Regulation of the Head of Drug and Food Control Agency of R.I. No. 43/2013 on the amendment to Regulation of the Head of Drug and Food Control Agency of R.I. No. HK.03.1.5.12.11.099556 of 2011 on Processed Food Registration

48 GOVERNMENT REGULATIONS AMENDMENT TO REGULATION OF THE HEAD OF THE DRUG AND FOOD CONTROL AGENCY NO. HK.03.1.5.12.11.09956 OF 2011 ON THE PROCEDURE OF REGISTERING PROCESSED FOODS (Regulation of the Head of the Drug and Food Control Agency No. 43/2013 dated June 28, 2013) BY THE GRACE OF GOD ALMIGHTY THE HEAD OF THE DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA, 4. Government Regulation No. 69/1999 on Food La­ bels and Advertisements (Statute Book of 1999 No. 131, Supplement to Statute Book No. 3867); 5. Government Regulation No. 28/2004 on Food Security, Quality and Nutrition (Statute Book of Considering : 2004 No. 107, Supplement to Statute Book No. To adjust provisions on the registration of pro- 4244); cessed foods, it is necessary to stipulate Regulation 6. Presidential Decree No. 103/2001 on the Posi of the Head of the Drug and Food Control Agency on tion, Tasks, Functions, Authority, Organizational Amendment to Regulation of the Head of the Drug and I Structure and Work Mechanism of Non-Ministerial Food Control Agency No. HK.03.1.5.12.11.09956 Government Institutions as already several times of 2011 on the Procedure of Registering Processed amended the latest by Presidential Regulation No. Foods; 3/2013; 1 7. Presidential Decree No. 110/2001 on Organiza ln view of : tional Units and Tasks of Echelon I Officials of 1. Law No. 8/1999 on Consumers Protection (Stat- Non-Ministerial Government Institutions as al ute Book of 1999 No. 42, Supplement to Statute ready several times amended the latest by Presi Book No. 3281 ); dential Regulation No. 4/2013; 2. Law No. 36/2009 on Health (Statute Book of 2009 No. 114, Supplement to Statute Book No. 5063); 3. Law No. 18/2012 on Food (Statute Book of 2012 No. 227, Supplement to Statute Book No. 5360); Business News 8526/3-7-2014 (S) 8. Regulation to be continued 42 GOVERNMENT REGULATIONS AMENDMENT TO REGULATION OF THE HEAD OF THE DRUG AND FOOD CONTROL AGENCY NO. HK.03.1.5.12.11.09956 OF 2011 ON THE PROCEDURE OF REGISTERING PROCESSED FOODS (Regulation of the Head of the Drug and Food Control Agency No. 43/2013 dated June 28, 2013) [Contined from Business news No. 8526 page 48] 8. Regulation of the Head of the Drug and Food Control Agency No. HK.03.1.5.12.11.09955 of Article I Several provisions in Regulation of the 2011 on the Registration of Processed Foods as Head of the Drug and Food Control Agency No. already amended by Regulation of the Head of HK.03.1.5.12.11.09956 of 2011 on the Procedure the Drug and Food Control Agency No. 42/ 2013 of Registering Processed Foods are amended as fol (State Gazette of 2013 No. 963); lows: 9. Regulation of the Head of the Drug and Food 1. Article 1 is amended so that it reads as follows: Control Agency No. HK.03.1.5.12.11.09956 of Article 1 2011 on the Procedure of Registering Processed Referred to in this Regulation as : Foods (State Gazette of 2011 No. 811 ). 1. Food is anything which originates from bio DECIDES: To stipulate : REGULATION OF THE HEAD OF THE DRUG AND FOOD CONTROL AGENCY ON AMENDMENT TO REG­ ULATION OF THE HEAD OF THE DRUG AND FOOD CONTROL AGENCY NO. HK.03.1.5.12.11.09956 OF 2011 ON THE PROCEDURE OF REGISTERING PRO­ CESSED FOODS. logical sources of agricultural, plantation, for estry, fishery, husbandry, waters and water products, whether or not they are processed, which are designed as food or beverage for human consumption including food additive, food raw material, and other materials which are used in the process of preparing, process­ ing and/or making food or beverage. 2. Processed food is food or beverage which re­ sults from a process through a certain way or method with or without food additive, in­ cluding certain processed food, food additive, Business News 8527-852813-12-2014 . genetically, engineered food product and irra­ diation food. 3. Food additive, hereinafter abbreviated into BTP, · is a material which is added to food to influence the characteristics and shape of the food. 4. R.egistretion is the,procedure of assessing the security, quality and nutrition of processed food to .obtaiO' a registration approval. 5. New · r,egjstcation ,is- tho registo1ti,on of pro­ cessed food .which has not received a regis­ tration approval. 6r. . .Variation-: reQffltratiQn. is tJ!le r~istration of a ch&n!l&. kt :d8t•· of •PfQC.$Sed food which has received a processed foOQ ~istration approv al without changing food registration number and/or evaluation erMi1 ifegistrQtion ;te91, 7. Repeat registration is the registration of ex-.· tended validity period of proce$$Qd;f()Qld'1r..e9", , . istration approval. 8. Certificate of registration approval is approval,\ 1 of the result of processed food assessment which is issued by the Agency Head within the framework of circulating food. 9. Label is any piece of information on food which comes in the form of picture, text, combination of both, or other form which is attached to food, put inside, stuck on or part of food pack. 10. Company is a producer, importer and/or dis­ tributor ot processed food who has secured a business permit according to the legislation. 11 . Register is a company or party which is given authority by company to register processed food to receive a registration approval. 12. Evaluation and registration fees are fees which are imposed within the framework of evaluating processed food according to the legislation. 13, Oifector is the Oirector of Food Security Eval­ uation. 14. Agency Head is the Head of the Drug and Food Control Agency of the Republic of Indo­ nesia. .. 16. Day is wor,king day, 2. The title of Part Two, Chapter II, the Procedure of 11 i Regj$terioo f>rocnsu Foods is amended so that it reads as follows: Part Two Variation Registration 3. Article 13 is amended so that it reads as follows : Article 13 ( 1 ) A change in processed foods that have re ceived registration approval shall be reported to the Agency Head through variation regis tration mechanism. (2) To obtain approval of data change, companies shall file written applications to the Agency Head through the Director. lul#m,p ~ 8!)27-ll!ill/3-fl-?01◄ 4 GOVERNMENT REGULATIONS 4. In-between Articles 13 and 14, one new article, namely Article 13A is inserted as follows: Article 13A ( 1) Var;uuon registration with minor change shall be proj)osed by filling the form as contained in Attachment 7 and enclosing variation reg­ istration documents according to the change proposed. (2) If the form and variation registration docu­ ments as referred to in paragraph ( 1) are complete and correct, no later than 10 (ten) working days, the Agency Head shall issue variation registration approval. (3) Without having to await the variation regis­ tration approval as referred to in paragraph (2), registers can start making the change as referred to in paragraph ( 1) after submitting variation registration documents along with a receipt of bank payment. 5. Article 14 is amended so that it reads as follows: Article 14 ( 1) Variation registration with major change shall be proposed by filling the form as contained in Attachment 7 and enclosing variation reg­ istration documents according to the change proposed. (2) The documents as referred to in paragraph (1) shall be audited and evaluation and registra­ tion fees shall be set. (3) The results of the audit of application docu ments as referred to in Article 13 paragraph ( 1) may come in the form of: a. being accepted for further evaluation; b. being returned to be completed; or c. being rejected. 6. Article 18 is amended so that it reads as follows: Article 18 ( 1) Approval of data change or rejection of data change as referred to in Article 17 for : a. certain processed foods are issued no later than 60 (sixty) days; b. functional foods/foods with claim, foods with herb are issued no later than 45 (forty five) days; c. Irradiation foods, genetically engineered foods, BTP, organic foods, and other foods are issued no later than 30 (thirty) days. (2) Other foods as referred to in paragraph ( 1) letter c cover types of foods other than those referred to in paragraph (1) letters a and b, ir­ radiation foods, genetically engineered foods, BTP, and organic foods. (3) The period of time as referred to in paragraph (1) and Article 13A paragraph (2) starts from the receipt of applications for data change as referred to in Article 16. (4) If the results of further evaluation need ad­ ditional data and/or further study, the calcu­ lation of time as referred to in paragraph ( 1) shall be temporarily halted starting from the Business News 8527-8528/ 3-12-2014 GOVERNMENT REGULATIONS date of application for additional data. (5) The temporarily halted calculation of time as referred to in paragraph (4) will be continued after the receipt date of letter fulfilling addi­ tional data. 7. The title of CHAPTER VI is changed so that it reads as follows: CHAPTER VI REPEAT REGISTRATION 8. Article 25 is amended so that it reads as follows: Article 25 ( 1) The repeat registration of processed foods can only be done to processed foods which are the same as those approved previously. (2) If processed foods which are registered again have changed, the company shall make varia­ tion registration first. (3) The repeat registration of processed foods can only be done in 6 (six) months at the ear­ liest and 1 0 (ten) working days at the latest before the validity date of registration approv­ al ends. Article II This Regulation shall come into force as from the date of promulgation. For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia Business News 8527-8528/3-12-2014