PCN submission

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.

 

Obliged to PCN submission

In case of placing on the market* of hazardous mixtures:

  • importers
  • downstream users (formulation of mixtures, re-import, as well as transferring and repacking 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.

Note:

Changing the name or the labelling of a product does not count as downstream use.

 

Does not have (direct) obligation to notification:

  • distributors (there may be an indirect obligation to notification)
  • end users

 

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.

  • the parent company instead of the subsidiary company
  • the distributor instead of the supplier
  • supplier outside of the EU instead of the importer
  • consulting company

 

Mixtures and products concerned

Mixtures classified in the following hazard categories are subject to notification:

  • health hazard (H phrases beginning with number 3)
  • physical hazard (H phrases beginning with number 2, except H200, H201, H202, H203, H204, H205, H280, H281)

 

Products that are not subject to notification:

  • gases under pressure (if they are not classified in any other hazard categories)
  • explosives (unstable explosives)
  • R&D (products subject to research and development)
  • PPORD (products subject to process orientated research and development)
  • all mixtures that are not subject to CLP regulation (wastes, drugs, mixtures under customs supervision etc.)

Warning!

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 following uses are concerned, based on the type of use:

  • consumer
  • professional
  • industrial

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

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.

 

Group submission

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:

  • submission shall be carried out before the placing on the market
  • submission shall be carried out in all Member States where the mixture is placed on the market
  • submission shall be carried out in the official language of the Member State or, in certain cases (where the given country allows it) it can also be carried out in English language
  • submission is carried out in PCN (XML) format (structured electronic format)
  • group submission is possible in the case of products with the same composition
  • 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)
  • the fees for notification can vary from country to country (it is the right of the country’s relevant authorities to decide whether an administrative fee will be imposed or not)
  • all information necessary for submitting the notification should be collected prior to the submission. Incomplete submissions cannot be closed
  • the unique formula identifier (UFI) generated previously or during the submission and the EuPCS classification of the product will be necessary for the notification
  • the official format of the submission is IUCLID XML format which can be created antecedently in offline mode, then the finished notification can be uploaded or sent in via the online PCN portal to the IUCLID Cloud with the help of the navigation wizard

 

Information to provide during PCN submission

  • Composition (100%)*
  • Exact concentration or concentration ranges
  • Trade name
  • Colour(s) (14 types)
  • Physical states
  • Packaging types (33 types), sizes
  • Uses (consumer, professional, industrial)
  • Product category (EuPCS)**
  • Toxicological information
  • Other data regarding the submitter (contact accessibilities)
  • Label elements
  • Unique formula identifier (UFI)
  • pH value (if available) or in the case of a solid mixture, the pH value of the aqueous liquid or solution by a given concentration. The concentration of the test mixture in water should be given. If no pH value is available, the reason for this should be stated.

 

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.

Our complex package of services regarding PCN submission

 

Making a submission up-to-date

According to Commission Regulation (EU) no. 2017/542, updating the information provided during the submission can be necessary in the following cases:

  • the product category and/or UFI of the mixture has changed
  • the hazard classification of the mixture has changed
  • additional toxicological data has been added to section 11 of the safety data sheet
  • the composition of the mixture has changed (addition, replacement or removal of one or more components)
  • the concentration of the mixture’s components has changed in an extent which exceeds the concentration range provided in the notification
  • change has occurred by a component for which an exact concentration was given in the notification, but the extent of the change does not exceed the data given in table 3, part B, annex VIII of CLP regulation
  • if perfumes in a group submission have changed, the list described in point 3.1 containing the mixtures and the perfumes present in them should be made up-to-date

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

Deadlines

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.

 

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