Diario Oficial de la Unión Europea del 8/5/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
EN
8.5.2023
Official Journal of the European Union
L 123/1
II
Non-legislative acts
REGULATIONS
COMMISSION REGULATION EU 2023/923
of 3 May 2023
amending Annex XVII to Regulation EC No 1907/2006 of the European Parliament and of the Council as regards lead and its compounds in PVC
Text with EEA relevance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation EC No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH, establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation EEC No 793/93 and Commission Regulation EC No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC 1, and in particular Article 681 thereof, Whereas:
1
On 16 December 2016, the European Chemicals Agency the Agency submitted, at the request of the Commission, a dossier 2 pursuant to Article 691 of Regulation EC No 1907/2006 the Annex XV dossier, demonstrating that releases of lead from articles produced from polymers or copolymers of vinyl chloride PVC containing lead stabilisers, during their life-cycle, contribute directly and indirectly to human exposure to lead. The Agency suggested in the Annex XV dossier to restrict the placing on the market or use of lead in articles produced from PVC if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material. Considering that lead compounds cannot stabilise PVC in an effective way at concentrations below approximately 0,5 % by weight, the concentration limit proposed should ensure that the intentional addition of lead compounds as stabilisers during PVC compounding can no longer occur in the Union. The Agency also included in the Annex XV dossier a number of derogations to this suggested restriction, notably for PVC articles containing recovered PVC. Recovered is used in line with the definition of material recovery in Article 3, point 15a, of Directive 2008/98/EC of the European Parliament and of the Council 3.
2
Lead is a toxic substance which affects the development of the nervous system, produces chronic kidney disease and has adverse effects on blood pressure. Although no threshold for neurodevelopmental effects in children and for renal effects has been established, according to the European Food Safety Agency the current human exposure to lead from food and other sources still exceeds the tolerable exposure levels and leads to adverse neurodevelopmental effects in children 4.
1 OJ L 396, 30.12.2006, p. 1.
2 https echa.europa.eu/documents/10162/e70aee23-157b-b2a4-2cae-c42a1278072c report; https echa.europa.eu/documents/
10162/cc1c37a8-22f9-7a7a-cb33-5c29edba7094 annex.
3 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives OJ L 312, 22.11.2008, p. 3.
4 EFSA Panel on Contaminants in the Food Chain CONTAM; Scientific Opinion on Lead in Food. EFSA Journal 2010; 84:1570.
