Four phthalate plasticisers, DEHP, BBP, DBP and DIBP, have been classified as Priority 1 Substances and added to the existing six substances restricted by EU Directive 2002/95/EC on the Restriction of Hazardous Substances (RoHS).

Product manufacturers, suppliers and contract manufacturers may be affected by this announcement. The four phthalates have been added to six other Annex II Restricted Substances with prescribed maximum concentration values (MCVs). Following publication in the Official Journal of European Union as Commission Delegated Directive (EU) 2015/863 the Annex II list now extends to:

  • Lead
  • Mercury
  • Cadmium
  • Hexavalent Chromium
  • Polybrominated Biphenyls (PBB)
  • Polybrominated Diphenyl Ethers (PBDE)
  • Bis (2-ethylhexyl) Phthalate (DEHP)
  • Butyl Benzyl Phthalate (BBP)
  • Dibutyl Phthalate (DBP)
  • Diisobutyl Phthalate (DIBP)

RoHS limits these substances to 0.1% or 1,000ppm (except for cadmium, which is limited to 0.01% or 100ppm) by weight of homogenous material.

Restrictions on the four new substances will come into effect for categories 1 to 7, 10 and 11 from July 22, 2019, and with effect from July 22, 2021 for categories 8 and 9, Medical and Monitoring Devices.

Cables & Spare Parts Exemption

In common with previous RoHS Directive updates, these most recent changes apply to cables and spare parts for the repair, re-use and updating of a device’s functionality, or capacity upgrade, with one exemption. Spare parts manufactured for medical devices already on the market before these dates are exempt from compliance with RoHS II. 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 July 22, 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 July 22, 2021.”

Phthalates in Electrical/Electronic Toys

Toys destined for EU markets are also subject to the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC 1907/2006), better known as REACH. This month’s amendment to the RoHS Directive states that the Annex XVII of the REACH Regulation, restricting phthalates in toys, takes precedence over the new maximum concentration levels in the RoHS Directive.

Planning for Implementation

Even at this early stage, it is pragmatic to closely examine materials being provided by suppliers, to determine whether the new substances are present in homogenous materials at levels in excess of the MCVs. In the event that materials do exceed the MCVs, suppliers and manufacturers will need to work together, either to find a substitute material, or to start the process of seeking an exemption specifically for the material and its application.

Product manufacturers, suppliers and contract manufacturers, if applicable, should analyse substitute materials and consider possible impacts to manufacturing methods, processes and fresh lot yields.

The new restrictions also have the potential to impact product reliability and long-term availability. Therefore, product manufacturers should also evaluate potential impacts, as well as the possibility that restrictions may be imposed upon the substitute materials in the future.

In addition, manufacturers should check with their suppliers to confirm whether or not they use any of the new hazardous substances, and if so, to identify and evaluate potential alternatives.

Delegated Directive 2015/863

European Delegated Directive (EU) 2015/8631 officially adding the four phthalate substances to the EU RoHS Directive was published on June 4, 2015. This was the final step to officially adding the four phthalates to the existing list of six RoHS hazardous substances.

The addition of these new hazardous substances resulted from their classification as Priority 1 Substances. These substances were part of a larger group of 11 Priority substances. More information about the methods used to select the 11 Priority Substances is available in SGS’s SafeGuards “RoHS – Methodology for Inclusion of Substances in Restricted Substances List”2.

Worldwide Expertise

Whatever the challenge, SGS is able to provide expert support for RoHS compliance. We specialise in partial and complete testing of finished products, and offer options for non-destructive testing. Our RoHS related services include: product risk assessments, process gap analysis and consulting, full product and material testing to IEC 62321 standards, XRF screening, RoHS Certificate of Conformity, and verification services.

With more than 90 years’ experience, we have a deep understanding of hazardous substances. We operate more than 28 accredited RoHS testing centres worldwide, staffed by more than 1,000 RoHS specialists.

Act now, to ensure your product’s compliance to the latest RoHS list before the latest additions are restricted. 

For additional information or support please contact:

Kenneth Stanvick
Technical Manager,
Environmental Compliance Management
SGS North America Inc.
t: +1 603-305-4103

1 Official Journal of the EU - Annex II to Directive 2011/65/EU
2 RoHS - Methodology for Inclusion of Substances in Restricted Substances List