PROPOSAL FOR A COUNCIL DECISION CONCERNING THE ADMINISTRATION OF BOVINE SOMATOTROPHIN ( B. S. T. )
Date: 1989-09-27
Institutions: European Commission
Subjects: dairy cow, hormone, pharmaceutical product, protection of animals

COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

COM(89) 379 final 

Brussels,  27  September  1989 

Proposal  for a 

COUNCIL DECISION 

concerning the administration of Bovine Somatotrophin  (B.S.T.) 

x 

x 

Report 

concerning Bovine Somatotrophin  (B.S.T.) 

x 

x 

(presented by the Commission) 

Explanatory  Memorandum 

&-

1. The  report  annexed  deals with  the main  considerations  that  need  to be  taken 

Into  account  In  connection  with  the  authorization  and  use  of  Bovine 

Somatotroph in  (BST).  When  administered  to  the  I actat Ing cow  BST  is capable 

of  bringing  about  a significant  Increase  in mille yield. 

2. The  existing  authorization  arrangements  in  relation  to  BST  provide  for  a 

national  decision-making  procedure  after  the  Committee  on  Veterinary 

Medicinal  Products  (CVMP)  established  under  Directive  81/851/EEC  has 

delivered  an opinion.  The  Committee  Is expected  to  issue  an opinion  on  two 

applications  In relation  to BST within  the next  six  months. 

3. The  conclusion  of  the  report  Is that  It would  be  Inappropriate  to decide on 

the  use  of  BST  until  all  the  necessary  studies  and  assessments  have  been 

completed.  Furthermore  a decision  on  BST  should  await  the  putting  In place 

of  revised  dispositions  in  relation  to  veterinary  medicinal  products  and 

feed  additives  intended  for  promotion  of  yield.  Present  indications  are 

that,  apart  from  BST,  other  comparable  products  applied  to  livestock  nay 

have  a  significant  effect  on  productivity,  with  potentially  far  reaching 

implications  for  production  and  socio/economic  structures  In agriculture. 

4.  It  is, accordingly,  proposed  to  the  Council  to  adopt  the  annexed  proposal 

with  a  view  to  establishing  an  evaluation  period,  until  31  December  1990 

as  regards  the  administration  of  BST.  There  are  no  Implications  for  the 

Community  budget. 

2 

Draft  Proposal 

for a 

Counc11  Dec I s Ion 

of 

Concerning  the administration of Bovine Somatotropin  (B.S.T.) 

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  of  the Commission, 

Having  regard  to the opinion of  the European Parliament, 

Having  regard  to the opinion of  the Economic and Social  Committee, 

Whereas  products  arising  from milk production  have a very  Important  place  In 

the  Community;  Whereas  they  are  an  essential  source  of  income  for  a  part  of 

the agricultural  population; 

Whereas knowledge acquired  gives the possibility  for  the placing on the market 

of  substances  which  may  have  a  significant  impact  on  productivity  In  milk 

product ion; 

Whereas  despite  the work  accomplished,  in particular  the evaluation  of  Bovine 

Somatotroph in by  the Committee  on veterinary Medicinal  Products  in accordance 

with  Council  Directive  81/851/EEC of  28th September  1981  on  the approximation 

of  the  laws  of  the  Member  States  relating  to  veterinary  medicinal 
products*1)  and  Council  Directive  87/22/EEC  of  22nd  December  1986  on  the 

approximation  of  national  measures  relating  to  the  placing  on  the  market  of 

high-technology 
medical 
biotechnology*2^, the various effects of new 

products, 

particularly 

<1> O.J. N° L 317 of 06.11.1981, p.  1 

(2) O.J. N° L  15 Of  12.01.1987, P. 38 

those 

derived 

from 

J 

-  2 

substances  such  as  Bovine  Somatotroph in  are  not  yet  sufficiently  clear;  in 

this  respect,  a necessary  period  should  be  forseen  for  In-depth  studies  to be 

made; 

"is 

Whereas  In  the  absence  of  a  Community  decision,  the  Member  States  may  adopt 

divergent  measures;  whereas  these  divergencies  may  lead  to  a  distortion  of 

competition  between  milk  producers  and  to  new  barriers  to  Intra-Communlty 

trade; 

Whereas  In  the  view  of  the  proceeding  considerations,  it  Is  a  matter  of 

overriding  public  interest  to  provide  for  a  temporary  prohibition  of 

administration  to  dairy  cows  of  the  substances  in  question,  until  all 

necessary  information  is obtained; 

Whereas  it will  be necessary  to re-examine  the overall  situation. 

HAS ADOPTED THIS DECISION: 

Article 1 

Notwithstanding  the  scientific  and  technical  examination  of  applications  in 

accordance  with  Community 

legislation,  until 

31  December 

1990  the 

administration  by  any  means  whatsoever  within  the  Community  to  dairy  cows  of 

Bovine  Somatotroph in, shall  not  be authorized  In the Member  States. 

Article  2 

In  derogation  from  Article  1,  the  Member  States  may  authorise  the 

administration  to  dairy  cows  of  Bovine  Somatotrophln  for  carrying  out 

scientific and  technical  trials. 

V 

-  3 -

Article  3 

À  '• -.-  .'•>,. 

On  a  proposal  from  the  Commission  the  Council  mayr  acting  by  a  qualified 

majority,  adopt  measures necessary  for  the  implementation of  this Decision. 

Article  4 

The  Commission  shall,  before  1 October  1990,  submit  a  report  to  the  Council 

and  to  the  European  Parliament  on  the  development  of  the  situation, 

accompanied  by  any  necessary  proposals.  The  Council  shall  decide  before  31 

December  1990. 

Article  S 

This Decision  Is addressed  to the Member  States. 

Done at  Brussels 

By  the CounclI 

_r 

REPORT 

from  the  Commission  to  the  Council 

and  to  Par I I ament 

concern Ing 

Bovine  Somatotroph In  (B.S.T.) 

G 

Report  from  the  Commission  to  the  Council 

and  to  Parliament  concerning 

Bovine  Somatotroph In  (B.S.T.) 

GENERAL  BACKGROUND 

Somatotroph in  is  a  growth  hormone,  secreted  by  the 

pituitary  gland.  In  general  the  activity  of  this  hormone 

is  species 

specific,  so 

that 

for 

example,  Bovine 

Somatotroph in  (BST)  from  the  cow  should  have  no  Influence 

on  human  growth.  It  has  been  known  since  the  1930s  that 

the  administration  of  BST  to  dairy  cattle  could  Increase 

milk  yields.  However,  since  BST  could  only  be  extracted  as 

a  natural  hormone  post  mortem,  the  quantities  available 

were  too  limited  and  too  expensive  to  permit  commercial 

use. 

Following  the  development  of  recombinant  DNA  biotechnology 

In  the  1970s,  It  became  possible  to  produce 

large 

quantities  of  somatotroph Ins at  relatively  low  cost.  Apart 

from  use  of  recombinant  BST  (rBST)  for  milk  production, 

for  which  authorisation  is  now  being  sought  by  the 

companies  concerned,  research  Is  being  conducted  into  use 

of  bovine,  porcine  and  ovine  somatotroph Ins  for  fattening 

purposes. 

A  further  factor  delaying  the  commercial  exploitation  of 

BST  was  the  need  to  provide  an  appropriate  sustained 

release  formulation,  which  would  eliminate  the  need  for 

daily  injections.  The  stage  has  now  been  reached  where 

administration  at  two  to  four  weekly  intervals  seems  to 

bring  about  the  desired  increase  in milk  yields. 

Studies 

have  indicated  increases  of  milk  yield  of  upwards  of  25% on 

administration  of  rBST  under  controlled  conditions.  It  is 

^ 

.  3  -

e s t i m a t ed  that,  given  the  k n o w l e d ge  and  ability  required 

for  e f f e c t i ve  use  of  the  p r o d u c t, 

yield  Increases  closer 

to  1 2%  are  m o re  likely  to  be  a c h i e v ed 

In  normal 

farm 

c o n d I t I o n s. 

The  p o s s i b le  use  of  rBST  in  milk  p r o d u c t i on  has  been  the 

subject  of  w i d e s p r e ad  public  Interest. 

In  the  Council  of 

A g r i c u l t u re  M i n i s t e rs  several  Member  S t a t es  have  expressed 

r e s e r v a t i o ns 

about 

Its 

u s e,  m a i n ly 

in 

relation 

to 

p o t e n t i a l ly  adverse  s o c l o / s t r u c t u ra I  c o n s e q u e n c es  and  the 

implications  as  regards  supply  and  demand  for  milk  and  milk 

p r o d u c t s.  The  matter 

has  been  e x a m i n ed 

e x t e n s i v e ly 

by 

v a r i o us  C o m m i t t e es 

in  the  European  P a r l i a m e nt  w h i c h,  on 

5  July  1 9 8 8,  adopted 

a  r e s o l u t i o n1 

on  the  e f f e c ts 

and 

risks  of  using  growth  h o r m o n es  and  the  BST  h o r m o ne  In  the 

dairy  and  meat  i n d u s t r i e s.  The  P a r l i a m e nt 

called  on  the 

C o m m i s s i on  to  e x a m i ne  the  c o n s e q u e n c es  of  the  use  of  rBST, 

to  c o n s i d e r, 

inter  alia,  the  n e c e s s i ty 

for 

additional 

c r i t e r i a, 

e.g. 

social 

and 

e c o n o m ic 

f a c t o r s, 

in  the 

e x a m i n a t i on 

of 

a p p l i c a t i o ns 

for 

a u t h o r i s a t i o ns  and 

to 

c r e a te  a  legal  framework  c o v e r i ng  g e n e t i c a l ly 

engineered 

growth  a c c e l e r a t o rs  or  yield  e n h a n c e r s.  Under 

existing 

legislation  a u t h o r i s a t i o ns  are  c o n s i d e r ed  on  the  basis  of 

three  c r i t e r ia  v i z,  s a f e t y,  quality  and  e f f i c a c y. 

The  BST 

q u e s t i on  was  d i s c u s s ed  at  length  at  a  seminar  held  in 

September  1988  under  the  a u s p i c es  of  the  C o m m i s s i o n. 

A 

wide  range  of  o r g a n i s a t i o ns  (listed  in  Annex  1)  have  been 

c o n s u l t ed  and  have  had  an  o p p o r t u n i ty  to  g i ve  their  v i e w s. 

It  is  clear  from  the  reaction  in  the  Council  of  M i n i s t e rs 

that,  w h i le  most  Member  S t a t es  are  very  hesitant  about 

the  a u t h o r i s a t i on  of  r B S T, 

there  may  not  be  u n a n i m i ty  on 

the 

issue.  Divergent 

p o s i t i o ns 

of 

Member 

S t a t es 

on 

a u t h o r i s a t i on  c a r r i es  a  s e r i o us  danger  of  d i s t o r t i on  of 

c o m p e t i t i on  and  trade  d i s p u t e s. 

O.J.  C  235  (Vol.  3 1)  Of  1 2 . 9 . 1 9 8 8,  pp.  4 1 - 4 4. 

-  4  -

EXISTING  LEGISLATION 

6. 

The  definition  of  a  medicinal  product  in  Article  1  of 

Directive  65/65/EEC  covers  not  only  products  Intended  to 

prevent  or  treat  disease  but  also  products  which  may  be 

administered  to  humans  or  animals  with  a  view  to  modifying 

physiological  functions,  such  as  an  increase  in  milk  yield 

In  c a t t l e.  BST  is  therefore  regarded  as  a  veterinary 

medicinal  product. 

7. 

Directive  81/851/EEC  Is  designed  to  harmonize  the  laws  of 

the  Member 

States  on  the  authorization  of 

veterinary 

medicinal  p r o d u c t s.  The  approach  to  authorisation  -  a 

matter  for  decision  by  the  Member  State  concerned  -  is 

based  on  three  exclusive  criteria  namely  quality,  safety 

and  efficacy  of  the  products  concerned.  The  procedure  in 

the  case  of  biotechnology  products  Is  somewhat  different  in 

that  under  Directive  87/22/EEC,  Member  States  may  not 

decide 

on 

any 

application 

for 

authorization 

for 

a 

veterinary  medicinal  product  derived  from  biotechnology 

until 

the  Committee 

for  Veterinary  Medicinal 

Products 

(CVMP)  has  given  an  o p i n i o n.  Final  evaluation  of  the  test 

results  and  the  decision  on  authorization  remains  the 

responsibility  of  the  Member  States. 

8. 

As  regards  other  comparable 

legislation  In  agriculture  , 

somatotroph In 

is 

not 

subject 

to 

Council 

Directives 

1981/602/EEC  of  31  July  1 9 8 12,  85/358/EEC  of  16  July 

1 9 8 53  and  88/146/EEC  of  7  March  1 9 8 84  in  relation  to 

prohibition  on  the  use  of  certain  hormones  for  fattening 

p u r p o s e s. 

It  is  not  affected  either  by  the  provisions  of 

Council 

Directive 

70/524/EEC  of 

23  November 

1970  on 

additives  in  f e e d I n g s t u f f s .5 

Under  this  Directive  the 

only  substances  that  may  be  used  as  additives  in  animai 

2 

3 

4 

5 

O.J.  L  222  Of  7.8.1981,  p.  32. 

O.J.  L  191  Of  2 3 . 7 . 1 9 8 5,  p.  46. 

O.J.  L  70  of  1 6 . 3 . 1 9 8 8,  p.  16. 

O.J.  L  270  Of  14.12.1979,  p.  1. 

3 

-  5  -

f e e d i n g s t u f fs  are  those  a p p r o v ed  by  a  C o m m u n i ty  p r o c e d u re 

and  listed  In  the  A n n e x es  to  the  D i r e c t i v e. 

Since  no  oral 

p r e p a r a t i on  Is  c u r r e n t ly  a v a i l a b le  in  the  case  of  rBST  -

f o r m u l a t i o ns  are  a d m i n i s t e r ed  by  I n j e c t i o n-  the  question 

of  a u t h o r i s i ng  rBST  as  an  a d d i t i ve  in  f e e d i n g s t u f fs  has  not 

a r i s e n. 

It  may  be  n o t e d,  h o w e v e r,  that  several  a n t i b i o t i cs 

and  other  chemical  a d d i t i v e s,  w h o se  effect  is  to  increase 

p r o d u c t i v i ty  of  livestock,  are  either  c u r r e n t ly  a u t h o r i s ed 

or  the  subject  of  a p p l i c a t i o ns 

for  a u t h o r i s a t i o n. 

9. 

Two  a p p l i c a t i o ns  for  a  m a r k e t i ng  a u t h o r i z a t i on  for  BST  were 

referred 

for 

an 

o p i n i on 

to 

the 

CVMP 

In 

1 9 8 7. 

One 

a p p l i c a t i on 

w o u ld 

cover 

all 

Member 

S t a t es 

except 

L u x e m b o u rg 

and 

the 

N e t h e r l a n d s. 

A 

s e c o nd 

a p p l i c a t i on 

c o n c e r ns  France  and  the  United  K i n g d o m. 

Under  e x i s t i ng  p r o c e d u r es  It  is  a  m a t t er  for  the  applicant 

to  submit 

the  data  n e c e s s a ry 

to  p r o ve  that 

the 

three 

c r i t e r ia  have  been  m e t; 

a p p l i c a t i o ns  are  a s s e s s ed  by  the 

national 

a u t h o r i t i es 

and 

by 

the 

C o m m i t t e e. 

The 

a u t h o r i t i es 

of 

the  Member 

S t a t es 

c o n c e r n ed 

receive  a 

c o m p l e te  set  of  the  data  s u b m i t t ed  by  each  c o m p a n y,  and 

have  the  o p p o r t u n i ty  to  submit  q u e s t i o ns  and  c o m m e n t. 

The 

commercial 

i m p l i c a t i o ns  of 

r e c e i v i ng 

a u t h o r i s a t i on 

r e q u i r es 

that 

the 

r e g u l a t o ry 

a u t h o r i t i es 

protect 

the 

c o n f i d e n t i a l i ty  of  the  data  s u b m i t t e d. 

The  C o m m i s s i on  is 

o b l i g ed  also  to  respect  the  c o n f i d e n t i a l i ty  of  d i s c u s s i o ns 

w i t h in  the  C V M P,  a  r e q u i r e m e nt  that  limits  the  d e g r ee  of 

detail  that  can  be  f u r n i s h ed  in  this  r e p o r t. 

1 0. 

In 

Its  e x a m i n a t i on  of  this  m a t t er 

the  CVMP 

has 

been 

a s s i s t ed  by  an  a d - h oc  g r o up  of  e x p e r ts  on  b i o t e c h n o l o g y. 

It  is  u n d e r s t o od  that  the  a s s e s s m e nt  p r o c e ss  w i t h in  the 

C o m m i t t ee  may  be  e n t e r i ng  its  final  p h a s e. 

E x p e c t a t i o ns 

are  for  an  o p i n i on  in  or  about  the  end  of  this  y e a r.  At 

this  s t a g e, 

t h e r e f o r e,  it  is  only  p o s s i b le  to  p r o v i de  an 

interim  review  of  the  a u t h o r i s a t i on  p r o c e s s. 

/o 

-  6  -

EXAMINATION  BY  COMMITTEE  ON  VETERINARY  MEDICINAL  PRODUCTS  (CVMP) 

11. 

Following  is an  Indication  of  progress  on  the  main  elements 

taken  into  account  in  the  Committee's  assessment. 

a) 

Safety  In  the  animal 

The  studies  initially  submitted  by  the  applicants  were 

considered  to  be  of  insufficient  duration.  Both  applicants 

have  been  requested  to  provide  substantial  additional  data 

covering 

three 

lactation  periods;  this 

involves  the 

monitoring  of  a  wide  range  of  physiological  parameters  in 

the  cow  and  her  progeny  to  enable  a  comprehensive 

assessment  to  be  made. 

Among  the  factors  which  are  being 

specifically 

considered 

under 

this  heading 

are  the 

potential  effects  of  BST  on  reproductive  performance,  on 

the  incidence  of  mastitis,  on  bone  growth  and  development 

In  the  calf  and  on  the  extent  and  clinical  significance  of 

Injection  site  rejections. 

b) 

Human  safety 

It  Is  assumed  at  present  that  any  residues  of  BST  in  milk 

should  not  pose  a  risk  to  consumer  health  since  the  overall 

level  of  BST 

is  not  significantly 

Increased  after 

administration.  Besides, 

BST 

Is 

destroyed 

during 

pasteurization,  the  hormone  is  broken  down  completely  in 

the  stomach  and  is  not  active  in man.  The  applicants  have 

been  required  to  provide  scientific  data  to  justify  these 

assumptions.  Since  BST  operates  either  directly  or  via 

stimulation  of  another  hormone  (IGFI)  the  effect  as 

regards  other  hormone  levels  has  to  be  considered  also. 

While 

BST 

Is 

designed 

to 

increase 

milk 

yields, 

consideration  must  be  given  also  to  residues  of  BST  in 

meat,  In  particular  to  any  persistence  of  residues  at  the 

injection  site.  As  with  any  veterinary  medicinal  product, 

the  applicant  must  propose  a  routine  method  of  analysis  of 

*<i 

-  7 -

sufficient  sensitivity  to  detect  residues  at  low  levels. 

Moreover,  In addition  to  studies  of  the  safety  of  residues, 

the  potential  risk  of  direct  human  contact  with  the 

products  must  be  addressed  to  ensure  the  safety  of  persons 

using  the  product  on  the  farm.  These  elements  form  part  of 

the  assessment  by  the  Committee. 

c) 

Quality  of  synthetic  B.S.T. 

While  BST 

is  a  naturally 

occurring 

substance,  the 

commercial  formulations  are  complex  products  requiring 

advanced  technology  In  manufacture.  The  applicants  have 

had  to  provide  appropriate  guarantees  of  their  ability  to 

produce  a  consistent,  pure  and  homogenous  product  on  an 

i ndustrI a I sea Ie. 

d) 

Efficacy  of  synthetic  B.S.T. 

While  the  effect  of  BST  In  increasing  milk  yields  Is  well 

documented,  further  Information  has  been  requested  to 

justify  the  proposed  dosage  levels  and  the  intervals 

between  Injections. 

12. 

Resume  of  examination  by  CVMP 

The  various  elements  Involved  are  still  under  assessment  by 

scientists  from  the  national  regulatory  authorities. 

The  examination  process  Is  now  entering  Its  final  phase-, 

It  is  expected  that  an  opinion  will  be  delivered  by  the 

Committee  by  the  end  of  the  year. 

OTHER  IMPACTS 

13. 

Apart  from  the  examination  by  the  Committtee,  some  of  the 

elements  involved  are  the  subject  of  other  studies  being 

carried  out  at  the  request  of  the  Commission  eg  on  quality 

and  composition  of  the  product,  and  likely  consumer  and 

producer  attitudes  to  the  use  of  BST. 

Other  important 

'U 

-  8  -

s o c i o - e c o n o m ic 

and 

e c o n o m ic 

factors 

eg 

e f f e c ts 

on 

a g r i c u l t u r al  p r o d u c t i on  and  s t r u c t u r es  are  not  at  present 

the  subject  of  in-depth  s t u d i e s. 

Food  Product  Q u a l i ty 

14. 

As  regards  milk  q u a l i t y,  apart  from  the  safety  of  r e s i d u e s, 

the 

a p p l i c a n ts 

for 

a u t h o r i s a t i on 

must 

identify 

any 

potential 

d i f f i c u l t i es 

in 

the 

s u b s e q u e nt 

industrial 

p r o c e s s i ng  of  f o o d s t u f f s. 

In  the  course  of  e x a m i n a t i on  by 

the  CVMP,  additional  Information  has  been  required  on  the 

e f f e c ts  of  the  use  of  BST  on  p r o t e i n,  fat  and  vitamin 

content  of  milk  and  on  the  e f f e c ts  for  the  m a n u f a c t u re  of 

c h e e s es  and  other  dairy  p r o d u c t s. 

15. 

An  aspect  requiring  p a r t i c u l ar  a t t e n t i on  r e l a t es  to  the 

s o m a t ic  cell  count  ( S CO  which  is  one  of  the  m a in  tests  of 

milk  b a c t e r i o l o g i c al  quality  and 

Is  used  as  an  indication 

of  m a s t i t is  In  a n i m a l s. 

R e p o r ts  from  the  United  States  and 

a  recent  G e r m an  study  (Heeschen  1 9 8 8 ),  Indicate  that  B S T-

a p p l i c a t i on  leads  to  an  increased  number  of  s o m a t ic  cells 

in 

the 

milk 

and 

to 

increased 

p y r u v a te 

levels 

also. 

Increased  SCC  levels  would  have  implications  as  regards 

the  s t a n d a r ds  laid  down  in  D i r e c t i ve  8 5 / 3 97  as  regards 

intra  Community  trade  in  milk  for  c o n s u m p t i on  and  the  price 

paid  to  p r o d u c e rs  for  milk  for  m a n u f a c t u r i n g.  An  Increase 

in  s o m a t ic  cells  a f f e c ts  the  c o m p o s i t i on  of  milk  eg  the 

l a c t o s e / s a l ts  r a t i o,  a  factor  that  could  Influence  product 

quality 

and 

y i e l d. 

A 

research 

project 

is 

currently 

u n d e r w ay 

(funded 

by 

r e s o u r c es 

from 

the 

milk 

co-

r e s p o n s i b i l i ty 

levy)  at 

the 

B u n d e s a n s t a It 

fur 

MI I c h f o r s c h u ng  at  Kiel  to  e x a m i ne  these 

a s p e c t s;  a  report 

is  e x p e c t ed  by  the  end  of  1 9 9 0. 

16. 

The  s t a n d a rd  of  farm  m a n a g e m e nt  Is  essential  if  the  likely 

a d v e r se  e f f e c ts  of  BST  on  c o m p o s i t i on  are  to  be  m i t i g a t e d. 

The  a v a i l a b i l i ty  of  good  quality  feeding  and  the  ability  of 

the 

cow 

to 

c o n s u me 

it 

in 

Increased 

a m o u n ts 

Is  a 

p r e r e q u i s i te 

to  e f f e c t i ve 

a p p l i c a t i on 

of 

r B S T. 

Should 

•/i 

-  9 -

producers  fall  to  operate  an  adequate  feeding  system,  the 

fatty  acid  composition  of  milk  fat,  and  in  turn  butter 

quality,  would  be  affected. 

The  impact  of  BST  on  milk  composition  needs  to  be  examined 

more 

fully, 

in 

relation 

to, 

for 

example, 

milk 

concentration,  the  combination  effects  of  heat  treatments 

and  the  effects  on  rennetabI Iity,  the  effect  of  increases 

In  the  level  of  whey  proteins  and  consequences  for  the 

consumption  of  liquid  mlik.  These  are  questions  that  need 

to  be  addressed  by  way  of  further  studies. 

ECONOMIC  AND  SOCIAL  CONSEQUENCES 

Impact  at  farm  level 

17. 

The  consequences  have  to  be  considered  in  the  context  of 

the  milk  quota,  established  as  part  of  the  Community's 

milk  policy,  remaining  beyond  its  review  date  in  1992. 

At  the  individual  farm  level  the  main  consequence  of  the 

Introduction  of  rBST  in  milk  production  Is  an  Increase  in 

the  milk  yield  per  cow.  The  actual  level  of  milk  yield 

Increase  would  be  less  (probably  about  12%)  than  the  25% 

recorded  In  research,  since  farm  management  In  normal 

circumstances  Is  likely  to  be  less  rigorous  than  under  the 

h Ighiy-controlled  conditions  of  experimental 

studies. 

While  Intake  of  feed  has  to  Increase  significantly,  perhaps 

by  as  much  as  10%, to  achieve  optimum  results, BST  can  lead 

to  an  Increase  In the  efficiency  of  feed  conversion  to milk 

by  up  to  6%. 

There  is  a  view  that  on  many  farms  BST  may 

be  used  as  a  tactical  management  tool,  for  example  to 

increase  milk  output  where  production  seems  likely  to  fall 

below  quota,  or  to  adjust  the  seasonalIty  of  production  or 

"4 

to  treat  individual  cows,  rather  than  as  a  routine 

treatment. 

<Kf 

-  10  -

W h i l e,  In  the  initial  period  at  least,  the  r e s p o n se  to  BST 

by  way  of  increased  milk  yield  at  farm  level  may  be  below 

the  r e s e a r ch  levels,  It  is  r e a s o n a b le  to  expect  a  growing 

increase  in  yield  levels  as  further  research  and  management 

are  r e f i n ed 

to  a c h i e ve  o p t i m um  r e s u l t s. 

It  has  to  be 

a s s u m ed  that  BST  would  be  made  a v a i l a b le  at  a  price  to 

permit  e c o n o m ic  u s e. 

18. 

The  C o m m u n i t y 's 

milk  quota  regime  is  d e s i g n ed  to  ensure 

that  m i lk  p r o d u c t i on  does  not 

Increase  beyond  a  fixed 

level. 

N e v e r t h e l e s s, 

the  present  tendency  for  large  scale 

dairy  f a r m e rs  to  p r o d u ce  in  e x c e ss  of  their 

individual 

q u o t as  c r e a t es 

an  o n g o i ng 

risk  of  higher  milk  d e l i v e r i e s. 

BST  w o u ld  add  to  this  r i s k. 

F u r t h e r m o re  its  use  by  milk 

p r o d u c e rs 

to  avoid  p r o d u c t i on 

being  under 

quota 

would 

r e m o ve 

an 

important 

"safety 

v a l v e" 

from 

the 

existing 

s y s t e m. 

19. 

The  g e n e r al  use  of  BST  would  likely  lead  to  reduced  dairy 

cow  n u m b e r s. 

T h is  w o u ld  affect  the  beef  sector 

through  an 

i n c r e a s e, 

in  the  s h o r t - t e r m, 

In  the  number  of  cows  taken 

out  of  m i lk  p r o d u c t i on  and  sent  for  s l a u g h t e r. 

In  the 

l o n g e r - t e rm  fewer  dairy  cows  should 

lead  to  lower  beef 

p r o d u c t i o n. 

In  the  normal  c o u r se 

le  without  B S T, 

beef 

p r o d u c t i on  from  the  dairy  herd  w o u ld  tend  to  fall  due  to 

the  o n g o i ng  Increase  in  milk  yield  as  a  result  of  improved 

f e e d i ng  and  h o u s i ng  t e c h n i q u es  and  better  s e l e c t i on  in  the 

dairy  h e r d. 

The  use  of  BST  would  a c c e l e r a te  this  trend; 

some  s t u d i es  suggest 

that 

the  d e c l i ne 

in  cow 

numbers 

w o u ld  a c c e l e r a te 

by  some  10  p e r c e n t. 

2 0. 

R e d u c t i on  In  dairy  cow  n u m b e rs  r a i s es  the  q u e s t i on  of  the 

u t i l i s a t i on  of  the  f a c t o rs  of  p r o d u c t i o n,  i.e.  labour  and 

c a p i t a l,  that  w o u ld  be  freed  at  the  farm 

level. 

Many 

f a r m e rs  a f f e c t ed  by  the  milk  quota  are  a l r e a dy  s t a r t i ng  new 

e n t e r p r i s e s,  e s p e c i a l ly 

in  b e e f,  s h e e p m e at  and  c e r e a l s. 

T h is  t e n d e n cy  could  g r ow  d e s p i te  there  being  few  increased 

o u t l e ts 

for 

further 

p r o d u c t i o n; 

beef 

and 

c e r e a ls 

are 

subject  to  the  s t a b i l i s er  m e c h a n i s m s, 

w h i le  sheepmeat  has 

•/r 

-  11  " 

been  the  subject  of  proposals  designed  to  reduce  the 

g u a r a n t e e,  In  view  of  the  sharp  rise  In  FEOGA  expenditure 

in  the  sector.  The  development 

of  opportunities 

for 

diversification  and  alternative  rural  enterprises  could  be 

a  factor  also. 

Ml Ik  Pol Icy  A s p e c ts 

21. 

In  considering  this  question  it  Is  necessary  also  to  bear 

In  mind  the  agricultural  policy  pursued  In  recent  years  by 

the  Community,  notably  since  1984.  This  has  Involved  a 

programme  to  control  output  directly  and  to  encourage 

farmers  to  diversify  and  engage  In  less  Intensive  forms  of 

production.  The  policy  was  developed  against  a  background 

of  sharply  increasing  production,  and  mounting  surpluses 

leading  to  unsustainable  pressures  on  the  Community  budget. 

2 2. 

Despite 

the 

quota 

system 

and 

a  satisfactory 

market 

situation, 

the 

milk 

regime  costs 

about 

5  000  MECU 

annually.  The  quota,  central  to  the  Community's  policy  of 

containing 

production 

and 

e x p e n d i t u r e, 

Is  a 

fragile 

mechanism  whose  beneficial  effects  are  at  constant  risk 

from  surplus  production.  Deliveries  In  the  1988/89  season 

were  some  1.8  million  tonnes  above  quota;  this  has  led  to 

requests  to  the  budgetary  authority  for  increased  credits 

for  the  milk  sector  this  year. 

Soclo-StructuraI 

23. 

As  regards  the  socio-structural 

a s p e c t s,  milk  production 

Is  central  to  incomes  of  smaller  producers  ie  those  with 

less  than  10  cows  in  the  Community.  While  such 

producers 

represent  some  5 3%  of  holdings  (1.6  m i l l i o n ),  only  1 2%  of 

dairy  cows  are  kept  on  their  h o l d i n g s. 

Producers  witn 

larger  resources  are  best  placed  to  take  advantage  of 

increases 

in 

productivity 

through 

the 

use 

of 

new 

technologies.  Smaller 

p r o d u c e r s, 

traditionally 

less 

capable  of  adapting  to  change  and  technical 

advances 

are  slow  to  b e n e f i t,  if  at  a l l,  from  such  o p p o r t u n i t i e s. 

-/s 

ïfi-

#: 

-  12 -

in  the  case  of  BST,  the  management  techniques  required  and 

the  need  to  provide  supplementary  high  quality  feed  for 

cows,  would  limit  any  possible  advantages  in  the  case  of 

small 

herds.  Besides,  there 

would 

normally 

be 

no 

incentive  to  a  herdowner  with  less  than  a  given  minimum 

number 

(8)  of  cows 

to  use  BST.  This  would 

have 

Implications  as  regards  the  regional  distribution  of  BST 

usage  in  the  Community. 

24. 

The  ability  of  BST  to  Increase  further  the  economies  of 

scale  and  profits  of  larger  producers  would  give  them  a 

greater  capacity  to  engage  in  other  forms  of  production 

and/or  to  purchase  smaller  holdings  with  milk  quotas. 

It 

Is  likely  also  to  lead  to  growing  pressures  to  break  the 

link,  In existing  legislation,  between  the  quota  and  the 

holding  -  quotas  may  not  be  purchased  Independently  of  the 

corresponding  holding  -  as  larger  producers  seek  to 

consolidate  their  positions  and  make  optimum  use  of  the  new 

techno logy. 

25. 

Consumer  View 

No  detailed  studies  have  been  made,  of  the  likely  consumer 

reaction  to  meat  and  dairy  products  In  the  event  of  BST 

being  authorised.  Consumers  organisations  have  warned 

that  this  could  be  very  negative.  At  the  meeting  of  the 

Veterinary  Advisory  Committee  on  15  March  and  at  the 

Advisory  Committee  for  milk  and  milk  products  on  31  March 

1989.  BEUC,  the  umbrella  consumer  group  organization, 

called  for  a  total  ban  on  BST.  The  consumer  view  is  that 

research  carried  out  to  date  does  not  demonstrate  any 

advantage  for  the  consumer  eg  by  reducing  retail  prices  for 

dairy  products  or  by  Improving  the  quality  of  milk  and 

meat  products  or  the  health  and  nutritional  standards  of 

milk. 

On  the  contrary  BST  Is  claimed  to  engender 

mistrust  and  suspicion  of  the  quality  of  meat  and  of  dairy 

products.  Consumers  are  concerned  also  at  the  animal 

welfare  aspects  (see  par 2 9 ). 

/-? 

26. 

Market  Aspects 

-  13 -

As  regards  the  market  for  dairy  products,  consumptIon  has 

been  Increasing  steadily  in  recent  years.  There  is  a 

growing  trend  away  from  traditional  products  such  as  butter 

-  perceived  by  some  consumers  as  harmful  to  health  -  to 

cheeses  and  diversified  products.  Dairy  products  face 

increasing 

competition 

from 

substitute 

products. 

Producers,  the  dairy  Industry  and  Indeed  the  Community, 

through  some  400 MECU  committed  from  the  coresponsIbI I Ity 

funds,  have  invested  heavily  In  recent  years  In  promoting 

an  image  of  milk  and  dairy  products  as  natural,  healthy 

products. 

27. 

It  would  be  a  serious  setback  to  producers  and  to  the 

Community's  milk  policy 

were 

present 

trends 

In 

consumption  to  be  reversed  as  a  result  of  adverse  consumer 

reaction.  This  points  to  the  need  for  the  most  careful 

evaluation  of  this  aspect. 

Since  existing  techniques  do 

not  permit  the  ready  identification  of  rBST  in  dairy 

products,  the  concerns  of  consumers  cannot  at  present  be 

met  through  labelling.  An  Important  research  project, 

financed  by  the  milk  co-r espons I b I I 11 y  funds,  Is  being 

carried  out  at  the  University  of  Munich  with  the  object  of 

finding  a  method  to  Identify  rBST  In  milk:  this  is 

expected  to  be  completed  in  the  second  half  of  1990. 

28. 

It  Is  intended  that  other  studies  currently  under  way  at 

the  Institute  fur  WIrtshaftsforshung  In  Munich  and  at  the 

University  of  Glessen  due  to  be  completed  In  November  1990 

will  provide  mora  Information  on  likely  consumer  reaction. 

The  studies  will  cover  farmer  reaction  also  to use  of  BST. 

29. 

Animal  Welfare 

Concern  at  the  animal  welfare  Implications  of  the  use  of 

BST  relates  to  short-term  and  long-term  effects,  and 

administration.  As  regards  the  short-term,  the  concern  is 

that  cattle  treated  with  BST  could  suffer  from  a  greater 

-  14 -

Incidence  of  metabolic  diseases.  In  relation  to  the  longer 

term  the  concern  is  that  the  administration  of  BST  over 

several 

lactations  could 

result 

in  changes 

in  the 

calcium/phosphorus  balance,  leading  to  musculo-skeI eta I 

deformities,  and  that  there  could  be  unforeseen  problems 

for  the  calves  of  treated  cows.  The  CVMP  is examining  these 

aspects. 

The  need  to  administer  BST  by  injection  and  to  restrain 

animals  for  the  purpose  of  administration  are  seen  also  as 

undesirable  on  animal  welfare  grounds. 

30. 

Other  Somatotroph Ins 

While  the  immediate  subject  of  this  report  relates  to  rBST 

for  milk  production,  somatotroph In has  a potential  to  be  an 

effective  commercial  growth  and  carcase  enhancer  in  other 

livestock.  Significant  Improvements  in  daily  gains  and 

feed  conversion  efficiency  have  been  recorded  in  the  course 

of  experimental  work  on  cattle,  sheep  and  especially  in 

pigs.  While  results  are  more  variable  than  in  the  case  of 

milk  and  the  techniques  involved  have  not  reached  the  stage 

of  commercialisation  -  the  need  for  frequent  Injections  is 

a  major  drawback  -  further  research  and  development  in 

these  fields  may  open  the  way  for  a  substantial  increase  in 

productivity  and  production  of  livestock  products. 

31. 

Views  of  Pharmaceutical  Industry 

The  pharmaceutical 

industry  would  be  concerned  about 

possible  adverse  impact  of  changes  in present  authorisation 

procedures  not  founded  on  a  sound  scientific  basis.  The 

industry  would  be  opposed  to 

criteria  relating  to  social 

and  economic  factors.  The  contention  is  that  departures 

from 

criteria 

established 

by 

legislation 

create 

uncertainty,  and  reduce  the 

likelihood  of  research, 

development,  innovation  and  investment. 

^3 

-  15  -

The  industry  s u p p o r ts  the  a u t h o r i z a t i on  of  BST  w h i c h,  It 

c l a i m s, 

will 

bring 

e c o n o m ic 

b e n e f i ts 

for 

Industrial 

s u p p l i e r,  farmer  and  c o n s u m e r. 

Feed  A d d i t i v es 

3 2. 

Apart  from  B S T,  c o n c e rn  has  been  e x p r e s s ed  In  the  Council 

of  M i n i s t e rs  in  relation  to  the  a u t h o r i s a t i on  of  growth 

p r o m o t e rs 

in 

animal 

f e e d I n g s t u f fs 

(see 

par 

8 ).  This 

c o n c e rn  r e l a t es  to  O w c o n s u m er  p r o t e c t i o n,  market  imbaianc 

and  b u d g e t a ry  c o s t s.  The  C o m m i s s i on 

has  u n d e r t a k en 

to 

present  the  r e s u l ts  of  s t u d i es  in  this  area  with  a  view  to 

d i s c u s s i on 

In  C o u n c i l. 

It 

Is  a c c o r d i n g ly 

intended 

to 

launch 

shortly  a  w i d e - r a n g i ng 

study  of  the 

impact  of 

g r o w th  f a c t o rs  in  the  p r o d u c t i on  of  livestock  p r o d u c t s. 

This  will 

cover 

the  e c o n o m ic 

a s p e c ts 

in  r e l a t i on 

to 

a g r i c u l t u r al 

p r o d u c t i v i t y, 

research 

and 

c o n s u m p t i o n; 

together  with  the  s o c i o - e c o n o m ic  e l e m e n t s. 

The  study  is 

e x p e c t ed  to  be  c o m p l e t ed  by  O c t o b er  1 9 9 0.  Nine  growth 

p r o m o t e rs  have  been  a u t h o r i s ed  as  feed  a d d i t i v es  under 

e x i s t i ng 

legislation 

and 

further 

a p p l i c a t i o ns 

for 

a u t h o r i s a t i on  are  c u r r e n t ly  being  c o n s i d e r e d; 

one  such 

a p p l i c a t i on  r e l a t es  to  a  s u b s t a n ce  c o n s i d e r ed  c a p a b le  of 

Increasing  milk  y i e l ds  by  u p w a r ds  of  5%.  No  a u t h o r i s a t i o ns 

for  milk  p r o d u c t i on  have  been  given  to  d a t e. 

3 3. 

C O N C L U S I O NS 

(a) 

The  use  of  recombinant  BST  ( r B S T)  is  c a p a b le  of  s i g n i f i c a nt 

Increase 

in 

milk 

y i e l d s. 

It 

Is 

likely 

to 

be 

the 

f o r e r u n n er  of  other  p r o d u c ts  c a p a b le  of  b r i n g i ng  about  a 

s u b s t a n t i al  Increase  in  meat 

p r o d u c t i o n. 

(b) 

On  the  a s s u m p t i on  of  the  C o m m u n i t y 's  milk  quota  regime 

c o n t i n u i ng  beyond  1 9 9 2,  the  use  of  BST  should  be  reflected 

in  a  r e d u c t i on  In  the  number  of  dairy  cows  rather  than  an 

increase  In  overall  milk  p r o d u c t i o n; 

this  Is  likely  to  be 

<b 

-  16  -

accompanied  by  a  release  of  resources  of  labour  and  capital 

Into  other  sectors  of  a g r i c u l t u r e,  greater  concentration  of 

milk  production  in  the  hands  of  the  larger  milk  producers 

and  greater  pressure  on  the  quota  regime. 

(c) 

Apart  from  the  Member  States  and  the  European  Parliament 

which  has  adopted  a  resolution  on  the  Issue,  this  is  a 

matter  of  considerable  public  Interest  especially  among 

c o n s u m e r s, 

p r o d u c e r s, 

Industry, 

animal 

welfare 

o r g a n i s a t i o ns  and  scientific 

Interests.  While 

directly 

opposing  positions  have  been  taken  up  by  consumers  and  the 

pharmaceutical  Industry,  most  other  interested  parties  have 

taken  a  more  cautious  position,  advocating  further  studies 

and  i n f o r m a t I o n. 

(d) 

Apart  from  the  purely  scientific  a s p e c t s,  the  reservations 

expressed  by  the  Member  States  and  the  position  taken  up  In 

the  Parliament  on  these  Issues,  as  well  as  the  considerable 

uncertainty 

In 

relation 

to 

consumer 

reaction 

and 

consequences  for  the  market,  requires  that  the  Community's 

approach  to  be  based  on  the  fullest  awareness  of  all  the 

Imp I I cat Ions . 

(e) 

The  present  authorisation  process  for  use  of  BST  provides 

for  a  decision  at  national  level.  Other  chemical  products, 

administered  to  livestock  by  means  of  an  oral  preparation 

for  nutritional  purposes  as  additives  in  feedingstuffs, 

are  subject  to  a  Community  authorisation  procedure.  While 

several  Member  States  have  expressed  reservations  about  use 

of  BST  there  may  not  be  unanimity  on  the  issue.  This  could 

have  Implications  in  relation  to  free  movement  of  products. 

Examination  of  the  matter  by  the  Committee  on  Veterinary 

Medicinal  Products  ( C V M P ),  conducted  on  the  basis  of  the 

"safety",  "efficacy"  and  "quality"  of  the  product  is  at  an 

advanced  stage. 

It  is  likely  that  Member  States  will  be 

faced  with  the  decision  of  whether  to  authorise  rBST  by  the 

end  of  this  year. 

Studies  under  way  into  other  aspects  eg 

milk  composition  and  quality,  consumer  reaction  etc  are  due 

to  be  completed  in  the  second  half  of  1990. 

*7 

-  17  -

(f) 

It  is  clear  that  a  s i t u a t i on  in  w h i ch  Member  S t a t es  may 

take  d i v e r g e nt  d e c i s i o ns  on  BST  must  be  a v o i d e d; 

to  this 

end 

the  C o m m i s s i on  will  present  c o m p r e h e n s i ve  p r o p o s a ls  to 

Council  by  the  end  of  this  y e a r.  H a v i ng  regard  to  the 

p o s i t i on  of  P a r l i a m e nt  and  the  general  p u b l ic  concern  on 

these  issues,  p r e p a r a t i on  of  the  p r o p o s a ls  will  require 

d e t a i l ed 

e x a m i n a t i on 

of 

the  most 

a p p r o p r i a te 

decision 

m a k i ng 

a r r a n g e m e n ts 

and 

s t r u c t u r es 

In  c o n n e c t i on 

with 

a u t h o r i s a t i on  of  all 

p r o d u c t i v i ty  e n h a n c i ng  s u b s t a n c es  In 

a g r i c u l t u r e,  w h e t h er 

v e t e r i n a ry 

m e d i c i n al 

p r o d u c t s, 

including  p r o d u c t s . of  b i o t e c h n o l o g y,  or  feed  a d d i t i v e s. 

(g) 

It  Is  clear  also  that  s u f f i c i e nt  time  s h o u ld  be  a v a i l a b le 

to  a s s e ss  the  r e s u l ts  of  the  current  s t u d i e s,  under  the 

a e g is  of  the  CVMP  and  of  the  C o m m i s s i o n.  At  the  same  time 

it  Is  e s s e n t i al  to  avoid  p r o l o n g ed  u n c e r t a i n ty  that  would 

be 

harmful 

to 

the 

Interests  of 

Industry, 

e s p e c i a l ly 

b i o t e c h n o l o g y, 

which 

has 

an 

important 

role 

in 

the 

C o m m u n i t y,  not  least  in  the  d e v e l o p m e nt  of  a g r i c u l t u r e. 

(h) 

It  will  be  important  a l so  to  have  an  e x c h a n ge  of  views  on 

the  issues  raised  with  any  interested  third  c o u n t r i e s,  as 

it  Is  c e r t a in  that  the  q u e s t i o ns  raised  are  of  deep  concern 

and  interest  not  Just  In  the  C o m m u n i ty  but  a l so  in  the 

major  p r o d u c er  and  c o n s u m er  c o u n t r i e s. 

R e c o m m e n d a t I o ns 

it  Is  a c c o r d i n g ly  p r o p o s ed  that  the  Council  adopt  a  d e c i s i on  to 

e s t a b l i sh  an  e v a l u a t i on  p e r i od 

up  to  the  end  of  1990  on  the 

a d m i n i s t r a t i on  of  r B S T. 

Th i s  p e r i od  Is  c o n s i d e r ed  to  be  the 

m i n i m um  n e c e s s a ry  to  a s s e ss  the  r e s u l ts  of  o n g o i ng  s t u d i es  and 

c o m p l e te  the  new  a r r a n g e m e n ts  to  be  a d o p t ed  on  p r o c e d u r e s. 

The 

target  date  for  c o m p l e t i on  of  some  of  the  s t u d i es  will  have  to  be 

brought  forward  to  e n a b le  the  C o m m i s s i on  to  fully  review  all 

a s p e c ts  in  twelve  m o n t hs  t i m e.  This  will  p r o v i de  the  o p p o r t u n i ty 

also 

to 

c o m p I e te 

the 

n e c e s s a ry 

c o n t a c ts  with 

Interested 

*< 

-  18  -

third  c o u n t r i e s. 

In  k e e p i ng  with  the  C o m m u n i t y 's  o p e n n e ss  on  the 

d e f i n i t i ve  c o n c l u s i on  on  this  q u e s t i o n, 

it  is  not  the  intention 

to  p r o h i b it 

Imports  of  BST  or  of  p r o d u c ts  d e r i v ed  from  BST 

treated  a n i m a ls  d u r i ng  the  e v a I u a t I on 

p e r i o d. 

T h is  a p p r o a ch  is 

not  c o n s i d e r ed  to  place  C o m m u n i ty  milk  p r o d u c e rs  at  a  c o m p e t i t i ve 

d i s a d v a n t a ge  in  p r a c t i c e. 

^ 

Annex I 

de 

des 

des 

Unions 

Bureau 

Liaison 

Européen 

ADVISORY 

consulted 

Commerces 

AgroaIImenta I res 

a)  THE  VETERINARY 

COMMITTEE 
Bodies 
representative  of  Agricultural  Producers  (COPA),  Agricultural 
Cooperatives  (COGECA).  industry,  Confederation  of  the  Food  and 
Drink  Industries  of  the  EEC  (C.I.A.A.).  Commerce,  Comité 
Européen 
(C.E.L.C.A.A.).  Workers,  European  Trade  Union  Confederation 
de 
(E.T.U.C).  Consumers, 
Consommateurs 
of  Consumer 
(B.E.U.C.),  European  Community 
Cooperatives  (E.U.R.0.C.0.0.P . ) ,  Confederation des Organisations 
Familiales  de  la CE  (C.0.F.A.C . E . ) .  Federation  of  Veterinarians 
of  the  European  Economic  Community  (FVE).  b)  The  ADVISORY 
COMMITTEE 
ON  MILK  AND  MILK  PRODUCTS,  (representatives  of 
Producers/Cooperatives,  Dairy  and  Dairy  Related  Industries, 
Trade, Workers and Consumers)  c)  OTHER  HEARINGS/ 
REPRESENTATIVES/OBSERVERS,  European  Community  Dairy  Industries 
(A.S.S.I.L.E.C.v  A.S.S.I.F.O.N.T.E.,  A.S.F.A.L.E.C.),  European 
Community  Dairy  Traders  (U.N.E.C.O.L.A.I.T. ,  E.U.C.0.L.A.I.T), 
Eurogroup  for  Animal  Welfare,  European  Federation  of  Animal 
Health  (F.E.D.E.S.A.),  Compassion  in  World  Farming  (C.I.W.F.), 
European 
Tlerschutzbund, 
Tierverschunger  -  NordrheIn-Westpha I I a  E.V.,  Gen-ethisches 
Netzwork  G.E.N. ,  EvangeI Isches  Bauernwerk  in  Wurttemberg,  Die 
Verbraucher  Initiative, European  Campaign Against  B.S.T., Working 
group  for  Lactlcal  Veterinary  Medicine  (A.G.K.T.),  EC  Livestock 
and  Meat  Trade  (U.E.C.B.V.) ,  EC  Meat  Processing  Industry 
(C.L.I.T.R.A.V.I . ) , European  Retail  Trade  Associations  (C.L.D., 
C.E.C.D.),  EC Meat  Wholesale  Trade  (A.E.C.G.V.) , The  London  Food 
CommIss ion. 

Coordination, 

Deutscher 

Farmers 

<v 

ISSN 0254-1475 

COM (89) 379 final 

DOCUMENTS 

EN 

03 

Catalogue number :CB-CO-89-430-EN-C 

ISBN 92-77-53228-9 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg 

^V