•-J--
COMMISSION OF THE EUROPEAN COMMUNITIES 
COMC93) 331 final 
Brussels, 16 September 1993 
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL 
AND THE EUROPEAN PARLIAMENT 
CONCERNING 
BOVINE SOMATOTROPHIN 
(B.S.T. L 
«W"8»W-
COMMUNICATION 
TO THE COUNCIL AND TO THE EUROPEAN PARLIAMENT 
CONCERNING 
BOVINE SOMATOTROPH IN (B.S.T.) 
INTRODUCTION 
1. On 27th Soptember 1989 the Commission presented for the first time a 
report to the Council and to the Parliament concerning the 
administration of Bovine Somatotrophin (B.S.T.) to dairy cows as a 
productivity aid to milk production (1). This was accompanied by a 
proposal to establish an evaluation period to enable the effects of the 
use of B.S.T. to be assessed. The Council by Decisions in April 1990 
(2) and subsequently in February 1991 (3) prohibited the marketing of 
B.S.T. and its administration to dairy cows for purposes other than 
scientific study and research until 31st December 1991 and asked the 
Commission to continue its studies. 
2. In January 1992 the Commission presented a second report to the Council 
and to the Parliament. The report indicated that several aspects of the 
evaluation were still unclear and that accordingly a further period was 
necessary to complete the studies and to draw final conclusions. The 
preliminary conclusions in the Commission's report highlighted the need 
to take account of the fact that B.S.T. though classified as a 
veterinarian medicinal product would not be used for the therapeutic 
benefit of the animal. The Council agreed (4) to prolong the 
restrictions until 31 December 1993. At the same time the Commission 
was Invited to present a further report to the Council and to the 
Parliament by 1st July 1993, together with proposals for future 
arrangements. 
PRESENT SITUATION 
3. Four aspects were identified in the 1992 report as needing further 
study, namely 
- aspects of "animal" safety in the context of the established criteria 
for assessing veterinary medicinal products, namely "safety", 
"quaIity" and "efficacy"; 
- the ethical aspects, namely the question of administering a medicinal 
product to an animal in order to increase production of a raw material 
i.e. milk which public policy sought to discourage, and which might 
indirectly give rise to health problems for the animal; 
- risks to export outlets for Community products, and international 
obiigations; 
- consistency with the approach adopted in the reform of the Common 
Agricultural Pol icy. 
(1) COM (89) 379 Final. 
(2) O.J. L 116 Of 08.05.1990, p. 27. 
(3) O.J. L 37 Of 09.02.1991, p. 39. 
(4) O.J. L 39 Of 15.02.1992, p. 41. 
A A 
Account must also be taken of the importance of technical progress and 
innovation for the competitiveness of European industries as indicated in the 
Commission's communication of 1991 on biotechnology. At the same time, 
however, it is important to outline that there is a need to assess the 
consequences of such progress in a broader context which is also a task of 
Community authorities. 
4. The Committee for Veterinary Medicinal Products (C.V.M.P.) has now 
(26th-27th January 1993) completed its studies of the two requests for 
marketing authorisation for B.S.T.-based products on the basis of the 
established criteria of "safety", "quality" and "efficacy". 
5. The Group of Advisers to the Commission on Ethical Aspects of 
Biotechnology have recently (12th March 1993) given their opinion on the 
"ethical Implications of the use of performance - enhancers in 
agriculture and fisheries". 
The Commission thanks both the C.V.M.P. and the Group of Advisers on the 
ethical implications of biotechnology for their work. 
ECONOMIC ASPECTS 
PRODUCTION 
6. Milk production in the Community is to a large extent limited by the 
system of milk quotas. Taking into account the 2 % quota cut agreed in 
principle under the reform of the Common Agricultural Policy and the 
likely adjustments in some individual Member States the global reference 
quantity for deliveries to dairies would be 100.9 mio t by the end of 
the decade. Based on the consumption trends of dairy products (a drop 
in butter consumption only partially compensated by the increase in 
consumption of fresh dairy products and cheese) overall demand expressed 
in milk equivalent is expected to decline to 96.3 mio t, leading to a 
surplus of 4.6 mio t. 
7. The findings so far suggest that: 
- The estimated productivity increase from B.S.T., is in a range of 6 % 
to 20 % (with a probable average of 12 %). In a quota regime the use 
of B.S.T. should not lead to a significant increase in milk 
production, (though the prospect for an individual farmer of being 
able to easily recover a temporary drop in production during the 
milking season together with the adjustment process, that is the time 
lag in slaughtering surplus dairy cows, will inevitably lead to more 
milk being available in the short-term at least). Present studies 
indicate that B.S.T. could be used both regularly or tactically at 
farm level. The likelihood of greater productivity due to use of 
B.S.T. especially on holdings with high levels of quota would lead to 
greater rationalisation at farm level, with a tendency for smaller 
producers to go out of business. 
- The impact on the beef sector would be twofold. In the early years 
(up to 1998) increased slaughterings of dairy cows (4 % - 6 % of the 
dairy herd) could be expected; there would also be a gradual 
displacement of production from dairy cows to beef-breed cows as the 
spare capacity available following the slaughter of dairy animals 
would not remain idle. 
CONSUMER REACTION 
8. Consumers are becoming increasingly conscious of the health and quality 
aspects of their food, and this has been particularly evident in the 
milk sector. Milk products amounting to 85 million tonnes in milk 
equivalent are consumed annually in the Community. Accordingly possible 
consumer reaction is a fundamental consideration in the approach to 
author izing B.S.T. 
Studies of likely consumer reaction indicate that consumers are more 
opposed to B.S.T. than in the case of other substances, such as the 
hormones for fattening. According to the Information und Forschung 
Institut (IFO) study the proportion of consumers which would favour a 
total "boycott" of products associated with B.S.T. would lead to a drop 
in consumption of some 11 % More than half of the responses given as 
the motivation for ceasing to buy milk relate to a health concern and 
the "non-natural" nature of food products seems to be associated with 
the use of B.S.T. (53 %). 
Similar reactions have been reported elsewhere. In the United States 
studies have found that nine out of ten consumers are in favour of 
labelling B.G.H. (bovine growth hormone) milk . In a recent survey 
conducted by dairy companies at least 40 % of the milk consumers said 
that they would cut back or eliminate purchases of milk and dairy 
products if B.G.H. milk were not clearly labelled. 
Similar problems are foreseen as regards consumer reactions to beef, 
linked to the treatment of cows. 
9. Although consumer behavior is difficult to predict with certainty, all 
surveys indicate an unfavourable reaction. Even if the market were to 
experience only a modest drop in consumption of say of 2 - 3 % there 
will be a very severe effect on the market balance. The fact that it is 
not possible to distinguish B.S.T. in milk means that consumers cannot 
be reassured through a system of labelling. 
STRUCTURES 
10. The Commission already indicated in previous reports its concern for the 
position of small milk producers following the introduction of B.S.T. 
[The findings suggest that regular use of B.S.T. would be confined to 
dairy herds with more then 15 cows.] In a quota system it is difficult 
for small producers to expand their output, and with the economies of 
scale available to large scale producers, B.S.T. would strengthen their 
position further. This would tend to concentrate dairy production in 
larger and more intensive holdings. This could have implications for the 
viability of milk processing facilities served largely by smaller 
producers. Such structures are usually to be found in the less favoured 
areas with few alternatives to milk production. 
THE INTERNATIONAL SITUATION CONCERNING B.S.T. 
11. It is impossible to predict the effects on the Community's export 
markets for milk and milk products (some 13 million tonnes in milk 
equivalent annually) in the event of B.S.T. being authorized. What can 
be said is that the world market is highly competitive, and the 
Community's competitors could be expected to take advantage of any 
difference of approach to authorizing B.S.T. Many importers, especially 
of sensitive products e.g. milk powder for human consumption, could be 
expected to demand a non B.S.T. related basic material. 
No major consumer or exporter of livestock products has authorized 
B.S.T. as a productivity enhancer. According to pharmaceutical industry 
sources, B.S.T. is approved in Russia, Bulgarie, in the Czech Republic, 
in the Republic of Slovakia, Romania, South-Africa, Algeria, Zimbabwe, 
Mexico, Brazil, Pakistan. It is understood that in some cases the 
authorization is only for scientific purposes or field trials. 
In the United States the Veterinary Medicine» Advisory Committee (VMAC) 
has given a positive scientific opinion on B.S.T. products. A hearing 
was held on 31st March 1993 during which different interested parties 
made comments. While the United States authorities have not yet taken a 
final decision, it appears that the United States Senate approved a 
moratorium until 30th September 1994 on the marketing and use of B.S.T. 
11. 
bis In the implementation of its decision in relation to B.S.T. the 
Community wiI I respect its international obligations. 
CAP REFORM 
12. The reform of the CAP had as its basic premise that solvent outlets 
could no longer be found for ever-increasing production, and that 
consumption levels could only be sustained through reassuring consumers 
about the quality of food products. As regards the structural aspects an 
active agricultural population was seen as essential to balanced rural 
societies, and prospects for employment outside agriculture were 
considered to be especially difficult in present economic conditions. 
13. The introduction of B.S.T. is likely to lead to the following : 
- in the short term increased slaughtering of dairy cows, with 
additional beef animals being raised to take up the slack; 
- a significant fall in consumption of milk and dairy products-, 
- a fall in beef consumption which is difficult to quantify; 
- an acceleration in the trend towards larger and fewer dairy farms, 
with small producers leaving the industry in greater numbers; 
- an increased concentration of dairy production in zones of intensive 
rearing, to the detriment of extensive production, often located in 
less favoured areas 
- difficulties in retaining export markets for dairy products and 
possibly for beef also. 
SAFETY. QUALITY AND EFFICACY CRITERIA AND ETHICAL ASPECTS 
SAFETY. QUALITY AND EFFICACY 
14. The C.V.M.P. arrived at the general view that the two products based on 
B.S.T. presented by Monsanto and Eli Lilly satisfy the traditional 
criteria for authorization of "quality", "safety" and "efficacy". 
However, the Committee indicates several requirements, apart from 
veterinary prescription, to ensure successful use of the products 
namely : 
M The Committee would emphasize that the successful use of OTTYSLEX 640 
and SOMATCH will require the maintenance of high standards of animal 
husbandry. Expert advice will be necessary for the choice of animals 
for treatment and their subsequent care. For these reasons, the 
Committee confirms that, in accordance with Article 4 (3) of Directive 
81/851/EEC, as amended, the product should be made available on 
veterinary prescription only. 
The Committee would emphasize that the successful use of the product 
will require measures to ensure : 
- a high nutritional regime for treated animals; 
- good hygiene at the injection site; 
-ongoing monitoring of somatic cell counts of milk obtained from 
treated animals; 
- specific instructions for use appear on the labelling and all 
product related literature; 
- a structured programme of pharmacovigilance. 
These precautions may imply substantial changes in current management 
practices for dairy cattle. " 
ETWÇS 
15. Subject to certain safeguard measures the Group of Advisers to the 
Commission concluded that the use of B.S.T. to increase lactation is 
unobjectionable in itself. But the safeguards recommended are similar 
to those Identified by the C.V.M.P. The Group gave the following 
recommendation : 
" The use of B.S.T. to increase lactation in cows is ethically 
unobjectionable, and safe for both human and animals, provided that 
the following measures are adopted : 
4.1 - assurance should be provided that B.S.T.-treated animals do 
not suffer extreme pain or even discomfort that is 
disproportionate to the human good expected from the use of 
the product; 
4.2 - treatment should be stopped when increased lactation of milk 
is associated with mastitits or other inflammatory reactions; 
4.3 - these reactions should be controlled through the application 
of simple hygienic measures or - if cured with antibiotics -
the milk produced by the animals so treated should be banned 
from human consumption until the antibiotics are totally 
eliminated; 
4.4 - the level of somatic cells per millilitre of milk should not 
be higher than the concentration found in the milk thus far 
produced by high-yield lactation cows obtained through 
select ive breeding; 
4.5 - if it becomes possible to distinguish milk derived from 
B.S.T.- treated cows from other milk, then the vendors should 
be required to label it and its derivatives to allow free 
choice to the buyers. " 
CONCLUSION 
16. In its second report on B.S.T. [Sec (91)25^1 Final] the Commission 
referred to its communication to the Council and to the Parliament 
concerning "Promoting 'he corrpstitive environment for the industrial 
activities based on biotechnology vithin thr Community [Sec (91)629 
Final] wherein it stated : "it is not the Intention to have another 
systematic assessment !n addition to the three criteria. The Commission 
will normally follow scientific advice. The Commission reserves the 
right however, to take a different view in the light of its general 
obligations to take into account other Community policies and 
objectives". 
17. Ensuring that the precautions required by the C.V.M.P. and the 
conditions for safety and absence of ethical objections established by 
the Group of Advisers on Ethics are respected imply a degree of 
monitoring, control and surveillance of individual animals equivalent to 
that required for their medicinal treatment under the care of a 
veterinary surgeon. However, the B.S.T. products examined are intended 
for bulk administration to herds as growth enhancers and not for 
therapeutic treatment of a reduced number of individual animals. 
Experience of the use of growth promoters in animal production suggest 
that such safeguards are very much the exception. Enforcement of the 
respect of these safeguards would require setting up an elaborate and 
prohibitively costly control regime at farm level. 
18. The introduction of B.S.T. is contrary to the policy direction in the 
C.A.P. reform. Negative consumer reactions and related effects on 
consumption, likely major changes in production practices, and 
potentially adverse effects on Community exports could combine to 
exacerbate market and structural imbalances in both the milk and beef 
sectors. 
19. Having regard to these considerations the Commission proposes to the 
Council that the marketing of B.S.T., or its administration to dairy 
cows in the Community be prohibited for the duration of the application 
of milk quotas. 
ISSN 0254-1475 
COM(93) 331 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-93-374-EN-C 
ISBN 92-77-58015-1 
Office for Official Publications of the European Communities 
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