EU urged to lift uncertainty over authorisation of 'safe and natural' bacteria killer
Bacteriophages could have key role to play in combating lethal infections, says former Belgian Prime Minister.
Listex P100 claims to kill listeria, a potentially deadly infection on ready-to-eat food products of animal origin.
While its Netherlands-based manufacturer says it can prevent up to 74 percent of listeriosis cases, EU authorisation for its use is currently restricted.
The company, Micreos, has now written to all MEPs asking to lend their support to its long-running campaign to get the product authorised.
It says the matter is urgent as the incidence of listeria contamination of ready-to-eat (RTE) food is at an all-time high.
The letter, seen by this website, argues that the European Food Safety Authority has said that Listex P100 is “absolutely safe and effective” and warns MEPs that, “Micreos cannot survive without your support and neither can those exposed to an ever-growing listeria threat.”
The appeal comes amid a recent outbreak of listeria in Europe which, according to Micreos, has affected an estimated 1,000 people.
Micreos says its product contains a Bacteriophage, also known simply as a phage, a type of virus used to treat bacterial infections. Phages only attack bacteria and are harmless to people, animals, and plants.
The company asserts that phages are abundant in the natural world, often found in seawater and soil, are the natural enemy of bacteria, and therefore can help control dangerous pathogens.
“Despite protests from the European Parliament, DG SANTE has cast a cloud of uncertainty over a life-saving product” Micreos letter to MEPs
The letter to MEPs states, “This safe and natural phage specifically kills only listeria bacteria and has no effect on other types of bacteria. Consequently, it cannot be used to cover up a lack of hygiene by food processors.”
It adds, “Nevertheless, the European Commission’s DG SANTE, the directorate responsible for public health, has in the past 12 years not been able to appropriately regulate Listex. This is despite the fact that since 2006 Listex has been approved and safely used as a processing aid in major markets around the world, including the USA, Canada, Australia and Switzerland."
“Despite protests from the European Parliament, DG SANTE has cast a cloud of uncertainty over a life-saving product.”
Since 2006, Micreos has tried to get approval for the use of Listex as a ‘non-decontaminating processing aid’ on animal-derived RTE food.
The letter says, “Against expert advice, DG SANTE determined that this product should be regarded as a ‘decontaminant’ and therefore needed an authorisation under an EU Regulation."
“Even though top phage experts explained that Listex can be used only to prevent the outgrowth of listeria on RTE food and not to decontaminate it, DG SANTE forced Micreos to start an authorisation of Listex as a ‘decontaminant’.”
It says that the authorisation process has now come to a standstill, adding, “Because DG SANTE ‘was too busy’ with other dossiers, its civil servants subsequently decided to simply stop the procedure and then started to actively and inappropriately imply that use of Listex was illegal.”
“According to the Commission itself, phages may have a decisive role to play in combating AMR and several other potentially lethal infections” Mark Eyskens, former Belgian Prime Minister
The letter adds, “To the total astonishment of Micreos and most, if not all, scientific and regulatory experts, after 12 years, the European Commission has not only neglected its role as regulator but has started to harass and discredit Micreos and Listex. The persistence of DG SANTE to not immediately address the case of Listex totally ignores the present risks of loss of (unborn) life and lifelong serious health problems and seems to protect rather its own position than public health.”
The company claims the Commission’s actions fly in the face of its stated aims to support Small and Medium-Sized Enterprises in developing alternatives to antibiotics and tackling the health threat posed by antibiotic resistance.
The issue, it says, also underlines the need for a regulation on the use of phages. Micreos is calling on the European Parliament to “immediately take steps towards the creation of a new phage regulation while considering the use of Listex as a safe and effective non-decontaminating processing aid on RTE animal-derived food.”
Support for the company’s case comes from Mark Eyskens, a former Belgian Prime Minister, who points out that listeria has affected about 1,000 people in the past two months alone, adding, “According to the commission itself, phages may have a decisive role to play in combating AMR and several other potentially lethal infections.”
Some of the allegations are addressed in a letter from the Commission, also seen by this website, that seeks to defend the authorisation process.
It speaks of “opposition” against approval of the product and reads, “there is no authorisation granted for the placing on the market of Listex P100. There is, in the view of the Commission, no scope for Member States to authorise Listex as a processing aid for food of animal origin.”
On Friday, no one from DG SANTE was immediately available for comment.
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