Custom software for the notification dossier and submission per market
A notification to poison centres requires your product to be described in someone else's terms. Your colour name must be matched to one of fourteen colours, your packaging to a fixed list of types and sizes, and your use to the European product categorisation system of around 250 categories. That translation is real work, and it is rarely recorded anywhere.
What a notification requires from you
Annex VIII of the CLP Regulation sets out the harmonised information for the notification under Article 45. It is submitted through ECHA's submission portal to the bodies designated by the Member States, and is used by national poison centres in an emergency. It is therefore not an archival obligation but information that must work in an acute situation.
Different provisions apply to the composition depending on the type of ingredient. Ingredients of concern are subject to different rules than other hazardous ingredients, and yet other rules apply to ingredients not classified as hazardous. This means one formulation is requested in three different ways.
In addition, a considerable part of the dossier consists of data that does not come from your formulation database. Use must be indicated using the European product categorisation system, which has around 250 categories. For packaging there is a fixed list of types and sizes to choose from. For colour there are fourteen options, into which your own names must be translated.
A notification is also never finished. Resubmission is required if the product identifier changes, including the UFI code, if the hazard classification for health or physical hazards changes, or if new information becomes available on the hazardous properties. Those who do not follow this will find that their dossier gradually falls out of step with the product.
How we build this
The core is the dossier per market. A single product may have been notified differently in different Member States, with a different language and sometimes different packaging, and each of those submissions has a life of its own.
Your own colour, packaging and application are mapped once to the fixed choices in the format, with the reason noted.
Product identification, composition by substance category, toxicological information and details of the physical form.
Which Member State, which language, which version and which status. A submission is only complete once it has been accepted.
If the identification, classification or knowledge of properties changes, the system flags which submissions need to be redone.
What the software actually does
The link between your own data and the fixed choices carries the whole. What else you need depends on the number of markets and the number of products.
Translation tables that persist
Which of your colour names corresponds to which of the fourteen options, and which packaging to which type. Once established, always the same.
EuPCS category per product
Choosing the right one from roughly 250 categories is a decision. We record that decision along with its justification, not just the outcome.
Composition by substance category
Substances of concern, other hazardous substances and unclassified substances are each queried differently.
Tracking submissions per Member State
Which country, which language, which version, which status. Without that overview, it is impossible to say where you are and are not covered.
Alert when resubmitting
A changed identification, a changed classification or new information about properties leads to a task, not an assumption.
History per submission
What was submitted, when, where and with which data. When an authority asks a question, that is the only useful answer.
Who we build for
Who builds the file differs from company to company. Four situations.
Regulatory affairs
They make the submissions and get stuck on the translation between your own data and the prescribed choices.
Product managers
They change a packaging or a trade name and do not always know that this affects a submission.
Exporting formulators
For them, each country is a separate submission, and things go wrong in the overview across those countries.
Smaller producers without a dedicated department
They do this alongside their other work and benefit most from a system that remembers the translation step.
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The format is extended, categories are revised and Member States set their own requirements. Choice lists, translation tables and fields should be configurable and not hard-coded.
Why Appfront
The translation step is the work
Your colour to fourteen options, your packaging to a fixed list, your use to hundreds of categories. We record those choices rather than making them afresh every time.
A submission is not a document but a status
Submitted, accepted, or awaiting a response from a Member State. Without that distinction, you do not know where you stand.
A change elsewhere affects your file
An altered packaging or a revised classification is a small decision for a product manager, but for your file it is a new submission.
We do not make the notification for you
The responsibility remains with you. We build the file that lets you carry it.
Security and privacy
A notification file contains full compositions, which is the most commercially sensitive thing a formulator has. We set access per role and per product, show a product manager the product's appearance without the recipe, and log every view. Integrations to your existing software run through secure connections.
For this topic, the reliability of the record at the time is the key point. A file that has been changed afterwards without a trace no longer shows what was submitted when the product went to market. We record versions in an immutable way, with time and person, and make any correction a visible correction alongside the original entry. How we handle security ourselves is set out in our information security policy.
Frequently asked questions about notifications to poison centres
Through the ECHA submission portal to the authorities that each Member State has designated for this purpose. The national poison information centres use that information in an emergency.
The European Product Categorisation System, which is used to indicate the use of a mixture. It contains around 250 categories, and choosing the right one is a decision that should be traceable.
Because the format recognises fourteen colours and your own product names do not map onto them. You have to make that translation once and then apply it consistently.
If the product identification changes, including the UFI code, if the hazard classification for health or physical hazards changes, or if new information becomes available about the hazardous properties.
This concerns the dossier and submission per market. We describe issuing and maintaining UFI codes per formulation on our page about PCN and UFI software.
It differs by type of ingredient. Ingredients of concern are subject to different rules than other hazardous ingredients, and different again for ingredients not classified as hazardous.
Do you know in which countries this product has now been submitted?
Pick one product and look up per member state which version was submitted, in which language and with what status. If that remains a search through mailboxes, your coverage is an assumption. We build this as a standalone application and as part of a broader software development project.