Commission Directive 1999/50/EC of 25 May 1999 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance)
Date: 1999-05-25
Institutions: European Commission
Subjects: baby food, early childhood, food inspection, foodstuffs legislation, prepared foodstuff

2. 6. 1999

EN

Official Journal of the European Communities

L 139/29

COMMISSION DIRECTIVE 1999/50/EC

of 25 May 1999

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 for particular nutritional
uses (1), as amended by Directive 96/84/EC of the Euro-
pean Parliament and of the Council (2), and in particular
Article 4(1) thereof,

After consulting the Scientific Committee for Food,

(1) Whereas Article 6 of Commission Directive 91/
321/EEC (3), as last amended by Directive 96/4/
EC (4), provides 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 and that necessary maximum levels
for such substances shall be established without
delay;

(2) Whereas different regulations on the maximum
levels of pesticide residues in such products cause
trade barriers between certain Member States;

(3) Whereas maximum levels for pesticide residues
stipulated in Council Directive 76/895/EEC of 23
November 1976 relating to the fixing of maximum
levels for pesticide residues in and on fruit and
vegetables (5), as last amended by Directive 97/41/
EC (6), 86/362/EEC of 24 July 1986 on the fixing
of maximum levels for pesticide residues in and on
cereals (7),
amended by Commission
Directive 98/82/EC (8), 86/363/EEC of 24 July
1986 on the fixing of maximum levels for pesticide
residues in and on foodstuffs of animal origin (9), as
last amended by Directive 98/82/EC, and 90/
642/EEC of 27 November 1990 on the fixing of
maximum levels for pesticide residues in and on
certain products of plant origin, including fruit and

last

as

(1) OJ L 186, 30.6.1989, p. 27.
(2) OJ L 48, 19.2.1997, p. 20.
(3) OJ L 175, 4.7.1991, p. 35.
(4) OJ L 49, 28.2.1996, p. 12.
(5) OJ L 340, 9.12.1976, p. 26.
(6) OJ L 184, 12.7.1997, p. 33.
(7) OJ L 221, 7.8.1986, p. 37.
(8) OJ L 290, 29.10.1998, p. 25.
(9) OJ L 221, 7.8.1986, p. 43.

vegetables (10), as last amended by Directive 98/
82/EC, are without prejudice to specific provisions
applicable
and follow-on
formulae;

to infant

formulae

(4) Whereas,

taking into account

the Community’s
international obligations, in cases where the rele-
vant scientific evidence is insufficient, the precau-
tionary principle allows the Community to provi-
sionally adopt measures on the basis of available
pertinent
an additional
assessment of risk and a review of the measure
within a reasonable period of time;

information, pending

Scientific Committee

(5) Whereas on the basis of the two opinions given by
the
for Food on 19
September 1997 and 4 June 1998 there are at
present doubts as to the adequacy of existing
acceptable daily intake values (ADI) for the protec-
tion of the health of infants and young children;
whereas the doubts expressed concern not only
pesticides
also
dangerous chemical substances, and consequently
the Commission will examine the possibility of
fixing, as soon as possible, maximum levels for
heavy metals in foods intended for infants and
young children;

pesticide

residues,

and

but

(6) Whereas, therefore, as far as foods for particular
nutritional uses intended for infants and young
children are concerned, it is appropriate to adopt a
very low common limit for all pesticides;

(7) Whereas this very low common limit should be
fixed at 0,01 mg/kg which is in practice the
minimum detectable level;

(8) Whereas severe limitations on pesticide residues
should be required; whereas, with careful selection
of raw materials, and given that infant formulae
extensive
and

follow-on

formulae

undergo

(10) OJ L 350, 14.12.1990, p. 71.

L 139/30

EN

Official Journal of the European Communities

2. 6. 1999

processing during their manufacture, it is feasible
to produce products containing very low levels of
pesticide residues;

(9) Whereas, however, for a small number of pesticides
even such low levels might allow the possibility
that under worst-case intake conditions the ADI of
these pesticides is exceeded; whereas,
therefore,
infant formulae and follow-on formulae should be
free of those particular pesticides and should be
produced without the use of such pesticides;

(10) Whereas this Directive reflects current knowledge
about these substances; whereas any amendment,
based on scientific or technical progress, will be
decided by the procedure laid down in Article 13
of Directive 89/398/EEC;

(11) Whereas Directive

91/321/EEC should

be

amended accordingly;

(12) Whereas

in this
the measures provided for
Directive are in accordance with the opinion of the
Standing Committee on Foodstuffs,

ready for consumption or as reconstituted according to
the instructions of the manufacturer.

Analytical methods for determining the levels of pesti-
cide residues shall be generally acceptable standardised
methods.

3.
Those pesticides listed in Annex IX shall not be
used in agricultural products intended for the produc-
tion of infant formulae and follow-on formulae.

4. Microbiological criteria shall be established as
necessary.';

3. the following is added as Annex IX:

‘ANNEX IX

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

Chemical name of the substance

. . .'

HAS ADOPTED THIS DIRECTIVE:

Article 2

Article 1

Directive 91/321/EEC is hereby amended as follows:

Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with
this Directive not later than 30 June 2000. They shall
forthwith inform the Commission thereof.

1. the following point (e) is added to Article l(2):

Those laws,
shall be applied in such a way as to:

regulations and administrative provisions

‘(e) “pesticide residue” means the residue in infant
formulae and follow-on formulae of a plant protec-
tion product, as defined in point 1 of Article 2 of
including its
Council Directive 91/414/EEC (*),
metabolites and products resulting from its degra-
dation or reaction;

(a) permit trade in products conforming to this Directive

no later than 30 June 2000,

(b) prohibit trade in products which do not comply with

this Directive, with effect from 1 July 2002.

(*) OJ L 230, 19.8.1991, p. 1.';

2. Article 6 is replaced by the following:

‘Article 6

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

1.
Infant formulae and follow-on formulae shall not
contain any substance in such quantity as to endanger
the health of infants and young children. Necessary
maximum levels shall be established without delay.

2.
contain residues of
exceeding 0,01 mg/kg of

Infant formulae and follow-on formulae shall not
levels
the product as proposed

individual pesticides at

Article 3

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

2. 6. 1999

EN

Official Journal of the European Communities

L 139/31

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 25 May 1999.

For the Commission

Martin BANGEMANN

Member of the Commission