Amended 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 pursuant to Article 250 (2) of the EC Treaty)
Date: 2007-10-24
Institutions: European Commission
Subjects: approximation of laws, consumer protection, enzyme, flavouring, food additive, food safety, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.10.2007 
COM(2007) 672 final 

2006/0143 (COD) 

Amended 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 pursuant to Article 250 (2) of the EC Treaty) 

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EXPLANATORY MEMORANDUM 

1. 

PROCEDURE 

1.  On  28th  July  2006,  the  Commission  adopted  the  proposal  for  a  European 
Parliament  and  Council  Regulation  establishing  a  common  authorisation 
procedure  for  food  additives,  food  enzymes  and  food  flavourings  [Document 
(COM  (2006)0423  final)]  as  part  of  a  package  of  four  proposals  on  food 
improvement  agents.  The  proposal  was  submitted  to  the  Council  and  the 
European Parliament on 28th July 2006. 

2. 

3. 

4. 

5. 

The Economic and Social Committee adopted its opinion on 25th April 2007. 

The  Council  has  agreed  a  ‘general  approach’  on  the  proposal  at  the  EPSCO 
meeting on 31st May 2007. 

The European Parliament has given in first reading a favourable opinion on the 
proposal on 10th July 2007. 

The  present  proposal  amends  the  original  proposal  [COM  (2006)0423  – 
2006/0143(COD)] so as to take into account the amendments of the European 
Parliament that were accepted by the Commission. 

With  regard  to  the  original  proposal,  the  European  Parliament  adopted  31 
amendments.  Commissioner  Kyprianou  had  indicated  to  the  plenary  meeting 
on  9th  July  2007  that  the  Commission  could  accept  most  of  the  amendments, 
wholly or in part, and subject to rewording. From the adopted amendments the 
Commission cannot accept the following amendments: 14, 20, 31, and 33. 

The  amendments  in  the  revised  proposal  are  in  bold  and  underlined.  A 
number of amendments have been reformulated so as to ensure consistency of 
the terminology used throughout the proposal.  

Within  certain  Articles,  the  numbering  of  the  paragraphs  has  been  adapted  in 
order  to  take  into  account  the  addition  or  deletion  of  elements  in  the 
Commission proposal. 

II. 

OBJECTIVES OF THE PROPOSAL 

6.  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  food  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 health as regards food 
additives, food enzymes and food flavourings.  

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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 (EFSA) and a 
risk  management  system  in  which  the  Commission  takes  action  within  the 
framework of a regulatory committee procedure (comitology). It assigns to the 
Commission,  on  the  basis  of  the  EFSA’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 in the Community. 

7. 

The proposed Regulation on the common authorisation procedure is part of the 
package  of  proposals  on  'food  improvement  agents’  which  refers  to  the 
proposals  on  food  additives,  food  enzymes  and  flavourings.  It  contributes  to 
the  Commission’s  simplification  programme  and  also  provides 
for 
harmonisation and promotes consistency between the three related areas. 

III. 

OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT 

8. 

Technical/editorial amendments 

The majority of the proposed amendments aim to improve the proposal from a 
technical  and  editorial  point  of  view.  These  amendments  have  largely  been 
taken  over  by  the  Commission  in  some  cases  subject  to  editorial  changes 
(Amendments concerned: 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 15, 19, 21, 23, 24, 25, 
27, 28, 30, 32).  

Amendment  23  is  acceptable  in  substance.  However,  it  is  already  stated  in 
Article  11  that  the  Authority  shall  make  its  opinions  public  without  delay; 
therefore repetition of the same provision in Article 5(2) is not appropriate for 
reasons of legal drafting. 

Amendment  31,  although  editorial,  cannot  be  accepted  for  reasons  of  legal 
drafting. 

9. 

Transparency 

Amendments  9,  10,  19,  21,  27,  28  and  32  strengthen  the  transparency  and 
information  provisions  which  were  already  underlying  principles  of  the 
Commission proposal.  

However,  amendment  20  requires  all  application  files  to  become  available  to 
stakeholders. The Commission intends to make public a list of all requests for 
authorisation  and  information  on  progress,  but  routine  publication  of  the  full 
application  files  is  not  acceptable.  Access  to  documents  held  by  the 
Commission  can  be  granted  under  the  provisions  of  Regulation  (EC)  No 
1049/2001  of  the  European  Parliament  and  of  the  Council  regarding  public 
access to European Parliament, Council and Commission documents. 

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10.  5 year data protection with individual authorisations (Article 2 and Article 

12) 

The  proposal  provides  for  a  system  of  positive  lists  of  food  additives,  food 
enzymes  and  flavourings.  The  inclusion  of  a  substance  on  one  of  these  lists 
means that its use is authorised in general for all operators in the Community. 
This is the situation today with regard to food additives.  

Amendments 14 and 33 provide for a 5-year period of data protection and as a 
result  preferential  authorisation  of  the  substance  during  this  time  for  the 
company  that  provided  the  data.  Such  provision  would  change  radically  the 
present system for food additives which has been in place for a long time and is 
generally  adopted  internationally.  It  would  also  result  in  a  duplication  of 
regulatory  approaches  (individual  authorization  for  5  years  followed  by  a 
general  authorisation),  a  complication  of  systems  of  control  and  increased 
administrative procedures. This approach is thus not in line with the objective 
of the simplification of the regulatory framework. Finally a system that grants 
exclusive  rights  to  individual  operators  could  hinder  the  free  movement  of 
products  that  are  safe  and  comply  with  the  criteria  of  the  specific  legislation, 
which  goes  against  the  objectives  of  a  measure  made  under  Article  95  of  the 
EC  Treaty.  Therefore,  these  amendments  have  not  been  taken  over  in  the 
amended proposal. 

11.  Deadlines (Article 5 (1) and Article 7(1)) 

Amendment  22  increases  the  time  for  the  European  Food  Safety  Authority 
(Authority) to give its opinion from six to nine months. This is accepted in the 
amended proposal.  

On  the  other  hand  amendment  37  reduces  the  time  for  the  Commission  to 
present  a  draft  measure  to  the  Standing  Committee  from  nine  to  six  months. 
There  are  cases,  notably  for  food  additives,  where  six  months  will  not  be 
enough  for  the  Commission  to  present  a  measure  after  having  consulted  the 
Member States and relevant stakeholders on the technological need, benefit to 
the consumer, the potential to mislead the consumer and other relevant factors. 
This form of consultation taking into account the views of stakeholders when 
drafting proposals can only be achieved if adequate time is available. Therefore 
this part of amendment 37 is not integrated in the amended proposal. 

12.  Comitology (Article 7 and Article 14) 

The Commission proposal referred to the normal regulatory procedure since it 
was  adopted  around  the  time  that  Council  Decision  2006/512/EC,  amending 
Decision  1999/468/EC  laying  down  the  procedures  for  the  exercise  of 
implementing  powers  conferred  on  the  Commission,  was  adopted.  Therefore 
the  proposal  should  be  amended  to  take  the  new  regulatory  procedure  with 
scrutiny into account.  

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Amendments  34,  35,  36  and  37  support  comitology  for  updating  the  lists  of 
food additives, food enzymes and flavourings whilst they align the text of the 
proposal to the provisions of the new regulatory procedure with scrutiny. These 
amendments are welcomed and accepted in principle, subject to some editorial 
changes.  Amendment  36  in  particular,  although  accepted  in  principle,  is  not 
taken  on  board  in  the  text  of  Article  2(1)  as  it  is  already  covered  by  the 
amendment  introduced  in  Article  7.  In  addition  the  possibility  to  use  the 
urgency  procedure  is  introduced  for  the  removal  of  substances  from  the 
Community  list  and  for  adding,  removing  or  changing  specifications  or 
restrictions of use, in case of a particular risk to human health.  

13.  Pursuant  to  Article  250(2)  of  the  EC-Treaty,  the  Commission  amends  it 

proposals in accordance with the lines set out above. 

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2006/0143 (COD) 

Amended 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 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the Commission1, 

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

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

Whereas: 

(1) 

(2) 

(3) 

(4) 

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 and of the environment 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 
lay  down  harmonised  criteria  and 
ingredients  with 
requirements concerning the assessment and authorisation of these substances.  

flavouring  properties5 

1 
2 
3 
4 
5 

OJ C […], […], p. […]. 
OJ C 168, 20.7.2007, p 34. 
OJ L […], […], p. […]. 
OJ L […], […], p. […]. 
OJ L […], […], p. […]. 

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(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

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.  

Transparency  in  the  production  and  handling  of  food  is  absolutely  crucial  to 
achieving consumer confidence. 

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  an  independent  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.  

(11)  The criteria laid down for authorisation in Regulations (EC) No XXX/2006, (EC) 
No  YYY/2006  and  (EC)  No  ZZZ/2006  should  be  fulfilled  for  authorisation 
pursuant to this Regulation. 

(12) 

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 must be taken into 
account. 

(13)  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.  

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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(14)  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 
organisations  operating  in  the  fields  within  the  European  Food  Safety  Authority’s 
mission7. 

(15)  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, in duly justified cases and for stated reasons 
in order to protect the competitive position of the applicant. 

(16)  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.  

(17)  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. 

(18) 

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

(19)  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. 

(20)  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. 
The  Commission  should,  as  appropriate,  consult  stakeholders  in  preparing  the 
measures to put before the Committee referred to in the above Decision. 

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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. Decision as amended by Decision 2006/512/EC (OJ L  200, 22.7.2006, 
p. 11). 

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(21) 

In  particular,  power  should  be  conferred  on  the  Commission  to  update  the 
Community  lists  of  food  additives,  food  enzymes  and  food  flavourings.  Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  or  supplement 
non-essential  elements  of  each  sectoral  food  law,  they  must  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in  Article 
5a of Decision 1999/468/EC. 

(22)  When,  on  imperative  grounds  of  urgency,  the  normal  time-limits  for  the 
regulatory  procedure  with  scrutiny  cannot  be  complied  with,  the  Commission 
should  be  able  to  use  the  urgency  procedure  provided  for  in  Article  5a  (6)  of 
Decision  1999/468/EC  for  the  removal  of  a  substance  from  the  Community  lists 
and  for  adding,  removing  or  changing  conditions,  specifications  or  restrictions 
associated with the presence of a substance on the Community lists. 

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
GENERAL PRINCIPLES 

Article 1 
Subject matter and scope 

1. 

2. 

3. 

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 food within the Community and to a high level 
of protection of human health and protection of consumers' interests. 

This Regulation shall not apply to smoke flavourings falling within the scope of 
Regulation (EC) No 2065/2003 of the European Parliament and of the Council 
of  10  November  2003  on  smoke  flavourings  used  or  intended  for  use  in  or  on 
foods10. 

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. 

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OJ L 309, 26.11.2003, p. 1. 

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Article 2 
Community list of substances 

1. 

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. 

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 human 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.  

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In  such  cases,  where  applicable,  the  Commission  shall  make  this  information 
public  subject  to  the  provisions  of  Article  12,  and  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. 

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

Article 5 
Opinion of the Authority 

The  Authority  shall  give  its  opinion  within  six  nine  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. 

2. 

1. 

2. 

1. 

2. 

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3. 

4. 

1. 

2. 

3. 

1. 

2. 

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,  unless  there  are  special  reasons  for 
extending the period as referred to in Article 10. 

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. 

The regulation updating the Community list shall explain the considerations on 
which it is based. Where the draft regulation is not in accordance with the opinion 
of  the  Authority,  the  Commission  shall  explain  the  difference  reasons  for  its 
decision. 

The  regulation  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 14(3) (2). 

On  imperative  grounds  of  urgency,  the  Commission  may  use  the  urgency 
procedure referred to in Article 14 (4) for the removal of a substance from the 
Community list and for adding, removing or changing conditions, specifications 
or  restrictions  associated  with  the  presence  of  a  substance  on  the  Community 
list. 

Additional information concerning risk management 

Article 8 

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 Commission may 
extend  the  period  referred  to  in  Article  7  may  be  extended  accordingly  and  shall 
inform the Member States of the extension. 

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. 

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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  and  the  Member  States  of  the 
extension and the reasons for it. 

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). 

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Article 12 
Confidentiality 

1. 

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

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

(a) 

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

(b) 

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). 

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 
the applicants and the Member States 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. 

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. 

2. 

3. 

4. 

5. 

6. 

7. 

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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. 

3. 

4. 

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. 

Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

Where  reference  is  made  to  this  paragraph,  Article  5a(1),  (2),  (4)  and  (6),  and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of 
Article 8 thereof.  

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. 

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. 

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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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