The PIC Prior Informed Consent Regulation (Regulation (EU) No. 649/2012) governs the import and export of some dangerous and prohibited substances in Europe and imposes obligations on those who want to export these substances to EXTRA-EU countries.
The aim is to implement the Rotterdam Convention in the EU, promoting cooperation in international trade.
Annex I lists the substances that are banned or subject to severe restrictions. The PIC Regulation also applies to chemicals whose export is prohibited under Annex V.
The export of these chemicals is subject to two types of requirements:
- export notification
- explicit consent.
ANNEX I
It contains a list of substances, groups of substances or mixtures containing substances in concentrations such as to trigger the CLP classification and labeling.
The list is divided into three parts which define the various obligations applied to chemicals.
Part 1
- export notification procedure if the substance falls within one of the four use subcategories set out in the PIC Regulation:
- industrial chemicals intended for professional use
- industrial chemicals intended for consumer use
- pesticides as plant protection products
- other pesticides, including biocides
Part 2
- export notification procedure and explicit consent.
The national authority must receive a communication from the authority of the importing country certifying the import agreement.
Part 3
- export notification procedure, explicit consent.
Explicit consent can be avoided when the export response is published in the PIC circular.
EXPORT NOTIFICATION
EU-based exporters are required to notify their intention to export chemicals listed in Annex I of the PIC to a non-EU country. Notification must be made in the period prior to the first export in the year under consideration and the first export in each subsequent calendar year, exporters are required to notify the designated national authority of the country from which the export will be made.
Each export notification is assigned a unique identifier as a reference identification number (RIN).
Content of the notification:
- identity of the substance, mixture or article to be exported.
- export information, such as the country of origin, the country of destination, the date of the first export of the year, the estimated quantity to be exported, the intended use of the substance in the importing country, the name and address of the exporter and importer;
- information on the precautionary measures to be taken;
- understood the physico-chemical, toxicological and ecotoxicological characteristics;
- uses of the chemical in the EU;
- summary indication of the restrictive measures adopted and related reasons.
- The complete set of data required can be found in Annex II of the PIC Regulation.
The notification must be made 35 days before the export takes place, within 25 days of the first export the national authority must validate it and 15 days before the ECHA must send it to the non-EU importing country.
EXPRESS CONSENT
In addition to the notification requirement, the export of chemicals included in Parts 2 and 3 of Annex I of the PIC Regulation is also subject to the existence of an explicit consent granted by the designated national authority of the non-EU importing country .
There are some exceptions to explicit consent.
An explicit consent remains valid for subsequent exports for a period of three calendar years, unless otherwise stated in the conditions relating to the explicit consent itself. During these three years, any company operating in the EU territory can export the same chemical to the country that granted the explicit consent (as long as allowed by the conditions of the consent), while still having to meet the annual notification and reporting obligations.
ECHA maintains a database of all notifications – existing and new – and responses regarding opt-in consent.
ANNUAL REPORT
During the first quarter of each year, exporters and importers of chemicals subject to the PIC procedure must report to their designated national authorities the exact quantities of the chemical shipped to or from each non-EU country during the last year.
ePIC
ePIC is the IT tool that was established and is managed by ECHA in order to ensure that the obligations under the PIC regulation are supported by adequate IT systems.
For more information contact one of our consultants