"Method acceptance criteria" are criteria, which should be fulfilled prior to the initiation of any method validation by the CRL.

According to the rules for the validation of methods, each sample was analysed twice consecutively to determine the alcoholic strength.

The updated description of this method, together with the experimental values for the validation parameters of the method, should be included in Chapter 3 of the Annex to Commission Regulation (EEC) No 2676/90(2).

In such a case, the applicant shall provide experimental data from an in-house validation in which the method module has been successfully applied in the context of the application for authorisation.

If the information provided about the method is considered adequate and fulfils the method acceptance criteria, the CRL will initiate the validation process for the method.

The results of determining the alcoholic strength of a wide range of wines show the comparability of measurements carried out with the hydrostatic balance and the electronic density-meter using a frequency oscillator and demonstrate that the values of the validation parameters are similar for both methods.

The "method performance requirements" define the minimum performance criteria that the method should demonstrate upon completion of a validation study carried out by the CRL according to internationally accepted technical provisions and this in order to certify that the method validated is fit for the purpose of enforcement of Regulation (EC) No 1829/2003.

Validation of the method.

processes for validation of analytical methods.

- Analytical Methods and Validation Reports

- the testing and evaluation or validation of the method for detection;

validation and qualification of chemical and physical measurement methods;

This chapter provides examples and/or references for validation procedures of analytical methods.

Non-pharmacopoeial methods (with validation) shall be included where appropriate.

results of method validation show new test procedure to be at least equivalent to the former procedure.

Validation procedures based on testing methods may be laid down under the procedure referred to in Article 33(2).

Results of method validation show new test procedure to be at least equivalent to the former procedure.

Validation shall demonstrate that the analytical method complies with the criteria applicable for the relevant performance characteristics.

Specific targeted innovation projects are designed to test, validate and disseminate new innovation concepts and methods at the European level.

- evaluating the data provided by the applicant for authorisation to place the feed additive on the market, for the purpose of testing and evaluation or validation of the method for detection;

Detailed information on the specifications, (release and shelf life) justification for their choice, methods of analysis and their validation shall be provided.

A screening method of analysis with proven, widely acceptable validation and high throughput could be used to select the samples with significant levels of dioxins.

Specific rules should be laid down on controls for processing plants, with particular reference to detailed procedures for the validation of processing methods and for self-supervision of production.

As a result of advances in analytical chemistry since the adoption of Directive 96/23/EC the concept of routine methods and reference methods has been superseded by criteria approach, in which performance criteria and procedures for the validation of screening and confirmatory methods are established.

Procedures for the validation of plants for the processing of animal waste of ruminant origin for the production of tallow in the United Kingdom, using methods described in the Annex to Decision 92/562/EEC

(ii) testing of blood/plasma donations and pools for infectious agents, including information on test methods and, in the case of plasma pools, validation data on the tests used.

The methods proposed must reflect the state of the art. The following criteria must be met in order to permit validation of the analytical methods proposed for post-registration control and monitoring purposes:

The determination of a method's reproducibility by the single laboratory studies (in-house validation) concept requires repeated participation in proficiency studies in accordance with ISO guide 43-1 (3) and 43-2 (4).

Detailed information on the specifications used for routine control of active substance(s), justification for the choice of these specifications, methods of analysis and their validation shall be provided.

(4) Some relevant developments have taken place concerning the validation of phthalates migration test methods and the comprehensive risk assessment of these phthalates under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances.

Validation can also be performed by conducting an interlaboratory study such as established by Codex Alimentarius, ISO or the IUPAC (12), or according to alternative methods such as single laboratory studies or in-house validation (13)(14).

(31) The SCTEE, consulted by the Commission. has concluded in its opinion of 28 September 1999 on TNO, LGC and United States CPSC reports on phthalate-migration test validation that none of the phthalate-migration test methods which have been subject to validation attempts is currently suitable for control purposes;

Single laboratory study (in-house validation) means an analytical study involving a single laboratory using one method to analyse the same or different test materials under different conditions over justified long time intervals.

(4) Some relevant developments have taken place concerning the validation of phthalates migration test methods and the comprehensive risk assessment of these phthalates under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances fn.

The CVMP was thereafter asked by the Commission to provide a scientific evaluation of the existing data including the state of validation of analytical methods for residue control, and to propose, if possible, residue limits for norgestomet for all target tissues including milk and for flugestone acetate for all target tissues except milk.

Where no specific methods for the determination of tin in canned foodstuffs are prescribed at Community level, laboratories may select any validated method provided the selected method meets the performance criteria indicated in Table 2. The validation should ideally include a certified reference material.

Addition of 13C-labelled 2,3,7,8-chlorine substituted internal PCDD/F standards (and of 13C-labelled internal dioxin-like PCB standards, if dioxin-like PCBs have to be determined) must be carried out at the very beginning or start of the analytical method e.g. prior to extraction in order to validate the analytical procedure.

Taking into account the response of CVMP and the need for further validation of the analytical methods, and the remaining scientific uncertainty, it is considered nevertheless appropriate to place norgestomet for all tissues and flugestone acetate for all tissues except milk in Annex III of Regulation (EEC) No 2377/90, in accordance with the conditions and the maximum residue limits specified for each of these substances in the Annexes to the present proposal for a Commission Regulation.

Validation of reference methods

Analytical Methods and Validation Reports

methods of validation and reconciliation of data sources,

the testing and evaluation or validation of the method for detection;

"Method acceptance criteria" are criteria, which should be fulfilled prior to the initiation of any method validation by the CRL.

According to the rules for the validation of methods, each sample was analysed twice consecutively to determine the alcoholic strength.

The updated description of this method, together with the experimental values for the validation parameters of the method, should be included in Chapter 3 of the Annex to Commission Regulation (EEC) No 2676/90(2).

validation of gross fixed capital formation and changes in stocks estimates derived from the commodity-flow method with the results of the Enterprise Survey,

evaluating the data provided by the applicant for authorisation to place the feed additive on the market, for the purpose of testing and evaluation or validation of the method for detection;

In such a case, the applicant shall provide experimental data from an in-house validation in which the method module has been successfully applied in the context of the application for authorisation.

Research will focus on: development, validation and harmonisation of technologies and methodologies to ensure complete traceability throughout the food chain;

If the information provided about the method is considered adequate and fulfils the method acceptance criteria, the CRL will initiate the validation process for the method.