Substance ban under TSCA Section 6(h)

Except for medical products, components of medical products and other products registered under the US FDA, all other products that Dräger brings onto the market in the USA must be compliant with the requirements of TSCA section 6 (h) requirements. This means that all components and parts that are part of a non-medical Dräger product must also comply with this regulation. Therefore, although you as a supplier may not be supplying products directly onto the US market, you have an obligation to support Dräger with information that allows Dräger to determine compliance of any products made using components and parts supplied by you.

1. If the non-medical products you supply to Dräger are TSCA Section 6(h) compliant, then: Fill out our substance declaration form quoting Dräger part numbers and return to the sender within the specified time frame.

2. If the non-medical products you supply are not TSCA Section 6(h) compliant, please also fill out our substance declaration form quoting Dräger part numbers of all the affected products. In this case provide the concentration of the substance. Take note that different threshold levels apply for each substance. For more information check the specific rules and orders applicable to each substance on the EPA website.

3. If the products you supply to Dräger is exempted from TSCA Section 6(h) because it is a medical device or is a component of a medical device, please send us your declaration quoting a relevant part numbers and state that the products are exempted.

4. If you do not have information required to determine compliance to the TSCA Section 6(h), please contact your suppliers and sub-suppliers to obtain the necessary information from them.

Please confirm compliance or non-compliance by filling out our substance declaration form within the time frame specified by Dräger.

You are at liberty to declare using our substance declaration form or provide your own certificate. However, as a minimum requirement, the certificates should contain the following information:

(a)The document should bear the company letter head with full address and contact details

b) The title should include these words "Declaration of conformity according to TSCA Section 6(h)"

c) Please declare whether the parts delivered to Dräger and listed in the declaration (please quote all Dräger part numbers) are compliant to TSCA Section 6(h) or do not comply with TSCA Section 6 (h).

d) Full names of the authorized person issuing the declaration, place, date, Signature and company stamp.