Dimethylnitrosoamine CAS:62-75-9 as prohibited substance acc. GADSL


Peter M.

Hello, I try to find any information about those substance. As I found is it on GADSL list , as law regulation there is written : Prohibition of Certain Toxic Substances Regulations, 2005 (SOR/SOR/2005-41. Published in Canada Gazette Part II, 2006-11-29 Vol. 140, No. 25.

Substance exist on that list from 2005 year , As I understand I cannot be used in automotive as intented use.Is there is any other regulation global that regulate somehow using of this substances ? It is use generally in rubber products.

Thank You in advance for help!!

Kales Veggie

People: The Vital Few

The GADSL is put together by the Automotive industry and is very comprehensive. So, if the substance was regulated elsewhere, then they would have included a reference in the GADSL list.

Peter M.

The subject retun as boomerang :whip: I have another question because is not in 100 % clear for me.Dimethylnitrosoamine is classified as P , there was no threshold , only written "Intentional additon prohibited" so there is prohibited beside general 0,1% weight of homologous material ? any less using is ok , or this threshold is only for declarable substances ?


Involved In Discussions
According to GADSL Guidance Document (Edition 2014), the default threshold for a substance content declaration is 0.1% w/w, unless otherwise indicated. In addition, unless specifically exempted, GADSL listed substances known to be present as impurities (i.e. not intentionally added), and which exceed the GADSL applicable content threshold, should be considered to be declarable.

Dimethylnitrosoamine (CAS:62-75-9) is classified as P and since there has no threshold therefore the default threshold of 0.1% shall apply. However, if the substance is the result of secondary or incomplete reactions during the production process and cannot be removed (i.e. it is an impurity) then dimethylnitrosoamine should be considered to be declarable (section 4.3.2 of the GADSL Guidance Document). Since this substance is regulated by the "Prohibition of Certain Toxic Substances Regulations" you need to find out if the parts are going going to be sold in Canada because this prohibition only applies to Canada. On the other hand, it may also be useful to read the regulation because the prohibition may only apply for certain applications (section 2.2 of the GADSL Guidance Document).

In my opinion, you should contact the supplier of the affected material(s) / part(s) to find out why the substance is present (i.e. if it is an impurity and if its use is prohibited by the regulation).


Peter M.

Ok thank You alex for replay. I also try to get that some information from GADSL Committee. I put respond below maybe It could be useful for someone :

" [FONT=&quot]The threshold prohibits the intentional addition of the nitrosamine. Perhaps the supplier?s statement means that there is no nitrosamine down to the 0.0001% level which would mean that no reporting is needed; however, if they are saying that it has been intentionally added then that is not allowed. The intention is to prohibit the use but it also recognizes that some unintended contamination may occur and if that remains below the threshold it is not an issue. In other words it is not necessary to analyze samples if knowledge of the preparation allows one to determine that the threshold is not being exceeded.[/FONT]
[FONT=&quot]N-Dimethylnitrosamine is a by-product is some manufacturing processes and the supplier may be saying that the potential exists for it to be present but only at ≤ 0.0001%."[/FONT]
Thread starter Similar threads Forum Replies Date
M Issue with CAPA system - Should Over Due CAs warrant a CAPA? Nonconformance and Corrective Action 17
R Method for Dew Point and Oil content - Qualifying our Compressed Air System (CAS) Qualification and Validation (including 21 CFR Part 11) 7
K IMDS concern (re: CaZn Complex Stabilizers) - No CAS number RoHS, REACH, ELV, IMDS and Restricted Substances 4
L Subcontractor in terms of CAN/CAS 13485:2003 CMDCAS vs. DIN EN ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 5
C How to "link" normal process variation and "triggers" for Internal CAs? Nonconformance and Corrective Action 6
G CAS No. - PPAP (I.3 and I.3.1 - requisite 8) APQP and PPAP 6
G Trying to find CAS numbers - The Database of chemical substance information IATF 16949 - Automotive Quality Systems Standard 3
N Is consultant prohibited in ISO9001 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
G When preventative action is prohibited by cost in 8D problem solving Problem Solving, Root Cause Fault and Failure Analysis 1
G When preventative action is prohibited by cost in 8D problem solving Problem Solving, Root Cause Fault and Failure Analysis 8
MichaelDRoach Where in ISO 9001 is White Out on Forms and Records Prohibited? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Chennaiite Instruments used in Auto industry on which engraving is strictly prohibited? General Measurement Device and Calibration Topics 11
P Are Canadian Auditors prohibited from Auditing U.S. based ITAR Companies? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S No prohibited materials in our products - Sample certifications needed Customer and Company Specific Requirements 3
K Prohibited metal verification - I am not sure of a PHYSICAL way to verify this Various Other Specifications, Standards, and related Requirements 9

Similar threads

Top Bottom