REGULATORY & COMPLIANCE
Figure 2 - CF4Polymers
Grouping several polymers under the same name means providing a registration dossier with a dataset that covers all the members . A first screening for toxicological effects would look at the properties of monomers impacting bioavailability , both structural ( monomers , RFG , and molecular volume and dimension ) and phys-chem properties ( solubility & extractability in water and solvents , pH and rheology ).
Before starting discussions , you need to work out the relevant amount of information needed . The second step is testing , at least for analytical and some phys-chem properties , before deciding which group is applicable , in order to optimise the high-tier studies to be performed . These may include :
• GPC or MALDI-TOF for molecular weight and oligomers
• HPLC for residual monomers
• Surface tension , if applicable
• Viscosity or rheology , depending on the polymer
• Bioavailability , based on logKow , water-solubility or extractables Shared work and investments should be shared and organised in advance in order to save money and time . Kahlberg ’ s suggested to-do list begins with making an inventory of your polymers , becoming confident with the criteria and starting analytics . From there you can develop ad hoc methods , then start evaluating your budgets before initiating cooperation with suppliers and competitors . The typical cost for a first screening is € 2,000-10,000 / molecule .
Reference : 1 : https :// www . legislation . gov . au / Details / F2019L01543 https :// www . industrialchemicals . gov . au / help-and-guides / polymer-low-concernplccriteria # polyesters
Software available
Dedicated software is essential for managing the process of polymers under REACH . It enables companies to store all the necessary information in one place , and it can help in making calculations and applying criteria for PRR , grouping , identification and communication . Finally , it can be used to transmit data into other systems like IUCLID without the need to write it out all over again .
One example is Kahlberg ’ s DB REACH Polymers . This includes all the necessary information at a glance : MWs , PRR criteria , reactive groups , phys-chem properties , notification grouping , FGEWs , monomers and analytics . To ensure data confidentiality and protection , the software has a centralised part , in order to be updated as legislation evolves , but each company has its own application and its own data remain private and confidential .
Subject to agreement , users can share selected data with Kahlberg in order to facilitate communication and grouping creation and the company will work with ECHA in order to agree on a format for sending the data in bulk extracted directly from the software .
A licence to use the software will be granted free of charge to those companies that sign the preconsortium agreement and then join the Polymer REACH consortium Kahlberg is creating . The consortium should start by the end of this year to start working together as soon as possible . ●
Michela Kahlberg
CEO
KAHLBERG CONSULTING k + 39 02 6700 319 J michela . kahlberg @ kahlbergconsulting . com j www . kahlbergconsulting . com
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