In the European Union, Scalp micropigmentation (SMP) pigments are regulated as cosmetic products and must comply with the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). The regulation sets out requirements for the safety of cosmetic products, including SMP pigments, to protect human health.
Manufacturers of SMP pigments are responsible for ensuring that their products meet the requirements of the Cosmetics Regulation. The process that SMP pigments go through when manufactured to make sure they are safe includes the following steps:
1. Ingredient selection: Manufacturers must select ingredients that are safe for use in cosmetic products and comply with the restrictions and conditions set out in the Cosmetics Regulation. Some ingredients are prohibited, while others are restricted in terms of the maximum concentration that can be used.
2. Product formulation: Manufacturers must formulate their tattoo inks to ensure that they are safe for use and comply with the requirements of the Cosmetics Regulation. This includes ensuring that the pH of the pigment is within a safe range and that preservatives are added to prevent microbial contamination.
3. Testing: Before placing a SMP pigments on the market, the manufacturer must carry out safety assessments and stability tests to ensure that the product is safe for use and will not deteriorate over time.
4. Labeling: SMP pigments manufacturers must provide clear and accurate labeling on their products, including a list of ingredients, the batch number, the manufacturer's name and address, and instructions for use.
5. Notification: Manufacturers must notify their products to the European Commission's Cosmetic Products Notification Portal (CPNP) before placing them on the market.
In addition to these steps, the European Chemicals Agency (ECHA) has developed a guidance document for SMP pigments manufacturers to help them comply with the requirements of the Cosmetics Regulation. The guidance covers issues such as impurities, contaminants, and colorants, and provides information on how to carry out safety assessments and stability tests.
Overall, the process that SMP pigments go through when manufactured to make sure they are safe in the European Union is rigorous and aimed at protecting human health.