New rules for food packaging materials used antimicrobials
Update: 2015-03-22 10:35:54
Now in the United States, when a new type of antimicrobial substances to be used in food packaging materials, we must first consider whether it needs in accordance with "the Federal Insecticide, Fungicide and Rodenticide Act" (FIFRA) in the US Environmental Protection Agency (EPA) to register, or whether by the US Food and Drug Administration (FDA) review of its exclusion from the ranks of the food additives, or need both. If the new antibacterial substance is considered to be a food additive, then you need to determine whether it can direct contact with food or food additives need to submit an application.
US regulations for food packaging change after several antimicrobials was up to today, this article will clarify the country's current rules and regulations on antimicrobial agents, particularly for food packaging antibacterial agent.
Of antimicrobials in food and food packaging used to regulate
"Federal Food, Drug, and Cosmetic Act" (FD & C Act) Section 301 provides that prohibits the introduction into interstate commerce of any adulterated food. Section 201 of the "food additive" is defined as a fair use and is expected to be the effect of the composition of the material in the food section. As a regulatory agency Food and Drug Administration (FDA) for the management of food additives in accordance with Section 409 of the bill, and (a) (2) (C) is not in accordance with the regulations on the use of additives in accordance with Article 402, in contact with food insecurity, determination of adulteration and other actions.
Historically, FDA addition to agricultural products other than roughing (RACs) of antimicrobial drug use in food packaging safety jurisdiction, the US Environmental Protection Agency (EPA) for roughing agricultural use of drugs (RACs) under the authority of Congress safety supervision. Therefore, FDA according to the "Federal Food, Drug, and Cosmetic Act." Section 409 to monitor the safety of food processing and food packaging materials, antimicrobials, and EPA under section 408 as a judge on the basis of the safety of agricultural products roughing.
In addition to regulate the use of pesticides in food and regulate the safe range, Congress decided that all pesticide products, including the production and use of antimicrobial agents are required to obtain licenses under strict surveillance program, the decision was referred to as "pesticide registration process of supervision." According to the "Federal Insecticide, Fungicide and Rodenticide Act" (FIFRA) requirements, pesticide production and sales in interstate trade is prohibited, unless the product has been registered by the EPA. EPA registered products require strict and thorough review, including the composition of products, production processes, the use of effects, and the need to assess the potential risks of pesticide products on human health and environmental damage.
FIFRA some extent in the pesticide is defined as "any substance or mixture of substances used to prevent, destroy, repel, mitigate pest." Determining whether a substance for pesticides, depending on whether the use of the registered product for insecticide. The term "pest" of the section is defined as:
(1) any insects, rodents, nematodes, weeds;
(2) any land or water in the form of plants and animals other life forms.
Thus, in the definition of FIFRA, such as fungi, bacteria and viruses as the presence of microorganisms, rather than pests. So, for these organisms produced by the "pesticides" product does not require registration. Generally, FDA will these products are classified as drugs.
Moreover, according to "The United States Code of Federal Regulations," Chapter 40 Section 152.5, EPA issued a statement saying microorganisms in food processing is not a "FIFRA definition of pests." Therefore, the antimicrobial agent used in processed foods do not belong to the scope of pesticides, does not require registration in the EPA, by the FDA as a food additive regulation. In addition, a small amount of antimicrobial agent as a preservative for food packaging materials are considered not need to register.
Antimicrobials in food-related provisions of the application you need for a clean and flexible packaging. EPA regulate agricultural roughing (RACs) the use of pesticides, FDA regulation as a preservative in food processing and food packaging materials. However, "the 1996 Food Quality Protection Act" (FQPA) 1996 was passed, by the late Senator Daniel? Moynihan called "the law of unintended consequences."
Of antimicrobials in food and food packaging used to regulate
The main purpose of "Food Quality Protection Act of 1996" (FQPA) is the alternative to the "Federal Food, Drug, and Cosmetic Act" (FD & C Act) does not count food provisions prohibiting add carcinogenic pesticide risk is negligible. However, in this process, the safe use of pesticides norms regulate jurisdiction in food and food-related applications transferred from the FDA to the EPA. Although the EPA decided not to process the exercise of jurisdiction antimicrobials in food, but it still advocates the implementation of antimicrobials in food packaging and food under the jurisdiction of the contact surface.
So, for food packaging and products with antibacterial agents designed to disinfect food contact surfaces clean. US Congress to attempt to correct the FDA through the "1998 Technical Corrections Act of antibiotics supervision" (ARTCA) transferred to the jurisdiction of EPA. Unfortunately, the law is only part of the supervision of, the fact that, once mastered agency then allowed to waive some rights is very difficult.
In essence, ARTCA FDA by dividing the problem of antimicrobial use in food safety in established, and EPA registered antimicrobial product authority. ARTCA trying to define the term "pesticide chemical" to designate EPA limit of chemicals, and explicitly excluded from Section 201 of the FD & C Act "food additive."
Nature ARTCA to exclude agricultural roughing (RACs) antimicrobial agents "pesticide chemical" residues, this antimicrobial pesticide is considered in the case of food additives, FDA will be monitored under the FD & C Act Section 409. But EPA RACs still retains its jurisdiction.
Although pesticide residues in food packaging materials antibacterial agents are also excluded from the definition of "pesticide chemical" residues, however, the safety of these products may be determined according to Section 409 FD & C Act. Although antimicrobial pesticide safety jurisdiction transferred back to FDA, but such products are also used in pesticides must be registered with EPA.
EPA retains jurisdiction over food safety, and delayed the approval of the FDA for food contact surface antimicrobials security issues. Such antibacterial agents and no sustained effect or sustained effect in the absence of exposure to the food section does not exist, however, the purpose of the antimicrobial agent is to ensure a permanent or semi-permanent safety of food packaging materials, to reduce the risk of reduced food contamination such as countertops, cutting boards, belts and so on. Used in food packaging and food contact products do not need FDA approval antibacterial agent, on the contrary, food residue or residues of these products must comply with FD & C Act Section 408, and by the EPA regulation.
It is worth noting, EPA indicate that you want to give up on food packaging safety jurisdiction, but in fact he did not do it. After review by ARTCA and begin to implement, EPA believes even though it does not need to build a complete product audit standards, but still need to determine the impact of FIFRA FQPA and antibacterial agents for human health, including those used in food packaging materials registered content. Although the FDA can determine the safety of food packaging, but EPA believes this is not enough, FQPA need to use different risk assessment procedures.
In short, food packaging FDA for approval by the antibacterial agent of the objective is sustained in the process of elimination of the bacteria in contact with food, including the production of additives, preservatives and other materials have a disinfecting effect. Although antimicrobials and safety of food packaging materials by the FDA regulation, but these products are still areas of pesticides, need to go through the audit and risk assessment of the EPA registration.
Food and food packaging regulations summary antimicrobials
This article has been trying to clarify the antimicrobial dual jurisdiction and regulatory applications in the food, but the problem is still not very clear. The following is part of FD & C Act, FIFRA, FQPA amendments to the bill and the amendment bill ARTCA:
In addition to ethylene and propylene oxide as a food packaging material outside antimicrobial food additive for use by the EPA for review and supervision of the FD & C Act Section 409;
RACs in antimicrobial residues by EPA reviewed and monitored under the FD & C Act Section 408, food processing facilities in the use of antimicrobial agents by the FDA for review in accordance with the regulation FD & C Act Section 409;
Antimicrobial use in food packaging by the FDA to regulate the FD & C Act Section 409, but they also need to comply with FIFRA, and registered in the EPA.
In all cases, the antibacterial agent in addition to the design used in food processing are outer FIFRA identified as pesticides, FDA does not have jurisdiction, need to be registered in the EPA.