A recently proposed universal ban on ‘forever chemicals’ in the EU would have a negative impact on pharmaceutical innovation and access to medicines, the pharmaceutical industry has warned.
Denmark, Germany, the Netherlands, Sweden, and non-EU member Norway on 13 January proposed an EU-wide ban on over 10,000 per- and polyfluoroalkyl substances (PFAS) under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
A restriction proposal, due to its broadness also known as universal PFAS restriction, aims to address the risks to the environment and human health from the manufacture, placing on the market and use of PFAS.
Peter van der Zandt, director of risk management at European Chemicals Agency (ECHA), said this is “one of the broadest restrictions we’ve ever seen in the EU,” during a debate with members of the European Parliament’s health committee (ENVI) on 27 June.
The proposal match with the Commission’s commitment, under the EU’s chemicals strategy, to phase out PFAS in the EU, unless their use is essential for society.
PFAS are a large, complex group of synthetic chemicals that have been used around the world since the 1950s. Carbon-fluorine bonds, one of the strongest chemical bonds in organic chemistry, give PFAS useful properties for making products non-stick, or oil-, stain-, and water-repellent.
On the flip side, PFAS persist in the environment, hence the ‘forever chemicals’ nickname.
These substances pollute water and soil and cause adverse health effects, such as liver damage, immune system disruption, and certain cancers. They can have negative effects on human reproduction and can harm the development of fetuses or interfere with the hormonal system as endocrine disruptors.
Despite the potential harm, PFAS are used across many industries and can be found in textile, food contact materials and packaging, cosmetics, medical devices, transport, electronics and semiconductors and others as well as medicinal products.
The dossier submitters proposed to ban the manufacture, use, and placing on the market of PFAS with a general transition period of 18 months after the entry into force. There are several use-specific and time-limited derogations based on the availability of alternatives, and on socio-economic considerations for those specific sectors.
“Also, there is a general derogation for the use [of PFAS] as an active substance in plant production, biocidal and medicinal products,” van der Zandt said, stressing that this is not a ‘blanket ban’.