Use of PFAS in ophthalmic optics

The Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on 1 June 2007. It aims to improve the protection of human health and the environment from the risks that can be posed by chemicals and, at the same time, to increase the competitiveness of the chemical industry in the EU. It also promotes alternative methods for the risk assessment of substances in order to reduce animal testing.
The REACH Regulation applies to all industrial chemicals. It is based on the precautionary principle: companies thus bear the burden of proof. All manufacturers, importers and end-users must ensure that the products they manufacture, place on the market and use do not adversely affect human health or the environment.1 Manufacturers and importers must demonstrate to the European Chemicals Agency (ECHA) how the product can be used safely and communicate the risk management measures to users. In the long term, substances with harmful effects on humans and the environment should be replaced by substances that are less hazardous.

PFAS

REACH is the phasing out of per- and polyfluoroalkyl substances (PFAS) in the EU.
"There are a total of 4,700 different PFASs, the effects of which on humans and the environment are largely unexplored. They spread across the globe via wind and water and accumulate in water, soil and living organisms - including humans. "2
PFASs are used in the field of ophthalmic optics for coatings on eyeglass lenses and in contact lens materials. According to EuromContact's published internal survey in Global Contact, Issue 1, 2023, three PFAS are used in the manufacture of RGP contact lenses (HFPM, TFEM, BHI) for which there is currently no alternative.3 Restrictions on the use of certain chemicals could have an impact on the medical devices available in the optical sector or the cost of these products or the supply situation. The Netherlands, Germany, Norway, Denmark and Sweden submitted a restriction proposal on 13 January 2023 covering a wide range of PFAS uses. A restriction proposal is a first step towards a European ban on PFASs. Now, within a deadline of 25 September 2023, justifications are being sought to justify a derogation. EuromContact is active in this area in cooperation with ECOO (European Council of Optometry and Optics).

Literaturnachweise

[1] BMUV (Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz). REACH Compliance: Data availability in REACH registrations. Part 2: Evaluation of data waiving and adaptations for chemicals ≥ 1000 tpa and Availability of human health and environmental data for high tonnage chemicals under REACH, https://www.bmuv.de/ suche?L=0&id=1892&q=REACH. Referencing: 27. Juni 2023.

[2] Umwelt Bundesamt (2020). Schwerpunkt 1-2020: PFAS. Gekommen, um zu bleiben, https://www.umweltbundesamt.de/publikationen/ schwerpunkt-1-2020-pfas-gekommen-um-zu-bleiben. Referencing: 27. Juni 2023.

[3] Diewald, H. (2023). PFAS forever?. Global Contact 2023 (93) – Issue 1, 16-18.