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Selasa, 17 Juli 2012

Food and Baverage Registration in Indonesia


Indonesia’s government also has been gradually implementing a strict food labeling law that requires labels written only in the Indonesian language on all consumer products.  Labels may not include any other languages.  Beginning January 2001, Indonesia’s regulations required labels identifying food containing "genetically engineered" ingredients and "irradiated" ingredients. BPOM, which is an arm of the Ministry of Health, must test all processed food products and is also responsible for labeling and the issue of registration numbers (MLs) for imported food products.
ML Numbers System in Indonesia
Under the Consumer Protection Law, a registration system covers all processed food products. Its key elements are:
  1. Details of products, including their ingredients, must be submitted to BPOM, together with samples and evidence of testing by authorities in the country of origin
  2. Upon approval, a registration number is issued (for imports the ML number, which must be printed on food package labels)
  3. Products must be re-registered every five years
  4. The ML numbers (abbreviation of “Makanan Luar” or “Imported Food”) are importer specific.
Products must be registered with BPOM before clearance through Customs and carry the appropriate sticker. Importers, distributors or retailers dealing in unregistered products are in breach of the regulations and subject to penalty. The time it takes to register goods is also significant—up to six months, although some cases can take longer.
Imported Food Products Registration
All processed food products imported must be registered with the National Agency of Drugs and Food Control (BPOM) except for:
  1. Processed food with a life of less than seven days at room temperature.
  2. Processed food representing a donation to the Government or to a Social Institution.
  3. Processed food in small quantities for the specific purposes of registration with the National Agency of Drugs and Food Control (BPOM), scientific research or personal consumption.
Registration requires submission of five standard forms in triplicate together with:
  1. A sample of the food.
  2. The label (10 copies) and brochure if applicable.
  3. For repackaged product, the operating license of the Indonesian business involved and a letter of reference from the original production plant.
  4. For product produced under license, the Indonesian company's license and a letter of reference from the overseas factory.
  5. For imported products a reference letter from the overseas factory, a health certificate and a radiation free certificate in accordance with existing law.
Following consideration, the product may be:
  1. Registered with the issue of Form M1;
  2. Conditionally registered with the use of Form M2; or
  3. Rejected from registration via the issue of Form M3.
Other Specific Standards
GMO’s (General Modified Organism)
Any producer using genetic engineering must ensure that the product is safe for human consumption before distribution. In terms of labeling requirements for GMO’s: 1) The words GENETICALLY ENGINEERED FOOD shall be contained in labels of food resulting from genetic engineering; 2) In the case of processed food which results from genetic engineering as meant in paragraph being ingredients used in certain food products, the information on genetically engineered ingredients of foods resulting from the genetic engineering on labels shall be enough.
Labeling
New food labeling requirements were introduced in 1999 and are the responsibility of the Food and Drug Control Body (Badan POM or BPOM). Labeling requirements are designed to ensure that the consumer can be accurately informed about the ingredients in processed food and its status as a halal or non-halal product. Post market control is maintained through sampling and testing food products. Where discrepancies occur there are powers to reprimand, order withdrawal of products from sale, or prosecute through the courts.
Key points of the current labeling requirements include:
  1. All packaged food products distributed in Indonesia must be labelled exclusively in Bahasa
  2. Indonesia language, Arabic numbers and Latin letters.
  3. The use of any other language, number and letters is permitted only where there are no
  4. Substitute Indonesian words or if there is a difficulty in finding Indonesian words with a similar meaning; such approval must be obtained from the Indonesian Attorney-General.
  5. The use of stickers was authorized temporarily (until new legislation was enacted).
  6. Specific wording regarding content is required for labels of certain food items including milk
  7. Products, baby food, alcoholic beverages, and halal food.
  8. If the product is halal, it must be certified by an approved authority
  9. The expiration date of perishable food items must be shown (and products must be landed
  10. in Indonesia with at least 2/3 of their stated shelf life remaining).
  11. Food additives must be identified.
  12. The name and address details of the importer must be stated.
  13. There are specific requirements for labeling of products with GMO content greater than
  14. 5% and also for irradiated products.
  15. SNI marks must be shown when relevant compulsory standards exist (these apply to sugar,
  16. Salt and wheat flour.
Halal certification
The Indonesian authorities do not require halal certification for all imported foodstuffs. But while certification is not compulsory, 88% of the Indonesian population is Muslim and the Indonesian Islamic Council (MUI) prefers all food products to be halal accredited. Halal is an Arabic word meaning lawful or permitted. The opposite of halal is haram, which means unlawful or prohibited. Halal and haram are universal terms that apply to all facets of life. However, in Indonesia, these terms are used only in relation to food products, meat products, cosmetics, personal care products, food ingredients, and food contact materials.
All foods are considered halal except the following, which are haram: a. Swine/pork and its by-products; b.  Animals improperly slaughtered or dead before processing;  c.  Animals killed in the name of anyone other than Allah (God); d.  Alcohol and intoxicants; e.  Carnivorous animals, birds of prey and land animals without external ears; f.  Blood and blood by-products; g.  Foods contaminated with any of the above products.
Food Additive Regulations
The Food Act of 1996 states that food additives are not to be used if they have been banned, or may not exceed specified limits.  This implies a "negative" regulation of food additives, but the subsequent clause states that the Government will determine which substances are banned as food additives and/or may be used in food production and also the content limit.  Hence the regulation is "positive" in that the Government states those additives that may be used. Approval is the prerogative of the Director of Food Safety Evaluation, a subordinate of the Deputy of Agency for the National Agency of Drugs and Food Control (BPOM).  The regulation states that approval will be based on assessment against guidelines prepared by the Head of Agency.
Every import of food additives must be reported in writing to the Division of Food Certification, BPOM after the goods arrive in harbor.  The report must include:
  1. The name of the substance and batch quantity and weight.
  2. The name and address of the importer.
  3. The name and address of the exporter.
  4. The name and address of the producer.
  5. The port and date of lading.
  6. The port of destination and date of arrival.
  7. The name, nationality and registration number of the ship or aircraft carrying the food
  8. Additive import.
  9. The name and address of the warehouse and date into store.
  10. An outline of any accidents that may have occurred during shipping.
A certificate of analysis for the applicable batch must accompany every import of food additives.  The certificate may be issued by the production plant or by the responsible authority in the country of origin.  Before the import is cleared from the point of entry the Director of Food Certification, BPOM must agree the certificate.  If a certificate does not accompany an intended import, then a certificate must be requested from the Director of Food Certification before the food additive shipment may enter the country.
The certificate must include:
  1. Date that the sample was taken.
  2. Batch number of the product
  3. Test date.
  4. Test method.
  5. Statement that the test result was in accordance with criteria for the product.
A food additive product from an animal source must also have a certificate of conformity with Islamic purity, "Halal".  That certificate is to be issued by the responsible authority in the country of origin.  Food additives produced, imported or distributed must comply with the Indonesian Food Codex or conditions approved by the National Agency of Drugs and Food Control (BPOM).  For food additives not listed in the Indonesian Codex, or not having conditions determined by the National Agency of Drugs and Food Control (BPOM), the FAO/WHO Codex Alimentary Commission or Food Chemicals Codex is applicable. 
***Compiled from various sources.

Disclaimer: The above is provided for informational purposes only and is NOT to be relied upon as legal advice. This information is not a substitute for the advice of an attorney and should not be construed as a solicitation. No attorney-client relationship is established by use of information found anywhere in this article nor in this website.
 adapted from wijaya & co

Selasa, 21 Februari 2012

PSB atau Pemeriksaan Sarana Bangunan oleh Balai Besar POM Provinsi/ Setempat



PSB (Pemeriksaan Sarana Bangunan) oleh Balai Besar POM provinsi atau setempat adalah syarat mutlak bagi para produsen atau importer  yang akan mendaftarkan Produk makanan atau minuman nya ke BPOM Pusat ( JL. Percetakan Negara Salemba)
PSB adalah langkah awal sebelum anda registrasi /mendaftar kan produk tersebut ke BPOM.
Peran penting Balai Besar POM selain untuk mengawasi peredaran produk di lapangan /market2 yang tersebar di Indonesia juga mengawasi langsung tempat produksi (pabrik lokal) dan Gudang untuk importer.
Petugas Balai Besar POM biasanya akan datang langsung ke Lokasi pabrik atau gudang distributor untuk memeriksa sarana prasarana produksi, gudang dan kantor , memeriksa hygienis dan sanitasi, factor penangan hama, dan kelengkapan dokumen perusahaan untuk MD maupun ML.

Syarat untuk mengajukan PSB (pemeriksaan sarana bangunan) :

·        Surat Permohonan PSB (diajukan ke Balai Besar POM setempat/Provinsi).(Download format ada disini)
·         Izin Industri /IUI (untuk produk MD)
·         SIUP (makanan dan minuman)
·         NPWP
·         TDP
·         KET DOMISILI
·         AKTE NOTARIS
·         PERJANJIAN SEWA MENYEWA min 2 tahun (apabila sarana tempat status sewa)
·         UUG/HO
·         DENAH LOKASI 6 lembar
·         DENAH BANGUNAN gudang,kantor,pabrik, 6 lembar.
·         HASIL UJI LABOLATORIUM
·         SOP Hygienis dan sanitasi.
·         SOP Penerimaan barang
·         SOP Penangan hama
·         Struktur Organisasi
·         API –u (makanan,minuman) untuk IMPORTER produk ML
·         FREE SALE / HEALTH CERTIVICATE (asli) untuk produk ML.
L    LOA (Surat Penunjukan dari Produsen sebagai distributor di indonesia)
·         Tabung Pemadam Kebakaran. (wajib ada)
·         PALET/RAK penyimpanan barang (wajib ada)

Dokumen tersebut diatas dilampirkan saat pengajuan ke Balai Besar POM setempat.
Setelah dokumen tersebut diajukan anda akan mendapat konfirmasi oleh Balai Besar POM mengenai jadwal kunjungan / survey ke lokasi sehari sebelumnya.

Bagi yang masih kurang jelas harap datang langsung ke Balai Besar POM setempat.

atau bisa email saya ke ari_aliest@yahoo.co.id (08176437989)

yang merasa terbantu jangan lupa komenya.

Thx Ari..


Jumat, 02 Desember 2011

CARA ISI TEMPLATE NOTIFIKASI KOSMETIK DAN PEDOMAN CARA PEMBUATAN KOSMETIK YANG BAIK CPKB


Cara notifikasi kosmetik
siapin aja laptop dengan akses internet...
langsung aja agan ke http://www.pom.go.id/  pilih notifikasi kosmetik ONLINE
jangan lupa siapin dulu DIP, secangkir kopi dan sebungkus rokok . (biar enggak ngantuk gan!!)

klo yang masih bingung cara isi template nya klik aja link di bawah

CARA ISI TEMPLATE NOTIFIKASI KOSMETIK YANG BENAR klik aja

Nah ini dia Gan Contoh spesifikasi, dokumen kosmetiknya berikut INCI Name dan CAS Nomer nya, klik aja DISINI Lumayan buat acuan bagi yang pemula.

Jangan sampai salah untuk pengisian kategori produk, klaim produk, klaim penggunaan produk dan jumlah persentase dari ingredient nya (sesuai peraturan BPOM) kalo agan salah bisa di rejeck atau ditolak.


untuk contoh pembuatan CPKB khusus kosmetik produk LOKAL klik Contoh CPKB



Ok ...Gan semoga bermanfaat, yang merasa terbantu tolong kasih komentar...!!

Jumat, 16 September 2011

cara daftar obat tradisional ke bpom

PERSYARATAN ADMINISTRASI PENDAFTARAN OBAT TRADISIONAL


L o k a l


  • Fotokopi izin usaha Industri Obat Tradisional/Industri Kecil Obat Tradisional
  • Fotokopi ijazah, Surat Ijin Kerja Apoteker Penanggung Jawab Teknis yang telah divisum atau Surat Penugasan dari Kantor Wilayah Departemen Kesehatan RI setempat dimana industri tersebut berada
  • Surat Pernyataan Apoteker sebagai Penanggung Jawab Teknis
  • Contoh Obat Tradisional yang didaftarkan
  • Rancangan Penandaan siap cetak
  • Contoh simplisia/bahan baku

L i s e n s i

Persyaratan sama dengan produk lokal, disertai dengan:
  • Surat Penunjukan Lisensi
  • Free Sale Certificate (asli) dari negara asal yang disahkan oleh Pejabat Perwakilan Pemerintah RI di negara tersebut

I m p o r

Persyaratan sama dengan produk lokal
Pemohon selain industri Obat Tradisional juga boleh didaftarkan oleh suatu Badan Usaha, dan disertai dengan:
  • Surat Penunjukan dari produsen negara asal
  • Free Sale Certificate (asli) dari negara asal yang disahkan oleh Pejabat Perwakilan Pemerintah RI di negara tersebut
  • Sertifikat uji laboratorium yang ditunjuk oleh Badan POM
  • Data Uji toksisitas untuk obat tradisio

PERSYARATAN TEKNIS PENDAFTARAN OBAT TRADISIONAL


L o k a l

Formulasi/Khasiat:
  • Komposisi: nama bahan baku dan jumlahnya
  • Khasiat/Kegunaan: khasiat/kegunaan obat tradisional, didukung khasiat /kegunaan bahan baku yang ditunjang daftar pustaka
  • Cara Pemakaian: cara pemakaian dan takaran/dosis obat tradisional (terperinci): peringatan, perhatian, pantangan/anjuran, lama pemakaian
Mutu dan Teknologi:
  • Cara Pembuatan: jumlah produk yang direncanakan untuk satu kali pembuatan lengkap dengan jumlah bahan baku yang digunakan, semua tahap pembuatan/ Prosedur Operasional Standar; alat atau mesin yang digunakan
  • Sumber perolehan bahan baku
  • Penilaian Mutu Bahan Baku; pemerian/organoleptik, makroskopik, mikroskopik dan uji fisika-kimia disesuaikan dengan jenis bahan baku (simplisia atau ekstrak)
  • Penilaian Mutu Produk Jadi: sertifikat analisa produk jadi meliputi pemeriksaan fisika, kimia, cemaran mikroba dan cemaran logam
  • Metoda dan Hasil Pengujian Stabilitas/Keawetan

I m p o r

Persyaratan sama dengan produk lokal, dengan melampirkan data-data dari industri asal (asli atau fotokopi yang dilegalisir)

P e n a n d a a n

Pada penandaan/etiket sekurang-kurangnya memuat:
  • Nama Obat Tradisional
  • Ukkuran kemasan (Berat bersih/isi bersih)
  • Nomor Pendaftaran, nama dan alamat industri (sekurang-kurangnya nama kota dan negara)
  • Komposisi (nama latin bahan baku)
  • Khasiat/Kegunaan
  • Cara pemakaian
  • Peringatan dan kontra indikasi (bila ada)
  • Nomor kode produksi
  • Kadaluwarsa
Untuk Produk Lokal, tambahkan kata jamu dalam lingkaran (logo jamu)
Untuk Produk Lisensi, tambahkan lambang daun (logo produk OT Lisensi) dan nama pemberi lisensi
Untuk Produk Impor, tambahkan nama importir/distributor di Indonesia, dan informasi harus ditulis dengan huruf latin dalam bahasa Indonesia disamping bahasa aslinya

CHEK LIST UNTUK DAFTAR MAKANAN MINUMAN MEREK LUAR KE BPOM UNTUK PRINSIPAL



INDONESIA HEALTH CODE REGISTRATION PROCEDURES (ML) CHECKLIST

No
Formula
Data
Available
Un-available
1
Letter Of Distributor Appointment from the Principle or factory
2
Free Sale Certificate From Country Of Origin Or Health Certificate
3
v Raw Materials Specification
E.g.: Preservatives E133 or Colour E120, they want to know
- The source & which company did you procure it from.
- Metals/Chemical properties
- Micro-bacteria specification
- (Appearance & Colour)
- (Taste & Smell)
- (Viscosity)
4
v Product Composition
(Serving per package, Service size)
Average Quantity Per Serving. Average Qty Per
100gm / 100mL... etc)
E.g. :
Water : 20 %
Sugar : 20%
Creamer : 20%
Coco: 20%
Total : 100%
5
v Production Process Flow Chart
6
v Packaging Specification
- Inner packaging material
- What’s the Carton box material
- Brand name, Product description, Packaging Count (1 Count=? Outer/Pcs), Size (200gm?)
7
v Expiry Date Specification (Shelf Life?)
Expiry date code : DD?MM?YYYY
8
v Lab test analysis certification of the products
(Original needed). The result validity is within 1 year from the data of the certification.
1) Chemical / Metal Analysis
2) Micro – biology analysis
3) Lab Analysis Parameters
9
v Non GMO
v The following parameters have to be testedè
Microbiology Parameters
1
TPC
2
Coliform
3
E.Coli
4
Salmonella
5
Yeast & Mould
6
S. Aureus
7
Colostridium Perfringens
8
Vibrio. Sp (For Drinks ONLY)
9
Aflatoksin Total (For Nuts, condense milk, milk powder, pudding, yogurt, whey product, product from corn, herbs and spices powder)
10
Bacilius Cereus, Deoksinivalenol (For Spice Paste)
11
Okratoksin A (for Raisin, Instant Coffee, Coffee Powder
Heavy Metal Parameters
1
Pb (Lead)
2
Hg (Mercury)
3
As (Arsenic)
4
Sn (Tin)
5
Cd (Cadmium)
Coloring test
If your product contains the following colours, they need to be tested:
- Colour content value needs to clearly indicated on the report