Public manual: Application for permission of a product and correction of permitted items: for food for weight control person Service agency: Food and Drug Administration, Ministry of Public Health. Criteria, Procedure, Conditions (if any) for application and consideration of permission Criteria 1. Products shall be categorized as food for weight control person according to the Notification of Ministry of Public Health regarding Food for weight control person ( study additional details in Criteria and Guideline of permission for food for weight control person page 1-3 and 7). 2. Food for weight control person means food specifically used to control or to reduce weight, divided into 2 categories as follows; 2.1 Food for weight control person intending to control weight used as a replacement for one or more meals or all meals of total daily diet. 2.2 Food for weight control person intending to control weight used as a replacement for some parts of diet as follows; 2.2.1 Reduced energy diet; 2.2.2 Low energy diet. However, it shall not include beverages under the Notification of the Ministry of Public Health regarding Beverages in sealed containers, which contained artificial sweeteners. 3. Applying product 3.1 Production or import premise of the applying product shall previously have permission and its license still valid. If it is a food production premise, it shall also be complied with Good Manufacturing Practice according to relevant Notification of Ministry of Public Health. 3.2 Shall not fall in a scope of novel food or food contained novel ingredients (see details in Public Manual regarding Application for safety assessment of food). 3.3 Shall have qualities or standards of product complied with Notification of Ministry of Public Health regarding food for weight control person and other related Notifications of Ministry of Public Health (see details criteria and guideline for product permission for food for weight control person, page 7-10 and 19-22). 3.4 If use of food additives, it shall be complied with Notification of Ministry of Public Health regarding food additives. 3.5 Shall not use of prohibited substances to use in food and/or food prohibited to produce, import or sell according to relevant Notifications of Ministry of Public Health.
3.6 Shall have details of formulation complied with Notification of Ministry of Public Health regarding food for weight control person (see additional details in criteria and guideline for product permission for food for weight control person, page 7). 4. Product contained health claim shall be assessed according to Public manual regarding Application for health claim assessment. 5. Use of food containers shall be complied with Notification of Ministry of Public Health regarding Containers and use of plastic containers and colored plastic covers contacted with liquid or semisolid food shall also have analysis report of plastic containers and colored plastic covers according to Notification of Ministry of Public Health regarding Plastic containers (see additional details in criteria and guideline for product permission for food for weight control person, page 6). 6. Entitling of food name or brand or trademark or registered trademark shall follow Notification of Ministry of Public Health regarding Food for weight control person and Labeling of prepackaged food (see additional details in criteria and guideline for product permission for food for weight control person, page 4-6). 7. Food labeling shall follow Notification of Ministry of Public Health regarding Food for weight control person and Labeling of prepackaged food (see additional details in criteria and guideline for product permission for food for weight control person, page 9-17). 8. If products are complicated or overlapped with many regulations, it shall be considered by working group/committee/or experts. Therefore, its duration will be increased from the specified duration in this manual about 15 to 45 working days as the case maybe. Procedure For application for permission and correction of permitted items of products, an applicant shall prepare documents and evidence and also completely fill in data in specified form as follows: 1. Application for product permission 1.1 In case of import or production premise has already been permitted, 1 copy of application form for food recipe registration (Orr. 17 Form) shall be submitted together with supplementary evidence and documents for permission application. 1.2 In case of production premise not fall in a scope of factory which a number of food production premise has already been received, 2 copies of application form for use of food label (SorBor. 3 Form and typed only) shall be submitted together with supplementary evidence and documents for application. 2. Correction of permitted items of products
2.1 In case of import or production premise has been received a document for food recipe registration of products, an applicant shall apply 1 copy for correction of registered food recipe items Form (Orr. 19 Form) with supplementary document and evidence for permission application. 2.2 In case of production premise not fall in a scope of permitted factory for use of food label of product, an applicant shall apply 2 copies of Form for correction details of permitted food to use food label (SorBor. 4 Form and typed only) with supplementary document and evidence for permission application. 2.3 In case of correction for permitted items of product not relevant to beneficial characteristic, qualities, properties, standards or safety of food according to list 4 No.7 annex to Food and Drug Administration Regulation on operation relevant to Food Serial Number B.E.2557 (2014). 2.3.1 Case of product has been received a document for food recipe registration (Orr. 18 Form), an applicant shall apply for 2 copies of correction registered items of food recipe Form (Orr. 19 Form and typed only) by specifying only part intended to correct with supplementary document and evidence for permission application. 2.3.2 Case of product has been permitted to use food label (SorBor. 3 Form), an applicant shall apply for 2 copies of correction details of food permitted to use label Form (SorBor. 4 Form and typed only) by specifying only part intended to correct with copy of SorBor. 3 Form and/or SorBor. 4 Form as permitted. 2.4 Addition of label for export. 2.4.1 Case of product has been received a document for food recipe registration (Orr. 18 Form), an applicant shall apply for 2 copies of declaration letter for addition of food label produced for export to outside of the Kingdom (typed only) with supplementary document and evidence for permission application. 2.4.2 Case of product has been received permission to use food label (SorBor. 3 Form), an applicant shall apply for 2 copies of correction of details of food permitted to use food label form ( SorBor. 4 Form and typed only) with supplementary document and evidence for permission application. 3. A business operator is able to request Food and Drug Administration for issuance a substitution of food registration document (Orr. 18 Form) if the original document is lost or damaged. 3.1 In case of lost, the following documents shall be submitted: 3.1.1 1 copy of application form for substitution of food registration document (Orr. 20 Form). 3.1.2 Original copy of a notice indicated food registration document No (indicate number of food recipe lost ). is lost.
3.1.3 1 copy of food production license ( Orr. 2 Form) or copy of license for import or ordering of food into the Kingdom (Orr. 7 Form). 3.1.4 1 copy of letter of general authorization certified by the Bureau of Food. 3.2 In case of the food recipe registration is damaged or destroyed in whole or part ; 3.2.1 Application form for substitution of food registration document (Orr. 20 Form). 3.2.2 Damaged or destroyed food registration document. 3.2.3 1 copy of food production license ( Orr. 2 Form) or copy of license for import or ordering of food into the Kingdom (Orr. 7 Form). 3.2.4 1 copy of letter of general authorization certified by the Bureau of Food. 4. Signing in application forms. 4.1 Person who has authorization to sign in application forms includes a business operator as receiving permission in Forms of SorBor. 1/Orr. 2/ Orr. 7 or; 4.2 A director who has authorization to oblige legal entity as in legal registration document (a copy of legal entity registration document done by the Ministry of Commerce no longer than 6 months till the date of application for permission the document shall be enclosed). Conditions 5. In case an application or evidence documents are not complete and/or error, not complete and cause to be unable to consider, an official will make a record of defects of document items or additional document to be submitted. The applicant shall proceed to correct or submit additional documents specified and within the period indicated in the record otherwise it is deemed to abandon by the applicant. Note: Working procedure in the manual will start to count duration when an officer has already received fully complete documents as specified in the public manual and result of consideration will be notified with 7 working days from the day of finished consideration. Note: Total duration - No longer than 35-90 working days for application for food recipe registration (Orr. 17 Form), Application for use of food label (SorBor. 3 Form) (duration depends on complication of food recipe, production method, label of food product). - No longer than 25 working days for application for correction of food recipe registration (Orr. 19 Form), Correction form for details of permitted food to use food label ( SorBor. 4 Form) (excluding application required assessment by working group or experts).
- No longer than 7 working days for application for correction of food recipe registration (Orr. 19 Form), Correction form of details of food permitted to use food label (SorBor. 4 Form) according to annex 4 No.7 of Food and Drug Administration Regulation on operation relevant to food serial number B.E.2557 (2014). - No longer than 3 working days to consider clarification letter for addition of food label for export to outside of the Kingdom. - No longer than 3 working days for substitution of food recipe registration document. By start to count duration when receiving complete and accurate documents until consideration finished and data is recorded in IT system excluding duration of clarification by a business operator and/or considering by expert/ assessment team.