Pending a systematic reform of the REACH (Registration and Authorization of Chemicals) regulation – already promised but not even proposed by Ursula von der Leyen in the previous legislature (1) – the European Commission has introduced some restrictions on the use of PFHxA, a substance of the PFAS group, in various industrial applications. (2)
1) PFAS, introduction
PFAS (per- and polyfluoroalkyl substances), also known as ‘forever chemicals‘, are a large group of chemical compounds known for their exceptional properties of resistance to heat, water and fats. These characteristics have been attributed to PFAS:
-wide diffusion in a wide range of industrial applications. From food packaging to non-stick coatings, even in food contact materials (FCM), to waterproof fabrics and fire-fighting foams;
– the cause of a public health problem, linked to the toxicity of these substances, as well as of widespread and permanent environmental pollution on a global scale, precisely because of the substantial impossibility of degradation of their molecules. (3)
2) PFAS, dangers for health and the environment
Two common features of all the chemicals in the PFAS group, which adds to their persistence in the environment, are:
-high mobility, because PFAS spread through water, air, rain, animals, food; is
-the bioaccumulation capacity in living organisms, which in turn poses a significant challenge to public health, food safety and the environment.
IARC (International Agency for Research on Cancer) confirmed in 2023 the carcinogenicity of PFOA and PFOS, two of the most widespread substances in the PFAS group. (4)
Other studies have confirmed a correlation between exposure to PFAS – already known as endocrine and immune system disruptors – and premature mortality from all causes. (5)
3) PFHxA, PFAS group
PFHxA (perfluorohexanoic acid) is a single chemical compound that belongs to the family of PFAS and derivatives. Its chemical structure makes it similar to other better-known perfluoroalkanoic acids, such as PFOA (perfluorooctanoic acid).
This substance, like others, is used in various industrial applications such as technical textiles, fire-fighting foams and food packaging. It is less persistent than long-chain compounds, but its mobility in water is a cause for concern.
4) Five years of labor
The 20 December 2019 Germany has submitted a dossier to the European Chemicals Agency (ECHA), highlighting that the use and placing on the market of PFHxA, its salts and related substances in certain mixtures and products pose an unacceptable risk to human health and the environment.
Germany has therefore proposed to introduce maximum concentration limits for the use of PFHxA as a component for the production of other substances and objects, with a transition period of 18 months. And longer application periods for certain applications, taking into account the socio-economic implications of the measures.
On June 3 2021 ECHA’s Risk Assessment Committee (RAC) has partially acknowledged the validity of the evidence presented by Germany, acknowledging the toxicity of PFHxA to the liver in particular. Recognizing ‘food contact materials’, textiles and fire-fighting foams as the main sources of exposure.
The 19 September 2024 The European Commission has finally acknowledged the request for restrictions and limits proposed by Germany, given the irreversibility of PFHxA emissions into the environment. However, it has extended the transitional period and exemptions beyond measure, privileging, as always, industrial interests over public and environmental health.
5) Restrictions on the use of PFHxA in the European Union
Regulation (EU) 2024 / 2462, partially amending the REACH regulation, therefore introduces the ban on the use of perfluorohexanoic acid (PFHxA) in concentrations exceeding 25 ppb, for the sum of PFHxA and its salts, and 1.000 ppb for related substances, starting from October 2026.
Restrictions apply to numerous products, including:
–food packaging, such as paper and cardboard intended for contact with food (6,7)
–cosmetics (i.e. skin creams and lotions, shampoos and conditioners, nail care products, lipsticks, toothpastes, mouthwashes, perfumes)
–textiles (e.g. fabrics, leather, furs, skins and related accessories waterproofed with PFAS)
–other products and materials (i.e. carpets, rugs, curtains, shutters, tapestries, fabric wall coverings, tablecloths, bed sheets).
6) Five years of transition
The application of the new limits is postponed, in tranches, until five years after the entry into force of the regulation (10 October 2024). And so:
-18 months for fire-fighting foams used for training, testing and public fire services;
–24 months for fabrics, leather, furs and skins used in clothing and related accessories and footwear for the public, paper and cardboard used as materials in contact with food, mixtures for the public and cosmetic products;
-36 months for fabrics, leather, furs and skins not used in clothing and related accessories for the public;
-5 years for fire-fighting foams used in civil aviation.
7) Exceptions ‘sine die’
Some ‘strategic’ sectors will still be able to continue using the toxic chemical until ‘safe alternatives’ become available. An oxymoron. The indiscriminate use of PFHxA can therefore continue for the production of:
-personal protective equipment (PPE), which requires ‘high technical features to ensure worker safety in extreme environments‘;
-certain medical devices, for which the use of PFHxA would once again be essential to ensure specific performance;
-textile products used in the construction sector such as tents, stadium coverings, pavilions, car parks, reinforcements for road surfaces and bridges, thermal insulation materials, agricultural roofing.
Dario Dongo and Paolo Rebolini
Footnotes
(1) Alessandra Mei. Approval of REACH changes postponed. The chemical lobby can rejoice. GIFT (Great Italian Food Trade). 26.10.22 https://
(2) Commission Regulation (EU) 2024/2462 of 19 September 2024 amending Annex XVII to Regulation (EC) No 1907/2006 as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances https://tinyurl.com/mmyw8abk
(3) Marta Strinati, Dario Dongo. PFAS in rainwater and food, a global ban is urgently needed. GIFT (Great Italian Food Trade). 26.8.22 h
(4) Marta Strinati. PFAS substances are carcinogenic, IARC confirms. GIFT (Great Italian Food Trade). 3.12.23
(5) Marta Strinati, Ylenia Desiree Patti Giamello. PFAS pollution, almost four thousand more deaths in 30 Veneto municipalities. GIFT (Great Italian Food Trade). 25.6.24
(6) Marta Strinati, Dario Dongo. Toxic chemicals in disposable tableware and packaging. Survey on PFAS in the EU. GIFT (Great Italian Food Trade). 29.5.21
(7) Marta Strinati. PFAS, Toxic Chemicals in Fast Food Containers and Tableware. IPEN Investigation. GIFT (Great Italian Food Trade). 19.12.23