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Commission Regulation (EU) 2017/542: involved subjects, Unique Formula Identifiers (UFI) and EuPCS (European product categorisation system)

corresponding

BARBARA MILIANO
Flashpoint S.r.l., Monza, Italy

Abstract

Currently, there are significant differences between notification systems, data formats and country-specific requirements. As a result, importers and downstream users who placed mixtures on the EU market had to submit similar information multiple times and in different formats. This situation would lead to inconsistencies in the information available to medical personnel and the general public in the event of poisoning in the different Member States.
Given the significant differences between the notification systems of each Member State as per Article 45 of the CLP Regulation, the European Commission has introduced Annex VIII, which harmonises the requirements to make them clearer and more effective.


INTRODUCTION
Annex VIII to the CLP Regulation on harmonised information relating to emergency health response was implemented on 22 March 2017.
Before its publication, the regulatory framework consisted solely of Article 45 of the CLP Regulation concerning the submission of information relating to emergency health response to appointed bodies.
Each member state had different notification systems with different data formats and requirements.
The European Commission has thus introduced Annex VIII, which harmonises the requirements to make them clearer and more effective.


MAIN CONTENTS
According to Article 45 of the CLP Regulation, anyone who places mixtures on the market classified as hazardous (health or chemical and physical effects) must submit information relating to emergency health response to appointed bodies.
Annex VIII to the CLP Regulation defines the requirements that importers and downstream users who place mixtures on the EU market must meet to submit this information to the appointed bodies in compliance with Article 45.
Namely, it defines who needs to notify the appoin ...




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