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NEA newsletter-202305

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

Germany intends to propose 1,4 dioxane in REACH annex 17
Germany has notified ECHA on its intention to propose a REACH restriction on the manufacture, placing on the market and use of 1,4-dioxane in surfactants. Germany expects to submit the final dossier on 12 April 2024. ECHA will open Germany's call for evidence on 20 April and close it on 20 June.
Once 1,4-dioxane is emitted into the aquatic environment, 1,4-dioxane is distributed via the water system, including drinking water resources. Due to its persistence and mobility it is difficult to remove during drinking water production. Germany will therefore assess its persistent, bioaccumulative and toxic (PBT) properties.
The substance has been identified as an SVHC due to its carcinogenic properties since July 2021.

California proposes lowering Prop 65 safe harbour level for ethylene oxide
California's Office of Environmental Health Hazard Assessment (OEHHA) has proposed significantly reducing the Proposition 65 'no significant risk level' (NSRL) for ethylene oxide. The 7 April proposal would set the safe harbour level for the chemical at 0.058 μg/day, replacing the existing value of 2μg/day. If OEHHA adopts the lower NSRL, companies that expose individuals to the substance above the new threshold would have to provide a warning under the state's right-to-know scheme.
Ethylene oxide has been listed as a Prop 65 carcinogen since 1987. Possible applications of ethylene oxide include electric vehicle batteries; household cleaners; personal care item; disinfectants and grain fumigants.

Latest updates on two EU RoHS consulting substances
In April 2023, the European Commission has announced the recent progress of the initiative on the review of the EU Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment, which recommended adding tetrabromobisphenol A (TBBPA) and medium chain chlorinated paraffins (MCCPs) to the list of RoHS restricted sub-stances. According to the latest updates, the Commission expects to adopt the proposal in the fourth quarter of 2023. The revised draft has not been released yet, and the final re-striction requirements will be subject to the final decision of the European Commission. In May last year, the EU announced the proposal process for these two substances, which was originally scheduled to be adopted in the fourth quarter of 2022, but was not completed as planned.

The EU has officially launched an enforcement action on PFCAs
On 23 March 2023, ECHA's Enforcement Forum agreed to run a pilot project to check for the presence of restricted perfluorocarboxylic acids (PFCAs) and related substances in consumer products. Inspections in this pilot project will begin in 2023 and continue throughout 12 participating countries during 2024. The objective is to protect consumers from being exposed to PFCAs and related substances, including perfluorooctanoic acid (PFOA), which have been identified as sub-stances of very high concern due to their hazardous properties. Inspectors may enforce restrictions under the REACH or POPs Regulation. Where breaches are detected, inspectors will take enforcement measures (such as recall products, with-draw from the market, prohibit sales, etc.) to ensure compliance with the applicable legislation. The project report should be published at the end of 2024.

EU issues new proposals for packaging and packaging waste
On 27 February 2023, the EU issued a draft Regulation on Packaging and Packaging Waste to amend Regulation (EU) 2019/1020 and Directive (EU) 2019/904 and repeal Directive 94/62/EC. It lays down sustainability requirements for placing packaging on the EU market related to its composition, design with the view to packaging minimisation, recyclability, use of secondary raw materials in plastic packaging, compostability and requirements on reusable packaging; and it restricts the use of some packaging formats and establishes obligations on economic operators and Member States, including packaging reuse and waste prevention targets. As regards recycling targets and the related rules on their calculation, it maintains obligations from the existing EU packaging legislation. Final date for comments is May 28.

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