Annual review of China’s administrative license of new food contact materials and articles in 2017
According to the article 37 of the food safety law, related safety assessment materials for new food-related products such as new food varieties, new food raw materials, as well as new food additives should be submitted to NHFPC (National Health and Family Planning Commission) for further evaluation. The food related products in article 37 also covers categories of food contact materials and articles, disinfectants and detergents.
This means that new food contact materials and articles which were neither listed in the national standard positive list such as resin list of GB4806.6-2016 and permitted additives list for food contact materials of GB 9685-2016, nor approved by NHFPC in official announcement should be submitted related new food related application to NHFPC.
Here we mainly summarizes and analyzes the application for new food contact materials and articles in the state of accepted by NHFPC, released by NHFPC’s website for public comments as well as approved NHFPC in 2017. We also focuses on the general state of approval, product usage, product type and applicants for these new food contact materials and articles.
1、Summary and analysis of new varieties of food contact materials and articles accepted by NHFPC in 2017
In 2017, a total of 9 new applications for food-related product were accepted by the NHFPC. Two of them have been published on the official website of the NHFPC on May 2, 2017 and September 11, 2017 for public comments respectively. These 2 products account for 22% of the total 9 applications. Other 7 products were in the phase of supplementary application, which accounts for 78% of the total 9 applications. The details are shown in Figure 1.
Figure 1 New applications for food-related product were accepted by NHFPC in 2017
As far as the category of application is concerned, 5 applications were new additives used in food contact materials and articles (hereinafter referred to as “New varieties of additives”), taking 56% of the total 9 applications. And 3 applications were new resin verities used in food contact materials and articles (hereinafter referred to as “New varieties of resins”), taking 33% of the total 9 applications. Also 1 application was expanding the use scope or the dosage of additives used in food contact materials and articles (hereinafter referred to as ” New varieties of expand the use scope or the dosage “), taking 11% of the total 9 applications. The details are shown in Figure 2.
Figure 2 Categories of new varieties accepted by NHFPC in 2017
With respect to the usage of new products, 3 products (33% of total application) were used to produce coatings, 3 products (33% of total application) were used for new resins, 2 products (22 % of total application) were used to produce paper and paper board, and 1 product (11% of total application) was used as additives to produce all type of plastics. The details are shown in Figure 3.
Figure 3 Usages of new products accepted by NHFPC in 2017
Regarding to the enterprise attribute of these applicants, 8 applications (89% of total application) were submitted by oversea enterprises, merely 1 application (11% of total application) was submitted by Chinese local enterprise. The data in each past years also shows that the number of new product applications that submitted by foreign enterprises were far higher than that of domestic enterprises, that more than 75% applications were submitted by foreign enterprises. This may be attributed to a strong foreign legal system that has greater supervision over food-related products. In addition, the compliance consciousness of foreign enterprises were also stronger than that of domestic enterprises.
Figure 4 Enterprise attributes of new products accepted by NHFPC in 2017
2、 Summary and analysis of new varieties of food contact materials and articles for public comments in 2017
Although NHFPC had accepted many products applications several years ago, many applications for public comments were not published by NHFPC’S official website until 2017. The time from new product applications accepted by NHFPC to new product applications for public comment ranges from 3 to 46 months, with an average of 15.5 months per product.
In 2017, the NHFPC’S official website published 26 new applications were related with food contact material for public comment, 14 products of them were use as new additives, 14 products of them were used as new resin, and other 5 products of them were new varieties to expand the use scope or the dosage.
There were 13 food-related products among these 26 applications were approved by NHFPC on Oct 31, 2017 and Nov 27, 2017 respectively. In the approval announcement issued by the NHFPC, these 13 new products can be used in food contact materials in compliance under certain conditions of use. The average time from new product application accepted by NHFPC to application approved by NHFPC were 15.5 months per product.
3、 Summary and analysis of new varieties of food contact materials and articles approved by NHFPC’s announcements in 2017
A total of 20 new food related varieties were approved by 3 NHFPC’s announcements in 2017, 10 products among them (50 % of total products) were new additives, 4 products (20 % of total products) were new resin, 5 products (25 % of total products) were new varieties to expand the use scope or the dosage, and 1 product (5 % of total products) was one of new food contact materials and articles. The details are shown in Figure 5.
Figure 5 New varieties of food-related products approved by NHFPC’s announcements in 2017
As shown in Figure 6, 6 products (30 % of total 20 approved products) were approved by NHFPC within 1.5 years since the time of products accepted by NHFPC. And 6 products (30 % of total 20 approved products) were approved within 1.5 to 2 years, 3 products (15% of total 20 approved products) were approved within 2 to 3 years, other 5 products (25% of total 20 approved products) were approved by NHFPC over 3 years. So the time from new product applications accepted by NHFPC to new product approved by NHFPC ranged from 10 to 55.5 months, the average time for each product to be approved were 25.6 months.
Figure 6 Approval time for new food-related products in NHFPC’s announcements in 2017
Summary
Compared with 2016, the number of new food-related products accepted and approved by NHFPC were reduced in 2017. And number of new food-related products for public comments increased in 2017.
One the one hand, the approval process for new food-related product takes certain time, and the approval result was highly correlated with the previous acceptance application and number of new food-related products for public comments. For instance, there were merely 6 new products for public comments in 2016, so the number of approved new products would low than 6 as well.
On the other hand, 53 new national standard have been released in 2016 and officially implemented in 2017. The new national standard system has put forward higher compliance requirements for food contact materials in Chinese market. As a related regulatory authority, NHFPC has also improved the examination and approval requirements of new product administrative licensing.
REACH24H accumulates rich experience in dealing with food contact substances in China/ USA/ EU could provide tailor-made compliance services for enterprises. If you have further questions, please contact Alex Wu by +86 153 8108 7368 (M) ,+86 571 87007520 (T), or send email to wudapeng@reach24h.cn.