Q2. What categories of production aids can be used in manufacturing paper pulp?

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1 Q&A of the 4 th Food Contact Material Safety Forum With the publication of new Chinese FCM national safety regulations, the focus of this forum is to discuss the possible impacts on both the surveillance and compliance sides, in turn, to align understandings of the regulation. Here are some of the recorded Q&A from this event. Q1. Since substances listed in the GB Table A.2 can be used as food contact additive, how is the requirements of quality specification for these substance? A: Taking citric acid as example, citric acid quality should comply with National Food Safety Standard Food Additive Citric Acid (GB ), while industrial grade citric acid can also be used if product safety & risk assessment is carried out to ensure the harmful substances in the impurities (such as heavy metals) are well-controlled. Q2. What categories of production aids can be used in manufacturing paper pulp? A: Substances in Table A.6 of GB can be used. While other substances, such as those listed in Appendix C of GB food production aids, and et al can also be used in manufacturing paper pulp. Q3. Based on GB , How to conduct the testing to meet the QS certification for manufacturers of paper pulps and final paper and paperboard materials and articles? A: Manufacturers of paper pulps shall conduct the residue limit indexes (QM), while migration tests shall be conducted by final paper and paperboard materials and articles for QS certification.

2 Q4. Based on GB general safety requirement, how to understand the labeling requirement for product shelf-life? A: According to Article 8.3, the product shelf-life shall be labeled when necessary. For example, certain food contact products sold to consumers must be guaranteed within a specific shelf life. Beyond the specified shelf life, the product might endanger the health of consumers. It is up to the food contact material/articles manufacturers to decide when to apply. Q5. Whether Food contact wordings shall be labeled in every part of electric cooker? A: Food contact wordings shall be labeled in main body of electric cooker. Q6. According to article 3.6 of GB , finished products/articles are obviously very different from the raw materials (such as pellets, printing ink, adhesives), how to perform migration tests in accordance with GB ? How to determine the testing specimen s thickness and area? A: The specific requirements of the finished products shall comply with GB and the relevant regulations of other national food safety standards. For raw material (such as resins listed in GB with annotation 1, 2, 3, 4, 5) shall be tested according to the requirements of old standards. While for other resins, only DoC is needed to convey SML/QM information along the value chain. Q7. How to understand the article of GB ? A: The principle originated from the Chromium migration from the non-stick coating. When the chromium of non-stick pan is tested, Chromium migrates not only from coating, but also from the base stainless steel. For multi-layer

3 (e.g. food packaging), multi-part (e.g. coffee machine) or coated FCM (e.g. non-stick pan), if the restricted substance resides in more than one component, the final migration limit shall be calculated as weighed result. It is not finalized, for now, what model (by weight? by contact area?) shall be taken to perform this weighed result calculation. It is recommended to follow the lowest limit for the compliance of whole article, as also mentioned in Q8. How to understand the A.13 C) of GB ? The sodium salt, potassium salt and calcium salt (including acid salt and complex salt) of the acid, alcohol or phenol substances listed in Annex can also be used, and shall conform to the pertinent restriction on acid, alcohol or phenol additives. What impact will this bring to those sodium, potassium and calcium salt (including acid salt and complex salt) already listed in this standard? A: The principle isn t applicable to the acid, alcohol or phenol substances whose sodium salt, potassium salt and/or calcium salt (including acid salt and complex salt) are directly listed in GB In these cases, only sodium, potassium and/or calcium salts themselves can be used as food contact additives. While their acid, alcohol or phenol shall still undergo the new FCM application. Q9. As a coating manufacturer, if downstream customers ask for the composition information through DoC, what kind of principle shall be adopted to handle this information disclosure? A: Only substance with restriction (QM, SML, etc.) shall be passed on through DoC to downstream customers, not full composition.

4 Q10. There exist 4 national standards related to lubricant oil, which standard shall be respected for food contact lubricant oil? A: National safety standard Food Contact Lubricant Oil is still under planning. Before its publication, the existing mandatory standards are still effective. Q11. Interior coating of metal can must comply with GB , while exterior coating may contact the interior coating (set off), should exterior coating comply with GB also? A: It is difficult and impossible that exterior coating complies with GB The manufacturer needs to ensure manufacturing process to be in compliance with China GMP requirements (GB ) and avoid contaminations from exterior coating to interior coating. Q12. What is the migration testing condition for microwave oven? A: Usually, the food is only process in microwave for a short amount of time. For fatty foods simulant, 130 x 15 min should be sufficient. For aqueous foods, 100 x 15min should be sufficient. Depends on the actual use, the worst scenario for fatty food simulant can be 175 x 2 hour. Q13. As to solvent use and residue control, what are the specific GB requirement to comply with? Which kinds of solvent can be used? A: Solvent residue shall meet the requirements of GB9683 (under revision) and printing inks standard (under development). It shall also comply with the requirements of GB and GB Solvents listed in C list of GB can be used in manufacturing of food contact substances. Q14. How to understand the contact area of polymeric materials in full immersion method?

5 A: The test shall simulate the real exposure scenario. When the thickness of test sample is less than 0.5mm, single side is counted. When thickness is higher than 0.5mm and below 2mm, double sides are counted. When thickness is higher than 2mm, lateral area (cut) shall also be included. Q15. If there is no QM or SML imposed on any substance used in food contact materials and articles, how to conduct quality control? A: You can use OML and other specified requirements from related regulation(s) to perform quality control. Q16. Since GB will be fully implemented in Oct 19 th, 2017, how to provide the DoC from the perspective of raw material supplier? A: When GB is fully implemented, raw material supplier shall prepare the DoC, label, et al to convey the SML information to downstream users. If any SML info can t be provided due to the protection of intellectual property, one option is to obtain help from the certified third party organization. Q17. How to evaluate the functional barrier conception in DoC? Whether these substances used behind the functional barrier should be disclosed to downstream user? A: Mr. Zhong Huai-ning is drafting the technical guidance of functional barrier now, while the second question of disclosing substances used behind the functional barrier will be submitted to CFSA Dr. Zhu Lei for further comments.

6 Q18. CFSA Dr. Sui Hai-xia introduced the risk assessment models of food contact substances from EU and US, which model is preferred by China? As to consumption survey organized by CFSA, how to collect the typical sample and what is the approximate sample quantity? A: Risk assessments model of food contact substances from EU and US are both accepted by CFSA for now. The Chinese model is under development, which will most likely combine the merits of both models. The selection of samples is based on statistical principles. Impacting factors are also considered, such as the income level, geographical difference, et al. The sampling quantity is around 40,000. Q19. If the restriction limit is different in new standards than old ones, how to implement these newly issued food contact standards during the transition period? A: Before these newly issued standards becomes effective, manufacturers can either refer to the existing standards or these newly published standards. Q20. Since China food contact substances GMP regulation (GB ) is effective now, whether the imported food contact material and articles shall comply with it in China? A: FCM manufacturing process in a foreign country is beyond the administration scope of Chinese government. In these cases, Chinese GMP compliance isn t checked by China AQSIQ.