EU Proposes to Expand Lead Restrictions under REACH

On July 12, 2019, the World Trade Organization (WTO) circulated a proposal from the European Union (EU) announcing its intention to expand the scope of lead restrictions falling under entry 63 to Annex XVII of REACH. The draft regulation and Annex, notified under G/TBT/N/EU/668, contain the following:

  • Prohibits the use of lead in articles manufactured from polymers or copolymers of vinyl chloride (PVC)
  • Prohibits the placing goods on the market containing at least 0.1% lead when manufactured from polymers or copolymers of PVC.
  • Provides a 15-year exemption for specific rigid articles containing no more than 2% lead in recovered PVC materials – the lead concentration is strengthened to 0.1% in the layer that prevents leaching and formation of lead-containing dust during service covering the recovered PVC in these applications
  • Provides a 15-year exemption for specific flexible articles containing no more than 1% lead in recovered flexible (soft) PVC materials – the lead concentration is strengthened to 0.1% in other materials that prevent leaching and formation of lead-containing dust during article service used with recovered PVC in these applications
  • Requires suppliers of rigid and flexible articles containing recovered PVC materials to mark the item with the phrase ‘Contains recovered PVC’ on the packaging before these articles can be sold
  • Providing a 10-year exemption for PVC-silica separators in lead acid-batteries
  • Requires suppliers of rigid and flexible PVC articles to submit documentary evidence (EN 15343 or similar standards) on the recovered origin of PVC in these articles when requested
  • Exempts the following articles – food contact materials and articles (Regulation (EC) 1935/2004), electrical and electronic equipment (EEE, Directive 2011/65/EU), packaging (Directive 94/62/EC) and toys (Directive 2009/48/EC)
  • Exempts jewelry articles and articles supplied to the general public described in the preceding paragraphs under entry 63 to Annex XVII of REACH

According to the WTO document, the draft regulation is proposed to be adopted in Q3 of 2019. The proposed date of entry into force is 20 days after publication in the Official Journal of the EU (OJEU), and the provisions would be implemented in phases starting two years after the date of entry into force.

Highlights of the general prohibition/restriction of lead-containing PVC or PVC copolymer goods are summarized in the below table.

Substance Scope Requirement Effective date 
Lead and its compounds (as lead) Use in PVC or PVC copolymer articles Prohibited 2 years after the date of entry into force (possibly late 2021)
Placing on the market for PVC or PVC copolymer articles < 0.1%