PIC stands for prior informed consent. The PIC Regulation governs the import and export of hazardous chemicals.
The PIC Regulation must be taken into account when exporting restricted and prohibit-ed chemicals. It governs the notification procedure and the process for requesting explicit consent prior to export. Hazardous substances, when exported, must be labelled as usual within the EU, but in the official language of the receiving country.
Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous industrial chemicals, plant protection products and biocides (PIC procedure) within the European Union.
Substances in Annex I to this regulation are chemicals that are prohibited or subject to severe restrictions in the European Union. Exports of substances in Annex I are subject to notification, i.e. the exporter must report the first export of any such substance to a non-EU country in each calendar year in accordance with Article 8(2).
This notification requirement also applies to mixtures containing such substances in concentrations that affect the mixtures' labelling in accordance with the CLP Regulation.
Under special circumstances, this also applies to articles containing substances listed in Part 2 or 3 of Annex I in their initial state whose use in this specific product is prohibited or subject to severe restrictions under EU law, e.g. if this special form is associated with a risk of leaching.
The first notification must be submitted at least 35 days prior to export. As a rule, the export can then take place without further delay.
For substances listed in Parts 2 and 3 of Annex I, explicit consent must be obtained from the recipient country, and the export is not allowed to take place without this consent.
Part 2 contains substances that are EU candidates for inclusion in the PIC procedure of the Rotterdam Convention. Substances already subject to this procedure can be found in Part 3.
Responsibilities
The Federal Office for Chemicals (BfC) of the Federal Institute for Occupational Safety and Health (BAuA) is the competent authority, or the so-called Designated National Authority (DNA), for implementing the Regulation in Germany.
At the European Chemicals Agency (ECHA) in Helsinki, the European Union maintains a database (ePIC) that is used to electronically manage the entire procedure.
If you have specific technical questions, we recommend using the ECHA's corresponding contact form. A contact form is provided specifically in relation to the ePIC account (account management).
Procedure
BAuA reviews the industry’s notifications in ePIC and also uses ePIC to forward these to ECHA. In turn, ECHA represents the European Union towards third countries as a common authority and forwards the notifications to the third countries concerned.
If there are errors in a notification, these are communicated to the exporter via ePIC along with a deadline for resubmission. For more information, please refer to the official notification provided in ePIC. (In ePIC, please click on the arrow, speech bubble or highlighted envelope.)
Prior to any export of chemicals that are prohibited or subject to severe restrictions in the EU, the recipient countries are informed of the existing EU regulations. This measure is intended to assist countries that are, for example, in the process of establishing a chemicals management system. This allows these countries to implement additional measures as appropriate, e.g. concerning worker protection or legislation.
On the other hand, should an explicit consent be required, this is sought by BAuA, in its capacity as the competent DNA. BAuA also documents this step in ePIC.
Within the software, each notification has three history features. Under "View", users can display the Event/Message/Submission history in order to gain a better insight into the processing status.
The ECHA provides corresponding guides on its website to give users a deeper understanding of the procedure.
Exemptions from the notification requirement
Regulation (EU) No 649/2012 establishes exemptions from the standard notification procedure for exports of substances in quantities of up to 10 kg per country and per calendar year where these are to be exported exclusively for research or analysis purposes (Article 2(3)). Please notify these exports as so-called "special RIN requests".
In this context, RIN stands for reference identification number, an ID number that is created for each notification process in the ePIC database and proves to the customs authorities that the Regulation has been complied with. This ID number is to be entered in free text field 44 in the export declaration.
With regard to special RINs, "bulk requests" are available for large numbers of chemicals that are to be exported to one or more countries. Please note that bulk special RIN requests for chemicals in Annexes I and V (export ban list, essentially for persistent organic pollutants, POPs) are to be submitted separately. All applications pursuant to Article 2(3) of the Regulation are free of charge.
Costs
An administration fee of €108 is incurred in Germany for notifications of substances in Part 1 of Annex I, and a fee of €216 for notifications of substances in parts 2 and 3 of Annex I (fee nos. 4.1 or 4.2, Section 1 Annex to the Special Fees Ordinance of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (Besondere Gebührenverordnung des Bundesministeriums für Umwelt, Naturschutz und nukleare Sicherheit, BMUBGebV)).
Other obligations
In addition, Article 10 of the Regulation requires importers and exporters to report the actual quantities of PIC chemicals imported and exported via the ePIC database by 31 March of the following year.
Infringements are punished by fines as set out in the Ordinance on Sanctions (ChemSanktionsV).