  the  basis 
for securing a high level of protection for human health and for protecting the 
interests of the consumers 

Legal basis 

Article 95 of the the Treaty establishing the European Community 

Subsidiarity principle 

The subsidiarity principle applies insofar as the proposal does not fall under 
the exclusive competence of the Community. 

The objectives of the proposal cannot be sufficiently achieved by the Member 
States for the following reason(s): 

Action  by  Member  States  only  could  lead  to  a  confusing  situation  for  the 
consumers,  with  different  levels  of  protection,  and  a  loss  of  confidence  in 
certain Member States and in the internal market.  

Community  action  will  better  achieve  the  objectives  of  the  proposal  for  the 
following reason(s): 

A positive list with about 2600 flavouring  substances  needs  to  be  managed. 
About 100 applications for authorisations per year are expected. This requires 
a harmonised and centralised approach.  

Efficiency  of  the  authorisation  procedure  and  effective  functioning  of  the 
internal market will indicate that the objectives are best met by the Union.  

Effective functioning of the internal market in relation to flavourings used in 
and  on  food  while  protecting  the  health  and  the  interest  of  the  European 
consumers can best be met via a centralised procedure for authorisation. 

The proposal therefore complies with the subsidiarity principle. 

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• 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reason(s). 

To  make  better  use  of  the  control  capacity  of  the  Member  States  and 
organised  risk  based  controls,  focus  will  be  given  on  flavourings  and 
substances present in foods which are most of concern 

Safety  assessment  of  flavourings  is  limited  to  only  flavouring  substances, 
preparations that are not traditional and source of vegetable and animal origin 
other than food.  

Obligatory  labelling  is  limited  to  "flavouring",  "smoke  flavouring”  and  the 
source of natural flavourings.  

• 

Choice of instruments 

Proposed instruments: regulation. 

Other means would not be adequate for the following reason(s). 

The area of flavouring has through Council Directive 88/388/EEC achieved a 
high  level  of  harmonisation.  In  order  to  insure  continuing  effective 
functioning  of  the  internal  market  while  protecting  human  health  and  the 
interests of consumers a regulation is considered the most appropriate tool.  

4)  BUDGETARY IMPLICATION 

The Community may finance the establishment of a harmonised policy and system in 
the  field  of  food  flavourings  and  food  ingredients  with  flavouring  properties, 
including: 

development  of  an  appropriate  database  for  gathering  and  storing  all  information 
relating to Community legislation on flavourings, 

undertaking of studies necessary for the preparation and development of legislation on 
food flavourings, 

undertaking  of  studies  necessary  to  harmonise  procedures,  decision-making  criteria 
and  data  requirements,  to  facilitate  work  sharing  between  Member  States  and  to 
develop guidance in these areas. 

5)  ADDITIONAL INFORMATION 

• 

Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation. 

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• 

European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the 
European Economic Area. 

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2006/0147 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on flavourings and certain food ingredients with flavouring properties for use in and on 
foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) 
No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Articles 37 and 95 thereof, 

Having regard to the proposal from the Commission1, 

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

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

Whereas: 

(1) 

(2) 

(3) 

1 
2 
3 

4 
5 

Council  Directive 88/388/EEC  of 22 June 1988 on the approximation  of the laws of 
the Member States relating to flavourings for use in foodstuffs and to source materials 
for  their  production3  needs  to  be  updated  in  the  light  of  technical  and  scientific 
developments.  In  the interests of clarity and efficiency Directive 88/388/EEC should 
be replaced by the present Regulation.  

Council  Decision  88/389/EEC  of  22  June  1988  on  the  establishment,  by  the 
Commission,  of  an  inventory  of  the  source  materials  and  substances  used  in  the 
preparation  of  flavourings4  provides  for  the  establishment  of  that  inventory  within 
24 months of its adoption. That Decision is now obsolete and should be repealed. 

Commission  Directive  91/71/EEC  of  16  January  1991  completing  Council  Directive 
88/388/EEC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
flavourings  for  use  in  foodstuffs  and  to  source  materials  for  their  production5  lays 
down  rules  on  the  labelling  of  flavourings.  These  rules  are  being  replaced  by  the 
present Regulation and the Directive should now be repealed. 

OJ C , , p. . 
OJ C , , p. . 
OJ  L  184,  15.7.1988,  p.  61.  Directive  as  last  amended  by  Regulation  (EC)  No  1882/2003  of  the 
European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 184, 15.7.1988, p. 67. 
OJ L 42, 15.2.1991, p. 25.  

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

The free movement of safe and wholesome food is an essential aspect of the internal 
market  and  contributes  significantly  to  the  health  and  well  being  of  citizens  and  to 
their social and economic interests. 

In order to protect human health the scope of this Regulation should cover flavourings, 
source materials for flavourings and foods containing flavourings. It should also cover 
certain  food  ingredients  with  flavouring  properties  which  are  added  to  food  for  the 
main purpose of adding flavour and which contribute significantly to the presence in 
food  of  certain  naturally  occurring  undesirable  substances  (‘food  ingredients  with 
flavouring properties’), their source material and foods containing them.  

Flavourings and food ingredients with flavouring properties may only be used if they 
fulfil  the  criteria  laid  down  in  this  Regulation.  They  must  be  safe  when  used,  and 
certain  flavourings  should,  therefore,  undergo  a  risk  assessment  before  they  can  be 
permitted in food. They should not mislead the consumer and their presence in food 
should, therefore, always be indicated by appropriate labelling. 

Since  1999,  the  Scientific  Committee  on  Food  and  subsequently  the  European  Food 
Safety  Authority  has  expressed  opinions  on  a  number  of  substances  occurring 
naturally  in  source  materials  for  flavourings  and  food  ingredients  with  flavouring 
properties6 which, according to the Committee of Experts on Flavouring Substances of 
the  Council  of  Europe,  raise  toxicological  concern.  Substances  for  which  the 
toxicological concern was confirmed by the Scientific Committee on Food should be 
regarded as undesirable substances which should not be added as such to food. 

Due to their natural occurrence in plants, undesirable substances might be present in 
flavouring preparations and food ingredients with flavouring properties. The plants are 
used traditionally as food or food ingredients. Appropriate maximum levels should be 
established for the presence of these undesirable substances in foods which contribute 
most  to  the  human  intake  of  these  substances,  taking  into  account  both  the  need  to 
protect human health and their unavoidable presence in traditional foods. 

Provisions should be established at Community level in order to prohibit or restrict the 
use  of  certain  plant  or  animal  materials  which raise  concern for human health  in the 
production  of  flavourings  and  food  ingredients  with  flavouring  properties  and  their 
applications in food production. 

(10)  Risk  assessments  should  be  carried  out  by  the  European  Food  Safety  Authority, 
to  as  “the  Authority”,  established  by  Regulation  (EC) 
hereinafter  referred 
No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European 
Food Safety Authority and laying down procedures in matters of food safety7. 

(11) 

In order to ensure harmonisation, the risk assessment and approval of flavourings and 
source  materials  that  need  to  undergo  an  evaluation  should  be  carried  out  in 

6 
7 

http://europa.eu.int/comm/food/food/chemicalsafety/flavouring/scientificadvice_en.htm 
OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1642/2003  (OJ  L  245, 
29.9.2003, p. 4). 

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accordance  with  the  procedure  laid  down  in  Regulation  (EC)  No  […]establishing  a 
common approval procedure for food additives, food enzymes and food flavourings8. 

(12)  Flavouring  substances  are  chemically  defined  substances  with  flavouring  properties. 
An  evaluation  programme  of  flavouring  substances  is  ongoing  in  accordance  with 
Regulation  (EC)  No  2232/96  of  the  European  Parliament  and  of  the  Council  of  28 
October 1996 laying down a Community procedure for flavouring substances used or 
intended  for  use  in  or  on  foodstuffs9.  Under  that  Regulation  a  list  of  flavouring 
substances is to be adopted within five years of adoption of that programme. A  new 
deadline  should  be  set  for  the  adoption  of  that  list.  That  list  will  be  proposed  for 
inclusion in the list referred to in Article 2(1) of Regulation (EC) No […].  

(13)  Flavouring  preparations  are  flavourings  other  than  chemically  defined  substances 
obtained  from  materials  of  vegetable,  animal  or  mineral  origin,  by  appropriate 
physical,  enzymatic  or  microbiological  processes,  either  in  the  raw  state  of  the 
material or after processing for human consumption. Flavouring preparations produced 
from food do not need to undergo an evaluation or an approval procedure for use in 
and on foods unless there is doubt about their safety. However, the safety of flavouring 
preparations produced from non-food material should be evaluated prior to approval. 

(14)  Regulation  (EC)  No  178/2002  defines  food  as  any  substance  or  product,  whether 
processed, partially processed or unprocessed, intended to be, or reasonably expected 
to be ingested by humans. Materials of vegetable, animal or microbiological origin, for 
which  hitherto  there  is  significant  evidence  of  use  for  the  production  of  flavourings, 
are  considered  as  food  materials  for  this  purpose,  even  though  some  of  these  source 
materials,  such  as  rose  wood,  oak  wood  chips  and  strawberry  leaves,  may  not  have 
been used for food as such. They do not need to be evaluated. 

(15)  Likewise,  thermal  process  flavourings  produced  from  food  under  authorised 
conditions need not undergo an evaluation or an approval procedure for use in and on 
foods unless there is doubt about their safety. However, the safety of thermal process 
flavourings  produced  from  non-food  material  or  produced  under  non-authorised 
conditions should be evaluated prior to approval. 

(16)  Regulation (EC) No 2065/2003/EC of the European Parliament and of the Council of 
10  November  2003  on  smoke  flavourings  used  or  intended  for  use  in  or  on  foods10, 
lays  down  a  procedure  for  the  safety  assessment  and  approval  of  smoke  flavourings 
and aims to establish a list of primary smoke condensates and primary tar fractions the 
use of which is authorised to the exclusion of all others. 

(17)  Flavour precursors impart flavour to food by chemical reactions occurring during food 
processing.  Flavour  precursors  produced  from  food  do  not  need  to  undergo  an 
evaluation or an approval procedure for use in and on foods unless there is doubt about 
their  safety.  However,  the  safety  of  flavour  precursors  produced  from  non-food 
material should be evaluated prior to approval. 

8 
9 

10 

OJ L […], […], p […]. 
OJ L 299, 23.11.1996, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 
31.10.2003, p. 1). 
OJ L 309, 26.11.2003, p. 1. 

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15 

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(18)  Other flavourings which do not fall under the definitions of the previously mentioned 
flavourings may be used in and on foods after they have undergone an evaluation and 
approval procedure. 

(19)  Material of vegetable, animal, microbiological or mineral origin other than food may 
only be authorised for the production of flavourings after its safety has been evaluated 
scientifically.  It  might  be  necessary  to  authorise  the  use  of  only  certain  parts  of  the 
material or to set conditions of use. 

(20)  A  flavouring  or  a  source  material  which  falls  under  the  scope  of  Regulation  (EC) 
No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on  genetically  modified  food  and  feed11  should  be  authorised  according  to  that 
Regulation, prior to its approval under this Regulation. 

(21)  Flavouring substances or flavouring preparations should only be labelled as ‘natural’ if 
they comply with certain criteria which ensure that consumers are not misled. 

(22)  Specific  information  requirements  should  ensure  that  consumers  are  not  misled 
concerning  the  source  material  used  for  the  production  of  natural  flavourings.  The 
source of vanillin obtained from wood will, for example, have to be mentioned.  

(23)  Consumers  should  be  informed  if  the  smoky  taste  of  a  particular  food  is  due  to  the 
addition of smoke flavourings. In accordance with Article 5 of 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 foodstuffs12, the name under which the product is sold should not 
confuse the consumer as to whether the product is smoked conventionally with fresh 
smoke  or  treated  with  smoke  flavourings.  This  Directive  needs  to  be  adapted  to  the 
definitions of flavourings, smoke flavourings and the term ‘natural’ for the description 
of flavourings laid down in the present Regulation.  

(24)  For the evaluation of the safety of flavouring substances for human health, information 
on  the  consumption  and  use  of  flavouring  substances  is  crucial.  The  amounts  of 
flavouring substances added to food should therefore be checked on a regular basis. 

(25)  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 Commission13.  

(26)  Annexes  II  to  V  to  this  Regulation  should  be  adapted  to  scientific  and  technical 

progress. 

(27) 

In  order  to  develop  and  update  Community  legislation  on  flavourings  in  a 
proportionate and effective way, it is necessary to collect data, share information and 
coordinate  work  between  Member  States.  For  that  purpose,  it  may  be  useful  to 
undertake  studies  to  address  specific  issues  with  a  view  to  facilitating  the  decision-

11 
12 

13 

OJ L 268, 18.10.2003, p. 1.  
OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, 
p. 15). 
OJ L 184, 17.7.1999, p. 23. 

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making process. It is appropriate that the Community finance such studies as part of its 
budgetary procedure. The financing of such measures is covered by Regulation (EC) 
No  882/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on 
official controls performed to ensure the verification of compliance with feed and food 
law, animal health and animal welfare rules14 and consequently the legal basis for the 
financing of the above measures will be Regulation (EC) No 882/2004. 

(28)  Pending  the  establishment  of  the  Community  list,  provision  should  be  made  for  the 
evaluation  and  approval  of  flavouring  substances  which  are  not  covered  by  the 
evaluation  programme  provided  for  in  Regulation  (EC)  No  2232/96.  A  transitional 
regime should therefore be laid down. Under that regime such  flavouring  substances 
should  be  evaluated  and  approved  in  accordance  with  the  procedure  laid  down  in 
Regulation (EC) No [procedural Regulation]. However the time periods provided for 
in  that  Regulation  for  the  Authority  to  adopt  its  opinion  and  for  the  Commission  to 
submit a draft Regulation updating the Community list to the Standing Committee on 
the Food Chain and Animal Health should not apply, because priority should be given 
to the ongoing evaluation programme. 

(29)  Since the objective of the action to be taken, namely to lay down Community rules on 
the use of flavourings and certain food ingredients with flavouring properties in and on 
foods,  cannot  be  sufficiently  achieved  by  the  Member  States  and  can  therefore,  by 
reason  of  market  unity  and  high  level  of  consumer  protection,  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. 

(30)  Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on 
the  definition,  description  and  presentation  of  spirit  drinks15  and  Council  Regulation 
(EEC)  No  1601/91  of  10  June  1991  laying  down  general  rules  on  the  definition, 
description  and  presentation  of  aromatised  wines,  aromatised  wine-based  drinks  and 
aromatised wine-product cocktails16 need to be adapted to certain new definitions laid 
down in the present Regulation. 

(31)  Regulations  (EEC)  No  1576/89,  (EEC)  No  1601/91  and  (EC)  No  2232/96  and 

Directive 2000/13/EC should be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

14 
15 
16 

OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). 
OJ L 160, 12.6.1989, p. 1. Regulation as last amended by the 2003 Act of Accession. 
OJ L 149, 14.6.1991, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003. 

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CHAPTER I 

SUBJECT MATTER, SCOPE AND DEFINITIONS 

Article 1 
Subject matter 

This  Regulation  lays  down  rules  on  flavourings  and  food  ingredients  with  flavouring 
properties for use  in and on  foods to  ensure the  effective  functioning  of  the  internal  market 
and a high level of human health protection and consumer protection. 

For those purposes, this Regulation provides for: 

(a) 

(b) 

a  Community  list  of  flavourings  and  source  materials  approved  for  use  in  and  on 
foods, set out in Annex I (‘the Community list’); 

conditions  of  use  of  flavourings  and  food  ingredients  with  flavouring  properties  in 
and on foods; 

(c) 

rules on labelling of flavourings. 

1. 

This Regulation shall apply to: 

Article 2 
Scope 

(a) 

flavourings  which  are  used  or  intended  to  be  used  in  or  on  foods,  with  the 
exception  of  smoke  flavourings  falling  within  the  scope  of  Regulation  (EC) 
No 2065/2003; 

(b) 

food ingredients with flavouring properties; 

(c) 

food containing flavourings and food ingredients with flavouring properties; 

(d) 

source  materials  for  flavourings  and  food  ingredients  with  flavouring 
properties. 

2. 

This Regulation shall not apply to: 

(a) 

substances which have exclusively a sweet, sour or salty taste;  

(b) 

raw or non-compound foods. 

3. 

Where necessary, it may be decided in accordance with the procedure referred to in 
Article 18(2) whether or not a given substance or mixture of substances, material or 
type of food falls within the scope of this Regulation.  

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Article 3 
Definitions 

1. 

2. 

For  the  purposes  of  this  Regulation,  the  definitions  laid  down  in  Regulations  (EC) 
Nos 178/2002 and 1829/2003 shall apply. 

The following definitions shall also apply: 

(a) 

'flavourings' shall mean products: 

(i) 

not intended to be consumed as such, which are added to food in order to 
impart odour and/or taste; 

(ii)  made  or  consisting  of  the  following  categories:  flavouring  substances, 
flavouring preparations, thermal process flavourings, smoke flavourings, 
flavour precursors or other flavourings or mixtures thereof; 

(b) 

(c) 

'flavouring  substance'  shall  mean  a  chemically  defined  substance  with 
flavouring properties; 

'natural  flavouring  substance'  shall  mean  a  flavouring  substance  obtained  by 
appropriate physical, enzymatic or microbiological processes from material of 
vegetable,  animal  or  microbiological  origin  either  in  the  raw  state  or  after 
processing  for  human  consumption  by  one  or  more  of  the  traditional  food 
preparation processes listed in Annex II;  

(d) 

'flavouring  preparation’  shall  mean  a  product,  other  than  a  flavouring 
substance, obtained from: 

(i) 

food  by  appropriate  physical,  enzymatic  or  microbiological  processes 
either  in  the  raw  state  of  the  material  or  after  processing  for  human 
consumption by one or more of the traditional food preparation processes 
listed in Annex II and/or appropriate physical processes; 

and/or 

(ii)  material of vegetable, animal or microbiological origin, other than food, 
obtained  by  one  or  more  of  the  traditional  food  preparation  processes 
listed 
II  and/or  appropriate  physical,  enzymatic  or 
in  Annex 
microbiological processes; 

(e) 

‘thermal process flavouring’ shall mean a product obtained after heat treatment 
from  a  mixture  of  ingredients  not  necessarily  having  flavouring  properties 
themselves,  of  which  at  least  one  contains  nitrogen  (amino)  and  another  is  a 
reducing  sugar;  the  ingredients  for  the  production  of  thermal  process 
flavourings may be: 

(i) 

food; 

and/or 

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19 

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(f) 

(g) 

(h) 

(i) 

(j) 

(ii) 

source material other than food; 

‘smoke  flavouring’  shall  mean  a  product  obtained  by  fractionation  and 
purification  of  a  condensed  smoke  yielding  primary  smoke  condensates, 
primary tar fractions and/or derived smoke flavourings as defined in points (1), 
(2) and (4) of Article 3 of Regulation (EC) No 2065/2003;  

‘flavour  precursor’  shall  mean  a  product,  not  necessarily  having  flavouring 
properties itself, intentionally added to food for the sole purpose of producing 
flavour  by  breaking  down  or  reacting  with  other  components  during  food 
processing; it may be obtained from: 

(i) 

food; 

and/or 

(ii) 

source material other than food; 

‘other  flavouring’  shall  mean  a  flavouring  added  or  intended  to  be  added  to 
food  in  order  to  impart  odour  and/or  taste  and  which  does  not  fall  under  the 
definitions (b) to (g); 

‘food ingredient with flavouring properties’ shall mean a food ingredient other 
than flavourings which may be added to food for the main purpose of adding 
flavour to it or modifying its flavour; 

‘source material’ shall mean material of vegetable, animal, microbiological or 
mineral  origin  from  which  flavourings  or  food  ingredients  with  flavouring 
properties are produced; it may be: 

(i) 

food; 

or 

(ii) 

source material other than food; 

(k) 

‘appropriate  physical  process’  shall  mean  a  physical  process  which  does  not 
intentionally  modify  the  chemical  nature  of  the  components  of  the  flavouring 
and  does  not  involve  the  use  of  singlet  oxygen,  ozone,  inorganic  catalysts, 
metal catalysts, organometallic reagents and/or UV radiation. 

For  the  purpose  of  the  definitions  listed  in  paragraph  2  (d),  (e),  (g)  and  (j),  source 
materials for which hitherto there is significant evidence of use for the production of 
flavourings, are considered as food. 

Where necessary, it may be decided in accordance with the procedure referred to in 
Article 18(2) whether or not a given substance falls within a specific category listed 
in paragraph 2(b) to (j).  

3. 

4. 

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CHAPTER II 

CONDITIONS FOR USE OF FLAVOURINGS, FOOD INGREDIENTS WITH 
FLAVOURING PROPERTIES AND SOURCE MATERIALS 

Article 4  
General conditions for use of flavourings or food ingredients with flavouring properties 

Only  flavourings  or  food  ingredients  with  flavouring  properties  which  meet  the  following 
conditions may be used in or on foods: 

(a) 

they do not, on the basis of the scientific evidence available, pose a safety concern to 
the health of the consumer; 

(b) 

their use does not mislead the consumer. 

Article 5 
Presence of certain substances 

1. 

2. 

3. 

1. 

2. 

Substances listed in Part A of Annex III shall not be added as such to food.  

Maximum  levels  of  certain  substances,  naturally  present  in  flavourings  and  food 
ingredients  with  flavouring  properties,  in  the  compound  foods  listed  in  Part  B  of 
Annex  III  shall  not  be  exceeded  as  a  result  of  the  use  of  flavourings  and  food 
ingredients with flavouring properties in and on those foods.  

The  maximum  levels  shall  apply  to  the  compound  foods  as  offered  ready  for 
consumption or as prepared according to the instructions of the manufacturer. 

Detailed rules for the implementation of paragraph 2 may be adopted in accordance 
with the procedure referred to in Article 18(2). 

Article 6 
Use of certain source materials 

Source materials listed in Part A of Annex IV shall not be used for the production of 
flavourings and food ingredients with flavouring properties. 

Flavourings  and  food  ingredients  with  flavouring  properties  produced  from  source 
materials  listed  in  Part  B  of  Annex  IV  may  only  be  used  under  the  conditions 
indicated in that Annex. 

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Article 7  
Flavourings for which an evaluation and approval is not required  

1. 

The following flavourings may be used in or on foods without an approval under this 
Regulation, provided that they comply with Article 4: 

(a) 

flavouring preparations referred to in Article 3(2)(d)(i); 

(b) 

thermal process flavourings referred to in Article 3(2)(e)(i) and which comply 
with  the  conditions  for  the  production  of  thermal  process  flavourings  and 
maximum levels for certain substances in thermal process flavourings set out in 
Annex V; 

(c) 

flavour precursors referred to in Article 3(2)(g)(i);  

(d) 

food ingredients with flavouring properties.  

2. 

Notwithstanding  paragraph  1,  if  the  Commission,  a  Member  State  or  the  European 
Food Safety Authority (‘the Authority’) expresses doubts concerning the safety of a 
flavouring or food ingredient with flavouring properties referred to in paragraph 1, a 
risk assessment of such flavouring or food ingredient with flavouring properties shall 
be  carried  out  by  the  Authority.  Articles  4  to  6  of  Regulation  (EC)  No  [procedural 
Regulation] shall then apply mutatis mutandis.  

If  necessary,  the  Commission  shall  adopt  measures  following  the  opinion  of  the 
Authority,  in  accordance  with  the  procedure  referred  to  in  Article  18(2).  Such 
measures shall be laid down in Annexes III, IV and/or V as appropriate.  

CHAPTER III 

COMMUNITY LIST OF FLAVOURINGS AND SOURCE MATERIALS APPROVED 
FOR USE IN OR ON FOODS 

Article 8 
Flavourings and sources materials for which an evaluation and approval is required  

The present Chapter applies to: 

(a) 

(b) 

(c) 

flavouring substances; 

flavouring preparations referred to in Article 3(2)(d)(ii); 

thermal  process  flavourings  obtained  by  heating  ingredients  which  fall  partially  or 
totally  under  Article  3(2)(e)(ii)  or  for  which  the  conditions  for  the  production  of 
thermal  process  flavourings  and  the  maximum  levels  for  certain  undesirable 
substances set out in Annex V are not met; 

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(d) 

(e) 

(f) 

flavour precursors referred to in Article 3(2)(g)(ii);  

other flavourings referred to in Article 3(2)(h); 

source materials other than food referred to in Article 3(2)(j)(ii). 

Article 9 
Community list of flavourings and source materials 

Of  the  flavourings  and  source  materials  referred  to  in  Article  8,  only  those  included  in  the 
Community list may be placed on the market as such and used in or on foods. 

Article 10 
Inclusion of flavourings and source materials in the Community list 

1. 

A  flavouring  or  source  material  may  be  included  in  the  Community  list,  in 
accordance  with  the  procedure  laid  down  by  Regulation  (EC)  No  [common 
procedure], only if it complies with the conditions set out in Article 4. 

2. 

The entry for a flavouring or source material in the Community list shall specify: 

(a) 

the identification of the flavouring or the source material approved; 

(b)  where necessary, the conditions under which the flavouring may be used. 

3. 

The Community list shall be amended in accordance with the procedure referred to in 
Regulation  (EC)  No  […]  establishing  a  common  authorisation  procedure  for  food 
additives, food enzymes and food flavourings.  

Article 11 
Flavourings or source materials falling within the scope of Regulation (EC) No 1829/2003  

A  flavouring  or  source  material  falling  within  the  scope  of  Regulation  (EC)  No  1829/2003 
may be included in the Community list only after it has been authorised in accordance with 
the procedure referred to in Article 7 of Regulation (EC) No 1829/2003.  

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CHAPTER IV 

LABELLING 

SECTION 1 

LABELLING OF FLAVOURINGS NOT INTENDED FOR SALE TO THE FINAL 
CONSUMER 

Article 12  
Labelling of flavourings not intended for sale to the final consumer 

Flavourings  not  intended  for  sale  to  the  final  consumer  may  be  marketed  only  if  their 
packaging,  containers  or  accompanying  documents  bear  the  information  provided  for  in 
Articles 13 and 14, which must be easily visible, clearly legible and indelible. 

Article 13 
General information requirements for labelling of flavourings 

1. 

The  packaging  or  containers  of  flavourings  not  intended  for  sale  to  the  final 
consumer shall bear the following information: 

(a) 

(b) 

(c) 

the sales description: either the word ‘flavouring’  or a more specific  name or 
description of the flavouring; 

the name or business name and address of the manufacturer or packager, or of 
a seller; 

the statement either ‘for use in food’ or the statement ‘restricted use in food’ or 
a more specific reference to its intended food use; 

(d) 

a list in descending order of weight of: 

(i) 

the categories of flavourings present; and 

(ii) 

the  names  of  each  of  the  other  substances  or  materials  contained  in  the 
product or, where appropriate, their E-number; 

(e) 

an  indication  of  the  maximum  quantity  of  each  component  or  group  of 
components  subject  to  quantitative  limitation  in  food  and/or  appropriate 
information in clear and easily understandable terms enabling the purchaser to 
comply with this Regulation or other relevant Community legislation; 

(f) 

if necessary, the special conditions for storage and use; 

(g) 

a date of minimum durability;  

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2. 

1. 

2. 

3. 

4. 

5. 

6. 

(h) 

a mark identifying the batch or lot; 

(i) 

the net quantity. 

By way of derogation from paragraph 1, the information required in points (c) to (g) 
of that paragraph may appear merely on the documents relating to the consignment 
which  are  to  be  supplied  with  or  prior  to  the  delivery,  provided  that  the  indication 
'intended  for  the  manufacture  of  food  and  not  for  retail  sale'  appears  on  an  easily 
visible part of the packaging or container of the product in question.  

Article 14  
Specific information requirements for the sales description of flavourings  

The term ‘natural’ may only be used to describe a flavouring in the sales description 
referred to in Article 13(1)(a) as provided for in paragraphs 2 to 6. 

The  term  ‘natural’  for  the  description  of  a  flavouring  may  only  be  used  if  the 
flavouring  component  comprises  only  flavouring  preparations  and/or  natural 
flavouring substances.  

The  term  “natural  flavouring  substance(s)”  may  only  be  used  for  flavourings  in 
which the flavouring component contains exclusively natural flavouring substances. 

The term ‘natural’ may only be used in combination with a reference to a food, food 
category or a vegetable or animal flavouring source, if at least 90% [by w/w] of the 
flavouring component has been obtained from the source material referred to. 

The  flavouring  component  may  contain  flavouring  preparations  and/or  natural 
flavouring substances.  

The  description  shall  read  “natural  <<food(s)  or  food  category  or  source(s)>> 
flavouring”. 

“Natural  <<food(s)  or  food  category  or  source(s)>>  flavouring  with  other  natural 
flavourings” may only be used if the flavouring component is partially derived from 
the source material referred to and can easily be recognised. 

The  flavouring  component  may  contain  flavouring  preparations  and/or  natural 
flavouring substances. 

The  term  “natural  flavouring”  may  only  be  used  if  the  flavouring  component  is 
derived from different source materials and where a reference to the source materials 
would not reflect their flavour or taste.  

The  flavouring  component  may  contain  flavouring  preparations  and/or  natural 
flavouring substances. 

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SECTION 2 

LABELLING OF FLAVOURINGS INTENDED FOR SALE TO THE FINAL 
CONSUMER 

1. 

2. 

1. 

2. 

1. 

2. 

Article 15 
Labelling of flavourings intended for sale to the final consumer 

Without prejudice to Directive 2000/13/EC, flavourings intended for sale to the final 
consumer may be marketed only if their packaging contains the statement either ‘for 
use in food’ or the statement ‘restricted use in food’ or a more specific reference to 
its intended food use, which must be easily visible, clearly legible and indelible. 

The  term  ‘natural’  shall  be  used  to  describe  a  flavouring  in  the  sales  description 
referred to in Article 13(1)(a) only as provided for in Article 14.  

CHAPTER V 

PROCEDURAL PROVISIONS AND IMPLEMENTATION 

Article 16 
Reporting by the food business operators 

The food business operators or their representatives shall report to the Commission 
the annual amounts of flavouring substances added to foods in the Community and 
the use levels for each food category in the Community. 

Detailed rules for the implementation of paragraph 1 shall be adopted in accordance 
with the procedure referred to in Article 18(2). 

Article 17 
Monitoring and reporting by the Member States 

Member  States  shall  establish  systems  to  monitor  the  consumption  and  use  of 
flavourings  set  out  in  the  Community  list  and  the  consumption  of  the  substances 
listed in Annex III and report their findings each year to the Commission and to the 
Authority.  

After the Authority has been consulted, a common methodology for the gathering of 
information by the Member States on the consumption and use of flavourings set out 
in the  Community list  and of  the substances listed in Annex III  may be adopted in 
accordance with the procedure referred to in Article 18(2). 

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Article 18 
Committee 

1. 

2. 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health (hereinafter referred to as ‘the Committee’). 

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

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

3. 

The Committee shall adopt its Rules of Procedure. 

Article 19 
Amendments to Annexes II to V 

Amendments to Annexes II to V to this Regulation to reflect scientific and technical progress 
shall be adopted in accordance with the procedure referred to in Article 18(2). 

Article 20 
Community financing of harmonised policies  

The legal basis for the financing of measures resulting from this Regulation is Article 66(1)(c) 
of Regulation (EC) No 882/2004. 

CHAPTER VI 

TRANSITIONAL AND FINAL PROVISIONS 

Article 21 
Repeals 

1. 

Directive 88/388/EEC, Decision 88/389/EEC and Directive 91/71/EEC are repealed.  

Regulation  (EC)  No  2232/96  is  repealed  from  the  date  of  application  of  the  list 
referred to in Article 2(2) of that Regulation. 

2. 

References to the repealed acts shall be construed as references to this Regulation. 

EN 

27 

   EN 

 
Article 22  
Establishment of the Community list of flavourings and source materials and transitional 
regime 

1. 

2. 

The Community list shall be established by placing the list of flavouring substances 
referred  to  in  Article  2(2)  of  Regulation  (EC)  No  2232/96  in  Annex  I  to  this 
Regulation at the time of its adoption. 

Until  the  establishment  of  the  Community  list,  Regulation  (EC)  No  […]  [the 
common  procedure]  shall  apply  for  the  evaluation  and  approval  of  flavouring 
substances  which  are  not  covered  by  the  evaluation  programme  provided  for  in 
Article 4 of Regulation (EC) No 2232/96.  

By way of derogation from that procedure, the time periods of six months and nine 
months  referred  to  in  Article  5(1)  and  Article  7  of  Regulation  (EC)  No  […]  [the 
common procedure] shall not apply to such evaluation and approval. 

3. 

Any  appropriate  transitional  measures  may  be  adopted  in  accordance  with  the 
procedure referred to in Article 18(2). 

Article 23 
Amendment to Regulation (EEC) No 1576/89 

Regulation (EEC) No 1576/89 is hereby amended as follows: 

1. 

Article 1(4)(m) is amended as follows: 

(a) 

In point (1)(a), the second subparagraph shall be replaced by the following: 

“Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) 
No  […],  and/or  aromatic  plants  or  parts  of  aromatic  plants  may  be  used  in 
addition,  but  the  organoleptic  characteristics  of  juniper  must  be  discernible, 
even if they are sometimes attenuated.” 

(b)  Point 2(a) shall be replaced by the following:  

“The drink may be called ‘gin’ if it is produced by flavouring organoleptically 
suitable  ethyl  alcohol  of  agricultural  origin  with  flavouring  substances  as 
defined  in  Article  3(2)(b)  of  Regulation  (EC)  No  […]  and/or  flavouring 
preparations as defined in Article 3(2)(d) of that Regulation so that the taste is 
predominantly that of juniper.” 

EN 

28 

   EN 

 
 
 
(c) 

In point 2(b), the first subparagraph shall be replaced by the following:  

“The drink may be called ‘distilled gin’ if it is produced solely by redistilling 
organoleptically  suitable  ethyl  alcohol  of agricultural  origin of  an  appropriate 
quality  with  an  initial  alcoholic  strength  of  at  least  96  %  vol  in  stills 
traditionally used for gin, in the presence of juniper berries and of other natural 
botanicals  provided  that  the  juniper  taste  is  predominant.  The  term  ‘distilled 
gin’ may also apply to a mixture of the product of such  distillation and  ethyl 
alcohol of agricultural origin with the same composition, purity and alcoholic 
strength.  Flavouring  substances  as  defined  in  Article  3(2)(b)  of  Regulation 
(EC)  No  […]  and/or  flavouring  preparations  as  specified  at  (a)  may  also  be 
used to flavour distilled gin. London gin is a type of distilled gin.” 

2. 

In Article 1(4)(n)(1), the second subparagraph shall be replaced by the following: 

“Other  flavouring  substances  as  defined  in  Article  3(2)(b)  of  Regulation  (EC) 
No […]  and/or  flavouring  preparations  as  defined  in  Article  3(2)(d)  of  that 
Regulation  may  additionally  be  used  but  there  must  be  a  predominant  taste  of 
caraway.” 

3. 

In Article 1(4)(p), the first subparagraph shall be replaced by the following: 

“Spirit drinks with a predominantly bitter taste produced by flavouring ethyl alcohol 
of  agricultural  origin  with  flavouring  substances  as  defined  in  Article  3(2)(b)  of 
Regulation (EC) No […] and/or flavouring preparations as defined in Article 3(2)(d) 
of that Regulation.” 

4. 

In Article 1(4)(u), the first subparagraph shall be replaced by the following: 

“A  spirit  drink  produced  by  flavouring  ethyl  alcohol  of  agricultural  origin  with 
flavouring  of  cloves  and/or  cinnamon  using  one  of  the  following  processes: 
maceration and/ or distillation, redistillation of the alcohol in the presence of parts of 
the  plants  specified  above,  addition  of  flavouring  substances  as  defined  in 
Article 3(2)(b) of Regulation (EC) No […] of cloves or cinnamon or a combination 
of these methods.” 

5. 

In Article 4(5), the first and second paragraphs, excluding the lists in points (a) and 
(b), shall be replaced by the following: 

“Only  natural  flavouring  substances  and  flavouring  preparations  as  defined  in 
Article 3(2)(b) and (d) of Regulation (EC) No […] may be used in the preparation of 
the  spirit  drinks  defined  in  Article  1(4),  except  in  the  case  of  those  defined  in 
Article 1 (4) (m), (n) and (p).  

However,  flavouring  substances  as  defined  in  Article  3(2)(b)  of  Regulation  (EC) 
No […] and flavouring preparations as defined in Article 3(2)(d) of that Regulation 
shall be authorized in liqueurs except those mentioned below:” 

EN 

29 

   EN 

 
 
Article 24 
Amendment to Regulation (EEC) No 1601/91 

Article 2(1) is hereby amended as follows: 

1. 

In point (a), the first sub-indent of the third indent shall be replaced by the following:  

“− 

flavouring  substances  and/or 
Article 3(2)(b) and (d) of Regulation (EC) No […], and/or”  

flavouring  preparations  as  defined 

in 

In  point  (b),  the  first  sub-indent  of  the  second  indent  shall  be  replaced  by  the 
following: 

“− 

flavouring  substances  and/or 
Article 3(2)(b) and (d) of Regulation (EC) No […], and/or”  

flavouring  preparations  as  defined 

in 

In  point  (c),  the  first  sub-indent  of  the  second  indent  shall  be  replaced  by  the 
following: 

2. 

3. 

“− 

flavouring  substances  and/or 
Article 3(2)(b) and (d) of Regulation (EC) No […], and/or”  

flavouring  preparations  as  defined 

in 

Article 25 
Amendment to Regulation (EC) No 2232/96 

In Article 5 of Regulation (EC) No 2232/96, paragraph 1 shall be replaced by the following: 

“1. 

The  list  of  flavouring  substances  referred  to  in  Article  2(2)  shall  be  adopted  in 
accordance with the procedure referred to in Article 7 by 31 December 2008 at the 
latest.” 

Article 26 
Amendment to Directive 2000/13/EC 

In Directive 2000/13/EC, Annex III shall be replaced by the following: 

“Annex III 

DESIGNATION OF FLAVOURINGS IN THE LIST OF INGREDIENTS 

1. 

Without prejudice to paragraph 2, flavourings shall be designated by the terms 

– 

“flavourings”  or  a  more  specific  name  or description  of  the  flavouring,  if  the 
flavouring  component  contains  flavourings  as  defined  in  Article  3(2)(b),  (d), 
(e), (g) and (h) of Regulation (EC) No […] of the European Parliament and of 
the Council* [Regulation on flavourings]; 

EN 

30 

   EN 

 
– 

“smoke  flavouring(s)”  if  the  flavouring  component  contains  flavourings  as 
defined  in  Article  3  (2)  (f)  of  Regulation  EC  No  […]  [Regulation  on 
flavourings] and imparts a smoky flavour to the food. 

The  term  ‘natural’  for  the  description  of  flavourings  shall  be  used  as  laid  down  in 
Article 14 of Regulation (EC) No […] [Regulation on flavourings].” 

OJ L […], […], […] 

2. 

* 

Article 27  
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 [please insert date] [24 months after entry into force]. However, Articles 9, 
23 and 24 shall apply from the date of application of the Community list. 

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 

EN 

31 

   EN 

 
Community list of flavourings and source materials approved for use in and on foods 

ANNEX I 

EN 

32 

   EN 

 
ANNEX II 

List of traditional food preparation processes by which natural flavouring substances 
and natural flavouring preparations are obtained 

Chopping 

Coating 

Cooking, baking, frying (up to 240°C) 

Cooling 

Cutting  

Drying 

Evaporation 

Fermentation 

Grinding 

Infusion 

Microbiological processes 

Peeling 

Pressing 

Distillation / rectification 

Emulsification 

Extraction, incl. solvent extraction 

Filtration 

Heating 

Maceration 

Mixing 

Percolation 

Refrigeration/Freezing 

Roasting / Grilling  

Squeezing  

Steeping  

EN 

33 

   EN 

 
 
 
ANNEX III 

Presence of certain substances 

Part A: Substances which may not be added as such to food 

Agaric acid 

Capsaicin 

Hypericine 

Beta-asarone 

1-Allyl-4-methoxybenzene 

Hydrocyanic acid 

Menthofuran 

4-Allyl-1,2-dimethoxybenzene 

Pulegone 

Quassin 

1-Allyl-3,4-methylene dioxy benzene, safrole 

Teucrin A 

Thujone (alpha and beta) 

Part  B:  Maximum  levels  of  certain  substances,  naturally  present  in  flavourings  and  food 
ingredients  with  flavouring  properties,  in  certain  compound  food  to  which  flavourings 
and/or food ingredients with flavouring properties have been added 

Name of the 
substance 

Compound food in which the presence of 
the substance is restricted 

Maximum level 
[mg/kg] 

Beta-asarone 

Alcoholic beverages  

1-Allyl-4-
methoxybenzene 

Dairy products 

Processed fruits, vegetables (incl. 
mushrooms, fungi, roots, tubers, pulses and 
legumes), nuts and seeds 

Fish products 

Non-alcoholic beverages 

1.0 

50 

50 

50 

10 

EN 

34 

   EN 

 
 
 
Hydrocyanic acid  Nougat,  marzipan  or 

its  substitutes  or 

similar products 

Canned stone fruits 

Alcoholic beverages 

Menthofuran 

Mint/peppermint  containing  confectionery, 
freshening 
except 
confectionery 

breath 

micro 

Micro breath freshening confectionery17 

Chewing gum 

Mint/peppermint 
beverages 

containing 

alcoholic 

4-Allyl-1,2-
dimethoxybenzene,  

Dairy products 

Meat  and  meat  products,  including  poultry 
and game 

Fish and fish products 

Soups and sauces 

Ready-to-eat savouries 

Non-alcoholic beverages 

Pulegone 

Mint/peppermint  containing  confectionery, 
except 
freshening 
confectionery 

breath 

micro 

Micro breath freshening confectionery17 

Chewing gum 

Mint/peppermint  containing  non-alcoholic 
beverages 

Mint/peppermint 
beverages 

containing 

alcoholic 

50 

5 

35 

500 

3000 

1000 

200 

20 

15 

10 

60 

20 

1 

250 

2000 

350 

20 

100 

17 

Candies with intensive taste; weight per candy not more than 1 g. 

EN 

35 

   EN 

 
 
 
 
 
 
 
 
                                                 
Quassin 

Non-alcoholic beverages 

1-Allyl-3,4-
methylene 
benzene, safrole 

dioxy 

Bakery wares 

Alcoholic beverages  

Meat  and  meat  products,  including  poultry 
and game 

Fish and fish products 

Soups and sauces 

Non-alcoholic beverages 

Teucrin A 

Alcoholic beverages 

Thujone (alpha and 
beta) 

Alcoholic beverages, except those produced 
from Artemisia species 

Alcoholic 
Artemisia species 

beverages 

produced 

from 

0,5 

1 

1.5 

15 

15 

25 

1 

2 

10 

35 

EN 

36 

   EN 

 
 
 
 
ANNEX IV 

List of source materials to which restrictions apply for their use in the production of 
flavourings and food ingredients with flavouring properties 

Part A: Source materials which shall not be used for the production of flavourings and 
food ingredients with flavouring properties 

Source material 

Latin name 

Common name 

Tetraploid form of Acorus calamus 

Tetraploid form of Calamus 

Part  B:  Conditions  of  use  for  flavourings  and  food  ingredients  with  flavouring 
properties produced from certain source materials 

Source material 

Latin name 

Common name 

Conditions of use 

Quassia amara L. 
and 
Picrasma excelsa 
(Sw)  

Laricifomes 
officinales (Vill.: Fr) 
Kotl. et Pouz 
or 
Fomes officinalis 

Hypericum 
perforatum 

Teucrium 
chamaedrys 

Quassia 

White agaric mushroom 

Flavourings  and  food  ingredients  with 
flavouring  properties  produced  from  the 
source  material  may  only  be  used  for  the 
production of beverages and bakery wares. 

Flavourings  and  food  ingredients  with 
flavouring  properties  produced  from  the 
source  material  may  only  be  used  for  the 
production of alcoholic beverages 

St Johns wort 

Wall germander 

EN 

37 

   EN 

 
 
Conditions for the production of thermal process flavourings and maximum levels for 
certain substances in thermal process flavourings 

ANNEX V 

Part A: Conditions for the production: 

(a) 

(b) 

The temperature of the products during processing shall not exceed 180°C. 

The  duration  of  the  thermal  processing  shall  not  exceed  15  minutes  at  180°C  with 
correspondingly  longer  times  at  lower  temperatures,  i.e.  a  doubling  of  the  heating 
time for each decrease of temperature by 10°C, up to a maximum of 12 hours. 

(c) 

The pH during processing should not exceed the value of 8,0. 

Part B: Maximum levels for certain substances 

Substance 

2-amino-3,4,8-trimethylimidazo [4,5-f] quinoxaline (4,8-DiMeIQx) 

2-amino-1-methyl-6-phenylimidazol [4,5-b]pyridine (PhIP) 

Maximum levels 
µg / kg 

50 

50 

EN 

38 

   EN 

 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on 
flavourings and certain food ingredients with flavouring properties for use in and on 
foods  and  amending  Council  Regulation  (EEC)  No  1576/89,  Council  Regulation 
(EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC. 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned: Health and Consumer Protection 

Activity/Activities: Food Safety, Animal Health, Animal Welfare and Plant Health 

3. 

BUDGET LINES 

3.1.  Budget  lines  (operational  lines  and  related  technical  and  administrative 

assistance lines (ex- B..A lines)) including headings: 

17.01.04.05.  Feed  and  food  safety  and  related  activities  —  Expenditure  on 
administrative management. 

3.2.  Duration of the action and of the financial impact: 

Open ended 

3.3.  Budgetary characteristics : 

Budget line 

Type of 
expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

17.01.04.05  Comp/  Diff18 

NO 

NO 

NO 

No 1a 

In  order  to  develop  and  update  Community  legislation  on  flavourings  in  a 
proportionate and effective way, it may be useful to undertake studies to collect 
data,  share  information  and  coordinate  work  between  Member  States.  This 
kind  of  support  expenditure,  indicated  under  points  4.1  and  8.1,  is  covered  by 
Regulation  (EC)  no  882/2004  on  official  feed  and  food  controls  within  the 
amounts foreseen for its implementation during 2007/2013. 

18 

Differentiated appropriations. 

EN 

39 

   EN 

 
 
 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1.  Financial Resources 

4.1.1. Summary  of 

commitment  appropriations 

(CA)  and  payment 

appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1  n + 2  n + 3  n + 4 

n + 5 
and 
later 

Total 

Operational expenditure19 

Commitment 
Appropriations (CA) 

8.1. 

Payment 
Appropriations (PA) 

a 

b 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

Administrative expenditure within reference amount20 

Technical & 
administrative 
assistance (NDA) 

8.2.4. 

c 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

Payment 
Appropriations 

a+c 

b+c

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

Administrative expenditure not included in reference amount21 

Human resources 
and associated 
expenditure (NDA) 

Administrative costs, 
other than human 
resources and 
associated costs, not 
included in reference 
amount (NDA) 

8.2.5. 

d 

8.2.6. 

e 

Total indicative financial cost of intervention 

TOTAL CA 
including cost of 
Human Resources 

a+c
+d
+e 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

19 
20 
21 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

40 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
TOTAL PA 
including cost of 
Human Resources 

b+c
+d
+e 

Co-financing details 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

EUR million (to 3 decimal places) 

Year 
n 

n + 1 n + 2 n + 3 n + 4  n + 5 
and 
later 

Total 

Co-financing body 

…………………… 

TOTAL  CA 
financing 

including  co-

f 

a+c
+d
+e
+f 

4.1.2. Compatibility with Financial Programming 

x 

Proposal is compatible with existing financial programming. 

(cid:133) 

(cid:133) 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the 
financial perspective. 

Proposal  may  require  application  of  the  provisions  of  the 
Interinstitutional Agreement22 (i.e. flexibility instrument or revision 
of the financial perspective). 

4.1.3. Financial impact on Revenue 

x 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

EUR million (to one decimal place) 

Situation following action 

[Yea
r n] 

[n+1] [n+2]  [n+3

] 

[n+4] [n+5]

23 

Prior to
action 
[Year 
n-1] 

Budget line 

Revenue 

(a) Revenue in absolute terms 

22 
23 

See points 19 and 24 of the Interinstitutional agreement. 
Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

41 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(b) Change in revenue 

 ∆ 

EN 

42 

   EN 

 
 
 
 
 
 
 
 
4.2.  Human Resources FTE (including officials, temporary and external staff) 

– see detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total number of human resources 

0.4 

0.4 

0.4 

0.4 

0.4 

0.4 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1.  Need to be met in the short or long term 

At the moment flavourings substances and substances of toxicological concern 
are being evaluated by the European Food Safety Authority (EFSA). In about 
2/3  of  the  cases  EFSA  expresses  the  need  for  additional  data  on  intake.  This 
data are needed for risk management decisions. 

In  order  to  assure  proportionality  of  the  implementing  measures  that  will  be 
taken in the framework of the proposed regulation and to meet the objectives of 
Regulation  (EC)  882/2004  on  official  feed  and  food  control,  the  following 
instruments are therefore needed:  

• 

• 

• 

An appropriate database for gathering and storing all information relating 
to Community legislation on flavourings, 

undertaking  of  studies  necessary  (e.g.  in  relation  to  composition  and 
intake  of  foodstuffs)  for  the  preparation  and  development  of  legislation 
on food flavourings, 

undertaking  of  studies  necessary  to  harmonise  procedures,  decision-
making criteria and data requirements, to facilitate work sharing between 
Member States and to develop guidance in these areas 

5.2.  Value-added  of  Community  involvement  and  coherence  of  the  proposal 

with other financial instruments and possible synergy 

The data and information obtained will help assuring the best protection of the 
health of the consumer while allowing industry to continue to develop and use 
flavourings.  At  the  moment  insufficient  data  are  available  to  take  the  best 
decisions which protect the consumer, but do not lead to overregulation. 

In  the  harmonised  market  this  can  only  be  achieved  via  coordinate  approach 
allowing exchange of comparable information between Member States. 

EN 

43 

   EN 

 
 
 
 
 
5.3.  Objectives,  expected  results  and  related  indicators  of  the  proposal  in  the 

context of the ABM framework 

Objective 1:  Create  and  maintain  a  database  and  organise  related  studies  in 
collaboration with external organisations to be selected via the 
appropriate procedures.  

Objective 2:  Assure  that  the  use  of  flavourings  and  their  sources  does  not 
lead  to  unacceptable  risks  for  the  consumer  and  at  the  same 
time does not impose unnecessary burden to the industry. 

Objective 3:  To  make 

risk  management  decision  based  on  correct 
estimations  of  intake  via  a  centralised  database  containing 
updated 
the  use  of 
flavourings.  

information  about  composition  and 

5.4.  Method of Implementation (indicative) 

X 

Centralised Management 

x 

directly by the Commission 

(cid:133) 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

(cid:133) 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of 
the Financial Regulation 

national  public-sector  bodies/bodies  with  public-service 
mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

EN 

44 

   EN 

 
 
 
 
 
 
 
 
 
6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The content of the database, the conclusions of the results of the studies can be 
monitored  via  their  usability  for  proposing  good  implementing  measures.A 
basic  tool  will  be  the  Standing  Committee  for  the  Food  Chain  and  Animal 
Health. 

6.2.  Evaluation 

6.2.1. Ex-ante evaluation 

Some  data  are  already  available  in  the  FLAVIS  database  used  for  the 
ongoing evaluation programme of flavouring substances.  

6.2.2. Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons 

learned from similar experiences in the past) 

Experience  with  the  FLAVIS  database  will  be  used  to  better  develop  a 
new system and the data collection.  

6.2.3. Terms and frequency of future evaluation 

Ongoing in function of the need to propose implementing measures. 

7. 

ANTI-FRAUD MEASURES  

EN 

45 

   EN 

 
 
 
 
 
8. 

DETAILS OF RESOURCES 

8.1.  Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

(Headings of Objectives, 
actions and outputs 
should be provided) 

Type of 
output 

Av. cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

OPERATIONAL 
OBJECTIVE 
24……… 

No.1 

TOTAL COST 

1 

1 

0.125 

0.1 

1 

1 

0.0526 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

6 

6 

0.35 

0.35 

24 
25 
26 

As described under Section 5.3. 
Creating of the Database. 
Updating and maintaining of the database, organising related studies. 

EN 

46 

EN 

 
  
 
 
 
 
                                                 
8.2.  Administrative Expenditure 

8.2.1. Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year 
n+1 

0.2 

0.2 

Year 
n+2 

0.2 

0.2 

Year 
n+3 

0.2 

0.2 

Year 
n+4 

0.2 

0.2 

Year 
n+5 

0.2 

0.2 

Year n 

Officials or 
temporary 
staff27  
(17 01 01) 

A*/AD 

0.2 

B*, 
C*/AST 

0.2 

Staff  financed28  by  art. 
XX 01 02 

Other  staff29  financed  by 
art. XX 01 04/05 

TOTAL 

0.4 

0.4 

0.4 

0.4 

0.4 

0.4 

8.2.2. Description of tasks deriving from the action 

Examination  of 
commitments and pass to payment 

technical  and  financial  reports,  preparations  of 

8.2.3. Sources of human resources (statutory) 

X 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts  currently  allocated  to  the  management  of  the  programme  to 
be replaced or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the 
managing service (internal redeployment) 

Posts  required  for  year  n  although  not  foreseen  in  the  APS/PDB 
exercise of the year in question 

27 
28 
29 

Cost of which is NOT covered by the reference amount. 
Cost of which is NOT covered by the reference amount. 
Cost of which is included within the reference amount. 

EN 

47 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4. Other  Administrative  expenditure  included  in  reference  amount  (XX  01 

04/05 – Expenditure on administrative management) 

Budget line 

(number and heading) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5  
and 
later 

TOTAL 

EUR million (to 3 decimal places) 

1. 

Technical and 
administrative 
assistance (including 
related staff costs) 

Executive agencies30 

Other 
and 
technical 
administrative assistance 

– 

– 

intra muros  

extra muros 

Total Technical and 
administrative assistance 

8.2.5. Financial cost of human resources and associated costs not included in 

the reference amount 

Type of human resources 

Year n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and later 

EUR million (to 3 decimal places) 

Officials and temporary 
staff (XX 01 01) 

Staff financed by Art XX 
01 02 (auxiliary, END, 
contract staff, etc.) 

(specify budget line) 

Total cost of Human 
Resources and 
associated costs (NOT 
in reference amount) 

Calculation – Officials and Temporary agents 

Calculation – Staff financed under art. XX 01 02 

30 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

48 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.6. Other  administrative  expenditure  not  included  in  reference 

amount 

EUR million (to 3 decimal places) 

Year n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year  
n+5 
and 
later 

TOTAL 

XX  01  02  11  01  – 
Missions 

XX  01  02  11  02  – 
Meetings & Conferences 

XX  01  02  11  03  – 
Committees31  

XX 01 02 11 04 – Studies 
& consultations 

XX  01  02  11  05 
Information systems 

- 

Total Other 
Management 
Expenditure 
(XX 01 02 11) 

Other expenditure of 
an administrative 
nature (specify including 
reference to budget line) 

2. 

3. 

Total Administrative 
expenditure, other than human 
resources and associated costs 
(NOT included in reference 
amount) 

Calculation – Other administrative expenditure not included in reference amount 

31 

Specify the type of committee and the group to which it belongs. 

EN 

49 

   EN