05. EU Standard （14-）| v.20211122
5.1 CE Marking
5.1.1 Application Scope
The CE Marking is required only for products for which a CE Marking directive or regulation has been adopted. There are directives/regulations for the following types of products (please note that one or more directive/regulation can apply to a single product).
If you are a manufacturer, you have to follow these 6 steps to affix a CE Marking to your product:
1. Identify the applicable directive(s) and harmonised standards
2. Verify product specific requirements
3. Identify whether an independent conformity assessment (by a notified body) is necessary
4. Test the product and check its conformity
5. Draw up and keep available the required technical documentation
These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE Marking to products that don’t fall under the scope of one of the directives providing for its affixing.
When importing from non-EU countries, importers must check that products fulfill all EU safety, health, and environmental protection requirements before placing them on the market. The importer has to verify that:
1. the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market
2. the necessary documentation such as the EU Declaration of Conformity and the technical documentation is available upon request
3. contact with the manufacturer is possible at any time
Distributors must handle the product carefully and they mustn’t affect its compliance with EU legislation. The distributor has to know which products must bear the CE marking and the accompanying documentation. They should be able to identify products that are not in compliance.
Distributors must be able to demonstrate to national authorities that they:
1. have confirmation from the manufacturer or the importer that the necessary measures have been taken
2. are able to assist national authorities in their efforts to receive the required documentation
If importers or distributors market the products under their own names, they take over the manufacturer’s responsibilities. In this case, they must have sufficient information on the design and production of the product because they will be assuming legal responsibility when affixing the CE marking.
5.1.5 EU Declaration of Conformity
An EU Declaration of Conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC, you take full responsibility for your product's compliance with the applicable EU law.
How to draw up a Declaration of Conformity
As a manufacturer, it is your responsibility to draw up the EU Declaration of Conformity(DoC). It should contain the following information:
1. your name and full business address or that of your authorised representative
2. the product's serial number, model, or type identification
3. a statement, stating you take full responsibility
4. means of identification of product allowing traceability – this can include an image
5. the details of the notified body which carried out the conformity assessment procedure (if applicable)
6. the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
7. your name and signature
8. the date the declaration was issued
9. supplementary information (if applicable)
For imported products, the importer must ensure that the product is accompanied by the DoC and must keep a copy of it for 10 years after the product has been placed on the market.
You must translate the EU Declaration of Conformity into the language or languages required by the EU country in which your product is sold.
22.214.171.124 Technical Document
In addition to the declaration document, a test report is required. Both are used together.
5.2 2009/48/EC Toy Safety Directive
CE requirements for toy products need to comply with the harmonized standard 2009/48/EC. The toy safety directive has the following requirements for testing items:
|No||Reference of the standard|
|1.||EN71-1: 2014+A1: 2018 Safety of toys — Part 1: Mechanical and physical properties|
|2.||EN71-2: 2011+A1: 2014 Safety of toys — Part 2: Flammability|
|3.|| EN71-3: 2019 Safety of toys — Part 3: Migration of certain elements
|4.|| EN71-4: 2013 Safety of toys — Part 4: Experimental sets for chemistry and related activities
|5.|| EN71-5: 2015 Safety of toys — Part 5: Chemical toys (sets) other than experimental sets
5.2.1 EN71-1：Mechanical and Physical
5.2.3 EN71-3: Migration of Certain Elements
Forced, 19 specific elements migrate.
EN 71-4:2013 Safety of toys — Part 4: Experimental sets for chemistry and related activities
EN 71-5:2015 Safety of toys — Part 5: Chemical toys (sets) other than experimental sets
EN 71-7:2014+A2:2018 Safety of toys — Part 7: Finger paints
The complete test program requires sending samples to the laboratory, which provides the necessary tests according to the material and function of the samples.
The following chemicals are typically required to be tested. Laboratories are specifically required to select the test items required by REACH based on the material of the product.
5.3.1 REACH Phthalates
5.3.2 REACH Cadmium
5.3.3 REACH PAHs
5.3.4 REACH Organic tins