Serving society

Stimulating innovation

Supporting legislation

www.jrc.ec.europa.eu

Diana Rembges

Chemical Assessment and Testing Unit

European Reference Laboratory for Food Contact Materials

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Joint Research Centre

Institute for Health and Consumer Protection

Chemical Assessment and Testing Unit

Method Development

and Validation

Pollution Sources, Chemistry and

Modelling

Risk Analysis

Metabolomics Food Contact

Materials

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● Operating the Food Contact Materials European Reference Laboratory.

● Harmonising by developing analytical methods for detection and quantification of chemicals in food and consumer products.

● Developing tools for assessing human-health risk from different factors (chemicals, emissions, nanomaterials, noise…).

To protect the

consumers

Supporting policymakers

OUR OBJECTIVES

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Import-Export of dangerous chemicals: more than 3500 export notifications and ca. 231 import notifications

SCOEL (Scientific Committee on Occupational Exposure Limits) support activity in areas like aviation fuels, aviation engine oils, hydraulic fluids etc.

Impact: Our reports serve as basis for recommendations of occupational exposure limits for legislation/s

Biocides Product Directive:

3 guidance documents for public consultation and 27 Risk Assessment Reports of Biocides were finalised in 2012.

Impact: Essential guidance tools for the implementation of the Biocides Product Directive

Food and feed disinfectants

Wood preservatives

Rodenticides

Indoor Air Quality

Cluster 1

Cluster 2 Cluster 3

Cluster 4

Finalisation of the project SINPHONIE: Schools Indoor Pollution and Health Observatory Network in Europe

First European database containing 18 environmental parameters and 13 biological contaminants measured with harmonised methods from 120 schools over Europe (38 organisations from 25 countries) Impact: Capacity building by training (JRC) and supporting EU legislation on public health, consumer protection, noise and air pollution.

Support to innovation: safety by design

CLEAR-UP: Clean and Resource Efficient Buildings for Real Life

Develop photocatalysts

Develop paint

Reformulate paint and create a product

IN

DU

STR

Y

Testing efficiency of photocatalysts

Testing safety of the paint

Testing the new product

JR

C-I

HC

P-C

AT

0

5

10

15

20

25

Before optimization of paint components After optimization of paint components

Photocatalytic paint

Co

nc

en

tra

tio

n,

µg

/m3

Formaldehyde

Acetaldehyde

Acetone

Propanal

Butanal

Benzaldehyde

Hexanal

Health risk reduction

On textiles

Development of a new Differential Scanning Calorimetry (DSC) method for the quantification of binary mixtures PET/PTT (polyethylene terephthalate / polytrimethylene terephthalate) that cannot be quantified via chemical dissolution methods.

Impact: After validation this method will be introduced into the EU legislation on Textile Names and Labelling (EU Reg. 1007/2011).

On WINE AND SPIRITS

Development of methods to guarantee the wines and spirits authenticity.

Impact: Our methods are proposed as international standards and we provide essential support to MS.

On metabolomics

NIMAC : Non Invasive Monitoring of Asthmatic Children (in collaboration with Pediatric Dpt of Padova Hospital)

The gold standard to investigate airway inflammation in vivo is broncoscopy

with broncho-alveolar lavage and bronchial biopsy. These are invasive

techniques and cannot be routinely used.

Alternative technique for diagnostic purpose:

analysis of Exhaled Breath Condensate (EBC)

Collection of EBC is non-invasive, safe

and can easily be performed on children

which was measured by NMR technique.

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1. Setting the scene

2. Legal framework

3. European Reference Laboratory for Food Contact material (EURL-FCM)

Objectives and our network Migration test How do we work

What are Food Contact Materials?

Gloves, cutting

boards, etc

Food processing

equipment, tubing,

conveyor belts, etc Packaging,

Kitchenware,

utensils etc..

Types of food packaging materials

Conventional • Plastics, • Regenerated cellulose, • Paper and board, • Glass and ceramics, • Elastomers, • Metals, • Wood, textile, waxes etc. • Biobased: made from

renewable sources Eg polylactic acid

Active: acts on atmosphere inside package Intelligent: indicators that can follow quality during shelf life

Contamination from food packaging

• Prolonged contact between food and non-food material

• Possibility that ingredients from the packaging could be transferred into the food = migration

What is migration?

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

• May impact food in two ways

• Food safety – migration of harmful substances

• Food quality – migration of substances which impart taint or odour

Migration

Food Packaging

Factors affecting migration

Migration is a diffusion and partitioning process that is

dependent on:

• The nature of the food contact material (FCM)

Plastic, paper, coated metal etc

• The nature and concentration of the migrating

substance

Polar or non polar, volatile or not etc

• The nature of the foodstuff

Aqueous, fatty etc

• The nature, the extent and the type of contact between

the food contact material/article and the foodstuff

High temperature treatments, long shelf life etc.

Potential migrants from printing inks

• Binders (monomers)

• Colourants and pigments

• Solvents to dissolve pigments and resins

• Catalysts or initiators of UV curing

Potential migrants from paper & board

INGREDIENTS SUBSTANCES MIGRATING

Chlorine bleaches chlorophenols formation

Sizing agents waxes, starch derivatives

(strength of paper when wet)

Fat repellents fluoroalkyl polymers

Volatiles aldehydes, ketones

Potential migrants from (coated) metal

Epoxy and epoxy-phenolics

BADGE, BFDGE from the epoxy resin –

hydroxy and chlorinated derivates

Vinyl systems

vinyl chloride and vinyl acetate

Lacquers

Tinplate for cans

Tin, chromium Tin

Safety of Food Contact Materials

Prevent migration of chemicals to food in unsafe levels • Allow use of substances (toxicological data) • Impose limits of migration Overall migration + Specific migration for each

substance Testing: • Need of (harmonised) methods • Number of substances (> 3000) and materials • Testing = migration & (identification – quantification)

FCM legislation: positive list

List of substances not specific to final material

The EU SML are based on toxicology and exposure

The EU system is based in migration assuming that:

1 person of 60 kg

ingest daily 1 kg of food

in contact with 6 dm2 of surface

containing the substance at the maximum concentration

permitted (SML)

Food safety: who does what?

• Risk assessment:

• European Food Safety Authority (EFSA)

• Risk management:

• Commission DG Health and Consumer Protection (SANCO)

• Enforcement:

• Member States

Food contact safety: who does what?

• Monitoring and inspection:

• National Official Control Laboratories supported by National Reference Laboratories

• Scientific support:

• European Union Reference Laboratory (JRC)

• Regulation OFFC EC/882/2004 supported by Network of NRLs

Roles:

– Providing analytical methods

– Comparative testing

– Training

– Scientific/technical advice to

Commission

– Collaborating with third countries

Since 2004 also nominated as European

Reference Laboratories for food safety

under official feed and food controls

JRC role support to policies on food contact materials (e.g.

packaging, kitchenware, food processing equipments)

Official control

laboratories

National Reference Laboratory network

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Materials and articles

in contact with food

intended for food contact

expected to come into contact with food

Use of materials for

Food packaging

Kitchen- and tableware

Machines or articles used for food manufacture and processing

NOT

Antiques

Covering/coating materials that

− form part of the food and

− are consumed with the food

Fixed public or private water supply equipment

Framework Regulation (EC) No 1935/2004

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+ Coatings

Nitrosamines 93/11/EEC

Plastics (EU) No 10/2011

BADGE/BFDGE/NOGE 1895/2005/EC

Recycled plastics (EC) No 282/2008

Ceramics 84/500/EEC

Plastics Elastomers and rubbers

Active and intelligent materials (EC) No 450/2009

Regenerated cellulose film 2007/42/EC

Food contact materials (EC) No 1935/2004

Good manufacturing practice (EC) No 2023/2006

EU legislation for food contact materials

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Role

Established in Reg. 882/2004 on official controls for feed and food

Coordination of EU National Reference Laboratories and its network

Providing analytical methods to official controls and stakeholders

Organisation of comparative testing (proficiency; validation)

Training to National Reference Laboratories, third countries, FVO, EFSA

Scientific/technical advice to DG SANCO

Impact

Delivering robust analytical results

Harmonisation of analytical controls throughout EU

Better implementation of legal limits

Reduction of number of analyses in EU Member States

Safe food for European consumers 26

Scope of EU Reference Laboratory for FCM

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In foods: recognise a “migrant” in a forest of peaks

In food simulants: mimic “worst case” foods

10% aqueous ethanol (e.g. beer)

3% aqueous acetic acid (e.g. tomato soup with pH<4.5)

20% aqueous ethanol (e.g. ice creams)

50% aqueous ethanol (e.g. milk)

Vegetable oil (e.g. fresh fish)

Poly(2,6-diphenyl-p-phenylene oxide) (e.g. crystal sugar)

Migration test – compliance check

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Proficiency of official controls on kitchenware –

formaldehyde and melamine (70) and PAAs (29)

Impact: implementation of EU Reg. 284/2011 on

imports from China and Hong Kong

Validation of a new JRC method for testing migration

to dry food simulant (17) for a range of chemicals

Impact: Our validated method has become the

proposed standard for testing compliance of EU Reg.

10/2011 for migration into dry food

Inter-laboratory comparisons

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Source of

>500 analytical methods

>500 chemicals/materials

Available on request

Trainings for NRLs and third parties

China, Luxembourg, Hungary, Indonesia,

Singapore, Sweden, Thailand, Turkey,

Vietnam,

Food and Veterinary Office (DG SANCO)

EFSA

Hong Kong Accreditation body

Analytical methods and training

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Guidelines on technical implementation of legislation

Sampling and test conditions for kitchenware

Sampling and testing of polyamide and melamine kitchen utensils imported from China + HK

Impact: implementation of Reg. 284/2011

Applicability of generally recognised diffusion models for the estimation of specific migration

Impact: screening tool replacing analysis for compliance checking Reg. No 10/2011; industry

Performance criteria and validation procedures of analytical methods

Impact: harmonised approach by NRLs

Guidelines

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Baby bottles – polycarbonate and its replacements

Impact:

Review of bisphenol A migration from polycarbonate

Migration of chemicals from alternative materials

Migration of BPA far below legal limit

Identification of chemicals not listed in plastic Reg.

Foresight studies

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Hoekstra E.J., Simoneau C. (2013) Release of bisphenol A from polycarbonate: a review. Critical Reviews in Food Science and Nutrition 53(4), 386-402

Simoneau C., Van den Eede L., Valzacchi S. (2012) Identification and quantification of migration of chemicals from plastics baby bottles used as substitutes for polycarbonate. Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment 29(3), 469-480

Simoneau C., Valzacchi S., Morkunas V., Van den Eede L. (2011) Comparison of migration from polyethersulphone and polycarbonate baby bottles. Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment 28(12), 1763-1768

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FACET – Flavouring, Additives and Food Contact Materials Exposure Tool

validated software programme for modelling of food chemical intake

First tool for exposure assessment using validated models

High stakeholder interest: EFSA, OECD, FDA, ECHA

Test pilot FACET for the panels of EFSA and for the BPA exposure assessment

JRC will organise “train the trainers” for stakeholders in 2013 (EFSA, COM, MS CA, etc)

New data on food consumption already being fed into our EU Expofacts database

EU research projects

Technical guidelines for migration testing and migration modelling (Reg. 10/2011)

Active and intelligent materials –review and test methods (Reg. 450/2009)

Inter-laboratory comparisons

dry food simulant

polymer identification,

surface area kitchenware

Foresight studies

Metals from ceramics and glass

Primary Aromatic Amines from napkins

Current activities

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Thank you for your attention http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m

M.P Steven, Journal of Chemical Education, 1993, 444

Typical additives for plastics

Anti-oxidants

Plasticisers

Lubricants

Emulsifiers

Fillers

Flame retardants

Impact modifiers

Stabilisers

UV absorbers

Preservatives

Optical brighteners

Foaming agents

Release agents

etc