REACH Annex 17 Expansion Update

On May 8th, 2023, the European Commission issued amending Directive (EU) 2023/923, revising the restriction requirements for lead and its compounds in entry 63 of Annex XVII to the REACH Regulation (EC) No 1907/2006, adding new restriction requirements for PVC materials. The amending Directive will come into effect on May 28th, 2023.

The list of restricted substances of lead in Annex 17 of the EU’s REACH has been expanded to include PVC materials

On May 8th, 2023, the European Commission issued amending Directive (EU) 2023/923, revising the restriction requirements for lead and its compounds in entry 63 of Annex XVII to the REACH Regulation (EC) No 1907/2006, adding new restriction requirements for PVC materials. The amending Directive will come into effect on May 28th, 2023.

The detailed content of the new requirements in the directive are as follows:

Restricted substanceNew restriction conditions
Chì và các hợp chất của nó
CAS No. 7439-92-1
EC No. 231-100-4 
15. If the concentration of lead in PVC material is equal to or greater than 0.1% (by weight), it shall not be placed on the market or used in articles produced from vinyl polymer or copolymer.
16. Article 15 shall enter into force on November 29th, 2024.
17. As an exemption, Article 15 shall not apply to recycled flexible PVC articles until May 28th, 2025.
18. As an exemption, until May 28th, 2033, Article 15 shall not apply to recycled rigid PVC articles with lead concentrations below 1.5% (by weight) in the following categories:
a. Profile and sheets for use outside buildings and civil engineering works, excluding decking and terrace boards;
b. Profile and sheets for use in decking and terrace boards, provided that the recycled PVC is used as an intermediate layer and is fully covered by a layer of PVC or other material with a lead concentration below 0.1%;
c. Profile and sheets for use in concealed spaces or cavities in buildings or civil engineering works that cannot be accessed during normal use, excluding access for maintenance, such as cable ducting;
d. Profile and sheets for indoor building use, provided that the profile or sheet is fully covered on the surface facing the occupied area of the building with PVC or other material produced with a lead content below 0.1% after installation;
e. Multi-layer pipes (excluding pipes for drinking water), provided that the recycled PVC is used as an intermediate layer and is fully covered by a layer of PVC or other material with a lead concentration below 0.1%;
f. Pipe fittings, excluding fittings for pipes for drinking water.
From May 28th, 2026, recycled rigid PVC from categories (a) to (d) can only be used to produce new articles within the said categories.
Suppliers of PVC articles containing recycled rigid PVC with lead concentrations equal to or greater than 0.1% shall ensure that these articles bear a clear, legible, and indelible marking “contains lead ≥ 0.1%” before placing them on the market. Where it is not possible to indicate this information on the article, it shall be indicated on the packaging of the article.
Suppliers of PVC articles containing recycled rigid PVC shall provide written evidence to the competent national enforcement authorities to demonstrate the origin of the PVC used for recycling in these articles. Certificates that provide proof of traceability and the proportion of recyclable components, such as certificates developed in accordance with EN 15343:2007 or equivalent recognized standards, may be used to support such declarations for PVC articles produced in the EU. Declarations regarding the origin of PVC recycling in imported articles shall be accompanied by equivalent certificates of traceability and recyclable components issued by independent third-party bodies.
By May 28th, 2028, the Commission shall review this provision in light of new scientific information and make the necessary modifications where appropriate.
19. As an exemption, Article 15 shall not apply to:
a. PVC-SiO2 separators in lead-acid batteries until May 28th, 2033;
b. Articles covered by point 1, which shall comply with exemptions under points 2 to 5; articles covered by point 7, which shall comply with exemptions under points 8 and 10;
c. Products falling within the scope of the following directives:
i. Regulation (EC) No 1935/2004;
ii. Directive 2011/65/EU;
iii. Directive 94/62/EC;
iv. Directive 2009/48/EC.
20. As an exemption, Article 15 shall not apply to PVC products placed on the market before November 28th, 2024.

CTT is capable of doing, the directive does not specify a testing method.

This revision expands the scope of material control for lead and its compounds in Annex 17 of REACH. Enterprises producing products containing PVC materials should pay extra attention to the requirements of this revised directive, and take corresponding improvement measures for their products before November 29th, 2024, by stopping the use of PVC materials with excessive lead content or using safe alternative materials.

Original link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.123.01.0001.01.ENG&toc=OJ%3AL%3A2023%3A123%3ATOC

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