Where are we now?

The sector group, FPP4EU, understands and supports the need for balanced regulatory action to protect human health and environment.

The group’s main purpose is to gain a common understanding of what a broad PFAS restriction would look like, given the expected focus of the restriction and the complexity of the PFAS universe – which includes thousands of substances with very different properties and a multitude of applications.

Norway, the Netherlands, Sweden, Denmark, and Germany are working on a proposal for a REACH restriction on PFAS. EU policymakers are concerned that PFAS might pose risks to people and the environment. The upcoming proposal may impact the entire group of PFAS in the EU.

What is REACH?

REACH is an EU regulation aimed at improving the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals (the 5 main processes), and it entered into force in 2007.
In principle, it applies to all chemical substances and therefore it has an impact on most companies across the EU.
More detailed information can be found on the European Chemicals Agency website:
https://echa.europa.eu/regulations/reach/understanding-reach

How does a REACH restriction work?

The Restriction process has been included in REACH aims to protect human health and the environment from unacceptable risks posed by chemicals.
Through a restriction, it is possible to limit or ban the manufacture, placing on the market (including imports) or use of a substance, as well as to impose any relevant condition, such as requiring technical measures or specific labels. A restriction may apply to any substance on its own, in a mixture or in an article, including those that do not require registration.
The process for restrictions is quite long and it usually involves several stakeholders such as EU Member States, the European Chemicals Agency, and the European Commission.
More detailed information can be found on the European Chemicals Agency website:
https://echa.europa.eu/regulations/reach/restrictions/restriction-procedure

Water legislation

Concerning water legislation, some PFAS are regulated as individual substances, but also as a group in the Drinking Water Directive. The recast of the Drinking Water Directive, which took effect on 12 January 2021, includes a limit of 0.5 µg/l for all PFAS. This is in line with a grouping approach for all PFAS. The European Commission will define the specific group of “all PFAS” by January 2024.

The ongoing review of the lists of pollutants under the Water Framework Directive is considering inclusion of PFAS through a grouping approach in the legislation for surface and ground waters.

The Groundwater Directive does not include EU quality standards on PFAS. Member States establish threshold values for PFAS and monitor them, if these put groundwater bodies at risk of not achieving environmental objectives. The Commission has collected overall information on a voluntary basis on PFAS in groundwater. Participating Member States provided data from the most relevant monitoring sites (which could have been located near airports among other facilities).

The Urban Waste Water Treatment Directive is currently under revision and the revised version will be published by the European Commission in the second quarter of 2022. The evaluation report touches upon the issue of PFAS regarding sludge reuse, e.g. as fertiliser. 

Soil legislation

The European Commission has adopted the Zero Pollution Action Plan for air, water and soil, and published a new EU Soil Strategy for 2030 in November 2021 to better address soil pollution and degradation in the EU. The Soil Strategy specifically mentions the upcoming REACH PFAS restriction as a tool to prevent soil degradation.

Swedge sludge legislation

The New Circular Economy Action Plan outlined the need to revise the Sewage Sludge Directive (SSD). A 2014 study carried out on behalf of the Commission found a number of shortcomings for the Directive such as the concern on pollutants in sludge. In 2020 the Commission launched a study to support an evaluation of the SSD in view of a potential revision. Within the public consultation of the study, some organisations, e.g. The European Cement Association, showed support for proposals which aim to divert sewage sludge used as agricultural fertiliser, due to possible contamination of the soil with PFAS.

Industrial emissions / Air legislation

The Industrial Emissions Directive (IED) regulates emissions of PFAS from industrial installations. It is being revised with a publication of a proposal expected in early 2022. The review will assess whether the sectoral scope will be altered and whether there will be measures to address PFAS. PFAS might also be addressed as a chemical class under the IED.

The review of the European Pollutant Release and Transfer Register’ (E-PRTR) completed on February 2020 recommended adding to the E-PRTR reporting requirements for PFHxS, PFOS and PFOA. The European Commission is planning to publish a revision proposal of the E-PRTR Regulation together with the IED proposal in April 2022.

Food packaging & food contact regulation

Certain perfluorinated substances fall within the scope of Union legislation on plastic food contact materials and are subject to specific restrictions on their use. Their use in other food contact materials such as in paper and cardboard may be regulated at national level under Article 6 of Regulation (EC) No 1935/2004(2) as there are no specific measures for these materials at EU level.

The Commission continues to monitor specific issues such as perfluorinated substances in food packaging. The Commission is also undertaking a more general study on food contact materials for which there are no specific harmonised measures at EU level. This study will provide information on the scale of use of different materials and constitute a basis for assessing the need for possible action at EU level.

PFAS may be used in the manufacture of food contact materials (FCMs), including coated paper and board and other fibrous materials. Business operators are legally obliged to ensure that FCMs do not transfer their constituents to food in amounts hazardous to human health in accordance with Regulation (EC) No 1935/2004(3). 

Pesticides legislation

All matters related to legal limits for pesticide residues in food and feed are covered by Regulation (EC) No 396/2005. Active substances, such as essential chemicals in the products, are assessed through the pesticides peer review system. After EFSA drafts a report on the active substance, the European Commission then decides whether to include it in the EU’s list of approved active substances. The list of approved substances includes some substances which would fall under the definition of PFAS used by the 5 competent authorities for the wide PFAS restriction.

Pharmaceuticals

The European medicines regulatory system is based on a network of national authorities from the 31 EEA countries and the European Medicines Agency (EMA). In the EU medicines, including active ingredients are approved either by national medical agencies, and subsequently mutually recognised in other states, or by the European Medical Agency (EMA). Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorisation route for a medicine. The list of approved medicines includes some substances which would fall under the definition of PFAS used by the 5 competent authorities for the wide PFAS restriction.

The Commission adopted the Pharmaceutical Strategy for Europe on November 2020 and committed to revise the pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004, by the end of 2022).