The Codex committee charged with developing world trade standards for nutritional and special dietary foods made significant progress in draft guidelines for vitamins and mineral supplements this week, including a historic agreement to base maximum levels on safety and risk assessment rather than recommended daily allowance (RDA) of nutrients.
After almost ten years of discussions the Codex Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU), meeting in Bonn, Germany since Monday, has agreed to move the amended draft guidelines on supplements to step five of the eight-stage standard-making process.
The key breakthrough, reported earlier this week, was a decision to delete the 100 per cent RDA option for setting maximum levels of vitamins and minerals, under section 3.2.2. This would have required that the maximum level of each vitamin/mineral contained in a supplement should not exceed 100 per cent of the recommended daily intake determined by the FAO.
Such assessment is still supported by countries such as Norway, Malaysia, Thailand, and much of Latin America, but there is growing backing for the use of upper safe levels instead of RDA to set maximum levels. The decision by Codex to also follow a risk assessment approach is a major victory for the industry, according to the International Alliance of Dietary Supplement Associations (IADSA).
"This is probably the single biggest decision to take place in the dietary supplements industry. Its impact is on the same level as DSHEA in 1994 (US regulation) and the EU Food Supplements Directive of 2002," Simon Pettman, executive director of IADSA, told NutraIngredients.com.
The Codex vote to remove RDA will play a major role in shifting views to support safety-based guidelines among those governments still backing RDAs, he added. For new members to WTO, such as China, Codex standards are likely to be key to future policy.
"There is nothing more critical than this for many manufacturers. This is fundamental to whether their products can enter international markets," continued Pettman.
Industry members did not succeed in removing bracketed text at the end of section 3.2.2, specifying that account should be taken of the reference intake values of vitamins and minerals for the population.
However maximum levels are now to be set based on upper safe levels established by generally accepted scientific data on risk assessment and the daily intake of vitamins and minerals from other dietary sources.
"We now have proof in a Codex guideline that risk assessment is the basis for calculating maximum levels of vitamins and minerals and the Recommended Daily Allowance now has no basis at the international level. Work will now have to be accelerated in many countries to explain to governments what risk assessment means in practice," said IADSA in a statement.
Last year's EU food supplements directive, which also bases maximum levels on established risk assessment data, significantly helped this decision, said Pettman.
"The directive has given the EU one voice, and especially since the inclusion on of new members, such as Poland, supporters of RDA were much less vocal in the meeting."
He added that some elements of the Codex guidelines are more practical than the directive and that this could help those outside Europe interpret the new regulations.
The meeting also agreed on deleting section 3.2.3 which gave countries the possibility to establish at the national level different maximum limits for the daily dose of vitamin and minerals, with a narrow safety margin between the recommended daily intake and the adverse effect level.
In addition the committee removed paragraph 3.1.3 which would have meant that the use of individual vitamins and minerals in supplements could be limited 'for reasons of health protection and consumer health and taking into account regional and national peculiarities on the supply situation of the population'.This section could have opened the door to arbitrary restrictions on product marketing.
Other articles under discussion included packaging requirements and labelling of supplements. Section 4.3, stating that vitamin and mineral supplements should be distributed in child-resistant packaging where necessary, has been deleted but a new paragraph (5.9), proposed by the EU, suggests that the label should contain a statement 'to the effect that the product should be stored out of the reach of young children'.
Further work needs be carried out on labeling reference values for vitamins and minerals, to come under section 5.5. The South African delegation has volunteered to chair an electronic working group in which the industry will be closely involved to discuss this issue further.
Other labelling requirements under section 5, such as a warning statement regarding the nutrient's toxicity level, were modified to be include more practical, positive advice.Section 5.9, asking labels to bear a statement that the supplement should be taken on the advice of a nutritionist, a dietician or a medical doctor, has also been deleted.
The new text, to be finalised at conclusion of the meeting tomorrow, can still be overruled by the Codex Alimentarius Commission, meeting next year in Geneva. The commission generally follows the committee recommendations but IADSA will now work to communicate the new text to governments to gain their support. The Bonn meeting saw less than 50 delegations while Geneva will attract around 140 member countries, noted Pettman.
But some governments are already talking about a significant change in approach and potential changes to legislation after this week's discussions, according to IADSA, including Thailand, which is currently rethinking regulation of supplements.
"Perceptions about our products and business appear to be improving. The 'health freedom lobby' was fortunately less aggressive and less visible than in previous years. This helped us communicate the responsible side of the industry and this was appreciated by governments attending the meeting," concluded IADSA's report.
IADSA is holding a regional conference in May in Prague to discuss future regulatory issues for the supplements industry.