CELEX: 51974PC1101
Language: en
Date: 1974-07-15
Title: Proposal for a Second Council Directive amending the Directive of 23 November 1970, concerning additives in feedingstuffs. (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (74) 1101
Vol. 1974/0180
 ---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 EUEOPMAN COMMUMTIES
                                     COM ( 74) Hol final .
                                     Brussels , 15 July 1974
                              Proposal for a
                          Second Council Directive
               amending the Directive of 23 November 1970 »
               concerning additives in feedingstuffs .
               ( submitted to the Council by the Commission)
     CQM ( 74) llol final .
 ---pagebreak---                                   Justification
 The Council Directive of 23 November 1970 ( OJ No L 270 of 14 December , 1970 ,
p.l ) concerning additives in feedingstuffs has been generally regarded as an
 important step towards the harmonisation cf legislation on this subject .
       Directive not only regulate the use of additives in feedingstuffs , but
also for the first time protects consumers in the Community against the excessive
use of additives .
Tii is tendency has been reinforced as the Directive has been applied .
When the original Directive was amended by the Council Directive of 28 April 1973
amending the Directive of 23 November 1970 concerning additives in feedingstuffs
( OJ No L 124 of 10 May 1973 , p. 1 7 ) » and "the procedure of the Standing Committee
on Feedingstuffs was introduced to amend the Annexes , the Commission lost no
time in seizing the opportunity of eliminating a number of antibiotics from
Annex I ( list of additives which are to be permitted throughout the Community ).
It also placed limitations and conditions on the use of a number of additives
listed in Annex II ( list of additives which may continue to be used temporarily
within individual states ).
Cn the other hand , the Commission further developed the Annexes with the purpose
of improving the conditions for agricultural production .       This process continues
and up to the present , since the first reform of the provisions of the Directive
in April 1973 there have been eight amendments to the Annexes .       Further amendments
are in preparation .
Experience gained in the course of making the above-mentioned amendments has
shown , however , that the present procedure is still not completely satisfactory .
According to the present concept , which is expressed in the Directive in force ,
Annex I was regarded as being the rule .      Annex II was only set up   in order
to cover those substances on which agreement had not been reached when the
Directive was passed , but which at the time were permitted in at least one
Member States in accordance with principles whieh at least approximated to
those est out in the Directive .    The substances listed in Annex II were to be
at the free disposal of individual states ; however , a Member State which did
not make use of this opportunity would , according to Article 14 » have no right
to bar animal products from its market on the pretext that substances from
Annex II had been added in the country of origin .
 ---pagebreak---                                        -  2  -                               •
   We were concerned here with materials which had been well known for a long time ,
   the use of which had already been discontinued in some Member States , and partly
   with new materials , about which some Member States still wanted to gather
   information .  Proceeding on the assumption that within five years following
   the issue of the Directive to the Member States , this situation would have
   resolved itself , the Council limited the applicability of Annex II accordingly .
   This time limit runs out during November 1 975 •
   In fact , however , Annex II has already proved its general value as a phasing*-
 . in and phasing-out category .   New materials or uses proposed since the Directive
   was issued have in fact almost without exception been first included in Annex II ,
   because in every instance there were Member States which required a certain
   period of time to make their own tests on new materials from other Member
   States .  Contrariwise , it was possible to eliminate a number of additives
   from Annex I only because they could be given a certain phasing-out period
   by including them in Annex II .                                 ■ ' '   '
   /
   This procedure is now to be generalised , in that a time limit is to be put
'.on the availability to the governments of Member States of materials listed
    in Annex II . Under this arrangement the time limit applicable to products
   listed at present in Annex II ( end of 1975 ) will in practice remain unchanged,
   while time limits will in future be determined under Standing Committee
   procedure .                                                         ,
   Since the revision of the Annexes has been retarded by the accession of the
   new Member States , the five-year limit is also to be extended by three years
   during which Member States may permit the use of substances belonging to
   groups of substances listed in Annex II which in part extend beyond those
   listed in Annex I.    Care is still taken to ensure in the process that this
    authorisation does not extend to substances having a hormonal or anti–hormonal
    effect .
                                                                          ./•
 ---pagebreak---  It is further important that in future for all substances coming within
Annex II evidence must also be produced showing that the substances are not
harmful , that they can be analysed and. that they fulfil medical and veterinary
 requirements .
Furthermore , the amending Directive should eliminate a point of contention
which has arisen concerning the range of applicability .    In fact the majority
of Member States either proceed from the assumption or have recognised that
the Directive applies to the feedingstuffs of all animals .    One of the new
Member States takes issue with this and for the moment wishes to apply the
Directive only to productive animals .
There is much to be said for the usefulness of this kind of limitation ,
particularly with regard to pets , e.g. dogs , cats , canaries and ornamental .
fish .  For this reason the Commission reserves the right to reconsider at
an appropriate time whether a special regulation should not be dra.jn up for
these animals , particularly in view of the fact that the composition of
their feed is different from that of productive animals .    On the other hand ,
wild animals , including most of those kept in zoos , should already be excluded
from the area of application of the Directive .
The first amendment omitted to make the criteria of purity subject to
Standing Committee procedure .  Since it is here a question of technical imple­
menting measures this should now be corrected .   This procedure should also
be applied when fixing criteria for the composition and character of permitted
substances .
A number of further amendments to the Directive are purely technical in nature ,
but must be referred to the Council , because they are not established in
the Annexes .
The essential provisions of the Directive should be incorporated in national
legislation by 1 July 1975 » BO as to avoid any legal hiatus resulting from
the lapse of the time limit for Annex II .
                                                                        /•
 ---pagebreak--- The draft has been discussed with representatives or governments in the
Commission Working Group on Feedingstuffs Legislation . • It was found that
a considerable measure of agreement existed on questions of principle .
Professional and consumer organisations throughout the Community have also
been consulted concerning the draft . Again it was found that there was
considerable agreement in favour of the draft .
 ---pagebreak---                    . Second Council Directive of                         amending the
   Directive of 23 November 1970 » concerning additives in feedingstuffs
   THE COUNCIL OP THE EUROPEAN COMMUNITIES ,
  Having regard to the Treaty establishing the European Economic Community^
   and in particular Article 43 thereof ;
  Having regard to the proposal from the Commission ;
  Having regard to the Opinion of the European Parliament ;
                                                        V
  Whereas during the application of the Council Directive of 23 Novemoer
   1970 ( 1 ), concerning additives in feedingstuffs , as last amended "by the
T*-* - 1 - J- 1 .
              ^   Come lesion Directive of 26 February 1974 ( 2 ), amending the Annexes
  of the aforesaid Directive , it appeared necessary to define the term
  " animal ";
  Whereas it is advisable , in so far as this tern relates to pets ,
  to examine subsequently if it would not be advisable to adopt a special
  Directive in the case of feedingstuffs intended for these animals ;
  Whereas taking account of the amendments made by the Commission to the
  Annexes , it is necessary to make some corrections and amendments of a
  technical nature to the provisions of the Directive ;
  Whereas experience gained in relation to Annex II , which lists all the
  additives which may be permitted by Member States at national level up to
  the end of 1975 » has shown that this Annex must , henceforth , act as a
  buffer regulating the entry or the deletion of additives permitted at community
  level ( Annex 1 ); whereas such a measure necessitates the laying down of
  special conditions governing the introduction of substances to Annex II ;
   ( 1 ) OJ No L 270 , 14.12.1970 , p.1
   ( 2 ) OJ No L
 ---pagebreak--- Whereas , under Directive (EEC ) No 73/103 of the Cpuncil of 28 April 1973
( 3 ), the adaptation of the Annexes to the growth of scientific and
technical knowledge and honce the admission or deletion of additives has
been "brought under the procedure of the Standing Committee for Feedingstuffs ;
whereas , consequently, it would be advisable to specify likewise the
criteria of purity for these substances in accordance with this saoe
procedure ,
Whereas , finally, it is also advisable to provide for the specification
of criteria on the composition and quality of permitted additives ,
Whereas experience obtained during the marketing of feedingstuffs
containing additives' demonstrates the necessity to improve the marking
of these feedingstuffs which also include premixtures ,
HAS ADOPTED THIS DIRECTIVE :
                                    Article 1
The Directive of 23 November 1970 shall be amended as follows :
1.    The following subparagraph shall be inserted in Article 2 ;
      "g) Animals : The animals belonging to species' which are normally
                        kept and nourished by man",
2.    The following text shall be substituted for the first sentence of
      Article 3 ( 4 ) s
      "4. Antibiotics ( Annex I ( A) and Annex II (A)) and growth promoters
           (Annex I ( j ) and Annex II (E )) may be mixed with only one single
           other antibiotic or growth promoter , unless the mixture to be
           produced is already provided for in those Annexes".
( 3 ) OJ No L 124 , 10.5.1973 , p. 17
 ---pagebreak--- In the introduction to Article 3 ( 7 ) "the words "except in the case
of substances E 709 and E 712" shall be deleted .
In Article 3 ( 7 ) (B) , the words "Zinc bacitracin and spiramycin;        Virginia my
shall be substituted for the words "All other antibiotics".
In Article 4 0 ) ( a )> the word "eight" shall be substituted for the
word "five",             rrords " in Annex I or II" shr.ll be substituted for the word
Annex I".
In Article 4 ( 1 ) ( h ), the words "during a period of five years
following notification of this Directive" shall be deleted .
The following text shall be substituted for the text of Article
6 1 ):
" 1 . The criteria concerning the composition , purity end quality
     . of additives listed in this Directive shall be f xed , taking
       account of scientific and technical knowledge , in accordance
       with the procedure laid down in Article 16 ( a)".
The following sentence shall be added to Article 6 ( 2 ) ( b):
" The substance may be inserted in Annex II for a determined period ,
when ihe conditions of subparagraph A (b)/S$4 Li111 satisfied".
The following subparagraph shall be added to Article 6 ( 2 ):
" C.   A new substance or a new usage attributed to a substance may
       be inserted in Annex II only when conditions ( b) . ( c)'and ( e )
       subparagraph A are satisfied and it can be assumed , taking
       account of available results , that the other conditions of s\\i>»
       paragraph A are also satisfied".
In the introduction to Article 9 0 ) "the words "and grovrth promoters
(Annex I ( J) )" shall be inserted after the words "Vitamins D (Annex I ( H)
No . 1 )".
 ---pagebreak---                                                     ï
                                         mm A  mm                 ' ' 'W /' / v ^
11 . In Article 9 ( 1 ) ( b ), the words "or growth promoters " shall "be
     inserted .
12 . In Article 4 ( 1 ) ( C ) , the following indent shall be inserted :
          for growth promoters , 1000 ppm".
13 . The following text shall be substituted for the text of 'Article
     10 ( 1 ) ( g) :
     "g ) additives permitted under Article 4 ( 1 ) ( c)i ( d ) and ( e ):
            nature and content ".
14 . In Article 10 , the following paragraph shall be inserted after
     paragraph 2 :
     "( 2a ) The Member States shall prescribe that the nature of the
              additives which they have permitted under Article 4 0 )
              ( a ), ( b ) and ( f ) must be specified on the package or label .
              They may prescribe that the content must also be specified".
15 . In Article 11 ( i ), second subparagraph , the words "of Annex I or II"
     shall be substiuted for the words " of Annex I".
16 . The following Article shall be inserted after Article 11 :
                                      " Article 11a
     Member States shall prescribe that premixtures may not be placed on
     the market unless the label or package bears a statement indicating :
     a) that the premixture is not intended for direct animal consumption .
     b ) the -maxiuum pemittod content of the premixture in the daily r<~t °n
17 . A new column , entitled "Period of authorisation", shall be added to
     Annex II .     The date of " 31 December 1975" shall be entered in this
     column for all the additives listed at ■ present . in the Annex­
                    , ;      (. \ '      •/ ,   - .      :   ;vb-
                                               •  l «/a- y 1 97 6 .
 ---pagebreak---                                   - 5 -
                                 Article 2
Member States shall bring into force the laws , regulation and
administrative provisions necessary to comply :
a) by 1 July 1975 at the latest with Article 1 ( 9 ) ( 6 ) ( 7 ) ( 8 ) and
    ( 9) ;
b ) by 1 July 1976 at the latest , with the other provisions of this
    Directive .
                                Arti cle 3
This Directive is addressed to the Member States .