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2018 FCM regulation international forum, Beijing, 24 October 2018

EU PET recycled material requirements and safety assessment

Eric Barthélémy

European Food Safety Authority (EFSA)

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This is not an EFSA official position!

The content of this presentation does not necessarily represent the position of EFSA

To consult the opinions of EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF), and CEP Panel since July 2018 (= CEF without flavourings)

see www.efsa.europa.eu

2018 FCM regulation international forum , Beijing, 23 October 2018

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Outline

EU background and scope of the regulation

EFSA PET Criteria for evaluation


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Regulation (EU) 282/2008

EFSA doesn’t assess (out of the scope of the regulation)

Re-uses of articles

Offcuts and factory scraps

Chemical processes

EFSA assesses

Closed and controlled loop processes

Open loop mechanical processes

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R0282&from=EN


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EFSA guidance (EFSA AFC Panel, 2008)

Guidelines on submission of a dossier for safety evaluation of a plastic recycling process

It gives guidance on the format of the application, on administrative matter, and technical data to be supplied for evaluation as below

E.g. flow chart diagram, process description, characterisation of the input, determination of the decontamination efficiency, characterisation of the recycled plastic, intended application, compliance with 10/2011, process analysis, QAS, etc.

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2008.717


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Closed and controlled loop processes

Regulation Art. 4:“input must originate from a product loop… ensuring that only materials and articles which have been intended for food contact are used and any contamination can be ruled out”

Approx. 10 processes evaluated (on polyolefin)

Evaluation of ‘closure and control’ based on the description

Evaluation of the impact of repeated recycling on the formation of degradation products

It is largely discussion about GMP rather than chemical risk assessment


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Input coming from post consumer waste, so there is no control of what happens after the primary use and it can be contaminated

Potential/incidental chemical contamination

• misuse by consumers: e.g. paint remover, detergents, shampoo, pesticides, solvents, fuel

• non-food contact applications: non-authorised substances & content (e.g. cosmetics, personal hygiene products, household cleaner)

• non-PET, chemicals from recycling, degradation, food components)

Risk = migration of contaminants from recycled plastic into food

Open loop mechanical process


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Risk assessment for open loop mechanical process

Regulation (EU) 282/2008, Art. 4:

recycled plastic shall be food grade/compliant with (EU) 10/2011

quality of plastic input must be characterised and controlled

all steps from the input to the output

should be demonstrated that the recycling process is able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health


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EFSA CEF Panel ‘PET criteria’ (2011)

Criteria to be used for safety evaluation of a mechanical process to produce recycled PET (EFSA CEF Panel, 2011) = setting of “contamination level”, the assessment of the decontamination efficiency and the setting of the level of contaminant in cleaned recycled PET which lead to migration below a level of negligible health concern

Approx. 130 processes evaluated


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Manual and automated

sorting

Plastic waste Food-uses PET waste

Shredding

Automated sorting and

washing

Polyethylene terephthalate (PET)

Washed & dried plastic flakes

Recycling process: Input


http://en.wikipedia.org/wiki/File:PET.svg

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Recycling process Decontamination

Washed & dried plastic flakes

Pellets

Films

Bottles

Trays

Recycling process: Decontamination and Output

Flakes


http://www.phoenixtechnologies.net/products-applications/food-gradestar-lno™-c-pellets.aspx

http://www.shutterstock.com/subscribe.mhtml

http://3.bp.blogspot.com/-nso2z1_vXDQ/TzKdz8QchBI/AAAAAAAADPo/qRkFn3Sruc8/s1600/plastic-water-bottle.JPG

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Criteria for the evaluation (EFSA CEF Panel, 2011) DEFAULT EXPOSURE BELOW WHICH THE RISK TO

HUMAN HEALTH WOULD BE NEGLIGIBLE AND THAT

SHOULD NOT BE EXCEEDED

= 0.0025 µg/kg bw/day (Kroes, 2004)

Yes No

No safety

concern

Further

considerations

Cres < Cmod

PLASTIC INPUT: Average reference

contamination of washed and dried flakes

3 mg/kg PET

RECYCLING PROCESS WITH DECONTAMINATION

TECHNOLOGY

Decontamination efficiency measured using a

challenge test Eff (%)

PLASTIC IN CONTACT

Cmod = modelled residual contamination in

the recycled PET

PLASTIC OUTPUT

Residual contamination in the recycled PET

Cres = 3 (mg/kg PET) *(1-Eff %)

MIGRATION IN FOOD (DEFAULT INFANTS SCENARIO)

0.1 µg/kg food = highest concentration of a

contaminant (in water)


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Yes No

No safety

concern

Further

considerations

Cres < Cmod

PLASTIC INPUT

Average Reference Contamination level

3 mg/kg PET


TECHNOLOGY



PLASTIC IN CONTACT


the recycled PET

PLASTIC OUTPUT



Cres = How much of potential unidentified contaminant would remain in the plastic?





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Input: reference Contamination level 1/2

The Reference Contamination level is aimed to represent the contamination of the input to be recycled

Available information, data, evidence - Existing guidance (FDA, AFSSA/ANSES, ILSI) - Literature (Franz, Bayer, Begley, Demertzis, EU FAIR project, etc.)

- EU, USA - Contamination, sorption of PET flakes, pellets, bottles

Two possible approaches - Sorption capacity - Contamination (severity + frequency)


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Input: reference Contamination 2/2

EU FAIR project is the pivotal study (Franz et al., 2004)

• Statistically powerful = 7000 to 10 000 bottles

• Conventionally recycled flakes = washed & dried

• 12 EU countries (likely covering the MSs with existing plants)

• Misuse contaminants -> Toluene, xylene

• Severity -> 2000-3000 & 4500-6700 mg/kg PET

• Frequency -> 3 / 7000-10 000 bottles -> 0.03-0.04%

• 0.04% x 6700 ppm -> 2.7 rounded to 3 mg/kg washed & dried PET


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Input: non-food uses 1/3

Non-food uses are ‘do it yoursef’, detergents, cosmetics, personal hygiene, paint removers, etc.

Non-food use PET applications are food grade =

manufactured acc. to Reg EU 10/2011 Contamination peculiarities

- Misuses (possible higher frequency and/or higher level of contamination)

- PLUS non-food content of the containers


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Input: non-food uses 2/3

2 Levels of information from applicants (dossiers): - Fraction ≤ 5% (based on market data) - Fraction < 1 up to 5% (control info & data on collecting and sorting)

Littérature - Bayer, 2002: 15 mg methyl salicylate /kg PET as highest average

(mixed non food batch) - Begley, 2002: 130 to 204 mg methyl salicylate/kg in the wall of a

single antiseptic mouth wash bottle (possible peak with no frequency)


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Input: 5% non-food uses 3/3

By applying the highest value of 5%, the highest average of 15 mg methyl salicylate/kg PET would be reduced to less than 3 mg/kg (Ref. Cont. level) what gives reinsurance about the ability to decontaminate up to the safe residual level -> 5% of non-food uses containers is covered by the

proposed scenario

Non-food uses containers should not be intentionally used - chemical/industrial containers should not be used


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Yes No

No safety

concern

Further

considerations

Cres < Cmod

PLASTIC INPUT


3 mg/kg PET


TECHNOLOGY



PLASTIC IN CONTACT


the recycled PET

PLASTIC OUTPUT







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Decontamination steps

- Starts after washed and dried flakes - Ends with the production of recycled flakes, pellets (also films)

Decontamination

Washed & dried flakes

Pellets

Films

Flakes

Steps applied to decontaminate should be identified, described, explained, and processing parameters (e.g. T, P, flow, t) provided




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Decontamination Efficiency

Decontamination Efficiency is calculated for tested steps - Example: Extrusion + Crystallisation/drying + SSP


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Washing & drying to remove superficial contamination

Challenge test

Decontamination part(s) of the

process

Concentration Cf

Efficiency for each surrogate is calculated

using their residual concentration

measured before and after the tested steps

of the process Concentration Ci

Challenge test at reduce or full scale and under conditions no more severe as the ones of the

industrial process

Surrogate contaminants: toluene, methyl salicylate,

chlorobenzene, benzophenone, …




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Bias: Cross-contamination

When mixture of non-contaminated and contaminated PET are used, transfer from contaminated to non-contaminated may occur

=> Decontamination efficiency (%) based on amount of residual surrogates in both contaminated and initially non-contaminated PET (cf. EFSA PET criteria)


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Yes No

No safety

concern

Further

considerations

Cres < Cmod

PLASTIC INPUT


3 mg/kg PET


TECHNOLOGY



PLASTIC IN CONTACT


the recycled PET

PLASTIC OUTPUT







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From safe exposure to safe concentration in food

Exposure level that does not pose a risk to human = exposure for chemicals with structural alerts that raises concern for potential genotoxicity & below which probability for adverse effect in human is negligible= 0.0025 µg/kg bw/day

Default (highest) consumption for water bottle

Infants consume 150 g water/kg bw/day (5 kg bw bw/0.75l)

For uses other than water bottles (trays): scenario for toddlers

Concentration of contaminant in food that does not pose a risk

to human = 0.017 µg/kg food


http://3.bp.blogspot.com/-nso2z1_vXDQ/TzKdz8QchBI/AAAAAAAADPo/qRkFn3Sruc8/s1600/plastic-water-bottle.JPG

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… to a modelled safe concentration in PET

Concentration in food (0.017 µg/kg food) for infant scenario/bottles

Modelled concentration in PET (Cmod)

Migration modelling (over-estimation x 5-100)

We have integrated this over-estimation of 5 in the safe concentration in food (0.017 µg/kg food*5) that becomes 0.1 µg/kg food modelled safe concentration in food (infant scenario)

This value of 0.1 µg/kg food is then used to set the safe concentration in PET (Cmod) which should not be exceeded


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Modelled safe concentration in PET: Cmod

Cmod = concentration of contaminant in PET that leads to 0.1 µg/kg food using migration modelling

Parameters: 1 year at 25°C, Kp,F=1 (good solubility), 6dm²/1kg food, 300µm thickness, Ap‘=3.1 & tau=1577 for tau <=70°C (EC, 2010)


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Yes No

No safety

concern

Further

considerations

Cres < Cmod

PLASTIC INPUT


3 mg/kg PET


TECHNOLOGY



PLASTIC IN CONTACT


the recycled PET

PLASTIC OUTPUT







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Example

http://www.efsa.europa.eu/en/efsajournal/pub/2828.htm


http://www.efsa.europa.eu/en/efsajournal/pub/2828.htm

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THANK YOU FOR YOUR ATTENTION

EFSA:

http://www.efsa.europa.eu/

EFSA Journal on Wiley:

https://efsa.onlinelibrary.wiley.com/journal/18314732

EFSA Scientific Network on FCM: https://www.efsa.europa.eu/it/food-ingredients-and-packaging/networks


Let us contribute together to a safe food…






https://www.efsa.europa.eu/it/food-ingredients-and-packaging/networks








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