K-BPR: Clear Exemption Items for 17 Disinfecting Substances Subject to Simplified Approval

K-BPR: Clear Exemption Items for 17 Disinfecting Substances Subject to Simplified ApprovalOn May 24, 2021, the South Korean National Institute of Environmental Research (NIER) disclosed the required/exempted data items of 17 disinfecting active substances that have been evaluated internationally and to be approved through a simplified process.

The detailed requirements were compiled into 17 separate files, specifying the product type, use site, user scope, as well as each endpoint. Compared to the conventional process, an internationally evaluated substance can almost be exempted from all tests including physical, chemical, biological property, toxicity, ecotoxicity and environmental behaviors. For applications other than those evaluated and approved in the EU or the US, additional data may be required, or approval would restrict for related purposes. In addition to the “additional data” conditionally required considering the product type, exposure, and use, etc.,  90-day inhalation toxicity test or in-vivo genotoxicity tests would be conditionally required for certain active substances.

The product type, eligible uses overseas and the conditionally required tests of the 17 active substances are summarized as follows:

No

Active Substance

CAS No.

Users and Use Space Approved in EU/ US

Conditionally Required Test

1

1-4. Chlorocresol

59-50-7

EU: Professional and non-professional users in private areas;

US: Occupational handlers and residential users in industrial preservatives

90-day inhalation toxicity;

2

Propan-2-ol

67-63-0

Professional and non-professional users in laboratories, sanitation areas, medical practices, pharmaceutical and cosmetic and industry areas

US: Occupational and non-occupational users in sanitation areas and medical practices

 

3

Ethylene oxide

75-21-8

EU: Industrial users for Industrial sterilization of single-use medical devices, hospitals, musical instruments, museum artifacts

US: Occupational workers in hospitals, contract sterilization facilities, and for beekeeping use

90-day inhalation toxicity;

 

4

Citric acid

77-92-9

EU: Consumers (Non-professional user) in facial tissues;

US: By Occupational and non-occupational users targeting toilets, urinals, bathrooms, dairy and food processing equipment, tanks, vats, pails, pipelines, closed systems

 

5

Peracetic acid

79-21-0

EU: by professional and non-professional users in health and animal care areas and food industry, laundry disinfection in closed washing machines, sewage, wastewater, animal house, pharmaceutical and cosmetic industry, industrial and public and health care areas;

US: by occupational handlers for food, livestock, premises, food handling and serving areas, food dispensing equipment/vending machines, food contact equipment, animals(lap, research), reverse osmosis water systems, hospital/medical institution premises and bathroom

90-day inhalation toxicity;

6

L-(+)-lactic acid

79-33-4

EU: By Professional users and non-professional users in general public areas (ex. Bathrooms)

 

7

o-Phenylphenol

90-43-7

EU: By Professional users and non-professional users targeting surface, hospitals, health care settings and private homes

US: By occupational and non-occupational users in agricultural, food handling, commercial/institutional/industrial, residential, public access, and medical settings

 

8

Phenol

108-95-2

US: By occupational and non-occupational users targeting agricultural premises and Equipment, commercial, institutional and industrial premises & equipment, food handling/storage

establishments premises & equipment, medical premises and equipment, residential and public premises, materials preservative

 

9

1,3-Dichloro-5,5-dimethylhydantoin

118-52-5

US: By occupational and non-occupational users targeting agricultural premises and Equipment, commercial, institutional and industrial premises & equipment, food handling/storage establishments premises & equipment, medical premises and equipment, residential and public premises, materials preservative

 

10

3-(3,4-dichlorophenyl)-1,1-dimethylurea

330-54-1

US: By occupational and non-occupational users targeting agricultural food and non-food crops; ornamental trees, flowers, and shrubs; paints and coatings; ornamental fish ponds, and catfish

production; rights-of-way and industrial sites and residential uses include ponds and aquariums

90-day inhalation toxicity;

In-vivo genotoxicity;

11

Calcium dihydroxide

1305-62-0

EU: By industrial and professional users for sewage sludge treatment

90-day inhalation toxicity;

 

12

Calcium oxide

1305-78-8

EU: By industrial and professional users for sewage sludge treatment

 

13

Didecyldimethylammonium chloride

7173-51-5

EU: By industrial and professional users for wood and constructional timbers treatment;

US: By occupational handlers and residential handlers for Industrial processes and water system, swimming pools, aquatic areas, wood treatment, agricultural premise and equipment, residential and public access premise, medical premise and equipment, commercial institutional and industrial premise and equipment, food handling/storage establishments premises and equipment

90-day inhalation toxicity;

14

3-Iodo-2-propynyl butylcarbamate

55406-53-6

EU: By professional and non-professional users for in-can preservation process, pre-treatment of timber, protective treatment of wood and by professional and industrial users in emulsifiable metalworking fluid and water-soluble metalworking fluid;

US: By general users targeting Industrial processes and water system, swimming pools, aquatic areas, wood treatment, agricultural premise and equipment, residential and public access premise, medical premise and equipment, commercial institutional and industrial premise and equipment, food handling/storage establishments premises and equipment

 

15

Quaternary ammonium compounds, benzyl C12-C16-alkyldimethyl chlorides

68424-85-1

EU: By professional and industrial users for preventive protection of wood and constructional timbers;

US: By occupational and residential handlers targeting industrial processes and water system, swimming pools, aquatic areas, wood treatment, agricultural premise and equipment, residential and public access premise, medical premise and equipment, commercial institutional and industrial premise and equipment, food handling/storage establishments premises and equipment

 

16

Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid; Ampholyt 20

139734-65-9

EU: By professional users in industry, public health areas, veterinary areas

 

17

Reaction mass of N,N-didecyl-N,N-dimethylammonium carbonate and N,N-didecyl-N,N-dimethylammonium bicarbonate

894406-76-9

EU: By Professional users for timber preservation

90-day inhalation toxicity

NIER also planned to release the exempted information for other substances next week.

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