℮-marked prepackaged products control and monitoring

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

e-marked prepackagescontrol 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. Workshop on requirements for prepackaged products

e-marked prepackagescontrol e-marked prepackages use average system • contents mustcomply with three important rules Workshop on requirements for prepackaged products

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

e-marked prepackagescontrol 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 than2.5%) These prepackages are known are referred to as ‘defectives. Workshop on requirements for prepackaged products

e-marked prepackagescontrol 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” Workshop on requirements for prepackaged products

e-marked prepackagescontrol 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. 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”. 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 naturewithout the purchaser being present, and • the quantity of product contained in the package has a predeterminedvalue and cannot be altered without the package either being opened orundergoing a perceptible modification 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 constantunit 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. Workshop on requirements for prepackaged products

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

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

e-marked prepackages The Directive does not restrict the way the prepackages aresold • apply equally to business-to-consumer transactions aswell as • business-to-business transactions 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 Workshop on requirements for prepackaged products

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

System of prepackages control Controls are performed by: • Competent departments • Packers • Importers • Surveillance authorities 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 premisesor • on the premises of the importer or • his agent established in the Community. Workshop on requirements for prepackaged products

System of prepackages control Competent department • checks to ensure that prepackages comply with the requirements of the Directive 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 adequatelymaintained, • the adequacy of the records, and their accuracy by checking prepackagesfrom the appropriate batch • the quantity in prepackages. Workshop on requirements for prepackaged products

System of prepackages control Control frequency • Checks on ‘e’ marked products and the quantity control system used for theirproduction should be carried out at packers’ and importers’ premises generally at leastonce a year 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. 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 systemsaudits. Workshop on requirements for prepackaged products

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

System of prepackages control Measuring the actual content The error made in measuring the actualcontents of a prepackage shall not exceed one-fifth of the tolerable negative error for the nominal quantity in the prepackage 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. Workshop on requirements for prepackaged products

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

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

System of prepackages control Destructive testing – sampling plan used only for batches of 100 ormore 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 thepurpose of this check if the mean value Workshop on requirements for prepackaged products

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

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

System of prepackages control Manufacturer or the importer responsibilities concerning the actual content of the prepackage • The manufacturer orthe importer isresponsible for ensuring that the prepackages meet the requirements Workshop on requirements for prepackaged products

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

System of prepackages control Procedures suitability The characteristics of filling and packing process arehighly dependent upon • the nature of the product which is packed • the type of package and • the way in which it is filled. . 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. . 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 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 bedetermined and evaluated. • The same applies for the number or percentage of prepackages with a content below the TU1 and TU2 limits. Workshop on requirements for prepackaged products

℮-marked prepackaged products control and monitoring