What is a Technical File?
In the context of detergent products, a Technical File is a comprehensive dossier that demonstrates the safety, composition, and regulatory compliance of a product in accordance with EU legislation. A compliant Technical File contains all required information specified in the Detergents Regulation (EC) No 648/2004.
Chemleg supports manufacturers, importers, and brand owners by preparing fully compliant Technical Files, ensuring your detergent products are ready for market placement and regulatory inspection.
What Does a Technical File Contain?
A compliant Technical File should include the following sections:
- Manufacturer Information
Name of the manufacturer, address of the production and design facilities, and contact details of the authorized representatives in the EU, if applicable. - Declaration of Conformity
A statement declaring that the product complies with relevant EU legislation, particularly the Detergents Regulation (EC) No 648/2004. - Product Information
Commercial name, description and type of the product, intended use and application areas, general and technical product data and usage and maintenance guidance. - Safety Data Sheet (SDS) and Usage Instructions
An SDS must be prepared in the standard 16-section format in accordance with REACH Annex II and the CLP. It should include the UFI code, where applicable. Instructions for safe use of the detergent product should also be included. - Ingredient Information & Ingredient Data Sheet (IDS)
A complete list of ingredients in descending order by concentration, CAS numbers and chemical names. Certain components such as perfumes, colorants, enzymes, and disinfectants must be listed regardless of their concentration.
An IDS are required under Article 9 of the Detergents Regulation. Full disclosure of all substances with names, CAS numbers, and concentration ranges should be given. It must be kept up to date and made accessible to medical personnel. - Biodegradability Information of Surfactants
The file must include test results and documentation demonstrating the final biodegradability of the surfactants used in the detergent. Evidence that these tests were conducted in laboratories compliant with Good Laboratory Practice (GLP) and accredited to EN ISO/IEC 17025 must be provided. - Toxicological and Ecotoxicological Data – Complementary Risk Assessment
Where relevant, an assessment of potential risks to human health and the environment should be included. This assessment complements the toxicological and ecotoxicological data already available for the product’s ingredients. - Test Results and Reports
All available physical, chemical, and toxicological test results relevant to the product should be included.
Key Considerations During Technical File Compliance Process
Once a Technical File is correctly compiled, it must be retained for at least 10 years from the date the product is placed on the market. The dossier must be readily accessible and kept up to date in case of an inspection by competent authorities. Therefore, the Technical File should be regularly reviewed and updated in response to:
- Changes in product composition
- Modifications to classification or labelling
- Alterations in product use or intended purpose
- Updates in relevant EU or national legislation
- Availability of new scientific data or test results
- Changes in the manufacturing process or facility
Smooth Technical File Preparation Process with Chemleg
Chemleg ensures a seamless Technical File preparation process through the following steps:
With industry experience and a team of regulatory experts, Chemleg guarantees a smooth Technical File preparation process for your detergent products. With industry knowledge and regulatory expertise, Chemleg guarantees a smooth and compliant Technical File preparation process tailored to your detergent’s formulation. We continue to support you throughout the product’s lifecycle — from initial documentation to ongoing market presence.
Our Detergent Technical File Service Includes:
- Regulatory Compliance & Data Verification
- Comprehensive Technical Dossier Preparation
- Sectional Content Development
- Multi-Language Technical File Preparation
- Ongoing Regulatory Support & Expert Consultation
Get in touch with our team by filling out the contact form.
Frequently Asked Questions
Which regulations should be considered when preparing a Technical File?
When preparing a Technical File for the EU market, Regulation (EC) No 648/2004 on detergents, REACH Regulation, and CLP Regulation must be taken into account. Our experts ensure your Technical File is fully compliant with all relevant legislation.
For which detergent products is a Technical File mandatory in the EU?
A Technical File is mandatory for all detergent products, including laundry detergents, dishwasher products, surface disinfectants, and industrial cleaning agents.
I am a manufacturer outside the EU. Who is responsible for preparing the Technical File?
Non-EU manufacturers must appoint an EU-based authorized representative to place their products on the EU market. While the manufacturer is responsible for compiling the Technical File, the authorized representative must keep it available and ensure communication with the competent authorities upon request.
What are the consequences of not preparing a Technical File?
Improper or missing technical documentation may result in product withdrawal from the market, administrative fines, legal actions, and reputational damage for the manufacturer or their authorized representative.
Can I export detergent products to the EU without a Technical File?
No. Under the EU Detergents Regulation, preparing a Technical File is mandatory for detergent products. Without a complete and compliant Technical File, your product cannot be legally imported, distributed or sold in the EU.
