COMMISSION OF THE EUROPEAN COMMUNITIES 
Sf^'êr^W C0MC93) 636 final 
Brussels, 7 December 1993 
r^waS^iHr J * \ *VV ir* tWL J 
Ml** Amended proposal for a 
COUNCIL PI RECTI YE 
amending Directive 70/524/EEC 
concerning additives in feedingstuffs 
(presented by the Commission pursuant to Article 189A(2) of the EC-Treaty) 
Explanatory memorandum 
At its plenary session of 15-19 November 1993, the European Parliament 
gave its opinion on the proposal for a Council Directive amending 
Directive 70/524/EEC on additives in feedingstuffs (C0M(93) 110 final). 
The Commission has accepted amendments 1 and 2 as proposed, and the 
part of amendment 3 referring to scientific documents concerning GMOs, 
as well as amendments 23 and 24 (extending the composition of the 
Scientific Committee on Animal Nutrition and assessment of enzymes 
obtained from genetically modified micro-organisms in order to remove 
risks to human and animal health and the environment). 
However, the Commission has not accepted the second part of amendment 3 
according to which two authorization procedures should be applied to 
products obtained from GMOs, i.e. the procedure under Directive 
70/524/EEC on additives and the procedure under Directive 90/220 EEC on 
the deliberate release into the environment of genetically modified 
organisms. (The Commission would rather opt for integrating the 
substantive provisions of Directive 90/220/EEC into Directive 
70/524/EEC). 
The Commission has accepted the spirit of amendments 4, 5, 6 and 7 on 
the label ting of GMO additives since, in accordance with the position 
it adopted during the discussion on the Roth-Behrendt report on NOVEL 
FOODS, such labelling would be on a case-by-case basis to indicate the 
presence of one or more significant special characteristics due to the 
manufacturing process. 
This proposal amends the Commission's initial proposal in accordance 
with Article 189A(2) of the Treaty. 
AMENDED PROPOSAL 
FOR A 
COUNCIL DIRECTIVE 
amending Directive 70/524/EEC concerning additives in feedingstuffs 
(presented by the Commission pursuant to Article 189A(2) of the EC 
Treaty) 
As a result of the opinion delivered by Parliament at its plenary 
session of 15-19 November 1993 on the proposal for a Directive amending 
Directive 70/524/EEC concerning additives in feedingstuffs, presented 
to the Council on 24 March 1993, the Commission has decided to amend 
its initial proposal as follows, in accordance with Article 189A(2) of 
the Treaty: 
1. After the first recital, the following recitals are added: 
"Whereas the inclusion of enzyme and microorganism products in 
Directive 70/524/EEC means that products belonging to both of these 
new categories and their manufacturers are subject to the same 
requirements which apply to the authorization of additives and to 
manufacturers in general; whereas it is particularly necessary to 
ensure that the products marketed are innocuous to the 
environment, workers, animal owners and consumers of animal 
products and furthermore that they satisfy the requirements set as 
regards effectiveness, quality and ability to be checked; 
Whereas in order to make possible the evaluation and authorization 
of enzymes produced by or derived from genetically modified 
organisms, the Commission must provide an assessment of such 
products with the aim of preventing damage to human or animal 
health or the environment; 
Whereas it appears necessary that the Scientific Committee for 
Feedingstuffs should be assisted by experts in the field of genetic 
engineering so as to ensure that the testing procedure is such as 
to rule out any damaging effects on human or animal health or the 
environment caused by the products concerned; 
Whereas in the Community authorization procedure for additives the 
requirements of Directive 90/220/EEC3 concerning a specific 
environmental risk evaluation must be applied in respect of all 
additives which contain genetically modified organisms: whereas 
these requirements should therefore b© inserted in Directive 
87/153/EEC fixing guidelines for the assessment of additives in 
animal nutrition4 and that they apply concomitantly with the 
provisions of the present directive;". 
3 OJ No L 117, 8.5.1990, p. 15. 
4 OJ No L 64, 7.3.1987, p. 19. 
2. The following is inserted in Article 1: 
"1. The following Article is Inserted after Article 7: 
"Article 7a 
If an additive contains genetically modified organisms within the 
meaning of Article 2(1) and (2) of Council Directive 90/220/EEC on 
the deliberate release into the environment of genetically modified 
organisms, a specific environmental risk assessment similar to that 
laid down in the abovementioned Directive shall be carried out; for 
this purpose, the following documents to be included in the dossier 
submitted pursuant to Article 9 in order to ensure compliance with 
Article 7(2): 
a copy of the competent authority's written consent to the 
deliberate release of genetically modified organisms for 
research and development purposes pursuant to Article 6(4) of 
Directive 90/220/EEC and the results of the release(s) with 
respect to the risk in each case to human health and the 
envIronment; 
the complete technical file with the information required by 
Annexes I and II to Directive 90/220/EEC and the environmental 
risk evaluation carried out on the basis of this information. 
3. Point 1(c) (now point 2(c)) of Article 1 is replaced by the 
fol lowing: 
"C. for additives belonging to the groups: 
(a) of enzymes: the specific name of the active constItuent(s) 
according to its (their) enzymatic activity(les) 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 adress or registred 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 and, where applicable, indication 
of any particular significant characteristics due to the 
manufacturing process, in accordance with the provisions 
concerning labelling in the column entitled "Other provisions" 
in the Annexes; 
(b) of 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 name or business name and the 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 and, 
where applicable, Indication of any particular significant 
characteristics due to the manufacturing process, in accordance 
with the provisions concerning label Sing in the column entitled 
"Other provisions" in the Annexes." 
4. Point 2(a) (now point 3(a)) of Article 1 Is replaced by the 
fol lowing: 
"(a) Subparagraphs (h) and (i) below are added: 
(h) enzymes: the specific name of the active constItuent(s) 
according to its (their) enzymatic activity(les) 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 mi), the expiry 
date of the guarantee or the storage life from the date- of 
manufacture, the name or business naina and the address or 
registered place of business of the manufacturer if he is not 
responsible for the particulars on the label and, where, 
applicable, indication of any particular significant 
characteristics due to the manufacturing process, in accordance 
with the provisions concerning labelling In th© column entitled 
"Other provisions" in the Annexes; 
(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 nam© and the address 
or registered place of business of the manufacturer if he is 
not responsible for the particulars on the label and, where 
applicable, indication of any particular significant 
characteristics due to the manufacturing process, in accordance 
with the provisions concerning labelling in the column entitled 
"Other provisions" in the Annexes;" 
5. Point 3 subparagraphes (h) and (i) (now point 4 subparagraphes (h) 
and (i)) of Article 1 is replaced by the following: 
"(h) for enzymes: the specific name of the active 
const I tuent(s) according to its (their) enzymatic 
act ivity( les) 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 and, where 
applicable, indication of any particular significant 
characteristics due to the manufacturing process, in 
accordance with the provisions concerning labelling in the 
column entitled "Other provisions" in the Annexes; 
(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 (CFU/g), 
the expiry date of the guarantee or the storage life from the 
date of manufacture and, where applicable, indication of any 
particular significant characteristics due to the manufacturing 
process, in accordance with the provisions concerning labelling 
in the column entitled "Other provisions" in the Annexes." 
6. Point 4 of Article 4 becomes point 5. 
ISSN 0254-1475 
COM(93) 636 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-93-676-EN-C 
ISBN 92-77-62409-4 
Office for Official Publications of the European Communities 
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