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Regulation No. 2015/2283

In view of these difficulties and obstacles encountered after the promulgation of the NFR for nearly two decades, the EU legislature proposed a revised version of the NFR (Regulation No.

2015/2283, nNFR) on January 1, 2015, and sus­pended Regulations No. 258/97 and No. 1852/2001. Through this revision,

Revisiting Novel Food Regulation 151 the nNFR is expected to improve the conditions under which food enterprises are allowed to efficiently distribute new and innovative foods, provided that the high-quality food safety standard set by the EU agencies is met. Besides, it’s worth noting that, within the nNFR, issues related to the interests of EU citizens are formally juxtaposed with business operations and incorporated into the text of the provisions[553] in response to previous criticism.

As for other significant amendments, they can be summarized as follows:

• Expanded categories: The definition of novel foods includes more differ­ent items of foods that originated from plants, animals, microorganisms, cellular breeding, minerals, and so on and specific food categories such as whole insects, while foods resulting from novel production processes and practices and those resulting from advanced technologies which could not be produced before 1997 may be also classified as novel food.

• Improved efficiency and transparency.

• Another simplified and faster notification system for third-world tradi­tional foods based on historical records of food usage.

• Generalized authorizations: Under the nNFR, all authorizations (new or old) are general. This means that any enterprise is qualified to place a certi­fied novel food on the European market legally, provided that the condi­tions of use, labeling requirements, and authorized specifications are met.

• Simplified procedure for authorization: The procedure is managed by the European Commission and can be applied for online.

• Centralized safety assessment: The European Food & Safety Authority will be responsible for a centralized safety assessment.

• Establishment of a union list of authorized novel food: The Commission of Rule Implementation holds the duty to update this list. Once an item is added to the list, it is legal to commercialize it within the EU market.

• Encouragement to innovation: By granting a five-year individual authori­zation in the protection of confidential data, this aim is expected.

However, even with these endeavors, there are some obstacles yet to be overcome.

IV.

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Source: Ni Kuei-Jung, Lin Ching-Fu (eds.). Food Safety and Technology Governance. Routledge,2022. — 252 p.. 2022

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