Europe: UFI module and EU declaration available

The UFI code, among the most important innovations introduced by Annex VIII, must be printed on the label of hazardous mixtures in order to uniquely correlate the mixture placed on the market with the information contained in the declaration sent to the Poison Centers.

Therefore, any company that places on the market EU hazardous mixtures, must generate their own UFI codes, include them in the declaration for Poison Centers and print them on the labels of their dangerous products.

Annex VIII to the CLP: what it introduces

Annex VIII of the CLP (Reg. 2017/542) harmonised the information to be declared to the Poison Centres at European level. In particular, importers and downstream users (such as formulators) will have to provide detailed information on hazardous mixtures before placing them on the market in Europe.

As clarified by the Regulation itself, Annex VIII declarations should be submitted electronically in an XML format provided by the European Chemicals Agency (ECHA).

To date, the majority of EU countries (including Italy) are not ready to receive notification according to Annex VIII, but are expected to update their publications on the regulation and transmission formats in order to ensure proper notification

The software solution

Trace One is constantly working to support its customers in the organization of their work and in compliance with regulatory requirements.

The new versions of the Trace One SDS Authoring and Trace One Devex PLM suites enable the first part of the UFI module, which will allow you to:

• Automatically generate UFI for your products
• Insert Mime UFI of MiM (Mixtures in Mixtures)
• Manage and maintain your UFI portfolio
• Automatically extract the relevant data already present in the system
• Insert new specific information required by Annex VIII

The UFI code creation window in Trace One SDS Authoring Professional and Trace One SDS Authoring Corporate.

The EU declaration (PCN dossier)

The second part of the PCN file generation module will enable you to:

• Have a preview of the information to be declared and generate the PCN dossier
• Calculate when the UFI and declaration need to be updated.

The second part of the module will be available by the end of 2020, following the official publication of the 2nd amendment of Annex VIII (currently available in DRAFT in public consultation) and the update of the PCN format by ECHA.

To know in detail all the solutions available for Trace One SDS Authoring Professional, Trace One SDS Authoring Corporate, HSM and Trace One Devex PLM please contact our Customer Service at EU-customer-service@selerant.com.

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