Regulatory landscape of nanotechnology and nanoplastics from a global perspective.

Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regulatory bodies have spent many efforts in the last two decades to cope with these challenges. Although there has been a significant advancement related to analytical approaches for labelling purposes as well as to the development of suitable test guidelines for nanomaterials and their safety assessment, there is a still a need for greater global collaboration and consensus in the regulatory field. Furthermore, with growing societal concerns on plastic litter and tiny debris produced by degradation of littered plastic objects, the impact of micro- and nanoplastics on humans and the environment is an emerging issue. Despite increasing research and initial regulatory discussions on micro- and nanoplastics, there are still knowledge gaps and thus an urgent need for action. As nanoplastics can be classified as a specific type of incidental nanomaterials, current and future scientific investigations should take into account the existing profound knowledge on nanotechnology/nanomaterials when discussing issues around nanoplastics. This review was conceived at the 2019 Global Summit on Regulatory Sciences that took place in Stresa, Italy, on 24-26 September 2019 (GSRS 2019) and which was co-organised by the Global Coalition for Regulatory Science Research (GCRSR) and the European Commission's (EC) Joint Research Centre (JRC). The GCRSR consists of regulatory bodies from various countries around the globe including EU bodies. The 2019 Global Summit provided an excellent platform to exchange the latest information on activities carried out by regulatory bodies with a focus on the application of nanotechnology in the agriculture/food sector, on nanoplastics and on nanomedicines, including taking stock and promoting further collaboration. Recently, the topic of micro- and nanoplastics has become a new focus of the GCRSR. Besides discussing the challenges and needs, some future directions on how new tools and methodologies can improve the regulatory science were elaborated by summarising a significant portion of discussions during the summit. It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently. The harmonisation of methodologies for quantification and risk assessment of nanomaterials and micro/nanoplastics, the documentation of regulatory science studies and the need for sharing databases were highlighted as important aspects to look at.

[A new occupational and environmental hazard - nanoplastic]. / Nowe zagrozenie zawodowe i srodowiskowe ­ nanoplastik.

Problems arising from the accumulation of plastic waste in the environment have become global. Appeals to stop the usage of disposable drinking straws or plastic cutlery did not come out without reason - 320 million tons of plastic products are produced annually, of which 40% are disposable items. More and more countries and private enterprises are giving up these types of items in favor of their biodegradable substitutes, e.g., cardboard drinking straws. Plastic waste in the environment is subject to a number of physicochemical interactions and biodegradation in which bacteria are involved. By using synthetic waste, they reduce the size of plastic garbage while increasing its dispersion in the environment. Small plastic particles, invisible to the naked eye, are called nanoplastic. Nanoplastic is not inert to living organisms. Due to its size, it is taken up with food by animals and passed on in the trophic chain. The ability to penetrate the body's barriers through nanoplastic leads to the induction of biological effects with various outcomes. Research studies on the interaction of nanoplastic with living organisms are carried out in many laboratories; however, their number is still a drop in the ocean of the data needed to draw clear-cut conclusions about the impact of nanoplastic on living organisms. There is also no data on the direct exposure to nanoplastic contamination at workplaces, schools and public utilities, standards describing the acceptable concentration of nanoplastic in food products and drinking water, and in vitro tests on nanoparticles other than polystyrene nanoparticles. Complementing the existing data will allow assessing the risks arising from the exposure of organisms to nanoplastic. Med Pr. 2020;71(6):743-56.