Regulatory Status
Product Information: Regulatory Status
USA : FDA
The information provided herein is for reference only. You should check the official website for any updated regulation criteria. Please refer to https://www.ecfr.gov/ for updated regulatory criteria.The MARCUS low molecular weight polyethylene homopolymers and oxidised homopolymer M3400 comply with the FDA regulations governing the use in food packaging and food component applications. Homopolymers refer only to M200, 300 and 500 grades. However, in some cases there are extraction limitations and other restrictions, which are applicable.
The compliance with specific applications are: -
21 CFR 172.260 Food coatings
Oxidized polyethylene may safely be used as a component of food provided it meets certain requirements.
The oxidized polyethylene M 3400 is produced by a mild air oxidation process and also conforms to the requirements laid down in 21 CFR 177.1520 ( c ) item 2.3. It is therefore permitted for use either by itself or as a component of a protective coating for a broad range of fresh fruit ranging from Avocados to Walnuts.See https://www.ecfr.gov for updated regulation.
The oxidized polyethylene M 3400 is produced by a mild air oxidation process and also conforms to the requirements laid down in 21 CFR 177.1520 ( c ) item 2.3. It is therefore permitted for use either by itself or as a component of a protective coating for a broad range of fresh fruit ranging from Avocados to Walnuts.See https://www.ecfr.gov for updated regulation.
21 CFR 175.105 Food packaging adhesives
Adhesives, which may be safely used as components of articles intended for use in packaging, transporting or holding food in accordance with, prescribed conditions.
The homopolymer grades (including micronized types) and oxidized polyethylene M 3400 conforms to the requirements for use as a component of an adhesive for food packaging.See https://www.ecfr.gov for updated regulation information.” target=”_blank”>https://www.ecfr.gov for updated regulation information.
The homopolymer grades (including micronized types) and oxidized polyethylene M 3400 conforms to the requirements for use as a component of an adhesive for food packaging.See https://www.ecfr.gov for updated regulation information.” target=”_blank”>https://www.ecfr.gov for updated regulation information.
21 CFR 175.125 Pressure - sensitive adhesives
Pressure – sensitive adhesives, which may be safely used as the food, contact surface of labels and / or tapes applied to food in accordance with prescribed conditions.
The homopolymer grades (including micronized types) and oxidized polyethylene M 3400 conform to the specifications required of their product classes and therefore comply with the requirements for use as a component of a pressure – sensitive adhesive for food packaging.See https://www.ecfr.gov for updated regulation information.
1. Homopolymer
As identified and meeting the parameters laid down in 21CFR 172.888.
Ultra violet Absorbance:
| 280 – 289 | .010 | 0.15 |
| 290 – 299 | .07 | 0.12 |
| 300 – 359 | .02 | .08 |
| 360 – 500 | 0.00 | 0.02 |
Molecular weight (Vapour pressure osmometry):
Typical: 1500 – 1700
2. Oxidized
As identified under 21 CFR 177.1620 ( a ) and meeting all limits.
Molecular weight (VPO): > 1200
Oxygen content: < 5%
Acid number (mgms KOH / gm): >9 < 19
Extracion data (as defined under 21 CFR 177.1520 ( c ) item 2.3
Maximum n – hexane soluble fraction at 50°C 53%
Maximum xylene soluble fraction at 25°C 75%
21 CFR 175.300 Resinous and polymeric coatings
The coating is applied as a continuous film or enamel over a metal substrate, or the coating is intended for repeated food contact use and is applied to any suitable substrate as a continuous film or enamel that serves as a functional barrier between the food and the substrate.
The homopolymer grades (including the micronized types) are permitted as components of the subject coatings in amounts of up to 50% by weight
The coatings are subject to extraction limits with a number of solvents, which simulate varying types of foods and beverages. The tests prescribed in this regulation have been carried out on pure (100%) MARCUS polyethylene coatings and the results confirm that any coating containing them as a component would fall within the limitations set.See https://www.ecfr.gov for updated regulation information.
| Extractants | Extractive | Test Limit |
| Water (212° F — 30 mins ) | 0.1 | 0.5 Max. |
| Heptane ( 150° F — 2 hrs) | 0.4 | 0.5 Max |
| 8% Alcohol ( 150° F — 2hrs) | 0.1 | 0.5 Max. |
Extractants Extractive Test Limit
Water ( 2120 F—30 mins ) 0.1 0.5 Max
Heptane ( 1500 F—2 hrs ) 0.4 0.5 max.
8% Alcohol ( 1500 F—2 hrs ) 0.1 0.5 max.
21 CFR 175.320 Resinous and polymeric coating for polyolefin films
The coating is applied as a continuous film over one or both sides of a base film produced from one or more of the basic olefin polymers complying with 21 CFR 177.1520. These coatings may safely be used as the food contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating packaging, transporting or holding food.See https://www.ecfr.gov for updated regulation information.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted for use as components of the subject coatings in amounts of up to 50% by weight.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted for use as components of the subject coatings in amounts of up to 50% by weight.
21 CFR 176.170 Components of paper and paperboard in contact with aqueous and fatty foods
See https://www.ecfr.gov for updated regulation information.The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted as components. In the instance of the homopolymers, they comply with the parameters identified in 21 CFR 178.3720 and meet the specifications prescribed in 21CFR 172.888. The homopolymers may be used in amounts of to 50% by weight. The oxidized polyethylene M 3400 complies with the identity specified in 21 CFR 177. 1620 (c ). This oxidized product is not subject to any limit regarding the amount used.
21 CFR 176.180 Components of paper and paperboard in contact with dry food
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted for use in amounts intended to accomplish the intended technical effect as components of the uncoated or coated food contact surface of paper and paperboard intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding dry food of the types identified under 21 CFR 176.170 ( c )
21CFR 176.200 Defoaming agents used in coatings
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted as components of Defoaming aids coming into contact with foodstuffs. The amount permitted is a reasonable level to induce the desired effect as a defoamer.
21 CFR 176.210 Defoaming agents used in the manufacture of paper and paperboard
The homopolymer grades (including the micronized grades) and the oxidized polyethylene M 3400 are permitted as components of Defoaming aids for the subject application. The amount permitted is such as not to exceed the level required to obtain the intended technical effect.
21 CFR 177.1200 Optional substances for cellophane
Cellophane may be safely used for food packaging. Frequently cellophane, which is made from regenerated cellulose, is modified with additives, which are approved for food contact use.
The homopolymers (including the micronized grades) and the oxidized polyethylene M 3400 are permitted as components of cellophane which is used for food packaging purposes. The homopolymers may be used in an amount of up to 50% by weight. The M 3400 is permitted as it conforms to the specification set in 21 CFR 177.1620.
The homopolymers (including the micronized grades) and the oxidized polyethylene M 3400 are permitted as components of cellophane which is used for food packaging purposes. The homopolymers may be used in an amount of up to 50% by weight. The M 3400 is permitted as it conforms to the specification set in 21 CFR 177.1620.
21 CFR 177.1210 Closures with sealing gaskets for food containers
Closure sealing gaskets and overall discs may be safely used on containers intended for use in producing, manufacturing, packing, processing, preparing, treating, and packaging transporting or holding food.
The homopolymers (including the micronized types) are permitted in amounts of up to 50%. The oxidized polyethylene M 3400 is also permitted. There are extraction limitations applicable for different types of food.
The homopolymers (including the micronized types) are permitted in amounts of up to 50%. The oxidized polyethylene M 3400 is also permitted. There are extraction limitations applicable for different types of food.
21 CFR 177.1520 Olefin polymers
This regulation is the covering one for polyolefins and compliance to which is required for other food contact regulations.
The homopolymers (including the micronized types) are permitted as components for food contact purposes and in an amount of up to 50% by weight. The homopolymers do conform to the requirements set in the section of this regulation ( (c ) item 2.3 ). This has previously been outlined under 21 CFR 175.125.
The homopolymers (including the micronized types) are permitted as components for food contact purposes and in an amount of up to 50% by weight. The homopolymers do conform to the requirements set in the section of this regulation ( (c ) item 2.3 ). This has previously been outlined under 21 CFR 175.125.
21 CFR 177.1620 Oxidized polyethylene
This regulation is the covering one for oxidised polyethylenes and compliance to which is required for food contact regulations.
The oxidized polyethylene M 3400 is permitted as it conforms to the identity specified (and as previously outlined under 21 CFR 175.105). The M3400 use is subject in some regulations to extraction limitations. These do not apply in the instances of 21 CFR 175.105, 175.125, 176.170 ( a ), 176.210 or 177.1200.
The oxidized polyethylene M 3400 is permitted as it conforms to the identity specified (and as previously outlined under 21 CFR 175.105). The M3400 use is subject in some regulations to extraction limitations. These do not apply in the instances of 21 CFR 175.105, 175.125, 176.170 ( a ), 176.210 or 177.1200.
21 CFR 177.2600 Rubber articles intended for repeated use
Rubber articles (and prepared from natural and/or synthetic polymers) intended to come into contact by various means as previously stated under other regulations.
The homopolymers (including the micronized types) and the oxidized polyethylene M 3400 are permitted in an amount not to exceed that required to produce the intended technical effect and this is a maximum of not more than 2% upon the weight of the rubber product.
The homopolymers (including the micronized types) and the oxidized polyethylene M 3400 are permitted in an amount not to exceed that required to produce the intended technical effect and this is a maximum of not more than 2% upon the weight of the rubber product.
21 CFR 177.200 Textile and textile fibres
Textile fibres may be safely used for food contact purposes by various means as previously stated under other regulations. However, fibres are frequently subjected to a variety of treatments prior to use in order to impart desirable property improvements. This regulation governs what may be used and in an amount not to exceed that required to produce the intended effect.
The oxidized polyethylene M 3400 in its capacity as a product produced by an air blowing technique and as conforming to the parameters defined under 21 CFR 177.1620, is a permitted treatment for fibres coming into contact with foodstuffs.
The oxidized polyethylene M 3400 in its capacity as a product produced by an air blowing technique and as conforming to the parameters defined under 21 CFR 177.1620, is a permitted treatment for fibres coming into contact with foodstuffs.
21 CFR 178.3570 Lubricants with incidental food contact
Lubricants with incidental food contact and arising from various means as previously described may be safely used subject to certain restrictions. The incidental food contact arises as the lubricant is used on food processing equipment as a protective antirust film or, as a release agent or machine part lubricant.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted providing that the amount does not exceed that required to achieve the intended effect and, that the amount which may be incorporated into the food does not exceed 10 parts per million.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted providing that the amount does not exceed that required to achieve the intended effect and, that the amount which may be incorporated into the food does not exceed 10 parts per million.
21 CFR 178.3850 Reinforced wax for food packaging
Reinforced wax may safely be used as an article or component of an article intended for use in producing and manufacturing vinyl chloride polymers and the modifying polymers present in the polymer mixture used in the manufacture of the food contact article.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted for use provided the amount used is no more than necessary to achieve the intended effect and, that the extraction limitations for the packaging of cheese and cheese products are observed.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted for use provided the amount used is no more than necessary to achieve the intended effect and, that the extraction limitations for the packaging of cheese and cheese products are observed.
21 CFR 179.45 Packaging for use during the irradiation of pre-packaged foods
A number of packaging materials are identified in this regulation which may be safely subjected to irradiation incidental to the radiation treatment and processing of pre-packaged food. This is also subject to the requirement that no induced radioactivity is detectable in the packaging material itself.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted.
The homopolymer grades (including the micronized types) and the oxidized polyethylene M 3400 are permitted.