Although the EHPM/ERNA generated model of dosage regulation is not perfect, says Bert Schwitters, CEO of International Nutrition Company, it should very well be put to use in an effort to regulate and manage the risks of nutrient concentrations in foods, in the context of Normal Intended Use. Only by showing that the food industry is capable of implementing and following a set of regulations - even industry generated ones - can the push for top-down legislative control of health foods be headed off. The health food industry, in other words, has to demonstrate it can be trusted with the responsibility to regulate itself by actually following a set of rules, such as the EHPM/ERNA risk model, if it wishes to avoid the restrictive and at times destructive interference by law makers and regulators.

"The discussion about the assessment and management of micronutrients has become somewhat of an academic, extra-industry affair. It’s very theoretical, hypothetical and academic, although the word academic is an overstatement in view of the thin scientific varnish that covers most models and the related discussions. Today, the EHPM/ERNA Model and its 'competing counterparts' are floating in the higher extra-industrial political, regulatory and semi-scientific echelons. Industry should kick in and respond by putting the EHPM/ERNA Model to use and test it in the setting it was designed for: risk management in and by Food Business Operators."

Alliance for Natural Health

Another entity that responded to the EU Commission with a detailed submission is the Alliance for Natural Health (ANH), situated in the UK but representing medical doctors, complementary health practitioners, consumers as well as food manufacturers and distributors from all over Europe. The Alliance's director Dr Robert Verkerk says that the EU authorities' approach to risk assessment and management will lead to inconsistent outcomes and in some cases to restrictions on dosage that may prevent optimal amounts of nutrients from being available to consumers.

"The EC and EFSA appear to be prematurely seeking to establish limits on allowed vitamin and mineral ingredients (and soon phytonutrients, essential fatty acids, amino acids, and other groups of nutrients) (under Article 4 of the Food Supplements Directive) as well as limits on dosages (Article 5) when proper methodologies for risk assessment, and more specifically risk/benefit assessment, have yet to be defined and validated properly.

Such an approach can only be made to work if extremely and disproportionately precautionary approaches are adopted, and while these can be justified for environmental chemicals and other toxins, there is no evidence of adequate justification for their use in the case of nutrients which are consumed primarily for their beneficial properties."

The entire ANH document - Consultation response to the European Commission Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs - is available here.

Links:

EU Food Supplements - Will Directive Worsen Consumer Health?