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SUBSIDIARY LEGISLATION 231.31
MATERIALS AND ARTICLES IN CONTACT
WITH FOODSTUFFS REGULATIONS
1st January, 1997
Legal Notice 4 of 1996.
Title.
Contact with Foodstuffs  Regulations.
Scope.
which, in their finished state, are brought or are intended to be
brought into contact with foodstuffs or with water which, in either
case, are intended for human consumption.
(2) These regulations shall not apply to:
( a ) covering or coating substances, including the
substances covering cheese rinds, prepared meat
products or fruit, which form part of foodstuffs and
may be consumed together with those foodstuffs;
( b ) fixed public or private water supply equipment.
Interpretation.
"ceramic articles" means articles manufactured from a mixture of
inorganic materials with a generally high argillaceous or silicate
content to which small quantities of organic materials may have
been added; these articles are first shaped, the shape thus obtained
being permanently fixed by firing and they may be glazed,
enamelled and/or decorated;
"EEC" as used in these regulations and in the Schedules thereto
means the European Economic Community;
Cap. 231.
"foodstuffs" has the same meaning as is attributed to "food" in
article 2 of the Food, Drugs and Drinking Water Act;
"N-nitrosatable substances" means substances capable of being
converted into N-nitrosamines;
"not detectable" means that the analyte should not be detected by
a validated method of analysis which should detect it at the
detection limit specified;
"plastics" means the organic macromolecular compounds
obtained by polymerization, polycondensation, polyaddition or any
other similar process from molecules with a lower molecular
weight or by chemical alteration of natural macromolecules, and
includes silicones and other similar macromolecular compounds to
which other substances or matter may be added, but does not
include:
- varnished or unvarnished regenerated cellulose film;
- elastomers and natural and synthetic rubber;
- paper and paperboard, whether modified or not by the
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addition of plastics;
- surface coatings obtained from:
- paraffin waxes, including synthetic paraffin
waxes and/or micro-crystalline waxes; or
- mixtures of such waxes with each other and/or
with plastics;
- ion-excnange resins;
"regenerated cellulose film" means a thin sheet material obtained
from a refined cellulose derived from unrecycled wood or cotton
and to which suitable substances may be added either in the mass or
on the surface to meet technical requirements and which may be
coated on one or both sides;
"validated method" means an analytical method which is proven
to give precise and accurate results.
Manufacture of 
materials and 
articles.
4. Materials and articles must be manufactured in compliance
with good manufacturing practice so that, under their normal or
foreseeable conditions of use, they do not transfer their constituents
to foodstuffs in quantities which could -
(i) endanger human health;
(ii) bring about an unacceptable change in the composition
of the foodstuff or a deterioration in the organoleptic
characteristics thereof.
Groups of 
materials and 
articles.
5. The groups of materials and articles listed in the First
Schedule and, where appropriate, combinations of these materials
and articles, shall be subject to the provisions of these regulations.
Materials and 
articles not already 
in contact with 
foodstuffs.
6. (1) Without prejudice to any exceptions provided for in
these regulations, materials or articles intended to come into, but
not already in contact with foodstuffs may not be sold or imported
unless accompanied by a label or other indication bearing:
( a ) the words "for food use", or
- a specific indication as to their use, such as
coffee-machine, wine bottle, soup spoon, or
- a symbol as indicated in the Second Schedule
( b ) where appropriate, any special conditions to be
observed when they are being used;
( c ) either the name or trade name and address or
registered office,
- or the registered trade mark
of the manufacturer or processor, or of a seller
established in Malta.
(2) At the retail stage to the ultimate consumer, particulars
listed in sub-regulation (1) must be conspicuous, clearly legible and
indelible and shall appear -
( a ) on the materials or articles or on their packaging; or
( b ) on labels affixed to the materials or articles or to their
packaging; or
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( c ) on a notice in the immediate vicinity of the materials
and articles and clearly visible to the purchasers:
Provided that, in respect of those particulars referred to in
sub-regulation (1)( c ), the option in sub-regulation (2)( c ) shall only
apply if these particulars or a label bearing them, cannot, for
technical reasons, be affixed to the said materials or articles.
(3) At the marketing stages other than the retail stage to the
ultimate consumer the following provisions shall apply:
( a ) materials or articles must be accompanied by a written
declaration attesting that they comply with the rules
applicable to them, and
( b ) in addition, the particulars listed in sub-regulation (1)
shall appear:
(i) on the accompanying documents, and
(ii) on the labels or packaging, or
(iii) on the materials or articles themselves.
(4) The particulars listed in sub-regulation (1)( a ) and the
provision referred to in sub-regulation (3)( a ) shall not be
compulsory for materials or articles which by their nature are
clearly intended to come into contact with foodstuffs.
(5) The particulars provided for in sub-regulation (1)( a ) and
( b ) shall be confined to materials or articles which comply -
( a ) with the criteria laid down in regulation 4, and
( b ) with those provisions in these regulations relating to
the specific group of materials or articles.
(6) The particulars required in this regulation shall be given in,
at least, one of the official languages of Malta. This requirement
does not however preclude the use of other languages in addition to
the language or languages of Malta.
Limits for vinyl 
chloride monomer.
7. (1) Materials or articles prepared with vinyl chloride
polymers or copolymers must not contain vinyl chloride monomer
in a quantity exceeding 1 milligram per kilogram in the final
product.
(2) Materials or articles referred to in sub-regulation (1) must
not pass on to foodstuffs which are in or have been brought into
contact with such materials or articles, any vinyl chloride in a
quantity equal to or in excess of 0.01 mg per kilogram of the
foodstuff.
(3) The methods of analysis for the determination of the vinyl
chloride levels referred to in sub-regulations (1) and (2) shall be as
laid down in the European Community Directives 80/766/EEC and
81/432/EEC respectively. The determination of vinyl chloride
released by materials or articles to foodstuffs referred to in sub-
regulation (2) shall preferably be determined in the foodstuffs
themselves, except that, when such determination is shown to be
impossible for technical reasons, determination by simulants for
these particular foodstuffs is permitted.
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Plastic materials 
and articles.
8. (1) Materials or articles consisting exclusively of plastics,
or composed of two or more layers of materials, each consisting
exclusively of plastics, which are bound together by means of
adhesives or by any other means, shall not transfer their
constituents to foodstuffs in quantities exceeding 10 milligrams per
square decimetre (mg/dm 2 ) of surface area of material or article
(overall migration limit):
Provided that, this limit shall be 60 milligrams of the
constituents released per kilogram of foodstuff in the following
cases:
- articles which are containers or are comparable to
containers or which can be filled, with a capacity of
not less than 500 millilitres and not more than 10
litres;
- articles which can be filled and for which it is
impracticable to estimate the surface area in contact
with foodstuffs;
- caps, gaskets, stoppers or similar devices for sealing.
(2) The provisions of this regulation shall not apply to
materials and articles composed of two or more layers, one or more
of which does not consist exclusively of plastics, even if the one
intended to come into direct contact with foodstuffs does consist
exclusively of plastics.
(3) ( a ) Only those monomers and other starting substances
listed in Sections A and B of the Third Schedule may
be used for the manufacture of plastic materials and
articles subject to the restrictions specified therein:
Provided that the starting substances listed in
Section B of the said Schedule shall not be so used
after the 1st January 1997.
( b ) The quantities specified in column 4 of Sections A and
B of the Third Schedule shall be determined by a
validated method of analysis at the specified limit.
(4) An initial list of additives which may be used for the
manufacture of plastic materials and articles is set out in the Fourth
Schedule.
(5) The specific migration limits laid down in the list set out in
the Third Schedule are expressed in milligrams per kilogram (mg/
kg). Such limits are expressed in milligrams per square decimetre
(mg/dm 2 ) in the following cases:
- articles which are containers or are comparable to
containers or which can be filled, with a capacity of
less than 500 millilitres or more than 10 litres;
- sheet, film or other materials which cannot be filled or
for which it is impracticable to estimate the
relationship between the surface area of such materials
and the quantity of foodstuff in contact therewith.
In these cases, the limits set out in the Third Schedule
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expressed in mg/kg shall be divided by the conventional conversion
factor of 6 in order to express them in mg/dm 2 .
(6) Verification of compliance with the migration limits shall
be carried out in accordance with the rules laid down in European
Community Directives 82/711/EEC, 85/572/EEC and 90/128/EEC.
(7) Verification of compliance with the specific migration
limits laid down in the Third Schedule shall not be compulsory, if -
- it can be established that compliance with the overall
migration limit laid down in sub-regulation (1) implies
that the specific migration limits are not exceeded; or
- if it can be established that, by assuming complete
migration of the residual substance in the material or
article, it cannot exceed the specific limit of migration.
Regenerated 
cellulose film.
9. (1) The provisions of this regulation shall apply to
regenerated cellulose film, which either - 
- constitutes a finished product in itself; or
- forms part of a finished product containing other
materials,
and which is intended to come into contact with foodstuffs, or
which,  by virtue of its purpose, does come into such contact.
(2) The provisions of this regulation shall not apply to:
- regenerated cellulose film which on the side intended
to come into contact with foodstuffs or which, by
virtue of its purposes does come into such contact, has
a coating exceeding 50mg/dm 2 ;
- synthetic casings of regenerated cellulose.
(3) Only those substances or groups of substances listed in the
Fifth Schedule may be used for the manufacture of regenerated
cellulose film and only under the conditions laid down therein:
Provided that, substances other than those listed in the
Fifth Schedule may be used when these substances are employed as
colouring matter (dyes and pigments) or as adhesives, provided that
there is no trace of migration of the substances into or onto
foodstuffs, detectable by a validated method.
(4) Printed surfaces of regenerated cellulose film shall not
come into contact with the foodstuffs.
Ceramics.
ceramic articles shall not exceed the limits laid down in sub-
regulation (3). Such quantities shall be determined by the methods
laid down in European Community Directive 84/500/EEC.
(2) Where a ceramic article consists of a vessel fitted with a
ceramic lid, the lead and/or cadmium limit which may not be
exceeded (in mg/dm 2  or mg/l) shall be that which applies to the
vessel alone. The vessel alone and the inner surface of the lid shall
be tested separately and under the same conditions. The sum of the
two lead and/or cadmium extraction levels thus obtained shall be
related as appropriate to the surface area or the volume of the
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vessel alone.
(3) A ceramic article shall be recognised as satisfying the
requirements of this regulation if the quantities of lead and/or
cadmium extracted as described in the preceding sub-regulations do
not exceed the following limits:
- Category 1: This category comprises:
(i) articles which cannot be filled, and
(ii) articles which can be filled, the internal depth of
which, measured from the lowest point to the
horizontal plane passing through the upper rim,
does not exceed 25 mm:
0.8 mg/dm 2  for lead
0.07 mg/dm 2  for cadmium
- Category 2: All other articles which can be filled:
4.0 mg/l for lead
0.3 mg/l for cadmium
- Category 3: This category comprises:
(i) cooking ware, and
(ii) packaging and storage vessels having a capacity
of more than three litres.
1.5 mg/1 for lead
0.1 mg/1 for cadmium
Provided that, if a ceramic article exceeds the above
quantities by less than 50%, that article shall nevertheless be
recognised as satisfying the requirements of this regulation, if, at
least three other articles with the same shape, dimensions,
decoration and glaze are subjected to a test carried out as described
in the preceeding sub-regulations, and the average quantities of
lead and/or cadmium extracted from those articles do not exceed
the limits set, with none of those articles exceeding those limits by
more than 50%.
Teats and soothers. 11. Teats and soothers made of elastomer or rubber must not
pass on to the release-test liquid (saliva test solution) under the
conditions specified in European Community Directive 93/11/EEC
any N-nitrosamine and N-nitrosatable substance detectable by a
validated method which can detect the following quantities:
- 0.01 mg in total of N-nitrosamines released per
kilogram of the parts of teat or soother made of
elastomer or rubber;
- 0.1 mg in total of N-nitrosatable substances per
kilogram of the parts of teat or soother made of
elastomer or rubber.
Compliance with 
these regulations.
12. (1) No person may import, sell, keep for sale, or supply by
way of compensation or otherwise, any material or article or any
foodstuff which has been or is in contact with such material or
article in either case unless the material or article is in compliance
with the provisions of these regulations.
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(2) No person may manufacture any material or article or put,
wrap or pack any foodstuff in such material or article which in
either case does not comply with the provisions of sub-regulation
(1).
FIRST SCHEDULE
(Regulation 5)
List of groups of materials and articles
Plastics, including varnish and coatings
Regenerated cellulose
Elastomers and rubber
Paper and board
Ceramics
Glass
Metals and alloys
Wood, including cork
Textile products
Paraffin waxes and micro-crystalline waxes
SECOND SCHEDULE
(Regulation 6)
Symbol that may accompany materials and articles intended to 
come into contact with foodstuffs
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THIRD SCHEDULE
(Regulation 8)
List of Monomers and other Starting Substances which may be used in the 
manufacture of Plastic Materials and Articles
General introduction
1. This Schedule contains the list of monomers or other starting substances.
The list includes:
- substances undergoing polymerization, which includes
polycondensation, polyaddition or any other similar process, to
manufacture macromolecules,
- natural or synthetic macromolecular substances used in the manufacture
of modified macromolecules, if the monomers or the other starting
substances required to synthesize them are not included in the list,
- substances used to modify existing natural or synthetic macromolecular
substances.
2. The list does not include the salts (including double salts and acid salts) of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of
the authorized acids, phenols or alcohols which are also authorized. However, names
containing ".... acid(s), salts" appear in the lists if the corresponding free acid(s) is
(are) not mentioned. In such cases the meaning of the term "salts" is "salts of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc".
3. The list also does not include the following substances although they may be
present:
( a ) substances which could be present in the finished product as:
- impurities in the substances used,
- reaction intermediates,
- decomposition products;
( b ) oligomers and natural or synthetic macromolecular substances as well
as their mixtures, if the monomers or starting substances required to
synthesize them are included in the list;
( c ) mixtures of the authorized substances.
The materials and articles which contain the substances indicated under ( a ),
( b ) and ( c ) shall comply with the requirements stated in regulation 4.
4. Substances shall be of good technical quality as regards the purity criteria.
5. The list contains the following information:
- column 1 (PM/REF No): the EEC packaging material reference number
of the substances of the list,
- column 2 (CAS No): the CAS (Chemical Abstracts Service) Registry
number,
- column 3 (Name): the chemical name,
- column 4 (Restrictions).
These restrictions in column 4 may include:
- specific migration limit (SML)
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- maximum permitted quantity of the "residual" substance in the
material or article (QM),
- any other restriction specifically mentioned.
6. If a substance appearing on the list as an individual compound is also
covered by a generic term, the restrictions applying to this substance shall be those
indicated for the individual compound.
7. Where there is any inconsistency between the CAS number and the chemical
name, the chemical name shall take precedence over the CAS number. If there is an
inconsistency between the CAS number reported in EINECS (the European
Inventory of Existing Commercial Chemical Substances) and the CAS Registry, the
CAS number in the CAS Registry shall apply.
8. A number of abbreviations or expressions are used in column 4 of the table,
the meanings of which are as follows:
DL = detection limit of the method of analysis;
FP = finished material or article;
NCO = isocyanate moiety;
ND = not detectable;
QM = maximum permitted quantity of the "residual" substance in the material or
article;
QM (T) = maximum permitted quantity of the "residual" substance in the material
or article expressed as total of moiety or substance(s) indicated;
SML = specific migration limit in food or in food simulant, unless it is specified
otherwise;
SML (T) = specific migration limit in food or in food simulant expressed as total
of moiety or substance(s) indicated.
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FOURTH SCHEDULE
(Regulation 8(4))
Initial list of additives which may be used in the manufacture of plastic materials and 
articles
General introduction
1. This schedule contains the list of:
( a ) substances which are incorporated into plastics to achieve a technical
effect in the finished product. They are intended to be present in the
finished articles;
( b ) substances used to provide a suitable medium in which polymerization
occurs (e.g. emulsifiers, surfactants, buffering agents, etc.).
The list does not include the substances which directly influence the
formation of polymers (e.g. the catalytic system).
2. The list does not include the salts (including double salts and acid salts) of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of
the authorized acids, phenols or alcohols which are also authorized. However, names
containing ".... acid(s), salts" appear in the lists if the corresponding free acid(s) is
(are) not mentioned. In such cases the meaning of the term "salts" is "salts of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc".
3. The list also does not include the following substances although they may be
present:
( a ) substances which could be present in the finished product as:
- impurities in the substances used,
- reaction intermediates,
- decomposition products;
( b ) mixtures of the authorized substances.
The materials and articles which contain the substances indicated under ( a )
and ( b ) shall comply with the requirements stated in regulation 4.
4. Substances shall be of good technical quality as regards the purity criteria.
5. The list contains the following information:
- column 1 (PM/REF No): the EEC packaging material reference number
of the substances of the list,
- column 2 (CAS No): the CAS (Chemical Abstracts Service) Registry
number,
- column 3 (Name): the chemical name,
- column 4 (Restrictions). These may include:
- specific migration limit (SML),
- maximum permitted quantity of the "residual" substance in the
material or article (QM),
- any other restriction specifically mentioned.
6. If a substance appearing on the list as an individual compound is also
covered by a generic term, the restrictions applying to this substance shall be those
indicated for the individual compound.
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7. Where there is any inconsistency between the CAS number and the chemical
name, the chemical name shall take precedence over the CAS number. If there is an
inconsistency between the CAS number reported in EINECS (the European
Inventory of Existing Commercial Chemical Substances) and the CAS Registry, the
CAS number in the CAS Registry shall apply.
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FIFTH SCHEDULE
(Regulation 9)
List of Substances authorized in the Manufacture of Regenerated Cellulose Film
The percentages in this Schedule, first and second parts, are expressed in
weight/weight (w/w) and are calculated in relation to the quantity of anhydrous
uncoated regenerated cellulose film The substances used shall be of good technical
quality as regards the purity criteria.
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