Review of EU legislation on dietary food could mean a significant backward step for the treatment and management of Phenylketonuria (PKU)
On March 28th, 2105 the Spring Meeting of the European Society for Phenylketonuria and Allied Disorders took place in Berlin, Germany. 24 delegates from 13 national PKU Associations took part and discussed the latest political developments.
PKU patients have to follow a strict low protein diet supplemented by an amino acid replacement. They have to calculate the intake of Phenylalanine to avoid any health problems related to the disease. Therefore quantitative labelling of Phenylalanine is crucial for their daily life. The tailored low protein food is far more expensive than comparable regular food.
Resulting from a presentation by Norbert Pahne from Diätverband (Germany) the attending delegates were informed that the on-going revision process of European legislation on dietary food may have an impact on reimbursement and labelling of low protein products. Currently low protein foods as required for the PKU diet may be marketed as “foods for particular nutritional purposes sui generis” according to Article 11 of Directive 2009/39/EC – the current so-called framework directive for dietary foods. The concept of dietary foods and Directive 2009/39/EC including its Article 11 is repealed by Regulation 609/2013 which introduces a new legal framework for foods for special consumer groups (FSG) instead. This new Regulation will enter into force in July 2016 and does not foresee any rules for low protein foods as required for the PKU diet. As a consequence the affected products will have to be switched to foods for general consumption and the relevant legislation will apply. In this case the quantitative labelling of Phenylalanine will not be possible from July 2016 onwards. Alternatively low protein products could to be switched to medical food in the sense of the legislation for foods for special medical purposes (FSMP). But the European Commission and the Member States are not supposed to accept low protein convenience foods as part of the FSMP category. This development may also have an implication on reimbursement of low protein food.
Currently there is no clarity. The meeting decided that the ESPKU should contact the European Commission the initiator of the legislation directly. This is of immediate concern for all those suffering from PKU and therefore ESPKU and its members delegates will try to resolve this as soon as practically possible.
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