Planning to import toys to the European Union? In this article, we cover the essentials of EN 71, lab testing, documentation, and CE marking.
This is covered:
- Toy Safety Directive and European Standard (EN) 71
- REACH
- CE Mark
- Tracking Label
- Declaration of Conformity (DoC)
- Technical File
- Lab Testing
- Quality Inspections
Toy Safety Directive and European Standard (EN) 71
EN 71 covers a wide range of safety requirements for toys and other children’s products, helping importers and manufacturers to ensure compliance with the Toy Safety Directive. Compliance with EN 71 is mandatory when selling toys in the EU, and it also requires the CE mark.
What exactly is EN 71?
EN 71 is not a single standard, but split up in parts, each covering a certain safety aspect. This includes physical and mechanical properties, such as sharp edges, loose parts and so on, but also chemicals and flammability.
Here’s an overview:
- EN 71-1: Mechanical and physical properties
- EN 71-2: Flammability
- EN 71-3: Specification for migration of certain elements
- EN 71-4: Experimental sets for chemistry and related activities
- EN 71-5: Chemical toys (sets) other than experimental sets
- EN 71-6: Graphical symbols for age warning labeling
- EN 71-7: Finger paints
- EN 71-8: Swings, slides and similar activity toys for indoor and outdoor family domestic use
- EN 71-9: Organic chemical compounds – Requirement
- EN 71-10: Organic chemical compounds – Sample preparation and extraction
- EN 71-11: Organic chemical compounds – Methods of analysis
- EN 71-12: N-nitrosamines and N-Nitrosatable Substances
- EN 71-13: Olfactory board games, cosmetic kits, and gustative games
Tip: I suggest that you contact a testing and certification company to let them assess which specific EN 71 standards apply to your product. This is normally provided free of charge when you request a lab test quote.
Further, you also need to inform your manufacturer that your product will be subject to lab testing and that compliance with certain EN 71 standards is mandatory
REACH
REACH restricts chemicals, heavy metals, and pollutants in all consumer products, including toys. Further, REACH is applicable to all types of materials, including plastics, metal, wood, paints, coatings, ceramics and so on.
Here are a few examples:
- Lead
- Cadmium
- Mercury
- AZO dyes
- Phthalates
It’s worth to note that EN 71-3: Specification for migration of certain elements also covers chemicals and heavy metals, and may even overlap with REACH.
You should also inform your supplier that they need to ensure that all materials (e.g. plastics) must be REACH compliant.
CE Mark
The CE mark signals compliance with all mandatory and applicable EU directives, which also happens to include the toy safety directive. As such, the CE mark is found on a wide range of products, including electronics, helmets, bikes, and toys.
That said, the CE mark itself is not a standard, but show that the toy is compliant with relevant EN 71 standards.
Note that the CE mark is mandatory, and must be printed on the product, manual and packaging. Products that are not covered by a “CE marking directive” should not carry the CE mark.
Further, the CE mark must be permanent. As such, a sticker or other “temporary” label is not accepted. Only a print or engraving will do.
Tracking Label
You need to ensure that your product is traceable, in case the product is unsafe and must be recalled. This is normally done by printing a batch ID or tracking ID that can tie down the product to a specific production run and facility.
Example
- SKU: ABC001
- Purchase Order Date: June 2020
- Location: Dongguan, Guangdong, China
- Factory ID: F2
Batch ID: ABC001-062020-DG-CN-F2
Declaration of Conformity (DoC)
When importing a product with your own brand, or a product made according to your design specifications, then it’s mandatory to issue a Declaration of Conformity. This is a self-issued document which basically states that a certain product, imported or manufactured by your company, is compliant with certain directives and EN standards.
- Produce identification/SKU (e.g. Teddy Bear Model A)
- Product features
- Name and address of the manufacturer/importer
- List of EN standards or directives
- Location
- Responsible individual
Notice that the DoC must correspond to the standards listed in the lab test report. Further, don’t expect your manufacturer to provide one for you as most contract manufacturers don’t have the expertise to create a DoC.
The customs authorities or national product safety authorities often ask for the Declaration of Conformity when doing regular checks or investigate certain products and importers. They can fine importers for simply not having a DoC, even if the test reports are in place and the product is technically speaking EN 71 compliant.
Technical File
In addition to the Declaration of Conformity, you must also create a technical file. This is a set of documents that normally include the following:
- Bill of materials (e.g. List of all watch parts)
- Design drawings
- Label files
- Packaging files
- List of applied standards and directives (e.g. RoHS)
- Test reports
- QC reports
- Risk assessment
- User manual photocopies
Lab Testing
Third-party lab testing is the only way to verify if your product is actually EN 71 compliant. Lab testing can cost anything from a few hundred US dollars and up. Ultimately the testing cost depends on the following factors:
- Number of applicable EN 71 standards
- Number of materials, components, and colors that must be tested
Further, testing costs also multiply with each product. The more product SKUs you have, the more it’ll cost you.
Some importers try to get around this by using test reports from the supplier. However, you are not allowed to use test reports in any of the following scenarios:
1. The test report is valid for a different product (or the same SKU but different material or color)
2. The test report is issued in the name of another company (e.g. another importer)
It doesn’t matter if the supplier tells you that they’ve been exporting to the EU for years, or if the product is “similar” to what other importers are already selling - lab testing is mandatory
Not only that, but the test report must be valid for the same product that you place on the market. This is a rather narrow definition because it’s not technically the same product if you use a test report that is issued for a previous order, or if the design, material, and colors are not the same.
Quality Inspections
While quality inspections cannot replace lab testing, it’s still essential to verify that your products and the packaging are correctly labeled with the CE mark. Further, the QC inspector can also collect product samples that can be taken back to their testing facility.