The upcoming PFAS ban

6 minutes01/31.2024

There are topics in hazardous chemicals management that most people, literally, have no points of contact with. When it comes to protecting employees from substances hazardous to health, we often think of solvents like toluol or xylene, used in vehicle painting, or calcium oxide released during cement production. However, there is also a group of chemicals that has a widespread presence in our everyday life - PFAS. Anyone who has ever drunk coffee from a disposable cup or prepared dinner in a non-stick pan has likely come into contact with PFAS.

PFAS are as common as sand in the sea, which poses a significant problem for manufacturing companies as the European Union proposes a comprehensive restriction of their use.

In this article, you will learn everything you need to know about PFAS, the REACH regulation, and the upcoming ban. Above all, we will show you how to respond to these changes in a timely and effective manner.

What are PFAS?

The acronym PFAS stands for Per- and polyfluorinated alkyl substances and refers to a group of more than 10,000 chemicals that can be found in countless consumer products. For instance, in shampoo, rainproof clothing, wall paints, baking paper, coffee cups or even on frying pans. This is because PFAS are water, grease, and dirt repellent, convincing with chemical and thermal stability. These favorable properties make them popular amongst various industries and manufacturing companies. The plastic Polytetrafluoroethylene (PTFE), also falls under the group of PFAS, and is better known by another name: Teflon.

What dangers do PFAS pose?

PFAS also have a downside: Certain PFAS have been found to have harmful effects on health and the environment. In addition, long-chain PFAS are barely degradable and persist over longer periods. For this reason, they have also been described as "forever chemicals". It is possible that they can enter the human body through food and drinking water, where they can have harmful effects at high concentrations. Consequently, the use of some of the substances belonging to the PFAS has been legally restricted or completely prohibited in the REACH regulation - this includes, for instance, Perfluorooctane sulfonate, C8 (PFOS), and Perfluorooctanoic acid (PFOA).

REACH and PFAS

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. This European regulation came into effect on July 1, 2007, and has been constantly undergoing revision ever since. It sets specific requirements for companies that manufacture, use, or place chemicals on the market.

The REACH regulation provides specific guidelines for certain PFAS and thus, constitutes an essential reference for hazardous chemicals managers and officers. Changes and new provisions within the REACH regulation are communicated by the European Chemicals Agency (ECHA). To ensure constant legal compliance, it is advisable to regularly retrieve updates from the official ECHA homepage: echa.europa.eu/home.

In addition to the aforementioned PFOS and PFOA, comprehensive restrictions on the production, use, and marketing of perfluorinated carboxylic acids with 9 to 14 carbon atoms (C9-C14-PFCA) apply since 2023. This also includes their salts and precursor compounds that can be converted into these perfluorinated carboxylic acids.

REACH Annex XVII

REACH Annex XVII lists substances where the production, usage, and marketing are either restricted or completely forbidden due to unacceptable risks to human health or the environment. It includes, for instance, perfluorooctanoic acid (PFOA) falling into the PFOS category, including its salts and precursor compounds.

REACH Candidate List

Article 57 of the REACH regulations specifies the criteria for substances of very high concern (SVHC) included in the Candidate List. These are substances with properties that cause concern. This includes substances that carry carcinogenic, mutagenic, or reprotoxic risks. Upon entry into the Candidate List, these substances may subsequently be featured in Annex XIV of the REACH regulation.

REACH Annex XIV (page 42)

This annex includes substances subject to authorization. Items on this list may not be used in the EU. Exceptions: when no alternative substances are available, or there are socio-economic reasons for the use, companies have the possibility to apply for authorization.

Further European and international PFAS regulations

POP Regulation

In addition to the REACH Regulation, which governs the use of PFAS at the EU level, it is also worthwhile to take a look at the so-called EU POP (Persistent Organic Pollutants) Regulation. This regulation governs persistent organic pollutants, which are, in turn, managed by the globally valid prohibition list of the Stockholm Convention. Certain PFAS are included in these pollutants and are therefore also regulated in the POP Regulation.

Good to know

As soon as a chemical or a group of chemicals is included in the EU POP Regulation, the corresponding restriction entries in the REACH Regulation are deleted. This process is intended to prevent parallel regulations.

EU Chips Act

The European Parliament has passed legislation intending to boost semiconductor production across the European Union, named the EU Chips Act. However, the European Semiconductor Industry Association (ESIA) has expressed concern over the potential impact on innovation due to comprehensive PFAS restriction. The legislation aims to address supply chain vulnerabilities revealed by the pandemic and to thwart potential semiconductor shortages. It has allocated €3.3 billion for research and innovation.

U.S. Safer Products for Washington program

The state of Washington is evaluating potential PFAS-disclosure mandates for various product categories under its Safer Products for Washington program. This step reflects the state's ongoing efforts to identify safer substitutes for numerous PFAS-containing priority products, as stipulated by a law enacted in 2022. The law aims to expedite pollution prevention linked to PFAS.

U.S. Environmental Protection Agency (EPA)

The U.S. Environmental Protection Agency (EPA) has announced a new enforcement initiative that holds both manufacturers and users of PFAS accountable for pollution. This enforcement and compliance initiative will be implemented for the fiscal years 2024-2027.

The initiative aims at enforcing anticipated hazardous substance listings, specifically for PFOA and PFOS, under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). This would necessitate manufacturers and users of these chemicals to fund costly remediation associated with PFAS pollution.

Canada Prohibition of Certain Toxic Substances Regulations

The Canadian government has declared that firm plans for imposing stricter regulations on long-chain PFASs and a pair of flame retardants will not be concluded until the summer of 2024 at the earliest. This information was communicated in a notification to the World Trade Organization (WTO). Environment and Climate Change Canada (ECCC) and Health Canada had initially proposed an update to the Prohibition of Certain Toxic Substances Regulations in the country in May 2022. They had envisaged finalizing these changes by the end of the same year.

Comprehensive PFAS ban through the REACH Regulation?

An EU-wide ban on PFAS has been in discussion for quite some time. This also entails a corresponding revision of the REACH regulation. A proposal to this effect was submitted to the EU Chemicals Agency (ECHA) on February 23, 2023 by Germany, Sweden, Norway, Denmark and the Netherlands.

Which PFAS are affected?

The restriction proposal targets all substances and mixtures containing at least one fully fluorinated methyl group (-CF3) or methylene group (-CF2-) without any further H-, Cl-, Br- or I-atoms.

What limit values are proposed?

The proposal recommends specific limit values for these substances:

• ≥ 25 ppb for PFAS that can be determined by targeted analysis (except for polymers)

• ≥ 50 ppb if no targeted analysis is possible (for example, in the case of polymers)

• ≥ 250 ppb as a sum parameter of all existing PFAS

When will the PFAS ban be implemented?

The consultation process for the restriction proposal ended in September 2023. However, the EU Commission has continually postponed a final decision. The binding implementation of a comprehensive PFAS restriction is therefore not expected until 2026.

What transition periods will there be?

If a comprehensive restriction of PFAS becomes obligatory as part of the revision of the REACH regulation, companies will need to respond accordingly. They must comply with the given values, check for substitution possibilities, and implement suitable measures. Transition periods of 18 months to 12 years are being discussed within the framework of the PFAS restriction proposal. However, it is expected that the majority of PFAS will be banned 18 months after the revision of the REACH regulation comes into effect.

How can companies act now and stay ahead?

Companies must be familiar with the requirements of the REACH regulation regarding PFAS and conduct corresponding evaluations. But how can this be accomplished with 10,000 substances? A feasible approach in the PFAS evaluation is to focus on 13 compounds for which insignificant threshold values or health advisory levels (HAL) are defined. For these substances, there is also the possibility to carry out an analysis according to DIN standards.

Conclusion

Even though numerous regulatory frameworks such as the POP and REACH Regulations exist, dealing with PFAS poses a challenge for hazardous materials managers and officers. The evaluation of all substances is hardly feasible solely due to the large quantity of more than 10,000 substances. Therefore, it is recommended that the assessment initially focuses on 13 compounds for which clear threshold values or health advisory levels (HAL) exist. Whether a comprehensive PFAS restriction will be enshrined in the REACH Regulation is currently not clear-cut. A proposal for revision has indeed been submitted, but the EU has not yet made a final decision. Experts currently assume that a comprehensive ban on PFAS in the REACH Regulation could come into force in 2026. The transition periods will then likely range from 18 months to 12 years.