Insights on Environmental Health & Safety (EH&S), Operational Risk and Product Stewardship

European Poison Center Reporting Changes Don’t Have to Be a Poison Pill for Your Business

March 23rd, 2017
Francis Trudeau
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On March 22, 2017, the European Commission adopted Commission Regulation (EU) 2017/542 amending the Classification, Labelling and Packaging, or CLP, regulation by adding an Annex (Annex VIII) on harmonized information relating to emergency health response. You can read the regulation here.


As parents, we do everything we can to keep our kids safe. We childproof kitchens so they can’t get into the silverware drawer, we teach them to look both ways before crossing the street and we put up gates in front of stairs so the little ones won’t go tumbling down.

Still many kids find a way to fall into trouble—including touching and many times ingesting the dangerous chemicals found in everyday consumer products from laundry detergent to mouthwash.

Poison Centers in the European Union alone receive a reported 600,000 phone calls per year about accidental exposure to chemicals of which about half are related to concerns about children. Sadly, more than 400 people die each year in the EU from poisoning related to hazardous chemicals.

Under the European Chemicals Agency’s Article 45 of the Classification, Labelling and Packaging, or CLP, companies are required to submit all information about products with hazardous mixtures to the national appointed bodies of each EU member state.

However, there is currently no standardization between the 28 EU member states for how companies should register those products with the various poison centers—from the Croatian Institute for Toxicology and Antidoping to the Poisoning Information Centre Health Board in Estonia and a score of other similar organizations. Each country has its own standards and regulations, which can lead to confusion for poison control center staff who need to be able to determine what’s in a product to assess the situation as quickly as possible.

While this is cumbersome for the individual poison centers, it’s a nightmare for companies that are forced to comply with the various data content and format requirements from each EU country.

But that’s about to change.

Last fall, the EU voted in favor of the European Commissions’ plan to standardize the hazard and safety information across the board so that, in an emergency health response situation, every poison center can easily identify the hazardous product, know what’s in it and what to do to advise the person on the other end of the phone.

Any company selling products to consumers in the EU will have to submit information electronically to the poison centers to be in full compliance with the new regulation by 2020. For products used in the professional or industrial settings, they will need to comply by 2021 and 2024, respectively.

Basically, what the EU has done here is taken an innovative approach to compliance in the areas of Product Stewardship and hazard communication.

For industries, ECHA has laid out four core areas that companies need to do to prepare:

  1. 1) Identify Your Obligations: This includes understanding your portfolio and history and identifying deadlines.
  2. 2) Prepare Your IT Systems: Basically, decide how you will be able to comply.
  3. 3) Know Your Deadlines: Know when you will need to start using the electronic system and re-labeling your products.
  4. 4) Keep Up-to-Date: Expect guidelines and mandatory and voluntary updates to emerge from this new regulation.

In other words, there’s a lot to do.

In the past few months, I’ve heard from many customers about this new regulation. It’s a big change so it’s a big concern. Sphera is committed to helping our customers stay in compliance with these upcoming regulations.

As we perfect our chemistry in this area, if you will, we welcome the possibility of learning more about your thoughts and concerns about the new EU poison center regulations. You can contact us directly through our website.

Francis Trudeau

Francis Trudeau has worked for nearly 20 years in product compliance and chemical management. He has significant experience in solutions management and development, global regulations and industry standards enforced worldwide. He has worked on a wide variety of projects that support Sphera's integrated information management solutions, and address legal compliance challenges and the implementation of regulations in databases and software applications.

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