regulation 10/2011 johannes bergmair - ofi, regulation 2011
DESCRIPTION
COMMISSION REGULATION (EU) No 10/2011 of 14 January 2011on plastic materials and articles intended to come into contact with food (FCM)TRANSCRIPT
PowerPoint-Präsentationwww.ofi.at
of 14 January 2011
on
plastic materials and articles intended to come into contact with food (FCM)
Dr. Johannes Bergmair
Scope of the commisson regulation (EU) No. 10/2011
Regulation for plastic materials and articles to be placed on the market
Specific approach concerning the regulation (EU) No. 10/2011
www.ofi.at
Materials and articles (exclusively) of plastic
Article 2
Scope
1. This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:
(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.
with coating,
Plastic materials & articles intended to come in contact with food
NOT in the scope of Regulation (EU) No. 10/2011
Ion exchange resin
incl. synthetic paraffin wax a/o microcristalline wax
www.ofi.at
Plastic materials & articles intended to come in contact with food
Whereas.... (Preamble, Pt 6)
Printed or coated plastic materials and articles as well as those held together by adhesives should be within the scope of the Regulation.
Adhesives, coatings and printing inks are not necessarily composed of the same substances as plastics. Regulation (EC) No 1935/2004 foresees that for adhesives, coatings and printing inks specific measures can be adopted. Therefore plastic materials and articles that are printed, coated or held together by adhesives should be allowed to contain in the printing, coating or adhesive layer other substances than those authorised at EU level for plastics.
Those layers may be subject to other EU or national rules.
www.ofi.at
Plastic materials & articles intended to come in contact with food
Article 19
Assessment of substances not included in the Union list
Compliance with Article 3 of Regulation (EC) No 1935/2004 of substances referred to in Articles
6(1) (polymer production aids),
6(2) (colorants and solvents),
6(4) (non-intentionally added substances as well as aids to polymerisation),
6(5) (additives form the „provisional list“) as well as
14(2) (materials behind a functional barrier)
of this Regulation which are not covered by an inclusion in Annex I to this Regulation shall be assessed in accordance with internationally recognised scientific principles on risk assessment.
www.ofi.at
Placing on the market of plastic materials and articles
Plastic materials and articles may only be placed on the market if they: (Article 4)
comply with the relevant requirements set out in Article 3 of Regulation (EC) No 1935/2004 under intended and foreseeable use
endanger human health
bring about an unacceptable change in the composition of the food
bring about a deterioration in the organoleptic characteristics
comply with the labelling requirements set out in Article 15 of Regulation (EC) No 1935/2004; and
comply with the traceability requirements set out inArticle 17 of Regulation (EC) No 1935/2004; and
are manufactured according to good manufacturing practiceas set out in Commission Regulation (EC) No 2023/2006(1)
comply with the compositional and declaration requirementsset out in Chapters II, III and IV of this Regulation.
www.ofi.at
Practical approach (1)
Formal inspection of composition
a) Are monomers, starting materials and additves listed and approved in the regulation?
Best
Noodels
www.ofi.at
Unionlist of authorised materials
Additives exclusiv of colorants
www.ofi.at
Regulation (EU) No. 10/2011
Chapter II: Compositional requirements
The following substances not included in the Union list maybe present in the plastic layers of plastic materials or articles: (Article 6)
non-intentionally added substances („NIAS“)
Evaluation of the composition
...other material- a/o substance specific european regulations/directives
Regulation on epoxy derivatives (EC No. 1895/2005)
Regulation on plasticisers in gaskets in lids
(EC No. 372/2007)
(EC No. 597/2008)
Regulation on recycled plastic materials (EC No. 282/2008) incl. EFSA-Guideline from May 2008
Regulation on intelligent materials and articles (EC No. 450/2009) incl. EFSA-Guideline from July 2009
as well as applicable existing national regulations
www.ofi.at
Practical approach (2)
c) Are there certain specifications a/o restrictions?
EC No. 10/2011 Annex I, Tab. 1.:
?
?
?
?
Specific migration limits:
Barium 1 mg/kg
Cobalt 0,05 mg/kg
Copper 5 mg/kg
Iron 48 mg/kg
Lithium 0,6 mg/kg
Manganese 0,6 mg/kg
Zinc 25 mg/kg
Release of (not listed) primary aromatic amines:
The detection limit is 0,01 mg of substance per kg of food or food simulant.
www.ofi.at
Specific migration limits: (Article 11)
For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.
Special limitations for „dual additives“
Overall migration limit: (Article 12)
Max. 10mg/dm²
plastic materials andarticles intended to be brought into contact with food intendedfor infants and young children: max. 60 mg/kg
www.ofi.at
Practical approach (3)
Best
Noodels
www.ofi.at
Ethanol 10 Vol.-%
Acetic acid 3 Gew.-%
Ethanol 20 Vol.-%
Ethanol 50% (v/v)
D lipophilic foodstuff
Concrete approach (4)
b) Clarification of conditions of contacts when using food simulants
c) Conduction of appropriate test conditions
Check of overall migration
Check of specific migration
Compliance testing
CHAPTER 1:
Testing for specific migration of materials and articles already in contact with food
CHAPTER 2:
Testing for specific migration of materials and articles not yet in contact with food
CHAPTER 3:
Correction factors applied when comparing migration test results with migration limits
Fat Reduction Factor (FRF)
www.ofi.at
Testing for specific migration: Time/Temperature
„special conditions“:
But max. 10 days/ 60°C
Ea...the worst case activation energy 80kJ/mol
R...8,31 J/Kelvin/mol
Testing for specific migration: Time/Temperature
For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions.
www.ofi.at
Testing for specific migration: Time/Temperature
Time/ Temperature – Standard conditions
Testing for 10 days at 20 °C shall cover all storage times at frozen condition.
Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including heating up to 70 °C/2 h, heating up to 100 °C /15 min.
Testing for 10 days at 50 °C shall cover all storage time at refrigerated and frozen conditions including heating up to 70 °C/2 h, or heating up to 100 °C/15 min and storage times of up to 6 months at room temperature.
Testing for 10 days at 60 °C shall cover long term storage above 6 months/room temperature and below including heating up to 70 °C/ 2 h, or heating up to 100 °C/15 min.
www.ofi.at
Testing for overall migration: Time/Temperature
Standardised testing conditions:
OM 5 covers OM1, OM2, OM3, OM4.‘worst case‘ conditions for all food simulants in contact with polyolefins.
OM1, OM2, OM3, OM4 and 5 covered!
`worst case`for non-polyolefines
OM1, OM2, OM3, OM4 and 5 covered! `worst case`for fatty food simulants in contact with non-polyolefines
www.ofi.at
Testing for overall migration: Time/Temperature
Substitute test for OM7 with food simulant D2 (2h/ 175 °C):
www.ofi.at
Practical approach (5)
Practical approach (6)
?
?
EC No. 10/2011 Annex I, Tab. 1; Annex II, Tab. 2:
www.ofi.at
Practical approach (8)
Sensory Evaluation/ Verification
Odor of packaging
As well as....
…appropriate transfer of test results in the declaration of conformity of the product of!
www.ofi.at
Additionally:
Identity and address of the business issuing the Declaration of compliance
Declaration of compliance for products from intermediate stages of production
Sufficient information about the used materials or their degradation products…(so far only adequate information on the substances used)
Information required in the presence of a functional barrier is now required in all cases (so far only in functional barriers made of plastic)
www.ofi.at
Plastic multi-layer materials and articles: (Article 13)
Option of using the 'functional barrier' - approach to individual plastic layers, if
No direct foodstuff contact given
Limit violation and / or
Conditions
NO Migration of the substances into food or food simulant should be detectable measured with statistical certainty by a method of analysis with a limit of detection of 0,01 mg/kg = 10 ppb (for structurally or toxicological related substances = Total limit)
Migration limit (OM, SML) observed in the total product
www.ofi.at
Dr. Johannes Bergmair
E: [email protected]
Brehmstraße 14a
1110 Wien
of 14 January 2011
on
plastic materials and articles intended to come into contact with food (FCM)
Dr. Johannes Bergmair
Scope of the commisson regulation (EU) No. 10/2011
Regulation for plastic materials and articles to be placed on the market
Specific approach concerning the regulation (EU) No. 10/2011
www.ofi.at
Materials and articles (exclusively) of plastic
Article 2
Scope
1. This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:
(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.
with coating,
Plastic materials & articles intended to come in contact with food
NOT in the scope of Regulation (EU) No. 10/2011
Ion exchange resin
incl. synthetic paraffin wax a/o microcristalline wax
www.ofi.at
Plastic materials & articles intended to come in contact with food
Whereas.... (Preamble, Pt 6)
Printed or coated plastic materials and articles as well as those held together by adhesives should be within the scope of the Regulation.
Adhesives, coatings and printing inks are not necessarily composed of the same substances as plastics. Regulation (EC) No 1935/2004 foresees that for adhesives, coatings and printing inks specific measures can be adopted. Therefore plastic materials and articles that are printed, coated or held together by adhesives should be allowed to contain in the printing, coating or adhesive layer other substances than those authorised at EU level for plastics.
Those layers may be subject to other EU or national rules.
www.ofi.at
Plastic materials & articles intended to come in contact with food
Article 19
Assessment of substances not included in the Union list
Compliance with Article 3 of Regulation (EC) No 1935/2004 of substances referred to in Articles
6(1) (polymer production aids),
6(2) (colorants and solvents),
6(4) (non-intentionally added substances as well as aids to polymerisation),
6(5) (additives form the „provisional list“) as well as
14(2) (materials behind a functional barrier)
of this Regulation which are not covered by an inclusion in Annex I to this Regulation shall be assessed in accordance with internationally recognised scientific principles on risk assessment.
www.ofi.at
Placing on the market of plastic materials and articles
Plastic materials and articles may only be placed on the market if they: (Article 4)
comply with the relevant requirements set out in Article 3 of Regulation (EC) No 1935/2004 under intended and foreseeable use
endanger human health
bring about an unacceptable change in the composition of the food
bring about a deterioration in the organoleptic characteristics
comply with the labelling requirements set out in Article 15 of Regulation (EC) No 1935/2004; and
comply with the traceability requirements set out inArticle 17 of Regulation (EC) No 1935/2004; and
are manufactured according to good manufacturing practiceas set out in Commission Regulation (EC) No 2023/2006(1)
comply with the compositional and declaration requirementsset out in Chapters II, III and IV of this Regulation.
www.ofi.at
Practical approach (1)
Formal inspection of composition
a) Are monomers, starting materials and additves listed and approved in the regulation?
Best
Noodels
www.ofi.at
Unionlist of authorised materials
Additives exclusiv of colorants
www.ofi.at
Regulation (EU) No. 10/2011
Chapter II: Compositional requirements
The following substances not included in the Union list maybe present in the plastic layers of plastic materials or articles: (Article 6)
non-intentionally added substances („NIAS“)
Evaluation of the composition
...other material- a/o substance specific european regulations/directives
Regulation on epoxy derivatives (EC No. 1895/2005)
Regulation on plasticisers in gaskets in lids
(EC No. 372/2007)
(EC No. 597/2008)
Regulation on recycled plastic materials (EC No. 282/2008) incl. EFSA-Guideline from May 2008
Regulation on intelligent materials and articles (EC No. 450/2009) incl. EFSA-Guideline from July 2009
as well as applicable existing national regulations
www.ofi.at
Practical approach (2)
c) Are there certain specifications a/o restrictions?
EC No. 10/2011 Annex I, Tab. 1.:
?
?
?
?
Specific migration limits:
Barium 1 mg/kg
Cobalt 0,05 mg/kg
Copper 5 mg/kg
Iron 48 mg/kg
Lithium 0,6 mg/kg
Manganese 0,6 mg/kg
Zinc 25 mg/kg
Release of (not listed) primary aromatic amines:
The detection limit is 0,01 mg of substance per kg of food or food simulant.
www.ofi.at
Specific migration limits: (Article 11)
For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.
Special limitations for „dual additives“
Overall migration limit: (Article 12)
Max. 10mg/dm²
plastic materials andarticles intended to be brought into contact with food intendedfor infants and young children: max. 60 mg/kg
www.ofi.at
Practical approach (3)
Best
Noodels
www.ofi.at
Ethanol 10 Vol.-%
Acetic acid 3 Gew.-%
Ethanol 20 Vol.-%
Ethanol 50% (v/v)
D lipophilic foodstuff
Concrete approach (4)
b) Clarification of conditions of contacts when using food simulants
c) Conduction of appropriate test conditions
Check of overall migration
Check of specific migration
Compliance testing
CHAPTER 1:
Testing for specific migration of materials and articles already in contact with food
CHAPTER 2:
Testing for specific migration of materials and articles not yet in contact with food
CHAPTER 3:
Correction factors applied when comparing migration test results with migration limits
Fat Reduction Factor (FRF)
www.ofi.at
Testing for specific migration: Time/Temperature
„special conditions“:
But max. 10 days/ 60°C
Ea...the worst case activation energy 80kJ/mol
R...8,31 J/Kelvin/mol
Testing for specific migration: Time/Temperature
For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions.
www.ofi.at
Testing for specific migration: Time/Temperature
Time/ Temperature – Standard conditions
Testing for 10 days at 20 °C shall cover all storage times at frozen condition.
Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including heating up to 70 °C/2 h, heating up to 100 °C /15 min.
Testing for 10 days at 50 °C shall cover all storage time at refrigerated and frozen conditions including heating up to 70 °C/2 h, or heating up to 100 °C/15 min and storage times of up to 6 months at room temperature.
Testing for 10 days at 60 °C shall cover long term storage above 6 months/room temperature and below including heating up to 70 °C/ 2 h, or heating up to 100 °C/15 min.
www.ofi.at
Testing for overall migration: Time/Temperature
Standardised testing conditions:
OM 5 covers OM1, OM2, OM3, OM4.‘worst case‘ conditions for all food simulants in contact with polyolefins.
OM1, OM2, OM3, OM4 and 5 covered!
`worst case`for non-polyolefines
OM1, OM2, OM3, OM4 and 5 covered! `worst case`for fatty food simulants in contact with non-polyolefines
www.ofi.at
Testing for overall migration: Time/Temperature
Substitute test for OM7 with food simulant D2 (2h/ 175 °C):
www.ofi.at
Practical approach (5)
Practical approach (6)
?
?
EC No. 10/2011 Annex I, Tab. 1; Annex II, Tab. 2:
www.ofi.at
Practical approach (8)
Sensory Evaluation/ Verification
Odor of packaging
As well as....
…appropriate transfer of test results in the declaration of conformity of the product of!
www.ofi.at
Additionally:
Identity and address of the business issuing the Declaration of compliance
Declaration of compliance for products from intermediate stages of production
Sufficient information about the used materials or their degradation products…(so far only adequate information on the substances used)
Information required in the presence of a functional barrier is now required in all cases (so far only in functional barriers made of plastic)
www.ofi.at
Plastic multi-layer materials and articles: (Article 13)
Option of using the 'functional barrier' - approach to individual plastic layers, if
No direct foodstuff contact given
Limit violation and / or
Conditions
NO Migration of the substances into food or food simulant should be detectable measured with statistical certainty by a method of analysis with a limit of detection of 0,01 mg/kg = 10 ppb (for structurally or toxicological related substances = Total limit)
Migration limit (OM, SML) observed in the total product
www.ofi.at
Dr. Johannes Bergmair
E: [email protected]
Brehmstraße 14a
1110 Wien