EFSA is calling for stakeholder opinions on the two draft documents on applications for novel foods generally and applications for traditional foods from third countries.
The new EU rules on novel foods, which passed into EU law last year, sees EFSA take over responsibility for applications from EU member states.
The European Commission billed the changes as a streamline version of a previously long-winded procedure, slashing in half average processing time from three years to 18 months.
The system also sought to ease access to the EU market for foods and ingredients novel to the EU, but with a history of traditional use in other parts of the world.
Commenting on the guidance released last week Lara Skoblikov, partner at Brussels-based legal firm Food Compliance International, doubted whether this would be the case.
“I think the requirements for the third country applications are too burdensome in some cases, especially for plants which traditionally form part of the regular diet in other continents,” she told NutraIngredients.
More or less
The guidance states qualitative and quantitative compositional testing should be provided on at least five representative batches of the traditional food that have been independently produced.
This should include the main constituents, characterising components, anti-nutritional factors, toxic, addictive, psychotropic or other substances, impurities or by-products, residues and contaminants, as well as stability testing.
Skoblikov said this was excessive.
“If a plant has been taxonomically classified and compositional data has already been documented in literature, it should suffice to simply specify the species and refer to the relevant literature.
“This is how plants are normally assessed for inclusion in national positive plant lists. I do not see any reason why it should be any different for novel foods.”
She said this neglected one of the most important principles of EU food law: that it is the responsibility of the ‘food business operator’ to ensure safety and food law compliance of its products.
“Whether a food is novel or not, food business operators are always to ensure that it is safe, produced in accordance with HACCP [Hazard Analysis and Critical Control Point] principles, complies with the applicable microbiological criteria, maximum contaminant levels, pesticide residue levels, etc.
“When it comes to novel foods, I sometimes think that the responsible authorities have lost sight of this. Their extreme scrutiny towards novel foods is simply not always justified.”
Yet not everybody is calling for less scrutiny.
At the time of drafting, evidence of safety proved something of a sticking point. European consumer lobby group BEUC expressed concern about how this would be defined for traditional foods.
Speaking at a European Parliament workshop back in 2014, BEUC senior food policy officer Camille Perrin said: "The fact that a product has been consumed for many years in a country should not be assumed to mean it is safe."
She said inadequate monitoring may have meant adverse effects were not recorded.
She called for clear guidance and criteria on the type of evidence required to demonstrate a history of safe use in these countries.
Now guidance has been released the organisation said it would be consulting its members before it defined its position.
It declined to give further comment at this stage but added it would be submitting feedback on the drafts by the given deadline of 21st April.
EFSA will also be holding a stakeholder meeting on the two drafts on 11th April in Brussels.
Cheaper for some
Meanwhile Luca Bucchini, managing director of Rome-based food law consultancy firm Hylobates Consulting, said the documents were “a fair attempt” to provide detailed guidance.
“There seems to be a significant emphasis on analytical data, which will require applicant to identify reliable labs with experience, for example, in botanicals. Literature searches are also recognised as important, and applicants will need to be careful to be inclusive of all results, and fully explain any concern which the literature may suggest.”
He said this also applied to analytical data since compounds may be at levels similar to other food supplement ingredients in use in Europe, but for which limited safety information is available.
He said the guidance should make applications cheaper for companies, but added professional advice would still be needed.
“Weak dossiers will still likely fail,” he told us. “Of course, one will have to see what the response to actual dossiers will be because guidance documents issued before actual applications cannot foresee all the questions and challenges applicants will face in reality.”