Carbon dioxide as alternative to sterilization using ethylene oxide

Number

148-EN

Section

General Section

Use

Sector

Manufacture of bulk, large scale chemicals (including petroleum products)
Manufacture of food products

Function

Biocide

Process

Other

Product category

Biocidal products

Application

Sterilisation of food produce

Abstract

Ethylene oxide is a disinfectant used in different sectors such as food industry. It is classified as carcinogen, mutagen and reproductive toxicant of category 1B. It may be substituted by different other less hazardous chemicals or technologies. Carbon dioxide may be used as an effective and less toxic alternative.

Substituted substances

Ethylene oxide

CAS No. 75-21-8 EC No. 200-849-9 Index No. 603-023-00-X

Chemical group

Epoxides

Classification: hazard statements

H220 Extremely flammable gas
H350 May cause cancer
H340 May cause genetic defects
H360Fd May damage fertility. Suspected of damaging the unborn child
H331 Toxic if inhaled
H301 Toxic if swallowed
H335 May cause respiratory irritation
H336 May cause drowsiness or dizziness
H372 Causes damage to organs through prolonged or repeated exposure
H314 Causes severe skin burns and eye damage
H318 Causes serious eye damage

Other adverse effects

The substance is: 1 carcinogen (IARC), neurotoxic cat. 4 (Vela et al.) as listed in the Substance Database according to SUBSPORT Screening Criteria (SDSC).

Alternative Substances

Carbon dioxide

CAS No. 124-38-9 EC No. 204-696-9 Index No.

Chemical group

Carbonyl compounds

Reliability of information

Evidence of implementation: there is evidence that the solution was implemented and in use at time of publication

Reason substitution

CMR
neurotoxicant

Hazard Assessment

Substance to be substituted: Ethylene oxide may cause cancer cat. 1B ,according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). It fulfils the criteria to be listed in the Substance Database according to SUBSPORTplus Screening Criteria (SDSC). Alternative substance: Carbon dioxide is not toxic and has no harmonised classification according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation), but leakages in confined, unventilated spaces may be hazardous due to oxygen replacement. It is not listed in the Substance Database according to SUBSPORTplus Screening Criteria (SDSC). Carbon dioxide is a greenhouse gas and unless it is generated as by-product or recovered from a natural source, the sterilisation technology may be considered to increase the company's carbon footprint.

Description of Substitution

Germ reduction in food or personal care products is important for health and for preventing material damage. Some of the chemical agents used for sterilisation are problematic because of their hazards and/ or unwanted changes they generate in the quality of the treated materials. Ethylene chloride is effective but is classified carcinogen 1B and mutagen 1B. It is also highly flammable. Other chemicals like ozone or peroxides generate structural changes in the product. Physical methods are also available, like thermal ones, but they may induce structural changes of products. Other technologies, for example hydrostatic pressure of up to several thousand bar has high costs for the foreseeable future. Evonik’s sterilisation method uses moderate pressures - up to 400 bar (approx. 5,800 psi) - and is inspired by supercritical fluid extraction technology using carbon dioxide. It is effective with mould, yeast, enterobacteria, E. coli and it does not affect product quality (denatured proteins, mineral and vitamin depletion, sensorial alterations). Advantages The advantages of sterilisation with carbon dioxide: - Gentler process than conventional thermal methods - Can be combined with other extractive applications - Not restricted in use - No process-related solvent residue

Case/substitution evaluation

The sterilisation by carbon dioxide allows avoiding the use of hazardous substances like ethylene oxide. Supercritical fluid treatment with carbon dioxide is less expensive than other physical methods and does not cause depreciation of product qualities.

State of implementation

In use

Date and place of implementation

Germany

Availability ofAlternative

Alternative available on the market

Producer/Provider

corporate.evonik.com

Type of information supplier

Producer / distributor

Contact

corporate.evonik.com

Type of publication and availability

Website presentation and brochure freely available

Publication source: author, company, institute, year

The presentation page and the brochure were published by Evonik Industries on their website, in 2009.

Date, reviewed

November 26, 2021