Number

290-EN

Section

General Section

Use

Abstract

Sterisol is a Swedish company manufacturing skin care products. By manufacturing the products in a very clean environment and then using a special package that protects the product against contamination of microorganisms, the need to add preservatives to the products has been eliminated.

Substituted substances

Reliability of information

Evidence of assessment: there is evidence of an official (positive) assessment of the substitution

Reason substitution

other toxic effects
ecotoxicity
skin/respiratory sensitizing

Other type of alternative

The process for manufacturing and packaging of the products, as well as the type of package has been developed to eliminate the need for preservatives.

Hazard Assessment

Substances to be substituted: Methyl paraben, ethyl paraben, propylparaben and butylparaben have no harmonised classification according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). They are all endocrine disruptors of category. 1 (EU EDC database) as listed in the Substance Database according to SUBSPORTplus Screening Criteria (SDSC). Propylparaben is also on SIN List as an endocrine disruptor according to SUBSPORTplus Screening Criteria (SDSC). Formaldehyde 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). Methylisothiazolinone may cause allergy or asthma symptoms or breathing difficulties if inhaled, 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). Thimerosal is causing morphological changes in cells in the central nervous system (CNS) or peripheral nervous system(PNS) (e.g. cell death, axonal injury or sub-cellular morphological alterations), according to ISTAS RISCTOX database on neurotoxicants (Level 4). Alternative substance: The preservatives have not been replaced but eliminated.

Description of Substitution

Most personal care products contain preservatives to prevent growth of microorganisms. Several preservatives used today do have hazardous properties, and the safety of using them in personal care products is regularly publicly debated. Some debated preservatives are formaldehyde and related compounds (sensitisers, possible carcinogens), isothiazolinones (sensitisers) and parabens (endocrine disruptors). The SterisolSystem® was developed in the middle of the 70’s. The basics elements in the system are an air- and bacteria tight valve and a collapsible bag, constituting a disposable dispensing system for liquids. The system makes it possible to eliminate all preservatives since the content is protected by the package – also during usage - and not by added chemicals. The manufacturing facility is highly automated and operates under strictly clean room conditions, which is necessary to avoid the use of preservatives. Sterisol is certified both according to GMP (Good Manufacturing Practice EN-ISO 9001 (Quality) and ISO 14001 (Environment). The packaging process involves a production area in which mixing and heating of the content is performed. The product is thereafter transferred, in another line process, to pre-prepared plastic packaging. Filling, labelling and boxing are followed by a cooling period prior to transport. In the Nordic countries, Sterisol AB is the leading manufacturer of liquid soaps, hand disinfectants, emollients and other skin care products for professional use. Sterisol specialises in hand hygiene for work places, from heavy and dirty industry to work places where requirements for high quality and a high level of hygiene are important. Such areas are the health care sector (hospitals, nursing homes, etc.), the food industry and other industrial segments such as hotels, offices, public washrooms etc. Today, the SterisolSystem also includes a range of products designed for consumers. Additional environmental objectives during product development is to ensure the biodegradability of the products and to minimise the waste materials.

Case/substitution evaluation

This solution makes it possible to eliminate preservatives and thereby a category of chemicals that may have problematic properties.

State of implementation

Full capacity

Date and place of implementation

1970´s, Sweden

Availability of Alternative

On the market

Producer/Provider

www.sterisol.se

Type of information supplier

Producer / distributor

Contact

www.sterisol.se

Further information

MSDS´s and other information can be found on the company">http://www.sterisol.se">company webpage.

Date, reviewed

November 26, 2021