Proposal for a European Parliament and Council Regulation on smoke flavourings used or intended for use in or on foods
Date: 2002-07-15
Institutions: European Commission
Subjects: consumer protection, flavouring, food additive, foodstuff, foodstuffs legislation, health policy, smoked product

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Proposal for a European Parliament and Council Regulation on smoke flavourings used or
intended for use in or on foods

(2002/C 262 E/38)

COM(2002) 400 final — 2002/0163(COD)

(Submitted by the Commission on 15 July 2002)

EXPLANATORY MEMORANDUM

Smoke flavourings fall within the scope of Council Directive 88/388/EEC on flavourings. Article 5 of this
Directive 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. As part of the
framework to improve Community legislation in the area of foods, the Commission announced in the
White Paper on Food Safety a proposal for a European Parliament and Council Regulation on smoke
flavourings used or intended for use in or on foods.

The current situation in the Member States concerning the authorisation of smoke flavourings is diverse.
Some Member States have a very strict authorisation procedure, others have none at all. Thus, there is a
need for harmonisation at Community level.

The objective of the present proposal is 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.

Smoke flavourings are produced from condensed smoke. The chemical composition of smoke is complex
depending among other things on the species 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. The condensed smoke is however fractionated and
purified during the production of smoke flavourings. Because of this purification process, the use of smoke
flavourings is generally considered to be of less health concern than the traditional smoking process.

A wide range of different smoke flavourings is produced from the purified primary smoke condensates.
The Scientific Committee on Food (SCF) concluded in its report of 25 June 1993 that the existing
multitude of smoke flavourings is based on only a limited number of commercially available smoke
condensates and that, therefore, the toxicological evaluation should focus on the limited number of
individual smoke condensates rather than on the multitude of derived smoke flavourings.

The present draft proposes to establish a safety assessment and authorisation procedure for primary smoke
condensates and primary tar fractions which can be used as such in and on foods and/or for the
production of derived smoke flavourings. The primary products for which no health concern is
revealed during evaluation and their conditions of use will be included in a positive list of products
authorised to the exclusion of all others in the Community.

Smoke flavourings for the Community market are produced by few companies inside and outside of the
EU. Each of these companies has a very limited number of primary products. It is estimated that not more
than 20 products need to be evaluated.

It is proposed to restrict the authorisations to a period of ten years after which the authorisations will need
to be renewed. This provision ensures that products are regularly re-evaluated according to the latest
scientific and technical knowledge and ensures also that authorised products which are no longer used will
disappear from the Community positive list.

For an application for authorisation of a primary product, detailed information on the production method
of this product as well as on the further steps in the production of derived smoke flavourings, the intended
uses in or on specific food or food categories, chemical specifications, toxicological studies and validated
methods for sampling and detection of the primary product and derived smoke flavourings have to be
provided by the applicant. The evaluation will be done by the European Food Safety Authority according

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to a defined time limited and transparent procedure. The Authority has to inform the Commission and the
Member States about the receipt of an application and has to provide a summary thereof or the whole
dossier. Confidentiality for sensitive data is provided if requested by the applicant, except for information
of direct relevance to the assessment of the safety of the product.

After the European Food Safety Authority has completed its scientific evaluation, the Commission will
propose a risk management decision to be adopted by the regulatory procedure laid down by Council
Decision 1999/468/EC.

the transition to a
Since many smoke flavourings are already on the market
Community positive list should be smooth and should not lead to unfair conditions for smoke flavouring
producers. Therefore, the proposal foresees an initial period of eighteen months during which applications
for existing and new products can be submitted to the European Food Safety Authority. The establishment
of the Community list will take place in a single step procedure after the European Food Safety Authority
has expressed opinions on all products for which applications have been submitted during the 18-month
period. This procedure will ensure that all companies are subject to the same conditions. After the initial
establishment new products may be added following evaluation by the European Food Safety Authority.

in the Community,

The Scientific Committee on Food in its report on smoke flavourings of 25 June 1993, provided a
non-exhaustive list of types of wood which may be used for the production of smoke flavourings. This
list is annexed to the present Regulation. Additional species of wood, not present in the list, may be
included after primary products produced from those species have received a favourable opinion from the
European Food Safety Authority.

This Proposal
intends to ensure a high level of protection of human health and the protection of
consumers' interests with respect to smoke flavourings intended for use in or on foods and to ensure
market unity while abiding by the principle of proportionality.

This Proposal has no financial implications for the budget of the European Community.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,

significantly to the health and well-being of citizens, and
to their social and economic interests.

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

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

Having regard to the proposal from the Commission,

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

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

Whereas:

(1) Council Directive 88/388/EEC of 22 June 1988 on the
approximation of the laws of the Member States relating
to flavourings for use in foods and to source materials for
their production (1), 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.

(2) The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes

(1) OJ L 184, 15.7.1988, p. 61.

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

assessment

undergo

through

a

(5) Differences between national laws, regulations and admin-
istrative provisions concerning the assessment and auth-
orisation of smoke flavourings may hinder their free
movement, creating conditions of unequal and unfair
competition. An
should
authorisation
therefore be established at Community level.

procedure

(6) 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 purifi-
cation processes, the use of smoke flavourings is generally
considered to be of less health concern than the tradi-
tional smoking process.

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(7) The present Regulation covers

primary

separated

processes

condensate,

by physical

smoke. The

smoke flavourings as
defined in Article 1(2)(e) of Directive 88/388/EEC. The
production of these smoke flavourings starts with the
is
condensation of
condensed smoke
a
normally
into
water-based
a water
smoke
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
The primary smoke condensates and fractions of
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
solvents, without
food additives or
food ingredients,
prejudice to more specific Community legislation.

(8) 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
toxicological evaluation should focus
and, accordingly,
on
condensates.
smoke
individual
of
safety
Following this advice, this Regulation provides for the
scientific evaluation of primary smoke condensates and
primary tar fractions 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.

the

(9) 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
1993 (1),
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’ (2).

(11) 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, estab-
lishing the European Food Safety Authority and laying
down procedures in matters of food safety (3).

the product

(12) The safety assessment of a specific primary product
should be followed by a risk management decision as to
entered on the
whether
that
Community list of authorised primary products;
decision should be adopted in accordance with the regu-
latory procedure so as
to ensure close cooperation
between the Commission and the Member States.

should be

should

flavourings

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

necessary,

all

of

if

the

the applicant

information necessary for

transition to a Community

(14) Since many smoke flavourings are already on the market
in the Member States, provision should be made to ensure
that
authorisation
procedure is smooth and does not disturb the existing
time should be
smoke flavourings market. Sufficient
to make available to the
allowed for
Authority 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 fractions for which sufficient
information has been submitted during the first phase.

the

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

should clearly describe

(1) Reports of the Scientific Committee for Food, Thirty-fourth series,

pp. 1-7.

(15) 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 fractions to
be added thereto by decision of
the Commission,
following the safety assessment by the Authority.

(2) Council of Europe Publishing, 1992,

reprinted 1998,

ISBN

92-871-2189-3.

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

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(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.

(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
the environment and where such risk cannot be
or
contained satisfactorily by measures
the
Member State(s) concerned.

taken by

(18) It

flavourings be

is appropriate that

food business operators using
primary smoke condensates or primary tar fractions or
required to establish
derived smoke
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.

(19) 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.

(20) Provision should be made for the Annexes to this Regu-
lation to be adapted to scientific and technical progress.

(21) Since

those Annexes, which are necessary for

the
this Regulation, are measures of
implementation 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 Commission (1), 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
(EC)

in Article 58(1)

of Regulation

referred
No 178/2002,

to

in the
fractions for use as such in or on foods or
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 auth-
orised 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:

— 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
to primary smoke condensates and primary tar
refer
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.

2.

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

HAVE ADOPTED THIS REGULATION:

3.

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

shall

flavourings’

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

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;

— a Community procedure for the evaluation and author-
isation of primary smoke condensates and primary tar

— it does not mislead consumers.

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

Each authorisation may be subject to specific conditions of use.

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No person shall place on the market a smoke flavouring
2.
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.

2.
The wood referred to in paragraph 1 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 smoke
condensates and primary tar
fractions or derived smoke
flavourings or food containing smoke flavourings must be
able to demonstrate by appropriate certification or documen-
tation that the requirements laid down in the first paragraph
have been met.

The conditions for the production of primary smoke
3.
condensates and primary tar
fractions are laid down in
Annex II. The water insoluble oily phase which is a by-product
of the process shall not be used for the production of smoke
flavourings.

to other Community legislation,
4. Without prejudice
primary smoke condensates and primary tar fractions 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 18(2).

Article 6

Community list of authorised products

1.
A list of the primary smoke condensates and primary tar
fractions 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 18(2).

In respect of each authorised product, the list referred to
2.
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.

Following the establishment of

3.
the list referred to in
paragraph 1, primary smoke condensates or primary tar

fractions may be added to that list in accordance with the
procedure referred to in Article 18(2).

Article 7

Application for authorisation

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 III;

— a reasoned statement affirming that the product complies

with Article 4(1), first indent;

— a summary of the dossier.

4.
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’ (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.
inform the
applicant, the Commission and the Member States.

In such a case it shall

request

to supplement

The Authority may, where appropriate,

2.
the
the particulars accompanying the
applicant
application within a time limit specified by the Authority
which in no event
shall exceed six 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
time allowed to the
suspended for
applicant to prepare oral or written explanations.

shall be

the

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;

(1) Until publication,

for

submissions
Committee on Food, of 11 July 2001 or
http://europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf

shall

follow the

‘Guidance on
evaluations’ by the Scientific
latest update:
its

applicants
food additive

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(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;

(c)

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

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

— an assessment as

the analytical method
proposed in accordance with point 3 of Annex III is appro-
priate for the intended control purposes.

to whether

The Authority

5.
shall
Commission, the Member States and the applicant.

forward its opinion to the

The Authority shall make its opinion public, after
in

6.
deletion of any information identified as confidential
accordance with Article 14.

Article 9

Community authorisation

the Commission shall prepare a draft of

1. Within three months of receiving the opinion of the
Authority,
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
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
Commission shall provide an explanation for the reasons for
the differences.

the Authority,

into account

the

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
4.
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

5.
inform the Commission
and the Authority immediately of any new scientific or
information which might affect the assessment of
technical
the authorised primary product or derived
the safety of
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
6.
liability of any food business
general civil and criminal
operator
smoke
condensate, primary tar fraction, derived smoke flavouring or
food containing the authorised primary product or derived
smoke flavouring.

authorised primary

in respect

to the

Article 10

Initial establishment of the Community list of authorised
smoke flavourings

1.
During the eighteen months following the entry into
force of this Regulation, business operators shall submit an
application in accordance with Article 7 in view of the estab-
lishment of an initial Community list of authorised primary
products. Without prejudice to Article 9(1),
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.

this initial

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

submission of

specified

limits

for

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 auth-
orised products, in accordance with the requirements under
Article 6(2) or

— a draft decision, addressed to the applicant, refusing auth-

orisation.

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

the initial establishment of

regulation for

receiving all

The list referred to in Article 6(1) shall be established in

3.
accordance with the procedure referred to in Article 18(2).

2.
The measure shall be adopted in accordance with the
procedure laid down in Article 18(2). The Commission shall
inform the applicant of its adoption without delay.

3. Without prejudice
the authorisation
granted in accordance with the procedure laid down in this

to Article 11,

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.

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2. Where, on 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 opinion following the procedure laid down in
Article 8, where applicable.

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

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

5.
A final decision on the modification, suspension or revo-
cation of the authorisation shall be adopted in accordance with
the procedure referred to in Article 18(2).

The Commission shall without delay inform the author-

6.
isation holder of the decision taken.

Article 12

Renewal of authorisations

1.
Authorisations under this Regulation shall be renewable
for ten-year periods on application to the Authority by the
authorisation holder, at the latest eighteen months before the
expiry date of the authorisation.

The Authority shall acknowledge in writing receipt of the
to the authorisation holder within
its receipt. The acknowledgement

2.
application for renewal
fifteen working days of
shall state the date of receipt of the application.

The application shall be accompanied by the following

3.
particulars and documents:

(a) a reference to the original authorisation;

(b) any available information concerning the points listed in
Annex III 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.

4.

Articles 7 to 9 shall apply in a like manner.

5. Where, for reasons beyond the control of the author-
isation holder, no decision is taken on the renewal of an auth-
orisation before its expiry date, the period of authorisation of
the
automatically be
the product
Commission takes a decision. The Commission shall
inform
the authorisation holder about the delay.

extended until

shall

Article 13

Traceability

1.
At the first stage of the placing on the market of an
authorised primary smoke condensate or primary tar fraction

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 trans-
mitted to the food business operator receiving the product:

(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 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

4.
requirements under Community legislation.

Article 14

Confidentiality

1.
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.

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

after

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
the particulars mentioned in Article

evaluated product,
6(2);

(c)

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

Notwithstanding paragraph 2,

4.
the Authority shall on
request supply the Commission and the Member States with
all information in its possession.

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Official Journal of the European Communities

29.10.2002

The Commission, the Authority and the Member States
5.
shall keep confidential all the information identified as confi-
dential under paragraph 2, except
in cases where certain
information must be made public in order to protect human
health.

If

6.
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 devel-
opment
information as well as information on which the
Authority and the applicant disagree as to its confidentiality.

Article 15

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 16

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 on 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.

If necessary, the Commission shall, after having requested
3.
scientific and technical assistance from the Authority, adopt
quality criteria for validated analytical methods proposed in
accordance with point 3 of Annex III,
including substances
to be measured, in accordance with the procedure referred to
in Article 18(2).

Article 17

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 18(2), after having
technical
for
consulted the Authority
assistance.

scientific

and/or

Article 18

Implementing powers of the Commission

2. 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

3.
1999/468/EC shall be three months.

Article 19

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 [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);

(b) 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);

(c)

for which a valid
foods containing primary products
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 foods that have been lawfully put on the market
before the end of the periods referred to in (a) to (c) may be
marketed until stocks are exhausted.

Article 20

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 Communities.

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.

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

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

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Official Journal of the European Communities

C 262 E/531

LIST OF UNTREATED WOOD WHICH MAY BE USED FOR THE PRODUCTION OF PRIMARY SMOKE
CONDENSATES OR PRIMARY TAR FRACTIONS

ANNEX I

Acer negundo L.

Betula pendula Roth.
verrucosa Ehrh.)

Betula pubescens Ehrh.

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.

Prosopis juliflora DC.

Prunus avium L.

Quercus alba L.

Quercus ilex L.

Quercus robur L.

Rhamnus frangula L.

Robinia pseudoacacia

Ulmus fulva Michx.

Ulmus rubra Mühlenb.

Latin name

Common name

(with ssp. B. alba L. and B.

White birch

Maple tree

European birch

Hornbeam

Hickory

Chestnut tree

Eucalyptus

Beech

Beech

Common ash

Walnut tree

Apple

Mesquite wood

Cherry tree

White oak

Holm oak

Common red oak

Alder Buckthorn

Black locust

Sweet elm

Elm

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ANNEX II

CONDITIONS FOR THE PRODUCTION OF PRIMARY SMOKE CONDENSATES AND PRIMARY TAR
FRACTIONS

1. Smoke is generated from wood species listed in Annex I. 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.

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

3,4 benzopyrene 10 µg/kg

1,2 benzanthracene 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 benzopyrene 10 µg/kg

1,2 benzanthracene 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 III

INFORMATION NECESSARY FOR THE SCIENTIFIC EVALUATION OF PRIMARY SMOKE CONDENSATES
AND PRIMARY TAR FRACTIONS

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. Detailed information on the production methods of the primary smoke condensates or primary tar fractions and the

further processing in the production of derived smoke flavourings.

2. 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 analytical methods, e.g. chromatographic spectra.

3. Validated analytical method(s) for identification and characterisation of the primary product and of derived smoke

flavourings.

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

5. 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.