Scientific Documentation REGULATORY

Scientific Documentation REGULATORY

Bio Basic Europe can count on a skilled and always updated technical-regulatory area that provides different consultancy services in order to assure even more reliability and technical functionality for:

COSMETIC PRODUCTS, according to the European Regulation (EC) no. 1223/2009:
• Writing the Technical File (PIF - Product Information File) and relative updates or the only evaluation of the potential toxicological risk of a product (Safety Assessment)
• Registration of the person Responsible for the Product, Notification to the European Portal (CPNP) in order to put the new product on the market and following updates
• New proposals and checks for claims and suggestions on the most suitable tests to support them
• Realization and/or verification of the labelling, according to the Norms
• Support for Import from EU and extra EU countries and Export towards EU and extra Eu countries

DIETARY SUPPLEMENTS, according to the European Directive 2002/46/EC:
• Notification to the Ministry of Health
• Compliance check of the label, composition and claims

MEDICAL DEVICES, according to the new European Regulation “MDR” (Medical Device Regulation) 2017/745:

• Assistance and regulatory consultancy
• Support to EC certification
• Writing the technical file
• Writing the analysis, risk assessment and identification according to ISO 14971
• List of the essential requirements according to MDD 93/42/EEC and further amendments
• Writing the clinical evaluation and bibliography
• Label check and revision
• National and international approvals, Italian and European ministerial Registration
• Request for a ministerial authorization in order to get advertising material

DANGEROUS PREPARATIONS, according to the Regulation (EC) N. 1272 of 2008 (CLP) and the Regulation (EC) n.1907 of 2006 (REACH)
• Writing and updates of Safety sheets according to the Regulation (UE) 2015/830, which has an amendment of annex II of the Regulation (EC) n.1907/2006 (REACH)
• Company database Registration to share information related to dangerous and not dangerous preparations , referred to D.Lgs 65 of 14/03/2003 and D.Lgs. 21 del 6/2/2009 and art. 45(4) of CLP
• Label evaluation and revision according to the Regulation CLP

BIOCIDES, according to the Regulation (UE) n. 528 of 2012
• Application for Ministerial Authorization
• Label evaluation and revision according to the CLP Regulation

DETERGENTS, according to the Regulation (EC) n. 648 of 2004
• Label evaluation and revision according to the CLP Regulation

According to what is contained in the:
- European Regulation 1907/2006 (REACH) about electronic cigarettes considered as "articles" and the liquids considered as "mixtures";
- European Regulation 1272/2008 (CLP) about the liquids;
- Directive 2014/40/UE (TPD) that regulates devices and liquids containing nicotine and its National transpositions;
Bio Basic Europe, in order to support manufacturers and distributors to comply with those European and National legal requirements, offers regulatory and notification consultancies and testing services, in order to demonstrate the compliance of the product with the requirements of the TDP, through the following services:
• Regulatory assistance;
• MSDS (Material Safety Data Sheet) production;
• Labelling;
• National and International notifications.

Below the main analysis performed within our laboratories:
• cytotoxicity test on cell cultures of keratinocytes and fibroblasts;
• cytotoxicity test on cell cultures of the oral mucosa and / or airway cells;
• determination of heavy metals (Cd, Cr, Cu, Ni, As, Pb ) in e-cig's emissions;
• titration of nicotine fluids;
• determination of the "flash-point" according to the method “Pensky-Mertens closed cup” (ASTM D93) on certain liquids.

Dermo-cosmetic and medical R&D center