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The Use of Recycle Plastic (US Framework (Recycled Plastics in Food…

- - - - On materials and articles intended to come into contact with food
        
        Article 9
        Application for authorisation of a new substance
        
        A technical dossier containing the information specified
        in the guidelines for the safety assessment of a substance shall be submitted
    - - GMP
    - - Relating to plastic materials and articles intended to come into contact with foodstuff
        
        Positive list of authorized monomer
        
        Annex II
        Name + SML + Maximum permitted quantity
  - - - (7) Offcuts and scraps from the production of plastic food contact materials would be considered as suitable for food contact applications
      - (10) Only recycled plastics from a recycling process managed by an effective quality assurance system should be placed on the market.
      - (14) A combination of input characterization together with an adequate process to remove possible contamination is necessary to control the safety of the final product.
      - (15) The contaminants should only migrate in levels comparable to or well below levels demonstrated in the challenge tests of that recycling process or in other appropriate analytical test
      - (6) Plastic waste can be treated mechanically to produce recycled materials and articles or it can be broken down to monomers and oligomers by chemical depolymerisation.
        
        Monomer need to comply with Directive 2002/72/EC
      - (19) A safety assessment of the recycling process should be carried out by the EFSA
      - (20) The safety assessment of the recycling process should be followed by a risk management decision as to whether this recycling process should be authorized.
      - EN ISO 14021
        labelling of recycled plastics
      - Except for
        
        Monomer or Recycled plastic derived from chemical polymerization
        
        Recycled plastic complied with Directive 2002/72/EC
        
        Recycled plastic used behind barrier layer
- - - - Modified PET modifier < 5%w/w PET
        Mind Use Condition
        Chloroform-soluble < 0.08 mg/cm2
        
        DI Water 49 C / 24 hr
        
        n-heptane 49 C / 24 hr
        
        8% EtOH 49 C / 24 hr
        
        Strong Use Condition
        Chloroform-soluble < 0.08 mg/cm2
        
        DI Water 121 C (250 F), 2 hr
        
        n -heptane 65.5 C (150 F), 2hr
        
        50% EtOH 49 C (120 F), 24hr
      - 77-97% PET Content
        Mind Use Condition
        Chloroform-soluble < 0.02 mg/in2
        
        DI Water 121 C / 2 hr
        
        n -heptane 65.5 C / 2hr
        
        50% EtOH 49 C / 24hr
        
        Strong Use Condition : Baking Product > 121 C
        Chloroform-soluble < 0.02 mg/in2
        
        DI Water 100 C / 2 hr
        
        n-heptane 65.5 C / 2 hr
        
        50% EtOH 49 C / 24hr
        
        > 98% PET Content
        
        95% EtOH 49 C / 24 hr
        
        Greater than 500 ml capacity: chloroform-soluble 0.005 mg/in2
        
        Lower than 500 ml capacity: chloroform-soluble 0.05 mg/in2
  - - - Definition
        
        - Primary recycling (1°)
        pre-consumer industrial scrap and salvage form new packaging, a common practice in industry.
        
        It is not expected to pose a hazard to the consumer.
        
        - Secondary recycling (2°)
        physical reprocessing (e.g., grinding and melting) and reformation of post-consumer plastic packaging materials.
        
        The size of the polymer flakes or pellets can influence the effectiveness of the washing.
        
        During the grinding or melting phases, the reprocessed material may be blended with virgin polymer
        
        Even if all the incoming post-consumer polymer were comprised of FCM, limitations on food type or conditions of use could be compromised in the finished recycled product.
        
        FDA's evaluation of the processes, address these concerns.
        
        implementing controls on the source of the post-consumer polymer,
        
        adequate sorting procedures for the incoming post-consumer material,
        
        use limitations on the finished recycled packaging (such as use at room temperature or below), or
        
        food-type restrictions (such as dry or aqueous foods only).
        
        - Tertiary recycling (3°)
        post-consumer plastic packaging to chemical treatment whereby its components are isolated and reprocessed for use in manufacture.
        
        Involving polymerization with subsequent regeneration and purification of resulting monomers (or oligomers).
        
        re-polymerized and the regenerated or reconstituted polymer is formed into new packaging.
      - Exposure to chemical contaminants
        recommended a maximum acceptable level for chemical contaminants in recycled food-contact articles
        
        Threshold of Regulation (21 CFR 170.39)
        a contaminant in PET that would result in an EDI of no more than 1.5 micrograms/person/day.
        
        Procedures & required documents
        
        The chemical composition of the substance for which the request is made
        
        The intended technical effect of the substance in the food-contact article (e.g., stabilizer, catalyst, defoamer)
        
        Detailed information on the conditions of use of the substance (e.g., temp., type of contact food, the duration of contact, repeated or single use applications)
        
        A clear statement that it involves the use of a regulated direct food additive for which the dietary exposure is at or below 1% of the acceptable dietary intake (ADI)
        
        Validated migration data obtained under worst-case (time/temp.) including the life time of product (multiple or single use)
        
        The residual level of the substance present in the finished food-contact article. Estimate a worst-case dietary concentration level assuming 100% migration to food.
        
        The results of a literature search of existing toxicological information on the substance and its impurities.
      - Surrogate contaminant testing
        by exposing virgin polymer (either in container form or as flake) to selected surrogate contaminants and then running the exposed or "challenged" polymer through the recycling process.
        
        A. Choice of Surrogates
        
        Volatile Polar
        
        Chloroform
        
        Chlorobenzene
        
        1,1,1-Trichloroethane
        
        Diethyl ketone
        
        Volatile Non-Polar
        
        Toluene
        
        Heavy Metals
        
        Copper(II) 2-ethylhexanoate
        ** Not recommend for PET test
        
        Non-Volatile Polar
        
        Benzophenone
        
        Methyl salicylate
        
        Non-Volatile Non-Polar
        
        Tetracosane
        
        Lindane
        
        Methyl stearate
        
        Phenylcyclohexane
        
        1-Phenyldecane
        
        2,4,6-Trichloroanisole
        
        B. Contamination of the Plastic
        
        Challenged Test
        
        Bottle/Container
        By filling
        
        Flake (kgs)
        By soaking
        
        Cocktail
        
        Do no react each other
        
        Hexane as diluent
        
        10% (v/v) of volatile solvent
        
        1% (v/v, w/w) of non-volatile solvent
        
        14 วัน 40 องศา
        
        C. Other Consideration
        
        The recycled package will not introduce contaminants into the diet at unacceptable levels
        
        Additional factors / limitations to control contamination
        -- the use of a recycled / virgin blend
        -- source controls,
        -- restricted uses,
        -- the fraction of contaminant that migrates into food or a food simulant or the use of an effective barrier.
      - Plastic containers from non-food-contact applications as feedstock
        
        up to 100% of the post-consumer plastic feedstock might consist of non-food containers
        
        FDA believes that
        
        2° recycling processes can't remove unapproved adjuvants (such as colorants or antioxidants)
        
        2° recycling processes could remove residual amounts of non-food substances such as household cleaning solutions
        
        Ref: Begley et al., 2002, and Demertzis et al., 1997 show the concentration value of sorbed chemical on surface of non-food PET
      - Use of an effective barrier
        
        The use of 2° or 3° recycled material as a non-food-contact layer of a multilayer food package is a potential application for recycled plastics.
        
        No concern about potential contaminant migration into food as long as the recycled polymer is separated from the food by an effective barrier made from virgin polymer or other appropriate material, e.g., an aluminum film.
        
        Barrier layer from virgin PET
        
        thickness ≥ 25 µm at RT and below, and
        
        thickness ≥ 50 µm at higher temperatures, including use as a dual-ovenable container for cooking food at 150°C for 30 min
        
        ** with FCM as feedstock
    - - Description of the source of the recyclable plastic
        
        Description of any steps that are taken to ensure that the recyclable plastic is not contaminated at some point, either before collection for recycling, or during the recycling process.
        
        Results of any tests performed to show that the recycling process removes possible contaminants.
        
        Description of the proposed conditions of use of the plastic (temp, type of food)