The EU’s new novel food regulations will provide greater clarity and reduce the administrative burden for food manufacturers, as well as boost the sector’s competitiveness, according to industry experts.
The new legislation, given final approval on 25 November, will allow manufacturers to apply for an EU-wide authorisation rather than making individual applications to the 28 member states. It also updates the legal definition of novel foods, reflecting technological progress and introducing new legal clarity.
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It states novel foods are products or ingredients that have not been consumed to any significant degree in the EU before May 1997, when the first novel food legislation entered into force.
A spokesperson for the UK’s Food Standards Agency (FSA) told just-food: “The new novel food regulation explains novel foods more clearly. For example, one area where clarity is added in the new legislation is to make clear that whole insects are within scope of the regulation.”
In particular, the regulation’s definition of novel foods takes into account developments in the industry: “The definition has been expanded, based on scientific developments since the original regulation was published in 1997. This should make it clearer what is – and is not – in scope,” said Luke Murphy, regulatory manager of the UK-based Leatherhead Food Research.
The new regulation has detailed categories of food that are considered novel. Examples are foods with a new or intentionally modified molecular structure that was not used as, or in, a food within the EU before 15 May 1997; and food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae. The legislation also includes a category for food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices used safely for food production within the EU before the same date. According to European Parliament documents, cloned animals will fall under food from animals obtained by non-traditional breeding practices.
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By GlobalDataBut while this definition has certainly become clearer, “guidance is nevertheless needed, especially for small-and-medium-sized enterprises [SMEs],” said a spokesperson for the Brussels-based industry association FoodDrinkEurope. “For instance, sometimes the word ‘consists of’ is used, while for vitamins and minerals the word ‘contains’ is being used, one would need to look into guidance to know how to interpret this notion.”
The association, however, hailed the regulation as an important push for new food development. “FoodDrinkEurope looks to this regulation to contribute to research and innovation by simplifying and streamlining the current regulatory framework. It will contribute to the functioning of the internal market, and facilitate market access for novel food products by SMEs,” it said in a note sent to just-food.
Barbara Gallani, chief scientist and policy and sustainability director at UK-based industry association Food & Drink Federation was similarly positive. “The main advantages of having this piece of legislation in place are a more predictable outcome of novel food applications and a more streamlined approach thanks to the agreed central authorisation process,” she said, adding: “We will continue to work with the authorities to develop guidance for the correct interpretation of the legislation.”
The new authorisation process could help level the playing field for the EU and foreign novel food producers, such as in the US, according to Mr Murphy. “Some novel foods have taken twice as long to approve under current EU system then current US system. The new regulation should reduce this gap, and make the EU more competitive.”
The time taken to approve a novel food in the EU is expected to fall to about 18 months from three years under the current rules. “Once authorised and added to the EU list, a novel food may be placed on the market by any food business operator. This avoids the re-submission of new applications by other companies for the same novel food,” a document from the EU Council of Ministers published last month read.
Leatherhead’s Murphy noted some foods considered ‘novel’ that could benefit from the regulation are products that may have a history of safe use (for 25 years or more) in a large relatively wealthy non-EU country – but that has not been consumed in the EU. Traditional foods from countries deemed to have safe food health standards could undergo a simplified procedure where the applicant must demonstrate that there is such a history of safe consumption by a significant part of that country’s population.
“This will help businesses seeking to innovate in this way,” added the FSA spokesperson. Businesses looking to supply new meat species to the EU, but which have been consumed for a long-time outside of the EU, are likely to benefit from the simplified authorisation procedure, he said.
The EU’s Council of Ministers approved the proposed regulation on 11 November, following a 28 October vote at the European Parliament. The legislation is awaiting publication in the EU’s Official Journal, although the text is final, and will enter into force 20 days following publication.
