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The General Product Safety Directive 2001/95/EC (GPSD) is an important piece of legislation in demonstrating the presumption of conformity for certain product categories where there is no specific European regulation.
In January 2015, the EU published Commission Communication 2015/C 014/03 harmonizing a wide range of standards for demonstration of compliance with the GPSD.
On 31 July 2015, the European Union published commission implementing decision (EU) 2015/1320 announcing the withdrawal of certain standards from the Official Journal of the European Union (OJEU) for the presumption of conformity with the General Product Safety Directive 2001/95/EC (GPSD) which includes soother and soother holder standards:
Soother holders are intended to be fastened to children’s garment, in order to prevent them from getting lost. Products of this type, which only have a “keep safe” function are not toys. For these soother holders, the General Product Safety Directive 2001/95/EC and the dedicated soother holder standard EN 12586 apply.
In the US, regulation 16 CFR 1511 – Requirements for pacifiers specify the physical and mechanical requirements. On the other side, there is no specific requirement for soother or pacifier holders and thus such items shall comply with general children product requirements under 16 CFR 1500. CPSC Total lead content and California Proposition 65 (CA Prop 65) chemical requirements shall also be complied.
The test will be conducted in compliance with the following standards :
For children products in the US, additional testing is required:
Sample Size
It will be advised in order confirmation email upon purchase
Turnaround Time (working days)
18 Days (for performance test only)
7 Days (EN 1186 Food grade and FDA test)
There are specific standards required to be tested for compliance in the US and EU markets. Therefore, the following tests will be included in the US / EU market test package.
For items designed for children, CPSIA according to U.S. regulation shall be performed in order to ensure the safety requirements for children.
Standard / Regulation | Content |
EN 1400 (EU) | A physical and mechanical standard for ensuring the performance of soothers according to EU standard |
EN 12586 (EU) | A physical and mechanical standard for ensuring the performance of soother holder according to EU standard |
Regulation (EU) No 10/2011 (EN 1186) | Food contact material regulation in the market according to EU regulation |
CPSC Physical and mechanical Test (US) | Physical safety testing applied for items designed for children under 12 years of age or below |
CPSC Flammability to solid (US) | Flammability testing applied for items designed for children under 12 years of age or below |
CPSIA Total lead content (US) | Total lead content shall be tested according to CPSIA for children items |
CPSIA Tracking label (US) | Tracking label shall be required on both product & packaging for children products |
Prop 65 court case (US California) | Chemical testing according to US California Proposition 65. Specific court case will be selected. |
Only applicable test items will be conducted on selected product nature and destination market. A detailed test item list will be included in order confirmation email upon order purchase. If the battery is included, additional battery requirements shall be arranged.
Regulatory Experts
Ensure your product compliance to specific countries’ requirements
Global Network
Provide worldwide coverage and access to all key locations & markets
1. Check Out
Confirm selections and fill in contact info
2. Arrange Payment
Pay by credit card or bank transfer offline
3. Confirm Test Plan
Confirm test and product details
4. Send Sample
Send the sample with printed form
5. Receive Report
Receive our test report by email
Online Payment |
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Offline Payment |
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You can add them to shopping cart and proceed to checkout for placing your order online. You will receive an order acknowledgment with order details after online order.
It is not necessary to create an account for online purchase, you can select Guest Checkout to place an order without an account.
However, creating an account offers additional benefits:
If you place an order as a guest, please check our notifications at your email box. Please remember to check promotional and junk mail box if you can’t find it.
If you place an order as a member, please log in and check the status of your order under “Quote Request” or “Orders”.
SGS TIC Mall only accepts US$ for checkout.
You will receive a test application form, sample requirement and delivery details in confirmation email upon successful payment, please complete the form and send the required sample(s) to our competence center in Hong Kong.
Please contact your dedicated specialist to submit your request. It will be reviewed case by case depending on the order process.
No, you can’t cancel and refund the paid order unless there is a quality or service delivery issue.
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