Opinion on the use of bovine somatotropin in the European Union (94/C 393/27)

On 24 February 1994, the Economic and Social Committee, acting under the third paragraph of Article 23 of its Rules of Procedure, decided to draw up an Opinion on the use of bovine somatotropin in the European Union.

The Section for Agriculture and Fisheries which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 2 September 1994. The Rapporteur was Mr Silva.

At its 318th Plenary Session (meeting of 15 September 1994), the Economic and Social Committee adopted the following Opinion by a majority vote in favour and three votes against, with ten abstentions.

1. Bovine somatotropin

1.1. Bovine somatotropin (BST) is a hormone produced by genetic engineering; it is similar to the natural hormone produced by the pituitary gland (hypophysis) located at the base of the cow's brain.

1.2. The principle function of this hormone is to direct the main part of the energy input from feeding to the mammary gland, to the detriment of fat storage.

1.3. It is currently produced using bacteria from animals injected with the BST gene.

1.4. For the purpose in hand, this hormone is only effective in injected form. The digestive enzymes render the hormone inactive when it is ingested with feedingstuffs. The quantity of BST injected corresponds to 4 to 8 times the level of the hormone normally produced by a cow.

2. History

2.1. BST is a veterinary medicinal product and as such falls within the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products; the directive imposes a system of prior authorization to be granted by Member States on the basis of safety, quality and efficiency criteria. However, since this is a biotechnological product, the opinion has to be channelled through the Committee for Veterinary Medicinal Products, as stipulated in Directive 87/22/EEC.

2.2. On the other hand, since this product is not used for therapeutic purposes but is designed to increase 'animal milk yields', any divergence between national authorities could cause difficulties in trade within the Community and distortions in competition.

3. Request for authorization

3.1. Authorization has been sought for placing on the Community market two medicinal products whose principle active agent is somatotropin produced using recombinant DNA.

3.2. According to the initial request submitted by the two American companies who applied for authorization to put BST on the market, BST should be administered by subcutaneous, subscapular injection. In the light of comments made by the Committee for Veterinary Medicinal Products (CVMP) about the local reactions observed in the area of injection (long-lasting, painful swellings), the two bodies subsequently proposed that the injection be administered in the sub-caudal area which, applicants felt could partly reduce the discomfort suffered by the animal. Nevertheless, as pointed out by some members of the CVMP, serious disadvantages persist in terms of hygiene and the possibility of secondary infections, particularly if BST is to be used in farming and not in an optimal, experimental environment.

3.2.1. After analysis of the data provided by the applicant bodies in connection with the authorization requests, both these products were deemed satisfactory by most members of the CVMP which felt that they satisfied the criteria set out in Directives 81/851/EEC and 81/852/EEC.

3.2.2. The CVMP accepted the fact that both applicants had thus proved that the residues from these products did not in principle comprise any health risk for consumers of meat or milk obtained from animals treated with BST. However, doubts remain in the minds of some CVMP members as to a) whether use of BST would not cause animals to suffer disproportionately to the supposed benefit of its use, b) the potentiation for mastitis () and c) the increase in somatic cells (), which could contain some risks for consumers' health.

3.2.3. The CVMP felt that the products were effective, taking account of the purpose in mind and of the fact that, in terms of quality, both products satisfied the criteria laid down by the Community Directives.

3.2.4. The Veterinary Scientific Committee also stressed that it was concerned with the fact that in discussions on the use of biotechnological products such as recombinant BST, little attention was being paid to the product's impact on the well-being of the animals treated with this hormone. Widespread use of a new product of this type should not be authorized before sufficient data from scientific studies have been collected and analyzed.

3.2.4.1. Particular attention should be paid to the possible implications for consumers' health of using BST, particularly relating to the increase in somatic cells in milk and the possibility of higher levels of antibiotic residues because of the potential increase in incidence of clinical and sub-clinical mastitis in cows treated with BST. This concern is moreover shared not only by the CVMP but also the group of Commission advisers on ethical aspects of bio-technology.

3.2.4.2. In an Opinion running along similar lines to that of the CVMP, these advisers drew attention to the need for milk from cows treated with BST - in cases where these cows had been treated for mastitis or other inflammations with antibiotics - not to be used for human consumption, and for the level of somatic cells per millilitre of milk not to be higher than the level found in milk produced normally.

3.2.5. In addition to the above, various animal welfare bodies have expressed reservations regarding the use of a medicinal product which is not used for therapeutic purposes and which causes repeated, chronic suffering for animals.

3.2.6. The CVMP's conclusions are in no way fully shared by specialists in this area in Europe or in the USA, Canada and other countries. More recently, research carried out by eminent virologists from the INRA (Institut National de la Recherche Agronomique - French National Institute for Agricultural Research) seems to indicate that, use of BST could contain the risk of triggering a virus existing in a latent state in a healthy carrier animal. These suspicions have arisen as a result of an experiment carried out by the INRA Department of Animal Pathology in Lyons; this has led the official responsible for the French organization which oversees the placing of veterinary medicinal products on the market, to call for additional experiments to be carried out.

3.2.7. The authorization which the FDA granted in the USA on 15 November 1993 to place this product on the market, followed by a 90-day moratorium imposed by Congress, aggravated the ethical, technical and socio-economic polemic which had always surrounded this growth promoter.

3.2.7.1. Although it is not possible to extrapolate the reactions of the American market and consumers to Europe, it should be pointed out here that the brief time which has elapsed since BST was placed on the American market does not lend credibility to any deductions about the real impact on consumers, the manufacturing industry and agriculture itself in the USA.

3.2.8. As mentioned above, the use of BST is, unlike other veterinary medicinal products, exclusively geared to improving milk productivity. The protection of human and animal health, vegetation and the environment all demand the rigorous application of product evaluation criteria by the Community, prior to placing a medicinal product on the market. However, in the case of BST, this cannot be limited to the usual questions relating to scientific evaluation and to the three key criteria (safety, quality and efficacy) which underlie decisions on the evaluation and authorization of a biotechnological product.

3.2.9. For the Community, protection of public health requires that 'decisions on the authorization of such medicinal products should be based on the objective scientific criteria of the quality, the safety and the efficacy of the medicinal product concerned to the exclusion of economic or other considerations; .... however, Member States should exceptionally be able to prohibit the use on their territory of medicinal products for human use which infringe objectively defined concepts of public order or public morality; moreover a veterinary medicinal product may not be authorized by the Community if its use would contravene the rules and objectives laid down by the Community within the framework of the Common Agricultural Policy' ().

3.2.10. The Community, it is stressed, without introducing additional criteria to the three mentioned above, would be fully justified in taking into account other objectives or giving heed to specific aspects of Community policies which could be affected ().

3.2.11. In a number of resolutions on bio-technology and growth promoters such as BST, the EP also stressed the need for biotechnological goods to be geared less to increasing production and yield and more to improving quality and health.

3.2.12. Since the effects of this product were not fully known initially and, given the potential repercussions on the CAP, the Council banned the administration of BST to dairy cows on Community territory for successive periods. In December 1993 the Council prolonged this ban until 31 December 1994.

4. The impact of legalizing BST

4.1. In addition to continuing ethical and technical questions, the use of BST does, in fact, raise serious questions about the socio-economic repercussions.

4.2. Broadly speaking BST does not fall within the new guidelines of the Common Agricultural Policy, since current CAP prospects do not include encouraging intensified production.

4.2.1. The CAP intends to reestablish agriculture's position as an environmental protector, significantly reducing the use of pollutant inputs, highlighting its role in maintaining rural areas and rewarding agriculture's contribution in line with these objectives.

4.3. If BST were to be placed on the market, then a number of questions would immediately arise:

- In view of i) the risk that the public image of milk, which the consumer views as a natural product, would deteriorate and ii) the consequences of a sharp fall in consumption, would it be worthwhile to use a product which, moreover, would not lead to high profitability levels?

- Could the increase in yield not be obtained by improvements in farming and genetic selection?

- Will the agri-food sector have to shoulder the cost of changes inherent in the inevitable coexistence of one product which is treated and another which is not?

For a better evaluation of the impact of authorizing this product, it would be most useful if the Commission, in addition to the enquiries and sectoral studies it has already carried out, could refer to a study of the overall impact of the use of BST in the sectors concerned.

4.4.

Milk Production and Market

4.4.1. Bovine somatotropin aspires to provide a new management instrument for milk producers. Its supporters' ambition is that it stand alongside other technical elements which have to date marked the progress of milk production, such as artificial insemination, new methods of breeding and feeding, techniques to combat animal disease, genetic selection, etc.

4.4.1.1. The interest in purely economic terms of using this technological innovation is not clearly established for agriculture or a market such as in the EEA, where the dairy farming is of a type which already has extensive technological resources available for increasing productivity.

4.4.2. Using current profitability studies (), including those commissioned in a number of countries by the producers of BST, it is difficult to gauge the real advantages for milk producers of using BST. None of the studies indicate costs in relation to doses of BST per cow.

4.4.3. What is known is that use of BST will make other fixed and variable costs rise, such as those necessitated by the increase in cattle fodder caused by the fact that hormone-treated cows consume more feed.

4.4.3.1. Moreover, use of BST calls for a level of caution and veterinary scrutiny of each animal, similar to what is needed for medical treatment of animals under veterinary care. Such a requirement, imposed for non-therapeutic purposes and not just to a handful of animals but to a whole herd, could not fail to place a burden on the dairy farming economy.

4.4.3.2. In order for the recommendations of a whole series of Community bodies and the requirements of the CVMP to be complied with, a weighty, cumbersome scheme would have to be set up in each Member State to monitor those farms using BST.

4.4.4. In the Opinion of the companies producing the hormone, its use requires a complex management strategy which takes account of a variety of determining factors such as, for example, i) the need for superior quality production with increased veterinary supervision, ii) the fact that not all the cows react in the same way to the stress, or iii) the need to take account of peaks in the lactation periods. These elements are outside the scope of many, if not most of the Community's producers. On the whole, according to some studies, including one report collating the results of 68 studies carried out throughout Europe, the increase in average yields for milk production would only be between 0.3 and 1.2 % per annum ().

4.4.5. Small and medium-sized producers do not at the outset appear to obtain either major productivity increases or, consequently, yield increases.

4.4.5.1. Purely in agricultural economy terms, no significant results will flow from use of this growth promoter. The effects of use of the hormone can be to a large extent replaced by the inevitable adjustments to production structures caused by quota reductions and increases of per capita yield resulting from new production methods and other techniques.

4.4.5.2. In addition to these aspects, there is concern as to the future in the EU of breeds with greater production potential. Specialists fear that use of BST may in the long term lead to a loss of existing genetic potential a) because of increased difficulty in distinguishing those animals with greater potential or b) if animals with higher genetic potential were passed over in favour of animals with lower capacity which were treated with the hormone.

4.4.6. The structural surplus is currently running at 4.5 million tonnes. The sector is still experiencing difficulties. Decisions on farm prices have led to a reduction in quotas (2 % in 1991/1992 and 1 % in the current proposal), aimed at rebalancing the market.

4.4.7. Any reduction in consumption will tend to worsen an already inherently unbalanced situation. Enquiries ordered by the Commission and carried out by independent bodies have indicated that there would be a substantial drop in consumption of up to 20 % if BST were to be used. (The IFO () enquiry refers to a drop in consumption of the order of 17-18 million tonnes).

4.4.8. In that case, quotas would have to fall by the same percentage. On the other hand, the Commission stresses that BST does not in any way help maintain milk deliveries within quota limits. Any instrument which increases the quantity of milk in the system creates pressures for increasing quotas, provides more incentives to fraud, ... and destabilizes the markets.

4.4.9. In addition to the problems inherent to the milk sector, there are problems in the bovine meat sector. Replacing surplus dairy cows with animals earmarked for beef production, as would be the case if BST were used extensively, would jeopardize the market equilibrium.

4.4.10. In environmental terms, the benefits of reducing the quantity of manure and methane as a result of the hormone's action could be positive if, in the meantime, they were not cancelled out by an increase in the number of cattle being bred.

4.4.11. The Commission also points out that other imbalances in the milk and beef-producing sectors would have serious consequences for the budget.

4.4.12. The prospect of authorization of the use of this hormone gives rise to legitimate concerns as to the consequences for those regions where milk production constitutes a key element for balanced economic and social development.

4.4.13. It could increase even further the threats already hanging over rural communities, aggravating the continuous decline in agricultural employment and the constant population drift away from rural areas, which are seriously damaging the socio-economic fabric of these communities throughout the EU.

4.4.14. In conclusion, introduction of this element is quite out of keeping with the productive structure and type of market existing in the EU's agricultural economy. It contributes nothing to the prospect of controlling production strictly as necessary for balancing the markets so as to avoid accumulation of stock and excessive growth of agricultural expenditure.

5. Reactions from consumers and producers

5.1. Under the auspices of the Commission, surveys were carried out among consumers (in four Member States) () among producers in six Member States ().

5.2. The surveys revealed that the reaction to the use of BST would trigger a fall in consumption - estimated at around 20 % in the countries polled.

5.2.1. Of the various studies carried out to assess consumer reaction to the use of this hormone in production, two stand out as being genuinely representative.

5.2.2. The IFO enquiry was carried out in four Member States (Germany, France, Italy and the United Kingdom) over a cross-section representing 71.5 % of the total population of the Community. The other enquiry, CEAS (II), only covered Germany and the United Kingdom.

5.2.3. We can infer the following conclusions about consumer reaction from these two surveys:

- Use of BST in milk production is felt to prejudice the quality of milk and to adulterate its image as a natural product.

- If the product were to be authorized, consumers would find it particularly important for there to be transparency and suitable labelling.

5.2.4. Both surveys revealed a strong and clearly negative reaction among consumers to the use of BST, although each raises different aspects because of the different way in which the surveys were structured; a negative reaction of this type, would trigger a sharp fall in the consumption of milk and milk by-products, if the growth hormone were to be authorized in the Community.

5.2.5. All EU consumer organizations oppose authorization of BST and there would therefore be a negative impact on the public image of the product with repercussions for producers, trade and downstream industries in the whole sector, if it were to be authorized.

5.3. Producers have displayed strong opposition to BST, based on the effects it could trigger on the milk market and in terms of a fall in the consumption of milk and its by-products.

5.4. This real opposition cannot be ignored by Member States, Community bodies or even the agri-foodstuffs sector.

5.5. This sector is aware that it cannot underestimate consumer concerns about food quality and safety. Public opinion is also increasingly sensitive to matters relating to the quality of production conditions and particularly animal welfare.

5.5.1. This has been confirmed by studies carried out in the EU which demonstrate that if the hormone were to be authorized, producers not using BST would have competitive advantages over the others.

5.5.2. This tendency has also been observed in world trade in milk and dairy products. In a highly competitive world market, our main competitors on the world market would not fail to take advantage of any EU authorization of BST - something none of them have done.

5.6. As the FAST II report stressed, quality is the key to winning consumer confidence and a decisive factor in guaranteeing the future of farm production and of the agri-foodstuffs sector.

5.7. Agriculture and industry, including the biotechnology sector itself, are both dependent on this. It is the price to pay to ensure that competitiveness is maintained in the future.

5.8. In the light of what was known at the time, the CVMP considered that Bovine Somatotropin satisfied the criteria required by Community measures, and which were also accepted in the GATT agreements.

5.9. Since it appears that research is not yet complete because new data subsequently emerging contradict a number of previous conclusions, it is vital for this specific subject to be reviewed at international level.

5.10. The fact that a limited number of countries with production deficits have authorized use of the hormone should not mean that, at international level, health regulations be relaxed.

5.11. The EU should refuse any downward alignment in statutory health, plant health and hygiene regulations on international food production and marketing.

6. Technological innovation

6.1. Technological innovation is now also assuming a key role in agriculture where biotechnology and its applications look particularly promising.

6.2. European agriculture and current developments in the CAP provide fertile ground for developing an industrial sector linked to biotechnology.

6.3. In overall terms, this sector requires an environment which is conducive to its development, while remaining subject to existing rules and measures applying to industrial activities.

6.4. Farming and the agri-foodstuffs sector themselves have much to gain from biotechnological progress and applications of biotechnology, some of which are revolutionizing this sector.

6.5. In matters of foodstuffs, it seems in the interests of both farming and the agrifoodstuffs sector that they adopt the same approach for integrated development.

7. Conclusions and recommendations

7.1. Authorization of BST has given rise to a number of legitimate technical and ethical queries which are raised alongside questions about the need for having recourse to a hormone for increasing milk production when there is already a surplus of natural production, which is weighing heavily on the Community budget ().

7.2. In all truth, having assessed all the pros and cons, it can be said that if BST were to be used, it would not constitute a positive input for either the primary or secondary sectors. Likewise it does not constitute a significant revolution in milk production methods since growth in milk production can be successfully obtained by other means, inter alia animal selection, without any major drawbacks for animal welfare or health.

7.3. Use of BST as a growth promoter and production improver has only been authorized by a limited number of countries ().

7.4. Authorization of BST and its administration to dairy cattle in the Community could, if we heed the confirmed scepticism and concerns of Community consumers, bring about a significant change in European consumer habits, aggravating existing market and structural imbalances in the milk, dairy products and bovine meat sector.

7.5. BST authorization might even have a marked negative impact on the competitiveness of the European industry and serious repercussions on the export side, since no major milk or dairy consumer or producer/exporter on the world market, with the current exception of the USA, has authorized use of BST.

7.6. Authorization of BST does not fit in with the new philosophy and new direction of the Common Agricultural Policy which the ESC has also debated and on which it has issued a number of Opinions ().

7.7. As a result of its impact on production structures, BST authorization could aggravate the rural exodus () and the trend towards urban concentration and, furthermore, could contribute to the deteriorating unemployment situation in the Community.

7.8. Under these circumstances, the ESC recommends that the European Union lend more support to research being carried out in various Member States into a) the effects of the hormone on human and animal health and b) identifying a method for detecting BST. The European Union has an irreplaceable role to play here.

7.9. This could open the way for a solution allowing Community consumers a genuine choice in matters of labelling which is, moreover, in accordance with European cultural tradition and with Community legislation on labelling. This could be a first step towards an international agreement on BST.

7.10. Thus, in view of the sector's current situation, measures adopted under the CAP, the EU's international commitments and the need to develop current research on this hormone, the Committee recommends maintaining the ban on the marketing of BST and its administration to dairy cows in the Community.

7.11. This ban should be extended at least until the period of application of the milk quota system has come to an end as proposed by the Commission.

7.12. Taking account of the agreements flowing from the GATT negotiations, measures should be taken as regards the labelling of products imported from countries which have adopted use of the hormone for milk production.

Done at Brussels, 15 September 1994.

The President

of the Economic and Social Committee

Susanne TIEMANN

() Opinions of the CVMP on Somatech and Optiflex 640.

() COM(90) 283 final.

() COM(90) 283 final.

() SEC(91) 629 final.

() Commissioned by a number of countries producing BST.

() The socio-economic effects of BST, Wye College, University of London.

() Institut für Wirtschaftsforschung - Institute for Economic Research - Munich.

() Germany, France, Italy, UK - 70 % of the Community population.

() UK, Germany, France, Netherlands, Denmark, Ireland - 52 % of producers, 80 % of milk production.

() Milk and dairy product surpluses in 1993 cost ECU 5,297 thousand million.

() BST has been authorized for production and/or scientific purposes in Russia, Ukraine, Bulgaria, the Czech Republic, the Slovac Republic, Romania, South Africa, Zimbabwe, Jamaica, Mexico, Brazil, Pakistan and the USA; for scientific purposes it has been authorized by Algeria and the Honduras.

() ESC Opinions: 'Reform of the Common Agricultural Policy' - OJ No C 40, 17. 2. 1992; 'Young farmers and the problem of succession in agriculture'.

() ESC Opinion: the Future of Rural Society - OJ No C 298, 27. 11. 1989.