ECHA

If you are an exporter in the EU and trade certain chemicals with non-EU countries, you have to inform your national authority about your export activity. This information not only helps protect human health and the environment, but also bolsters cooperation between the EU and non-EU countries in the international trade of hazardous chemicals.

There is a system to alert importing countries about chemicals that have been banned or severely restricted in other countries, which can help them avoid unwanted trade. This system is in place in the EU due to the PIC Regulation, which applies the Rotterdam Convention, a global treaty that establishes the prior informed consent procedure for certain hazardous chemicals and pesticides throughout the world.

The regulation also tries to safeguard human health and the environment by providing information on how to store, transport and dispose of chemicals safely.
 

Are your chemicals subject to PIC?

If you export certain chemicals which are banned or severely restricted in the EU as industrial chemicals (either for professional or consumer uses), or pesticides used as plant protection products or biocides, they fall under the scope of PIC. You have to notify your exports through the IT tool ePIC.

All PIC chemicals and groups are listed in Annex I to PIC which has three parts:

1. Chemicals that need an export notification (186 entries, for example, benzene and dibutyltin compounds).
2. Chemicals that need an export notification and a statement of agreement from authorities in the importing country (87 entries, including nicotine, nonylphenol ethoxylates and atrazine).
3. Chemicals that need an export notification and are subject to the rules of the Rotterdam Convention (44 entries, including ethylene oxide).

Other chemicals banned for export, such as persistent organic pollutants and mercury compounds under the Stockholm Convention, are listed separately in Annex V to PIC (which currently contains 22 entries).

Chemicals that can be found in drugs, radioactive materials, waste, chemical weapons, food and food additives, feeding stuffs, genetically modified organisms, and pharmaceuticals (except disinfectants, insecticides and parasiticides) are not covered by PIC.

Chemicals are added to the list by the European Commission each year. For example, until now they have checked the substances restricted under REACH, or active substances that have not been approved under the Biocidal Products Regulation (BPR) or the Plant Protection Products (PPP) Regulation. Any changes to chemicals under the Rotterdam Convention and the Stockholm Convention are also reflected in the list.
 

Adding chemicals to group entries

Within the list of chemicals that need an export notification, you can find both individual substances and group entries. Group entries collect individual substances based on their similar chemical identities. While it is easy to see whether or not your individual substances are included in the list, things are not always so clear for group entries.

Sometimes, ECHA receives a request from a company asking whether a substance should be included in a certain group entry, and the Agency has to verify it. If it is found that the substance does not belong to the group entry, ECHA informs that there are no further obligations under PIC. However, if the substance is verified as belonging to a group entry, it is added on a case-by-case basis. Since the process is done on a one-to-one basis between ECHA and the requesting company, the group entries listed in the IT tool ePIC are never fully comprehensive.

To remedy this, ePIC has been updated to include a list of substances added to group entries after the date on which the latest amendment of the group was published.
 

What you need to notify

If your chemical is on the export notification procedure list, you need to notify your national authority about your intent to export it. You must do this in ePIC before your first export takes place each calendar year. From your national authority, the notification goes through ECHA to the receiving authority in the importing country.

You have to include the identity of the substance (its CAS, EC or name), the countries of origin and destination, the date of the first export, and the expected yearly amount of the chemical exported. You also have to give the intended use, the names and addresses of the exporters and importers, the precautions to be taken when handling the chemical, a summary of the chemical’s properties, information on how it is used in the EU, and any reasons for regulatory restrictions.

Your exports receive a reference identification number, which customs can use to control them. The number is a unique identifier that allows customs to see the export type, whether it is allowed and during which time period.
 

Sometimes, you need more than a notification

For some chemicals, you also need a statement of agreement from the national authorities of the importing countries. These are known as explicit consents.

In certain cases, these can be waived, for example, when the importer does not respond within 60 days of your request. The explicit consent is also not needed if you are exporting the listed pesticide or industrial chemical to an OECD country and have proof that it is authorised or licensed there.

Explicit consents are valid for any subsequent exports of the substance in the next three years – unless the explicit consent specifies otherwise.
 

The broader the consent, the better

Sometimes the consent can be too narrow – it may be for a particular company or product instead of being substance-specific.

The importing country may have defined specific conditions in the explicit consent that only apply to a particular company or product, but not to yours. This is why your export may be rejected, while another company is allowed to export the same substance. EU Member States encourage importers to give the broadest possible consent to exporters.

The explicit consents are never made available in ePIC because they may include sensitive commercial information such as trade names. Therefore, you cannot compare why one company has received the consent but another has not.
 

The challenge with biocides

The trade of biocides can sometimes be problematic as the term can be misunderstood. In the EU, biocides are used to destroy, deter, render harmless, or control harmful organisms by chemical or biological means, but some non-EU countries do not define them in the same way.

Under PIC, biocides fall under the pesticides subcategory. So even if the intended use is biocidal, the export is classified as an export of a “pesticide”, which authorities in many importing countries may misunderstand as a plant protection product to be used, for example, on crops. Take, for instance, a sterilisation agent such as ethylene oxide, which is used to disinfect hospital equipment. Even if the company needs it for this purpose, the importing authority sees it categorised as a pesticide, and may reject its import due to what is essentially a misunderstanding.
 

Ways to improve

While cooperation in the international trade of hazardous chemicals and the protection of human health and the environment are heading in the right direction, there is still room for improvement.

The recent report on the operation of PIC highlights specific areas such as better planning of ECHA’s workloads and improvements to the current waiver workflow system.

ECHA is seeking to address the points in the report with the Commission and the Member States when the next recast of the PIC Regulation takes place.

ePIC   ePIC is an IT tool used to securely exchange information about the import and export of certain hazardous chemicals between industry users, authority users (ECHA, designated national authorities and the Commission) and customs users. The latest version of the tool has been updated with new features. Companies now have: improvements in annual reporting on the previous year’s trade; access to a new feature which lets them see the substances added to group entries after the date on which the group became subject to PIC. This gives better visibility to substances subject to PIC; to declare the language of the safety data sheets they provide, which will speed up the process and reduce the number of requests for resubmission; and validation rules to help submit better quality data and reduce human error.

Further information:

Understanding PIC

Report on the operation of PIC 2017

List of chemicals subject to export notification procedure

Explicit consent

ePIC

Text by Paul Trouth

Published on: 16 November 2017

Top image: © iStock.com/andresr

If you liked this article, you may also like: Notifying the trade of hazardous chemicals more easily through ePIC, Newsletter 3/2015  ECHA's role under the PIC Regulation, Newsletter 1/2014