REGULATION & COMPLIANCE
SSbD & SIA
Is it possible to reach a point where substitution is no longer required ? If products , processes and services incorporate safety and sustainability throughout their development lifecycle , it may be possible to achieve this . There are two novel concepts that can contribute towards this goal .
The Safe and Sustainable by Design ( SSbD ) concept is a core part of the EU ’ s Chemical Strategy for Sustainability ( CSS ). In this , ‘ safe ’ refers to the absence of unacceptable risk for humans and the environment and ‘ sustainable ’ refers to the ability of a chemical ( a material , product or service ) to deliver its function without exceeding environmental and ecological boundaries along its entire life cycle , while providing welfare and socioeconomic benefits .
The SSbD concept ( Figure 2 ) is an expansion of the existing Safe by Design concept that aims to incorporate several other fields , including green chemistry , risk assessment , life cycle assessment , and green engineering . By contrast , the Safe Innovative Approach ( SIA ) consists of two main concepts : Safe ( r ) -by-Design and Regulatory Preparedness . Safe ( r ) -by- Design incorporates :
• Safer materials : Minimising possible hazardous properties of the material in the R & D phase while maintaining function
• Safer production : Ensuring industrial safety during the manufacturing process
• Safer use & end of life : Minimising exposure and adverse effects through the life cycle , recycling and disposal Regulatory preparedness refers to the capacity of regulators to anticipate regulatory challenges for emerging technologies . Becoming aware of these early will allow for regulatory tools to
Figure 2 - Safe & Sustainable by Design criteria
be developed or modified as needed . This allows for new materials to undergo suitable safety assessment prior to entering the market .
Upcoming changes
There are several proposed changes in the pipeline related to the substitution principle , which have been prompted by the EU ’ s CSS . This aims to boost innovation for safe and sustainable chemicals with specific actions around banning the most harmful chemicals and promoting the concept of SSbD .
Specific actions have been targeted for the Authorisation portion of the REACH Regulation . Historically , this has been considered to be meeting its objectives , but issues have been raised around a lack of efficiency and a high administrative burden . Three options have been proposed2 : 1 . Continue : Maintain and simplify the existing Authorisation process 2 . Merge : Combine the Authorisation and Restriction processes 3 . Abolish : Remove the Authorisation process Various opinions exist regarding the three options . The simplification considered under Option 1 is considered to be necessary , especially for SMEs . Option 2 can offer the potential of a lower administrative burden through the merged process , but this should not exacerbate any ongoing issues . Option 3 is perceived to be radical and may undermine the overall goal of protecting human health and the environment . These changes are continuing to be discussed by the European Commission ( EC ) and relevant stakeholders .
The Competent Authorities for REACH and CLP ( CARACAL ) is an expert group advising the EC and the European Chemicals Agency ( ECHA ) consisting of representatives from Member States competent authorities , observers from non-EU countries , international organisations and other stakeholders . 3
CARACAL meetings discuss the planning and implementation actions required under the CSS and cover a wide range of topics including changes to REACH , CLP and substance-specific topics , such as polymers , endocrine disruptors , and nanomaterials and nanoforms .
Conclusion
The challenge of substitution has a long and troubled history within modern day chemical regulation . Moving forward , the EC has plans to amend how the substitution principle will be applied in regulation with the goal to make substitution projects more efficient and less burdensome . In parallel we can see that there is also a trend to consider approaches where substitution can be avoided altogether . ●
Elisabeth Luther
PRINCIPAL - SUSTAINABILITY & KNOWLEDGE TRANSFER
References 1 : CEFIC Paper on Substitution and Authorisation under REACH , 2005 , 1 – 3 2 : Competent Authorities for REACH and CLP ( CARACAL ) documents : March 2021-August 2022 3 : https :// ec . europa . eu / environment / chemicals / reach / competent _ authorities _ en . htm , accessed March 2023
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YORDAS GROUP e . luther @ yordasgroup . com www . yordasgroup . com / sustainability
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