Skip to main content
SpringerLink
Log in

Novel and Traditional Foods: Novel Food Regulation in the EU

  • Living reference work entry
  • First Online:
Regulatory Toxicology

Abstract

The ongoing globalization, together with a continuing development of new technologies, has led to the emergence of novel foods seeking to enter the markets. These include exotic food from distant countries, biotechnologically gained products, edible microorganisms, or components containing new types of molecules or nanosized food components.

Safety regulations have been developed by many countries with the major aim to allow only safe novel food on the market.

In order to clearly exclude any known risks that may be associated with various nutrients and their ingredients or residues, and to avoid unknown risks that may potentially accompany novel technologies, the regulations became increasingly differentiated and complex.

The present contribution briefly introduces regulations in different jurisdictions around the world, and analyzes the new European Novel Food Regulation (EU) 2015/2283 in greater detail.

It elucidates the historic evolution of the European regulation by comparing with the previous Regulation (EC) No 258/97 and presents central new aspects aiming of the new regulation to enhance the efficiency of the authorization process and reduce unnecessary trade barriers, while ensuring food safety. Along with the authorization process, the chapter elaborates the risk assessment process and, amongst others, the requirements concerning the assessment of compositional, toxicological, and allergological safety. Beyond this, the simplified notification procedure for traditional foods from third countries with a safe history of use is presented, including the respective requirements for the safety assessment.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution

Institutional subscriptions

Similar content being viewed by others

References

  • Commission Decision 2008/575/EC (2008) Commission Decision of 27 June 2008 authorising the placing on the market of Baobab dried fruit pulp as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C (2008) 3046). Off J Eur Union L183

    Google Scholar 

  • Commission Decision 2009/827/EC (2009) Commission Decision of 13 October 2009 authorising the placing on the market of Chia seed (Salvia hispanica) as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C (2009) 7645). Off J Eur Union L294

    Google Scholar 

  • Commission Implementing Decision 2013/49/EU (2013) Commission Implementing Decision of 22 January 2013 authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C (2013) 110). Off J Eur Union L21

    Google Scholar 

  • Commission Implementing Regulation (EU) 2017/2468 (2017) Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Off J Eur Union L351

    Google Scholar 

  • Commission Implementing Regulation (EU) 2017/2469 (2017) Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Off J Eur Union L351

    Google Scholar 

  • Commission Implementing Regulation (EU) 2017/2470 (2017) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Off J Eur Union L351

    Google Scholar 

  • Commission Implementing Regulation (EU) 2018/1023 (2018) Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods. Off J Eur Union L187

    Google Scholar 

  • Commission Implementing Regulation (EU) 2018/1991 (1991) Commission Implementing Regulation (EU) 2018/1991 of 13 December 2018 authorising the placing on the market of berries of Lonicera caerulea L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470. Off J Eur Union L320

    Google Scholar 

  • Commission Implementing Regulation (EU) 2018/2016 (2018) Commission Implementing Regulation (EU) 2018/2016 of 18 December 2018 authorising the placing on the market of decorticated grains of Digitaria exilis as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470. Off J Eur Union L323

    Google Scholar 

  • Commission Implementing Regulation (EU) 2018/2017 (2018) Commission Implementing Regulation (EU) 2018/2017 of 18 December 2018 authorising the placing on the market of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470. Off J Eur Union L323

    Google Scholar 

  • Commission Implementing Regulation (EU) 2018/456 (2018) Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Off J Eur Union L77

    Google Scholar 

  • Commission Implementing Regulation (EU) 2020/206 (2020) Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorising the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470. Off J Eur Union L43

    Google Scholar 

  • Commission Recommendation 97/618/EC (1997) Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council. Off J Eur Communities L253

    Google Scholar 

  • Commission Regulation (EC) No 1852/2001 (2001) Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97. Off J Eur Communities L253

    Google Scholar 

  • EC (European Commission) (2008) Commission staff working document – draft report on impact assessment for a Regulation replacing Regulation (EC) No 258/97 on novel foods and novel food ingredients. [COM(2007) 872 final] [SEC(2008) 13]

    Google Scholar 

  • EC (European Commission). Information and guidance document “Human consumption to a significant degree”. https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_leg_guide_humn-consumption.pdf. Accessed 30 Mar 2020

  • EFSA (European Food Safety Authority) (2008) The maintenance of the list of QPS microorganisms intentionally added to food or feed – scientific opinion of the panel on biological hazards. EFSA J 4(12):923

    Article  Google Scholar 

  • EFSA (European Food Safety Authority) (2011a) Use of the EFSA comprehensive European food consumption database in exposure assessment. EFSA J 9(3):2097

    Article  Google Scholar 

  • EFSA (European Food Safety Authority) (2011b) Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database. EFSA J 9(3):1970

    Article  Google Scholar 

  • EFSA (European Food Safety Authority) (2018a) Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283. EFSA Supporting publication 2018 EN-1381

    Google Scholar 

  • EFSA (European Food Safety Authority) (2018b) Technical report on the notification of berries of Lonicera caerulea L. as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283. EFSA Supporting publication 2018:EN-1442

    Google Scholar 

  • EFSA (European Food Safety Authority) (2019a) Technical report on the notification of leaf powder of Moringa stenopetala as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283. EFSA Supporting publication 2019:EN-1672

    Google Scholar 

  • EFSA (European Food Safety Authority) (2019b) Technical report on the notification of powder or juice concentrate of berries of Aristotelia chilensis as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283. EFSA Supporting publication 2019:EN-1685

    Google Scholar 

  • EFSA (European Food Safety Authority) (2020) Technical report on the notification of infusion from coffee leaves (Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner) as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283. EFSA Supporting publication 2020:EN-1783

    Google Scholar 

  • EFSA ANS PANEL (European Food Safety Authority Panel on Food Additives and Nutrient Sources added to Food) (2012) Guidance for submission for food additive evaluations. EFSA J 10(7):2760

    Google Scholar 

  • EFSA FEEDAP Panel (European Food Safety Authority Panel on Additives and Products or Substances used in Animal Feed) (2012) Guidance on the assessment of bacterial susceptibility to antimicrobials of human and veterinary importance. EFSA J 10(6):2740

    Google Scholar 

  • EFSA NDA Panel (European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies) (2016a) Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. EFSA J 14(11):4594

    Google Scholar 

  • EFSA NDA Panel (European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies) (2016b) Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283. EFSA J 14(11):4590

    Google Scholar 

  • EFSA SC (European Food Safety Authority Scientific Committee) (2015) Risk profile related to production and consumption of insects as food and feed. EFSA J 13(10):4257

    Article  Google Scholar 

  • EFSA SC (European Food Safety Authority Scientific Committee) (2018) Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: part 1, human and animal health. EFSA J 16(7):5327

    Google Scholar 

  • FDA (U.S. Food and Drug Administration). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras. Accessed 30 Mar 2020

  • FSANZ (Food Standards Australia New Zealand). https://www.foodstandards.gov.au/industry/novel/Pages/default.aspx. Accessed 30 Mar 2020

  • Government of Canada. https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods.html. Accessed 30 Mar 2020

  • MHLW (Ministry of Health, Labour and Welfare). https://www.mhlw.go.jp/english/topics/foodsafety/. Accessed 30 Mar 2020

  • OECD (Organisation for Economic Co-Operation and Development) (1997) OECD guidelines for the testing of chemicals – bacterial reverse mutation test (OECD TG 471). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2008) OECD guidelines for the testing of chemicals – repeated dose 28-day Oral toxicity study in rodents (OECD TG 407). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2013) OECD guidelines for the testing of chemicals – transgenic rodent somatic and germ cell gene mutation assays (OECD TG 488). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2016a) OECD guidelines for the testing of chemicals – in vitro mammalian cell micronucleus test (OECD TG 487). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2016b) OECD guidelines for the testing of chemicals – mammalian erythrocyte micronucleus test (OECD TG 474). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2016c) OECD guidelines for the testing of chemicals – in vivo mammalian alkaline comet assay (OECD TG 489). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2018a) OECD guidelines for the testing of chemicals – repeated dose 90-day oral toxicity study in rodents (OECD TG 408). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2018b) OECD guidelines for the testing of chemicals – chronic toxicity studies (OECD TG 452). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2018c) OECD guidelines for the testing of chemicals – carcinogenicity studies (OECD TG 451). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2018d) OECD guidelines for the testing of chemicals – combined chronic toxicity/carcinogenicity studies (OECD TG 453). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2018e) OECD guidelines for the testing of chemicals – prenatal developmental toxicity study (OECD TG 414). OECD Publishing, Paris

    Google Scholar 

  • OECD (Organisation for Economic Co-Operation and Development) (2018f) OECD guidelines for the testing of chemicals – extended one-generation reproductive toxicity study (OECD TG 443). OECD Publishing, Paris

    Google Scholar 

  • Regulation (EC) No 1332/2008 (2008) Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97. Off J Eur Union L354

    Google Scholar 

  • Regulation (EC) No 1333/2008 (2008) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Off J Eur Union L354

    Google Scholar 

  • Regulation (EC) No 1334/2008 (2008) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC. Off J Eur Union L354

    Google Scholar 

  • Regulation (EC) No 178/2002 (2002) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Off J Eur Communities L31

    Google Scholar 

  • Regulation (EC) No 1829/2003 (2003) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. Off J Eur Union L268

    Google Scholar 

  • Regulation (EC) No 258/97 (1997) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. Off J Eur Communities L43

    Google Scholar 

  • Regulation (EU) 2015/2283 (2015) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. Off J Eur Union L327

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department “Food Safety”, German Federal Institute for Risk Assessment (BfR), Berlin, Germany

    Julika Lietzow, Claudia Luckert & Bernd Schäfer

Authors
  1. Julika Lietzow
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Claudia Luckert
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Bernd Schäfer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Bernd Schäfer .

Editor information

Editors and Affiliations

  1. Universität München Inst. Pharmakologie und Toxikologie, München, Germany

    Franz-Xaver Reichl

  2. Tübingen, Germany

    Michael Schwenk

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer-Verlag GmbH Germany, part of Springer Nature

About this entry

Check for updates. Verify currency and authenticity via CrossMark

Cite this entry

Lietzow, J., Luckert, C., Schäfer, B. (2020). Novel and Traditional Foods: Novel Food Regulation in the EU. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-36206-4_144-1

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-36206-4_144-1

  • Received:

  • Accepted:

  • Published:

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-36206-4

  • Online ISBN: 978-3-642-36206-4

  • eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences

Publish with us

Policies and ethics

Search

Navigation