OptiNanoPro PU Deliverable 1.4

H2020 – NMP PILOT 02

Integration of novel nano materials into

existing production lines

Title: Processing and control of novel nanomaterials in packaging, automotive

and solar panel processing lines

Acronym: OptiNanoPro

Grant Agreement No: 686116

Deliverable 1.4 Safety-by-Design Protocol

Associated WP WP1

Associated Task(s) Task 1.4 – Implementation of a safe-by-design approach

Due Date 29/02/2016

Date Delivered 26/02/2016

Prepared by

(Lead Partner)

IOM

Partners involved IRIS, OWS

Authors Steve Hankin, Sheona Read, Craig Poland (IOM)

Kamila Mascart, Lasse Six (OWS)

Dissemination Level PU

OptiNanoPro PU Deliverable 1.4

© European Communities, 2016.

The information and views set out in this publication are those of the author(s) and do

not necessarily reflect the official opinion of the European Communities. Neither the

European Union institutions and bodies nor any person acting on their behalf may be

held responsible for the use, which may be made of the information contained

therein.

OptiNanoPro PU Deliverable 1.4

Page I of I

Publishable Executive Summary

Safety by design is an ethos rather than a specific procedure as it can be used in a diverse range of

industries or activities from planning a maintenance project in the railway industry or surgical

procedure to developing a toothpaste or new particle. Fundamentally, the Safe by Design process

could be seen to consist of three main common elements of i) identify, ii) evaluate, and iii) mitigate.

The initial action is to identify possible risks such as emissions of hazardous materials in a process.

This part of the process involves the consideration of both hazards and exposures to determine the

nature of the risk as well as possible routes to mitigation. The next step is to evaluate the identified

risks by considering the nature of severity of the risk to determine if it is an acceptable risk or if it

needs to be addressed and what the options of for addressing the risk are. The final step is to

implement outcome of the evaluation such as sealing a process or perhaps switching to a less

hazardous material in a product, etc. This activity is continuous as demonstrated by the feedback

arrow in the diagram above and the item under consideration (e.g. material, process, plan etc.)

should be re-considered to understand if the mitigation strategy is effective or if perhaps it has

resulted in unintended negative consequences. Another common attribute to the Safe by Design

ethos is that it should encompass the whole life cycle from conception to completion. In terms of a

product this would include the raw materials used, the processes involved in production, its use (and

potentially miss-use) by consumers, and finally its disposal or recycling. Nanotechnology through its

focus on design and modification to develop materials that are ‘engineered’, offers a level of control

in designing out potential issues not seen with other materials and therefore provides an ideal

subject for SbD.

The aim of this document is to provide guidance on the application of SbD in the development of

products utilising nanotechnology. The first step is to establish the regulatory requirements

surrounding the product area of interest, as these will outline the minimum safety requirements

including any reporting requirements that need to be adhered to. In addition, understanding the

regulatory framework also helps the making of correct decisions elsewhere in the process, for

example if further testing is required for hazard analysis, what approaches to take. The next step is

to consider safety by considering the various parts of the design process. The first is process safety

and this can include development and production issues such as nanoparticle release resulting in

exposure or hazardous machinery. Process safety is followed by material safety, which considers the

safety of any materials handled based on their intrinsic toxicities and potential exposures. This

protocol focuses on nanomaterials but other materials such as solvents etc. would equally need to be

addressed through normal risk assessment procedures such as the control of substances hazardous

to health (COSHH) in their various forms adopted in Europe and around the world. After

consideration of safety involving the process and materials, the next step is to consider the safety of

the overall product, which must align with relevant regulatory requirements (as established in step 1)

in order to be released onto the market. These steps are not a single isolated event in the product

chain and should be applied across the life cycle of a product where it will consider the relevant risks

during development, production, use and disposal. This is because risks may change at different

points across the life cycle. In summary, this protocol recommends a series of logical steps during

which potential issues can be identified, evaluated and mitigated in light of the regulatory

requirements that form the basis of safe product design.