background image
The status of additives acting as polymerisation
production aids (PPA) should be clarified. The PPA
which also function as additives are to be evaluated
and included in the future positive list of additives.
Some of them are already included in the current
incomplete list of additives. As regards additives which
exclusively act as PPA and are therefore not intended to
remain in the finished article, it should be made clear
that their use will remain possible, subject to national
law, even after the adoption of the future positive list
of additives. That situation should be reassessed at a later
Studies have shown that azodicarbonamide decomposes
into semicarbazide during high temperature processing.
In 2003 the Authority was asked to gather data and to
assess the possible risks posed by semicarbazide in food.
Until that information was obtained and in accordance to
Article 7 of Regulation (EC) No 178/2002 of the
European Parliament and of the Council of 28 January
requirements of food law, establishing the European
Food Safety Authority and laying down procedures in
matters of food safety (
), the use of azodicarbonamide
in plastic materials and articles was suspended by
Commission Directive 2004/1/EC (
). In its opinion of
21 June 2005, the Authority (
) concluded that carcino-
genicity of semicarbazide is not of concern for human
health at the concentrations encountered in food, if the
source of semicarbazide related to azodicarbonamide is
eliminated. Therefore it is appropriate to maintain the
prohibition of use of azodicarbonamide in plastic
materials and article.
The concept of the plastic functional barrier, that is a
barrier within plastic materials or articles preventing or
reducing the migration from behind this barrier into the
food should be introduced. Only glass and some metals
may ensure complete blockage of migration. Plastics may
be partial functional barriers with properties and effec-
tiveness to be assessed and may help reducing the
migration of a substance below a SML or a limit of
detection. Behind a plastic functional barrier, non-
authorised substances may be used, provided they fulfil
certain criteria and their migration remains below a given
detection limit. Taking into account foods for infants and
other particularly susceptible persons as well as the diffi-
culties of this type of analysis affected by a large
analytical tolerance, a maximum level of 0,01 mg/kg in
food or a food simulant should be established for the
migration of a non-authorised substance through a
plastic functional barrier.
Article 9 of Directive 2002/72/EC provides that materials
and articles must be accompanied by a written
declaration of compliance attesting that they comply
with the rules applicable to them. In accordance with
1935/2004, to strengthen the co-ordination and respon-
sibility of the suppliers at each stage of manufacture,
including that of the starting substances, the responsible
persons should document the compliance with the
relevant rules in a declaration of compliance which is
made available to his customer. Further, at each stage
of manufacture, supporting documentation, substan-
tiating the declaration of compliance, should be kept
available for the enforcement authorities.
Article 17(1) of Regulation (EC) No 178/2002 requires
the food business operator to verify that foods are
compliant with the rules applicable to them. To this
end subject to the requirement of confidentiality, food
business operators should be given access to the
relevant information to enable them to ensure that the
migration from the materials and articles to food
complies with the specifications and restrictions laid
down in food legislation.
Compliance with Article 3 of Regulation (EC) No
1935/2004 for substances non-listed in Annexes II and
III of Directive 2002/72/EC such as impurities or
reaction products referred to in point 3 of Annex II
and point 3 of Annex III to Directive 2002/72/EC
should be assessed by the relevant business operator in
accordance with internationally recognised scientific prin-
For a more adequate estimation of exposure of the
consumer, a new reduction factor should be introduced
in migration testing, called Fat Reduction Factor (FRF).
Until now, the exposure to substances migrating predo-
minantly into fatty food (lipophilic substances) was based
on the general assumption that a person ingests daily 1
kg of food. However, a person ingests at most 200 g of
fat on a daily basis. This should be taken into consid-
eration through the correction of the specific migration
by the FRF applicable to lipophilic substances in
Committee on Food (SCF) (
) and the opinion of the
Authority (
L 91/18
Official Journal of the European Union
) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission
Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).
) OJ L 7, 13.1.2004, p. 45.
) The EFSA Journal (2005) 219, 1-36.
) SCF opinion of 4 December 2002 on the introduction of a Fat
(Consumption) Reduction Factor (FRF) in the estimation of the
exposure to a migrant from food contact materials.
) Opinion of the Scientific Panel on Food Additives, Flavourings,
Processing Aids and Materials in Contact with Food (AFC) on a
request from the Commission related to the introduction of a Fat
(consumption) Reduction Factor for infants and children, The EFSA
Journal (2004) 103, 1-8.