Dr Michela Kahlberg of Kahlberg Consulting and Dr Monica Locatelli of Team Mastery look at a complex emerging challenge under EU chemical legislation
How to prepare for polymers in REACH
Dr Michela Kahlberg of Kahlberg Consulting and Dr Monica Locatelli of Team Mastery look at a complex emerging challenge under EU chemical legislation
The European Commission ’ s planned REACH revision will take place in Q4 2023 , including polymers . Among the anticipated changes are the amendment of relevant articles in the registration chapter and the addition of a new annex for requirements applicable to polymers . This will include :
• Information to be submitted at notification
• Criteria for identifying polymers requiring registration ( PRRs )
• Placeholder for criteria for grouping of PRRs or via guidance
• Placeholder for information to be submitted at registration At a Chemical Watch conference in April , DG Environment policy officer
Table 1 – Purposes of notification process
1 + 2 : Information for authorities ( 1 ) & the public ( 2 ) as to how many PLC / PRR / non-PRR / precursors are marketed and which polymer has which status
3 : Information for companies to facilitate forming of joint registrations and eventually grouping PRRs for registration
4 : Information for authorities to check process conditions linked with precursor status
5 : Information for authorities to check conclusion on PLC or non-PRR status in case of concern arising on the polymer in question
Katrin Schütte gave a glimpse of the EC ’ s thinking on several elements of the plan . The proposal will contain basic provisions for polymers but the specific information requirements will probably not be part of it . Instead , this would be included in the annex , which the EC will amend via the comitology process “ some years later ”.
The deadlines and transition periods will be set based on the type of polymer , measured by molecular weight ( MW ) and bioavailability , as follows :
• Type 1 - < 1,000 Da , potentially bioavailable
• Type 2 - ≥1,000 - < 10,000 Da , moderately bioavailable
• Type 3 - ≥10,000 Da , reduced bioavailability
• Listing CAS ( or IUPAC ) names and numbers per legal entity
• Notifying the result of PLC / PRR assessment to the extent already known
• Does not necessarily require a specific name
• Listing CAS ( or IUPAC ) names and numbers ( chemistry ), including structural qualifiers as applicable
• Database with additional information on which criteria ( possibly ) trigger PRR status
• Enables companies to identify possible partners and initiate further joint activities , without compromising confidential information
• Clearly flagging precursors as such
• Justification for how the process conditions fulfil adequate control criteria to be included in notification
• Listing conclusion on each individual PRR criterion . Any polymer having been notified in the first submission with PRR criteria information ‘ yet to be determined ’, will require a second submission with a definitive yes / no
• Base for authorities to request evidence in case of concern arising on a polymer
Assuming publication in November- December 2023 , the revised requirements would potentially enter into force in 2026-7 , with notification in 2029-30 . There would be a first registration deadline for Type 1 PRRs in 2034-5 and a second for Types 2 and 3 in 2038-9 .
The number of polymers on the EU market is estimated to be around 200,000 . Focusing on PRRs means registering about 30,000 . In this context , it might be useful to look at the current limitations on animal testing and risk management of polymers in groups .
The thorniest issue will undoubtedly be what ‘ one polymer ’ actually is . Substance identification will not be a trivial matter , so the six years to the first notification deadline is not too far away . Companies need to start thinking about this now .
Notification
Notification to ECHA of any polymers produced in or imported into the EU will be the first step to be implemented . Table 1 shows the various purposes of the process and how they will be fulfilled . All polymers , regardless of volume consumption , will be assessed as PPR or non- PRR against the criteria along an established decision tree ( Figure 1 ).
Polymers that are produced solely as precursors and handled like an intermediate under strictly controlled conditions ( SCCs ) to produce other polymers or articles are non-PRRs and exempt from registration . Those
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