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- Practical Guide -
Page 35 of 153
confronted with the overwhelmingly complex task of dealing with substances that migrated
into foodstuffs e.. Their first efforts concerned the preparation of a positive list of the
ingredients (monomers and additives) used for the manufacture of food contact materials
and articles. The
toxicological evaluation of these substances was made following the
criteria of the time, these differ from those used today.
The Commission services decided not to change the criteria in listing the substances and
compiled all the national lists in an
"EU inventory list" of substances, which may be
included at the end in an EU positive list. Obviously, this approach neglects that the
migrants into foods may include substances that were not ingredients but which may be
derived from them during the manufacturing process, the so-called reaction products, or
impurities not integrated into the polymer. The safety requirement laid down by Article 2
of the Framework Directive 89/109/EEC is only fully achieved when these components are
also under control. For this reason, this issue is largely debated at the EU and Council of
Europe level to find the appropriate legislative solutions.
3.1. Positive list of monomers and other starting substances
The Directive 2002/72/EC [28] states:
"Art. 3.1.
Only those monomers and other starting substances listed in Annex II, section A and B may be used for the manufacture of
plastic materials and articles subject to the restrictions specified.
Annex II, paragraph 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 synthesise them are included in the list;
(c) Mixtures of the authorised substances.
The materials and articles, which contain the substances indicated under (a), (b) and (c), shall comply with the requirements
stated in Article 2 of Directive 89/109/EEC."
The aim of a positive list is to protect the consumer against health risks from the exposure to
substances migrating into the food. They should contain all substances migrating into
foodstuffs, but this is a demanding task, because of many migrants neither the identity nor
the potential impact on health is known.
The EU positive list of "monomers and other starting substances" includes substances
deliberately used in the manufacture of the finished material and article and constituting a
repeating unit of a polymer chain or polymer network and the substances used to modify
existing natural or synthetic macromolecular materials. All these substances should be the
subject of a request for authorisation (application). Directive 2002/72/EC defines them in the
following way.
Substances undergoing polymerisation, which include polycondensation, polyaddition or any other similar process, to
manufacture macromolecules;