New Novel Food Regulation enters into force – what does it mean for your business?

January 11, 2018 9:44 am

As of 1 January the new EU Regulation (2015/2283) on novel foods became applicable. This Regulation has the ambitious aim of creating more favourable conditions for businesses to innovate and market new food products across the EU. But what are the practical implications of this law for EU food businesses and will our novel food consumption increase as a result of its provisions?

The term ‘novel food’ refers to food not consumed to any significant degree by humans in the EU prior to 15 May 1997. While the new Regulation does not change this definition, it has expanded on the categories of novel foods to include, among others, insects (a seemingly rising trend in Europe), vitamins, food supplements as well as foods produced with technology such as nanomaterials. Businesses likely to be most affected by this are, for example, those marketing novel food products like chia seeds, those developing ingredients for use in food products like DHA rich oils as well as operators placing insects for human consumption on the market, as their products will now fall under the scope of the Novel Food Regulation. The broadening of the definition will also likely pave the way for wider use of novel food products.

With the expansion of novel food categories subject to the new Regulation and the simplification of the application procedure, it is expected that novel food products and ingredients will become more widely available to consumers in the EU. However, concerns remain, whether it be regarding EFSA’s slow evaluation procedures or the uncertainty businesses face with regard to their intellectual property rights.

The Regulation also puts in place a centralised authorisation procedure for novel foods, taking away this responsibility from Member States. The new system will task the European Food Safety Authority (EFSA) to conduct the scientific risk assessment and the Commission will in turn manage the application files. This change should provide applicants with greater certainty, simplicity and speed during the authorisation process, which will be welcomed by businesses who previously had to wait over three years on average to get approval.

Under the new provisions, the authorisation of novel foods has not only become simpler, but is now also generic as opposed to applicant-specific. This means that once a novel food is approved, it will be authorised for use by every operator on the market, removing the need for businesses to demonstrate substantial equivalence with a previously authorised novel food. A big saving of time and resources.

However, these changes raise the question of whether companies will still be incentivised to invest significant resources – as has been the case until now – in safety investigations for food products, as they may not feel their data is protected. The EU has attempted to address these concerns by including in the new Regulation data protection provisions that will allow a five-year period of intellectual property protection for scientific evidence and data produced in support of applications. It remains to be seen what businesses will actually do in practice and whether the new provisions will incentivise a free riding behaviour.

Many food business operators suspended their novel food activities waiting for the provisions of the Novel Food Regulation to become applicable: 2018 will likely already provide a pretty good picture of whether or not the new law does indeed facilitate the use and consumption of novel foods in the EU.

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