2023

PFAS: the biggest restriction proposal ever

by cyb2025

ANTONIO CONTO
Chemsafe, Colleretto Giacosa (TO), Italy

Following the procedure laid down by Annex XV of the REACH Regulation, on January 13, 2023, five Member States (Germany, The Netherlands, Denmark, Sweden and Norway) has submitted a restriction proposal on PFAS (per-polyfluoroalkyl substances) to ECHA (European Chemical Agency). On February 7, 2023, ECHA published this long-awaited restriction proposal for PFAS. The procedure started and the discussion as well! This restriction proposal is aimed to ban from manufacture and use a huge amount of chemicals (up to 10.000) considered harmful to the environment and to human health but, on the other way, will impact dozen of industries including the textile sector, medical devices and consumer cookware. Substitution will be the main issue!
Per- and polyfluoroalkyl substances (PFASs) are a group of synthetic organic chemicals that have been in use since the 1950s, i.e. as ingredients or intermediates for industrial and consumer applications. They have attracted much public attention since the late 1990s and early 2000s, when the hazards and ubiquitous occurrence in the environment of two PFASs, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), started to be reported and recognized. Early communications used many different terminologies for what nowadays are called PFASs (e.g. per- and polyfluorinated chemicals, perfluorinated organics, perfluorochemical surfactants or highly fluorinated compounds).
According to the proposal, PFASs means substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom, without any H/Cl/Br/I attached to it. This definition contains few exceptions and is consistent with the July 2021 Organization for Economic Cooperation and Development (July 2021 OECD) definition.
PFAS are a class of chemical compounds that are used in everyday products—clothes, furniture, adhesives, food packaging, nonstick cooking surfaces, and the insulation of electrical wire—to make them resistant to heat, oil, stains and water. Often referred to as “forever chemicals” which don’t exist in nature and are referred to as “forever chemicals” because the chemical compounds don’t naturally degrade. This means they end up contaminating groundwater for decades after their release into the environment.

 

WHAT IS THE CONCERN?
The main concern for all PFASs and/or their degradation products that are in the scope of this restriction proposal is the very high persistence, exceeding the criterion for very persistent (vP) according to Annex XIII of the REACH Regulation by far. PFASs and their degradation products may persist in the environment longer than any other man-made chemical. Further supporting concerns are their bioaccumulation, mobility, long range transport potential (LRTP), accumulation in plants, global warming potential and eco-toxicological effects. PFASs enter the environment via emissions during manufacture, the use phase and the waste stage.

 

ABOUT THE AUTHOR

Antonio Conto is the founder of Chemsafe, an indipendent Regulatory Affairs company established in 2001. He has been working as Experimental Toxicologist in an Italian CRO for 13 years (1988-2001) before founding Chemsafe.
He manages a lot of REACH registration dossiers and related Risk Assessment at international level. In 2011 he was recognized as European Registered Toxicologist i within EUROTOX as well as RENTIC (the Italian Registry of Toxicologist). Antonio pubblished around 100 papers in the field of regulatory science and attended lots of regulatory/scientific events as invited speaker. He is active members of various associations both in the chemical and medical areas (pharma and Medical Devices).

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