Key elements related to GMOs and novel food, MM Antofie, C Sand, A Brezeanu

Tags: implementation, genetically modified organisms, Cartagena Protocol on Biosafety, GMOs, procedures, risk assessment, European legislation, food ingredients, novel food, Directive, capacity building, European Union, human consumption, genetically modified food, national level, Regulation, substantial equivalence, European Food Safety Authority, legal provisions, system, Commission Regulation, Conclusions Biosafety, management system, legislation development, Calgene Company, safe food, Novel food legislation, European Community, conceptual terms, scientific community, human resources, system performance, communication, communication system, specific performance evaluation, Council Directive, Risk Assessment procedure, NF, hazard identification, World Trade Organization, EU legislation, food component, assessment, food ingredient, technical requirements, Member States, risk management, legislative framework, scientific approach, modified organisms, living modified organisms, Belinda Martinau, international instruments, Cartagena Protocol, authorization procedure, novel foods, development, Monsanto Company
Content: Annals of RSCB
Vol. XV, Issue 1
Summary This paper is analysing the main similarities and differences regarding the scientific approach in the present legal framework for two new domains: biosafety and novel food. Also it proposes recommendations for the coherent implementation at the national level of EU provisions in agreement with the scientific and technical terminology. The SWOT analysis was applied for elaborating this paper in which international treaties, European legislation and recommendations were analyzed. By analyzing the general accepted terminology (scientifically and technically) we noticed that even the domain of genetically modified organisms (GMOs) has been developed later compared to the novel food domain it imposed a specific terminology responsible for changing the use of terms for other domains. Thus, GMOs may be used as food and the novel food in the primary EU legislation adopted in 1997 included GMOs but not for the authorization procedure. Still, a major difference is that in agreement with the international terminology accepted through the Cartagena Protocol on Biosafety to the Convention on Biological Diversity the GMOs may reproduce and multiply by themselves compared to the novel foods which may not express this characteristics. For both type of food the precautionary principle is applied for the placing on the market authorization procedure. Also, in both cases it is discussed the substantial equivalence for the risk assessment procedure. Risk assessment in both cases should be realized according to very strict procedures established at community level and established by the scientific Panel of the European Commission or EFSA. If in the case of GMO the risk assessment is targeting also the environment for the novel foods this procedure is targeting especially the human health. Regarding the implementation capacity at community and national level both domains require scientific competencies at national and European levels. Thus it is easy to notice differences between policies, legislative framework, implementations requirements, enforcement, monitoring and public communication. The most important specific procedures remain risk assessment, risk management and risk communication. A pivotal role in the coherent implementation of the legislation in these domains is occupied by the scientific research as it is not possible the implementation of specific procedures such as risk assessment, risk management and risk communication without such type of research at national level taking into account the continuous development of new food products entering the market. Key words: genetically modified organisms (GMOs), Cartagena Protocol on Biosafety, novel food. [email protected]
Introduction This article is treating the main conceptual differences and similarities Aamong the legislative frameworks regulating genetically modified organisms and novel foods with the aim of underlying certain recommendations for the appropriate and coherent implementation and development at the national level of the EU legislation. Even the biosafety domain is developed later compared to the food legal framework however it imposed the
development of a specific capacity building at the EU level with specific requirements for each Member State. In order to ensure the coherency in the full implementation of these both regulatory systems the Members States are required to develop the research domain and associated scientific expertise for both categories of issues: negotiations in the development of new procedures, policies, strategies and action plans and also for the implementation of the EU legislative framework into the EU context. Due to the
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tremendous development of the today science and especially due to technology development during the last 30 years new regulations and new international instruments are in place to support States and countries in harmonizing their national legislation at regional or even international levels.
Material and Methods Based on published European political statements, strategy and existing legislation at the EU level and also based on the analysis of international instruments adopted documents and applying Albert Humphrey' SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) of the legislation and also Negotiators' terms of references this review was realized.
Results and discussions
Use of terms Extremely important
in the development and implementation of
political commitments and legislation either
at national level either in international
context are definitions and the use of terms.
Thus only based on the same terminology
use it is possible to harmonize the
legislation or common policy no matter of
domain. Starting with the use of terms and
definitions it is compulsory also in this
short analysis of the biosafety framework
compared to the food framework. Words
are essential to be correct understood and
translated in the national legislation and
used accordingly for legal, technical and
scientific purposes as any further
development of the political commitments
depends on the correct use of terms which
further will influence the development of
new legal provisions.
What the GMOs are? Defining the GMOs is
a very difficult task because if the scientific
world may use different definitions
however the authorities have to comply
with the conceptual terms adopted by the
negotiations, such as the Cartagena
Protocol on Biosafety to the Convention on
Biological Diversity (ratified by 156 Parties
from 196 signatory Countries in the beginning of 2010) and the European legislation complying with the international instruments (e.g. the Directive 2001/18/EC). As it is very well known the GMOs as food were placed on the market for the first time in 1994 when Flavr Savr tomato was licensed for production, commercialization and human consumption in the USA (Belinda Martinau, 2001). The Calgene Company's production ceased three years later in 1997 when it was took over by the Monsanto Company, but it is now known in the modern biotechnology history as the first Company succeeding the first license granting for a GMOs. During this period of time hundreds of transformation events were granted science based for being approved for placing on the market in the worldwide. Still, the European Union approved for cultivation two events: MON810 and last year the starch potato (Decision 2010/135/EU) due to a lack of compulsory applying the Risk Assessment procedure for risk assessment developed by the European Food Safety Authority in line with the procedure adopted by the Directive 2001/18/EC. We should underline that both events should also comply to the procedures laid down by the Cartagena Protocol which is a set of measures and procedures regulating the transboundary movement of the living modified organisms between Parties and between Parties and non-Parties. Moreover this Protocol was adopted in response to art 19.3. of the Convention on biological diversity which states that the Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including in particular advance informed agreement in the field of the safe transfer, handling and use of the living modified organisms resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. According to the Cartagena Protocol on Biosafety and the Directive 2001/18/EC art. 2.2. the GMO is an organism, with the exception of human
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beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Novel food (NF) as a concept is defined by the Regulation (EC) 258/1997 such as foods and food ingredients that have not been used for human consumption to a significant degree within the Community before 15 May 1997 (the date of entering into force of the Regulation 258/1997) and which are falling under the following categories: [i] foods and food ingredients with a new or intentionally modified primary molecular structure; [ii] foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae; [iii] foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use; [iv] and foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. We note that in the original form this Regulation was also covering the genetically modified organisms but they were removed when the Directive 2001/18/EC was adopted and entered into force in 2001. For the food commercialized before the entry into force of this Regulation, it is still applied for the EU market the "principle of mutual recognition". According to these definitions the main difference is that when we are taking about GMOs we are talking about food comprising nucleic acids intentionally modified and or their proteins or RNA molecules and also we are talking about living or not living organisms and when we are talking about novel food we are talking about food as chemicals (proteins, lipids, sugars, vitamins, enzymes) which in fact if
they are natural products ­ than they are
produced as a result of primary or
secondary secretion pathways based on a
natural existing genetic information and
traditionally known industrial processes and
also very important ­ novel processes ­
such as industrial processes never used
When into the European procedures we are
dealing with GMOs as living modified
organisms in the context of the Cartagena
Protocol on biosafety, being an issue of
self-maintenance and self-reproduction, the
risk assessment procedure is addressing
also environmental safety and when we are
dealing with novel foods as new chemicals
or new processes, without being able of self
multiplication or maintenance, the risk
assessment procedure is not always
involving the environment risk assessment.
For NFs and GMOs used as a food or food
ingredient the legislation adopted another
concept namely substantial equivalence
which according to the Regulation (EC)
258/1997 that existing organisms used as
foods or as food sources can serve as a
basis for comparison when assessing the
safety of human consumption of a food or
food component that has been modified or is new regarding their composition,
nutritional value, metabolism, intended use
and the level of undesirable substances contained therein. When it is proved that such characteristics are accomplished by NFs and GMOs it is considered that there exists substantial equivalence and the new food or food ingredient are assessed according to the known food or food ingredient. Once the definitions and the use of terms are agreed at the national level the GMOs and NF legislation may be developed and even the negotiation capacity may be improved for international and EU levels. In applying the legislative framework some key principles are implemented such as the precautionary principle. This principle was for the first time mentioned in the Asilomar Conference on Recombinant DNA held in
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February 1975, USA when were discussed
the biohazard and the regulation of
biotechnology. Later on it was adopted as the 15th Principle of the Rio Declaration
which states that "In order to protect the
environment, the precautionary approach
shall be widely applied by States according
to their capabilities. Where there are
threats of serious or irreversible damage,
lack of full scientific certainty shall not be
used as a reason for postponing cost-
effective measures to prevent environmental degradation"
World Health Organization, Food and
Alimentarius, World Trade Organization
with its agreements and the Organization
for Economic Co-operation and
Development are some of the main
international instruments dealing with rules
and procedures both for GMOs and NFs
being harmonized with the current national
and European legislation.
As food and food ingredients are used for
human consummation the specific
legislation covering the NFs and GMOs
provides specific procedures for hazard
identification, risk assessment and risk
management. All these procedures are
scientifically based and should comply with
the technical requirements of the EU
legislation in the case of European
countries. Once a risk or hazard is identified
than it is assessed for its impact and if the
risk assessment shows that the risk is
negligible than the product often may be
granted for the commercial purpose
approval with specific requirements for risk
management and risk communication.
There are also EU legislative provisions for
re-assessing the risk if new information are
issuing regarding the GMOs. Still, the
technical provisions regarding risk
assessment should be further developed
once new scientific evidences are available.
Hazard identification and risk assessment
are closely related procedures and are
highly depending on the scientific
complexity of the subject. GMOs as a
domain is very complex especially when
we are talking about living modified organisms because of the possible scenario for environment impact. For this reason the European procedure entitled environmental risk assessment includes both the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II of D 2001/18/EC. For this specific procedure European Food Safety Authority through the GMO Panel adopted, scientifically based, a guidance document for the use of the Member States entitled Guidance document for the risk assessment of genetically modified plants and derived food and feed by the Scientific Panel on Genetically Modified Organisms (GMO) including draft document updated in 2008. Also for NF European Commission issued a specific guiding document entitled Commission Recommendation 97/618/EC 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. The main similarity for these domains is that both novel food and GMOs are the products of high tech science which for being approved to be placed on the market they should first comply with specific international and European rules and procedures. As these products are produced through high tech science also the Member States should develop their own scientific capacity enough competent to understand and to assess this products through the risk assessment procedures. Thus, in Romania this role is given to the Biosafety Commission for the GMOs under the Ministry of Environment and to the Food Safety Commission for the novel food under the Ministry of Agriculture and National Sanitary Veterinary Authority.
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Still under the GMOs there exist guidelines for GMO risk assessment developed by EFSA they are not compulsory for the Member States to refer to them and for this reason the authorization procedures are highly in delay compared to the situation under the novel food legislation. However for both authorization procedures (NFs and GMOs) risk assessment principles are applying as following: Risk assessment should be carried out in a scientifically sound and transparent manner for toxicity, allergenicity, substantial equivalence; The lack of scientific knowledge should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk; Risk assessment should be carried out on a case-by-case basis; If new information on its effects on human health or the environment becomes available, risk assessment may need to be readdressed; Different approaches according to specific technical requirements which become more complex for GM compared to NFs; Developing new regulation and adopting new procedures is a process usually requiring a high negotiation capacity and involving the scientific community, technical and legal expertise for a specific domain addressing ethical aspects too and also institutional capacity for implementing the political statements or legislation framework. Very important for the European legislation development should be the appropriate capacity for Public Awareness, education, information and participation in the decision making. For implementing the EU legislation framework in the NF and GMO domains the following two main categories of issues should be addressed by the Member States or the accessing countries: - Negotiation capacity for policies, strategies and statements development at the EU and international levels and
- Capacity building (human resources, evaluating the system performance, setting performance indicators, financial) for legislation development, adoption, implementation and enforcement. This includes also monitoring, surveillance, data archiving, reporting and public consultation as a part of public communication. We should mention that for both categories a specific place should be granted to the scientific capacity of closely working with legal and technical experts as part of internal and external communication at the administration level. Also, we should underline that the implementation of any of the legal requirements for the GMOs and for the NFs is essentially involving the scientific community for which a specific communication system should be developed. Today at the European Union (EU) level GMOs are considered by the Council Decision taken during December 2008 as a "subject of public controversy because their advantages for society in general and for agriculture in particular are disputed". And a question mark was raised too: "Could a better analysis of these socio- economic aspects clarify these points in the public's perception?" (Antofie and Sand, 2009). A very interesting and common feature for both domains is that the institutional capacity is rather developed at horizontal level through networking at national and European Community levels different institutions and different levels of expertise (Antofie and Baz, 2006). Also it is important to address in the best possible way the human and financial resources by taking into account the communication needs at national, European and International levels. In the end we should mention the need for implementing a specific Performance Evaluation system based on a specific adaptive management system. In terms of capacity building NFs without GMOs are part of the EU Food framework and the GMOs are part of the Biosafety
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framework. Both of these frameworks
generate corresponding legislative
frameworks such as food framework
legislation and biosafety framework
The Biosafety legislative framework is
more complex and based mainly on the
provisions of the Directive 2001/18/EC on
the deliberate release into the environment
of genetically modified organisms. Based
on this Directive were issued the following
EC legal acts: Regulation (EC) 1829/2003
on genetically modified food and feed,
Regulation (EC) 1830/2003 concerning the
traceability and labelling of genetically
modified organisms and the traceability of
food and feed products produced from
Commission Regulation (EC) 65/2004
establishing a system for the development
and assignment of unique identifiers for
genetically modified organisms and
Commission Regulation (EC) 641/2004 on
detailed rules for the implementation of
Regulation (EC) 1829/2003.
Novel food legislation framework is based
mainly on the Regulation (EC) 258/97
concerning the placing on the market of
novel foods and novel foods ingredients.
Exemptions in the scope of this Regulation
are as following: [i] food additives, falling
within the scope of Council Directive
89/107/EEC concerning food additives
authorized for use in foodstuffs intended for
human consumption; [ii] flavourings for use
in foodstuffs, falling within the scope of
Council Directive 88/388/EEC relating to
flavourings for use in foodstuffs and to
source materials for their production which
is also referring to flavourings [iii]
extraction solvents used in the production
of foodstuffs, falling within the scope of
Council Directive 88/344/EEC on
extraction solvents used in the production
of foodstuffs and food ingredients.
The authorization procedures ­ very
specific ­ and scientific based, are laid
down in the Novel Food Regulation (EC)
258/97 for NFs and both in the Directive
2001/18/EC on deliberate release of GMOs
into the environment and the Regulation (EC) 1829/2003 on genetically modified food and feed. The scientific advice in the authorization procedure is a consultative advice and the procedure should be developed and implemented accordingly at each Member State. Conclusions Biosafety and NFs are new economic domains based on the achievements of science development and are requiring scientific expertises for capacity building both in negotiation and legislation implementation at national and international levels. The hazard identification, risk assessment, risk management and monitoring are procedures applied for both domains and are requiring huge investment in these science domains in order to comply with the EU legislation demands. These procedures are requiring the use of a high expertise in appropriate sciences, training the science resources for complying with the technical requirements for risk assessment and continuously training for further involvement of the scientific expertise in the negotiations for further development of new international instruments or for developing already existing international instruments and legislation. Science may be assessed only by science expertise in the technical frame provided by the legal framework in grounding the best scientific advice in the authorization procedure. As we stated before never a completely new scientific discovery, approved to be commercialized or placed on the market, will receive a satisfactory social acceptance if there are not solved less complicated issues highly depending on politics and society and this is a strong argument for applying in practices the philosophical principles described four centuries ago by Rene Descartes and Francis Bacon which grounded the modern philosophy. We may add here aside modern biotechnology also novel food as products or processes associating new scientific concepts
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regarding the living world which are now implemented through practical experiences at the highest scientific standards. Even we are living in the beginning of the XXI century the general public is not completely ready to cope with the complexity of these domains either from scientific point of view either from technical and political points of views either from all points of view. These new emerging domains such as modern biotechnology, novel food or nanotechnology are practically living the first years of "ripping as philosophical concepts" because the society needs to develop further and needs to understand more in-between science, technical, legal and politics. This sine qua non condition of completely acceptance of new technologies on the market is however the time passing in the favour of applying high level standards in science. References Antofie M.M., Sand C., 2009, Insights into the biotech policy and Europeans tendency, Research Journal of Agricultural Science, Vol. 41 (2), 3-8 Antofie M.M.,, Baz A., 2006, "Draft National Biosafety Framework for Romania" p.pdf Europrint Publishing House, ISBN 97387565-2-9 Martineau, Belinda. 2001. First Fruit: The Creation of the Flavr Savr Tomato and the Birth of Biotech Food McGraw-Hill Publishing House. Cartagena Protocol on Biosafety to the Convention on Biological Diversity EFSA European Commission Food Framework .htm
European Commission Biosafety Framework
Regulation (EC) 1829/2003 http://eur-
Regulation (EC) 1830/2003 http://eur-
Commission Regulation (EC) 65/2004
Commission Regulation (EC) 641/2004:

MM Antofie, C Sand, A Brezeanu

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