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Document 01976L0211-20190726
Council Directive 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 (76/211/EEC)
Consolidated text: Council Directive 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 (76/211/EEC)
Council Directive 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 (76/211/EEC)
01976L0211 — EN — 26.07.2019 — 003.001
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COUNCIL DIRECTIVE 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 (OJ L 046 21.2.1976, p. 1) |
Amended by:
|
|
Official Journal |
||
No |
page |
date |
||
L 311 |
21 |
4.11.1978 |
||
DIRECTIVE 2007/45/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 |
L 247 |
17 |
21.9.2007 |
|
REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 198 |
241 |
25.7.2019 |
COUNCIL DIRECTIVE
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
(76/211/EEC)
Article 1
This Directive relates to prepackages containing products ►M2 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:
Article 2
Article 3
Article 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:
1 g = 0.0353 ounces (avoirdupois),
1 kg = 2.205 pounds
1 ml = 0.0352 fluid ounces,
1 l = 1.760 pints or 0.220 gallons.
Article 5
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.
Article 6
The Commission is empowered to adopt delegated acts in accordance with Article 6a amending Annexes I and II to adapt them to technical progress.
Article 6a
Article 7
Article 8
This Directive is addressed to the Member States.
ANNEX I
1. OBJECTIVES
Prepackages covered by this Directive shall be made up in such a way that the completed packages satisfy the following requirements:
the actual contents shall not be less, on average, than the nominal quantity;
the proportion of prepackages having a negative error greater than the tolerable negative error laid down in 2.4 shall be sufficiently small for batches of prepackages to satisfy the requirements of the tests specified in Annex II;
no prepackage having a negative error greater than twice the tolerable negative error given in the table in 2.4 may bear the EEC sign provided for in 3.3.
2. DEFINITIONS AND BASIC PROVISIONS
The nominal quantity (nominal weight or nominal volume) of the contents of a prepackage is the weight or volume indicated on the prepackage, i.e. the quantity of product which the prepackage is deemed to contain.
The actual contents of the prepackage are the quantity (weight or volume) of product which it in fact contains. In all operations for checking quantities of products expressed in units of volume, the value employed for the actual contents shall be measured at or corrected to a temperature of 20 °C, whatever the temperature at which packaging or checking is carried out. However, this rule shall not apply to deep frozen or frozen products, the quantity of which is expressed in units of volume.
The negative error of a prepackage is the quantity by which the actual contents of the prepackage are less than the nominal quantity.
The tolerable negative error in the contents of a prepackage is fixed in accordance with the table below:
Nominal quantity Qn in grams or millilitres |
Tolerable negative error |
|
as % of Qn |
g or ml |
|
5 to 50 |
9 |
— |
from 50 to 100 |
— |
4.5 |
from 100 to 200 |
4.5 |
— |
from 200 to 300 |
— |
9 |
from 300 to 500 |
3 |
— |
from 500 to 1 000 |
— |
15 |
from 1 000 to 10 000 |
1.5 |
— |
When using the table, the values of the tolerable negative errors shown as percentages in the table, calculated in units of weight or volume, shall be rounded up to the nearest one-tenth of a gram or millilitre.
▼M1 —————
3. INSCRIPTIONS AND MARKINGS
All prepackages made up in accordance with this Directive shall bear on the package the following markings affixed in such a manner as to be indelible, easily legible and visible on the prepackage in normal conditions of presentation:
The nominal quantity (nominal weight or nominal volume) expressed in kilograms, grams, litres, centilitres or millilitres, and marked in figures at least 6 mm high if the nominal quantity exceeds 1 000 g or 100 cl, 4 mm high if it is from 1 000 g or 100 cl inclusive down to but not including 200 g or 20 cl, 3 mm high if it is from 200 g or 20 cl down to but not including 50 g or 5 cl, 2 mm high if it is not more than 50 g or 5 cl, followed by the symbol for the unit of measurement used or where appropriate by the name of the unit in accordance with Directive 71/354/EEC, as last amended by Directive 76/770/EEC.
Markings in imperial (UK) units shall be in letters and figures of dimensions not larger than those of the corresponding markings in SI units.
a mark or inscription enabling the competent departments to identify the packer or the person arranging for the packing to be done or the importer established in the Community;
a small ‘e’, at least 3 mm high, placed in the same field of vision as the indication of the nominal weight or nominal volume, constituting a guarantee by the packer or the importer that the prepackage meets the requirements of this Directive.
This letter shall have the form shown in the drawing contained in section 3 of Annex II to Directive 71/316/EEC.
Article 12 of this latter Directive shall apply mutatis mutandis.
4. RESPONSIBILITY OF THE PACKER OR IMPORTER
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.
5. CHECKS TO BE CARRIED OUT BY THE COMPETENT DEPARTMENTS ON THE PREMISES OF THE PACKER OR OF THE IMPORTER OR OF HIS AGENT ESTABLISHED IN THE COMMUNITY
Checks to ensure that the prepackages comply with the provisions of this Directive shall be carried out by the competent departments of the Member States by sampling on the packer's premises or, if this is not practicable, on the premises of the importer or of 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.
Thus as regards the criterion for the minimum contents, a sampling plan used by a Member State shall be regarded as comparable with that recommended in Annex II if the abscissa of the 0.10 ordinate point of the operating characteristic curve of the first plan (probability of acceptance of the batch = 0.10) deviates by less than 15 % from the abscissa of the corresponding point of the operating characteristic curve of the sampling plan recommended in Annex II.
As regards the criterion for the mean calculated by the standard deviation method, a sampling plan used by a Member State shall be regarded as comparable with that recommended in Annex II if, taking into account the operating characteristic curves of the two plans having as the abscissa axis
6. OTHER CHECKS CARRIED OUT BY THE COMPETENT DEPARTMENTS
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.
Article 15 (2) of Directive 71/316/EEC shall apply mutatis mutandis.
ANNEX II
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.
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 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:
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 comprise all the prepackages of the same nominal quantity, the same type and the same production run, packed in the same place, which are to be inspected. The batch size shall be limited to the amounts laid down below. |
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 actual contents of a prepackage
The minimum acceptable contents shall be calculated by subtracting the tolerable negative error for the contents concerned from the nominal quantity of the prepackage.
Prepackages in the batch whose actual contents are less than the minimum acceptable contents shall be considered defective.
2.2.1. Non-destructive testing
Non-destructive testing shall be carried out in accordance with a double sampling plan as shown in the table below:
The first number of prepackages checked shall be equal to the number of units in the first sample, as indicated in the plan:
The defective units found in the first and second samples shall be added together and:
Number in batch |
Samples |
Number of defective units |
|||
Order |
Number |
Aggregate number |
Acceptance criterion |
Rejection criterion |
|
100 to 500 |
1st |
30 |
30 |
1 |
3 |
2nd |
30 |
60 |
4 |
5 |
|
501 to 3 200 |
1st |
50 |
50 |
2 |
5 |
2nd |
50 |
100 |
6 |
7 |
|
3 201 and over |
1st |
80 |
80 |
3 |
7 |
2nd |
80 |
160 |
8 |
9 |
2.2.2. Destructive testing
Destructive testing shall be carried out in accordance with the single sampling plan below and shall be used only for batches of 100 or more.
The number of prepackages checked shall be equal to 20.
Number in batch |
Number in sample |
Number of defective units |
|
Acceptance criterion |
Rejection criterion |
||
Whatever the number (≥ 100) |
20 |
1 |
2 |
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 if the mean value
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, t(1 — α) = 0.995 confidence level of a Student distribution with ν = n — 1 degree of freedom. |
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:
|
2.3.3. |
Criteria for acceptance or rejection of the batch of prepackages for checking the mean:
|
►M2 ( 1 ) OJ No L 42, 15.2.1975, p. 1. ◄
( 2 ) OJ No L 243, 29.10.1971, p. 29.
( 3 ) OJ L 123, 12.5.2016, p. 1.