MAKING-UP BY WEIGHT OR BY VOLUME OF CERTAIN PREPACKAGED PRODUCTS REGULATIONS

MAKING-UP BY WEIGHT OR BY VOLUME

OF CERTAIN PREPACKAGED PRODUCTS

SUBSIDIARY LEGISLATION 454.13

MAKING-UP BY WEIGHT OR BY VOLUME OF

CERTAIN PREPACKAGED PRODUCTS

REGULATIONS

15th September, 2006 *

LEGAL NOTICE 417 of 2002, as amended by Legal Notice 209 of 2008.

The title of these regulations is the Making-Up by Weight

or By Volume of Certain Prepackaged Products Regulations.

For the purposes of these regulations, all the definitions in

the Malta Standards Authority Act shall apply, and in addition, in

these regulations, unless the context otherwise requires

"prepackage" shall mean the combination of a product and the

individual package in which it is prepacked;

"prepacked product" shall refer to a product which 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

w i t h o u t t h e p a c k a g e e i t h e r b e i n g o p e n e d o r u n d e rg o i n g a

perceptible modification

These regulations relate to prepackages containing

products intended for sale in constant unit nominal quantities

which are

(a) equal to values predetermined by the packer,

(b) expressed in units of weight or volume,

(c) not less than 5 g or 5 ml and not more than 10 kg or 10

litres.

(1) The prepackages which may bear the EEC sign

specified in regulation 3(3) of Annex I are those which comply

with these regulations and with Annex I thereto.

(2) They shall be subject to metrological control under the

conditions defined in Annex 1. section 5 and Annex II.

(1) All prepackages referred to in regulation 4 must, in

accordance with Annex I bear an indication of the weight or

volume of the product, known as 'nominal weight' or 'nominal

volume', which they are required to contain.

(2) Prepackages containing liquid products shall be marked

with their nominal volume and prepackages containing other

products shall be marked with their nominal weight, except in the

case of trade practice.

*See regulation 1(2) of these regulations as originally promulgated, and Legal Notice

218 of 2006.

MAKING-UP BY WEIGHT OR BY VOLUME

OF CERTAIN PREPACKAGED PRODUCTS

(3) If trade practice or national regulations are not the same in

Malta and the country of destination for a category of products or

for a type of prepackage, those prepackages must at least show the

metrological information corresponding to the trade practice or

national regulations prevailing in thc country of destination.

The Authority may not refuse, prohibit or restrict the

placing on the market of prepackages which satisfy the

requirements and tests laid down in these regulations for reasons

concerning the markings requircd to be borne by such prepackages

pursuant to these regulations, the determination of their volume or

weight, or the methods by which they have been measured or

checked.

ANNEX I

1. OBJECTIVES

Prepackages covered by these regulations shall be made up in such a way that the

completed packages satisfy the following requirements

1.1.

The actual contents shall not be less, on average, than the nominal

quantity;

1.2.

The proportion of prepackages having a negative error greater than the

tolerable negative error laid down in 2.4 shall be sufficiently small for batches of

prepackages to satisfy the requirements of the tests specified in Annex II;

1.3.

No prepackage having a negative error greater than twice the tolerable

negative error given in the table in 2.4 may bear the EEC sign provided for in 3.3.

2. DEFINITIONS AND BASIC PROVISIONS

2.1.

The nominal quantity (nominal weight or nominal volume) of the

contents of a prepackage is the weight or volume indicated on the prepackage, i.e.

the quantity of product which the prepackage is deemed to contain.

2.2.

The actual contents of the prepackage are the quantity (weight or

volume) of product which it in fact contains. In all operations for checking quantities

of products expressed in units of volume, the value employed for the actual contents

shall be measured at or corrected to a temperature of 20°C, whatever the temperature

at which packaging or checking is carried out. However, this rule shall not apply to

deep frozen or frozen products, the quantity of which is expressed in units of

volume.

2.3.

The negative error of a prepackage is the quantity by which the actual

contents of the prepackage are less than the nominal quantity.

2.4.

The tolerable negative error in the contents of a prepackage is fixed in

accordance with the table below

Tolerable negative error

Nominal quantity Qn in grams or millilitres

as % of Q n

g or ml

5 to 50

-

from 50 to 100

-

4.5

from 100 to 200

4.5

-

from 200 to 300

-

from 300 to 500

-

from 500 to 1 000

-

from 1 000 to 10 000

1.5

-

When using the table, the values of the tolerable negative errors shown as

percentages in the table, calculated in units of weight or volume, shall be rounded up

to the nearest one-tenth of a gram or millilitre.

3. INSCRIPTIONS AND MARKINGS

All prepackages made up in accordance with these regulations shall bear on the

package the following markings affixed in such a manner as to be indelible, easily

legible and visible on the prepackage in normal conditions of presentation

3.1.

the nominal quantity (nominal weight or nominal volume) expressed in

kilograms, grams, litres, centilitres or millilitres, and marked in figures at least 6

mm high if the nominal quantity exceeds 1 000 g or 100 cl, 4 mm high if it is from

MAKING-UP BY WEIGHT OR BY VOLUME

OF CERTAIN PREPACKAGED PRODUCTS

1000 or 100 cl inclusive down to but not including 200 g or 20 cl, 3 mm high if it is

from 200 g or 20 cl down to but not including 50 g or 5 cl, 2mm high if it is not more

than 50 g or 5 cl, followed by the symbol for the unit of measurement used or where

appropriate by the name of the unit in accordance with Schedule 1 of the Metrology

Act;

markings in imperial (UK) units shall be in letters and figures of dimensions not

larger than those of the corresponding markings in SI units.

3.2. 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;

3.3. a small 'e', at least 3 mm high, placed in the same field of vision as the

indication of the nominal weight or nominal volume, constituting a guarantee by the

packer or the importer that the prepackage meets the requirements of these

Regulations.

This letter shall have the form shown in the drawing contained in item 3 of Annex

II to the Measuring Instruments and Methods of Metrological Control Regulations.

Regulation 12 of these latter regulations shall apply mutatis mutandis.

4. RESPONSIBILITY OF THE PACKER OR IMPORTER

The packer or importer shall be responsible for ensuring that prepackages meet the

requirements of these regulations.

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. The measurement or check shall be

carried out by means of a legal measuring instrument suitable for effecting the

necessary operations.

The check may be carried out by sampling.

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.

This condition is fulfilled if the packer carries out production checks in

accordance with procedures recognized by the competent departments and if he

holds at the disposal of those departments the documents containing the results of

such checks, in order to certify that these checks, together with any corrections and

adjustments which they have shown to be necessary, have been properly and

accurately carried out.

In the case of imports from non-EU 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.

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

regulations relating thereto, filled under the conditions prescribed in those

regulations and herein.

5. CHECKS TO BE CARRIED OUT BY THE COMPETENT

DEPARTMENTS ON THE PREMISES OF THE PACKER OR OF THE IMPORTER

OR OF HIS AGENT ESTABLISHED IN MALTA

Checks to ensure that the prepackages comply with the provisions of these

regulations shall be carried out by the competent departments by sampling on the

packer’s premises or, if this is not practicahle, on the premises of the importer or of

his agent established in Malta.

This statistical sampling check shall be 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 II.

Thus as regards the criterion (or the minimum contents, a sampling plan used by

the Authority shall be regarded as comparable with that recommendcd in Annex II if

the abscissa of the 0.10 ordinate point of the operating characteristics curve of the

first plan (probability of acceptance of the batch = 0.10) deviates by less than 15%

from the abscissa of the corresponding point of the operating characteristic curve of

the sampling plan recommended in Annex II.

As regards the criterion for the mean calculated by the standard deviation method

a sampling plan used by the competent Authority shall be regarded as comparable

w i t h t h a t r e c o m m e n d e d i n A n n ex I I i f , t a k i n g i n t o a c c o u n t t h e o p e r a t i n g

characteristic curves of the two plans having as the abscissa axis

Qn - m

s

* the abscissa of the 0.10 ordinate point of the curve of the first plan (acceptance

probability of the batch = 0.10 ) deviates by less than 0.05 from the abscissa of the

corresponding point of the curve of the sampling plan recommended in Annex II.

6. OTHER

CHECKS

CARRIED

OUT

BY

THE

COMPETENT

DEPARTMENTS

These Regulations shall not preclude any checks which may be carried out by the

competent departments at any stage in the marketing process, in particular for the

purpose of verifying that prepackages meet the requirements of the Regulations.

Regulation 15(2) of the Measuring Instruments and Methods of Metrological

Control Regulations shall apply mutatis mutandis.

ANNEX II

This Annex lays down the procedures of the reference method for statistical

checking of batches of prepackages in order to meet the requirements of regulation 5

of these regulations and of item 5, Annex I thereto.

1. REQUIREMENTS FOR MEASURING THE ACTUAL CONTENTS OF

PREPACKAGES

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.

Irrespective of the method used, 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.

The procedure for measuring the actual contents of a prepackage may be the

subject of domestic regulations.

*m = actual batch mean.

MAKING-UP BY WEIGHT OR BY VOLUME

OF CERTAIN PREPACKAGED PRODUCTS

2. REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES

The checking of prepackages shall be carried out by sampling and shall be 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.

A batch of prepackages shall be considered acceptable if the results of both these

checks satisfy the acceptance criteria.

For each of these checks, there arc two sampling plans

•

one for non-destructive testing, i.e., testing which does not involve

opening the package,

•

the other for destructive testing, i.e., testing which involves

opening or destroying the package.

For economic and practical reasons, the latter test shall be limited to the

absolutely essential minimum; it is less effective than the non-destructive test.

Destructive testing shall therefore be used only when non-destructive testing is

impracticable. As a general rule it shall not be applied to batches of fewer than 100

units.

2.1.

Prepackage batches

2.1.1.

The batch shall comprise all the prepackages of the same nominal

quantity, the same type and the same production run, packed in the same place,

which are to be inspected. The batch size shall be limited to the amounts laid down

below.

2.1.2.

When prepackages are checked at the end of the packing line, the number

in each batch shall be equal to the maximum hourly output of the packing line,

without any restriction as to batch size.

In other cases the batch size shall be limited to 10 000.

2.1.3.

For batches of fewer than 100 prepackages, the non-destructive test,

where carried out, shall be 100%

2.1.4.

Before the tests in 2.2 and 2.3 are carried out, a sufficient number of

prepackages shall be drawn at random from the batch so that the check requiring the

larger sample can be carried out.

For the other check, the necessary sample shall be drawn at random from the first

sample and marked.

This marking operation shall be completed before the start of measuring

operations.

2.2.

Checking of the actual contents of a prepackage

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.

2.2.1.

Non-destructive testing

Non-destructive testing shall be carried out in accordance with a double sampling

plan as shown in the table below

The first number of prepackages checked shall be equal to the number of units in

the first sample, as indicated in the plan

if the number of detective units found in the first sample is less

than or equal to the first acceptance criterion, the batch shall be

considered acceptablc for the purpose of this check,

if the number of detective units found in the first sample is equal to

or greater than the first rejection criterion, the batch shall be

rejected,

if the number of defective units found in the first sample lies

between the first acceptance criterion and the first rejection

criterion, a second sample shall be checked, the number of units in

which is indicated in the plan.

The defective units found in the first and second samples shall be added together

if the aggregate number of defective units is less than or equal to

the second acceptance criterion, the batch shall be considered

acceptable for the purpose of this check,

if the aggregate number of defective units is greater than or equal

to the second rejection criterion, the batch shall be rejected.

Samples

Number of defective units

Number

Order

Number

Aggregate Acceptance

Rejection

in batch

number

criterion

criterion

1st

100 to 500

2nd

1st

501 to 3 200

2nd

1st

3 201 and

over

2nd

Destructive testing

Destructive testing shall be carried out in accordance with the single sampling

plan below and shall be used only for batches of 100 or more.

The number of prepackages checked shall be equal to 20.

If the number of defective units found in the sample is less than or

equal to the acceptance criterion. the batch of prepackages shall be

considered as acceptable.

If the number of defective units found in the sample is equal to or

greater than the rejection criterion, the batch of prepackages shall

be rejected.

Number of defective units

Number in

Number in

Acceptance

Rejection

batch

sample

criterion

criterion

Whatever the

number ( > 100 )

Checking of the average actual contents of the individual prepackages

MAKING-UP BY WEIGHT OR BY VOLUME

OF CERTAIN PREPACKAGED PRODUCTS

making up a batch

2.3.1.

A batch of prepackages shall be considered acceptable for the purpose of

this check if the mean value

Σ x i

x =

n

of the actual contents x i of n prepackages in a sample is greater than the value

s

Q n -

· t

√ n (1 - a)

In this formula

Q n

the nominal quantity for prepackage,

n

he number of prepackages in the sample for this check,

s

the estimated standard deviation of the actual contents of the batch,

t (1 - a)

0.995 confidence level of a Student distribution with v = n - l degree of

freedom.

2.3.2.

If x 1 is the measured value for the actual contents of the i-th item in the

sample containing n items then

2.3.2.1. the mean of the measured values for the sample is obtained by the

following calculation

n

Σ

x =

X i

n

i = 1

2.3.2.2. and the estimated value of the standard deviation s by the following

calculation

•

the sum of the squares of the measured values

n

X i2

Σ

i = 1

•

the square of the sum of the measured values

n

(

)

Σ

X i

i = 1

then

n

(

)

Σ

X i

n

i = 1

•

the corrected sum

n

n

(

)

Σ X i -

Σ

X i

SC =

n

i = 1

i = 1

•

the estimated variance

SC

v =

n - 1

the estimated value of the standard deviation is

√ v

s =

2.3.3.

Criteria for acceptance or rejection of the batch of prepackages for

checking the mean

2.3.3.1. Criteria for non-destructive testing

Criteria

Number in

Number in batch

sample

Acceptance

Rejection

x > Q n - 0.503s

x < Q n - 0.503s

100 to 500

(inclusive) > 500

x > Q n - 0.379s

x < Q n - 0.379s

2.3.3.2. Criteria for destructive testing

Criteria

Number in

Number in batch

sample

Acceptance

Rejection

Whatever the

x > Q n - 0.640s

x < Q n - 0.640s

number ( > 100)