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On May 20, 2019, National Health Commission released consultation drafts of 26 national food safety standards including National Food Safety Standard for Adhesives Used in Food Contact Materials and Articles (refer to news: China consults on 26 food standards[1]). This is going to be the first standard for adhesives used in food contact materials and articles (food contact adhesives for short). The formulation of this standard was written into the 2014 annual plan and drafting of the new regulation began in June 2014. The draft is now under consultation, and the deadline for comments is July 20 this year.
History of its development
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Status Quo of Food Contact Adhesive Regime
In China, a basic framework of FCM standards has been established, comprising general standard, product standards, standards for test methods and good manufacturing practice. However, the overall regulatory framework for food contact materials still needs some work and some individual standards for widely applied materials such as food contact adhesives, ink, composite FCM are still under development.
| General Standard | GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles GB 9685-2016 Standard for the Application of Food Contact Product Additives |
| Product Standard | GB 4806.2 Nipple; GB 4806.3 Enamel; GB 4806.4 Ceramic Articles; GB 4806.5 Glass; GB 4806.6 Resin; GB 4806.7 Plastics; GB 4806.8 Paper and paperboard; GB 4806.9 Metal; GB 4806.10 Coating and paints; GB 4806.11 Rubber; |
| GMP | GB 31603-2015 General Hygienic Practice for Production of Food Contact Materials and Articles |
| Test Method Standards | GB 31604.1 General Rules for Migration Test of FCM; etc. |
At present, GB 9685 Standard for the Application of Food Contact Product Additives is the main regulation to determine which additives and base polymers are allowed in food contact adhesives.[2] If stakeholders want to use a substance not listed in the appendix of GB 9685 or approved by former NHFPC or NHC, they shall submit an application at competent authority according to Administrative Provisions on the Approval of New Varieties of Food Related Products[3] and Rules on the Application and Acceptance of Food Related Products[4]. For other aspects of food contact adhesives refer to GB 4806.1 General Safety Requirements for FCM. Major developed countries have formed relatively systematic regulatory frameworks of food contact adhesives, which China has used as a reference during the development of its own standards[5].
US, indirect food additives
America developed FCM regulations early in the beginning of 20th century. FCM in US is managed in the same system with food additives by FDA. There are three types of food additives, and FCM is classified as “indirect food additive”.
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Code of Federal Regulations Chapter 21 part 175.105 and 175.125 regulate adhesives used in FCM. 21CFR175.125 is applicable to pressure sensitive adhesives and 21CFR175.105 the rest of adhesives. The two parts contains positive lists of substances allowed in adhesives, application scopes, maximum using level and so forth.
For those substances not in the regulations, stakeholders need to undergo food contact substance notification (FCN) if the exposure level is 0.5~1ppm. When exposure level is below 0.5ppm, they can submit TOR request (Threshold of Regulations) so that they could be exempt from FCN. Substance with an exposure level of > 1ppm will be regarded as a food additive.
| FAP Food additive petition | FCN Food contact substance notification | TOR Request | |
| Exposure level | >1ppm | 0.5~1ppm | ≤0.5ppm |
| Period | >180 days | 120 days | Not sure |
| Approval is applicable to | All | Only applicants and consumers | all |
EU, Plastic Products
European Union does not have designated regulations for FCM adhesives. Given that adhesive is not in direct contact with food just like the plastic part of composite FCM, the European Commission adopted the management mode of plastic products to regulate adhesives. Relevant regulations are:
| EC 1935/2004: General requirements for FCM EC 2023/2006: GMP EU 10/2011: Plastics intended to come into contact with food (include positive list) |
Substances used in food contact adhesives shall either be approved in EU regulations or relevant regulations of countries in EU and beyond. Otherwise stakeholders shall submit application of using new substances in food contact adhesives, which is a common practice shared by major countries in the world.
Analysis on the Draft Standard for Food Contact Adhesives
The consultation draft is divided into 6 parts and 2 appendixes. They are:
Appendix B base polymers allowed in indirect food contact adhesives |
As I mentioned in the first part of this article, currently GB 9685 the primary reference to ascertain compliance requirements for both additives and polymers used in food contact adhesives. But GB 9685 is indeed a standard of FCM additives, base polymers are not additives. Positive lists of polymers of food contact adhesives would be separated from GB 9685 and has already been written into this draft national standard for adhesives used in FCM.
Terminology
The draft clarifies the definition of “adhesives used in food contact materials and articles”. It refers to materials which are used in food contact materials and articles to bond two FCMs physically or chemically, which have direct or indirect contact with food.
It is commonly applied in composite FCMs such as plastic-plastic, aluminum-plastic, paper-aluminum-plastic materials. According to the definition, food contact adhesives falls into two types:
Adhesives that are expected to be in direct contact with food;
Adhesives that are expected to be in indirect contact with food.
Basic requirements
In the first place, food contact adhesives, like all the other food contact materials and articles, need to comply with GB 4806.1 General Safety Requirements for Food Contact Materials and Articles.
The draft also requires manufacturers to properly design the seam and edge of composite FCM during production, and to use block layer etc. to minimize migration of adhesive substances into food.
Besides, it requires manufacturers to control oligomers and other the non-intentionally added substances in that the components of adhesives are complex and some are reactive. (read analysis on non-intentionally added substances in China here)[6]
Technical requirements
Catalogue of permitted base polymers and corresponding restrictions are attached to the draft as two appendixes. Appendix A includes 68 polymers allowed in both direct and indirect food contact adhesives, appendix B includes 236 polymers allowed only in indirect food contact adhesives. The lists comprise polymers in GB 9685, previous Hygienic Standard for Food Containers and Package Materials, new food related products approved by former NHFPC and National Health Commission.
| Application scope | |
| Appendix A |
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| Appendix B |
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In China, management of FCM mainly focus on polymers instead of monomers/starting materials. Some industry insiders proposed to change management mode from polymers to monomers/starting materials. Some countries or regions regulate monomers exclusively, such as EU and US. The US has realized the drawbacks of this monomer-only approach and launched food contact substance notification system which requires risk assessment on unapproved polymers and users are confined to the applicants.
Sensory requirements and physiochemical indexes are not criteria for adhesive itself but for its finished food contact products.
| Item | Index | Test method | |
| Total migration level (mg/dm2) | 10a | GB 31604.8 | |
| potassium permanganate consumption/(mg/kg) water (60℃，2h) | ≤ | 10 | GB31604.2 |
| Heavy metal (Pb)/ (mg/kg) 4% acetic acid (volume fraction) (60℃，2h) | ≤ | 1.0 | GB 31604.9 |
| Primary aromatic amines (PAAs)b / (mg/kg) | 0.01 | National standard for determination of PAAs in FCM (under development)[7] | |
| a for food contact materials and articles applied in infant and young children foods, the total migration level shall not exceed 60mg/kg after conversion. b index of PAAs is applicable exclusively to aromatic polyurethane adhesives, epoxy adhesives that using amine curing agent, polyimide adhesives and so forth that are likely to send out PAAs during curing reaction. After curing reaction, migration test of PAAs is required. | |||
Migration Test
The target of migration test is finished food contact product rather than specific adhesives. Test should comply with GB 31604.1 General Rules for Migration Test of FCM and GB 5009.156 General Principle to the Pretreatment for Migration Test of Materials and Articles in Contact with Food.
Labeling
The labeling of food contact adhesives refers to GB 4806.1. But considering aromatic polyurethane adhesives, epoxy adhesives that using amine curing agent, polyimide adhesives are likely to generate PAAs, manufacturers shall label the whole name of the adhesive if using these three types of adhesives.
