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 foods
Date: 2003-11-10
Institutions: Council of the European Union, European Parliament
Subjects: consumer protection, flavouring, food standard, foodstuff, smoked product

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(Acts whose publication is obligatory)

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 foods

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1)

(2)

Council Directive 88/388/EEC of 22 June 1988 on the
approximation of the laws of the Member States relating
to flavourings for use in foodstuffs and to source mate-
rials for their production (4), 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 reac-
tion 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.

(3)

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

(1) OJ C 262 E, 29.10.2002, p. 523.
(2) OJ C 85, 8.4.2003, p. 32.
(3) Opinion of

the European Parliament of 5 June 2003 (not yet
published in the Official Journal) and the Council Decision of 9
October 2003.

(4) OJ L 184, 15.7.1988, p. 61; Directive as amended by Commission

Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).

(4)

(5)

(6)

(7)

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

laws,

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

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 concerns, especially with
respect to the possible presence of polycyclic aromatic
hydrocarbons. Because smoke flavourings are produced
from smoke which is subjected to fractionation and puri-
fication processes, the use of smoke flavourings is gener-
ally 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.

This Regulation covers smoke flavourings as defined in
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 frac-
tions of the water-insoluble high-density tar phase, the
‘primary tar fractions’, are purified to remove compo-
nents 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 flavour-
ings 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.

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(8)

(9)

(10)

(11)

(12)

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 conden-
sates. Following this advice,
this Regulation should
provide for the scientific evaluation of primary smoke
condensates
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.

and primary tar

this Regulation
As regards conditions of production,
reflects the findings set out by the Scientific Committee
on Food in its report on smoke flavourings of 25 June
1993 (1), in which it specified various production condi-
tions 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 (2). 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.

Provision should be made for the establishment, on the
basis of
the safety assessment, of a list of primary
products 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
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 proce-
dures in matters of food safety (3).

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 Commu-
nity 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.

mation necessary for the safety assessment. The appli-
cant should also propose a validated method of sampling
and detection for the primary products to be used for
control of compliance with the provisions of this Regu-
lation. If necessary, the Commission should adopt quality
after having
criteria
consulted the Authority for scientific and technical assis-
tance.

analytical methods

those

for

(14)

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
to make available to the
allowed for the applicant
the safety
Authority the information necessary for
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 products
for which sufficient
information has been submitted
during the first phase.

(15)

the completion of

The Community positive list should be established by
the Commission after
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 appli-
cants, 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 products to be added thereto by deci-
sion 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.

(13)

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 infor-

(1) Reports of the Scientific Committee for Food, 34th series, pp. 1 to

7.

(2) Council of Europe Publishing, 1992, reprinted 1998, ISBN 92-871-

2189-3.

(3) OJ L 31, 1.2.2002, p. 1.

(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
taken by the
contained satisfactorily by measures
Member State(s) concerned.

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(18)

(19)

(20)

(21)

is necessary that

food business operators using
It
primary products 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 Regu-
lation to be adapted to scientific and technical progress.

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 Commission (1),

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter

1.
The purpose of this Regulation is to ensure the effective
functioning of the internal market in relation to smoke flavour-
ings 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) a Community procedure for the evaluation and authorisa-
tion of primary smoke condensates and primary tar frac-
tions for use as such in or on foods or in the production of
derived smoke flavourings for use in or on foods;

(b) 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.

Article 2

Scope

This Regulation shall apply to:

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

2. source materials for the production of smoke flavourings;

(1) OJ L 184, 17.7.1999, p. 23.

3. the conditions under which smoke flavourings are prepared;

4. 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.

2.

3.

4.

‘primary smoke condensate’ shall refer to the purified water-
based part of condensed smoke and shall fall within the defi-
nition of ‘smoke flavourings’;

‘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 flavour-
ings’;

‘primary products’ shall refer to primary smoke condensates
and primary tar fractions;

flavourings’

‘derived smoke
to flavourings
produced as a result of the further processing of primary
products and which are used or intended to be used in or
on foods in order to impart smoke flavour to those foods.

shall

refer

Article 4

General use and safety requirements

The use of smoke flavourings in or on foods shall only be

1.
authorised if it is sufficiently demonstrated that

— it does not present risks to human health,

— it does not mislead consumers.

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 accor-
dance with this Regulation are not adhered to.

Article 5

Conditions of production

The wood used for the production of primary products
1.
shall not have been treated, whether intentionally or uninten-
tionally, with chemical substances during the six months imme-
diately 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 must
be able to demonstrate by appropriate certification or docu-
mentation that the requirements laid down in the first subpara-
graph have been met.

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The conditions for the production of primary products
2.
are laid down in Annex I. The water-insoluble oily phase which
is a by-product of the process shall not be used for the produc-
tion of smoke flavourings.

to other Community legislation,
3. Without prejudice
primary products may be further processed by appropriate
physical processes for the production of derived smoke flavour-
ings. Where opinions differ as to whether a particular physical
process is appropriate, a decision may be reached in accor-
dance with the procedure referred to in Article 19(2).

Article 6

Community list of authorised primary products

1.
A list of the primary products 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 19(2).

2.
In respect of each authorised primary product, the list
referred to in paragraph 1 shall give a unique code for that
product, the name of the product, the name and address of the
authorisation holder, a clear description and characterisation of
the product, the conditions of its use in or on specific foods or
food categories and the date from which the product
is
authorised.

3.
Following the establishment of the list referred to in para-
graph 1, primary products may be added to that list in accor-
dance with the procedure referred to in Article 19(2).

Article 7

Application for authorisation

1.
To obtain the inclusion of a primary product in the list
referred to in Article 6(1), an application shall be submitted in
accordance with the following provisions.

2.

(a) The application shall be sent to the competent authority

of a Member State.

(b) The competent authority:

(c) a reasoned statement affirming that the product complies

with Article 4(1), first indent;

(d) a summary of the dossier.

The Authority shall publish detailed guidance concerning

4.
the preparation and the submission of the application (1).

Article 8

Opinion of the Authority

1.
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 expla-
nation for the delay to the applicant, the Commission and the
Member States.

The Authority may, where appropriate, request the appli-
2.
cant to supplement the particulars accompanying the applica-
tion within a time limit specified by the Authority which in no
event shall exceed 12 months. Where the Authority requests
supplementary information, the time limit laid down in para-
graph 1 shall be suspended until such time that this informa-
tion 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) inform the applicant, the Commission and the Member

States if an application is not valid.

In the event of an opinion in favour of authorising the

4.
evaluated product, the opinion shall include:

(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;

(a) any conditions or restrictions which should be attached to
the use of the evaluated primary product either as such
and/or as derived smoke flavourings in or on specific foods
or food categories;

(ii) shall

inform without delay the European Food
referred to as the

Safety Authority (hereinafter
‘Authority’); and

(iii) shall make the application and any supplementary
information supplied by the applicant available to
the Authority.

(c) 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.

3.

The application shall be accompanied by the following:

(a) the name and address of the applicant;

(b) the information listed in Annex II;

(b) an assessment as

the analytical method
proposed in accordance with point 4 of Annex II is appro-
priate for the intended control purposes.

to whether

The Authority shall forward its opinion to the Commis-

5.
sion, the Member States and the applicant.

6.
The Authority shall make its opinion public, after deletion
of any information identified as confidential in accordance with
Article 15.

(1) Until publication, applicants shall follow the ‘Guidance on submis-
sions for food additive evaluations’ by the Scientific Committee on
Food, of 11 July 2001 or its latest update: http://europa.eu.int/
comm/food/fs/sc/scf/out98_en.pdf

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Article 9

Community authorisation

1. 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
primary product in the list referred to in Article 6(1), taking
into account the requirements of Article 4(1), Community law
to the matter under
and other legitimate factors relevant
consideration. Where the draft measure is not in accordance
with the opinion of
the Commission shall
the Authority,
provide an explanation for the reasons for the differences.

The measure referred to in the first subparagraph shall be

(a) 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

(b) a draft decision, addressed to the applicant, refusing author-

isation.

2.
The measure shall be adopted in accordance with the
procedure referred to in Article 19(2). The Commission shall
inform the applicant of its adoption without delay.

3. 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 10 years and shall
be renewable in accordance with Article 12.

4.
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
5.
information
immediately of any new scientific or technical
which might affect
the
the assessment of
authorised primary product or derived smoke flavourings in
relation to human health. If necessary, the Authority shall then
review the assessment.

the safety of

The granting of an authorisation shall not diminish the
6.
general civil and criminal liability of any food business operator
in respect of the authorised primary product, derived smoke
flavouring or food containing the authorised primary product
or derived smoke flavouring.

Article 10

Initial establishment of the Community list of authorised
primary products

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

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

Article 11

Modification, suspension and revocation of authorisations

The authorisation holder may,

1.
in accordance with the
procedure laid down in Article 7, apply for a modification of
the existing authorisation.

On its own initiative or following a request

2.
from a
Member State or the Commission, the Authority shall deliver
an opinion on whether an authorisation is still in accordance
with this Regulation, following the procedure laid down in
Article 8, where applicable.

the
The Commission shall examine the opinion of
3.
Authority without delay and prepare a draft of the decision to
be taken.

4.
A draft measure modifying an authorisation shall specify
any necessary changes in the conditions of use and, if any, in
the restrictions attaching to that authorisation.

The final measure,

5.
i.e. the modification, suspension or
revocation of the authorisation, shall be adopted in accordance
with the procedure referred to in Article 19(2).

The Commission shall without delay inform the authori-

6.
sation holder of the measure taken.

Article 12

Renewal of authorisations

1. Without prejudice to Article 11, authorisations under this
Regulation shall be renewable for 10-year periods on applica-
tion to the Commission by the authorisation holder, at the
latest 18 months before the expiry date of the authorisation.

The application shall be accompanied by the following

2.
particulars and documents:

(a) a reference to the original authorisation;

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

(b) any available information concerning the points listed in
the information already
Annex II which supplements
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.

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3.

Articles 7 to 9 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the authorisa-
tion holder, no decision is taken on the renewal of an authori-
sation until one month before its expiry date, the period of
authorisation of the product shall automatically be extended by
six months. 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
1.
authorised primary product or smoke flavouring derived from
the authorised products specified in the list referred to in
Article 6(1),
the
following information is transmitted to the food business
operator receiving the product:

food business operators shall ensure that

(a) the code of the authorised product as given in the list

referred to in Article 6(1);

(b) the conditions of use of the authorised product as set out

in the list referred to in Article 6(1);

(c) 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
the derived smoke
flavouring in compliance with the conditions of use set out
in the list referred to in Article 6(1).

can use

2.
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.

3.
Food business operators shall have in place systems and
procedures making it possible to identify the person from
whom and to whom the products mentioned in paragraph 1
have been made available.

Paragraphs 1 to 3 shall be without prejudice to other

4.
specific requirements under Community legislation.

Article 14

Public access

Applications for authorisation, supplementary informa-
1.
tion from applicants and opinions
from the Authority,
excluding confidential information, shall be made accessible to
the public in accordance with Articles 38, 39 and 41 of Regu-
lation (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 (1) when hand-
ling applications
to documents held by the
Authority.

for access

(1) OJ L 145, 31.5.2001, p. 43.

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

2. Without prejudice to paragraph 3, the Commission shall
determine, after consultation with the applicant, which infor-
mation should be kept confidential and shall inform the appli-
cant and the Authority of its decision.

3. 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 evalu-
ated 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 point 4 of Annex II.

Notwithstanding paragraph 2,

4.
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
5.
shall take the necessary measures to ensure appropriate confi-
dentiality of the information received by them under this Regu-
lation except for information which must be made public if
circumstances so require in order to protect human health.

6.
If an applicant withdraws or has withdrawn an applica-
tion, the Authority, the Commission and the Member States
shall respect the confidentiality of the commercial and indus-
trial information provided, including research and development
information as well as information on which the 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.

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Article 17

Inspection and control measures

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

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

3.
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 II, including substances to
be measured, in accordance with the procedure referred to in
Article 19(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 19(2), following consulta-
tion of the Authority for scientific and/or technical assistance.

Article 19

Committee procedure

The Commission shall be assisted by the Committee

1.
referred to in Article 58(1) of Regulation (EC) No 178/2002.

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

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

3.

The Committee shall adopt its Rules of Procedure.

Article 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) primary products for which a valid application is submitted
in accordance with Article 7 and Article 8(3) before 16
June 2005 and derived smoke flavourings: until the estab-
lishment of the list referred to in Article 10(1);

(b) foods containing primary products for which a valid appli-
cation is submitted in accordance with Article 7 and Article
8(3) before 16 June 2005 and/or containing derived smoke
flavourings: until 12 months after the establishment of the
list referred to in Article 10(1);

(c) foods containing primary products for which a valid appli-
cation is not submitted in accordance with Article 7 and
Article 8(3) before 16 June 2005 and/or derived smoke
flavourings: until 16 June 2006.

Foods that have been lawfully placed on the market before the
end of the periods referred to in (b) 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 Union.

Article 4(2) shall apply from 16 June 2005. 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.

Done at Brussels, 10 November 2003.

For the European Parliament

The President

P. COX

For the Council

The President

A. MARZANO

L 309/8

EN

Official Journal of the European Union

26.11.2003

ANNEX I

Conditions for the production of primary products

1. Smoke is generated from the wood 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 distilla-
tion or treatment with superheated steam in a controlled oxygen environment with a maximum temperature of
600 °C.

2. 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]pyrene

benz[a]anthracene

10 µg/kg
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:

benzo[a]pyrene

benz[a]anthracene

10 µg/kg
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.

ANNEX II

Information necessary for the scientific evaluation of primary products

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 products and the further processing in the produc-

tion of derived smoke flavourings;

3. 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 infor-
mation 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 analytical methods, e.g. chromatographic or spectrometric methods;

4. a validated analytical method for sampling, identification and characterisation of the primary product;

5.

information on the intended use levels in or on specific foods or food categories;

6. 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.