1. Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged products Belgrade, Republic of Serbia - June 2010

2. Workshop on requirements for prepackaged products e-marked prepackages control General reasons to make a control Checking of the actual quantity of product in prepackages is: important part of compliance testing It is used to facilitate fair trade maintain a competitive marketplace and protect consumers against under-filled prepackages.

3. Workshop on requirements for prepackaged products e-marked prepackages control e-marked prepackages use average system contents must comply with three important rules

4. Workshop on requirements for prepackaged products e-marked prepackages control First rule The contents of packages must not on average be less than the amount marked on the label. This amount is known as the Nominal Quantity. (Qn)

5. Workshop on requirements for prepackaged products e-marked prepackages control Second rule The number of prepackages, in a randomly selected sample, that are under-filled by more than a permitted quantity is less than or equal to a permitted number (not more than 2.5%) These prepackages are known are referred to as ‘defectives.

6. Workshop on requirements for prepackaged products e-marked prepackages control Third rule No packages may contain less than the nominal quantity by more than twice the TNE TNE – tolerable negative error These packages are sometimes referred to as “inadequates”

7. Workshop on requirements for prepackaged products e-marked prepackages control Metrology control metrology officials are required to check whether prepackages in an inspection lot comply with these requirements by sampling prepackages at the point-of- pack, wholesale outlets and retail stores.

8. Workshop on requirements for prepackaged products e-marked prepackages Directive 76/211/EEC defines „prepackage ‟ in article 2 as being: “the combination of a product and the individual package in which it is prepacked”.

9. Workshop on requirements for prepackaged products e-marked prepackages The Directive also defines when a product is prepacked ‟ : 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

10. Workshop on requirements for prepackaged products e-marked prepackages Article 1 of the Directive specifies the prepackages that are controlled, they are prepackages containing products 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.

11. Workshop on requirements for prepackaged products e-marked prepackages The interpretation generally says that: prepackages bearing an e-mark shall comply with the Directive

12. Workshop on requirements for prepackaged products e-marked prepackages The Directive states, in article 3, that prepackages may bear the EEC sign or mark defined if they comply with the requirements of Annex I to the Directive, which covers labelling and quantity requirements.

13. Workshop on requirements for prepackaged products e-marked prepackages The Directive does not restrict the way the prepackages are sold apply equally to business-to-consumer transactions as well as business-to-business transactions

14. Workshop on requirements for prepackaged products e-marked prepackages Following prepackages are not considered to be e- marked: They are weighed out while the purchaser is present, for instance at the delicatessen counter, are in open packing material, for example a French loaf (baguette) prepackages not made up to a predetermined quantity and are individually weighed. These prepackages are generally referred to as „catchweight ‟ products, and the marked quantity is outside the above ranges of weight or volume, or is expressed in terms of length, area or number

15. Workshop on requirements for prepackaged products e-marked prepackages Table of tolerable negative errors (tolerances)

16. Workshop on requirements for prepackaged products System of prepackages control Controls are performed by: Competent departments Packers Importers Surveillance authorities

17. Workshop on requirements for prepackaged products System of prepackages control The supervision of the government is done through: Controls performed by Competent departments mostly at packer premises or on the premises of the importer or his agent established in the Community.

18. Workshop on requirements for prepackaged products System of prepackages control Competent department checks to ensure that prepackages comply with the requirements of the Directive

19. Workshop on requirements for prepackaged products System of prepackages control The checks shall cover the adequacy of the quantity control system This include: the labeling of the product, the accuracy and suitability of the equipment and whether it was adequately maintained, the adequacy of the records, and their accuracy by checking prepackages from the appropriate batch the quantity in prepackages.

20. Workshop on requirements for prepackaged products System of prepackages control Control frequency Checks on ‘e’ marked products and the quantity control system used for their production should be carried out at packers’ and importers’ premises generally at least once a year

21. Workshop on requirements for prepackaged products System of prepackages control Control frequency There are various ways of determining the frequency of visits, which include assessing the number of prepackages, the value of the product packed, the quality system in use and complaints received, the level of compliance found on visits.

22. Workshop on requirements for prepackaged products System of prepackages control Control frequency However frequency can depend on the risk the business poses and is related to:- the area of distribution, the value of the product the difficulty of packing, and the result of previous checks, including quantity control systems audits.

23. Workshop on requirements for prepackaged products System of prepackages control Control frequency A generic risking system is based on the following initial risk and frequency: sold from packer ‟ s premises - low risk - every 5 years regional distribution in a country - medium every 2 years international distribution - high risk - annually.

24. Workshop on requirements for prepackaged products System of prepackages control Checks are done by means of statistical sampling check 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 1 of Directive 76/211/EEC.

25. Workshop on requirements for prepackaged products System of prepackages control Methodology of testing destructive testing or non destructive testing Preferably non destructive tests are used.

26. Workshop on requirements for prepackaged products System of prepackages control Methodology of testing Destructive testing is carried out only in special cases e.g.: empty wrappings are not available to determine a tare or mass of wrappings vary significantly and consequently the average value is not easy to determine.

27. Workshop on requirements for prepackaged products System of prepackages control Methodology of testing Statistical method of the control generally means that: the number of samples taken from the butch to be controlled depends on the size of the butch which in practice determined from hourly production of a packing line. maximum size of a butch is limited to 10 000 pieces. the average value is then corrected by a coefficient depending on the method of statistic used

28. Workshop on requirements for prepackaged products System of prepackages control Advantages of sampling (statistical method) Inspection of the sample instead of the total lot reduction of costs possible choice of “test intensity” by a suitable operating characteristic

29. Workshop on requirements for prepackaged products System of prepackages control Reference test (Annex II, Dir. 76/211/EEC) Two requirements: REQUIREMENTS FOR MEASURING THE ACTUAL CONTENTS OF PREPACKAGES REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES

30. Workshop on requirements for prepackaged products System of prepackages control Measuring the actual content 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

31. Workshop on requirements for prepackaged products System of prepackages control Measuring the actual content 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

32. Workshop on requirements for prepackaged products System of prepackages control Checking batches Carried out by sampling 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.

33. Workshop on requirements for prepackaged products System of prepackages control Checking batches A batch of prepackages shall be considered acceptable if the results of both these checks satisfy the acceptance criteria.

34. Workshop on requirements for prepackaged products System of prepackages control Checking of the actual content 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.

35. Workshop on requirements for prepackaged products System of prepackages control Non-destructive testing – sampling plan

36. Workshop on requirements for prepackaged products System of prepackages control Destructive testing – sampling plan used only for batches of 100 or more

37. Workshop on requirements for prepackaged products System of prepackages control Checking of the average actual contents A batch of prepackages shall be considered acceptable for the purpose of this check if the mean value

38. Workshop on requirements for prepackaged products System of prepackages control Checking of the average actual contents is greater than the value:

39. Workshop on requirements for prepackaged products System of prepackages control Checking of the average actual contents

40. Workshop on requirements for prepackaged products System of prepackages control Checking of the average actual contents Criteria for acceptance or rejection of the batch of prepackages for checking the mean

41. Workshop on requirements for prepackaged products System of prepackages control Checking of the average actual contents Criteria for acceptance or rejection of the batch of prepackages for checking the mean

42. Workshop on requirements for prepackaged products System of prepackages control Manufacturer or the importer responsibilities concerning the actual content of the prepackage The manufacturer or the importer is responsible for ensuring that the prepackages meet the requirements

43. Workshop on requirements for prepackaged products System of prepackages control Importer in case of import from countries outside the EEA

44. Workshop on requirements for prepackaged products System of prepackages control It means that checks are needed to confirm that the equipment used to make up the prepackages is legal and suitable and that records are available for competent departments to verify Checks shall be so organized so as to effectively guarantee the quantity of product in a prepackage

45. Workshop on requirements for prepackaged products System of prepackages control Measuring During the filling the actual content of the prepackage is measured by means of a legal and suitable measurement instrument

46. Workshop on requirements for prepackaged products System of prepackages control recognizing procedures Methods of process control shall effectively ensure that the prepackages meet the requirements. The determination of whether this requirement is met is determined by the competent department based on an evaluation of the procedures.

47. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability The characteristics of filling and packing process are highly dependent upon the nature of the product which is packed the type of package and the way in which it is filled..

48. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability Characteristics such as the average quantity packed, and the variation of the individual packages round this average, give important indications for the quality of the process, and how it should be controlled..

49. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability The procedures have to ensure that, through control and correction of the packaging process, the e-marked prepackages that are put on the market satisfy the Directives’ requirements

50. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability Measurement results must be representative At least once an hour the average content of the produced prepackages must be determined and evaluated. The same applies for the number or percentage of prepackages with a content below the TU1 and TU2 limits.

51. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability Identification of variations of the production process Variations in the filling process that cause repackages to fail to meet the requirements must be identified In general a deviation must be detected within an hour, since every hour’s production must meet the requirements.

52. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability The measuring and sampling methods A packer must draw a sample of enough items of the running production on a regular basis. The content of each item in the sample is determined. Parts of this may be automated (for instance by using a checkweigher).

53. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability Sampling Frequency The sampling frequency depends on the deviation of the filling process and the number of adjustments, but it should be at least once an hour and after adjustment. In certain situations (for instance bottle filling carousels that can not be adjusted) a lower frequency might be possible. Checks must be carried out before the prepackages are distributed.

54. Workshop on requirements for prepackaged products System of prepackages control Procedures suitability Sample size The sample size can be calculated with following formula

55. Workshop on requirements for prepackaged products System of prepackages control

56. Workshop on requirements for prepackaged products System of prepackages control

57. Workshop on requirements for prepackaged products System of prepackages control Example:

58. Workshop on requirements for prepackaged products System of prepackages control Overfill The target quantity (nominal quantity + overfill) should be the greatest of : the nominal quantity TU1 + 2 x S TU2 + 3,72 x S

59. Workshop on requirements for prepackaged products System of prepackages control Overfill The target quantity (nominal quantity + overfill) should be the greatest of : the nominal quantity TU1 + 2 x S TU2 + 3,72 x S If the standard deviation is larger than target quantity – TU1 the standard deviation must be monitored.

60. Workshop on requirements for prepackaged products System of prepackages control Import (from third countries) The importer has the same responsibilities as a packer but they may not physically come into contact with the prepackages being imported. 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

61. Workshop on requirements for prepackaged products System of prepackages control Import (from third countries) Acceptable guarantees: a) evidence from a competent department in a Member State, b) evidence from an EEA accepted competent department in the exporting country, c) records of checks carried out by a competent sub-contractor at the place of first entry into the EEA, d) to obtain records from the packer and to carry out checks to verify the data contained in them.

62. Workshop on requirements for prepackaged products System of prepackages control Import (from third countries) Evidence shall state that the quantity control system had been assessed and that the controls and records guarantee compliance with the requirements.

63. Workshop on requirements for prepackaged products System of prepackages control Thank you for your attention Ivan Kříž ČMI ikriz@cmi.cz www.cmi.cz