The process of PCN submission: different approaches, needed data, and the importance of its management

Let us put the process in 4 steps needed for the successful PCN submission:

1. Generate Unique Formula Identifier (= UFI)
2. Prepare and submit the application through IUCLID Cloud
3. Get status Success
4. Track & manage

Generate UFI 

It was explained in the previous article what UFI is and its purpose. But it is not only a question of generating UFI codes. Before generating a UFI code, it is essential to think about the strategy that fits your product portfolio. 

I suggest you decide on the right one before you go into the process of PCN submission. There are three different approaches. 

The most cost-effective option

One UFI for one formulation

many/all names, and

many/all member states

Pros:

• 1 notification
• 1 UFI code for labeling
• 1 service fee (lowest costs)

Cons:

-The single UFI number on various product labels discloses that one formulation is sold under different names (and maybe at different prices). Are you comfortable disclosing this to your customers?

-Harder to manage products that have the same UFI. 

Differentiate products by name

One UFI for

one formulation

one name, and

many/all member states

Pros:

• 1 notification
• 1 service fee (lowest costs)
• Easier to manage: one name - one UFI
• No formulation equivalence disclosure (compared to the most effective option)

Cons:

Although the formulation is the same, each synonym (product name) has its own UFI number and this also applies to the label; in other words: different UFI codes mean different labels!

The simplest option

One UFI for

one formulation

one name, and

one member state

Pros:

• Full differentiation of products (names)
• 1 submission
• No formulation equivalence disclosure (compared to the most effective option)
• Submissions are multiplied by each name and member state (however, the original submission can be updated with additional names and member states).
• Additional costs for each submission (and also updates are not free of charge)

Note:

A notification that covers many member states requires a safety data sheet (and consequently a label) in each member state’s official language. 

e.g., If you want to notify a product in Germany, Italy, Poland, and Spain, you have to enclose safety data sheets in German, Italian, Polish, and Spanish language. 

What data do you need to prepare before submitting the application?

For a legal entity:

1.Name and full address of the company

2.VAT number

3.Contacts (name, surname, email, phone)

4.ECHA account and its authorization 

For each product:

1.Safety datasheet

2.Label

3.Packaging information (e.g. bottle, 150 ml; can, 500 ml; bag, 80 kg; etc.)

4.Detailed composition information (100% composition information)

5.Target member states

6.UFI number (if already available), or

7.Formulation number (custom/internal formulation identification number (any number between 1 and 268 435 455))

Status monitoring 

Following PCN submission, you can get three statuses:

1. Pending - this means that you have submitted the notification application, but it is still not completely processed; you have to check for the success status regularly!
2. Success - this means that you have successfully submitted the notification application; this should typically be the final result of the process.
3. Failed - this means that something went wrong, and you have to check the reason for failure.

Don’t have time & resources to do everything in-house?

Bens Consulting experts will deliver a fast, affordable, and professional PCN submission process.

We do the complicated regulatory work so you can focus on your business.