FREQUENTLY ASKED QUESTIONS
Underneath you can find Frequently Asked Questions and their anwers. In case you have a question that is not mentioned please contact us and we are happy to help you.
New requirements for SDS
When do SDSs have to be compliant with the new requirements?
New SDSs must meet the new requirements from 1-1-2021. For existing SDSs, there is a transition period until December 2022. Starting January 1, 2023, all SDSs must comply with the new requirements. If an update takes place after 1-1-2021, e.g. addition of a UFI-code, the SDS must also be updated to the new requirements.
Is it required to mention the UFI-code on the SDS?
It is not mandatory to state the UFI on the SDS unless it concerns a product that does not have packaging.
In our opinion, it is advisable to state the UFI on the SDS. This ensures that the correct SDS can always be linked to the correct UFI/formulation. If the UFI is mentioned on the SDS, it will be listed in Section 1.1.
unique formula identifier
Where can I request a UFI-code?
A UFI-code cannot be requested, it must be generated.
NL Update: deze vraag staat nu 2x op de pagina!
How can I generate a UFI-code?
A UFI can be generated using the UFI generator. The UFI generator (https://ufi.echa.europa.eu/#/create) calculates a UFI based on a European VAT number and a self-chosen formulation number.
Is it allowed to use the same UFI on multiple products?
Yes, as long as the formulation of the products is exactly the same.
The UFI is linked to a formulation. If the formulation changes, the UFI will also change.
It is also possible to link multiple UFIs to one formulation.
Does the UFI code have to be on the label or can it also be mentioned elsewhere on the packaging?
According to the current rules, the UFI must be on the label. New legislation is being drafted at the moment. This will describe that the UFI may also be mentioned on the packaging, as long as the UFI is clearly recognizable.
From when can I mention the UFI on a product?
Once the product has been registered under the new legislation via the new PCN portal. A UFI is always combined with a Poison Center Notification. The use of a UFI without a notification has no added value, and is also strongly discouraged by ECHA.
Can I generate a UFI-code without a VAT number?
Yes, in this case a Company Key must be used.
For more information, please contact us email@example.com
Do I have to notify the product at each of the national Poison Centers in the countries where the product is marketed?
Yes, this is required by law. There is no central database for Poison Centers in Europe.
If a product is marketed with multiple trade names (private label, rebranding, etc.), can I notify all the different names, packagings and UFIs at once?
Yes, that is allowed. As long as the formulation of the product remains the same, all names, packagings and UFIs may be merged into one notification. This registration can also be done in several countries at once if necessary.
Can I outsource the tasks regarding a PCN notification to a external partner?
However, the responsibility for the notification always remains with the Dutyholder.
Who is the Dutyholder for PCN and UFI if products are imported from outside the EU, for example from the United States?
In this case, the European importer is the Dutyholder for UFI and PCN for the countries where they will put the product on the market.
What information do I need to be able to do a PCN notification in the new format?
- General company information
- Classification of the product
- section 11 from the SDS of the product
- user type (consumer, professional and/or industrial)
- trade name(s) of the product
- UFI-code and EuPCS-code of the product
When can I do one group notification for multiple products?
A group notification is allowed for product with:
- the same classification; and
- the same EuPCS-code; and
the exact same composition, except for ≤5% UNCLASSIFIED perfumes or ≤25% UNCLASSIFIED colour pigments.
When do I update a notification, and when do I have to do a whole new notification?
A new registration is required if the composition of the product, and therefore also the UFI, has changed. If anything changes in the other data of the product, the packaging or the data of the supplier, an update of the registration is sufficient.
When does a PCN notification expire?
A registration never expires. Products can remain on the market for a very long time after production and sale. Therefore, a PCN notification can always be updated, but it will never expire.
When do I have to start using the new PCN portal for notifications?
For consumer and professional products new on the market, the notification must be done according to the new format since January 1, 2021. For new industrial products, the new format will be mandatory starting January 1, 2024.
There is a transition period for products that have already been registered at a Poison Center. These products must be registered in accordance with the new format, including UFI code, no later than 1 January 2025. Any updates or notifications in new countries before then must already be done according to the new format.
Updating Safety data sheets
How long are safety data sheets valid?
Safety data sheets are valid as long as the information they contain is correct and complete. The REACH legislation, in which the requirements for the SDS are determined, says in art 31 paragraph 9: “Suppliers shall update the safety data sheet without delay on the following occasions:
(a) as soon as new information which may affect the risk management measures, or new
information on hazards becomes available;
(b) once an authorisation has been granted or refused;
(c) once a restriction has been imposed.”
This means that you have to continuously check and update your SDSs. We therefore recommend a fixed review period of 1x per year or 1x per 2 years, depending on the type of products. If you combine a fixed review period with good planning (such as with our SDS subscription), you keep in touch with changes in legislation and regulations and you can spread work and costs well.
Who should I send an update of a SDS?
The REACH legislation, in which the requirements for the SDS are determined, says in art 31 paragraph 9: “The new, dated version of the information, identified as “Revision: (date)”, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months.”
Does this also apply if the product is no longer supplied?
Yes, this also applies if the product is no longer supplied. Anyone who has received the substance or mixture in the last 12 months before the update is entitled to the revised SDS.
Do changes in an SDS have to be mentioned?
Yes, changes to the SDS during an update must be stated in Section 16 (unless stated elsewhere).
Is the non-EU supplier/producer of a product responsible for the PCN notification?
No. The importer in the EU is the official duty holder (geen streepje ertussen) in the EU for the PCN notification.
Can a non-EU based supplier/producer arrange a PCN notification?
No. A notification via the PCN portal can only be done with an ECHA account and this requires an EU legal entity. The non-EU supplier/producer can however (geen komma’s) provide a voluntary submission via a third party in the EU (e.g. the SDS factory).
One of my products is imported from outside the EU. Am I responsible for the PCN Notification?
Yes. As an EU based importer you are then the duty holder for the PCN Notification.