Safety data sheet knowledge base – PCN submission
The unified, harmonized notification of mixtures with a unique formula identifier (UFI) specified in Commission Regulation (EU) no. 2017/542 (PCN submission) provides an opportunity in all EEC Member States to rapidly report information regarding the mixture during an emergency health response situation.
In case of placing on the market* of hazardous mixtures:
Shared responsibility between the members of the supply chain is also fundamental in PCN submission. The distributor may also be obliged to notification!
* Placing on the market: import activity. Off-site storage of a mixture formulated only for export.
Changing the name or the labelling of a product does not count as downstream use.
Does not have (direct) obligation to notification:
Distributor as obliged to notification
In certain cases, the distributor can also be obliged to notification:
If the distributor places the mixture on the market in such an EU Member State for which the supplier has not submitted the notification, or if the supplier has not been informed about this by the distributor. The distributor is obliged to submit the notification for the target country.
If the distributor who creates a new trade name or a new label does not inform the formulator of the mixture, the distributor is obliged to submit the necessary notification.
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May submit notification:
Instead of the obliged party, a third person can submit the notification.
Mixtures classified in the following hazard categories are subject to notification:
Products that are not subject to notification:
Biocides and plant protection products are not exempt!
Notification is not mandatory but recommended:
In cases where it can be supposed that the given mixture can be an ingredient of another mixture, assigning a unique formula identifier may also be reasonable to non-hazardous products or products that are classified for environmental hazards only (H400, H410, H411, H412, H413, H420). In possession of an UFI, the complete composition does not need to be given to the customer who, in spite of this, will be able to submit their own notification.
The deadline for notification is also defined by the type of the end use (in the case of more than one uses, certainly the earlier date should be respected).
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Limited submission can only be chosen in the case of industrial use (according to point 3.1.1, part B and point 5.3 of Commission Regulation (EU) no. 2017/542).
Data to be supplied is limited to the information contained in the safety data sheet, provided that the accessibility of the components’ data is ensured 24 hours per day, 7 days per week (it is mandatory to provide a name, a telephone number and an e-mail address at which rapid access to detailed additional product information is available for appointed bodies during emergencies.
Submitting information regarding more than one mixture is also possible within the framework of a single submission if all the mixtures in a group belong to the same hazard class and product category and their composition is also the same (the total concentration of fragrances differ up to 5%).
General provisions concerning PCN submission
The submitter specified by Commission Regulation (EU) no. 2017/542 carries out the submission towards the appointed bodies of the Member State (generally poison centres) in accordance with the following general criteria:
Provisions regarding composition*:
Data contained in the safety data sheet is not necessarily sufficient for fulfilling the obligation for submission. During the submission, information should be given about the non-hazardous ingredients (which are present at a concentration of at least 1%). Substances present at a concentration of at least 0,1% should be indicated based on their health or physical effects, and identified substances present at a concentration below 0,1% should also be indicated.
Exact identification of the ingredients is also necessary (chemical name, CAS and EU numbers).
In the case of SVHC substances, the indication of the exact concentration is mandatory, in other cases, concentration ranges may be used.
If not all of the components are known (one of the components is a mixture – MiM), the involved mixture has to have a UFI code which has to be given during the submission together with the concentration). If it does not have a UFI and neither the actual components nor their concentrations are known, the data of the supplier and the safety data sheet of the mixture have to be attached to the submission.
General denominations like “perfume” or “colouring agent” can be used if they do not have health effects and their total concentration does not exceed 5% in the case of perfumes, and 25% in the case of colouring agents.
Product category (EuPCS)**
A product category according to the European product categorisation system (EuPCS) has to be assigned to all products that are subject to submission. The EuPCS is used to describe the classification of a product according to its intended use.
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According to Commission Regulation (EU) no. 2017/542, updating the information provided during the submission can be necessary in the following cases:
All this means in the practice that by giving a new UFI code, the dossier prepared with the notification will get a new PCN number and a reference has to be made to the older one.
Read more about the conditions of the preparation of a new UFI
Involved persons have an obligation for notification before placing on the market and until the deadline depending on the final use, in accordance with the relevant regulation.
1 January 2021
Submission of the UFI and the product information (PCN submission) in the case of products intended for consumer and in the case of products intended for professional use.
1 January 2024
In the case of products intended for industrial use.