Commission Directive 2004/1/EC of 6 January 2004 amending Directive 2002/72/EC as regards the suspension of the use of azodicarbonamide as blowing agent (Text with EEA relevance)
Date: 2004-01-06
Institutions: European Commission
Subjects: adjuvant, chemical product, foodstuff, marketing, packaging product, plastics, public health

13.1.2004

EN

Official Journal of the European Union

L 7/45

COMMISSION DIRECTIVE 2004/1/EC

of 6 January 2004

amending Directive 2002/72/EC as regards the suspension of the use of azodicarbonamide as
blowing agent

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity,

Having regard to Council Directive 89/109/EEC of 21
December 1988 on the approximation of
the
Member States relating to materials and articles intended to
come into contact with foodstuffs (1), and in particular Article
3 thereof,

the laws of

Whereas:

(1)

(2)

(3)

(4)

Commission Directive 2002/72/EC of 6 August 2002
relating to plastic materials and articles intended to come
into contact with foodstuffs (2) authorises the use of
azodicarbonamide as a blowing agent in plastic materials
and articles intended to come into contact with food-
stuffs in accordance with the opinion of the Scientific
Committee on Food (SCF).

in the
Azodicarbonamide is used as blowing agent
manufacture of plastic gaskets in metal lids used for the
closure of glass jars. New findings have shown that
azodicarbonamide decomposes into semicarbazide (SEM)
when heated during production of the foamed gasket
and during sterilisation of the sealed glass jar.

On 8 July 2003 the European Food Safety Authority
(hereinafter called ‘the Authority’) was informed by
industry that SEM had been found in a number of foods
contained in glass jars. The levels of SEM in these foods
were variable (up to 25 µg/kg), with the highest concen-
trations found in baby foods.

Based on the existing scientific data,
including recent
research commissioned by the Authority, the Scientific
Panel on food additives, flavourings, processing aids and
materials in contact with food (hereinafter called ‘the
Panel’) concluded, in its statement of 1 October 2003,
that SEM has a weak carcinogenic activity in laboratory
animals and weak genotoxicity in vitro but that it was
not possible according to the current scientific knowl-
edge to conclude whether SEM poses a carcinogenic risk
to humans.

(6)

(7)

(8)

sure to SEM per body weight is likely to be the highest.
In evaluating the possible consequences of SEM in baby
foods, the expert group reviewed toxicological aspects
alongside microbiological and nutritional considerations.

On 9 October 2003 they advised that,
taking into
account the current available information on the levels
of SEM in food, intake and toxicology, the risk to both
infants and adults eating foods containing SEM was
probably very small. However, the Panel stated that the
presence of SEM in baby food was undesirable and
recommended that it would be prudent to reduce expo-
sure to SEM as swiftly as technological progress safely
allows.

Considering the conclusions of the Panel and the ad hoc
expert group and the remaining scientific uncertainties it
is appropriate,
in order to achieve the high level of
health protection chosen in the Community, to suspend
the use of azodicarbonamide in accordance with the
precautionary principle referred to in Article 7 of Regu-
lation (EC) No 178/2002 of the European Parliament
and of the Council (3)
(Food law). The suspension of
azodicarbonamide from the incomplete list of additives
fully harmonised at Community level should apply while
the Community seeks more complete information from
any source, which could clarify the gaps in the present
state of knowledge of SEM.

The Commission has been informed that alternatives for
azodicarbonamide will become available in the near
future. With respect
to the possible replacement of
azodicarbonamide in packaging materials for baby foods,
it is critical that careful consideration and evaluation of
seal integrity be carried out prior to their introduction in
order not to compromise the microbiological safety of
the food. It is therefore necessary to provide for a transi-
tional period of 18 months to allow such evaluation to
be carried out over a time period, which takes account
of the minimum shelf-life for such packaged foods.

(5)

An ad hoc expert group was specifically commissioned
by the Authority to advise further on possible risks to
infants, the consumer group for which potential expo-

(1) OJ L 40, 11.2.1989, p. 38. Directive as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ L
284, 31.10.2003, p. 1).
(2) OJ L 220, 15.8.2002, p. 18.

(9)

A transitional period should also be provided for in
respect of materials and articles which are brought into
contact with foodstuffs before the deadline for imple-
mentation of this Directive.

(3) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

L 7/46

EN

Official Journal of the European Union

13.1.2004

(10)

This transitional period should also take into account
the requirements of Directive 2000/13/EC of the Euro-
pean Parliament and of the Council of 20 March 2000
on the approximation of the laws of the Member States
relating to the labelling, presentation and advertising of
foodstuffs (1).

(11) Directive 2002/72/EC should therefore be amended

accordingly.

(12)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

regards

As
the additive azodicarbonamide with reference
number 36640 the text in column 4 of Section A of Annex III
to Directive 2002/72/EC is replaced by the following:

‘For use only as blowing agent. Use prohibited as from 2
August 2005.’

However, materials and articles filled before 2 August 2005
may continue to be placed on the market provided that the
date of filling appears on the materials and articles. The date of
filling may be replaced by another indication, provided that
that indication permits the identification of the date of filling.
Upon request the date of filling shall be made available to the
competent authorities and any person enforcing the require-
ments of this Directive.

The first and second subparagraphs shall apply without preju-
dice to the requirements of Directive 2000/13/EC.

When Member States adopt the provisions referred to in para-
graph 1, they shall contain a reference to this Directive or be
accompanied by such a reference on the occasion of their offi-
cial publication. Member States shall determine how such refer-
ence is to be made.

3. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

Article 2

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

1. Member States shall adopt and publish, by 2 August
2005 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions
and this Directive.

2. Member States shall apply the provisions referred to in
paragraph 1 from 2 August 2005 in such a way as to prohibit
the placing on the market and importation into the Com-
munity of plastic materials and articles intended to come into
contact with foodstuffs and which do not comply with this
Directive.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 6 January 2004.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive

2003/89/EC (OJ L 308, 25.11.2003, p. 15.)