Application of standardization for the design and construction of carbon nanotube-based product pilot lines in compliance with EU regulation on machinery

The "PLATFORM" manufacturing ecosystem for pilot production of pre-commercial CNT-based nano-enabled products, consists of three pilot lines (PPLs) for the manufacture of buckypapers, doped prepregs and doped veils. The PPLs have been constructed with the ultimate goal to commercialize these products in the European market in 2020/2022.This goal requires having the PPLs in compliance with the applicable product safety regulation by that date (CE marking). The main EU regulation for new machinery (as the PPLs) is the Directive 2006/42/EC on Machinery (MD). This Directive sets out the general mandatory Essential Health and Safety Requirements (EHSRs) related to the design and construction of machinery, while particular technical specifications for fulfilling them are provided in European harmonized standards. Application of harmonized standards is voluntary but confers a presumption of conformity with the EHSRs they cover. The PPLs are unique machines for own use and must comply with the MD before they are put into service, in 2020/2022. But the MD does not provide specific EHSRs for nanosafety and no harmonized standards are available in this field for the safe design of the PPLs. In this context, this paper shows the standardization strategy followed by the project PLATFORM (GA 646307) to design the PPLs in compliance with the EHSR referred to the risks to health resulting from hazardous substances emitted by machinery (MD, Annex I, EHSR 1.5.13). In the absence of nanosafety harmonized standards to satisfy the aforementioned EHSR, the design and design verification of the PPLs were carried out through A & B - type harmonized standards (e.g. EN ISO 12100, EN ISO 14123-1/2), and other European and international standards.The projects PLATFORM and OASIS have received funding from the European Union’s Horizon 2020 research and innovation programme, under grant agreements Nº 646307 and Nº 814581, respectively. This paper reflects only the authors’ views, and the Commission is not responsible for any use that may be made of the information contained therein