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-9-      〈General Manager Yoshiko Nakamura〉Argon helps keep wine in open bottles delicious.Village Cellarsʼ long road to getting Argon registered as a legal food additive.On 2nd August 2018, the Ministry of Health, Labour and Welfare ocially recognised Argon as a food additive in Japan, nearly 20 years after it entered everyday use by the food and beverage industries in Europe and the US. Village Cellars General Manager Yoshiko Nakamura was the driving force behind its ocial recognition, having embarked in 2011 on what she believed would be a simple journey, that over 7 years turned into a long and winding road to gaining ocial recognition. This is an abridged edition of her journey.In a newsletter on 2nd August 2018, the Food Sanitation Investigation Council Subcommittee on Designation of Food Additives of the Ministry of Health, Labour and Welfare (MHLW) published a report that the rare gas element ʻArgonʼ has been ocially recognized in Japan as a specied food additive as laid out in the Food Sanitation Act. Argon, which undergoes almost no chemical reaction in nature, is the third most common component in the atmosphere after nitrogen and oxygen, comprising about 1% of the air around us. Every day we breath in approximately 160 liters of Argon. Although it is a rare gas, in Japan (and globally) it is used in metal welding and medical practices, and its safety is accepted internationally, often used as a ller to prevent oxidation in packaged foods and beverages including wine.In Japan, because the use of Argon in food processing or preservation is not permitted, Nitrogen is the most commonly used protective covering gas in wine. However, in other countries it is recognized as safe and like Nitrogen is often used as a packaging gas, and included in international food standards. In the United States, its use was approved via the commonsense Generally Recognized As Safe (GRAS) approval process in the year 2000 and its use was permitted with fruit, vegetable juices and wines, while in the European Union (EU) its use in principle was allowed with all foods.Application for Argonʼs inclusion as a new food additive in JapanThe Shuhan News Trade Journal No. 1992 reported on the 21st August 2018: “Prior to the start of EPA (Economic Partnership Agreement) negotiations, the Ministry of Health, Labour and Welfare had repeatedly considered a request from a private Japanese company to designate Argon as a food additive.” That private company was Village Cellars. In response to our request, the MHLW requested the Cabinet Oce Food Safety Committee to prepare a health impact assessment based on the Basic Food Safety Law, together with a “Summary on Argon” prepared by Village Cellars. As a result, the Food Safety Committee advised the MHWL on June 12 that using Argon as an additive would not harm human health. Following this, in order to examine whether to give Argon a new ʻfood additiveʼ designation, the Additives Subcommittee of the Pharmaceutical Aairs and Food Sanitation Council of the MHWL deliberated on the standards on August 2, and decided to go ahead with the designation.Village Cellars rst became involved in working on the designation of Argon as food additive through our relationship with Vinotec in Australia, who had developed the preservative product “Winesave” which used compressed Argon gas in an aerosol pack. We wanted to get Argon legally designated as a food additive, believing it would be an indispensable tool for wine enthusiasts to enjoy a wide range of expensive wines by being able to keep wine in opened bottles for an extended period of time without any oxidation eects.Yoshiko tells the story: “In January 2011, I visited the MHLW and received an explanation on the requirements and data needed to prepare a request for a designation based on the “Food Additives Evaluation Guide” in line with guidelines set by the Food Safety Commission and the MHLW. In the EU, the Scientic Committee on Food (SCF) declared in 1990 there was no need to set an Acceptable Daily Intake (ADI) for Argonʼs use in packaging and spraying gas, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) included Argon when they set food additive standards in 1999, and in the United States the Food and Drug Administration (FDA) certied Argon as a Generally Recognized As Safe (GRAS) substance in 2000. The international community also supported Winesave, with Philippe Guigal, head of E. Guigal, and British wine critic Jancis Robinson actively promoting the use of Winesave with wine, and wine magazine Decanter advocating the use of Winesave to help keep wines fresh after opening. With this strong international backdrop, I thought that the application to certify Argon as a food additive would be quite straight-forward. At that time, I didnʼt understand how challenging the request to certify a new substance, even one as obviously safe as Argon would be.In fact, to achieve a new accreditation, the requestor must propose a draft of what kind of substance it is, how to manufacture it and conrm its purity, and if they don't exist, create national standards for its components and quality tests. In addition, we needed to dene its range of uses, and provide a draft on how to set usage criteria. Although the request itself is made by one individual and one company, at Village Cellars we didnʼt have the expertise to do all this on our own, so by the time the request form was completed to the satisfaction of the ministry we had received the advice and cooperation of many experts in the eld of new drugs and additives. Initially in 2011, Village Cellars worked alone on the request for application. I managed to put together a draft request and took it to the MHLW, but they wouldnʼt accept it because it required more specialized content. Things looked a little bleak until the turning point when a friend who understood Village Cellars commitment became interested, and in turn introduced a good friend who shared a passionate enthusiasm for chemistry, and subsequently worked as a voluntary advisor from late 2013. From their network, we enlisted experts with extensive knowledge and experience in creating new designation requests, and the Argon team was formed.In 2014, quite separate to our attempts at ling an application, the Food Additives Designation Consultation Center (FADCC) was established in the National Institute of Health Sciences under the jurisdiction of the MHLW. My Argon team set up the national standards for Argon, consulting intensively and professionally with experts at the consultation center to move the conrmation process forward. In addition, we received valuable advice and cooperation from the Japan Sommelier Association, many research institutes, argon manufacturing companies, and others. In this way, the eectiveness and safety of Argon, its component specications and test methods, the daily human intake etc. were studied in detail, and the request form and details attached to it were completed.Ocial acceptance and looking to the futureTogether, the Argon team and experts who provided me with dedicated help over seven years, and the cooperation of relevant MHLW ocials who changed over the years but always provided careful guidance, contributed to the successful acceptance of the request by Village Cellars to designate Argon as a new food additive by the MHLW on 31st May, 2018.In the near future, after its approval by the Additives Subcommittee of the Pharmaceutical Aairs and Food Sanitation Council of the MHWL, public comment, reporting of the change to WTO and other required declarations, and ocial revision of the ministerial ordinance, we expect Argon will nally be available for use with food in Japan in Spring 2019 at the latest.After Argon is ocially designated a food additive, I believe that its ecacy and practical use in the eld of food production will help to cut food waste over the long term, and with additional research open up its use in other elds.” Syuhan news → No.1992(21st August, 2018)↓Winesave

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