Amended proposal for a European Parliament and Council Regulation on smoke flavourings used or intended for use in or on foods (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2003-07-04
Institutions: European Commission
Subjects: consumer protection, flavouring, food additive, foodstuff, foodstuffs legislation, health policy, smoked product

EN

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 4.7.2003
COM(2003) 407 final

2002/0163 (COD)

Amended proposal for a

EUROPEAN PARLIAMENT AND COUNCIL REGULATION

on smoke flavourings used or intended for use in or on foods

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

 
 
EXPLANATORY MEMORANDUM

1.

PROCEDURE

On 15 July 2002, the Commission adopted a proposal for a European Parliament and
Council Regulation on smoke flavourings used or intended for use in or on foodsA.
The proposal was sent to the European Parliament and the Council on the same day.
The Economic and Social Committee issued its opinion supporting the Commission
proposal on 11 December 2002.

On 8 May 2003, Coreper agreed unanimously on a revised text. 

On 4 June 2003, the European Parliament voted in favour of amendments in line with
the revised text resulting from Coreper.

In respect to the the evaluation and authorisation procedure, the European Parliament
and  Coreper  agreed  to  the  same  procedure  as  adopted  as  Common  Position  on  the
Regulation of the European Parliament and the Council on genetically modified food
and feed which has been accepted by the Commission.

As  there  is  agreement  between  the  European  Parliament  and  the  Council,  it  is  the
intention  of  the  Council  to  adopt  the  proposal  in  Coreper  as  an  A  point  during  the
Greek presidency.

2.

OBJECTIVE OF THE COMMISSION PROPOSAL

The Commission proposal aims at

– 

– 

– 

to  establish  Community  procedures  for  the  safety  assessment  and  the
authorisation of smoke flavourings intended for use in or on foods in order to
ensure a high level of protection of human health and protection of consumers’
interests, as well as to ensure fair trade practices.

to establish a positive list of primary products authorised to the exclusion of all
others  in  the  Community  to  be  used  as  such  in  and  on  foods  or  for  the
production of derived smoke flavourings.

to ensure a smooth transition from national to Community regulations without
disturbing the existing market.

3.

COMMISSION  OPINION  ON  THE  AMENDMENTS  ADOPTED  BY  THE  EUROPEAN
PARLIAMENT

The  Commission  can  accept  all  the  amendments  adopted  by  the  European
Parliament.

A            COM(2002) 400 final - 2002/0163 (COD)

2

                                                
4.

CONCLUSION

Having  regard  to  Article  250  paragraph  2  of  the  EC  Treaty,  the  Commission
modifies its proposal as follows:

3

2002/0163 (COD)

Amended proposal for a

EUROPEAN PARLIAMENT AND COUNCIL REGULATION

on smoke flavourings used or intended for use in or on foods

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission1,

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

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

Whereas:

(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 foods and to source materials for
their  production3,  and  in  particular  Article  5  (1)  seventh  indent  thereof,  provides  for
the  adoption  of  appropriate  provisions  concerning  source  materials  used  for  the
production  of  smoke  flavourings  and  reaction  conditions  under  which  they  are
prepared.

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.

In  order  to  protect  human  health  smoke  flavourings  should  undergo  a  safety
assessment through a Community procedure before being placed on the market or used
in or on foods within the Community.

laws,  regulations  and  administrative  provisions
Differences  between  national 
concerning  the  assessment  and  authorisation  of  smoke  flavourings  may  hinder  their
free  movement,  creating  conditions  of  unequal  and  unfair  competition.  An
authorisation procedure should therefore be established at Community level.

1

2

3

(…)OJ C 262, 29.10.2002, p. 523.
(…)OJ C 85, 8.4.2003, p. 32.
OJ L 184, 15.7.1988, p. 61.

4

                                                
(6)

(7)

(8)

(9)

The chemical composition of smoke is complex  and  depends  among  other  things  on
the types of wood used, the method used for developing smoke, the water content of
the  wood  and  the  temperature  and  oxygen  concentration  during  smoke  generation.
Smoked  foods  in  general  give  rise  to  health  concern,  especially  with  respect  to  the
possible  presence  of  polycyclic  aromatic  hydrocarbons.  Because  smoke  flavourings
are  produced  from  smoke  which  is  subjected  to  fractionation  and  purification
processes,  the  use  of  smoke  flavourings  is  generally  considered  to  be  of  less  health
concern  than  the  traditional  smoking  process.  However,  the  possibility  of  wider
applications of smoke flavourings in comparison to conventional smoking has to
be taken into account in safety assessments.

The  present  Regulation  covers  smoke  flavourings  as  defined  in  Article  1  (2)  (e)  of
Directive  88/388/EEC.  The  production  of  these  smoke  flavourings  starts  with  the
condensation  of  smoke.  The  condensed  smoke  is  normally  separated  by  physical
processes  into  a  water-based  primary  smoke  condensate,  a  water  insoluble  high
density tar phase and a water insoluble oily phase. The water insoluble oily phase is a
by-product  and  unsuitable  for  the  production  of  smoke  flavourings.  The  primary
smoke condensates and fractions of the water insoluble high density tar phase, the so
called ‘primary tar fractions’, are purified to remove components of smoke which are
most  harmful  to  human  health.  They  may  then  be  suitable  for  use  as  such  in  or  on
foods or for the production of derived smoke flavourings made by further appropriate
physical  processing  such  as  extraction  procedures,  distillation,  concentration  by
evaporation, absorption or membrane separation and the addition of food ingredients,
other  flavourings,  food  additives  or  solvents,  without  prejudice  to  more  specific
Community legislation.

The  Scientific  Committee  on  Food  concluded  that  because  of  the  wide  physical  and
chemical differences in smoke flavourings used for flavouring food, it is not possible
to  design  a  common  approach  to  their  safety  assessment  and,  accordingly,
toxicological evaluation should focus on the safety of individual smoke condensates.
Following this advice, this Regulation provides for the scientific evaluation of primary
smoke  condensates  and  primary  tar  fractions,  hereinafter  referred  to  as  “primary
products”,  in  terms  of  the  safety  of  their  use  as  such  and/or  for  the  production  of
derived smoke flavourings intended for use in or on foods.

As regards conditions of production, this Regulation reflects the findings set out by the
Scientific Committee on Food in its report on smoke flavourings of 25 June 19934, in
which  it provided  a  non-exhaustive  list  of  types  of  wood  which  may  be  used  for
the  production  of  smoke  flavourings  and  specified  various  production  conditions
and the information necessary to evaluate smoke flavourings used or intended for use
in or on foods. That report was based, in turn, on the report of the Council of Europe
on “health  aspects of  using smoke flavours  as food ingredients”5.  It  also  contains  a
non-exhaustive list of types of wood which may be regarded as an indicative list
of woods suitable for the production of smoke flavourings.

(10)

Provision should be made for the establishment, on the basis of the safety assessment,
of  a  list  of  primary  smoke  condensates  and  primary  tar  fractionsproducts
authorised  for  use  as  such  in  or  on  foods  and/or  for  the  production  of  smoke
flavourings  for  use  in  or  on  foods  within  the  Community.  That  list  should  clearly

4

5

Reports of the Scientific Committee for Food, Thirty-fourth series, p. 1 – 7.
Council of Europe Publishing, 1992, reprinted 1998, ISBN 92-871-2189-3.

5

                                                
(11)

(12)

(13)

(14)

(15)

describe the primary products, specifying conditions of their uses and the dates from
which the authorisations are valid.

In  order  to  ensure  harmonisation,  safety  assessments  should  be  carried  out  by  the
European Food Safety Authority (“the Authority”), 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  safety  assessment  of  a  specific  primary  product  should  be  followed  by  a  risk
management decision as to whether the product should be entered on the Community
list of authorised primary products; that decision should be adopted in accordance with
the  regulatory  procedure  so  as  to  ensure  close  cooperation  between  the  Commission
and the Member States.

It is appropriate that the person (“the applicant”) who intends to place on the market
primary  products  or  derived  smoke  flavourings  should  submit  all  the  information
necessary  for  the  safety  assessment.  The  applicant  and  should  also  propose  a
validated methods of sampling and detection for the primary product to be used for
control  of  compliance  with  the  provisions  of  this  Regulation;  if  necessary,  the
Commission  should  adopt  quality  criteria  for  those  analytical  methods  after  having
consulted the Authority for scientific and technical assistance.

Since  many  smoke  flavourings  are  already  on  the  market  in  the  Member  States,
provision should be made  to  ensure that  the  transition to a Community  authorisation
procedure  is  smooth  and  does  not  disturb  the  existing  smoke  flavourings  market.
Sufficient time should be allowed for the applicant to make available to the Authority
the  information  necessary  for  the  safety  assessment  of  these  products.  Therefore,  a
certain time period, hereinafter referred to as the ‘first phase’, should be fixed during
which  the  information  for  existing  primary  products  should  be  submitted  by  the
applicant  to  the  Authority.  Applications  for  authorisation  of  new  primary  products
may also be submitted  during the  first  phase. The Authority  should evaluate without
delay  all  applications  for  existing  as  well  as  new  primary  smoke  condensates  or
primary  tar fractionsproducts for which sufficient  information  has  been  submitted
during the first phase.

The  Community  positive  list  should  be  established  by  the  Commission  after  the
completion  of  the  safety  assessment  of  all  primary  products  for  which  sufficient
information  was  submitted  during  the  first  phase.  In  order  to  ensure  fair  and  equal
conditions for all applicants, this  initial  establishment of the list  should be done in a
single step. After the initial establishment of the list of authorised primary products, it
should  be  possible  for  additional  primary  smoke  condensates  and  primary  tar
fractionsproducts to be added thereto by decision of the Commission, following the
safety assessment by the Authority.

(16) Whenever the evaluation by the Authority indicates that an existing smoke flavouring
already on the market in the Member States constitutes a serious risk to human health,
this product should be removed from the market without delay.

6

OJ L 31, 1.2.2002, p. 1.

6

                                                
(17) Articles  53  and  54  of  Regulation  (EC)  No  178/2002  establish  procedures  for  taking
emergency measures in relation to food of Community origin or imported from a third
country. They allow the Commission to adopt such measures in situations where food
is 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)

(19)

(20)

(21)

It  is  appropriate  necessary  that  food  business  operators  using  primary  smoke
condensates  or  primary  tar  fractionsproducts  or  derived  smoke  flavourings  be
required to establish procedures in accordance with which it is possible, at all stages of
placing  a  primary  product  or  derived  smoke  flavouring  on  the  market,  to  verify
whether  it  is  authorised  by  this  Regulation  and  whether  the  conditions  of  use  are
respected.

In order to ensure equal access of existing and new primary products to the market, an
interim period should be established during which national measures continue to apply
in the Member States.

Provision  should  be  made  for  the  Annexes  to  this  Regulation  to  be  adapted  to
scientific and technical progress.

Since those Annexes, which are necessary for the implementation of this Regulation,
are  measures  of  general  scope  within  the  meaning  of  Article  2  of  Council  Decision
1999/468/EC  of  28  June  1999  laying  down  the  procedures  for  the  exercise  of
implementing  powers  conferred  on  the  Commission7,  amendments  thereto  should  be
adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

(22)

The  Commission  shall  be  assisted  by  the  Committee  referred  to  in  Article  58  (1)  of
Regulation (EC) No 178/2002.

HAVE ADOPTED THIS REGULATION:

Article 1
Subject matter

1.

This  Regulation  seeks  to  ensure  the  effective  functioning  of  the  internal  market  in
relation  to  smoke  flavourings  used  or  intended  for  use  in  or  on  foods,  whilst
providing the basis for securing a high level of protection for human health and the
interests of consumers.

2.

To this end, this Regulation lays down

– 

– 

a Community procedure for the evaluation and authorisation of primary smoke
condensates and primary tar fractions for use as such in or on foods or in the
production of derived smoke flavourings for use in or on foods;

a  Community  procedure  for  the  establishment  of  a  list  of  primary  smoke
condensates and primary tar fractions authorised to the exclusion of all others
in the Community and their conditions of use in or on foods.

7

O.J. L 184, 17.7.1999, p. 23.

7

                                                
Article 2
Scope

This Regulation shall apply to:

– 

– 

– 

– 

smoke flavourings used or intended for use in or on foods;

source materials for the production of smoke flavourings;

the reaction conditions under which smoke flavourings are prepared;

foods in or on which smoke flavourings are present.

Article 3
Definitions

For the purposes of this Regulation,  the  definitions  laid  down  in  Directive  88/388/EEC  and
Regulation (EC) No 178/2002 shall apply.

The following definitions shall also apply:

1.

“primary  smoke  condensates”  and  “primary  tar  fractions”  shall  refer  to  the
purified  water-based  part  of  condensed  smoke  and  shall  fall  within  the
definition of ‘smoke flavourings’.

2.            “primary tar fraction” shall refer to the purified fraction of the water insoluble
high density tar phase of condensed smoke and shall fall within the definition of
‘smoke flavourings’.primary smoke condensates and primary tar fractions used
or intended to be used as such in or on foods in order to impart smoke flavour
to those foods; it shall also refer to primary smoke condensates and primary tar
fractions used for the production of derived smoke flavourings used or intended
to be used in or on foods.

3.

4.

1.

“primary  products”  shall  refer  to  primary  smoke  condensates  and  primary  tar
fractions.

“derived  smoke  flavourings”  shall  refer  to  flavourings  produced  as  a  result  of  the
tar
further  processing  of  primary 
fractionsproducts and which are used or intended to be used in or on foods in order
to impart smoke flavour to those foods.

smoke  condensates  and  primary 

Article 4
General use and safety requirements

The  use  of  smoke  flavourings  in  or  on  foods  shall  only  be  authorised  if  it  is
sufficiently demonstrated that

– 

– 

it does not present risks to human health;

it does not mislead consumers.

8

Each authorisation may be subject to specific conditions of use.

2.

No person shall place on the market a smoke flavouring or any food in or on which
such a smoke flavouring is present if the smoke flavouring is not a primary product
authorised  in  accordance  with  Article  6,  or  if  is  not  derived  therefrom,  and  if  the
conditions of use laid down in the authorisation in accordance with this Regulation
are not adhered to.

Article 5
Conditions of production

1.            Only  those  types  of  untreated  wood  listed  in  Annex  I  may  be  used  for  the

production of primary smoke condensates and primary tar fractions.

1.

2.

3.

1.

2.

The  wood  referred  to  in  paragraph  1  used  for  the  production  of  primary
products shall not have been treated, whether intentionally or unintentionally, with
chemical  substances  during  the  six  months  immediately  preceding  felling  or
subsequent  thereto,  unless  it  can  be  demonstrated  that  the  substance  used  for  the
treatment does not give rise to potentially toxic substances during combustion.

The  person  who  places  on  the  market  primary  products  smoke  condensates  and
primary  tar  fractions  or  derived  smoke  flavourings  or  food  containing  smoke
flavourings  must  be  able 
to  demonstrate  by  appropriate  certification  or
documentation that the requirements laid down in the first paragraph have been met.

The conditions for the production of primary smoke condensates and primary tar
fractionsproducts are laid down in Annex III. The water insoluble oily phase which
is  a  by-product  of  the  process  shall  not  be  used  for  the  production  of  smoke
flavourings.

Without prejudice to other Community legislation, primary smoke condensates and
primary  tar  fractionsproducts  may  be  further  processed  by  appropriate  physical
processes for the production of derived smoke flavourings. Where opinions differ as
to whether a particular physical process is appropriate, a decision may be reached in
accordance with the procedure referred to in Article 1819 (2).

Article 6
Community list of authorised products

A  list  of  the  primary  smoke  condensates  and  primary  tar  fractionsproducts
authorised to the exclusion of all others in the Community for use as such in or on
foods and/or for the production of derived smoke flavourings shall be established in
accordance with the procedure referred to in Article 1819 (2).

In respect of each authorised product, the list referred to in paragraph 1 shall give a
unique code for that product, the name of the primary product, the name and address
of  the  authorisation  holder,  a  clear  description  and  characterisation  of  the  primary
product, the conditions of its use in or on specific foods or food categories and the
date from which the product is authorised.

9

3.

Following  the  establishment  of  the  list  referred  to  in  paragraph  1,  primary  smoke
condensates  or  primary  tar  fractionsproducts  may  be  added  to  that  list  in
accordance with the procedure referred to in Article 1819 (2).

Article 7
Application for authorisation

1.         To  obtain  the  authorisation  referred  to  in  Article  6(1),  an  application  shall  be

submitted in accordance with the following provisions.

2.         The  application  shall  be  sent  to  the  national  competent  authority  of  a  Member

State.

(a)        The national competent authority:

(i)      shall  acknowledge  receipt  of  the  application  in  writing  to  the  applicant
within 14 days of its receipt. The acknowledgement shall state the date of
receipt of the application;

(ii)     shall 

inform  without  delay  the  European  Food  Safety  Authority

(hereinafter referred to as the "Authority"); and

(iii)    shall  make  the  application  and  any  supplementary  information  supplied

by the applicant available to the Authority.

(b)        The  Authority  shall  inform  without  delay  the  other  Member  States  and  the

Commission  of  the  application  and  shall  make  the  application  and  any  supplementary

information supplied by the applicant available to them.

1.            To  obtain  the  authorisation  referred  to  in  Article  6  (1),  a  written  application
shall be submitted to the European Food Safety Authority, hereinafter referred
to as “the Authority”.

2.            The  Authority  shall  acknowledge  in  writing  receipt  of  the  application  to  the
applicant within fifteen working days of its receipt. The acknowledgement shall
state the date of receipt of the application.

3.

The application shall be accompanied by the following:

– 

– 

– 

the name and address of the applicant;

the information listed in Annex IIIII;

a  reasoned  statement  affirming  that  the  product  complies  with  Article  4  (1),
first indent;

– 

a summary of the dossier.

10

4.

1.

2.

The  Authority  shall  publish  detailed  guidance  concerning  the  preparation  and  the
submission of the application. Pending such publication, applicants shall consult the
“Guidance on submissions for food additive evaluations” drawn up by the “Scientific
Committee on Food” 8.

Article 8
Opinion of the Authority

The  Authority  shall  give  an  opinion  within  six  months  of  the  receipt  of  a  valid
application  as  to  whether  the  product  and  its  intended  use  complies  with  Article  4
(1).  The  Authority  may  extend  the  said  period.  In  such  a  case  it  shall  provide  an
explanation for the delay toinform the applicant, the Commission and the Member
States.

The  Authority  may,  where  appropriate,  request  the  applicant  to  supplement  the
particulars  accompanying  the  application  within  a  time  limit  specified  by  the
Authority which in no event shall exceed 6 12 months. Where the Authority requests
supplementary  information,  the  time  limit  laid  down  in  paragraph  1  shall  be
suspended  until  such  time  that  this  information  has  been  provided.  Likewise,  this
time limit shall be suspended for the time allowed to the applicant to prepare oral or
written explanations.

3.

In order to prepare its opinion, the Authority shall:

(a)

verify  that  the  particulars  and  documents  submitted  by  the  applicant  are  in
accordance with Article 7 (3) in which case the application shall be regarded as
valid;

(b)     make available to the Member States and to the Commission a summary
of  each  application,  and,  at  the  request  of  a  Member  State  or  of  the
Commission, transmit the full application dossier and any supplementary
information supplied by the applicant;

(b)

inform the applicant, the Commission and the Member States if an application
is not valid.

4.

In the event of an opinion in favour of authorising the evaluated product, the opinion
shall include

– 

– 

where appropriate, any conditions or restrictions which should be attached to
the  use  of  the  evaluated  primary  smoke  condensate  or  primary  tar
fractionproduct  either  as  such  and/or  as  derived  smoke  flavourings  in  or  on
specific foods or food categories;

an assessment as to whether the analytical method proposed in accordance with
point 3 of Annex IIIII is appropriate for the intended control purposes.

8

Until publication, applicants shall follow the “Guidance on submissions for food additive evaluations”
by 
latest  update:
http://europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf

the  Scientific  Committee  on  Food,  of  11 

July  2001  or 

its 

11

                                                
5.

6.

1.

2.

3.

4.

5.

6.

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

The  Authority  shall  make  its  opinion  public,  after  deletion  of  any  information
identified as confidential in accordance with Article 1415.

Article 9
Community authorisation

Within three months of receiving the opinion of the Authority, the Commission shall
prepare a draft of the measure to be taken in respect of the application for inclusion
of  a  substance  in  the  list  referred  to  in  Article  6  (1),  taking  into  account  the
requirements of Article 4 (1), Community law and other legitimate factors relevant to
the  matter  under  consideration.  Where  the  draft  measure  is  not  in  accordance  with
the  opinion  of  the  Authority,  the  Commission  shall  provide  an  explanation  for  the
reasons for the differences.

The measure referred to in paragraph 1 shall be

– 

a draft regulation amending the list referred to in Article 6 (1), by including the
primary  product  on  the  list  of  authorised  products,  in  accordance  with  the
requirements under Article 6 (2) or

– 

a draft decision, addressed to the applicant, refusing authorisation.

The  measure  shall  be  adopted  in  accordance  with  the  procedure  laid  down  in
Article 1819 (2). The Commission shall inform the applicant of its adoption without
delay.

Without  prejudice  to  Article  11,  the  authorisation  granted  in  accordance  with  the
procedure laid down in this Regulation shall be valid throughout the Community for
ten years and shall be renewable in accordance with Article 12.

After  an  authorisation  has  been  issued  in  accordance  with  this  Regulation,  the
authorisation holder or any other food business operator using the authorised primary
product or derived smoke flavourings shall comply with any condition or restriction
attached to such authorisation.

The  authorisation  holder  shall  inform  the  Commission  and  the  Authority
immediately  of  any  new  scientific  or  technical  information  which  might  affect  the
assessment  of  the  safety  of  the  authorised  primary  product  or  derived  smoke
flavourings in relation to human health. If necessary, the Authority shall then review
the assessment.

The  granting  of  an  authorisation  shall  not  diminish  the  general  civil  and  criminal
liability  of  any  food  business  operator  in  respect  to  the  authorised  primary  smoke
condensate,  primary  tar  fractionproduct,  derived  smoke  flavouring  or  food
containing the authorised primary product or derived smoke flavouring.

12

Article 10
Initial establishment of the Community list of authorised smoke flavourings

During  the  18  months  following  the  entry  into  force  of  this  Regulation,  business
operators  shall  submit  an  application  in  accordance  with  Article  7  in  view  of  the
establishment of  an initial Community list of  authorised  primary products.  Without
prejudice to Article 9 (1), this initial list shall be established after the Authority has
issued  an  opinion  on  each  primary  product  for  which  a  valid  application  has  been
submitted during this period.

Applications  for  which  the  Authority  could  not  issue  an  opinion  owing  to  the
applicant’s  failure  to  comply  with  the  time  limits  specified  for  submission  of
supplementary information in accordance with Article 8 (2)  shall  be excluded  from
consideration for inclusion in the initial Community list.

Within  three  months  of  receiving  all  the  opinions  referred  to  in  paragraph  1,  the
Commission  shall  prepare  a  draft  regulation  for  the  initial  establishment  of  the  list
referred to in Article 6 (1), having regard to the requirements of Article 6 (2).

The  list  referred  to  in  Article  6  (1)  shall  be  established  in  accordance  with  the
procedure referred to in Article 1819 (2).

Article 11
Modification, suspension and revocation of authorisations

The  authorisation  holder  may,  in  accordance  with  the  procedure  laid  down  in
Article 7, apply for a modification of the existing authorisation.

Where, oOn its own initiative or following a request from the authorisation holder,
a Member State or the Commission, the Authority has reviewed the assessment of a
primary product authorised in accordance with  this Regulation, it shall deliver
its  an  opinion  on  whether  an  authorisation  is  still  in  accordance  with  this
Regulation, following the procedure laid down in Article 8, where applicable.

The  Commission  shall  examine  the  opinion  of  the  Authority  without  delay  and
prepare a draft of the decision to be taken.

A  draft  decision  measure  modifying  an  authorisation  shall  specify  any  necessary
changes  in  the  conditions  of  use  and,  if  any,  in  the  restrictions  attaching  to  that
authorisation.

A The final decision measure, i.e.on the modification, suspension or revocation of
the  authorisation,  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in
Article 1819 (2).

The Commission shall without delay inform the authorisation holder of the decision
measure taken.

1.

2.

3.

1.

2.

3.

4.

5.

6.

13

Article 12
Renewal of authorisations

1.

Without  prejudice  to  Article  11,  aAuthorisations  under  this  Regulation  shall  be
renewable for ten-year periods on application to the Authority Commission by the
authorisation  holder,  at  the  latest  18  months  before  the  expiry  date  of  the
authorisation.

2.            The  Authority  shall  acknowledge  in  writing  receipt  of  the  application  for
renewal  to  the authorisation  holder  within  15 working days  of  its  receipt.  The
acknowledgement shall state the date of receipt of the application.

2.

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

3.

4.

1.

(a)

a reference to the original authorisation;

(b)

any  available  information  concerning  the  points  listed  in  Annex  IIIII  which
supplements the information already provided to the Authority in the course of
the  previous  evaluation(s)  and  updates  this  in  the  light  of  the  most  recent
scientific and technical developments;

(c)

a  reasoned  statement  affirming  that  the  product  complies  with  Article  4  (1),
first indent.

Articles 7 to 9 shall apply in a like mannermutatis mutandis.

Where,  for  reasons  beyond  the  control  of  the  authorisation  holder,  no  decision  is
taken on the renewal of an authorisation until one month before its expiry date, the
period  of  authorisation  of  the  product  shall  automatically  be  extended  by  6
monthsuntil  the  Commission  takes  a  decision.  The  Commission  shall  inform  the
authorisation holder and the Member States about the delay.

Article 13
Traceability

At  the  first  stage  of  the  placing  on  the  market  of  an  authorised  primary  smoke
condensate or primary tar fractionproduct or smoke flavouring derived from the
authorised  products  specified  in  the  list  referred  to  in  Article  6  (1),  food  business
operators  shall  ensure  that  the  following  information  is  transmitted  to  the  food
business operator receiving the product:

(a)

(b)

(c)

the  code  of  the  authorised  product  as  given  in  the  list  referred  to  in
Article 6 (1);

the conditions of use of the authorised product as set out in the list referred to
in Article 6 (1);

in  the  case  of  a  derived  smoke  flavouring,  the  quantitative  relation  to  the
primary  product;  this  shall  be  expressed  in  clear  and  easily  understandable
terms  so  that the  receiving  food business operator can  use  the  derived  smoke
flavouring in compliance with the conditions of use set out in the list referred
to in Article 6 (1).

14

2.

3.

4.

At  all  subsequent  stages  of  the  placing  on  the  market  of  products  referred  to  in
paragraph  1,  food  business  operators  shall  ensure  that  the  information  received  in
accordance with paragraph 1 is transmitted to the food business operators receiving
the products.

Food business operators shall have in place systems and procedures in accordance to
which  it  is  possible  to  identify  the  person  from  whom  and  to  whom  the  products
mentioned in paragraph 1 have been made available.

Paragraphs  1  to  3  are  without  prejudice  to  other  specific  requirements  under
Community legislation.

Article 14
Public access

1.            The  application  for  authorisation,  supplementary 

information  from  the
applicant and opinions from the Authority, excluding confidential information,
shall be made accessible to the public in accordance with Article 38, 39 and 41
in Regulation (EC) No 178/2002.

2.            The Authority shall apply the principles of 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  documents  when
handling applications for access to documents held by the Authority.

3.            Member States shall handle applications for access to documents received under

this regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

Article 15
Confidentiality

1.

2.

3.

The applicant  may indicate which information  submitted under  Article  7  should  be
treated  as  confidential  because  disclosure  may  significantly  harm  his  competitive
position. Verifiable justification must be given in such cases.

Without prejudice to paragraph 3, the Authority Commission shall determine, after
consultation  with  the  applicant,  which  information  should  be  kept  confidential  and
shall inform the applicant and the Authority of its decision.

Without  prejudice  to  Article  39  (3)  of  Regulation  (EC)  No  178/2002,  information
relating to the following shall not be considered confidential:

(a)

the name and address of the applicant and the name of the product;

(b)

in  the  case  of  an  opinion  in  favour  of  authorising  the  evaluated  product,  the
particulars mentioned in Article 6 (2);

(c)

information of direct relevance to the assessment of the safety of the product;

(d)     the analytical method referred to in Annex II (4).

15

4.

5.

6.

Notwithstanding paragraph 2, the Authority shall on request supply the Commission
and the Member States with all information in its possession.

The  Commission,  the  Authority  and  the  Member  States  shall  take  the  necessary
measures  to  ensure  appropriate  confidentiality  of  the  information  received  by
them under the present Regulation except for information which must be made
public if circumstances so requirekeep confidential all the information identified
as  confidential  under  paragraph  2,  except  in  cases  where  certain  information
must be made public in order to protect human health.

If  an  applicant  withdraws  or  has  withdrawn  an  application,  the  Authority,  the
Commission  and  the  Member  States  shall  respect  the  confidentiality  of  the
commercial and industrial information provided, including research and development
information  as  well  as  information  on  which  the  Authority  Commission  and  the
applicant disagree as to its confidentiality.

Article 16
Data protection

The information in the application submitted according to Article 7 may not be used for the
benefit  of  another  applicant,  unless  the  other  applicant  has  agreed  with  the  authorisation
holder that such information may be used.

Article 17
Inspection and control measures

1.

2.

3.

Member  States  shall  ensure  that  inspections  and  other  control  measures,  as
appropriate, are carried out to ensure compliance with this Regulation.

Where necessary and on the request of the Commission, the Authority shall assist in
developing  technical  guidance  on  sampling  and  testing  to  facilitate  a  co-ordinated
approach for the implementation of paragraph 1.

If  necessary,  the  Commission  shall,  after  having  requested  scientific  and  technical
assistance from the Authority, adopt quality criteria for validated analytical methods
proposed  in  accordance  with  point  4  of  Annex  IIIII,  including  substances  to  be
measured, in accordance with the procedure referred to in Article 1819 (2).

Article 18
Amendments

Amendments to the Annexes to this Regulation and to the list referred to in Article 6 (1) shall
be  adopted  in  accordance  with  the  procedure  referred  to  in  Article  1819  (2),  after  having
consulted the Authority for scientific and/or technical assistance.

Article 19
Implementing powers of the Commission

1.

The Commission shall be assisted by the Committee referred to in Article 58 (1) of
Regulation (EC) No 178/2002.

16

2.

3.

Where  reference  is  made  to  this  paragraph,  the  regulatory  procedure  laid  down  in
Article  5  of  Decision  1999/468/EC  shall  apply,  in  compliance  with  Article  7  and
Article 8 thereof.

The  period  provided  for  in  Article  5  (6)  of  Decision  1999/468/EC  shall  be  three
months.

Article 20
Transitional measures

Without  prejudice  to  Article  4  (2),  trade  in  and  use  of  the  following  primary  products  and
derived smoke flavourings, as well as foods containing any of those products, already on the
market on the date of entry into force of this Regulation, shall be permitted for the following
periods:

(a)

(b)

(c)

primary  products  for  which  a  valid  application  is  submitted  in  accordance  with
Article 7 and Article 8 (3) before [18 months after the date of entry into force of this
Regulation]  and  derived  smoke  flavourings:  until  the  establishment  of  the  list
referred to in Article 10 (1);

foods  containing  primary  products  for  which  a  valid  application  is  submitted  in
accordance with Article 7 and Article 8 (3) before [18 months after the date of entry
into force of this Regulation] and/or containing derived smoke flavourings: until 12
months after the establishment of the list referred to in Article 10 (1);

foods containing primary products for which a valid application is not submitted in
accordance with Article 7 and Article 8 (3) before [18 months from the date of entry
into  force  of  this  Regulation]  and/or  derived  smoke  flavourings:  until  [30  months
after the date of entry into force of this Regulation];

Products and fFoods that have been lawfully put placed on the market before the end of the
periods referred to in (ba) to and (c) may be marketed until stocks are exhausted.

Article 21
Entry into force

This Regulation shall enter into force on the 20th day following that of its publication in the
Official Journal of the European CommunitiesUnion.

Article 4 (2) shall apply from [18 months from the date of entry into force of this Regulation].
Until this date, national provisions in force concerning smoke flavourings and their use in and
on foods continue to apply in the Member States.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

17

Done at Brussels,

For the European Parliament
The President

For the Council
The President

18

ANNEX I

List of untreated wood which may be used for the production of primary smoke
condensates or primary tar fractions

Latin name

Common name

Acer negundo L.

Betula pendula Roth. (with ssp. B. alba L.
and B. verrucosa Ehrh.)

Maple tree

White birch

Betula pubescens Ehrh.

European birch

Carpinus betulus L.

Carya ovata (Mill.) Koch

Castanea sativa Mill.

Eucalyptus sp.

Fagus grandifolia Ehrh.

Fagus silvatica L.

Fraxinus excelsior L.

Juglans regia L.

Malus pumila Mill.

Hornbeam

Hickory

Chestnut tree

Eucalyptus

Beech

Beech

Common ash

Walnut tree

Apple

Prosopis juliflora DC.

Mesquite wood

Prunus avium L.

Quercus alba L.

Quercus ilex L.

Quercus robur L.

Rhamnus frangula L.

Robinia pseudoacacia

Ulmus fulva Michx.

Cherry tree

White oak

Holm oak

Common red oak

Alder Buckthorn

Black locust

Sweet elm

Ulmus rubra Mühlenb.

Elm

19

ANNEX II

Conditions for the production of primary smoke condensates and primary tar
fractionsproducts

1.

2.

Smoke is generated from wood species listed in Annex Ias referred to in Article 5
(1).  Herbs,  spices,  twigs  of  juniper  and  twigs,  needles  and  cones  of  picea  may  be
added if they are free of residues of intentional or unintentional chemical treatment
or if they comply with more specific Community legislation. The source material is
subjected to controlled burning, dry distillation or treatment with superheated steam
in a controlled oxygen environment with a maximum temperature of 600°C.

The  smoke  is  condensed.  Water  and/or,  without  prejudice  to  other  Community
legislation,  solvents  may  be  added  to  achieve  phase  separation.  Physical  processes
may  be  used  for  isolation,  fractionation  and/or  purification  to  obtain  the  following
phases:

(a)

a  water-based  “primary  smoke  condensate”  mainly  containing  carboxylic
acids, carbonylic and phenolic compounds, having a maximum content of

benzo[a]pyrene3,4 benzopyrene

10 µg / kg

1,2 benz[a]anthracene 20 µg / kg

(b)

a water insoluble high density tar phase which during the phase separation will
precipitate,  and  which  cannot  be  used  as  such  for  the  production  of  smoke
flavourings  but  only  after  appropriate  physical  processing  to  obtain  fractions
from  this  water  insoluble  tar  phase  which  are  low  in  polycyclic  aromatic
hydrocarbons,  already  defined  as  “primary  tar  fractions”,  having  a  maximum
content of

3,4 benzopyrenebenzo[a]pyrene

10 µg / kg

1,2 benz[a]anthracene 20 µg / kg

(c)

a “water insoluble oily phase”.

If  no  phase  separation  has  occurred  during  or  after  the  condensation,  the  smoke
condensate  obtained  must  be  regarded  as  a  water  insoluble  high  density  tar  phase,
and  must  be  processed  by  appropriate  physical  processing  to  obtain  primary  tar
fractions which stay within the specified limits.

20

ANNEX III

Information necessary for the scientific evaluation of primary smoke condensates and
primary tar fractionsproducts

The  information  should  be  compiled  in  accordance  with  the  guidelines  referred  to  in
Article 7 (4) and should be submitted as described therein. Without prejudice to Article 8 (2),
the following information should be included in the application for authorisation referred to in
Article 7:

1.

The type of wood used for the production of the primary product.

2.            Detailed information on the production methods of the primary smoke condensates
or  primary  tar  fractionsproducts  and  the  further  processing  in  the  production  of
derived smoke flavourings.

3.

4.

5.

6.

The qualitative and quantitative chemical composition of the primary product and the
characterisation  of  the  portion  which  has  not  been  identified.  Of  major  importance
are  the  chemical  specifications  of  the  primary  product  and  information  on  the
stability  and  the  degree  of  variability  of  the  chemical  composition.  The  portions
which  have  not  been  identified,  i.e.  the  amount  of  substances  whose  chemical
structure is not known, should be as small as possible and should be characterised by
appropriate  validated 
chromatographic  orphic
spectraometric methods.

analytical  methods, 

e.g. 

A vValidated analytical  method(s) for sampling,  identification and characterisation
of the primary product and of derived smoke flavourings.

Information on the intended use levels in or on specific food or food categories.

Toxicological data following the advice of the Scientific Committee on Food given
in its report on smoke flavourings of 25 June 1993 or its latest update.

21