REACH 161 Substances of Very High Concern

On December 17^th, 2014, the European Chemical Agency (ECHA) added six new substances to the REACH candidate list of Substances of Very High Concern.

REACH 161 Substances of Very High Concern Applications and Health Concerns

Below is a table describing the six substances newly added to the REACH 161 SVHC candidate list.

Substance Name	CAS #	Usage	Health and Environmental Concerns
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) (MDTP)	25973-55-1	Additive in plastics, UV absorber in packaging, etc.	Persistent, bioaccumulative, and toxic (PBT) Very persistent and very bioaccumulative (vPvB)
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)	3846-71-7	Used as UV-absorbers for: Plastics (PVC, PET, PC, PA, ABS and other polymers) Rubber Polyurethanes	Persistent, bioaccumulative, and toxic (PBT) Very persistent and very bioaccumulative (vPvB)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)	15571-58-1	Used as stabilizer for PVC processing	Reprotoxic
Cadmium fluoride	7790-79-6	Used in phosphors and glass	Carcinogenic Mutagenic Reprotoxic Damages organs after repeated exposure Fatal if inhaled Causes acute and long-term damage to aquatic environments
Cadmium sulphate	10124-36-4; 31119-53-6	Used in: Phosphors and glass dyeing on cotton Dyeing on cambric Viscose Vinylon Etc.	Carcinogenic (causes cancer) Mutagenic (can cause genetic mutation) Reprotoxic Damages organs after repeated exposure Causes acute and long-term damage to aquatic environments
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)	-	Used in the production of PVC as a heat stabilizer. It is present in various consumer products: Packaging Credit cards Plastic pipes Windows Bags Bottles Toys Electric articles Textiles Etc. Used to produce rigid PVC films and sheets.	Reprotoxic (damages fertility and unborn child)

Enviropass keeps up to date with the REACH SVHC and Annex XVII list as the ECHA continually adds new substances. Moreover, we have updated our Product Environmental Compliance EPEC Form.

What do PBT and vPvB Mean?

Specifically, PBT stands for Persistent, Bioaccumulative, and Toxic. Next, vPvB stands for very Persistent and very Bioaccumulative. PBT and vPvB substances, such as PFAS, do not easily break down in the environment.

Bioaccumulation occurs when an organism consumes a chemical faster than it eliminates the substance. Thus, the chemical accumulates in the organism’s tissues. When a predator eats the organism, it receives all the collected chemicals in its prey. Therefore, the concentration of bioaccumulative substances exponentially increases up the food chain. This phenomenon is called biomagnification. Furthermore, parents pass down the chemicals to their newborns.

What Are the Criteria for PBT vs. vPvB?

There are criteria that a substance must meet for it to be considered PBT or vPvB by the ECHA.

Firstly, see the difference between a persistent (P) or very persistent (vP) substance in the table below:

Environment	Criteria for Persistent (P)*	Criteria for Very Persistent (vP)*
Marine Water	60	60
Fresh or Estuarine Water	40	60
Marine Sediment	180	180
Fresh or Estuarine Water Sediment	120	180
Soil	120	180

* Half-life Degradation (in days) higher than…

Secondly, a substance is “bioaccumulative” when its bioconcentration factor in aquatic species is higher than 2000. A substance is “very bioaccumulative” when this factor is higher than 5000.

Finally, the ECHA considers a chemical toxic when it is:

Carcinogenic;
Mutagenic;
Reprotoxic; or
Damaging to organs after repeated exposure.

PBTs and vPvBs are harmful to animals, plants, and humans

Enviropass can assist you with your REACH, SVHC, Annex XVII, and SCIP needs. Contact Enviropass for a free online consultation hour!