New Chinese National Standard for Nipples Applies in September - Regulatory News - Food & Food Contact Materials

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.

The standard applies to products made of natural rubber, polyisoprene and silicone rubber. However, it is not applicable to pacifiers. Meanwhile, these products shall comply with general safety requirements of national standard for food safety— food contact materials and articles.

Compared with the previous version, the new standard adds technical requirements for raw materials and lists polyisoprene as a new raw material for rubber nipples.

GB 4806.2-2015 makes major adjustments in physic-chemical indexes as the following:

Add overall immigration, migration of 2,6-Di-tert-butyl-4-methylphenol, migration of 2,2'-Methylenebis(6-tert-butyl-4-methylphenol), release of N-Nitrosamines and N-Nitrosatable substances;
Lower limits for potassium permanganate consumption and migration of zinc;

While the requirements for heavy metals remain unchanged.

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	Test Method for Migration of Zinc in Food Contact Materials and Articles
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
Release of 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

In addition, GB 4806.2-2015 includes requirements for natural latex. For instance, a product shall bear an instruction to indicate it contains natural latex if this is the case.

? GB standards are the Chinese national standards issued by the Standardisation Administration of China (SAC), the Chinese National Committee of the ISO and IEC. It deserves notice that all products imported to China shall comply with GB standards as they are mandatory.

It is advised that manufacturers should adjust production techniques and strengthen quality control before 22 September 2016 so as to ensure their products comply with the new standard, or send their products to a professional body for testing if necessary.

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