Impact of the Novel Food Regulation on innovative product development in the EU food sector

Dr. Peer RiehleSenior Consultant at analyze & realize GmbH, Berlin, Germany

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Agenda

§ Scope of the Novel Food Regulation (NFR) in the EU – pre- and post-BREXIT

§ Innovative food products affected by the NFR

§ Regulatory route(s) to EU market for Novel Foods

§ Impact of the NFR for Food Business Operators (FBO)

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Scope of the NFR (EU) 2015/2283

§ NFR is applicable to 10 specific categories of Novel Foods in the EU

• Novel Food application to EC is required to gain market authorization in the EU

• Simplified notification procedure applicable for traditional foods from EU third countries

§ Regulatory situation post-BREXIT:

• NFR applies to UK products exported or marketed in the EU

• Additional national regulations may be implemented by UK for food products imported to or marketed in the UK

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Regulatory basics of the NFR

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Definition of Novel Food in the EU

Innovative foods affected by the NFR

Regulation (EU) 2015/2283

‘Novel food’ means any food that was not used for human consumption to a significant degree within the Union

before 15 May 1997,

irrespective of the dates of accession of Member States to the Union, and

that falls under at least one of the following categories:

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Novel Food Categories

§ Food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997.

§ Food consisting of, isolated from or produced from microorganisms, fungi or algae.

§ Food consisting of, isolated from or produced from material of mineral origin.

§ Food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:

• Traditional propagating practices [...]

• Non-traditional propagating practices [...] where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances.

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Novel Food Categories

§ Food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices.

§ Food consisting of, isolated from or produced from culture or tissue culturederived from animals, plants, micro-organisms, fungi or algae.

§ Food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances.

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Novel Food Categories

§ Food consisting of engineered nanomaterials [...].

§ Vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) 1925/2006 or Regulation (EU) 609/2013, where:

• A production process not used for food production within the Union before 15 May 1997 has been applied [...];or

• They contain or consist of engineered nanomaterials [...]

§ Food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements [...].

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Regulatory route(s) to EU market

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Route to EU market for Novel Food

New Food Ingredient

Regular foodstuffRegulation (EU) 178/2002

Food for special groupsRegulation (EU) 609/2013

Novel food authorizationRegulation (EU) 2015/2283

Verification Novel Food statusRegulation (EU) 2015/2283, Article 4

Novel food

No Novel food

Food supplementsDirective 2002/46/EC

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Verification Novel Food status

§ Where Food Business Operators (FBO) are unsure if a new food product falls within the scope of the NFR they shall consult the Member State where they first intend to place the NF

• FBOs shall provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of this Regulation

• Member States and EC will be informed about the decision regarding the NF status

Ref.: https://ec.europa.eu/food/safety/novel_food/consultation-process_en

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Novel Food authorization process (Art. 10)

Applicant

Risk assessment

Adoption by the panel

Publication

European Commission

EFSA

Dossier

Valid application

9 months(+ request for additional information)

1 monthEFSA mandate

European Commission implementing act proposal

7 months

7 months

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Novel Food application (NFR Art. 10)§ Required information for a Novel Food dossier (Article 10):

• Production process • Compositional data • Specifications• Proposed uses and use levels and • Anticipated intake • History of use of the Novel Food and/or its source • Absorption, distribution, metabolism, and excretion (ADME)• Nutritional information• Toxicological information• Allergenicity

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Simplified route to EU market for traditional food from a third country

SECTION IISpecific rules for traditional foods from third countries

Article 14Notification of a traditional food from a third country

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Novel Food notification

Article 3 requires for traditional food from a third country:

§ ‘History of safe food use in a third country’ has been confirmed prior to the notification with:

• Compositional data and

• Experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country

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Novel Food notification§ Novel Food notification applicable only to food produced from

• Plants• Animals• Microorganisms

§ Derived from primary production (Article 3 of Regulation (EC) 178/2002) with a history of safe food use in a third country

§ Article 3 ‘primary production’ means the production, rearing or growing of primary products including

• Harvesting (cultivated and wild products)• Milking• Farmed animal production prior to slaughter • Hunting• Fishing

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Novel Food notification process

Applicant

Reasoned objections

European Commission

EFSA

Notification (Article 14)

Valid notification

4 months

1 month

AuthorizationUpdate of the Union List

Member States

No objections

Application(Article 16)

Ref.: https://www.efsa.europa.eu/sites/default/files/applications/apdeskapplworkflownutritraditional2018.pdf

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Novel Food notification§ Requirements information for a Novel Food notification (Article 14):

• Name and description of the traditional food• Production process• Product composition• Country or countries of origin• Documented data demonstrating the history of safe food use in a third country• Proposal for the conditions of intended use and for specific labelling requirements

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Novel Food notification

§ Data from experience of continued food use in the third country:

• Extent of use • Characteristics of the population group(s) • Role in the diet • Information on the handling and preparation • Precautions for the preparation and restrictions of use • Human data

HISTORY OF SAFE USEfor 25 years (> 1993)

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Impact of the NFR for FBOs

§ Food business operators (FBO) have to verify the food/ Novel Food status of newly developed or imported food products, if a marketing in the EU is intended

§ FBOs should consider time and costs for NF application/ notification• Comprehensive product analyses• Safety studies • Compilation of a novel food dossier• Submission of the application/ notification

§ FBOs should further schedule timeframes needed by the Authorities for • Safety assessment (EFSA)

o EFSA request for additional information– Compilation and submission of required data

• Marketing approval (EC)

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Thank you!

analyze & realize GmbH . Waldseeweg 6 . 13467 Berlin/ Germany

Dr. Peer RiehleSenior Consultant

email: priehle@a-r.comphone: +49 30 4000 8102

website: www.a-r.com