Key data
| Regulation | Delegated Regulation (EU) 2026/1278 — amends Regulation (EU) No. 649/2012 |
|---|---|
| Publication | August 12, 2026 |
| Entry into force | September 1, 2026 |
| Affected parties | Manufacturers, importers and exporters of pesticides and industrial chemical products in the EU |
| Category | European Regulation |
| International framework | Rotterdam Convention — Prior Informed Consent (PIC) Procedure |
| CELEX reference | 32026R1278 |
If your company exports pesticides or industrial chemical products outside the EU, the Delegated Regulation (EU) 2026/1278 requires you to review your catalog immediately. From September 1, 2026, thirteen substances will require prior consent from the importing country before they can be exported. Blocking an export without this procedure is not a warning: it is a direct and immediate consequence of non-compliance.
The regulation amends the annexes of the Regulation (EU) No. 649/2012, which implements in the EU the Rotterdam Convention on the prior informed consent procedure (PIC) for dangerous chemicals in international trade.
What does this regulation establish?
Regulation 2026/1278 incorporates two groups of substances into the annexes of Regulation 649/2012, activating the PIC prior consent procedure for all of them:
Incorporated pesticides
The following substances are added because they have been withdrawn from the approval processes as pesticides in the EU — that is, they are prohibited for that use within the European market:
| Substance | Reason for inclusion |
|---|---|
| Carbendazim | Withdrawn from the approval process as a pesticide in the EU |
| Metribuzin | Withdrawn from the approval process as a pesticide in the EU |
| Dodemorph | Withdrawn from the approval process as a pesticide in the EU |
| Fenpyrazamine | Withdrawn from the approval process as a pesticide in the EU |
| Flumetralina | Withdrawn from the approval process as a pesticide in the EU |
| Metaflumizone | Withdrawn from the approval process as a pesticide in the EU |
| Pyridalyl | Withdrawn from the approval process as a pesticide in the EU |
| Tritosulfuron | Withdrawn from the approval process as a pesticide in the EU |
Incorporated industrial chemicals
The following substances are added because they are classified as carcinogens or mutagens of category 1A or 1B:
| Substance | Classification |
|---|---|
| DEHP (bis(2-ethylhexyl) phthalate) | Carcinogen/mutagen category 1A/1B |
| DBP (dibutyl phthalate) | Carcinogen/mutagen category 1A/1B |
| Arsenic trioxide | Carcinogen/mutagen category 1A/1B |
| Trichloroethylene | Carcinogen/mutagen category 1A/1B |
| Chromium VI compounds | Carcinogen/mutagen category 1A/1B |
The PIC mechanism requires exporting companies to formally notify the intention to export and to await express consent from the importing country before proceeding with shipment. This procedure is managed through the designated national authorities in each country.
Economic and operational impact
The impact is not only regulatory: it has direct consequences on operation times and costs.
- Export delays: The notification process and waiting for consent adds time to each export operation of these substances. Companies must anticipate this timeframe in their logistics and contractual planning.
- New administrative costs: Managing PIC notifications requires internal or external resources (foreign trade advisors, compliance personnel). For companies exporting several of these substances to multiple destinations, the management volume can be significant.
- Risk of export blocking: If an attempt is made to export without prior consent, the export can be blocked. This implies storage costs, contractual penalties with customers and possible regulatory sanctions.
- Review of contracts with foreign customers: Supply contracts that include these substances must be reviewed to incorporate clauses on PIC procedure timeframes and allocation of responsibilities.
Who does it affect?
- Pesticide manufacturers that produce or formulate any of the eight listed substances (carbendazim, metribuzin, dodemorph, fenpyrazamine, flumetralina, metaflumizone, pyridalyl, tritosulfuron) and export them outside the EU.
- Manufacturers and distributors of industrial chemical products that work with DEHP, DBP, arsenic trioxide, trichloroethylene or chromium VI compounds in export operations.
- Exporters and traders that intermediate in the international sale of these substances, even if they are not the original manufacturers.
- Importers that re-export these substances from the EU to third countries.
- Compliance, legal and foreign trade departments of companies in the chemical and phytosanitary sector.
- Foreign trade advisors and chemical regulation consultants that manage international operations for their clients.
Practical example
A Spanish phytosanitary product manufacturer regularly exports carbendazim to customers in Latin American and Asian countries. Until now, the export process followed the standard flow of customs documentation.
From September 1, 2026, before sending any batch of carbendazim to those destinations, the company will have to:
- Formally notify the intention to export to the designated national authority in Spain (within the framework of the PIC procedure).
- Wait for the importing country to issue its express consent.
- Only once that consent is received, proceed with shipment.
If the company sends the batch without having completed this process, the export can be blocked at customs and the company may face sanctions. Additionally, if the contract with the customer does not contemplate these additional timeframes, penalties could be generated for late delivery.
The same scenario applies to a plastics manufacturer that uses DEHP or DBP as plasticizers and exports them as industrial chemicals, or to a company in the metallurgical sector that works with chromium VI compounds.
What should companies do now?
- Audit the export catalog: Review what products or substances the company exports and identify if any contain or are any of the thirteen substances incorporated into the annexes of Regulation 649/2012 by this delegated regulation.
- Contact the competent national authority: In Spain, identify the designated body to manage PIC notifications and learn about the specific procedure, timeframes and required documentation.
- Update export processes: Incorporate the notification step and waiting for consent in the operational flow of each affected export, before September 1, 2026.
- Review contracts with international customers: Add clauses that contemplate PIC procedure timeframes and define responsibilities in case of delays derived from the consent process.
- Train the foreign trade team: Ensure that personnel responsible for exports know the PIC procedure and the substances now subject to it.
- Consult with a specialist advisor in chemical regulation: If the company exports several of these substances to multiple destinations, the complexity of management justifies the support of a specialist in foreign trade of chemical products.
Frequently asked questions
What specific substances require prior consent for export from September 1, 2026?
Delegated Regulation (EU) 2026/1278 incorporates thirteen substances: eight pesticides (carbendazim, metribuzin, dodemorph, fenpyrazamine, flumetralina, metaflumizone, pyridalyl and tritosulfuron) and five industrial chemicals (DEHP, DBP, arsenic trioxide, trichloroethylene and chromium VI compounds). All of them are subject to the PIC procedure of Regulation (EU) 649/2012 from that date.
What is the PIC procedure and what exactly does it require?
The PIC procedure (Prior Informed Consent) is the mechanism of the Rotterdam Convention implemented in the EU by Regulation 649/2012. It requires exporting companies to formally notify the intention to export a dangerous substance and to obtain express consent from the importing country before proceeding with shipment. Without that consent, the export cannot be carried out legally.
What happens if I export these substances without obtaining prior consent?
Non-compliance can result in export blocking and the imposition of sanctions. Additionally, if the shipment is made without the completed PIC procedure, the company assumes the risk of cargo retention at customs, additional storage costs and possible contractual penalties with the customer for failure to meet delivery deadlines.
Why are these pesticides added to the PIC list?
The eight pesticides (carbendazim, metribuzin, dodemorph, fenpyrazamine, flumetralina, metaflumizone, pyridalyl and tritosulfuron) are incorporated because they have been withdrawn from the approval processes as pesticides in the EU, which is equivalent to their prohibition for that use within the European market. The five industrial chemicals (DEHP, DBP, arsenic trioxide, trichloroethylene and chromium VI compounds) are added because they are classified as carcinogens or mutagens of category 1A or 1B.
When does Delegated Regulation (EU) 2026/1278 enter into force and how much time is there to adapt?
The regulation was published on August 12, 2026 and enters into force on September 1, 2026. This leaves an adaptation margin of approximately three weeks from publication. Affected companies must act urgently to review their export catalogs and adapt their processes before that date.
Official source
Consult complete regulation in official source
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R1278