Authors: Arantxa Ballesteros, Raúl Díaz, ITENE
Why it is so important to consider safety aspects during the development of new products?
Ensuring safety during the development of new products, particularly those involving innovative nano-enabled bio-based materials and polymer bionanocomposites, is crucial for several reasons. At the forefront is the commitment to human and environmental health, alongside the necessity to meet stringent safety regulations—a fundamental prerequisite for introducing new products to the market. In response, BioNanoPolys offers a suite of specialized services tailored to the unique requirements of each project. These services are designed to identify and address any potential challenges throughout the product’s life cycle, ensuring safety and compliance from conception to disposal.
Our approach to implementing safety measures adheres to established European guidelines for nanosafety assessments and follows the EC’s recommendations for creating products that are safe and sustainable by design (SSbD). This comprehensive strategy encompasses hazard profiling to assess the potential impact of new bionanomaterials, thorough exposure assessments, and diligent risk management practices. Additionally, we ensure regulatory compliance for products intended for food contact and cosmetics by conducting precise testing to fulfill these specific standards.
How can we assess safety?
Assessing safety involves a thorough two-step process:
Hazard Profiling Assessment: This first step utilizes a comprehensive set of experimental in vitro tests, aligned with OECD guidelines for chemical testing and specific recommendations for nanomaterials. The goal is to evaluate potential impacts on both human and environmental health. For human health, we employ representative human cell lines to simulate the main routes of exposure, assessing their effects on cell function, viability, DNA, and potential inflammatory responses. For environmental health, bioassays are performed to examine the acute effects on aquatic organisms, providing a holistic view of the potential hazards.
Risk Assessment and Risk Management: The second step focuses on both assessing and managing risks, particularly concerning occupational exposure. This involves three key actions:
- Identification of Occupational Exposure Scenarios: We start by pinpointing potential emission or release sources in workplace environments, mapping out scenarios where exposure could occur.
- Experimental Characterization of Exposure: Through real-time analysis conducted directly at industrial sites, we characterize potential exposure to nanoparticles, including their number concentration, size distribution, and surface area. This detailed profiling helps in understanding the exposure level during critical tasks.
- Implementing Risk Management Measures: We define and apply stringent risk management strategies to mitigate risks throughout the entire life cycle of engineered nanomaterials (ENMs) and nano-enabled products (NEPs). This includes evaluating personal protective equipment and engineering controls for their effectiveness in reducing particle penetration and ensuring particle removal efficiency.
By systematically addressing these components, we ensure a comprehensive safety assessment that not only identifies risks but also provides effective strategies for risk management, safeguarding human health and the environment.
How does the BioNanoPolys project ensure its developments are suitable for food contact applications?
The BioNanoPolys project is dedicated to developing safe additives and materials suitable for food contact. This commitment is grounded in strict adherence to European legislation, particularly Regulation (EC) No. 1935/2004. This regulation mandates that materials and articles coming into contact with food must not compromise human health, alter the composition of the food, or degrade its taste and smell under normal use conditions. Ensuring this level of safety requires manufacturing practices that prevent any harmful constituents from transferring to food in significant amounts.
To align with these requirements, the project specifically follows the guidelines set out for various materials, including plastics, as outlined in Regulation (EU) No. 10/2011. This detailed regulation covers all plastic materials intended for food contact, setting standards for their composition, safety, and the requirement for a declaration of conformity, ensuring that all used substances are listed in the Union List (Annex I of the Plastics Regulation).
For non-plastic materials, such as paper and board, which the BioNanoPolys project also explores, there isn’t a unified European legislation. However, these materials must still demonstrate their safety for food contact purposes. Various national legislations and industry guidelines within the EU provide frameworks for assessing the safety of paper and board, such as the German Recommendations (BfR XXXVI) for paper and board intended for food contact and the French national legislation (Fiche MCDA n°4) concerning organic materials based on plant fibers for foodstuffs.
These guidelines universally emphasize the importance of using substances that have been evaluated and approved for safe use, conducting thorough tests for any potential migration of substances, and adhering to good manufacturing practices (GMP). Through these rigorous standards and practices, the BioNanoPolys project ensures the development of food contact materials that are safe, compliant, and uphold the highest quality and safety standards.
How to ensure the safety of cosmetic packaging developed in the framework of the BioNanoPolys project
Ensuring the safety of cosmetic packaging aligns with the rigorous standards set by the EU Cosmetics Regulation (EC) No. 1223/2009. This regulation stipulates that all cosmetic products introduced to the market must not pose any harm to human health under normal or foreseeable conditions of use. Achieving this level of safety necessitates that the packaging materials not only be safe but also fully compatible with the cosmetic formulations they contain.
To fulfill these requirements, the BioNanoPolys project follows the guidelines for materials intended for food contact, leveraging this framework to guarantee the safety and inertness of cosmetic packaging. This approach ensures that the packaging materials are devoid of any banned or restricted substances outlined in the relevant cosmetic legislation. Additionally, the project adheres to the REACH Regulation, specifically avoiding Substances of Very High Concern (SVHC), heavy metals, and carcinogenic, mutagenic, or reprotoxic (CMR) substances as mandated by Regulation 1272/2008/EC. Through this comprehensive compliance strategy, the BioNanoPolys project upholds the highest safety standards for cosmetic packaging, safeguarding both product integrity and consumer health.
Nanomaterials and their use in food packaging and cosmetic applications
The use of nanomaterials in food packaging and cosmetics presents unique challenges due to their distinct chemical and physical characteristics, which can differ significantly from their larger-scale counterparts, potentially altering their toxicological profiles. Consequently, the standard risk assessments for substances based on their conventional particle sizes are not sufficient for engineered nanoparticles. This necessitates a detailed, case-by-case risk assessment process overseen by the European Food Safety Authority (EFSA), culminating in an authorization and listing of the nanoform substance for use in material and product formulations.
Within the scope of the BioNanoPolys project, we offer specialized services focused on navigating the complex landscape of European regulations for food contact materials (FCM) and cosmetic packaging. Our approach includes comprehensive conformity assessments of the materials we develop, detailed risk analyses tailored to each case, evaluations of substance migration, checks for non-intentionally added substances (NIAS), and overall risk assessments tailored to the specific end-use of the material. This holistic methodology ensures that nanomaterials used in our project are not only innovative but also safe and compliant with the highest regulatory standards.
Foto von Alena Shekhovtcova