Commission Implementing Regulation (EU) 2016/1240Show full title

[F1 Appendix

Evaluation of compliance of a consignment with the legal limit U.K.

1. Principle U.K.

Where public intervention and private storage legislation lay down detailed sampling procedures then those procedures shall be followed. In all other cases a sample of at least 3 sample units taken randomly from the consignment submitted to control shall be used. A composite sample may be prepared. The result obtained shall be compared with the legal limits by calculation of a 95 % confidence interval as 2 x standard deviation, where the relevant standard deviation depends on whether (1) the method is validated through international collaboration with values for σ _r and σ _R or (2) in the case of in-house validation, an internal reproducibility has been calculated. This confidence interval will then equate to the measurement uncertainty of the result.

2. The method is validated through international collaboration U.K.

In this case, the repeatability standard deviation σ _r and the reproducibility standard deviation σ _R have been established and the laboratory can demonstrate compliance with the performance characteristics of the validated method.

Calculate the arithmetic mean of the n repeated measurements.

Calculate the expanded uncertainty ( k = 2) of as

If the final result x of measurement is calculated using a formula of the form x = y ₁ + y ₂ , x = y ₁ – y ₂ , x = y ₁ · y ₂ or x = y ₁ / y ₂ the usual procedures for combining standard deviations in such cases shall be followed.

The consignment is judged to be not in compliance with the upper legal limit UL if

;

otherwise it is judged to be in compliance with UL.

The consignment is judged to be not in compliance with the lower legal limit LL if

;

otherwise it is judged to be in compliance with LL.

3. In-house validation with calculation of internal reproducibility standard deviation U.K.

In cases where methods not specified in this Regulation are used and precision measures have not been established, an in-house validation shall be carried out. Internal repeatability standard deviation σ _ir and the internal reproducibility standard deviation σ _{i R} shall be used instead of σ _r and σ _R , resp., in the formulae for the computation of the expanded uncertainty U .

The rules to be followed to determine compliance with the legal limit are as set out under point 1. However, if the consignment is judged to be non-compliant with the legal limit, the measurements shall be repeated with the method specified in this Regulation and the result evaluated in accordance to point 1.

(*) The produce Ampholine® pH 3,5-9,5 (Pharmacia) and Resolyte® pH 5-7 and pH 6-8 (BDH, Merck) have proved particularly suitable for obtaining the required separation of γ-caseins. U.K.

(**) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules ( OJ L 165, 30.4.2004, p. 1 ).] U.K.

Textual Amendments

F1 Inserted by Commission Implementing Regulation (EU) 2018/150 of 30 January 2018 amending Implementing Regulation (EU) 2016/1240 as regards methods for the analysis and quality evaluation of milk and milk products eligible for public intervention and aid for private storage.