It's ensure compliance with all applicable regulations, in any Country of the world, looking for and use only raw materials guaranteed by large industrial groups and selected for you and always supported by scientific tests and certifications based on strict technical standards that protect the work of thousands of professionals in the world.
The goal of an ISO 9001 quality system is to ensure that the product supplied by the company meets specific requirements. They are defined by the standard as the Client's explicit and implicit expectations.
The Ministry of Economic Development Decree No. 206 of 15/10/2015 makes a list of the equipment authorized for aesthetic use and defines the technical features and use methods. 23 types of equipments are listed. The n.23 sheet concerns the "Micropigmentation Dermograph" which contains the technical regulations to which the manufacturer must comply to ensure the safety and use standards in compliance with European ones.
The GMP provides guidelines about the minimum requirements that a manufacturer must meet to ensure that the products are of high quality and present no risk to the consumer or the general public.
The manufacturer of a product in the European Union declares that the product complies with the safety requirements of the applicable directives or regulations.
All the colors of the BioResistent range (Set 1 / Set 2 / Set 3) comply with current European and non-European regulations where the product has been placed on the market. In particular, it responds to the indications expressed by the European Commission on February 20, 2008, with the issuance of the ResAP European Resolution (2008) 1.
MSDS safety data sheets are technical documents for information purposes on the physico-chemical, toxicological and environmental hazard properties necessary for the correct and safe handling of substances and mixtures.
In addition to producing in compliance with the Resap European resolution, Biotek has carried out analysis on its pigments, relying on different laboratories to guarantee you always the maximum safety.
The CTL is one of the most famous German analysis laboratories. At CTL Biotek requested analysis of heavy metals, aromatic amines, mutogens, sensitizers and impurities.
All tests were negative. With Biotek, there's no risk for you and your customers.