Safety and efficacy of hydroxypropyl methyl cellulose for all animal species

Hydroxypropyl methyl cellulose, E 464, technological additive, safety, efficacy
First published in the EFSA Journal
31 July 2020
Adopted
2 July 2020
Type
Scientific Opinion

Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on hydroxypropyl methyl cellulose as a feed additive for all animal species. Hydroxypropyl methyl cellulose is intended for use as a technological additive (functional group: stabiliser) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of hydroxypropyl methyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to hydroxypropyl methyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that hydroxypropyl methyl cellulose is considered safe for all animal species. The use of hydroxypropyl methyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of hydroxypropyl methyl cellulose for the user. The use of hydroxypropyl methyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Substances
Hydroxypropyl methyl cellulose
Cas: 9004-65-3
Inchi: InChI=1S/C36H70O19.C20H38O11/c1-19(37)9-45-17-27-29(47-11-21(3)39)31(48-12-22(4)40)34(51-15-25(7)43)36(54-27)55-30-28(18-46-10-20(2)38)53-35(52-16-26(8)44)33(50-14-24(6)42)32(30)49-13-23(5)41;1-21-9-11-13(23-3)15(24-4)18(27-7)20(30-11)31-14-12(10-22-2)29-19(28-8)17(26-6)16(14)25-5/h19-44H,9-18H2,1-8H3;11-20H,9-10H2,1-8H3/t19?,20?,21?,22?,23?,24?,25?,26?,27-,28-,29-,30-,31+,32+,33-,34-,35-,36+;11-,12-,13-,14-,15+,16+,17-,18-,19-,20+/m11/s1
Iupac: (2R,3R,4S,5R,6R)-2,3,4-trimethoxy-6-(methoxymethyl)-5-[(2S,3R,4S,5R,6R)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxyoxane;1-[[(2R,3R,4S,5R,6S)-3,4,5-tris(2-hydroxypropoxy)-6-[(2R,3R,4S,5R,6R)-4,5,6-tris(2-hydroxypropoxy)-2-(2-hydroxypropoxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]propan-2-ol

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Kos Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6214
EFSA Journal 2020;18(7):6214
Question Number
On request from
European Commission