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EFSA publishes novel food guide as centralised system kicks in

EFSA publishes novel food guide as centralised system kicks in

The European Food Safety Authority (EFSA) has published guidance documents on what it will look for in novel food applications under new EU rules.

The Parma-based agency released the final versions of its guidance on novel food and traditional food from outside of the EU, as well as write-ups of the public consultation held for each.

EFSA received 60 comments from 18 interested parties in the public consultation for the traditional novel food guidance held at the beginning of this year and 193 comments from 25 interested parties on the novel food guidance.

The documents follow the adoption of new EU regulation on novel food last year, which will see a centralised procedure come into force in January 2018.

Between 1997 and 2014, there were about 170 novel food applications across the EU. That’s seven to 10 applications per year. Over 90 novel foods have been authorised for use under this member state managed system. 

The European Commission hopes this will increase under the new system and estimates EFSA will receive 15 novel food applications and 25 third country notifications each year when it takes the reins.

It says the new regulation will cut processing time from the current average of 3.5 years to around 18 months.

Under the regulatory revamp, responsibility for novel food applications will largely shift from member states to EFSA.

A novel food is a food or ingredient that has not been consumed to a significant degree in Europe prior to the cut off date of May 1997.

This has included new sources of food like omega-3 krill oil, food discovered through new technologies like nanotechnology or by using new substances like phytosterols and stanols.

The regulation was also updated to include a new concept of traditional food from third countries to make EU market access easier for food long consumed safely outside of the bloc.

This subset of novel food refers to plant, microorganism, fungi, algae and animal (including insect) food sources.

On these third country dossiers both EFSA and member states will assess the evidence in parallel procedures.

There have been various concerns about what evidence will be needed to prove safety of this traditional food, something which has concerned those hoping for simplification of the system. 

Another key concern from both those advocating slim and strict regulation is how much and what kind of evidence will be needed to prove safety of a food consumed traditionally outside of the EU.

One stakeholder asked EFSA for clarification of what was meant by a “significant number of people” consuming the food, yet EFSA said this and other questions related to risk management and were therefore not part of itss remit. 

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