Starting from 2023, the amendments to Annex II of 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).
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 emergency situations.
How do you use a UFI?
To guarantee smooth commercial activities, non-EU enterprises must notify their formulas 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 emergency situations 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 period of PCN
In accordance with CLP, mixtures shall make a unified EU notification within the transitional period. The following are the transitional period of products for different uses:
- Mixtures for special uses and consumers: entered into force on January 1, 2021
- Mixtures for industrial uses: WILL enter into force on January 1, 2024.
CIRS warmly reminds you that a self-check must be made if enterprises intend to export mixtures to the EU market for smooth subsequent commercial activities. Mixtures that are not subject to the regulation shall finish the UFI application and PCN and upgrade their SDSs as soon as possible. We can help you with UFI applications, PCN, SDSs, and provide you with comprehensive REACH compliance services.
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