Commission Regulation (EC) No 1425/2003 of 11 August 2003 amending Regulation (EC) No 466/2001 as regards patulin (Text with EEA relevance)
Date: 2003-08-11
Institutions: European Commission
Subjects: food standard, fruit juice, pip fruit, public health, toxic substance

12.8.2003

EN

Official Journal of the European Union

L 203/1

I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 1425/2003

of 11 August 2003

amending Regulation (EC) No 466/2001 as regards patulin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EEC) No 315/93 of 8
February 1993 laying down Community procedures
for
contaminants in food (1), and in particular Article 2(3) thereof,

After consulting the Scientific Committee for Food (SCF),

Whereas:

Commission Regulation (EC) No 466/2001 (2), as last
amended by Regulation (EC) No 563/2002 (3),
sets
maximum levels for certain contaminants in foodstuffs.
Maximum levels have been established for nitrates, afla-
toxins, ochratoxin A, lead, cadmium, mercury, 3-MCPD
and dioxins.

Some Member States have adopted, or plan to adopt,
maximum levels for patulin in fruit juices in particular
apple juice, solid apple products such as apple compote
and apple puree and in such products intended for
infants and young children. In view of the disparities
between Member States and the consequent risk of
distortion of competition, Community measures are
necessary in order to ensure market unity while abiding
by the principle of proportionality.

Patulin is a mycotoxin produced by fungi belonging to
including Penicillium, Aspergillus, and
several genera,
Byssochlamys species. Although patulin can occur
in
many mouldy fruits, grains and other foods, the major
sources of patulin contamination are apple products.

(1)

(2)

(3)

(4)

In 2001, a specific task ‘Assessment of the dietary intake
of patulin by the population of EU Member States’ in the
framework of Council Directive 1993/5/EEC of 25
February 1993 on assistance to the Commission and
cooperation by the Member States in the scientific exam-
ination of questions relating to food (4)
(SCOOP) has
been performed. It can be concluded from the assess-
ment that the average exposure seems to be quite below
the PMTDI of 0,4 µg/kg bw. Nevertheless taking into
consideration specific groups of consumers, especially
small children, and assuming worst cases, the exposure
to patulin is more significant but still below the PMTDI.

(6)

(7)

Regulation (EC) No 466/2001 should therefore be
amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 466/2001 is amended as follows:

1. In Article 5, the following paragraph is added:

‘4.
The Commission shall review the maximum levels for
patulin laid down in points 2.3.1 and 2.3.2 of section 2 of
Annex I by 30 June 2005 at the latest with a view to redu-
cing them to take account of the progress in scientific and
technological knowledge and the implementation of
the
“Code of practice for the prevention and reduction of
patulin contamination in apple juice and apple juice ingredi-
ents in other beverages”.’

2. Annex I shall be amended as set out in the Annex to this

Regulation.

The Scientific Committee for Food endorsed in its
meeting on 8 March 2000 the provisional maximum
tolerable daily intake (PMTDI) of 0,4 µg/kg body weight
(bw) for patulin.

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

Article 2

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 77, 16.3.2001, p. 1.
(3) OJ L 86, 3.4.2002, p. 5.

It shall apply from 1 November 2003.

(4) OJ L 52, 4.3.1993, p. 18.

L 203/2

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Official Journal of the European Union

12.8.2003

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 August 2003.

For the Commission

David BYRNE

Member of the Commission

12.8.2003

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Official Journal of the European Union

L 203/3

In Section 2 (Mycotoxins) of Annex I, the following point 2.3 is inserted:

ANNEX

‘Products

Patulin: maximum levels
(µg/kg or ppb)

Sampling method

Reference analysis
method

2.3.

Patulin

2.3.1. — Fruit juices and fruit nectar,

in
particular apple juice, and fruit
juice
other
beverages (1)

ingredients

in

— Concentrated fruit juice (1) after
reconstitution as instructed by
the manufacturer

2.3.2. Spirit drinks (2),
fermented
drinks
apples or containing apple juice

derived

and other
from

cider

2.3.3. Solid apple products, including apple
compote, apple puree intended for
direct consumption

2.3.4. — Apple

juice

and solid apple
apple
including
products,
compote and apple puree,
for
infants and young children (3)
and labelled and sold as intended
for infants and young children

50,0

Directive 2003/78/EC

Directive 2003/78/EC

50,0

25,0

Directive 2003/78/EC

Directive 2003/78/EC

Directive 2003/78/EC

Directive 2003/78/EC

10,0 (4)

Directive 2003/78/EC

Directive 2003/78/EC

— other baby food (5)

(1) Fruit juices, including fruit juices from concentrates, concentrated fruit juice and fruit nectar as defined in Annex 1 and 2 to Council
Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption
(OJ L 10, 12.1.2002, p. 58).

(2) Spirit drinks as defined in Article 1 of Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the defi-
nition, description and presentation of spirit drinks (OJ L 160, 12.6.1989, p. 1), as last amended by Regulation (EC) No 3378/94 of
the European Parliament and of the Council of 22 December 1994 (OJ L 366, 31.12.1994, p. 1).
Infants and young children as defined in Article 1 of Commission Directive 91/321/EEC of 14 May 1991, on infant formulae and
follow-on formulae (OJ L 175, 4.7.1991, p. 35), as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37) and Article 1
of Commission Directive 96/5/EC of 16 February 1996 on processed cereal based foods and baby foods for infants and young
children (OJ L 49, 28.2.1996, p. 17), as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

(3)

(4) A method of analysis will be validated by an international collaborative ring trial which will be performed before 1 November 2003
in order to demonstrate that the level of 10 µg/kg patulin can be reliably determined. In case there is no evidence by 1 November
2003 that the level of 10 µg/kg patulin can be reliably determined, the level of 25 µg/kg will apply.

(5) Baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal based foods and baby
foods for infants and young children (OJ L 49, 28.2.1996, p. 17), as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p.
33).’