PCN notification in case of toll manufacturing: who notifies ECHA?

PCN notification in the case of contract manufacturing: the EC Regulation no.
1272/2008 (CLP) states that importers and downstream users of hazardous mixtures shall notify the information specified in Annex VIII to poison control centers through ECHA (European Chemicals Agency).
What are the obligations relating to notification to poison centers (PCN notification) and the UFI code in case of contract manufacturing of dangerous mixtures?

Third party production

Contract manufacturing refers to a process in which a company manufactures goods or provides services on behalf of other companies. In essence, a company that offers contract manufacturing services carries out the manufacturing or supply of services on behalf of another company, which becomes the principal or customer.

This practice is common in several industries. For example, a company that specializes in a specific production may produce goods on behalf of other companies that wish to label and market those products under their brand name.

There are several reasons why a company may choose to use contract manufacturing. It may be due to a lack of internal capabilities or resources to produce certain goods or provide certain services. In addition, contract manufacturing can allow companies to focus on their core competencies and reduce operating costs, as they do not have to invest in additional equipment, personnel or resources to carry out the manufacturing task.

In conclusion, contract manufacturing is a business in which a company manufactures goods or provides services on behalf of other companies, acting as a manufacturing service provider. This type of collaboration can offer benefits to both the service provider and the client, allowing them to focus on their core competencies and optimize available resources.

54 / 5.000 Risultati della traduzione Risultato di traduzione star_border Notification to poison centers (called NCP UFI notification)

Notification to poison centers (Poison Control Notification) is a requirement introduced to improve the safety of chemicals and provide timely information to the competent authorities and poison centers in case of accidents or exposures to dangerous chemical mixtures.

The notification of dangerous mixtures existed before the introduction with Annex VIII to the CLP Regulation of the Harmonized System, called PCN.

The acronym PCN stands for Poison Center Notification and is a harmonized system introduced in the European Union to allow manufacturers and suppliers of chemical products to send detailed information on products classified as dangerous under the CLP regulation. This information includes the UFI code, chemical composition, first aid measures and indications for treatment in case of exposure or poisoning.

It is called a UFI notification because with it the UFI code (Unique Formula Identifier) was also introduced, which is a unique alphanumeric code assigned to a specific mixture or chemical product. This code uniquely identifies the composition of the chemical and is used as poison center notification information.

When a hazardous chemical is placed on the market, the supplier or manufacturer must notify the UFI number and related information to designated poison centers. This allows poison centers to be ready to provide advice and assistance in the event of an emergency or accidental exposure to the chemical mixture. The information notified to the poison centers is also accessible to the competent authorities, who can use it for surveillance and risk management purposes.

The main objective of notifying UFI PCN poison centers is to ensure a quick and effective response in case of emergencies related to dangerous chemicals. The system facilitates communication and sharing of important information between manufacturers, suppliers, poison centers and regulatory authorities, helping to protect the health and safety of people who come into contact with these substances.

A PCN notification must be submitted for each hazardous mixture (physical and health hazards e) placed on the market.

By “placing on the market” we mean “the offer or making available to third parties, for consideration or free of charge. Importing from non-European countries is considered placing on the market”.

Article 45 and Annex VIII of the CLP Regulation identify the importers and downstream users who place certain hazardous mixtures on the market as responsible for submitting information to the appointed bodies.

Contract manufacturing and PCN notification

This article does not consider particular cases, for which I refer you to the ECHA guide, which is very detailed on these aspects.

Considering the case of production by company A and placing on the market by company B, we have three options:

  • Manufacturer A generates a UFI code and reports information about that product. Company B will put A’s UFI on its label. In this case the UFI code will be the same for company A and B.
  • The manufacturing company A notifies the information relating to that product and inserts in this notification dossier the UFI code generated by the company B, which wants it to be different for commercial reasons.

In both cases, if the mixture is placed on the market under different commercial names, all of these and each UFI number must be included in a communication made by the manufacturer.

  • The third option sees Company B (customer commissioning the product) making its own submission, relieving the commissioned formulator of the job. The latter option is the one that allows the client company to have greater control over the conformity of its products.

Whatever the choice for the management of PCN (Poison Control Notification) notifications in a third party production, effective collaboration and communication is required between the company that offers the production services and the customer.

Here are some key points to consider when managing PCN notifications:

  • Communication and Awareness: It is imperative that both parties involved understand the importance of PCN notifications and are aware of the legal requirements associated with them.
  • Exchange of information: The contract manufacturing company must request from the outsourcing customer all the information necessary to correctly fill in the PCN notifications. This information may include the use and recipients of the blend, in which countries it will be sold.
  • Contractual Responsibilities: In the context of a contract manufacturing contract, it is important to establish who is responsible for handling the PCN notifications. It could be the contracting customer or the contract manufacturing company, or a sharing of responsibilities could be agreed. This aspect should be clearly defined in the contract or agreement between the parties.
  • Timing of notifications: It is essential to comply with the notification times required by current regulations. The contract manufacturing company should plan and organize activities to send PCN notifications on time, avoiding delays that could cause legal compliance problems.
  • Record Keeping: It is important that the contract manufacturing company maintains accurate records of sent and received PCN notifications. These records should include complete information on the chemicals used, notification submission dates, and any other relevant documentation. This will help demonstrate regulatory compliance and provide traceability of activities performed.
  • Update of information: In case there are changes in the chemical composition of the products or in the information relevant to the PCN notifications, the contract manufacturing company should request the outsourcing customer to promptly provide the updated information. This ensures that notifications are always accurate and up-to-date.

In summary, the management of PCN notifications in a contract manufacturing requires a close collaboration between the contract manufacturing company and the outsourcing customer.

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