Notifying the first placing on the market of food supplements. ACCIÓ

8763 - Notificació de la posada al mercat de complements alimentaris Departament de Salut accio

WHO: Companies and professionals

HOW: Online

WHEN: At any time

What do you need to know?

What is it?

Companies marketing food supplements which have their registered office in Catalonia must notify the Public Health Agency of Catalonia of placing their food supplements on the domestic market before or at the same time as their first marketing.

This procedure can only be done online. Any documents you submit through another channel will not be processed and will not be considered for the purposes of the date of submission. Before starting the application, we recommend you check the electronic processing help section and the instructions in the ‘Related documents’ tab.

When submitting the form, you have to sign in with a digital certificate or idCAT Mòbil if you are the owner of the company or with a digital certificate of representation if you are its representative.

Specific forms are provided for applications and/or notifications in this procedure which must be used. These forms can be downloaded from this same page. If the application and/or notification is submitted using other forms, they will be deemed not to have been submitted pursuant to Article 16.8 of the Law 39/2015, of 1 October, on the common administrative procedure of public administrations, and consequently the date on which the application and/or notification is deemed to have been submitted is the date of entry of the specific form indicated.

Applicable regulation

Authority responsible

Who is it for?

Companies and professionals

Companies with registered offices in Catalonia which place food supplements on the market.

Deadlines

As soon as the change occurs

Documentation

The notification must be accompanied by the documentation listed below.

In all cases:

Form Annex to the notification of amendment of the details of the food supplements placed on the market

In the event of a change in the owner company marketing the product (it must be applied for by the new organisation marketing the product)

Notarised or private instrument signed by both parties in proof of the change of organisation marketing the product.
Updated labelling.

In case of a change of name and/or trademark

Updated labelling.

In case of a change in the contents of the packaging (both new and discontinued contents must be reported)

Updated labelling (for new contents).

In case of a change in the composition of the product

Updated labelling.

Documentation for mutual recognition if the product is already being marketed in another Member State of the European Union:

Labelling of the product marketed in the other Member State (MS) of the European Union (EU) or the European Economic Area.
Document of notification in another MS and the reply of the competent authority, if any. In the case of countries where the notification procedure is not required (Austria, the Netherlands and Sweden), a document issued by the competent authority certifying that the product is marketed as a food supplement in that MS must be submitted.
Translation of the two above documents.
Instead of this documentation, it is possible to present the Declaration of Mutual Recognition indicated in the annex to Regulation 2019/515, of March 19. You can find the model of this declaration in the following document: https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/gestion_riesgos/Procedimiento_de_Reconocimiento_mutuo_complementos_alimenticios.pdf.

Change of the EU member state that certifies marketing by mutual recognition of the food supplement

Updated labelling.
Labelling of the product marketed in the other Member State (MS) of the European Union (EU) or the European Economic Area.
Documentation of notification in another MS and the reply of the competent authority, if any. In the case of countries where the notification procedure is not required (Austria, the Netherlands, the United Kingdom and Sweden), a document issued by the competent authority certifying that the product is marketed as a food supplement in that MS must be submitted.
Translation of all documentation from the other MS.
Instead of this documentation, it is possible to present the Declaration of Mutual Recognition indicated in the annex to Regulation 2019/515, of March 19. You can find the model of this declaration in the following document: https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/gestion_riesgos/Procedimiento_de_Reconocimiento_mutuo_complementos_alimenticios.pdf.

Waiver of mutual recognition because the product only contains harmonised ingredients(*)

Updated labelling.

(*)Harmonised ingredients means ones regulated by RD 1487/2009 amended by RD 130/2018, by Commission Regulation (EC) No 1170/2009 and new foods or food ingredients expressly authorised in food supplements included in the list in Commission Implementing Regulation (EU) 2017/2470.

Labelling or documentation update

Updated labelling or new documentation.

Other changes affecting the product

Documentation in proof of the change

Documents

Annex to the amendment of the details of the food supplements placed on the market

Fees

64.25

Complementary information

The amount of this fee is fixed.

Other information

Owner companies must report any of the following changes to the products already notified:

Change in the company in charge of commercialising the product
Change in name and/or trademark
Change in the contents of the packaging (both new and discontinued contents must be reported)
Change in the composition of the product
Change of the EU member state that certifies marketing by mutual recognition of the food supplement
Waiver of mutual recognition because the product only contains harmonised ingredients(*)
Labelling or documentation update
Other changes affecting the product

Steps to follow

1

Step one

Report the changes
This procedure may only be done by Internet.

When you send the form, you have to identify yourself with a digital certificate or idCAT Mòbil if you are the owner of the company, or with the digital certificate of representation if you are its representative.
By Internet
Reporting amendments in food supplements
Start . Go to Reporting amendments in food supplements

How to do it

Step 1. Download, fill in and validate the forms

Download the form Annex to the notification of amendments to the details of the food supplements placed on the market (if you have trouble downloading it, see how to download PDF forms)

Fill it in and save it.

Download the form Notification of amendments to the details of the food supplements placed on the market.

Fill it in.

Add in the ‘Documents’ section the form ‘Annex to the notification of amendments to the details of the food supplements placed on the market’ you saved and the other documents.

Validate it (the form is only validated if all the obligatory information has been filled out and all the obligatory documentation attached).

Save it to your computer.

Step 2. Submit for processing

Go back to the online procedure. You can do this with the Online procedure link at the end of the form before the Save

Choose the file that contains the filled-in form and click on the Send button. (If you have not previously signed in, you need to do so with a digital certificate or by using idCat Mòbil then re-select the file and resend it.)

To send the file, you have to choose the type of certificate with which you are signing: digital certificate or the idCAT Mòbil system if you are the owner of the company, or a digital certificate of representation if you are its representative.

Step 3. Confirmation of the processing carried out

If the application has been successfully submitted, the acknowledgement of receipt will appear on the screen. It is important that you save or print it as this document contains the entry record, which is the date on which this procedure was begun and may be significant in certain calculations and deadlines, and the procedure identifier, which you can use to find out its status in ‘My Folder’ on this website.

If the application contains an error, it will not be sent and a message will come up stating what the error is.

Key points to bear in mind when making your application:

Remember that you have to fill in all the fields marked in red. If you do not, you will get an error message when you validate your application and will not be able to send it until you sort out the problem.

If you click the Next button at the bottom of a page, the system will validate all the data entered on that page and tell you if there are any errors (field not filled in, incorrect formatting, etc.) so you can remedy it.

Pay special attention to the fact that there are dropdown lists in some fields.

To add attached documents you have to click the Attach button and then browse your computer for the document and attach it. Remember that the size of the form plus the attached documents may not be greater than 5 Mb.

You cannot use the same form for different applications; once you have submitted an application, if you want to send another one, you will have to re-download the form template and fill it in again.

The procedure allows the signature of a legal entity and an individual. If you are a legal entity, you must submit the form using a certificate for the person listed on the form as a representative.

To access electronic notifications, see the following page in the Canal Empresa which you may find useful: http://canalempresa.gencat.cat/ca/tramits-i-formularis/notificacions-electroniques/.

You may watch the video tutorials on this procedure: Procedures with PDF forms (download, fill out, validate and save) and Procedures with PDF forms (send for processing).

In case of questions, check the security recommendations available on Tràmits Gencat or phone the telephone assistance services 012 .

Please remember that in order to do procedures remotely, you must have a valid digital certificate. In this sense, we recommend that you check the different certificates allowed as well as the other conditions for doing procedures online.

If you have any processing problems, first check the recommendations in the Support to Processing section in Tràmits Gencat.

Secondly, once you have checked that you have all the means needed and have proceeded as instructed, you can check if there has been any service outage or incident in the Alerts and Service Outages on the Seu electronica, which contains complete information on the type of incident and where it occurred; you can look for service incidents for the corresponding year (Incidències per a l'any 2019) and check the Start Date and Time field in descending order. If you cannot process it because of an incident in the system, please try again later.
2

Step two

Pay the fee

Once you have submitted your application together with the documents specified, you will receive a notification showing the fees to be paid. You can pay the fee:
Once you have submitted your application together with the documents specified, you will receive a notification showing the fees to be paid. You can pay the fee:
- Online on CaixaBank’s Línia Oberta page with a credit or debit card from any bank. You can find more information about this in the means of payment section in the Canal Empresa.
- By CaixaBank’s network of cash machines: the fee may be paid with a credit or debit card from any bank or, if available, with a passbook or current account with
You can find more information in the video tutorial How to pay the fee.
The timeframe to pay the fee is indicated on the payment receipt. The fee must be paid in order to continue the processing of the application. If you have not made the payment after this timeframe has elapsed, it is understood that the application will cease being processed and the procedure will be filed away.
3

Step three

Provide documentation

Once the application and the documentation submitted have been reviewed, the Administration may require the provision of additional documentation. The contribution of these documents must be made [...]
Once the application and the documentation submitted have been reviewed, the Administration may require the provision of additional documentation. The contribution of these documents must be made from:
- View the status of a procedure or transaction
- Private area
An acknowledgement of receipt is generated for each document submitted.
4

Step four

Check the status of my procedure

You can do this in:
You can do this in:
- Private Area (‘My Folder’) (with idCAT Mòbil and/or digital certificate)
- In Status of my procedures (Tràmits Gencat)(with the procedure identifier and your DNI/NIF)
- In Status of my procedures (Canal Empresa)(with the procedure identifier and your DNI/NIF)
- 012 helpline(with the procedure identifier and your DNI/NIF)
For more information, see the video tutorial “Check the Status of My Procedure”

What is the identifier code (ID) of the application and where can I find it?

It’s an alphanumerical code that you get with the confirmation of receipt once you have submitted the application, and it allows you to check the processing status and do certain procedures without the need to have a digital certificate.
5

Step five

Get a reply from the Administration

The Catalan Public Health Agency (ASPCAT) reviews amendments received to check that the products comply with general and specific health legislation applicable to them and sends a copy of the [...]
The Catalan Public Health Agency (ASPCAT) reviews amendments received to check that the products comply with general and specific health legislation applicable to them and sends a copy of the amendment file to the Spanish Agency for Food Safety and Nutrition (AESAN) in the Ministry of Health, Consumer Affairs and Social Welfare. If an incident is identified when examining the documents submitted, ASPCAT will send an electronic notification to the company marketing the product asking it to remedy the error or send the documents required.

Once any incidents have been resolved, ASPCAT sends a copy of the amendment file to AESAN with the corrections and also reports this transfer to the organisation marketing the product by electronic notification.

How do I get a reply?

You will receive the response via an electronic notification placed in the e-NOTUM notification portal. You have 10 calendar days from the date the notification is placed to accept or reject it. If you have not checked the notification after this timeframe, it will be understood as rejected. From the time you access the content of the notification, it is considered effective.

You can check the electronic notifications from any of these channels:
- From the link in the notice that you receive at the email or mobile phone you listed on the application.
- From the Electronic notifications section.
- From the Private Area (‘My Folder’) of Canal Empresa.
You can access it via a digital certificate, idCAT Mòbil or a single-use code. If you do so via the Private area (‘My Folder’), you have to previously identify yourself with idCAT Mòbil or a digital certificate.

For more information, check the electronic notifications section of the Ministry of Health or Tràmits Gencat websites. You can also check the Video tutorial E-notification to the administration of the Government of Catalonia.