REGULATION Changes to EU Poison Centres regulation:

“harmonised information relating “to emergency health response “and lubricants: the next burden?

Dr. Stephan Baumgartel, Executive Director, Verband Schmierstoff-Industrie eV

The “Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging (CLP) of substances and mixtures by adding an Annex (VIII) on harmonised information relating to emergency health response“, comes into force in all EU member states from 01.01.2020.

The intention was to replace national legislation on information submission about dangerous mixtures to the Poison Centres. This means that for the first time EU member states will work to a common European- wide standard.

According to article 45 of the CLP regulation, EU member states are still entitled to “appoint a body or bodies responsible for receiving information (…) for formulating preventative and curative measures, in particular in the event of emergency health response”. That means to collect all “necessary” information on mixtures classified as hazardous, physical hazards (H2xx category), with some exemptions, and human health (H3xx category) hazards.

All EU member states therefore will still have to appoint a body, or Poison Centre, responsible locally for emergency health response. Thus, Annex VIII does not replace the national requirements. Nationally- appointed bodies may, however, ask for additional information over and above that required by the new EU regulation concerning hazardous mixtures and may also require the payment of registration fees.


The new Annex VIII applies to all mixtures classified as “dangerous” for human health (plus the classification of some physical hazards) for consumer, professional an industrial use. This is hard to understand since industrial end users already receive a Safety Data Sheet (SDS) with all the necessary information on hazards and first aid measures. Industrial users should therefore already know how to handle dangerous mixtures safely. Consequently the new legislation is expected to have little benefit in the case of work accidents. Exempted from submitting information are radioactive mixtures, mixtures used in scientific research, waste, medicinal products, cosmetic products and food, explosives and gases under pressure.

Whenever an importer, formulator, toll blender, or re-packer brings a hazardous mixture (e.g. a lubricant) to the market, they are obliged to submit information on the mixture to the appointed bodies or Poison Centres. “Information” means the full formulation plus physical and chemical data.

This is nothing new to the industry. So far, in many European countries, formulators are already obliged to do so but frequently they are not aware of these duties. On the other hand, in most cases only consumer products had been a subject of local legislation so far.

It is a common understanding that “industrial use” means use in areas without public access, e.g. private premises such as factories, but not workshops or households.

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