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EC number: 273-620-4
CAS number: 68990-67-0
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Quillaja saponaria, Rosaceae.
According to Annex XI section 1 of the REACH Regulation, the study does
not need to be conducted when testing does not appear scientifically
necessary. Annex XI considers the opportunity of evaluating historical
As documented in the "BIOPESTICIDES REGISTRATION ACTION DOCUMENT" for
Quillaja Saponaria, the U. S. Environmental Protection Agency
considered Quillaja Saponaria as not a reproductive toxicant since
humans are regularly exposed to Quillaja saponins via their use as an
FDA-approved flavoring agent and food additive without any reported
adverse effects on human health.
Chronic feeding studies have shown that Quillaja Saponaria is not
carcinogenic to mice and rats even when fed up to levels of 2200 mg/kg
bw. For a long time Quillaja saponaria extracts are widely used as
foaming agents in beverages and emulsifiers in foods with no report of
any adverse effects. In soft drinks Quillaja extracts are used at levels
of 100-500 mg/kg.
Quillaja is used in cocktail mixes and as emulsifiers in foods such as
baked goods, candies, frozen dairy products, gelatine, and puddings.
Other saponins are widely used in commonly consumed human food,
flavoring, herbs, and spices also with no report of any adverse effects.
The WHO /FAO Expert Committee on Food Additives established an ADI
(Acceptable Daily Intake) for Quillaja extracts of up to 5 mg/kg
The General Standard for Food Additives (GSFA) of the Codex Alimentarius
Commission lists Quillaja Saponaria as suitable for use as foaming agent
in water-based flavoured drinks, including sport, energy or electrolyte
drinks with a maximum use level of 500 mg/kg (Codex Alimentarius
Commission, Joint/WHO Food Standards Programme, Codex Committee on Food
Additives and Contaminants, Thirty-seventh Session, The Hague, The
Netherlands, 25-29 April 2005, CX/FAC 05/37/9).
Quillaja Saponaria extract are generally considered as safe (GRAS) by
the Food and Drug Administration (FDA) of the United States (FEMA GRAS
Based on the existing human data and human experience with Quillaja
Saponaria the substance is not a reproductive toxicant. Therefore
testing for reproductive toxicity is scientifically unjustified.
As outline above no classification and subsequent labelling of Quillaja
saponaria ext. for reproductive toxicity is justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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