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Legislative Issues Relating to Smart Packaging 311
document. Therefore the document can be taken as a starting point for requirements on
active and intelligent packaging.
The draft regulation deals in particular with the authorisation procedure for active and
intelligent ‘components’. Active and intelligent packaging shall comply with the require-
ments of Regulation (EC) No 1935/2004 [5] and they should be ‘suitable and effective
for the intended purpose’ and the active and intelligent components shall be included in
the Community list. Only if these requirements are fulfilled is an active and intelligent
packaging considered to comply with the requirements of this draft regulation.
Active and intelligent components are defined as ‘individual substances or a combination
of substances which cause the active function or provide the intelligent information’. As
mentioned already, most active and intelligent packaging has a complex structure. In gen-
eral, active and intelligent packaging can be split into two parts. One part includes the active
or intelligent components, while the second part concerns the so-called carriers or passive
parts that contain the component. Carriers may be interpreted as including a material on
which a releasing component is adsorbed, but also the packaging of the components. In the
example of an ethanol releaser, the ethanol is absorbed onto a silica gel, which in turn is
packaged in a paper or plastic sachet. The ethanol is defined as the active component, which
is subject to authorisation. The silica gel and the sachet form the passive part and should
comply with safety requirements as defined in the framework regulation and implemented
EU or national measures, but they are not subject to this draft regulation.
Migration of food contact materials (FCM) is subject to EU or national regulations.
Overall migration and specific migration limits are established in the various regulations
[15,16]. These limits are set to assure inertness and safety of the FCM. Active releasing
packaging is not designed to be inert. It will in many cases exceed the overall migration limit
and in some cases the specific migration limits set for FCM. Thus a substance released on
purpose from an active packaging material should not be included in the overall migration.
So special protocols may be needed for the determination of the overall migration. CEN
methods EN 1186, Parts 1–15 [17] may not be suitable. Specific migration limits mentioned
in the regulations on packaging materials may be exceeded provided the final food complies
with the rules and restrictions applicable to processed foods.
Authorisation of the active or intelligent components will be granted after a positive
opinion from EFSA and will only be valid to the applicant for an authorisation. The autho-
risation will be valid for a period of 10 years and may be renewed for another period of 10
years. The authorisation will be published in a Decision to the applicant. In addition the
active and intelligent components will be inserted into a list of authorised components. In
the Community list, issues like name and address of the applicant, name of the component,
description of the active or intelligent system and the conditions of use, maximum amount
of released components and any other relevant restriction will be inserted and made public.
Besides the requirements for labelling of FCM there is an addition requirement for active
and intelligent packaging. Materials that may be mistaken as a part of the food such as loose
sachets must be labelled using the words ‘DO NOT EAT’ and where possible the symbol
for a non-edible part (Figure 17.1).
A requirement, in line with Regulation (EC) No 1935/2004 [5], concerning a declaration
of compliance and the availability of appropriate documentation, has been confirmed in the
draft regulation. It means that for any active and intelligent material a statement shall be
provided that certifies that the material is safe to be used in contact with food under specified
conditions of contact. To support such a statement the certifier shall have documentation