91997E3388

WRITTEN QUESTION E-3388/97 by John Iversen (PSE) to the Commission (23 October 1997)

Subject: Growth promotors

Can the Commission confirm the suspicion that the use of the growth promotor Tylosin in pigfeed can cause pathogenic bacteria in humans to become resistant to the drug Erythromycin?

If so, will it take steps to impose a ban on Tylosin?

Answer given by Mr Fischler on behalf of the Commission (2 December 1997)

Tylosin is an antibiotic growth promoter authorised by Directive 78/974/EEC ((OJ L 330, 25.11.1978. )) for use in feed for piglets and pigs in accordance with Directive 70/524/EEC ((OJ L 270, 14.12.1970. )). One of the preconditions for authorisation under this Directive is the absence of unfavourable effects on human health. Moreover, an additive may be authorised only in as far as, for serious reasons concerning human health, the use of such a substance is not restricted to medical purposes. In order to determine whether these authorisation criteria are satisfied, the file provided by the firm must, in particular, contain studies on cross-resistance to therapeutic antibiotics and studies to determine whether the additive can select resistance factors and whether such factors are transferable.

It should be noted that tylosin is also administered as a medicine to animals.

To date, the Commission has no information proving a causal relationship between the use of tylosin in pig feed and the appearance of resistance to erythromycin in pathogenic bacteria in humans. However, if the Honourable Member is in possession of new scientific data, the Commission would study it with great care and take any legislative measures required.

However, the Honourable Member should know that the Commission is currently examining scientific justification recently submitted by Finland under the Treaty of Accession. Finland is requesting an amendment of Community legislation to ban the use of tylosin and spiramycin as additives, in order to preserve their effectiveness as substances authorised as veterinary medicinal products.