Global regulatory system needs ‘history of safe use’ definition: International scientific panel

By Stephen Daniells

- Last updated on GMT

Related tags: Codex alimentarius, Risk

An internationally recognized definition for history of safe use would greatly help policy recommendations is just one of many points argued by an international panel of scientists.

The paper, published in Regulatory Toxicology and Pharmacology​, summarizes a 2010 scientific conference held in Europe, sponsored by CRN-I, the international subsidiary of the Council for Responsible Nutrition.

Talking to NutraIngredients-USA, corresponding author John Hathcock, PhD, from CRN-I, explained that the meeting, and the subsequent paper, focused on two key areas: Risk assessment and health claims.

Health claims

“Measuring the health benefits of a food is a dramatic challenge,”​ wrote the authors. “Foods are complex mixtures of nutrients and other bioactives, concurrently triggering many metabolic pathways.”

“The challenge to developing regulations to promote public health with nutrition is to combine scientific scrutiny with a pragmatic approach to decision making without misleading the consumer or misdirecting critical resources.”

“It is critical to offer to the largest number of people access to the entirety of potential benefits that can be provided by foods and nutrients.”

The authors also turn their attention to the substantiation of such health benefits, noting that basing policy decisions solely on the results of Randomized Control Trials (RCTs) is not the optimal way of determining how nutrients can support good health.

“Although RCTs present one approach toward understanding the efficacy of nutrient interventions, the innate complexities of nutrient actions and interactions cannot be adequately addressed through RCTs or any single research design,” ​they wrote.

“Because of the limitations inherent in RCTs of nutrients, policy decisions should be made using the totality of the available evidence, as required by law in many jurisdictions.”


When assessing safety, Dr Hathcock said that this should follow a risk assessment approach, and that measures such as RDAs are not a basis for safety evaluation.

“Studying dose–response, and developing pertinent dose–response experimental designs are central to determining ‘safe,’ ‘admissible,’ ‘tolerable,’ ‘hazardous’ and ‘toxic’ exposures for advertent or intentional chemicals in food, contaminants, persistent pollutants, and other substances to which humans or other organisms are exposed.

“The identification of acceptable limits (by applying risk assessment), based on a robust scientific approach, should be the primary basis for risk management policy.”

The authors also argue that a product category’s history of safe use should be considered in making policy recommendations, and they go so far as stating that, “The global regulatory system would benefit from an internationally recognized definition for history of safe use and agreed set of criteria to establish such a history.”

The Codex Alimentarius framework

Codex is recognized by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).

Despite Codex decisions being not binding, many governments do routinely look to Codex when developing their national food regulations.

Dr Hathcock explained that many countries help Codex, and the “routinely ignore the results”​. On the other hand, many small countries that have insufficient total scientific resources, do turn to Codex documents as “templates”​.

With the paper in publication, Dr Hathcock and his co-authors will now start sharing their views with select members of the relevant Codex committee, he said.

Source: Regulatory Toxicology and Pharmacology
​Volume 60, Issue 1, 1 June 2011, Pages 161-164
“Scientific issues related to Codex Alimentarius goals: A review of principles, with examples”
Authors: A. Somogyi, J. Hathcock, H.K. Biesalski, J.B. Blumberg, J-M. Antoin, G. Edwards, P. Prock

Related topics: Regulation

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