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NEA newsletter-202201

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

The 76th restriction entry was added to the Annex XVII of REACH
On November 22, 2021, the European Union published the Regulation (EU) 2021/2030 on its Official Journal, adding the 76th entry which sets restrictions on the use of N,N-dimethylformamide (DMFa) to the Annex XVII of the REACH Regulation ((EC) No 1907/2006). This entry restricts the manufacturing, use and placing on the market of DMF itself and substances or mixtures with a content of ≥0.3%, in order to protect the health of workers. Since DMFa is widely used as solvent in the production of textiles, paper, polyurethane materials and synthetic fibres, the obligations of the restriction requirements in this entry shall apply from December 12, 2024 in relation to placing on the market for use, or use, as a solvent in direct or transfer polyurethane coating processes of textiles and paper material or the production of polyurethane membranes, and from December12, 2025 in relation to placing on the market for use, or use, as a solvent in the dry and wet spinning processes of synthetic fibres. There have been many updates for the Annex XVII of REACH since it came into effect, SGS suggests relevant enterprises pay attention to the latest requirements to ensure the compliance of products.

ECHA Enforcement Project Reported Thousands of Non-Compliant Products
On December 8, 2021, the European Chemicals Agency (ECHA) published the report of the eighth major Forum Enforcement Project (REF-8), finding a large number of products were non-compliant with at least one requirement under EU's REACH, CLP and BPR regulations. The national enforcement authorities (NEAs) in the 29 participant countries inspected a total of 5 730 products, and the product categories of the products are as follows:

Product Category Substance Mixture Article
Number of non-compliant products 323 4631 776

The inspection results are as follows:
Regulation Number of Products Inspected Number of Non-Compliant Products Percentage of Non-Compliance
REACH Annex XVII 2629 2042 78%
REACH SDS (Article 31) 956 49 5%
CLP 2752 2065 75%
BPR 1153 891 77%
Among the non-compliant products related to REACH, the restriction requirements under Annex XVII to REACH regulation were mainly checked, a total of 655 article products were inspected, of which 164 (25%) were non-compliant. The enforcement report reveals thousands of non-compliant products and recommends inspections on products sold online regularly. Relevant enterprise shall ensure the compliances of products to avoid trade risks.

The EU proposed to restrict PFHxA
On December 9, 2021, the Committee for Socio-Economic Analysis (SEAC) has adopted its final opinion on Germany’s proposal to restrict perfluorohexanoic acid(PFHxA), its salts and related substances. Previously, the Committee for Risk Assessment (RAC) has supported the proposal to restrict these substances in June 2021. PFHxA, its salts and related substances are a subgroup of per- and polyfluoroalkyl substances (PFAS) and known to be persistent, remotely migratory, toxic and bioaccumulative. They are widely used in many sectors, like paper and cardboard (food contact materials), textiles such as personal protective equipment, home textiles and apparel, as well as in fire-fighting foams. In the future, the European Commission will formulate a draft regulation restricting PFHxA in combination with the opinions of SEAC and RAC. After the adoption of the draft regulation, PFHxA, its salts and related substances will be regulated under Annex XVII to REACH regulation.

The EU plans to establish a 'whistle-blowing mechanism' on non-compliance
Recently, the European Commission's high-level roundtable has called for a 'whistle-blowing mechanism' on non-compliances of hazardous substances to improve the lack of a clear whistle-blowing mechanism at EU or member state level. This mechanism will allow businesses and their employees to flag illegal substances and products from competitors or their own companies to strengthen enforcement of EU chemicals legislation, particularly with regard to online sales of imported products. This new mechanism also tried to empower consumer organisations to become "market watchdogs" and issue alerts to national authorities and the Commission of suspected infringements of chemical laws. The roundtable noted that such organisations should receive further support to develop their capacities for collective redress actions related to breaches of EU chemicals legislation, while the power of social media and influencers could also be tapped to raise awareness on consumer safety issue. With the continuous improvement of supervision mechanism, SGS suggests enterprises pay continuous attention to the latest requirements of relevant to ensure the smooth entry of products into the target market.

OEHHA published the new proposal of CP 65 Short-Form Warning Label
On December 13, 2021, the Office of Environmental Health Hazard Assessment (OEHHA) published a new proposal to revise the use of CP 65 Short-Form Warning Label, including the application condition, warning words, font requirements, warning language, and etc. California Proposition 65 (CP 65), short for Safe Drinking Water and Toxic Enforcement Act of 1986, aims at reducing chemicals that cause cancer, birth defects or other reproductive harm in products and protecting consumers and the environment. Manufacturers and distributors must put a warning label on the product if it contains the hazardous substances listed in CP 65. In August 2016, the OEHHA approved new requirements for a short-form warning. In order to limit the use of the short-form warnings to small products and to provide more specific information to consumers, the OEHHA has proposed to revise the relevant contents of short-form warning label on January 8, 2021. The new proposal further revised the requirements of short-form warning label on the basis of the first proposal. At present, the proposal is under public consultation, comments are accepted before January 21, 2022.

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