New version of the Chemicals Penalties Regulation – Risk of criminal liability when dealing with PFAS

The dangers posed to consumers by per- and polyfluoroalkyl substances (PFAS) have been broadly publicised, even before the billion-dollar legal battles in the United States became widely known. Chemical companies were sued after their products were suspected of having released PFAS into drinking water. Comprehensive regulation of PFAS has also been a concern for companies in the EU for several years.

Legislators in Germany have recently become active again in connection with PFAS: after more than five years of unclear legislation, offences involving PFAS have now been newly regulated. The correspondingly amended German Chemicals Penalties Regulation (Chemikaliensanktionsverordnung – ChemSanktionsV) came into force on 18 January 2025. As a result of the amended provisions, manufacturers, importers and distributors may face fines and criminal penalties even for minor breaches of certain thresholds.

I. PFAS and related regulation

PFAS have water-, oil- and dirt-repellent properties and are therefore found in many consumer products (cosmetics and textiles, for example). However, because they persist in the environment – and hence are known as “forever chemicals” – they have a considerable impact on the environment and health as well. This prompted the European Union to strictly regulate how to deal with PFAS several years ago. At present, two EU regulations in particular play a central role in this: Regulation (EU) 2019/1021, also known as the POPs Regulation (Persistent Organic Pollutants), and Regulation (EC) 1907/2006, better known as the REACH Regulation.

The following chemicals are among the main PFAS currently subject to mandatory regulation: In addition to perfluorooctanesulfonic acid (PFOS) and its derivatives, the POPs Regulation also regulates perfluorooctanoic acid (PFOA). Perfluorohexanesulfonic acid (PFHxS) was also subsequently included in the Regulation. All of these substances are therefore subject to the regulation on the control of manufacture, placing on the market, use and intake of substances (Article 3 POPs Regulation) and the provisions relating to waste management (Article 7 POPs Regulation).

The REACH Regulation also regulates perfluorinated carboxylic acids (PFCAs) in the PFAS group with chain lengths of nine to fourteen carbon atoms. With effect from 10 October 2024, undecafluorohexanoic acid (PFHxA), among others, has also been newly included in Annex XVII (No 79).

The REACH Regulation and POPs Regulation not only govern PFAS, but also chemicals with similar chemical compounds and similarly serious potential effects on the environment and health, such as short-chain chlorinated paraffins (SCCPs).

II. Current legal situation in Germany

Penalties for breaching the REACH Regulation and the POPs Regulation are specified at national level. Certain breaches of individual prohibitions laid down in the POPs Regulation and the REACH Regulation are punishable under criminal law or subject to fines in Germany in accordance with the Chemicals Penalties Regulation. The penalty or the size of the fine is set by the German Chemicals Act (Chemikaliengesetz – ChemG).

Before the new version of the Chemicals Penalties Regulation came into force on 18 January 2025, there was no clarity on the risks of criminal liability and fines when dealing with regulated PFAS. This is because sections 1 and 2 of the Chemicals Penalties Regulation (old version) continued to refer to the previous provision in the current POPs Regulation, Regulation (EC) No 850/2004, even after it had expired. The reference in sections 1 and 2 of the Chemicals Penalties Regulation (old version) has therefore been inapplicable since 14 July 2019. This raised the question of whether criminal liability or an administrative offence could still be established or whether there was a loophole in criminal liability given the criminal-law principle of certainty under Article 103(2) of the German Basic Law (Grundgesetz – GG).

III. Changes arising from the new version of the Chemicals Penalties Regulation

The federal legislators have now rectified this potential criminal liability loophole with the new version of the Chemicals Penalties Regulation: Since 18 January 2025, sections 10 and 11 of the new version of the Chemicals Penalties Regulation have set forth criminal and regulatory offences when dealing with the substances listed in Annex I of the POPs Regulation, including PFAS.

Provisions on offences against the REACH Regulation, which were previously covered in sections 5 and 6 of the Chemicals Penalties Regulation (old version), have been supplemented and can now be found in sections 1 and 2 of the Chemicals Penalties Regulation (new version).

IV. Criminal liability risks and risks of fines in the new legal situation

1. Criminal offences according to section 27 of the Chemicals Act

Intentional or negligent offences in dealing with PFAS, such as the manufacture, placing on the market or use of these substances, are punishable under section 27 of the Chemicals Act.

• Wilful conduct is generally punishable by a fine or a custodial sentence of up to two years.
• The manufacture and placing on the market of consumer goods containing PFAS (toys, packaging or cleaning and care products) fulfils the classification criteria in section 27(1a) of the Chemicals Act, which specifies a custodial sentence of up to three years on top of a fine. In the case of health hazards, the legislation even specifies a custodial sentence of up to five years (section 27(2) of the Chemicals Act).
• Even an attempt to commit one of these offences is a criminal offence (section 27(3) of the Chemicals Act).
• Negligent conduct is also expressly subject to criminal liability (section 27(4) of the Chemicals Act), i.e. failure to pay due care and attention in traffic.

2. Administrative offences according to section 26 of the Chemicals Act

Wilful and negligent offences relating to the waste management of substances listed in Annex IV of the POPs Regulation may lead to fines of up to €50,000.

V. Outlook

It is likely that both European and national legislators will continue to intensify the regulation of PFAS to protect human health and the environment. Companies would therefore be well advised to closely monitor compliance with the stricter conditions and future changes. Otherwise, they may face severe penalties.