In-depth Analysis of PFAS Regulation in the European Union
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Per- and Polyfluoroalkyl Substances (PFAS) refer to substances that contain at least one perfluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/CI/Br/I). According to existing data, there are over 10,000 substances that meet this definition.

Chemical Hazards

PFAS exhibit extremely high thermal stability and chemical stability, allowing them to withstand high temperature heating, light exposure, chemical reactions, microbial activity, and metabolic processes in higher vertebrates. They are among the most persistent organic pollutants discovered worldwide and have high bioaccumulation potential. Upon ingestion by organisms, they do not accumulate in adipose tissue but instead form bonds with proteins in the bloodstream and accumulate in tissues such as the liver, kidneys, and muscles, exhibiting significant bioaccumulation.

Both PFOA and PFOS can cause weight reduction and smaller body size in newborns. PFOA can disrupt endocrine function and is associated with carcinogenicity and thyroid diseases. In general, the longer the carbon chain of perfluorinated compounds, the more difficult their degradation and the greater their hazards. The production, market release, and use of PFAS also contribute to the pollution of drinking water and soil through total emission levels.

Common Applications

These substances are widely used in various products due to their oil resistance, water resistance, and low reactivity. They are utilized in products such as stain repellents, lubricants, non-stick coatings for cookware, textiles, cosmetics, paper, food packaging, optoelectronics, semiconductors, and firefighting foams. They have also been found in plastic toys, metal surface coatings, ski wax, dental floss, cosmetics, and drinking water.

EU Regulation on PFAS

The European Union's chemical sustainability strategy places PFAS control at the forefront and center of its vision for 2025. The European Commission has committed to gradually phasing out all PFAS, allowing their use only in cases where they are proven irreplaceable and crucial to society.

On February 7, 2023, the European Chemicals Agency (ECHA) published a proposal recommending the ban of nearly 10,000 PFAS substances, aiming to restrict the widespread use of "forever chemicals" PFAS. The proposal includes comprehensive control measures for fluoropolymers (such as PVDF) and other related products, causing significant impact on the fluorine industry and downstream consumer sectors.

The EU's regulation on Persistent Organic Pollutants (POPs) and Annex XVII of the REACH regulation have already imposed controls on perfluorooctanoic acid (PFOA) and its salts and related substances, perfluorooctanesulfonic acid (PFOS) and its derivatives, C9-C14 perfluorocarboxylic acids (C9-C14PFCA) and their salts and related substances. Perfluorohexanoic acid (PFHxA) and its salts and related substances, perfluorohexanesulfonic acid (PFHxS) and its salts and related substances, C9-C21 perfluorocarboxylic acids (C9-C21PFCA) and their salts and related compounds are also included in the REACH and POPs regulations.

Standards

Restricted Substances and Limit Values

Implementation Date/Status

REACH Annex XVII

Sum of C9-C14 PFCA and its salts 0.025 mg/kg
Sum of related substances of C9-C14 PFCA
0.26 mg/kg

February 25, 2023.
Implemented

PFHxS and its salts sum ≤0.025 mg/kg
Sum of related substances of PFHxS ≤1 mg/kg

Proposal

PFHxA and its salts sum ≤0.025 mg/kg
Sum of related substances of PFHxA ≤1 mg/kg

Proposal

All PFAS
Targeted analysis of individual PFAS content: ≤0.025 mg/kg
Sum of targeted analysis of PFAS content ≤0.25 mg/kg
Total fluorine content: ≤50 mg F/kg

Proposal

POPs

PFOA and its salts sum ≤0.025 mg/kg
Sum of related substances of PFOA ≤1 mg/kg

July 4, 2020.
Implemented

PFOS and its derivatives substances/mixtures: 10 mg/kg
Articles: ≤1000 mg/kg
Textiles/Leather: ≤l ug/m2

August 26, 2010.
Implemented

PFHxS and its salts sum ≤0.025 mg/kg
Sum of related substances of PFHxS ≤1 mg/kg

Proposal

Long-chain perfluorocarboxylic acids (LC-PFCAs) (C9-C21 PFCAs) and their salts and related compounds.

Risk assessment

Recently, the European Union has announced that a special enforcement action targeting PFCAS-related substances will be carried out between 2023 and 2024. For more details, please click here to view: [EU will Start Enforcing Restrictions on PFCAs and Related Substances

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