EU POPs Amendment: Draft Delegated Regulation to Reduce Maximum PFOS Concentration

In a critical move, the European Commission has unveiled a draft Delegated Regulation aimed at fortifying environmental safeguards, specifically targeting perfluorooctane sulfonic acid and its derivatives (PFOS). This regulatory proposal seeks to amend Regulation (EU) 2019/1021, focusing on aligning the existing framework with the latest scientific and technical advancements.

(EU) 2019/1021 Regulatory Framework:

Regulation (EU) 2019/1021 is a cornerstone legislation implementing the Union's commitments under the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants. This framework is designed to protect human health and the environment by prohibiting, phasing out, or restricting the manufacturing, placing on the market, and use of substances subject to the Stockholm Convention on POPs

PFOS and its derivatives are listed in Annex I of EU POPs Regulation (EU) 2019/1021

• PFOS is listed in Annex I of Regulation (EU) 2019/1021, with specific provisions, including Unintentional Trace Contaminant (UTC) limits and exemptions for certain uses.

• The UTC limits for substances, mixtures, and articles are outdated, and there is a need for adjustments based on scientific and technical progress.

PFOS Regulatory History under POPs Compliance

Perfluorooctane sulfonic acid and its derivatives (PFOS) are intricately addressed in Annex I of Regulation (EU) 2019/1021, denoted as the 'PFOS entry.' This regulatory framework, under Article 4(1)(b) and Article 15(1), allows for Unintentional Trace Contaminant (UTC) limits and specific exemptions, subject to potential modifications aligning with scientific and technical progress. Being the pioneer per- and polyfluoroalkyl compound (PFAS) regulated in the EU, PFOS has historical UTCs, set long ago. A comprehensive screening by the European Chemicals Agency (ECHA) on the REACH registrations dossier indicates a low likelihood of PFOS presence at the current UTC level (10 mg/kg) in substances and mixtures.

PFOS Unintentional Trace Contaminant (UTC) Alignment with PFOA:

Considering similarities in applications, especially with PFOA, another PFAS listed in Annex I, the need for a different UTC for PFOS in articles is questioned. Both substances share common uses like coating textiles, leather, and applications in semiconductors.

The description of the PFOS entry in column 1 diverges from PFOA. While PFOA is specified as 'PFOA, its salts and PFOA-related compounds,' PFOS is outlined as 'PFOS and its derivatives.' However, the shared intention is to encompass the entire group of substances.

Need for Modifications:

• PFOS was the first per- and polyfluoroalkyl compound (PFAS) regulated in the EU, and the existing UTCs are likely outdated.
• A screening of REACH registrations did not find indications of PFOS at the current UTC level (10 mg/kg) in substances and mixtures.
• PFOS uses in articles are similar to those of another regulated PFAS (PFOA), justifying alignment of UTC levels

Context of the Delegated Act:

At the core of this initiative is Regulation (EU) 2019/1021, a pivotal piece of legislation designed to safeguard human health and the environment from persistent organic pollutants (POPs). PFOS, a significant concern within this regulatory landscape, is listed in Annex I. The proposed amendments are strategically crafted to address Unintentional Trace Contaminant (UTC) limits and specific exemptions, demonstrating the dynamic nature of regulations responding to evolving scientific insights.

Proposed Modifications to Article 15(1) of EU POPs Regulation (EU) 2019/1021 Explored:

PFOS, a significant concern within this regulatory landscape, is listed in Annex I of EU POPs Regulation (EU) 2019/1021. The proposed amendments are strategically crafted to address Unintentional Trace Contaminant (UTC) limits and specific exemptions, demonstrating the dynamic nature of regulations responding to evolving scientific insights.

1 Substance Identification Alignment: A fundamental proposal in the draft is the alignment in substance identification. The wording of the PFOS entry is recommended for revision, now encompassing "Perfluorooctane sulfonic acid (PFOS), its salts and PFOS-related substances." This harmonization with PFOA standards ensures a comprehensive coverage of substances falling within the PFOS spectrum.

2 UTC Level Modifications: The draft recommends pivotal adjustments to UTC levels:

• Lower UTC for PFOS and its salts: Introducing a lower UTC level (0.025 mg/kg), mirroring the approach taken for PFOA.
• Reduced UTC for PFOS-related substances: The proposal aims to reduce the UTC for these substances in substances, mixtures, and articles to 1 mg/kg, aligning with the standards set for PFOA.

3 Deletion of Specific Exemption: A noteworthy proposal is the deletion of the specific exemption allowing PFOS use as a mist suppressant for non-decorative hard-chromium plating. This is rooted in the confirmation that PFOS has been successfully substituted for this use in the European Union. The removal of this exemption aligns with the evolving landscape of chemical usage and technological advancements.

4 Deletion of Point 5: The draft advocates for the removal of Point 5 in the PFOS entry, pertaining to the availability of analytical methods. This deletion is proposed to bring uniformity to the POPs Regulation, as no other entry specifies such details.

CONSULTATIONS BEFORE THE ADOPTION OF THE ACT

Before the adoption of the act, the draft delegated act underwent consultations during the 'POPs CA meetings' held on November 24, 2022, June 14, 2023, and November 29, 2023. Valuable insights and comments were actively considered during this process. The 'POPs CA meeting' comprises a diverse group of stakeholders, including representatives from Member States, the European Chemicals Agency, the chemicals industry, and civil society."

Conclusion: The European Commission has introduced a draft Delegated Regulation to enhance environmental safeguards, focusing on perfluorooctane sulfonic acid and its derivatives (PFOS). Aimed at amending Regulation (EU) 2019/1021, the proposal addresses outdated limits and exemptions for PFOS in Annex I. As the initial regulated per- and polyfluoroalkyl compound (PFAS) in the EU, PFOS undergoes scrutiny for alignment with scientific progress. Proposed modifications involve substance identification, UTC level adjustments, and the removal of specific exemptions. The process includes consultations and adheres to legal principles outlined in Article 15(1) of POPs Regulation (EU) 2019/1021, showcasing a dynamic response to evolving environmental challenges.