Toothpaste Regulations in South Africa

Table of Contents

If you are an importer from South Africa and planning to import a batch of customized toothpaste from China, then the regulations regarding the importation of toothpaste into South Africa will be very important for you.

We will look at classification, labeling, and tariff code & duty respectively.

Classification

In fact, a large proportion of toothpastes in South Africa are imported. There may be a lack of awareness and misunderstanding of regulations if the manufacturer is unfamiliar with local laws (larger companies may have “in-house” legal departments) and due to the multitude of acts governing marking procedures.

Fortunately, according to the CTFA, South Africa ascribes to the European Regulations and Ingredient Annex to facilitate import and export. In other words, if you find a Chinese manufacturer that has exported toothpaste to Europe, then the toothpaste produced by that manufacturer also complies with South African toothpaste regulations, and it would be great if that manufacturer is familiar with South African toothpaste regulatory requirements.

In reference to European Regulations, toothpaste can potentially be classified as a cosmetic, a medicinal product, or a medical device depending on its composition, mode of action, and how the product is presented.

And toothpastes are indeed classified as cosmetic products within the South African context.

Labeling

The SANS 1302:2008 (edition 1.1) guidelines pertaining to toothpastes were ratified by the National Committee of the South African Bureau of Standards SC271B, Cosmetics – Toothpastes, and was published in June 2008.

Toothpaste is packaged in tubes, and permissible tube volumes include 15ml, 35ml, 50ml, 75ml, 100ml, 125ml, 150ml, 175ml and 200ml.

The following are the SANS labeling regulations for toothpaste tubes:

  1. nominal volume,
  2. brand name, the name of the toothpaste,
  3. the name and contact details of the manufacturer or responsible distributor,
  4. complete listing of ingredients,
  5. batch number,
  6. and if the product is fluoridated, the phrase, “Fluoride Toothpaste” or “Fluoride Dental Crème” is to be displayed.

Similarly, the labeling requirements for tubes also apply to the labeling of outer cartons, packaging of composite packs, and bulk packages.

The ISO 11609:2010 document also includes the following labeling specifications:

  1. expiry date, (some researchers refer to a 3-year shelf life, while the ADA stipulates a 2-year product stability),
  2. the active ingredient, the chemical form of fluoride, total fluoride concentration (between 1000ppm and 1500ppm),
  3. cautionary statements, for example, a cautionary note regarding use in paediatric consumers,
  4. storage instructions,
  5. and directions for use.

Tariff Code & Duty

The South African tariff book is hosted and maintained by SARS Customs, but you can view our tariff code directory by clicking here, and finding the tariff code for toothpaste on page 231.

The tariff code of a toothpaste is 3306.10, and the last check digit is 7.

If you import a batch of custom toothpaste from China to South Africa, the duty is 10%.

Acronyms

CTFA: Cosmetics, Toiletries and Fragrance Association of South Africa,
SANS: South African National Standards,
ADA: American Dental Association,
ISO: International Organisation for Standardisation.

Vesper Luo
Vesper Luo

Hello, I'm Vesper Luo, co-founder of dentalmfg.com, I've been running a factory in China for ten years that mainly produces toothpaste and the purpose of this article is to share knowledge related to dental care products from a Chinese supplier's perspective.

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