An industry regulatory perspective following CCNFSDU45
6 min read
Working with food supplement regulations across different countries has taught me something important: a product that complies with the requirements of one market may face a completely different regulatory situation in another.
Sometimes the difference lies in how the product is classified. In other cases, it concerns the ingredients, the claims permitted on the label or the procedures required before the product can be marketed.
These differences are part of the everyday reality of international regulatory affairs. They also explain why international harmonisation remains such an important subject for the food supplement industry.
During the 45th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU45), held in Nuremberg, Germany, I had the opportunity to follow discussions that brought many of these challenges back into focus.
One of them was the proposal to revise the Codex Guidelines for Vitamin and Mineral Food Supplements (CXG 55-2005).
An important opportunity to revisit international guidelines
The Guidelines for Vitamin and Mineral Food Supplements were adopted in 2005, following years of discussions among Codex members.
At the time, reaching an international agreement on vitamins and minerals was already a considerable achievement.
The Committee recognised that food supplements could contain a broader range of ingredients. However, given the differences between national regulatory frameworks, the guidelines focused on vitamins and minerals, while leaving open the possibility of considering other substances in the future.
More than two decades later, the food supplement sector has evolved considerably. Product development, scientific research and consumer expectations have contributed to a market that includes an increasingly diverse range of ingredients and formulations.
Against this background, I welcome the initiative presented by Panama at CCNFSDU45 to review and update CXG 55-2005.
Panama's willingness to bring this proposal forward represents an important contribution to the Committee's work. International standard-setting benefits from national delegations prepared to take the initiative, engage with different stakeholders and facilitate discussions on matters of common regulatory interest.
Nevertheless, proposing an initiative is only the starting point.
Once a proposal is submitted to the Committee, its technical content, scope and justification become part of a collective evaluation process involving member delegations with different regulatory experiences and national priorities. This is not necessarily an obstacle. It is part of how international consensus is developed.
At CCNFSDU45, the Committee agreed to submit the proposal to revise the guidelines for approval by the Codex Alimentarius Commission, maintaining the immediate focus on vitamins and minerals.
The possible consideration of other substances was treated separately, through a preliminary assessment to determine whether future work could be justified.
I see this as a practical approach. It allows progress on an established international reference while recognising that other ingredient categories may require their own technical consideration.
??????The discussion goes beyond vitamins and minerals
The question of how international guidance should address other substances used in food supplements has been discussed for many years. It is also worth acknowledging the work undertaken by different organisations and national delegations to bring these subjects to the attention of Codex.
A relevant example is the initiative introduced by the International Probiotics Association (IPA) in 2017 to develop harmonised guidance for probiotics in foods and food supplements.
The proposal was subsequently advanced through the work of Argentina, together with Malaysia and China, addressing matters such as definitions, quality, safety and labelling. In 2024, the Committee agreed to request an updated scientific review from FAO and WHO, leaving open the possibility of considering a new work proposal on probiotics once that assessment is completed.
These efforts reflect a broader interest in developing internationally recognised scientific and technical references for ingredient categories that are already part of the global food market.
They also demonstrate the value of engagement between national authorities, scientific organisations and industry stakeholders.
Importantly, work on specific categories such as probiotics should be considered on its own merits. It is distinct from the current proposal to revise the guidelines addressing vitamins and minerals.
There may be opportunities for these initiatives to complement one another over time, provided their objectives and respective scopes are clearly understood.
For me, this is one of the strengths of the Codex process: different proposals can contribute to a broader regulatory discussion, even when they follow different technical and procedural paths.
What this means in practice: The Latin American experience
International harmonisation becomes particularly relevant when we consider the regulatory landscape of Latin America.
Although countries within the region share certain regulatory references and, in some cases, participate in regional harmonisation initiatives, their national requirements for food supplements can differ significantly.
From my experience, there are five areas that companies need to consider when developing or introducing food supplements into these markets.
Regulatory classification
Classification is the starting point. A product recognised as a food supplement in one market may be subject to different legislation elsewhere, depending on its composition, intended use, presentation or the definitions established under national law.
In certain circumstances, the same product could fall under food legislation in one country and medicinal product legislation in another.
This can substantially change the regulatory strategy required for market access.
Labelling
Labelling is another area where regulatory differences become particularly visible. Compliance is not simply a matter of translating an existing label into Spanish or Portuguese.
Countries may establish different requirements for nutrition information, ingredient declarations, mandatory statements, warnings and other particulars.
Even within the same product category, these differences can require substantial adaptations to labelling.
Nutrition and health claims
Claims present an additional challenge. The existence of scientific evidence supporting a particular claim does not automatically mean that its use is permitted on a food supplement label.
Some markets allow specific nutrition or health claims under defined conditions, while others impose more restrictive approaches, including prohibitions on certain categories of claims.
This distinction is fundamental when companies develop international communication and labelling strategies.
Composition
The regulatory treatment of ingredients is equally important.
Vitamins, minerals, botanicals, probiotics, enzymes and other bioactive substances may be subject to different conditions of use, safety requirements or restrictions depending on the country.
An ingredient permitted in one market may require additional evaluation or may not be authorised in another.
These differences have direct implications for formulation development and the feasibility of introducing the same product across several markets.
Market access
Market access procedures also vary, and they are not necessarily static.
Brazil provides a particularly interesting example: in September 2024, ANVISA introduced a revised framework for the regularisation of food products under RDC No. 843/2024 and IN No. 281/2024.
Under the previous system, many food supplements were subject to a communication of the start of manufacturing or importation to the local health authority. Supplements containing probiotics or enzymes were generally subject to registration with ANVISA.
Under the revised framework, food supplements, including those containing probiotics or enzymes, became subject to notification with ANVISA.
This is a significant procedural change, although notification does not remove the obligation to comply with applicable safety, composition and labelling requirements.
It illustrates how regulatory requirements can evolve even when the underlying product category remains the same.
For companies operating internationally, understanding these developments is essential. Market access involves not only identifying the requirements applicable today, but also anticipating and managing regulatory changes over time.
Making Regulatory Harmonisation Work for Industry
The Latin American experience illustrates why harmonisation should not be confused with uniformity.
Countries have legitimate reasons to maintain different regulatory approaches, reflecting their public health priorities, legal frameworks and national circumstances. At the same time, excessive regulatory divergence can create uncertainty and unnecessary complexity for companies seeking to operate across several markets.
I believe the value of international standards lies in helping bridge these differences. Codex texts provide common scientific and technical references that support the development and review of national regulations. However, international guidance does not automatically replace national legislation, nor should we expect every country to implement it in exactly the same way.
The challenge is to establish sufficiently clear principles that support regulatory convergence while allowing authorities to address their national priorities. This becomes especially relevant when considering ingredients and product categories for which international approaches are still evolving.
Regulatory leadership is also about building consensus
Following the discussions in Nuremberg, I was reminded that international regulatory work requires more than technical knowledge. It requires dialogue, an understanding of different national/industry perspectives and a willingness to examine proposals beyond one's own regulatory experience.
The involvement of organisations representing industry, scientific expertise and other stakeholder interests is valuable in this process. These contributions can help identify regulatory needs, provide technical evidence and support the development of practical solutions. National delegations, in turn, have an important role in bringing these matters into the Codex process and participating in their collective evaluation.
Regulatory leadership also involves fostering constructive dialogue, recognising different perspectives and working towards consensus on matters of common interest. Sometimes the most valuable contribution is helping to identify an achievable scope, strengthening the scientific justification or creating the conditions for future work. In this respect, I consider Panama's initiative an encouraging example of international regulatory engagement.
The responsibility for determining the outcome, however, belongs to the Committee and, where applicable, the Codex Alimentarius Commission.
Looking ahead
With the next CCNFSDU session tentatively scheduled for April 2028, the work undertaken between sessions will be important.
The proposed revision of CXG 55-2005 offers an opportunity to review international guidance that has been in place for more than twenty years. At the same time, developments involving other ingredient categories highlight the continuing need for scientific discussion and regulatory cooperation.
For those of us working directly with food supplement regulations, these discussions are far from theoretical. Their outcomes may eventually influence the way national authorities classify products, assess ingredients, establish labelling requirements or approach market access. That is why I believe regulatory professionals should remain actively engaged in following and contributing to international standard-setting.
The real value of harmonisation lies in developing practical international guidance that supports national authorities, facilitates market access and protects consumers. That, to me, is what meaningful progress in international food supplement regulation should look like.
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