遺伝子組換え微生物を利用して製造された添加物のうち、アミノ酸等の最終産物が高度に精製された非タンパク質性添加物の安全性評価の考え方（「遺伝子組換え微生物を利用して製造された添加物の安全性評価基準（平成１６年３月２５日　食品安全委員会決定）」附則）（平成１７年４月２８日　食品安全委員会決定）

Stance on Safety Assessments of Additives Produced Using Genetically Modified Microorganisms, whose End Product is a Highly Purified Nonprotein Additive, such as Amino Acids(Supplementary Provisions of Standards for Safety Assessments of Food Additives produced Using Genetically Modified Microorganisms, Food Safety Commission Decision of March 25, 2004)(Food Safety Commission Decision of April 28, 2005)

遺伝子組換え微生物を利用して製造された添加物（以下、遺伝子組換え添加物）については、「遺伝子組換え微生物を利用して製造された添加物の安全性評価基準（以下、評価基準）」（平成１６年３月２５日　食品安全委員会決定）に基づき、食品衛生法で認められている添加物の範囲内のものにつき個別に安全性評価を行っているところである。この評価基準の中で、遺伝子組換え添加物に関しては、一般に、組換え体そのままを食する遺伝子組換え食品とは異なり、最終産物としての添加物製品の安全性評価を行うことが適切であると述べている。従って、この観点から、アミノ酸等の最終産物が高度に精製された非タンパク質性の添加物の安全性評価については、次のとおり取り扱うこととする。

In respect of additives produced using genetically modified microorganisms (hereinafter referred to as "Genetically Modified Additives"), based on "Standards for Safety Assessment of Food Additives produced Using Genetically Modified Microorganisms (hereinafter referred to as "Assessment Standards") (Food Safety Commission Decision of March 25, 2004), safety assessment is carried out individually for the additives within the scope of those approved for use by the Food Sanitation Act. Regarding Genetically Modified Additives, the Assessment Standards state that generally speaking it is appropriate to perform a safety assessment of an additive product which is an end product, since this is different from the case of genetically modified foods in which the recombinant is consumed as it is. Therefore, from this point of view, safety assessments of additives whose end product is a highly purified nonprotein additive, such as amino acids, are carried out in the following way:

アミノ酸等の最終産物が高度に精製された非タンパク質性の添加物については、下記に示す①～②の要件をすべて満たす場合、一般に、安全性が確認されたと判断される。

Regarding additives whose end product is a highly purified nonprotein additive, such as amino acids, if all the requirements shown in 1 and 2 below are satisfied, generally speaking the confirmation of the safety of said additive will be deemed have been reached.

① 製品の精製度は、例えば、指定添加物として告示されているアミノ酸、ヌクレオチド、ビタミン、単糖類と同等若しくはそれ以上の高度な精製度であること。

1. The purity of the product is equal to or greater than that of , for example, amino acids, nucleotides, vitamins, and monosaccharides, which are announced as a designated additive in a public notice.

②　従来の添加物に比べ、既存の非有効成分の含有量が当該添加物中で安全上問題となる程度にまで有意に増加しておらず、かつ、有害性が示唆される新たな非有効成分を含有しないこと。

2. Compared to conventional additives, the content of existing non-active ingredients have not increased significantly in the relevant additive to a level that could cause a safety issue, and no new non-active ingredients suggested to be harmful are included.

なお、当該添加物の製造方法の概要（遺伝子組換え微生物の作製方法、添加物の抽出方法及び精製方法）、用途、化学構造・組成、物理的化学的性質及び品質が明らかであることが必要である。

In addition, it is essential that the overview of the production methods (methods for producing the genetically modified microorganisms, methods for extracting and purifying the additive), uses, chemical structure and composition, physiochemical properties, and quality of the relevant additive are clarified.