Abstract
Pre-market approval is a high barrier to market entry. Its impact on innovation and competitiveness of food businesses depends to a large extent on the requirements and duration of the authorisation process. The higher the number of unknown variables in the equation, the more reluctant businesses are with their decision to invest in innovation. The European authorisation process for Novel Foods contains a number of elements that make it difficult for companies to form a reliable plan for their route to market. Key issues are the lack of binding time lines for regulatory decisions, of effective protection of the applicant’s proprietary scientific data and of a transparent process for the consideration of so-called “other legitimate factors”. These shortcomings are not addressed by Regulation (EU) No. 2015/2283 (the new Novel Foods Regulation) and can only be eliminated if the European Commission, Member States and the European Food Safety Authority tackle these issues in the implementation of the Regulation.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
See e.g. Gounelle de Pontanel (1973).
- 2.
Protein Advisory Group (1966).
- 3.
Protein Advisory Group (1972).
- 4.
Protein Advisory Group (1974a).
- 5.
Protein Advisory Group (1974b).
- 6.
United Nations (1983).
- 7.
United Nations (1983).
- 8.
House of Commons (1999).
- 9.
COM (85) 310 final of 14 June 1985.
- 10.
COM (92) 295 final of 7 July 1992.
- 11.
European Commission (n.d.-b).
- 12.
European Commission (n.d.-b).
- 13.
European Commission (n.d.-b).
- 14.
European Commission (n.d.-b).
- 15.
USDA (2011).
- 16.
COM(2013) 892 and 893 final.
- 17.
- 18.
- 19.
Food Standards Agency (2013).
- 20.
European Commission (n.d.-a).
- 21.
Piironen et al. (2003).
- 22.
European Food Safety Authority (2005).
- 23.
European Food Safety Authority (2005).
- 24.
European Food Safety Authority (2005).
- 25.
European Food Safety Authority.
- 26.
ACNFP (2007); European Food Safety Authority.
- 27.
Cf. FDA (2002).
- 28.
CJEU, case C-211/03, HLH Warenvertriebs GmbH a.o./Federal Republic of Germany, ECLI:EU:C:2005:370.
- 29.
European Commission (n.d.-b).
- 30.
Coppens (2015).
- 31.
Knirsch et al. (2010), p. 436 f.
- 32.
For an overview on the innovation pipeline in food processing cf. Doona et al. (2010).
- 33.
European Food Safety Authority (2016a).
- 34.
European Food Safety Authority (2016a).
- 35.
European Food Safety Authority (2016a).
- 36.
ACNFP (n.d.).
- 37.
Decision 2001/122/EC.
- 38.
Decision 2001/424/EC.
- 39.
CJEU, case C-189/01, Jippes/Minister van Landbouw, Natuurbeheer en Visserij, ECLI:EU:C:2001:420, para 81; CJEU, joined cases C-133/93, C-300/93 and C-362/93, Crispoltoni and others, ECLI:EU:C:1994:364, para 41; CJEU, case C-331/88, The Queen/Ministry of Agriculture, Fisheries and Food, ex parte FEDESA and others, ECLI:EU:C:1990:391, para 13.
- 40.
CJEU, case C-601/11 P, France/Commission, ECLI:EU:C:2013:465, para 142; CJEU, case C-236/01, Monsanto Agricoltura Italia and others, ECLI:EU:C:2003:431, para 135.
- 41.
CJEU, case C-312/00 P, Commission/Camar and Tico, ECLI:EU:C:2002:736, para 54; GC, case T-291/04, Enviro Tech/Commission, ECLI:EU:T:2011:760, para 124.
- 42.
CJEU, joined cases C-341/06 P and C-342/06 P, Chronopost, ECLI:EU:C:2008:375, para 88.
- 43.
CJEU, joined cases C-341/06 P and C-342/06 P, Chronopost, ECLI:EU:C:2008:375, para 88; CJEU, case C-501/00, Spain/Commission, ECLI:EU:C:2004:438, para 73; CJEU, case C-367/95 P, Commission/Sytraval, ECLI:EU:C:1998:154, para 63.
- 44.
GC, case T-390/08, Bank Melli Iran/Council, ECLI:EU:T:2009:401, para 82.
- 45.
GC, case T-296/12, Health Food Manufacturers’ Association and others/Commission, ECLI:EU:T:2015:375, para 150; GC, case T-539/10, Acino/Commission, ECLI:EU:T:2013:110, para 130; case T-390/08, Bank Melli Iran/Council, ECLI:EU:T:2009:401, para 82.
- 46.
Cf. EGC, case T-539/10, Acino/Commission, ECLI:EU:T:2013:110, para 130.
- 47.
Cf. Szajkowska (2012).
- 48.
European Commission (2013).
- 49.
EGC, case T-296/12, Health Food Manufacturers’ Association and others/Commission, ECLI:EU:T:2015:375, para 106.
- 50.
EU Commission (2015).
- 51.
- 52.
European Commission (2015).
- 53.
- 54.
Nielsen Holdings (2014).
- 55.
Lagnevik et al. (2004).
- 56.
- 57.
- 58.
Winger and Wall (2006).
- 59.
Wendelin (2009).
- 60.
- 61.
Brookes (2007).
- 62.
Brookes (2007).
- 63.
European Parliament (2014).
- 64.
Wijnands et al. (2006).
- 65.
Brookes (2007).
- 66.
European Commission (2012).
- 67.
European Parliament (2015).
- 68.
European Parliament (2014).
- 69.
- 70.
European Commission (2008).
- 71.
CJEU, case 247/87, Star Fruit Co./Commission, ECLI:EU:C:1989:58, para 12.
- 72.
European Parliament (2015).
- 73.
European Food Safety Authority (2016a).
- 74.
Brookes (2007).
- 75.
Brookes (2007).
- 76.
Brookes (2007).
- 77.
Holle (2014).
- 78.
European Parliament (2015).
- 79.
European Parliament (2014).
- 80.
Pilegaard et al. (2007).
- 81.
FPS Health (2013).
- 82.
- 83.
European Parliament (2014).
- 84.
Trollope (2015).
- 85.
European Parliament (2014).
References
Advisory Committee on Novel Foods and Processes (ACNFP) (2007) Annual Report 2007. Food Standards Agency, London
Advisory Committee on Novel Foods and Processes (ACNFP) (n.d.) Guidelines on the use of human studies in the pre-market safety assessment of novel foods. http://acnfp.food.gov.uk/committee/acnfp/acnfppapers/inforelatass/guidetastehuman/guidlinespre-market. Accessed 31 Mar 2018
Broberg M (2009) European Food Safety Regulation and the Developing Countries. Regulatory problems and possibilities. DIIS Working Paper 2009:09. Copenhagen. http://subweb.diis.dk/graphics/Publications/WP2009/WP2009-09_European_Food_Safety_Regulation_web2.pdf. Accessed 31 Jan 2016
Brookes G (2007) Economic impact assessment of the way in which the EU novel foods regulatory approval procedures affect the EU food sector. Briefing paper for the Confederation of the Food and Drink Industries of the European Union (CIAA) & the Platform for Ingredients in Europe (PIE)
Coppens P (2015) Potential impact of 2013 Regulation on Innovation in the Food Sector. In: Proceedings of the Workshop on Novel Foods. Brussels, 7 October 2014. European Parliament. IP/A/ENVI/2014-07. Document PE 518.774
Doona CJ, Kustin K, Feeherry FE (eds) (2010) Case studies in Novel Food processing technologies. Innovations in processing, packaging and predictive modelling. Woodhead Publishing, Oxford
European Commission (2008) 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
European Commission (2012) Administrative Guidance on Submissions for Safety Evaluation of Substances Added for Specific Nutritional Purposes in the Manufacture of Foods. European Commission, Health and Consumers Directorate-General. February 2004. Revised: April 2012
European Commission (2013) Food safety risk analysis. How it is applied in the EU and in the Codex Alimentarius Commission. Presentation at the conference food safety risk analysis – fifty years with codex alimentarius in the European Region. Pulawy, 19–20 September 2013. http://cceuro.pl/index.php/conference-on-food-safety-risk-analysis-fifty-years-with-codex-alimentarius-in-the-european-region.html. Accessed 12 Feb 2016
European Commission (2015) Economics of Industrial research and Innovation. The 2015 EU R&D Scoreboard. http://iri.jrc.ec.europa.eu/scoreboard15.html. Accessed 8 Feb 2016
European Commission (n.d.-a) Human Consumption to a Significant Degree. Information and Guidance Document. http://ec.europa.eu/food/safety/docs/novel-food_guidance_human-consumption_en.pdf. Accessed 22 Feb 2016
European Commission (n.d.-b) EU Guidelines for the presentation of data to demonstrate substantial equivalence between a novel food or food ingredient. http://www.aecosan.msssi.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/evaluacion_riesgos/NOVEL_FOOD_SUBSTANTIAL_EQUIVALENCE_UE_2013.pdf. Accessed 8 Feb 2016
European Food Safety Authority (2005) Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to an application on the use of α-tocopherol-containing oil suspension of lycopene from Blakeslea trispora as a novel food ingredient (Request N° EFSA-Q-2004-169). Adopted on 21 April 2005. EFSA J 212:1–29
European Food Safety Authority (2008) Use of lycopene as a food colour. Scientific opinion of the panel on food additives, flavourings, processing aids and materials in contact with food (Questions No EFSA Q-2007-001, Q-2007-081, Q-2008-076). Adopted on 30 January 2008. EFSA J 674:1–66
European Food Safety Authority (2016a) 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
European Food Safety Authority (2016b) 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
European Parliament (2014) European Parliamentary Research Service. Complementary Impact Assessment reviewing and updating the European Commission’s 2008 Impact Assessment for a Regulation on Novel Foods. Document PE 528.801
European Parliament (2015) Directorate General for Internal Policies. Proceedings of the Workshop on Novel Foods. Brussels, 7 October 2014. IP/A/ENVI/2014-07. Document PE 518.774
Food Standards Agency (2013) Novel foods checklist. http://www.food.gov.uk/sites/default/files/multimedia/pdfs/novel-foods-checklist.pdf. Accessed 1 Feb 2016
FPS Health (2013) Belgian Federal Public Service. Health, Food chain safety and environment. Indicative list of plants/plant parts/substances and their novel food status (non-exhaustive list). Last updated 28 October 2013. http://www.health.belgium.be/eportal/foodsafety/foodstuffs/novelfoods/?fodnlang=en#.VpzytFK4JG0. Accessed 11 Jan 2016
Fu T-J, Singh G, Curtis R (1999) Plant cell and tissue culture for the production of food ingredients. In: Proceedings of the symposium on plant cell and tissue culture for food ingredient production held on April 13–17, 1997 at the American Chemical Society National Meeting in San Francisco, CA, New York
Gounelle de Pontanel H (1973) Proteins from hydrocarbons. In: The proceedings of the 1972 symposium at Aix-en-Provence and relevant guidelines of the UN Protein Advisory Group, London and New York
Hermann M (2009) The impact of the European Novel Food regulation on trade and food innovation based on traditional plant foods from developing countries. Food Policy 34:499–507
Holle M (2014) The protection of proprietary data in Novel Foods. How to make it work. Eur Food Feed Law Rev 5:280–284
House of Commons (1999) Select committee on agriculture minutes of evidence. Memorandum submitted by Professor Janet Bainbridge, Chairman of the Advisory Committee on Novel Foods and Processes (ACNFP) (R29). https://publications.parliament.uk/pa/cm199900/cmselect/cmagric/71/9121413.htm. Accessed 31 Mar 2018
Janssen KL (2011) Driving the food market. Proactive consumer involvement to support radical product innovation. Dissertation, Nijmegen
Knirsch MC, dos Santosa CA, Vicente AAM d OS, Vessoni Pennaa TC (2010) Ohmic heating – a review. Trends Food Sci Technol 21(9):436–441
Lagnevik M, Sjoholm I, Lareke A, Ostberg J (2004) The dynamics of innovation clusters: a study of the food industry. Edward Elgar, Cheltenham
Lanza R, Langer R, Vacanti JP (2013) Principles of tissue engineering, 4th edn. Academic, London
Neville Craddock Associates (2005) The EU Novel Food Regulation. Impact on the potential export of exotic traditional foods to the EU: suggestions for revision. Discussion paper prepared for UNCTAD and CBI. http://www.underutilized-species.org/Documents/PUBLICATIONS/cbi_unctad_paper_on_eu_nfr.pdf. Accessed 31 Jan 2016
Nielsen Holdings NV (2014) Breakthrough innovation report. European edn. http://www.nielsen.com/content/dam/nielsenglobal/eu/nielseninsights/pdfs/Breakthrough_Innovation_Report_EU_FINAL.pdf. Accessed 11 Jan 2016
Piironen V, Toivo J, Puupponen-Pimiä R, Lampi A-M (2003) Plant sterols in vegetables, fruits and berries. J Sci Food Agric 83:330–337. https://doi.org/10.1002/jsfa.1316
Pilegaard K, Eriksen FD, Soerensen M, Gry J (2007) EuroFIR-NETTOX plant list. European Food Information Resource Consortium, Norwich
PricewaterhouseCoopers (2014) 17th Annual Global CEO Survey. Fit for the future. Capitalising on global trends. http://read.pwc.com/i/243985-pwcs-17th-annual-global-ceo-survey. Accessed 12 Jan 2016
Protein Advisory Group of the United Nations System (1966) WHO/FAO/UNICEF PAG Meeting - Geneva, Switzerland, 17–19 Aug 1966. Note on human testing of supplementary food mixtures. New York
Protein Advisory Group of the United Nations System (1972) Production of single-cell protein for human consumption. PAG guideline No. 12. New York
Protein Advisory Group of the United Nations System (1974a) Preclinical testing of novel sources of protein. PAG guideline No. 6. PAG Bulletin (FAO/WHO/UNICEF) IV(3):17–31. New York
Protein Advisory Group of the United Nations System (1974b) Nutritional and safety aspects of protein sources for animal feeding. PAG guideline No. 15. New York
Raisio (1998) Annual Report 1998. http://www.raisio.com/pt/web/raisio-oyj/vuosikertomukset. Accessed 11 Jan 2016
Raisio (1999) Annual Report 1999. http://www.raisio.com/pt/web/raisio-oyj/vuosikertomukset. Accessed 11 Jan 2016
Statista (2013) Year-on-year change in volume of FMCG sales and volume of FMCG sales on promotion in Europe in 2013, by selected countries. http://www.statista.com/statistics/375570/fmcg-sales-volume-change-vs-sales-on-promotion-european-countries/. Accessed 11 Jan 2016
Szajkowska A (2012) Regulating food law. Risk analysis and the precautionary principle as general principles of EU law. Wageningen Academic Publishers, Wageningen
Trollope K (2015) State of play on Novel Foods. In: Proceedings of the Workshop on Novel Foods. Brussels, 7 October 2014. European Parliament. IP/A/ENVI/2014-07. Document PE 518.774
U.S. Food and Drug Administration (FDA) (2002) Agency Additional Correspondence Letter GRAS Notice No. GRN 000117. http://www.fda.gov/Food/IngredientsPackaging Labeling/GRAS/NoticeInventory/ucm352955.htm. Accessed 19 Feb 2016
United Nations (1983) Food and Nutrition Bulletin 5(1), Tokyo. http://archive.unu.edu/unupress/food/8F051e/8F051E00.htm#Contents. Accessed 28 Dec 2015
United States Department of Agricuture (USDA) (2011) Global Agricultural Information Network (GAIN). EU Novel Foods Proposal failed to win Approval. Gain Report E60023. http://gain.fas.usda.gov/Recent%20GAIN%20Publications/EU%20Novel%20Foods%20Proposal%20failed%20to%20win%20Approval_Brussels%20USEU_EU-27_4-15-2011.pdf. Accessed 4 Jan 2016
Wendelin MP (2009) European regulation on Novel Food: grey areas and future perspectives. Vienna
Wijnands JHM, van der Meulen BMJ, Poppe KJ (eds) (2006) Competitiveness of the European Food Industry. An economic and legal assessment. LEI, The Hague. http://bookshop.europa.eu/en/competitiveness-of-the-european-food-industry-pbNB7807110/. Accessed 15 Dec 2015
Winger R, Wall G (2006) Food product innovation A background paper. Agricultural and Food Engineering Working Document 2. Food and Agricultural Organization of the United Nations, Rome
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2018 Springer International Publishing AG, part of Springer Nature
About this chapter
Cite this chapter
Holle, M. (2018). Pre-Market Approval and Its Impact on Food Innovation: The Novel Foods Example. In: Bremmers, H., Purnhagen, K. (eds) Regulating and Managing Food Safety in the EU. Economic Analysis of Law in European Legal Scholarship, vol 6. Springer, Cham. https://doi.org/10.1007/978-3-319-77045-1_14
Download citation
DOI: https://doi.org/10.1007/978-3-319-77045-1_14
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-77043-7
Online ISBN: 978-3-319-77045-1
eBook Packages: Law and CriminologyLaw and Criminology (R0)