How To Comply Your Product with European Product Safety Legislation

1. “How to Comply Your Product with European
Product Safety Legislation”
Ferry Vermeulen
October 2020

2. Do you find European legislation confusing?

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

5. Compliance & Selling on Amazon

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?

13. EU Legislation

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.

15. General Product Safety
See blog about product safety
Directive 2001/95/EC

16. Liability for Defective Products
Directive 85/374/EEC

17. Liability for defective products

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

20. What products are regulated?

21. What products are regulated?

22. What products are regulated?

23. What products are regulated?

24. What products are regulated?

25. What products do you sell?

26. What products are regulated?
● https://instrktiv.com/en/ce-marking/
● https://instrktiv.com/en/ce-directives/
● https://ec.europa.eu/growth/single-market/european-standards/harmonised-st
andards_en

27. What if you do not comply?
● Blocked Amazon listing
● You may be held liable
● Customs won’t let your product through

28. So How Do You Comply?

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.

37. QUESTIONS
?