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8.5.2023

EN

Official Journal of the European Union
L 123/3

9

The Agencys Forum for Exchange of Information on Enforcement was consulted on the proposed restriction and its opinion was taken into account, resulting in a modified description of the scope and of the derogations from the proposed restriction.

10

On 26 April 2018, the Agency submitted the final opinions of RAC and SEAC to the Commission.

11

Taking into account the Annex XV dossier and the opinions of RAC and SEAC, and considering that there is an unacceptable risk to human health from lead in PVC articles, the Commission proposed a draft Commission regulation restricting the use of any concentration of lead and its compounds in PVC articles and the placing on the market of lead and its compounds in PVC articles in a concentration equal to or greater than 0,1 % by weight of the PVC material the draft regulation. The draft regulation received a favourable opinion of the Committee established under Article 133 of Regulation EC No 1907/2006 on 20 November 2019.

12

In accordance with the regulatory procedure with scrutiny referred to in Article 1334 of Regulation EC
No 1907/2006, a resolution objecting to the draft regulation was adopted by the European Parliament plenary on 12 February 2020 9. Consequently, the draft regulation was not adopted by the Commission.

13

In its resolution, the Parliament asked the Commission to remove the derogations for recovered PVC, as it would lead to the carry-over of lead into new products. The Parliament also requested the removal of the derogation for the two lead pigments subject to the authorisation regime under REACH. Furthermore, the Commission was asked to delete the proposed marking requirements for PVC articles containing recovered PVC as it considered it misleading and not reflecting that recovered PVC contains higher amounts of lead than newly produced PVC. Finally, the Parliament asked the Commission to reduce the proposed transitional period for when the provisions of the regulation shall apply.

14

The Commission has carefully assessed the resolution of the Parliament and acknowledges the need to address certain concerns. In addition, it considers that there is still an unacceptable risk to human health from lead in PVC
articles, which needs to be addressed on a Union-wide basis. Against this background, the Commission decided to amend some of the provisions of the draft regulation to reflect the arguments brought forward by the Parliament and take into account relevant new data received from the Agency and stakeholders.

15

In particular, the Commission considers that clean recycling technologies which allow the removal of legacy substances of concern, including lead, from PVC waste should be encouraged. Current recycling technologies, however, can reduce but not completely eliminate legacy substances. It is therefore necessary to set a concentration limit of 0,1 % of lead by weight not only for the placing on the market but also the use of lead and its compounds in PVC, in order to allow both the placing on the market of articles containing less than 0,1 % of lead by weight of the PVC material and the continued use in articles of PVC material containing lead below that limit, such as PVC
material recovered through chemical recycling or solvent dissolution and containing very small amounts of lead.

16

As a means of limiting the carryover of lead in new products, the derogation for PVC articles containing recovered flexible PVC should be removed from the draft regulation. However, economic operators should be granted a 24-month period to adapt to the new requirements.

17

However, a derogation for certain PVC articles containing recovered rigid PVC should be laid down to achieve an appropriate balance between the overall long-term benefits from the circular use of those materials and the overall long-term health concerns relating to that recovered material. Following industry reports that the average lead concentration in recovered rigid PVC is below 1,5 % due to routine mixing of preand post-consumer waste, the allowed lead concentration limit in recovered rigid PVC should be reduced from 2 % to 1,5 % by weight. To prevent the possible leaching of lead and the formation of lead-containing dust, recovered rigid PVC in derogated articles should be entirely enclosed within a layer of newly produced PVC, recovered PVC or other suitable material that
9 European Parliament resolution of 12 February 2020 on the draft Commission regulation amending Annex XVII to Regulation EC
No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH as regards lead and its compounds OJ C 294, 23.7.2021, p. 2.