Project #646221, Funded by the Horizon 2020 Framework Programme of the European Union

Safe by Design Safe Innovation Approach

Cornelle Noorlander (RIVM)

Innovation

Safe

Approach

Consortium meeting Paris, February 2019

Why do we need a Safe Innovation Approach?§ Technology and innovation are advancing at a dynamic

speed and in numbers§ Uncertain risks are a growing concern

§ How can we get insight on safety?§ How to balance safety and innovation?

Improved innovation process to come to safe products in an efficient manner

Why do we need a Safe Innovation Approach?

Ingredients for an improved innovation process leading to safe(r) products

1. Ideally safety should be addressed early in the innovation process onwards

2. This can only be achieved if industry and regulators come into dialogue and share knowledge about safety information needs, and

3. If regulators are aware and prepared for innovations

Basis for the Safe Innovation Approach

What is the Safe Innovation Approach?

SIA can be seen as proactive approach both from industry and regulatory perspective where safety of innovations are effectively addressed

What are the potential benefits of SIA?

§ Safer products

§ Reduced time required for R&D

§ More cost-effective innovation

§ Shorter time to market

§ Ready for future regulatory changes

§ Better consumer acceptance

SIA Framework

, a practical SIA can be achieved

Operational SIA frameworkFrom exploration towards implementation

Exploration and Awareness SIA Methodology Implementation. . .

• SIA video• SbD training• SbD workshops• SbD webinars • RP workshop• BIORIMA

training courses

• Nanomaterial Science Spring School: lecture and workshop

• OECD SIA project

• SbD and RP embedded in governance andbusiness models

• SbD scenarios• SbD implementation platform• SIA Toolbox• NR2 database user guidance

• Safe Innovation Guidance manual

• Trusted environment• RP infrastructure

From exploration towards implementation

Exploration and Awareness SIA Methodology Implementation. . .

• SIA video• SbD training• SbD workshops• SbD webinars • RP workshop• BIORIMA

training courses

• Nanomaterial Science Spring School: lecture and workshop

• OECD SIA project

• SbD and RP embedded in governance andbusiness models

• SbD scenarios• SbD implementation platform• SIA Toolbox• NR2 database user guidance

• Safe Innovation Guidance manual

• Trusted environment• RP infrastructure

SbD Scenarios

§ The SbD scenarios provide a general guide for SbD implementation and provide transparency of action perspectives.

§ They bring the SbD concept of reducing uncertainties, health and environmental risks, and the management of potential risks, into more practical use.

§ The SbD scenarios might help all the stakeholders involved with SbD(innovators, manufacturers, suppliers, regulators, policy makers, etc) with the application and communication of SbD.

§ 5 scenarios:– Scenario 0: regulatory compliance– Scenario 1: reduced uncertainty by collecting nano-specific information – Scenario 2: reduced nano-specific exposure – Scenario 3: reduced nano-specific hazard – Scenario 4: reduced nano-specific hazard and exposure

SbD case studies illustrating the SbD scenarios Case Study Start Level Safety Element:

Uncertainty

Is nano-specific information collected?

Safety Element: Hazard

Is nano-specific hazard considered?

Safety Element:

Exposure

Is nano-specific exposure information collected?

Safety Element:

Exposure

Is nano-specific exposure controlled?

End Level

Avanzare Scenario 0: Regulatory compliance

Yes Yes, but no measures for reduction

Yes Yes, synthesis in wet phase with no liquid waste

Scenario 2

NANOGAP

Scenario 0: Regulatory compliance

Yes Yes, but no measures for reduction

Yes Yes, change in synthesis to reduce fibres in waste

Scenario 2

Grupo Antolín Scenario 0: Regulatory compliance

Yes Yes, but no measures for reduction

Yes Yes, measures taken for reduction.

Scenario 2

NANOMAKERS Scenario 1: MNM toxicity information collected

Yes Yes, selected MNM with reduced toxicity

Yes No Scenario 3

HiQ-nano Scenario 0: Regulatory compliance

Yes Yes, selection of alternative with lower toxicity

Yes No Scenario 3

NANO-COMPOSIX

Scenario 0: Regulatory compliance

Yes Yes, measures taken for reduction

Yes No Scenario 3

Safe Innovation Guidance Manual§ Safe Innovation Guidance Manual describes the information needed to

support “go” or “no go” decisions during development of NMs in each phase of the stage gate innovation model

§ Balancing safety and functionality and implement SbD actions– Functionality, comprising the use-oriented properties of the NM or nanoproduct that

are directly derived from the identity of the used NM and its corresponding application

– Safety aspects related to potential risks connected with the envisaged NM/nanoproduct throughout its whole life-cycle

– SbD actions can be taken aimed at improving safety while maintaining functionality

Functionality aspects Safety aspects

1) Which use-oriented properties are needed to fulfil the requirements of the envisaged application? Which NMs show these properties? How is their identity defined?

1a) Is it a NM?

1b) Does it look like asbestos (HARN)?

1c) Is it persistent?

2) Which use-oriented properties does the envisaged NM exhibit? Which applications are enabled by use of this NM? What are existing applications for the chosen NM?

2) Which routes of exposure can be expected?

3) In what form can it be used for the envisaged application? Does it have to be modified? Which steps have to be performed to produce the envisaged NM/nanoproduct? In which form will it be marketed?

3) How are the chemical components of the (pristine) NM labeled? Are there any restrictions?

4) Which types of exposure and release scenarios can be expected?

4) What amounts of the NM are needed for the application(s)?

5) What is the toxicity of the (pristine) NM or similar (N)Ms

Safe Innovation Guidance ManualExample of guidance in stage 2

• definition of the identity, functionality, and application field with the help of existing data (literature, databases).

• identification of safety aspects (hazard and exposure) related to the NMs and/or nanoproducts with the help of existing data (literature, databases). The use of qualitative tools to assess risk may be introduced at this point (e.g. control banding tools).

identification of potential SbD actions, based on the available information and suitable to design out hazard or to avoid release and exposure

SbD Implementation Platform-

Input project information

Parameters and information

Direct link tocategories

Web-based platform which helps innovators implementing SbD

following the stage-gate innovation model

• Structured approach based on project phases/gates

• Safety regulatory requirements per phase – Safety Dossier

• Guidance/tools to address needs

• Final Safety Profile for Go/no Go decision making

• Available for NanoReg2 https://temas.taglab.ch/SbDimplementation/index.php

Outputs SbD Implementation Platform-

Go/no Go criteriaComparison of project data points vs standard thresholds

Risk assessmentEarly phases – Overlay of safety results from 3 qualitative RA tools

Innovation processes for materials and products

Phase 1 Phase 2 Phase 3 Phase 4

SbDOK

NO

SbDOK

NO

SbDOK

NO

SbD

NO

EnvironmentWorker

Consumer

Carcinogenicity

BasicToxicokinetics

DermalAbsorption

SIA ToolboxThe SIA Toolbox is a coherent set of tools and guidanceto be used by various actors along the innovation chain.

The selection of tools was based on several criteria:§ A tool must be nanospecific or nano-applicable§ The tool supports SbD or RP§ The tool addresses at least one part of the ‘risk-benefit-cost-triangle’

NR2 database user guidance which serves as a guidance to retrieve data from the NR2 database for the input parameters (i.e. physicochemical, toxicological, eco-toxicological, exposure and environmental fate related) of the tools in the SIA toolbox

www.siatoolbox.com

SIA Toolbox: filter system

Trusted Environment

What is a TE?A physical or virtual environment in which industry, universities and other research institutes (innovators) and (semi-)governments (regulators) can openly share and exchange knowledge, information and views on new technologies, such as innovative NMs and nano-enabled products

Engagement of various stakeholders, including fundamental researchers, market players, regulators and policy makers is needed for knowledge sharing and exchanging information about recent developments.

Graphical representation of how a TE can be applied in a knowledge sharing system

Trusted Environment

Conclusions from survey

A TE is needed to support safe information exchange between innovators and regulators during the innovation process

The most valuable aspect of the TE is to facilitate informal knowledge and information exchange on specific issues during the innovation process

Overall assessment of the trusted environment blueprint

Regulatory Preparedness- International regulators workshop hosted by JRC (2017)

- Objective of the workshop was to have open discussions with various regulatory bodies about the regulatory challenges with regards to new nanotechnology innovations including:– Gather views on RP concept– Awareness and consensus for the need for RP– Insight on current practices in regulatory work on safety of innovative products– Identify the potential tools needed to achieve RP– Gaining insight on the incentives and barriers surrounding RP

Proposal of a future proof RP framework

Summary of SIA methodology

Exploration and Awareness SIA Methodology Implementation. . .

• SIA video• SbD training• SbD workshops• SbD webinars • RP workshop• BIORIMA

training courses

• Nanomaterial Science Spring School: lecture and workshop

• OECD SIA project

• SbD and RP embedded in governance andbusiness models

• SbD scenarios• SbD implementation platform• SIA Toolbox• NR2 database user guidance

• Safe Innovation Guidance manual

• Trusted environment• RP infrastructure

Safe Innovation Approachfrom ideas towards implementation

NANoREG

SbD concept

Toolbox/platform

TE

RP concept

SbD scenarios

Prosafe

Thanks to all consortium partners!