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Job Ridderbecks
Application Specialist Food Contact
Nadine Thomis
Business Development Manager
Regulatory Services
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EU Plastics Regulation 10/2011
Agenda:
Framework Regulation EU 1935/2004
Regulation (EU) 10/2011:
Basic principles
Amendments including 6th amendment
Guidance documents
Declaration of Compliance
Q&A
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EU landscape for food contact materials
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EU landscape for food contact materials
GMP 2023/2006/EC
Amendments
1282/2011,1183/2012 ,202/2014, 2015/174, 2016/1416
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EU Plastics Regulation 10/2011
Compositional requirements
Specific provisions for certain materials and articles
Declaration of Compliance
Compliance testing
Transitional provisions
6 Annexes with detailed information on above topics
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EU Plastics Regulation 10/2011
Scope
Plastic mono-layers
Plastic multilayers bound by adhesives
Plastic layers or coatings forming gaskets in caps & closures
Plastic layers in multi-material multi-layer materials
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Authorized substances
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Migration limits:
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EU Plastics Regulation 10/2011
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EU Plastics Regulation 10/2011
Migration testing Test conditions: Test Contact time & temperature Intended food contact conditions
OM2 10d at 40C Long term storage including short term heating
7 standard test conditions
OM3
2h at 70 C Short term heating
2 alternative test conditions OM4 1h at 100 High temperature application
2h at 100C or at reflux or 1
(high temperature) OM5
h at 121C
High temperature application up to 121 C
OM6 4h at 100C or at reflux Any food contact conditions with food simulant
A,B,C at temp > 40 C
OM7
2h at 175 C High temperatures application with fatty foods
Specific migration:
Combination of contact times and temperatures
4 standardized conditions for exposure > 30 days
Frozen: 10 days 20C
Refrigerated: 10 days 40C
Storage 6 months RT: 10 days 50C
Storage > 6 months RT: 10 days 60C
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EU Plastics Regulation 10/2011
Screening Approaches:
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EU Plastics Regulation 10/2011 - Amendments
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6th Amendment: Regulation (EU) 2016/1416
Substances with FCM No. 871, 1031 and 1052 listed in Annex I for
which a restriction (50 ppb) on the migration of oligomers (< 1000
Dalton) is laid down in that Annex shall only be used if a suitable
method of analysis for determining the migration of oligomers can be
provided. In future EFSA will provide test methods.
For caps, gaskets, stoppers and similar sealing articles, the specific
migration value shall be expressed in mg/kg using the actual volume
of food in the container (option to express in mg/dm2 removed)
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6th Amendment: Regulation (EU) 2016/1416
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6th Amendment: Regulation (EU) 2016/1416
Transitional provisions:
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Upcoming changes
2020
EU Plastics Regulation 10/2011 Guidance documents
Guidance documents:
1. EU guidance on Regulation 10/2011:
definitions of terms that relevant in the context of food contact materials and
articles,
explanations why substances are exempted from inclusion in the Union list and
applicable provisions for these substances,
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EU Plastics Regulation 10/2011 Guidance documents
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EU Plastics Regulation 10/2011 DoC
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Regulatory Support in the Supply Chain
Product &
Packaging Manufacturer
Process
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EU Plastics Regulation 10/2011
nadine.thomis@intertek.com
job.ridderbecks@intertek.com
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