Standards

Specific requirements in respect of hand sanitisers

3. (1) A person must not - (a) manufacture or distribute a hand sanitiser in Namibia; or (b) import a hand sanitiser into Namibia, unless the person complies with these regulations.

(2) A manufacturer, an importer or a distributor of a hand sanitiser must comply with the requirements - (a) relating to the type, bacterial efficacy, storage stability, freedom from visible impurities and dermal irritation set out in Clause 4 of NAMS/SANS 490; (b) of inspection and methods of test set out in Clause 5 of NAMS/SANS 490; and (c) of packing and marking set out in Clause 6 of NAMS/SANS 490.

(3) A manufacturer must manufacture a hand sanitiser according to the following formula consistent with the WHO recommendations: (a) alcohol (ethanol/ethyl alcohol) 75% (v/v) to 85% (v/v) or isopropyl alcohol 70% (v/v) to 80% (v/v); (b) glycerol 1.45% (v/v); (c) hydrogen peroxide 0.125% (v/v).

(4) An importer must not import into Namibia a hand sanitiser which has not been manufactured in accordance with the formula set out in subregulation (3).

(5) A manufacturer, an importer or a distributor of a hand sanitiser must ensure that the hand sanitiser complies with one of the following types specified in Clause 4.1 of NAMS/SANS 490: (a) type 1: liquid type; (b) type 2: gel type.

(6) A manufacturer, an importer or a distributor of a hand sanitiser must ensure that the hand sanitiser does not contain any other active or inactive ingredients to -

(a) improve the smell or taste of the hand sanitiser;

(b) prevent the risk of accidental ingestion in children; or

(c) impact the quality and potency of the hand sanitiser. 7201 Government Gazette 30 April 2020 5

(7) A manufacturer, an importer or a distributor of a hand sanitiser must ensure that the ethanol (ethyl alcohol) or isopropyl alcohol active ingredient in the hand sanitiser is correct and the correct amount of the active ingredient is used in the manufacturing of the hand sanitiser.

(8) A manufacturer, an importer or a distributor of a hand sanitiser must ensure that the hand sanitiser has a material safety data sheet providing detailed and comprehensive information on -

(a) the health effects of exposure to the hand sanitiser;

(b) hazard evaluation related to the handling, storage or use of the hand sanitiser;

(c) measures to protect workers or consumers at risk of exposure to the hand sanitiser; and

(d) the emergency procedure relating to the use of the hand sanitiser.

(9) A manufacturer, an importer or a distributor of a hand sanitiser must ensure that the packaging label of the hand sanitiser is in accordance with the Trade Metrology Act, 1973 (Act No. 77 of 1973) and that the packaging of the hand sanitiser -

(a) is marked in accordance with the requirements of the SADCMEL Document 1 and Document 4;

(b) complies with marking that must appear on the packaging contemplated in Annexure 1;

(c) complies with the unit of measurements, symbols and quantities contemplated in Annexure 2; and

(d) complies with the packing and marking requirements as contemplated in clause 6 of NAMS/SANS 490. (10) If a person manufactures, imports or distributes a hand sanitiser that does not comply with this regulation, the person commits an offence and on conviction is liable to a fine not exceeding N$5 000 or to imprisonment for a period not exceeding six months or to both such fine and such imprisonment