Manufacturers are reminded that the phthalates restrictions (DEHP, DBP, BBP, DIBP) in EEE products start to take effect in less than one year. The date that a specific EEE product needs to comply depends on the product category as shown in Table 1. Phthalates have been commonly used in plastic materials, especially wire and cable sheathing, requiring many products to be redesigned to substitute the parts that are non-conformant. Technical documentation files also need to be updated.
Placed on the Market
EEE products need to comply if they are “placed on the EU market” on or after the date that the restriction take effect. For imported products, “placed on the EU market”, typically refers to the import date. If a manufacturer has a tight transition timeline for its products, it’ll be important to closely manage the inventory that is not phthalate-free to ensure that it’s placed on the market before the deadline.
Table 1: Date of phthalate restrictions based on product category
| Product Category | Date of phthalate restrictions |
|---|---|
| All EEE Categories except as specified below | July 22, 2019 |
| Medical devices (Category 8) (including in vitro medical devices) | July 22, 2021 |
| Monitoring and control instruments (including industrial monitoring and control instruments) (Category 9) | July 22, 2021 |
| Toys that are already subject to restriction of DEHP, BBP, and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006 | DIBP – July 22, 2019 DEHP, BBP and DBP – n/a |
| Spare parts and cables for repair, reuse or upgrade of EEE that was placed on EU market before the phthalate restriction came into effect | n/a |
Phthalate substances and thresholds
The RoHS Directive (2011/65/EU), Annex II was amended by Delegated Directive (EU) 2015/863 to add the four phthalate substances. The substances and maximum concentration in homogeneous material are:
- Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
- Butyl benzyl phthalate (BBP) (0,1 %)
- Dibutyl phthalate (DBP) (0,1 %)
- Diisobutyl phthalate (DIBP) (0,1 %)
Technical Documentation
The technical documentation files (as per EN 50581 or IEC 63000) will need to be updated to reflect the additional substances – even if no redesign was required, the technical documentation still needs to be updated with supplier documentation and other documentation to demonstrate that the four phthalates aren’t present.
ECD Compliance can provide support to manufacturers and suppliers in implementing IEC 63000 to develop technical document for a EEE product being imported into the EU or other jurisdictions with RoHS regulations.