EU Commission to add dozens of chemicals to PIC Regulation
As part of its annual review of the Prior Informed Consent Regulation’s first annex, the Commission has proposed the inclusion of dozens of new hazardous chemicals. The delegated act implements the Rotterdam Convention as well as relevant EU chemicals legislation to subject new substances to export notification and PIC procedures.
- The Prior Informed Consent Regulation (EU) 649/2012 (PIC) is the authoritative law for the import and export 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 dually aims to protect human health and the environment while reaffirming the sovereignty of third nations in deciding when hazardous chemicals may 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 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, it appears that both forms of relevant regulatory progress have been made, requiring changes in all three parts of Annex I.
- A new Commission delegated act, published for feedback on March 20, 2023, seeks to harmonize PIC with technical progress this year. It draws from across the EU chemical regulatory landscape, aligning PIC with new developments in legislation concerning pesticides, biocides, and substances of very high concern (SVHCs).
EU legislation additions
- The bulk of the proposed additions to PIC relate to chemicals primarily regulated by the Plant Protection Products Regulation (PPPR) (1107/2009/EC), the Biocidal Products Regulation (BPR) (528/2012/EC) and Annex XIV, the authorization list, of the REACH Regulation (1907/2006/EC). AgencyIQ has consolidated these new entries, along with their reasons for inclusion and regulatory origins, in the chart below:
|Substance(s)||CAS RN||Reason for addition||Implementing act||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.||1379/2021/EU||PPPR||Added to parts 1 and 2|
|Indoxacarb||173584-44-6 144171-61-9||2081/2021/EU||PPPR and BPR|
|Commission withdrew approval as active substance under PPPR. CLP Regulation classification indicates hazard.||795/2021/EU||PPPR and CLP||Added to part 1|
|Withdrawn from PPPR pesticide approval process by industry. CLP Regulation classification indicates hazard.||PPPR and CLP||Added to part 1|
|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|
|Commission withdrew approval as pesticide active substance under the PPPR.||782/2022/EU||PPPR||Added to parts 1 and 2|
|Azimsulfuron; Carbetamide; carboxin; Cyproconazole; diuron; Ethametsulfuron-methyl; Etridiazole; Fenbuconazole; Fluqinconazole; Lufenuron; Metosulam; Myclobutanil; Pencycuron; Prochloraz; Profoxydim; Spirodiclofen and Triflumizole||
120162-55-2; 16118-49-3; 5234-68-4; 94361-06-5; 330-54-1; 97780-06-8; 2593-15-9; 114369-43-6; 136426-54-5; 103055-07-8; 139528-85-1; 88671-89-0; 66063-05-6; 67747-09-5; 139001-49-3; 148477-71-8; and 68694-11-1
|Withdrawn from PPPR pesticide approval process by industry. CLP Regulation classification indicates hazard.||PPPR and CLP||Added to parts 1 and 2|
|Commission decided not to approve as active substances under BPR. Banned for use in pesticides.||622/2018/EU and 1765/2020/EU||BPR||Added to parts 1 and 2|
|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|
|Withdrawn from PPPR pesticide approval process by industry. Banned for use in pesticides. CLP Regulation risk assessment indicates hazard.||PPPR and CLP||Added to part 2; already in part 1|
|Ban on use in pesticides invalidates BPR approval for use as ‘other pesticide including biocides’ (product-type 18).||BPR||Added to part 2; already in part 1|
|Not approved as active substances under the PPPR and BPR. Banned for use in pesticides.||PPPR and BPR||Added to part 2; already in part 1|
1-bromopropane; diisopentyl phthalate; 1,2 benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich; 1,2-benzenedicarboxylic acid, di-C7-11- branched and linear alkyl esters; 1,2-benzenedicarboxylic acid, dipentylester, branched and linear; bis(2-methoxyethyl) phthalate; dipentyl phthalate and n-pentyl-isopentyl phthalate
106-94-5;605-50-5; 71888-89-6; 68515-42-4; 84777-06-0; 117-82-8; 131-18-0; and 776297-69-9
|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|
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 are already listed in part 2 of Annex I of PIC, the proposed delegated act would delete their entries there and transfer them into part 3 which corresponds with the Rotterdam Convention’s third annex. Functionally, there is little to 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.
- For three substances already included in parts 1 and 2, their entries are 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.
- The deadline to provide feedback on the proposed delegated regulation is April 17. Because this is a delegated act, it does not require approval from the EU Parliament nor the Council, though it can be vetoed by either body during the scrutiny period following the Commission’s adoption of the act.
- Looking across the regulatory landscape, obligations to provide export notifications and attain prior informed consent are not always observed. Just this week, the Commission published an implementation report for the Waste Shipment Regulation (1013/2006/EC), which governs the shipment of hazardous waste. The report found a more than doubling in the volume of hazardous waste shipped between 2001 and 2019 from 3.9 million metric tons to 8.1 million metric tons. The volume of this waste for which an export notification was issued, however, was relatively stable throughout. This mismatch in trends suggests an influx of hazardous waste illegally shipped without following procedure. Indeed, the report identified an increase in the number of illegal shipments detected by member states. This reveals a general willingness and capacity to shirk shipment requirements that may hold relevance with respect to PIC and its own compliance.
Key Documents and Dates
- Draft Delegated Regulation amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides and industrial chemicals (March 20, 2023)
- 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 (July 4, 2012)