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2022-06-20

NEA newsletter-202206

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

CEN Issues CEN/TR 12471:2022 for Nickel Screening
In February 2022, the European Committee for Standardization (CEN) published CEN/TR 12471:2022 'Screening test for the presence of nickel in articles which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin', which supersedes CR 12471:2002. This latest screening method is based on the formation of a red colored metal complex when nickel ions react with dimethylglyoxime in the presence of ammonia. It contains a pretreatment step where artificial sweat and heat are used to induce corrosion of the surface to increase the sensitivity of the test, and a detailed procedure for confirmation of the presence of nickel using dithiooxamide.

CEN/TR 12471:2022 contains several important points:

  • Clarifies that the reference method for nickel release is EN 1811 (or EN 16128 for spectacle frames and sunglasses);
  • Emphasizes that a quantitative test using EN 1811, or EN 12472 followed by EN 1811, can be carried out to verify compliance with entry 27 to Annex XVII of REACH Regulation ((EC) 1907/2006);
Advises that a positive result in the screening test may not be compliant with the respective nickel release limits falling under entry 27 to Annex XVII of REACH.

EU RAPEX 2021 annual report published
According to the European Commission's annual Safety Gate report, published on 25 April, 2022, 2,142 alerts in total were circulated in 2021. The figure remains largely the same as that reported in the previous five years. And 4,965 actions were taken by other members in the network in response to those alerts. The presence of hazardous substances in consumer goods accounted for a quarter of all product risks. The findings highlight recurring problems with products – particularly in toys and in products sold online. Chemicals have remained the second most common risk notification for three years in a row (after injuries). As in previous years, concerns over the presence of phthalates, such as bis(2-ethylhexyl) phthalate (DEHP), in plastic came high on the list. Notifications also concerned excessive levels of lead in metals, and nickel in various materials.

TBEP, TPHP, EHDP and TBBPA detected in high concentrations in consumer products
Recently, according to the research report carried out by Norwegian Institute for Air Research (NILU), additives such as organophosphorus flame retardants (OPFRs), brominated flame retardants (BFRs) and chlorinated substances were found in consumer products including extension cords, electrical sockets, personal computers, mouse devices, flooring, wallpaper, etc. Ten of the chemical additives targeted were observed in detectable concentrations in at least one product group and four in multiple product groups. The following four additives were found in high concentrations in several products:
Substance Products detected
Tris(2-butoxyethyl) phosphate (TBEP) Flooring, wallpaper
Triphenyl phosphate (TPHP) Flooring, wallpaper, upholstery, computer mouse devices
2-ethylhexyldiphenyl phosphate (EHDP) Wallpaper, mouse devices
2,2',6,6'-tetrabromo-4,4'- isopropylidenediphenol (TBBPA) Mouse devices, personal computers

Article importers in US must pay special attention to TSCA
At present, a series of measures taken by the US Environmental Protection Agency (EPA) show that it will make more use of the authority of the Toxic Substances Control Act (TSCA) to regulate and require the reporting of chemicals in articles in the future, and companies that import and distribute articles in US must be prepared for that shift. Relevant professionals also mentioned that in the first 40 years after the promulgation of TSCA regulations, the EPA rarely regulated chemicals in articles. After the amendment of the law in 2016, the regulate requirements for articles gradually increased. In January 2021, the EPA issued final rules on five persistent, bioaccumulative and toxic (PBT) chemicals, as well as the upcoming PFAS reporting mandate, all of which involve the compliance requirements of article importers. Companies importing and distributing goods in the US must pay attention to the details in TSCA regulations in an unprecedented way, and Chinese enterprises exporting goods to the United States also need to understand the relevant requirements in order to ensure product compliance.

Saudi Arabia to proceed with RoHS conformity assessments
On April 6, 2022, the World Trade Organization (WTO) issued a circular G/TBT/W/768 that Saudi Arabia will proceed with conformity assessments under its RoHS-like regulation, set to come into effect on 4 July, along with a staged implementation based on product category. To raise the level of quality in the national industry and the safety of imported goods presented in the Saudi market, the government published guidelines on the assessment procedure and the documents companies will be required to submit. As for the conformity assessment procedures, the test report is considered valid unless there is any change in the materials used to manufacture the type. In case it is not possible to perform the test on the entire product, the critical components of the device must be tested.

The country announced last December that it was postponing the implementation of the technical regulation for six months.

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