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NEW PCN RULES 2022

If you want to register a product, which you can do at the online PCN portal, you must provide certain data. These data relate to the product composition, but also to information about, for example, the UFI, the physical properties and the packaging of the product in question.

 

There are some new rules that have to do with people and companies who handle or workm withe dangerous elements. The new rules are effective from 1 January.

According to Article 45 of the CLP Regulation, companies that market dangerous preparations are obliged to make available to the national competent authorities information on certain dangerous substances. The notified body passes this information on to the poison center so that it can provide advice to laypeople or people working in the health sector in case of emergency.

 

The requirements to meet these new obligations are (in short) as follows:

 

–          Adding a legal entity.

–          Creation of UFI code.

–          Addition of the UFI code to the product safety data sheet and label.

–          Registration of the user on the ECHA portal.

–          Create a dossier for notification to the Poison Control Centre:

–          Enter pH of the mixture

–          enter toxicological information

–          Create a new dossier

–          Add contacts

–          report on the composition of the mixture.

–          Assigning UFI and other identifiers

–          enter information about the classification of mixtures and labeling elements

–          Provide product information.

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After completing all steps, the file is submitted for review. If everything is completed without errors, the submission is confirmed. If the system finds errors or missing information, the errors must be corrected.

 

If you don’t want to go through this long and sometimes complicated process yourself, contact us! Our experienced team can do everything for you. Upon completion of the submission, we will also send you a confirmation (submission report) for auditing purposes.

https://www.thesdsfactory.com/pcn-poison-notification-center/