Por: Carlos A. FERREYROS SOTO
Doctor en Derecho
Université de Montpellier I Francia.
M. Sc. Institut Agronomique Méditerranéen
cferreyros@hotmail.com
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Acerca de esta iniciativa: La Oficina Comunitaria de Variedades Vegetales propone establecer un nuevo marco jurídico para los vegetales, abriendo esta Hoja de Ruta para comentarios.
https://europa.eu/european-union/about-eu/agencies/cpvo_es
Esta iniciativa propondrá un marco jurídico para los vegetales obtenidos mediante mutagénesis dirigida y cisgénesis, y sus piensos y productos alimenticios. Se basa en los resultados de un estudio de la Comisión sobre nuevas técnicas genómicas.
El objetivo es mantener un elevado nivel de protección de la salud de las personas, los animales y el medio ambiente, permitir la innovación en el sistema agroalimentario y contribuir a los objetivos del Pacto Verde Europeo y de la Estrategia «De la Granja a la Mesa».
Hojas de ruta
La Comisión quiere saber lo que piensa
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INCEPTION IMPACT ASSESSMENT |
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Inception Impact
Assessments aim to inform citizens and stakeholders about the Commission's
plans in order to allow them to
provide feedback on the intended initiative and to participate effectively in
future consultation activities. Citizens and
stakeholders are in particular invited
to provide views
on the Commission's understanding of the problem and possible solutions and to make available any relevant information that they may have, including on possible impacts
of the different options. |
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TITLE OF THE
INITIATIVE |
Legislation for plants produced by certain new genomic techniques |
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LEAD DG
(RESPONSIBLE UNIT) |
DG SANTE (Unit E3 – Biotechnology) |
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LIKELY TYPE OF INITIATIVE |
Legislative proposal |
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INDICATIVE PLANNING |
Q2 2023 |
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ADDITIONAL
INFORMATION |
https://ec.europa.eu/food/plant/gmo/modern_biotech_en https://ec.europa.eu/food/plant/gmo/modern_biotech/new-genomic-techniques_en |
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The Inception Impact Assessment is
provided for information purposes only. It does not prejudge the final
decision of the Commission on
whether this initiative will be pursued or on its final content. All elements
of the initiative described by the
Inception impact assessment, including its timing, are subject to change. |
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A. Context,
Problem definition and Subsidiarity Check |
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Context |
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In the last decades, advances in biotechnology have led to the
development of new genomic techniques (NGTs). These are techniques capable of altering the genetic material of an organism
that have emerged
or have been developed
since 2001, when the current legislation on
genetically modified organisms (GMOs) was adopted. The Court of Justice of the EU in 2018
clarified that
organisms produced by targeted mutagenesis1 are GMOs, therefore subject
to the requirements of the EU GMO legislation. Based on the reasoning followed by the Court, the
GMO legislation also applies to organisms produced by other NGTs, including cisgenesis1. In November 2019,
the Council requested2 the Commission to prepare a study on the status
of NGTs under
EU law. The study, published in April 2021,
has confirmed that
NGTs have developed rapidly in many parts of the world and are
expected to continue to do so on a global scale.
There is significant interest both in the EU and globally
for plant applications of NGTs. Some of their applications are already on the market outside the EU and this
trend is likely to continue, across different sectors and countries. The study has also concluded
that plants obtained from NGTs have the potential to contribute to the
objectives of the European Green Deal and in particular
to the Farm to Fork and Biodiversity Strategies and the United Nations’ Sustainable Development Goals (SDGs) for a more resilient and
sustainable agri-food system. Examples of potential benefits
include plants more resistant to pests, diseases and environmental conditions
or to the effects of climate
change (e.g. droughts), or requiring less
natural resources and fertilisers. NGTs could also improve the nutrient
content of plants for healthier diets, or reduce content of harmful
substances such as toxins and allergens. At the same
time, the study
reported concerns linked
to the use of these
technologies, e.g. on their potential safety and environmental impacts, including on biodiversity, the
coexistence with organic and GM-free agriculture as well as concerns on labelling and
consumers’ right to information and freedom of choice. Among NGTs, targeted mutagenesis and cisgenesis can be used to produce alterations of the
genetic material that can also be obtained by natural mutations or conventional breeding techniques. The European Food Safety Authority (EFSA) concluded that plants
obtained by targeted mutagenesis and cisgenesis can have the same risk profile
as plants produced with conventional breeding. EFSA has not yet assessed the
safety of targeted mutagenesis and cisgenesis in microorganisms
or animals, nor the safety of other techniques. The Council also
requested1 the Commission to submit, if appropriate in view of the outcomes of the study,
a proposal accompanied by an
impact assessment, or otherwise to inform the Council of other measures required. Based on the outcome of the study,
the Commission will prepare
a policy initiative on plants obtained by |
1 In targeted mutagenesis, mutation(s) are induced in selected target locations of the genome without insertion of genetic material. In cisgenesis, genetic material (e.g. a gene) is inserted into a recipient organism from a donor organism with which the recipient is sexually compatible (crossable) in nature, e.g. a gene from a wild potato indo a domesticated potato.
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targeted mutagenesis and
cisgenesis, accompanied by an impact assessment. It will also cover food and feed
derived from such plants (hereinafter, references to
plants obtained by targeted mutagenesis and cisgenesis will refer as well to their food and feed products). Such an action
follows from the study conclusions and is particularly timely in view of the potential contribution
of plants obtained by targeted mutagenesis
and cisgenesis to the sustainable agri-food system objectives of the European
Green Deal and its related
strategies, as mentioned
above. The initiative shall maintain the objectives of the current
legislation as regards a high level of protection of human and animal health and
the environment. Animals and microorganisms, and
other NGTs, are outside the scope of this initiative; in these areas, the Commission
intends to continue to build up the required scientific knowledge at this
stage. Considerations related to the use of NGTs in medicinal products will be addressed in the context
of the Commission’s Pharmaceutical Strategy. |
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Problem
the initiative aims to tackle |
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NGTs are regulated under the GMO legislation. The Commission study, however, has indicated that the current
legislation is no longer fit for purpose and is in need of adaptation
to scientific and technological progress for
some NGTs and their products. This confirms the conclusions of the 2010-2011 evaluations of the GMO legislation as regards NGTs,
which showed that ensuring the relevance of the existing legislation is likely
to be an ongoing challenge. This is mainly due to: ·
Legal uncertainties in Directive 2001/18/EC (and other legislation based on it) that have been intensified by developments in biotechnology. Certain terms and notions in the legislation, relevant to but
not concerning only plants obtained by targeted mutagenesis and cisgenesis, are unclear or undefined (e.g.
“mutagenesis”, “conventional
use in a number of applications”, “long safety record”). ·
These techniques can be used to produce alterations of the genetic
material that can also be obtained by natural
mutations and conventional breeding techniques, or can be used to produce
alterations that are more complex.
Current regulatory oversight and requirements, however, are not adapted to the resulting diverse risk profiles, and in some
cases can be disproportionate or inadequate. EFSA
has concluded that
plants produced by targeted mutagenesis and cisgenesis generally pose lower risks
than plants obtained with conventional
genetic modification techniques (transgenesis)3. However, they are subject to
the same requirements. In addition, EFSA
also concluded that, in some cases, plants produced by targeted mutagenesis
and cisgenesis do not pose new
hazards compared to plants produced with classical mutagenesis or conventional breeding techniques. ·
The GMO legislation includes
authorisation, traceability and labelling requirements that, for certain plants obtained
by targeted mutagenesis or cisgenesis, raise implementation and enforcement
challenges, as it will be difficult or impossible to
differentiate them from plants from conventional breeding. In such cases, applicants might
not be able to provide
a specific detection method required for a marketing authorisation under
the GMO legislation. The above issues impact applicants, agri-food system
operators and enforcement authorities, and may also negatively
affect innovation and trade. ·
The current legislative
framework does not take into account whether products have the potential to contribute to societal challenges, notably sustainability. It therefore lacks
mechanisms to incentivise the development and placing on the market
of products that contribute to the sustainability objectives of the European Green Deal
and Farm to Fork and Biodiversity strategies, provided they are safe. The main driver
behind these problems is that the current framework is based on defined techniques/methods of biotechnology
as understood in the late 1990s. This leads to difficulties to keep up with
the rapidly evolving field of NGTs, where new
techniques/methods are rapidly
discovered and applied, and where the procedures currently embedded in the legislation make it difficult to adapt to the
specificities of the products or to scientific advances. In addition,
the current authorisation procedure was not designed to promote
sustainability in the agri-food sector. The issue is of EU magnitude; these
problems could negatively affect numerous operators across the agri-food system, including in agricultural biotechnology innovation and research, non-food/feed bio-based and biotechnology
industries, operators in EU trade partners, organic and GM-free operators, EU
and national authorities (e.g. Member States competent authorities and
evaluation bodies, especially those responsible for enforcement/detection
controls, EFSA), and EU citizens and consumer organisations. The issues are
of interest to a broad spectrum of stakeholders,
including NGOs active in the environmental protection, agri-food system, biotechnology and consumer protection areas. Over time, and in case of no action, the problems identified
above will persist and even exacerbate, as
described in the baseline
scenario under section B. |
3 https://www.efsa.europa.eu/en/efsajournal/pub/2561, https://www.efsa.europa.eu/en/efsajournal/pub/2943, https://www.efsa.europa.eu/en/efsajournal/pub/6299.
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Basis
for EU intervention (legal basis and subsidiarity check) |
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The legal basis of this initiative would be Articles 43, 114
and 168(4)(b) TFEU. Organisms produced by NGTs are already regulated
as GMOs by a harmonised EU-level framework based on Articles 114 TFEU
(Directive 2001/18, Regulations 1829/2003 and 1830/2003) as well as Articles 43 and 168(4)(b) TFEU (Regulation 1829/2003). Any action in this area
should continue to be at EU level
to ensure the smooth functioning of the internal market of plants obtained by targeted mutagenesis or
cisgenesis, and a high level of protection of health, environment and consumers, in accordance with
Article 114 TFEU.
Action at EU level would
also prevent fragmentation of the internal
market in case Member States
decided to take their own initiatives. The
action is also
linked to the achievement
of the objectives of EU-level strategies (notably the European Green Deal and
the Farm to Fork and Biodiversity Strategies). |
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B. Objectives and Policy options |
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The envisaged policy action on plants obtained from targeted
mutagenesis and cisgenesis will aim at an appropriate regulatory oversight for
the concerned plant
products, ensuring a high level
of protection of human and animal health and the environment, and
enabling innovation and the contribution of safe
NGTs to the objectives of the European Green Deal and
the Farm to Fork Strategy. In particular, the objectives of this initiative are to: ·
Maintain a high level of protection of human and animal health
and of the environment; more specifically, to ensure the placing on the market of plants
produced by targeted mutagenesis or cisgenesis provided they are safe for health and for the environment. ·
Enable safe plants to provide
benefits and contribute to the innovation and sustainability objectives of the European
Green Deal and of the Farm to Fork and Biodiversity strategies; more
specifically, to ensure that the legislation takes into account whether the
plants and their products contribute to sustainability, ensuring coherence with the ongoing work on a proposal establishing a
framework for a Union sustainable food system. ·
Enhance the competitiveness of
the EU agri-food sector, and possibly beyond, and ensure a level-playing field for its operators; more specifically, to promote a future-proof legislation that is able to keep up with scientific developments, and which is proportionate
to the risk involved. ·
Ensure the effective
functioning of the internal market; more specifically, to ensure that the
legislation provides legal clarity and certainty, is enforceable and uniformly applied
and sets out proportionate requirements and efficient and
transparent procedures. In the baseline scenario (status quo is maintained), plants obtained by targeted mutagenesis and cisgenesis will continue
to be regulated under the current GMO framework, maintaining the current risk
assessment, traceability and labelling requirements and not including a sustainability analysis. Based on the findings of the study,
the cultivation and
market uptake of these products is expected to be limited in the EU.
In some cases,
applicants might not be able
to meet the traceability requirements as they stand today. Research,
development and commercialisation of these products are likely to increase in most major
EU trade partners that have a more enabling regulatory oversight; some of
them already regulate them differently than GMOs, or do not regulate them at all, while others
are now in the process
of changing their legislation. With the existing difficulties in detection, the above developments are expected to further jeopardise the enforcement of the legislation, and potentially negatively impact trade and the competitiveness of EU researchers, agri-food system business operators and SMEs. Obstacles would remain for
innovative plant biotechnology to contribute to the objectives of the European Green Deal and Farm to Fork Strategy, e.g. for a sustainable food system. Different interpretations of the GMO legislation at national level
may further affect
the correct functioning of the EU single market
in the products concerned. Different policy elements will be considered in the subsequent
development of the policy options, including: ·
Risk assessment and approval requirements proportionate to the risk involved, e.g.
in terms of data and studies,
in line with risk profiles and on a case-by-case basis, taking into account
elements such as the specific technique
used, the type of modification or the novelty
of the trait. In this context, mechanisms to enable the applicant
to identify the regulatory requirements applying to a specific product may be
considered. Meeting the safety requirements would remain a
prerequisite for the deliberate release or placing on the market. ·
A sustainability analysis to examine whether, and in which
way, these products contribute to sustainability, taking into account
the criteria developed under the policy
action on a sustainable food systems framework. Specific regulatory mechanisms may be considered to introduce sustainability-related
requirements or incentives. ·
Appropriate
traceability and labelling provisions that are implementable and enforceable
and take into account the capacity of plants obtained by
targeted mutagenesis and cisgenesis to contribute to a sustainable food system
and ensure consumers’ right to make informed
choices. ·
Mechanisms to be able
to rapidly adjust
elements of the
legislation and its implementation over time, as warranted
by scientific and technological progress, for a future-proof regulatory framework. The policy options will be developed on the basis of the above
elements, together with other elements that
might |
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emerge from
the feedback from the public to this document and from the consultation
activities. They will be assessed against the baseline scenario and
compared in the Impact Assessment. |
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C. Preliminary Assessment of Expected Impacts |
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Likely
economic impacts |
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The initiative is expected to incentivise and facilitate the development and placing on the market
of safe plants obtained by targeted mutagenesis and cisgenesis and avoid potential negative consequences outlined in the baseline
scenario on innovation, competitiveness, trade and
missed opportunities for the agri-food system and other sectors.
Concerns regarding the potential negative
impact on other areas of the agri-food system (such as organic agriculture) will also need to be considered. The policy options
will explore how to maximise the benefits from the positive impacts and minimise any
negative ones identified. The following potential economic impacts, and others yet to be identified (e.g.
during the consultation) will be assessed during the impact assessment: ·
Primary agricultural production and its capacity to address specific needs across the EU. In particular the initiative
will look at levels and cost of agricultural inputs (e.g. plant protection
products, fertilisers), use of natural resources, development of more
resilient varieties (e.g. to environmental or specific geographical conditions
and plant diseases and pests), capacity to support local agricultural
solutions and reduce costs and time in plant breeding. Aspects that may
impact product prices will also be explored. ·
Innovation and research in the EU in agri-food system, as well as in bio-based and biotechnology industries, which may benefit from a framework providing legal clarity and a
more adapted regulatory environment for plants produced by targeted mutagenesis
and cisgenesis. ·
Potential negative impacts for organic and GM-free agriculture and their premium retail sector (e.g.
due to compliance, certification and segregation costs). ·
The engagement of SMEs in the
agri-food sector, which could increase due to faster product development and lower
market access costs (including regulatory costs of the current authorisation procedures). ·
The impact assessment will also
consider issues related to the contribution of intellectual property to innovation, as well as issues concerning access to these
technologies and to genetic material by economic operators. |
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Likely
social impacts |
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The impact assessment should
provide evidence to better understand, identify and qualify
social effects. The planned
initiative is intended to ensure high levels of safety and the protection of
consumer health. The introduction of a sustainability analysis, to ensure
products placed on the market
bring a clear
added value to society, will also be analysed; benefits
for consumers could occur due to reduced
toxin or allergen content or by improved nutritional profiles in certain products, contributing to healthy diets.
Impacts affecting the
variety of products meeting consumers’ demand for
sustainable food production will also be examined. Impacts on sustainability and biodiversity on a local
level (including rural
areas, supply chains
and minor, niche
or orphan crops that address
local needs) will be assessed, taking into account
the objectives of the European
Green Deal and Farm to Fork and Biodiversity
strategies and the ‘Long term vision for rural areas’ Communication. |
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Likely
environmental impacts |
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The planned initiative aims to
maintain a high level of environmental protection. It shall aim at
facilitating the development and uptake
of innovative plants
that could provide
direct and indirect benefits to the environment. Several of the plant products obtained
from targeted mutagenesis and cisgenesis have the potential to contribute to the objectives of the European Green Deal and Farm to Fork and Biodiversity strategies and the United
Nations’ Sustainable Development Goals for a more resilient and
sustainable agri-food system. Examples include plants more resistant to diseases and environmental conditions or climate change
effects in general, improved agronomic or
nutritional traits, reduced use of natural resources (e.g. water) and
agricultural inputs. At the same time, concerns exist on potential negative impacts
of plants obtained by NGT on the environment
and on
biodiversity, e.g. due to potential displacement of traditional varieties and
loss of agricultural diversity, concerns for increased use of pesticides. These possible impacts will also be assessed. Application of NGTs in the agri- food
system must not undermine other aspects of sustainable food production, e.g.
as regards organic agriculture, or biodiversity. |
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Likely
impacts on fundamental rights |
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The initiative has the potential to contribute to a number
of objectives contained in the Charter
of Fundamental Rights of the EU, including the principle
of sustainable development. It should ensure a high level of human health protection (Article 35), a high level of
environmental protection and improvement of the quality of the environment (Article 37), and a high level of consumer protection (Article
38). The impacts on health, environment and consumers’ right to information will be
assessed. Adapting legal requirements for plants obtained by targeted mutagenesis and cisgenesis in accordance with their risk levels
may bring new opportunities for agri-food system |
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and biotechnology operators, as well as researchers, and SMEs,
enhancing their freedom to conduct their business. Organic and GM-free
operators have expressed concerns that their
freedom to conduct
business might be negatively
affected. The impact assessment will identify and assess any limiting
factors, with the goal of minimising them. It will
also tackle potential ethical concerns related
to environmental, economic and social impacts. |
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Likely
impacts on simplification and/or administrative burden |
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This initiative aims at exploring options to introduce a
streamlined framework, including, if and where appropriate, proportionate risk assessment, traceability and labelling requirements and approval procedures. In addition, it is expected
to increase legal
certainty by clarifying certain aspects, in the new legislation. It is thus expected to reduce
current costs and administrative burden incurred by researchers, applicants,
control and enforcement authorities, risk assessors and risk managers and other actors
and which act
as entry barriers for the internal market. The policy
action might, introduce new requirements, which
could have an administrative burden
on the economic actors involved in placing these products on the EU market. The impact assessment will quantify, to the extent
possible, these positive and negative contributions to the administrative burden, with the goal of an
overall net burden reduction. |
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D. Evidence Base, Data collection
and Better Regulation Instruments |
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Impact assessment |
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An impact assessment will underpin this
initiative and assess
the policy options
and their likely
impacts. The impact assessment will take into account
the evidence base and data collection outlined below, and the feedback received during the consultation process. |
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Evidence
base and data collection |
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The evidence base
will be built
on and complement existing information gathered from past work
on the topic,
including the Commission study on the status of new genomic
techniques, past evaluations of the GMO legislation, and work from the European
Food Safety Authority4, the European Network
of GMO Laboratories, the Joint Research
Centre5, the Scientific
Advice Mechanism High-Level Group and the European Group
on Ethics in Science and New
Technologies. In addition, a study supporting the impact assessment will be
carried out. |
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Consultation of citizens and stakeholders |
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The Commission will carry out a series of consultation activities to gather
data and opinions on this initiative and give
any interested party the possibility to contribute. A 12-week public
consultation will be carried out (indicative timing Q2 2022). To this end, a
questionnaire will be available in all EU languages and replies can be made
in any official EU language; it will be accessed via the Commission’s ’Ha ve Your S a y’ portal. A
factual summary of the contributions to the public
consultation will be published after
its closure. The
activities above will
build on and take into account the information received during the comprehensive targeted consultation with Member State competent authorities and EU-level stakeholder associations that are impacted by or have expressed interest in NGTs in the context
of the NGT study. The latter group encompassed agri-food business operators (including organic and GM-free sectors), the biotechnology industry,
environmental and agri-food non-governmental organisations and academia/research organisations. |
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Will
an Implementation plan be established? |
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The need for an implementation plan will be assessed in the Impact
Assessment and will depend on further analysis
of the policy
options and measures; should one be needed, it will include
necessary support actions
for the Commission and Member States. |
4 https://www.efsa.europa.eu/en/efsajournal/pub/2561, https://www.efsa.europa.eu/en/efsajournal/pub/2943, https://www.efsa.europa.eu/en/efsajournal/pub/6299, https://www.efsa.europa.eu/en/efsajournal/pub/6314
5 https://op.europa.eu/en/publication-detail/-/publication/5a661f2b-a180-11eb-b85c-01aa75ed71a1/language-en, https://publications.jrc.ec.europa.eu/repository/handle/JRC123830
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