Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B7: Product quality, safety or performance requirements 

Date when the measure came into force

14 July 1999 

Publication where the measure is specified

Government Notice R529 (Government Gazette 19999) Of 14 May 1999 

Regulation where the measure is specified

Compulsory Specification For Disinfectants And Detergent-Disinfectants 

Country/Region applying the measure

South Africa 

The rationale of the measure

This specification covers requirements for disinfectants and detergent-disinfectants intended for use on inanimate surfaces. 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

4 General requirements for the disinfectant or detergent-disinfectant

4.1 Type

The various types of disinfectant or detergent-disinfectant are shown in table 1. These are provided as examples and do not limit the development of new formulations or types.
4.2 Disinfecting efficacy
When the disinfectant or detergent-disinfectant is tested in accordance with the relevant test procedures given in 5.6 to 5.13 and 6.4 (see table 1), at the prescribed concentration, the claims made in regard to the efficacy of the disinfectant or detergent-disinfectant on the package, in the package leaflet or on the label attached to the package (see 7.2(f)) or in product support information, shall be regarded as the
disinfecting efficacy requirement for the disinfectant or detergent-disinfectant.
NOTES
1 Should new disinfectants or detergent-disinfectants be developed and formulated, and these methods not be suitable for use on the new disinfectants or detergent-disinfectants, additional test methods might have to be developed and validated before implementation and use. In most cases, however, new disinfectants or detergent-disinfectants can be tested using existing procedures with or without slight modifications.
2 Where more than one active ingredient is used, the substance with the highest concentration determines the type of test.
4.3 Corrosiveness
Where applicable, when the disinfectant or detergent-disinfectant is tested in accordance with 6.1 at the prescribed concentration, it shall not cause more than slight dulling of the surface of the aluminium and the test strip shall show no evidence of pitting, etching or discoloration. If claims are made for non- corrosiveness of a specific material, the manufacturer shall substantiate his claim.
4.4 Water-insoluble-matter content
Where applicable, when the disinfectant or detergent-disinfectant is tested in accordance with 6.2 at the prescribed concentration, the water-insoluble-matter content shall not exceed the appropriate of the following:
a) liquid disinfectants or detergent-disinfectants: 5,0 g/l; or
b) solid disinfectants or detergent-disinfectants: 2,5 % (by mass).
4.5 Rinsing properties of detergent-disinfectants
When the detergent-disinfectant is tested in accordance with 6.3 at the prescribed concentration, it shall be free-rinsing.
NOTE - Although the test for rinsing properties in the case of quaternary ammonium compounds can show that the detergent-disinfectant is free-rinsing, non-rinsable residues might still be retained on the treated surface.
4.6 Cleaning efficacy of detergent-disinfectants

When the detergent-disinfectant is tested in accordance with 6.4 at the prescribed concentration, except in the case of a chlorine type, its mean cleaning efficacy shall be at least 80 % of the mean cleaning efficacy of the standard detergent-disinfectant. In the case of a chlorine type detergent-disinfectant, the mean cleaning efficacy shall be at least 60 % of that of the standard detergent-disinfectant.

4.7 Storage Stability
4 7.1 Detergent-disinfectants based on iodophors
When the detergent-disinfectant is tested in accordance with 6.5.1 :
a) no visible separation shall occur during either the 24 h cooling period or the 24 h warming period; and
b) the highest of the four values of the available iodine content shall not differ from the lowest one by more than 10 % of the lowest value.
4.7.2 Coal-tar type disinfectants
4.7.2.1 Stability before dilution
When coal-tar type disinfectants are tested in accordance with 6.5.2.1 , the disinfectant liquid shall not, during either of the two tests, show more than traces of separation of oil at either the top or the bottom.
A creamed liquid (see 2.6) that can be rendered uniform by inverting the cylinder and restoring it to an upright position three times, shall not be deemed to have undergone separation.
NOTE -The quick test given in 6.5.2.2 may not be regarded as a substitute for the normal test given in 6.5.2.1. but it may be used to give an indication of the stability of a white disinfectant liquid. In this test, stability is indicated if the diameter
of a deposit does not exceed 1 mm.
4.7.2.2 Stability after dilution
When coal-tar type disinfectants are tested in accordance with 6.5.2.3, the disinfectant liquid shall be miscible with the hard water (see 5.4.18.4) at both the highest and the lowest dilutions recommended on the container and the emulsions shall show no sign of separation and not more than traces of separation of oil at either the top or the bottom.
4.7.3 Disinfectants and detergent-disinfectants based on glutaraidehyde
4.7.3.1 When tested in accordance with 6.5.3.1 , a type 1 disinfectant or detergent-disinfectant and the liquid component of a type 2 disinfectant or detergent-disinfectant shall remain homogeneous and free- flowing and shall comply with 4.2.
4.7.3.2 When tested in accordance with 6.5.3.2, the solid component of a type 2 disinfectant or detergent-disinfectant shall remain free-flowing, and the type 2 disinfectant or detergent-disinfectant that it activates shall still comply with 4.2.

4.7.3.3 After a type 1 disinfectant or detergent-disinfectant has been diluted or after the two components of a type 2 disinfectant or detergent-disinfectant have been mixed to the prescribed concentration and the disinfectant has been stored in closed dark containers at 25 °C for the effective life as stated on the label (see 7.2(j)), the resulting dilution shall still comply with 4.2.
4.7.4 Disinfectants or detergent-disinfectants based on chlorhexidine gluconate
4 7.4.1 When stored in accordance with 6.5.4.1 , the disinfectant or detergent-disinfectant shall remain homogeneous. After standing for a further 24 h at a temperature of 20 °C ± 5 °C, the disinfectant or detergent-disinfectant shall show no sign of precipitation or separation.
4.74.2 When stored in accordance with 6.5.4.2, the disinfectant or detergent-disinfectant shall show no sign of precipitation or separation and shall still comply with all the requirements of 4.2.
4.7.5 Disinfectants or detergent-disinfectants based on quaternary ammonium compounds, stabilized inorganic chlorine compounds and organic or inorganic halogen compounds (other than iodine compounds)
4.7.5.1 When a liquid disinfectant or detergent-disinfectant is tested in accordance with 6.5.5.1 , it shall remain homogeneous and free-flowing.
4.7.5.2 When a solid disinfectant or detergent-disinfectant is tested in accordance with 6.5.5.2, it shall not cake into hard lumps.
4.8 pH value
Where applicable, when tested in accordance with 6.6 at the prescribed concentration, the pH value shall be as specified on the container (see 7.2(g)).
4.9 Freedom from visible impurities of solid disinfectants or solid detergent- disinfectants based on quaternary ammonium compounds, stabilized inorganic chlorine compounds and organic or inorganic halogen compounds (other than iodine compounds)

When a solid disinfectant or solid detergent-disinfectant is tested in accordance with 6.7, the number of visible specks of impurities shall not exceed five.
4.10 Added colouring matter for disinfectants or detergent-disinfectants based on iodophors.
When tested in accordance with 6.8, a disinfectant or detergent-disinfectant shall not contain any added colouring matter. 

Reference of the measure

Regulation 4 

Measure also domestic

Yes 

Products affected by the measure.

Description

Disinfectants and detergent-disinfectants intended for use on inanimate surfaces. 

Countries/Regions affected by the measure.

Description

All countries