EU Food authorisation requirements
Bernd van der Meulen and Anna Szajkowska (2012)
Regulatory Challenges of Innovation in Food and Agriculture Market Authorization Requirements for New Foods
Applied Studies in Agribusiness and Commerce – APSTRACT 2012 p. 137-142
Regulatory authorities face the challenge to strike a fair balance between the interests of consumers to ensure the safety of innovative foods and agricultural products and the interest of innovative businesses. World-wide prior authorization schemes are applied. This contribution explores characteristics, pros and cons of such schemes. It identifies concerns but also best practices that may contribute to improving food safety without unduly hampering innovation.
Bernd van der Meulen, Harry Bremmers, Jo Wijnands and Krijn Poppe (2012)
Structural Precaution: The Application of Premarket Approval Schemes in EU Food Legislation
Food and drug law journal 2012 67(4):453-73
Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities and till then are presumed unsafe. In the EU such authorization is granted after provision of conclusive scientific evidence of the product's safety by the applicant. The objective of this article is to critically evaluate structural precaution in the EU against the general principles of European and international law. Moreover, it addresses the positive and negative side-effects of structural precaution for food businesses. The methods which are applied are legal-systematic and empirical. Legal-systematic research shows that the European system of structural precaution may come into conflict with the principles of free trade. Empirical research on the effects of structural precaution shows that the barriers to market access impede food innovations, negatively impact competitiveness, and induce opportunistic strategic responses by food businesses. Among the opportunistic strategic responses that were identified are window-dressing, trespassing and circumventing. These may have adverse effects on food safety. This is remarkable since food safety is the key driving force behind the application of structural precaution. The article advocates an overhaul of the present European risk prevention framework. It argues that the newly proposed European legal framework for innovative foods only partly addresses the identified problems with which the food industry is confronted. Supplementary to legal-systematic overhaul, authorities should invest in accessibility and transparency of the legal framework and provide compliance assistance to reduce regulatory burdens.
Corinne Sprong, Rick van den Bosch, Sven Iburg, Kathelijne de Moes, Elleander Paans, Sofia Sutherland Borja, Hannah van der Velde, Henk van Kranen, Henk van Loveren, Bernd van der Meulen and Hans Verhagen (2014)
Grey Area Novel Foods: An Investigation into Criteria with Clear Boundaries
European Journal of Nutrition & Food Safety 4(4): p. 342-363, 2014
In the European Union novel foods are defined by the Novel Foods Regulation as food products and food ingredients that have not been consumed to a significant degree in the European Union before May 1997. However, there are new foods for some reason not considered as novel foods, although it may not be excluded that they differ from conventional foods to such an extent that an assessment of their safety prior to their entry to the market would be called for. Previously, we reported that this ‘grey area’ of novel foods exists and comprises: (1) food products or ingredients for which the current Novel Foods Regulation leaves too much space for different interpretations and (2) food products or ingredients that are not novel according to the current Novel Foods Regulation, because it contains gaps. This paper focuses on how to handle these interpretation differences and gaps and provides recommendations to improve these pitfalls of the current Novel Foods Regulation. To this end, we propose criteria with clear boundaries as part of an assessment tool to reduce the uncertainties in interpretation with respect to consumption to a significant degree in the European Union, which take into account the commercial availability, length, extent and frequency of use of the particular food/ingredient. In addition, biological relevant boundaries for the criteria regarding changes in the nutritional value, metabolism (better all aspects of absorption, distribution, metabolism and excretion), and levels of undesirable substances are proposed for significant changes in the composition of foods due to changes in the production process. In addition, criteria are proposed to cover ambiguities and gaps in the Novel Foods Regulation dealing with food products and food ingredients obtained from 1) animals on a new feeding regime, 2) new varieties of organisms, 3) other growth stages of crops. Finally, a criterion that takes into account the total ingredient intake rather than single product intake is added to deal with the risk of overexposure to substances. Taken together, the proposed boundaries and criteria may contribute to diminishing the interpretation issues regarding the Novel Foods Regulation and thus to reducing the extent of the grey area of novel foods.
Bernd van der Meulen (2017)
Concurring opinion
rivista di diritto alimentare Anno XI, numero 3 • Luglio-Settembre 2017 p. 31-33
Shall Article 1(2)(c) of Regulation (EC) No 258/97 be interpreted as meaning that the expression ‘new primary molecular structure’ relates to foods or food ingredients which were not used for human consumption in the territory of the EU before 15 May 1997, or to those whose molecular structure did not exist as such in nature before that date? In case C448/14, the EU Court opts for the first solution, thus including in the scope of the Novel Food Regulation also substances of mineral origin. This short note is critical, and in this regard concurs with the note by Valeria Paganizza - not with the ruling as the abstract by the editors erroneously states.
Bernd van der Meulen en Antonia Corinni (2017)
Naar een circulaire voedselketen. Juridische uitdagingen voor het inzetten van insecten als technologische sluitschakel
Chris Backes et al. Met recht naar een circulaire economie, Publicatie van de Vereniging voor Milieurecht 2017-1 BJu p. 131-147
Deze bijdrage gaat in op de juridische uitdagingen voor het inzetten van insecten als voedingsmiddel. Insecten vormen de grootste dierlijke biomassa op aarde. In veel gevallen voeden zij zich met stoffen die door mensen als afval worden beschouwd, zoals mest, slachtafval en verliezen langs de voedselketen. Door het kweken van insecten die hetzij rechtstreeks, hetzij indirect door gebruik van insectenproteïnen als diervoeder dienen zou enerzijds een belangrijke bijdrage kunnen worden geleverd aan de toekomstige voedselvoorziening en zou anderzijds het circulair gebruik van mest en slachtafval kunnen worden bevorderd. Niet de techniek, maar de juridische obstakels verhinderen een doorbraak in deze ontwikkeling, zo stellen de auteurs. Zij laten zien dat dienaangaande het huidige producten- en stoffenrecht nog niet op deze ontwikkeling(smogelijkheden) is afgestemd en dat bij de toepassing bovendien grote verschillen tussen de EU-lidstaten bestaan en ook rechtsonzekerheid heerst. De auteurs bespreken de mogelijkheden deze problemen op te lossen door deregulering of juist door het ontwerpen van een toegespitst wettelijk kader en dus door verdere, specifiekere regulering.
Bernd van der Meulen and Anna Szajkowska (2012)
Regulatory Challenges of Innovation in Food and Agriculture Market Authorization Requirements for New Foods
Applied Studies in Agribusiness and Commerce – APSTRACT 2012 p. 137-142
Regulatory authorities face the challenge to strike a fair balance between the interests of consumers to ensure the safety of innovative foods and agricultural products and the interest of innovative businesses. World-wide prior authorization schemes are applied. This contribution explores characteristics, pros and cons of such schemes. It identifies concerns but also best practices that may contribute to improving food safety without unduly hampering innovation.
Bernd van der Meulen, Harry Bremmers, Jo Wijnands and Krijn Poppe (2012)
Structural Precaution: The Application of Premarket Approval Schemes in EU Food Legislation
Food and drug law journal 2012 67(4):453-73
Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities and till then are presumed unsafe. In the EU such authorization is granted after provision of conclusive scientific evidence of the product's safety by the applicant. The objective of this article is to critically evaluate structural precaution in the EU against the general principles of European and international law. Moreover, it addresses the positive and negative side-effects of structural precaution for food businesses. The methods which are applied are legal-systematic and empirical. Legal-systematic research shows that the European system of structural precaution may come into conflict with the principles of free trade. Empirical research on the effects of structural precaution shows that the barriers to market access impede food innovations, negatively impact competitiveness, and induce opportunistic strategic responses by food businesses. Among the opportunistic strategic responses that were identified are window-dressing, trespassing and circumventing. These may have adverse effects on food safety. This is remarkable since food safety is the key driving force behind the application of structural precaution. The article advocates an overhaul of the present European risk prevention framework. It argues that the newly proposed European legal framework for innovative foods only partly addresses the identified problems with which the food industry is confronted. Supplementary to legal-systematic overhaul, authorities should invest in accessibility and transparency of the legal framework and provide compliance assistance to reduce regulatory burdens.
Corinne Sprong, Rick van den Bosch, Sven Iburg, Kathelijne de Moes, Elleander Paans, Sofia Sutherland Borja, Hannah van der Velde, Henk van Kranen, Henk van Loveren, Bernd van der Meulen and Hans Verhagen (2014)
Grey Area Novel Foods: An Investigation into Criteria with Clear Boundaries
European Journal of Nutrition & Food Safety 4(4): p. 342-363, 2014
In the European Union novel foods are defined by the Novel Foods Regulation as food products and food ingredients that have not been consumed to a significant degree in the European Union before May 1997. However, there are new foods for some reason not considered as novel foods, although it may not be excluded that they differ from conventional foods to such an extent that an assessment of their safety prior to their entry to the market would be called for. Previously, we reported that this ‘grey area’ of novel foods exists and comprises: (1) food products or ingredients for which the current Novel Foods Regulation leaves too much space for different interpretations and (2) food products or ingredients that are not novel according to the current Novel Foods Regulation, because it contains gaps. This paper focuses on how to handle these interpretation differences and gaps and provides recommendations to improve these pitfalls of the current Novel Foods Regulation. To this end, we propose criteria with clear boundaries as part of an assessment tool to reduce the uncertainties in interpretation with respect to consumption to a significant degree in the European Union, which take into account the commercial availability, length, extent and frequency of use of the particular food/ingredient. In addition, biological relevant boundaries for the criteria regarding changes in the nutritional value, metabolism (better all aspects of absorption, distribution, metabolism and excretion), and levels of undesirable substances are proposed for significant changes in the composition of foods due to changes in the production process. In addition, criteria are proposed to cover ambiguities and gaps in the Novel Foods Regulation dealing with food products and food ingredients obtained from 1) animals on a new feeding regime, 2) new varieties of organisms, 3) other growth stages of crops. Finally, a criterion that takes into account the total ingredient intake rather than single product intake is added to deal with the risk of overexposure to substances. Taken together, the proposed boundaries and criteria may contribute to diminishing the interpretation issues regarding the Novel Foods Regulation and thus to reducing the extent of the grey area of novel foods.
Bernd van der Meulen (2017)
Concurring opinion
rivista di diritto alimentare Anno XI, numero 3 • Luglio-Settembre 2017 p. 31-33
Shall Article 1(2)(c) of Regulation (EC) No 258/97 be interpreted as meaning that the expression ‘new primary molecular structure’ relates to foods or food ingredients which were not used for human consumption in the territory of the EU before 15 May 1997, or to those whose molecular structure did not exist as such in nature before that date? In case C448/14, the EU Court opts for the first solution, thus including in the scope of the Novel Food Regulation also substances of mineral origin. This short note is critical, and in this regard concurs with the note by Valeria Paganizza - not with the ruling as the abstract by the editors erroneously states.
Bernd van der Meulen en Antonia Corinni (2017)
Naar een circulaire voedselketen. Juridische uitdagingen voor het inzetten van insecten als technologische sluitschakel
Chris Backes et al. Met recht naar een circulaire economie, Publicatie van de Vereniging voor Milieurecht 2017-1 BJu p. 131-147
Deze bijdrage gaat in op de juridische uitdagingen voor het inzetten van insecten als voedingsmiddel. Insecten vormen de grootste dierlijke biomassa op aarde. In veel gevallen voeden zij zich met stoffen die door mensen als afval worden beschouwd, zoals mest, slachtafval en verliezen langs de voedselketen. Door het kweken van insecten die hetzij rechtstreeks, hetzij indirect door gebruik van insectenproteïnen als diervoeder dienen zou enerzijds een belangrijke bijdrage kunnen worden geleverd aan de toekomstige voedselvoorziening en zou anderzijds het circulair gebruik van mest en slachtafval kunnen worden bevorderd. Niet de techniek, maar de juridische obstakels verhinderen een doorbraak in deze ontwikkeling, zo stellen de auteurs. Zij laten zien dat dienaangaande het huidige producten- en stoffenrecht nog niet op deze ontwikkeling(smogelijkheden) is afgestemd en dat bij de toepassing bovendien grote verschillen tussen de EU-lidstaten bestaan en ook rechtsonzekerheid heerst. De auteurs bespreken de mogelijkheden deze problemen op te lossen door deregulering of juist door het ontwerpen van een toegespitst wettelijk kader en dus door verdere, specifiekere regulering.