REACH compliance for low volume product

zork_14

Starting to get Involved
#1
Hi,

I'm selling in EU/UK 5 products per year. The product is similar to a 3D printer in its composition (a few small motors, custom CNC metal parts, enclosed control box with a control panel). Could someone check whether my reasoning below is correct?

1. If I obtain a REACH certification for every single of the components of my product, then I know that my product is REACH compliant. I do not have to make any declaration. If some authority asks me about REACH, then I can show them my documentation.

2. I have to know the REACH status of every single item my product is made of. It is not acceptable to not know whether an item is REACH compliant or not.

3. If for a component I cannot obtain a REACH certificate then I have two choices:

a. send the component to a testing lab to check its REACH compliance
b. make a risk analysis and declare the REACH status of the component (compliant or not)

4. If I am aware that a component is not REACH compliant (through risk analysis, testing, or supplier documentation), then I have to notify the consumer (typically in the user manual) that my product contains item #X which is not REACH compliant because it contains >x% of a certain substance. Because I'm selling only very low volume, there is no further declaration to make.

Am I understanding things right?
Thanks for any hint
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
REACH compliance is usually managed through the procurement processes. Suppliers of the raw materials (particularly that which goes into the final product which would come in contact with the customer) you use can provide certification of analysis (CofA) per lot or batch. I have seen CofA for each shipment, and I have seen contractual arrangements to provide upon request.

With this retained information you can make your own declaration of conformance.
 
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