Dispatches from EFSA stakeholder meeting in Brussels
Novel regulation - same old delays? Stakeholders express novel food process concerns
Set to come into force from 1 January 2018, the update sees assessment responsibilities pass from overburdened member state authorities to the centralised European Food Safety Authority (EFSA) in Parma, Italy.
The Commission says the new regulation will cut processing time from the current average of 3.5 years to around 18 months.
Yet EU member states will retain the right to raise ‘reasoned scientific objections’ on traditional foods from outside the EU – and it is as yet unclear how this will be managed.
A stakeholder meeting in Brussels yesterday (11 April) highlighted concerns among member states, industry and EFSA alike that these objections could be routine and time consuming.
Other concerns were the sheer volume of dossiers EFSA would receive and the level of assistance it would offer to applicants.
What is a reasonable objection?
Representing the Commission’s Directorate-General for Health and Food Safety (DG SANTE), Dr Rafeal Perez Berbejal said it would be working with member states to produce guidance on what would constitute a reasoned scientific objection by next summer and conceded this point would be a challenge.
Yet he said the ultimate aim was that member states would not have anything to raise objections about, adding it would be difficult to find fault once EFSA had deemed something safe.
“The starting point is that member states don’t have objections,” he told us.
Yet with 28 member state voices, each with their own food culture to defend, some stakeholders at the Brussels meeting yesterday doubted it would be this straight forward.
Herding 28 cats
Several members of the audience said particular member state authorities would be likely to raise objections regularly.
Dr Patrick O’Mahony, chief food technology specialist for the Food Safety Authority of Ireland (FSAI), told us roughly 80% of novel food dossiers under the current rules received member state objections when the opinions were forwarded to the Commission.
“It depends how the Commission sets up reasoned safety objections. But I fear the same objection policies will prevail into the new regulation.”
The UK and Ireland receive the most novel food applications under the current system, followed by the Netherlands, Belgium, Finland, France, Germany, Italy, Spain, Denmark, Malta and Poland.
Between 1997 and 2014, there were about 170 novel food applications across the EU – that’s seven to 10 applications per year.
So far around 90 novel foods have been authorised for use. Yet the new fee-free system seeks to increase those numbers, particularly from SMEs.
The Commission estimated EFSA will receive 15 novel food applications and 25 third country notifications each year when it takes the reins.
Dr O’Mahony said the centralisation of novel food would be a huge relief for resource-strapped national authorities.
"You will have some reply – it will be the best reply that can be given.”
Yet Dr Mark Tallon, managing director at UK consultancy, Legal Foods, lamented the loss of expertise held by national authorities, which offered ‘admissibility checks’ saving time and confusion.
He asked EFSA panel members if they would be offering the same service.
“Based on our health claim experience, our ability to interact with EFSA is limited,” he said.
Valeriu Curtui, head of EFSA's Dietetic Products, Nutrition and Allergies (NDA) panel, replied: “We will not offer a service of consultation before submission. I know this is very much desired – especially in the case of claims.”
However he said EFSA was contactable, adding member states could offer advice and teleconferences were possible.
“I wouldn’t say there was no way to interact with EFSA. You will have some reply – it will be the best reply that can be given.”
The draft guidance on application is open to public feedback, with a final publication set for June or September depending on the number of comments received.
EFSA will also be holding a webinar on novel foods at the end of the year.
Deadline 21 April! #EFSA seeks your input on draft guidance docs for #NovelFood and traditional food! https://t.co/mkVf5tEK6t
— EFSA (@EFSA_EU) April 12, 2016
