If you are an importer from Chile and plan to import a batch of toothpaste from China, then the Chilean regulation regarding toothpaste imports will be very important for you.
Below you will find the classification of toothpaste, the labeling of toothpaste, the documents to be submitted, and the sanitary authorization.
Toothpaste Classification
There are two types of toothpaste, classified according to their fluoride concentration:
- cosmetic, when they have 1500 ppm or less of fluoride,
- pharmaceutical, when they have more than 1500 ppm of fluoride.
Chilean legislation outlines two distinct cosmetic categories:
- high-risk cosmetics including colored make-up, body lotions/treatments, aging skin treatments, hand sanitizers, and insect repellant.
- low-risk cosmetics including enamel, nail enamel remover, wax body hair remover, hairsprays, hair conditioning/shampoo, disposable sanitary pads, tissues, deodorants, shaving products, mouthwash, toothpaste, eau de toilette, perfumes, and others.
In fact, one of my Chilean customers said
Most kinds of toothpaste are considered a cosmetic of medium risk, and the costs of registration are a bit expensive. We can avoid the high and the medium risk if the kinds of toothpaste do not include fluoride in their formulations.
Chilean legislation requires that importers register toothpaste at the Instituto de Salud Publica (ISP), and registration ensures their toothpaste can be imported into Chile. In addition, only companies (local and foreign) that are legally established in Chile may file for registration.
The ISP publishes a list of prohibited cosmetics ingredients, which is referenced by the European Commission database. So, exporters cannot use the prohibited cosmetics ingredients mentioned here in the production of toothpaste.
Toothpaste Labeling
Labeling must be in Spanish and include:
- Name
- Cosmetics purpose
- Qualitative formula with ingredients in INCI nomenclature
- Information on expiration date, storage precautions, and indications
- ISP registration approval number
The registration fee for low-risk cosmetics is approximately US $55.
Submitting Items
To file for registration, the importer should present the following items to the ISP:
- Product samples
- Complete qualitative and quantitative formula
- Quality specifications
- Label wrote in Spanish
- Stability tests and quality control
- A free sale certificate granted by the China Council for the Promotion of International Trade (CCPIT) was notarized and legalized at Chilean Consulate.
Sanitary Authorization
What’s more, for toothpaste to be marketed in Chile, sanitary authorization is required. And the fee is Chilean Peso $386.990. Please click here and see more details.
