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Johanna Salomaa-Valkamo
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Are you importing or exporting hazardous chemicals?
The Prior Informed Consent (PIC) Regulation regulates the import and export of hazardous chemicals between the EU and third countries, and implements the global Rotterdam Convention within the European Union. The recast of PIC will enter into operation on 1 March 2014 and, at the same time, ECHA will take over the operational responsibility from the Joint Research Centre of the European Commission.
"The use of chemicals regulated under PIC is by definition either banned or severely restricted in the EU, but are under certain derogations still manufactured and exported all over the world," says Chiara Macchi from ECHA's Registration Directorate.
The regulation applies to two lists of chemicals that can be found in Annexes I and V. Annex V includes the chemicals, which are subject to an export ban. "These chemicals can only be exported in quantities below 10kg and exclusively for research and analysis purposes," Ms Macchi says, and continues, "What we mostly work with are the chemicals in Annex I. This list is updated on average once or twice a year."
The Annex I chemicals are hazardous industrial chemicals, biocides or pesticides. "It currently contains 162 entries, including 26 group entries, such as ‘cadmium and its compounds'. When the groups are expanded, the list covers 977 different chemicals altogether. All of these are subject to an export notification - meaning that the receiving country must be informed about the details of the export before it can take place," Ms Macchi explains.
The export notification is valid for one calendar year and does not oblige the exporter to export. "The notification is a theoretical document – it's about expected exports. In reality, some of these exports may never take place. In the subsequent calendar year, exporters have a legal obligation to report on the actual exports that have taken place."
Notification to the national authorities
The notification of the export is done by the exporter 35 days before export to the designated national authority of the Member State in which the company is established. National authorities then have to do a compliance check and send the notification to ECHA, who forwards the notification to the national authority in the receiving country.
"For the more hazardous chemicals, the export notification is not enough and the national authorities in the exporting country have to ask for explicit consent from the receiving country before the export can take place. If the receiving country does not give consent, the export cannot take place. The extension of the explicit consent requirement to a larger number of chemicals is one of the additions of the PIC regulation in comparison to the Rotterdam convention," Ms Macchi points out.
Nailing down the timelines that the different actors have to perform their tasks under PIC, is one of the changes introduced by the recast. "The old regulation has different deadlines for first time exports and exports that have previously taken place. This was an unnecessary complication. Now, there is one set of deadlines irrespectively: the exporter has to notify no later than 35 days before export, the national authority has to process the notification no later than 25 days, and ECHA has to send the notification to the importing country no later than 15 days before the expected date of export."
The notifications are currently done through an IT application called EDEXIM. "ECHA will begin operations by using EDEXIM in March. In parallel, we are also developing a new IT application, ePIC, that will be easier to use and have more automated steps which should streamline the work. This tool will be launched in September 2014," Ms Macchi highlights.
Updated guidance and IT manuals coming
The PIC recast adapts the regulation to the Classification, Labelling and Packaging (CLP) Regulation and shifts the operational responsibility from the European Commission to ECHA. "These are the main reasons for the recast. Other changes are the new timelines, as already mentioned, and the fact that the REACH Enforcement Forum will have a role in coordinating enforcement under PIC," Ms Macchi says.
In autumn 2014, the Agency will publish an updated PIC guidance, which also highlights those legal provisions that are new and provides guidelines on how to implement them. IT manuals for both industry and designated national authorities on the use of ePIC are also under preparation.
"In addition, we will publish and keep regulatory information on the Annex I chemicals up-to-date on our website. We will also provide statistics on export notifications."
ECHA has a legal obligation to report on the exact exports that have taken place. "We will assist the national authorities in collecting this information from the exporters and importers and will make a non-confidential version of the report available online," Chiara Macchi explains.
Promoting informed exports and raising awareness
The aim of the Rotterdam Convention – and PIC in the EU – is to protect the health of consumers and workers as well as the environment against potentially harmful impacts from certain hazardous chemicals and pesticides. It also contributes to environmentally sound use of these chemicals by promoting shared responsibilities and cooperative efforts in the international market.
According to Ms Macchi, the PIC Regulation is all about facilitating informed exports of hazardous chemicals. In many cases, as already mentioned, exports cannot take place without the consent from the responsible authorities in the importing country.
"With PIC, in certain cases we have no legal basis for preventing an export from taking place if all conditions have been fulfilled. However, what we still do is alert the national authorities in the receiving country that a particular import is going to take place. Among other things, we provide the name of the importing company and their contact details.
The national authorities of the importing countries are therefore more aware of the substances that companies are trading in their territory and can also alert customs on an upcoming import if needs be," she says.
With each export notification, ECHA provides the receiving country with a regulatory information package that includes the safety data sheets in the local language, information as to why these chemicals are not in use in the EU anymore and, if available, names of safer alternatives.
"We are not just asking ‘do you agree to this export – yes or no'. The receiving country has a choice and can make an informed decision," Ms Macchi emphasises, and continues, "A lot happens to the side of PIC activities. The EU plays an important role in awareness-raising with third countries about the chemicals exported, replying to their questions, organising workshops and assisting underdeveloped countries to improve their controls and risk assessment. We assist in building working relations that may even lead to joint projects on chemical safety."
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| Heidi Pihol, Istvan Mak, Chiara Macchi and Raluca Pica are part of the team working on PIC at ECHA. |
Further information:
Interview by Hanna-Kaisa Torkkeli
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