CELEX: 51978PC0488
Language: en
Date: 1978-09-29
Title: Proposal for a COUNCIL DIRECTIVE amending for the 14th time Directive 64/54/EEC on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (78) 488
Vol. 1978/0181
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983
concernant l'ouverture au public des archives historiques de la Communauté économique
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983,
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003
(JO L 243 du 27.9.2003, p. 1), ce dossier est ouvert au public. Le cas échéant, les documents
classifiés présents dans ce dossier ont été déclassifiés conformément à l'article 5 dudit
règlement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243,
27.9.2003, p. 1), this file is open to the public. Where necessary, classified documents in this
file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
Februar 1983 über die Freigabe der historischen Archive der Europäischen
Wirtschaftsgemeinschaft und der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983,
S. 1), geändert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003
(ABI. L 243 vom 27.9.2003, S. 1), ist diese Datei der Öffentlichkeit zugänglich. Soweit
erforderlich, wurden die Verschlusssachen in dieser Datei in Übereinstimmung mit Artikel 5
der genannten Verordnung freigegeben.
 ---pagebreak---  COMMISSION OF THE EUROPEAN COMMUNITIES
                                                COM(78)488 final.
                                                Brussels . 29 September 1978
                               Proposal for a
                              COUNCIL DIRECTIVE
 amending for the 14th time Directive 64/ 54/ EEC on the approximation of
        the laws of the Member States concerning the preservatives
              authorized for use in foodstuffs intended for
                              human consumption
               ( submitted to the Council by the Commission )
                                      /^7
                                       #
                                                -
                                                   W : \\
                                                      "Ε*
                                      te*        % wï* ' H
                                      vi a                   J
C0M<78 ) 488 final .
                                             t
 ---pagebreak---                                  EXPLANATORY NOTE
1 * The annex of Council Directive 64/54/EEC of 5 November 1963 on the
      approximation of the laws of the Member States concerning the preservatives
      authorized for use in foodstuffs intended for human consumption   as
      modified "by the Council Directive 76/629/EEC of 20 July 1976^ -
      authorises the presence of thiabendazole at up to a maximum residual
      amount of 6 mg/kg for citrus fruit and 3 mg/kg for bananas. This
      authorisation has been given on a temporary basis by the Directive of
      20 July 1976   up to 1 January 1979 "to permit the necessary examination
      to take place on<the efficacity of the additive , and in particular the
      level to be retained definitively.
       J                       '
2 . As far as questions of safety in use were concerned , the Commission 's
      proposal was based on the advice of the Scientific Committee for Food
      of 2 April 1976 « The Commission has reconsulted the Committee on the
      basis of toxicological and technological data submitted to it since
      that date .  On 23 June 197& "the Scientific Committee for Pood
      advised the Commission that after considering all the relevant toxicological
      data the Committee could establish an ADI of 0.3 mg/kg body weight for
      thiabendazole which it understands to be the same as that established
      by the Joint FAO/WHO Committees on pesticide residues. The Committee
      has been provided with a good deal of information concerning residues
  -   of thiabendazole in raw agricultural products and in food commodities ,
    - and seme data on the total human intake from all sources , including the
      intake resulting from the use of thiabendazole as a pesticide and in
      veterinary medicine .
      In the absence of convincing evidence of technological justification
      for an increase in the levels already stipulated in the Directive on
      Preservatives , the Committee recommends that the provisions in the
      Directive be maintained and that the permitted residue levels for
      citrus fruits and bananas should not be raised .
      X0J No 12 of 27.1.1964, P. 161/164
      20J No L 223 of 16.8.1976 , p. 23
 ---pagebreak--- The presort proposal implements this advice "by the deletion of the time
period in the Directive relating to thiabendazole®
Following consultations with the Advisory Cor-imittee for Pood the Commission
also proposes the reintroduction of the mandatory labelling provision
for citrus fruit sold "by retail . This provision was temporarily
suspended until a definitive decision was taken on the inclusion of
Thiabendazole in the text#
The Commission has "been informed that there is technological justification
in having several permitted treatment agents for the protection of
fruits ( in this case citrus fruit and bananas ) against deterioration
by microorganisms because the spectrum of activity is not the' same for
each substance#   The Commission continues to examine the possibility of
proposing a comprehensive Directive on such fruit treatment agents btxt
has not yet completed the necessary consultations .,  In the meantime the
Commission sees no reason to suggest other amendments to the Directive
on preservatives in respect of the vise of biphenyl (E 230 ) , orthophenylphenol
(E 23l ) and sodium orthophenylphenate (E 232 )*
 ---pagebreak---      Proposal for a Council Directive amending for "the I4"th "time Directive
     64/54/BEC on the approximation of the laws of the Member States concerning
     the preservatives authorized for use in foodstuffs intended for human
                                       consumption
THE COUNCIL OP THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community ,
and in particular Article 100 thereof ,
Having regard to the proposal from the Commission ,
Having regard to the opinion of the European Parliament ,         x
Having regard to the opinion of the Economic and Social Committee ,
Whereas Council Directive 64/54/EEC of 5 November 1963 on the approximation .
of the laws of the Member States concerning the preservatives authorized for
use in foodstuffs intended for human consumption^, as last amended "by
Directive 78/l45/EEC2,and in particular "by Directive 76/ 629/ EEC "*,
provides for the temporary use of thiabendazole -until 1 January 1979 at a
maximum residue level of 6 mg / kg in the case of citrus fruit and 3 mg / kg in the
case of bananas ;
Whereas , on a toxicological basis , the use of thiabendazole on the surface of
these fruits in quantities leading to such residues in the . whole fruit
is acceptable ;
Whereas experience in the use of thiabendazole has shown that the maintenance
of these levels is technologically justified ;
Whereas / theref ore, it is now possible to take a final decision to authorize
the use of thiabendazole without prejudice .to its possible inclusion in
subsequent Community system on the treatment of fruits         and vegetables ;
Whereas , therefore, the mandatory labelling provision for citrus fruit sold
by retail oan be reintroduced.                 "    .        .
X0J No 12 of 27.1.1964, P. 161/ 64                         '
20J No L 44 of 15.2.1978 , p. 23
30J.No L 223 of 16.8.1976 , p. 3
 ---pagebreak--- HAS ADOPTED THIS DIRECTIVE :
                          Article 1
In No E 233 of Section I of the Annex "to Directive 64/ 54/EEC , the
column " Conditions of use" is amended as follows :
1 * The text of subparagraph (b)(ii ), second indent , shall "be replaced
    "by the following :
        in the retail trade , a visible indication shall "be given
        ensuring "beyond doubt that the consumer is made aware that the
        fruit has "been treated ."
2 . Subparagraph ( c ) is deleted*
                          Article 2
Member States shall "bring into force not later than 31 December 1978
the laws , regulations or administrative provisions necessary to comply
with, thia Directive and shall forthwith inform the Commission thereof .
                           Article 3
This Directive is addressed to the Member States