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2021-03-25

NEA newsletter-202103

Latest Progress in Environmental Protection Laws and Regulations, Product Recall Case, and Experts Q&A

The Candidate List of SVHC updated to 211 substances
On January 19, 2021, two new substances were added to the SVHC Candidate List by the European Chemicals Agency (ECHA), and hence 211 substances are included in the list now. The added substances are bis(2-(2-methoxyethoxy)ethyl) ether, and dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety. As a major focus of REACH regulation, the candidate list of Substances of Very High Concern (SVHC) has been updated multiple times since the entry into force of REACH regulation. If an article contains any SVHC (concentration above 0.1%(w/w)) included in the Candidate List, suppliers of the article must fulfill the obligations of communication and notification stipulated in REACH regulations. As of 5 January 2021, article suppliers must notify substances of very high concern in their articles to ECHA’s SCIP database under the Waste Framework Directive (WFD). SGS recommends enterprises to review relevant substances in products to ensure compliance.

TPCH Updates its Toxics in Packaging Model Legislation
On February 16, 2021, the US TPCH issued the 2021 update to the Model Toxics in Packaging Legislation. Established in 1992, TPCH (Toxics in Packaging Clearinghouse) is mainly responsible for promoting the ‘Model Toxics in Packaging Legislation’ to all States, and to support and coordinate the implementation of the regulation. The current TPCH enacted in 19 states prohibit the intentional use of cadmium, lead, mercury, and hexavalent chromium and the total concentration of the four heavy metals being limited up to 100 ppm. The revised Model Legislation expands the list of regulated chemicals to include (ortho) phthalates (≤ 100 ppm (sum)) and perfluoroalkyl and polyfluoroalkyl substances (PFAS) (Prohibited (Not detected)); adds new processes and criteria for identifying and regulating additional chemicals of high concern in packaging; provides a new definition for ‘Post-consumer recycled material’; Upon request, a Certificate of Compliance stating that a package or packaging component is in compliance with the requirements of this Act shall be furnished by its manufacturer or supplier to the purchaser of the packaging or packaging component. This revised Model Legislation has come into effect on the date of its publication.

The EU RoHS consultation project PACK 24 has been launched
On January 19, 2021, a new RoHS project Pack 24 for the assessment of seven exemption requests listed in Annex III and Annex IV of Directive 2011/65/EU has started. The study covers exemptions 18(b), 18(b)-I, 24, 29, 32 and 34 of Annex III and exemption 34 of Annex IV. A stakeholder consultation is planned to be launched towards end of March 2021, and the project will end on October 16, 2021. An interim report shall be delivered to the European Commission at the end of May 2021, and the final report is due at the end of the project. The exemptions under evaluation shall remain valid until the evaluation results are published. In the event that the application for renewal of an exemption is rejected or that an exemption is revoked, the exemption shall expire at the earliest 12 months, and at the latest 18 months after the date of notification. SGS suggests relevant enterprises pay attention to the latest status of the renewal of these exemptions, and make preparations in advance.

Indonesia publishes a regulation to phase out PCBs
On December 30, 2020, Indonesia’s environment ministry has published a regulation to manage polychlorinated biphenyls (PCBs) in certain products and encourage phase-out of their use, as part of efforts to meet its requirements under the Stockholm Convention.  The Regulation requires domestic manufacturers, importers and distributors of transformers, capacitors and dielectric oil to reduce the use of PCBs in products to below 50 ppm, label them properly and dispose them responsibly. The regulation came into effect immediately. However, the regulation set transition periods that until 31 December 2022 to label products, and until 31 December 2028 to completely remove the substances.


EU Commission amends exemptions for PFOA in POPs Regulation
On February 2, 2021, the European Commission issued Directive (EU) 2021/115 to amend Appendix I of the Persistent Organic Pollutants Regulations (POPs) regarding the application of perfluorooctanoic acid (PFOA) and its salts and PFOA-related compounds. The main amendments include: in point 3, the prefix "perfluorooctanoic acid" is added before the word "carbon chain"; in point 4, the content "up to 400 kGy" before "ionizing radiation" is deleted; adding point 10, for non-invasive and non-implantable medical devices, the concentration of perfluorooctanoic acid (PFOA) and its salts and/or PFOA-related compounds shall not be higher than 2 mg/kg, this exemption shall be reviewed and assessed by the Commission no later than February 22, 2023. The amendments came into effect on February 22, 2021.

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