2.

REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES The checking of prepackages shall be carried out by sampling and shall be in two parts: - a check on the actual volume of the contents of each prepackage in the sample, another check covering the average of the actual volumes of the contents of the prepackages in the sample. A batch of prepackages shall be considered acceptable if the results of both these checks satisfy the acceptance criteria. For each of these checks, there are two sampling plans: - one for non-destructive testing, i.e., testing which does not involve opening the package, the other for destructive testing, i.e., testing which involves opening or destroying the package. For economic and practical reasons, the latter test shall be limited to the absolutely essential minimum, and it is less effective than the former. Destructive testing shall therefore be used only when non-destructive testing is impracticable. As a general rule it shall not be applied to batches of fewer than 100 units. 2.1. Composition of the prepackage batch 2.1.1. The batch shall be made up of all the prepackages of the same type and the same production run which are to be inspected. 2.1.2. When prepackages are checked at the end of the packing line, the number in each batch shall be equal to the maximum hourly output of the packing line. In other cases the batch size shall be limited to 10 000. 2.1.3. For batches of fewer than 100 prepackages, the non-destructive test, where carried out, shall be 100 %. 2.1.4. Before the tests in 2.2 and 2.3 are carried out, a sufficient number of prepackages shall be drawn at random from the batch so that the check requiring the larger sample can be carried out. For the other check, the necessary sample shall be drawn at random from the first sample and marked. This marking operation shall be completed before the start of measuring operations. 2.2. Checking of minimum acceptable volume of the contents of a prepackage 2.2.1. The minimum acceptable volume of the contents shall be calculated by subtracting the tolerable negative error for the nominal volume of the contents concerned from the nominal volume of the contents of the prepackage. 2.2.2. Individual units in the batch whose actual volume of contents is less than the minimum acceptable volume of contents shall be considered defective. 2.2.3. For checks by sampling, one of the following sampling plans (single or double) shall be used, to be chosen by each Member State. 2.2.3.1. Single sampling plan The number of prepackages checked shall be equal to the number in the sample, as indicated in the plan: - if the number of defective units found in the sample is less than or equal to the criterion for acceptance, the batch of prepackages shall be considered acceptable for the purpose of this check, if the number of defective units found in the sample, is equal to or greater than the criterion for rejection, the batch of prepackages shall be rejected. 2.2.3.1.1. Non-destructive testing plan >PIC FILE= "T0006686"> 2.2.3.1.2. Destructive testing plan >PIC FILE= "T0006687"> 2.2.3.2. Double-sampling plan The first number of prepackages checked shall be equal to the number of units in the first sample as indicated in the plan: - if the number of defective units found in the first sample is less than or equal to the first acceptance criterion, the batch shall be considered acceptable for the purpose of this check, if the number of defective units found in the first sample is equal to or greater than the first rejection criterion, the batch shall be rejected, if the number of defective units found in the first sample lies between the first acceptance criterion and the first rejection criterion, a second sample shall be checked, the number of units in which is indicated in the plan. The defective units found in the first and second samples shall be added together: - if the aggregate number of defective units is less than or equal to the second acceptance criterion, the batch shall be considered acceptable for the purpose of the check, if the aggregate number of defective units is greater than or equal to the second rejection criterion, the batch shall be rejected. 2.2.3.2.1. Non-destructive testing plan >PIC FILE= "T0006688"> 2.2.3.2.2. Destructive testing plan >PIC FILE= "T0006689"> 2.3. Checking of average actual volume of the contents of the individual prepackages making up a batch 2.3.1. A batch of prepackages shall be considered acceptable for the purpose of this check >PIC FILE= "T0006690"> In this formula: Vn = the nominal volume of the contents of the prepackage, s = the estimated standard deviation of the actual volume of the contents of the batch, n = the number of prepackages in the sample for this check, >PIC FILE= "T9000618"> 2.3.2. If xi is the measured value for the actual volume of the contents of the i-th item in the sample containing n items, then: 2.3.2.1. the mean of the measured values for the sample is obtained by the following calculation: >PIC FILE= "T0006691"> 2.3.3. Criteria for acceptance or rejection of batches of prepackages tested in this check: Criteria for non-destructive testing >PIC FILE= "T0006692"> Criteria for destructive testing >PIC FILE= "T0006693">

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Source: EUR-Lex (Cellar) · retrieved 2026-11-10 · Text as adopted (Official Journal); later amendments are not incorporated in this text.