Regulatory Open Forum

Dear colleagues,

We have been informed by the supplier of the main component of one of our devices, that the material contains a SVHC (cat. 1B) in a concentration lower than the maximum limit allowed by the REACH regulation (0.3%).

Based on our calculations, the maximum amount of this SVHC in our device would be 0.2% w/w.

Since our device is a mixture of substances, according to REACH, is the maximum limit of 0.3% applicable also to the finished device?

Reg (EU) 2017/745 when there are substances of category 1A or 1B in a concentration higher than 0.1%, we have to provide additional information (e.g. rationale on the potential patient exposure etc) and the related labelling: is this applicable in our case? 

Since there are discrepancies between regulations, we are discussing with other departments which one has the priority.

Thanks in advance.

Dear colleagues,

We have been informed by the supplier of the main component of one of our devices, that the material contains a SVHC (cat. 1B) in a concentration lower than the maximum limit allowed by the REACH regulation (0.3%).

Based on our calculations, the maximum amount of this SVHC in our device would be 0.2% w/w.

Since our device is a mixture of substances, according to REACH, is the maximum limit of 0.3% applicable also to the finished device?

Reg (EU) 2017/745 when there are substances of category 1A or 1B in a concentration higher than 0.1%, we have to provide additional information (e.g. rationale on the potential patient exposure etc) and the related labelling: is this applicable in our case? 

Since there are discrepancies between regulations, we are discussing with other departments which one has the priority.

Thanks in advance.

Dear colleagues,

We have been informed by the supplier of the main component of one of our devices, that the material contains a SVHC (cat. 1B) in a concentration lower than the maximum limit allowed by the REACH regulation (0.3%).

Based on our calculations, the maximum amount of this SVHC in our device would be 0.2% w/w.

Since our device is a mixture of substances, according to REACH, is the maximum limit of 0.3% applicable also to the finished device?

Reg (EU) 2017/745 when there are substances of category 1A or 1B in a concentration higher than 0.1%, we have to provide additional information (e.g. rationale on the potential patient exposure etc) and the related labelling: is this applicable in our case? 

Since there are discrepancies between regulations, we are discussing with other departments which one has the priority.

Thanks in advance.