REACH Regulation Update: Stricter Limits on Lead in PVC and Vinyl Products

On May 8th, 2023, the European Union (EU) made an important announcement through Regulation (EU) 2023/9231, which was published in the Official Journal. The purpose of this regulation is to modify the existing lead restriction in the REACH Annex XVII entry 63. The modification involves the addition of a new restriction specifically focusing on lead in polymers or copolymers of vinyl chloride (PVC). The proposed restriction aimed to limit the placing on the market or use of lead in PVC articles where the concentration exceeded 0.1% by weight of the PVC material. This restriction was based on scientific evidence that lead compounds were ineffective as stabilizers in PVC at concentrations below 0.5% by weight. Interestingly, the restriction also accounted for PVC articles containing recovered PVC, which were exempted from the proposed limit. The term "recovered" referred to the recycling process, aligning with the concept of material recovery in EU directives.

Risk Associated with Lead in PVC

Lead, known for its adverse effects on the nervous system and blood pressure, posed significant health risks. Although precise thresholds for these effects had not been established, the European Food Safety Agency emphasized that current human exposure to lead exceeded tolerable levels, causing neurodevelopmental issues in children. To mitigate these risks, industry stakeholders in the European Union voluntarily phased out the use of lead stabilizers in PVC compounding and articles, successfully completing the transition in 2015. However, PVC articles containing lead, especially those used in construction, still posed a challenge due to their long service life and potential for recycling.

The Annex XV dossier revealed a striking statistic: 90% of the estimated total emissions of lead from PVC articles in the Union in 2016 were attributed to imported PVC articles. This finding stemmed from the phase-out of lead stabilizers within the EU, highlighting the significance of addressing imports to ensure effective regulation. To facilitate enforcement, the regulation sought to restrict any lead present in PVC, regardless of its intended function. This approach aimed to ensure comprehensive and effective control over lead in PVC articles.

Evaluation & Amendment: Lead in PVC under REACH Annex XVII

The Agency's Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) extensively evaluated the proposed restriction. They concluded that the restriction was the most appropriate and effective measure to address the identified risks associated with lead compounds in PVC articles. While RAC proposed a complete ban on lead in PVC articles, it also acknowledged the need for derogations. For PVC articles containing recovered PVC, RAC suggested higher lead content limits of 2% for rigid PVC and 1% for flexible PVC, considering the impact on recycling volumes and the different leaching characteristics of each type. SEAC echoed the conclusions of RAC and emphasized the socioeconomic benefits and costs associated with the proposed restriction. It also highlighted the availability of suitable alternatives within the Union and the cost-effectiveness of the restriction.

Taking into account the opinions of RAC, SEAC, and the Parliament's resolution objecting to the initial draft regulation, the Commission made amendments to address concerns raised. The derogation for PVC articles containing recovered flexible PVC was removed to prevent lead carryover into new products.

REACH Annex XVII Updated

In entry 63, column 2, of Annex XVII to Regulation (EC) No 1907/2006, significant amendments have been made to restrict the use of lead in polymers or copolymers of vinyl chloride (PVC). These changes aim to enhance consumer safety and protect the environment. Here are the key updates you need to know:

  • Restricted Concentration: According to paragraph 15, PVC articles or products must not contain lead in concentrations equal to or exceeding 0.1% by weight of the PVC material.
  • Effective Date: The restrictions specified in paragraph 15 will be enforced from 29 November 2024. Manufacturers and suppliers must comply with these regulations by ensuring their products meet the prescribed lead concentration limits.
  • Derogation for Recovered Flexible PVC: PVC articles containing recovered flexible PVC are exempted from the restrictions until 28 May 2025. This provision allows for a transitional period to accommodate the use of recovered PVC materials.
  • Derogation for Recovered Rigid PVC: Specific PVC articles containing recovered rigid PVC will not be subject to the restrictions until 28 May 2033. However, the concentration of lead in these articles must remain below 1.5% by weight of the recovered rigid PVC. This exemption applies to profiles, sheets, multi-layer pipes, fittings (excluding those for drinking water), and other specified applications.
  • Marking and Documentation Requirements: Suppliers of PVC articles containing recovered rigid PVC with lead concentrations equal to or exceeding 0.1% by weight must ensure proper marking on the article or its packaging. Documentary evidence substantiating the claims on the recovered origin of the PVC in these articles must be provided to national enforcement authorities upon request. Certificates from recognized schemes or independent third parties may be used for this purpose.
  • Review and Potential Modifications: By 28 May 2028, the Commission will review paragraph 15 in light of new scientific information and make appropriate modifications if necessary.
  • Derogations for Specific Applications: Certain PVC-silica separators in lead-acid batteries, articles covered by other regulations (EC) No 1935/2004, 2011/65/EU, 94/62/EC, and 2009/48/EC, and PVC articles placed on the market until 28 November 2024 are exempted from paragraph 15 restrictions.

These updated regulations aim to foster the use of safer alternatives to lead-containing PVC materials while allowing for a phased transition and supporting the circular economy. Stay informed about these regulatory changes to ensure compliance and explore sustainable options for PVC and vinyl products.

Conclusion:

The European Union's updated regulations on lead in PVC articles mark a significant milestone in protecting human health and the environment. By restricting the concentration of lead in PVC materials, the EU aims to reduce exposure to this toxic substance and encourage the use of safer alternatives. This progressive approach reinforces the Union's commitment to sustainable practices and paves the way for a healthier future. As economic operators and consumers adapt to these changes, we can expect safer and more environmentally friendly PVC products in the market.

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