Proposal for a COUNCIL DIRECTIVE AMENDING DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS
Date: 1993-07-09
Institutions: European Commission
Subjects: adjuvant, animal health, animal nutrition, foodstuffs legislation, public health, veterinary drug

COMMISSION  OF  THE EUROPEAN  COMMUNITIES 

COM(93) 251 final 

Brussels, 09 July  1993 

Proposal  for a 

COUNCIL  DIRECTIVE 
AMENDING DIRECTIVE  70/542/EEC 
CONCERNING ADDITIVES IN FEEDINGSTUFFS 

(presented by  the Commission) 

Jim 

4, ' **  'V 

fi''.**' 

»,  »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. 

309 days 

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Inclusion  In  th» 
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STANDIHS COVMITTEE 
(Beginning  of  exanln-
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of  tho 

STANDING  C0OJITTŒ 

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330  day* 

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AUTHORIZATION 

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authorization 

Ccmrunlty  AUTHORIZATION of 

generic  oddltlvw 

Provisional  AUTHCRIZATION of  generic 
oddltlvw  ( t w t l n g)  maxlm/n  3  years 

Inclusion  In  Chapter  I II  of 

the  annual 

list 

Inclusion  In  Chapter  IV  of 

Protection  of  data 

the  annual  Met 

Protect Ion  of  data 

Inclusion  In  Chapter  I 

Inclusion  In  Chapter  11  of 

of  the  annuoI 

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the  annual 

list 

(1)  Addltlvw  belonging  to  the  groups  listed  In  Council  Decision  ../.../OX. 

(zootechnlcs) 

Generic  eddltN 

AUTOMATIC AUTHORIZATION 

T R A N S I T I O N AL 

A R R A N G E M E N TS 

Addltlv 
former 

Addltlvw  m  referred  to  In 
Article  2(b)  Included  In 
Annex  I  K> years  before 
adaption 

INCLUSION 
IN 

ANNEX  8 
CHAPTER  I 

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 

Addltlvw  es  referred  to 
In  Article  2(b)  Included 
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10 years  before  adaption 

AN APPLICATION FOR AUTHOR 

IZATION LINKED TO  PERSON 

RESPONSIBLE FOR  MARKETIM3 

ISIXDGED 

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DECISION  TO GRANT AUTHORIZ 

ATION LINKED  TO PERSON  OR 

BCOY RESPONSIBLE FOR 

MMCTINB  TAKES EFFECT 

ADOPTION 

ENTRY  INTO FORCE OF ARTICLES Sd 
TO  91 

TRANSPOSITION 

1 
6 MONTHS 

1 YEAR 
• 

EXAMINATION OF DOSSIERS  UNDER 

THE NEW  RULES 

2YEARS 

9YEARS 

8YEARS 

I 

ConorIc  addltlvw 

MAXIMUM 9  YEARS PROVISION AUTHORIZATION TAKINC 

ACCOUNT GF  THE PERIOD OF  IN0LU5ION  IN ANNEX  11 

Addltlvw  from 
former  Amex  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 

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; 

- 4 -

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: 

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

Article 1 

1. The following title is inserted above Article 1: 

"SCOPE" 

2. The following title is inserted between Articles 1 and 2: 

3. Article 2(a) is replaced by the following: 

"DEFINITIONS" 

"(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): 

- 5 -

"(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: 

- 8 -

(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. 

-  10 -

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. 

- 11 -

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. 

- 12 -

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. 

- 13 -

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. 

-  14 -

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. 

- 16 -

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. 

- 17 -

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." 

-  18 -

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; 

-  19 -

(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: 

19.  The following  is added after Article 21: 

"INSPECTION MEASURES". 

"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: 

24.  Annex  III becomes Annex A. 

"FINAL PROVISIONS". 

- 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. 

This Directive is addressed to the Member States. 

Article 3 

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 

1996 
1997 
1998 

1999 

CA 
0.492 
0.492 
0.501 

0.501 

AP 
0.492 
0.492 
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) 
Effectiveness  (5 to 6 pages) 
2. 
3.  Metabolism  (4 pages) 
4.  Pharmacology  (3 pages) 
5.  Environment  (2 pages) 
6. 

Product quality  (2 pages) 

48 hours work 
48 hours 
32 hours 
24 hours 
16 hours 
16 hours 

TOTAL 
Rounded up to 

: 

184 hours 
200 hours 

ECU 75 X 200 

= ECU  15 000 x 

4 requests = ECU  60 000 

B. Complex dossier(3) 

= ECU  9 000 X 

8 requests = ECU 72 000 

c. Standard dossier 

= ECU  4 500 x  40 requests = ECU  180 000 

D. Simple dossier 

= ECU  1 500 x 120 requests = ECU  180 000 

E. Adjustment 

= ECU 900 

1996 - 1997: 
1998 - 1999: 

= 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