What is a food contact material (FCM)?

Ø Intended to be brought into

contact with food
Ø Already in contact with food
and intended for that purpose
Ø Can reasonably be expected to be
brought into contact with food or
to transfer constituents to
food under normal or foreseeable
conditions of use
Ø Examples:
Ø food packaging, kitchenware and tableware, food
processing equipment, work surfaces, …
 What is a food contact material?
(continued)
• FCM legislation:
• covers chemical risks of substances migrating from the
contact material to the food,
• it does not cover other risks for instance hygiene, risks
due to foreign bodies (glass splinters),…
• states that materials and articles, shall be manufactured so
that, under normal or foreseeable conditions, they do not
transfer their constituents to food in quantities which
could endanger human health
• does not require direct food contact, it is the potential
transfer which is important à Contact can be direct or
indirect
EU Framework legislation:
Regulation (EC) No 1935/2004
Food contact materials must not:
Ø Endanger human health
Ø Bring about an unacceptable change
in the composition of the food
Ø Bring about a deterioration in the
organoleptic characteristics

Definitions, specific measures, role of EFSA and

authorisation procedure, labelling, traceability,
declaration of compliance (DoC)
 legislative
overview
Framework Regulation GMP Regulation
All FCM

(EC) No 2023/2006
(EC) No 1935/2004
requirements for Good
General requirements for all

ê
Manufacturing Practices
FCM + Mandate for specific
measures Applicable to all FCM

ê ê
SPECIFIC UNION MEASURES
ê ê
• Materials • Substances
Specific FCM

• Ceramics • Vinyl chloride

• Regenerated cellulose monomer
film • Nitrosamines
• Plastics • BADGE, BFDGE &
• Recycled plastics NOGE
• Active and intelligent
Materials

(national legislation, if existing, applies to materials

for which no specific Union measures exist)
 Framework Regulation (EC) No 1935/2004
ê
SPECIFIC MEASURES – 'toolkit' provided by the FWR
ê ê ê
POSITIVE LISTS RESTRICTIONS OF USE PROHIBITION OF USE
(referred to as 'Union Lists' • Migration limits in plastics • BFDGE and NOGE in
in legislation) • Leaching limits for cadmium plastics, coatings and
• Positive list of plastic and lead ceramics adhesives
monomers and additives • Nitrosamines limits in rubber
• Bisphenol A in infant
• Positive list of substances teats and soothers
feeding bottles
in regenerated cellulose • BADGE limits in plastics,
film (cellophane) coatings and adhesives • Certain Phthalates in
• List of active and • Residual content of FCM intended for infants
intelligent substances substances in plastics or & young children
(Future) cellophane
• Substances which are
individual decisions, registry not on a Positive list
Authorization of plastic that are not covered by
recycling processes a derogation
(Future)
 Plastics Regulation
(EU) No 10/2011

• specific measure for plastics

• covers exclusively plastics
• plastic multilayers bound by adhesives
• Plastic layers, coatings forming gaskets
• Plastic layers in multi-materials

• All plastics can be coated and/or printed

• covered by national legislation
• Adhesives
• Printing Inks
• Coatings
 Plastics Regulation
(EU) No 10/2011

• Only substances in Union list can be used to

manufacture plastic FCM
• listing only after Safety evaluation by the European Food
Safety Authority
• Evaluates the use of the substance in the food contact
material
• Non-tox evaluation: focus on use of substance in FCM
• tox evaluation: focus on the toxicity, basis for migration limit
• Evaluation on-going for over 30 years.
Union list

• General Information
• identity (FCM number, CAS, PM REF, name)
• use of the substance (monomer, additive)

• Requirements
• Restrictions (SML, group restrictions, QM, use)
• specifications (impurities, use)
• notes on compliance

https://webgate.ec.europa.eu/sanco_foods/main/?event=display
 Plastics Regulation
(EU) No 10/2011

• Other important provisions of the plastics

regulation:
• suitability
• compositional requirements (including migration limits)
• derogations (some substances subject to national law)
• testing procedures
• declaration of compliance + supporting documentation
Plastic recycling

Why regulate recycled plastics?

Virgin plastic regulated by 10/2011

However: Plastic packaging waste

may contain residues from previous use,
contaminants from misuse and contaminants from
non-authorised substances

Chemical recycling and recycled plastic behind functional

barrier outside the scope of this Regulation
Recycling Process

Input Process Output

PET from e.g. 1-3 Critical Cleaning Steps e.g. Sales of

Collection Shredding, Parameters to be Extrusion, recycled
Washing, controlled Packaging, PET
Sorting, … Mixing, …

•Critical cleaning steps subject to EFSA

evaluation