[ISSION OF THE EUROPEAN COMMUNITIES 
COM(93) <|iofinal 
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. 
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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) 
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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; 
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(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 ml), 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. 
Article 3 
This Directive is addressed to the Member states. 
Done at Brussels, 
For the Council 
The President 
ISSN 0254-1475 
1 
UN «3 
Catalogue number : CB-CO-93-132-EN-C 
ISBN 92-77-53815-5 
OfEce for Official Publications of the European Communities 
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