Food Additive Status

North America

OPTIM™ Glycerine 99.7% USP/EP is Generally Recognized As Safe (GRAS) as multiple-purpose food substances. In addition to indirect food additive regulations, which specifically mention glycerine, it may be used under those regulations where optional ingredients include substances Generally Recognized As Safe (for use in food and/or food packaging).

Food Additive Status for OPTIM™ Glycerine for North America

European Union

OPTIM™ Glycerine 99.7% USP/EP is an approved food additive in the European Union (EU). Reference: Directive 95/2/EC on food additives other than colours and sweeteners, as amended through Directive 2006/52/EC (OJ (L 204) 10, 26 Jul 2006) (registration number: E 422) and local laws like the German "Zusatzstoff-Verkehrsverordnung".

OPTIM™ Glycerine 99.7%, USP/EP is listed as Glycerol (refnr. 18100) in the list of monomers and other starting substances which may be used in the manufacture of plastic materials and articles for food contact. Reference: Directive 2002/72/EC relating to plastic materials & articles intended to come into contact with foodstuffs (Monomers Directive), as last amended by OJ (L 302) 28, 19 Nov 2005

Switzerland - Food Contact Ordinance (BedarfsgegenstaendeV), Annex 1 (monomers and additives permitted in plastics intended for food contact), AS, n. 51, p. 6363, 27 Dec 2005

Asia/Pacific

OPTIM™ Glycerine 99.7%, USP/EP is an approved food additive in the following countries:

  • Japan - Designated Food Additives Approved for Use (Food Sanitation Law Enforcement Regulations, MHLW Ordinance No. 23 (July 1948), Article 12, Table 1, as amended through Sept. 12, 2006)
    Food Additives Approved for Use (Standard for Use of Food Additives, as amended through September 12, 2006)
  • Korea - Food Additives - Synthetic, Natural, Mixtures (Korea Food Additive Code, 2004
  • Malaysia - Permitted Food Additives (Food Regulations 1985, Schedules 6-11, as amended through PU (A) 358/2005, Sept. 2005)
  • Australia / New Zealand - Food Additives - Permitted Uses of Food Additives by Food Type (Australia/New Zealand Food Standards Code-Standard 1.3.1: Food Additives, Schedule 1, as amended through Feb 10, 2006)
  • Philippines - Permissible Food Additives (Administrative Order No. 88-A s. 1984: Regulatory Guidelines Concerning Food Additives, List of Permissible Food Additives)
  • Singapore - Food Additives (Food Regulations, G.N. No. S 264/88, Articles 15-28, as revised in 2005)

OPTIM™ Glycerine complies with the compendial specifications in the:
Food Chemicals Codex (FCC)
United States Pharmacopeia (USP)
European Pharmacopeia (EP)
APAG


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