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EU: REACH Annex XVII restriction on lead in PVC was published

MAY 2023 - HARDLINES, SOFTLINES, TOYS AND CHILDREN'S PRODUCTS

On 8 May 2023, the European Union (EU) published a regulation (Regulation (EU) 2023/9231) on the Official Journal, to amend the REACH Annex XVII entry 63 – lead restriction by adding the new restriction on lead in polymers or copolymers of vinyl chloride (PVC). 

Lead is a toxic substance which affects the development of the nervous system, producing chronic kidney disease and has adverse effects on blood pressure. PVC articles containing lead have long service lives, remaining in use for periods exceeding several decades, after which they become waste upon disposal and may undergo recycling, potentially reintroducing lead into products via the recovered PVC material. The European Chemicals Agency (ECHA) prepared a restriction report to propose the restriction on lead in PVC back to 2016. Taking into account the Annex XV dossier and the opinions of European Chemicals Agency’s committees, the European Commission (EC) considers that there is an unacceptable risk to human health from lead in PVC articles. REACH Annex XVII lead restriction should be amended accordingly to address such risk.

The new restriction will apply from 29 November 2024, and some applications can enjoy longer transition periods.

Please refer to Table A for the restriction on lead in PVC.

Scope of restriction

Articles produced from polymers or copolymers of PVC

Limit

< 0.1% by weight of PVC material

Exemption

 

a) Articles covered under existing legislation: 

  • Articles covered by paragraph 1, in accordance with paragraphs 2 to 5, and by paragraph 7 in accordance with paragraphs 8 and 10 of Entry 63 of REACH Annex XVII;
  • Food contact materials covered by Regulation (EC) No 1935/2004;
  • Electrical and electronic equipment covered by RoHS Directive 2011/65/EU;
  • Packaging and packaging waste covered by Directive 94/62/EC;
  • Toys covered by Directive 2009/48/EC;

B) PVC-silica separators in lead acid batteries until 28 May 2033;

C) PVC articles containing recovered flexible PVC until 28 May 2025;

D) i) Following article types containing recovered rigid PVC contain lead less than 1.5% by weight of the recovered rigid PVC until 28 May 2033;

a) profiles and sheets for exterior applications in buildings and civil engineering works, excluding decks and terraces;
b) profiles and sheets 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 content of lead is lower than 0.1% by weight;
c) profiles and sheets for use in concealed spaces or voids in buildings and civil engineering works (where they are inaccessible during normal use, excluding maintenance);
d) profiles and sheets for interior building applications, provided that 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;
e) multi-layer pipes (excluding pipes for drinking water), 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; 
f) fittings, excluding fittings for pipes for drinking water.

ii) From 28 May 2026, rigid PVC recovered from the categories of articles referred to in points a) to d) shall only be used for the production of new articles of any of those categories;

iii) 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 shall ensure, before placing those articles on the market, that they are visibly, legibly and indelibly marked with the statement: “Contains ≥ 0.1 % lead”;

iv) Suppliers of PVC articles containing recovered rigid PVC shall submit to national enforcement authorities upon request documentary evidence to substantiate the claims on the recovered origin of the PVC in those articles.

Date of application
29 November 2024
 
 

 


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