Article 1Subject matter

1.

The purpose of this Regulation is to ensure the effective functioning of the F1... 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 F2... 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 F3, and their conditions of use in or on foods;

F4(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 2Scope

This Regulation shall apply to:

  1. 1.

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

  2. 2.

    source materials for the production of smoke flavourings;

  3. 3.

    the conditions under which smoke flavourings are prepared;

  4. 4.

    foods in or on which smoke flavourings are present.

Article 3Definitions

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. 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. 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. 3.

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

  4. 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.

  5. 5.

    F5“Authority” means—

    1. (a)

      as regards England and Wales, the Food Standards Agency;

    2. (b)

      as regards Scotland, Food Standards Scotland

  6. 6.

    “prescribe”, means prescribe by regulations;

  7. 7.

    “appropriate authority” means—

    1. (a)

      in relation to England, the Secretary of State;

    2. (b)

      in relation to Wales, the Welsh Ministers;

    3. (c)

      in relation to Scotland, the Scottish Ministers;

  8. 8.

    F6...

Article 4General 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 F7this Regulation, 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 5Conditions 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 F8F9assimilated law, primary products may be further processed by appropriate physical processes for the production of derived smoke flavourings. F10...

Article 6F11Content of authorisations

F121.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.

In respect of each authorised primary product, the F13authorisation must include 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.

F143.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15Article 6ADomestic list of authorised smoke flavouring primary products

(1.

The Authority must establish and maintain a list (the “domestic list”) of primary products for use as such in or on foods or for the production of derived smoke flavourings, which have been authorised in accordance with this Regulation, including the details described in Article 6(2).

(2.

The Authority must make the domestic list available to the public.

Article 7Application for authorisation

1.

To obtain the F16authorisation of a primary product F17..., an application shall be submitted in accordance with the following provisions.

2.

(a)

The application shall be sent to the F18appropriate authority.

F19(b)

The appropriate authority must acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement must state the date of receipt of the application;

F20(c)

The appropriate authority must inform the Authority of the application without delay and make the application and any supporting information supplied by the applicant available to the Authority.

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 application9.

Article 8Opinion 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 F21....

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, F22... 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 F23appropriate authority 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 9F24... Authorisation

F251.

Within three months of receiving the opinion of the Authority, the appropriate authority must take the decision whether to F26authorise the primary product, taking account of the opinion of the Authority, the requirements of Article 4(1), any relevant provisions of F27assimilated law and other legitimate factors relevant to the matter under consideration. The appropriate authority must F28specify the date on which the authorisation (if it is a decision to authorise) is to have effect, and inform the Authority and the applicant of its decision without delay. Where the decision is not in accordance with the opinion of the Authority, the appropriate authority must provide an explanation for the differences to the Authority and to the applicant.

F292.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F293.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 F30Authority 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.

F31Article 9ASupervision

(1.

This Article applies where the Authority receives, or becomes aware of, any information which might affect the assessment of the safety of an authorised primary product or derived smoke flavouring.

(2.

Where the Authority receives, or becomes aware of, information under paragraph 1, the Authority must consider whether it is necessary to issue an opinion under Article 11(2).

(3.

The Authority may ask a relevant person to provide, within a specified period, such other information as the Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 11(2).

(4.

The Authority may extend the period of time described in paragraph 3.

(5.

Where the Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Authority must consider whether it is necessary to issue an opinion under Article 11(2) based on such information as the Authority has which might affect the assessment of the safety of the authorised primary product or derived smoke flavouring concerned.

(6.

In this Article, “relevant person” means any person who is—

(a)

the authorisation holder of the authorised primary product or derived smoke flavouring concerned;

(b)

a producer or manufacturer of the authorised primary product or derived smoke flavouring concerned; or

(c)

any food business placing on the market or using the authorised primary product or derived smoke flavouring concerned.

F32Article 10Initial establishment of the Community list of authorised primary products

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 11Modification, 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.

F332.

An opinion on whether an authorisation or the requested modification is still in accordance with this Regulation, following the procedure laid down in Article 8, where applicable:

(a)

may be delivered by the Authority of its own initiative to the appropriate authority; or

(b)

must be delivered by the Authority to the appropriate authority:

(i)

following an application under paragraph 1, but only where the modification could affect the safety assessment of the authorised primary product; or

(ii)

following a request to do so from the appropriate authority.

F343.

The appropriate authority must examine the opinion of the Authority without delay and take the decision whether to modify F35, suspend or revoke the authorisation.

F364.

Where the appropriate authority decides to modify, suspend or revoke an authorisation, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the decision to the Authority, and the Authority must update the domestic list referred to in Article 6A accordingly.

(4A.

For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—

(a)

existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)

the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)

the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied.

(4B.

The appropriate authority may prescribe other transitional measures not falling within paragraph 4A in relation to the modification, suspension or revocation of an authorisation.

F375.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.

The F38Authority shall without delay inform the authorisation holder of the measure taken.

F39Article 12Renewal of authorisations

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 13Traceability

1.

At the first stage of the placing on the market of an authorised primary product or smoke flavouring derived from the authorised products F40..., 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 F41...;

(b)

the conditions of use of the authorised product F42...;

(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 F43for that product.

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 F44F45assimilated law.

F46Article 14Public access

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 15Confidentiality

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 F47Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant F48... 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 F49appropriate authority with all information in its possession.

5.

The F50appropriate authority and the Authority 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, F51and the appropriate authority shall respect the confidentiality of the commercial and industrial information provided, including research and development information as well as information on which the F52Authority and the applicant disagree as to its confidentiality.

Article 16Data 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 17Inspection and control measures

1.

F53The Authority 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 F54appropriate authority, the Authority shall assist in developing technical guidance on sampling and testing to facilitate a coordinated approach for the implementation of paragraph 1.

F553.

The appropriate authority may, taking account of available scientific evidence, supplement this Regulation by prescribing quality criteria for validated analytical methods referred to in point 4 of Annex 2, including substances to be measured.

F57Article 18 Amendments F56to the Annexes

The appropriate authority may, following a request to the Authority for scientific and/or technical assistance, prescribe amendments to—

(a)

the Annexes; F58...

F59(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F60Article 18a Exercise of the delegation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F61Article 19Committee procedure

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F62Article 19ARegulations and devolved powers

1.

Any power to make regulations under this Regulation—

(a)

so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b)

so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;

2.

Any power to make regulations under this Regulation includes power—

(a)

to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);

(b)

to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

3.

Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—

(a)

in the case of England, of either House of Parliament;

(b)

in the case of Wales, of Senedd Cymru;

(c)

in the case of Scotland, of the Scottish Parliament;

4.

In this Regulation, any power—

(a)

of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b)

of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c)

of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;

F63Article 20Transitional measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 21Entry 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.

F64...