Navigating through the new regulatory updates on EU ...

Navigating through the new regulatory updates on EU plastic food contact materials

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Content

1. What is Food Contact Materials?

2. EU Regulation and Directive

3. Plastic Regulation

4. Examples

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01What is Food Contact Materials?

Definition

Classification

Risk type

Risk Source

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Definition

Intended to be brought into contact with food

CookwareTableware Kitchen appliances

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Definition

Already in contact with food

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Definition

Reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use

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Definition: Migration

The safety of food contact materials must be evaluated as chemicals can migrate from the materials into the food

Food products

Food contact materials

MonomersAntioxidants

Heavy metals

Heat stabilizersPlasticizersCompression, humidity

Migration

* Figure. Migration of food contact materials to food products

Taste and Odor

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Classification

By material types

Plastic Ceramic Glass Silicone

Rubber Metal & Alloy Coating Enamel

Paper and boards

Wood and bamboo

Textiles

Others

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Risk type and source

Materials and articles, shall be manufactured in compliance with good manufacturing practice so

that they do not transfer their constituents to food in quantities which could:

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Endanger human health

Toxic chemical substance migration into foodstuff, e.g.

Primary aromatic amine

Heavy metals

Monomer or other starting substances

And more

Bring about an unacceptable change in the composition of the food

Color release into foodstuff

Rust occur

And more

Bring about a deterioration in the organoleptic characteristics

Unpleasant odor of some materials

Clear odour and/or taste changing

And more


02EU Regulation and Directive

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EU Regulation and Directive

General legislation (framework regulation)

Legislation on specific materials

Legislation on specific substances

Products originating or consigned from China or Hong Kong


EU Regulation and Directive

(EC) No.1935/2004

Framework Regulation

Plastics 1895/2005/EC

(EU) No10/2011

(EU) No 321/2011 amend 1st

(EU) No 1282/2011 amend 2nd

(EU) No 1183/2012 amend 3rd

(EU) No 202/2014 amend 4th

(EU) No 865/2014 amend 5th

(EU) 2015/174 amend 6th

(EU) 2016/1416 amend 7th

(EU) 2017/752 amend 8th

(EU) 2018/79 amend 9th

(EU) 2018/213 amend 10th

(EU) 2018/831 amend 11th

(EU) 2019/37 amend 12th

(EU) 2019/988 amend 13th

(EU) 2019/1338 amend 14th

(EU) 2020/1245 amend 15th

(EC) No 450/2009

Ceramic

84/500/EEC&2005/31/EC1st amend.

Upcoming new regulation 2007/42/EC

Elastomer or rubber teats 93/11/EC

Others

Paper and board

Varnish and coating

Glass

Cork

Rubber

Silicone

Metal and alloy

Enamel

Ion exchange resin

(EC) No 2023/2006

Good Manufacturing

practice


03Plastic Regulation

Regulation (EU) No 10/2011 and its amendment Regulation (EU) 2020/1245 on plastic materials and articles intended to come into contact with food



(EU) No 10/2011 and (EU) 2020/1245 (AMD) on plastic materials and articles intended to come into contact with food1. Scope:

a) materials and articles and parts thereof consisting exclusively of plastics;

b) plastic multi-layer materials and articles held together by adhesives or by other means;

c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating;

d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;

e) plastic layers in multi-material multi-layer materials and articles.

* Do not apply to ion exchange resins, rubber and silicones



((EU) No 10/2011 and (EU) 2020/1245 (AMD) on plastic materials and articles intended to come into contact with food


2. Requirements:

For all plastic:

• Overall Migration

• Specific migration of heavy metals

• Specific migration of primary aromatic amines(PAAs)

For specific plastic:

• Specific migration of substances based on material type

• Substances on union list set out in Annex I of (EU) No 10/2011

• Specific migration of substances test based on material type

• For example: - Specific migration limit (SML) of Acrylonitrile in ABS, SAN plastic

- SML of Formaldehyde and Melamine in Melamine products

- SML of BPA in Polycarbonate (PC) plastic

- SML of phthalates in plasticized plastic

- Total phthalates in plasticized plastic


What is NEW in the amendment Regulation (EU) 2020/1245?


2. Requirements:

No BEFORE AFTER i.e. since Regulation (EU) 2020/1245 Remark

1 OM1-OM9 OM0-OM9:Add new test number OM0 (40 °C, 30 mins) for any food contact at cold or room temperatures for no more than 30 minutes (Example: Fruit / vegetable peeler, pasta cutter, etc.)

--

2 Specific migration of heavy metals- 9 elements

Specific migration of heavy metals- 24 elements 1) Same test method with addition of new restricted heavy metals and primary aromatic amine

2) Analyzed at the same time

3 Specific migration of PAA: Sum of PAAs ≤0.01mg/kg

Specific migration of PAA: Sum of PAAs ≤0.01mg/kg and ≤ 0.002 mg/kg for each primary aromatic amine (PAA) listed in Appendix 8 to entry 43 of Annex XVII of REACH

4 Compliance evaluation for repeated use articles:3rd migration test shall be verified for the compliance

Compliance evaluation for repeated use articles:3rd migration test and the stability of the material or article from the first to the third migration test shall be verified for the compliance

1) Every single test result needs to consider

2) Extended in the testing lead time


2. Requirements - Specific migration of heavy metals:

Name Specific migration limit (mg/kg)

Name Specific migration limit (mg/kg)

Barium 1 Chromium ND

Cobalt 0.05 Europium 0.05

Copper 5 Gadolinium 0.05

Iron 48 Lanthanum 0.05

Lithium 0.6 Terbium 0.05

Manganese 0.6 Lead ND

Zinc 5 Mercury ND

Aluminum 1.0 Ammonium --

Nickel 0.02 Calcium --

Antimony 0.04 Magnesium --

Arsenic ND Potassium --

Cadmium ND (LOD 0.002) Sodium --

Blue elements are newly added to the regulation


2. Requirements - Specific migration of PAAs:

Name SML(mg/kg) Name SML(mg/kg)

biphenyl-4-ylamine4-aminobiphenyl xenylamine

0.002 4,4'-methylenedi-o-toluidine 0.002

benzidine 0.0026-methoxy-m-toluidinep-cresidine

0.002

4-chloro-o-toluidine 0.0024,4'-methylene-bis-(2-chloro-aniline)2,2'-dichloro-4,4'-methylene-dianiline

0.002

2-naphthylamine 0.002 4,4'-oxydianiline 0.002o-aminoazotoluene4-amino-2',3-dimethylazobenzene4-o-tolylazo-o-toluidine

0.002 4,4'-thiodianiline 0.002

5-nitro-o-toluidine 0.002o-toluidine2-aminotoluene

0.002

4-chloroaniline 0.002 4-methyl-m-phenylenediamine 0.0024-methoxy-m-phenylenediamine 0.002 2,4,5-trimethylaniline 0.0024,4'-methylenedianiline4,4'-diaminodiphenylmethane

0.002o-anisidine 2-methoxyaniline

0.002

3,3'-dichlorobenzidine3,3'-dichlorobiphenyl-4,4'-ylenediamine

0.002 4-amino azobenzene 0.002

3,3'-dimethoxybenzidineo-dianisidine

0.002 1,3-phenylenediamine 0.002

3,3'-dimethylbenzidine4,4'-bi-o-toluidine

0.002Sum of PAAs 0.01




2. Requirements – Compliance evaluation for repeated use articles:


Issues Overall Migration Specific Migration

Number of migration test

Three times Three times

Compliance judgment criteria

1) Compliance with limit based on the 3rd

migration test result

2) Stability test result: 1st migration test result > 2nd > 3rd

1) Compliance with limit based on the 3rd migration test result

2) Stability test result: 1st migration test result > 2nd > 3rd

Remark: for a specific substance with limit as “prohibited” or “not detectable” - never in compliance if a substance is detected in the first migration


Overall migration - Examples:

Test results(mg/dm2)

Limit (mg/dm2)

BEFORE AFTER i.e. since Regulation (EU) 2020/1245

1st migration: 12 2nd migration: 133rd migration: 9

10 PASS FAIL

1st migration: 8 2nd migration: 83rd migration: 9

10 PASS FAIL

1st migration: 152nd migration: 123rd migration: 7

10 PASS PASS



Specific migration - Examples:

Test results(mg/dm2)

Limit (mg/dm2)

BEFORE AFTER i.e. since Regulation (EU) 2020/1245

SML- Acrylonitrile 1st migration: ND2nd migration: ND3rd migration: ND

ND(0.01mg/kg) PASS PASS

SML- Acrylonitrile 1st migration: ND2nd migration: 0.023rd migration: ND

ND(0.01mg/kg) PASS FAIL

SML- Acrylonitrile 1st migration: 0.032nd migration: 0.023rd migration: ND

ND(0.01mg/kg) FAIL FAIL



3. Test condition - Food simulant:‘Food simulant’ means a test medium imitating food

Food simulant abbreviation

Food simulant Food category

A 10% (v/v) ethanol 10% (v/v)

Food that have a hydrophilic character and can extract hydrophilic substances

B 3% (w/v) acetic acid Food which have a pH below 4.5

C 20% (v/v) ethanol Alcoholic food with an alcohol content of up to 20 % and food that contains a relevant amount of organic ingredients that render the food more lipophilic.

D1 50% (v/v) ethanol Alcoholic food with an alcohol content of above 20 % and for oil in water emulsions

D2 Vegetable oil Food that contains free fats at the surface

Substitute of D2 95%ethanol(v/v) and isooctane

Food that contains free fats at the surface

E MPPO Dry food


3. Test condition Overall migration testing shall be performed under the standardized testing conditions.

Test

numberContact time at contact temperature Intended food contact conditions

OM0 (NEW)

30min at 40 °C

Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes).

OM1 –OM9

- Existed before the publication of Regulation (EU) 2020/1245- For overall migration under different temperature, contact time and contact food types


Specific migration testing shall be performed based on the test conditions listed in Table 1 and 2 to Annex V to Regulation (EU) 10/2011 and its amendments.



04Examples



Examples


Polypropylene (PP) storage box (not suitable for microwave use)

Specific food contact test parameters: • Overall migration • Specific migration (SM) of heavy metals• SM of Primary Aromatic Amines (PAA)

Foreseeable use:• Long term food storage • Would contact all kinds of foodstuff

Test condition:• OM2 (40oC, 10 days) in simulant A, B, D2• SM (40oC, 10 days) in simulant B

High risk parameters:• Nil



Examples


Melamine bowl

Specific food contact test parameters: • Overall migration • SM of heavy metals• SM of PAA• SM of formaldehyde• SM of melamine

Foreseeable use:• Melamine articles which cannot safely

contact foodstuff at 70℃ or above • Would contact all kinds of foodstuff

Test condition:• OM3 (70oC, 2 hours) in simulant A, B, D2• SM (70oC, 2 hours) in simulant B

High risk parameters:• SM of formaldehyde• SM of melamine



Examples


Water bottle

Specific food contact test parameters: • Overall migration • SM of heavy metals• SM of PAA• SM of BPA (for PC only)

Foreseeable use:• Would contact cold or hot

beverages, not for storage purpose

Test condition:• OM3 (70oC, 2 hours) in simulant

B & D1 • SM (70oC, 2 hours) in simulant B

High risk parameters:• Overall migration• Specific migration of BPA


1. Lid cover- non-food contact2. Soft nozzle and straw- silicone3. Lid- PP plastic 4. Nylon tap- non-food contact5. Bottle body- PC plastic 6. Sealing ring- silicone 7. Hard nozzle and straw- PP plastic


Examples of non-food contact materials but the market may apply the FCM test

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Examples - Nonfood contact

Product with intended Oral contact



Toys for small children



Pill box

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