Laboratori Archa – Pilot Results

Pilot Company

Laboratori Archa S.r.L (Archa), Italy is a small-to-medium size enterprise (SME), with the mission to provide assistance, technological innovation and know-how to companies to enable them to produce while respecting human health and the environment, preventing risk and complying with moral and ethical principles.

The NanoCube project,co- coordinated by Archa  develops innovative technologies aimed at producing nanocapsules and nanosystems providing controlled release of bioactive agents for cosmetic and biomedical applications. Partners include research organizations, cosmetic producers, hospitals, a company developing the production equipment and a private research centre.

The specific products of NanoCube include:

• A dermocosmetic (detergency) product, providing innovative and more effective ways of using a natural active substance for antimicrobial action. The system has manifold advantages: reduce the risks for workers and users in handling and using the active substance, reduce the use of active substances compared to conventional treatments, improve the efficiency of the final product.
• A bioactive 3D nanostructured patch for chronic lesions care, using a complex nanostructure surface to improve adherence with skin and nano-capsules for the controlled releases of active substances. The product is expected to improve efficacy of the healing and tissue regeneration processes in case of chronic derma lesions and in the long term to reduce costs correlated to lesion care. The expected time to market is in the medium term.

The Challenge

The key challenge for this pilot was:  how to address ethical and social issues are addressed along the R&D pathway? This  includes: precautionary approach in the risk management of nanomaterials, research ethics (research activities on humans, replacing and reducing animal testing), addressing specific ethical values in product development (in line with demanding ethical certifications for natural and organic cosmetics), address issues of risk perception, and user acceptability in relation with nanotechnologies.

Another challenge is: how could acceptability of the final product be ensured considering public risk perception of nanotechnologies (in particular cosmetics)? How are the concerns of distributors and certification bodies in using new technologies linked to uncertainties in terms of risks, public concern and regulatory development? How can the scepticism of users/customers of green and natural cosmetics regarding the use of new technologies could be addressed?

Results

Values

Reflection with the company and dialogue with stakeholders helped to identify the most relevant values to pursue for NanoCube products:

• Product efficacy: the added value, beyond existing product benchmarks, provided by the new technology (in terms of advantages given by nano-capsules for the controlled releasSafety of the product, and nanomaterials in particular: ensuring safe use of nanomaterials all along the product life cycle
• Natural ingredients: product based on the use of natural substance, and without the use of chemical solvents
• Improvement of quality and shelf life (dermo-cosmetic product)
• >Highly efficient lesion care, with no side effects (medical device)
• Efficient and safe production system for nanocapsules
• Accessible/affordable cost of the final product
• Compliance with sustainability and business ethics principles, including in particular respect for workers’ rights, ethics in supplying of raw materials, reduced environmental impact in processing and production.

Safe by design

So, how should safety of nanomaterials be addressed during the development process and all along the life cycle, considering the existing debate (and related uncertainties) in methodologies for testing, classification and future regulatory developments of nanomaterials?

A safe by design approach has been considered in NanoCube and it should be further sustained. This includes a precautionary approach in selection, design and functionalization of ingredients of the product; consideration of the state of the art practices and standards (beyond normative requirements) for the characterization, measurement and safety testing of nanomaterials.

The computational pre-screening techniques and in-vitro approaches already considered by NanoCube have been identified as valuable to this end. Further insights are needed to ensure a full assessment of potential exposure to nanomaterials during the production of nano-capsules, and regarding the end of life of the product.

Standards and guidance developed by OECD on nanomaterials, use of control banding approaches for safety of NM in occupational settings, expert advice, continuous update on regulatory developments are also  among the tools identified to this end.

At the process level, the advice has been to integrate safety procedures for nanomaterials developed within NanoCube in the usual risk management and quality procedures used by the company (in line with the above mentioned certifications). This might include indication for researchers to implement safe by design approaches, procedures for safe handling of nanomaterials in the workplace, indication for end of life management of nano-related products. Control banding tools for safety of nanomaterials (such as the ones in the PRISMA- RRI toolkit) might be considered to this end.

At the product level, the explicit consideration of aspects related to nanomaterials (e.g. application of the precautionary principle in selection of formulations; implementation of best practices for safety, etc.) within existing certification mechanisms could be pursued.

(Ethical) acceptability and societal desirability of products

Key aspects include the development of a communication strategy, with a focus on the use of nanomaterials, and ensure that product claims are supported by scientific evidence (through data from testing activities). Specific criteria to take into account for communication along the supply chain and to consumers include:

• Distinguishing between use of ingredients (including nanomaterials) based on natural substances (molecules non modified with respect to the natural molecules) and synthetic substances
• Highlighting improvements in durability and efficacy of the product, achieved thanks to the use of nanotechnologies.
• Providing indication on the safe use of nanomaterials during production, use and disposal
• Ensuring transparent and sound communication, based on scientific evidence, of information on product characteristics, including use of nanotechnologies.

In order to ensure acceptability of the final products, the communication strategy should be enriched by regular dialogue (co-creation) on the product development with stakeholders, in particular, developers, producers, certification bodies, distributors of the cosmetic products. This dialogue, started during the PRISMA- project, should continue all along the product development phases.

Roadmap