Food Additives: Slow Progress (Reflections on the Codex Alimentarius Committee on Food Additives’ recent meeting)

May 12, 2011

Progress on the GSFA at the 43rd session was very slow, and a number of agenda items were held over until next year. However, some items relevant to supplements were discussed.

The 43rd session of the Codex Alimentarius Committee on Food Additives (CCFA) met in China from March 11 to 18. This Committee represents part of the regulatory arm of the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO). The CCFA is responsibile for assessing all food additives, agreeing on the categories of food in which additives can be used, and assigning maximum levels of use for the additives in each category.

The principal objective of the Committee is to develop and maintain a compendium of permitted food additives and levels, known as the General Standard for Food Additives (GSFA). The GSFA is now at an advanced state and is already being used by countries around the world as the basis for their food additive legislation.

Supplements are a category covered by the GSFA. In countries where supplements are sold under food law, the permissions and levels in the GSFA will eventually apply. Thus, the GSFA is extremely important to the long-term regulatory environment for supplements.

Progress on the GSFA at the 43rd session was very slow, and a number of agenda items were held over until next year. However, some items relevant to supplements were discussed.

First, while the European Union delegation and some other European countries had reservations on almost all the proposed maximum levels for steviol glycosides (INS 960), the CCFA agreed to take into consideration a proposal from the International Alliance of Dietary/Food Supplement Associations (IADSA) to increase the level from 1820 mg/kg to 2500 mg/kg (as steviol equivalents), based on technological justification. However, this level was agreed on with the reservation that it apply only to chewable supplements.

Secondly, erythrosine (INS 127) is no longer a permitted color for supplements in the GSFA following the concerns of the European Union and a large number of other countries.

Additionally, there was a proposal to delete the “magnesium salts of fatty acids” from the Codex International Numbering System (INS). This category includes magnesium stearate, an essential additive for the production of supplement and confectionery tablets. IADSA offered technological justification for not deleting the additive, which was endorsed and assigned the INS number 470(iii).

However, although the additive was scheduled for deletion and has now instead been reinstated with a new INS number, it must now be evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) before it can be added to the GSFA. A further complication is that the application for a JECFA evaluation can only be made by a Codex Member State and must be supported by data demonstrating the safety of the additive. And the final complexity: this data can only be provided by the manufacturer of the additive. With current pressure on JECFA priorities, an application for an assessment of magnesium stearate must therefore be made to the 44th session of the CCFA in March 2012. To do this, there will need to be speedy cooperation from the manufacturers or suppliers of the substance and the Member State coordinating the project, because the application must be filed no later than the end of October of this year.

There was also extensive discussion on the future of food additives containing aluminium. Proposals from last year’s discussions were to revoke all provisions in the GSFA permitting aluminium-containing additives and to only agree on future provisions for such additives when there is a full technological justification that their function cannot be undertaken by other permitted additives-for example, in the case of anticaking agents where aluminium silicates could not be replaced by silicon dioxide.

JECFA had been requested to evaluate the safety of aluminium-containing compounds, but its report was not available in time for this session of the CCFA. Therefore, the Chair finally decided not to remove any aluminium substances from the GSFA until the report is available. It is clear, however, that the objective is to significantly reduce the current exposure of aluminium-containing compounds, and it is highly probable that most uses of aluminium-containing additives will be revoked. Therefore, companies should put effort into finding suitable alternatives.