EU restricts lead in PVC products
Chemicals
| By SCOTT STEPHENS, MPA
The European Commission has adopted legislation expanding the existing REACH annex XVII restriction on lead to include the toxic substance’s elimination from products made of polyvinyl chloride. The restriction, which includes temporary exemptions, begins to apply as of November 29, 2024.
Regulatory background
- Lead (CAS RN 7439-92-1), whose toxicity to human health and the environment is well documented, has been restricted under the REACH Regulation ( 1907/2006/EC) for over a decade. Entry 63 of REACH’s annex XVII – the list of substances subject to EU-wide restrictions on manufacturing, use, and placing on the market – includes existing restrictions on the placing on the market and use of lead in certain jewelry articles, articles that may be placed in the mouth by children, as well as use in gunshot used in or near wetlands.
- The European Chemicals Agency (ECHA) submitted a proposal to add a new annex XVII restriction on lead and its compounds in products made of polyvinyl chloride (PVC) in December 2016 pursuant to article 68(1) of the REACH Regulation. The proposal demonstrated that “releases of lead from articles produced from polymers or copolymers of vinyl chloride … containing lead stabilisers, during their life-cycle, contribute directly and indirectly to human exposure to lead.”
- In 2020, the EU Parliament (EP) objected to the Commission’s first draft regulation introducing the lead-in-PVC restriction, which was based on ECHA’s proposal, subsequent opinions by the agency’s risk assessment and socio-economic analysis committees (RAC and SEAC), and input from ECHA’s Enforcement Forum. Specifically, the EP disagreed with certain exemptions that had been originally proposed for recovered PVC, pointing to the possibility of lead carrying over into new products. European lawmakers requested several other changes to the Commission’s draft, including the deletion of exemptions for two lead pigments, a reduction in the proposed transition period before the new restriction applies, and the removal of a labeling requirement for PVC articles containing recovered PVC. They asked for this last change because they considered such provision misleading and potentially resulting in increased exposure to lead, since recovered PVC contains higher amounts of lead than that newly produced.
EU expands REACH annex XVII restriction to include lead in PVC products
- Commission Regulation (EU) 2023/923 was published in the May 8 issue of the EU Official Journal, expanding the existing REACH annex XVII entry on lead (entry no. 63) to include its restriction in articles containing PVC in concentrations equaling or exceeding 0.1% by weight. The following table provides the details of the new restriction, including the dates that restrictions for exempted article types begin to apply, applicable transition periods, and other obligations, including labeling and reporting requirements:
| Paragraph no. in entry 63 (lead and its compounds) | Corresponding restriction, exemption, or requirement | Date paragraph 15 restriction or requirement applies | Transition period |
| 15 | Restriction on placing on the market and use of lead in articles produced from polymers or copolymers of vinyl chloride in concentrations equal to or greater than 0.1% by weight of the PVC material (Note: PVC articles already on the market are not subject to this restriction until November 28, 2024) | November 29, 2024 | 1.5 years |
| 17 | PVC articles containing recovered flexible PVC | May 28, 2025 | 2 years |
| 18 |
The following types of profiles and sheets containing recovered rigid PVC, if concentration of lead is lower than 1.5% by weight of recovered rigid PVC: (1) For exterior applications in buildings and civil engineering works, excluding decks and terraces, (2) For decks and terraces, provided that the recovered PVC is used in a middle layer and is entirely covered with a layer of PVC or other material for which the concentration of lead is lower than 0.1% by weight, (3) For use in concealed spaces or voids in buildings and civil engineering works (where they are inaccessible during normal use, excluding maintenance) (e.g., cable ducts), and (4) For interior building applications, provided that the entire surface of the profile or sheet facing the occupied areas of a building after installation is produced using PVC or other material for which the concentration of lead is lower than 0.1 % by weight |
May 28, 2033 | 10 years |
| 18 | Rigid PVC recovered from the profile and sheet articles stipulated above is only allowed to be used to produce new articles of any of these article types | May 28, 2026 | 3 years |
| 18 | multi-layer pipes (excluding pipes for drinking water) containing recovered rigid PVC, if concentration of lead is lower than 1.5% by weight of recovered rigid PVC, and provided that the recovered PVC is used in a middle layer and is entirely covered with a layer of PVC or other material for which the concentration of lead is lower than 0.1% by weight | May 28, 2033 | 10 years |
| 18 | fittings, excluding fittings for pipes for drinking water | May 28, 2033 | 10 years |
| 18 | During exemption, suppliers of PVC articles containing recovered rigid PVC with a concentration of lead equal to or greater than 0.1% by weight of the PVC material must label such articles, prior to placement on the market, with statement: “Contains ≥ 0,1 % lead”; where marking cannot be provided on the article due to nature of article, it must be on article packaging | May 28, 2033 | 10 years |
| 18 | During exemption, suppliers of PVC articles containing recovered rigid PVC are required to submit upon request documentary evidence to substantiate claims on origin of recovered PVC in those articles (proof of traceability and recycled content accepted per EN 15343:2007 or equivalent standards for PVC articles produced in EU); claims made on recovered origin of PVC in imported articles shall be accompanied by a certificate that provides equivalent proof of traceability and recycled content, issued by independent third party | May 28, 2033 | 10 years |
| 18 | Commission required to review paragraph 18 considering new scientific information and, if appropriate, modify it accordingly. | May 28, 2028 | 5 years |
| 19 | PVC-silica separators in lead acid batteries | May 28, 2033 | 10 years |
| 19 | Paragraph 15 restriction does not apply to jewelry articles and articles that may be placed in the mouth by children per entry 63’s corresponding restrictions | Not applicable | None |
| 19 | Paragraph 15 restriction does not apply to food contact materials, RoHS-regulated articles, packaging and packaging waste, and toys (articles within scope of 1935/2004/EC, 2011/65/EU, 94/62/EC, and 2009/48/EC, respectively) | Not applicable | None |
To contact the author of this analysis, please email Scott Stephens.
To contact the editor of this analysis, please email Patricia Iscaro.