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L 123/2

EN

Official Journal of the European Union
8.5.2023

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Lead stabilisers increase the thermal stability of PVC during compounding and article production. They also protect PVC against photo-degradation. Industry in the Union voluntarily phased out the use of lead stabilisers in PVC
compounding and PVC articles and reported that that process was successfully completed in 2015 5. PVC articles containing lead, especially construction products, have long service lives, remaining in use for periods exceeding several decades, after which they become waste upon disposal and may undergo recycling, potentially re-introducing lead into products via the recovered PVC. The Annex XV dossier showed that 90 % of the estimated total emissions of lead from PVC articles in the Union in the year 2016 was attributable to imported PVC articles, due to the phase-out of lead stabilisers in the Union.

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To facilitate the enforcement of the proposed restriction, it is appropriate to restrict any lead present in PVC
regardless of its intended function.

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On 5 December 2017, the Agencys Committee for Risk Assessment RAC adopted its final opinion 6, concluding that the restriction proposed by the Agency is the most appropriate Union-wide measure to address the identified risks posed by lead compounds present as stabilisers in PVC articles in terms of effectiveness in reducing such risks, practicality and monitorability.

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RAC proposed to ban the use of any concentration of lead in PVC articles. RAC also agreed with the Agency that a derogation should be laid down for PVC articles containing recovered PVC. RAC however proposed that higher lead content limits for certain PVC articles containing recovered rigid and flexible PVC should be established, respectively, at 2 % and 1 % by weight. That proposal took account of the estimation that the alternative to recycling such articles, i.e. disposal of PVC waste via landfilling and incineration, would increase the emissions to the environment and not reduce the risk. The different limits proposed took into account the estimated average lead content of rigid and flexible PVC waste in 2013, the expected impact on recycling volumes and the fact that the release of lead from flexible PVC is known to be higher compared to the one from rigid PVC. Due account was taken of the fact that some articles have a high content of recovered PVC that may reach 100 % by weight of the PVC in the final article.

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On 15 March 2018, the Agencys Committee for Socio-Economic Analysis SEAC adopted its final opinion 7 in which it concluded that the restriction proposed by the Agency, as modified by both RAC and SEAC, was the most appropriate Union-wide measure to address the identified risk, in terms of its socioeconomic benefits and socioeconomic costs. SEAC reached that conclusion based on best available evidence, taking into account the properties of lead as a non-threshold toxic substance and its impact on human health, and the affordability of the costs associated with the proposed restriction. SEAC considered that there are suitable alternatives widely available and already used in the Union. It also considered the cost-effectiveness of the restriction. Finally, it concluded that even limited human health impacts in terms of intelligence quotient loss, would be sufficient to break even with the costs of the restriction.

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SEAC agreed with the proposal in the Annex XV dossier that, considering the projected evolution of the concentration of lead in recovered PVC, that concentration would decrease sufficiently by 2035 2040 to allow PVC articles containing recovered PVC to comply with the proposed general lead concentration limit of 0,1 %.
Therefore, the derogation for certain PVC articles containing recovered PVC should apply for 15 years from the entry into force of the restriction. SEAC further agreed that, in order to account for the uncertainty with respect to the future trends regarding the amount of PVC waste going to recycling and its lead content, that period of application should be reassessed within 10 years from the entry into force of the restriction. In line with the aim of the 2015 EU Action Plan for the Circular Economy 8 to promote non-toxic material cycles and preserve the high level of protection for human health and the environment, the Commission considered that that period of application should be reassessed within 7,5 years from the entry into force of the restriction.

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VinylPlus progress report of 2017, p. 14; see https vinylplus.eu/uploads/downloads/VinylPlus_Progress_Report_2017.pdf https echa.europa.eu/documents/10162/86b00b9e-2852-d8d4-5fd7-be1e747ad7fa https echa.europa.eu/documents/10162/86b00b9e-2852-d8d4-5fd7-be1e747ad7fa Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Closing The Loop An EU Action Plan for the Circular Economy. COM/2015/0614 final.