1. Organised in co-operation with Serbian Chamber of Commerce Technical characteristic of package and metric bottles for prepacked products Workshop on requirements for prepackaged products Belgrade, Republic of Serbia - June 2010

2. Workshop on requirements for prepackaged products Control of packing and filling Reasons to control Fulfillment of requirements set up for prepackages Effectiveness of production (reduction of overfilling)

3. Workshop on requirements for prepackaged products Factors of filling process Factors affecting process of control Sort of a product Price of product Batch size Possibility to regulate a filling line Way of packing

4. Workshop on requirements for prepackaged products Selection of control system Statistical control Sampling in a certain time period Usually used in: Lower and mean output Easy regulation High quality of filling process

5. Workshop on requirements for prepackaged products Selection of control system Statistical control Advantages: Lower acquisition costs Lower requirements on service

6. Workshop on requirements for prepackaged products Selection of control system Statistical control Disadvantages: qualified staff is needed random error can occur

7. Workshop on requirements for prepackaged products Selection of control system 100% control every single piece is control Can be used where: The regulation is difficult Filling process is problematic

8. Workshop on requirements for prepackaged products Selection of control system 100% control Advantages Avoiding random error Staff do not need to be so qualified

9. Workshop on requirements for prepackaged products Selection of control system 100% control Disadvantages High acquisition costs Higher requirements for service

10. Workshop on requirements for prepackaged products control system and basic terms Production batch Usually a hourly production Average A measure of filling process setting Standard deviation A measure of measuring process stability

11. Workshop on requirements for prepackaged products control system and basic terms Warning limits Action limits Zone of regulation Regulation interval

12. Workshop on requirements for prepackaged products control system and basic terms Warning limits When reached a warning that required values can be extent is provide Action: Higher sampling frequency or Control of filling process

13. Workshop on requirements for prepackaged products control system and basic terms Action limits When reached a regulation is necessary There is a exceeding limit risk

14. Workshop on requirements for prepackaged products control system and basic terms Zone of regulation a zone where regulation takes place this zone is determined by action limits

15. Workshop on requirements for prepackaged products control system and basic terms Regulation interval interval determined by a number of pieces after a number of pieces a regulation is carried out

16. Workshop on requirements for prepackaged products control system Influence of a product (control selection) 100% control High density, adhesion Inhomogenity of products Regulation is difficult

17. Workshop on requirements for prepackaged products control system Influence of a product (control selection) Statistical control Liquids, inadhesive materials homogenous products Regulation is relatively easy

18. Workshop on requirements for prepackaged products Evaluation of control process Quantity evaluated Interval statistic (pieces or minutes) Daily – influence of operators Monthly and annually - economics indicators Batch statistics Depends on batch size Product statistics Characteristic of products and process of production is taken into account

19. 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..

20. 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..

21. 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.

22. 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.

23. 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).

24. 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.

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

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

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

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

29. 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

30. 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.

31. Workshop on requirements for prepackaged products Use of MCB in packing process RESPONSIBILITY OF THE PACKER OR IMPORTER The packer or importer shall be responsible for ensuring that prepackages meet the requirements 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

32. Workshop on requirements for prepackaged products Use of MCB in packing process RESPONSIBILITY OF THE PACKER OR IMPORTER 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

33. Workshop on requirements for prepackaged products Use of MCB in packing process RESPONSIBILITY OF THE PACKER OR IMPORTER 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

34. Workshop on requirements for prepackaged products MCB – 75/107/EEC MCB – Measuring Container Bottle Covered by Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers

35. Workshop on requirements for prepackaged products MCB – 75/107/EEC MCB – Measuring Container Bottle MCB which bear the reversed epsilon sign “э” have to meet the requirements of the Directive.

36. Workshop on requirements for prepackaged products MCB – 75/107/EEC MCB – Measuring Container Bottle Requirements: a) the average volume each bottle contains and the variability of the volume in a batch of MCB, b) the markings on the bottles, c) an approved mark to identify the manufacturer

37. Workshop on requirements for prepackaged products MCB – 75/107/EEC MCB – Definition bottles, of glass or other rigid and stable substance, that are designed to be stoppered, and intended for storage, transport or delivery of liquids, have a nominal capacity between 0.05 L and 5 L inclusive, that when filled to a specified level or specified percentage of their brim capacity, can measured with sufficient accuracy.

38. Workshop on requirements for prepackaged products MCB – 75/107/EEC MCB – not covered by this definition bottles made of flexible materials, such as thin plastic material, bottles that are not designed to be capped or stoppered, bottles used for non-liquid products, such as thick sauces, bottles with a capacity less than 50 ml or more than 5 L, bottles that are not manufactured to measure with sufficient accuracy.

39. Workshop on requirements for prepackaged products MCB – 75/107/EEC MCB having „3 ‟ have to: meet the requirements of the Directive, and be subject to metrological control specified in the Annexes

40. Workshop on requirements for prepackaged products MCB – 75/107/EEC Directive on prepackages and MCB Directive 76/211/EEC on prepackages permits using of MCB when making up prepackages, where the quantity is expressed in units of volume, when filled to the appropriate fill level.

41. Workshop on requirements for prepackaged products MCB – 75/107/EEC Non „3 ‟ marked MCB They do not have to meet the requirements nor be subject to metrological controls. But these cannot be used as measures for the purposes of Directive 76/211/EEC. Free movement is not allowed under the Directive

42. Workshop on requirements for prepackaged products MCB – 75/107/EEC Free movement of MCB No Member Sate may refuse, prohibit or restrict the marketing and use of MCB which satisfy the requirements and tests specified in the Directive for reasons of: their volume, the determination of their volume, or the methods by which they have been checked

43. Workshop on requirements for prepackaged products MCB – 75/107/EEC Technical Requirements The nominal capacity Vn the volume which is marked on the bottle; the volume which the MCB is deemed to contain when it is filled in the conditions of use for which it is intended ‟. The Brim Capacity the volume of liquid it contains when filled to the brim, and The Actual Capacity the volume of liquid that contains when it is filled exactly under the conditions corresponding theoretically to the nominal capacity.

44. Workshop on requirements for prepackaged products MCB – 75/107/EEC Methods of filling bottles to a constant level, where liquid is introduced and the MCB is filled up to the stated fill height, and to a constant vacuity, where the MCB is filled to the brim and then a specific quantity is removed.

45. Workshop on requirements for prepackaged products MCB – 75/107/EEC In order to meet the Directive 76/211/EEC requirements for prepackages, the maximum permissible errors (both positive and negative) are specified. These errors relate to the differences between the nominal capacity and the actual capacity when filled as specified, at the standard temperature of 20 o C.

46. Workshop on requirements for prepackaged products MCB – 75/107/EEC Maximum permissible errors

47. Workshop on requirements for prepackaged products MCB – 75/107/EEC Maximum permissible errors Manufacturers cannot use systematic exploitation of tolerances

48. Workshop on requirements for prepackaged products MCB – 75/107/EEC Determination of the MCB actual capacity measuring the quantity of water at 20oC which the MCB actually contains when filled to the level theoretically corresponding to the nominal capacity weighing the quantity of a liquid of known density needed to the fill the MCB to the required level, and determining the volume by dividing this weight by the density

49. Workshop on requirements for prepackaged products MCB – 75/107/EEC „3 ‟ mark on an MCB is certifying that the bottle meets all the requirements of the Directive generally moulds increase in size as they wear, and a manufacturer needs to have a suitable system in place to ensure that the Directives accuracy requirements are met

50. Workshop on requirements for prepackaged products MCB – 75/107/EEC Competent department Is responsible for : approving marks, notifying other competent departments and the Commission of the marks that have been approved, and checking that MCB comply with the provisions of the Directive – statistical check- reference method

51. Workshop on requirements for prepackaged products MCB – 75/107/EEC Control using MCB The uncertainty of measurement, from both the error permitted on the MCB and the measurement of the liquid level, must be taken into account when establishing the appropriate fill height and control limits.

52. Workshop on requirements for prepackaged products MCB – 75/107/EEC Control using MCB Unless other means of controlling the contents are employed, MCB can only be used for monitoring content fill if they are used with a certificated template.

53. Workshop on requirements for prepackaged products MCB – 75/107/EEC The template must bear the following inscriptions identity mark, identity of MCBs for which it is to be used the nominal quantity being packed graduations to permit the determination of fill quantity errors the operational temperature of the liquid, and if that temperature is not 20 0C, a description of the liquid and the apparent thermal co-efficient of cubical expansion 24 by reference to which the template has been graduated. if it is to be used over a closure a statement to that effect and the identity of the closure

54. Workshop on requirements for prepackaged products MCB – 75/107/EEC Setting the target fill volume The packer should take into account following : variation in the filling process variation in the MCBs, and possible error in determining the fill height using the template

55. Workshop on requirements for prepackaged products Thank you for your attention Ivan Kříž ČMI ikriz@cmi.cz www.cmi.cz