Regulation of the Head of Drug and Food Control Agency of R.I. No. HK.03.1.5.12.11.09955/2011 concerning Processed Food Registration

REGULATION OF HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA NO. HK.03.1.5.12.11.09955 YEAR 2011 CONCERNING PROCESSED FOOD REGISTRATION WITH THE GRACE OF THE ALMIGHTY GOD HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA Considering: that, to implement the provisions of Article 42 paragraphs (5) and (6) of Government Regulation No. 28/2004 on Food Safety, Quality, and Nutrition, it is necessary to stipulate Regulation of Head of Drug and Food Control Agency on Processed Food Registration; In view of: 1. Law No. 7/1996 on Food (Statute Book of 1996 No. 99, Supplement No. 3656); 2. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement No. 3821); 3. Law No. 36/2009 on Health (Statute Book of 2009 No. 144, Supplement No. 5063); 2 4. Government Regulation No. 69/1999 on Food Label and Advertisement (Statute Book of 1999 No. 131, Supplement No. 3867); 5. Government Regulation No. 28/2004 on Food Safety, Quality, and Nutrition (Statute Book of 2004 No. 107, Supplement No. 4424); 6. Presidential Decree No. 103/2001 on Position, Task, Function, Authority, Organization Structure, and Work Procedure of Non Departmental Government Institution as already amended several times and lastly by Presidential Regulation No. 64/2005; 7. Presidential Decree No. 110/2001 on Organization Unit and Task of Echelon I of Non-Departmental Government Institution as already amended several times and lastly by Presidential Regulation No. 52/2005; 8. Decree of Head of Drug and Food Control Agency No. 02001/SK/KBPOM Year 2001 on Organization and Work Procedure of Drug and Food Control Agency as already amended by Decree of Head of Drug and Food Control Agency No. HK.00.05.21.4231 Year 2004; DECIDED: To stipulate: REGULATION OF HEAD OF DRUG AND FOOD CONTROL AGENCY CONCERNING PROCESSED FOOD REGISTRATION. 3 CHAPTER I GENERAL PROVISIONS Article 1 Hereinafter referred to as: 1. Food is anything derived from biological and water sources, processed or unprocessed, intended as food or beverage for human consumption including Food Additive, food raw material, and other material used in the process of preparation, processing, and/or production of food and beverages. 2. Processed Food is food or beverage as a result of processing by specific means or method with or without additive, including Certain Processed Food, Food Additive, Genetically Engineered Food, and Irradiated Food. 3. Food Additive, hereinafter called BTP, is a material allowed to be added into Food to affect Food characteristic or form. 4. Registration is procedure of assessment of safety, quality, and nutrition of Processed Food to obtain Registration Approval Letter. 4 5. Registration Approval Letter is approval on result of Processed Food Assessment issued by Agency Head in the framework of Processed Food Distribution. 6. Label is every information concerning Food in the form of picture, word, and a combination of both, or other form that accompanies the Food, inserted into, attached to, or is a part of Food packaging. 7. Company is processed food producer, importer, or distributor who already obtains business license in accordance with the prevailing legislation. 8. Producer is individual and/or business entity making, processing, modifying, preserving, and re-packaging processed food to be distributed. 9. Importer is individual and/or business entity importing Food to Indonesian territory. 10.Distributor is individual and/or business entity distributing Processed Food in Indonesian territory. 11.Registerer is a company or a party authorized by the company to perform Processed Food Registration in the framework of obtaining Registration Approval Letter. 5 12.Licensed Processed Food is processed food produced based on license. 13.Repackaged Processed Food is processed food which is repackaged into processed food with smaller or larger package. 14.Processed Food Produced Based on Contract is food produced by contract acceptor upon request of contract giver. 15.License Giver is producer or research agency of formula and technology owner domestically or overseas who grants license to company requesting for registration. 16.Contract Acceptor is an industry in Processed Food sector who accepts Processed Food making work based on contract and who has industrial business license in accordance with the type of Processed Food produced. 17.Contract Giver is a person and/or business entity having business license in Food Production sector who uses other party’s production facility based on contract. 18.Food Registration Number is a number given for Processed Food in the framework of Food distribution as contained in Registration Approval Letter. 6 19.Evaluation and Registration Cost is cost imposed in the framework of Processed Food Assessment in accordance with the provisions of the legislation. 20.Head of Center is Head of Drug and Food Control Center as head of technical operating unit within the Drug and Food Control Agency. 21.Director is the Director of Food Safety Assessment. 22.Agency Head is Head of Drug and Food Control Agency of the Republic of Indonesia. Article 2 (1)Processed Food produced domestically or imported to Indonesian territory to be traded in retail packages shall have a Registration Approval Letter. (2)Registration Approval Letter, as referred to in paragraph (1), shall be issued by the Agency Head. (3)Retail package, as referred to in paragraph (1), is the final package of Food which is not allowed to be opened to be re packaged into smaller packages to be traded. Article 3 7 (1)Excepted from the provisions of Article 2 paragraphs (1) and (2) are Processed Food: a. produced by home industry; b. having a storage period of less than seven (7) days at room temperature; c. imported to Indonesian territory in small volume for: 1. samples in the framework of registration application; 2. research; 3. self-consumption; and/or d. to be used further as raw material and not to be sold directly to end consumer. (2)Small volume, as referred to in paragraph (1) letter c is a volume required only for related purposes in accordance with assessment result on worthiness of application for importer’s need upon submission of import recommendation letter. (3)Further provisions concerning types of Processed Food that can be produced by home industry, as referred to in paragraph (1) letter a, shall be stipulated by the Agency Head. Article 4 8 Food home industry producing Processed Food, as referred to in Article 3 paragraph (1) letter a, shall have a home industry Food production certificate in accordance with the provisions of the legislation. CHAPTER II CRITERIA Part One Criteria of Processed Food Article 5 (1)Processed Food is divided into: a. self-produced Processed Food; b. licensed Processed Food; c. repackaged Processed Food; d. Processed Food produced based on contract. (2)Processed Food Registration, as referred to in paragraph (1) letters b, c, and d, shall be accompanied with supporting data in the form of agreement letter or similar letter. Article 6 9 (1)Processed Food that will be registered shall meet safety, quality, and nutrition criteria. (2)Safety, quality, and nutrition criteria, as referred to in paragraph (1), consist of: a. safety parameter, namely maximum limit of microbial contaminant, physical contaminant, and chemical contaminant; b. quality parameter, namely fulfillment of quality requirement in accordance with the prevailing standards and requirements and good Food manufacturing practices for Processed Food produced domestically or good Food distribution practices for Processed Food imported to Indonesian territory; and c. nutrition parameter in accordance with the stipulated requirements. (3)In addition to meeting the criteria as referred to in paragraphs (1) and (2), it shall also meet labeling requirement. Article 7 10 (1)For Processed Food containing raw material, Food Additive, other material, and/or stating claims which are not yet stipulated in the provisions of the legislation, an assessment shall first be performed. (2)Assessment, as referred to in paragraph (1), shall be performed in accordance with the provisions of the legislation. Part Two Criteria and Responsibility of Company Article 8 (1)Processed Food Registration, as referred to in Article 5 paragraph (1) letters a, b, and c produced domestically shall be submitted by Producer. (2)Processed Food Registration, as referred to in Article 5 paragraph (1) letter d, produced domestically shall be submitted by Contract Giver. (3)Producer as referred to in paragraph (1) and Contract Giver shall meet the following requirements: a. having industrial business license in accordance with the provisions of the legislation; and 11 b. meeting good Food manufacturing practices requirement for type of Food registered. Article 9 (1)Registration of Processed Food imported to Indonesian territory shall be submitted by Importer or Distributor. (2) Importer or Distributor, as referred to in paragraph (1), shall meet the following requirements: a. having license in Food importation or distribution; b. having letter of appointment from company of origin overseas; and c. meeting good Food distribution practices requirement in accordance with the provisions of the legislation. (3)Registration of Processed Food imported to Indonesian territory which is a licensed processed food, repackaged food, or food produced based on contract in overseas shall be accompanied with supporting data in the form of agreement letter or similar letter. Article 10 12 Fulfillment of good Food manufacturing practices requirement, as referred to in Article 8 paragraph (3) letter b, and good Food distribution practices requirement, as referred to in Article 9 paragraph (2) letter c, shall be proven by certificate on result of audit by officer of the local Center. Article 11 (1)Before performing Processed Food Registration, the Registerer shall submit a request for audit of production facility or distribution facility to Head of the local Center. (2)Audit of production facility, as referred to in paragraph (1), shall be performed in accordance with Guidelines on Good Food Manufacturing Practices. (3)Audit of distribution facility, as referred to in paragraph (1), shall be performed in accordance with Guidelines on Good Food Distribution Practices. (4)Result of audit of production facility or distribution facility, as referred to in paragraph (1), shall be given by Head of Center to the Registerer with copies submitted to the Director and the Director for Food Inspection and Certification. Article 12 13 (1)Audit of facility in the framework of Registration, as referred to in Article 10, shall only be performed one (1) time for each Registration and the same type of Processed Food. (2)In case that type of Processed Food registered is different from the type of Processed Food as referred to in paragraph (1), a repeat audit shall be performed. Part Three Criteria and Responsibility of Registerer Article 13 (1)Processed Food Registration shall be performed by the Registerer. (2)The Registerer, as referred to in paragraph (1), shall have knowledge about criteria and requirement of Processed Food registered. Article 14 In case that Registration is performed by an authorized party: a. The Company shall report the authorized party to the Agency Head. 14 b. Processed Food Registration Approval shall be issued for the company requesting for registration. Article 15 (1)The Registerer is responsible for completeness, correctness, and validity of document submitted upon Processed Food Registration. (2)In case that the document submitted upon Registration, as referred to in paragraph (1), is proven to be false or falsified, Registration application shall be rejected and the Company concerned cannot perform Processed Food Registration for three (3) years since date of rejection letter. CHAPTER III REQUIREMENT OF PROCESSED FOOD REGISTRATION Part One General Registration Article 16 (1)Registration requirement consists of administrative requirement and technical requirement. 15 (2)Registration requirement, as referred to in paragraph (1), as specified in Attachment I which forms an inseparable part of this Regulation. Part Two Amendment of Processed Food Data Article 17 (1)Company may perform amendment of data on Processed Food that already has a Registration Approval Letter. (2)Data amendment, as referred to in paragraph (1), shall be approved by the Agency Head. (3)Amendment of Processed Food data, as referred to in paragraph (1), can be done as long as it does not cause change of Food Registration Number and/or change of Evaluation and Registration Cost. (4)In case that amendment of Processed Food data causes change of Food Registration Number and/or change of evaluation cost, the Registerer shall file a new Registration application. Article 18 16 (1)Amendment, as referred to in Article 17 paragraph (1), can be in the form of: a. change of name of Company; b. change of name of Importer and/or Distributor; c. inclusion and/or change of Nutritional Value Information; d. change and or addition of claim; e. change of trade name; f. change of package design; g. change and/or addition of net weight/content; h. change of composition; and/or i. change for promotional purposes within a certain period. (2)Requirement and completeness of document for the data amendment, as referred to in paragraph (1), are as specified in Attachment 2 which forms an inseparable part of this Regulation. Part Three Requirement of Processed Food Label 17 Article 19 Label requirement, as referred to in Article 6 paragraph (3), shall be in accordance with requirement of Processed Food Label as specified in Attachment 3 which forms an inseparable part of this Regulation. CHAPTER IV PROCESSED FOOD REGISTRATION PROCEDURE Part One Submission of Registration Article 20 Registration shall be submitted for each processed Food including those which have differences in: a.label design; b. package type; c. composition; and/or d. name and/or address of producer. Article 21 Registration Application shall be submitted in writing by filling out Registration form accompanied with completeness of Registration document. 18 Article 22 Registration document is a confidential document which is only used for the purpose of evaluation by the authorized party. Part Two Inspection and Evaluation Article 23 (1)Inspection and evaluation shall be performed on Registration document, as referred to in Article 21, in accordance with the requirement and criteria as referred to in Article 6. (2)In case that registration document mentions claim variation, discussion with expert team shall be performed. Part Three Deciding Article 24 Result of evaluation, as referred to in Article 23, can be in the form of: a. Registration Approval Letter; or b. Rejection Letter. Article 25 19 (1)Decision in the form of Registration Approval Letter, as referred to in Article 24 letter a, shall be stipulated by the Agency Head. (2)The Agency Head may delegate the issuance of Registration Approval Letter to other official appointed. Article 26 (1)The Registration Approval Letter, as referred to in Article 25 paragraph (1), shall be accompanied with Label design that has been approved. (2)Registration Approval Letter for Processed Food shall be issued by stating Food Registration Number. Article 27 (1)Food Registration Number, as referred to in Article 26 paragraph (2), for Processed Food produced domestically shall be in the form of the words “BPOM RI MD” followed with numerical digits. (2)Food Registration Number, as referred to in Article 26 paragraph (2), for Processed Food produced overseas shall be in the form of the words “BPOM RI ML” followed with numerical digits. 20 (3)The numerical digits, as referred to in paragraphs (1) and (2), shall contain information on processed food identity consisting of company, location of producer, serial number of product, package type, and food type. (4)Food Registration Number shall be stated on Label in such a way to make it visible and readable by consumers. Article 28 (1)In case that the decision is in the form of rejection of Registration, as referred to in Article 24 letter b, a rejection letter will be issued along with reasons of the rejection. (2)In case that Registration is rejected due to safety, quality, or nutritional reasons, re-Registration may only be submitted after there is a newest supporting data. Article 29 Procedure of processed food registration will be further stipulated. CHAPTER V COST Article 30 21 (1)Application for Processed Food Registration in the framework of obtaining Registration Approval Letter or amendment of Processed Food data shall be subjected to cost as a non-tax state revenue in accordance with the provisions of the legislation. (2)In case that the application, as referred to in paragraph (1), is rejected, the cost that has been paid is non refundable. CHAPTER VI HEARING Article 31 (1)In case that there is an objection to the result of assessment of safety criteria of processed food, the Company may file a request for hearing to the Agency Head in writing. (2)The request for hearing, as referred to in paragraph (1), shall be completed with new data and/or data that was once submitted, completed with justification. CHAPTER VII REVIEW 22 Article 32 (1)In case there is an objection to rejection of registration, the Company may file a request for review to the Agency Head in writing. (2)Request for review shall be completed with new data and/or data that was once submitted, completed with justification. (3)Request for review can be submitted in the form of hearing. CHAPTER VIII VALIDITY PERIOD OF REGISTRATION APPROVAL LETTER Article 33 (1)Registration Approval Letter shall be valid for five (5) years and can be extended by re-registration. (2)Registration Approval Letter which has expired shall be invalid. (3)Processed Food, whose validity period of Registration Approval Letter has expired, shall not be distributed. (4)Excepted from the provisions of paragraph (1), Registration Approval Letter for Processed Food, as referred to in Article 5 paragraph (1) letters b, c, and d, its validity period shall 23 be adjusted to the validity period of agreement letter or similar letter. CHAPTER IX RE-REGISTRATION Article 34 Re-registration of Processed Food can be performed at least six (6) months before expiry of Registration Approval Letter. CHAPTER X IMPLEMENTATION OF REGISTRATION APPROVAL Article 35 (1)Processed Food distributed shall be in accordance with safety, quality, and nutrition criteria and Label requirement approved during registration. (2)Label of Processed Food circulating shall be in accordance with Label design approved during registration. Article 36 (1)Import of Processed Food that has obtained Registration Approval Letter to Indonesian territory can be done by: a. company who has Registration Approval Letter; or 24 b. other party who has license as importer in accordance with the provisions of the legislation and who receives authority from the company as referred to in letter a. (2)At the time the processed Food, as referred to in paragraph (1), enters Indonesian territory, the label shall have met the provisions of Article 35 paragraph (2). Article 37 (1)The Company shall be responsible for safety, quality, and nutrition and Label of Processed Food distributed in accordance with the information approved during Registration. (2)The responsibility, as referred to in paragraph (1), for self-produced Processed Food, licensed Processed Food, and re packaged Processed Food, shall be borne by Producer. (3)The responsibility, as referred to in paragraph (1), for Processed Food produced domestically based on contract, shall be borne by the Contract Giver. (4)The responsibility, as referred to in paragraph (1), for Processed Food imported to Indonesian territory, shall be borne by Importer or Distributor performing Registration. CHAPTER XI 25 RE-ASSESSMENT Article 38 (1)Re-assessment may be conducted by the Agency Head on Processed Food which has obtained Registration Approval Letter. (2)The re-assessment, as referred to in paragraph (1), shall be performed if there is new data and/or information concerning safety, quality, nutrition, and Label of Processed Food. (3)Result of re-assessment shall be conveyed in writing to the Company as holder of Registration Approval Letter. (4)The Company as holder of Registration Approval Letter shall perform action in accordance with result of the re-assessment, as referred to in paragraph (3). CHAPTER XII ADMINISTRATIVE SANCTIONS Article 39 (1)Violations against the provisions of this Regulation may be subjected to administrative sanctions in the form of: a. written reminder; 26 b. temporary prohibition on distribution; c. temporary cessation of operation; or d. revocation of Registration Approval Letter. (2)Administrative sanctions, as referred to in paragraph (1) letter d, may be imposed based on or in the case: a. result of re-assessment identifies non-compliance with safety requirement; b. the Processed Food distributed is not in accordance with the data approved upon obtainment of Registration Approval Letter or data amendment approval; c. result of inspection and/or testing of Processed Food distributed shows non-compliance with the criteria as referred to in Article 7; d. the Processed Food advertised violates the provisions of the legislation; e. final and binding court verdict concerning Processed Food; f. the Company commits violations in Food production and/or distribution; 27 g. Importer or Distributor as holder of Registration Approval Letter is no longer appointed by factory of origin overseas. h. industrial business license for producing food, importer license, and/or distributor license is revoked; i. location of importer is not in conformity with the one stated in Registration Approval Letter or data amendment approval; j. location of production facility is not in conformity with the one contained in Registration Approval Letter or data amendment approval; and/or k. upon request of holder of Registration Approval Letter. (3)Company shall be responsible for Processed Food which is still in circulation whose Registration Approval Letter has been revoked. CHAPTER XIII TRANSITORY PROVISIONS Article 40 28 (1)Food Registration Approval Letter that has been issued based on Regulation of Minister of Health No. 382/Menkes/Per.VI/1989 on Food Registration shall be adjusted to this Regulation within not later one (1) year since date of enactment of this Regulation. (2)Application for Processed Food Registration that has been submitted before this Regulation comes into effect, shall be processed in accordance with Decree of Head of Drug and Food Control Agency No. HK.00.05.1.2569 Year 2004 on Criteria and Procedure of Assessment of Food Product. CHAPTER XIV CLOSING PROVISIONS Article 41 On the date this Regulation comes into effect: 1. Decree of Head of Drug and Food Control Agency No. HK.00.05.52.4321 Year 2003 on General Guidelines on Labeling of Food Product; and 2. Decree of Head of Drug and Food Control Agency No. HK.00.05.1.2569 Year 2004 on Criteria and Procedure of Assessment of Food Product; 29 shall be revoked and declared inapplicable. Article 42 This Regulation comes into effect since the date of enactment. In order that everyone shall take cognizance, it is ordered to enact this Regulation by placing it in the State Gazette of the Republic of Indonesia. Stipulated in Jakarta December 5, 2012 HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA Sgd KUSTANTINAH Enacted in Jakarta December 12, 2011 MINISTER OF JUSTICE AND HUMAN RIGHTS OF THE REPUBLIC OF INDONESIA Sgd AMIR SYAMSUDDIN STATE GAZETTE OF THE REPUBLIC OF INDONESIA OF 2011 NO. 810 Attachment 1 Regulation of Head of Drug and Food Control Agency 30 No. HK.03.1.5.12.11.09955 Year 2011 Concerning Processed Food Registration REQUIREMENT OF PROCESSED FOOD REGISTRATION I. Administrative Requirement A. processed food produced domestically No. Document Completeness 1. Power of Attorney 2. Industry license For self-produced food: Industrial business license For food produced basewd on contract: a. Industrial business license of contract giver b. Industrial business license of contract acceptor c. Agreement/contract letter between contract giver and contract acceptor For repackaged food: a. industrial business license for repackaging b. letter of cooperation between factory of origin and repackaging factory For food produced by license: a. industrial business license 31 b.agreement letter between license giver and license acceptor 3. Result of production facility audit 4. Certificate stating inter-company relationship (if necessary) B. Processed food imported to Indonesian territoey No. Document Completeness 1. Power of Attorney 2. Trading Business License (SIUP) or Importer Identification Number (API) 3. Appointment letter from company of origin overseas 4. Health Certificate or Certificate of Free Sale 5. Result of distribution facility audit 6. Certificate stating inter-company relationship (if necessary) II. Technical Requirement of Processed Food Registration No. Document Completeness 1. Composition or list of ingredients used 2. Explanation on certain raw materials used 3. Process of production or GMP/HACPP certificate 4. Certificate of Analysis 32 5. Information on storage period 6. Information on production code 7. Label design III. Other Supporting Documents (if necessary) No. Document Completeness 1. Brand Certificate 2. Certificate on Use of SNI (Indonesian National Standard) Mark 3. Organic Certificate 4. Certificate on GMO (Genetically Modified Organism)-free status 5. Information on Food Irradiation 6. Establishment Number (NKV) of slaughterhouse 7. Letter of Approval on Inclusion of the Word “Halal” on Food Label 8. Other supporting data 9. Letter of Stipulation as Registered Importer (IT) for Alcoholic Beverages HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA Sgd KUSTANTINAH Attachment 2 33 Regulation of Head of Drug and Food Control Agency No. HK.03.1.5.12.11.09955 Year 2011 Concerning Processed Food Registration REQUIREMENT AND COMPLETENESS OF DOCUMENT FOR AMENDMENT OF PROCESSED FOOD DATA I. General Requirement for All Data Amendment No Requirement 1. Application letter according to the format stipulated 2. Photocopy of registration approval letter 3. Photocopy of label approved in registration approval letter 4. Photocopy of latest approval letter on amendment of processed food data 5. Photocopy of label on latest approval on amendment of processed food data 6. New color label design 7. Label and original package of circulating food product II. Additional Requirement for Certain Foods No Requirement Remark 1. Photocopy of brand For food with ™ and or ® symbol 34 certificate 2. Photocopy of license for inclusion of the word “halal” For food containing the word “halal” 3. Photocopy of SNI certificate For food required to have SNI (bottled drinking water/AMDK, wheat flour, iodized salt, cocoa powder, and refined sugar) 4. Photocopy of cooperation letter For food produced by cooperation (license, repackaging, or contract, etc) 5. Photocopy of appointment letter from factory of origin For imported food 6. Photocopy of SIUP For imported food III. Additional Requirement Based on Amendment Requested No Amendments Completeness of Data 1. Change of name of producer a. Industrial business license or Industry Registration Certificate (TDI) b. Notarial deed stating about status of amendment 35 2. Change of name of importer/distributor a. Photocopy of latest appointment letter from factory of origin with name of importer/distributor (by showing the original copy) b. Photocopy of latest SIUP under the name of importer/distributor 3. Inclusion and or change of nutritional value information and or claim addition a. Result of latest analysis ORIGINALLY from accredited laboratory or government laboratory for nutritional substances or functional components b. Method of calculation of AKG % on label on nutritional value information 4. Change of trade name SNI certificate with new trade name (for food required to have SNI) 36 5. Change of composition a. Old and new composition b. Explanation on certain materials c. latest result on product analysis ORIGINALLY from accredited laboratory or government laboratory 6. Change for promotional purposes within a certain period of time a. Statement or certificate from the company explaining the objective and time of promotion b. promotion license from authorized institution (for instant prize or prized lottery) HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA Sgd KUSTANTINAH Attachment 3 Regulation of Head of Drug and Food Control Agency No. HK.03.1.5.12.11.09955 Year 2011 37 Concerning Processed Food Registration REQUIREMENT OF PROCESSED FOOD LABEL I.GENERAL PROVISIONS 1. Processed Food produced domestically or imported to Indonesian territory to be traded in packages, shall contain label on, inside, and/or in the food package. 2. Inclusion of label shall be in accordance with the provisions of the legislation. 3. In addition to complying with the provisions of the legislation, label inclusion shall also meet the provisions of this Regulation. 4. Information and or statement concerning processed food in label shall be correct and shall not be misleading, whether the words, pictures, or other forms whatsoever. 5. Label shall contain clear, readable, orderly words and shall not contain tightly compressed words. 6. The use of background, whether pictures, colors, or other design, shall not obscure the words on the Label. 38 7. Labeling shall be done in such a way so that: a. label does not easily stick off from the package; b. label does not easily lose its color or damage; and c. label is located on part of the food package which is easily visible and readable. 8. In addition to the provisions of point 7, label which sticks or is attached to the package shall sticks strongl so if it is detached it will damage itself/the original package. 9. Inclusion of statement on benefit of food for health in Label may only be done if it is supported by scientific facts which are accountable and in accordance with the prevailing legislation. 10.Processed food label consists of main part and other part. 11.Processed food label shall contain at the minimum: a. name of processed food; b. net weight or content; c. name and address of the party producing or importing food to Indonesian territory; 39 d. list of ingredients used; e. food registration number; f. expiry information; and g. production code. 12.In addition to the information as referred to in point 11, the following information shall also be stated on processed food label: a. information on nutrient content; b. information on food irradiation; c. information on organic food; d. information on genetically engineered food; e. information on food made of natural raw materials; f. guidelines on use/preparation; g. guidelines on storage method; h. information on serving guidelines or suggestions; i. information on intended use; 40 j. other information which is necessarily understood concerning the effect of food on human health; k. warning. 13.Inclusion of the information as referred to in points 11 and 12 shall be in accordance with the provisions of the legislation. II. WORDS AND PICTURES 1. Language, Letters, and Numerals a. Information as referred to in Part I points 12 and 13 shall be written and printed in the Indonesian language, Arabic numerals, and Latin alphabets. b. The use of foreign terms in the information as referred to in Part I points 12 and 13 could be done as long as there is no equivalents, their equivalents cannot be created or used for the purpose of food trade overseas. c. Foreign terms as referred to in letter b include language, numerals, or alphabets other than Indonesian language, Arabic numerals, or Latin alphabets and technical or scientific terms, for example, chemical formula to state a type of material used in composition. 41 d. On the label with the information as referred to in letters and b, similar information in language other than Indonesian language, Arabic numerals, and Latin alphabets may be added. 2. Pictures a. Pictures shall show the actual condition, including characteristic and/or condition of processed food and shall not be misleading; b. Pictures of fruit, meat, fish, or other foodstuff may only be included if the food contains those materials, not as flavor (including natural flavor, natural identical flavor, and artificial flavor). In the composition part, quantity of ingredients used shall be mentioned. For example: “Composition: water, sugar, mango fruit extract (10%), mango flavor” “Composition: sugar, orange fruit extract (2%), orange flavor”. 42 c. The provisions of letters a and b are not applicable for the requirement of inclusion of picture as serving suggestion. d. For processed food requiring or having serving guidelines or guidelines on use, picture of other foodstuff can be included in accordance with explanation on serving guidelines or guidelines on use. 3. Size of Letters and Words a. Letters and numerals used on label shall be clear and readable and proportional to size of label surface. b. Size of letters shall at least be equal to or larger than small letter “o” on Arial font type with size of 1 mm (Arial 6 point), except for certain information. c. Information in Indonesian language shall be written with letter whose size is proportional to other language and shall not be less than 1 mm. d. Size of letters for type name shall be proportional to size of letters for trade name. e. Size of letters for information, as referred to in letter d, shall not be smaller than small letter “o” on Arial font 43 type with 2 mm size or in accordance with the provisions stipulated in the legislation. f. Exception from labeling requirement is granted for processed food whose package is too small so that technically it is difficult to state all information required such as the one required for other processed food, with requirements: 1) small size as mentioned above is size of label surface equal to or less than 10 cm2; 2) containing information at least name and address of producer; and 3) food is put into a larger package that enables to contain information required to be included. g. For food label whose surface size is equal to or smaller than 10 cm2, size of letters and numerals written shall not be smaller than 0.75 mm. 4. Words and Warning In addition to the information as referred to in Part I, certain food label shall contain words or warning. a. Processed food containing materials derived from pig 44 1) Processed food containing certain materials derived from pig shall contain a special mark in the form of the words “CONTAINING PORK” and pig picture in red in a red box on a white background, as specified below: CONTAINING PORK 2) The words as referred to in letter 1) shall be clearly readable and proportional to size of label surface with a size of at least 1.5 mm and shall be placed on the part which is mostly visible to consumers. 3) The writing of foodstuff derived from pig shall be followed with the word “pork”. For example: “pork meat”, “pork gelatin”, and “pork fat”. 4) Foodstuff which is probably derived from pig is, amongst others, in the form of gelatin, enzyme, fat, collagen, colostrum, blood extract, hydrolyzed hemogoblin, keratin, hair extract, placenta, protein, thymus extract, thymus hydrolysate, stomach extract, formation materials (stereatic acid, palmitic acid, glycerol), oil, kidney extract, shortening, thickener, emulsifier, stabilizers, l sistine, monoglyceride, diglyceride, triglyceride, and nisin. b. Alcoholic Beverages 45 1) Label of alcoholic beverage shall mention the words: a) “ALCOHOLIC BEVERAGE” and type name in accordance with food category. b) “ANYONE UNDER THE AGE OF 21 OR PREGNANT WOMEN SHALL NOT DRINK” c) “Containing Alcohol ± …% v/v” 2) If the type name, as referred to in point 1) letter a) is not contained in Food Category, type name shall be stated as follows: “ALCOHOLIC BEVERAGE CATEGORY …” 3) Alcohol beverage category, as referred to in point 2), shall be based on alcohol content as follows: a) Category A: 1 – 5% b) Category B: more than 5 – 20% c) Category C: more than 20 – 55%. 4) The words as referred to in points 1) and 2) shall be contained on the part which is mostly visible to consumers. c. Processed Food Containing Alcohol 1) For food containing alcohol, alcohol content shall be stated on the label. 46 2) Alcohol content shall be stated in percentage. For example: “containing alcohol ± …%”. 3) Alcohol content as referred to in points 1) and 2) shall be placed on the part most visible to consumers. 4) Food containing alcohol or raw material containing alcohol, but undetected in the finished product, information on alcohol content is not necessarily mentioned on the label. d. Sweet Condensed Milk 1) Label of sweet condensed milk shall be written with the words “Warning! Unsuitable for Infants”. 2) The words, as referred to in point 1) shall be written in red in a red rectangular box as specified below: Warning! Unsuitable for Infants 3) The words, as referred to in point 2), shall be clearly readable and proportional to size of label surface with a size of at least 1.5 mm and shall be placed on the part mostly visible to consumers. e. Infant formula Infant formula label shall contain words and other conditions in accordance with stipulated requirements 47 (pursuant to Regulation of Head of Drug and Food Control Agency No. HK.03.1.52.08.11.07235 Year 2011 on Control of Infant formula and Infant formula for Special Medical Purposes). f. Processed Food Containing Allergen 1) Processed food containing materials that may cause allergy to certain consumers may state information on allergen in accordance with the prevailing regulations. 2) Materials that may cause allergy, as referred to in point 1), include cereal containing gluten (such as wheat, rye, barley, oats, and spelt), molluscs and products thereof, eggs and products thereof, fish and products thereof, peanuts, soybean and products thereof, milk and products thereof including lactose, tree nut and processed nuts, and sulfite (10 ppm or more). g. Processed Food Containing Artificial Sweetener Labeling requirements for processed food containing artificial sweetener: 1) stating the words “Containing artificial sweetener”; 2) stating content of artificial sweetener indicated in mg/kg or percent, except if the label contains 48 information on nutritional value, content of artificial sweetener indicated in mg/serving. 3) Stating ADI (Acceptable Daily Intake) value, except for those who do not have ADI value. 4) Stating the words “Containing artificial sweetener, not recommended for consumption by children, pregnant mothers, and breastfeeding mothers”. 5) Stating the words “For diabetes sufferers and or anyone who needs low calorie food”. 6) For processed food containing artificial sweetener aspartame, the warning “Containing phenilalanin, unsuitable for phenylketonuria sufferers” shall be mentioned. 7) For processed food containing artificial sweetener sorbitol, the warning “Consumption of greater than 20 gram per day may cause laxative effect” shall be mentioned. 8) For processed food containing artificial sugar and sweetener, the words “containing artificial sugar and sweetener” shall be mentioned. h. Food Additive Supplies 1) Label of food additive supplies shall contain: 49 a) The words “Food Additives, b) Category name of food additive, c) Name of food additive, and d) Registration Number of Food Additive Producer, except for artificial sweetener supplies in the form of tabletop. 2) On artificial sweetener label, in addition to the information as referred to in point 1), the following shall also be stated: a) Quantity of artificial sweetener in solid form supplies (for example, tablet, granule, or powder) indicated in mg and liquid form indicated in ml, in a one-time use supplies quantity. b) Comparison of sweetness if compared to sugar. c) mg quantity of artificial sweetener each day per kg of body weight (ADI); d) the words “for diabetes sufferers or anyone who needs low calorie food”. e) The words “Containing artificial sweetener, not recommended for consumption by children, pregnant mothers, and breastfeeding mothers”. f) For supplies containing artificial sweetener sorbitol, xylitol, maltitol, mannitol, isomal, and or laxitol, 50 the warning “Consumption of greater than 20 gram per day may cause laxative effect” shall be stated. g) For artificial sweetener aspartame, the words “unsuitable for use in material which is to be heated” shall be stated. h) For processed food containing artificial sweetener aspartame, the warning “Containing phenilalanin, unsuitable for phenylketonuria sufferers” shall be stated. 3) On food coloring label, in addition to the information as referred to in point 1), the following shall also be mentioned: a) Index number (Color Index, Cl) b) The words “food coloring” written in green capital letters in a green rectangular box. For example: FOOD COLORING c) Letter M logo in a black circle as specified below: M 51 i. Words and Pictures Concerning Sponsor of an Event 1) The inclusion as sponsor of an event could be done after obtaining approval from Drug and Food Control Agency on recommendation of the event organizer. 2) Words and pictures concerning sponsor shall not conceal information required to be stated. 3) Inclusion of words and pictures concerning sponsor shall be valid in accordance with the period of time stipulated in registration approval or data amendment approval. III. MAIN PART OF LABEL 1. Main part of label is part of label which contains the most important information to be understood by consumers. 2. Main part of label is located on package side which is most easily visible, observable and or readable by society in general. 3. Information that shall be contained on main part of label is at the minimum: a. type name, and trade name if there is any; b. net weight or content; 52 c. name and address of party producing or importing food to Indonesian territory. IV.INCLUSION OF INFORMATION ON LABEL 1. Name of Processed Food a. Name of processed food consists of type name and trade name. b. Type name is a statement or information on identity of processed food. c. Type name on label shall be placed on the main part of label. d. Requirement of granting of type name: 1) type name shall be in accordance with mandatory SNI. 2) type name which is not incorporated in point 1) shall be in accordance with food category requirement. 3) in case that type name is not stipulated in SNI and/or Food Category, the type name concerned may only be used after it has obtained prior approval from the Directorate for Food Product Standardization. 53 e. Trade Name is a mark in the form of picture, name, word, letters, numerals, color composition, or combination of those elements that have distinguishing features and used in food distribution activity. f. Trade name on label, amongst others: 1) shall not be in violation with the prevailing legislation, religious morality, decency, and public order; 2) shall not have distinguishing characteristics; 3) shall have become public property; 4) is an information or concerning the food registered; 5) shall use type name or common name that may be related to the food concerned; or 6) shall use adjective which may directly or indirectly affect interpretation of food such as natural, pure, sacred, and other words having similar meaning. g. Trade name used shall not be a trade name which has obtained brand certificate for similar type of processed food or name of other person or business entity. 54 h. Trade name that has obtained brand certificate may be used by stating ® or ™ mark as long as it is not related to safety and nutrition aspects. 2. List of Ingredients Used a. Inclusion of List of ingredients used or composition on label shall use complete common name and shall not be in the form of abbreviation. b. Information on composition or list of ingredients used in food production activity or process shall be stated on label completely and consecutively starting from the largest quantity. c. Inclusion of list of ingredients used shall be preceded with the words “composition”, “list of ingredients”, “ingredients used”, or “ingredients”. d. Inclusion of list of ingredients consecutively, as referred to in letter b, shall be excepted for carryover food additives, vitamins, minerals, and other nutrient adding substances. e. Carryover food additive shall be mentioned after ingredients containing the food additive. 55 For example: “Composition: “…, soybean sauce (containing natrium benzoate preservative)”. “List of ingredients used: “… orange flavor (containing tartrazine Cl coloring). “Ingredients: … condiment (carryover mononatrium glutamate), …”. f. Food additive, as referred to in letter e, consists of categories of artificial sweetener, preservative, antioxidant, coloring, and flavor enhancer. g. Inclusion of Food Additive on list of ingredients: 1) Processed food containing food additive shall mention category name. 2) In addition to the inclusion of information, as referred to in point 1), for artificial sweetener, antioxidant, preservative, flavor enhancer, and coloring, name of type of food additive shall be stated. 3) In addition to the inclusion of information, as referred to in points 1) and 2), for coloring, index number (Cl…) shall be mentioned. 56 4) In addition to the inclusion of information, as referred to in points 1) and 2), for artificial sweetener, quantity in mg/kg or mg/serving shall be stated. This requirement is also applicable for carryover artificial sweetener food additive. 5) In addition to the inclusion of information, as referred to in point 1), for flavor, name of flavor group (natural, natural identical, and artificial) shall be at least be stated. h. Inclusion of water in list of ingredients: 1) Water on list of ingredients shall be contained if it is used or added as ingredient in food making. 2) Water which completely evaporates during food processing, is not necessarily mentioned. 3) Complete evaporation, as referred to in point 2) is if final form of processed food is in dry/solid form. i. Inclusion of name of origin of ingredient For certain ingredients such as fat/oil, protein, extract and ingredient derived from animal, name of type and origin of the component shall be mentioned. 57 j. Percentage of ingredient content 1) Beverages containing fruit extract or vegetable extract shall state percentage (%) of the fruit or vegetable extract. 2) Statement of percentage (%) of fruit and vegetable extract may be placed close to type name and shall use letters which are not smaller than name of processed food type. 3) Percentage (%) of fruit and or vegetable extract shall be stated with, for example “…% ... fruit extract”, …% ... vegetable extract”, or “… fruit and vegetable extract”. 4) Beverages containing less than 10% fruit extract shall not contain information on fruit extract or percentage (%) of fruit extract on type name, but on list of ingredients or composition. 5) Percentage (%) of fruit extract shall be counted as brix ratio of fruit extract (whether as a result of reconstitution or without reconstitution) with brix standard of fruit extract multiplied by 100%. k. Information concerning origin and characteristic of food 1) Natural: this statement may only be used for processed food which is unmixed or unprocessed or processed food 58 which is chemically processed without changing its characteristic and content. 2) Pure: this statement may only be used for processed food which is not added with anything, for example: bottled drinking water. 3) Made of … (name of ingredient): this statement may only be used if the processed food concerned is entirely composed of one ingredient. 4) Made of … (name of ingredient): this statement may only be used if the ingredient is one of the main raw materials used in the processed food concerned. 5) 100%: this statement may only be used for processed food which is not added/mixed with other ingredient. 6) Original: this statement may not be used for processed food which is mixed with ingredients that may conceal its originality, such as the use of flavor. For example: chocolate milk that uses cocoa and chocolate flavor may not state the words ”Made of Original Cocoa”. 3. Information on Net Weight or Content a. Net weight or content is a statement on label providing information regarding quantity or amount of processed food contained in the package or container. 59 b. Drained volume or weight is a weight measure for solid food using liquid medium counted by reducing net weight by weight of liquid medium. c. Information on net weight or content and drained volume shall be placed on main part of label. d. Requirement for inclusion of net weight or content is: 1) Solid food shall be indicated in net weight; 2) Semi solid or viscous food shall be indicated in net weight or content; 3) Liquid food shall be indicated in net weight. e. Net weight or content on label shall be stated in metric unit. The following are examples for stating net weight or content: 1) Solid: milligram (mg), gram (g), kilogram (kg) 2) Liquid: milliliter (ml or mL), liter (l or L) 3) Semi solid: milligram (mg), gram (g), kilogram (kg), milliliter (ml or mL) or liter (l or L). f. The stating of information about piece or unit is as follows: 60 “Net weight: 1 gram (content 5 pieces @ 200 mg)” “Net weight: 1 gram (5 pieces @ 200 mg)”. 4. Information on Name and Address a. Inclusion of information on name and address of food producer on processed food label produced in Indonesian territory: 1) Information that shall be stated consists of name and address of producer. 2) Company’s address shall at least contain name of city, postal code, and Indonesia, except if name and address of the company concerned is not registered in city directory or phone directory of the location where the company is domiciled, therefore company’s address shall be stated clearly and completely. 3) If the food produced is licensed processed food or repackaged processed food, information connecting producer and license giver and or repackager shall be stated. (4) If the food produced is processed food produced based on contract, information connecting name of company requesting 61 for registration and producer shall be mentioned, for example: “produced by … for …” b. Inclusion of information concerning name and address of producer on label of processed food imported to Indonesian territory: 1) Information that shall be stated consists of name and address of overseas producer. 2) Address of the company as referred to in point 1), name of city and country shall at least be mentioned. 3) If the food is a licensed processed food or repackaged processed food, information connecting the producer and license giver and or repackager shall be mentioned. 4) If the food is processed food produced based on contract, information connecting the producer and contract giver shall be mentioned, for example: produced by … for …”. c. Inclusion of information concerning name and address of food importer on processed food label: 1) Information that shall be contained consists of name and address of importer. 62 2) If the party requesting for registration is not an importer as referred to in letter a, name and address stated shall include name and address of importer and name and address of the registerer accompanied with information connecting name of company requesting for registration and importer, for example: “imported by … for …” or imported by … and distributed by …”. 3) Company’s address shall at least include name of city, postal code, and Indonesia, except if name and address of the company is not registered in city directory or phone directory of the location where the company is domiciled, therefore company’s address shall be stated clearly and completely. 5. Halal Food a. The word “Halal” may only be stated on label of processed food that has “Halal” certificate from authorized institution in Indonesia and has obtained approval for the inclusion of the word “Halal” from the Directorate for Food Inspection and Certification. b. Processed food from overseas which has had halal certificate from country of origin or other country may state the word “Halal” if its compliance has been evaluated and has been recognized by authorized institution in Indonesia and has 63 obtained approval for the inclusion of the word “Halal” from the Directorate for Food Inspection and Certification. c. The word or statement “Halal” may be contained on main part of label and in accordance with the provisions of the prevailing legislation. 6. Expiry Information a. Expiry information is the expiry date of a processed food whose quality is guaranteed as long as it is stored in accordance with the guidelines given by producer. b. Producer shall mention expiry information on food label. c. Expiry information contained on label shall be preceded with the words “Best before”. d. Expiry information of processed food whose storability is up to three (3) months shall be indicated in date, month, and year. e. Expiry information of processed food whose storability is more than three (3) months shall be indicated in month and year. 64 f. Expiry information may be stated separately from the words “Best before”, but shall be accompanied with guidelines on place for the inclusion of expiry date. For example: “Best before, see bottom of the can”. “Best before, see bottle cap”. g. If expiry date is significantly affected by storage method, storage guidelines/methods shall be stated on label, and shall be placed close to expiry information. For example: “Best before 10 11 if stored at 5°C - 7°C temperature. h. Processed food which does not necessarily contain expiry date information includes: 1) alcoholic beverage wine; 2) beverages containing alcohol of more than ten (10) percent; 3) vinegar; 4) sugar (sucrose); and 5) bread and cookies having storage period of less than or equal to twenty-four (24) hours. 65 i. Processed food, as referred to in letter h, is required to contain production date and or packaging date. 7. Food Registration Number a. Food registration number stated on label shall be in accordance with food registration number stated in Registration Approval Letter. b. Inclusion of food registration number: 1) for processed food produced domestically, the words “BPOM RI MD” shall be stated. 2) for processed food imported to Indonesian territory, the words “BPOM RI ML” shall be stated. 8. Information on Production Code a. Production code is a code that may provide information concerning history of production of processed food processed in similar condition and time. b. Production code can be stated in the form of batch number. c. Production code may be accompanied with or in the form of production date. 66 d. Production date, as referred to in letter c, is date, month, and year when the processed food is produced. 9. Information on Nutrient Content a. Information on nutrient content shall be stated as information on nutritional value and/or claim (nutrition claim and health claim). b. Inclusion of nutritional value information is required on label: 1) which is accompanied with a statement stating that the food contains vitamin, mineral, and or other nutritional substances added; or 2) which is required based on the provisions of prevailing legislation on food quality and nutrition, vitamin, mineral, and or other nutritional substances shall be added. c. Type of nutritional substance that must be stated, format, and requirement of inclusion of nutritional value information shall be in accordance with Guidelines on Inclusion of Nutritional Value Information on Food Product Label. d. Nutrition claim and health claim shall be stated in accordance with the requirements stipulated. 67 10.Information on Food Irradiation a. On label of processed food experiencing irradiation treatment, the following shall be contained: 1) the words “IRRADIATED FOOD”, 2) objective of irradiation, 3) the words “Not to be Re-Irradiated” if the processed food is not allowed to be re-irradiated, 4) name and address of irradiation operator, if irradiation is not self-performed by food producer, 5) date of irradiation in month and year, and 6) name of country where irradiation is performed. b. In case that processed food contains materials which experience irradiation treatment, The Label shall only state information on irradiation treatment on the irradiated material concerned. For example: “Composition: wheat flour, pepper (irradiated food), salt”. 68 c. In addition to the inclusion of information, as referred to in letters a and b, special logo of irradiated food as specified below, may be contained on Label: 11.Information on Food Genetic Engineering a. Label of genetically engineered food shall contain the words “GENETICALLY ENGINEERED FOOD” on type name. For example: “CORN (GENETICALLY ENGINEERED FOOD)”. b. In case that processed food contains genetically engineered material, the Label shall only state information on genetically engineered food on the material which is genetically engineered food. For example: “Composition: soybean (genetically engineered food), water, brown sugar, salt”. c. Special logo of genetically engineered food may be contained on label. 69 d. In addition to the inclusion of information, as referred to in letters a, b, and c, label of processed organic food shall meet the provisions on labeling of genetically engineered food. 12.Information on Organic Food a. Food that has met organic food requirement may contain the word “organic” and Indonesian organic logo on label: Organic logo: b. The word, as referred to ion letter a, shall be stated after the writing of name of product type. c. Size of letters for the word, as referred to in letter b, shall be proportional to and shall not be larger than size of letters for name of product type. d. Organic information, as referred to in letter a, is prohibited for use on food which does not meet the provisions on requirement of processed organic food. 70 e. Information stating excellent qualities of organic food if compared to non-organic food on label shall not be stated on label. 13.Information on Food Made of Natural Raw Material a. Food made of natural raw material may be given label containing information that the food is derived from the natural material if the food contains the natural material not less than the minimum content stipulated in Indonesian National Standardization. b. Food made of natural raw material which has undergone further process, information stating that the material concern has undergone further process shall be stated on label. c. Label of food made without using or partly using natural raw material shall not contain statement or information that the food concerned is entirely made of natural ingredient. 14.Information on Serving Guidelines and/or Guidelines on Use a. Processed food requiring preparation before it is served or used, shall contain preparation guidelines and/or guidelines on use. 71 b. Processed food, as referred to in letter a, consists of, amongst others, infant formula, follow-up formula, breastmilk supplementary food (MP-ASI), special drinks for pregnant and/or breastfeeding mothers, food for sufferers of certain diseases, food for weight control, or other special dietary food. 15.Information on Storage Guidelines a. Processed food requiring special storage methods that includes, amongst others, ice cream, bottled drinking water, and processed meat shall contain information on the proper storage guidelines/methods. b. Packaged processed food which is impossible to be consumed for one time or in one serving, shall contain information on storage methods after opening of the package. 16.Information on Serving Guidelines/Suggestions a. Serving guidelines/suggestions shall be contained on label of food requiring such guidelines. b. For food requiring or having serving or use suggestions, pictures of other food material may be contained in accordance with serving guidelines/suggestions or use 72 guidelines/suggestions accompanied with the words “serving suggestions”. 17.Information on Intended Use Processed food intended for consumption by certain target consumers (amongst others, infants, children, pregnant mothers, breastfeeding mothers, sufferers of certain diseases, sportspersons, or people with special diets), shall contain information on intended use. For example: “Infant formula for 0 – 6 month old”. “Special dietary food for patients with kidney disorder”. 18.Other Information Terms to distinguish quality of a processed food may be used with the following requirements: a. Terms that may be used to show differences of a processed food type are, amongst others, “special”, “premium”, “gold”, “platinum”, or other words with similar meaning. b. The processed food has a clear distinguishing characteristic concerning quality and/or nutrition with similar type of processed food. 73 c. Similar food, as referred to in letter b, is processed food produced by the same company with the same type name. d. The terms, as referred to in letter a, shall be accompanied with asterisk mark (*) and explanation on the star mark contained on main part of label. e. The explanation, as referred to in letter d, consists of distinguishing characteristic and if necessary a similar type of processed food may be stated as a comparison. V.MATTERS PROHIBITED TO BE CONTAINED ON PROCESSED FOOD LABEL Statement, picture, or information prohibited to be contained on Label include: 1. Incorrect statement or information. Incorrect information is information whose content is in contradictory to the actual condition or does not contain the information required so that the information could provide the actual description or image about food. 2. Misleading statement or information. Misleading information is a statement concerning matters such as characteristic, price, material, quality, composition, benefit, or safety of food, which, even though it is correct, may cause a misunderstanding about the food concerned. 74 3. Inclusion of statement that processed food contains a nutritional substance which has more excellent qualities if compared to other processed food which is not in accordance with the provisions of the legislation. 4. Statement that processed food is healthful. 5. Statement or information in any form that the processed food may function as medicine. 6. Picture of health officer or person acting as health officer. 7. Statement that processed food can increase intelligence or IQ. 8. Statement on excellent quality of processed food if the excellent quality is not entirely derived from the food, but is partly contributed by other food that can be consumed at the same time. 9. Statement containing unavailability of a component which naturally does not exist in processed food, except if there is supporting data/general standard on processed food containing such component. 10. Statement stating free from certain material, but the food contains such material unintentionally or as participating material/compound. 11. Information stating that processed food has tonic characteristic, only because the food contains alcohol, 75 sugar, or other carbohydrate, protein, caffeine, or substances derived from protein hydrolysis or purine derivative. The inclusion of the word “tonic” may only be used for tonic or quinine wine. 12. Words or pictures describing as if an artificial sweetener is derived from nature. 13. Name, logo, or identity of institution performing processed food analysis. 14. Using name and picture of a figure which has become public property, except with license from the party concerned. 15. Stating name of location, country, city, province, ethnic, and other similar things in any form that has no relationship with the processed food (amongst others, type name, origin of ingredient, or production site). 16. Statement or information, which directly or indirectly underestimates goods and/or services of other party. 17. Statement which is in the form of reference, advice, reminder, or statement from health officer or person acting as health officer with the aim to increase sales directly or indirectly. 18. Information, words, or pictures offending certain ethnic, religion, race, and/or group. 76 19. Inclusion of information on lottery, contest, prize, and words or pictures whatsoever which is not in accordance with the label approved in food product registration approval or approval on amendment of processed food data. 20. Other information, words, or pictures which are contradictory to and prohibited by the provisions of the legislation. HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA Sgd KUSTANTINAH 77 78 79