The European Delegated Directive (EU) 2015/863 officially adding the four (4) Phthalate substances to the EU RoHS Directive was published today, June 4, 2015. The new phthalate restrictions take effect beginning July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments). Category 8 and 9 products have an additional 2 years and need to comply by July 22, 2021. EEE manufacturers and their suppliers now have just over four years to prepare.
The amendment adds the four phthalates shown below to Annex II (Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials) of the the RoHS Directive . A maximum concentration value of 0.1% w/w in homogeneous material was specified for the phthalates in the amendment.
Four Phthalate Substances to be Added to RoHS Directive
|Substance Name||CAS Number||Maximum Concentration
in homogeneous material
|Bis(2-ethylhexyl) phthalate (DEHP)||117-81-7||0.1%|
|Benzyl butyl phthalate (BBP)||85-68-7||0.1%|
|Dibutyl phthalate (DBP)||84-74-2||0.1%|
|Diisobutyl phthalate (DIBP)||84-69-5||0.1%|
Spare Parts and Cables
The official publication of the amendment was delayed by a few months to allow the European Commission time to add verbiage clarifying the implication on cables and spare parts. This new text aligns with the general RoHS intention to allow products to be repaired using the same parts that were used in the original product when if was first put on the EU market. The published amendment states:
The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
Phthalates in Electrical/Electronic Toys
The amendment is also explicit that the phthalates in toys restriction in Annex XVII of the REACH regulation takes precedence over the maximum concentration levels in the RoHS Directive.
What’s the Impact? How to Proceed?
The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing the parts and materials that require substitution. However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.
In electrical and electronic equipment (EEE), DEHP is generally considered to be the most commonly used of the four phthalates. DBP and BBP also have known applications; whereas DIBP is considered to have minimal usage within the EEE supply chain.
The results of a study published in 2010 at the IPC APEX conference “Where are REACH SVHC in Electronic Products and Parts?” may provide some insight to the use and prevalence of these substances. The study investigated and compiled analytical test results for the initial batch of SVHCs added to the REACH Candidate List (including 3 of the phthalates just added to RoHS). The analytical testing was performed in Asia, North America, and Europe on EEE and materials typically used in EEE. DEHP was detected above the SVHC threshold (0.1% wt/wt in the article) in 64 of 391 testing results (16%). The study was focused on the REACH SVHC threshold which is based on articles. However, had the study considered a concentration threshold based on homogeneous material, the number of products above the threshold would likely have been much higher.
In the time since 2010, many manufacturers that have been trying to eliminate SVHCs from their product have removed the phthalates from external cables (where they are above 0.1% in the article); but DEHP may still be present in internal cables which are relatively small and for which the phthalate content did not trigger the 0.1% threshold based on imported article.
Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. The amendment to the RoHS Directive is posted on the Official Journal of the EU. ECD Compliance provides services to track environmental regulations and can assist in upgrading your RoHS program to address the phthalate restrictions.