Pigments for Scalp Micropigmentation
The prepared colouring agents used in Scalp Micropigmentation are subject to a strict regulation at European and the national levels. National authorities have published the prerequisites to grant authorisation for the prepared colouring agents. Without fulfilling these requirements, it is not possible to proceed with the sale of the colouring agents.
The Resolution of the European Council on tattooing and micropigmentation released in 2008 and derived from the decision published in 2003 warns about the health risks if certain substances are implanted. The health risks are of two types: those that result from the use of harmful ingredients and those resulting from microbiological contamination due to incorrect preparation or containers.
The colouring agents used in Tricopigmentation cannot contain a series of ingredients which could be harmful for health, such as aromatic amines or ingredients considered to be carcinogenic, mutagenic or reprotoxic, and other ingredients that could cause hypersensitivity. Moreover, the prepared colouring agents used in Tricopigmentation cannot contain preservatives according to the European Resolution.
To prevent the microbiological contamination of the prepared colouring agent within the container, the Resolution of the European Council on tattooing and micropigmentation released in 2008 states that the prepared agents for Scalp Micropigmentation must be sterilised and conditioned in a container which keeps them sterile until their application.
The above-mentioned Resolution similarly specifies the information that the container must contain. This way, the products used in Scalp Micropigmentation must have the following information on their packaging, as well as previous health authorisation for their commercialisation:
- The product’s usage.
- Name and address of the manufacturer or the person responsible for putting the product on the market.
- Minimum storage life.
- Conditions of use and warnings.
- Batch number or reference used by the manufacturer for the identification of the batches.
- List of ingredients in accordance with the name of the International Union of Pure and Applied Chemistry (IUPAC), CAS (Chemical Abstract Service of the American Chemical Society) number or the Colour Index (CI) number.
- Guarantee of the sterilisation of the contents.