Commission Regulation (EC) No 455/2004 of 11 March 2004 amending Regulation (EC) No 466/2001 as regards patulin (Text with EEA relevance)
Date: 2004-03-11
Institutions: European Commission
Subjects: baby food, food additive, food contamination, food standard

12.3.2004

EN

Official Journal of the European Union

L 74/11

COMMISSION REGULATION (EC) No 455/2004
of 11 March 2004
amending Regulation (EC) No 466/2001 as regards patulin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Regulation (EC) No 466/2001 (2),
sets
maximum levels for certain contaminants in foodstuffs.
Maximum levels have been established for amongst
others patulin.
A maximum level of 10,0 µg/kg has been established for
apple juice and solid apple products,
including apple
compote and apple puree, for infants and young children
and other baby food on the condition that a method of
analysis would have been validated by an international
collaborative ring trial
to 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 was no evidence by 1 November 2003 that the
level of 10 µg/kg could be reliably determined, the level
of 25 µg/kg would apply.

A collaborative trial has been organised to provide the
evidence that the level of 10,0 µg/kg can be reliably
determined. A report indicating that a method can reli-
ably determine levels of patulin in clear apple juice and
fruit puree at 10 µg/kg and lower has been provided on
27 October 2003.

It is appropriate to adopt transitional arrangements for
products manufactured and put on the market before
the date of application.

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

(6)

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 7, the following paragraph is added:

‘Τhe maximum levels established in point 2.3. Patulin of
section 2 (Mycotoxins) of Annex I shall not apply to
products which have been lawfully placed on the Com-
munity market before 1 November 2003. The burden of
proving when the products were placed on the market shall
be borne by the food business operator.’

2. Footnote 4 of point 2.3 Patulin of section 2 (Mycotoxins) of

Annex I is deleted.

3. The second indent of the point 2.3.4. of section 2 (Myco-

toxins) of Annex I shall read:
‘— other baby foods other than processed cereal-based

foods (4)’.

4. Footnote 5 of point 2.3 Patulin of section 2 (Mycotoxins) of

Annex I becomes footnote 4 and shall read:
‘(4) Baby foods other than processed cereal-based foods as
defined in 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, 14.02.2003, p. 33)’.

Article 2

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

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

Done at Brussels, 11 March 2004.

For the Commission
David BYRNE
Member of the Commission

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 77, 16.3.2001, p.1. Regulation as last amended by Regulation

(EC) No 1425/2003 (OJ L 203, 12.8.2003, p. 1).