REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring

1. Article 45 of directly acting EU classification, labelling and packaging (CLP) Regulation (Regulation (EC) No 1272/2008) obliges Member States to appoint a body responsible for receiving certain information about chemical mixtures that are hazardous to health, including details of chemical composition, from importers and downstream users of these mixtures. This information is used for emergency response and for developing preventative and curative measures in the event of a poisoning incident.

2. In 2017, European Commission Regulation (EU) No 2017/542 amended the CLP Regulation by adding an Annex (“Annex VIII”). Annex VIII is intended to harmonise the emergency health information provided to all EU Member States’ appointed bodies. Although Annex VIII has been in force since 2017, it was only intended to apply on 1 January 2020 and the first applicability date was not until 1 January 2020.

3. In their report, the European Commission is proposing an amendment of the first applicability date of Annex VIII from 1 January 2020 to 1 January 2021. This postponement will allow time for solutions to workability concerns raised by stakeholders regarding Annex VIII to be found and for any ensuing changes to be made before the new first applicability date.

Topic  Health 
Department  Health 
Council Reference  14425/19 
COM Reference  COM(19)591 
SEC Reference   
PE Cons   
JOIN   
SWD   
C Reference   

Associated file(s)


  1. 14425/19 - 463 KB - pdf
  2. EM 14425/19 - 85 KB - pdf

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