The Regulation of Food Packaging Materials in Japan

Abstract

With an efficient food distribution system in Japan, and emphasis on food safety and quality of packaging, Japan continues to be an attractive market for exporters of food products and food packaging materials. A critical component to marketing food products in Japan rests on ensuring that packaging materials comply with the regulatory scheme in place for food-contact materials. The Japanese regulatory framework for food packaging materials combines government regulations based on the Food Sanitation Law of 1947 and industry standards that have been established by industry trade associations. The Japanese Food Sanitation Law sets out a general safety standard that covers not only food, but also food additives, food packaging materials and equipment, detergents for vegetables and fruits, eating utensils, and toys for young children. The general specifications that apply to all food containers and packaging materials primarily address the use of certain metals, particularly lead, in various food contact applications.

With an efficient food distribution system in Japan, and emphasis on food safety and quality of packaging, Japan continues to be an attractive market for exporters of food products and food packaging materials. A critical component to marketing food products in Japan rests on ensuring that packaging materials comply with the regulatory scheme in place for food-contact materials.

The Japanese regulatory framework for food packaging materials combines government regulations based on the Food Sanitation Law of 1947 and industry standards that have been established by industry trade associations. The Japanese Food Sanitation Law sets out a general safety standard that covers not only food, but also food additives, food packaging materials and equipment, detergents for vegetables and fruits, eating utensils, and toys for young children. Regarding food-contact materials, the legislation prohibits the sale of equipment or packages containing toxic or harmful substances that could be deleterious to human health. In addition, the Food Sanitation Law includes an enforcement component that includes inspection of domestic food-business facilities, import notification requirements, monitoring and testing requirements, and the imposition of penalties.

Food Sanitation Law Specifications

While Japan presently does not have a "positive list" of substances that are permitted for use in articles that contact food or require premarket approval or review of food-contact substances prior to their use in the marketplace, the Food Sanitation Law authorizes the establishment of specifications for food containers and packaging, and the raw materials used to manufacture such articles. The Japanese Ministry of Health, Labour, and Welfare (MHLW)-under the Pharmaceutical and Food Safety Bureau, Department of Food Safety, Standards and Evaluation Division-is responsible for developing such specifications. To date, three different types of specifications for containers and packaging materials have been established: (1) general specifications that apply to all containers and packaging; (2) material-specific standards; and (3) certain specifications that apply to the end-use application for the packaging.

The general specifications that apply to all food containers and packaging materials primarily address the use of certain metals, particularly lead, in various food contact applications. The specifications also prohibit, for example, the use of di(2-ethylhexyl) phthalate as a plasticizer for polyvinyl chloride (PVC) used in contact with foods containing edible fats and oils. As for colors intended for use in packaging materials, such colors must be approved by MHLW unless it can be shown that they do not migrate to the food.

Material-specific standards are in place for a variety of articles, such as metal cans, glass/ceramic/enamel articles, and rubber articles, including nursing apparatuses. Standards also exist for synthetic polymers generally, as well as for 15 specific resins, including PVC, polyethylene, polypropylene, polystyrene and foamed polystyrene, polyvinylidene chloride, polyethylene terephthalate, polymethyl methacrylate, nylon, polymethyl pentane, polycarbonate, polyvinyl alcohol, and synthetic resins made from formaldehyde. These standards include information on end tests that are aimed at ensuring that the materials meet various specifications. The specifications include limits on heavy metals, total non-volatile extractives under specified extraction conditions, as well as restrictions on volatile content and residual monomer levels.

The third category of standards are based on end use application, including apparatuses and containers or packaging used in retort applications (except for cans and bottles), soft drinks, flavored ice, food sold in vending machines, and soft drink dispensers. Packaging for milk and milk-based products is subject to additional specifications.

Food Safety Commission

Another Japanese agency with food safety responsibility is the Food Safety Commission (FSC). This cabinet-level office was established under the Food Safety Basic Law, which the Japanese Parliament passed in May 2003 in response to several events affecting food safety in Japan, such as an outbreak of Bovine Spongiform Encephalopathy (BSE), microbial contamination of various foods, and high levels of pesticide residues on imported vegetables.

The FSC functions independently from the MHLW and is comprised of four commissioners who are ex* perts on food safety and charged with the responsibility of conducting risk assessments. More specifically, the FSC's mission is to: (1) conduct risk assessments using scientific information and knowledge and provide its conclusions to the relevant ministries (i.e., the MHLW) to implement risk management; (2) communicate its risk assessments and recommendations to interested stakeholders-such as consumers and business operators-via public meetings, its website, and other forms of public media; and (3) respond to food-borne outbreaks and emergencies by providing information to the public and coordinating with relevant ministries.1 To assist with its mission, the FSC is supported by 14 Expert Committees charged with handling specific areas. For example, there are committees devoted to food additives, apparatus and containers/packages, emergency response, microorganisms and viruses, and pesticides.

Guidance Documents on Recycled Paper and Recycled Plastics

On April 27, 2012, the MHLW published two guidance documents concerning the use of recycled paper and recycled plastics in utensils and food packaging. The recycled paper guidance ("Guidelines Related to Recycled Paper in Utensils and Food Packaging") sets out basic requirements for ensuring the safety of recycled paper intended for use in utensils and food packaging. The guidance is quite general in nature, and does not include any detailed information on testing protocols for recycled paper. Interestingly, the guidance notes that, based on inspections and a survey of the relevant literature, residual levels in recycled paper of most heavy metals and substances like polychlorinated biphenyls, bisphenol A, phthalates, polycyclic aromatic hydrocarbons, and aromatic amine and azo compounds, are at sufficiently low levels to indicate no safety concerns (of course, this may not be the case with all recycled paper and, thus, one should consider the source of the recycled paper to ensure that these, and other potential contaminants, are present at sufficiently low levels). The guidance does note, however, that special attention is needed to ensure the safety of residual levels of lead in utensils and food packaging made with recycled paper. The guidance also states that contact of recycled paper should be avoided in microwave and oven cooking applications or in cases where there is significant contact with water or oil (e.g., tea bags, coffee filters, and oil strainers). Based on this guidance, new standards currently are being proposed in Japan concerning the use of recycled paper in utensils and food packaging; these standards are currently before the World Trade Organization for comment.

The recycled plastics guidance ("Guidelines Related to Recycled Plastics in Utensils and Food Packaging") is much more detailed, and applies to three categories of raw materials used in the production of recycled plastics: (1) Scraps recovered in the manufacturing facility during production of products for food containers or packaging materials; (2) Recovered packaging and wrapping material of special substances made for re-use, and first used for food; and (3) Plastics recovered by alternative methods. The guidance suggests that Japan will implement a procedure wherein manufacturers and importers of utensils and food packaging can request MHLW's concurrence regarding the safe use of recycled plastics in these applications. To support such an inquiry, details on manufacturing processes, raw materials, and the results of challenge testing must be submitted to the Ministry.

In addition, the guidance provides some general comments on the studies that should be undertaken to demonstrate that chemical contaminants are adequately removed from plastics during the recycling process. The guidance makes explicit reference to FDA's 2006 recycled plastics guidance, and includes representative "proxy contaminant substances" that mirror the substances described in the FDA guidance. As with FDA's guidance, MHLW's guidance states that the functional barrier concept may be used to show that migration of a contaminant is reduced.

Voluntary Industry Standards

A discussion of Japan's regulation of food packaging materials is not complete without discussing the role and function of certain Japanese trade associations. This is because, in addition to the governmental standards and specifications in place, Japan has many voluntary standards that serve as another vehicle for marketing various food packaging materials that may not have been considered under the governmental framework.

These voluntary standards are widely respected in Japan. Oftentimes companies will require their suppliers to have their products sanctioned by the appropriate trade association before purchasing them. The Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA), the Japan Hygienic PVC Association (JHPA), the Japan Hygienic Association of Vinylidene Chloride (JHAVDC), and the Japan Paper Association (JPA) are among the more visible trade associations in Japan in this regard.

JHOSPA

JHOSPA was established in 1973, and is represented by a variety of raw material suppliers, compounding and processing companies, converters, distributors, and food companies, thereby representing all aspects of the supply chain. As a result, JHOSPA maintains a neutral posture with respect to the specific interest of any one industry sector. JHOSPA publishes a set of voluntary standards, titled, "Self-Restrictive Requirements on Food-Contacting Articles Made of Polyolefins and Certain Polymers," which include "positive lists" of polymers, additives, and colorants for use in food containers, packaging materials, and utensils.

JHOSPA has developed voluntary standards for 30 basic polymers commonly used in food-contact applications. The JHOSPA list of polymers goes beyond the number of polymeric standards established by the MHLW; where there is overlap, however, the end test requirements are identical. Initially, JHOSPA's "positive list" for additives was established by listing additives that were permitted in select foreign countries (e.g., the United States) for use in food-contact applications. New substances can be added to JHOSPA's positive list by filing a petition; however, only members of JHOSPA are permitted to submit such a petition. This makes the submission of new filings difficult for non-members, such as foreign entities. In order to pursue a filing, non-members must be sponsored by a JHOSPA member.

JHPA

JHPA was established in 1967, and is composed of both companies that manufacture materials used to produce PVC and companies that manufacture finished PVC products. JHPA maintains a "positive list" of substances that have been petitioned and reviewed for use in PVC, along with standards for materials used in making PVC. An English version of JHPA's positive list, along with criteria for registering substances on the list, can be found in "JHP Recommended Substances" (1st Version, November 2009).

JPA

Established in 1997, JPA first published its "Voluntary Standard of Paper and Paperboard Intended for Use in Food Contact" in May 2007. These voluntary standards, which impose limits on substances like heavy metals, were developed to promote the safe use of paper and paperboard in food-contact containers and packages.

JPA announced in September 2010 that it would establish a "positive list" for materials used in paper and paperboard applications. As part of this effort, JPA instituted a registration process for existing chemical substances used in producing paper and paperboard for food-contact containers and packaging. The registration process was completed in March 2011, and by that date, over 1,900 substances were registered. JPA has tentatively classified these substances into six categories, and will conduct a risk assessment of each substance based on its hazards and exposure.

In terms of the exposure assessment, JPA intends to classify these substances into one of the three following categories: (1) substances used in the papermaking process for quality control, which remain in the finished paper; (2) substances used for controlling the papermaking process, which are unlikely to remain in finished paper; and (3) substances used in wood pulp or recovered paper pulp production processes, which are unlikely to remain in paper produced. Once completed, the results of these risk assessments will be made available to the public, along with the categorization of whether the substance is listed on JPA's positive or negative list, or is on a positive list for western countries. Substances on JPA's negative list will be banned for use in the manufacture of food-contact paper and paperboard.

JPA accepts registration applications for new chemical substances. As part of the registration process, applicants are required to submit information on the substance, including potential, estimated exposure (e.g., additive amount in paper making and residual volume in paper produced), and information on whether the material is subject to regulation.

As with JPA, some other trade associations also have established so-called "negative" lists, which are intended to prohibit the use of certain materials in food packaging. For example, the Japan Printing Ink Makers Association has a negative list that excludes substances classified as carcinogenic, mutagenic, or acutely toxic, as well as heavy metals and reproductive toxicants. Consequently, it is important to ensure that any substance that will be marketed in Japan for use in food packaging is not included on these negative lists.

Possible Future Developments

Officials from MHWL have indicated that Japan currently is considering the introduction of a positive list for food-contact plastics. The adoption of a positive list system by the Japanese government could provide a welcome opportunity for foreign companies looking to enter Japan's $700 billion food and beverage market. This is because Japan's current system for regulating food packaging materials, which has evolved over the past 60 years, is one that foreign companies often find difficult to penetrate since companies must often be a member of a particular trade association or seek sponsorship from an existing member to obtain a voluntary standard on a food packaging material.

If Japan shifts to a "positive list" system, the processes for obtaining a new standard or getting a substance on a positive list would, presumably, be open to anyone and, thus, would give foreign companies greater access to marketing food packaging materials in Japan.

Footnote

1. See www.fsc.go.jp/english/aboutus/organizationof thefoodsafetycommission.html