Page 19 - FoodFocusThailand No.176 November 2020
P. 19

SPECIAL TALK BY FDA
 ดิิษญา กิิตติธนวิิมล
 Dissaya Kittithanavimon
 Bureau of Food            Requirement                                          Specifications
 Food and Drug Administration
 Ministry of Public Health  1. Quality or standards of ingredients
 dissayak@fda.moph.go.th
                    (1.1) active ingredient or   (1)  Shall not be hazardous or harmful to health
                         active compound        (2)  Shall have the quality or standard according to one of the following conditions:
                                                   (a)  Combined Compendium of Food Additive Specifications, FAO JECFA Monographs, latest version
                                                   (b)  Food Chemical Codex Monograph, latest version
                                                   (c)  The Code of Federal Regulations Title 21- USA, latest version
                                                   (d)  As approved by Food and Drug Administration considered on recommendations of Food committee
                                                      according to the conditions of the Notification of the Ministry of Public Health Re: Food Additives
                                                (3)  The use of the active ingredient or active compound shall be followed with the product category and
                                                   also complied with the list of name of substances, type of food, functional classes, maximum permitted
                                                   use level, and maximum residue level as specified in annex of this Notification.
                    (1.2) Other ingredients     (1)  Shall not be hazardous or harmful to health.
                                                (2)  Shall be followed conditions as the case may be.
                                                   (a)  Food Additives: such as food additives which are used to prolong or maintain quality of active
                                                      ingredients or active compound in a product. The use of food additive shall be followed by name
                                                      and functional classes according to the Notification of the Ministry of Public Health Re: Food Additives
                                                   (b)  Flavoring agent: shall be flavoring agent for food used or food grade
                                                   (c)  Water: quality and standard shall be complied with the Notification of the Ministry of Public Health
                                                      Re: Drinking Water in Sealed Containers.
                                                   (d)  Other ingredients not specified in the Notification: They shall be approved by Food and Drug
                                                       Administration. The other ingredients shall neither interact with the active ingredients nor interfere
                                                       with efficacy of product by considering as following cases:
                                                       •  In case of substances that have history of use as food such as sugar, oil, salt, vinegar, etc.
                                                         Manufacturer or importer can apply these substances as food ingredients in the process of product
                                                        registration.
                                                       •  Extracts obtained from plants or animals including any substance which is no history of use as
                                                         food such as aloe vela extract, rose extract, tea extract, trumpet leaf extract, etc. Manufacturer
                                                         or importer shall submit document to Food and Drug Administration for safety evaluation according
                                                         to the rules, conditions and procedures for permission, as the case may be.

                    2. Standard of contaminant
                    (2.1) Product contains only one   The quality or standard of the active ingredient shall be complied with the conditions (under (1.1))
                         active ingredient/active compound

                    (2.2) Products obtained by mixing of   (1)  The quality or standard of each active ingredient shall be complied with the conditions (under (1.1))
                         two or more active ingredients,   (2)  shall be complied as follows
                         or mixed with other ingredients      (a)  Arsenic not exceed 3 mg/kg
                         (under (1.2))             (b)  Lead not exceed 10 mg/kg
                    3. Additional quality or standard requirements of cleaning products consisting of surfactant for washing vegetables and fruits


                    pH value                    -   Products containing fatty acid based surfactants as the main ingredient (When diluted 30 times with
                                                   distilled water) shall have pH between 6.0-10.5.
                                                -   Products containing non-fatty acid based surfactants as the main ingredient (when diluted 150 times
                                                   with distilled water) shall have pH between  6.0-8.0.

                    Methanol                    Not more than 1 μl/g (in liquid form)
                    Enzymes                     Not permitted
                    Substance which has bleaching   Not permitted
                    property
                    Biodegradability of the surfactant  Not less than 85% within 19 days, only those products containing anionic surfactant.
                    Concentration of Surfactant in   -   The concentration of fatty acid based surfactants as the main ingredient such as alkyl polyglycoside
                    ready-to-use condition         (non-ionic surfactant) shall not exceed 0.5% (5,000 mg/L).
                                                -   The concentration of non-fatty acid based surfactants as the main ingredient shall not exceed 0.1%
                                                   (1,000 mg/L).

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