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- Practical Guide -
Page 42 of 153
level of this additive in the respective food the latter prevails. It is provided for that for
these substances information on the level of migration should be supplied to enable the
user of these materials and articles to comply with the relevant Community provisions or,
in their absence, with national provisions applicable to food. This rule is especially
important for additives such as 54880/59280/87840/88240/87600 etc. for which the
maximum level of additive authorised in some foods is less than 60 ppm.
List of polymers used as starting substances or additives
3.3.1 Explanation of important terms
Since the Directive 2002/72/EC does not define the related terms, the Commission consulted
the SCF and decided to use the terms according to the descriptions set out below. "Polymeric substance used as additive" generic expression which is used when it is impossible to indicate if a
substance is covered by the definition of "polymeric additive" or by the definition of "basic substance".
This expression intends to overcome the difficulty to define the situation where a polymeric substance
(substance B) is mixed/added to another polymeric substance (substance A). How the two components should
be considered? Should B be considered "additive"? If not, why not if it is mixed/added to A to achieve a
technical effect in the finished product as requested by the definition of "additive" of sub-paragraph 2.2.11. "Polymeric additive" means any polymer and/or prepolymer and/or oligomer, which may be added to plastics
in order to achieve a technical effect but which cannot be used in the absence of other polymers as the main
structural component of finished materials and articles." "Polymeric monomer" means any polymer (including prepolymer and oligomer), which may used as starting
substance in a polymerisation process. "Monomer and starting substance" means any starting substance (regardless of its chemical nature
(compound, mixture, monomer, oligomer, prepolymer natural or synthetic macromolecules etc.) used in any
type of polymerisation process including the modification of natural or synthetic substances. According to
the Directive 2002/72/ EC the substances to be listed as monomers and starting substances are: substances
undergoing polymerisation, 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 synthesise them are not
included in the list,
substances used to modify existing natural or synthetic macromolecular substances. "Oligomer" means any substance consisting of a few repeating units of a monomer and/or starting substance. "Prepolymer" means a macromolecule or oligomer molecule capable of entering, through reactive groups,
into further polymerisation, thereby contributing more than one monomeric unit to at least one chain of the
final macromolecule (IUPAC definition) "Polymer" means any macromolecular compound obtained by polymerisation (polyaddition, polycondensation
or any other similar process) of monomers and other starting substances. "Plastic" 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. Other substances or matter may be added to such macromolecular
This definition of "plastic"appears in Directive 2002/72/EC.