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) 
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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 products, particularly those derived from 
biotechnology*2^, the various effects of new 
<1> O.J. N° L 317 of 06.11.1981, p. 1 
(2) O.J. N° L 15 Of 12.01.1987, P. 38 
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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. 
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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 
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estimated that, given the knowledge and ability required 
for effective use of the product, yield Increases closer 
to 12% are more likely to be achieved In normal farm 
condItIons. 
The possible use of rBST in milk production has been the 
subject of widespread public Interest. In the Council of 
Agriculture Ministers several Member States have expressed 
reservations about Its use, mainly in relation to 
potentially adverse soclo/structura I consequences and the 
implications as regards supply and demand for milk and milk 
products. The matter has been examined extensively by 
various Committees in the European Parliament which, on 
5 July 1988, adopted a resolution1 on the effects and 
risks of using growth hormones and the BST hormone In the 
dairy and meat industries. The Parliament called on the 
Commission to examine the consequences of the use of rBST, 
to consider, inter alia, the necessity for additional 
criteria, e.g. social and economic factors, in the 
examination of applications for authorisations and to 
create a legal framework covering genetically engineered 
growth accelerators or yield enhancers. Under existing 
legislation authorisations are considered on the basis of 
three criteria viz, safety, quality and efficacy. The BST 
question was discussed at length at a seminar held in 
September 1988 under the auspices of the Commission. A 
wide range of organisations (listed in Annex 1) have been 
consulted and have had an opportunity to give their views. 
It is clear from the reaction in the Council of Ministers 
that, while most Member States are very hesitant about 
the authorisation of rBST, there may not be unanimity on 
the issue. Divergent positions of Member States on 
authorisation carries a serious danger of distortion of 
competition and trade disputes. 
O.J. C 235 (Vol. 31) Of 12.9.1988, pp. 41-44. 
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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 cattle. 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 products. 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 opinion. 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 19812, 85/358/EEC of 16 July 
19853 and 88/146/EEC of 7 March 19884 in relation to 
prohibition on the use of certain hormones for fattening 
purposes. It is not affected either by the provisions of 
Council Directive 70/524/EEC of 23 November 1970 on 
additives in feedIngstuffs.5 Under this Directive the 
only substances that may be used as additives in animai 
2 O.J. L 222 Of 7.8.1981, p. 32. 
3 O.J. L 191 Of 23.7.1985, p. 46. 
4 O.J. L 70 of 16.3.1988, p. 16. 
5 O.J. L 270 Of 14.12.1979, p. 1. 
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feedingstuffs are those approved by a Community procedure 
and listed In the Annexes to the Directive. Since no oral 
preparation Is currently available in the case of rBST -
formulations are administered by Injection- the question 
of authorising rBST as an additive in feedingstuffs has not 
arisen. It may be noted, however, that several antibiotics 
and other chemical additives, whose effect is to increase 
productivity of livestock, are either currently authorised 
or the subject of applications for authorisation. 
9. Two applications for a marketing authorization for BST were 
referred for an opinion to the CVMP In 1987. One 
application would cover all Member States except 
Luxembourg and the Netherlands. A second application 
concerns France and the United Kingdom. 
Under existing procedures It is a matter for the applicant 
to submit the data necessary to prove that the three 
criteria have been met; applications are assessed by the 
national authorities and by the Committee. The 
authorities of the Member States concerned receive a 
complete set of the data submitted by each company, and 
have the opportunity to submit questions and comment. 
The commercial implications of receiving authorisation 
requires that the regulatory authorities protect the 
confidentiality of the data submitted. The Commission is 
obliged also to respect the confidentiality of discussions 
within the CVMP, a requirement that limits the degree of 
detail that can be furnished in this report. 
10. In Its examination of this matter the CVMP has been 
assisted by an ad-hoc group of experts on biotechnology. 
It is understood that the assessment process within the 
Committee may be entering its final phase. Expectations 
are for an opinion in or about the end of this year. At 
this stage, therefore, it is only possible to provide an 
interim review of the authorisation process. 
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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 
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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 
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socio-economic and economic factors eg effects on 
agricultural production and structures are not at present 
the subject of in-depth studies. 
Food Product Quality 
14. As regards milk quality, apart from the safety of residues, 
the applicants for authorisation must identify any 
potential difficulties in the subsequent industrial 
processing of foodstuffs. In the course of examination by 
the CVMP, additional Information has been required on the 
effects of the use of BST on protein, fat and vitamin 
content of milk and on the effects for the manufacture of 
cheeses and other dairy products. 
15. An aspect requiring particular attention relates to the 
somatic cell count (SCO which is one of the main tests of 
milk bacteriological quality and Is used as an indication 
of mastitis In animals. Reports from the United States and 
a recent German study (Heeschen 1988), Indicate that BST-
application leads to an increased number of somatic cells 
in the milk and to increased pyruvate levels also. 
Increased SCC levels would have implications as regards 
the standards laid down in Directive 85/397 as regards 
intra Community trade in milk for consumption and the price 
paid to producers for milk for manufacturing. An Increase 
in somatic cells affects the composition of milk eg the 
lactose/salts ratio, a factor that could Influence product 
quality and yield. A research project is currently 
underway (funded by resources from the milk co-
responsibility levy) at the BundesanstaIt fur 
MI Ichforschung at Kiel to examine these aspects; a report 
is expected by the end of 1990. 
16. The standard of farm management Is essential if the likely 
adverse effects of BST on composition are to be mitigated. 
The availability of good quality feeding and the ability of 
the cow to consume it in Increased amounts Is a 
prerequisite to effective application of rBST. Should 
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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 
"4 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 
to treat individual cows, rather than as a routine 
treatment. 
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While, In the initial period at least, the response to BST 
by way of increased milk yield at farm level may be below 
the research levels, It is reasonable to expect a growing 
increase in yield levels as further research and management 
are refined to achieve optimum results. It has to be 
assumed that BST would be made available at a price to 
permit economic use. 
18. The Community's milk quota regime is designed to ensure 
that milk production does not Increase beyond a fixed 
level. Nevertheless, the present tendency for large scale 
dairy farmers to produce in excess of their individual 
quotas creates an ongoing risk of higher milk deliveries. 
BST would add to this risk. Furthermore its use by milk 
producers to avoid production being under quota would 
remove an important "safety valve" from the existing 
system. 
19. The general use of BST would likely lead to reduced dairy 
cow numbers. This would affect the beef sector through an 
increase, in the short-term, In the number of cows taken 
out of milk production and sent for slaughter. In the 
longer-term fewer dairy cows should lead to lower beef 
production. In the normal course le without BST, beef 
production from the dairy herd would tend to fall due to 
the ongoing Increase in milk yield as a result of improved 
feeding and housing techniques and better selection in the 
dairy herd. The use of BST would accelerate this trend; 
some studies suggest that the decline in cow numbers 
would accelerate by some 10 percent. 
20. Reduction In dairy cow numbers raises the question of the 
utilisation of the factors of production, i.e. labour and 
capital, that would be freed at the farm level. Many 
farmers affected by the milk quota are already starting new 
enterprises, especially in beef, sheepmeat and cereals. 
This tendency could grow despite there being few increased 
outlets for further production; beef and cereals are 
subject to the stabiliser mechanisms, while sheepmeat has 
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been the subject of proposals designed to reduce the 
guarantee, 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 Aspects 
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. 
22. 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 expenditure, 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 aspects, milk production 
Is central to incomes of smaller producers ie those with 
less than 10 cows in the Community. While such producers 
represent some 53% of holdings (1.6 million), only 12% of 
dairy cows are kept on their holdings. Producers witn 
larger resources are best placed to take advantage of 
increases in productivity through the use of new 
technologies. Smaller producers, traditionally less 
capable of adapting to change and technical advances 
are slow to benefit, if at all, from such opportunities. 
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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 29). 
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26. Market Aspects 
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 
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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. 
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The industry supports the authorization of BST which, It 
claims, will bring economic benefits for Industrial 
supplier, farmer and consumer. 
Feed Additives 
32. Apart from BST, concern has been expressed In the Council 
of Ministers in relation to the authorisation of growth 
promoters in animal feedIngstuffs (see par 8). This 
concern relates to Owconsumer protection, market imbaianc 
and budgetary costs. The Commission has undertaken to 
present the results of studies in this area with a view to 
discussion In Council. It Is accordingly intended to 
launch shortly a wide-ranging study of the impact of 
growth factors in the production of livestock products. 
This will cover the economic aspects in relation to 
agricultural productivity, research and consumption; 
together with the socio-economic elements. The study is 
expected to be completed by October 1990. Nine growth 
promoters have been authorised as feed additives under 
existing legislation and further applications for 
authorisation are currently being considered; one such 
application relates to a substance considered capable of 
Increasing milk yields by upwards of 5%. No authorisations 
for milk production have been given to date. 
33. CONCLUSIONS 
(a) The use of recombinant BST (rBST) is capable of significant 
Increase in milk yields. It Is likely to be the 
forerunner of other products capable of bringing about a 
substantial Increase in meat production. 
(b) On the assumption of the Community's milk quota regime 
continuing beyond 1992, the use of BST should be reflected 
in a reduction In the number of dairy cows rather than an 
increase In overall milk production; this Is likely to be 
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accompanied by a release of resources of labour and capital 
Into other sectors of agriculture, 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 
consumers, producers, Industry, animal welfare 
organisations 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 nformatIon. 
(d) Apart from the purely scientific aspects, 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 (CVMP), 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. 
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(f) It is clear that a situation in which Member States may 
take divergent decisions on BST must be avoided; to this 
end the Commission will present comprehensive proposals to 
Council by the end of this year. Having regard to the 
position of Parliament and the general public concern on 
these issues, preparation of the proposals will require 
detailed examination of the most appropriate decision 
making arrangements and structures In connection with 
authorisation of all productivity enhancing substances In 
agriculture, whether veterinary medicinal products, 
including products.of biotechnology, or feed additives. 
(g) It Is clear also that sufficient time should be available 
to assess the results of the current studies, under the 
aegis of the CVMP and of the Commission. At the same time 
it Is essential to avoid prolonged uncertainty that would 
be harmful to the Interests of Industry, especially 
biotechnology, which has an important role in the 
Community, not least in the development of agriculture. 
(h) It will be important also to have an exchange of views on 
the issues raised with any interested third countries, as 
it Is certain that the questions raised are of deep concern 
and interest not Just In the Community but also in the 
major producer and consumer countries. 
RecommendatIons 
it Is accordingly proposed that the Council adopt a decision to 
establish an evaluation period up to the end of 1990 on the 
administration of rBST. Th i s period Is considered to be the 
minimum necessary to assess the results of ongoing studies and 
complete the new arrangements to be adopted on procedures. The 
target date for completion of some of the studies will have to be 
brought forward to enable the Commission to fully review all 
aspects in twelve months time. This will provide the opportunity 
also to compIete the necessary contacts with Interested 
*< 
- 18 -
third countries. In keeping with the Community's openness on the 
definitive conclusion on this question, it is not the intention 
to prohibit Imports of BST or of products derived from BST 
treated animals during the evaIuatIon period. This approach is 
not considered to place Community milk producers at a competitive 
disadvantage in practice. 
^ 
Annex I 
Bodies consulted a) THE VETERINARY ADVISORY COMMITTEE 
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 de Liaison des Commerces AgroaIImenta I res 
(C.E.L.C.A.A.). Workers, European Trade Union Confederation 
(E.T.U.C). Consumers, Bureau Européen des Unions de 
Consommateurs (B.E.U.C.), European Community of Consumer 
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 Farmers Coordination, Deutscher 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. 
<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 
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