02003R2065 — EN — 27.03.2021 — 003.001
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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 (OJ L 309 26.11.2003, p. 1) |
Amended by:
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page |
date |
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REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 |
L 188 |
14 |
18.7.2009 |
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REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 198 |
241 |
25.7.2019 |
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REGULATION (EU) 2019/1381 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 231 |
1 |
6.9.2019 |
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
Article 1
Subject matter
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.
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 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:
‘primary smoke condensate’ shall refer to the purified water-based part of condensed smoke and shall fall within the definition 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 flavourings’;
‘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 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.
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
Each authorisation may be subject to specific conditions of use.
Article 5
Conditions of production
The person who places on the market primary products must be able to demonstrate by appropriate certification or documentation that the requirements laid down in the first subparagraph have been met.
Article 6
Community list of authorised primary products
Article 7
Application for authorisation
The application shall be sent to the competent authority of a Member State.
The competent authority:
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;
shall inform without delay the European Food Safety Authority (hereinafter referred to as the ‘Authority’); and
shall make the application and any supplementary information supplied by the applicant available to the Authority.
The Authority shall:
inform without delay the Commission and the other Member States of the application and shall make the application and any supplementary information supplied by the applicant available to them; and
make public the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15.
The application shall be accompanied by the following:
the name and address of the applicant;
the information listed in Annex II;
a reasoned statement affirming that the product complies with Article 4(1), first indent;
a summary of the dossier.
Article 8
Opinion of the Authority
In order to prepare its opinion, the Authority shall:
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;
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 evaluated product, the opinion shall include:
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;
an assessment as to whether the analytical method proposed in accordance with point 4 of Annex II is appropriate for the intended control purposes.
Article 9
Community authorisation
The measure referred to in the first subparagraph 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.
Article 10
Initial establishment of the Community list of authorised primary products
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.
Article 11
Modification, suspension and revocation of authorisations
Article 12
Renewal of authorisations
The application shall be accompanied by the following particulars and documents:
a reference to the original authorisation;
any available information concerning the points listed in Annex II 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;
a reasoned statement affirming that the product complies with Article 4(1), first indent.
Article 13
Traceability
At the first stage of the placing on the market of an authorised primary product 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:
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).
Article 14
Public access
Article 15
Confidentiality
In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002:
the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and
the Authority shall assess the confidentiality request submitted by the applicant.
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
Article 18
Amendments
Article 18a
Exercise of the delegation
Article 19
Committee procedure
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
▼M2 —————
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:
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 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 16 June 2005 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 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.
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 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:
(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:
(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:
the type of wood used for the production of the primary product;
detailed information on the production methods of the primary products and the further processing in the production of derived smoke flavourings;
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 analytical methods, e.g. chromatographic or spectrometric methods;
a validated analytical method for sampling, identification and characterisation of the primary product;
information on the intended use levels in or on specific foods 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.
( 1 ) OJ L 145, 31.5.2001, p. 43.
( 2 ) OJ L 123, 12.5.2016, p. 1.