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According to Article 37 of Food Safety Law of the People’s Republic of China, the application of new raw materials for food production, or the production of new food additives and new food-related products is subject to safety assessment by health administrative department of the State Council. In other words, if a substance is not listed in the positive list (such as the GB 9685-2016 positive list for additives used in food contact materials and articles) or in the relevant announcements, it is required to be reported for record filing. This article analyzes and summarizes the announcement on new food contact materials in the first quarter of 2018.
In the first quarter of 2018, National Health Commission of the People’s Republic of China released one announcement in which it approved the application of 6 new substances in food contact material. We will explore these 6 substances including their basic information, application, declaration type and filing cycle time.
1. Basic info.
No. | English Name | CAS No. |
1 | Homopolymers of distillates (petroleum), C3-6, piperylene-rich (C5) and copolymers with one or more of the following: isobutylene (C4), styrene, and alpha-methylstyrene | —— |
2 | 3-Aminopropyltriethoxysilane | 919-30-2 |
3 | Polymer of adipic acid with isophthalic acid, maleic anhydride, 2-methyl-1,3-propanediol, 2,2-dihydroxymethyl butanol and dimethyl-2,6-naphthalene dicarboxyla | —— |
4 | Polymer of isophthalic acid, maleic anhydride, phthalic anhydride, phosphoric acid, trimethylol propane and 2-methyl-1,3-propanediol | —— |
5 | Polymer of isophthalic acid and terephthalic acid, adipic acid, trimethylol propane, 2-methyl-1,3-propanediol and ethylene glycol | —— |
6 | Polyvinyl chloride | 9002-86-2 |
Table 1 Summary data of new substances announced in the first quarter
2. Application
As shown in Figure 1, among the six new substances announced in the first quarter, one substance (No.1 substance) is applied to adhesives, and one substance (No.2 substance) is applied to polyamide (PA) plastics. The rest of them (No.3/4/5/6 substances) are used in paintings and coatings.
3. Declaration type
As shown in Figure 2, among the six new substances announced in the first quarter, one substance (No.1 substance) is new additive, two substances (No.2 and No.6) is expanded in scope and maximum level, and the other three (No.3/4/5) are new resins. Items that have their scopes and maximum level expanded is divided into new additive and new resin.
Substance | Period from acceptance to public review | Period from public review to announcement | Overall Application period |
Homopolymers of distillates (petroleum), C3-6, piperylene-rich (C5) and copolymers with one or more of the following: isobutylene (C4), styrene, and alpha-methylstyrene | 3 years and 3 months | 6 months | 3 years and 9 months |
3-Aminopropyltriethoxysilane | 8 months | 9 months | 1year and 5 months |
Polymer of adipic acid with isophthalic acid, maleic anhydride, 2-methyl-1,3-propanediol, 2,2-dihydroxymethyl butanol and dimethyl-2,6-naphthalene dicarboxyla | 11 months | 6 months | 1year and 4 months |
Polymer of isophthalic acid, maleic anhydride, phthalic anhydride, phosphoric acid, trimethylol propane and 2-methyl-1,3-propanediol | 11 months | 6 months | 1 year and 4 months |
Polymer of isophthalic acid and terephthalic acid, adipic acid, trimethylol propane, 2-methyl-1,3-propanediol and ethylene glycol | 11 months | 6 months | 1 year and 4 months |
Polyvinyl chloride | 6 months | 6 months | 1 year |
Table 2: Periods of new substances announced in the first quarter
4. Filing cycle time
As shown in Table 2, the filing cycle time (the span from case acceptance to final announcement) of these six new substances varies from 12 months to 45 months. Besides, due to various practices such as expert evaluation, enterprise defense, and/or submission of additional supporting data, it takes more time to run from public review to the final announcement than to run from the acceptance of the new substance to the public review. Once a new substance passes risk assessment, it will be subject to further public review. If the public has no objection to it for safety reason or other special circumstance, then the substance will be officially announced within six months to one year.
Summary：Article 5 of GB4806.1-2016 National Standards for Food Safety-General Safety Requirements for Food Contact Materials and Articles lays out general principles on compliance: food contact material, its raw material and additives applied shall comply with food safety standards and related announcements. The six new substances introduced in the first quarter of 2018 take regulatory effect as those in the positive list do, and can be used in the food contact material only if it is used according to valid regulations and announcements.
