Proposal for a COUNCIL DIRECTIVE amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition
Date: 1997-01-08
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, marketing, public health

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

Brussels,  08.01.1997 
COM(96)  715  final 

97/0014  (CNS) 

Proposal  for  a 

COUNCIL  DIRECTIVE 

amending  Directive  93/113/EC  concerning  the use  and marketing  of  enzymes, 
micro-organisms  and their preparations  in animal  nutrition 

(presented  by  the  Commission) 

EXPLANATORY  MEMORANDUM 

On 14 December  1993 the Council adopted Directive 93/113/EC concerning the use and 
marketing  of  enzymes,  micro-organisms  and their  preparations  in animal  nutrition. 

The  measures  concerned: 

authorize the Member  States to permit provisionally  the use on their territory  of 
enzymes  and  micro-organisms  appearing  on  their  national  lists  before  1 
November  1994,  and 

apply  Council  Directive  70/524/EEC  concerning  additives  in  feedingstuffs 
(Community  registration  procedure,  common  rules  on use  and  labelling)  to  the 
products  in  question. 

The  timetable  set  by  Directive  93/113/EC  requires  the  Commission  to  decide  before 
I  January  1997 on the authorization  applications  that  the Member  States  were  obliged 
to  send  it,  along  with  supporting  evidence,  before  1 January  1996  (the  2b Committee 
procedure).  The  Commission  received  203  case  files  by  that  date,  a  list  of  which  was 
published 
the  European  Communities  No  C  263  of 
II  September  1996. 

in  Official  Journal  of 

Eight  meetings  have  so  far  been  held  and  only  half  of  the  submitted  files  have  been 
initially  examined;  it  should  be  pointed  out  that  neither  the  Member  States  nor  the 
Commission expected to receive such a large number of authorization  applications when 
Directive 93/113/EEC was adopted. In addition,  it became obvious during appraisal  that 
many  of the files  were  incomplete  and additional  information  would  be required  before 
a decision  could  be taken  on the products  that  actually  met the conditions  laid  down in 
Directive 70/524/EEC  as regards  safety  of use and effectiveness  for  authorization  as an 
additive. 

In view of the economic consequences  for  companies that an uncompromising  rejection 
of  incomplete  files  would  entail,  it  was  decided  at  the  Meeting  of  the  Standing 
Committee  on  Food  Additives  of  25 June  1996 to  allow  companies  four  months  grace 
to complete  their  files  (31 October  1996). 

Under the circumstances,  it is impossible to decide on these applications for  authorization 
by  1 January  1997 and  it  is proposed  to postpone  the date  for  one  year. 

Proposal  for a 
Council Directive 
of 
amending  Directive  93/113/EC concerning  the use  and marketing  of enzymes, 
micro-organisms  and their preparations  in animal nutrition 

THE COUNCIL OF THE EUROPEAN UNION 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in particular 

Article 43 thereof, 

Having regard  to the proposal  from the Commission1, 

Having  regard to the opinion of the European Parliament2, 

Having  regard  to the opinion of the Economic  and Social Committee3, 

Whereas  Council  Directive  70/524/EEC  of 23 November  1970 concerning  additives in 
feedingstuffs4,  as  last  amended  by  Commission  Directive  96/66/EC5,  lays  down  the 

principles  relating  to the admission  and the use of additives; 

Whereas Council Directive  93/113/EC  of  14 December  1993 on the use and marketing 
of enzymes,  micro-organisms  and their preparations  in animal  nutrition6 authorizes the 

Member States to permit provisionally  the use and marketing of the products in question 

provided  that,  on  the  basis  of  available  scientific  evidence,  they  do  not  present  any 

danger to human or animal health; 

1 OJNoC  .... 
2O J N oC  ... 
3O J N oC  ... 
4O J N o L 2 7 0,  14.12.1970,  p.  1. 
5 OJ N*  L 272,  25.10.19%,  p.  32. 
6 OJ No L 334,  31.12.1993,  p.  17. 

Whereas  Directive  93/113/EEC  requires  the  Commission  to  decide  before  1 January 

1997  on  case  files  submitted  by  the  Member  States  before  1 January  1996  for  the 

purpose  of  obtaining  Community  authorization  under  Directive  70/524/EEC; 

Whereas  the  large  number  of  case  files  submitted  by  the  Member  States  makes  it 

impossible to decide, in full  knowledge of the facts,  on all the authorization  applications 

by  31 December  1996; whereas  the date by which the Commission  must decide  should 

thus  be  postponed  by  one  year  so  that  the  Commission  and  the  Member  States  have 

sufficient  time to give  serious  consideration  to the files  submitted  to them, 

HAS ADOPTED  THIS  DIRECTIVE: 

Article  1 

The  date  of  1  January  1997  in  Article  5  of  Directive  93/113/EC  is  replaced  by 

1  January  1998. 

Article  2 

This  Directive  shall  enter  into force  on the seventh  day  following  its publication  in the 

Official  Journal  of  the  European  Communities. 

Article  3 

This  Directive  is addressed  to the Member  States 

Done  at Brussels, 

For  the  Council 

ISSN 0254-1475 

COM(96) 715 final 

DOCUMENTS 

EN 

03  05 

Catalogue number  : CB-CO-96-729-EN-C 

ISBN 92-78-14091-0 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg 

4-