Emerging Global Food Packaging Regulation Trends

TAGS:  Food Packaging Plastics   

The system for regulating food contact materials and food packaging in the United States is fairly well established, although it has evolved over the years in response to certain lessons learned.

Pursuant to the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (the Act), all substances that are intended to become components of food must receive premarket clearance from the Food and Drug Administration (FDA) unless they are subject to a specific exemption.

The FDA supported the 1998 amendment of the Federal Food, Drug, and Cosmetic Act to provide for the submission of Food Contact Notifications (FCNs) in lieu of food additive petitions for food contact substances.

In the European Union (EU), efforts to harmonize the various systems in place at the national level in the individual EU member states continue, though several important pieces of legislation, including:

• The Framework Regulation applicable to all types of food contact materials,
• As well as the Plastics Regulation applicable to food contact plastic materials and articles.

Before we start with the trends that are being followed globally in food packaging regulations, first let’s understand how much other countries in the world are concerned about food safety.

Evolving Food Contact Regulations Worldwide

In many other jurisdictions around the world, including South America, China, Japan, and Korea, just to name a few examples, food contact regulatory systems are still evolving. For example:

• China, for example, is in the process of updating and “harmonizing” its National (GB) Standards for food contact materials that were in place prior to the June 1, 2009, adoption of its Food Safety Law of the People’s Republic of China, which prohibits the importation, use, or purchase of food-related products—including food packaging materials—not complying with an applicable Chinese Food Safety Standard.

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• The Japanese authorities are now working toward modifying their regulatory framework for food contact materials. The present framework combines government regulations based on the Food Sanitation Law of 1947, together with industry standards that have been voluntarily established by industry trade associations.

While the development of regulatory systems for food contact materials in different parts of the globe may result in some movement toward a greater degree of global harmonization, the systems most assuredly are not harmonized at present.

Now let’s turn our attention towards the prevailing trends in food packaging industry that could change the current scenario shortly.

Trend 1: More Restrictive Requirements for Food Contact Materials for Sensitive Populations

The authorities in several jurisdictions, notably the United States and the European Union, are taking a closer look at how they regulate materials used in contact with foods and beverages consumed by sensitive populations such as infants and children.

For example, The U.S. FDA has begun to use adjusted body weights and food consumption values when determining infant exposure to food contact materials. Accordingly, the FDA has started to regularly impose limitations on uses of food contact materials for use with infant food, ingredients, and breast milk unless those uses are specifically addressed in an FCN submission. The FDA currently is working on updating its 2007 Chemistry Guidance for FCN submissions, however, and may adjust its exposure analysis for sensitive population groups, such as infants and the elderly, in the updated version.


Concurrently European authorities concurrently are recognizing the need for more data relevant to sensitive populations, such as infants and children. The lack of child-specific exposure data to chemicals from food was pointed out in a December 2009 fact sheet by the European Environment and Health Information System (ENHIS) and the World Health Organization (WHO), titled, “Exposure of Children to Chemical Hazards in Food.”

French Initiative in the Formation of EFSA

France began conducting total diet studies (TDS), which are used to gather information on chemical substances in food, in 2000. A decade later, in 2010, France launched a TDS specifically targeting children under 3-years-old (results were published in 2014). The first French TDS, launched in 2000, focused on the general French population’s level of exposure to:

• Mycotoxins
• Minerals
• Trace elements

The second French TDS commenced in 2006, but while the list of substances that were monitored was expanded, it still did not focus on any particular subset of the population. A European Food Safety Authority (EFSA) Working Group of experts was formed in 2010 to develop a guidance document on a harmonized approach to TDSs.

In December 2012, France passed a law that:

• Suspended the production, trade, and marketing of food containers containing Bisphenol A (BPA), and
• Mandated that food packaging containing BPA will be required to bear a warning label addressed at pregnant and lactating women, and infants aged less than 3 years.

France has notified the European Union and hopes to extend its BPA suspension to the EU level, but the European Union remains steadfast in its conclusion that BPA poses a low health risk to consumers in general, as exposure to the chemical is well below the current tolerable daily intake (TDI) value developed on the basis of a wealth of toxicology studies.

In similar fashion, Canada, although banning the use of BPA in baby bottles, continues to reaffirm the safety of BPA in food packaging, generally. Other country jurisdictions are likely to eventually take similar action.

Trend 2: Emphasis on Novel Materials and How to Regulate Them

Technological advances have enabled to the use of novel materials, such as nanomaterials and “active ingredients,” in food packages. This has led to discussions about how these types of materials should be regulated and what testing should be required.

Notably, the U.S. FDA has not defined “nanomaterial,” “nanotechnology,” or “nanoscale.” In its guidance entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” (published in June 2014), however, the Agency has identified two points that will be considered when determining whether an FDA-regulated product involves the application of nanotechnology. These are:

1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1–100 nm).
2. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, which are attributable to its dimension(s), even if these dimensions fall outside of the nanoscale range, up to 1 mm (1000 nm).

Defining Nanocomponents for Food Packaging

An important distinction between the EU definition and the U.S. FDA’s approach is that the EU definition applies not only to engineered nanoscale materials, but also to those substances that naturally or incidentally contain one or more external dimensions that are less than 100 nm in size. The European Union already has adopted several pieces of legislation and a technical guidance that contain references to nanomaterials.

For example, the EU Plastics Regulation, Regulation (EU) No 10/2011, requires separate clearances for substances that are in nanoform, even if their non-nanoform counterparts are already the subject of an existing listing on the Plastics Regulation. Additionally, substances in nanoform are not eligible for exemption under the functional barrier doctrine, which may be used to permit certain materials to be used in food contact plastics even in the absence of a positive listing.

The EU authorities have specifically approved three nanoproducts for use in plastic food contact packaging namely:

• Silicon dioxide
• Titanium nitride, and
• Carbon black

Canada is taking a case-by-case approach to the safety assessment of “novel” food products, including food packaging containing nanomaterials. In 2011, Health Canada defined a nanomaterial as any manufactured substance or product and any component material, ingredient, device, or structure that is:

1. At or within the nanoscale (1–100 nm) in at least one external dimension, or has internal or surface structure at the nanoscale, or
2. Smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties that are attributable to size and their effects, and are distinguishable from the chemical or physical properties of individual atoms and molecules, and bulk material.

Canada notes that it has held bilateral discussions with the U.S. FDA, the European Commission, the Food Standards Australia New Zealand, and Japanese regulatory authorities, and has participated in international harmonization efforts on the safety and regulation of nanotechnology in food.

Trend 3: Increased Focus on "Chemicals of Concern"

Over the last few decades, more and more attacks have been made on chemical substances, calling them inherently harmful to human health and the environment. Concerns in this area have been fueled by the popular press, which often sensationalizes a single study indicating that there may be a problem with a particular chemical, even when other studies generate conflicting results. These attacks on chemical substances have extended to ones used in food packaging.

BPA Safety Continues to Remain a Question...

Bisphenol A (BPA) is a prime example. It is a monomer used in making polycarbonate containers, can enamels, and in other products where a stable polymer or modified coating composition is required.

Researchers around the world have studied the safety of BPA extensively. Well publicized but poorly designed experiments with results that often cannot be duplicated have led to legislation banning its use in food contact applications—particularly ones that involve infants or young children—in jurisdictions throughout the world, as well as its deselection as a packaging material by manufacturers, retailers, and consumers.

For example, as mentioned above, the use of BPA in all packaging, containers, and utensils intended for children up to 3 years of age has been banned in France since 2013, and is expected to be further banned in all packaging, containers, and utensils intended to be used in direct contact with food in France beginning in 2015.

Demands have made by some authorities that legislation should impose restrictions on the use of BPA in certain applications on the basis of the “precautionary principle.” This “principle” espouses the view that action should be taken by governments and others whenever a threat of possible danger is at hand, with or without any supporting data.

This is Canada’s approach, and is the approach typically advanced in the European Union. Despite concluding that the current dietary exposure to BPA through food packaging is not expected to pose a health risk to the general population—including newborns and young children. The use of BPA in baby bottles was banned in Canada in 2008. By way of explanation, Health Canada stated that “due to the uncertainty raised in some animal studies relating to the potential effects of low levels of BPA, the Government of Canada is taking action to enhance the protection of infants and young children.”

Research studies conducted by the FDA’s National Center for Toxicological Research have shown no effects of BPA at any dose in the low-dose range in a rodent study, and that orally administering BPA results in rapid metabolism of BPA to an inactive form. The FDA also found that primates (including humans) of all ages effectively metabolize and excrete BPA much more rapidly and efficiently than rodents.

Other Food Packaging Materials Under Scrutiny

In the future, there likely will be similar levels of scrutiny applied to other substances that are commonly used in food packaging materials and even whole classes of packaging components.

• The attention that mineral oil hydrocarbons are now receiving in Europe is an example of a group of chemical substances that are just beginning to undergo this scrutiny.
• Concern about potential endocrine disruptors (e.g., phthalates) in food packaging is heating up.

The difficulty with this issue, of course, is that the science is still not well understood, which can result in chemicals showing only slight endocrine disrupting effects being branded as inherently harmful when this may not be the case, and lead to deselection of well-studied chemicals in favor of substances about which little is known.

The food packaging industry will need to find better ways in which to educate the public and the regulators on how to understand and act on the basis of sound science. Otherwise, it risks continuing the deselection of materials to the point that the food supply is adversely affected. The need for manufacturers of food packaging materials to be ready with solid science to show that their products are safe will become more important than ever, as will the need to effectively communicate that information.

Trend 4: More Recycled Food Packaging

As environmental awareness continues to grow, food manufacturers are under a greater degree of pressure to expand the use of recycled materials in food packaging. Regulations exist in some jurisdictions around the world specifically addressing the safety of recycling processes and materials, and we likely will see more of these types of regulations in the future. Ultimately, however, food and food packaging manufacturers are responsible for ensuring that food packages comply with applicable regulatory requirements and are of a suitable purity for their intended use.

US Approach Towards Recycle Content

The United States does not have regulations specific to recycled food contact materials or the recycling processes used to produce such food contact materials. Therefore, a company is permitted to establish to its own satisfaction—using scientifically sound methods—that a recycled material complies with the existing regulations on the “virgin” counterpart materials, and is suitably pure for its intended use.

In this regard, companies that produce recycled food contact materials and have generated information sufficient to confirm this position may on a voluntary basis, ask the FDA to review their determinations and issue a letter of no objection if the Agency agrees with the determination. Such “no objection letters” are posted on the FDA’s website and, while not legally required, can be very useful for marketing purposes.

EU’s Focus on Recycled Content

In the European Union, recycled food contact materials must comply with any applicable EU or member state legislation (depending on whether the recycled material is plastic or paper) and must meet the safety requirements outlined in the EU Framework Regulation. With respect to recycled plastic, Regulation (EC) No 282/2008 mandates that only food contact materials and articles that contain recycled plastic obtained from an authorized recycling process may be marketed in the European Union.

The European Union does not have harmonized legislation governing the use of food contact paper and board materials. Therefore, these materials must comply with the appropriate laws of each EU member state.

Advancements in RIC System

The future also is expected to bring better separation of materials. ASTM International’s Subcommittee on Recycled Plastics is currently discussing modifications to the Resin Identification Code (RIC) Standard system to improve the system’s core mission of resin identification and quality control prior to recycling.

The RIC was developed by the Society of the Plastics Industry (SPI) in 1988 to provide a way for recyclers and the public to distinguish resin content of plastic containers commonly found in the residential waste stream. It was never intended to be an indicator of recyclability.

In 2008, the SPI began work with ASTM International to involve technical and industry stakeholders in updating and maintaining the RIC system to better address changing societal needs and advancements in plastics materials.

In Europe, an EU-organized consortium has undertaken an initiative to develop a food container marking and identification system that will allow reliable separation of food contact approved from nonfood contact approved post-consumer plastic waste. The EU regulation on recycled plastic materials and articles intended to come in contact with food does not allow plastic containers that have been used for a nonfood application to be recycled and subsequently used in a food contact applications. A goal of the initiative is to help meet the growing demand for high-quality PET suitable for food contact applications.

Conclusion

As mentioned above, currently, global food packaging regulations are not harmonized, with many of the differences lying in the details. Nevertheless, in a common thread, future laws and regulations around the world are expected to be influenced by:

• Safety concerns with respect to food packaging aimed at sensitive populations
• An increased focus on novel materials
• A greater awareness of chemicals of concern, and
• Environmental concerns leading to more recycling—both of food packaging and the use of recycled materials for food contact.

Whether these trends will lead to a greater degree of regulatory harmonization remains to be seen.

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