Commission Directive 2003/14/EC of 10 February 2003 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance)
Date: 2003-02-10
Institutions: European Commission
Subjects: baby food, early childhood, food inspection, foodstuffs legislation, prepared foodstuff

14.2.2003

EN

Official Journal of the European Union

L 41/37

COMMISSION DIRECTIVE 2003/14/EC

of 10 February 2003

amending Directive 91/321/EEC on infant formulae and follow-on formulae

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

that products are free from such pesticides, since some
pesticides contaminate the environment and their resi-
dues may be found in the products concerned.

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/398/EEC of 3 May 1989
on the approximation of the laws of the Member States relating
to foodstuffs intended for particular nutritional uses (1), as last
amended by Directive 1999/41/EC of the European Parliament
and of the Council (2), and in particular Article 4(1) thereof,

(5)

The health of infants and young children can be better
protected by applying additional requirements which
can be enforced by analysis regardless of a product's
origin.

(1)

(2)

(3)

(4)

Having regard to the opinion of the Scientific Committee on
Food,

(6)

Whereas:

Article 6 of Commission Directive 91/321/EEC (3), as last
amended by Directive 1999/50/EC (4), stipulates that
infant formulae and follow-on formulae shall not contain
any substance in such quantity as to endanger the health
of infants and young children.

On the basis of opinions given by the Scientific
Committee on Food on 19 September 1997 and 4 June
1998, Directive 91/321/EEC established a general
maximum residue level of 0,01 mg/kg for any individual
pesticide in infant formulae and follow-on formulae.

(7)

In the case of a small number of pesticides or metabo-
lites of pesticides even a maximum residue level of
0,01 mg/kg might, under worst-case intake conditions,
allow infants and young children to exceed the accep-
table daily intake. This is the case for pesticides or meta-
bolites of pesticides with an acceptable daily intake
lower than 0,0005 mg/kg body weight.

Directive 91/321/EEC establishes the principle of the
prohibition of the use of these pesticides in the produc-
tion of agricultural products intended for infant formulae
and follow-on formulae. The pesticides
in question
should be listed in Annex IX to Directive 91/321/EEC.
However, this prohibition does not necessarily guarantee

(1) OJ L 186, 30.6.1989, p. 27.
(2) OJ L 172, 8.7.1999, p. 38.
(3) OJ L 175, 4.7.1991, p. 35.
(4) OJ L 139, 2.6.1999, p. 29.

lower

Most of the pesticides which have acceptable daily intake
values
than 0,0005 mg/kg body weight are
already prohibited in the Community or will be prohib-
ited by July 2003. The prohibited pesticides should not
be detectable in infant formulae and follow-on formulae
by state of the art analytical methods. However, some
pesticides degrade slowly and still contaminate the envir-
onment. They might be present in infant formulae and
follow-on formulae even if they have not been used. For
the purposes of control, a harmonised approach has to
be followed.

Pending Commission decisions on whether they satisfy
the safety requirements of Article 5 of Council Directive
91/414/EEC of 15 July 1991 concerning the placing of
plant protection products on the market (5), as last
amended by Commission Directive 2003/5/EC (6), the
continued use of
should be
permitted as long as their residues comply with the
maximum residue levels established in the present Direc-
tive. The latter should be set at levels ensuring that their
respective
are not
exceeded by infants and young children under worst-
case intake conditions.

authorised pesticides

acceptable daily

values

intake

(8)

Directive 91/321/EEC should be amended accordingly.

(9)

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

(5) OJ L 230, 19.8.1991, p. 1.
(6) OJ L 8, 14.1.2003, p. 7.

L 41/38

EN

Official Journal of the European Union

14.2.2003

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 91/321/EEC is amended as follows:

1. Article 6 is amended as follows:

— Paragraph 1 is replaced by the following:

‘1.
Infant formulae and follow-on formulae shall not
contain any substance in such quantity as to endanger
infants and young children. Necessary
the health of
maximum levels for substances other than those referred
to in paragraphs 2 and 3 shall be established without
delay.’

— Paragraph 3 is replaced by the following:

‘3.

infant

(a) Those pesticides listed in Annex IX shall not be
used in agricultural products intended for the
production of
formulae and follow-on
formulae. However, for the purpose of control:
(i) pesticides listed in Table 1 of Annex IX are
considered not to have been used if their
residues do not exceed a level of 0,003 mg/
kg. This level which is considered to be the
limit of quantification of
analytical
methods shall be kept under regular review
in the light of technical progress;

the

(ii) pesticides listed in Table 2 of Annex IX are
considered not to have been used if their
residues do not exceed a level of 0,003 mg/
kg. This level shall be kept under regular
review in the light of data on environmental
contamination.

(b) By derogation of paragraph 2, for the pesticides
listed in Annex X, the maximum residue levels
specified therein shall apply.

For pesticides listed in Annex X, where a decision
concerning
an active
the non-inclusion of
substance in Annex I to Directive 91/414/EEC is
taken, Annex IX and Annex X to this Directive
shall be amended accordingly.

(c) The levels referred to in subparagraphs (a) and
(b) shall apply to the products as proposed ready
for consumption or as reconstituted according to
the instructions of the manufacturers.’

2. Annex IX is replaced by Annex I to this Directive.

3. Annex II to this Directive is added as Annex X.

Article 2

1.
The Member States shall authorise trade in products
which comply with Article 6(3) of Directive 91/321/EEC by 6
March 2004 at the latest.

The Member States shall prohibit trade in products which
2.
do not comply with Article 6(3) of Directive 91/321/EEC by 6
March 2005.

Article 3

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc-
tive by 6 March 2004 at the latest. They shall forthwith inform
the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 10 February 2003.

For the Commission

David BYRNE

Member of the Commission

14.2.2003

EN

Official Journal of the European Union

L 41/39

ANNEX I

‘ANNEX IX

Pesticides which shall not be used in agricultural production intended for the production of infant formulae
and follow-on formulae

Table 1

Chemical name of the substance (residue definition)

Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton)

Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion)

Fentin, expressed as triphenyltin cation

Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop)

Heptachlor and trans-heptachlor epoxide, expressed as heptachlor

Hexachlorobenzene

Nitrofen

Omethoate

Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)

Table 2

Chemical name of the substance

Aldrin and dieldrin, expressed as dieldrin

Endrin’

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Official Journal of the European Union

14.2.2003

ANNEX II

‘ANNEX X

Specific maximum residue levels of pesticides or metabolites of pesticides in infant formulae and follow-on
formulae

Chemical name of the substance

Maximum residue level
(mg/kg)

Cadusafos

Demeton-S-methyl/demeton-S-methyl
or combined, expressed as demeton-S-methyl)

sulfone/oxydemeton-methyl

(individually

Ethoprophos

Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)

Propineb/propylenethiourea (sum of propineb and propylenethiourea)

0,006

0,006

0,008

0,004

0,006’