Opinion of the European Economic and Social Committee on the "Proposal for a European Parliament and Council Regulation on smoke flavourings used or intended for use in or on foods" (COM(2002) 400 final — 2002/0163 (COD))
Date: 2002-12-11
Institutions: European Economic and Social Committee
Subjects: consumer protection, flavouring, food additive, foodstuff, foodstuffs legislation, health policy, smoked product

C 85/32

EN

Official Journal of the European Union

8.4.2003

Opinion of the European Economic and Social Committee on the ‘Proposal for a European
Parliament and Council Regulation on smoke flavourings used or intended for use in or on foods’

(COM(2002) 400 final — 2002/0163 (COD))

(2003/C 85/08)

On 24 July 2002 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 29 October 2002. The rapporteur
was Mrs Davison.

At its 395th plenary session on 11 and 12 December 2002 (meeting of 11 December 2002), the
European Economic and Social Committee adopted the following opinion by 95 votes in favour, 1 against
and 6 abstentions.

1. Gist of the Commission proposal

1.1.
On 15 July 2002, the European Commission adopted
a proposal laying down new procedures for the safety assess-
ment and authorisation of ‘smoke flavourings’. Smoke flavour-
ings are often used instead of fresh smoke to impart a smoky
flavour to foods such as meat, fish or snacks.

1.2.
The chemical composition of smoke is complex,
depending among other things on the species of woods used,
the method used for developing smoke, etc. Smoked foods in
general give rise to health concerns.

1.3.
Smoke flavourings are produced by condensing fresh
smoke in water. The condensed smoke is then fractionated
and purified during the production of smoke flavourings.
Because of this purification process, the use of smoke flavour-
ings is generally considered to be of less health concern than
the traditional smoking process.

1.4.
The Commission proposes to establish a procedure for
the safety assessment and authorisation of smoke condensates
(the existing multitude of smoke flavourings are based on
only a limited number of commercially available smoke
condensates). Smoke flavourings for the Community market
are produced by few companies inside and outside the EU.
Each of these companies has a very limited number of primary
products. It is estimated that no more than 20 products need
to be evaluated.

The Commission will make a decision on each appli-
1.6.
cation based on the outcome of the evaluation. The Com-
mission proposes to restrict the authorisations to a period of
ten years after which the authorisations will need to be
reviewed.

2. General comments

2.1.
The Committee welcomes the Commission proposal
which will ensure that a uniform and harmonised procedure
for authorisation of smoke flavourings is in place in the EU.
Currently, the situation is very diverse among Member States,
from no legislation, to very strict requirements. Consumers,
industry, and all parties involved will benefit from a transparent
procedure, based on a high level of protection of public health
and the protection of consumers’ interests.

2.2.
The Committee supports the procedure that is pro-
posed, and in particular the designation of the EFSA as the
central body for the assessment of smoke flavourings.

3. Specific comments

3.1.
The Committee welcomes the establishment of a
positive list of authorised products. The list will contain
information such as 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. The Committee notes that this list, and any
further updated version, will be made available to the public.

1.5.
For an application for authorisation of a smoke
condensate, the producer will need to provide detailed infor-
mation on the production method as well as on the further
steps in the production of derived smoke flavourings, the
intended toxicological studies and validated methods for
sampling and detection. The evaluation will be carried out by
the European Food Safety Authority (EFSA).

3.2.
Applications for authorisation shall be accompanied
by, inter alia, information necessary for the scientific evaluation
of primary smoke condensates and primary tar fractions. It is
the responsibility of the person who places the product on the
market to provide such information. The requested infor-
mation includes toxicological studies on the primary product.

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Official Journal of the European Union

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3.3.
The Committee is concerned that the existence of
various analytical methods, and variations in the quality of
these methods in detecting potential problems may undermine
the stated objectives of the proposal of ensuring a harmonis-
ation of the situation at EU level, and ensuring a high level of
public health and consumer protection.
therefore
important to adopt strict criteria on sampling and testing and
validate methods that will ensure the comparability and
high quality of the results provided by the applicants. Such
possibility is only considered in the Commission’s proposal
(Art. 16.2 and 16.3). The Committee believes that only
applications for products assessed by using these methods
should be valid.

is

It

3.4.
An authorisation may be modified, suspended or
revoked. This can be done at the initiative of the authorisation
holder, the EFSA or a Member State. The Committee welcomes
this provision and underlines its importance. Once a product
is on the market,
it is important to allow for some post-
marketing assessment. If it appears that the use of a product is
associated with adverse effects on humans or on the environ-
ment for example, and that the reasons for concern are serious
and well documented, there must be a possibility to restrict or
ban its use after the authorisation has been granted.

Brussels, 11 December 2002.

3.5.
The Committee considered the opportunity to rec-
ommend that all interested parties should have the possibility
to ask the Authority for a review of authorisations. The
Committee recognises that this may add to the workload of
the Authority, which would have to consider any request
lodged by the public. Such amendment to the Commission’s
proposal may not be advisable, nevertheless, the Committee
calls on Member States, the Commission, the Authority and
authorisation holder to be open and transparent and consider
with due attention any well supported request for a review of
authorisations.

3.6.
Authorisations granted under the proposed regulation
shall be renewed every ten years. The Committee fully supports
this provision. The time limit set to the authorisations ensures
that a regular assessment and review of the products on the
market is made.

4. Conclusions

4.1. While welcoming and supporting the proposal, the
EESC invites the Commission to take into consideration its
recommendations for the adoption of strict criteria on sam-
pling and testing and validated analytical methods, so as to
ensure the objective of harmonisation of the situation at
European level.

The President

of the European Economic and Social Committee

Roger BRIESCH