On 2 February 2021, the European Commission has approved and published Commission Delegated Regulation (EU) 2021/115 to amend Annex I to POPs Regulation (EU) 2019/1021 as regards the entry of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. It shall enter into

force on 22 February 2021. The followings are the highlight:

1. In point 3, “perfluoro” shall be added before carbon chain.
2. In point 4, the limit of ionizing irradiation 400 kilograys shall be deleted.
3. Point 10 shall be newly added:

   For the purposes of this entry, exemption from the control measures shall apply to concentrations of PFOA and its salts and/or PFOA-related compounds equal to or below 2 mg/kg (0.0002 % by weight) where they are present in medical devices other than invasive devices and implantable devices. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.

Note:

Annex I: Substances prohibited to be used for manufacturing, placing on the market and use.

Details of requirements on PFOA, its salts and PFOA-related compounds in EU POPs Regulation please refer to previous Insight.

About Intertek

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.

www.intertek.com.cn