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2020-09-28

NEA Newsletter-202009

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

Restriction of dicofol has been added to EU POPs regulation
On August 18, 2020, the Official Journal of the European Union published Regulation (EU) 2020/1204 amending EU POPs Regulation ((EU) 2019/1021) by listing dicofol in part A of Annex I, prohibiting the production, sale and usage of dicofol. Dicofol (CAS No.  115-32-2) is a kind of organochlorine insecticide which has been widely used before, and there are evidences that it has strong toxicity and dicofol is classified as persistent organic pollutant, which may cause long lasting damage to organisms, especially aquatic organisms. This regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The final report of EU RoHS consultation project Pack 18 has been published
Recently, the EU RoHS consultation agency has published the final report on exemption requests of Pack 18, which involves 2 exemptions in Annex IV of RoHS Directive. One is the extension application of an existing exemption, the other is request for a new exemption. Among them, for existing exemption 27, it is suggested to modify the scope of application and extend the period of validity to June 30, 2027. For the new exemption proposed to be added to Annex IV, which is lead in bismuth lead strontium calcium copper oxide superconductor cables and wire and lead in electrical connections to these wires, it is suggested to set the period of validity to June 30, 2027.

The final report of EU RoHS consultation project Pack 20 has been published
Recently, the EU RoHS consultation agency has published the final report on exemption requests of Pack 20, which involves one request for a new exemption in Annex IV, for bis-(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils. The report points out that the lack of alternative coils for the full range of this application, substitution of DEHP containing coils at this stage would lead to negative impacts on health of at least estimated 11 million patients (longer waiting times, lower quality of diagnosis and in both cases subsequent increase in symptoms), and the environmental impacts when MRI equipment is scrapped before its end-of-life is not expected to have a significant impact, hence it is recommended to grant the exemption validity until January 1, 2024.

EU proposes to ban C9-C14 PFCAs substances
On August 3, 2020, the European Commission submitted notification G/TBT/N/EU/731 to the WTO proposing the restrictions of C9-C14 PFCAs in Annex XVII of REACH regulation ((EC) No 1907/2006). The restricted substances include: 1) Linear and branched C9-C14 PFCAs, their salts and any combinations thereof; 2) Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n+1 - directly attached to another carbon atom, where n=8, 9, 10, 11, 12, or 13, including any combinations thereof; 3) Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n+1 - that it is not directly attached to another carbon atom, where n= 9, 10, 11, 12, 13 or 14 as one of the structural elements, including any combinations thereof. The requirements are: 1) Shall not be manufactured, or placed on the market as substances on their own 18 months after date of the entry into force; 2) 18 months after the entry into force, shall not be used in, or placed on the market, unless the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances. Exemptions are given in some cases. At present, the draft regulation is under public consultation for 60 days from the date of the notification released.

State of New York to ban PFAS in food packaging
On July 23, 2020, the US State of New York has passed a bill by the State House and Senate chambers as bills A.4739-C and S.8817, to ban all per- and polyfluoroalkyl substances (PFAS) in food packaging sold or distributed in the State. PFAS is often used in food packaging, household cleaners and non-stick cookware. PFAS chemicals are associated with a series of human health risks, including cancer, immune system diseases, reproductive abnormalities and fetal development problems. PFAS cannot be degraded in the environment and is called a permanent chemical. Therefore, in order to prevent PFAS from entering the human body through drinking water, New York prohibits the use of food packaging containing PFAS. The bill will be signed into law by the governor of New York, and the ban would become effective at the start of 2023.

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