ECHA

More than half a million calls are made to European poison centres every year. In some countries, poison centres respond mainly to questions from healthcare professionals. In others, they give direct advice to concerned citizens. In both cases, quick access to accurate information is a must. Three experts working for national authorities tell how they expect the new information requirements to help poison centres and what companies should keep in mind when preparing their notifications.

To improve the protection of citizens across the EU and ensure a level playing field for companies, harmonised information requirements for notifying hazardous mixtures under the Classification, Labelling and Packaging (CLP) Regulation start to apply from 1 January 2021. This will replace the national implementations of the regulation that will be in place until then.

Mette Ekeland, Senior Adviser at the Norwegian Poisons Information Centre welcomes the change as information is key when it comes to poison centre work. “Our average call time is four minutes. During this time, we have to find out what has happened, find information on the product, make an assessment of what needs to be done and explain this to the caller. To manage all this in such a short time, we need immediate access to product information,” she explains.

Mette Ekeland. Image: Mette Ekeland.

“I sincerely hope that the system will be manageable for companies because we are completely dependent on the information they provide. There can be no success without this cooperation.”

Improving the accuracy of advice

But it’s not only about having quick access to information. To provide correct advice at the end of a short call, poison centres must be able to precisely identify which product is involved in the incident. In addition to harmonised information requirements, Annex VIII to the CLP Regulation also requires companies to include a unique formula identifier (UFI) in their notification and in the corresponding product label.

The UFI links the mixture composition to a certain product. With the help of the UFI, it will be easier and faster for poison centres to reliably identify the product in question.

“The UFI code is the most important change for poison centres. For some years already, we have called for some kind of a precise identifier to be linked to each mixture,” says Herbert Desel, Head of the Exposure Assessment of Hazardous Products Unit at the German Federal Institute for Risk Assessment (BfR), which is the appointed body for poison centres in Germany.

The UFI is particularly important for consumer products and can make a real difference in an emergency situation. “Labels in consumer products often include lots of information. It is sometimes difficult for the caller to tell the exact name of the product when they are distressed and worried. Sometimes they may also refer to a wrong product name because it is very similar to another product name which could lead to very severe mistakes. Similar names don’t necessarily mean similar chemical formulations,” Dr Desel explains.

If the poison centres can’t find precise information on substances or their concentrations, then they have to base their assessments on ‘worst-case scenarios’ and consumers may need to be referred for further examination at the hospital, just to be sure that exposure won’t cause any delayed medical conditions. The UFI code can help decrease the number of unnecessary visits – benefitting both the individual and society.

In addition to the UFI, companies are also required to include the full composition of their mixture in the notification. This is something that Patricia Casey, Manager of the National Poisons Information Centre in Ireland, looks forward to. “Toxicologists love the saying by Paracelcus, ‘All things are poison and nothing is without poison, the dosage alone makes it so that a thing is not a poison’. For us, this is very true. If we know exactly what components are in the mixture and what their concentration ranges are, we would be in a much better position to assess if the patient has taken a toxic dose,” Ms Casey explains.

Herbert Desel. Image: Herbert Desel.

“The UFI code is the most important change for poison centres. For some years already, we have called for some kind of a precise identifier to be linked to each mixture.”

Common errors in notifications

Sometimes the devil is in the detail. A simple typo can have severe consequences if included in a poison centre notification. If a poison centre is not able to find the product information or confuses the product with another due to a misspelled name, in the worst case, it could cost a life.

According to Dr Desel, this is one of the most common types of error poison centres see in notifications. Other common errors include:

• the same product information being notified twice;
• missing full mixture formulas; and
• classification and labelling information not corresponding to the given formula.

The German appointed body already accepts notifications through the ECHA Submission portal and according to Dr Desel they have noticed an encouraging change in the quality of notifications compared to those received under national legislation. “We see that the data coming through ECHA’s portal is of much better quality. So the validation rules seem to work and are successfully filtering out the more technical errors.”

And Dr Desel expects the positive development with data quality to continue. “We recognise that most of the submitters are currently creating their datasets manually using IUCLID. We believe that when bigger companies start to submit their notifications using the system-to-system upload, the number of typos and small errors will continue to decrease because the information will no longer be typed in manually but extracted directly from their company databases,” he explains.

The concept of mixture in mixture

Mixture in mixture is one of the concepts included in the harmonised information requirements. It refers to a formulation that is created using another mixture. When these formulations are placed on the market, the notification must also provide information on those substances included in the mixture in mixture.

Even though detailed information on mixtures in mixtures is important, Ms Casey says that without proper training, their staff may not be able to benefit from this information. “Not all staff members are familiar with the different substances in the mixtures. It is very time consuming to find information on all the chemicals used in mixtures in mixtures. This is something that requires additional training for our staff,” she explains.

Also Ms Ekeland is worried about the complexity of the mixture in mixture concept. “It will be too time consuming for us in an emergency situation to have to find the composition of several mixtures and then calculate what is in the final mixture,” Ms Ekeland says and continues, “I would like to see an app or a program developed that would make the calculation of the final composition for us.”

Overall, the challenge for poison centres is to find a balance. In most cases, it is sufficient to have concise information about the product, but there are times when more detailed information must be available. So, while the mixture in mixture concept helps industry fulfil their obligations, it poses additional complexities for poison centre staff.

Patricia Casey. Image: Ailís Odell.

“My recommendation to companies is to get to know the new information requirements, read the guidance documents and understand the concentration ranges.”

Messages to companies

Industry sometimes raise concerns about the security measures in place to safeguard their confidential business information. This has been heard and apart from securing IT systems and physical office locations, authorities are in regular contact with industry representatives to be able to better address the concerns. To show that companies can trust the system, the appointed body and poison centres in Germany are considering to let industry perform a stress test on authorities’ systems once the implementation of the harmonised procedure is completed.

And since the first application date in January 2021 is not far away, it means that companies should already be underway with their preparations. “My recommendation to companies is to get to know the new information requirements, read the guidance documents and understand the concentration ranges. There is very good information about all of these on ECHA’s Poison Centres website and on the websites of national poison centres,” Ms Casey points out.

As the UFI code is something new and it is expected to offer easy and quick access to correct information, Dr Desel would like to remind companies to take a particularly good look at the documents explaining how the UFI is used correctly. “Since the UFI is directly linked to one formula, companies need to remember that if their formula changes, it’s not enough to just resubmit the data, but they would need to generate a new UFI, too. If this isn’t the case and the submitter is using the ECHA Submission portal, they will get a warning about this discrepancy,” he says and continues, “Companies must also remember that the UFI in the notification must be the same as the UFI printed on the label. If the UFI is wrong, it could lead to wrong advice.”

While the poison centres answer the calls, search through the information, make risk assessments and give advice to EU citizens, ultimately, companies are responsible for submitting accurate notifications. And by doing that, they can help save lives. “I sincerely hope that the system will be manageable for companies because we are completely dependent on the information they provide. There can be no success without this cooperation,” Ms Ekeland concludes.

Member State readiness to accept notifications   Germany has been accepting notifications through the ECHA Submission portal since May 2019, but also has a parallel national system in place.   Most Member States will only accept notifications through the ECHA Submission portal closer to the first applicability date in January 2021, including Norway and Ireland.   Check the readiness of different Member States to accept harmonised notifications through the ECHA system from this overview.

Further information:

ECHA’s Poison Centres website

Steps for industry

Support

Updated guidance clarifies labelling requirements for poison centre notifications

Guidance on Annex VIII

Overview of Member States decisions in relation to implementation of Annex VIII to CLP Regulation (Poison Centre Notification)

Interview by Päivi Jokiniemi

Published on: 28 May 2020

Top image: © Unsplash/Petr Machacek

If you liked this article, you may also like: 5 tips for preparing poison centre notifications, Newsletter 4/2019 Get to know ECHA’s Submission portal for poison centre notifications, Newsletter 2/2019