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By Alfredo Gris, Daniele Pisanello and Massimo Scuccato

As part of a new series in EAS-E-News on services provided through EAS partnerships, Italy-based food technology and consulting firm Almater shares the following insights on regulatory developments in the EU in the area of foods, including so-called novel foods.

The European Union has significantly revised its legal and regulatory framework for novel foods in recent years, as well as its requirements for labeling, presentation and advertising of food.

The EU updated its 1997 regulation on novel foods with the adoption of a new novel food regulation (No 2283/2015) on November 25, 2015. The regulation, a centralized authorization procedure for novel foods at EU level, offered new provisions on nano-ingredients and on “insect-food,” and a simplified authorization procedure for “traditional products” from third countries. It also clarified requirements for food produced from cloned animals.

Under EU law, a “novel food” means any food that was not used for human consumption to a significant degree within the Union before May 15, 1997. Genetically modified foods fall within a different regulatory framework, as do food additives, enzymes, flavorings and extraction solvents. Some food categories may fall within the scope of the novel food regulation, requiring a prior-authorization to access the EU market. These include: food with a new or intentionally modified molecular structure (for instances a patented synthetic polymer); food from microorganisms, fungi or algae (such as extracts obtained from a mycelium cultivated in a submerged fermentation), food from plants or their parts, or from animals or their parts (for instances lipid extract from a specie of krill), food from cell culture or tissue culture (upcoming cultured meat, for example).

The novel food regulation also includes food consisting of engineered nanomaterials, food consisting of, isolated from or produced from material of mineral origin and food resulting from a new production process.

From January 1, 2018, the EU marketing authorization procedure will be centralized at the European Commission, which will evaluate novel food applications taking into account the European Food Safety Authority’s risk assessment and “other legitimate factors.” The current individual licensing authorizations will be replaced by generic permissions.

The novel food regulation allows applicants protection – for a limited time – for new scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the EU list. The regulation also includes a simplified authorization procedure for traditional foods from third countries that have historically proved safe for food use.

The novel food regulation includes a better definition and ad hoc provisions on nano-ingredients. As the term “engineered nanomaterials” is currently defined in Regulation (EU) No 1169/2011, nano-ingredients are considered novel foods under EU law. The Commission is called upon to reformulate this definition to reflect scientific and technological change and internationally agreed definitions. EFSA and EU Member State risk assessors are working to enforce scientific and regulatory framework on nanoscience and nanotechnologies in the food and feed chain. The novel foods regulation provides a clear opening for the use of whole insects and their parts in foods, if they pass an EFSA risk assessment.

Regulation (EU) No 2283/2015 entered into effect on January 11, 2016 and will become fully applicable from January 1, 2018, except for certain provisions.

EU regulatory framework on food information

The EU’s regulation on the provision of food information to consumers (No 1169/2011), which went into effect in December 2014, will be fully applicable from December 2016 for nutrition declarations on prepacked food.

A cornerstone of food labeling in the EU market, this regulation requires new mandatory information on allergens and nutrition. In addition, it includes new requirements for specific products such as nano-ingredients, refined oils/fats of vegetable or animal, de-frozen foods or formed fish/meat etc.

The regulation also broadens the role of the European Commission.

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