COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 26.04.1995 
COM(95) 132 final 
Draft 
COUNCIL DIRECTIVE 
amending Directive 70/524/EEC 
concerning additives in feedingstuffs 
(presented by the Commission) 
EXPLANATORY MEMORANDUM 
Since 23 November 1970 the use of additives in livestock feedingdstuffs in 
the Community has been governed by Council Directive 70/524/EEC1. Since 
that date only those substances authorized under the Directive may be 
incorporated in feedingstuffs. Two types of authorization are provided for, 
depending on the extent of the guarantees offered by the additive. Annex 
I to the Directive liste those additives which meet all its requirements and 
which, therefore, may be freely used throughout the Community; Annex II 
lists those in respect of which examination has not been completed, but 
which nonetheless offer adequate guarantees of innocuousness for the 
Member States to be allowed to authorize them, provisionally and at national 
level, for a period which has since 3 December 1986 been limited to five 
years. 
As in other fields where Community legislation is greatly affected by 
constantly advancing scientific and technical knowledge, the Council has 
entrusted the Commission with the task of making the necessary 
amendments to the annexes to the Directive. The procedure adopted 
involves the Standing Committee for Feedingstuffs. 
In order to avail itself of all the scientific guarantees required, the 
Commission set up, on 2 September 1976, the Scientific Committee on 
Animal Nutrition2, which it consults on any proposals for measures which 
might have repercussions on animal health and consequently upon human 
health. When such proposals are being prepared, great importance is 
attached to the opinions of the Scientific Committee. 
OJ No. L 270, 14.12.1970, p. 1. 
OJ No. L 279, 09.10.1976, p. 35 
t. 
2. On 28 March 1995 a draft was put to the Standing Committee for 
Feedingstuffs authorizing, throughout the Community, the use of Avoparcine 
in feed for dairy cattle: 
The additive has been listed in Annex I to Directive 70/524/EEC since 
«he application of Directive S0/2Q&ÏEEC3 of 9 April 1990. It has been 
authorized for several years in most Member States arising to its 
beneficial effect on milk producëouL 
A decision must be taken on Community authorization, given that the 
five-year limit on national authorization expires on 10 April 1995. 
The Scientific Committee for &mma\ Nutrition, after a thorough 
examination of the dossier and after requesting further studies, has 
issued a favourable opinion on $KS additive4. 
The vote of the Standing Committee dtd not aftow an opinion to be issued. 
54 for 
24 against 
7 abstentions 
OJ No. L 106, 26.04.1990, p. 30. 
Opinion of 25 March 1994, confirmed on 29 September 
1994. To be published in the 10th Series of the 
Reports of the Scientific Committee for Animal 
Nutrition. 
Supplementary opinion of the Scientific Committee of 
24 March 1995. 
3. In the absence of an opinion from the Standing Committee for Feedingstuffs, 
the Council must decide whether the measures proposed by the Commission 
are justified. 
4. This draft has no impact on the Community budget. 
<# 
Council Directive 
of 
amending Directive 70/524/EEC 
concerning additives in feedingstuffs 
THE COUNOI* OF THE EUROPEAN UNION, 
Having regard to the Traty establishing the European Community, 
Having regard to Council Directive 70/524/EEC of 23 November 1970 
concerning additives in feedingstuffs1, as last amended by the 
Act of Accession of Austria > Finland and Sweden, and in 
particular Article 7 thereof, 
Having regard to the proposal from the Commission, 
Whereas Directive 70/524/EEC provides for regular amendment of 
the content of its Annexes to take account of advances in 
scientific and technical knowledge; whereas the annexes were 
consolidated by Commission Directive 91/248/EEC2; 
Whereas a new use of the antibiotic "Avoparcin" has been widely 
tested in several member States; whereas, on the basis of 
experience gained and studies undertaken, it appears that this 
new use can be authorized throughout the Community; 
Whereas the Scientific Committee for Animal Nutrition issued an 
opinion on this new use of Avoparcin; 
Whereas in absence of an opinion from the Standing Committee for 
Feedingstuffs, the Commission has been unable to adopt the 
provisions planned in accordance with the procedure provided for 
in Article 23 of the abovementioned Directive, 
OJ N* L270, 14.12.1970, p. 1, 
OJ N* L 124, 18.5.1991, p. 1 
HAS ADOPTED THIS DIRECTIVE : 
ArUpjle, I 
Annex I to Directive 70/524/EEC is hereby amended as set out in 
the Annex hereto. 
Article 2 
1. Member States shall bring into force the laws, regulations 
or administrative provisions necessary to comply with this 
Directive by 1st July 1995 at the latest. They shall 
immediately inform the Commission thereof. 
When member States adopt these measures, they shall contain 
a reference to this Directive or shall be accompagnied by 
such reference at the time of their official publication. 
The procedure for such reference shall be adopted by Member 
States. 
2. Member states shall communicate to the Commission the text 
of the main provisions of domestic law which they adopt in 
the field governed by this Directive. 
Article 3 
This Directive shall enter into force on the third day following 
its publication in the Official Journal of the European 
Communities, 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, For the Commission 
6 
ANNEX 
In Annex I to Directive 70/524/EEC, Part A "Antibiotics", the following is added to entry n* E 715 
"Avoparcin": 
^ EC 
N* Additive Chemical 
formula, 
description Species or 
category of 
animal 
Dairy 
cattle Maximum 
age 
i Minimum 
content Maximum 
content 
mg/kg of complete 
feedingstuff 
4 10 other provisions 1 
Indicate in the 
instructions for 
use : 
"The dose of 
avoparcin in the 
daily ration i 
-must not exceed 
150 mg, 
-must not be less 
than 50 mg." 
i 
i 
-4 
1 
•4 BSN 0254-1475 
C0M(95) 132 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-95-141-EN-C 
ISBN92-77-87659-X 
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