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South Korea to Revise Hazchem Concentration Limits for Children’s Products

South Korea’s Common Safety Standards for Children’s Products is under revision. The concentration limits of nitrosamines and nitrosatable substances will be set for oral use children's product. The concentration of Lead (Pb) will be changed from 300 mg/kg to 100 mg/kg.

On Jun 4th, 2015, The Korean Agency for Technology and Standards (KATS) implemented a Special Act on Safety Management of Children’s Products for all products or parts/components designed for children under 13 years. Children’s products are regulated under the Special Act which is supported by the Common Safety Standards and product specific vertical standards.

The Common Safety Standards is currently under revision. The draft revision was notified to the WTO on Aug 22nd, 2019, and will be open for comments for 60 days (WTO notification). As planned, the revised standards will be adopted in June 2020 or later.

Many nitrosamines are carcinogenic and must be strictly regulated due to their presence in rubber products, food and cosmetics, etc. As proposed, concentration limits are newly set for nitrosamines and nitrosatable substances that will be used in oral use children’s products e.g. pacifiers, molar rods, toothbrushes, mouthpieces, and elastomers (e.g. balloon), etc. The details are listed as below.

Substances

Concentration

nitrosamine

N-nitrosodimethylamine,

CAS No. 62-75-9

 

Below 0.01 mg/kg

N-nitrosodiethylamine,

CAS No. 55-18-5

N-nitrosodi-n-propylamine,

CAS No. 621-64-7

N-nitrosodi-n-buthylamine,

CAS No. 924-16-3

N-nitrosopiperidine,

CAS No. 100-75-4

N-nitrosopyrrolidine,

CAS No. 930-55-2

N-nitrosomorpholine,

CAS No. 59-89-2

nitrosatable substances 

N-nitrosodimethylamine,

CAS No. 62-75-9

Below 0.1 mg/kg

N-nitrosodiethylamine,

CAS No. 55-18-5

N-nitrosodi-n-propylamine,

CAS No. 621-64-7

N-nitrosodi-n-buthylamine,

CAS No. 924-16-3

N-nitrosopiperidine,

CAS No. 100-75-4

N-nitrosopyrrolidine,

CAS No. 930-55-2

N-nitrosomorpholine,

CAS No. 59-89-2


The maximum permitted concentration of Lead (Pb) detectable in children’s products will be more stringent and is changed from 300 mg/kg to 100 mg/kg. For paint or surface coatings, the limit will be kept as below 90 mg/kg.

In addition, six kinds of plasticizers (DEHP, DBP, BBP, DINP, DIDP, DnOP) will be subject to tightened management. The permitted concentration (below 0.1%) will apply to synthetic resin children's products, irrespective of for oral use or not.

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