Mengantisipasi Isu Food Allergen

REGULASI:
Mengantisipasi Isu Food Allergen
ROY SPARRINGA Deputi Bidang Pengawasan Keamanan Pangan dan Bahan Berbahaya
Badan Pengawas Obat dan Makanan
Disampaikan pada Acara Seminar
Understanding and Managing Food Allergen in Food Industries
Bogor, 26 September 2013
1 AGENDA 1.  Pendahuluan
3. Regulasi Global 4. Regulasi di Indonesia
5. Penutup
Pendahuluan Pendahuluan
§  Prevalensi alergi 30-­‐40% dari total populasi dunia (World Allergy Organiza0on/WAO, 2011) §  Angka kejadian alergi meningkat 3x lipat sejak 1993 hingga 2006 (Center for Disease Control and Preven0on/CDC) §  6-­‐8% anak dibawah 3 th dan 2% orang dewasa memiliki seEdaknya satu jenis alergi pangan (Food Safety Centre Allergen Bureau, Australia) §  Di Amerika, peningkatan alergi makanan sampai 2x lipat dalam 10 th terakhir, khususnya alergi kacang (www.foodallergy.org) §  Di Indonesia, diperkirakan ada peningkatan kasus alergi mencapai 30% per tahun (PD PERSI, 2012) Pendahuluan What is Allergy? A reac=on of the immune system to a normally harmless substance •  Food Protein •  Substances (eg. Latex) •  Aeroallergens –  House Dust Mites –  Pollens –  Moulds and more…. •  SEnging Insects •  Drugs (Food Safety Centre Allergen Bureau, Australia) Pendahuluan Allergen Utama pada Pangan 90%
Peanut
Tree nut
Milk
Egg
Soy
Fish
Shellfish
Wheat
Sesame
10%
Hundreds of others
(Food Safety Centre Allergen Bureau, Australia) Pendahuluan Adverse Reac=ons to Foods Non-Toxic
Toxic
Food Poisoning
Food Intolerance
Food Allergy
eg. Lactose intolerance
Gluten intolerance
IgE/Th2 Mediated
Non-IgE mediated
eg. Eczema
Urticaria (hives)
Anaphylaxis
Intestinal Manifestations
(Food Safety Centre Allergen Bureau, Australia) Regulasi Global Eropa Amerika Serikat Jepang Kanada Codex Australia Codex Except for single ingredient foods, a list of ingredients shall be declared on the label : ð  The following foods and ingredients are known to cause hypersensi=vity and shall always be declared: • Cereals containing gluten; i.e., wheat, rye, barley, oats, spelt or their hybridized strains and products of these; • Crustacea and products of these; • Eggs and egg products; • Fish and fish products; • Peanuts, soybeans and products of these; • Milk and milk products (lactose included); • Tree nuts and nut products; and • Sulphite in concentraEons of 10 mg/kg or more. GENERAL STANDARD FOR THE LABELLING OF PREPACKAGED FOODS
CODEX STAN 1-1985
Amerika Serikat •  The Food Allergen Labeling and Consumer ProtecEon Act of 2004 (FALCPA) is a law that was enacted in August 2004. Among other issues, FALCPA addresses the labeling of all packaged foods regulated by the FDA •  Under FALCPA, a "major food allergen" is an ingredient that is one of the following eight foods or food groups or an ingredient that contains protein derived from one of them: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans •  FALCPA labeling requirements apply to foods that are made with any ingredient, including flavorings, colorings, or incidental addiEves (e.g., processing aids), that is or contains a major food allergen. Guidance for Industry: A Food Labeling Guide FDA, October
2006
Amerika Serikat Labelling
Eropa ArEcle 9 List of Mandatory Par=culars ....following parEculars shall be mandatory : ...(c)any ingredients or processing aid listed in Annex II or derived from a substances or product listed in Annex II causing allergies or intolerances used in the manufacture .... REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL of 25 October 2011
on the provision of food information to consumers
Eropa SUBSTANCES OR PRODUCTS CAUSING ALLERGIES OR INTOLERANCES 1.  Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof, except: (a) wheat based glucose syrups including dextrose ( 1 ); (b) wheat based maltodextrins ( 1 ); (c) glucose syrups based on barley; (d) cereals used for making alcoholic disEllates including ethyl alcohol of agricultural origin; 2. Crustaceans and products thereof; 3. Eggs and products thereof; 4. Fish and products thereof, except: (a) fish gelaEne used as carrier for vitamin or carotenoid preparaEons; (b) fish gelaEne or Isinglass used as fining agent in beer and wine; 5. Peanuts and products thereof; ethyl alcohol of agricultural origin; 6. Soybeans and products thereof, except: (a) fully refined soybean oil and fat ( 1 ); (b) natural mixed tocopherols (E306), natural D-­‐alpha tocopherol, natural D-­‐alpha tocopherol acetate, and natural D-­‐alpha tocopherol succinate from soybean sources; (c) vegetable oils derived phytosterols and phytosterol esters from soybean sources; (d) plant stanol ester produced from vegetable oil sterols from soybean sources; 7. Milk and products thereof (including lactose), except: (a) whey used for making alcoholic disEllates including ethyl alcohol of agricultural origin; (b) lacEtol; 8. Nuts Eropa Labelling of certain substances or products causing allergies or intolerances •  they shall be indicated in the list of ingredients in accordance with the rules laid down in ArEcle 18(1), with a clear reference to the name of the substance or product as listed in Annex II; and •  In the absence of a list of ingredients, the indicaEon of the parEculars referred to in point (c) of ArEcle 9(1) shall comprise the word ‘contains’ followed by the name of the substance or product as listed in Annex II. REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL of 25 October 2011
on the provision of food information to consumers
Australia This declaraEon is necessary because there may be allergenic proteins present in the final product which may sEll cause adverse reacEons in highly sensiEve individuals. Australia Most food allergies are caused by peanuts,tree
nuts, milk, eggs, sesame seeds, fish and
shellfish, soy and wheat, and these must be
declared on the food label however small the
amount added.
Some food labels say ‘may contain’ certain
allergens, such as ‘may contain nuts’
FSANZ, 2013
Kanada •  Food allergen” means any protein from any of the following foods, or any modified protein, including any protein fracEon, that is derived from any of the following foods: (a) almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts;(b) peanuts; (c) sesame seeds;(d) wheat or triEcale; (e) eggs; (f) milk; (g) soybeans;(h) crustaceans; (i) shellfish; (j) fish; or(k) mustard seeds. (allergène alimentaire) •  If a food allergen is present in a prepackaged product, the source of the food allergen or gluten, as the case may be, must be shown on the label of the product in (a) the list of ingredients; or (b) in a statement enEtled “Contains” that complies with the requirements On February 16th, 2011 Health Canada Published Amendments to the Food
Allergen Labelling Regulations in Canada Gazette, Part II (CGII)
Jepang Mandatory labeling is enforced by the ministerial ordinance, and the ministerial noEficaEon recommends that foods containing walnut and soybean be labeled with sub specific allergenic ingredients. AddiEonal labeling of shrimp/prawn and crab has also become mandatory since 2008. To standardize the official methods, the Japanese government described the validaEon protocol criteria in the 2006 official guidelines. The guidelines sEpulate that any food containing allergen proteins at greater than 10mg/kg must be labeled under the Law. This review covers the selecEon of the specific allergenic ingredients by the Japanese government, the implementaEon of regulatory acEon levels and the detecEon methods to support them, and the assessment of the effecEveness of this approach. Japan food allergen labeling regulation--history and evaluation.
Akiyama H, Imai T, Ebisawa M
Copyright © 2011 Elsevier Inc. All rights reserved.
Indonesia Pangan Olahan yang Mengandung Alergen 1) Pangan olahan yang mengandung bahan yang dapat menimbulkan alergi pada konsumen tertentu dapat mencantumkan keterangan tentang alergen sesuai ketentuan yang berlaku. 2) Bahan yang dapat menimbulkan alergi sebagaimana dimaksud pada angka 1) melipuE sereal yang mengandung gluten (seperE gandum, rye, barley, oats, spelt), kerang-­‐kerangan dan hasil olahnya, telur dan hasil olahnya, ikan dan hasil olahnya, kacang tanah, kedelai dan hasil olahnya, susu dan hasil olahnya termasuk laktosa, treenut dan hasil olah kacang, sulfit (10 ppm atau lebih). PERATURAN KEPALA BADAN PENGAWAS OBAT DAN MAKANAN RI
NOMOR HK.03.1.5.12.11.09955 TAHUN 2011 TENTANG
PENDAFTARAN PANGAN OLAHAN
Kemampuan Laboratorium PPOMN 1. Histamin dalam porduk Ikan 2. Gliadin (glutein) dalam MP-­‐ASI 3. Alergen kacang dalam kue kacang 4. Beta Laktobulin dalam produk susu dan yoghurt (dalam pengembangan MA) Laboratorium Lain ?
Penutup 1.  Pelabelan allergen di Indonesia saat ini masih voluntary. 2.  Apakah sudah saatnya pelabelan allergen diberlakukan secara mandatory? →Perlu kita diskusikan: regulator, pelaku usaha, akademia dan masyarakat 3.  Industri perlu mempersiapkan manajemen allergen: iden=fikasi dan meminimalkan risiko, pencegahan kontaminasi silang, desain peralatan, formulasi, pemilihan bahan baku, proses produksi, pengemasan & pelabelan, pela=han karyawan, recall plan. 4.  Perlu peningkatan kapasitas laboratorium untuk uji allergen di Indonesia. ROY SPARRINGA
NATIONAL AGENCY FOR DRUG AND FOOD CONTROL
REPUBLIC OF INDONESIA
Tel: 021 4253857, 0818731078
E mail sparringa@gmail.com, deputi3@pom.go.id