Section A: Principles governing the establishment and revision of specifications and other related issues

Compendium of food additive specifications

The current Compendium of Food Additive Specifications was published in 1992, it consolidated all the food additives specifications that had been elaborated by the Committee up to that time. Specifications updated and developed at meetings since 1992 have been published in a series of Addenda, and FAO now plans to consolidate these together with the earlier specifications in a proposed new 2nd Edition of the Compedium.

At the 65th meeting the Committee considered a paper describing a number of issues that had arisen as a result of an exercise to draft a new introduction for the proposed 2nd Edition of the Compendium of Food Additive Specifications. As well as updating the current Introduction and current texts, the new Introduction is intended to serve as the basis for revising those sections of the Principles for the Safety Assessment of Food Additives and Contaminants in Food (Environmental Health Criteria 70) dealing with specifications.

The Committee noted that the new Introduction emphasizes that the setting of specifications is an inherent part of the risk assessment process for food additives, and that the safety evaluation of an additive should therefore always be read in conjunction with the specifications of identity and purity that describe the additive. The Committee also discussed the conditions under which the 'tentative' designation is applied to additive specifications and the possible link with the 'temporary' ADI designation. It agreed that although there should always be a clear link between the specifications and the safety assessment, the conditions under which the 'tentative' specifications and 'temporary' ADI designations are used should continue to be judged on a case-by-case basis. The Committee also reaffirmed that these designations should be time-limited.

Use of the terms "Anhydrous" and "Dried Basis" in specifications

In previous evaluations the Committee has used the terms "anhydrous", "dried basis" and "dry basis" in food additive specifications. The Committee agreed that this has been a source of misunderstanding, especially relating to "dry basis".

To clarify the position, the Committee agreed to discontinue the use the term "dry basis"and recommended that provisions in future food additive specifications should refer to either "anhydrous" or "dried basis" and agreed to interpret these terms as follows:

Anhydrous basis relates a) to the calculated amount of substance adjusted for the known stoichiometric number of molecules of water of hydration; and b) to the amount of substance adjusted for the measured amount of water as determined by the use of a method such as the Karl Fischer Method described in FNP 5.

Dried basis expresses the mount of substance rmaining after subjecting a sample to the stated conditions for loss on drying (duration, temperature, pressure, presence of a desiccant etc.).

Residual solvents

At the 61st meeting, the Committee recognized the need to revise the general method for the determination of residual solvents, which is published in FNP 5, and following that meeting, a tentative general method using headspace capillary gas chromatography with flame ionisation detection for the determination of residual solvents was published in FNP 52 Add. 11.

In reviewing the responses in the call for data for comments on the tentative general method, the Committee noted that the critical parts of the determination are the liberation of the solvent residues from the food additive and their capture through headspace sampling prior to the gas chromatographic step. The Committee decided, therefore, that the critical steps should be included in future individual additive specifications rather than in the general method. The Committee also decided that there was a need to revise the tentative general method to include more solvents. The Committee further recommended that methods for the analysis of many common solvents used in the preparation of food additives should be reviewed during the revision of FNP 5.

Safety evaluation of enzymes produced by Genetically Modified Microorganisms (GMM)

In 1987, the Committee outlined criteria for the safety evaluation of enzymes (Environmental Health Criteria 70, Annex III, 135-136). It was proposed to group enzyme preparations into 5 major groups on the basis of their origin (enzymes obtained from edible tissues of animals commonly used as foods; enzymes obtained from edible portions of plants; enzymes derived from microorganisms that are traditionally accepted as constituents of foods or are normally used in the preparation of foods; enzymes derived from non-pathogenic microorganisms commonly found as contaminants of foods; enzymes derived from microorganisms that are less well known). At the same time, the Committee envisaged three cases for the safety assessment of enzymes (added directly to food but not removed, added to food but removed; or immobilized enzyme preparations) and indicated guidelines that are appropriate for evaluation of safety in each case.

In 1987, the case of enzymes produced by genetically modified microorganisms (GMM) was not considered. Since then, the Committee has evaluated several enzymes produced by GMM, for example, laccase from Myceliophthora thermophila expressed in Aspergillus oryzae and xylanase from Thermomyces lanuginosus expressed in Fusarium venenatum. The Committee evaluated the safety of these two enzyme preparations on the basis of toxicological data that included, in both cases, a 90-day study in the rat, a test for reverse mutation in vitro, and a test for chromosomal aberration. The committee allocated an ADI 'not specified' to these enzyme preparations.

The present Committee evaluated an enzyme preparation of Phospholipase A1 produced by the same host strain of A. oryzae that had been modified to produce other enzymes. However, it could not assess the safety of Phospholipase A1 using the information available on one of the other enzymes produced by this host strain as comparators, and the Committee concluded that guidelines need to be developed for the safety assessment of enzymes produced by GMM. These guidelines should set out what information is essential for different enzyme preparations and what details of molecular characterization of the producing microbial strain are necessary to allow an adequate assessment of safety. Furthermore, the Committee reiterated the view expressed at its 57th meeting that the existing General Specifications and Considerations for Enzyme Preparations used in Food Processing should be revised, together with the elaboration of the guidelines for the safety evaluation of enzyme preparations within the Project to Update the Principles and Methods for the Risk Assessment of Chemicals in Food.

The Committee also recommended that the report from the Joint FAO/WHO Expert Consultation on Safety Assessment of Food Derived from Genetically Modified Microorganisms (2001) should constitute a starting basis for this future task.

Hexane

As used in the food industry, 'hexane' is a mixture of hydrocarbons. Recent changes in environmental regulations have led to a change in composition of hexanes since the original specifications were established. In addition, the composition of hexanes will depend on the region of production, the source of the raw material and the site of production. Therefore, the Committee concluded that the present articles of commerce differ from those previously evaluated by the Committee and that the composition of the residues and their levels in foods may not be the same as those evaluated in the original safety assessment. The Committee also concluded that there was insufficient information available to change the current specifications, and therefore recommended a re-evaluation of hexanes.

Monomagnesium phosphate and trisodium phosphate

As no information was received on these substances, the existing tentative specifications were withdrawn.

Previously evaluated flavourings agents

The Committee noted that seven of the 131 flavouring agents had been evaluated previously by the Committee and had food additive specifications. For such substances, the Committee has previously agreed that the material used for flavouring should comply with the existing food additive specifications:

• two of the substances, Maltol (No.1480) and Ethyl maltol (No. 1481), were believed to have uses in addition to flavouring agent uses. In addition to the prepared new specifications presented in flavouring agent format, the existing food additive specifications were revised;

• five of the substances (Eugenol (No. 1529), Methyl anthranilate (No. 1534), Methyl N-methylanthranilate (No. 1545), Ethyl 3-phenylglycidate (No. 1576) and Ethyl methylphenylglycidate (No. 1577)) have no other functional uses than as flavouring agents, and therefore the Committee decided that the specifications presented in flavouring agent format should replace existing food additive specifications.

Flavouring agents with a conditional safety evaluation

The Committee noted that an increasing number of the flavouring agents submitted for evaluation in recent years had no recorded poundage data in either the EU or the USA, and MSDI values could only be calculated on the basis of an annual poundage anticipated by the manufacturer. This was the situation for 60 of 135 flavouring agents on the agenda of the present meeting, and for a number of those evaluated during the 59th, 61st and 63rd meetings. As MSDI estimates based only on anticipated poundage data contain additional uncertainty, the Committee decided that in future either the dietary exposure to such substances should be assessed using an alternative approach, or the assessment should be deferred until actual poundage data were available.

The Committee decided that the Procedure would be applied where appropriate for the safety evaluation of flavouring agents submitted to this meeting, including those where anticipated poundage data were submitted for the USA and/or the EU. The evaluation was made conditional if it was based on an MSDI derived from anticipated poundage estimates, and the Committee decided that the results of the conditional assessments will be revoked if use levels or poundage data are not provided before the end of 2007.^[1] This decision was not unanimous, and two members registered a minority opinion.^[2]

The Committee also requested use levels or poundage data to be provided for the flavouring agents it had previously evaluated using MSDIs calculated from anticipated poundage. This includes any substances where the MSDI based on an anticipated poundage for one region (EU or USA) was higher than the MSDI based on a recorded poundage in the other region. The existing assessments for the following flavourings will be revoked if such data are not forthcoming by the end of 2007:

Further information required for specifications

Sodium 3-methyl-2-oxobutanoate (No. 631.2), Sodium 3-methyl-2-oxopentanoate (No. 632.2), Sodium 4-methyl-2-oxopentanoate (No. 633.2) and Sodium 2-oxo-3-phenylpropionate (No. 1479)

The existing tentative specifications for these four flavouring agents were revised to include new information on methods of assay. However, the tentative designations of the specifications were maintained, pending more detailed information on these methods. For the first three substances, information on an assay by HPLC using an ion exchange column are required, and for flavouring No. 1479 information on an assay by HPLC is required.

Maltol (No.1480) and Ethyl maltol (No. 1481)

New specifications were prepared for these substances in the flavouring agent format. However both substances are believed to have uses in addition to flavouring agent uses, and the existing specifications in the standard food additive format were revised and made tentative. In both cases information on functional uses other than flavouring uses and on the method of assay is required.

Maltyl isobutyrate (No. 1482), 3-Acetyl-2,5-dimethylfuran (No. 1506) and 2,4,5-Trimethyl-delta-3-oxazoline (No. 1559)

New tentative specifications were prepared for these substances. In each case, further information is required on the reasons why the quoted specific gravity ranges are wider than would be expected given the level of purity of the substances. In addition, further information is required on why the refractive index range for flavouring No. 1559 is wider than would be expected given the level of purity of the substance.

Sucrose esters of fatty acids

The specifications for sucrose esters of fatty acids were revised but maintained as tentative. Information is required on

• a method of analysis for the determination of free sucrose using capillary GC or HPLC;

• an alternative and less toxic solvent than pyridine for preparing the standard and sample solutions for the determinations of free sucrose and propylene glycol; and

• a method of analysis for the determination of dimethyl sulfoxide that does not require a packed column.

The tentative specifications mentioned above will be withdrawn unless the requested information is received before the end of the year 2006.