European Parliament
2014-2019
Committee on Petitions
30.3.2016
NOTICE TO MEMBERS
Subject:
1.
Petition No 1869/2014 by Gustaf van der Feltz (Dutch) on Listeriosis
infection
Summary of petition
The petitioner, who is a former listeriosis patient, was horrified to hear that sausages
contaminated with listeria bacteria recently (August 2014) killed at least twelve people in
Denmark. He believes that an effective and safe listeria killer is available, namely the
bacteriophage product Listex P100. In the European Union, however, it is claimed that the
approval has been hampered for years, while this European biological product has been
approved and is being used successfully in many countries, including the United States,
Canada, Australia and New Zealand. Since he had recovered from a severe listeria infection,
he had immersed himself into this subject and read numerous documents and studies available
in the public domain. He believes that many listeriosis cases and deaths could have been
prevented if the EU had already approved the use of Listex P100. According to the most
recent EU data, 1642 cases were reported in 2012, of which 198 were deadly.
2.
Admissibility
Declared admissible on 16 June 2015. Information requested from Commission under Rule
216(6).
3.
Commission reply, received on 26 August 2015
Article 3 (2) of Regulation (EC) No 853/20041 provides a legal basis to the Commission to
approve, and therefore authorise, the use of substances other than potable water to remove
surface contamination from products of animal origin. Such approval must be carried out in
the framework of the risk analysis process. Therefore any risk management decision must
1
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying
down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
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take into account the results of a risk assessment made by the European Food Safety
Authority (EFSA) based on the available scientific evidence.
Regarding the bacteriophage product Listex P100, EFSA has already issued in 2012 a
scientific Opinion1 on the evaluation of the safety and efficacy of Listex P100 for the removal
of Listeria monocytogenes surface contamination of raw fish, but the Commission has not
taken any legislative proposal, as EFSA opinion leaves uncertainties concerning the
effectiveness of Listex TM P100 in the fishery products.
In June 2015, the Commission received a new application for the approval of Listex P100 for
reduction of Listeria monocytogenes in ready to eat foods (meat, poultry, fish, seafood and
dairy products), as a preventive measure.
Conclusion
In accordance with Regulation (EC) No 178/20022, the Commission requested EFSA to
evaluate the safety and efficacy of Listex P100 solution intended to be used by food business
operators during processing for the reduction of Listeria monocytogenes in these products,
and to deliver an opinion not later than 6 months after the acceptance of the dossier.
The Commission should wait for EFSA opinion before taking further steps.
4.
Commission reply, received on 30 March 2016
The European Commission can confirm that it received a new application from a Dutch
company at the end of 2015 for the approval of the use of Listex P100 in the reduction of
Listeria monocytogenes in ready-to-eat food. The Commission has requested the European
Food Safety Authority (EFSA) to evaluate the safety and efficacy of this solution and EFSA’s
opinion is scheduled for adoption at the beginning of July 2016. Thereafter, the Commission
will take this into account as part of its risk assessment exercise.
It is worth mentioning that the Commission received a previous application in 2011 from a
Dutch company for the approval of Listex TM P100 to remove Listeria monocytogenes
surface contamination in raw fish. However, to date, this substance has not been approved
by the Commission because of insufficient scientific data to demonstrate the effectiveness of
Listex TM P100 in fishery products which does not allow EFSA to draw definitive
conclusions.
1
http://www.efsa.europa.eu/en/efsajournal/pub/2615.htm
2
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food
safety (OJ L 31, 1.2.2002, p. 1)
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