UN’s ECHA Indentifies Gen X Chemicals as SVHCs

GenX Chemical is a brand name for a chemical process that uses a chemical compound, 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propanoic acid) (FRD-903), which not biodegradable and not hydrolyzed by water, ammonium salt (2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propanoate) (FRD-902), and heptafluoropropy 1,2,2,2-tetrafluoroethyl ether (E1).

These chemicals have been in use in products supply chain, such as food packaging, paints, cleaning products, and non-stick coatings; out-door fabrics, cellular phones, laptops, cable wires and firefighting foam.

These chemicals replace the use of Perfluorooctanoic acid (PFOA) known as (C8) for manufacturing fluoropolymers such as Teflon. PFOA and related compounds have been found to be toxic and carcinogenic.

Recently the European Union (UN)’s Chemical Agency (ECHA)’s Member State Committee (MSC) has agreed to identify GenX-related chemicals as substances of very high concern (SVHCs). GenX chemicals have been found in surface water, groundwater, finished drinking water, rainwater, and air emissions in some areas.

Substances of very high concern identification

Substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHCs). If a substance is identified as an SVHC, it will be added to the Candidate List for eventual inclusion in the UN’s ECHA Authorization List. Recently, six new substances added to the Candidate List, webpage at: https://echa.europa.eu/-/six-new-substances-added-to-the-candidate-list.

Member States or the European Chemicals Agency (ECHA), on request of the European Commission, may propose a substance to be identified as an SVHC by preparing a document containing the details in accordance with the requirements set out in Annex XV to REACH (Registration, Evaluation, Authorization and Restriction of Chemicals).

In the US, the Federal, state, tribal, and local governments are working together to address per- and polyfluoroalkyl substances (PFAS) in the environment. PFAS are man-made chemicals used in a wide range of products because of their ability to repel water, grease, and oil. While PFOA and PFOS are the two most extensively produced and studied chemicals in the group, the US Environmental Protection Agency (EPA) is asking for public comment on draft toxicity assessments for GenX chemicals and perfluorobutane sulfonic acid (PFBS) to increase the amount of information the public has on other PFAS. When issued, the toxicity assessments can be used along with exposure information and other important considerations to assess potential health risks to determine if, and when, it is appropriate to act and address these chemicals. Basic Information on PFAS is available, at webpage at: https://www.epa.gov/pfas/basic-information-pfas.

On March 18, 2019, Dutch government has proposed polymer-processing chemical, commonly known as GenX chemicals (2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides) to be candidates for regulation in the European Union as substances of very high concern (SVHC). If approved by the REACH Committee, they will subsequently place them on the Candidate List, following the endorsement by the European Commission (EC).

The proposal says that exposure could adversely impact human health at intake levels as low as 21 ng/kg of body weight per day. The US EPA has previously defined a safe daily intake level of 80 ng/kg of body weight per day. It is the first time that chemicals have been proposed as SVHCs, based on their mobility and persistence in the environment.

In the in June this year, the MSC agreed unanimously to identify 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid (HFPO-DA), its salts and acyl halides as SVHCs due to their “probable serious effects on human health and the environment”.

The committee agreed that the substances, collectively referred to as HFPO-DA in the proposal, pose an equivalent level of concern (Eloc) to carcinogenic, mutagenic and reprotoxic (CMR), persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances.
In January, the MSC agreed that a plant producing GenX chemicals should set up a bio monitoring program with volunteer workers.

For further info and on these issues, ECHA) web page at: https://echa.europa.eu/.

 

References:
  • GEN X Chemical Proposed as the EU substances of very high concern (SVHC), web page at: References: https://www.foodpackagingforum.org/news/genx-chemicals-proposed-as-svhcs
  • Technical Fact Sheet: Draft Toxicity Assessments for GenX Chemicals and PFBS,webpage at:https://www.epa.gov/sites/production/files/2018-12/documents/tech_fact_sheet_genx_pfbs_draft_tox_assess_final_508.pdf
  • Fact Sheet: Draft Toxicity Assessments for GenX Chemicals and PFBS, webpage at: https://www.epa.gov/sites/production/files/2018-11/documents/factsheet_pfbs-genx-toxicity_values_11.14.2018.pdf.
  • EPA’s Conducting a Human Health Risk Assessment, webpage at: https://www.epa.gov/risk/conducting-human-health-risk-assessment
  • GenX web page at: https://en.wikipedia.org/wiki/GenX
  • European Chemical Agency (ECHA) web page: https://echa.europa.eu/

 

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