navigating through the new regulatory updates on eu
TRANSCRIPT
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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
Definition
Intended to be brought into contact with food
CookwareTableware Kitchen appliances
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
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
Classification
By material types
Plastic Ceramic Glass Silicone
Rubber Metal & Alloy Coating Enamel
Paper and boards
Wood and bamboo
Textiles
Others
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:
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
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
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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
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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
What is NEW in the amendment Regulation (EU) 2020/1245?
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
What is NEW in the amendment Regulation (EU) 2020/1245?
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2. Requirements – Compliance evaluation for repeated use articles:
What is NEW in the amendment Regulation (EU) 2020/1245?
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
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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
What is NEW in the amendment Regulation (EU) 2020/1245?
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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
What is NEW in the amendment Regulation (EU) 2020/1245?
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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
What is NEW in the amendment Regulation (EU) 2020/1245?
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
What is NEW in the amendment Regulation (EU) 2020/1245?
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.
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
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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