Regulations+on+Aspartame





Aspartame was discovered in 1965 by James M. Schlatter, a chemist working for G.D. Searle Company Schlatter had synthesized aspartame in the course of producing an antulcer drug candidate. It was agreed by FDA (Food and Drug Administration) in 1974. But permission of aspartame distribution was cancelled several month later because of the complain about the danger of it also as carcinogen agent then must be evaluated again. In 1981 aspartame had FDA approval about the existing in several kinds of food. For the approval, be sure many researches must be done before it. After stated safe, then FDA accept the development of aspartame continuously. FDA had evaluated usage of the aspartame in food and drink product for twenty sixth times since first time discovered. And from the evidences, since 1996 FDA accept aspartame usage as artificial sweetener that permitted in food and beverage all of things. Now aspartame presents as various types, such as liquid, granule, and powder. So, the aspartame can be used in various type and also for various kinds of food and beverage. After got the permission, doesn’t mean no studies about it. More than 100 researches had been done since 1981, and until now, FDA doesn’t change the agreement. Aspartame was approved in more 100 countries include Indonesia.



Aspartame was known used safely for diabetes suffering, pregnant women, and also for children. Except for phenylketonuria men. According US Food and Drug Administration (FDA), The Joint Expert Committee on Food Additives (JEFA), American Medical association (AMA), The American Council On Science and Health (ACSH) aspartame is food additive material safe for health, only effects for sweetness. Research use aspartame by bolus is 34 mg/kg weight seems although metabolism product can pass placenta blood canal, the quantity not influence neuritis (nervous breakdown) for foetus. Big studies was done for the human, not for mice in experiment concluded no evidences that soda with aspartame sweetener can increase cancer risk. Aspartame can be removed in a body to be both amino acid compound as composer and include nutritive sweetener. Just aspartame not stand in the high temperature, since in high temperature aspartame change to be compound named diketopiperazyne that not danger, but will miss the sweetness. Because of that, aspartame doesn’t use for making cakes, and only used for beverages, ice cream, and yoghurt. If It digested normally of the body, aspartame will produce aspartic acid and phenylalanine. So, It’s safe for consumption.

Phenylketonuria is a disease where the sufferer can’t process metabolism phenylalanine well because the body doesn’t have enzyme to oxidize phenylalanine to be tyrosine and can cause damage in children brain. And because that need for controlling phenylalanine consumption. This disease never found in Indonesia, but in white skin people, even that happen only one over fifteen hundred peoples. Not only aspartame, but also all kind of food that contain phenylalanine such as rice, meat, and milk product. Because of it warning sign for phenylketonuria men about the product consumed contain phenylalanine. For increasing safety, FDA gives suggestion safety boundaries. The terminology that used is Acceptable Daily Intake (ADI) means daily consumption permitted. Usage standard is total sweeter per kilograms per day can be consumed safely along life without create risks. ADI is conservative level, generally appear quantify 100 time smaller than maximum level that not appear side effects in animal experiment. ADI for aspartame is 40 mg/kg weight.  For the several times the safety for the aspartame begin asked by many people. But safety certificate released by FDA and FSA Europe light critics and controversy. Investigation was proposed to explain the relation between aspartame and many negative effects possible, such as headache, tumour, and lymphoma. Development of invention about aspartame danger truth can make people remind for using aspartame. Documentary movie in 2001 Sweet Misery : A Poison World show the condition of aspartame controversy also.  One of the newest invention in 2008 that contradicts aspartame can create cancer is Magnuson and Williams’s research supported by Burdock Group. It is an independent inventor institute supported financially by Ajinomoto Group, one of aspartame producer. Even that in 2009, research that supported by Italian Association for Cancer Research and The Italian League Against Cancer released no evidences aspartame can make stomach cancer, pancreas, and womb layer (endometrium). Aspartame had been creating controversy since the first invented not only in Indonesia, but also in America, and other countries. But, FDA and several organizations still reveal about aspartame safe for human based on researches in the world from era to era.  In Indonesia the question about safety of aspartame for the human, Actually had been answered by competent independent institute in medicine and food field is BPOM RI (Medicine and Food Control Institute Republic of Indonesia) strictly. BPOM RI released Circulation Letter No. KH.00.01.234.084 on August, 11, 2006 about Food Product contain artificial sweetener Announcement Dispute. Until now no collision aspartame consumption in foods, drinks, and also supplement products if match with the existence suggestion.  As consumers, we must believe to government institute who responsible create a regulation. If in fact artificial sweetener ( aspartame ) had been stated safe, therefore we respond government’s statement surely about the product of aspartame. We all know knowledge and technology always develop. If in someday be valid evidences about aspartame bad-effects, certainly FDA (Food and Drug Administration) in America or BPOM in Indonesia will forbid aspartame usage. In Indonesia aspartame attend in 18 food and drink products, such as Extra Joss and other brand product, safe for human. And also on the product packing had stuck BPOM registration code. FDA is known as punctual and careful institute before permit distribution the product in a market. This related with protection consumers effort from danger materials especially in food product. So, slogan that states consumer as a king indirectly had been prepared by FDA. ADI’s regulation that 40 mg/kg almost impossible to exceeded in general daily consumption. In a fact, average consumption total only about 10 % from ADI regulation. With high sweetness level, so a little of part the aspartame create sweetness more than sugar. In Indonesia BPOM RI determine ADI boundary likes FDA (40 mg/kg weight). Food and drink industries in Indonesia surely know the fact. They had invested with very big finance, so they won’t bet the consumer safety. They will accept safety standard that approved by responsibility institute.  In 2005, ERF in Europe released their research with consumption the aspartame for mice for long time. The inventor from ERF concluded the aspartame can create cancer and the distribution of this artificial sweetness must be back evaluated. However, after European Food Safety Authority-EFSA observed study conclusion of ERF, EFSA say ERF’s conclusion isn’t valid / wrong statement, also EFSA consider don’t need study about ADI’s regulation.  According Health Ministry Regulation (Permenkes) 208/Menkes/Per/IV/1985, artificial sweetener only permitted for diabetes suffering, and people who need low calory, There are aspartame, saccharine, cyclamate, and sorbitol. Health Ministry Regulation (Permenkes) about artificial sweetener in chapter 11 verse 2 sounds, In food label contain artificial sweetener also must be written notification, “Contain artificial sweetener: (a), “contain sugar and artificial sweetener”, if the food not only contain artificial sweetener but also sugar (b), also notification “for diabetes, and people who need low calory” (c). · Health Ministry Regulation (Permenkes) 208/Menkes/Per/IV/1985 chapter 11 verse 2 in original text : Permenkes No. 208/Menkes/Per/IV/1985 Pasal 11 Ayat 2 berbunyi, label makanan yang mengandung pemanis buatan juga harus mencantumkan tulisan, "mengandung pemanis buatan" (a), "mengandung gula dan pemanis buatan", jika makanan tersebut selain mengandung pemanis buatan juga mengandung gula (b), serta tulisan "untuk penderita diabetes, dan atau orang yang membutuhkan makanan berkalori rendah" (c).

This is documentary movie "Sweet Misery : A Poisoned World"

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<span style="font-family: 'Comic Sans MS',cursive; font-size: 130%;"> So, about food and drink additive material especially aspartame. If the product match with the standard, consumer will safe when they consume it. We believe to BPOM RI who responsible for food and drink products in market controlling.
 * <span style="font-family: 'Comic Sans MS',cursive; font-size: 130%;">Conclusion **