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Regulations & EHS&S



Poison Centres: What’s Changing?

By The Hazard Communication Team at Yordas Group - 15/02/2018

The Hazard Communication Team at Yordas Group explains how CLP regulations on hazardous chemicals are changing, how to determine whether your products are affected, and the information that chemicals companies need to provide.
 
Poison Centres play an important role in ensuring the safe use of chemicals by providing vital information in case of a poisoning incident.  EU Poison Centres answer an average of 600,000 calls each year in response to accidental exposure, providing medical advice to general consumers and physicians when health emergencies arise from exposure to hazardous chemicals. Up until recently, industry requirements relating to Poison Centres differed between member states.  The information submitted varied widely, adding administrative strain on Poison Centres.  Under Article 45 of the Classification, Labelling and Packaging (CLP) Regulation, the requirements on industry are set to change with the aim of harmonization of requirements across the EU.
 
Under the CLP Implementing Regulation, importers and downstream users placing mixtures classified as hazardous to human health on the market will be responsible for submitting information to poison centres in the relevant Member State(s).  New online tools and a harmonized EU format will be introduced, with the aim of helping companies submit this information. Once the Implementing Regulation is adopted, deadlines for the submissions will apply in a stepwise manner ,depending on the intended use of the mixture. 
 
The differing deadlines depending on the intended use of the mixture are as follows:
  • Consumer Use - January 2020
  • Professional Use - January 2021
  • Industrial Use - January 2024.

These are general deadlines; however, if recipients of products have notified under the current regulation, they are not obligated to notify under the new regulation until 2025.

Which products are applicable to these changes?
In order to determine if the regulation applies to you, it is beneficial to determine whether your products fall under the regulation.

Any product that falls under the CLP regulation, and is a mixture classified as hazardous to human health or causing physical effects, will meet the requirement to notify. Biocides, detergents and cleaning products are also applicable.

Out of scope products include all explosives, gases under pressure and mixtures with environmental hazards. Please be aware that some member states have alluded to wanting information on components classified as environmentally hazardous, but this will be at a national rather than EU level. It's also worth noting that if a product falls outside the scope of CLP, it will be exempt from notification requirements, and if any of your products have the sole purpose of R&D these will also be exempt.

The Proposed Notification Process
Currently, where notification can be undertaken is not fully defined. However, ECHA is currently developing a poison centre notification portal that aims to provide a central point where industry can submit notifications. Information submitted to the portal will be disseminated to the poison centres or appointed bodies of the relevant member states.

ECHA believes that a central notification portal will simplify the process of submission of information for industry, in addition to harmonizing the documentation received by the Member States' appointed bodies and poison centres. From a Member State perspective, the portal will also reduce costs and administration by removing the need for notifiers to contact Members States directly. Industry has also been assured that confidential business information will be even more secure, as the number of channels that data will need to be passed along will be reduced. It has been proposed that companies will be able to submit information in their own language, with appointed bodies receiving the information in their local language, reducing errors associated with mistranslation.


Although where to submit the notification is not yet finalized, ECHA has stated that information which is submitted to poison centres needs to be provided in a harmonized format, and there are currently two proposed methods to do this.

  1. The first is the ‘poison centres notification format’ which will be particularly useful for companies dealing with a large number of formulations as the XML allows them to integrate the data requirements into their own IT systems.
  2. The second option is the PCN editor. The PCN editor is a basic application that can be used by companies to prepare and update files for the submission of information to poison centres in the harmonized format. It is particularly intended for small and medium sized enterprises.

The notification process is a complex one, with the potential for a lot of administration work to get the information into the harmonized format required for successful submission.

What information is requred?
Under the new regulation, a lot more information is required during the notification process. Notifiers will need to submit specific information on the composition of applicable mixtures, including in-depth details on the percentage inclusion of components.

Notifiers will also need to include a unique formula identifier (UFI) in the notification and on the label of their hazardous mixtures. The UFI can be generated using ECHAs online tool, or companies can obtain the logic to integrate the UFI generator into their own IT-system. This identifier will create a direct and unambiguous link between the mixture they place on the market and the information on the specific mixture they provide to the poison centres.

Information on the product category (in line with the EU Product Categorization System), type and size of packaging and intended use of the product will also be required.

What you can do now?
Firstly, complete as many Poison Centre notifications as you can now to make use of the transitional period allowing current notifications to stand until 2025. You can take advantage of the member states where notification is free, as the new regulation is expected to put an extra burden on member states and consequently increase costs, which may be put onto the notifier in the form of notification fees. It must also not be forgotten that in order to be compliant notification must be made now.

As well as getting ahead of the new requirements, now is also the time to start preparing yourself for the new regulation. Put together an overview of the products which trigger the requirement of notification to a poison centre, and start to collate the data required for submission. Make sure you also know which member states you place the applicable products on the market into.

You will be expected to disclose more compositional information than ever before so make sure you have a good understanding of the minimum amount of information you will be required to disclose, and begin discussions with your legal department where this is in not in line with your current disclosure policies.

Contact:
The Hazard Communication Team at Yordas Group, Lancaster Environment Centre, Lancaster University, Lancaster LA1 4YQ, UK
T: +44 (0)1524 510278
www.yordasgroup.com | www.chemtracglobal.com