Amendment to the European Regulation (EC) No 2017/542 covering poison centre notifications, and adoption of the 14th ATP to CLP

November 29, 2019

A new draft Commission Regulation, amending Annex VIII to the Classification Labelling and Packaging (CLP) Regulation, was issued during the 31st Meeting of Competent Authorities for REACH and CLP.

European Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures, otherwise known as the CLP Regulation, came into force on 20 January 2009 in all EU Member States, including the UK.

The CLP Regulation adopts the United Nations’ Globally Harmonised System (GHS) on the classification and labelling of chemicals. The purpose of GHS and CLP is to protect human health and the environment by stipulating how certain substances, mixtures and articles should be labelled and packaged.

Commission Regulation (EU) No 2017/542 amended the CLP Regulation by adding an Annex VIII, which relates to emergency health response. This Regulation requires companies placing hazardous mixtures on the EU market to provide poison centre notifications and was adopted in March 2017.

The Regulation applied to consumer use mixtures from 1 January 2020, meaning that all companies must have submitted poison centre notifications for consumer use mixtures by this date.

Recently the Commission proposed an amendment to Regulation (EC) No 2017/542 covering poison centre notifications (as a delegated act) that postponed the compliance date for consumer use hazardous mixtures from 1 January 2020 to 1 January 2021. The act makes a number of other changes to the poison centre notification Regulation making the notification requirements and process more straightforward. The act will now undergo a two-month period of scrutiny by the European Parliament and Council. If no objections are adopted, the act will apply from 1 January 2020.

Separately, the 14th ATP to CLP was also discussed and adopted on 4 October 2019. The most significant changes to CLP are:

  • Mixtures containing ≥1% titanium dioxide particles with diameter ≤10 μm and not bound within a matrix must be classified as a carcinogen by inhalation
  • Cobalt is to be classified as carcinogen category 1B
  • 28 other opinions on various substances have also been issued

This new ATP may be expected to be published by the end of 2019 or early 2020 if the European Parliament and Council do not raise any objections to this regulation. Following publication, the ATP shall apply from 18 months after entry into force.

How TSG can help

With extensive experience through our dedicated EU chemical regulatory teams, supported by technical specialists, TSG Consulting is on hand to assist in preparing and submitting regulatory dossiers and Safety Data Sheets, and to support you with any other queries throughout the regulatory process.

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