A whole new class of emerging and advanced materials are increasingly being developed and brought into our lives. They are designed for a variety of sectors, from renewable energy to healthcare and offer new or enhanced properties that benefit the economy and society. Many of these materials possess an additional complexity, e.g. a new or enhanced functionality and/or multiple components which may lead to further challenges compared to other chemicals. These materials are also being developed at such a rapid pace that a gap can arise between technological innovations and the development of suitable risk assessment tools and frameworks.
There is a need for a change of mindset to ensure that newly developed materials combine safety and sustainability from the innovation phase. SSIA proposes a systematic and comprehensive approach that considers sustainability aspects hand in hand with safety considerations very early on at the material design stage.
A way to minimise this gap is for industry to reduce uncertainties and risks to human and environmental safety, starting at an early phase of the innovation process and covering the whole innovation value chain (or life cycle for product development) (the ‘Safe(r) and Sustainable -by-Design’ concept, SSbD); and for regulators to anticipate the regulatory challenges posed by innovations, their applications and potential safety issues (Regulatory Preparedness, RP). SSbD and RP require a dialogue between innovators and regulators at the early stage, which is supported by Trusted Environment (TE). These three distinct components form the Safe(r) and Sustainable Innovation Approach (SSIA).
The Safe and Sustainable Innovation Approach (SSIA) seeks to enhance the ability of all stakeholders to address the safety and sustainability assessment of innovations in a robust yet agile manner. SSIA aims at reducing the time gap between the emergence of technological innovations and the development of suitable risk assessment tools and frameworks. SSIA combines:
Both SSbD and RP concepts are supported by a process to share and exchange knowledge, information and views in a Trusted Environment (TE). SSIA thus relies on dialogue between innovators and regulators.
Safe-and-Sustainable-by-Design (SSbD) can be described as an approach that focuses on providing a function (or service), while avoiding onerous environmental footprints and chemical properties that may be harmful to human health or the environment. In essence, the SSbD approach aims to identifying and minimising, at an early phase of the innovation process, the impacts concerning safety for humans and the environment and for sustainability, minimising the environmental footprint, regarding climate change and resource use and, protecting ecosystems and biodiversity, taking a lifecycle perspective. The SSbD approach addresses the safety and sustainability of the material/ chemical/ product and associated processes along the different phases of a whole life cycle, including all the steps of the research and development (R&D) phase, production, use, recycling and disposal.
Regulatory Preparedness (RP) empowers regulators and policy makers in order to better anticipate and adapt governance to keep up with the pace of knowledge generation and innovation of nanomaterials, advanced materials and nano-enabled products (i.e., modify and/or develop regulatory tools for risk assessment/risk management decisions). This requires that regulators become aware of and understand innovations sufficiently early to take appropriate action, and that appropriate regulatory tools are modified or developed as needed.
A Trusted Environment (TE) is a physical or virtual space in which industry, innovators, governmental institutions, and other stakeholders can share and exchange knowledge, information, and views on new technologies (e.g., innovative nanomaterials, nano-enabled products, and advanced materials). A TE invites trust by ensuring confidentiality and protecting intellectual property. This dialogue ideally starts at an early stage of the innovation process.
Webinar on Early Awareness and Action System for Advanced Materials (Early4AdMa)
On 4 October, the OECD introduced Early4AdMa, a tool aiming to identify and describe potential safety, sustainability, and regulatory issues of advanced materials at the early stages of their development or use. The approach seeks to strengthen regulatory preparedness and facilitate regulators in making timely decisions to avoid or reduce safety and/or sustainability impacts. Early4AdMa could be implemented in the development, production, use, and end-of-life of safer and more sustainable advanced materials and the products into which they are incorporated. As such, it is considered a pre-regulatory and anticipatory risk governance tool for Advanced Materials.
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Webinar on the Safer and Sustainable Innovation Approach for more sustainable nanomaterials and nano-enabled products
On 3 November 2022, the OECD organised a webinar on the safer and sustainable innovation approach (SSIA) for more sustainable nanomaterials and nano-enabled products.
The Safer and Sustainable Innovation Approach (SSIA) is an approach aiming to boost safer and sustainable innovations by integrating safety and sustainability at an early stage of the design phase of innovative materials, products, applications, and processes. SSIA combines the Safe-and-Sustainable-by-Design (SSbD), Regulatory Preparedness (RP), and Trusted Environment (TE) concepts to identify and minimise sustainability impacts along with potential health and environmental risks in the innovation process. SSIA relies on early dialogue between industry and regulators and is facilitated by a Trusted Environment. SSIA aims to anticipate the regulatory challenges posed by innovative nanomaterials, nano-enabled products, or other advanced materials by minimising the gap between technological innovations and the development of suitable risk assessment tools and frameworks. The aim of this webinar was to increase awareness of this approach and gather inputs from the potential users, such as innovators and regulators, to ensure its applicability. Access the presentation here.
Early4AdMa help users (e.g., regulators) to identify potential issues of an advanced material, related to their safety, sustainability and/ or regulatory needs, at the early stages of its development or use. The document explains the rationale behind and gives instructions for the use of Early4AdMa.
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Early4AdMa help users (e.g., regulators) to identify potential issues of an advanced material, related to their safety, sustainability and/ or regulatory needs, at the early stages of its development or use. This Excel tool accompanies the document Early Awareness and Action System for Advanced Materials (Early4AdMa).
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The purpose of this report is twofold: firstly, to support innovation and ensure that nanomaterials and advanced materials are developed in a safe and sustainable way supported by a circular economy; and secondly to identify and prioritise the elements to be considered for safety and sustainability.
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This report presents common working descriptions to ensure a common understanding of concepts such as: Safe(r) Innovation Approach and its elements, Safe(r)-by-Design and Regulatory Preparedness. It also compiles existing risk assessment tools, frameworks and initiatives developed for Safe(r)-by-Design.
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