Article 45 of the CLP Regulation
According to Article 45 of the CLP Regulation, companies placing hazardous mixtures on the market are obliged to provide information about certain hazardous mixtures to the relevant national bodies. The national bodies make this information available to Poison Centres so that they can give advice to the citizens or medical personnel in the event of an emergency. Information is submitted for products classified as hazardous on the basis of their health or physical effects (toxic, harmful, irritant, corrosive, flammable, oxidative)
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The National Appointed Body IN CYPRUS is the Department of Labour Inspection (DLI).
For all hazardous mixtures placed on the Cyprus market, the companies must submit the required information via the ECHA SUBMISSION PORTAL before the placing on the market.
PCN portal will be used for all Consumer, Professional and Industrial mixtures according to the dates seen below. All obligations can be found in Annex VIII of CLP Regulation.
Submissions should be made according to the relevant date of applicability:
- 1 January 2021 for consumer or professional use;
- 1 January 2024 for industrial use
Unique Formula Identifier (UFI)
The unique formula identifier (UFI) is a unique code that will be required both in the submission of information and on the label, or in some cases the packaging, of the products that contain a hazardous mixture.
Together with a product’s trade name, the UFI allows the poison centre to precisely identify both the product involved in a poisoning incident and the composition of the mixture contained in that product.
- Generating a Unique Formula Identifier (UFI) and ensuring it is visible on the product is an industry obligation.
- In order to create a UFI in the UFI Generator you can use your company’s VAT number (though it is possible without) and the mixture specific formulation number.
- Entering this information into the UFI Generator will generate your unique UFI code.
- The UFI Generator tool is a web-based application that allows singular or bulk generation of UFIs in addition to a validate UFI functionality as well.
The creation of a UFI alone is not considered as a PCN notification.
The UFI has to be used in the PCN portal for submitting the notifications, otherwise the product cannot be considered as notified
Frequently Asked Questions and Important Notes :
- As of 1.1.2025, all past notifications submitted nationally have to be RE-SUBMITTED via ECHA PCN Portal. The national notification procedure is no longer valid.
- Companies that have submitted their notifications using the national procedure until 31.12.2020 can take advantage of the transitional period and their notifications will remain valid until 31.12.2024 unless there is an update of the notification. In cases of updates, the notifications have to be re-submitted through ECHA Submission Portal.
- A new UFI is needed when one of the following changes to the composition occur:
• adding, substituting or deleting a component
• supplier changes UFI and it has impact on MiM
• change in concentration beyond the allowed variation
- Notifications submitted before 1.1.2021 via the ECHA Submission Portal are not considered as valid if CYPRUS market was not included in the notifications. For these cases there is a need to update past notifications and include CYPRUS in order for the Appointed Body to have access to them.
- EU Suppliers / importers are urged to submit the notifications before placing their products on the Cyprus market.
- Non-EU manufacturers /suppliers cannot notify directly. They need to have an EU representative who will notify.
- No fee is required for the submissions, nor for the placing of the products on the national market.
- Once submitted via ECHA Submission Portal and passed all validations rules, the notifications are considered valid by the Appointed Body.
- After notification, the companies have to place the UFI numbers on the labels of the products placed on the Cyprus market.
- The Appointed Body has the right to request further related information by the submitters if needed.
- The Cyprus Appointed Body requests that the SDS of the mixture in GREEK language is uploaded as a pdf along with the submissions.
- No further approval or confirmation is provided by the Appointed Body regarding the submissions.
NOTES
- The CYPRUS POISON CENTER Number (emergency telephone number) to be included in point 1.4 of the SDS of the products placed on the Cyprus market, is 1401. The use of 1401 is free.
- The Emergency Telephone Number is only used for health / medical emergencies
- The contact point for the Appointed Body in Cyprus is Dr Maria Paleomilitou (tel. +35722405611, mpaleomilitou@dli.mlsi.gov.cy).
In case of emergency, the data are forwarded to the Cyprus Poison Center.
All information is kept strictly confidential.
https://poisoncentres.echa.europa.eu/questions-and-answers
Webinar: Poison centres: closing in on the first compliance date Questions and answers
LEGAL INFORMATION
Annex VIII to the CLP Regulation, adopted in March 2017, defines the harmonised requirements for poison centre notifications (PCN) applicable as of
1 January 2021.
Under Annex VIII, importers and downstream users placing hazardous mixtures on the EU market are obliged to provide specific information on their mixtures to the specified Appointed Bodies using a
Harmonised Format for notifications (PCN Format). The information contained in the notifications will be used by Poison Centres for emergency health response purposes in case of incidents involving these mixtures.
ECHA has developed IT tools to support preparing, submitting and receiving information on hazardous mixtures.
More information