Proposal for a Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings
Date: 2006-07-28
Institutions: European Commission
Subjects: approximation of laws, consumer protection, enzyme, flavouring, food additive, foodstuff, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.7.2006 
COM(2006) 423 final 

2006/0143 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

establishing a common authorisation procedure for food additives, food enzymes and 
food flavourings 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1) 

CONTEXT OF THE PROPOSAL 

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(cid:121) 

Grounds for and objectives of the proposal 

As part of the efforts undertaken to improve Community legislation on 
the  basis  of  the  “farm  to  table”  concept,  in  the  White  Paper  on  Food 
Safety, the Commission announced its intention to update and complete 
existing  legislation  with  regard  to  additives  and  flavourings  and  to  lay 
down specific provisions in respect of enzymes. (Actions 11 and 13 of 
the White Paper).  

This  proposal  aims  to  ensure  the  proper  functioning  of  the  internal 
market, while also ensuring a high level of protection of human life and 
health as regards food additives, food enzymes and food flavourings. 

In  order  to  do  this,  it  aims  to  establish  a  common  authorisation 
procedure  that  is  centralised,  effective,  expedient  and  transparent  and 
that is based on risk assessment carried out by the European Food Safety 
Authority  (hereinafter  referred  to  as  “the  Authority”)  and  a  risk 
management  system  in  which  the  Commission  and  the  Member  States 
take action within the framework of a regulatory committee procedure.  

It assigns to the Commission, on the basis of the Authority’s scientific 
assessments,  the  task  of  creating,  maintaining  and  updating  a  general 
positive list for each category of substances concerned. The inclusion of 
a  substance  on  one  of  these  lists  means  that  its  use  is  authorised  in 
general for all operators on the Community market. 

120 

(cid:121) 

General context 

So as to meet the objectives set in the White Paper, and for reasons of 
efficiency  in  the  areas  of  food  safety,  human  health  protection  and  the 
free  movement  of  the  products  concerned,  the  Commission  has 
developed,  in  parallel,  three  other  proposals  for  Regulations  that  make 
the  placing  on  the  Community  market  of  these  substances  subject  to 
compliance with harmonised criteria and the granting of authorisation: 

1. 

2. 

3. 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the 
Council on food additives; 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the 
Council on food enzymes; 

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. 

The new regulatory framework proposed for the substances in question 
must  be  completed  by  the  establishment  of  a  common  authorisation 

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procedure,  insofar  as  the  existence  of  different  national  authorisation 
in 
lead 
procedures  could  potentially 
consequence, hinder the free movement of the substances concerned and 
distort free competition. 

to  different  results  and, 

130 

(cid:121) 

Existing provisions in the area of the proposal 

1. 

Council  Directive  89/107/EEC  of  21  December  1988  on  the 
approximation of the laws of the Member States concerning food 
additives  authorised  for  use  in  foodstuffs  intended  for  human 
consumption. 

The  procedure  laid  down  in  the  above  Directive  is  close  to  the 
procedure  established  by  this  proposal  in  that  it  provides  for  the 
creation  of  a  positive  list  of  authorised  additives  at  Community 
level.  

It differs from the procedure envisaged in this proposal as regards 
the following aspects in particular: 

– 

– 

the existing procedure is out of date insofar as it does not use 
the  new  framework  for  risk  assessment  in  matters  of  food 
safety  established  by  Regulation  (EC)  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 safety; 

an  additive  is  included  on  the  positive  list  following  the 
adoption  of  a  directive  under  the  codecision  procedure, 
rather  than  by  means  of  a  regulation  and  the  comitology 
procedure as envisaged by this proposal. 

2. 

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 foodstuffs. 

The  procedure  laid  down  in  the  above  Regulation  is  close  to  the 
procedure  established  by  this  proposal  in  that  it  assigns  the 
Commission  the  task  of  creating  a  positive  list  of  flavouring 
substances  and  lays  down  that  this  list  be  adopted  in  accordance 
with the comitology procedure. 

It differs from the procedure envisaged in this proposal on several 
points, and on the following aspects in particular: 

– 

the existing procedure is out of date insofar as it does not use 
the  new  framework  for  risk  assessment  in  matters  of  food 
safety established by Regulation (EC) No 178/2002; 

– 

it  is  a  procedure  that  is  limited  to  notification  of  the 

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that  may, 

Commission  by  the  Member  States  of  all  the  flavouring 
in  accordance  with  Directive 
substances 
88/388/EEC,  be  used  in  or  on  foodstuffs  marketed  in  their 
territory.  Unlike  the  current  proposal,  it  does  not  make 
provision  for  private  operators  to  submit  authorisation 
requests;  

– 

– 

it  involves  the  creation  of  a  positive  list  of  flavouring 
substances  without  making  provision  for  the  list  to  be 
updated; 

the  existing  procedure  lacks  clarity  in  relation  to  new 
substances  and  the  deadlines  for  the  various  stages  of  the 
procedure. 

140 

(cid:121) 

Consistency with the other policies and objectives of the Union 

The proposed Regulation not only falls within the general framework of 
the  Lisbon  Strategy  but  also  fulfils  the  Commission’s  objectives  as 
regards simplification and “Better Regulation”.  

2) 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

(cid:121) 

Consultation of interested parties 

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Consultation  methods,  main  sectors  targeted  and  general  profile  of 
respondents 

The consultation methods and the organisations consulted are described 
in  detail  in  the  explanatory  memorandums  of  the  proposals  for 
regulations on additives, enzymes and flavourings.  

Summary of responses and how they have been taken into account 

The parties consulted welcomed the idea of a simplified, transparent and 
expedient common authorisation procedure.  

The involvement of the Member States in the authorisation procedure as 
compulsory  relays  between  applicants  and  the  Commission  was 
criticised  by  the  Member  States.  This  “extra-step  procedure”  seems  to 
be regarded as a bureaucratic complication that needlessly slows down 
the  procedure.  In  consequence,  this  proposal  abolishes  the  “letter-box” 
role of the national authorities in the common procedure. 

the  fear 

Some  consumer  organisations  expressed 
that  replacing 
codecision with the comitology procedure in the authorisation procedure 
for  additives  would  reduce  the  current  transparency.  Nevertheless,  use 
of  the  comitology  procedure  is  desirable,  as  it  establishes  a  common 
procedure  for  the  three  types  of  substance.  Moreover,  the  codecision 
procedure currently applicable in relation to additives is an isolated case 
in  food  legislation  as  a  whole,  despite  its  use  not  being  justified  by  a 

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higher level of risk posed by additives. 

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(cid:121) 

Collection and use of expertise 

No recourse to external expertise was necessary. 

(cid:121) 

Impact assessment 

This proposal and the options considered have no environmental impact. 

1.  No action 

Economic impact 

The  current  authorisation  mechanisms 
for  additives  and 
flavourings  are  slow  and  outdated.  The  lack  of  clarity  and  the 
shortcomings  in  the  current  legislation  create  a  situation  of  legal 
uncertainty  that  could  hinder  industrial  innovation  and  new 
technological developments. 

Social impact 

The  different  national  approaches  to  assessing  the  safety  of  the 
substances  concerned  could  lead  to  different  levels  of  protection. 
This situation is liable to create confusion among consumers and 
undermine  their  confidence  in  the  public  authorities,  the  internal 
market and the scientific basis of food legislation. 

2.  No legislative action 

The nature of the action to be taken in this area is subject to and 
connected  with  the  nature  of  the  action  taken  in  the  sectors 
concerned.  Given  that  the  principle  of  general  Community-level 
authorisation  of  the  substances  is  accepted,  legislative  action  is 
needed  to  ensure  that  there  is  an  effective  and  fast  common 
procedure. 

Economic impact 

A coordination-based solution (possible adoption of guidelines for 
the  parties  concerned  in  relation  to  the  procedure  to  follow  or  a 
Community  code)  would  not  offer  the  protection  and  legal 
certainty  that  the  industry  requires.  Furthermore,  it  would 
contradict  the  legislative  approach  followed  for  the  authorisation 
of  other  food  substances.  This  situation  could  have  a  negative 
industrial 
economic 
innovation. 

it  could  discourage 

insofar  as 

impact 

Social impact 

Legal uncertainty as regards the procedures to be followed could 

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compromise  the  effectiveness  of  scientific  assessments  and  the 
level  of  human  health  protection.  This  situation  could  undermine 
consumer confidence. 

3.  Deregulation 

Economic impact 

procedures 

Deregulation  would  lead  to  the  introduction  of  different  national 
authorisation 
additional 
that 
administrative  burdens  for  the  competent  authorities  of  the 
Member States. Furthermore, the operators concerned would have 
to  submit  separate  authorisation  applications  to  each  Member 
State in which they wanted to market their product.  

create 

could 

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Social impact 

The  existence  of  different  procedures  for  assessing  the  safety  of 
substances would lead to there being different levels of protection. 
This  could  create  confusion  among  consumers  and  undermine 
their confidence. 

The  Commission  has  carried  out  an  impact  assessment  under  its 
Legislative  and  Work  Programme,  and  the  report  is  available  at: 
http://ec.europa.eu/food/food/chemicalsafety/additives/index_en.htm. 

3) 

LEGAL ELEMENTS OF THE PROPOSAL 

(cid:121) 

Summary of the proposed action 

This  proposal  establishes  an  effective,  expedient  and  transparent 
common  authorisation  procedure  for  food  additives,  food  enzymes  and 
food  flavourings  (in  the  form  of  a  list  of  substances  that  is  kept  up  to 
date).  Community  authorisation  will  be  granted  in  a  transparent, 
centralised  manner  on  the  basis  of  the  scientific  opinion  of  the 
Authority, provided that the authorisation criteria set out in the sectoral 
food laws are met. Such authorisation will take the form of a regulation 
to be adopted according to the comitology rules. 

310 

(cid:121) 

Legal basis 

Article 95 of the EC Treaty 

This proposal aims to improve the conditions for the functioning of the 
internal  market,  since  it  will  be  possible  for  products  authorised  in 
accordance  with  the  proposed  procedure  to  be  used  throughout  the 
Community. The Regulation envisaged will lead to the Member States’ 
legal provisions concerning the use of food additives, food enzymes and 
food  flavourings  being  harmonised  in  the  form  of  a  positive  list  of 
authorised substances to be created by the Commission pursuant to the 
Regulation. 

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Subsidiarity principle 

The  principle  of  subsidiarity  applies  insofar  as  the  proposal  does  not 
concern an area in which the Community has exclusive competence. 

The  objectives  of  the  proposal  cannot  be  sufficiently  achieved  by  the 
Member States for the following reasons. 

This proposal aims to establish a centralised authorisation procedure at 
Community  level.  It  would  not  be  possible  for  this  to  be  achieved  by 
national  legislators,  even  if  they  simultaneously  adopted  national 
provisions with the same content as the proposed Regulation.  

A Community measure on the authorisation procedure complements the 
other three harmonisation measures proposed in this area.  

Putting  in  place  authorisation  procedures  separately  in  each  Member 
State  would  make  the  authorisation  mechanisms  considerably  more 
unwieldy  and  would  create  needless  additional  administrative  burdens 
for the competent authorities of the Member States and for operators. 

The  objectives  of  the  proposal  can  be  better  achieved  by  Community 
action for the following reasons. 

Community  action  in  relation  to  the  authorisation  procedure  for  the 
substances  in  question  is  more  effective  than  action  taken  by  the 
Member  States  insofar  as  it  will  fully  benefit  all  operators  that  market 
the products concerned on the Community market as well as consumers, 
who  will  be  able  to  enjoy  the  same  level  of  protection  in  all  Member 
States. 

Community action in the area envisaged brings added value as regards 
legal certainty and efficiency for operators in the sector, administrative 
simplification,  the  functioning  of  the  internal  market  and  consumer 
protection.  

The proposal relates exclusively to the intrinsic elements of a centralised 
authorisation procedure. 

The proposal therefore complies with the subsidiarity principle. 

(cid:121) 

Proportionality principle 

The  proposal  complies  with  the  principle  of  proportionality  for  the 
following reasons. 

The  proposed  measure  is  procedural  in  nature  and  follows  from  the 
principle of pre-marketing authorisation that is established in the sectors 
concerned. A coordination-based solution would make the authorisation 
procedure  for  the  substances  concerned  considerably  more  unwieldy. 
The proposed act does not exceed the limits of what is appropriate and 

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necessary in order to achieve the legitimate objective of the legislation 
in  question,  namely  the  proper  functioning  of  the  internal  market  and 
human health protection. 

The  procedures  put  in  place  by  the  proposed  measure  streamline  the 
processing  of  authorisation  files,  the  majority  of  which  (except  for 
enzymes) have already been scientifically assessed by the Authority and 
processed  by  the  Commission.  Therefore,  this  has  an  impact  on  the 
procedures currently used by the Commission and the Authority, but one 
which  remains  limited.  Nevertheless,  the  proposed  measure  will 
considerably reduce the administrative burdens on the Member States by 
allowing them to devote their resources particularly to implementing the 
legislation and to control activities. The new rules will enable operators 
to  avail  of  a  clear,  transparent,  effective  and  fast  procedure  by 
submitting a single authorisation application. The creation and updating 
of  a  Community  list  of  authorised  substances  should  also  facilitate  the 
movement  of  the  products  concerned  and  increase  the  level  of 
information in this area.  

(cid:121) 

Choice of instruments 

Proposed instrument(s): Regulation. 

Other means would not be adequate for the following reasons. 

The nature of the proposed measure is subject to and connected with the 
nature of the action taken in the sectors concerned. A different solution 
(directive,  code  of  conduct,  guidelines)  would  make  the  authorisation 
procedure for the substances concerned considerably more unwieldy and 
would not offer the necessary legal certainty. 

4) 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

5) 

ADDITIONAL INFORMATION 

(cid:121) 

Simplification 

The  proposal  simplifies  the  legislative  framework,  the  administrative 
procedures  applicable  to  (national  or  European)  public  authorities  and 
the  administrative  procedures  applicable 
to  bodies  and  private 
individuals. 

A  single  regulation  will  set  out  the  applicable  procedure  for  the 
authorisation of additives, enzymes and flavourings. 

The competent authorities of the Member States will be able to follow 
all  the  stages  of  the  authorisation  procedure  without  being  burdened 
with needless administrative tasks. 

The  operators  concerned  will  benefit  fully  from  the  advantages  of  a 

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transparent, 

centralised, 
time-limited  procedure.  The  granting  of 
authorisation  by  means  of  a  regulation  updating  a  Community  list  will 
significantly speed up the authorisation procedure. 

The proposal is included in the Commission’s programme for updating 
and simplifying the Community acquis and in its Work and Legislative 
Programme under the reference 2005/SANCO/034. 

(cid:121) 

European Economic Area 

This draft act concerns an area covered by the EEA Agreement and must 
therefore be extended to the European Economic Area. 

(cid:121) 

Detailed explanation of the proposal by chapter or by article 

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570 

Chapter I: General principles 

A  common  procedure  is  established  for  assessing  and  authorising 
additives,  enzymes  and  flavourings.  This  procedure  has  been  designed 
to be simple, fast and effective, while respecting the principles of good 
administration and legal certainty. It is centred around the updating, on 
the  basis  of  the  criteria  laid  down  in  the  sectoral  laws,  of  a  list  of 
authorised  substances  that  must  be  created  and  maintained  by  the 
Commission. 

Chapter II: Common procedure 

Under  the  proposed  procedure,  requests  for  updates  must  be  addressed 
to the Commission, without first going through a national authority.  

The Commission shall send the request file to the Authority and to the 
Member States and shall seek the opinion of the Authority, which must 
issue such opinion within six months.  

So as to ensure the binding effect of the updating measures, the proposal 
provides for their adoption to take the legal form of a regulation adopted 
in accordance with the comitology procedure. 

When the list is being updated within the framework of this proposal for 
a  Regulation,  any  other  relevant  legitimate  factors  must  be  taken  into 
account.  Thus,  when  initiating  the  decision-making  process,  the 
Commission, as risk manager, may propose a measure that is not in line 
with  the  outcome  of  the  risk  assessment  carried  out  under  the 
responsibility  of  the  Authority.  In  such  cases,  the  Commission  must 
explain its reasons for such a departure. This is in line with the Codex 
Alimentarius General Principles on Risk Analysis. 

Chapter III: Miscellaneous provisions 

So as to take account of the specific characteristics of each sectoral food 
law,  this  proposal  gives  the  Commission  the  power,  following 
consultation of the Authority, to take decisions on various details of the 

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procedure  and  provides  for  a  certain  degree  of  flexibility  as  regards 
complex and sensitive cases. 

All non-confidential data should be made available to the public. 

If the Member States or the Commission consider that a substance that 
has been authorised in accordance with this proposal poses serious risks 
to human health, animal health or the environment, emergency measures 
must be adopted.  

F-11958 

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2006/0143 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

establishing a common authorisation procedure for food additives, food enzymes and 
food flavourings 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the Commission1, 

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

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

Whereas: 

(1) 

(2) 

(3) 

(4) 

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. 

A high level of protection of human life and health should be assured in the pursuit of 
Community policies. 

So as to protect human health, the safety of additives, enzymes and flavourings for use 
in foodstuffs for human consumption must be assessed before they are placed on the 
Community market. 

Regulation (EC) No XXX/2006 of the European Parliament and of the Council of … 
on food additives3, Regulation (EC) No YYY/2006 of the European Parliament and of 
the  Council  of  …  on  food  enzymes4  and  Regulation  (EC)  No  ZZZ/2006  of  the 
European  Parliament  and  of  the  Council  of  …  on  food  flavourings  and  certain  food 
ingredients with flavouring properties5 lay down harmonised criteria and requirements 
concerning the assessment and authorisation of these substances.  

1 
2 
3 
4 
5 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L […], […], p. […]. 
OJ L […], […], p. […]. 
OJ L […], […], p. […]. 

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(5) 

(6) 

(7) 

(8) 

(9) 

It is envisaged, in particular, that food additives, food enzymes and food flavourings, 
to  the  extent  that  the  safety  of  the  latter  must  be  assessed  in  accordance  with 
Regulation (EC) No ZZZ/2006, must not be placed on the market or used in foodstuffs 
for human consumption, in accordance with the conditions laid down in each sectoral 
food law, unless they are included on the Community list.  

In this context, it appears appropriate to establish a common Community assessment 
and  authorisation  procedure  for  these  three  categories  of  substances  that  is  effective, 
time-limited  and  transparent,  so  as  to  contribute  to  their  free  movement  within  the 
Community market. 

This common procedure must be founded on the principles of good administration and 
legal certainty and must be implemented in compliance with these principles. 

This  Regulation  will  thus  complete  the  regulatory  framework  concerning  the 
authorisation of the substances by laying down the various stages of the procedure, the 
deadlines for these stages, the role of the parties involved and the principles that apply. 
Nevertheless,  for  some  aspects  of  the  procedure,  it  is  necessary  to  take  the  specific 
characteristics of each sectoral food law into consideration.  

In  accordance  with  the  framework  for  risk  assessment  in  matters  of  food  safety 
established  by  Regulation  (EC)  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 safety6, the placing of substances on the market must be 
authorised  only  after  a  scientific  assessment,  of  the  highest  possible  standard,  of  the 
risks that they pose to human health. This assessment, which must be carried out under 
the  responsibility  of  the  European  Food  Safety  Authority  (hereinafter  referred  to  as 
“the  Authority”),  must  be  followed  by  a  risk  management  decision  taken  by  the 
Commission under a regulatory procedure that ensures close cooperation between the 
Commission and the Member States. 

(10) 

It is recognised that, in some cases, scientific risk assessment alone cannot provide all 
the information on which a risk management decision should be based, and that other 
legitimate  factors  relevant  to  the  matter  under  consideration  may  be  taken  into 
account. 

(11)  So  that  both  business  operators  in  the  sectors  concerned  and  the  public  are  kept 
informed of the authorisations in force, the authorised substances should be included 
on a Community list created, maintained and published by the Commission.  

(12)  Networking between the Authority and the Member States’ organisations operating in 
the  fields  within  the  Authority’s  mission  is  one  of  the  basic  principles  of  the 
Authority’s operation. In consequence, in preparing its opinion, the Authority may use 
the network made available to it by Article 36 of Regulation (EC) No 178/2002 and by 
Commission  Regulation  (EC)  No  2230/2004  laying  down  detailed  rules  for  the 
implementation  of  Regulation  (EC)  No 178/2002  with  regard  to  the  network  of 

6 

OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  1642/2003  (OJ  L  245, 
29.9.2003, p. 4). 

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organisations  operating  in  the  fields  within  the  European  Food  Safety  Authority’s 
mission7. 

(13)  The common authorisation procedure for the substances must fulfil transparency and 
public  information  requirements  while  guaranteeing  applicants’  right  to  preserve  the 
confidentiality of certain information. 

(14)  Pursuant  to  Article  41  of  Regulation  (EC)  No  178/2002,  Regulation  (EC) 
No 1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001 
regarding public access to European Parliament, Council and Commission documents8 
applies to documents held by the Authority.  

(15)  Articles  53  and  54  of  Regulation  (EC)  No  178/2002  establish  procedures  for  taking 
emergency measures in relation to foodstuffs of Community origin or imported from 
third  countries.  They  authorise  the  Commission  to  adopt  such  measures  in  situations 
where foodstuffs are likely to constitute a serious risk to human health, animal health 
or the environment and where such risk cannot be contained satisfactorily by measures 
taken by the Member State(s) concerned. 

(16) 

In  the  interests  of  efficiency  and  legislative  simplification,  there  should  be  a 
medium-term examination as to whether to extend the scope of the common procedure 
to other legislation in the area of food.  

(17)  Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States  on  account  of  differences  between  national  laws  and  provisions  and  can 
therefore be better achieved at Community level, the Community may adopt measures 
in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Regulation does not go beyond what is necessary in order to achieve these objectives. 

(18)  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 Commission9, 

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8 
9 

OJ L 379, 24.12.2004, p. 64.  
OJ L 145, 31.5.2001, p. 43. 
OJ L 184, 17.7.1999, p. 23. 

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HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
GENERAL PRINCIPLES 

Article 1 
Subject matter and scope 

1. 

2. 

3. 

1. 

This  Regulation  lays  down  a  common  assessment  and  authorisation  procedure 
(hereinafter  referred  to  as  the  “common  procedure”)  for  food  additives,  food 
enzymes, food flavourings and sources of food flavourings used or intended for use 
in or on foodstuffs (hereinafter referred to as the “substances”), which contributes to 
the free movement of these substances within the Community. 

The common procedure shall set the procedural arrangements for updating the lists 
of  substances  the  marketing  of  which  is  authorised  in  the  Community  pursuant  to 
Regulation  (EC)  No  XXX/2006,  Regulation  (EC)  No  YYY/2006  and  Regulation 
(EC) No ZZZ/2006 (hereinafter referred to as the “sectoral food laws”). 

The  criteria  according  to  which  substances  can  be  included  on  the  Community  list 
provided for in Article 2, the content of the Regulation referred to in Article 7 and, 
where applicable, the transitional provisions concerning ongoing procedures are laid 
down in each sectoral food law. 

Article 2 
Community list of substances 

Under each sectoral food law, substances that have been authorised to be placed on 
the Community market shall be included on a list the content of which is determined 
by the said law (hereinafter referred to as the “Community list”). The Community list 
shall be updated by the Commission. It shall be published in the Official Journal of 
the European Union. 

2. 

“Updating the Community list” means: 

a) 

adding a substance to the Community list; 

b) 

removing a substance from the Community list;  

c) 

adding or changing conditions, specifications or restrictions associated with the 
presence of a substance on the Community list. 

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CHAPTER II 
COMMON PROCEDURE 

Article 3 
Main stages of the common procedure 

1. 

2. 

3. 

4. 

The common procedure for updating the Community list may be initiated either on 
the  initiative  of  the  Commission  or  following  an  application.  Applications  may  be 
made  by  a  Member  State  or  by  an  interested  party,  who  may  represent  several 
interested  parties,  according  to  the  conditions  provided  for  by  the  implementing 
measures referred to in Article 9(1)(a) (hereinafter referred to as “the applicant”). 

The  Commission  shall  seek  the  opinion  of  the  European  Food  Safety  Authority 
(hereinafter referred to as “the Authority”) in advance, in accordance with Article 5.  

However, for the updates referred to in Article 2(2)(b) and (c), the Commission shall 
seek the opinion of the Authority only if these updates are liable to have an effect on 
public health. 

The  common  procedure  shall  end  with  the  adoption  by  the  Commission  of  a 
regulation implementing the update, in accordance with Article 7. 

By  way  of  derogation  from  paragraph  3,  the  Commission  may  end  the  common 
procedure  and  decide  not  to  proceed  with  a  planned  update,  at  any  stage  of  the 
procedure, if it judges that such an update is not justified. Where applicable, it shall 
take account of the opinion of the Authority, any relevant provisions of Community 
law and any other legitimate factors relevant to the matter under consideration.  

In such cases, where applicable, the Commission shall inform the applicant directly, 
indicating in its letter the reasons for the update not being considered justified. 

Article 4 
Initiating the procedure 

1. 

On receipt of an application to update the Community list, the Commission: 

a) 

shall acknowledge receipt of the application in writing to the applicant within 
14 working days of receiving it; 

b)  where  applicable,  notify  the  Authority  of  the  application  and  request  its 

opinion. 

The application shall be made available to the Member States by the Commission. 

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2. 

1. 

2. 

1. 

2. 

3. 

4. 

Where  it  initiates  the  procedure  on  its  own  initiative,  the  Commission  shall  inform 
the Member States and, where applicable, request the opinion of the Authority. 

Article 5 
Opinion of the Authority 

The  Authority  shall  give  its  opinion  within  six  months  of  receipt  of  a  valid 
application. 

The Authority shall forward its opinion to the Commission, the Member States and, 
where appropriate, the applicant.  

Article 6 
Additional information concerning risk assessment 

In  duly  justified  cases  where  the  Authority  requests  additional  information  from 
applicants, the period referred to in Article  5(1) may  be extended.  After consulting 
the  applicant,  the  Authority  shall  lay  down  a  period  within  which  this  information 
can be provided and inform the Commission of the additional period needed. If the 
Commission  does  not  object  within  eight  working  days  of  being  informed  by  the 
Authority,  the  period  referred  to  in  Article  5(1)  shall  be  automatically  extended  by 
the additional period.  

If  the  additional  information  is  not  sent  within  the  additional  period  referred  to  in 
paragraph  1,  the Authority  shall finalise its opinion on the basis of the information 
already provided. 

Where  applicants  submit  additional  information  on  their  own  initiative,  they  shall 
send  it  to  the  Authority  and  to  the  Commission.  In  such  cases,  the  Authority  shall 
give its opinion within the original period. 

The  additional  information  shall  be  made  available  to  the  Member  States  by  the 
Authority. 

Article 7 
Updating the Community list 

Within nine months of the Authority giving its opinion, the Commission shall submit to the 
Committee referred to in Article 14(1) a draft regulation updating the Community list, taking 
account of the opinion of the Authority, any relevant provisions of Community law and any 
other legitimate factors relevant to the matter under consideration. 

Where  the  draft  regulation  is  not  in  accordance  with  the  opinion  of  the  Authority,  the 
Commission shall explain the difference. 

The regulation shall be adopted in accordance with the procedure referred to in Article 14(2). 

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Article 8 
Additional information concerning risk management 

1. 

2. 

Where  the  Commission  requests  additional  information  from  applicants  on  matters 
concerning risk management, it shall determine, together with the applicant, a period 
within which this information can be provided. In such cases, the period referred to 
in Article 7 may be extended accordingly. 

If  the  additional  information  is  not  sent  within  the  additional  period  referred  to  in 
paragraph  1,  the  Commission  shall  act  on  the  basis  of  the  information  already 
provided. 

CHAPTER III 
MISCELLANEOUS PROVISIONS 

Article 9 
Implementing measures 

1. 

In accordance with the procedure referred to in Article 14(2), within a period of no 
longer than 24 months from the adoption of each sectoral food law, the implementing 
measures for this Regulation shall be adopted, and shall concern in particular: 

a) 

the  content,  drafting  and  presentation  of  the  application  referred  to  in 
Article 4(1); 

b) 

the arrangements for checking the validity of applications; 

c) 

the  type  of  information that  must be included  in the opinion of  the Authority 
referred to in Article 5. 

2. 

With  a  view  to  the  adoption  of  the  implementing  measures  referred  to  in 
paragraph 1(a),  the  Commission  shall  consult  the  Authority,  which,  within  six 
months  of  the  date  of  entry  into  force  of  this  Regulation,  shall  present  it  with  a 
proposal  concerning  the  data  required  for  risk  assessment  of  the  substances 
concerned. 

Article 10 
Extension of time periods 

The periods referred to in Article 5(1) and Article 7 may be extended by the Commission on 
its own initiative or, where applicable, at the Authority’s request, if the nature of the matter in 
question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases, where 
appropriate, the Commission shall inform the applicant of the extension and the reasons for it. 

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Article 11 
Transparency 

The Authority shall ensure the transparency of its activities in accordance with Article 38 of 
Regulation (EC) No 178/2002. In particular, it shall make its opinions public without delay. It 
shall  also  make  public  any  request  for  its  opinion  as  well  as  any  time  period  extension 
pursuant to Article 6(1). 

Article 12 
Confidentiality 

1. 

Among the information provided by applicants, confidential treatment may be given 
to  information  the  disclosure  of  which  might  significantly  harm  their  competitive 
position. 

Information  relating  to  the  following  shall  not,  in  any  case,  be  considered 
confidential: 

a) 

b) 

the name and address of the applicant and the name of the substance;  

a  clear  description  of  the  substance  and  the  conditions  for  its  use  in  or  on 
specific foodstuffs or food categories; 

c) 

information that is relevant to the assessment of the safety of the substances; 

d)  where applicable, the analysis method(s). 

2. 

3. 

4. 

5. 

So  that  paragraph  1  can  be  implemented,  applicants  shall  indicate  which  of  the 
information provided they wish to be treated as confidential. Verifiable justification 
must be given in such cases. 

The Commission shall decide which information can remain confidential and notify 
applicants accordingly.  

After  being  made  aware  of  the  Commission’s  position,  applicants  shall  have  three 
weeks in which to withdraw their application so as to preserve the confidentiality of 
the information provided. Confidentiality is preserved until this period expires. 

The  Commission,  the  Authority  and  the  Member  States  shall  take  the  necessary 
measures  to  ensure  appropriate  confidentiality  of  the  information  received  by  them 
under  this  Regulation,  except  for  information  which  must  be  made  public  if 
circumstances  so  require  in  order  to  protect  human  health,  animal  health  or  the 
environment. 

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6. 

7. 

If  an  applicant  withdraws,  or  has  withdrawn,  its  application,  the  Authority,  the 
Commission and the Member States shall respect the confidentiality of commercial 
and industrial information, including research and development information, as well 
as  information  the  confidentiality  of  which  is  the  subject  of  disagreement  between 
the Commission and the applicant. 

The  implementation  of  paragraphs  1  to  6  shall  not  affect  the  circulation  of 
information between the Commission, the Member States and the Authority. 

Article 13 
Emergencies 

In the event of an emergency concerning a substance on the Community list, particularly in 
the  light  of  an  opinion  of  the  Authority,  measures  shall  be  adopted  in  accordance  with  the 
procedures referred to in Articles 53 and 54 of Regulation (EC) No 178/2002. 

Article 14 
Committee 

1. 

2. 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health established by Article 58 of Regulation (EC) No 178/2002. 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply, having due 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 15 
Competent authorities of the Member States 

Not later than six months after the entry into force of this Regulation, the Member States shall 
forward  to  the  Commission  and  to  the  Authority,  in  relation  to  each  sectoral  food  law,  the 
name  and  address  of  the  national  competent  authority  for  the  purposes  of  the  common 
procedure, as well as a contact point therein. 

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CHAPTER IV 
FINAL PROVISION 

Article 16 
Entry into force 

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

For each sectoral food law, it shall apply from the date of application of the measures referred 
to in Article 9(1). 

Article 9 shall apply from the date of entry into force of this Regulation. 

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 

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