1. An overview of the definition of total migration

Migration in food is mainly used to examine the potential ability to migrate from packaging to food and the presence or absence of toxicity of migrated substances, including packaging materials, containers, tools, and equipment used in food production, processing, transportation, storage, and use and inks, adhesives, lubricants, etc. that may come into direct or indirect contact with food. Total migration is one of the quality control indicators of food contact materials, its method is simple, short cycle time and other characteristics, become an important basis for enterprises and technical supervision departments to control product quality, is a vital part of the field of food safety testing.

Total migration refers to the total amount of all non-volatile substances that migrate from food contact materials and products to food simulants in contact with them under specific immersion conditions, expressed in milligrams of non-volatile migration per kilogram of food simulant (mg/kg), or milligrams of non-volatile migration per square decimeter of contact area (mg/dm²).

2. What are the standards in each country?

The standards for Migration Testing For food Contact Materials (FCMs) will vary from country to country.

China

On September 7, 2021, the National Health Commission of the People's Republic of China and the State Administration of Market Supervision and Administration issued the National Standard for Food Safety Determination of Total Migration for Food Contact Materials and Products (GB 31604.8-2021), which will officially take effect on March 7, 2022, and compared with (GB 31604.8- This standard will come into effect on March 7, 2022, compared with (GB 31604.8-2016), which mainly modifies the scope of application and precision requirements of the standard, while increasing the requirements for the determination of total migration in olive oil.

EU

Within the EU, FCM is assessed by the European Food Safety Authority (EFSA) but there is no single regulation covering all FCM. The EU does have a harmonized legal EU framework, Regulation (EC) No 1935/2004, which sets out the general principles of good manufacturing practice (GMP), safety, and inertness for FCM, but it is not the whole story. Different forms of FCM are also covered by their own harmonized regulations, for example:

Ceramics: Directive 84/500/EEC, amended by Directive 2005/31/EC

Regenerated cellulose film: Directive 2007/42/EC

Plastics: Regulation (EU) No 10/2011 and its amendments

N-Nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers: Directive 93/11/EEC

Epoxy derivatives: BADGE (2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether), BFDGE (Bis (hydroxyphenyl)methane bis(2,3-epoxypropyl) ethers) and NOGE (Novolac glycidyl ethers) in certain epoxy derivatives: Regulation (EC) No 1895/2005

At the same time, member states are also free to complement these EU regulations with national legislation, if no EU regulation exists. The reality is that many EU member states have national requirements for one or more of the non-harmonized FCM and/or additional requirements for FCM with harmonized regulations. For example, the EU regulations on ceramics include migration limits for lead and cadmium but, in France these are complemented by legislation administered by the French General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), adding migration limits for aluminum, cobalt and arsenic. Unlike general EU requirements, France also demands the composition of metals being used in FCM – e.g. stainless steel must contain at least 13% chromium.

To further complicate matters, the way certain regulations are enforced can be different in each member state. For example, according to Regulation (EC) No 1935/2004, the organoleptic test is a requirement in Article 3. However, in France this test is not performed for all materials or articles, only those that are considered high risk – paper, board, wood, bamboo, varnishes and/or paints. Materials or products that are considered medium risk (plastics, rubber, and silicone rubber) will also undergo the test if the material smells bad. The same sensory test is, however, mandatory in

Germany

EU FCM regulations act as a benchmark for member states but they are not always enough to guarantee compliance in all European countries. Countries outside of the EU may have their own rules or may have adopted some aspects of EU regulation, such as in Switzerland. At the same time, member states may also add further restrictions or interpret the regulations differently – e.g. Belgium’s Royal Decree on food contact varnishes and coatings has added a stipulation regarding citric acid in the specific migration of varnishes on metal.

Without one single harmonized standard for all European countries, manufacturers must ensure their products are compliant with the target market but, since a product will often be marketed in more than one country, this can be a complex matter. （Citation from SGS)

United States of America

United States of America Food contact packaging has a long history of regulation in the US. The US Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act (FFDCA) from 1958. This is the basic regulation on food contact materials which has a pre-clearance requirement that any substance that is intended to become a component of food (eg. migrates from packaging into food) must be: generally recognized as safe (GRAS), used in accordance with a sanction of approval issued prior to 1958, the subject of a “Threshold of Regulation” exemption letter or cleared by a Food Contact Notification or a food additive regulation. Requirements for food contact materials are briefly summarised below. Detailed information is available at

The US Congress granted authority to the FDA to regulate food additives in 1958 by adding section 409 to the Federal Food Drug and Cosmetic Act (FFDCA). A food additive is defined as ‘any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food.’ As a result, the FDA established a petition process through which individuals could petition the FDA requesting approval of a food additive. However, experience showed that the promulgation of regulation for a food additive was an unnecessarily lengthy and resource-intensive process. This led to the development of two additional processes intended to largely supplant the petition process. Those processes are the Threshold of Regulation (ToR) exemption process and the Food Contact Notification (FCN) process. The ToR process, established in 1995, exempts certain substances used in food contact articles from the requirement for an authorizing regulation prior to use in contact with food. It is an abbreviated review process that can result in faster approval. However, the approval is not proprietary. To obtain this exemption, the following criteria must be met: · the estimated daily intake from the proposed substance must be less than or equal to 1.5 µg per person per day (equivalent to less than or equal to less than 0.5 µg per kg of food consumed). The method of estimating daily intake is different to that used in the EU and relies on market share information on packaging use in different types of food matrices; OR · cleared as a direct additive (part 172) and exposure form the food-contact use is less than 1% of the ADI; AND · the substance must not be known to be a carcinogen in man or animals. The FDA may decline to grant an exemption if the substance is known to be a potent toxin, or based on the chemical structure the substance may be suspected to be a carcinogen. The substance must also not contain a carcinogenic impurity above specified levels. 5 European Food Safety Authority; Report of ESCO WG on non-plastic Food Contact Materials. Supporting Publications 2012:139 [63 pp.]. Available online: www.efsa.europa.eu 5      The FCN process was established in 1997 through an amendment to Section 409 of the FFDCA. This established a process by which food additives that are food contact substances could be deemed to be safe without going through the petition process. The FFDCA defines an food contact substance (FCS) as ‘any substance intended for use as a component of materials used in the manufacturing, packing, packaging, transporting or holding food if such use is not intended to have any technical effect in such food.’ This process is designed as the primary method of authorising new uses of the FCS, however there are circumstances where a petition can still be used. Notably, the FCN process results in an authorisation only for the notifier and manufacturer listed in the FCN, in contrast to a ToR or petition. For a petition a Code of Federal Regulation listing is generated, whereas an effective list of ToR exemptions and FCNs is maintained on the FDA website. Regardless of the process involved, the submitter must demonstrate that the intended use of the FCM is safe, meaning that there must be a reasonable certainty of no harm. This means that the data and information required are generally comparable under the three processes for a given level of exposure. The FDA has received and processed hundreds or ToR reception requests and FCN applications. Notably, the FDA will not accept an FCN, a ToR exemption submission or a petition for review in the absence of an environmental component. Product classes specifically regulated under Title 21 of the Code of Federal Regulations Regulations for FCM primarily relate to substances in 21 CFR 174 – 178 which are functionally separated into lists of specific polymers or classes of polymers, a list of FCM by use or function, and a list based on the type of packaging that they may be used in. These are: 175 Adhesives and coatings 176 Paper and paperboard 177 Polymers 178 Adjuvants and production aids Information about a particular substance in a regulation, ToR exemption or FCN Agency letters generally include a unique chemical descriptor, specifications for the FCM and restrictions related to its use. For FCMs that are the subject of petitions, those specifications ensure that the FCM marketed by the manufacturer is equivalent to the FCM that was subjected to safety assessment. Recycled materials In the US, recycled products are not considered to be a new use and, as such, if the recycled product meets the specifications for the virgin material, the recycler is not required to get FDA approval prior to marketing the recycled material for food contact use. There is formal guidance for recycled plastics6 and opinion letters are issued by the FDA. There is currently no regulation in the US for recycled paper, and it is considered an undeclared Generally Recognized As Safe (GRAS) material. Draft guidance to evaluate recycled paper products is under development.

Canada

In Canada, regulations prohibit the sale of foods that may impart harmful substances to their contents and, similar to Australia/New Zealand requirements, the responsibility lies with the manufacturer or distributor to ensure the safety of their products. However, in the absence of positive lists7 , voluntary submissions can be made to the Food Directorate for a premarket safety assessment (Magnuson et al. 2013). In terms of data requirements, food packaging submissions are divided into two categories: those on ‘formulated products and finished articles’ (normally submitted by converters and formulators) and those on ‘specific constituents or single additives’ (from raw material suppliers). The Food Directorate may then issue a ‘no objection’ letter which can be used by submitters to reassure their clients that their products are acceptable in terms of safety. Notably, in a legal sense, the letter does not relieve the manufacturer from their responsibilities in terms of food safety. （cite from:Nielson C. and Ng Clark M. (2004) Update of regulation of food packaging in the Pacific Rim. Keller Heckman Packaging Site.)

Japan

Japan currently regulates FCMs under the Food Sanitation Law which sets out general food safety standards including food packaging materials (Ettinger and Ng Clark 2012). There is no positive list of permitted substances for use in FCMs, but the Food Sanitation Law authorises the establishment of specifications for food containers and packaging and the raw materials used to manufacture these articles. Examples of these specifications are the use of certain metals (particularly lead) and prohibition of the use of di(2-ethylhexyl) phthalate as a plasticiser for polyvinyl chloride (PVC) used in contact with food containing edible fats and oils.

Japan also has many voluntary industry standards which are sanctioned by specific well established trade associations (e.g. The Japan Hygienic Olefin and Styrene Plastics

Association and the Japan Paper Association). Positive lists exist for food additives for most standards, though the Japan Printing Ink Makers Association holds a negative list excluding

substances classified as carcinogenic, mutagenic or acutely toxic. New substances can be added by filing a petition to the relevant association. Only members of these associations (orsponsored companies) can apply for a voluntary standard on an FCM. The Japanese Ministry of Health Labour and Welfare is also now considering introducing a positive list for monomers and additives for food contact plastics.

For more information on national standards, please click on the website of flexible films testing instruments.

GBPI is highly focused on product innovation and development to provide customers with more accurate and convenient testing equipment, and has developed the ZF3600 Full-automatic Total Migration Tester for this purpose.

Standard

GB 31604.8-2016, GB/T 9740-2008, GB/T 5009.156-2016, GB/T 5009.156-2016, YBB00342002-2015, YBB00102005-2015, YBB00082002-2015.

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