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Organised in co-operation w ith Serbian Chamber of Comm erce -marked prepackaged -marked prepackaged products control and products control and monitoring monitoring Workshop on requirements for Workshop on requirements for prepackaged products prepackaged products Belgrade, Republic of Serbia Belgrade, Republic of Serbia - - June June 2010 2010

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Page 1: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Organised in co-operation with Serbian Chamber of Commerce

℮℮-marked prepackaged products -marked prepackaged products control and monitoringcontrol and monitoring

Workshop on requirements for prepackaged Workshop on requirements for prepackaged productsproducts

Belgrade, Republic of SerbiaBelgrade, Republic of Serbia - - June 2010June 2010

Page 2: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 3: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

e-marked prepackages control

e-marked prepackages use average system

contents must comply with three important rules

Page 4: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

e-marked prepackages control

First ruleThe 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)

Page 5: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

e-marked prepackages control

Second ruleThe 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.

Page 6: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

e-marked prepackages control

Third ruleNo 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”

Page 7: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 8: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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”.

Page 9: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 10: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 11: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

e-marked prepackages

The interpretation generally says that:

prepackages bearing an e-mark shall comply with the Directive

Page 12: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 13: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 14: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 15: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

e-marked prepackages

Table of tolerable negative errors (tolerances)

Page 16: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Controls are performed by:

Competent departments Packers Importers Surveillance authorities

Page 17: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 18: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Competent department

checks to ensure that prepackages comply with the requirements of the Directive

Page 19: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 20: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 21: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 22: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 23: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 24: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 25: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 26: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 27: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 28: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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 costspossible choice of “test intensity” by a

suitable operating characteristic

Page 29: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 30: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 31: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 32: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 33: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 34: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 35: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Non-destructive testing – sampling plan

Page 36: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Destructive testing – sampling plan

used only for batches of 100 or more

Page 37: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 38: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Checking of the average actual contents

is greater than the value:

Page 39: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Checking of the average actual contents

Page 40: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 41: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 42: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 43: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Importerin case of import from countries outside

the EEA

Page 44: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 45: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 46: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 47: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

.

Page 48: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

.

Page 49: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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

Page 50: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 51: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 52: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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).

Page 53: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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 beadjusted) a lower frequency might be possible.

Checks must be carried out before the prepackages are distributed.

Page 54: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Procedures suitability

Sample sizeThe sample size can be calculated with

following formula

Page 55: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Page 56: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Page 57: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Example:

Page 58: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Overfill

The target quantity (nominal quantity + overfill) should be the greatest of :

the nominal quantityTU1 + 2 x STU2 + 3,72 x S

Page 59: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 60: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Import (from third countries)

The importer has the same responsibilities as a packerbut they may not physically come into contact with theprepackages 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

Page 61: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 62: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

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.

Page 63: Organised in co-operation with Serbian Chamber of Commerce ℮-marked prepackaged products control and monitoring Workshop on requirements for prepackaged

Workshop on requirements for prepackaged products

System of prepackages control

Thank you for your attention

Ivan Kříž

ČMI

[email protected]

www.cmi.cz