At Zertify & Comply, we have assisted numerous companies and entrepreneurs in the complex process of ensuring that their products, especially toys, comply with rigorous European regulations.
In this 2-minute read, we want to share a detailed perspective on the technical file for toys, a crucial element in complying with the Toy Directive and obtaining the CE marking in Spain.
What is the Technical File for Toys?
The technical file for toys is a comprehensive collection of documents that demonstrate that a toy complies with all applicable European Union regulations, particularly the Toy Safety Directive (2009/48/EC). In this post, we will refer exclusively to the technical file for toys, but we have a post on technical documentation here
This file is essential for applying the CE marking to toys in Spain and any other EU member state.
Importance of the Technical File
This document is not only a requirement for marketing toys in the EU, but also serves as a guarantee that the product is safe for children, as well as being an essential requirement for assessing the conformity of our toy.
Containing detailed information on the design, manufacture, and compliance of toys, the technical file is the first line of defense against any legal or safety issues that may arise.
Creating the Technical File for Toys: A Practical Guide
Developing a complete and compliant technical file for toys may seem like a daunting task. However, with the right guidance, it can be a structured and efficient process. Here is a detailed guide on how to compile this vital document: Please note that each point is a document that, when combined with the rest, will form the toy’s file.
- Product Description
General Details: Include the name, description, and all variants of the toy. - Technical Specifications: Document dimensions, materials, and any electronic or mechanical functions.
- Risk Analysis
Conduct a risk assessment to identify and document all potential hazards that the toy could present. - Design and Manufacturing Documentation
Provide detailed drawings, material specifications, and descriptions of manufacturing processes. - Testing and Certificates of Conformity
Include copies of all tests performed (mechanical, chemical, flammability, etc.) and test reports obtained that demonstrate compliance with relevant regulations. - EC Declaration of Conformity
This document is a formal statement from the manufacturer that the product complies with all applicable EU directives. - Quality Control Record
Document quality control procedures and the results of toy inspections.
Implementation of CE Marking on Toys
Once the technical documentation and everything that goes with it has been completed, we will be able to assess the toy’s conformity and award it the CE marking that certifies that conformity.
The CE marking must meet the following requirements:
Visibility: Ensure that the CE marking is visible, legible, and indelible on the toy or its labeling.
Consistency: The marking must reflect the results of the conformity assessments carried out as part of the technical file.
Common Challenges and How to Overcome Them
Compiling a complete technical file for toys can present challenges, especially for new manufacturers or those introducing innovative products to the market.
The key to overcoming these challenges is to stay well informed about legislative updates and work closely with regulatory compliance specialists.
Tips for Maintaining Compliance
- Continuous Updates: Keep technical file documents up to date with any changes in product design or legislation.
- Regular Audits: Conduct regular audits of the technical file to ensure full compliance.
- Continuous Updates: Keep technical file documents up to date with any changes in product design or legislation.
- Regular Audits: Conduct regular audits of the technical file to ensure full compliance.
The technical file and Amazon
If you are an Amazon seller, you will have noticed that the requirements for technical documentation have increased over time, and even more so for products such as toys that are handled by children and have always been in the spotlight when it comes to safety.
These requirements will continue to be with us, especially given the entry into force of the new General Safety Regulation, which has led to the extension of documentation requests to all products, not just those with specific regulations.
We have an article on the new RSGP. here.
Your path to the technical file for toys
The technical file for toys is more than just a bureaucratic requirement; it is a fundamental part of the regulatory compliance strategy that protects companies and consumers.
At Zertify & Comply, we are dedicated to helping our clients navigate this process with confidence and precision. If you need assistance in ensuring that your toys comply with the Directive and obtain the CE marking for toys in Spain and the European Union, we are here to help.
We can prepare the complete technical file for your toy, including the SDS, construction plans, and all technical documentation.
For more information on how we can support you in this and other regulatory compliance issues, you can browse our blog where we have another article on the toy safety directive.
Or better yet, contact us for a simplified solution to your regulatory compliance needs. Together we can ensure that your products are not only safe and compliant, but also successful in the competitive European market.
