Documents required for application of Food Registration and Food Labelling
Documents required for application of Food Registration and Food Labelling |
17th October B.E. 2002 For those who intend to apply for Food Registration and Food Labelling shall submit the application form and required documents as follows: 1. Application form 1.1 1 Copy of application form of food registration (form Orr. 17) for specific controlled food which is applied from food licensed manufacturer or food licensed importer. 1.2 2 copies of application form of food labelling (form Sor Bor. 3) (please use typerwrtier). For Specific controlled food in which production premise is not recognised as factory and food production license is already granted. And food which the Minister of Public Health prescribed to have food labelling in which Food Manufacturing License or Import Food into the Kingdom License or Food Production License is already granted. 2. 4 copies of Thai and foreign language labels (for food importation case) including traslation in case where the expressed language is not in English. (See details for labelling display). 3. Food analysis report from governmental offices or institutions which are prescribed by the Food and Drug Administration which is issued not more than one year start from the analysis date to the application submitted date as the following details: 3.1 Analysis report by quality or standard as prescribed in the particular notification of the Ministry of Public Health, containing complete details as prescribed to be analyzed in the handbook of analysis report. - In case of analysis result is not entirely complete as prescribed in the particular notification of the Ministry of Public Health, the applicant must certify to carry on to complete analysis result. - In case of food name analyzed in result report is not accurate to name defined in the application form Orr. 17, the applicant shall certify correct that the sample which is sent to analyze bear the same formula as the one which is applied for registration. - In case of analysis result report define the name and manufacturing premise are not accurate to those denoted in the application form Orr. 17, the applicant shall certify correct that the sample which is sent to analyze bear the same formula as the one which is applied for registration and produced by the applicant and explain why the analysis result report define the name and manufacturing premise are not accurate to those defined in the application filed. 3.2 Utilised of painted container, in which the paint is directly contacted to food, may release other contaiminants to food shall be submitted for analysis to follow to the notification of the Ministry of Public Health, Re: Containers, except for dry food. 3.3 Some other kind of foods shall be submitted for additional analysis. (1) Analysis result report of Anthraquinone Derivatives in Aloe Vera drinks and Aloe Vera in sealed container shall be sumitted. (2) Analysis result report of Alfatoxin of food with peanut as main ingredients and pollen grain food shall be submitted. (3) Analysis result report of type and content of protein, amino acid, arsenic and lead of Chollera products and Spirulina shall be submitted. (4) Analysis result report of caffein and declared nutrients on labels of caffein-contained drinks shall be submitted. (5) Analysis result report of type and declared nutrients on labels of infant foods and follow- up formula foods for infant and young children, modified milk for infant and follow-up formula modified milk for infant and young children, supplementary food for infants and young children and medical foods shall be submitted. (6) Analysis result report of Methyl Salicylate and Free Salicylic Acid of food with Wintergreen Oil and Methyl Salicylate ingredient shall be submitted for consideration. (7) Analysis result report of protein content, type and amino acid content of food with bird nest ingredient and analysis result report of real bird nest content shall be submitted. (8) Analysis result report of protein content, type, and amino acid content of livestock extraction soup food type shall be submitted. (9) Analysis result report of real ginsen ingredient content of food with ginsen and preferred to use “ginsen” in name of food shall be submitted. 4. Analysis result report of type and nutrient content of prescribed food to have nutrition labelling as the following details. 4.1 Analysis result report which is issued from governmental laboratories or prescribed institutions by Committes, or 4.2 Analysis result report which is issued from laboratories which is certified by internation accepted authorized body or private laboratories or company laboratories. Either local or international laboratories shall bear certifed documents in standard analysis such as, ISO or governmental or other reliable certified body. 4.3 Analysis result report from several laboratories shall be altogether submitted. 4.4 In case of formula is not altered from original, analysis result report more than one year old can be accepted. Analysis result report according to 4.2, 4.3 and 4.4 are allowed to be used for consideration of nutrition labelling approval until 27th March B.E. 2545 (2002). 5. Other documents , such as: 5.1 Original formulation and manufacturing processes from manufacturers. 5.2 In case of imported food with utilization of unable to declare of details of the used flavour, certificate of free sale as prescribed by the Food and Drug Administration shall be submitted. 5.3 In case of food importation for sale, certifacate or document of certification of manufacturing premise to follow to the notification of the Ministry of Public Health (No.193) B.E. 2543 (2000) shall be submitted. 5.4 The following data of medical foods shall be submitted for consideration: 5.4.1 Clearly define the purpose of use of such products. 5.4.2 Define the targeted consumer group. 5.4.3 Only published academic journal articles of clinical data indicating that these products can be safely used and yield the claimed purposes. 5.4.4 Declaration of protein, fat, cabohydrate sources to be calculated in percentages of total calories. 5.4.5 Declaration of vitamins and minerals amount to be calculated in percentages of RDA prescribed by WHO. 5.4.6 Declaration of detailed fatty acid composition and to be calculated in percentages of requirement. 6. One unit of food specimen. |