Regulatory Open Forum

Does the EU require country of origin marking for consumer products manufactured outside of the EU?

Thanks,

-------------------------------------------
Paula Bojsen
Global Regulatory Compliance Manager
Ranir Global
Grand Rapids, MI
United States
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Hi Paula, If the consumer good in question is classified as a medical device according to MDD then yes. Regards ------------------------------------------- Romit Singh Regulatory Affairs Associate Device Technologies Pty Ltd Frenchs Forest Australia -------------------------------------------
Original Message: Sent: 05-31-2013 09:27 From: Paula Bojsen Subject: EU Country of Origin marking Does the EU require country of origin marking for consumer products manufactured outside of the EU? Thanks, ------------------------------------------- Paula Bojsen Global Regulatory Compliance Manager Ranir Global Grand Rapids, MI United States -------------------------------------------

Dear Paula

2010, the European Parliament had approved a proposal that an official mark for goods imported into the EU should be imposed (for example, "Made in USA"). Concerned consumer goods:
medicines, leather goods, clothing, china and glassware, fasteners, contact lenses, etc..
Products manufactured in the EU must continue to not be marked.
The scheme would have caused numerous bureaucratic problems, therefore, the German Chambers of Commerce have spoken out against this provision. The European Commission on 17 January 2013 have announced that there is no majority in favor of this proposal and wants to withdraw it.

So finally I think there is no requirement.

Hope this helps

-------------------------------------------
Carsten Keller
Director QM/RA
SOPRO-COMEG GmbH
Tuttlingen
Germany
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Original Message:
Sent: 05-31-2013 09:27
From: Paula Bojsen
Subject: EU Country of Origin marking

Does the EU require country of origin marking for consumer products manufactured outside of the EU?

Thanks,

-------------------------------------------
Paula Bojsen
Global Regulatory Compliance Manager
Ranir Global
Grand Rapids, MI
United States
-------------------------------------------

Dear Paula,

In addition to Carsten's statement I would like to make you aware that there may be product specific rules for displaying the country of origin on the labels. For medical devices there is as far as I know currently no such requirement, but the new cosmetic regualtion 1223/2009 states in article 19 that the country of origin shall be specified for imported cosmetic products.

-------------------------------------------
Jens Gerdelmann
Consultant
MDSS Gmbh
Hannover
Germany
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Original Message:
Sent: 06-09-2013 10:55
From: Carsten Keller
Subject: EU Country of Origin marking

Dear Paula

2010, the European Parliament had approved a proposal that an official mark for goods imported into the EU should be imposed (for example, "Made in USA"). Concerned consumer goods:
medicines, leather goods, clothing, china and glassware, fasteners, contact lenses, etc..
Products manufactured in the EU must continue to not be marked.
The scheme would have caused numerous bureaucratic problems, therefore, the German Chambers of Commerce have spoken out against this provision. The European Commission on 17 January 2013 have announced that there is no majority in favor of this proposal and wants to withdraw it.

So finally I think there is no requirement.

Hope this helps

-------------------------------------------
Carsten Keller
Director QM/RA
SOPRO-COMEG GmbH
Tuttlingen
Germany
-------------------------------------------






Original Message:
Sent: 05-31-2013 09:27
From: Paula Bojsen
Subject: EU Country of Origin marking

Does the EU require country of origin marking for consumer products manufactured outside of the EU?

Thanks,

-------------------------------------------
Paula Bojsen
Global Regulatory Compliance Manager
Ranir Global
Grand Rapids, MI
United States
-------------------------------------------

Dear Paula,

CE 93/42
The label must bear the following particulars:
▼M5
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community, in view of their distribution
in the Community, the label, or the outer packaging, or
instructions for use, shall contain in addition the name and
address of the authorised representative where the manufacturer
does not have a registered place of business in the Community

Katia


-------------------------------------------
Katia Toebosch
Volcano Europe
Zaventem
Belgium
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Original Message:
Sent: 06-09-2013 10:55
From: Carsten Keller
Subject: EU Country of Origin marking

Dear Paula

2010, the European Parliament had approved a proposal that an official mark for goods imported into the EU should be imposed (for example, "Made in USA"). Concerned consumer goods:
medicines, leather goods, clothing, china and glassware, fasteners, contact lenses, etc..
Products manufactured in the EU must continue to not be marked.
The scheme would have caused numerous bureaucratic problems, therefore, the German Chambers of Commerce have spoken out against this provision. The European Commission on 17 January 2013 have announced that there is no majority in favor of this proposal and wants to withdraw it.

So finally I think there is no requirement.

Hope this helps

-------------------------------------------
Carsten Keller
Director QM/RA
SOPRO-COMEG GmbH
Tuttlingen
Germany
-------------------------------------------






Original Message:
Sent: 05-31-2013 09:27
From: Paula Bojsen
Subject: EU Country of Origin marking

Does the EU require country of origin marking for consumer products manufactured outside of the EU?

Thanks,

-------------------------------------------
Paula Bojsen
Global Regulatory Compliance Manager
Ranir Global
Grand Rapids, MI
United States
-------------------------------------------