EU’s PIC Regulation adds 35 new entries

Chemicals | By SCOTT STEPHENS, MPA

The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

Regulatory background

The Prior Informed Consent Regulation (EU) 649/2012 (PIC) 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 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 consolidates all hazardous chemicals which are subject to special export and import procedures. Part 1 of the annex lists those which carry the obligation to submit an export notification. This is accomplished using the European Chemicals Agency’s (ECHA) 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 that prior informed consent be requested. Also accomplished through ePIC, consent must be granted by the importing country for the shipment to progress.
The chemicals listed in part 3 match exactly 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 Regulation update to avoid redundancy.
Article 23 of PIC mandates that the Commission reviews its first annex annually. This allows for a yearly update in light of developments in EU law, as well as additions to the Rotterdam Convention. This year, both kinds of regulatory progress have resulted in changes to all three parts of annex I.

The EU Commission updates the PIC Regulation

Delegated Regulation (EU) 2023/1656, published August 25 in the EU Official Journal, harmonizes PIC with technical progress this year. It has drawn from across EU chemical regulatory frameworks, aligning PIC with new developments in legislation concerning pesticides, biocides, and substances of very high concern (SVHCs).
Most of the additions to PIC relate to chemicals regulated under the Plant Protection Products Regulation (PPPR), the Biocidal Products Regulation (BPR), and the REACH Regulation’s annex XIV, or the authorization list. AgencyIQ has consolidated these new entries, along with their reasons for inclusion and regulatory origins, in the chart below:

Substance	CAS RN	Reason for addition	Primary regulation	PIC Regulation annex I action
Famoxadone	131807-57-3	Commission decided not to renew approval as active substances under PPPR. Banned for use in pesticides.	PPPR	Added to parts 1 and 2
Phosmet	732-11-6		PPPR
Indoxacarb	173584-44-6 and 144171-61-9		PPPR and BPR
Alpha-cypermethrin	67375-30-8	Commission withdrew approval as active substance under PPPR. CLP Regulation classification indicates hazard.	PPPR and CLP	Added to part 1
Bromadiolone	28772-56-7	Withdrawn from PPPR pesticide approval process by industry. CLP Regulation classification indicates hazard.	PPPR and CLP	Added to part 1
Metam-sodium	137-42-8	Withdrawn from BPR approval process for subcategory ‘other pesticide including biocides’ by industry. CLP Regulation classification indicates hazard.	BPR and CLP	Added to part 1
Isopyrazam	881685-58-1	Commission withdrew approval as pesticide active substance under the PPPR.	PPPR	Added to parts 1 and 2
Azimsulfuron	120162-55-2	Withdrawn from PPPR pesticide approval process by industry. CLP Regulation classification indicates hazard.	PPPR and CLP	Added to parts 1 and 2
Carbetamide	16118-49-3
Carboxin	5234-68-4
Cyproconazole	94361-06-5
Diuron	330-54-1
Ethametsulfuron-methyl	97780-06-8
Etridiazole	2593-15-9
Fenbuconazole	114369-43-6
Fluqinconazole	136426-54-5
Lufenuron	103055-07-8
Metosulam	139528-85-1
Myclobutanil	88671-89-0
Pencycuron	66063-05-6
Prochloraz	67747-09-5
Profoxydim	139001-49-3
Spirodiclofen	148477-71-8
Triflumizole	68694-11-1
Chlorophene	120-32-1	Commission decided not to approve as active substances under BPR. Banned for use in pesticides.	BPR	Added to parts 1 and 2
Esbiothrin	260359-57-7		BPR	Added to parts 1 and 2
Fenoxycarb	72490-01-8	Withdrawn from PPPR and BPR approval process by industry. Banned for use in pesticides. CLP Regulation classification indicates hazard.	PPPR and BPR	Added to parts 1 and 2
1-bromopropane	106-94-5	These substances are currently listed as SVHCs in REACH annex XIV. Because no authorizations have ever been granted for them, they are severely restricted.	REACH	Added to parts 1 and 2
diisopentyl phthalate	605-50-5
1,2 benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich	71888-89-6
1,2-benzenedicarboxylic acid, di-C7-11- branched and linear alkyl esters	68515-42-4
1,2-benzenedicarboxylic acid, dipentyl ester, branched and linear	84777-06-0
bis(2-methoxyethyl) phthalate	117-82-8
dipentyl phthalate	131-18-0
n-pentyl-isopentyl phthalate	776297-69-9

Rotterdam Convention additions

At its tenth meeting in June 2022, the conference of the parties to the Rotterdam Convention added two more entries to annex III of the Convention. The first concerns decabromodiphenyl ether while the second is for perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds.
Because these chemicals were already listed in part 2 of annex I, the delegated regulation has deleted their entries there and transferred them into part 3, which corresponds with the Rotterdam Convention’s third annex. Functionally, there is no difference in how these chemicals are to be treated, as parts 2 and 3 both require export notification and prior informed consent. This transfer is simply to prevent redundancy between the latter two parts of PIC’s annex I.

Clarifications

For three substances already included in parts 1 and 2, their entries have been altered to clarify their scope or identification. An entry previously made for “bromoxynil” is expanded to include the substance as well as “its butyryl, heptanoyl, and octanoyl esters.”
In the case of epoxiconazole, an additional CAS number (CAS RN 133855-98-8) is included. The entry for nonylphenol ethoxylates has European Community (EC) numbers added.

Looking forward

Companies now have until November 1, 2023 to make the necessary preparations to comply with the requirements triggered by the new annex I listing of substances pursuant to Regulation (EU) 2023/1656. For the 35 substances listed above, this will entail new reporting obligations, including export notifications and export and/or import reports, via the ePIC dossier submission tool.

Featuring previous analysis by Rayan Bhargava

To contact the author of this analysis, please email Scott Stephens.
To contact the editor of this analysis, please email Patricia Iscaro.