5. Living modified organisms for food, feed and processing

I would like to thank Ana Laura Mello for moderating this discussion and the Secretariat for facilitating it.
My name is Dr Werner Schenkel, I have been working as a risk assessor for the German Competent Authority for about 20 years and have been involved in Cartagena Protocol related issues since 2017.
Having joined last week's discussion late and not fully following the moderator's instructions, I will now try to correct both failures by starting early and following the questions set out to structure the discussion.
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Recognising that the topic "Living modified organisms for food, feed and processing" is likely to be a summary representing submissions to NTF-2025-017, I still have concerns as to whether the topic meets the condition of CP9/13 Annex I (a).
LMOs for food, feed and processing have been the focus of most applications for many years and risk assessments are routinely carried out by many Parties to the Protocol. Therefore, solutions obviously exist.
Nevertheless, I am sure that there have been and are challenges in assessing the risks of LMOs for food, feed and processing. However, these are probably not challenges to the existing risk assessment frameworks, guidelines and methodologies, but rather challenges in their practical implementation. Therefore, I do not believe that condition CP9/13 Annex I (c) is met.
These practical challenges cannot be adequately addressed by more guidance materials. Capacity building and development and knowledge sharing through bilateral or regional cooperation and, where appropriate, international support could be much more effective in addressing these practical challenges and improving biosafety locally and globally.

2. What could be the specific challenges to related to this issue?
The topic of risk assessment of LMOs for food, feed and processing is very broad, covering many types and classes of LMOs and many possible applications. Therefore, it may prove difficult to identify challenges specific to this issue.
3. What are the specific issues concerning this topic?
(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
(iii) Is there the potential to disseminate across national borders?
The only limitation on this issue seems to be that the focus is on LMOs for food, feed and processing (possibly after import) as opposed to cultivation or deliberate release. This observation leads me to conclude that conditions CP9/13 Annex I (e)(ii) and (iii), while not completely excluded, are much less likely to be of practical relevance. In the exercise of prioritising issues, this would at least suggest that it should be given a lower priority.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
As mentioned above, there are existing resources that directly address this issue. Any Party undertaking a risk assessment of LMOs for food and feed use should base its decisions on these resources and make them available through the BCH.
In the case of the European Union, these include:

COMMISSION IMPLEMENTING REGULATION (EU) No 503/2013
https://bch.cbd.int/en/database/BCH-LAW-EU-115173-1

Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003  https://bch.cbd.int/en/database/BCH-LAW-EU-115267-1

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed https://bch.cbd.int/en/database/BCH-LAW-EU-115266-1

Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects https://bch.cbd.int/en/database/BCH-LAW-EU-115266-1

Guidance on allergenicity assessment of genetically modified plants
https://bch.cbd.int/en/database/BCH-LAW-EU-115266-1

Guidance for risk assessment of food and feed from genetically modified plants
https://bch.cbd.int/en/database/BCH-LAW-EU-115266-1

On the basis of the above, I consider that this topic does not meet the criteria set out in decision CP-9/13 for the process of identifying and prioritising specific issues for risk assessment of living modified organisms.

Werner Schenkel

My name is Dr. Raja CHALGHOUMI, Lecturer in Animal Nutrition and Microbial Ecology. I am also a certified professional in biological risk management and biosafety. I have been a member of the last AHTEG-RA. I would like to respond to this topic, as it particularly interests me, both as a researcher in the field of animal nutrition and as a professional in biological risk management. Here is my modeste feedback.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Regarding my response to the first question, I fully agree with Dr. Shenkel's observations.
2. What could be the specific challenges related to this issue?
I would like to emphasize that developing countries still face the same major challenges, including:
- Limited capacity to formulate, implement, and enforce biosafety regulations.
- Insufficient scientific expertise and infrastructure to conduct adequate risk assessments.
3. What are the specific issues concerning this topic?
(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
(iii) Is there the potential to disseminate across national borders?
In developing countries lacking a national legal framework for LMOs, the absence of information and knowledge about genome editing, gene drive and synthetic biology makes it impossible to completely eliminate these two potential risks.

Raja CHALGHOUMI

Dear Colleagues,

I would like to thank Mr. Schenkel and Ms Chalghoumi for the first posts on this topic and sharing existing resources.

This is also a gentle reminder to contribute to the topic of LMOs for food, feed and processing before the close of the first week of discussions on Monday 5 May at 11 a.m. Montreal time.

This is a valuable opportunity to share experiences and insights when addressing these types of LMOs. Since the human consumption of LM maize was indicated as a priority during the submissions, I would be grateful to receive any information or existing resources related this more specific case.

Also, as a kind reminder, I would appreciate if you would be able to share the DOI or URL links when sharing references and resources.

I look forward to discussions,

Ana Laura Mello

In contribution to discussion on questions 1 and 2

Indeed risk assessment of LMOs for food, feed and processing (FFP) have been well applied globally by regulators and developers for the regulation of the transboundary movement of LMOs utilizing the Annex III of the Cartagena Protocol on Biosafety. Utilization of the global biosafety information mechanism, BCH, has also been helpful in this regard.
However, a context-specific data for effective risk assessment may pose a challenge in some regions, considering that risk assessment of LMOs for FFP often relies on data generated in different ecological, agricultural and dietary context, usually from country of the developer or origin. In some instances, it might pose a challenge for the importing country where food consumption patterns, local biodiversity and environmental conditions differ significantly. Therefore, risk perception and regulatory thresholds may differ based on national food, feed, industry, health and cultural priorities. In view of this, regulators of the importing country may struggle to interpret or apply foreign data, leading to delays, trade barrier and evidently in developing countries, public mistrust.

This then may underscore the need to start considering the contextualization of risk assessment reviews beyond relying solely on developer-submitted data. Therefore, a call for a deepened strategic data sharing frameworks under regional and sub-regional economic blocs and multilateral agreements be encouraged. Also a region/sub-region guidance for specific nutritional risk profiles and in some cases, exposure models be encouraged to help as a supplement on local assessment or bridging study when necessary. Not also forgetting the Importance for continuous capacity building and strengthening in low and middle income countries for independent data generation and interpretation.

Onyeka Nwosu
Nigeria

Esteemed colleagues,

In contribution to discussion I would like to comment on the suggested questions 1:

1. Considering that living modified organisms intended for food, feed, and/or processing may originate from organisms with highly diverse biological complexities, it is difficult to define specific challenges that can be universally applied to this topic. Therefore, it is suggested that the scope be limited to an individual organism or a group of organisms with comparable characteristics and aligned with the guidelines of notification CP9/13. Nonetheless, it is worth mentioning that the main challenges in this topic may not necessarily be related to the intrinsic characteristics of the living modified organisms, but rather to issues concerning its proper implementation and the prevention of unintended or unauthorized uses.

My name is Christoph Then. For my affiliations please see the first round of questions. In the following, I try to answer to the questions raised by the moderator.

Question 1
In our report published in 2021 we show gaps in current EU risk assessment for food and feed. Despite, so far, only a limited number of traits and plant species are used for food and feed production, fundamental issues remain unsolved in the safety assessment (also beyond the EU).  Some of these issues will become a much more pressing problem as soon as many of the ‘New LMOs’ will enter the markets. We tried to explore some of those issues in a our report published in 2022. We further tried to exemplify the issues in the case of New LM tomatoes (Testbiotech 2023).


Question 2
Specific challenges of previous LM plants e. g. include
- chronic health impacts,
- impact on the microbiome,
- the potential impact on the immune system and inflammatory processes,
- combinatorial effects from stacking events or from mixing of several LMOs in one diet, also including
- specific interactions with the residues from spraying of complementary herbicides.

So far, on most of these issues, there is no guidance. 

Improved methodology is needed e. g.
- how to introduce ‘-Omics’ in risk assessment,
- how to take into account the impact on various agricultural practises in the countries of cultivation
- how to adequately assess effects on gene expression and plant compositions under a broad range of environmental stress conditions (such as climate change) and
- the impact of plant constituents on the toxicity of newly produced proteins such as Bt toxins.

Question 3
All four questions can be answered with yes.

Question 4
In many cases, since several years, existing tools and methodology would be ready to become integrated into risk assessment.  

In other cases, such as combinatorial, cumulative and long term effects, adequate methodology is often missing and therefore new guidance should be developed.

In addition, market authorisations may be limited to avoid a steady increase of uncertainties and health risks due to deficiencies in the existing risk assessment. 


References:
Testbiotech (2021) Risk assessment of GE plants in the EU: Taking a look at the ‘dark side of the moon’, https://www.testbiotech.org/en/publikation/risk-assessment-ge-plants-eu-taking-look-dark-side-moon/

Testbiotech (2022) New genomic techniques (NGTs): agriculture, food production and crucial
regulatory issues, Commissioned by and written for Verbraucherzentrale Bundesverband (vzbv),
https://www.vzbv.de/sites/default/files/2022-11/vzbv-report_final_final.pdf

Testbiotech (2023) GE tomatoes on the march. What about the changing future of tomato salad https://www.testbiotech.org/en/resource/ge-tomatoes-march/

Dear Colleagues,

It's a pleasure to collaborate in this discussion, to contribute to questions 1 and 3:

As my colleague Kamal Kumar Rai stated in point three of this week’s forum discussion, I want to draw attention to the importance of including local community perspectives in the risk assessment framework. It is local people, such as Indigenous and rural communities, as well as women, who are most likely to be affected by both the advantages and disadvantages of introducing LMO foods into their environments [1], especially in underdeveloped countries.

Beyond the need for a better understanding of how LMOs affect local communities' food systems, food sovereignty, health, and environment, it is also essential to have a risk assessment framework that promotes and supports locally developed LMOs, those generated with local knowledge and suited to the local socio-economic and ecological conditions. This approach is crucial for the conservation of biodiversity, as locally developed products are more likely to take into account the rich diversity of ecosystems and cultural practices in these areas. Many experts are calling for such context-specific developments [2, 3], and initiatives like these are already taking place in countries like Colombia with maize [3]. As these efforts grow, risk assessment frameworks must be adaptable and supportive of these approaches, especially since LMOs developed by large corporations have been linked to significant issues such as seed ownership and control [4].

[1] doi: 10.1080/21645698.2020.1715156
[2] doi: 10.1111/j.1556-486X.2009.01016.x
[3] doi: 10.3389/fgeed.2023.1181811
[4] https://grain.org/en/article/7214-seeds-sovereignty-struggle-the-ongoing-battle-against-upov-seed-privatisation

Sol Parra

Dear participants,

My name is Luciana Ambrozevicius, I´m a regulator and a risk assessor at the Brazilian Biosafety Commission. Thank you for the opportunity to participate in the on line forum. For the proposed topic “Living modified organisms for food, feed and processing” I would like to make the following considerations regarding the criteria for new topics established in the annex I to decision CP-9/13:

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?

The Convention of Biological Diversity has three main objectives - the conservation of biological diversity, the sustainable use and the fair and equitable sharing of benefits. Cartagena is a CBD Protocol and the “taking also into account risks to human health” part of the Protocol objective has to be consider under the CBD scope. There are more appropriate international forums such as Codex Alimentarius with the main objective of consumer health protection with guidelines already available for food and feed risk assessment.

2. What could be the specific challenges to related to this issue?
3. What are the specific issues concerning this topic?

The topic “Living modified organisms for food, feed and processing” is too broad, no specific challenges can be identified, only general considerations that do not add value for risk assessors and that can duplicate the work already conducted by the Codex Alimentarius.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?

Beside multiple RA guidance available internationally, already mentioned by other participants, there are Codex guidelines:

- https://www.fao.org/fao-who-codexalimentarius/thematic-areas/biotechnology/en/ 

In my opinion, in this case the proposed topic does not fulfill the criteria according with the decision CP-9/13 and neither will be an outcome useful for Parties.


Best regards,
Luciana P. Ambrozevicius

Dear colleagues,

Thank you all very much for your contributions. I appreciate the exchange and the provision of references, which will undoubtedly be a very valuable contribution to the work of the AHTEG. For those who haven't yet participated, please remember that you have until 11 a.m. tomorrow (Montreal time).

Best regards,

Ana Laura

Dear Colleagues,
In contribution to the discussion, I submit my comments below:

Question 1: How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
This topic does not pose significant challenges to the existing risk assessment frameworks, guidance, or methodologies. In the context of LMOs for food, feed, and processing (FFP), the living modified (LM) plant in question would have already undergone comprehensive risk assessment for cultivation or food/feed use and determined to be as safe as its conventional counterpart. Therefore, the existing frameworks, including the information required concerning LMOs for FFP in Annex II, and the Annex III on risk assessment, are adequate and remain fit for purpose. It is important, however, that implementation remains risk-proportionate and does not result in unnecessary duplication of assessments, especially for LMOs already authorized elsewhere.

Question 2: What could be the specific challenges related to this issue?
A major practical challenge arises from the fact that LMOs for FFP are often traded by third-party actors (e.g., exporters, importers, or commodity traders) who are not the technology developers and therefore do not possess the full regulatory dossiers or proprietary information required for a comprehensive risk assessment. This makes it difficult for importing country regulators to conduct independent reviews in the absence of accessible data.

To address this, regulators in importing countries should rely on risk assessments already conducted by competent authorities in the countries of origin or where there had been prior approvals, especially for assessments conducted in line with Annex III of the Cartagena Protocol and Codex guidance. This approach promotes regulatory efficiency, avoids redundancy, and maintains appropriate safeguards for human health and the environment.

Additionally, developers should be encouraged to proactively seek authorization of their events in jurisdictions where there is a likelihood of trade involving LMOs for FFP. This would ensure that relevant risk assessment data is officially available to regulators in those countries and help prevent unnecessary trade disruptions due to asynchronous approvals. This approach also facilitates transparency and shared responsibility in the global movement of LMOs.

Question 3: What are the specific issues concerning this topic?
(i) Potential adverse effects on biodiversity/human health: Though LMOs for FFP have already been assessed and found as safe as conventional counterpart, the information on the assessment conducted may not always be easily accessible if not posted by the concerned authority. However, the likelihood of serious or irreversible adverse effects is minimal and post-release monitoring systems may be applied as appropriate.
(ii) Potential for deliberate or accidental release into the environment: While unintentional release may occur during handling or transportation, this risk is managed by having contingency plans. LMOs for FFP are not intended for propagation, and such risks are often managed by indicating in permit authorization that it shall not be cultivated and ensuring adherence to terms and conditions.
(iii) Potential for dissemination across national borders: Yes, particularly because LMOs for FFP are traded globally, this involves cross border trade and would require international and intranational cooperation, and information exchange. This highlights the importance for competent national authorities (CNA) on biosafety, authorities on customs and phytosanitary measures and their counterparts, importing, exporting and neighbouring countries, as well as their relevant regulatory authorities cooperating, to prevent unauthorized cross border trade.
(iv) Commercialization or current use globally: Many LMOs for FFP are already commercialized and used across multiple countries, including in social intervention aids to address emergency issues of food shortage or hunger. Reviewers or regulators in importing countries should have access to decisions made in other jurisdictions and consider those as part of their own regulatory processes, using mechanisms such as the Biosafety Clearing House (BCH), FAO GM food platform, and OECD biotrack product database for transparency and information exchange.

Question 4: Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
Yes, there are existing resources and platforms that can be leveraged to address the needs associated with risk assessment of LMOs for FFP. These include:
- Information required concerning LMO for FFPs and the Annex III of the CPB,
- The Biosafety Clearing House (BCH) [https://bch.cbd.int/en/], for accessing information on national decisions, risk assessments, and safety data,
- FAO GM food platform [https://www.fao.org/food/food-safety-quality/gm-foods-platform/en/], OECD biotrack product database and consensus documents [https://www.oecd.org/en/topics/sub-issues/biosafety-novel-food-and-feed-safety/consensus-documents-work-on-harmonisation-of-regulatory-oversight-in-biotechnology.html; https://www.oecd.org/en/topics/sub-issues/biosafety-novel-food-and-feed-safety/consensus-documents-on-the-safety-of-novel-foods-and-feeds.html] that provide access to safety and compositional data for various approved LM crops,
- Regional cooperation mechanisms and bilateral knowledge-sharing platforms, and
- AUDA-NEPAD guidelines on biosafety administration and risk assessment review serve as useful resources for AU Member States that are parties to the Cartagena Protocol.

Parties should be encouraged to actively share resources, experiences, and decision-making rationales to foster efficiency, harmonization, consistency, and transparency.

Thank you and best regards,
Modupe (AUDA-NEPAD)

Thank you Mr Onyeka Kingsley Nwosu for making the important point about regional and sub-regional agreements for data portability and data sharing as well as the possibility of joint decision making. In the African context there is definitely effort being made in this regard by the African Union through the New Partnership for Africa's Development (AU-NEPAD) as well as the African Biosafety Network of Expertise (ABNE) to organize at a regional level for biosafety decision making related to GMOs. There are lessons that can be learned as well from the African Medicines Regulatory Harmonization with regard to regional decision making and joint review activities.

best wishes
brinda Dass- FNIH, USA

Thank you to the moderators and the CBD Secretariat for facilitating this forum. I would like to add a reference of potential relevance to Question 4 in this thread-

National Academies of Sciences, Engineering, and Medicine. 2025. Heritable Genetic
Modification in Food Animals. Washington, DC: The National Academies Press.
https://doi.org/10.17226/27750

This is an excellent discussion of various aspects related to the risk assessment of heritable genetic changes specifically in food animal species. It addresses many of the points being raised in this forum. This document is free to download from the NASEM website.

many thanks

Brinda Dass
FNIH, USA

Dear colleagues,
My name is Ediner Fuentes-Campos, Deputy Director of Research and Development at the Secretariat of Sciences of Panama. I have been working as a risk assessor at the National Biosafety Commission for GMOs and as a public researcher.

I support post #12449, which indicates that this topic is too broad and lacks specificity. I agree that there are more appropriate international forums such as the Codex Alimentarius that already provide comprehensive guidelines for food and feed risk assessment. The current framework under Annex III of the Cartagena Protocol, along with existing resources from the Codex Alimentarius and various national regulatory bodies, provides adequate guidance for risk assessment of LMOs for food, feed and processing.

Respectfully,
Ediner Fuentes-Campos

Dear Colleagues,
I would like to thank Ana Laura Mello for an excellent guiding of the discussion in this forum and thank all colleagues for their insites and contributions to the topic.

My name is Angela Lozan, I am a project manager at the National Office for Environmental Projects Implementation Office of the Ministry of Environment of Moldova. I have scientific background in animal ecology, and being part of the Cartagena Protocol's implementation process since 2002.

I would like to bring my view to the specific topic on RA for FFP. I would consider that biosafety for FFP should be taken in a larger context, bearing in mind that socio-economic considerations are essential part is associated with food and feed products and consummation. Risk analysis for FFP as an instrument that enhances cross-sectoral biosecurity activities, and includes the emergence of risk analysis. Integration of risk analysis approaches and resources will also help in ensuring public confidence in overarching regulatory frameworks and assist in optimization of scarce biosecurity resources. It should be recognized that effective application of risk analysis in biosecurity is fully dependent on an appropriate legislative base, infrastructure and regulatory system, as well as equitable stakeholder engagement. There is a need to advise countries with a guideline for risk assessment and risk management of FFPs that would help to involve the following aspects:
• A risk analysis approach to address  cross-sectoral biosecurity concerns.
• Risk assessment modelling to develop and use new and innovative control measures.
• Risk assessment methodology to facilitate benefit cost analysis in case of competing priorities and/or lack of resources.
• Risk communication processes that involve stakeholders in multiple biosecurity sectors.
Balancing the importance of protection of health and life in all biosecurity sectors while fostering a competitive and sustainable food sector is a holistic biosecurity challenge. 
As my current activity is related to development of national capacities for risk assessment and risk management as part of decision making, it is important to establish clear regulation and guidance for FFPs and estimate possible risks of GM FFPs to the ecosystems, biodiversity and vulnerable and rare species, including endemic species, invasive alien species, climate change resilience etc.
Nutritional preferences, health care and cultural aspects, traditional food and child protection, gender etc., are also important parts of the risk analysis related to the FFPs.

Thank you.

Angela Lozan

Dear All,

Thank you for this interesting discussion.

I would like to support the points made in the Party submission on this issue, as well as the previous post #12432 on the challenges FFP products raise for RA. As stated in #12432, the import of LMOs in food feed and processing raises specific risks that challenge current RA methods and warrant updating, particularly with regard to cumulative and long term effects, an issue also raised by the increasing percentage of LM crops being of stacked varieties, including stacked herbicide tolerant crops.

As such, strengthening of oversight (see #12432) is warranted, over a potential weakening of oversight under proposals for data portability between countries made in a previous post. Moreover, such an approach would not meet obligations under the Protocol, specifically Annex II (j) on FFP which states the requirement of a risk assessment needs to be consistent with Annex III. Annex III requires  assessment of potential adverse effects on the 'likely receiving environment'. This is a central aspect of Annex III that is required to ensure against adverse impacts to biodiversity or human/animal health.

Many thanks
Eva

My name is Eder Toppa, and I have been working for the Brazilian Ministry of Agriculture and Livestock for the past decade. I am currently the Head of the Biosafety Service and a member of the National Biosafety Commission.

The risk assessment of LMOs for food, feed and processing has been carried out over the past decades by several countries that are parties to the Cartagena Protocol. The expertise of various scientists, as well as the regulatory experience of numerous agencies responsible for formulating public policies on biosafety, has resulted in numerous valuable documents for scientific risk assessment for this purpose, including the following:

Codex Alimentarius Commission (2003), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants, CAC/GL 45/2003, Annexes II and III adopted in 2008,
http://www.codexalimentarius.net/download/standards/10021/CXG_045e.pdf

FAO/WHO (2000), Safety Aspects of Genetically Modified Foods of Plant Origin, Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology Food and Agriculture Organization, Rome,
http://www.fao.org/fileadmin/templates/agns/pdf/topics/ec_june2000_en.pdf (accessed on 28 January 2015).

OECD (2019), Safety Assessment of Foods and Feeds Derived from Transgenic Crops, Volume 3, Novel Food and Feeds Safety, OECD Publishing, Paris, https://www.oecd.org/en/publications/safety-assessment-of-foods-and-feeds-derived-from-transgenic-crops-volume-3_f04f3c98-en.html

OECD (2015a), Safety Assessment of Foods and Feeds Derived from Transgenic Crops, Volume 2, Novel Food and Feeds Safety, OECD Publishing, Paris, http://dx.doi.org/10.1787/9789264180338-en.

OECD (2015b), Safety Assessment of Foods and Feeds Derived from Transgenic Crops, Volume 1, Novel Food and Feeds Safety, OECD Publishing, Paris, http://dx.doi.org/10.1787/9789264180147-en.

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003
https://bch.cbd.int/en/database/BCH-LAW-EU-115266-1

Health Canada (Food Dir.), Guidelines for the Safety Assessment of Novel Foods, Updated: July 2022
https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidelines-safety-assessment-novel-foods-2006.html

WHO (1991), Strategies for Assessing the Safety of Foods Produced by Biotechnology, Report of a Joint
FAO/WHO Consultation, World Health Organization of the United Nations, Geneva, out of print

I stress once again that any new guidance must add value, which is not the case here. Furthermore, limited financial resources should be allocated to other pressing priorities.


Eder Victor Braganti Toppa
Federal Inspector
Head of the GMO Biosafety Service
Plant Health Department
Ministry of Agriculture and Livestock

Dear participants,

We share the position of other participants who have emphasized that adequate guidelines already exist to address the topic of living modified organisms (LMOs) for food, feed, and processing, particularly the guidelines already available through the Codex Alimentarius. These guidelines have been developed by international experts with the aim of ensuring human health protection, and their scope adequately covers risk assessments related to LMOs in food and feed.

We believe that the Codex Alimentarius provides a robust and well-established framework for risk assessment in this context, reducing the need to create new guidelines or initiate new work in this area. Consequently, we do not see the need to pursue the development of an additional topic related to this issue.

We appreciate the opportunity to participate in this forum and reiterate our support for the position of those who consider that the existing resources are adequate for this topic.

Best regards.

Once again, with many thanks to the CBD Secretariat and to Ms. Mello for providing this opportunity.

I have been engaged in capacity building for risk assessment, including assessment of LMOs for use as food, feed and for processing for almost 20 years now.  While the subject remains challenging and technical for those wishing to learn it, none of these challenges are related to the lack of proper and thorough guidance.  I strongly support posts #12406, 12415, 12427, 12449, 12472 and 124586 in recognizing that there is no benefit to exploring additional guidance in this area. 

Kind Regards,
Andrew Roberts, PhD,
Agriculture & Food Systems Institute

Posted on behalf of Kamal Kumar Rai, Nepal Indigenous Biodiversity Forum (NIBF), Indigenous Knowledge and Peoples Network Society for Wetland Biodiversity Conservation Nepal
****
For Indigenous Peoples and local communities, women,  Food systems are the culture, spiritual, rituals, customary and knowledge based harmony with soil, natural weaves, motions of planetary symbolic with animistic holistic approach close with health and spirits in local. Indigenous Food systems are diverse that contribute for agro biodiversity conservation goes to genetic resources for further more science and technological innovations and feed industries to food as a simpleat at local

LMO, EGD LMO, EGD could help or contribute to alter the systems that we have for biodiversity, transgenic  food, feed in general  leads to biodiversity loss and crises, loss of diversity, culture, languages, ritual, symbol and knowledge in system including identities that adverse impacts for human being, animal, native species and micro-organism  as society of the ecological niches.  The transgenic impacts of LMO, EGD-LMO may transfer through food chains into phenotypic, genotypic into plants, animal and micro organisms.

IPLCs, women, youth and Person with disabilities propose to have a dynamic system for Risks Assessment and Risk Management under Biosafety Measures, precautionary Principles in inclusion in the right based approach.

Kamal Kumar Rai
IPLCs

Dear Moderator and Colleagues,

As mentioned by other colleagues, the existing international guidelines, such as Annex III of the Cartagena Protocol and Codex, are sufficient for the risk assessment of LMOs for food, feed, and processing (LMO-FFP). Provided that the definition and scope of LMOs under previous topic, '2. Living Modified Organisms produced through new biotechnologies' are clarified and reinforced, the development of redundant or unnecessary additional guidelines would not be required. However, to ensure harmonized regulatory implementation, it is critical to explicitly distinguish between data requirements specific to individual national contexts and those universally applicable. This distinction will streamline regulatory processes and facilitate rational application. To achieve this, the central role of the Biosafety Clearing-House (BCH) in fostering transparent and standardized data sharing must be prioritized.

Dear participants,

Thank you again for the opportunity to contribute to these discussions. For this topic I am unable to find specific “issues” in the Party submissions, so I will broadly address the moderator’s questions:

Questions 1 and 2
This topic does not appear to be challenging existing risk assessment frameworks, given that almost 3000 regulatory authorizations have been granted in at least 30 countries since 1995 (https://gm.agbioinvestor.com/approvals-database; filters: “food”, “feed”, “food (oil):, “food/feed”; accessed 2 May 2025).

The World Health Organization has stated the following: “GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.” (WHO 2014; https://www.who.int/news-room/questions-and-answers/item/food-genetically-modified).

As pointed out by previous contributors (#12406, #12449, #12472, #12486), existing resources have been developed in other international fora (see question 4 below). If there are practical challenges for implementing existing safety assessment frameworks, a solution is the sharing of the wealth of knowledge that has accumulated over the past 30 years in conducting these assessments. This would be a more productive approach to training and building capacity than developing additional duplicative guidance materials.

Question 3
Biotech crops have been in commercial production for at least 30 years. In 2022, the global cultivated area of biotech crops was 202.1 million hectares across 27 countries (AgbioInvestor GM Monitor 2023, https://fundacion-antama.org/wp-content/uploads/2023/05/Global-GM-Crop-Area-Review.pdf).

Question 4
Several relevant international resources have been developed, including detailed Codex Alimentarius texts:

Principles for the Risk Analysis of Foods Derived From Modern Biotechnology (CAC/GL 44-2003)

Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003)

Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Micro-organisms (CAC/GL 46-2003)

Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals (CAC/GL 68-2008)

These texts are available in multiple languages at: https://www.fao.org/fao-who-codexalimentarius/thematic-areas/biotechnology/en/, and compiled here: https://openknowledge.fao.org/server/api/core/bitstreams/3229fca1-ff5a-4561-8e89-cd4a48a6438a/content.

The Codex Alimentarius Commission is the international food standards setting body, and in our experience as developers of biotech crops, CAC/GL 45-2003 is the basis for national regulatory frameworks for LMO food safety assessment, with aligned approaches tailored to national circumstances. National frameworks are typically administered by competent authorities whose representatives in many cases will not be aware of or contributing to this online discussion. Food safety authorities do not only assess LMO food/feed but have a broader public health mandate and conduct safety assessments based on a risk analysis framework. The consideration of this as a Cartagena Protocol topic is perplexing, since any guidance development would be duplicative and of questionable value.

Other international resources have been developed by the OECD Novel Food and Feed Working Party, which is in intergovernmental forum for the exchange of information, approaches and experience in risk/safety assessment (see: https://www.oecd.org/en/topics/biosafety-novel-food-and-feed-safety.html).

This Working Party has developed a series of consensus documents that compile science-based information and data for use by regulators and risk assessors in the consideration of key composition elements in novel foods/feeds compared to conventional counterparts (see: https://www.oecd.org/en/topics/sub-issues/biosafety-novel-food-and-feed-safety/consensus-documents-on-the-safety-of-novel-foods-and-feeds.html).

As for environmental risk assessment, a problem formulation approach should be applied in food/feed safety assessment.

Dear Participants,

Thank you kindly for your insights and your continued active engagement during the second week of discussions.

Week 2 of the Open-Ended Online Forum is now closed.

The online forum remains open for the Week 3 topics. Kindly refer to the ongoing discussions at https://bch.cbd.int/en/portals/risk-assessment/forum/week-3.

Best regards,

The Secretariat