Notes on the 42nd Session
of the
Codex Committee on Food Additives
Held in
Beijing, China 13th to 19th March 2010
1. Background
The 42nd session of the Codex Committee on Food Additives (CCFA) was attended by IADSA, an accredited NGO. The main objective of this committee is to complete and maintain the General Standard for Food Additives (GSFA). The GSFA, which has been in use for the last few years and which can now be accessed on line, is becoming the authoritative international list of food additives together with maximum levels of use in food products. At present the food products are contained in 16 categories with each main category being subdivided into more specific sub-categories. For example, food supplements fall into sub-category 13.6, with 13 being dietetic foods. Maximum levels for an additive in each category are derived from the Acceptable Daily Intake (ADI) and apportioned to each sub-category on the basis of justified technological need and usage/intake of the product.
Each annual session of the CCFA is preceded by both an electronic working group and a physical working group on the GSFA, with the physical working group being held during the weekend before the Plenary Session of the CCFA.
As discussions on some additives have taken longer than expected (e.g. over two and a half hours on Caramel III), it was recommended to the Committee that, from next year, an extra day be added to the physical working group to try and speed up the decisions on the thousands of additive provisions still to be discussed.
For the past few years additives for supplements have featured strongly in the discussions, and IADSA have only succeeded in getting adoptions of the additives and their levels through good groundwork on the technical justifications.
In addition to the GSFA, the CCFA has a role in reviewing and adopting additive proposals put forward by the other Codex Committees.
2. Specific Issues Relating to Supplements and their Ingredients in the GFSA
During the 42nd Session progress on the GFSA was very slow and relatively few provisions were adopted. The two adoptions relevant to supplements were:
- INS 150c. Caramel III Ammonia process, which was agreed at 20,000 mg/kg for colouring purposes.
- INS 338, 339 i-iii, 341 i-iii, 342 i-ii, 343 i-ii, 450 i-iii, 450 v-vii, 451 i-ii, 452 i-v, 542 Phosphates.
The committee agreed a maximum level of 2,200 mg/kg (as phosphorus) as a technological additive for supplements. It was based on the need being mainly for liquid supplements. The use of phosphates for nutritional purposes (e.g. supply of calcium and phosphorus) was not considered to be an additive use and therefore outside the scope of the GFSA.
Due to recent safety concerns over the para-hydroxybenzoates (INS 214, 218) and their prohibition for use in supplements by the European Union and some other countries, there was no support from the EU and American delegations for their use in supplements.
There was a brief discussion on the categories of use for INS960 steviol glycosides as a sweetener. It was agreed during the meeting that the input levels should be based on the steviol content.
Although food supplements (13.6) were accepted for inclusion in the categories of use for steviol glycosides, there was a wide disparity between levels suggested by member states/NGOs. The following levels had been submitted:
5500mg/kg – by CGMA / FAC
2000mg/kg – by the Philippines
50mg/kg – by Australia and Mexico
Information is urgently needed from companies using steviol glycosides as a sweetener in liquid and chewable supplements giving the range of levels currently in use, the justification for the use of the sweetener, and the lowest level of use that will achieve the desired effect.
There was a problem concerning salts of fatty acids (INS 470) in that the committee had been recommended by an electronic working group to delete magnesium salts of fatty acids. This would affect magnesium stearate, which is essential to the production of supplement and confectionery tablets. An intervention by IADSA to support the retention of magnesium stearate was held over until the next meeting in 2011. In the meantime data on the use of magnesium stearate will be requested from the industry so that a full justification may be submitted in advance of the next meeting.
There was considerable discussion on the use of lycopene as a colour. In the EU the EFSA has recommended a very significant reduction in the permitted lycopene levels and this was reflected in the EU delegation’s stance at the meeting. There was concern and confusion at some of the high levels submitted, particularly a request for 500mg/kg for fermented milk drinks. The main cause of the problem was that there are different lycopene contents in the commercially available sources and the committee agreed to emphasize that the levels must be based on pure lycopene content.
The following additives recommended for adoption for use in supplements were not discussed due to time limitations and will be considered at the 2011 meeting:
- INS 200-203 Sorbates. Recommended for adoption at 2000mg/kg for use in liquid supplements.
- INS 474 Sucroglycerides. Recommended for adoption at GMP level. It is unlikely that GMP will be replaced by a numeric maximum. Information on current levels of use is urgently required.
- INS 962 Aspartame-Acesulfame salt. This double salt is recommended for adoption for supplements at 2000mg/kg.
There will also be continuing discussions on levels of use of aluminium-containing additives.
3. JECFA Priorities
The committee discussed the future work and priorities for the Joint Evaluation Committee on Food Additives (JECFA).
A request for a safety evaluation of aluminium-containing food additives was given high priority and scheduled for 2011 when further data should be available.
Other substances accepted for safety/exposure assessments were pullulan (as a dietary fibre source), pullulanase and gum benzoin (Benzoe tonkinensis). A request for a safety assessment of Panax ginseng was refused on the basis that ginseng had no food additive function. The EU delegation requested a re-evaluation of the safety of three colours: quinoline yellow (INS 104), sunset yellow (INS 110) and Ponceau 4R (INS 124). This request was on the basis of a recent EFSA safety assessment that recommended lower ADIs. The JECFA secretariat requested data on the key studies used by EFSA for their evaluation.
Following discussions at the Codex Alimentarius Commission in June 2009 on the proposed levels for the use of erythrosine (INS 127) as a colour, the recommendations on erythrosine were returned to the CCFA for re-consideration. JECFA was requested to carry out a refined exposure assessment but pointed out that it was unaware of relevant new data. It was suggested that industry be consulted to determine the scope of use of erythrosine in foods. Under the circumstances it was concluded that there was no need for JECFA to carry out further work on exposure at this stage. If erythrosine is currently being used in supplements will the companies using it please urgently notify IADSA of the products using it together with the levels of use and an indication of approximate volumes (e.g. millions or billions of tablets or capsules). It is very likely that the permitted usage of this colour will be drastically reduced over the next few years.
JECFA was asked to carry out a re-evaluation of the safety of octenyl succinic acid (OSA) modified gum following a specific question that had been raised. There was also agreement that polydimethylsiloxane (INS 900a) should be re-evaluated to resolve issues concerning the temporary ADI. It was confirmed that new data will be available by November 2010.
4. Other Issues
At present, additives are only considered for the authorised functional classes, most of which were determined three or four decades ago. During discussions on magnesium stearate and the cellulose ethers it became apparent that their use in tablets did not fit into the authorised functions. Tabletting aid is not an authorised function. During informal discussions with other NGOs and two member states it was suggested that IADSA formally petition the committee to have a new functional category of tabletting aids. If the petition goes ahead it would have to be inclusive of all additives performing that function. Information is urgently required on the use of approved food additives as tabletting aids.
5. Urgent Requests for Data
In order to speed up work on the GSFA, the committee agreed to set up a number of electronic working groups, each with specific tasks. These working groups will start operating in the near future and there are likely to be a number of calls for data over the year. Those relevant to supplements of which we are already aware are:
i) Usage and usage levels of steviol glycosides as a sweetener.
ii) Usage and usage levels of magnesium stearate in tablets.
iii) Usage and usage levels of lycopene as a colour in liquid and solid supplements.
iv) Confirmation that 2000mg/kg of sorbates is acceptable for use as a preservative.
v) Current levels of use and functions of Sucroglycerides in supplements.
vi) Confirmation that the recommended maximum level of 2000mg/kg of aspartame-
acesulfame double salt is appropriate for liquid and chewable supplements.
P. Berry Ottaway
31st March 2010