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What does the ‘e’ mark mean on a prepackage?
The ‘e’ mark on a prepackage means that the prepackage complies with the EU Council Directive 76/211/EEC or 75/106/EEC. These Directives set out requirements for the quantity of product in the prepackage, for labelling and controls. With the e-mark the manufacturer (or importer) guarantees that the prepackage originates from a batch with a quantity of product that meets the requirements of the Council Directives’ average principle, which has been agreed within the EEC area.
What does the average principle mean?
The average principle means that:
the prepackages on average do not contain less product than the quantity indicated on the package;
only a small number of prepackages contain less product than the quantity specified on the package minus the specified permissible error;
no prepackage contains less product than the quantity specified on the package minus twice the specified permissible error;
The specified permissible error relates to the nominal quantity (Qn).
What prepackages may bear the e-mark?
This relates to prepackages manufactured in batches where the quantity of product:
has a previously determined equal nominal quantity
is filled while the consumer is not present
is expressed in kg, g, l, cl or ml
lies between 5 g and 10kg or 5 ml and 10 l
What way can e-marked prepackages be put on the market?
measuring of the quantity of product of every prepackage at the time of packing, or
the use of a quantity control system for packing which is recognised by the national authority/Competent Department or
supervision of the packer (importer) by the national authorities/Competent Department.
Which departments supervise "e" pre-packaging?
In each Member State the Competent Department has different responsibilities. WELMEC Publication 6.0 gives guidance on the Competent Departments and their responsibilities.
Where can information be obtained?
In each Member State the Competent Department has different responsibilities. WELMEC Publication 6.0 gives guidance on this.
When may the ‘e’ sign be applied on a prepackage?
In some Member States permission is necessary before applying the e-mark. In others packers only need to inform their Competent Department. WELMEC Publication 6.0 gives guidance.
How can permission be obtained?
Contact the Competent Department in the country of packing/import.
Is the "e" regime mandatory?
In some Member States there is no difference between e-marked and non e-marked products. In others non e-marked prepackages must meet other requirements. Use of the "e"-regime is not compulsory under the law. The EU directives are "optional". If you wish to contact the Competent Department in your country.
What are the charges involved in using the ‘e’ sign?
Packers applying the e-mark for certification should be aware that they will have to pay any applicable charges themselves. Some Member States have different philosophies and do not impose charges. Contact the Competent Department in your country.
How does the assessment of the procedures of the quantity control system take place?
The assessment takes place in 2 phases, namely:
documentary assessment of the procedures followed by
practical assessment in the form of an on-site inspection by the evaluator In the event of approval this will result in recognition of the procedures.
What requirements do the procedures have to meet to be recognized?
The procedures of the quantity control system must be set up in such a way that, when properly applied, it is effectively ensured that the actual contents of the prepackages comply with the average principle. Requirements have been set for, among other things:
the procedures of the quantity control system itself;
the accuracy of the control measuring devices;
the sampling procedures;
the handling of the sample results.
WELMEC 6.6 gives more guidance.
The advantages and disadvantages of the ‘e’ regime for the packer
Advantages:
a single standard for the whole EEC area
the average principle
hallmark of correct filling
Disadvantages:
there may be an investment required in control resources and/or in
manpower
How must the data be recorded?
The general rule is that the records must show that the procedures of the procedures of the quantity control system are actually implemented as they were recognized:
a number of basic details must be recorded such as date, time, machine, product, quantity, etc.
the extent to which there is compliance with the average principle should be demonstrated;
it must be clearly stated which permitted corrections have been carried out and what the result of these were
The records must be clearly comprehensible and it must be kept for at least a year from the date on which they were created. Possible methods of recording measurement data are:
manual records on control sheets or control cards;
semi-automatic recording on a computer and printer linked to the control weighing device;
automatic recording using, for example, a checkweigher.
What is the size of a batch?
For practical reasons, the packer and the inspector define the size of the batch in different ways.
Inspector’s definition: when checking at the end of the packing line, the number of prepackages in each batch shall be equal to the maximum hourly output of the packing line, without any restrictions as to the batch size. In all other cases, the batch size shall be limited to 10 000 prepackages.
Packer’s definition: the packer can define the size of his batch according to his needs and his system for identifying prepackages belonging to the batch. The requirements for e-marking shall be fulfilled for any defined batch.
Density measurement of liquids in the company control system
If prepackaged liquids are checked by weighing and are converted to volume using density then the methodology for density measurement and the associated measurement devices must be included in the assessment of the company control system.
Which control measurement devices are generally used?
a non-automatic weighing instrument
a checkweigher
a automatic gravimetric filling instrument
a volumetric measure
an EEC measuring container bottle with accompanying measurement template.
If production is checked using random checks, how many samples must there be in the random check and how often must the random check be carried out?
The packer chooses the size and frequency of the random sample so long as he can demonstrate that the filling process is able to ensure effectively that the batches comply with the tolerances. A number of factors, which may be taken into consideration in this, are:
the stability of the production and/or filling process
the type of product
the filling rate
the number of filler heads
control of the filling process
destructive or non-destructive sampling
mechanical limitations
degree of over-filling
reporting time
batch or continuous process
corrective actions
targets
limits
set points
What are the mandatory requirements for the ‘e’ mark
the nominal quantity marked in figures which are sufficiently large;
the ‘e’ mark itself in the prescribed form and at least 3 mm high;
the unit of weight or volume in full or indicated by the correct symbol;
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
Desiccating and hygroscopic products
Member States have different philosophies regarding desiccating and hygroscopic products. In some Member States prepackages must meet the requirements at the time of packaging. In other Member States prepackages must meet the requirements at another moment in time. Packers should ask the Competent Department of their Member State.
Can the ‘e’ mark also refer to the drained weight of solids in liquids?
No, the ‘e’ mark only refers to the content (product plus surrounding liquid) of the prepackages at present, athough some countries allow the drained weight to be e-marked as well.