Overview
Hello. This is MDSKorea.
The EU PIC Regulation is a law that controls chemical substances exported outside the EU.
As EU suppliers can proceed with the export of regulated substances once the import consent of your country is confirmed, we recommend checking in advance whether your planned imports fall under this category.
Key Points
1. Rotterdam Convention
To better understand the EU PIC Regulation, let us first look at the Rotterdam Convention.
Background
PIC Procedure
Through this intergovernmental agreement, chemical import and export procedures were established to give importing countries the right to independently decide whether to accept hazardous chemicals.
This is known as the PIC (Prior Informed Consent) procedure.
How It Works
When a hazardous chemical is newly added to the convention's control list (Annex III), participating countries notify the secretariat regarding their import decisions.
The secretariat compiles these responses and distributes them twice a year via the PIC Circular. This allows exporters to verify in advance which countries have consented to import specific substances.
The convention is merely an intergovernmental agreement and only takes effect once each country incorporates it into its domestic law. The EU implemented this as a regulation directly applicable to all member states, which is the EU PIC Regulation.
2. EU PIC Regulation
1) Regulated Substances
Among the Annexes of the law, the lists of regulated substances are Annex I and Annex V.
Annex I consists of substances that require review upon export, while Annex V consists of substances whose export is completely prohibited. Each list is subdivided and managed as follows:
Category | Export Notification | Import Consent | Rotterdam Convention Annex III Status / Remarks |
Annex I | Part 1 | Required | Not Required | Substances that only require notification upon export |
Part 2 | Required | Required | Substances undergoing listing promotion for Rotterdam Convention Annex III |
Part 3 | Required | Required | Rotterdam Convention Annex III substances |
Annex V | Part 1 | N/A | N/A | POPs (Persistent Organic Pollutants) substances |
Part 2 | N/A | N/A | Substances banned within the EU other than POPs |
[Annex I and V Table]
2) Other Annexes
| Annex | Contents |
| Annex II | Information requirements for export notification |
| Annex III | Member states' import/export volume aggregate reporting format |
| Annex IV | Information requirements for PIC notifications submitted by the EU to the convention secretariat |
| Annex VI | List of transit notification target countries |
| Annex VII | Correlation table with the old regulation |
[Annexes II, III, IV, VI, and VII Table]
Please note that EU PIC Regulation Annex III (aggregate reporting format for import/export volumes) and Rotterdam Convention Annex III (list of PIC target substances) share the same name but are different lists, so please ensure they are not confused.
3) Target Scope of EU PIC Regulation
1) If a hazardous substance in a mixture exceeds specific CLP concentration limits, the mixture must be labeled. The EU PIC Regulation also applies to these mixtures.
2) Regulation (EC) No 1272/2008. This regulation implements the UN's GHS (Globally Harmonized System) within the EU to standardize chemical hazard classification and labeling.
4) Regulatory Exceptions
The items and specific transaction conditions below are excluded from the application of this regulation:
Narcotics, psychotropic substances, radioactive materials, waste, and chemical weapons
Food, food additives, feed, GMOs, pharmaceuticals, etc.
Small-scale imports and exports for research and analytical purposes with transactions of 10 kg or less per importing country per year.
Conclusion
The EU PIC Regulation imposes notification or import consent requirements for the export of Annex I substances, while prohibiting the export of Annex V substances. In practice, please verify the following three points:
Whether chemical substances and mixtures imported from EU suppliers are listed in Annex I or V.
Whether export notification deadlines are met (if an EU local entity is the exporter).
Whether substances remaining in an unreacted state within articles are included.
At MDSKorea, we are committed to providing you with valuable insights. Thank you.
[Glossary]
| Term | Description |
| PIC | Prior Informed Consent |
| PIC Circular | PIC Circular document (distributed twice a year) |
| Annex | Regulation appendix |
| CLP Regulation | Classification, Labelling and Packaging Regulation (Regulation (EC) No 1272/2008) |
| POPs | Persistent Organic Pollutants |
| Article | Finished products from which substances are not released during normal use |
| GHS | UN international standard unifying hazard classification and labeling of chemicals; basis of the CLP Regulation |
[Source]
Overview
Hello. This is MDSKorea.
The EU PIC Regulation is a law that controls chemical substances exported outside the EU.
As EU suppliers can proceed with the export of regulated substances once the import consent of your country is confirmed, we recommend checking in advance whether your planned imports fall under this category.
Key Points
1. Rotterdam Convention
To better understand the EU PIC Regulation, let us first look at the Rotterdam Convention.
Background
The Rotterdam Convention was established to address the issue of exporting pesticides or chemical substances to developing nations.
PIC Procedure
Through this intergovernmental agreement, chemical import and export procedures were established to give importing countries the right to independently decide whether to accept hazardous chemicals.
This is known as the PIC (Prior Informed Consent) procedure.
How It Works
When a hazardous chemical is newly added to the convention's control list (Annex III), participating countries notify the secretariat regarding their import decisions.
The secretariat compiles these responses and distributes them twice a year via the PIC Circular. This allows exporters to verify in advance which countries have consented to import specific substances.
The convention is merely an intergovernmental agreement and only takes effect once each country incorporates it into its domestic law. The EU implemented this as a regulation directly applicable to all member states, which is the EU PIC Regulation.
2. EU PIC Regulation
1) Regulated Substances
Among the Annexes of the law, the lists of regulated substances are Annex I and Annex V.
Annex I consists of substances that require review upon export, while Annex V consists of substances whose export is completely prohibited. Each list is subdivided and managed as follows:
Category
Export Notification
Import Consent
Rotterdam Convention Annex III Status / Remarks
Annex I
Part 1
Required
Not Required
Substances that only require notification upon export
Part 2
Required
Required
Substances undergoing listing promotion for Rotterdam Convention Annex III
Part 3
Required
Required
Rotterdam Convention Annex III substances
Annex V
Part 1
N/A
N/A
POPs (Persistent Organic Pollutants) substances
Part 2
N/A
N/A
Substances banned within the EU other than POPs
[Annex I and V Table]
2) Other Annexes
[Annexes II, III, IV, VI, and VII Table]
Please note that EU PIC Regulation Annex III (aggregate reporting format for import/export volumes) and Rotterdam Convention Annex III (list of PIC target substances) share the same name but are different lists, so please ensure they are not confused.
3) Target Scope of EU PIC Regulation
Chemical Substances and Mixtures
Not only single chemical substances, but also mixtures exceeding the concentration levels that trigger labeling obligations1) under the CLP Regulation2) are included in the regulatory scope.
Applicability to Articles (Finished Products)
In general, articles in which substances chemically react and bind and are not released during normal use are excluded from the regulatory scope in principle.
However, if substances corresponding to Annex I Parts 2 and 3 remain within the article in an unreacted form (without chemical reaction), that article may also be subject to export notification.
1) If a hazardous substance in a mixture exceeds specific CLP concentration limits, the mixture must be labeled. The EU PIC Regulation also applies to these mixtures.
2) Regulation (EC) No 1272/2008. This regulation implements the UN's GHS (Globally Harmonized System) within the EU to standardize chemical hazard classification and labeling.
4) Regulatory Exceptions
The items and specific transaction conditions below are excluded from the application of this regulation:
Narcotics, psychotropic substances, radioactive materials, waste, and chemical weapons
Food, food additives, feed, GMOs, pharmaceuticals, etc.
Small-scale imports and exports for research and analytical purposes with transactions of 10 kg or less per importing country per year.
Conclusion
The EU PIC Regulation imposes notification or import consent requirements for the export of Annex I substances, while prohibiting the export of Annex V substances. In practice, please verify the following three points:
Whether chemical substances and mixtures imported from EU suppliers are listed in Annex I or V.
Whether export notification deadlines are met (if an EU local entity is the exporter).
Whether substances remaining in an unreacted state within articles are included.
At MDSKorea, we are committed to providing you with valuable insights. Thank you.
[Glossary]
[Source]