Residual ethanol
Extraction solvents are used in the production of various food additives, and among these solvents is ethanol. Where solvents are employed, the specifications for those additives usually include limits for the residues of such solvents. The Committee was requested to consider whether a requirement for a limit for residual ethanol should also be included in such cases. It concluded that from the point of view of good manufacturing practice, ethanol should not be considered differently from other extraction solvents, and it reaffirmed the requirement for residue limits to be specified for all such solvents, including ethanol. The Committee noted, for instance, that the existing specifications for cochineal extract and xanthan gum indicate that ethanol is used as a solvent in their production, but that their specifications do not contain criteria for residual ethanol. An ethanol limit was included in the specification for xanthan gum which was revised at the present meeting.
Heavy metals (as lead) limit test
The Committee agreed to implement the decisions taken at its forty-ninth and fifty-first meetings to review and replace the heavy metals limit test with limits for individual metals of concern in all existing specifications as appropriate. In order to accomplish this, the Committee decided to review systematically the existing specifications on the basis of functional use (e.g. antioxidants, preservatives) and set a target of five years for completion of the task.
The call for data for future meetings will include requests for suggested limits for individual heavy metals in a group of additives together with supporting data. Once the Committee has considered the submissions, proposals will be submitted for consideration by the Codex Committee on Food Additives and Contaminants for adoption by the Codex Alimentarius Commission.
The Committee reaffirmed its earlier conclusions that it would usually set a maximum level of 2 mg/kg for lead and 1 mg/kg for cadmium and for mercury, except when there were good reasons for setting a lower or higher maximum level. The Committee also reaffirmed its earlier decision to include limits for arsenic only when the source from which the additive is prepared, or the nature of the manufacturing method, indicated that such a limit was necessary.
The Committee reaffirmed the point made at earlier meetings that, when the heavy metals limit test is replaced by specific limits, the intention is not to weaken the specifications but to ensure that limits are placed on the levels of those elements that are likely to be of potential concern.
Citation of microbial strains
At its fifty-first meeting, the Committee revised an addendum to the general specifications for enzyme preparations used in food processing which addressed preparations from a genetically modified organism, originally published in FAO Food and Nutrition Paper 52 as Appendix B to Annex 1, and published in Addendum 6. At the present meeting, the Committee further reviewed the specifications for numbering microbial strains in the light of comments received by the Codex Committee on Food Additives and Contaminants at its thirty-first meeting.
The Committee reaffirmed that the requirement for identification of a strain number in the source section of monographs on enzymes prepared from genetically modified organisms might impose unnecessary constraints on the development of production organisms for food-grade enzymes. The Committee concluded that the source section of the monograph on an enzyme derived from a non-pathogenic, non-toxicogenic strain that belongs to a species that includes pathogenic and toxicogenic strains should include the statement that 'the strain is non-pathogenic and non-toxicogenic', and citation of a suitable strain number could be included by way of example.
The Committee, therefore, amended the requirement for microbial strain numbers in the specifications section of Appendix B to Annex 1 as follows (new text in quotes):
Microbial strain numbers - Any microbial strain that meets the considerations described above should be a safe and suitable host for the introduced DNA. Citation in the monograph of the genus and species of the host organism is usually adequate for those that have been determined to be safe and suitable. Identification at the strain level may impose unnecessary constraints on the development of production micro-organisms used to produce food-grade enzymes. "In the case of a non-pathogenic, non-toxicogenic strain that belongs to a species that includes pathogenic and toxicogenic strains (e.g. Escherichia coli), there should be a requirement in the monograph that the strain be non-pathogenic and non-toxicogenic. Citation of a suitable strain number may be included by way of example."
The Committee further decided that lack of pathogenicity and toxicogenicity was a general requirement that should apply to all micro-organisms used to produce food-grade enzymes. It also agreed to the addition of the following text to the end of the section on source materials of the General specifications for enzyme preparations used in food processing published as Annex 1 to FAO Food and Nutrition Paper 52.
" When a non-pathogenic, non-toxicogenic strain belongs to a species that includes pathogenic and toxicogenic strains, the source section of the monograph for the enzyme should include a requirement that the strain be non-pathogenic and non-toxicogenic. Citation of a suitable strain number may be included by way of example."
The Committee further agreed that the source section of any monograph for a food additive that has been prepared from a micro-organism that belongs to a species that includes pathogenic and toxicogenic strains should include a requirement that the strain be non-pathogenic and non-toxicogenic. Citation of a suitable strain number may be included by way of example.
Tentative specifications for food additives
The Committee noted that many of the specifications for food additives (other than flavouring agents) published in the FAO Compendium of Food Additives Specifications and its addenda are designated as 'tentative', indicating that some information or data were missing or incomplete at the time the specifications were prepared. Some of these specifications have been designated 'tentative' for more than 30 years and often do not indicate why the designation was given. Newer specifications include the reasons for the designation.
The Committee prepared two lists that encompass all of the existing tentative specifications except those for flavouring agents. List 1 comprises older tentative specifications that do not include reasons for the tentative designation. List 2 contains the remaining tentative specifications, for which reasons are given for the designation.
Information on the present uses and the technical data on the additives in the list, will be requested if no data are received. If the substance is no longer used in foods, the tentative specifications will be withdrawn. Information will also be requested on the listed reasons for those substances in List 2 so the Committee can review the available information and data submitted to decide if the tentative specifications should be withdrawn.
Specifications for flavouring agents designated as 'tentative'
Between 1996 and 1998, the Committee developed specifications for the purity of 449 flavouring agents, of which 111 were designated as 'tentative' because certain necessary information was lacking. In making these designations, the Committee relied on its judgement rather than on a carefully defined system. The present Committee agreed that it was important to be consistent in applying tentative designations and agreed that specifications submitted for consideration at the present meeting should be designated as tentative if information had not been provided on:
chemical formula and relative molecular mass
identity test and
minimum assay value
and on the additional purity-related criteria:
boiling-point (for liquids)
melting-point (for solids)
refractive index (for liquids) and
specific gravity (for liquids).
The Committee will, however, consider full specifications when the absence of one or more of the last four purity-related criteria can be justified.
Using this approach, the Committee designated 110 of the 187 specifications submitted for consideration at the present meeting, as tentative. In order to ensure consistency, the Committee agreed that the specifications for the 449 flavouring agents evaluated at the forty-sixth, forty-ninth, and fifty-first meetings should be re-examined by the same approach. As a result, the tentative designation for one of the specifications (No. 8, allyl sorbate) was removed, and 54 other specifications were given a tentative designation. Although some of the flavouring agents are well-characterised substances, e.g. acetaldehyde and acetic acid, they are included because not all of the information required to satisfy the criteria set out above regarding their use as flavouring agents was included in the material submitted.
Overall, 164 out of the 449 specifications set at the previous three meetings are now designated as tentative, making a total of 277 designated as tentative out of the 636 specifications for substances considered between 1996 and the present meeting. The Committee agreed that flavouring agents submitted for evaluation at future meetings would not be considered for specifications unless the minimum information set out above was provided.
The Committee concluded that its first priority is to seek further information on these tentative specifications; however, it also intends to re-examine the specifications that may not be designated as tentative but for which the minimum assay values are less than 95%, and data will be called for review at its fifty-fifth meeting in 2000. If these data are not supplied, the specifications will be withdrawn.
