COMMISSION DIRECTIVE 1999/50/EC

Direktiva Komisije 1999/50/ES

of 25 May 1999

z dne 25. maja 1999

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

o spremembi Direktive 91/321/EGS o začetnih in nadaljevalnih formulah za dojenčke in majhne otroke

(Text with EEA relevance)

(Besedilo velja za EGP)

KOMISIJA EVROPSKIH SKUPNOSTI JE

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti,

Having regard to the Treaty establishing the European Community,

ob upoštevanju Direktive Sveta 89/398/EGS z dne 3. maja 1989 o približevanju zakonodaje držav članic, ki se nanaša na živila za posebne prehranske namene [1], kakor je bila spremenjena z Direktivo Evropskega parlamenta in Sveta 96/84/ES [2], ter zlasti člena 4(1) Direktive,

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 European Parliament and of the Council(2), and in particular Article 4(1) thereof,

po posvetovanju z Znanstvenim odborom za živila,

After consulting the Scientific Committee for Food,

(1) ker člen 6 Direktive Komisije 91/321/EGS [3], kakor je bila nazadnje spremenjena z Direktivo 96/4/ES [4], predvideva, da začetne formule za dojenčke in nadaljevalne formule ne smejo vsebovati nobene snovi v količini, ki bi ogrozila zdravje dojenčkov in majhnih otrok, in da je treba nemudoma določiti mejne vrednosti teh snovi;

(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) ker različna pravila o mejnih vrednostih ostankov pesticidov v tovrstnih izdelkih predstavljajo ovire v trgovini med nekaterimi državami članicami;

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

(3) ker mejne vrednosti ostankov pesticidov, določene v Direktivi Sveta 76/895/EGS z dne 23. novembra 1976 o določanju mejnih vrednosti ostankov pesticidov v in na sadju in zelenjavi [5], kakor je bila nazadnje spremenjena z Direktivo 97/41/ES [6], v Direktivi Sveta 86/362/EGS z dne 24. julija 1986 o določanju mejnih vrednosti ostankov pesticidov v žitih in na njih [7], kakor je bila nazadnje spremenjena z Direktivo Komisije 98/82/ES [8], v Direktivi Sveta 86/363/EGS z dne 24. julija 1986 o določitvi mejnih vrednosti ostankov pesticidov v živilih živalskega izvora in na njih [9], kakor je bila nazadnje spremenjena z Direktivo 98/82/ES, ter v Direktivi 90/642/EGS z dne 27. novembra 1990 o določitvi mejnih vrednosti ostankov pesticidov v nekaterih proizvodih rastlinskega izvora, vključno s sadjem in zelenjavo, in na njih [10], kakor je bila nazadnje spremenjena z Direktivo 98/82/ES, ne posegajo v posebne določbe, ki se uporabljajo za začetne formule za dojenčke in nadaljevalne formule;

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

(4) ker previdnostno načelo, ob upoštevanju mednarodnih obveznosti Skupnosti, kadar so ustrezni znanstveni dokazi nezadostni, omogoča, da Skupnost do izvedbe dodatne ocene tveganja in pregleda ukrepov v primernem času sprejme začasne ukrepe na podlagi razpoložljivih ustreznih podatkov;

(4) Whereas, taking into account the Community's international obligations, in cases where the relevant scientific evidence is insufficient, the precautionary principle allows the Community to provisionally adopt measures on the basis of available pertinent information, pending an additional assessment of risk and a review of the measure within a reasonable period of time;

(5) ker na podlagi obeh mnenj, ki ju je podal Znanstveni odbor za živila 19. septembra 1997 ter 4. junija 1998, trenutno obstaja dvom, ki zadeva ustreznost sedanjih vrednosti sprejemljivega dnevnega vnosa (ADI) za varovanje zdravja dojenčkov in majhnih otrok; ker izraženi dvomi ne zadevajo zgolj pesticidov in njihovih ostankov, temveč tudi nevarne kemikalije, zaradi česar bo Komisija preučila možnost čim prejšnje določitve mejnih vrednosti težkih kovin v živilih, namenjenih dojenčkom in majhnim otrokom;

(5) Whereas on the basis of the two opinions given by the Scientific Committee 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 protection of the health of infants and young children; whereas the doubts expressed concern not only pesticides and pesticide residues, but 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;

(6) ker je torej, kar zadeva živila za posebne prehranske namene, ki so namenjena dojenčkom in majhnim otrokom, primerno, da se sprejme zelo nizka skupna mejna vrednost za vse pesticide;

(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) ker naj bo ta zelo nizka skupna mejna vrednost določena pri 0,01 mg/kg, kar je v praksi najmanjša vrednost zaznavanja;

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

(8) ker je treba za ostanke pesticidov predpisati stroge omejitve; ker je možno s skrbno izbiro surovin in glede na to, da se začetne formule za dojenčke in nadaljevalne formule obsežno predelujejo med proizvodnjo, izdelati izdelke, ki vsebujejo zelo majhne količine ostankov pesticidov;

(8) Whereas severe limitations on pesticide residues should be required; whereas, with careful selection of raw materials, and given that infant formulae and follow-on formulae undergo extensive processing during their manufacture, it is feasible to produce products containing very low levels of pesticide residues;

(9) ker lahko pri majhnem številu pesticidov tudi tako majhne količine omogočajo, da je ADI teh pesticidov v najslabših pogojih vnosa presežena; ker morajo biti zato začetne formule za dojenčke in nadaljevalne formule brez teh posebnih pesticidov in jih je treba izdelovati iz surovin, ki ne vsebujejo takih pesticidov;

(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) ker odraža ta direktiva trenutno védenje o teh snoveh; ker se bo o kakršnih koli spremembah, ki temeljijo na znanstvenem ali tehničnem napredku, odločalo v skladu s postopkom, opredeljenim v členu 13 Direktive 89/398/EGS;

(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) ker je treba Direktivo 91/321/EGS ustrezno spremeniti;

(11) Whereas Directive 91/321/EEC should be amended accordingly;

(12) ker so ukrepi, predvideni s to direktivo, v skladu z mnenjem Stalnega odbora za živila,

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

SPREJELA NASLEDNJO DIREKTIVO:

HAS ADOPTED THIS DIRECTIVE:

Člen 1

Direktiva 91/321/EGS se s tem spremeni takole:

Article 1

1. členu 1(2) se doda naslednja točka (e):

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

"(e) "ostanek pesticida"; pomeni ostanek fitofarmacevtskega sredstva, kakor je opredeljeno v točki 1 člena 2 Direktive Sveta 91/414/EGS [11], v začetnih formulah za dojenčke in nadaljevalnih formulah, vključno z njegovimi presnovki in razkrojnimi ali reakcijskimi produkti.";

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

2. člen 6 se nadomesti z naslednjim:

"(e) 'pesticide residue' means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC(11), including its metabolites and products resulting from its degradation or reaction;

"Člen 6

2. Article 6 is replaced by the following:

1. Začetne formule za dojenčke in nadaljevalne formule ne smejo vsebovati nobene snovi v količini, ki bi lahko ogrozila zdravje dojenčkov in majhnih otrok. Potrebne mejne vrednosti je treba nemudoma določiti.

"Article 6

2. Začetne formule za dojenčke in nadaljevalne formule ne smejo vsebovati ostankov posameznih pesticidov v količinah, večjih od 0,01 mg/kg izdelka, ki je namenjen uživanju kot pripravljen obrok ali je pripravljen po navodilih proizvajalca.

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.

Analitski postopki za določanje vsebnosti ostankov pesticidov morajo biti splošno sprejemljivi standardizirani postopki.

2. Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.

3. Pesticidi, navedeni v Prilogi IX, se ne smejo uporabljati za kmetijske pridelke, namenjene izdelavi začetnih formul za dojenčke in nadaljevalnih formul.

Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.

4. Po potrebi se določijo tudi mikrobiološka merila.";

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

3. doda se naslednje, kot Priloga IX:

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

PRILOGA IX

3. the following is added as Annex IX:

Pesticidi, ki se ne smejo uporabljati za kmetijske pridelke, namenjene izdelavi začetnih formul za dojenčke in nadaljevalnih formul

"ANNEX IX

Kemijsko ime snovi

…

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

Člen 2

Chemical name of the substance

Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 30. junija 2000. O tem takoj obvestijo Komisijo.

..."

Ti zakoni in drugi predpisi se uporabljajo tako, da se:

(a) promet z izdelki, ki so v skladu s to direktivo, dovoli najpozneje od 30. junija 2000;

Article 2

(b) promet z izdelki, ki niso v skladu s to direktivo, prepove s 1. julijem 2002.

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.

Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi. Način sklicevanja določijo države članice.

Those laws, regulations and administrative provisions shall be applied in such a way as to:

Člen 3

(a) permit trade in products conforming to this Directive no later than 30 June 2000,

Ta direktiva začne veljati dvajseti dan po objavi v Uradnem listu Evropskih skupnosti.

(b) prohibit trade in products which do not comply with this Directive, with effect from 1 July 2002.

Člen 4

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 publication. Member States shall determine how such reference is to be made.

Ta direktiva je naslovljena na države članice.

Article 3

V Bruslju, 25. maja 1999

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

Za Komisijo

Martin Bangemann

Article 4

Član Komisije

This Directive is addressed to the Member States.

[1] UL L 186, 30.6.1989, str. 27.

[2] UL L 48, 19.2.1997, str. 20.

Done at Brussels, 25 May 1999.

[3] UL L 175, 4.7.1991, str. 35.

[4] UL L 49, 28.2.1996, str. 12.

For the Commission

[5] UL L 340, 9.12.1976, str. 26.

Martin BANGEMANN

[6] UL L 184, 12.7.1997, str. 33.

Member of the Commission

[7] UL L 221, 7.8.1986, str. 37.

[8] UL L 290, 29.10.1998, str. 25.

(1) OJ L 186, 30.6.1989, p. 27.

[9] UL L 221, 7.8.1986, str. 43.

(2) OJ L 48, 19.2.1997, p. 20.

[10] UL L 350, 14.12.1990, str. 71.

(3) OJ L 175, 4.7.1991, p. 35.

[11] UL L 230, 19.8.1991, str. 1.

(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.

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

(11) OJ L 230, 19.8.1991, p. 1.