Commission Implementing Regulation (EU) No 503/2013Dangos y teitl llawn

4. CERTIFIED REFERENCE MATERIAL U.K.

The certified reference material shall be produced under ISO Guide 34 (General requirements for the competence of reference material producers) by a producer accredited to ISO Guide 34.

The applicant shall provide information as regards the place where the certified reference material can be accessed. This shall be accompanied by adequate information demonstrating that the availability of the certified reference material will be maintained throughout the period of validity of the authorisation. For verification and value assignment, a method that has been properly validated (see ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories) shall be used.

Uncertainties shall be estimated according to the ISO Guide to the Expression of Uncertainty in Measurement (GUM).

The main characteristics of those internationally accepted technical provisions are the following:

1.

Genetically modified reference material containers:

(a)

genetically modified reference material container (such as bottles, vials, ampoules) shall be tight and contain not less than the stated amount of material;

(b)

the commutability of the genetically modified reference material must be assured;

(c)

packaging shall be appropriate to the purpose;

(d)

labelling shall be of good aspect and quality.

2.

Homogeneity testing:

(a)

samples shall have appropriate homogeneity;

(b)

between-bottle homogeneity shall be examined;

(c)

any possible between-bottle heterogeneity shall be accounted for in the overall estimated reference material uncertainty. This requirement shall apply even when no statistically significant between-bottle variation is present. In this case, the method variation or the actual calculated between-bottle variation, whichever is larger, shall be included in the overall uncertainty.

3.

Stability testing:

(a)

samples shall have appropriate stability;

(b)

stability shall be positively demonstrated by appropriate statistical extrapolation for the genetically modified reference material shelf-life to be within the stated uncertainty; the uncertainty related to this demonstration is part of the estimated reference material uncertainty. Assigned values are valid only for a limited time and shall be subject to a stability monitoring.

4.

Batch characterisation:

1.

The methods used for verification and for certification shall:

(a)

be applied under metrologically valid conditions;

(b)

have been properly technically validated before use;

(c)

have precision and trueness compatible with the target uncertainty.

2.

Each set of measurements shall:

(a)

be traceable to the stated references;

(b)

be accompanied by an uncertainty statement whenever possible.

3.

Participating laboratories shall:

(a)

have the required competence for the execution of the task;

(b)

be able to achieve traceability to the required stated references;

(c)

be able to estimate their measurement uncertainty;

(d)

have in place a sufficient and appropriate quality assurance system.

5.

Final storage:

1.

To avoid degradation after sample production, all samples shall be stored under conditions designated for the final storage of the genetically modified certified reference material before measurements are started.

2.

Otherwise, they shall be transported from door to door keeping them at all times under such storage conditions for which it has been demonstrated that there is no influence on the assigned values.

6.

Establishment of a certificate for certified reference material:

A certificate complemented by a certification report shall be established, containing all information relevant to and needed by the user.

The certificate and report shall be made available when the genetically modified certified reference material is distributed.

The information accompanying the certified reference material shall include information on the breeding of the plant which has been used for the production of the certified reference material and on the zygosity of the insert(s).

The certified value of the GMO content shall be given in mass fraction and, where available, in copy number per haploid genome equivalent.

Certified values (such as quantity of genetically modified material expressed in mass fraction) shall be traceable to stated references and be accompanied by an expanded uncertainty statement valid for the entire shelf-life of the genetically modified certified reference material.