Updated on January 16, 2024
Starting from 2023, the amendments to Annex II of the REACH regulation on safety data sheets (SDSs) became mandatory. This means that related enterprises must affix a unique formula identifier (UFI) code in section 1.1 of their SDS when exporting mixtures to the EU. Mixtures that meet specific conditions must also complete poison center notification (PCN).
The compliance date for industrial use only mixtures has come on January 1, 2024. This means from January 1, 2024, all newly submitted poison center notifications must comply with the harmonized information requirements outlined in Annex VIII of the CLP Regulation.
If an industrial use only mixture is on the market and already notified via national submission systems before the 2024 compliance date, it may benefit from the transitional period until 1 January 2025. However, if there are any changes to the product during this period, such as changes to the mixture composition, toxicological property, or UFI, the notification must be resubmitted in a harmonized format through the ECHA submission portal.
(Source: ECHA poison center)
What is a UFI?
A Unique Formula Identifier (UFI) is a unique 16-digit alphanumeric code (for instance YV9K-3J9A-G209-xxxx). It unambiguously links the submitted information on a mixture to a specific product. The UFI is an element of the submission of hazardous mixtures, which has to be carried out in a harmonized form (PCN). The application of the code makes it possible for Poison Centres to provide information about the hazardous mixture during emergencies.
How do you use a UFI?
To guarantee smooth commercial activities, non-EU enterprises must notify their formula to importers and fulfill obligations under CLP, which may bring a formula leakage issue. If enterprises want to protect their confidential formulas, they may entrust entities in the EU to make a voluntary notification and obtain a valid UFI for mixtures. Under this circumstance, it is necessary to transmit the notified UFI to importers on safety data sheets (SDSs) or other ways without specifying details of formulas for confidentiality.
What is poison center notification (PCN)？
In accordance with Annex VIII of CLP, products meet the following three conditions at the same time shall finish PCN:
1. Products are mixtures such as ethanol solution; if mixtures are combined with articles (used as containers or carriers) including ink in printer cartridges, adhesives, and solutions on a wet rag;
2. Their GHS classifications cover physical or health hazards; and
3. Products that are placed on the EU market.
It should be noted that biocidal products under the Biocidal Product Regulation (BPR) and plant protect products (PPP) must make a PCN. The intention of the EU on information collection is to make quick responses to emergencies caused by mixtures and to protect human and environmental health. Only when PCN is completed can relevant products be placed in the EU market.
The transitional periods of PCN
In accordance with CLP, mixtures shall make a unified EU notification within the transitional period. The following are the compliance dates of products for different uses:
- Mixtures for special uses and consumers: entered into force on January 1, 2021
- Mixtures for industrial uses: entered into into force on January 1, 2024.
CIRS warmly reminds that enterprises involved in the production or handling of hazardous chemicals should pay attention to the UFI changes. Companies need to assess whether their products meet the regulations and check their Unique Formula Identifier (UFI) on the labels. Besides, Enterprises that still benefit from the transitional period are commended to update their notified information to ensure their compliance with CLP Annex VIII. If the composition or intended use of a product changes, they should immediately update relevant information for product compliance.
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Source from CIRS
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