BRONOPOL - WORLDWIDE REGULATORY STATUS

Bronopol is used in many countries throughout the world in a wide range of application areas.  In many cases there is no requirement for a formal registration procedure, however, this report gives the updated status of where registrations have been granted.

UNITED NATIONS

As of January 1997, bronopol is listed as Class 4.1, packing group III with the UN number 3241.  Bronopol is not a flammable solid but is in 4.1 as a substance related to a self - reactive substance.

EUROPE

Listed in Annex VI of the EC Cosmetics directive as an approved preservative for use up to 0.1% except where there is a risk of nitrosamine formation.

Bronopol has recently been re-classified under the dangerous substances directive and has the following risk phrases;

R21/22, R37/38, R41, R50/53.

The EINECS number for Bronopol is 2001430.

Belgium

A submission for the use of Myacide in industrial applications is pending.

Denmark

Myacide AS for use as a paper slimicide has been registered since August 1993.

Finland

Myacide S1 was registered as a paper slimicide in July 1997.

France

Approved for food contact applications as a paper slimicide by the Ministere de la Consommation (Brochure No. 1227) and as a preservative under the Repression des Fraudes (July 1988).

Germany

Approved by the Kosmetics Verordnung.

Approved in 1983 by the Bundesgesundheitsamt (BGA) for food contact uses in latex preservation (No. 14) and paper slimicides (No. 36).

A preliminary classification for danger to the aquatic environment (WGK) as class 2 has been agreed with the KBwS.

Netherlands

Myacide AS was first registered in September, 1989 for use in recirculating cooling water systems and the paper and cardboard industry.  The registration number  from the Commissie Toelating Bestrijdingsmiddelen is 10207N.  Myacide S1 is also registered (No. 11329N) for the same uses. Bronopol is included in the Dutch Warewet under 2.2.1g for the preservation of coatings.

Sweden

Myacide S1 is registered for use as a paper slimicide.

Switzerland

Approved as a preservative at up to 0.05% in skin care formulations and up to 0.1% in rinse off products.

United Kingdom

Approved in December 1991 for decontamination of potable water storage tanks and associated pipework as regulated by the Drinking Water Inspectorate of the Department of the Environment (DOE) under the 1989 Water Act, section 53.

Myacide AS is listed as a category 2 product in the offshore chemical notification scheme (OCNS) as operated by the UK Department of Trade and Industry (DTI).  This voluntary system allows an annual discharge of up to 10 tons of product per site before notification of use.

NORTH AMERICA

Canada

Myacide AS Technical (number 18880) and 2K7 Bugstick (Reg. No. 21281) are registered under the 1986 Pest Control Products Act. The products were recently upgraded (January 1997) from temporary to permanent  registration which is valid for 5 years.

Myacide BT is registered (Number 25224) with Health Canada for use in household products.

Health Canada have granted letters of "no objection" for the use of bronopol as a slimicide used for manufacturing paper and for use in paper coatings intended for food contact.

Bronopol is listed on the Domestic Substances List.

USA

The Environmental Protection Agency have registered the following products:-

Manufacturing uses:

Myacide Pharma BP (33753-1) and Myacide AS (33753-3).

Application uses:  

Myacide AS Plus (33753-5), Myacide S1 (33753-6), Myacide S2 (33753-7),

Myacide S15 (33753-17), 2K7 Bugstick (33753-18) and Myacide S30 (33753-20).                                                                         

The above products are approved for one or more of the following applications:

Industrial recirculating water in cooling towers and evaporative condensers, air conditioners, air washers and humidifier systems, consumer products, household products, institutional products, surfactants, oil, gas and industrial process water, metal working fluids, adhesives, paper mill pulp and process water, starch, pigment and extender slurries, paints, latex and antifoam emulsions, absorbent clays, water based printing inks and print solutions, water based pesticides and chemical toilet solutions.

FDA approval for indirect food contact use in adhesives (21 CFR 175.105), paper slimicides at a maximum level of 0.6lb/ton of dry weight fibre (21 CFR 176.300) and paper components in contact with aqueous and fatty foods at a level not to exceed 0.01% by weight of those components (21 CFR 176.170).

FDA Drug Master File No. 1673.

Bronopol is listed under TSCA

CTFA's Cosmetic Ingredient Review stated in 1980 that bronopol is safe as a cosmetic ingredient at concentrations up to 0.1% except where there is a risk of nitrosamine or nitrosamide formation.

A large number of state registrations are held by BASF MicroCheck Limited in the USA. This includes registration of most of the above products in California, Florida Texas and New York to mention just a few.

The USDA Food Safety and Inspection Service has authorised bronopol for treatment of cooling and retort water in official establishments operating under the Federal meat and poultry products inspection program.

OTHER REGIONS

Bronopol is on the chemical substances lists of Australia (AICS) and South Korea (Number 2.542).

Brazil

Bronopol is approved by the Ministry of Health as a preservative and antiseptic for use in cosmetics and toiletry applications.

Japan

The MITI registration number is 2-325.  Bronopol is registered for pharmaceutical use in a wound irrigant solution.

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The information contained in this document is believed to be accurate but is given without warranty.