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2021-08-23

NEA newsletter-202108

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

The Candidate List of SVHC has been updated to 219 substances
On July 8, 2021, eight new substances were added to the Substances of Very High Concern (SVHC) Candidate List by the European Chemicals Agency (ECHA). Hence, 219 substances are included in the list now. The added substances are phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP); orthoboric acid, sodium salt; medium-chain chlorinated paraffins (MCCP); glutaral; 4,4'-(1-methylpropylidene) bisphenol (bisphenol B); 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers; 2,2-bis(bromomethyl)propane1,3-diol (BMP), 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA), 2,3-dibromo-1-propanol (2,3-DBPA) and 1,4-dioxane. As a major focus of the REACH regulation, the SVHC candidate list has been updated multiple times since the entry into force of the regulation. If an article contains any SVHC (concentration above 0.1%(w/w)) included in the Candidate List, suppliers of the articles must fulfil the obligations of communication and notification stipulated in REACH regulations. As of 5 January 2021, article suppliers must notify SVHCs 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.

The EU-wide enforcement project REF-11 will focus on the quality of information in SDS
On June 29, 2021, the European Chemicals Agency (ECHA) published the highlights of the 38th Enforcement Information Exchange Forum. The Forum agreed to focus on the quality of the information in safety data sheets (SDS) in the EU-wide enforcement project – REF-11, which will be carried out in 2023. SDS is an important tool for the transmission of safety information in the supply chain. If they are defective, workers and professionals may not receive adequate information on the safe use of hazardous substances and mixtures. The project will check the compliance with the revised requirements under Annex II to REACH, which sets the content and format required for SDS. The enforcement project will be prepared in 2022, inspected in 2023 and issued an enforcement report in 2024.

Three exemptions have been proposed for Annex IV to EU RoHS directive
On June 29, 2021, three notifications (G/TBT/N/EU/808, G/TBT/N/EU/809, G/TBT/N/EU/810) have been submitted to WTO by the European Commission, which intends to add three exemptions to Annex IV to RoHS Directive (2011/65/EU). The three exemptions are: Entry 45, Bis(2-ethylhexyl) phthalate (DEHP) in ion selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids; Entry 46, Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils; Entry 47, Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (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. Entry 45 and 47 will valid for 7 years after the adoption of the Delegated Directive. Entry 46 will expire on January 1, 2024.

South Korea intends to revise food contact material standards
In May 2021, South Korea’s MFDS published Notice No. 2021-234 to revise “Standards and Specifications for Food Utensils, Containers and Packaging”. The major revisions included: Adding a new material, polyketone, under synthetic resins; dividing synthetic resins with similar structures into nine categories including 6 polyolefins, 12 polyesters, 5 polystyrenes, 3 amines, 3 acrylics, 4 aldehydes, 5 polyethers, 2 vinyl chlorides, and three other types. Technical specifications for materials such as synthetic resin, rubber, paper, metals and other materials have been provided. Besides, safety requirements for active and smart substances in containers/packaging have been added as well. Standards for recycled PET and test methods for colorants and sulfur dioxide have been improved. According to the Notice, public comments are accepted until July 27, 2021. The notice will take effect immediately, and the relevant provisions for recycling PET are recommended to take effect on January 21, 2022.

Canada regulates formaldehyde emissions from Composite Wood Products
On July 7, 2021, Canada published “Formaldehyde Emissions from Composite Wood Products Regulations” (SOR/2021-148) under its Canadian Environment Protection Act (CEPA 1999). SOR/2021-148 adopted many of the elements from the US Toxic Substances Control Act Title VI “Formaldehyde Standards for Composite Wood Products” (TSCA Title VI) in regulating hardwood plywood (HWPW), particleboard (PB), medium-density fiberboard (MDF), thin-MDF and laminated products. This regulation sets the formaldehyde emission limits for these five composite wood products, and required manufacturers to conduct tests and certifications every quarter. If the product has obtained the US TSCA Title VI certification, the manufacturer can provide a declaration of certification (DoC) and related written evidence to prove the product’s compliance. Besides, the regulation has set requirements for the content and size for labels, and economic operators (manufacturers, importers, and sellers) must keep relevant records for five years. SOR/2021-148 will come into effective on January 7, 2023.

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