It is common knowledge now that the data requirements for submitting a dossier in the poison centre notification (PCN) format is extensive. Besides the new data points such as the UFI and EU Product Category, the PCN format requires full composition of the product and other data such as pH value and hazard classification.
This article focuses on pH value – often a hot topic of discussion with our customers. For a seemingly simple and straightforward field of information, there are 8 validation rules that check the data in this field. Some of these validation rules result in errors while others result in warnings. Let’s have a closer look at the validation rules governing pH value.
pH Validation Rules that Result in Errors
There are 5 validation rules that will result in an error, and therefore unsuccessful submission of a PCN dossier.
- BR512: Exactly one field of “pH” is provided.
- BR545: Either “pH not relevant” must be selected or a pH value must be reported (either one value or range)
- BR524: If a pH value is provided, the value must be between -3 and 15.
- BR615: Allowed pH qualifiers – if one pH value is provided, the value cannot have qualifiers. If a range is provided, it cannot have “c.a.”.
- BR585: If pH value is provided, “solution concentration” must be provided.
From the 5 validation rules above, there are strict guidelines on how the pH value must be reported. What does this mean for companies?
If testing for pH and entering that data is not yet part of your business process, it’s time to include it. From our experience, this information is often available but simply not entered into the SAP EH&S system. If pH value is already entered with qualifiers such as “circa” or “approx..” or a range that is too wide, this data needs to be clarified.
pH Validation Rules that Result in Warnings
There are 3 validations rules that will result in warnings. The warnings are meant to indicate that while you can proceed with submitting the data, it does not meet the quality expectation. Here are the validation checks for quality:
- QLT504: pH value must be indicated as an integer or specified to one decimal.
- QLT501: Maximum pH value range width is 1 unit (when pH =<3 or >=10).
- QLT510: Maximum pH value range width is 3 units (when pH 3 < pH <10).
Conclusion: How to enter pH information
The purpose of the poison centre notifications is a harmonized format that provides succinct and precise information for emergency health response. Whether a solution is acidic or alkali is crucial information for administering appropriate first-aid advice. Therefore,
- Provide a pH value.
- Provide a pH value as precise as possible, especially since the allowed ranges are narrow.
- Provide the solution concentration in %.
- Where a pH value is not relevant, we can expect that ECHA will provide a list of valid justifications such as:
- Mixture is a gas
- Mixture is non-polar/aprotic
- Mixture is non-soluble (in water)
- pH is extremely high (>15)
- pH is extremely low (< -3)
- Mixture reacts with water
- Mixture is not stable
- ECHA’s List of Validation Rules: https://poisoncentres.echa.europa.eu/documents/22284544/27425407/PCN+Format+-+Annex+-+Validation+rules.pdf/f8fca14a-4892-dd24-d330-9043b6b45acb
- ECHA’s Resource for PCN Format: https://poisoncentres.echa.europa.eu/poison-centres-notification-format