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 Community, 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) 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 materials 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 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 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.
(4) In order to protect human health, smoke flavourings should undergo a safety assessment through a Community procedure before being placed on the market or used in or on foods within the Community.
(5) Differences between national laws, 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 therefore be established at Community level.
(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 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 purification processes, the use of smoke flavourings is generally considered to be of less health concern than the traditional smoking process. However, the possibility of wider applications of smoke flavourings in comparison to conventional smoking has to be taken into account in safety assessments.
(7) 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 fractions of the water-insoluble high-density tar phase, the "primary tar fractions", are purified to remove components of smoke which are most harmful to human health. They may then be suitable for use as such in or on foods or for the production of derived smoke flavourings made by further appropriate physical processing such as extraction procedures, distillation, concentration by evaporation, absorption or membrane separation and the addition of food ingredients, other flavourings, food additives or solvents, without prejudice to more specific Community legislation.
(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 and, accordingly, toxicological evaluation should focus on the safety of individual smoke condensates. Following this advice, this Regulation should provide for the scientific evaluation of primary smoke condensates and primary tar fractions, hereinafter referred to as "primary products", in terms of the safety of their use as such and/or for the production of derived smoke flavourings intended for use in or on foods.
(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(5), in which it 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(6). It also contains a non-exhaustive list of types of wood which may be regarded as an indicative list of woods suitable for the production of smoke flavourings.
(10) Provision should be made for the establishment, on the basis of the safety assessment, of a list of primary 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.
(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, establishing the European Food Safety Authority and laying down procedures in matters of food safety(7).
(12) The safety assessment of a specific primary product should be followed by a risk-management decision as to whether the product should be entered on the Community list of authorised primary products. That decision should be adopted in accordance with the regulatory procedure so as to ensure close cooperation between the Commission and the Member States.
(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 information necessary for the safety assessment. The applicant 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 Regulation. If necessary, the Commission should adopt quality criteria for those analytical methods after having consulted the Authority for scientific and technical assistance.
(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 allowed for the applicant to make available to the Authority the information necessary for the safety assessment of these products. Therefore, a certain time period, hereinafter referred to as the "first phase", should be fixed during which the information for existing primary products should be submitted by the applicant to the Authority. Applications for authorisation of new primary products may also be submitted during the first phase. The Authority should evaluate without delay all applications for existing as well as new primary products for which sufficient information has been submitted during the first phase.
(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 products to be added thereto by decision of the Commission, following the safety assessment by the Authority.
(16) Whenever the evaluation by the Authority indicates that an existing smoke flavouring already on the market in the Member States constitutes a serious risk to human health, this product should be removed from the market without delay.
(17) Articles 53 and 54 of Regulation (EC) No 178/2002 establish procedures for taking emergency measures in relation to food of Community origin or imported from a third country. They allow the Commission to adopt such measures in situations where food is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.
(18) It is necessary that food business operators using 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.
(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 Regulation to be adapted to scientific and technical progress.
(21) 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(8),
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 flavourings used or intended for use in or on foods, whilst providing the basis for securing a high level of protection for human health and the interests of consumers.
2. To this end, this Regulation lays down:
(a) 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;
(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;
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. "primary smoke condensate" shall refer to the purified water-based part of condensed smoke and shall fall within the definition of "smoke flavourings";
2. "primary tar fraction" shall refer to the purified fraction of the water-insoluble high-density tar phase of condensed smoke and shall fall within the definition of "smoke flavourings";
3. "primary products" shall refer to primary smoke condensates and primary tar fractions;
4. "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
1. The use of smoke flavourings in or on foods shall only be authorised if it is sufficiently demonstrated that
- it does not present risks to human health,
- it does not mislead consumers.
Each authorisation may be subject to specific conditions of use.
2. No person shall place on the market a smoke flavouring or any food in or on which such a smoke flavouring is present if the smoke flavouring is not a primary product authorised in accordance with Article 6, or if is not derived therefrom, and if the conditions of use laid down in the authorisation in accordance with this Regulation are not adhered to.
Article 5
Conditions of production
1. The wood used for the production of primary products shall not have been treated, whether intentionally or unintentionally, with chemical substances during the six months immediately preceding felling or subsequent thereto, unless it can be demonstrated that the substance used for the treatment does not give rise to potentially toxic substances during combustion.
The person who places on the market primary products must be able to demonstrate by appropriate certification or documentation that the requirements laid down in the first subparagraph have been met.
2. The conditions for the production of primary products 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 production of smoke flavourings.
3. Without prejudice to other Community legislation, primary products 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 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 paragraph 1, primary products may be added to that list in accordance 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:
(i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;
(ii) shall inform without delay the European Food Safety Authority (hereinafter referred to as the "Authority"); and
(iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.
(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;
(c) a reasoned statement affirming that the product complies with Article 4(1), first indent;
(d) a summary of the dossier.
4. The Authority shall publish detailed guidance concerning the preparation and the submission of the application(9).
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 explanation for the delay to the applicant, the Commission and the Member States.
2. The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority which in no event shall exceed 12 months. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.
3. In order to prepare its opinion, the Authority shall:
(a) verify that the particulars and documents submitted by the applicant are in accordance with Article 7(3) in which case the application shall be regarded as valid;
(b) inform the applicant, the Commission and the Member States if an application is not valid.
4. In the event of an opinion in favour of authorising the evaluated product, the opinion shall include:
(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;
(b) an assessment as to whether the analytical method proposed in accordance with point 4 of Annex II is appropriate for the intended control purposes.
5. The Authority shall forward its opinion to the Commission, 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.
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 and other legitimate factors relevant to the matter under consideration. Where the draft measure is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the reasons for the differences.
The measure referred to in 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 authorisation.
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.
5. The authorisation holder shall inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the authorised primary product or derived smoke flavourings in relation to human health. If necessary, the Authority shall then review the assessment.
6. The granting of an authorisation shall not diminish the 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
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 established after the Authority has issued an opinion on each primary product for which a valid application has been submitted during this period.
Applications for which the Authority could not issue an opinion owing to the applicant's failure to comply with the time limits specified for submission of supplementary information in accordance with Article 8(2) shall be excluded from consideration for inclusion in the initial Community list.
2. Within three months of receiving all the opinions referred to in paragraph 1, the Commission shall prepare a draft regulation for the initial establishment of the list referred to in Article 6(1), having regard to the requirements of Article 6(2).
Article 11
Modification, suspension and revocation of authorisations
1. The authorisation holder may, in accordance with the procedure laid down in Article 7, apply for a modification of the existing authorisation.
2. On its own initiative or following a request 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.
3. The Commission shall examine the opinion of the 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.
5. The final measure, i.e. the modification, suspension or revocation of the authorisation, shall be adopted in accordance with the procedure referred to in Article 19(2).
6. The Commission shall without delay inform the authorisation 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 application to the Commission by the authorisation holder, at the latest 18 months before the expiry date of the authorisation.
2. The application shall be accompanied by the following particulars and documents:
(a) a reference to the original authorisation;
(b) 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;
(c) a reasoned statement affirming that the product complies with Article 4(1), first indent.
3. Articles 7 to 9 shall apply mutatis mutandis.
4. Where, for reasons beyond the control of the authorisation holder, no decision is taken on the renewal of an authorisation until one month before its expiry date, the period of authorisation of the product shall automatically be extended by six months. The Commission shall inform the authorisation holder and the Member States about the delay.
Article 13
Traceability
1. 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:
(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 can use the derived smoke flavouring in compliance with the conditions of use set out in the list referred to in Article 6(1).
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.
4. Paragraphs 1 to 3 shall be without prejudice to other specific requirements under Community legislation.
Article 14
Public access
1. Applications for authorisation, supplementary information 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 Regulation (EC) No 178/2002.
2. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(10) when handling applications for access to documents held by the Authority.
3. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.
Article 15
Confidentiality
1. The applicant may indicate which information submitted under Article 7 should be treated as confidential because disclosure 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 information should be kept confidential and shall inform the applicant 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 evaluated product, the particulars mentioned in Article 6(2);
(c) information of direct relevance to the assessment of the safety of the product;
(d) the analytical method referred to in point 4 of Annex II.
4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and the Member States with all information in its possession.
5. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation 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 application, the Authority, the Commission and the Member States shall respect the confidentiality of the commercial and industrial information provided, including research and development information as well as information on which the Commission and the applicant disagree as to its confidentiality.
Article 16
Data protection
The information in the application submitted according to Article 7 may not be used for the benefit of another applicant, unless the other applicant has agreed with the authorisation holder that such information may be used.
Article 17
Inspection and control measures
1. 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 consultation of the Authority for scientific and/or technical assistance.
Article 19
Committee procedure
1. The Commission shall be assisted by the Committee 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 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 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 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.
Done at Brussels, 10 November 2003.