While there is no published list of chemicals that meet the definition of PFAF, the statute requires any chemical containing at least one fully fluorinated carbon atom (a carbon atom on which all the hydrogen substituents have been replaced by fluorine) that is intentionally added to a product to be reported to the Department. Provided is a webpage of chemicals considered PFAS by the FDA, which, while not exhaustive, provides some clarity on what compounds are considered within the definition of PFAS.

Manufacturers impacted by this new legislation may request an extension if the presence of PFAS in their products is unknown and/or if they cannot provide sufficient information to meet the reporting requirements in Maine law by the reporting deadline.

Don’t hesitate to contact us if you have any questions about this update or would like our assistance determining if this new legislation could impact your products.

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1. p-Dichlorobenzene

2. 1,2-Dichloroethane

3. trans-1,2- Dichloroethylene

4. o-Dichlorobenzene

5. 1,1,2-Trichloroethane

6. 1,2-Dichloropropane

7. 1,1-Dichloroethane

8. Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester)

9. Butyl benzyl phthalate (BBP) – 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester

10. Di-ethylhexyl phthalate (DEHP) – (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)

11. Di-isobutyl phthalate (DIBP) – (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester)

12. Dicyclohexyl phthalate

13. 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)

14. Tris(2-chloroethyl) phosphate (TCEP)

15. Phosphoric acid, triphenyl ester (TPP)

16. Ethylene dibromide

17. 1,3-Butadiene

18. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)

19. Formaldehyde

20. Phthalic anhydride

With respect to this proposal, a High-Priority Substance is defined as “a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA”. It is important to note that the EPA has explicitly stated proposing a chemical substance be classified as High-Priority “is not a finding of unreasonable risk”, but rather, once the final ruling on the High-Priority Substance list is released, the chemical substances will then undergo a complete risk evaluation and a determination on their risk will be made.

The proposal is currently open for a comment period, where any interested party, including members of the general public, can submit comments on the list up until November 21, 2019. The EPA also released a corresponding list to this that outlined 20 chemical substance they proposed to be designated as Low-Priority Substances. Comments are being accepted on this proposal until November 13, 2019. For more

information on the proposal or the prioritization of chemicals visit the EPA’s webpage on Assessing and Managing Chemicals under TCSA here or read the full Federal Register notice here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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