WRITTEN QUESTION E-2692/97 by Patricia McKenna (V) to the Commission (1 September 1997)

Subject: Marketing of a test kit containing genetically modified micro-organism for detecting antibiotic residues in milk

In July 1997 the Commission authorized the marketing of a test kit containing a genetically modified micro-organism for detecting antibiotic residues in milk. The test kit is made by the Valio Oy company and will contain a genetically modified streptococcus thermophilus T102.

What scientific studies were undertaken before the Commission decided that authorizing the marketing of this product would not pose a significant risk to human health or the environment? Who undertook those studies? Are they available to the public for scrutiny and/or will they be made available?

On the subject of antibiotics in milk, has the Commission any proposals to reduce their use in the dairy industry? The World Health Organization (WHO) has identified resistance to antibiotics among humans as a major health risk, with possibly major consequences for modern medical treatment. This resistance is thought to be caused by the high level of antibiotics to which humans are routinely exposed in food products.

Answer given by Mrs Bjerregaard on behalf of the Commission (16 October 1997)

On 14 July 1997 the Commission adopted a decision concerning the placing on the market of the T102 test notified by the Finnish company Valio Oy ((OJ L 225, 15.8.1997. )). The test kit will be labelled indicating that it contains a genetically modified organism (Streptococcus thermophilus T102).

The decision was taken following a favourable opinion by qualified majority from the regulatory committee established under Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms ((OJ L 117, 8.5.1990. )). Following the adoption of that decision, consent will be granted by the competent authority of Finland allowing the product to be used for rapid detection of antibiotic residues in milk.

The authorisation procedure under Directive 90/220/EEC foresees that the applicant provides a notification dossier including all the necessary data and information to assess the potential impact on human health and the environment of the release of the genetically modified organism. In the case of the above-mentioned genetically modified T102 test, the notifier submitted such a dossier to the Finnish authority.

The dossier included a considerable number of scientific studies, reports and reviews which are all publicly available and which were mainly drawn up by different scientists of universities or other public institutions. The notifier and the Finnish authority are prepared to provide further details on all the information and data submitted in the framework of the authorisation procedure. However, it should be pointed out that, in accordance with Article 19 of Directive 90/220/EEC, the Commission and the competent authorities must not divulge to third parties any confidential information or data, in particular that covered by intellectual property rights or where disclosure might harm the notifier's competitive position. The notification dossier shows that the milk samples to be tested are not likely to contaminate other foodstuffs. According to the notifier the milk sample contained in the test kit will not re-enter the food chain. The milk from which the sample is drawn will therefore not be affected.

The Commission is well aware of the possible impact on human health from the use of anti-infective drugs in meat and milk farming but is however not aware that the World health organisation (WHO) has concluded, as the Honourable Member suggests, that the resistance problem in humans would be due to antibiotics absorbed through food. It should be noted in this context, that no antibiotic is authorised nowadays as an additive in dairy cows feed. The use of antibiotics in dairy herds can lead to residues in milk at a level exceeding the maximum residue limits authorised. Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products ((OJ L 125, 23.5.1996. )) introduced annual surveillance plans for residues in milk, and in particular antimicrobial substances. Official samples must be taken by each Member State, on farms or on dairies in order to be examined for the presence of residues of antibiotics in milk. According to Article 18 of this Directive, where there is evidence of residues of a level exceeding the maximum limit authorised, the competent authority shall carry out an investigation in the farm of origin or departure, and shall take all necessary measures to safeguard public health, with specific measures in the event of repeated infringements.

The Commission, in collaboration with the industry, has prepared a programme for surveillance of antimicrobial resistance in animals receiving feed additive antimicrobials. Moreover, the Commission is involved in reviewing possible in antimicrobial resistance in humans related to the use of antibiotic drugs in food producing animals. The Commission will actively participate in the next WHO meeting on the medical impact of the use of anti-microbial drugs in food animals, which will be held in Berlin in October 1997. The Biomedicine and health research programme (1994-1998) has financed with up to MECU 3 projects which are directly or indirectly related to the resistance to pharmaceutical products of human pathogens such as mycobacteria, enterohaemorrhagic escherichia coli, salmonella and listeria.