New Updates to the PIC Regulation in 2025

1. What is the PIC Regulation?

2. What do the latest updates imply?

Starting in March 2025, the PIC Regulation will undergo updates that impact chemical exports from companies based in the European Union. This is due to the European Chemicals Agency (ECHA) announcing the inclusion of 40 new hazardous substances in Annex I of the regulation.

The updates, announced by ECHA in January 2025, aim to strengthen control over the export and import of chemicals that pose significant risks to human health and the environment.

In this article, we will explain what the PIC Regulation is, outline the three types of procedures it implements to ensure the safe management of chemicals, and examine the implications of the updates, which impose new obligations on European companies.

What is the PIC Regulation?

The Prior Informed Consent (PIC) Regulation (EU No. 649/2012) governs the import and export of hazardous chemicals within and outside the European Union.

This regulation establishes a set of obligations for companies wishing to export these substances to non-EU countries. To ensure the safe handling of these products, three types of procedures apply:

Export Notification:

Chemicals listed in Part 1 of Annex I must be notified before export. If an exporter plans to ship a chemical product for the first time from the European Union to a non-EU country, they must submit a notification to the national authority of the exporting Member State at least 35 days prior to the planned export date.

This notification must be submitted annually for each product exported. The national authority will verify that the information meets the requirements and, if complete, forward it to ECHA 25 days before the export.

Explicit Consent:

The explicit consent procedure requires exporters to obtain approval from the national authority of the importing country. Substances listed in Parts 2 and 3 of Annex I require this express consent.

The exporter must request consent through the national authority of the EU Member State, which will consult with the European Commission and the importing country's authority. If the importing country approves the shipment, the export may proceed.

Export Ban:

Chemicals that are banned in the European Union due to health or environmental risks and listed in Annex V cannot be exported.

This regulation does not apply to pharmaceuticals, food, medicinal products, waste, chemical weapons, and other substances regulated by specific EU legislation.

What do the last update imply?

The updates announced by ECHA, effective from March 1, 2025, mean that companies based in the European Union wishing to export 40 additional hazardous substances must comply with new obligations under the PIC Regulation.

These substances, including 35 pesticides and 5 industrial chemicals, must be notified to ECHA prior to export. Additionally, 38 of these substances will require explicit consent from importing countries, emphasizing the need to ensure safety and compliance with international agreements.

Key Updates:

• Substances Requiring Explicit Consent: Cyanamide, warfarin, and other substances previously listed in Annex I will now require explicit consent from importing countries.

• New Export Ban: PFHxS and its related compounds, now classified as persistent organic pollutants, will be subject to a total export ban.

• Expansion of Annex I: The total number of chemicals listed in Annex I of the PIC Regulation now stands at 321 substances.

Companies must use ECHA’s ePIC IT system to submit the required notifications and ensure compliance with these new requirements.

Complying with current regulations is essential to bring your products to market and sell them safely. Do you need support simplifying the management of your chemical products? Contact one of our specialists to learn about eQgest software, designed for creating and managing compliance documents for the chemical industry.