Businesses may need to make some large changes in order to be compliant with the pending poison center notification requirements in the EU. All companies dealing with mixtures in the EU – e.g., paints, coatings, metals, adhesives, solvents, cleaning agents, etc. – should already be taking action to get ready. To help with these adjustments the European Chemicals Agency (ECHA) has released a publication on "How to prepare and submit information to poison centres." Key information in the publication includes:
- Harmonized format for poison center notification (PCN)
Currently, all information which is provided for emergency health response in the EU is allowed to be submitted in different formats. This makes it hard for medical personnel to quickly decipher. The new PCN format harmonizes this information. The harmonized format is compatible with IUCLID 6; this means businesses are able to use ECHA Cloud Services for data hosting to store their PCN data.
- The PCN portal
The PCN portal will be the central online location where industry may prepare and submit the data on hazardous mixtures; this data will be used by poison centers in cases where emergency health response is needed. The portal will rely upon a harmonized PCN format based upon requirements established in Annex VIII to the classification, labeling and packaging (CLP) Regulation (No 1272/2008). Businesses may submit information into the PCN portal if allowed by the member state in question. Information submitted to the portal would then be forwarded to the appointed body in the member state/s where the mixture is to be placed on the market. When using the PCN portal, companies have the option to prepare their PCN notifications in IUCLID format within their own systems and then use the system-to-system (S2S) integration to transfer their data into the PCN portal. Companies also have the option to prepare their submission offline.
Regulation (EU) 2017/542
added Annex VIII to the CLP Regulation and requires EU member states to identify appointed bodies
to accept information on hazardous mixtures in order to provide needed information for emergency health response.
Under the new Annex VIII, importers and downstream users who place mixtures on the EU market for the first time must report certain information to appointed bodies prior to placing the mixture on the market.
The required information must be submitted for all "new" products, i.e. those which are not already notified under national legislation, by the following dates:
- 1 January 2020 for mixtures for consumer use;
- 1 January 2021 for mixtures for professional use; and
- 1 January 2024 for mixtures for industrial use.
"Old" products, i.e. those which are already notified to national bodies and are already on the market, may be able to take advantage of a transitional period until 1 January 2025. If changes are made to the product, however, a new notification will likely be required, following the new requirements.
The new Annex VIII to the CLP Regulation lists some exemptions from the notification requirements. These include: mixtures for scientific research and development (R&D) or those for product- and process-oriented R&D, gases under pressure and explosives. Importers and downstream users of mixtures which are placed on the market for industrial-use-only may be able to utilize a limited submission option.
After the compliance dates, information must be submitted to the appointed bodies before placing mixtures on the market. The information must be submitted in the member state/s where the mixture is being placed on the market.
The requirements on importers and downstream users include:
- Before placing a mixture on the market, submit the required information on mixtures classified as hazardous on the basis of health or physical properties;
- The submission must be in the official language of the member state in which it is submitted (unless otherwise stated by that member state);
- The intended use of the mixture must be included following the harmonized product categorization system provided by ECHA;
- Submissions must be promptly updated when certain conditions are met; and
- A unique formula identifier (UFI), provided by ECHA, must be printed or affixed on the label of a hazardous mixture and also included in the submission to the appointed body.
The required information includes: trade name/s; contact information for the submitter; hazard identification; classification (provided in accordance with the CLP Regulation); proper label elements including the hazard pictogram code, signal word, hazard statement codes, and precautionary statement codes; toxicological effects; among other information.
The submission format is provided in Part C of Annex VIII.
Importers and downstream users of hazardous mixtures must take action now to be prepared to meet the forthcoming deadlines. The poison center notifications require more information than is normally presented in a safety data sheet (SDS). For example, all components of a mixture must be indicated by concentration or concentration range, including those which are non-hazardous. Product categorization must be done according to the Product Categorization System (PCS). Other information is also required, such as packaging information and color.
Acquiring the required information may require enhanced communication in the supply chain. If confidential business information (CBI) is a concern, using the UFI may help. Some products such as perfumes, fragrances and coloring agents may be able to utilize generic identifiers.
Products will also have to be re-labeled in order to accommodate the new labeling requirements to include the UFI on the label of hazardous mixtures.
To tackle all of these requirements, businesses may need a new or improved data management system, as well as a process for monitoring changes and then fulfilling their obligations relating to these changes.
Companies will also have to decide how to submit their information. They may submit online through the portal, may use S2S integration, or may prepare their submission offline using IUCLID 6 and then submit through member state systems or through the central portal. Bear in mind that options may be limited in certain member states, since member states have the power to decide how companies have to submit the information for that jurisdiction. While the PCN portal will make submissions easier for industry, some member states may allow or require submission through a national system.
Regardless of how the information is submitted, the harmonized format must be followed and the information must be submitted to the appropriate appointed bodies electronically in the XML format provided by ECHA.
The first version of the PCN portal is set be available in Q1 of 2019. Companies who desire assistance with preparing for compliance with the new poison center notification requirements should get in touch with Verisk 3E.