Navigating Compliance for CPG Manufacturers - UFI Codes and PCN Dossiers

Automate to innovate while remaining compliant – Create workflows to meet changing needs

Consumer Packaged Goods (CPG) product developers under EU CLP regulations for hazardous materials must ensure they plan from within their product lifecycle management (PLM) process to meet these regulatory requirements. Managing Unique Formula Identifier (UFI) codes and Poison Centres Notification (PCN) dossiers should, of course, encompass current regulations. Yet you must be able to plan for upcoming changes. Moreover, without an end-to-end approach, you’ll be stuck with manual processes and possibly impact launch goals and/or production schedules. Plus, creating a solid process will help you avoid fines and damage to your company reputation.

Here are the capabilities you’ll need to manage UFI codes and PCN dossier development and filing so you can develop innovative new products and ensure workflows for your existing portfolio are aligned for UFI/PCN compliance.

UFI Codes and PCN Dossiers: A Brief History

UFI codes and PCN dossiers were introduced by CLP Annex VIII, aiming to standardize and centralize information on hazardous products for poison centers starting from 1 January 2021

In 2023, updates to the CLP Regulation introduced new hazard classes and criteria for endocrine disruptors, impacting classification and labeling requirements, consequently in April 2024 the PCN format has been updated by EU authorities in order to include those new hazards.

Current UFI Code and PCN Regulations impacting the EU CPG industry

As of January 1, 2021, CPG companies in the EU included UFI codes on labels of hazardous mixtures intended for consumers. The ECHA mandates use of its UFI generator tool or similar, within your software, to comply with the regulation. Poison Centre Notification (PCN) requirements involve submitting a dossier containing the following information:

• Product identifiers, like trade names
• UFI code

• Mixture classification and labelling details
• The full composition of the mixture, including the chemical names, numeric identifiers, concentrations and classifications of all components.
• Toxicological information, such as acute toxicity data, skin corrosion or irritation data, and sensitization data present in section 11 of EU SDS,
• Packaging details, including the type and size;

Regulated materials within UFI and PCN notification

CPG manufacturers pay attention to the following categories of materials that may be hazardous as they may contain hazardous substances above certain thresholds within their products:

1. Cleaning and Sanitizing Agents: Cleaning products used in food processing facilities, such as detergents, degreasers, and sanitizers
2. Pesticides and Fertilizers: Products used for the treatment of ornamental or edible plants
3. Chemicals: Inks, paints, coatings, or adhesives
4. Fragrances and Perfumes: Fragrances and perfumes used as ambient deodorizers in home and vehicles like diffusers, incense, etc.

Automated PLM Software: Managing UFI Codes and PCN Dossiers

Automated PLM software, such as Trace One, simplifies compliance by streamlining hazardous product management. It allows accurate classification of mixtures, with the appropriate workflows needed to usher the end product to production while ensuring compliance. Trace One SDS helps you generate compliant labels and provides automated options for managing UFI codes and PCN dossiers.

UFI code generation

Trace One SDS automatically generates UFI code and enables PCN dossier generation and submission. Moreover, it allows you to:

• Add UFIs of the MiM (Mixture in Mixture)
• Manage and maintain your UFI portfolio

PCN dossiers

• Automatically extract data from the system that is relevant for each notification
• Allow the user to update relevant information as PCN needs change
• Preview the info needed for declaration, and generate the PCN dossier
• Calculate when the UFI code must be updated

As these regulations continue to evolve, it is crucial for companies to remain adaptable and informed and automate these processes to ensure traceability and compliance. Contact Trace One to help you alleviate UFI/PCN compliance challenges, allowing you to focus on what matters most: Delivering safe, innovative products to the market.