Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products
Date: 1976-01-20

num: Article 1
paragraphs: This Directive relates to prepackages containing products with the exception of those referred to in the Council Directive 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids (1), and intended for sale in constant unit nominal quantities which are: - equal to values predetermined by the packer,
- expressed in units of weight or volume,
- not less than 5 g or 5 ml and not more than 10 kg or 10 l.
num: Article 2
paragraphs: 1. A prepackage within the meaning of this Directive is the combination of a product and the individual package in which it is prepacked.
2. A product is prepacked when it is placed in a package of whatever nature without the purchaser being present and the quantity of product contained in the package has a predetermined value and cannot be altered without the package either being opened or undergoing a perceptible modification.
num: Article 3
paragraphs: 1. The prepackages which may bear the EEC sign specified in section 3.3 of Annex I are those which comply with this Directive and with Annex I thereto.
2. They shall be subject to metrological control under the conditions defined in Annex I, section 5 and in Annex II.
num: Article 4
paragraphs: 1. All prepackages referred to in Article 3 must, in accordance with Annex I, bear an indication of the weight or volume of the product, known as "nominal weight" or "nominal volume", which they are required to contain.
2. Prepackages containing liquid products shall be marked with their nominal volume and prepackages containing other products shall be marked with their nominal weight, except in the case of trade practice or national regulations which provide otherwise and which are identical in all Member States, or in the case of contrary Community rules.
3. If trade practice or national regulations are not the same in all Member States for a category of products or for a type of prepackage, those prepackages must at least show the metrological information corresponding to the trade practice or national regulations prevailing in the country of destination.
4. Until the expiry of the transitional period during which the use of the imperial units of measurement appearing in Annex II to Council Directive 71/354/EEC of 18 October 1971 on the approximation of the laws of the Member States relating to units of measurement (2), as amended by the Act of Accession, is authorized in the Community, the indication of the nominal weight and/or nominal volume of the contents expressed in SI units of measurement in accordance with section 3.1 of Annex I to this Directive shall, if the United Kingdom or Ireland so desires, be accompanied on their national territories by an indication of the equivalent value in imperial units of measurement (UK), calculated on the basis of the following conversion factors: >PIC FILE= "T0009090">
num: Article 5
paragraphs: Member States may not refuse, prohibit or restrict the placing on the market of prepackages which satisfy the requirements and tests laid down in this Directive for reasons concerning the markings required to be borne by such prepackages pursuant to this Directive, the determination of their volume or weight, or the methods by which they have been measured or checked.
num: Article 6
paragraphs: The amendments necessary to adapt the requirements of Annexes I and II to this Directive to technical (1)OJ No L 42, 15.2.1975, p. 1. (2)OJ No L 243, 29.10.1971, p. 29.
progress shall be adopted in accordance with the procedure laid down in Articles 18 and 19 of Directive 71/316/EEC.
num: Article 7
paragraphs: 1. Member States shall bring into force the laws, regulations and administrative provisions needed in order to comply whith this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.
2. By way of derogation from paragraph 1, Belgium, Ireland, the Netherlands and the United Kingdom may defer implementation of this Directive and the Annexes thereto until 31 December 1979 at the latest.
3. During the period in which the Directive is not operative in a Member State, that Member State shall not introduce stricter control measures regarding the quantity contained in prepackages covered by this Directive and coming from other Member States than those in force when the Directive was adopted.
4. During the same period, the Member States which have implemented the Directive shall accept those prepackages coming from Member States benefiting from the derogation provided for in paragraph 2 of this Article which comply with section 1 of Annex I, even if they do not bear the EEC sign referred to in section 3.3 of Annex I, on the same basis and under the same conditions as those prepackages which comply with all the requirements of the Directive.
5. The checks provided for by Annex I, section 5 shall be carried out by the competent authorities of the Member State of destination when prepackages manufactured outside the Community are imported into the territory of the Community in a Member State which has not yet implemented the Directive in accordance with this Article.
6. Member States shall ensure that the text of the main provisions of national law which they adopt in the field covered by this Directive is communicated to the Commission.
num: Article 12 of this latter Directive shall apply mutatis mutandis.
paragraphs: The packer or importer shall be responsible for ensuring that prepackages meet the requirements of this Directive.
The quantity of product contained in a prepackage (or packing quantity), known as the "actual contents", shall be measured or checked by weight or volume on the responsibility of the packer and/or importer. The measurement or check shall be carried out by means of a legal measuring instrument suitable for effecting the necessary operations.
The check may be carried out by sampling.
Where the actual contents are not measured, the check carried out by the packer shall be so organized that the quantity of the contents is effectively ensured.
This condition is fulfilled if the packer carries out production checks in accordance with procedures recognized by the competent departments in the Member State and if he holds at the disposal of those departments the documents containing the results of such checks, in order to certify that these checks, together with any corrections and adjustments which they have shown to be necessary, have been properly and accurately carried out.
In the case of imports from non-EEC countries, the importer may instead of measuring and checking provide evidence that he is in possession of all the necessary guarantees enabling him to assume responsibility.
In the case of products in quantities expressed in units of volume, one of several methods of meeting the measuring and checking requirements is to use, when making up the prepackage, a measuring container of the type defined in the Directive relating thereto, filled under the conditions prescribed in that Directive and herein.
Checks to ensure that the prepackages comply with the requirements of this Directive shall be carried out by the competent departments of the Member States by sampling on the packers' premises or, if this is not practicable, on the premises of the importer or his agent established in the Community.
This statistical sampling check shall be carried out in accordance with the accepted methods of quality acceptance inspection. Its effectiveness shall be comparable to that of the reference method specified in Annex II.
This Directive shall not preclude any checks which may be carried out by the competent departments of the Member States at any stage in the marketing process, in particular for the purpose of verifying that prepackages meet the requirements of the Directive.
num: Article 15 (2) of Directive 71/316/EEC shall apply mutatis mutandis.
paragraphs: This Annex lays down the procedures of the reference method for statistical checking of batches of prepackages in order to meet the requirements of Article 3 of the Directive and of section 5, Annex I thereto.
This check is based upon ISO standard No 2859 relating to methods of testing by attributes, taking an acceptable quality level of 2 75 %. The sampling level corresponds to level II of that standard in respect of non-destructive tests and to level S 3 in respect of destructive tests. 1. REQUIREMENTS FOR MEASURING THE ACTUAL CONTENTS OF PREPACKAGES
The actual contents of prepackages may be measured directly by means of weighing instruments or volumetric instruments or, in the case of liquids, indirectly, by weighing the prepacked product and measuring its density.
Irrespective of the method used, the error made in measuring the actual contents of a prepackage shall not exceed one fifth of the tolerable negative error for the nominal quantity in the prepackage.
The procedure for measuring the actual contents of a prepackage may be the subject of domestic regulations in each Member State.
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 covering the actual contents of each prepackage in the sample,
- another check on the average of the actual 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 ; it is less effective than the non-destructive test.
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. Prepackage batches 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, without any restriction as to batch size.
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 the minimum acceptable contents of a prepackage 2.2.1. The minimum acceptable contents shall be calculated by subtracting the tolerable negative error for the contents concerned from the nominal quantity of the prepackage.
2.2.2. Prepackages in the batch whose actual contents are less than the minimum acceptable 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= "T0009092">
2.2.3.1.2. Destructive testing plan >PIC FILE= "T0009093">
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 and: - 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= "T0009094">
2.2.3.2.2. Destructive testing plan >PIC FILE= "T0009095">
2.3. Checking of the average actual 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= "T0009096">
In this formula:
Qn = the nominal quantity of the prepackage,
n = the number of prepackages in the sample for this check,
s = the estimated standard deviation of the actual contents of the batch,
2.3.2. If xi is the measured value for the actual 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= "T0009097">
2.3.2.2. and the estimated value of the standard deviation s by the following calculation: >PIC FILE= "T0009098">
2.3.3. Criteria for acceptance or rejection of the batch of prepackages for checking the mean: 2.3.3.1. Criteria for non-destructive testing >PIC FILE= "T0009099">
2.3.3.2. Criteria for destructive testing >PIC FILE= "T0009100">