Africa Regulatory Update 02_2025

These ad-hoc Africa Regulatory Updates are intended to inform all members of developments, even if queries were received from specific members. Due to increased email burdens, information is shared when of sufficient volume and/or importance.

Republic of Botswana

The draft Guideline that CTFA recently considered and submitted input to the Botswana Medicines Regulatory Authority (BoMRA) on, is still being considered by the regulator. Please note that although the listing of products is currently voluntary, there are certain requirements that a cosmetic product must comply with, such as Good Manufacturing Practice; Botswana Standards 688-1 and -2; and labelling requirements (Regulations); among others. The respective Standards are:

• BOS 688-1: Dyes, colours and pigments - Classification of cosmetics raw materials and adjuncts — Part 1: Lists dyes, colours and pigments which are generally recognised as safe for use in cosmetics.
• BOS 688-2: Dyes, colours and pigments - Classification of cosmetics raw materials and adjuncts — Part 2: List of raw materials generally not recognized as safe for use in cosmetics. This standard lists cosmetic raw materials and adjuncts, other than dyes, colours and pigments in the following four groups:

1. List of substances classified as 'GNRAS' which shall not form part of the composition of cosmetic products (see Annex A);
2. List of substances which cosmetic products shall not contain except subject to the restrictions and conditions laid down (see Annex B);
3. List of preservatives allowed (see Annex C); and
4. List of U.V. filters allowed in sunscreen products (see Annex D).

Should the company wish to list products, please visit the BRIMS portal at https://brims.bomra.co.bw. The listing process currently does not attract any regulatory fees.

African Continental Free Trade Agreement (AfCFTA)

Rules of Origin, and additional countries included in South African Customs and Excise legislation

"Rules of Origin" are specific criteria used to determine the country where a product was manufactured, essentially defining its "origin”, which is crucial in international trade for applying appropriate tariffs and duties based on the exporting country, particularly when preferential trade agreements are involved, allowing certain goods to receive reduced or no tariffs if they originate from a specific region or country. Such a case is the AfCFTA that is still expanding.

Morocco; Burundi; and Uganda have recently been included in the Customs and Excise Act for the purposes of the AfCFTA, and the Rules of Origin have been updated for the Agreement.

It is important to note that the “cosmetic” parts of the tariff code book belong to the family of “chemicals”, for which there are special “chemical processing rules” to consider that confer originating status for preferential/zero tariffs to be realised. The Rules of Origin in the Act have been updated with respect to the AfCFTA.
For further information, please make contact.