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On 12 July 2019, the European Commission (EC) submitted a draft amendment to the World Trade Organization (WTO)1, 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. In 2016, the European Chemicals Agency (ECHA) prepared a restriction report to propose a restriction on lead in PVC. After 1st and 2nd public consultation, the ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) modified the restriction proposal, and the ECHA submitted the opinions to the EC. Based on the opinions submitted, the EC concluded that the REACH Annex XVII should be amended by adding the new restriction on lead in PVC.
The new restriction is expected to publish in the 3rd quarter of 2019. It will set a 24 months’ transition period, and some specific applications will have a longer transition period.
Please refer to Table A for the proposed restriction on lead in PVC.
Table A. Proposed restriction on lead in PVC
Proposed restricted substance
Lead and lead compounds excluding lead sulfochromate yellow (EC No: 215-693-7) and lead chromate molybdate sulfate red (EC No: 235-759-9)
Proposed scope of restriction
Articles produced from polymers or copolymers of PVC
< 0.1% by weight of PVC material
A) Articles covered under existing legislation:
B) Articles for which it can be demonstrated that they had already been placed on the market before the date of application (i.e. 24 months from the date of entry into force);
C) PVC-silica separators in lead acid batteries for a period of 10 years;
D) i) Specific article types containing recycled rigid PVC does not contain lead exceeding 2% by weight (expressed as metal) (e.g. profiles and sheets for exterior applications in buildings, profiles and sheets for use in concealed spaces, fittings) until 15 years from the date of entry into force;
ii) The concentration of lead in the layer that prevents leaching and formation of lead containing dusts during article service covering the recovered PVC in applications in D)i) shall be lower than 0.1 % by weight of the material used in the layer;
E) i) Some specific flexible articles containing recovered flexible (soft) PVC does not contain lead exceeding 1% by weight (expressed as metal) of the recovered PVC material
ii) The concentration of lead of other material in these articles that prevents leaching and formation of lead containing dusts during article service used in combination with recovered PVC in the applications in E)i) shall be lower than 0.1 % by weight of the other material.
Proposed date of application
24 months after the date of entry into force
Bosnia and Herzegovina