Policy Regulatory Technical Notification 01-2025
Dear CTFA member
Please find this week’s notification for information and consideration.
Botswana to further regulate cosmetics
Draft Guidelines released for comment
Following the virtual stakeholder engagement held by the Botswana Medicines Regulatory Authority (BoMRA) on 10 October 2024, the draft Guideline for the regulation of cosmetic products was released for public comment until 31 January 2025.
Cosmetics are included in Botswana’s Medicines and Related Substances Act, and Regulations. An exemption resulted in cosmetics not requiring authorisation or pre-approval prior to importation and sale in Botswana. The Guideline will provide the requirements to be followed in the future.
The following aspects are covered in the draft Guideline: safety; manufacture; good manufacturing practise; labelling (English); ingredient limitations; claims; therapeutic indications; responsibilities; listing with BoMRA and listing validity; information and documentation requirements; advertisements; fees; post-market surveillance; and licensing requirements (e.g. importation). Products will need to be listed before licences can be applied for.
Note that the proposed definition of “cosmetics” is: “”¦(a) any substance or mixture of substances manufactured, sold or represented for use by rubbing, pouring, spraying, or applying by any other means to the human body, for the purpose of cleansing, beautifying or altering the appearance; or (b) any article intended for use as a component of a cosmetic;”. Furthermore, i) it is stated that “Cosmetics are intended for beautifying, cleansing or superficial alteration of appearance”; and ii) helpful Annexes list what are considered cosmetics and what are not.
Please provide comments to CTFA by 20 January 2025 for consolidation along with CTFA’s inputs that will be submitted to BoMRA for consideration.
Draft amendments to the Extended Producer Responsibility Regulations and Listing Notices
Extension to submit comments
CTFA alerted members to the proposed amendments in PRT Notification 29/2024. The Department of Forestry, Fisheries and the Environment has extended the deadline for comments to be submitted on the proposed amendments, to 31 January 2025.
Please provide input to CTFA by 20 January 2025.
Working Draft (WD) African Harmonised Standards for review
Since the beginning of November 2024, CTFA; the South African Bureau of Standards (SABS) Technical Committee 217 (Cosmetics) Chairperson and the Department of Trade, Industry and Competition, who are the South African representatives of the African Organisation for Standardisation (ARSO) Technical Committee 40 (Cosmetics and Personal Care), have been considering the first batch of nine WD standards for the purposes of harmonisation and adoption:
- Labelling of cosmetics - requirements;
- List by category of cosmetic products;
- Cosmetics and cosmetic products – Part 1: List of prohibited substances;
- Cosmetics and cosmetic products – Part 2: List of substances which cosmetic products must not contain except subject to the restrictions laid down;
- Cosmetics and cosmetic products – Part 3: List of allowed colorants, preservatives and UV-filters;
- Lip balm (lip salve);
- Lip shine (gloss);
- Lipstick; and
- General requirements for safety of cosmetic products.
The objective of ARSO is to promote standardisation; enhance trade (for example under the African Continental Free Trade Area); improve product quality; provide consumer protection; and facilitate international cooperation.
As can be noted from the above, some of the proposed harmonised standards are product-specific that come with their own specification and test requirements that are not required in South Africa and many other jurisdictions. This is likely to result in increased costs and complexities to be able to access the markets where these harmonised standards may be adopted.
The South African representatives’ challenge is to determine whether there is support or not for each of the proposed harmonised standards, and if so, what comments should be provided to make them as implementable as possible (e.g. through alternative proposals and compromise).
It is important to note that having to implement the harmonised standards may have an impact on local market requirements, as the ultimate goal of ARSO – of which South Africa is a member – is for member countries to adopt harmonised standards.
Due to the importance of the matter, extensions were provided until 7 February 2025 for countries to provide inputs. The SABS TC217 has been requested to provide input on the WDs by 20 January 2025.
Should members wish to review the WDs, please request them from CTFA and provide any inputs also by 20 January 2025.
Importation of goods
Various amendments to the Customs and Excise Act
The South Africa Revenue Service has made numerous amendments to Notes; Parts; and Schedules of the Act, the most relevant of which include:
- General Rates of Duty for imports, as well as imports from specific regions where trade agreements are in place including the European Union; the United Kingdom; Southern African Development Community; MERCOSUR; and the African Continental Free Trade Area: Chapters 32 (pigments); Chapter 33 (essential oils); Chapter 34 (soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, “dental waxes” and dental preparations with a basis of plaster); and chemical raw materials in preceding chapters; and
- the inclusion of new codes that are of interest to regulation by the Department of Forestry, Fisheries and the Environment, such as perfluorooctanoic acid; hexabromocyclododecane; isophorate; and others.
Should there be any queries or if you would like further information/documentation, please do not hesitate to contact: Dr Glen Malherbe - glen@ctfa.co.za / 082 908 3383 or Nadia Rashid - nadia@ctfa.co.za
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