Caveats Concerning Limited Submissions
If you’re placing mixtures on the market only for industrial use, limited submission to the poison centre notification sounds very appealing. You fulfil your notification obligation while providing only minimal data about your mixture. Sounds like a win, right?
Well, take a closer look. Unless you have a hotline that meets the requirements outlined by the regulation, limited submissions may be more costly overall – measured by time and effort – as a standard submission. You also need to supply detailed information to the hotline.
Additional Requirements for PCN Limited Submission
The ECHA guidance document outlines the following regarding limited submissions:
- Additional details information must be rapidly available on request or in the event of an emergency incident
- The detailed information must be provided in the languages accepted by the specific Member State where the mixture is placed on the market
- If the mixture starts being used in consumer or professional products, the full set of information required for a standard submission needs to be submitted before placing on the market with the new use type
PCN Limited Submission and Hotline
Basically, what this means is that: if you would like to do limited submissions, you would need to have a 24/7 hotline that:
- Has access to all data as required in a standard submission such as:
- Full composition, not only hazardous ingredients
- Toxicological data of the mixture
- Toxicological data for all of the components
- Can speak all languages accepted by the specific Member State where you place the mixtures
Limited Submission or Standard Submission?
If you are certain that your mixture is used for industrial use only and already have a hotline in place that has access to all the required data and is available in all languages that are accepted by the Member States, then limited submission would be an option.
However, if there is a possibility that your mixtures are used in consumer or professional products and your existing hotline does not meet the outlined criteria, then we strongly recommend only carry out standard PCN submissions.
Using a solution that fits into your existing business process and IT landscape would be a tremendous help in reducing the amount of effort and time required for creating poison center notifications. If you’re using SAP, our solution opesus EHS Product Notification can be seamlessly integrated into your existing ecosystem. Contact us!