สิ่งที่ส่งมาด้ว ย 2 Form for Public Hearing (Draft) Ministry of Public Health’s Notification number ... B.E. .... For Enzyme for processing aid in Food use Information of submitted person Name – Surname .Patrick Fox ....Position...Secretary General Organization/ and Address…....AMFEP. 188A, Avenue de Tervueren, 1150 Brussels, Belgium.................................. Tel ... +32 2 761 16 77 Fax.............................................................................. These comments are being submitted on behalf of AMFEP, ETA and IFAC 1. Having Enzyme for processing aid to be classified as Food additive which is Special Control Food according to the Law today Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) Enzymes may be regulated, but should not be classified, as Food Additives because they are almost exclusively used as Processing Aids in accordance with the CODEX definitions and guidelines1: Processing Aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the non- intentional but unavoidable presence of residues or derivatives in the final product. Scope: Provisions for the use of processing aids (e.g. most enzyme preparations, clarifying and filtering aids, extraction solvents) are not included in the General Standard for Food Additives. 1 According to the Codex Alimentarius Commission, Procedural Manual, Section I, Definitions for the purpose of the Codex Alimentarius and Section II: Elaboration of Codex texts Thus, we propose to change Clause 1 to read: “Enzymes used in the food production process are food processing aids which are controlled foods.” 2. Definition of “Enzyme”, “Enzyme Preparation” and “Immobilized Enzyme” according to Article 2 in the draft Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) 3. 3.1 Enzyme for processing aid in Food use must be from Plants, Animals or Microorganisms that listed in the Annex 1 or as determined in Codex Advisory Specification for the Identity and Purity of Food Additive according to paragraph 1 of Article 3 of the draft. Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) Reference to Codex Advisory Specification for the Identity and Purity of Food Additive should not be included because a) enzymes are almost exclusively used as Processing Aids as outlined in comment item 1 above and b) all enzymes mentioned in the list of Codex Advisory Specification for the Identity and Purity of Food Additive are already included in Annex 1. Instead it is suggested to make reference to the JECFA Combined Compendium of Food Additive Specifications. It is noted that almost all enzymes mentioned in Annex 1 are already included in the list of enzymes that have been evaluated by JECFA, however a few JECFA evaluated enzymes are not included in Annex 1. JECFA evaluated enzymes should be incorporated in Annex 1 by reference. A limited number of enzymes that are not JECFA evaluated are included in Annex 1. It should be clarified what criteria were used for their inclusion in Annex 1 and additional enzymes should be added into Annex 1 based on recognition with other countries’ safety assessments. 3.2 In the case that enzyme is not on the list in Annex 1, Supplier or Importer shall submit Food and Drug Committee a safety assessment report for permission according to suggestion of Food committee in paragraph 2 Article 3 of the draft. Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) In case the enzyme is not listed in Annex 1, it is required to submit a safety assessment report to the Food and Drug Committee. It should be sufficient that such safety assessment report is the result of a JECFA evaluation or other countries’ safety assessments. Only in case there are no safety evaluation or assessment report available, it is appropriate to request data for FDA consideration by provision of documents listed in Annex 2. 4. Enzyme for processing aid in Food use must have quality and specification (Article 4 in the draft) 4.1 Enzyme efficiency by activity must not less than 85% of enzyme activity as specified (Article 4 (1) in the draft) Agree Required improvement of enzyme activity value as (Please identify area for suggestion and attach the documents support or having explanation) Agree that no need to determine it because (Please indicate the reason or attach the supporting documents) In general, internal company specific methods should be accepted for all analyses required to document quality specifications. 4.2 Not detected genetic-modified microorganism in 1 g in the case that enzyme is produced by genetic-modified microorganism (Article 4 (2) in the draft) Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) In general, internal company specific methods should be accepted for all analyses required to document quality specifications. 4.3 Required to have other qualities or other standards according to one of either conditions as following (1) Codex Advisory Specification for the Identity and Purity of Food Additive or (2) General specification and considerations for enzyme preparations used in food processing or (3) Notification of Food and Drug Administrative by approval of Food and Drug committee (Article 4 (3) in the draft) Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) In general, internal company specific methods should be accepted for all analyses required to document quality specifications. 5. Using enzyme for processing aid must be used according to one of either conditions as following (1) functional use as stated in Annex 1 or as determined in the most update version of Codex Advisory Specification for the Identity and Purity of Food Additives or (2) as determined in Ministry of Public Health Notification on Food additives or the most update version on general standard of Codex General Standard for Food Additives (Article 5 in the draft) Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) Reference to Codex Advisory Specification for the Identity and Purity of Food Additive or Codex General Standard for Food Additives should not be included because enzymes are almost exclusively used as Processing Aids and not included in the GSFA as outlined in comment item 1 above. Enzymes used as Processing Aids for food or food ingredient production will not have a technological function in the final food because they are typically removed and/or denatured during the manufacture process. Use of enzymes in food production depend on the reaction they catalyze and availability of substrate, and thus are characterized by food and food ingredient production processes and not by final food categories. Accordingly, the limitation of the enzyme uses to specific Food category in Annex 1 should be deleted which is appropriate taking the Not specified for ADI and As Appropriate for Maximum use permission into account. 6. Using Food additives in enzyme, it shall be allowed to be used according to the list and conditions determined in Annex 4. In the case, that Food additive is not in the list of Annex 4, it shall have supplier or importer submit safety assessment report of that Food additive as required by the Notification of Food additive and shall have Food and Drug Administrative consider for permission according to approval granted by Food and Drug Committee (Article 6 paragraph 2 in the draft). Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) 7. Determined the use of other ingredients such as water, salt, flour which are not food additives, in enzyme, they must be safe (Article 7 in the draft) Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) 8. Determined method of analysis according to Annex 5 (Article 8 in the draft) Agree Required improvement as (Please identify area for suggestion and attach the documents support or having explanation) Not agree because (Please indicate the reason or attach the supporting documents) Internal company specific methods should be accepted for all analyses required to document quality specifications. 9. Required suppler or importer