INFORMATION ABOUT MATERIALS

Some information listed below is grounded on our raw materials suppliers’ data. The most important information regarding the product management and the users’ security and health can be found in the Material Safety Data Sheet.

All the MSDS and certifications are stored in the headquarter of HSL srl, owner of the brand .exnovo. It is possible to verify the characteristics of the raw materials writing to the email address exnovo@exnovo-italia.com.

Manufacturing raw materials

The manufacturing material is PA 2200 – Pa12 Polyamide in partially recycled powder.

Biocompatibility:
ISO testing (CE Directives) – In vitro Cytotoxicity Assay: under the given conditions no leachable materials were released in cytotoxic concentrations from the test item.
Irritation Test (Intracutaneous Reactivity): the Primary Irritation Index (PN) for the nonpolar test item extract and the nonpolar reagent control was 0.
Test for Sensitization (Local Lymph Node Assay – LLNA): the PA 2200 partially reused powder causes no reactions identified as sensitization, as the Stimulation index was below 3.0 for each concentration tested.
USP (United States Pharmacopoeia) Biological Test: In the Systemic Injection Test no significant clinical signs were observed. The average score in the Intracutaneous Reactivity Test was 0. In the Implantation Test no compound related tissue reactions were found. Considering the reported data, the PA 2200 powder meets the requirements of USP Plastic Class VI.

Food compatibility:
DIRECTIVE 2002/72/EC – Plastic Materials and Articles intended to come into Contact with Foodstuffs: the raw material, used in this specific manufacturing process, is in compliance with the EU directive 2002/72/EC, called “Plastic directive”, in regards to the material employment with all kind of food (with the exception of hard liquors).
California Proposition 65 – Safe Drinking Water and Toxic Enforcement Act of 1986: none of the ingredients is listed (see MSDS chapter 15).
The raw material is free from sulfur, halogens, natural rubber, polyvinyl chloride, halogenated hydrocarbons, harmful substances indicated in the EU directive 2005/84/EC, lasting organic pollutants, substances of animal, vegetable and GMO origin, with the exception of unimportant impurities.

Chemical substances:
REACH (pre)-registration – REGULATION (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH): The raw material fully satisfies the requirements of the European Chemicals Regulation (REACH) in the field of monitoring and control of the chemical substances hazards and risks.
Substances of Very High Concern (SVHC) – REGULATION (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH): PA 2200 fully complies with the requirements of the European Chemicals Regulation (REACH).

Mechanical performance

The technology used could be prone to unpredictable variation of the operating parameters; it could happen that some products don’t have the desired mechanical features. For this reason, HSL subjects some sample products to validation tests.
Nevertheless, not all the layouts can be rigorously tested: should the customer finds out any suspected break, HSL could replace the product with a similar one, after any technical checks through pictures or the direct examination of the defective product.

Material disposal

Pa12 Polyamide is a completely recyclable material: HSL recycles all the waste and scraps of Pa12 Polyamide that are not reusable for technical reasons. HSL disposes of the coloring waste in full compliance with current regulations, bestowing the disposal on certificated and approved companies.