Commission Regulation (EC) No 242/2004 of 12 February 2004 amending Regulation (EC) No 466/2001 as regards inorganic tin in foods (Text with EEA relevance)
Date: 2004-02-12
Institutions: European Commission
Subjects: consumer protection, food contamination, food standard, foodstuff, public health, toxic substance

13.2.2004

EN

Official Journal of the European Union

L 42/3

COMMISSION REGULATION (EC) No 242/2004

of 12 February 2004

amending Regulation (EC) No 466/2001 as regards inorganic tin in foods

(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), as last
amended by Regulation (EC) No 2174/2003 (3), sets
maximum levels for certain contaminants in foodstuffs.

Commission Directive 91/321/EEC of 14 May 1991 on
infant formula and follow-on formula (4) as last amended
by Directive 2003/14/EC (5) provides
infant
formulae and follow-on formulae must not contain any
substance in such quantity as to endanger the health of
infants and young children and that necessary maximum
levels for such substances are to be established without
delay.

that

Commission Directive 96/5/EC of 16 February 1996 on
processed cereal-based foods and baby foods for infants
and young children (6), as last amended by Directive
2003/13/EC (7), provides
that processed cereal-based
foods and baby foods must not contain any substance in
such quantity as to endanger the health of infants and
young children and that necessary maximum levels for
such substances are to be established without delay.

Some Member States have adopted maximum levels for
inorganic tin in foods. 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 whilst abiding by the prin-
ciple of proportionality.

The Scientific Committee on Food concluded in its
opinion of 12 December 2001 that levels of inorganic
tin of 150 mg/kg in canned beverages and 250 mg/kg
in other canned foods may cause gastric irritation in

some individuals. Information is not available to indicate
whether or not infants and young children might be at
greater risk.

To protect public health from this acute health risk it is
necessary to set maximum levels for inorganic tin in
canned foods and canned beverages. Until data becomes
available on the sensitivity of infants and young children
to inorganic tin in foods, it is necessary on a precau-
tionary basis to protect the health of this vulnerable
population group. Lower maximum levels are necessary,
which are achievable through the strictly controlled
manufacturing and packaging of infant formulae, follow-
on formulae, baby foods and processed cereal-based
foods for infants and young children.

Regulation (EC) No 466/2001 should 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,

(6)

(7)

(8)

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 466/2001 is amended as set out
in the Annex to this Regulation.

Article 2

The Commission shall review the maximum levels for inorganic
tin as set in points 1 and 2 of the Annex to this Regulation by
1 January 2006 taking into account the progress in scientific
and technological knowledge.

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 77, 16.3.2001, p. 1.
(3) OJ L 326, 13.12.2003, p. 12.
(4) OJ L 175, 4.7.1991, p. 35.
(5) OJ L 41, 14.2.2003, p. 37.
(6) OJ L 49, 28.2.1996, p. 17.
(7) OJ L 41, 14.2.2003, p. 33.

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.

L 42/4

EN

Official Journal of the European Union

13.2.2004

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

Done at Brussels, 12 February 2004.

For the Commission

David BYRNE

Member of the Commission

In Annex I to Regulation (EC) No 466/2001 the following Section 6 is added:

ANNEX

‘Section 6: Tin (inorganic)

Product

Maximum
level
(mg/kg wet
weight)

Performance criteria for
sampling

Performance criteria for
methods of analysis

1.

Canned foods other than beverages

200

Commission Directive
2004/16/EC (*)

Directive 2004/16/EC

2.

3.

Canned beverages,
vegetable juices

including fruit juices and

100

Directive 2004/16/EC Directive 2004/16/EC

Canned foods for infants and young children,
excluding dried and powdered products:

3.1. Canned baby foods and processed cereal-
based foods for infants and young children (1)

3.2. Canned

infant

follow-on
formulae
formulae, including infant milk and follow-on
milk (2)

and

50

50

Directive 2004/16/EC Directive 2004/16/EC

Directive 2004/16/EC Directive 2004/16/EC

3.3. Canned dietary foods

for

special medical

50

Directive 2004/16/EC Directive 2004/16/EC

purposes (3) intended specifically for infants

(*) See page 16 of this Official Journal.
(1) Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Directive 96/5/EC. The

(2)

maximum level refers to the product as sold.
Infant formulae and follow-on formulae as defined in Article 1 of Directive 91/321/EEC. The maximum level refers to the
product as sold.

(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 refers to the product as sold.’