Proposal for a COUNCIL DIRECTIVE AMENDING DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS
Date: 1993-03-23
Institutions: European Commission
Subjects: animal nutrition, environmental impact, food additive, genetic engineering, impact study, public health

[ISSION  OF  THE  EUROPEAN  COMMUNITIES 

COM(93)  < | i of i n al 

Brussels,  23  March  1993 

Proposal 

for  a 

COUNCIL DIRECTIVE 

AMENDING DIRECTIVE 70/524/EEC CONCERNING ADDITIVES 
IN FEEDINGSTUFFS 

(presented by the Commission) 

Explanatory memorandum 

The purpose of the proposed measures is to amplify the provisions 

recommended by the Commission in the proposal for a Council Decision 

permitting the Member states to allow temporarily, at national level, the 

use of enzymes, microorganisms and their preparations in feedingstuffs until 

those products have received Community authorization pursuant to Council 

Directive 70/524/EEC concerning additives in feedingstuffs. 

A number of dossiers have now been submitted to the Commission by the Member 

States with a view to obtaining Community authorization and it is 

consequently necessary to adapt the provisions on the labelling of additives 

laid down by Directive 70/524/EEC to these new classes of products so that 

they can be identified and checked at all stages of use. 

- 2 -

COUNCIL DIRECTIVE 
Of 
amending Directive 70/524/EEC concerning additives 
in feedingstuffs 
(../../EEC) 

THE COUNCIL OF 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(1), 

Having regard to the opinion of the European Parliament<2), 

Having regard to the opinion of the Economic and Social Committee^), 

Whereas Council Directive 70/524/EEC concerning additives in 
feedingstuffs(*•), as last amended by Directive 92/113/EEc(5)  f  lays down 
the principles relating to the authorization and the use of additives; 

Whereas advances in scientific and technological knowledge permit the use 
of certain enzymes, microorganisms and their preparations in animal 
nutrition in order to improve the digestibility of nutrients or to 
stabilize the flora of the digestive system of animals and to reduce the 
quantity of certain substances dangerous to the environment; 

Whereas Decision 93/.. ./EEc(6) permits the Member States to allow 
temporarily and subject to certain conditions the use and marketing of 
enzymes, microorganisms and their preparations at national level until 
those products receive Community authorization pursuant to Directive 
70/524/EEC; 

(1) 
(2) 
(3) 
(4) OJ No L 270, 14.12.1970, p. 1. 
(5) OJ No L  16, 25. 1.1993, p. 2. 
(6) 

- 3 -

Whereas the grant of such authorization implies that special labelling 
provisions be inserted in the abovementioned Directive for this new 
generation of additives and for the premixtures and feedingstuffs in which 
they will be incorporated, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Council Directive 70/524/EEC of 23 November 1970 concerning additives in 
feedingstuffs is hereby amended as follows: 

1. Article 14(1) is amended as follows: 

(a)  The title of point A is replaced by the following: 

"A.  for all additives with the exception of enzymes and microorganisms:" 

(b)  In point B, subparagraph  (d) is worded as follows: 

(d) 

trace elements, colorants including pigments, preserving 
agents and other additives with the exception of those 
belonging to the groups of enzymes and microorganisms: 
active substance level. 

(c)  Point C below is added: 

"C. for additives belonging to the groups: 

"(a) of enzymes: the specific name of the active constituent(s) according 

to its (their) enzymatic activity(ies) in accordance with Annexes I 
or II, the identification number according to the International 
Union of Biochemistry, the activity units  (activity units per g or 
activity units per ml), the name or business name and the address or 
registered place of business of the person responsible for the 
particulars referred to in this paragraph, and the name or business 
name and the address or registered place of business of the 
manufacturer if he is not responsible for the particulars on the 
label, the expiry date of the guarantee or the storage life from the 
date of manufacture, the batch reference number and the date of 
manufacture, the words "to be used exclusively for the manufacture 
of feedingstuffs", the directions for use and, where appropriate, a 
safety recommendation where the column entitled "Other provisions" 
in the Annexes contains special provisions concerning the additives, 
the net weight and for liquid additives either the net volume or the 
net weight; 

- 4 -

(b)  of microorganisms: the identification of the strain(s) in accordance 

with Annexes I or II, the file number of the strain(s), the Dumber 
of units forming the colonies  (CFU/g), the name or business name and 
address or registered place of business of the person responsible 
for the particulars referred to in this paragraph, the name or 
business name and address or registered place of business of the 
manufacturer if he is not responsible for the particulars on the 
label, the expiry date of the guarantee or the storage life from the 
date of manufacture, the batch reference number and the date of 
manufacture, the words "to be used exclusively for the manufacture 
of feedingstuffs", the directions for use and, where appropriate, a 
safety recommendation where the column entitled "Other provisions" 
in the Annexes contains special provisions concerning the additives, 
the net weight and for liquid additives either the net volume or the 
net weight; 

2. In Article 15(1) B 

(a)  subparagraphs  (h) and (i) below are added: 

"(h) enzymes: the specific name of the  active constituent(s) according 

to its (their) enzymatic activity(ies) in accordance with Annexes I 
or II, the identification number according to the International 
Union of Biochemistry, the activity units  (activity units per g or 
activity units per ml), the expiry date of the guarantee or the 
storage life from the date of manufacture, the name or business name 
and the address or registered place of business of the manufacturer 
if he is not responsible for the particulars on the label; 

(i)  microorganisms:  the identification of the strain(s) in accordance 
with Annexes I or II, the file number of the strain(s), the number 
of units forming the colonies  (CFU/g), the expiry date of the 
guarantee or the storage life from the date of manufacture, the name 
or business name and the address or registered place of business of 
the manufacturer if he is not responsible for the particulars on the 
label;" 

(b) subparagraph  (h) becomes subparagraph  (j) and is worded as follows: 

"(j) other additives belonging to the groups referred to in (b) to (i) 
for which no maximum level is laid down and additives belonging to 
other groups provided for in Annexes I or II: specific name of the 
additive in accordance with Annexes I or II and active substance 
level, provided that these additives fulfil a function in the 
feedingstuff as such and the amounts present can be determined by 
official methods of analysis or, failing this, by valid scientific 
methods". 

3.. The  following subparagraphs (h) and  Ci) are added  to Article  16(1): 

(h)  for enzymes:  the pacific  name of  the  actives const i tuent (s) 

according  to  its (their) enzymatic activity(ies)  in accordance with 
Annexes  I or  il, the  identification number  according  to the 
international  Union of Biochemistry, the activity units  (activity 
units per g or activity units per m l ), the expiry  date of  the 
guarantee or  the storage  life from  the date of manufacture; 

(i)  for microorganisms:  the  identification of  the strain(s) in 

accordance with Annexes  I or  II, the  file number  of  the  strain(s), 
the number  of units forming  the colonies  CCFU/g),  the expiry  date of 
the guarantee or  the storage  life from  the date of manufacture. 

4.  In Articles 23 paragraph  4, second  line and  24 paragraph  4, second  line 
the part of  the sentence  "except where  the council  has voted by a simple 
majority against  such measures"  is deleted  in each  case. 

Article  2 

1. Member  States shall  bring  into force  the  laws, regulations and 

administrative provisions necessary  to comply  with  this Directive by 30 
June  1994.  They shall  notify  the Commission  thereof  forthwith. 

Where Member  States adopt  such provisions  they shall  contain a  reference 
to  this Directive or shall  be accompanied  by  such  reference when  they are 
officially published.  Details of  this  reference  shall  be  laid down by 
the Member  States. 

2. Member  States shall  communicate  to  the commission  the  text  of  the 

provisions of national  law which  they  adopt  in the area covered  by  this 
Directive. The Commission  shall  inform  the other  Member  States  thereof. 

This Directive  is addressed  to the Member  states. 

Article 3 

Done at  Brussels, 

For the Council 
The  President 

ISSN 0254-1475 

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Catalogue number : CB-CO-93-132-EN-C 

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