In furtherance of its goal to develop a formal "Positive List" (PL) system for food-contact materials, the Food Safety Commission of Japan (FSCJ) has released for public comment its proposed evaluation procedures for food-contact substances (FCS) that are not included on Japan's current Positive List. The proposal is available in Japanese at http://www.fsc.go.jp/iken-bosyu/pc1_kigu_kigushishin_310130.html.
Comments on these proposed procedures should be submitted to FSCJ - in Japanese - by February 28, 2019.
Japan's regulatory framework for food packaging historically has combined government regulations, based on the Food Sanitation Act of 1947, and standards that have been established by industry trade associations.Under this system, the Ministry of Health, Labour, and Welfare (MHLW) maintained various specifications for "apparatus, containers and packages," together with a standards for a limited number of resins, while the standards established by industry through such trade associations as the Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA), the Japan Hygienic PVC Association (JHPA), and the Japan Hygienic Association of Vinylidene Chloride (JHAVDC) include a list of the particular polymers and materials considered acceptable for use in food contact applications.
The current effort is intended to replace this system with one that will require the substances to be used in food-contact materials to be cleared by the government and not solely an industry trade group. MHLW is now in the process of compiling a positive list of substances permitted for use in plastic food-contact materials, starting first with food-contact plastic resins. When the new law takes effect, which is scheduled for June 2020, compositional compliance with the forthcoming PL system will be mandatory for resins marketed or used in contact with food in Japan.
Note: Pending the June 2020 effective date for the new PL System, MHLW continues to accept nominations from industry regarding substances that are currently marketed/used in FCM in Japan that are not included in the draft lists published last year. MHLW has requested that feedback from companies located outside Japan be submitted through the relevant embassy or other designated government agency. In the US, this is the Foreign Agricultural Service in the US Department of Agriculture and the EU Mission in Europe. Although such nominations are still being considered by MHLW for inclusion in the final Positive List, it is uncertain how much longer these submissions will be accepted by the Japanese authorities. MHLW intends to notify an updated draft positive list to the World Trade Organization (WTO) in June 2019, though further substance nominations may be accepted afterward.
Following below is a summary of the data requirements as described in the draft formal procedures released by FSCJ for comment. These requirements will pertain to petitions for the inclusion of new substances once the PL System is adopted. It is our current understanding that MHLW will be responsible for preparing the petitions.
I. Overview of the FCS
a. Basic information on the FCS
This information should include information on the chemical identity (e.g., chemical name, structure, CAS Registry Number, molecular weight, spectrum data, etc.), the physical and chemical properties (e.g., boiling point, melting point, glass transition temperature, density, etc.), as well as a description of the manufacture for the substance.
b. Intended use and conditions of use
These details should include the maximum use level, the group and type of synthetic resin to which the FCS will be added, the food types that will be contacted, permitted time and temperature conditions of use, etc. The petitioner also must provide information on the intended technical effect of the FCS when used as intended.
c. Draft standard and specifications
The petition should include a suggested standard and specifications on the proposed scope of use (the group and type of synthetic resin, food category, temperature, time, etc.), the maximum use level, etc.
d. Status in Japan and overseas
The Japanese procedures also require that submissions include details on the domestic and international status of the FCS. Of particular importance appears to be a description of the permitted uses of the FCS in Japan, the U.S., and the EU. Pertinent clearances in other countries may be provided as well. In addition to the above information, the petitions must include other useful information relevant to the assessment (e.g., related literature on migration to food, uses of the substance in products other than food-contact apparatus, containers, andpackages).
II. Migration and Exposure Assessments
The draft evaluation procedures include detailed information on the testing conditions prescribed for migration testing on the FCS. For example, the draft procedures specify the appropriate food-simulating solvents, as well as the testing times and temperatures for migration studies. Although many of these criteria are similar to those adopted in the U.S. Food and Drug Administration's (FDA) Chemistry Guidance, there are some notable differences. For example, rather than using 3% acetic acid, the draft procedures prescribe 4% acetic acid as the food-simulating solvent for acidic foods. Notably, the draft procedures indicate that worst-case migration may be calculated by assuming that 100% of the relevant substance migrates to food in lieu of conducting migration testing.
The procedures also include details on risk assessments, and methods for calculating dietary exposure to the FCS, which are similar to those used by FDA. Noteworthy, the authorities have developed "consumption factors" (CF) for the seven "synthetic resin groups" marketed in Japan. To determine the estimated dietary concentration (DC) for the FCS, the migration value is multiplied by the CF value. Although the CF concept has been utilized by FDA for many years, the resin groupings are relatively unique. In addition, there are various distribution factors (DF) that can be used to calculate the dietary concentration for a substance when used in plastics contacting certain food types. No information was provided in the draft documents on the market data underpinning these CF and DF values. Certainly, relevant comments from members of industry can be provided on the validity of the values included based upon commercial experience.
III. Safety Data
The draft procedures also specify the toxicological data that needs to be provided for a given FCS based upon the calculated dietary concentration. Specifically, FSCJ has designated four classes of dietary concentration, which are as follows:
For substances falling into Class I or Class II, the submission of genotoxicity test results is required, at least in principle. In addition to genotoxicity studies, submissions for Class III substances must include the results of subchronic toxicity studies, one rodent and one non-rodent, although waivers for the second study can be obtained upon a sufficient showing. For Class IV substances with an estimated DC above 1 mg/kg, additional toxicity data may be required (e.g., reproductive and developmental toxicity testing, chronic toxicity testing, carcinogenicity testing, etc.), but certainly discussions with the authorities would be in order prior to undertaking the work.
The draft procedures provide a number of details concerning the manner in which risk assessments will be undertaken for food-contact substances during the evaluation process.