EU executive consults on proposed update to PIC chemical lists

Regulatory background

• Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. It also implements EU commitments to the Rotterdam Convention on the prior informed consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade. It seeks to protect human health and the environment, while reaffirming the sovereignty of third nations in deciding when hazardous chemicals are allowed to enter their borders.
• Annex I of PIC Regulation consolidates all hazardous chemicals which are subject to special export and import procedures. Part 1 of the annex lists substances that carry the obligation to submit an export notification. This is accomplished using ECHA’s ePIC platform, allowing non-EU countries advance notice of hazardous substances potentially arriving in their countries.
• Parts 2 and 3 of annex I list substances which, in addition to needing export notification, require prior informed consent. The importing country must grant consent through ePIC for the shipment to progress.
• The chemicals listed in part 3 exactly match those included in annex III of the Rotterdam Convention. Any other chemicals that the EU determines should be subject to the same heightened export procedure, though not yet recognized by the Rotterdam Convention, are added to part 2. Where the Rotterdam Convention subsequently adds chemicals already listed in part 2, these chemicals are deleted from part 2 and added in part 3 in the next PIC update to avoid redundancy.
• Annex V of PIC Regulation lists substances added to annexes A and B of the Stockholm Convention and are subject to a complete export ban. Part 1 of annex V contains the convention-listed persistent organic pollutants (POPs), while part 2 comprises the chemicals other than POPs listed in the convention’s annexes.
• The Commission is mandated to review PIC Regulation’s annex I list of chemicals at least once a year, harmonizing it with new regulatory developments under the Rotterdam Convention and EU chemicals legislation regulating related hazardous substances. Specifically, PIC Regulation implements import and export regulatory measures based on the effective restrictions and bans placed on pesticide active substances under Regulation (EC) 1107/2009 on plant protection products (PPPR); biocidal active substances pursuant to Regulation (EU) 528/2012 on biocidal products (BPR); industrial chemicals under Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH); and persistent organic pollutants in accordance with Regulation (EU) 2019/1021 on POPs (POPs).

Commission proposes aligning PIC lists with amendments to PPPR, BPR, REACH and POPs

• The Commission on July 19 published a draft delegated regulation on its “Have your say” portal, launching a four-week pubic consultation to solicit feedback on proposed updates to annexes I and V listing hazardous substances subject to PIC’s import and export provisions.

Proposed updates to PIC’s parts 1, 2, and 3 of annex I and annex V

• In part 1 of annex I, the proposal is adding 41 new entries and making minor changes to three existing ones. See the entries (and accompanying CAS identifiers) below that are being added. The lion’s share of these substances have been added because they were either not renewed or not approved under PPPR – effectively banning them from use as pesticide active substances – and have been assigned harmonized classification and labeling under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP), demonstrating “sufficient evidence that” these substances “[raise] concerns for human health or the environment.”

• The existing entries for cyanamide (CAS RN 420-04-2), warfarin (CAS RN 81-81-2), and terbufos (CAS RN 13071-79-9) are updated to reflect the fact that the first two are being added to part 2 of annex I (i.e., they are now subject to the provisions qualifying them for PIC notification) and the final substance is being moved from part 2 to part 3 of the annex, because terbufos was included in May 2023 in annex III of the Rotterdam Convention).
• The substances proposed for listing in part 1 of annex I, except for abamectin (CAS RN 71751-41-2) and difenacoum (CAS RN 56073-07-5), are also being included in part 2 of the same annex. Cyanamide and warfarin, as mentioned above, are also being incorporated in part 2.
• Terbufos (CAS RN 13071-79-9) is being added to part 3 of annex I, as explained above.
• A minor change is being made to the existing entry for polychlorinated biphenyls (PCB) in part 3 of annex I to expand the entry to sufficiently cover all members of this substance group, including homologs, congeners and mixtures, as reflected in the corresponding annex III entry to the Rotterdam Convention.
• Part 1 of annex V is being harmonized with the amended POPs Regulation, encompassing an entry for perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds (355-46-4 CAS RN and others), as well as a minor update to the existing entry for endosulfan, to which additional CAS numbers have been added.

Analysis and next steps

• The deadline to provide feedback on the Commission’s proposed regulation is August 16 under the “Have your say” consultation. Because the proposal is a delegated act, aimed at updating “non-essential” elements of substantiative legislation, the EU Parliament and the Council are only minimally involved in the regulation’s development, empowered only to object to the regulation during a scrutiny period that will follow the consultation.
• Once adopted and having successfully completed scrutiny, the regulation will be published in the Official Journal. Affected stakeholders will then have until January 1, 2025, when the regulation begins to apply, to prepare for compliance with the requirements triggered by the listing of the new substances in annexes I and V of PIC Regulation. For the 41 substances listed above, this will entail new reporting obligations, including export notifications, via the ePIC dossier submission tool.

Featuring previous analysis by Rayan Bhargava

To contact the author of this piece, email Scott Stephens ( sstephens@agencyiq.com).
To contact the editor of this piece, email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• Export and import of hazardous chemicals – review of the list of chemicals subject to international trade rules; Have your say initiative; July 19, 2024
• Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals
• Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade