NEW REQUIREMENTS FOR SDS
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.
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.
CLP: NEW HAZARD CLASSES
- Endocrine disruptors, also known as endocrine disruptors (ED), for human health or the environment.
- Persistent, bioaccumulative, and toxic (PBT); very persistent and very bioaccumulative (vPvB).
- Persistent, mobile, and toxic (PMT); very persistent and very mobile (vPvM).
The new hazard classes came into effect on April 20, 2023. There are transitional periods during which companies are not required to classify their substances or mixtures according to the new hazard classes. However, they can be voluntarily applied. At the end of the transitional periods, all companies must apply the new hazard classes.
Different transitional periods have been specified for substances and mixtures. For new substances on the market, companies must comply with the new rules starting from May 1, 2025. Companies with substances already on the EU market have until November 1, 2026, to comply with the new hazard classes.
From November 1, 2026, all substances must comply with the new hazard classes.
For new mixtures on the market, companies must comply with the new rules starting from May 1, 2026. Companies with existing mixtures already on the EU market have until May 1, 2028, to comply with the new hazard classes.
From May 1, 2028, both substances and mixtures must comply with the new hazard classes, and the classification and labeling must be updated.
No, these hazard classes were introduced only in the EU. Outside the EU (including the UK), these hazard classes are not classified for substances and mixtures.
UPDATING SAFETY DATA SHEETS
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:
- as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
- once an authorisation has been granted or refused;
- 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.
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.”
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.
Yes, changes to the SDS during an update must be stated in Section 16 (unless stated elsewhere).
UNIQUE FORMULA IDENTIFIER
A UFI-code cannot be requested, it must be generated.
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.
- 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.
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.
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
Yes, this is required by law. There is no central database for Poison Centers in Europe.
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.
Yes, however, the responsibility for the notification always remains with the Dutyholder.
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.
The importer in the EU is the official duty holder in the EU for the PCN notification.
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 provide a voluntary submission via a third party in the EU (e.g. the SDS factory).
As an EU based importer you are then the duty holder for the PCN Notification.
- 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
- 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.
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.
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.
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.