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            COMMISSION REGULATION (EC) No 627/2006

of 21 April 2006         

implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 2065/2003 of the European Parliament and the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (1) and in particular Article 17(3) thereof,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

The quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products, as referred to in point 4 of Annex II to Regulation (EC) No 2065/2003, shall be as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

Done at Brussels, 21 April 2006.

For the Commission

Markos KYPRIANOU            

Member of the Commission

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(1)OJ L 309, 26.11.2003, p. 1.

(2)OJ L 191, 28.5.2004, p. 1.

(3)  SCF/CS/CNTM/PAH/29 Final, 4 December 2002.

(4)  EU-Report LA-NA-21679-EN-C, ISBN 92-894-9629-0.

(5)  ISO5725-1: Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions. 1994: Geneva.

(6)  Thompson, M., S.L.R. Ellison, and R. Wood, Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis. Pure and Applied Chemistry, 2002. 74(5): pp. 835-855.

(7)  Horwitz, W., Protocol for the design, conduct and interpretation of method-performance studies. Pure and Applied Chemistry, 1995. 67(2): pp. 331-343.

(8)  http://www.irmm.jrc.be/html/activities/intense_sweeteners_and_smoke_flavourings/liquid_smoke_components.xls

Faix, O., et al., Holz als Roh- & Werkstoff, 1991. 49: pp. 213-219.

Faix, O., et al., Holz als Roh- & Werkstoff, 1991. 49: pp. 299-304.

Faix, O., D. Meier, and I. Fortmann, Holz als Roh- & Werkstoff, 1990. 48: pp. 281-285.

Faix, O., D. Meier, and I. Fortmann, Holz als Roh- & Werkstoff, 1990. 48: pp. 351-354.

(9)OJ L 221, 17.8.2002, p. 8. Decision as last amended by Decision 2004/25/EC (OJ L 6, 10.1.2004, p. 38).

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ANNEX

Quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products

1.   Sampling

The basic requirement is to obtain a representative and homogeneous laboratory sample.

The analyst shall ensure that samples do not become contaminated during sample preparation. Containers have to be rinsed with high purity acetone or hexane (p.A., HLPC grade or equivalent) before use to minimise the risk of contamination. Wherever possible, apparatus coming into contact with the sample shall be made of inert materials e.g. glass or polished stainless steel. Plastics such as polypropylene are to be avoided, because the analyte can adsorb onto these materials.

All of the sample material received by the laboratory is to be used for the preparation of test material. Only very finely homogenised samples give reproducible results.

There are many satisfactory specific sample preparation procedures which may be used.

2.   Identification and characterisation

2.1.   Definitions

For the purpose of this Annex the following definitions shall apply:

2.2.   Requirements

Without prejudice to Article 11 of Regulation (EC) No 882/2004, the validated method for identification and characterisation to be selected by the laboratory shall comply with the quality criteria indicated in Tables 1 and 2.

Table 1

Quality criteria for methods for identification and quantification of chemical constituents in the solvent free mass and the volatile fraction of primary products

Table 2

Minimum method quality criteria for analysing Polycyclic Aromatic Hydrocarbons (PAHs)

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(1)  ISO 5725-1: Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions. Geneva, 1994.

(2)  Thompson, M., S.L.R. Ellison, and R. Wood, Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis. Pure and Applied Chemistry, 2002. 74(5): pp. 835-855.

(3)  Horwitz, W., Protocol for the design, conduct and interpretation of method-performance studies. Pure and Applied Chemistry, 1995. 67(2): pp. 331-343.

(*1)  Over the whole analytical range.

(*2)  The RSDi, RSDr and RSDR values are relatively high due to the low stability of the analytes in primary smoke condensate.

(*3)  Corrected for recovery.

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