WRITTEN QUESTION No. 1535/96 by Riccardo GAROSCI to the Commission. Crystalline lactulose and the proposal to lower quality requirements for the European Pharmacopoeia
Date: 1996-06-06
Institutions: European Parliament, GAROSCI
Subjects: directory, medicinal product, milk by-product, pharmaceutical industry, pharmaceutical legislation, pharmaceutical product, pharmacology, product quality, technical specification













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91996E1535

WRITTEN QUESTION No. 1535/96 by Riccardo GAROSCI to the Commission. Crystalline lactulose and the proposal to lower quality requirements for the European Pharmacopoeia  


Official Journal C 322 , 28/10/1996 P. 0083 





WRITTEN QUESTION P-1535/96 by Riccardo Garosci (UPE) to the Commission (6 June 1996)Subject: Crystalline lactulose and the proposal to lower quality requirements for the European PharmacopoeiaIs the Commission aware that some pharmaceutical companies are attempting to lower the quality requirements established for lactulose in the European Pharmacopoeia? The high degree of purity currently required for lactulose ensures that it is tolerated by patients of all ages suffering from disorders such as chronic hepatic encephalopathy, intestinal bacterial infections (where it is used as an adjuvant), syndromes caused by alimentary disorders in newborn babies and children, endogenous hyperproduction of ammonia and intestinal stasis occurring after an operation or prolonged confinement to bed.Lactulose is given inter alia to children, newborn babies and elderly persons suffering from chronic disorders, which explains why stringent quality requirements were originally set for substance, which is currently manufactured to an extremely high degree of purity (98 to 99% pure), with water being used as the sole solvent.Some European pharmaceutical companies are currently campaigning for the European Pharmacopoeia to require a lower degree of purity than that hitherto held to be the optimum level, and for the use of methanol or boron in the production process to be made admissible.Were these changes accepted, not only would lactulose be manufactured to a lower degree of purity, but the impurities it contained would be made up of methanol and boron, both of which are notoriously toxic.Would the Commission agree therefore that it should without delay approach the committees responsible with a view to ensuring that the above changes are rejected?Answer given by Mr Bangemann on behalf of the Commission (21 June 1996)A new European Pharmacopoeia monograph for anhydrous lactulose (crystalline powder) is currently being drafted, on the basis of one previously adopted for lactulose solution. The question therefore refers to a draft monograph submitted for public enquiry in September 1995. The results of the enquiry will be taken into account in the drafting of the final text, which should be adopted by the European Pharmacopoeia Committee in November 1996.The Community accepted the Convention on the European Pharmacopoeia in June 1994 ((Council Decision 94/358/EC of 16 June 1994, OJ L 158, 25.6.1994. )) and the Commission votes on non-technical matters on behalf of the Member States. For technical matters, such as the adoption of a monograph, the national delegations themselves take the vote, but unanimity is required. Therefore, the Commission is not competent in the matter at hand, but it has drawn the attention of the secretariat of the European Pharmacopoeia Commission to the concerns raised in this question.