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PFAS Restrictions Worldwide: A Regulatory Analysis

2024-03-08
314 Author: Shenzhen NTEK Testing Technology Co., Ltd.
Key words of this article:

PFAS are per- and polyfluoroalkyl substances. According to the guidance published by the OECD in 2021, PFAS are carbon compounds that contain at least one perfluoromethyl (CF3) or perfluoromethylene (CF2) group and no H, Cl, Br or I atoms. More than 10,000 substances meet this definition, including perfluorooctanoic acid and its salts and related compounds (PFOA), perfluorooctane sulfonic acid and its salts and perfluorooctane sulfonyl fluoride (PFOS), and perfluorohexane sulfonic acid and its salts and related compounds (PFHxS). In simple terms they include fluoropolymers (including fluoroelastomers) such as PVDF and PTFE, hydrofluorocarbons (HFCs) such as fluorinated refrigerants, and per- and polyfluoroalkyl acids (PFAA) and their precursors such as those used as additives in oil- and stain-resistant surface treatments.

PFAS restrictions worldwide: a regulatory analysis

Because of their many superior properties (high stability, water and stain repellency, high temperature resistance and low surface energy), PFAS are widely used in electronic and electrical products and their materials: food contact materials (food contact paper and board), cables, printed circuit boards (PCB), semiconductors, various electronic components, anti-fingerprint screens, liquid crystal displays (LCD), non-stick coatings, non-stick cookware, stain- and water-resistant fabrics and carpets, leather and clothing, paints and coatings, cleaning products and firefighting foams.

Because PFAS take hundreds of years to degrade in soil and water, they are called persistent organic pollutants (POPs) or "forever chemicals". PFAS also migrate easily in the environment. When people and animals ingest PFAS, they accumulate in the body and cause toxicity, affecting the immune and reproductive systems, interfering with the endocrine system, affecting infant growth and development and causing liver damage. They may increase the risk of thyroid disease, kidney cancer, hypertension and testicular cancer, and have potential carcinogenicity. These are only the known hazards; the hazards of most PFAS are still unknown. In recent years, as research has deepened, the health risks posed by PFAS have attracted increasing attention, and countries and regions around the world are stepping up the development of regulations and policies to strengthen control of PFAS.

Control of PFAS in the European Union

7 February 2023

The EU published a proposal for a PFAS restriction regulation, drafted by Denmark, Germany, the Netherlands, Norway and Sweden. On 7 February 2023, the European Chemicals Agency (ECHA) published on its official website the proposal from the five countries to ban almost 10,000 PFAS, prohibiting the widespread use of "forever chemicals" and including comprehensive control proposals for fluoropolymers (such as PVDF) and side-chain polymers (such as fluorinated PP). The proposal would have a major impact on the fluorochemical industry and downstream consumer product sectors.

The proposed restrictions are as follows:

Individual content of any specific PFAS 25 ppb or less (excluding PFAS polymers);

Sum of specific PFAS (excluding PFAS polymers) 250 ppb or less;

Total fluorine below 50 mg F/kg; where total fluorine is above 50 mg/kg, manufacturers, importers or downstream users shall, on request, provide evidence to enforcement authorities clarifying whether the content is PFAS or non-PFAS.

REGULATION (EU) 2019/1021 (POPs)

On 30 May 2023, the European Commission announced its decision to adopt the proposal amending Annex I to Regulation (EU) 2019/1021, confirming the inclusion of PFHxS and its salts and related substances in the list of prohibited substances under the POPs Regulation. The list in Annex I increased from 28 to 29 entries, and the number of prohibited PFAS substances under the POPs Regulation rose from two to three.

REGULATION (EU) 1907/2006 (REACH)

REACH is the comprehensive EU regulation governing chemical substances. The SVHC candidate list contains a further number of PFAS compounds and is being continuously updated and expanded.

REGULATION (EU) 2023/1608 (PFHxA)

On 13 June 2023, the World Trade Organization (WTO) announced a draft EU regulation intended to regulate undecafluorohexanoic acid (also known as perfluorohexanoic acid, PFHxA) and its salts and PFHxA-related substances in various consumer products. According to the WTO notice, the draft regulation was to be adopted in the fourth quarter of 2023.

Control of PFAS in the United States

On 29 June 2023, the US EPA published a regulatory control requirement for PFAS on its official website. The regulation aims to stop environmental releases of persistent, bioaccumulative and toxic (PBT) PFAS at source and to eliminate unreasonable risk before production activities take place. US state legislation on PFAS reflects complex rules that differ by state and product type. Some regulations are already in force or will take effect in the coming years. Besides bans on intentionally added PFAS, other regulatory measures include requirements to report or label products containing PFAS.

Control of PFAS in Japan

On 1 December 2023, the Japanese Ministry of Economy, Trade and Industry (METI) published Cabinet Order No. 343, designating perfluorohexane sulfonic acid (PFHxS) and its salts as Class I specified chemical substances under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No. 117 of 16 October 1973, also known as the Chemical Substances Control Law, CSCL).

The new order contains two important provisions:

Prohibition of the use, manufacture and import of PFHxS and its salts

Prohibition of the import of ten categories of specified products

There are two important dates:

1 February 2024 - Cabinet Order No. 343 enters into force

1 June 2024 - prohibition of the import of PFHxS and its salts in the ten categories of products

The table below summarises the key points of the new law prohibiting the ten categories of products.

Control of PFAS in China and elsewhere

On 29 December 2022, the Ministry of Ecology and Environment, together with the Ministry of Industry and Information Technology, the Ministry of Agriculture and Rural Affairs, the Ministry of Commerce, the General Administration of Customs and the State Administration for Market Regulation, jointly issued the List of New Pollutants for Priority Control (2023 Edition), which took effect on 1 March 2023. The list identifies 14 categories of new pollutants for priority control together with their environmental risk control measures, including prohibitions, restrictions and restricted discharge. It covers perfluorooctane sulfonic acid and its salts and perfluorooctane sulfonyl fluoride (PFOS group), perfluorooctanoic acid and its salts and related compounds (PFOA group), and perfluorohexane sulfonic acid and its salts and related compounds (PFHxS group). For these three fluorinated compounds the measures are a ban on production and a ban on processing and use (except for specific uses), and for the PFHxS group also a ban on import and export. Chemical substances used for laboratory-scale research or as reference standards are not subject to the above prohibitions or restrictions on production, processing, use, import or export. Unless otherwise specified, chemical substances present in products and articles as unintentional trace contaminants are not covered by the list.

On 16 June 2023, the Ministry of Ecology and Environment published the Catalogue of Strictly Restricted Toxic Chemicals in China (2023) (draft for comment) for public consultation. The catalogue includes PFOS and PFOA. Enterprises importing or exporting PFOS and PFOA must apply to the Ministry of Ecology and Environment for a toxic chemical import/export environmental management release notice in accordance with the regulations. Importers and exporters shall use the release notice to complete import and export formalities with customs.

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