The Norms For Gras Substance In The US Food Law

In accordance with the Food Safety Law, China will solely establishnational standards for the production of food additives, which probablyresults in the average use of the resource of administration supervision, thelack of the invest in the important fields of food safety, and even the barrierfor rapid development of the food industry. Therefore, the filing of enterprisestandards for food additives could be improved by reference to foreignexperience.In the U.S.,“generally recognized as safe”(GRAS) is a legal regime offood safety provided in21U.S.C.§321(s), a legal standard and a kind offood. The GRAS concept comes from the exception from the food additivedefinition. If an enterprise shows a particular use of an adding foodingredient is generally recognized by qualified experts as safe, the ingredientconstitutes the GRAS substance, which can be marketed without the“national standards” set by the government. General recognition of safety byexperts may be based on scientific procedures or experience based on common use in food. The notification procedure started in1997leads to theoverexpansion of the GRAS substance and seriously reduces theimplementation of the legal norms of food additive.The Coco Rico case complied in all-around manner with the norms ofdeciding GRAS in precedents, and interpreted by these norms the GRASdouble-layer determination structure of21U.S.C.§321(s). The Fmali caseanalyzed the legislative intents of21U.S.C.§321(s) and pointed out that thecore of the GRAS norms is general recognition of safety by experts. On thisground, the court reviewed the FDA’s regulation of21U.S.C.§321(s) andheld that this regulation was invalid. This case directly led to the FDA toabolish the geographical limit to “common use in food” in regulations andthis modified rule retains so far. This case also reflects the differentunderstanding of the Congress, the court and the agency about21U.S.C.§321(s), and the key role the court plays in eliminating this difference.Both national and enterprise standards are technical ones divided by theGRAS legal standard. The GRAS norms are the elements of this legalstandard. The GRAS legal standard may be used to review the enterprisestandards for food additives in China and reasonably divide nationalstandards and enterprise ones.