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2021-12-21

NEA newsletter-202112

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

NHC of China has released several test standards for food contact materials
The National Health Commission of China drafted and issued 34 national food safety standards (draft for comments), including:

  • Relevant standards for rubber materials and products used in food contact materials
  • Relevant standards for plastic materials and products used in food contact materials
  • Relevant standards for adhesives of food contact materials and products
  • Relevant standards for fluorescent substances in food contact materials, paper, cardboard and paper products
  • Determination of content and migration of phthalates in food contact materials and products
  • Determination of migration amount of 9 antioxidants in food contact materials and products
  • Determination of multi-element and migration of multi-element in food contact materials and products
  • Determination of migration of isothiazolinone compounds in food contact materials
The public consultation has ended on November 20, 2021. Relevant enterprises need to pay attention to changes in product standards to ensure that products meet the latest requirements.

Assessment of two EU RoHS exemptions has started
On November 10, 2021, the EU RoHS advisory agency announced the launch of two new advisory projects (Pack 25) regarding exemptions. This consulting project involves the exemption of mercury in the new pressure sensor and bis(2-ethylhexyl) phthalate (DEHP) in the new pressure sensor in Annex IV of the RoHS Directive (2011/65/EU).  Those exemptions listed in Annex IV of the RoHS directive are applicable to medical devices and control and monitoring instruments. At the same time, the public consultation project on the two exemptions has started on November 30, 2021, comments are accepted until February 8, 2022. The exemption clauses under the RoHS Directive are reviewed periodically with respect to the development of science and technology and the update and iteration of materials. There are situations in which existing clauses are cancelled and new exemptions are added. Related enterprises need to pay close attention to the latest requirements in exemptions to avoid trade risks.

EPA announced revisions to mercury invention reporting rule
On November 2, 2021, the U.S. Environmental Protection Agency (EPA) announced revisions to the 2018 Mercury Inventory Reporting Rule, which requires reporting from personnel who manufacture (including import) mercury or mercury-added products, or otherwise intentionally added mercury in a manufacturing process and vacates the exemption for companies that import pre-assembled products containing a mercury-added component, such as a watch with a mercury-added battery. This final rule, which will be effective 30 days after publication in the Federal Register, offers impacted communities adequate notice of the amended reporting requirements, as the deadline for reporting 2021 data is January 1, 2022. Additionally, the final rule will help EPA identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use in the United States. This will further assist the United States in its implementation of the Minamata Convention on Mercury. Relevant parties need to pay attention to the latest requirements of mercury inventory reporting rules to ensure compliance.

EAEU published the draft amendments of its RoHS regulation
On October 25, 2021, the Eurasian Economic Union published the draft amendments No. 1 to the Technical Regulations of the Eurasian Economic Union "On Restriction of the Use of Hazardous Substances in Electrical and Radio Electronics Products" (TR EAEU 037/2016, EAEU RoHS). The highlights of the amendments are: 
  • The 13th category is added to the scope of regulated products, other electrical and radio electronics products not covered in categories 1 to 12, and the scope of products to which the regulations are not applicable and relevant contents are revised. 
  • Four phthalates (bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP)) are included in the restricted substances list with the proposed limit 0.1%, and modification and supplement are made to the special requirements of restricted substances (exemption entries); 
  • New requirements for recycling and disposal of electrical and electronic products are added, it’s specified that waste recycling labels shall be posted on products or packages, and the size of labels and relevant contents in product operation instructions shall be specified.
Public comments on this draft amendment are received during November 19, 2021 to January 20, 2022.

Three new exemptions were added to Annex IV of EU RoHS Directive
On November 15, 2021, the European Commission published several amendments of RoHS Directive (2011/65/EU) on its Official Journal (OJ), adding three exemptions entries 45, 46 and 47 to Annex IV, the contents are as follows:
Entry Content Validity Date
45 DEHP in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids. July 21, 2028
46 DEHP in plastic components in MRI detector coils. January 1, 2024
47 DEHP, BBP, DBP and DIBP in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. July 21, 2028
These newly added exemptions have entered into force on the day of its publication in OJ. The newly added exemptions on phthalates to Annex IV of RoHS Directive applicable to medical devices provides a long transition period for relevant medical devices enterprises to upgrade technology and find suitable alternative materials.

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