By: Christopher Thelen | Regulatory Coordinator at M. Holland
In Douglas Adams’s classic book The Hitchhiker’s Guide to the Galaxy, the Guide is noted to have been created with the words “Don’t Panic” emblazoned on the cover.
Those words come to mind as the latest update to the European RoHS (or “Restriction of Hazardous Substances”) directive were recently announced; EU 2015/863 (or, the latest legislative iteration of RoHS) will restrict the use of four phthalates in the European Union:
– Bis(2-ethylhexyl) phthalate (DEHP), threshold level of 0.1%
– Butyl benzyl phthalate (BBP), threshold level of 0.1%
– Dibutyl phthalate (DBP), threshold level of 0.1%
– Diisobutyl phthalate (DIBP), threshold level of 0.1%
How Are Phthalates Used in Plastic?
Phthalates are plasticizers that are almost exclusively used in the modification of flexible PVC though they can be a component of some catalyst systems. And while all plastic manufacturers will have to issue new RoHS statements reflecting the legislation change, the actual impact should be minimal – since all four of these substances are already controlled by other legislation.
Specifically, DEHP, DBP and BBP were added to the candidate list for Substances of Very High Concern (SVHC) in 2008; DIBP made the SVHC list in 2010. In addition, DEHP, BBP and DBP are on the California Proposition 65 list.
For those not familiar with the “alphabet soup of regulation,” SVHC is the portion of the European REACH legislation that most affects thermoplastics; REACH is an acronym for “Registration, Evaluation, Authorisation and Restriction of Chemicals,” which requires the registration of substances being manufactured in or imported into the European Union.
This doesn’t necessarily mean that materials are all free from these substances – a statement on one grade of polypropylene shows that, as residuals from the catalyst system and manufacturing process, trace amounts of DBP and DIBP may be present.
How Does New RoHS Regulations Affect Resin Manufacturers and Buyers?
As regulations continue to tighten around the world, resin manufacturers are reviewing their manufacturing processes to see how even these trace amounts can be completely eliminated. But any current presence of these substances does not mean they have been used in the formulation of the resins, and the trace amounts will be well below the threshold limits established. Most manufacturers will state that, because these substances are not intentionally added when the resins are formulated, they don’t test for their presence.
Until manufacturers of resins issue updated statements referencing the new annex legislation number, statements regarding any possible use of phthalates (or an absence declaration for SVHC) should ease concerns about the impending change. For any branded prime resins purchased from M. Holland that you may have concerns about, we will be happy to provide you with such declarations.
The provisions in EU 2015/863 go into effect on July 22, 2019.
M. Holland Account Managers can provide you with updated documentation on materials that you are currently purchasing.
Please note that resin manufacturers are in the process of updating their regulatory documentation as well, and there may be delays in providing some letters.