Commission Regulation (EC) No 683/2004 of 13 April 2004 amending Regulation (EC) No 466/2001 as regards aflatoxins and ochratoxin A in foods for infants and young children (Text with EEA relevance)
Date: 2004-04-13
Institutions: European Commission
Subjects: baby food, consumer protection, food standard, public health, toxic substance

15.4.2004

EN

Official Journal of the European Union

L 106/3

COMMISSION REGULATION (EC) No 683/2004

of 13 April 2004

amending Regulation (EC) No 466/2001 as regards aflatoxins and ochratoxin A in foods for infants
and young children

(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,

After consulting the Scientific Committee for Food (SCF),

(5)

(6)

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,

Whereas:

HAS ADOPTED THIS REGULATION:

(1)

(2)

(3)

(4)

Commission Regulation (EC) No 466/2001 (2),
sets
maximum levels for certain contaminants in foodstuffs,
including food intended for infants and young children
covered by Commission Directive 91/321/EEC of 14
May 1991 on infant formulae and follow-on formulae (3)
and Commission Directive 96/5/EC of 16 February 1996
on processed cereal-based foods and baby foods for
infants and young children (4).

According to Regulation (EC) No 466/2001 specific
maximum levels of contaminants for food intended for
infants and young children are to be established by 5
April 2004 at the latest.

Some Member States have adopted maximum levels for
aflatoxin B1, aflatoxin M1 and ochratoxin A in food
intended for infants and young children. In view of the
disparities between the national provisions and the
risk of distortion of competition, Com-
consequent
to ensure
munity measures are necessary in order
market unity while abiding by the principle of propor-
tionality.

It is appropriate for the health protection of the infants
and young children, a vulnerable population group, to
establish the lowest maximum level, that is achievable
through a strict selection of the raw materials used for
the manufacturing of
follow-on
the infant
formulae, processed cereal-based foods and baby foods.
It is necessary that a validated method of analysis exists
for the enforcement of the maximum levels. For afla-
toxin M1, an international ring trial will be organised by
the Commission in order to verify if a level of 0,01 µg/
kg aflatoxin M1 can be reliably determined in view of
considering a reduction of
to
0,01 µg/kg aflatoxin M1.

the maximum level

formulae,

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation of
the European Parliament and of the Council (EC) No 1882/2003
(OJ L 284, 31.10.2003, p. 1).

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

(EC) No 455/2004 (OJ L 74, 12.3.2004, p. 11).

(3) OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive

2003/14/EC (OJ L 41, 14.2.2003, p. 37).

(4) OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive

2003/13/EC (OJ L 41, 14.2.2003, p. 33).

Article 1

Article 2(2) of Regulation (EC) No 466/2001 is replaced by the
following:

‘2.
The maximum levels specified in Annex I shall apply
also to food intended for infants and young children
covered by Directive 91/321/EEC and Directive 96/5/EC,
taking into account respectively, the changes of the concen-
tration of the contaminant caused by drying, dilution or
processing and the relative concentrations of the ingredi-
ents in the product. This does not apply to the contami-
nants for which specific Community maximum levels have
been set for the specified foods or to the cases where in the
absence of Community maximum levels, stricter levels have
been set by national legislation for the specified foods.’

Article 2

Annex I of Regulation (EC) No 466/2001 is amended in
accordance with the Annex to this Regulation

Article 3

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

It shall apply from 1 November 2004.

This Regulation shall not apply to products which were placed
on the market before 1 November 2004 in conformity with
the provisions applicable. The burden of proving when the
products were placed on the market shall be borne by the food
business operator. This Regulation shall be binding in its
entirety and directly applicable in all Member States.

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Official Journal of the European Union

15.4.2004

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

Done at Brussels, 13 April 2004.

For the Commission

David BYRNE

Member of the Commission

15.4.2004

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Official Journal of the European Union

L 106/5

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

ANNEX

1. In Section 2. Mycotoxins, 2.1. Aflatoxins the following points 2.1.5, 2.1.6 and 2.1.7 are added:

Products

‘2.1.5. Baby foods and processed cereal-
based foods for infants and young
children (1)

2.1.6 Infant

formulae

follow-on
and
including infant milk and

formulae,
follow-on milk (2)

2.1.7 Dietary foods

special medical
for
purposes (3) intended specifically for
infants

Maximum levels
(µg/kg or ppb)

B1 + B2 + G1 + G2

—

—

—

B1

0,10

—

0,10

M1

—

Sampling method

Reference analysis
method

Directive 1998/
53/EC

Directive 1998/
53/EC

0,025

Directive 1998/
53/EC

Directive 1998/
53/EC

0,025

Directive 1998/
53/EC

Directive 1998/
53/EC

(1) Baby foods and processed cereal-based foods for infants and young children 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).
The maximum level for baby foods and processed cereal-based foods for infants and young children refer to the dry matter. The dry matter is determined in accordance
with the provisions of Commission Directives 98/53/EC and 2002/26/EC.
Infant formulae and follow-on formulae 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 L41, 14.2.2003, p. 37).
The maximum level for infant formulae and follow-on formulae refer to the product ready to use (marketed as such or after reconstitution as instructed by the manufac-
turer).

(2)

(3) Dietary foods for special medical purposes as defined in Article 1(2) of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical

purposes (OJ L 91, 7.4.1999, p. 29).
The maximum level for dietary foods for special medical purposes intended specifically for infants refer
— in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as instructed by the manufacturer),
— in the case of products other than milk and milk products, to the dry matter. The dry matter is determined in accordance with the provisions of Commission Direc-

tives 98/53/EC and 2002/26/EC.’

2. In Section 2. Mycotoxins, 2.2. Ochratoxin A the following points 2.2.4 and 2.2.5 are added:

Products

Maximum levels
(µg/kg or ppb)

Sampling method

Reference analysis method

‘2.2.4. Baby foods and processed cereal-
based foods for infants and young
children (1)

2.2.5 Dietary foods

special medical
for
purposes (2) intended specifically for
infants

0,50

Directive 2002/26/EC

Directive 2002/26/EC

0,50

Directive 2002/26/EC

Directive 2002/26/EC

(1) Baby foods and processed cereal-based foods for infants and young children 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).
The maximum level for baby foods and processed cereal-based foods for infants and young children refer to the dry matter. The dry matter is determined in accordance
with the provisions of Commission Directives 98/53/EC and 2002/26/EC.

(2) Dietary foods for special medical purposes as defined in Article 1(2) of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical

purposes (OJ L 91, 7.4.1999, p. 29).
The maximum level for dietary foods for special medical purposes intended specifically for infants refer
— in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as instructed by the manufacturer),
— in the case of products other than milk and milk products, to the dry matter. The dry matter is determined in accordance with the provisions of Commission Direc-

tives 98/53/EC and 2002/26/EC.’