There are a number of restrictions relating to PFAS or specific PFAS uses either in place or coming through the pipeline. However, the broad PFAS restriction proposed by 5 Member States will impact many Industries, with its wide-reaching ban on manufacture, use & placing on the market, not just for substances but also use in a mixture or article at a concentration limit that will challenge analytical methods.
A group approach was taken due to concerns relating to Persistence, Bioaccumulation and Mobility & (Eco)Toxicity to avoid regrettable substitution. The restriction proposal for PFAS was submitted to ECHA on the 13th of January 2023, and the 6-month consultation period began on the 22nd of March 2023.
The proposal has laid out two options to restrict more than 10,000 PFASs.
- Full ban with a limited number of derogations and a transition period of 18 months after the Regulation enters into force.
- Full ban with full derogations and use-specific time-limited derogations that would carry an 18-month transition period and a 5–12-year derogation period, depending on the application& availability of alternatives.
The scope of the restriction proposal includes any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it). Fully degradable PFAS subgroups are excluded from the scope.
A full derogation shall apply to the following uses; however, companies must submit every two years information relating to identity and quantity of the active substance placed on the market.
- active substances in biocidal products within the scope of Regulation (EU) 528/2012
- active substances in plant protection products within the scope of Regulation (EC) 1107/2009
- active substances in human and veterinary medicinal products within the scope of (EC) No 726/2004, (EU) 2019/6 and Directive 2001/83/EC
If time-limited derogations are accepted these will carry an annual reporting requirement along with a site-specific management plan.
In the US, the “group assessment approach” has not been applied. PFAS and its related variances are under the oversight of EPA and FDA at a Federal level, along with some specific bans in several states. The US has focused regulatory attention on drinking water, hazardous communication, and banning uses of PFAS in specific product types.
- Drinking water:
The EPA has advised a list of Regional Screening Level (RSLs) for PFOA, PFOS, PFNA, PFHxS and HFPO-DA in ground water, but the list is promulgated as an enforceable ruling. In the absence of federally regulated drinking water standards, several states, such as Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, Vermont, etc., have adopted drinking water criteria and more specific PFAS standards independently.
- Consumer products:
There are more regulatory activities around PFAS in consumer products at state level. For example:
- cosmetics (e.g., California, Colorado and Maryland);
- food packaging (e.g., California, Colorado, Connecticut, Hawaii, Maine, Maryland, Minnesota, New York, Rhode Island, Vermont and Washington);
- textiles (e.g., California, Colorado, Maine, Maryland, New York, Vermont, and Washington).
- California enacted AB-1817 to strictly ban the manufacturing, distribution, and sale of textiles containing intentionally added PFAS by January 1, 2025, or 2027; certain concentration limits do apply.
- Firefighting Foam:
No timeline has been stated for a complete aqueous film forming foam (AFFF) ban. The National Defense Authorization Act (NDAA) has enacted a series of mandates to encourage the transition of AFFF to fluorine-free alternatives. Multiple states, such as Alaska, Arizona, California, Colorado, etc. followed and imposed bans, or restrictions on the use of AFFF for training and non-emergency purposes.
- Hazardous Communication:
The NDAA also added 172 PFAS to the Toxics Release Inventory in 2020. Therefore, suppliers of products containing PFAS are required to update their SDSs accordingly. PFOS, PFOA and additional PFAS have been listed as hazardous chemicals and may trigger other regulatory actions promulgated by states like Alaska, Massachusetts, New Jersey, New York and Vermont.
According to the PFAS Strategic Roadmap rolled out by the EPA, as a commitment against PFAS from 2021 to 2024, the following will continue to be the theme of federal actions: established bans, restrictions, and mandates for PFAS in drinking water, consumer products, and industrial discharges.
H2 Compliance has the expertise to support you with your EU and US PFAS related concerns and queries. Please don’t hesitate to reach out to our team today!