3. Help Amazon sellers in the EU to:
● Avoid commercial and legal pitfalls
● Sell compliant products
● Save money on CE consulting costs
My goal for this presentation
4. Who is Ferry Vermeulen?
● Raised in a machinery factory; background in product development
● Director at INSTRKTIV GmbH
● We support in the compliance process (CE, UL, EAC etc)
● European Advisory Board Legislation & Standards
● Guest author at webretailer.com
● Blog has >15k visitors/month
● Compliance podcast
6. Compliance & Selling on Amazon
“I currently import 3 separate plugs from China and sell in the British Market on
the Amazon platform. Just recently Amazon asked me for a Declaration of
Conformity for one of the plugs I sell + the instructions for use.”
James
7. Compliance & Selling on Amazon
“Where can I find out which directive should be assigned to my product? Can
we enter a Chinese company as a producer and as our importer? Because
Amazon doesn't want to accept our certificate.”
Jakub
8. Compliance & Selling on Amazon
“Amazon rejects us all the time. Our company lives off the sale of electric
scooters and I can't imagine situation when Amazon will remove all our
products..”
Karsten
9. Compliance & Selling on Amazon
“Hello, we sell eyeshadow palette on Amazon, do you have Declaration of
Conformity for cosmetics products?”
Cathy
10. Compliance & Selling on Amazon
“Hi! I have various lighting products on amazon and I am so confused. They are
asking for the declaration of conformity and I am trying to get it approved but
keeps being disapproved. I would like to talk to someone about this”
Christopher
11. Compliance & Selling on Amazon
“hello I am selling a posture corrector on amazon which DoC do I need thanks,
hagop”
Hagop
12. Amazon’s responsibility
● Ecommerce platforms are more and more taking their responsibility (there
is a new GPSD directive in the making)
● Amazon may ask for a pre-approval
● Product groups such as kitchen equipment, toys, lighting, batteries and
chargers.
● Is this a random list?
14. EU Legisation
● Treaties (primary legislation) are the basis or ground rules for all EU action
● Regulations, directives and decisions are derived from the principles and
objectives set out in the treaties (secondary legislation).
● Legislation on anti-discrimination, culture, energy, environment, finance,
privacy, IP, technology & safety, transport etc.
18. CE marking
● For products with certain risk factors, ‘being safe’ needed to be specified
● Resulted in 25 Regulations and Directives (CE legislation)
● Requirements on product, packaging, labelling, technical file, compliance
process, user manual, declaration of conformity
● CE marking in principle is self-certification
19. CE marking
● If you have a product that falls within the scope of one or more CE
directives/regulations, CE marking applies
● By placing the CE mark, you declare that the product meets the requirements
● You guarantee certain safety level, and
● The product can move freely between the member states
29. The 6 steps of CE Marking
● Step #1 Identify the applicable legislation and harmonised standards
● Step #2 Verify product specific requirements
● Step #3 Identify whether an independent conformity assessment (by a Notified
Body) is necessary
● Step #4 Conduct the conformity assessment
● Step #5 Draw up and keep available the required technical file
● Step #6 Affix the CE Marking and draw up the EU declaration of conformity
30. The 6 steps of CE Marking
● Step #1 Identify the applicable legislation and harmonised standards:
○ Identify the directives that most likely apply: https://instrktiv.com/en/ce-directives/
○ Download the applicable directives:
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
○ Verify if they apply to your product by checking the scope and the definitions
○ Verify what standards apply to your product:
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
31. The 6 steps of CE Marking
● Step #2 Verify product specific requirements
○ Highlight the requirements in the directive/standards that are relevant for your product, or
○ Create a spreadsheet and:
■ Copy/paste all requirements.
■ Add three columns behind the requirements
■ Indicate (later; step 4) if the product complies with the standard (YES), does not comply
(NO) or when the requirement does not apply to your product (N/A).
32. The 6 steps of CE Marking
● Step #3 Identify whether an independent conformity assessment (by a Notified
Body) is necessary
○ In the applicable directives, press ctrtl + f and search on ‘conformity assessment’ to find out if the
CE marking is fully self certifiable or if a NoBo is required.
33. The 6 steps of CE Marking
● Step #4 Conduct the conformity assessment
○ Test and document that your product actually conforms
○ Each directive outlines which conformity assessment procedures – also referred to as modules –
a manufacturer can undertake
○ There are 8 conformity assessment modules
○ The applicable directives outline which module(s) apply to a particular product category
34. The 6 steps of CE Marking
● Step #5 Draw up and keep available the required Technical File
○ Contains information which demonstrates that the product conforms to the requirements of the
directive.
○ The Technical File must be provided to enforcement authorities on demand, often within short
timelines.
○ Each directive has different requirements on what should be in the Technical File
35. The 6 steps of CE Marking
● Step #6 Affix the CE Marking and Draw up the EU Declaration of Conformity
○ Sign the Declaration of Conformity: https://instrktiv.com/en/declaration-of-conformity/
○ Affix CE Marking
36. Conclusion
● Take your responsibility
● If you have a product that falls within the scope of one of the CE marking
directives, follow the six steps
● It’s not up to you to determine if a directive applies, the definition does
● Non-CE Marking products still need to be safe
● Also take non-CE directives into account
● For each product, different legislation may apply and thus different
requirements. Start with step 1, not step 6.