Technical documentation development for chemical products
In the chemical industry, each product carries with it a legacy of information that is vital both for its correct use and to ensure the safety of those who handle it.
This information is provided through the technical documentation preparation. This is a compendium that compiles all the characteristics, properties, applications and precautions associated with this element.
We are in an era where environmental and health impacts responsibility and awareness have become essential. For this reason, having a chemical product safety consultancy has become more relevant than ever.
Not only does it ensure compliance with regulations. It also gives companies and their users the confidence that they are handling substances in an informed and safe manner.
Preparation of Safety Data Sheets
Safety data sheets are crucial tools. They provide detailed information on the nature, properties, hazards and safety measures associated with a particular chemical. Their preparation is not only a legal requirement, but also an ethical companies responsibility towards their employees, customers and environment.
When we talk about preparing data sheets, we are referring to a meticulous and rigorous process. It requires in-depth knowledge of chemistry, toxicology and safety regulations.
These data sheets must include details such as identification, properties, first aid measures, precautions for handling and storage, and procedures in case of spills or leaks.
The main purpose of these sheets is to ensure that all parties involved in the supply chain have access to essential information for handling the product safely. This documentation also facilitates appropriate intervention in case of emergencies, reducing the damage risk to health and the environment.
Which documents must a chemical product have? UFI code generation
Safe management requires several documents that provide essential information about its properties, hazards and handling measures. Here are some of the most important documents that a chemical must have:
- Safety Data Sheet (SDS):This is the main document. It details the properties, hazards, precautions to be taken into account during handling, storage and transportation, first aid measures, and recommendations in case of spillage or exposure.
- Label: Provides essential information, including its name, manufacturer, hazard information, and precautionary measures. The label should be attached to the container and be clearly visible.
- Technical Data Sheet: Details product specifications, composition, applications and technical properties. Although not specifically a safety document, it is essential to understand the use and applications of the product.
- UFI Codes (Unique Formula Identifier): The UFI is a unique alphanumeric code that provides information about the specific composition. It is especially relevant for emergency services in case of incidents.
- Códigos UFI (Identificador Único de Fórmula): El UFI es un código alfanumérico único que proporciona información sobre la composición específica. Es especialmente relevante para los servicios de emergencia en caso de incidentes.
From January 1, 2020, UFI codes became a requirement in the European Union for hazardous mixed products. These codes allow rapid identification of the composition and assist in the effective management of poisonings or other related incidents.
- Transport Documents: If the product is transported, especially if it is hazardous, additional documents that comply with local and international dangerous goods transport regulations will be needed.
Generating and maintaining these documents requires a thorough knowledge of the current regulations, as well as a product technical understanding. It is essential that companies keep up to date with requirements and updates to ensure safety in all chemical’s life stages.
When is a new UFI code required?
A new UFI code is required in the following circumstances:
- If the chemical mixture composition is changed in such a way that its hazard classification changes. Likewise, if health and safety measures are affected, a new UFI must be generated.
- If there is a change in the supplier or importer responsible for the mixture and its composition. In that case, a new UFI may be required, unless it is ensured that the composition and classification have not changed.
- Each time a new hazardous mixture is introduced to the market, it is necessary to assign it a unique UFI.
- If the same mixture is sold under different names or trademarks, it is possible to use the same UFI as long as the composition and classification are identical. However, if a company chooses to assign different UFIs to differentiate items internally, it may do so.
It is important to note that, once assigned, the UFI must be clearly indicated on the label. Companies should notify the competent authorities of the association between the UFI and the specific composition of the mixture. In addition, keeping up-to-date records is essential to ensure traceability and effective emergency management.
File development and submission to ECHA for registration and submission to the Poison Centers for commercialization.
Within the regulatory context of the European Union, registering products, especially those with biocidal properties, requires a meticulous process with the ECHA (European Chemicals Agency). This agency is responsible for ensuring safety and regulatory compliance within the EU.
A critical aspect of this process is the preparation and submission of appropriate files. This is vital for subsequent marketing and notification at the Poison Centers in the Member States.
Product Definition
Before registering biocides, it is essential to clearly identify their category, intended use, composition and other relevant details.
File Preparation
This document should contain detailed information (composition, properties, toxicology, ecotoxicology, first aid measures, and other relevant data) to assess its safety and potential risk.
Harmonized format use
ECHA has established a specific file format for the submission. This ensures that all required information is provided in a consistent and structured manner.
UFI Code Generation
As part of the file, it is necessary to include the Unique Formula Identifier (UFI) for each product. This will facilitate its identification in an emergency.
ECHA Electronic Submission
Once the file is complete, it must be submitted electronically to ECHA for review and approval.
Poison Center Registration
After approval, registration with the Poison Centers in the EU countries where it will be marketed is essential. These centers use the information provided to manage poisoning situations and provide first aid recommendations.
Publication of file information
The publication of file information, especially in the field of chemicals and biocides, is a practice that ensures transparency. It allows interested parties to access essential data on specific articles.
These publications are essential for professionals, researchers and authorities to have information on the properties, risks and recommendations associated with a substance.
Key aspects for file information publication
- Basic Information: Includes the product substance name, classification, intended use, and other identifying information.
- Physical and Chemical Properties: Details on composition, physical state, melting and boiling points, solubility, among others.
- Toxicity Data: Information on potential health hazards, including LD50, organ-specific effects, carcinogenicity, teratogenicity, among others.
- Safety Measures: Recommendations for handling, storage, transport and disposal of the substance.
- Environmental Information: Data on biodegradability, aquatic toxicity, bioaccumulation potential and other ecological effects.
- Limitations on Access: The objective is transparency. But, some data, especially those that are proprietary or confidential to a company, may not be published or redacted to protect commercial interests or intellectual property.
- Updates and Revisions: It is vital that the information in the files is kept up to date. Any changes in composition, classification or discovery of new risks should be reflected in the publications.
- Access Platforms: Depending on the regulatory body, information can be made accessible through specific web portals, online databases or official publications.
- Regulatory Compliance: In many cases, the publication of dossier information is not only a good practice, but a legal requirement. Companies must ensure that they comply with the specific regulations and guidelines of each jurisdiction or market in which they operate.
- Effective Communication: It is not enough to simply publish information. It is essential that it is structured and presented in a way that is understandable and accessible to the target audience.
Poison Center Notification Management (PCN)
The Poison Center Notification (PCN) management is an essential process to ensure the safe handling and use of chemicals in the market. Through these notifications, companies inform poison centers about composition, properties and safety measures.
This procedure not only meets regulatory requirements in many jurisdictions. It also reinforces the companies’ commitment to the protection of public health and the environment.
Registration Biocide Products
Bringing biocidal products to market involves a number of steps and regulations designed to ensure that they are safe for both the user and the environment.
These are any substance or mixture that is manufactured or used to destroy, deter or otherwise control organisms considered harmful to human or animal health. Also for those that cause damage to natural or manufactured materials.
Before a biocide is introduced into the market, it is essential to determine its efficacy and safety. This involves detailed studies on its toxicity, ecotoxicity and chemical properties.
In addition, authorization or licensing may be required before the biocidal product can be placed on the market. For example, in the European Union, biocidal products must comply with Regulation (EU) No. 528/2012.
Once the biocidal product is on the market, it is crucial to monitor its use and effects to identify any potential problems or unanticipated adverse effects.
Discharging biocidal products is not a simple task. It requires a commitment to excellence, regulatory compliance and responsibility towards society and the environment.
Biocide registration at AEMPS
The biocide registration at the Spanish Agency of Medicines and Health Products (AEMPS) is a mandatory procedure. This process ensures that biocides comply with established safety, efficacy and quality standards, thus protecting public health and the environment.
The correct technical documentation, toxicity studies and efficacy data submittal is essential to obtain the approval and to be able to introduce the article in the Spanish market.
Biocide registration at the Ministry of Industry
If an active substance receives approval as a biocidal product and you want to manage its authorization and registration according to Royal Decree 3349/1983 during the interim period, it is essential to do so at least six months before the official substance confirmation. In addition, this must be done under European regulations.
Those products that have a biocidal product registered under Royal Decree 3349/1983 and want it to continue to be available after the active substance has been added to Annex I of Royal Decree 1054/2002, have to submit a dossier according to the current regulations.
If modifications are detected (different composition, change of ownership, among others), it is necessary to process this modification before the substance is added to Annex I. If the modifications refer to the active substance, its proportion or the incorporation and proportion of coadjuvants, a change in its denomination must be requested.
