Workshop on Regulatory Preparedness for Innovation in Nanotechnology

This report summarises the presentations and discussions at the first NanoReg2 Workshop on Regulatory Preparedness for Innovation in Nanotechnology held in Ispra, Italy 5 to 6 October 2017 and attended by approximately 60 regulators, industry representatives and other stakeholders. NanoReg2 is a European Union (EU) Horizon 2020 project. At the workshop, Regulatory Preparedness was defined as the regulators' timely awareness of innovations and the regulator's actions to check whether present legislation covers all safety aspects of each innovation, including initiating revision of the legislation as appropriate. Regulatory Preparedness, and Safe-by-Design (SbD) jointly constitute the NanoReg2 Safe Innovation Approach (SIA) for developing innovative products based on nanotechnology. The workshop aimed to gather views and identify current practices in regulatory work on safety of innovative products, tools already in use or needed, and potential difficulties in implementing Regulatory Preparedness in the EU. Presentations addressed the current state of the safety of nanotechnology innovation. The viewpoints included the regulatory framework, the principles behind it and the agencies and authorities enforcing it; nanosafety research projects and their support system (e.g. the current EU Horizon 2020 Framework Programme); national nanosafety initiatives; and the development of tools, such as foresight tools and harmonised test guidelines by the OECD for data generation. The workshop served to generate ideas for achieving Regulatory Preparedness. The participants recognised that while regulators deal with the safety of innovations, only few systematic approaches to this work exist. Some innovative products may reach the market before their safety has been appropriately assessed, as illustrated by RAPEX, the Rapid Exchange of Information System. A continuous and proactive combination of interconnected activities was considered to be required for ensuring Regulatory Preparedness. Thus, anticipation, e.g. horizon scanning, was seen as important, as was communication between regulators, innovators (industry) and other stakeholders. Regulators need to become aware of innovative products under development to ensure that the legislation and methods for safety assessment are available and adequate. Innovators must be aware of regulatory requirements and their likely development. This mutual awareness helps to develop safe products and to avoid delays or other problems in obtaining market approval. Awareness can be achieved through communication, which requires trust, e.g. promoted via "trusted environments" for confidential inquiries and information sharing. Furthermore, regulators need early access to the existing information and data relevant to safety assessment of innovative products to provide timely guidance and advice to Industry as well as to develop strategies for dealing with uncertainty, e.g. by applying the precautionary principle. Regulatory Preparedness was discussed as part of the SIA, and a "road map" of actions was suggested and outlined. The workshop has thus contributed towards acceptance of implementing Regulatory Preparedness for innovation in nanotechnology through the participation of a variety of stakeholders. This paves the way for a better dialogue among stakeholders in a fast economic development cycle, where it is even more important to quickly identify emerging needs for new approaches to regulatory issues for innovationJRC.F.2-Consumer Products Safet

Biologie de l'oursin comestible (Paracentrotus lividus) :contrôle du cycle reproducteur et optimalisation de la phase de remplissage gonadique

Doctorat en Sciencesinfo:eu-repo/semantics/nonPublishe

Optimization of gonad growth by manipulation of temperature and photoperiod in cultivated sea-urchin: Paracentrotus lividus (Lamarck) (Echinodermata)

A starvation and then feeding method was developed to produce about 100% marketable sea urchins, Paracentrotus lividus, in 3 1/2 months. This method is needed because the reproduction cycle is desynchronized in the conditions imposed during the somatic growth stage in land-based closed systems. The major advantages of starving the animals are resetting the reproductive cycle to the spent stage (gonads almost devoid of sexual cells) and stressing the individuals so that they mobilize and restore the nutritive phagocytes, filling them with nutrients. Batches of sea urchins starved 2 months beforehand were fed ad libitum for 45 days with enriched food under eight combinations of four temperatures (12°C, 16°, 20°C and 24°C) and two photoperiods (9 and 17 h daylight). In our system, the best combination was 24°C and 9 h daylight for growth as well as for gonad quality. The gonadal indices obtained (in dry weight) were over 9% at 16°C and over 12% at 24°C, which are better than what is found in the field for this population.info:eu-repo/semantics/publishe

Differentiation of the genital apparatus in juvenile echinoids (Paracentrotus lividus)

info:eu-repo/semantics/publishe

The aboral ring and the development of early gonads in the echinoid Paracentrotus lividus (Echinodermata, Echinoidea)

The development of the genital apparatus is described for the echinoid Paracentrotus lividus. This apparatus derives from the aboral ring, an annular structure that includes an inconspicuous coelom and, in juveniles, the germinal rachis. The germinal epithelium grows out from the germinal rachis, and the gonadal wall and coelom in early (tubular) gonads share similarities with their equivalents in the aboral ring. The original germinal rachis regresses to form a genital cord one cell wide in late juveniles. A genital cord was observed in a few field-collected adult individuals (>40 mm test diameter).FLWINinfo:eu-repo/semantics/publishe

Comparison of three body-size measurements for echinoids

info:eu-repo/semantics/publishe

Cultivation of Paracentrotus lividus (Echinodermata: Echinoidea) on extruded feeds: digestive efficiency, somatic and gonadal growth

SCOPUS: ar.jFLWINinfo:eu-repo/semantics/publishe

Reproductive cycle of the echinoid Paracentrotus lividus: Analysis by means of the maturity index

SCOPUS: re.jinfo:eu-repo/semantics/publishe

Optimizing food distribution in closed-circuit cultivation of edible sea urchins Paracentrotus lividus (Echinoidea)

In the framework of echinoid cultivation, whose objective is to succeed in continuously producing large amounts of edible sea urchins (Paracentrotus lividus) under controlled conditions (aquaculture), gonadal growth is to be optimized. Among the various parameters influencing the production of roe, the quantity of food distributed was tested for optimization. After a 1-month fast, echinoids were fed artificial food pellets (enriched in soybean and fish proteins) for different periods of time over 48 h, the food thus being available ad libitum for 8, 16, 24, 32, 40, and 48 h; the cycles were repeated for a month. The results show that the quantity of food intake and the gonad index peak after about 35 h of food availability. This suggests food should be distributed discontinuously for optimal gonad production and minimal waste.info:eu-repo/semantics/publishe

Experimental study of growth in the echinoid Paracentrotus lividus (Lamarck, 1816) (Echinodermata)

Multimodal size frequency distribution (i.e. a few individuals growing very fast and a few individuals growing very slowly) among an originally homogeneous cohort of juveniles Paracentrotus lividus is observed in reared conditions when they are 6-24 months old. The splitting of this cohort into homogeneous size-classed subgroups results in an increased growth of the smaller animals that catch up with the bigger ones in 4 months time. This indicates that the smaller animals are not genetically less productive and suggests they were inhibited in their growth due to the presence of larger ones. Supposing such growth inhibition also occurs in the natural environment, the observed mechanism could be very efficient in stabilizing field populations of aggregative echinoid species by maintaining a protected pool of small individuals with high growth potential but inhibited by the density of larger ones.info:eu-repo/semantics/publishe