Soothers, Rubber Nipples and Feeding Bottles

As known to all soothers, rubber nipples and feeding bottles are in direct contact with babies and young children and therefore the their quality shall be tested with the most stringent requirements.

In general, EN 1400 Child Use and Care Articles—Soothers for Babies and Young Children serves as a reference for the Chinese standard GB 28482 Safety Requirements of Soothers for Babies and Young Children . The establishment of GB 28482 may ensure product quality and further standardise the current market.

Pursuant to GB 28482, soothers testing include the following:

Heavy metals: migration of specific elements (Sb, As, Ba, Cd, Pb, Cr, Hg and Se);
Phthalates: each of DBP, BBP, DEHP, DNOP, DINP and DIDP ≤ 0,1 % by weight;
Release of N-nitrosamine and N-nitroso compounds;
Release of MBT;
Release of antioxidant;
VOC (volatile organic compounds) content;
Mechanical and performance testing.

GB 4806.2 applies to products made of natural rubber, polyisoprene and silicone rubber. However, it is not applicable to pacifiers. Meanwhile, the standard shall comply with general safety requirements of national standard for food contact materials and products for food safety. The requirements are as the following:

Item	Index	Test Method
Overall migration / (mg/kg) Distilled water 24h at 40℃ Acetic acid 4 % (V/V) 24h at 40℃ Acetic acid 50 % (V/V) 24h at 40℃	≤30 ≤60 ≤60	GB 31604.8
Potassium permanganate consumption / (mg/kg) Distilled water 24h at 40℃	≤10	GB 31604.2
Heavy metals (calculated as lead metal [Pb]) / (mg/kg) Acetic acid 4 % (V/V) 24h at 40℃	≤1	GB 31604.9
Migration of zinc (mg/kg) Acetic acid 4 % (V/V) 24h at 40℃	≤5	Food Contact Materials and Products Test Method for Migration of Zinc
Migration of 2,6-Di-tert-butyl-4-methylphenol / (mg/kg)	≤0.3	GB 28482-2012
Migration of 2,2'-Methylenebis(6-tert-butyl-4-methylphenol) / (mg/kg)	≤0.15	GB 28482-2012
N-Nitrosamines and N-nitrosatable substances / (mg/kg) Artificial saliva 24h at 40℃ N-Nitrosamines N-nitrosatable substances	≤0.01 ≤0.1	Sample preparation and result are subject to GB 28482-2012, Instrument analysis is subject to GB/T 24153-2009
Volatiles /% (w/v)	≤0.5	GB 28482-2012

ZWX/QLB Safety Requirements of Feeding-bottle for Babies and Young Children stipulates scope, terms and definitions, safety requirements, labelling, test methods, packaging, packaging instructions, transportation and storage for feeding-bottles. It also includes requirements for accessories of feeding-bottles. The chemical testing for feeding bottles are similar with those in GB 28482. Based on that, this standard sets a migration limit of 0,03 μg/mL for bisphenol A (BPA).

Tip: GB 4806.2-2015 National Standard for Food Safety—Nipples applies on 22 September 2016 superseding GB 4806.2-1994 Hygienic Standard for Rubber Nipple.