TAGS: Food Contact Approved Plastics Barrier Solutions for Food Packaging
In plastics food contact packaging, there is a broad range of plastic resins possessing unique chemistries and physical properties. Recognizing these key property differences and remembering that all plastics are not necessarily compatible will lead to the careful selection of materials for food packaging applications.
For example, due to high as molded transparency harnessed to ultra-low carbonated gas permeation, Polyethylene Terephthalate (PET) is the perfect solution for large two-liter soda bottles. By comparison Polypropylene (PP) is not a good fit here. This is because, it is not as clear when molded and more importantly lacks a carbonated gas barrier for soda. Food products and in turn plastics food contact packages are subject to several environmental influences.
Let's explore the central theme to review food contact packaging legislative approaches over key global geographies. So that, geographic standardized approaches can be identified and over time harmonized global plastics food contact packaging legislation could evolve from these base points.
Let's begin with the commonly used plastics in food contact packaging...
Commonly Used Plastics in Food Contact Packaging
The most commonly used plastics in food contact packaging and that are subject to global legislation are summarized as follows:
Global food packaging legislation centers on
food contact material (FCM) laws and how to regulate FCM manufacturers. Also, this FCM focus covers when appropriate additives such as antioxidants, stabilizers, plasticizers, nucleators, and similar products are compounded into the base plastic packaging resin.
Plastic Barrier Film ComparisonsFood Packaging Legislative Approaches by Geographic Jurisdiction
Central to
plastics food contact packaging are the different world-wide geographies with their respective legislative approaches to plastic materials. We’ll now review and summarize these legislative regulatory schemes in the nine major geographic jurisdictions of:
So,
let's get going...
United States Food and Drug Administration
The primary regulatory group in the United States is the
U.S. Food and Drug Administration (USFDA). It utilizes a premarket review process to regulate a given Food Contact Material (FCM). Direct food additives and some specialized Food Contact Substance (FCS) types are still handled through a predecessor approach called the
Food Additive Petition (FAP).
Currently the USFDA’s key Food Contact Notification (FCN) process is the major approach used to handle premarket review of FCSs. Specific step by step details for these two preceding processes are available on the USFDA website. Significant differences exist between the two preceding FDA processes (FAP, FCN), but they are related only to process administration.
Basically, information detail is similar for both processes. There is a strict 120-day timing period for the FCN process, vis-à-vis the more flexible FAP procedure.
Also, FCN approval for a food contact plastic is company specific to the firm that applies for the application. Thus, the FCN Company is the only one that can market the FCS. A new legislative regulation is the result of the FAP process approval that in turn goes right into the U.S. Code of Federal Regulation (CFR). Hence, in this case any company can market a given plastic FCS provided the FCS regulation specification.
For further reference, food contact food or plastic additives are summarized in 21 CFR, Parts 170–199, in specific FCNs, in very limited examples are recognized by the USFDA as “
Generally Recognized as Safe (GRAS)”, or in even more limited cases are designated as Prior Sanctioned (PS) for food contact use.
Canadian Food Inspection Agency
A Food Contact Material (FCM) goes unregulated in Canada. However, fish, poultry, and meat, agriculture centered, processors come under the regulatory purview of the Canadian Food Inspection Agency (CFIA).
Digging deeper FCM type language is apparent in Division 23: B.23.001 of the Canadian Food and Drug Regulations. In this regulation, it states that no one can sell a packaged food where any of the content elements or ingredients causes injury to the food consumer’s health. As the preceding guidance is unspecific in nature, it led the
Canadian Health Products and Food Branch (HPFB) to establish and issue the Letter of No Objection (LONO) for acceptable plastic food packaging materials. The LONO is a voluntary, non-legal, legislative approach. This sanctioned scheme will allow a plastic Food Contact Material (FCM) to be marketed broadly in Canada. This LONO procedure is currently mandatory in the above-mentioned fish, poultry, and meat, agriculture market segments.
European Union
The European Union (EU) differs from the United States and Canada in legislative approach for plastic food contact packaging. Food Contact Substance (FCS) types are defined in
EU Regulation 1935/2004/EC or the Framework Regulation. Under this EU guideline, all food contact related items such as plastic materials and additives are risk assessed unless already defined in the Framework Regulation.
The next step is positive list development for plastic monomers, polymers, and additives. The EU does not qualify base polymer resins, but instead keys in on and qualifies a given monomer. Thus, any qualified single monomer or any monomer combinations are then approved for food contact.
- EU Regulation 10/2011/EC, or the nicknamed ‘Plastics Regulation’ defines the positive list of approved monomers
- Similarly, amendments to the ‘Plastics Regulation’ namely 321/2011/EC, 1282/2011/EC, and 1183/2012/EC list covers all acceptable plastics additives for food packaging use
These two EU plastic monomer and additive lists are dynamic in nature. They are always changing year to year, and can be influenced by the legislative approach of a separate member country with regard to plastic food packaging.
Plastic Food Packaging ApplicationsThe Food Safety and Standards Act of India
The Food Safety and Standards Act of 2006, or more specifically
FSSA, No. 34 of 2006, represents the core of India’s very advanced, analytical, food contact packaging, and regulatory approach. FSSA, No. 34 of 2006 created an entirely new Food Safety and Standards Authority of India (FSSAI) to develop specific plastics in food contact packaging use standards that encompass evaluation techniques, guidelines for accrediting and certifying of testing labs, and food contact risk / response methods.
There have also been defined six legislative categories covering namely:
- Contaminants
- Products / additives
- La sample analysis
- Licensing / registration
Packaging / labeling, and- Prohibition / restrictions
Furthermore, there exist ten major plastic food contact material regulations for reference, namely:
- Polyethylene Specification (IS 10146)
- Styrene Polymer Specification (IS 10142)
- Polyvinyl Chloride Specification (IS 10151)
- Polypropylene Specification (IS 10910)
- Ionomer Resin Specification (IS 11434)
- Ethylene Acrylic Acid Copolymer Specification (IS 11704)
- Polyethylene Terephthalate Specification (IS 12252)
- Nylon 6 Specification (IS 12247)
- Ethylene Vinyl Acetate Specification (IS 13601), and
- Ethylene Metha Acrylic Acid Specification (IS 13576)
Food Standards Australia / New Zealand
Both Australia and neighboring country New Zealand use a jointly developed Food Standards Code issued by
Food Standards Australia New Zealand (FSANZ). Within the legislatively approved Code by both countries there is a sub-section Standard 1.4.3 that regulates a given Food Contact Material (FCM). The standard basically does not define any specific materials for use in food packaging, but that says any such materials must be harmless to humans.
A legally binding note to Standard 1.4.3 states that Australian standard AS2070-1999 that specifically governs food contact plastics ties back into and references United States FDA and EU Regulation as guidance for compliance with FSANZ Standard 1.4.3. Interpretations of Australian standard AS2070-1999 notes with regard to the preceding U.S. and EU regulations further defines specific contaminant levels in certain plastic packaging materials (i.e., residual vinyl chloride monomer in PVC, etc.) and need to be monitored by companies.
China’s Ministry of Health
A Food Contact Material (FCM) is regulated by China’s Food Safety Law, under strict, central government mandate. Articles 20, 36, 38, 44, 62, and 63 directly outline plastics use in food contact packaging. Plastics compliance in China is multi-tiered through their GB (GuoBiao, in Chinese stands for (national) standard) system.
GB standards cover food packaging related plastic resins, compounds, and additives. Beyond GB standards,
China’s Ministry of Health (MOH) approves or removes plastic resins and additives through MOH notices of action.
The net result between MOH notices and GB standards is the derivation and maintenance of positive plastic lists for resins, additives, and compounds for food contact packaging use. Plastic resins to include
PVC,
PA,
PE,
PS,
PP,
PET,
unsaturated polyesters / glass fiber-reinforced plastics,
PC, and
polyvinylidene fluoride are currently covered under ten separate GB standards. MOH Notice 23-2011 covers an additional hundred plus resins. Similarly, GB9685-2008, MOH Notice 5-2012, MOH Notice 5-2013, and MOH Notice 11-2012 cover approved plastic food packaging additives.
Japan’s Food Sanitation Act
A combination of Japanese federal legislation and voluntary industrial standards regulate a Food Contact Material (FCM).
Japan’s Food Sanitation Act (FSA) sets forth standards and specifications for food packaging types and the plastics materials used in them.
The central rule here is no harm to humans by food package, packaging equipment, or materials / additives used. Food packaging details and standards creation consistent and in compliance with the FSA is administered by the Japanese Health, Labor and Welfare Ministry. Plastics food contact migration standards have been set up in this way. Japan does not operate with a positive list for FCMs.
It allows voluntary Japanese industry groups to develop specific lists for positive FCMs, which are then reviewed and further codified in law by the Japanese Health, Labor and Welfare Ministry.
Key Japanese trade associations to monitor with regard to food contact regulatory lists for plastics include the Japan Hygienic Olefin and Styrene Plastics Association, the Japan Hygienic PVC Association, and the Japan Hygienic Association of Vinylidene Chloride.
All plastic companies in Japan can submit requests to a given trade association to be eventually included on a government positive FCM list. In the interim while awaiting government list approval, a company can seek though a trade association and obtain a voluntary Product List (PL) Certificate that acknowledges that a given plastic or plastic compound is acceptable for food contact use.
Food Safety in South Korea
Food safety monitoring in South Korea is jointly handled by Ministry of Food and Drug Safety (MFDS) in concert with the Ministry of Health and Welfare and Ministry.
There is a general requirement in their Food Sanitation Act that a Food Contact Material (FCM) of any sort including a plastic cannot create any health problem for the general public.
Additional FCM requirements are outlined under a South Korean legislative regulation governing “
Packaging for Food Products.” This regulation further breaks down into five subsections of which the most important for plastic materials is the FCM specification that lists forty specific resins (i.e., PE, PP, PVC, PET, etc.) and their related compounds for use in food packaging.
Smart Thin-film Package Label Monitors Perishable Products
MERCOSUR of South America
In South America, no one country or agency legislatively regulates a Food Contact Material (FCM). Instead there is the major Common Market alliance or
MERCOSUR, composed of the countries of:
- Argentina
- Brazil
- Paraguay
- Uruguay, and
- Venezuela
MERCOSUR establishes FCM resolutions, which in turn are then integrated into each country’s food packaging legislation, similar to the EU approach.
MERCOSUR’s common market group that is called GMC bases their plastic food packaging resolutions on United States FDA and EU plastic regulations and updates, in the areas of:
- Migration limits for plastic materials
Concentration limits for plastic materials- Organoleptic (taste) properties
- Colorants / pigments, and
- Recycled plastics prohibition
Key GMC guidance resolutions to be plastics aware of, include:
- GMC Resolution 3/92 (FCM guidelines)
- GMC Resolution 02/12 (monomers and polymers)
- GMC Resolution 32/07 (additives)
- GMC Resolution 15/10 (colorants), and
- GMC Resolution 56/92 9 (plastics requirements)
Within MERCOSUR two national agencies are active in plastics food packaging guidance, namely:
- Brazil’s ANVISA (National Agency of Sanitary Surveillance)
- Argentina’s CONAL (National Food Commission)
In terms of other South American countries such as Bolivia, Chile, Ecuador, and Peru there is very little or no plastics food packaging requirements.
Future Food Packaging Legislative Trends to Watch
Single layer or monolayer packaging films for the most part is legislatively handled globally in any given country or broader geographic region just like a standard food contact material. Multilayer films that can range from two to seven layers represent a little more complicated from a legislative standpoint. For example, in multilayer packaging film certain material layers that may not be in direct food contact are occasionally used due to unique properties such as oxygen barrier or surface printing capability.
Analyzing these innovative multilayer films is the next frontier for global legislative initiatives. Multilayer film constructions will be more subject to legislative compliance due to the increasing use of post-consumer, recycle content food packaging layers.
Legislative defining of functional barriers will come into play here to regulate material layers that are or are not food packaging compliant to prevent migration into the base food product.
Compostable Multilayer Food Barrier Plastic FilmComplex Global Food Contact Packaging Regulation
In other legislative regulatory areas nanomaterial use in food barrier material systems are and will continue to come under review. Also,
Polyethylene Terephthalate (PET) has led the way in post-consumer recycle use due to successful waste disposal processing in place. Other plastic food packaging materials are and will be following the PET model given the general thrust towards emerging circular economy thinking taking hold globally.
Major global legislative processes to regulate new plastic food contact packaging materials are as follows:
- United States of America - Food Contact Notification (FCN); mandated by law
- Canada - Letter of No Objection (LONO); voluntary
- India - Major updating of Food Safety and Standards Act to consolidate and integrate all existing food packaging legislation and standards
- Japan - Food Contact Substance (FCS) positive list
- China - GB (GuoBiao—Chinese for National Standards); Food Contact Material (FCM) regulatory system currently updating all GB food contact standards for plastic resins and additives
- South America (MERCOSUR) - Initiating regionally harmonized Food Contact Material (FCM) legislative regulations
Complex Global Food Contact Packaging Regulation
Food contact packaging is complicated and continually changing. It is important to keep updated on data, information, and analysis relevant to global plastics food packaging legislation. Two good starting points here to assist companies and individuals in following emerging global plastics food contact packaging legislation are as follows:
- Keller and Heckman, law firm, Washington, DC
- Decernis, database service, Washington, DC
Plastics Professional: Stay Alert!
Stay “
connected” to Omnexus by SpecialChem’s Thermoplastics & Elastomers online resources and enhance your Plastics Technical Marketing Insights! Check out more on food contact plastics and food packaging:
This article was first published in October, 2017 and is revised in July, 2020.