The European Chemicals Agency (ECHA) had previously listed many chemicals as Substances of Very High Concern (SVHC) based on their mutagenic, carcinogenic, reproductive toxic, and environmental persistence of bioaccumulative properties. According to Regulation (EC) 1907/2006 (REACH), any chemical may be classified as an SVHC if it possesses properties of an equivalent level of concern. This 'equivalent concern' largely means substances that have endocrine-disrupting properties.
For the first time ever, a chemical substance called 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propionic acid (HFPO-DA/GenX) has been identified as an SVHC based on its environmental persistence and mobility, which means that the substance was being detected even far away from its apparent source. As a result, environmental mobility has been used the 'equivalent concern' for the first time. This major milestone was agreed upon by the ECHA's Member State Committee (MSC) and in its meeting held in June 2019, the MSC classified HFPO-DA, its salts and acyl halides as SVHCs by virtue of their probable serious effects on human health and environment. If the REACH Committee approves, the GenX-related chemicals will be added to the 'Candidate List for Authorization' followed by an endorsement by the European Commission.
The chemical substance 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propionic acid, its salts, and acyl halides are collectively referred to as HFPO-DA. The ammonium salt of HFPO-DA is called GenX and is also the trade name for the processing aid technology used to produce fluoropolymers that were developed by DuPont (Chemours).
Over the last few years, these substances have been used across Europe and have already been found in the location where there is no apparent source in the nearby area. With high solubility in water and low adsorption potential, these substances can travel long distances. The standard water treatment processes are not suitable because of their low adsorption potential.
Several studies have suggested that HPFO-DA is carcinogenic and has endocrine-disrupting effects as well as bears adverse effects on our liver, kidneys, immune system, and blood. The chemical does not accumulate in the human body, in fact, it gets eliminated from the body rapidly.
The manufacturers as well as importers wanting to place the substance that has been identified as an SVHC on the European Economic Area need to fulfil legal obligations under REACH, which includes the responsibility of providing information regarding the safe use of the substance to its downstream users, whether the substance is sold in a pure form or as a part of a product.
One of the ways the information on safe use could be communicated is the Safety Data Sheet (SDS), a must-have document for substances/mixtures containing an SVHC at levels greater than or equal to 0.1% by weight. If an SDS has been created already, Section 15 in the document needs to be updated in order to show the presence of an SVHC substance. If the product contains an SVHC at more than 0.1% by weight and the annual production volume exceeds 1 ton, then a notification dossier should be submitted to ECHA. Eventually, the importers and manufacturers of SVHCs will be forced to think towards reformulating their products and find safer alternatives. Once reformulated, the product needs a reassessment of hazards and associated SDS document and labels need to be developed.