International Harmonization of Food Safety Standards
By Food Safety Magazine
Food safety regulations differ between countries. While there are no scientific justifications for most of these differences, they can have dramatic consequences, such as the confiscation of food that was considered safe in the country of origin but not in the importing country. After confiscation, usually the food is destroyed, as its return is not allowed in most countries. Bureaucracy is complex; in particular, small companies have difficulty understanding the requirements. It is important to understand why these differences exist and what can be done to harmonize the most important regulations. Several of the Working Groups of the Global Harmonization Initiative (GHI) will try to develop global scientific consensus documents on topics that may reduce the risks that healthy food is unduly destroyed in a world where people in the exporting country suffer from undernourishment.
The word “standard” can have different meanings. It may mean a set of requirements applicable to a specific food, such as the standards of identity in the U.S. and quality standards in the EU. It may mean any food legal requirement like in Codex. Private systems like ISO 22000 may also be referred to as “standards.” Such private food safety standards mainly relate to food safety process requirements such as Hazard Analysis and Critical Control Points (HACCP). Among the private standards, ISO 22000 (in connection with FSSC 22000) is just another standard akin to the audit schemes (e.g., BRC, IFS, SQF). Whereas ISO is mainly used by food producers, the others are typically used by retailers. The Global Food Safety Initiative (GFSI) tries to overcome the diversity among these private standards.
Given the complexity and variety of these “standards” currently used in the food industry, Food Safety Magazine convened an expert panel, moderated by Huub Lelieveld, president of the Global Harmonization Initiative, to address some of the more critical questions regarding the challenges surrounding the international harmonization of food safety standards. Participating panelists were Sultan Ali Al Taher, M.Sc., head of food inspection in the Dubai Municipality Food Safety Department, UAE, Robert G. Ahern, Ph.D., leader of Agricultural Health, Food Safety and Food Quality at the Inter-American Institute for Cooperation on Agriculture (IICA) in Costa Rica, Camille E. Brewer, M.S., R.D., director, International Affairs Staff, Office of Foods and Veterinary Medicine and Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration (FDA), Professor Dr. Bernd van der Meulen, prior chair of law and governance at Wageningen University in the Netherlands, Adina Alexandra Baicu, M.Sc., Ph.D. candidate at the University of Agronomic Sciences and Veterinary Medicine of Bucharest, Faculty of Biotechnology, and Professor Li Li, a research fellow from the China Academy of Inspection and Quarantine.
Food Safety Magazine: How would you describe your specific role in assessing the safety of the food entering your country (in other words, what is your role in ensuring global food safety)?
Sultan Ali Al Taher: Dubai is a gateway for food imports and exports in the Middle East region; Dubai ports are handling approximately 90 percent of all food trade of the UAE [United Arab Emirates]. The safety of the food entering in Dubai is being ensured by the Food Safety Department. Some of my specific roles in the department related to food entering the United Arab Emirates area are as follows:
• All food items are registered with labels and assessed prior to import.
• The compulsory documents (full manufacturing details, health certificates, etc.) are checked and verified at the ports.
• Samples are collected from the consignment for microbiological and quality analysis.
• Only safe and quality products (based on laboratory results) are released.
Robert Ahern: As an international organization, IICA helps countries modernize their food safety systems to ensure that they can safeguard consumer health while facilitating safe trade. IICA can provide needs assessments for national food safety services, coordinate the development of a common vision for improvement among the public and private sectors, and identify interventions to strengthen key technical capacities along the production chain.
Camille Brewer: First, let me point out that FDA regulates most foods consumed in the United States, except for meat, poultry, most processed egg products, and catfish. These food products are regulated by our colleagues at the United States Department of Agriculture (USDA).
My role at FDA is to contribute to the policy and programmatic framework for engagement with other nations that produce and export foods to the United States. My portfolio covers equivalence, systems recognition, capacity building, bilateral partnerships, multilateral food safety engagement, and public health and trade. Collectively, these areas serve to create a multi-layered framework that supports the safety of imported foods.
Let me give you an example of one of our programs that involves assessment. Systems recognition is a regulatory cooperation activity that allows FDA through a rigorous assessment process to identify comparable food safety systems. Among other things, once we have assessed a country’s food safety system and found it comparable, FDA can rely on the competent authority in that country to follow up if there is a food safety problem. This allows FDA to allocate resources based on risk, which allows us to focus our time and attention on areas of higher risk.
The assessment to determine comparability is based on the model we use for assessing our states. It is critical that we are balanced and evenhanded in our approaches to domestic and international assessment activities and that our assessment processes be transparent and replicable.
In addition, FDA participates in Codex Alimentarius, the international food safety standard-setting organization. The goal of Codex is to foster fair trade in safe food. The concepts of protecting consumers through safe food and promoting fair trade are mutually reinforcing. We consider Codex guidance and standards as we develop our own approaches to assessment activities. In this regard, the Codex Committee on Food Import and Export Inspection and Certification Systems is of importance to FDA’s approach for import and assessment activities.
With respect to your question about ensuring global food safety, it is important to point out that FDA plays an important role regarding the safety of U.S. food exports. FDA supports safe, wholesome, and accurately labeled food exports through our export certification activities. We also coordinate foreign audits of the U.S. FDA system of oversight, where foreign regulators review the U.S. system for a product or set of products, and of individual U.S. manufacturers or producers.
Collectively, FDA’s food safety activities contribute to raising the food safety standards and production practices globally.
Bernd van der Meulen: I am a food legal expert active as scholar, teacher, and consultant, as well as one of the chairs of the GHI Food Law and Regulations Working Group.
Adina Alexandra Baicu: In 2017, I became the cochair of the Food Law and Regulations Working Group of the Global Harmonization Initiative (GHI). GHI is a nongovernmental, nonprofit network of scientists striving for the promotion of harmonized food safety legislation globally. The members of GHI do not represent their employer, but their contribution is based on their individual scientific conscience.
The Food Law and Regulations Working Group tries to understand causes of differences, advance and propose possible instruments for food law implementation, having scientific evidence as a main pillar.
Li Li: I engage in the assessment of the national supervision system for foods exported to China and research the application of HACCP systems.
FSM: Which areas of food regulations do you feel are the most discordant between countries [e.g., allowed chemicals and doses, GMOs, irradiation, analytical methods, labeling]? What suggestions do you have for harmonizing these current regulations?
SAAT: GMOs [genetically modified organisms], analytical methods, and labeling are the most discordant between countries with regards to current food regulations.
The harmonization of current food regulations can be achieved by:
• Engaging a broader range of relevant stakeholders and observer organizations (e.g., NGOs [nongovernmental organizations], private sector, consumers) through intensive communication efforts.
• Embracing new technological developments to avoid regulatory divergence among high-income countries, while ensuring to avoid creating barriers for low-income countries’ harmonization of food safety regulations and their participation in international trade.
RA: More so than any specific regulation, there is great discord between countries regarding how they develop regulations. Countries that focus on hazards rather than risks contribute to a general misunderstanding around the safety of global food systems and promote unproductive and unfounded activism among specific consumer groups. Unfortunately, countries do not take these approaches to protect consumers; they take them to promote or protect specific production practices that would not be economically viable without such protections. These include but are not limited to use of hormones and veterinary medications in animals, planting and cultivation of genetically modified organisms, and use of gene editing techniques to improve products, yields, and consumer health. In this way, some countries undermine the fundamental principles of food safety and international standards for the short-term benefit of a small number of domestic producers.
In order to meaningfully achieve harmonization of regulations, all countries must commit to making regulatory decisions based on available, scientifically documented evidence, and using a transparent process for risk analysis and risk management to inform decision making.
CB: It would be difficult to speculate which areas are the most discordant. It is important to understand the underlying reasons for these divergences. For example, the U.S. may develop an MRL [maximum residue limit] for a pesticide before Codex develops an MRL. There may be a difference in the level by the time Codex undertakes developing an MRL. In addition, there may be differences based on our risk assessment.
The World Trade Organization [WTO] Agreement on Sanitary and Phytosanitary (SPS) Measures confirms the right of each member to determine its appropriate level of protection and balances this right with the obligation to ensure its SPS Measures are based on science, including risk assessment. There may be many reasons for variation in regulations. For example, differences in dietary exposure may lead to differences in risk assessment results. Other factors (e.g., cultural preferences, animal welfare) may contribute to regional or country-specific approaches. In addition, Codex recognizes “other legitimate factors” such as economic feasibility, environmental concerns, availability of resources that countries may consider for their national legislation. Codex notes that these factors should not be used to impede the adoption of global standards. The strength of the Codex standards is their basis in science and risk assessment.
BVDM: Exporters must always adjust labeling already because of differing languages. GMOs are very discordant and [so are] levels of contaminants. Many countries rely on standards of identity of foods that may cause important barriers to trade.
AAB: At the European level, the tendency is to harmonize the food legislation at the community level, yet not all aspects have switched to this approach, so the member states are left with the freedom to choose whether to prohibit or approve the cultivation of GMOs, what foodstuffs can be irradiated, or to set permitted chemicals and doses to be used, etc. Moving on to a global market, food legislation has its own particularities and discrepancies, dependent on the jurisdiction; so it is not only one area of food law that needs attention regarding global harmonization. Inconsistencies of food regulations are not always justified and often lead to the needless destruction of food, trade barriers, and hindrance of innovation. Scientists around the world have conducted numerous studies, and, in many cases, there is enough scientific evidence to produce consensus documents that could serve as basis for food legislation. Knowledge, time, money, and dedication are and were invested in scientific research that can be used to frame harmonized, up-to-date food legislation.
LL: In my opinion, the most prominent problem is the different kind of allowable chemicals and their MRLs, and labeling standard (allergens) in different countries.
I suggest that the process of formulating and issuing food safety standards should be more transparent, supported by more powerful scientific data, and reduce unnecessary compulsory measures.
FSM: Do you feel that the global food community should be moving to a single set of standards (Codex, GFSI, etc.) to not only improve food security but also to enhance innovation and investment in new technologies across the food supply chain? If so, who should take the lead and what would be required to achieve this goal? If not, what suggestions do you have for addressing food security issues and improving distribution capabilities to global markets?
SAAT: A single set of standards would have a positive impact on the amount and cost of resources used to test and inspect foods to ensure that they are safe. Also, it would reduce disputes about the safety of food between regulatory authorities of different countries and therefore minimize the destruction of food by them.
Given this perspective, the Codex Alimentarius Commission (CAC) should take the lead, as it is an intergovernmental body with over 170 members within its framework. It is also a joint venture of the UN organizations FAO [Food and Agriculture Organization] and WHO [World Health Organization].
A CAC platform with the goal of a single set of standards could be achieved by promoting coordination of all food standards work undertaken by international governmental and nongovernmental organizations.
RA: It is important to differentiate between food safety and food security; the former refers to ensuring that consumers eat and have access to food that will not make them sick, while the latter refers to various approaches to ensure that people have access to food. Some concepts of food security also prioritize national production to supply national markets and reduce demand for imported products. Regardless, the global community must agree on what constitutes “safe food,” and the Codex Alimentarius is the international reference for food safety. Importantly, the global definition of safe food must be adopted and accepted for all production and value chains, including those of small-scale, rural producers who primarily supply informal markets, to ensure that all consumers both expect and have access to safe food, regardless of who produces it or where it is produced.
Given political realities and market demands, it may not be possible to agree on a single set of food safety standards; indeed, many countries struggle to agree on common approaches among agencies within their borders. However, over the past few years, countries and the private sector have taken important steps to promote harmonization of food safety practices. GFSI benchmarking requirements are aligned with Codex Alimentarius standards, and GFSI works with countries to promote alignment with national regulations as well. The global food community is driving this process at the local level by ensuring that producers implement food safety programs, such as those benchmarked by GFSI, even when their national competent authorities are not capable of certifying the sanitary status of specific value chains. The global food community is also driving this change by insisting that countries update their food safety policies or simply adopt Codex standards as a means to facilitate safe trade, increase transparency, and improve the overall predictability of market access.
CB: It is not clear that standards alone, or a single set of standards would be the determining driver for development. Making giant strides in food security, innovation, and new technologies will involve standards but will also involve many other strategic actions such as making targeted investments in food safety, coordinated approaches to capacity building, the strengthening of domestic food safety infrastructure, and encouraging innovation in technology. There are no simple answers to development and innovation questions, and different strategies and approaches will be needed.
For example, it would be very challenging to develop a single comprehensive set of standards addressing all areas of food safety due to the complexity of consumption patterns. But can we continue to move forward in developing strong, useful standards that are broadly applied? Absolutely.
Codex is currently working on standards that could support food security and innovation. Standards can be a key factor in developing the future state of strong global food systems, which ensure the safety of foods being traded around the world. Private standards have played a unique role (e.g., the GFSI benchmarked certification processes), but they should be based on Codex.
This is a very exciting time for advancing an agenda to increase the availability of safe, nutritious foods, innovation, and new technologies. Who should take the lead? There will be leaders from many sectors that will do their part in advancing strong global food safety systems, including the private sector, development institutions, donor organizations, global banking institutions, consumers and consumer organizations, and academia. The UN Sustainable Development Goals embrace these aspirational elements. FDA is advancing a new era of smarter food safety that seeks to leverage the use of new and emerging technologies to create a more digital, traceable, and safer system. However, with respect to international standards for food safety, Codex should take a leading role.
BVDM: It is important to agree as much as possible on common standards. To this end, countries should pay more attention to the Codex Alimentarius. This means that in drafting food legal requirements, the Codex should always be taken into account and discarded only for important reasons.
AAB: A single set of standards, based on scientific facts, could be used to bring clarity to the ways to ensure food safety and security, as well as to promote innovation. A joint effort is needed to achieve such a goal, so an international forum of national authorities, NGOs, the academic and scientific community, the food industry, and consumer representatives should cooperate and be engaged in providing equivalence of standards, taking into consideration cultural particularities, specific food allergies, and intolerances. More than anybody else, governments should be open to listening to the voice of the scientists and release and implement legislation accordingly.
LL: I think that the global food industry should achieve “international co-governance of food safety” from the perspective of strategic development. A single set of standards is not applicable at this stage. Food safety needs continuous improvement, and innovation and investment need to be strengthened.
Also, I think the country or the regional organization with the largest volume of international trade and relatively perfect national governance system of food safety, including China, the United States, the European Union, and so on, should play the leading role. Government regulatory authorities, the food industry, public welfare organizations, and scientists should participate together to promote the global development and progress of food safety.
FSM: Do you think the ISO 22000 standard already meets the need for international harmonization? Why or why not?
SAAT: ISO 22000, especially its latest version (ISO 22000:2018), is the ideal standard for international harmonization of food safety management for businesses. It combines and supplements the core elements of ISO 9001 and HACCP to provide an effective framework for the development, implementation, and continual improvement of a documented food safety management system. Furthermore, it has been following internationally desired objectives to:
• Strengthen food safety,
• Ensure consumer protection and strengthen their confidence,
• Encourage cooperation between industries and governments, and
• Improve cost performance throughout the food supply chain.
CB: Both ISO 22000 and the Codex food hygiene standards, guidelines, and Codes of Practice are widely used. However, Codex is referenced in the WTO-SPS agreement, providing Codex a large and important role in providing guidance to the WTO and its members. Thus, Codex standards should be the basis for international harmonization.
BVDM: ISO 22000 is a food safety management system. It could contribute to global harmonization insofar as countries would be willing to accept certification against this standard as proof of compliance with national process requirements. Private standards such as ISO can be used as a tool to deal with differences in national requirements.
Additionally, private standards may provide tools to deal with diversity in public law requirements, but only up to a point. It would be helpful if the EU would recognize compliance with a GFSI-benchmarked standard as compliance with HACCP, and if the U.S. would recognize it as compliance with HARPC [Hazard Analysis and Risk-Based Preventive Controls]. This being said, if a business wants to export to the EU, it has to identify CCPs in its process; if it wants to export to the U.S., it needs to have a risk-based control plan and employ a Preventive Controls-Qualified Individual.
Apart from process requirements, product requirements apply. These include quality standards addressing the composition of products (how much cocoa in chocolate? are noncocoa fats allowed?), levels of contaminants, and allowed ingredients (novel foods, GMOs, food additives).
AAB: ISO 22000 can be taken into account as a starting point to structure possible food safety aspects and issues, as its recent actual framework strives to encompass real-time pitfalls of food safety management systems. As ISO standards address recent developments and requirements for food products and food processes, the rationale can be taken into consideration as a model to always incorporate freshly obtained and generally agreed [upon] scientific facts into the food regulations. In addition, the idea to integrate in a single standard all the possible areas of food safety, from farm to fork, including food processing and handling or inspections, can be kept in mind when addressing the complexity of the food chain and the converging potential risks.
ISO 22000 is, however, in the end, a private standard, so its ownership and management is by the private sector. It should be accessible by all countries and be operational for businesses at all levels. A more active cooperation with the public sector authorities is needed, so to provide transparency and trustworthiness of the standard, as well as to ensure the requirements listed are in line with the regulatory provisions, as well as with the (financial) capacities of each country. In fact, if scientific consensus is achieved with regards to various areas of food safety and the result is integrated into the law, the necessity of a private standard becomes questionable. Most standards are known to use stricter metrics to ensure food safety; however, the scientific basis for using the chosen numbers or measures should be generally accepted and recognized, to avoid overregulation.
LL: It does not satisfy the requirements. The ISO 22000 standard only builds a management system model. International coordination needs to identify and import more food safety policies and standards, as well as professionals who fully understand the food safety requirements of countries (regions) to support.
FSM: (“And if not” from the last question) What do you feel is the greatest impediment to harmonization of food safety standards and why?
RA: The greatest threat to this progress toward global convergence around food safety is the increasing role that consumer preference plays in regulatory and standard-setting processes. “Preference” is a very different concept than “safe,” and unfortunately some countries increasingly apply equal weight to both when making regulatory decisions and when participating in the international standard-setting process. This approach devalues the enormous effort that companies and countries invest to produce and regulate safe food. It is also ultimately more detrimental to food security than many in the developed world care to recognize because it spuriously limits market access and market opportunities for safe products.
CB: Cultural and historical factors that are not based on science can be powerful determinants related to the rejection of international standards. Other challenges include rapidly developing new food technologies and new models for how food is processed, packaged, and delivered to consumers.
BVDM: Democracy. Governments do as they think is best for their people. International trade and harmonization may be taken into account but other considerations as well, such as the fact that countries all claim that safety requirements are based on risk analysis, that is, on science, but very few seem willing to accept each other’s scientific assessments.
AAB: An important obstacle in harmonizing food safety standards is represented by the defective communication and cooperation between the scientists and the lawmakers, and vice versa, without an existing clear procedure between the two bodies. The importance of a greater integration of generally agreed [upon] scientific facts into the law, in real time, so the food regulations are updated together with the scientific progress, discoveries, and changes, should be more strongly emphasized. GHI is a network of individual scientists, able to check whether it is possible to establish global scientific consensus concerning food safety aspects propping up food legis-lation.
Another aspect that is slowing down the possibility of having globally harmonized food safety standards is the lack of harmonized legal terms. It is crucial to understand that, in different countries and different languages, terms can have different meanings and thus different applications. Such misunderstandings can set barriers to food trade, despite that, in reality, the measures taken are the same, but they are just presented differently. Last but not least, Global Harmonization Initiative is working on simplifying the data obtained by scientists, without cutting corners or losing the scientific truths and facts, but to make it understandable at all levels, by all people. The reason for such an endeavor is creating tools for education and training available and digestible by everybody, because equipping people with information can lead to protecting them.
LL: Different requirements of food safety in different countries.
We would like to thank all the panelists for their insightful comments and engaging discussion.Categories: Regulatory: International Standards/Harmonization