Key takeaway
What This Development Means
The appellant asserts that the eMSCA delivered their assessment later than the regulation requires. Learn with Foresight.
DSM Nutritional Products GmbH, a German company, has formally appealed against a decision made by the European Chemicals Agency (ECHA) regarding the evaluation of a substance potentially harmful to the environment. The contested decision, dated 10 August 2023, involves the substance evaluation of 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione, a chemical suspected to have persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties. This chemical was first included in the Community rolling action plan (CoRAP) for evaluation in 2015 due to concerns over consumer use, environmental exposure, high volume, and widespread use.
In 2017, ECHA requested additional information from DSM regarding the substance's impact on the environment, specifically its aerobic mineralization in surface water and potential toxicity to aquatic life. The company complied with this request in 2021, leading the evaluating member state competent authority (eMSCA) to label the substance as potentially PBT.
However, the eMSCA subsequently raised additional concerns regarding the substance's endocrine disrupting properties in the environment, based on new academic research. This led to the contested decision by the ECHA, demanding further information through an amphibian metamorphosis assay by February 2026.
DSM Nutritional Products GmbH is now contesting this decision, arguing that the ECHA breached Article 46(3) and (4) of the REACH Regulation and the company’s legitimate expectations. The appellant asserts that the eMSCA should have completed its assessment within 12 months of receiving the requested information, which would have been by November 2022. However, the draft decision based on the eMSCA's assessment was not issued until 1 December 2022.
Furthermore, the company argues that the Agency's decision to address endocrine disruption concerns based on new information is a breach of Article 46(3) and fails to meet the legitimate expectations set by the initial substance evaluation process. DSM suggests that such decisions should be made under Article 47(1), which would require restarting the evaluation process, including another inclusion of the substance in CoRAP.
DSM also contends that the Agency made an error in assessing the concern related to endocrine disruption by relying on unreliable studies, instead of concluding based on reliable information that there is no remaining concern.
The appeal, received on 9 November 2023, requests the annulment of the contested decision and the refund of the appeal fee. The European Chemicals Agency has not yet publicly responded to the appeal.
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