fera and the role of the nrl food contact materials and articles – analysis and migration testing

Our role

• Regulation– Policy and inspectorate functions for plant health, bee health

and plant varieties and seeds

• Research– Robust scientific research, analysis and evidence for

government and commercial customers worldwide

• Response– Advice, guidance and support as part of the UK’s capability to

respond and recover in emergency situations

Blue Sky Science:•Global Challenges •Discoveries•Emerging Technologies

End User:•Government•Industry•International Consumers

solving practical problems rather than acquiring knowledge for knowledge's sake

Upstream Upstream ResearchResearch

Downstream Downstream ResearchResearch

Translational Translational ResearchResearch

Our position

Proficiency testing

Food Authenticity

Food Contaminants

Environmental

Contaminants

Pesticides

Veterinary medicines

Packaging

Testing Standards

MycotoxinsNational

Reference Laboratory

Chemical residues

Food safety

• FSA appointed FERA as NRL for:– Food contact materials and articles– Dioxins and PCBs in food an feed– Mycotoxins in food– PAHs in food– Trace elements in food

Also some vet drugs and pesticides

– VMD and CRD

Fera – NRL

• NRLs are required (under 882/2004) to:– Collaborate with the EU-RL– Co-ordinate the activities of official control laboratories (Public

Analysts)– Organise where appropriate comparative tests between the

official control laboratories and ensure follow-up of such comparative testing

– Ensure the dissemination to the competent authority and official national control laboratories of information that the EU-RL supplies

– Provide scientific and technical assistance to the competent authority

Role of the NRL

http://www.fera.defra.gov.uk/scienceResearch/nationalReferenceLaboratory

Website

• What is migration and what factors influence it

• Legislation

• Migration testing

Analysis and migration testing

What is migration?

• The mass transfer from an external source into food by sub-microscopic processes

• May impact food in two ways– Safety – migration of harmful substances– Quality – migration of substances which impart taint or odour

• Migration occurs from:– Food packaging– Materials and articles used in food manufacture, transport and storage– Materials and articles used in food preparation and consumption

Factors affecting migration

• Migration is a diffusion and partitioning process that is dependent on:– The nature of the food contact material (FCM)– The nature and concentration of the migrating substance– The nature of the foodstuff– The nature, the extent and the type of contact between the

food contact material/article and the foodstuff

Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

EU legislation

2007/42/EC

Regeneratedcellulose film

Framework Regulation (EC) No 1935/2004

Plastics

(EC) No 2023/2006Good Manufacturing Practice

84/500/EEC

Ceramics,as amended

1895/2005/ECBADGE/BFDGE/

NOGE

93/11/EECNitrosamines

and nitrosatable substances

(EC) No 450/2009 Active and intelligent materials

(EU) No 321/2011 restriction of use of

Bisphenol A in plastic infant feeding bottles

(EU) No 284/2011 polyamide and melamine

plastic kitchenware

(EU) No 10/2011 Plastics Implementation

Measure, as amended/corrected

(EC) No 282/2008 Recycled plastics

Framework Regulation

• First step to harmonising legislation

• Defines what is meant by ‘food contact materials and articles’

• Two general principles– Inertness– Safety– Article 3


EU legislation

2007/42/EC



Plastics


84/500/EEC

Ceramics,as amended


NOGE




Regulation (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles

Regulation (EU) No 284/2011 polyamide and melamine plastic

kitchenware

Regulation (EU) No 10/2011 – Plastics Implementation Measure,

as amended/corrected

Plastics

• Principle of inertness– Overall migration limit (OML)

• Principle of safety– Specific authorisation of substances– EFSA evaluation – risk assessment– Commission – risk management decision– Specific migration limit (SML)– Maximum permitted quantity in the material or article per unit

area (QMA)

• Non-intentionally added substances

• Nanoparticles– Different toxicological properties – Substances should be assessed on a case-by-case basis – Risk assessment of the conventional particle size of a substance do

not cover engineered nanoparticles

• Functional barrier– Not CMR substances, not substances in nanoform

• Reduction factors

Other aspects

• Analysis of foods

• Analysis of the material or article

• Exposure to and analysis of food simulants– The material or article can be tested for its suitability before

use by employing food simulants that are intended to mimic the migration properties of different categories of foods

– Introduced in the early-1980’s along with the rules for using simulants

How do we test?

• If the packaging material is already in contact with the foodstuff then the foodstuff itself should be analysed to test for compliance with the SML(s)– The food should be removed from contact with the packaging

before its expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety

– If applicable food should be cooked in-pack prior to testing

Analysis of the foodstuff

Analysis of the foodstuff

• Not always possible– Some substances are ubiquitous and their presence does not

necessarily mean migration from the material or article– Some migrants react with food components– Some materials and articles are sold for use with many

different foodstuffs– Impossible to test each and every combination

• Residual content– The migration potential can be calculated based on the residual

content of migratable substances determined in a complete extraction of the material or article

– If the total concentration of the extracted substances is less that the OML then compliance is demonstrated

– If the worst case concentration in the food (assuming 100% transfer from the material or article tested) is less that the SML then compliance is demonstrated

• Screening tests– Solvent extraction (substitute test media)– Migration modelling

Analysis of the material or article

Migration into food simulants

• Select simulant based on food type

• Select exposure type

• Select exposure conditions – time and temperature

Simulant AbbreviationEthanol 10% (v/v) Simulant A

Acetic acid 3% (w/v) Simulant B

Ethanol 20% (v/v) Simulant C

Ethanol 50% (v/v) Simulant D1

Vegetable Oil Simulant D2

Modified polyphenylene oxides, particle size 60-80 mesh, pore size 200 nm

Simulant E for dry foods

Food simulants

Column 1 Column 2 Column 3

Reference number

Description of food Simulants

A B C D1 D2 E

08.05 Mustard (except powdered mustard under heading 08.17)

X X(*) X/3(**)

(*) simulant B can be omitted if the food has a pH of more than 4.5. (**) the testing in simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is no `fatty contact’ with the plastic food contact material3 = Simulant D-Reduction factor (updated based on scientific evidence)

Food simulants

• For water– Distilled water or equivalent

• For all foods– Simulant A, Simulant B, and Simulant D2

• For aqueous, alcoholic and milk– Simulant D1

• For aqueous, acetic and alcoholic up to 20%– Simulant B and Simulant C

Food simulants

• Total immersion

• Pouch

• Reverse pouch

• Article fill

Which exposure type?

Test Number

Contact time atContact

temperatureIntended food contact conditions

OM 1 10d at 20°C Frozen, refrigerated

OM2 10 d at 40°C long term storage including short term heating

OM3 2 h at 70°C Short term heating

OM4 1h at 100°C High temperature application

OM52 h at 100°C or at

reflux or1 h at 121°C

High temperature applications up to 121°C.

OM6 4 h at 100°C or at reflux

Any food contact conditions with food simulants A, B or C, at temperature exceeding 40°C.

OM7 2 h at 175°C High temperature applications with fatty foods

Test conditions for overall migration

Test Number

Contact time atContact

temperatureIntended food contact conditions

OM5 Food simulant E for 2 hours at 175°C

and Food simulant D2 for

2 hours at 100°C

High temperature applications only

OM 9 Food simulant E for 2 hours at 175°C

and Food simulant D2 for

10 days at 40°C

High temperature applications including long term storage at room temperature

In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9

Test conditions for overall migration

Conditions of contact in worst foreseeable use Test conditions

Contact temperature Test temperatureT 5 °C 5 °C

5 °C < T 20 °C 20 °C20 °C < T 40 °C 40 °C40 °C < T 70 °C 70 °C

70 °C < T 100 °C 100 °C or reflux temperature100 °C < T 121 °C 121 °C(*)121 °C < T 130 °C 130 °C (*)130 °C < T 150 °C 150 °C (*)150 °C < T < 175 °C 175 °C (*)

T > 175 °C Adjust the temperature to the real temperature at the interface with the food (*)

(*) This temperature shall be used only for food simulants D2 and E. For applications heated under pressure migration testing under pressure at the relevant temperature may be performed. 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 in Table1.

Test conditions for specific migration

Contact time in worst foreseeable use

Test time

t 5 min 5 min

5 min < t 0.5 hour 0.5 hour

0.5 h < t 1 hour 1 hour

1 hour < t 2 hours 2 hours

2 hours < t 6 hours 6 hours

6 hours < t 24 hours

24 hours

1day < t 3 days 3 days

3 days < t 30 days 10 days

Above 30 days See specific conditions

Specific conditions

Alternative 1Exp -9627 * (1/T1-1/T2) T1 frozen/cold 278 K (5°C) T1 room temperature 298 K (25°C)

Alternative 2Frozen: 10 days 20°CRefrigerated: 10 days 40°CRT/6 months: 10 days 50°CRT all: 10 days 60°C

Alternative 3Equilibrium at 10 days 40°C

Test conditions for specific migration

• Defines simulants

• Testing rules for overall migration– 7 standard test conditions– 2 alternative test conditions

• Testing rules for specific migration

• Screening approaches for demonstration of compliance

• Verification for demonstration of non-compliance, mandatory for official control

Rules for migration testing

• The results of specific migration testing obtained in food shall prevail over the results obtained in food simulant

• The results of specific migration testing obtained in food simulant shall prevail over the results obtained by screening approaches (residual content/extraction solvents/migration modelling)

Hierarchy of results

• Combination of contact times and temperatures

• Repeated use– Third test result used to demonstrate compliance– First test when conclusive proof of no increase and

compliant– First test when non-detectable

Specific migration testing


EU legislation – non-plastics

2007/42/EC



Plastics


84/500/EEC

Ceramics,as amended


NOGE




(EU) No 321/2011 restriction of use of



plastic kitchenware




Ceramics

• Much less complicated

• Limits for lead and cadmium release• Depend on article type

• Only one simulant/test condition4% (v/v) acetic acid for 24 hours at 22°C

• Test methods defined in the Directive

Regenerated cellulose film

• RCF is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton

• To meet technical requirements substances may be added– Specifications given on permitted content– RCF, softeners, additives– Lists of authorised softeners and additives– Regenerated cellulose film may be coated on one or both

sides

Elastomer or rubber teats

• The release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers is restricted by Directive 93/11/EEC

BADGE/BFDGE/NOGE

• The restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food is given in Commission Regulation (EC) No 1895/2005 of 18 November 2005

Others?

• Paper and Board

• Glass

• Wood

• Cork

• Metals and alloys

• Textiles

• Adhesives

• Ion exchange resins

• Printing inks

• Silicones

• Varnishes and coatings

• Waxes


EU legislation – other recent developments

2007/42/EC



Plastics


84/500/EEC

Ceramics,as amended


NOGE



(EC) No 450/2009 Active and intelligent

materials

(EU) No 321/2011 restriction on use of



plastic kitchenware




• Recycled materials

• Active and intelligent food packaging

Recent developments

• Baby bottles

• Polyamide and melamine-ware imported from China and Hong Kong

Recent developments

fera and the role of the nrl food contact materials and articles – analysis and migration testing

Documents

food manufacture

food preparation

food packagingmaterials

food contact materialarticle

nrl food contact materials

type of contact

bee health

articles analysis