COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(93) 251 final 
Brussels, 09 July 1993 
Jim 
4, ' ** 'V 
fi''.**' Proposal for a 
COUNCIL DIRECTIVE 
AMENDING DIRECTIVE 70/542/EEC 
CONCERNING ADDITIVES IN FEEDINGSTUFFS 
(presented by the Commission) 
», »t 
Explanatory memorandum 
The experience gained since Directive 70/524/EEC was amended for the third 
time has shown that some aspects need to be revised so as to prevent poor 
copies of additives orginating in third countries, which might be harmful 
to health, from being placed on the market in the Community as has happened 
in recent months. 
In the interests of transparancy and safety with regard to both animal and 
human health and environmental protection, it is important in future to 
link to a particular individual authorization to market technological 
additives with a very specific composition. 
The introduction of this new concept requires a change in the authorization 
procedures and the introduction of arrangements to govern the transition 
from the old system to the new one. 
The procedure to be followed for the examination of dossiers has been 
specified and deadlines laid down to ensure the efficiency of the 
centralized mechanisms for the authorization to market additives. 
It should be noted that in future the examination of dossiers at national 
level will be subject to a fee. 
In addition, for safety reasons, dossiers on additives must in future be 
re-examined regularly to take account of scientific progress, particular 
regarding the toxlcological assessment of the substances concerned. 
To put an end to distortions of competition and obstacles to trade arising 
as a result of considerable delays in the transposition of directives 
authorizing the marketing of additives or differences between the Member 
States resulting from the conditions for admission into their territory of 
the additives listed in Annex II, provision has been made for additives to 
be authorized by means of Decisions, and for provisional authorization of 
additives which fulfil a minimum number of conditions to be extended 
throughout the Community . 
With regard to the latter measure, the objective is to avoid possible 
confict between Member States arising from national authorization 
procedures. Member States will, however, continue to have recourse to a 
safeguard clause where an additive is found to be dangerous despite the 
precautions taken. 
It should be emphasized that the new procedure leaves Member States 
completely free with regard to the assessment of the dossiers submitted to 
them for transmission to the Commission for authorization. 
-M-
To make the text easier to understand, two diagrams have been attached to 
this explanatory memorandum: 
- one concerning the organization of the new procedure for authorization 
of additives, 
- the other describing the above-mentioned transitional arrangements. 
Procedure for tho authorIzotlon of oddltlvw 
Manufacturer 
309 days 
49 
doyi COMISSIGN 
Inclusion In th» 
ogenca of the 
STANDIHS COVMITTEE 
(Beginning of exanln-
otlon) TrarMmiwIon to reporting U.S. 
application -f dowler + fw 
Merber Stote cet Ing 
O* rUPPCRTBUR 
(Verification end 
t of tho 
l«r) 
HRANSvllSSICN OF DOSSIER-
SCAN 
OPINION 
of tho 
STANDING C0OJITTŒ 
on tho Cormlsslon's 
draft proposal 
330 day* Othor Uerber Statw 
0 \ 
COMISSICN Decision 
Conrunlty 
AUTHORIZATION 
of oddltlvw linked to 
o porion responsible 
for marketing M 
Protection of data Provisional Ccmrunlty 
authorization of oddltlvw 
I Irked to a person rwp-
onelble for marketing 
(1)(twtlng) maxima* 3 yr« 
authorization Ccmrunlty AUTHORIZATION of 
generic oddltlvw 
Protect Ion of data Provisional AUTHCRIZATION of generic 
oddltlvw (twtlng) maxlm/n 3 years 
Inclusion In Chapter III of 
the annual Met Inclusion In Chapter IV of 
the annual list 
Inclusion In Chapter I 
of the annuoI list Inclusion In Chapter 11 of 
the annual list 
(1) Addltlvw belonging to the groups listed In Council Decision ../.../OX. (zootechnlcs) 
TRANSITIONAL ARRANGEMENTS 
Addltlv 
former Generic eddltN 
Addltlvw m referred to In 
Article 2(b) Included In 
Annex I K> years before 
adaption AUTOMATIC AUTHORIZATION 
INCLUSION 
IN 
ANNEX 8 
CHAPTER I 
Addltlvw es referred to 
In Article 2(b) Included 
In Ames I low than 
10 years before adaption 
ADOPTION PERSON RESPONSIBLE FOR MARKETIN3 
LOCOES DOSSIER WITH A VIEW TO ITS 
RE-CXAMI NATION COMISSICN DECIDES TO AUTHORIZE 
THE ADDITIVE LINKED TO THE PERSON 
RESPONSIBLE FOR MARKET IN3 
AN APPLICATION FOR AUTHOR­
IZATION LINKED TO PERSON 
RESPONSIBLE FOR MARKETIM3 
ISIXDGED DECISION TO GRANT AUTHORIZ­
ATION LINKED TO PERSON OR 
BCOY RESPONSIBLE FOR 
MMCTINB TAKES EFFECT 
A. 
ENTRY INTO FORCE OF ARTICLES Sd 
TO 91 
1 
6 MONTHS TRANSPOSITION 
1 YEAR 
• 2YEARS 
EXAMINATION OF DOSSIERS UNDER 
THE NEW RULES 
Addltlvw from 
former Amex 11 ConorIc addltlvw MAXIMUM 9 YEARS PROVISION AUTHORIZATION TAKINC 
ACCOUNT GF THE PERIOD OF IN0LU5ION IN ANNEX 11 
Addltlvw as referred to 
In Article 2(b) TRANSFER TO ANNEX B CHAPTER II 
MAXIMUM S YEARS TAX IMS ACCOUNT OF THE 
PERIOD OF INCLUSION IN ANNEX II 9YEARS 8YEARS I 
LOOCINB CF APPLICATION FOR AUTHORIZATION LINKED TO PERSON RESPONSIBLE FOR MARKET I rC 
- 2 -
COUNCIL DIRECTIVE 
amending Council Directive 70/524/EEC 
concerning additives in feedingstuffs 
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 commission1, 
Having regard to the opinion of the European Parliament^, 
Having regard to the opinion of the Economic and Social Committee3, 
Whereas application of Council Directive 70/524/EEC of 23 November 1970 
concerning additives in feedingstuffs4, as last amended by Commission Directive 
../../EEC5, has shown that certain basic concepts must be revised to take 
account of the need to ensure a greater degree of protection of animal and human 
health and of the environment; 
Whereas experience shows that the current rules on the use of additives in 
feedingstuffs do not provide all the necessary assurances as to safety, 
particularly because of the marketing in the Community of poor copies of 
zootechnical additives; whereas it is therefore necessary to link the 
authorization of such additives to the person responsible for the marketing of 
additives authorized by the community; 
Whereas a distinction should be made between additives known as "generic" 
because they are widely used and present no particular dangers, such as 
feedingstuff manufacturing aids, and high-tech additives with a very specific 
composition for which the person or body responsible for marketing must receive 
authorization, in order to avoid the marketing of copies which might not be in 
conformity and might therefore be unsafe; 
1 
2 
3 
4 OJ No L 270, 14.12.1970, p. 1. 
5 
- 3 
Whereas the Council should draw up a list of the groups of additives for 
which authorization to market is granted to a specific person; 
Whereas, to facilitate application of the Directive, the list of 
definitions should be supplemented and certain definitions should be 
amended; whereas, in particular, the concept of additives should be defined 
so as to take account of their possible effects on animal products, animal 
welfare or the environment; 
Whereas experience has shown that the authorization of additives by means 
of Directives causes considerable delays; whereas such delays in the 
transposition of Directives has sometimes resulted in the distortion of 
competition and even created obstacles to trade; whereas, to remedy this 
situation, additives should be authorized by means of Decisions; 
Whereas the authorisation of additives is a Community competence; whereas 
the Member States are closely associated with the examination and 
evaluation of additives dossiers with a view to their admission. 
Whereas a fee should be charged for the examination by the Member State 
acting as rapporteur of the dossier on the basis of which the authorization 
is to be granted; 
Whereas the introduction of fees must be accompanied by the assurance that 
a decision will be reached on the application for authorization to market 
an additive within a given deadline; 
Whereas certain feed additives may reach the human food chain, it is 
necessary that the Scientific Committee for Animal Nutrition collaborates 
with the Scientific Committee for Food for such matters which may have an 
influence on consumer health; 
Whereas, in order to put an end to the differences between Member States 
regarding the arrangements for admitting the additives in Annex II into 
their territory, the provisional authorization of additives meeting a 
minimum number of conditions should be extended throughout the Community, 
Whereas it is necessary to introduce special arrangements to facilitate the 
transition to the new authorization system; whereas the date of entry into 
force of the relevant provisions must therefore be moved forward; 
Whereas account should be taken of developments in techniques relating to 
the use of additives; whereas provision should therefore be made, in 
certain cases, for the possibility of administering additives, under 
certain conditions, by means other than incorporation in feedingstuffs ; 
Whereas monographs of zootechnical additives should no longer be published; 
whereas an information note on the additives in question should be 
published instead in order to facilitate their identification; 
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Whereas the national authorities should be provided with a standard sample to 
enable them to carry out checks; 
whereas, in view of the deletion of Annexes I and II, in the interests of 
clarity and transparency lists should be published each year of producers who 
have received from an authorized person the right to manufacture additives, on 
the one hand, and of all authorized additives on the other, 
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. The following title is inserted above Article 1: 
"SCOPE" 
2. The following title is inserted between Articles 1 and 2: 
"DEFINITIONS" 
3. Article 2(a) is replaced by the following: 
"(a) additives: substances or preparations containing substances other than 
premixtures as referred to in (j) which, when used in animal nutrition, 
are likely to affect the characteristics of feedingstuffs or livestock 
production or animal products or to reduce the possible harmful effects of 
stock farming on the human or animal environment;" 
4. The following points are added after Article 2(a): 
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"(b) additives subject to authorization linked to the person responsible for 
marketing: additives belonging to the groups of additives listed in 
Council Decision ../.../EEC; 
(c) generic additives: additives belonging to groups not subject to 
authorization linked to the person responsible for marketing;" 
5. The former points (b) to (h) in Article 2 become (d), (e), (f), (g), (h), (i) 
and (j) respectively. 
6. The following point is added after the new point (j) of Article 2: 
(k) raw materials: the various plant or animal products in their natural 
state, fresh or preserved, and derivatives from the industrial 
processing thereof, as well as organic or inorganic substances, whether 
or not containing additives, intended for marketing as straight 
feedingstuffs or for the preparation of compound feedingstuffs or as 
support to premixtures;" 
7. The former points (i) and (j) of Article 2 become points (1) and (m) 
respectively. 
8. The following point is added after the new point (m) of Article 2: 
"(n) placing on the market: the holding of additives with a view to their 
use, sale or other form of transfer to third parties, whether free or in 
return for payment, as well as the sale and other forms of transfer 
themselves." 
9. Articles 3 to 9 are replaced by the following: 
"PROCEDURE FOR THE AUTHORIZATION OF ADDITIVES 
Article 3 
1. Member States shall require that, as regards feedingstuffs, no additive 
shall be placed on the market unless a Community authorization has been 
granted under a Commission decision in accordance with the following 
procedure. 
- 6 -
2. In order to obtain the Community authorization referred to in paragraph 1, 
Member States shall ensure that: 
(a) the person responsible for marketing submits an application to the 
Commission for all additives or, in the case of an additive which has 
already been authorized, any new use; 
(b) that a dossier, compiled in accordance with paragraph 3 below, 
accompanies the application for authorization submitted to the 
Commission by the person responsible for marketing; the dossier and 
the application shall be transmitted officially by the Member state 
acting as rapporteur to the Commission and to the other Member states, 
which shall acknowledge receipt thereof as quickly as possible. 
3. The application and the dossier referred to in paragraph 2 must be 
prepared in accordance with Council Directive 87/153/EEC. subsequent 
amendments to the above-mentioned Directive as a result of scientific and 
technical developments shall be adopted in accordance with the procedure 
laid down in Article 23. 
Article 4 
1. Member States shall ensure that, from 1 July 1996, a fee is received for the 
examination of the dossier arising from the obligations laid down in Article 
7(2)(a). 
2. Member states shall ensure that direct or indirect reimbursement of the fee 
is prohibited and that the fee does not exceed the real cost of examining the 
dossier. 
3. Not later than 1 January 1998, the Council, acting by qualified majority on a 
, proposal from the Commission, shall fix the flat-rate amounts of the fee 
referred to in paragraph 1. 
(3) 
- 7 -
Article 5 
1. Member States and the Commission shall ensure that any information which, if 
disseminated, could affect industrial and commercial property rights is kept 
confidential. 
2. Industrial and commercial secrecy shall not apply to : 
- the denomination and composition of the additive, 
- the physico-chemical and biological characteristics of the additive, 
the interpretation of the pharmacological, toxicological and 
ecotoxicological data, 
the analytical methods for monitoring the additive in the feedingstuffs, 
- the methods for testing for residues of additives in animal products. 
Article 6 
1. The scientific Committee for Animal Nutrition established by Commission 
Decision 76/791/EEC, hereinafter referred to as 'the Scientific 
Committee',shall be responsible for assisting the Commission, at the latter's 
request, on all scientific questions relating to the use of additives in 
animal nutrition. 
2. At the request of the Commission, the Member State acting as rapporteur shall 
ensure that all or part of the dossier referred to in Article 3 is 
transmitted to the members of the Committee referred to in paragraph 1. 
Article 7 
1. A decision on the application for authorization shall be taken in accordance 
with the procedure laid down in Article 23. 
2. An application for authorization shall be included on the agenda of the 
Standing Committee for Feedingstuffs for initial examination provided that: 
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(a) the Member State acting as rapporteur has declared during transmission 
of the application, which, unless the latter is rejected or postponed 
for duly justified reasons, must take place not later than one year 
after the submission of the documentation required for the compilation 
of the dossier referred to in Article 3(2)(b): 
- that the dossier complies with Article 3(3), 
- that the product, according to the information given, appears to meet 
the conditions laid down in Article 8, 
(b) that the other Member States, within 45 days of receiving the dossier, 
have not raised any objection on the grounds of non-compliance with 
the rules on presentation of dossiers laid down in Council Directive 
87/153/EEC. 
If, after consulting the Standing Committee for Feedingstuffs, it is 
found that the rules on presentation of dossiers have not been 
complied with, the Commission shall notify this to the person 
responsible for the application for authorization to place on the 
market through the Member State acting as rapporteur. 
As soon as the Member State acting as rapporteur deems the dossier to 
have been brought into compliance with Directive 87/153/EEC, it shall 
communicate this fact to the other Member States and to the Commission 
with a view to its inclusion on the agenda of the above-mentioned 
Committee in accordance with this paragraph. 
The Commission shall ensure that a decision is taken on the application for 
Community authorization to place on the market within 330 days following 
inclusion on the agenda of the Standing Committee for Feedingstuffs in 
accordance with paragraph 2. However, this time limit shall be interrupted 
where a request is made for additional information. 
Where an application for Community authorization to place an additive on the 
market is rejected, the Commission shall inform the applicant, through the 
Member State acting as rapporteur, of the reasons for such rejection. 
- 9 -
Article 8 
The decision to authorize an additive shall be taken only if: 
a) when used in animal nutrition, it has a favourable effect on the 
characteristics of the feedingstuffs, on livestock production or on animal 
products, or helps reduce the possible harmful effects of stock farming on 
the human or animal environment; 
b) at the level permitted in feedingstuffs, it does not adversely affect 
human or animal health or the environment, nor harm the consumer by 
altering the characteristics of animal products; 
c) its presence in feedingstuffs can be monitored; 
d) at the level permitted in feedingstuffs, treatment or prevention of animal 
disease is excluded; this condition shall not apply to substances 
belonging to the group of coccidiostats and other medicinal substances; 
e) for serious reasons concerning human or animal health its use must not be 
restricted to medical or veterinary purposes. 
ARRANGEMENTS CONCERNING ADDITIVES LINKED TO 
THE PERSON RESPONSIBLE FOR MARKETING 
Article 9 
1. Community authorization of additives as referred to in Article 2(b) shall be 
valid for ten years from the date on which it takes effect and shall be 
renewable for ten-year periods, on application by the holder at least one 
year before the expiry date. 
2. Articles 3, 4, 5, 7 and 8 shall apply to applications for renewal. 
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Article 9a 
1. Notwithstanding Article 8, new additives as referred to in Article 2(b) or 
new uses of additives shall be provisionally authorized at Community level 
provided that the conditions laid down in sections (b), (c) and (e) are met 
and it is reasonable to assume, in view of the available results, that the 
other conditions laid down in that Article are also met. 
2. Provisional authorization as referred to in paragraph 1 may not exceed three 
years. 
Article 9b 
1. Where the Commission authorizes additives as referred to in Article 2(b), it 
may not use the scientific data and other information in the dossier for the 
benefit of another applicant unless the latter has agreed with the first 
applicant that such data and information may be used. 
2. The measures referred to in paragraph 1 shall apply to applicants from the 
date on which examination of additives as referred to in Article 2(b) has 
been included for the first time on the agenda of the Standing Committee for 
Feedingstuffs in accordance with Article 7(2). 
PROVISIONAL AUTHORIZATION OF GENERIC ADDITIVES 
Article 9c 
1. Notwithstanding Article 8, new generic additives or new uses thereof shall be 
provisionally authorized provided that the conditions laid down in 
Article 8(b), (c) and (e) have been met and it is reasonable to assume that 
the other conditions laid down in that Article have also been met. 
2. Provisional authorization as referred to in paragraph 1 may not exceed three 
years. 
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TRANSITIONAL ARRANGEMENTS 
Article 9d 
Notwithstanding Article 3(1), Member States shall permit the marketing of the 
additives listed in Annex B. 
Article 9e 
1. Additives as referred to in Article 2(c) included in [the former] Annex I 
before 1 January 1995 shall be authorized as generic additives. 
2. Additives as referred to in Article 2(b) included in [the former] Annex I 
before 1 July 1984 shall be transferred to Chapter I of Annex B with a view 
to their re-evaluation as additives linked to a person responsible for 
marketing. 
3. Member States shall ensure that the person responsible for marketing an 
additive as referred to in paragraph 2 submits, not later than 30 June 1999, 
the dossier referred to in Article 3 with a view to re-evaluation, where he 
fails to do so, the additive in question shall be prohibited. 
4. The Commission shall take all necessary measures to ensure that re-evaluation 
of dossiers referred to in paragraph 3 is completed not later than three 
years after the dossier is submitted. 
Article 9f 
1. Additives as referred to in Article 2(b) included in [the former] Annex I 
after 30 June 1984 shall be authorized provided that the persons responsible 
for compiling the dossiers on the basis of which the former authorizations 
were granted submit an application as provided for in Article 3(2) with a 
view to obtaining authorization for an additive linked to a person 
responsible for marketing before 1 July 1995. 
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2. Member states shall ensure that applications as referred to in paragraph 1 
are transmitted together with the monograph and information note provided for 
in Articles 9m and 9n. 
3. The Commission shall ensure that the authorization decision referred to in 
paragraph 1 takes effect on 1 July 1996. 
Article 9g 
1. Additives as referred to in Article 2(c) included in [the former] Annex II 
before 1 January 1995 shall be authorized for a period of not more than five 
years taking account of the period of inclusion in Annex II referred to 
above. 
2. Additives as referred to in Article 2(b) included in [the former] Annex II 
before 1 January 1995 shall be transferred to Chapter II of Annex B with a 
view to their authorization as additives linked to a person responsible for 
marketing, for a period of not more than five years taking account of the 
period of inclusion in Annex II referred to above. 
3. The additives included in Chapter II of Annex B must be the subject of an 
authorization application as provided for in Article 3(2) before 1 July 1995. 
4. Member States shall ensure that applications as referred to in paragraph 3 
are transmitted together with the monograph and information note provided for 
in Articles 9m and 9n. 
5. Detailed rules for carrying out the transfers referred to in paragraphs 1 and 
2 shall be adopted in accordance with the procedure laid down in Article 23. 
Article 9h 
Applications for authorization to place on the market submitted between 
1 January 1995 and 30 June 1996 in respect of which the Commission has not yet 
given a ruling at that date shall be examined in accordance with Articles 3, 5, 
7, 9, 9a, 9b, 9c, 9k, 9m and 9n as appropriate. 
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Article 9i 
1. Additives as referred to in Article 9g(l) which meet the conditions laid down 
in Article 8 shall be authorized. 
2. Additives as referred to in Article 9g(2) which meet the conditions laid down 
in Articles 8 and 9g(3) and (4) before 1 July 1996 shall be authorized. 
Articles 9, 9b(l) and 9k shall apply. 
DISTRIBUTION AND USE OF ADDITIVES 
Article 9j 
1. Member States shall ensure that in the field of animal nutrition only 
additives authorized in accordance with this Directive may be marketed and 
that they may be used only subject to the conditions set out in the 
authorization decision. Unless provision is made for them to be administered 
by another method, such additives may be used only if incorporated into 
feedingstuffs. 
2. Member States shall, in particular, ensure that additives are added to raw 
materials and straight feedingstuffs only where their use is expressly 
provided for in the authorization decision. 
REGISTRATION 
Article 9k 
1. Where additives as referred to in Article 2(b) are authorized, the person 
responsible for marketing shall be given a registration number and the 
additive shall be given an EEC registration number. 
2. Authorized additives as referred to in Article 2(c) shall be given an EEC 
registration number. 
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WITHDRAWAL OF ADDITIVES 
Article 91 
Authorization shall be withdrawn from an additive where any of the conditions 
set out in Article 8 are no longer met. 
However, such additives may continue to be authorized for a specified period if 
at least the conditions laid down in Article 8(b) and (e) continue to be met. 
MONOGRAPHS AND IDENTIFICATION NOTES 
Article 9m 
1. In accordance with Directive 87/153/EEC, Member States shall ensure that 
applicants present a monograph for additives as referred to in Article 2(b). 
2. During the authorization procedure for additives as referred to in 
Article 2(b), the Standing Committee for Feedingstuffs shall give an opinion, 
if appropriate after having made the necessary amendments, on the monograph 
of the additive presented in the dossier provided for in Article 3(2). 
The commission shall approve the opinion given by the standing Committee for 
Feedingstuffs on the monograph and its amendments in accordance with the 
procedure laid down in Article 23. 
3. Monographs may also be adopted for additives belonging to groups other than 
those referred to in paragraph 1. 
4. The competent authorities of the Member States shall have recourse to the 
monograph : 
(a) to ascertain whether the additive placed on the market actually 
corresponds to the additive described in the dossier on the basis of 
which the Community authorization was granted; 
(b) to determine whether an additive for which marketing authorization has 
been requested constitutes an innovation or should be considered as a 
copy. 
- 15 -
5. Subsequent amendments to be made to monographs on account of developments in 
scientific and technical knowledge shall be submitted to the standing 
Committee for Feedingstuffs. 
Article 9n 
1. In accordance with Directive 87/153/EEC, Member States shall ensure that the 
applicant presents an identification note summarizing the most important 
characteristics and properties given in the monograph of additives as 
referred to in Article 9m. 
2. The following shall be adopted in accordance with the procedure laid down in 
Article 23: 
the identification note, 
subsequent amendments to the identification note as a result of 
developments in scientific and technical knowledge. 
3. in order to facilitate the identification of the additives referred to in 
paragraph 1 during official checks, the identification note provided for in 
that paragraph shall be published in the Official Journal of the European 
Communities. 
STANDARD SAMPLE 
Article 9o 
1. The Member State which presented the dossier referred to in Article 3(2) for 
additivs as referred to in Article 2(b) shall take all the necessary measures 
to ensure that a standard sample having the characteristics and properties 
described in the monograph referred to in Article 9m is made available, upon 
request, to the national inspection authorities of the Member States. 
2. If the characteristics or properties of the additive are modified, a new 
standard sample corresponding to the new monograph shall be provided. 
3. Detailed rules concerning the provision and maintenance of standard samples 
may be adopted in accordance with the procedure laid down in Article 23. 
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MIXTURES AND PREMIXTURES 
Article 9p 
1. The maximum and minimum levels listed in the authorization decisions shall 
refer to complete feedingstuffs with a moisture content of 12% in so far as 
no special provisions are laid down in these decisions. 
If the substance permitted as an additive also exists in the natural state in 
certain ingredients of the feedingstuff, the amount of additive to be 
incorporated shall be calculated so that the total of the elements added and 
the elements present naturally does not exceed the maximum level provided for 
in the authorization decisions. 
2. The mixing of additives named in this Directive shall be permitted in 
premixtures and feedingstuffs only where there is physico-chemical 
compatibility between the components of the mixture in relation to the 
effects desired. 
3. Unless the mixture concerned is provided for in an authorization decision, 
Member States shall require that: 
(a) antibiotics and growth promoters may not be mixed together, either with 
substances from their own group or with substances from the other group; 
(b) coccidiostats may not be mixed with antibiotics and growth promoters 
where coccidiostats also act, for the same category of animal, as an 
antibiotic or as a growth promoter; 
(c) coccidiostats and other medicinal substances may not be mixed together 
if their effects are similar. 
4. Member States may, for experimental or scientific purposes, provide for 
derogations from Article 3 and paragraphs 2 and 3 of this Article on 
condition that there is adequate official supervision. 
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AMENDMENTS TO THE ANNEXES 
Article 9q 
Amendments to be made to the Annexes shall be adopted in accordance with the 
procedure laid down in Article 23. 
INFORMATION ON PRODUCERS OF ADDITIVES 
Article 9r 
Member States shall ensure that the beneficiaries of authorizations for 
additives as referred to in Article 2(b) transmit to the Commission as 
quickly as possible the name or corporate name and the address or registered 
office of the producers to whom they have granted the right to manufacture 
the additive and, if the producers are established in a third country, also 
the name or corporate name and the address or registered office of their 
representatives in the Community. 
PUBLICATION IN THE OFFICIAL JOURNAL 
Article 9s 
The Commission shall publish in the official Journal of the European 
Communities, c Series, not later than 30 November each year: 
the list of producers as referred to in Article 9r as well as their 
representatives in the Community if such producers are established in a 
third country, 
the list of authorized additives." 
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10. The following title is inserted between Articles 9t and 10: 
"PACKAGING" 
11. The following title is inserted between Articles 10 and 11: 
"SAFEGUARD MEASURES" 
12. In Article 11, the words "listed in Annex I" are replaced by "authorized" 
13. The following title is inserted between Articles 11 and 12: 
"ADDITIVE CONTENTS" 
14. The following title is inserted between Articles 12 and 13: 
"MARKETING OF ANTIBIOTICS, COCCIDIOSTATS AND GROWTH PROMOTERS" 
15. Article 13 is amended as follows: 
(a) references to "Annex III" are replaced by references to "Annex A"; 
(b) in paragraph 1, the words "listed in Annex I or Annex II" are replaced 
by "authorized"; 
16. The following title is inserted between Articles 13 and 14: 
"MARKETING CONDITIONS FOR ADDITIVES" 
17. Articles 14 to 17 are amended as follows: 
(a) in Article 14(1): 
- in the first subparagraph, the words "listed in Annex I or Annex II" 
are replaced by "authorized"; 
- A(a) is to read as follows : "the specific name of the additive, in 
accordance with the authorization decision or Annex B, the 
registration number and, where applicable, the number given to the 
person responsible for marketing"; 
(b) in Article 15: 
- in paragraph 1, the words "in accordance with Annexes I or II" are 
replaced by "in accordance with the authorization decision or, where 
applicable, with Annex B" and the words "complete feedingstuffs in 
Annexes I or II" are replaced by "complete feedingstuffs in the 
authorization decision or, where applicable, in Annex B"; 
- in paragraph 2(a), the reference to Article 4(1)(b) is replaced by a 
reference to Article 9a; 
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(c) in Article 16: 
- the words "in accordance with Annexes I or II" are replaced by "in 
accordance with the authorization decision or, where applicable, 
Annex B", and the words "laid down in Annexes I and II" are replaced 
by "laid down in the authorization decision or, where applicable, in 
Annex B"; 
- in paragraph 4, the reference to Article 4(1)(b) is replaced by a 
reference to Article 9; 
- paragraph 8 is deleted and paragraphs 9 and 10 are renumbered 8 and 9; 
(d) in Article 17(1), the words "of Annexes I and II" are replaced by "of 
the authorization decision and, where applicable, Annex B". 
18. The following title is inserted between Articles 20 and 21: 
"INSPECTION MEASURES". 
19. The following is added after Article 21: 
"VIGILANCE WITH REGARD TO INCOMPATIBILITY 
Article 21a 
Where there is found to be unforeseen undesirable interaction between additives 
as referred to in Article 2(b) and other additives or veterinary medicines, 
Member states shall ensure that the person responsible for marketing the 
additive gathers all the relevant information and forwards it to the competent 
authorities." 
20. The following title is inserted between Articles 21a and 22: 
"EXPORTS TO THIRD COUNTRIES". 
21. The following title is inserted between Articles 22 and 23: 
"IMPLEMENTATION POWERS OF THE COMMISSION". 
22. 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. 
23. The following title is inserted between Articles 24 and 25: 
"FINAL PROVISIONS". 
24. Annex III becomes Annex A. 
- 20 -
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with: 
(a) the provisions headed "TRANSITIONAL ARRANGEMENTS" laid down in 
Article 1(9) by 1 January 1995, 
(b) the other provisions of this Directive by 1 July 1996. 
They shall forthwith inform the Commission thereof. 
When these measures are adopted by the Member states, they shall contain a 
reference to this Directive or shall be accompanied by such reference on the 
occasion of their official publication. The methods of making such a 
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. 
Article 3 
This Directive is addressed to the Member States. 
Done at Brussels, 
For the Council 
The President 
FINANCIAL STATEMENT 
Proposal for a Council Directive amending Directive 70/524/EEC concerning 
additives in feedingstuffs 
1. Budget heading involved: B2-5102 Plant health measures 
2. Amount of appropriations entered under this(these) heading(s) for 1993 
Differentiated appropriations Commitment appropriations : ECU 4 000 000 
Appropriations for payments: ECU 3 000 000 
3. Amount of carry-overs authorized or requested (to be specified) 
- Automatic 
- Non-automatic 
4. Amount of expenditure arising from the proposal made to the Commission: 
(Estimate) 
ECU 0.492 million in CA and AP as from 1996 
(a) For the current year: None 
- using appropriations entered under 
the budget headings referred to 
- using carry-overs 
- applying other procedures (1) 
(transfers, supplementary budgets) 
(b) For subsequent years 
CA AP 
1996 0.492 0.492 
1997 0.492 0.492 
1998 0.501 0.501 
1999 0.501 0.501 
5. Other financial implications of the proposal (if any) 
None 
6. Method of calculation adopted (give details): 
See Annex 
Opinion of Director-General for Budgets: 
(1) In this exceptional situation, give detailed reasons. 
- 21-
ANNEX (Method of calculation) 
Estimate of the cost for the scientific examination of dossiers (experts' 
reports) 
A. Major dossier(1) 
1. Toxicology (5 to 6 pages)(2) 
2. Effectiveness (5 to 6 pages) 
3. Metabolism (4 pages) 
4. Pharmacology (3 pages) 
5. Environment (2 pages) 
6. Product quality (2 pages) 
ECU 75 X 200 
B. Complex dossier(3) 
c. Standard dossier 
D. Simple dossier 
E. Adjustment 
1996 - 1997: 
1998 - 1999: TOTAL : 
Rounded up to 48 hours work 
48 hours 
32 hours 
24 hours 
16 hours 
16 hours 
184 hours 
200 hours 
= ECU 15 000 x 
= ECU 9 000 X 4 requests = ECU 60 000 
8 requests = ECU 72 000 
= ECU 4 500 x 40 requests = ECU 180 000 
= ECU 1 500 x 120 requests = ECU 180 000 
= ECU 900 
= None 
= ECU 9 000 per annum 
(10 adjustments) 
TOTAL: 1996 
1997 
1998 
1999 ECU 492 000 
ECU 492 000 
ECU 501 000 
ECU 501 000 
(1) Zootechnical additives (study of a new molecule). 
(2) one page equivalent to +/- 8 hours. 
(3) Average price asked for an expert's report on an "additive" or 
"medicinal preparation" dossier. 
ISSN 0254-1475 
COM(93) 251 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-93-280-EN-C 
ISBN 92-77-56315-X 
Office for Official Publications of the European Communities 
L-2985 Luxembourg