FDA regulations on food grade water-based inks
Date: Oct 03 2024 From: Star Color
The regulations of the US Food and Drug Administration (FDA) for
food grade water-based inks are mainly covered in its Federal Food, Drug, and Cosmetic Act and related regulations. The following are FDA regulations on food grade water-based inks.
1. Regulatory framework
Main regulations: Federal Food, Drug, and Cosmetic Act and related implementation rules.
Specific regulations: The use of ink in food packaging materials must meet specific manufacturing and safety requirements, especially when the use of ink may constitute a "food additive", it must comply with food additive regulations or obtain a valid Food Contact Notification (FCN).
2. Ink composition and limitations
Color additives:
Color additives that can be directly used in food must comply with the regulations listed in 21 CFR § 73.1.
Regardless of certification, color additives must have purity suitable for their intended use and not render the food unsuitable for consumption.
Other components:
Other components in ink, such as adhesives, carriers, etc., also need to meet specific safety requirements.
If the ink contains any chemicals that are not explicitly allowed to be used under FDA regulations, the use of the ink is prohibited.
3. Specific migration limit (SML) and residual amount
Solvent residue:
According to QB/T 2929-2008 and other standards, the total residual amount of solvents in solvent based inks shall not exceed 10mg/m ², and the total residual amount of benzene, toluene, and xylene shall not exceed 3mg/m ².
The FDA has strict restrictions on benzene solvents as they are carcinogenic and require that they not be detected in packaging materials.
Heavy metals:
According to standards such as QB/T 2930.1-2008 and QB/T 2930.2-2008, there are clear requirements for the maximum limit of soluble heavy metals (such as antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium, etc.) in ink.
The EU and FDA also have strict restrictions on the content of heavy metals, such as lead, cadmium, mercury, hexavalent chromium, etc. The total content of heavy metals must meet specific migration limit requirements.
Photoinitiator:
Commonly used photoinitiators such as benzophenone (BP) and its derivative 4-methyl benzophenone (MBP) have skin contact toxicity and carcinogenicity.
The European Union and the United States have clear regulations on the total migration amount of photoinitiators in food packaging printing inks, such as the migration limit of benzophenone, which is usually 0.6mg/kg.
4. Production standards and safety requirements
Manufacturing process: The production process of ink must follow good manufacturing practices (GMP) to ensure the safety and quality of the product.
Labels and instructions: Ink products must provide detailed labels and instructions, including ingredient information, usage instructions, safety warnings, etc.
Compliance certification: Ink manufacturers may need to pass specific compliance certifications or tests to demonstrate that their products comply with FDA requirements.
5. Other precautions
The type of contact between ink and food: The type of contact between ink and food (such as direct or indirect contact with food) will affect its safety requirements.
Temperature and usage time: The stability of ink at specific temperatures and usage times is also a factor to consider.
Regulatory exemption: In some cases, if the use of ink does not have adverse effects on food, regulatory exemption may be granted.
The above are some regulations of the FDA on food grade water-based inks, including regulatory framework, ink composition and restrictions, specific migration limits and residue levels, production standards and safety requirements, etc. These regulations aim to ensure that the use of ink in food packaging materials does not pose a threat to food safety. In practical applications, ink manufacturers and food packaging manufacturers need to strictly comply with these regulations to ensure product compliance and safety.
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