Food Contact Compatibility Safety

Ref.
Ares(2020)1618949 - 17/03/2020
Deliverable 6.3
Food contact compatibility safety

testing according to the relevant
regulatory standards
Deliverable nature: Report

Dissemination level: (confidentiality) Public
WP number 6
Lead Beneficiary CTME
Development and Commercialisation of a complete compostable film

packaging system
Project information
Grant Agreement number: 869301
Project acronym: NatureFresh
Starting date: 01 July 2019
PROJECT CONSORTIUM
GRUPPO FABBRI VIGNOLA S.P.A. (GRUPPO FABBRI)
ESPERA-WERKE GMBH (ESPERA-WERKE)
G. F. PACKAGING ESPAÑA, SA (TEIXPAC)
FUNDACIÓN CENTRO TECNOLÓGICO DE MIRANDA DE EBRO (CTME)
NatureFresh_PN: 869301 H2020-EIC-FTI-2018-2020
Table of Contents
1 Introduction ...................................................................................................................... 5
2 EU framework Regulation ............................................................................................... 6
2.1 DEFINITIONS ...................................................................................................................................... 8

2.2 SCOPE OF APPLICATION ...................................................................................................................... 11
2.2.1 Exclusions............................................................................................................................ 12
2.3 REQUIREMENTS ................................................................................................................................ 13
2.3.1 Declaration of Compliance.................................................................................................. 14
2.3.2 Union list of approved active substances ........................................................................... 16
2.3.3 Good manufacturing practice (GMP).................................................................................. 22
2.3.4 Migration tests ................................................................................................................... 23
3 US framework Regulation ............................................................................................. 29
3.1 APPROVAL OF FOOD CONTACT MATERIALS .............................................................................................. 31

3.2 PREMARKET NOTIFICATION FOR A FOOD CONTACT SUBSTANCE (FCN) .......................................................... 34
3.3 GRAS NOTIFICATION PROGRAM .......................................................................................................... 36
4 NatureFresh project ....................................................................................................... 38
4.1 PACKAGING...................................................................................................................................... 38
4.1.1 Procedure for action ........................................................................................................... 38
4.1.2 Union list and Specific Migration Limit (SML) ..................................................................... 39
4.1.3 Test to be performed .......................................................................................................... 39
4.2 LABEL ............................................................................................................................................. 48
5 Conclusions ..................................................................................................................... 52
6 References........................................................................................................................ 53
7 Annex I. Union list and SML ......................................................................................... 55
7.1 MODIFICATIONS AND UPDATES .......................................................................................................... 110

7.1.1 Commission Regulation (EU) No 1282/2011 of 28 November 2011 ................................. 110
7.1.3 Commission Regulation (EU) No 202/2014 of 3 March 2014 ........................................... 116
7.1.4 Commission Regulation (EU) 2015/174 of 5 February 2015 ............................................. 117
7.1.5 Commission Regulation (EU) 2016/1416 of 24 August 2016 ............................................ 120
7.1.6 Commission Regulation (EU) 2017/752 of 28 April 2017.................................................. 123
7.1.7 Commission Regulation (EU) 2018/79 of 18 January 2018............................................... 124
7.1.8 Commission Regulation (EU) 2018/213 of 12 February 2018 ........................................... 125
7.1.9 Commission Regulation (EU) 2018/831 of 5 June 2018 .................................................... 126
7.1.10 Commission Regulation (EU) 2019/37 of 10 January 2019 .......................................... 127
7.1.11 Commission Regulation (EU) 2019/1338 of 8 August 2019 ......................................... 128
8 Annex II. Group restriction of substances ................................................................. 129
8.1 MODIFICATIONS AND UPDATES .......................................................................................................... 132

8.1.3 Commission Regulation (EU) No 202/2014 of 3 March 2014 ........................................... 132
8.1.4 Commission Regulation (EU) 2015/174 of 5 February 2015 ............................................. 132
Deliverable 6.3 2
8.1.5 Commission Regulation (EU) 2016/1416 of 24 August 2016 ............................................ 132

8.1.6 Commission Regulation (EU) 2019/37 of 10 January 2019............................................... 133
9 Annex III. Form 3480 – FCN....................................................................................... 134
List of Figures
FIGURE 1. DECISION TREE FOR TESTING ................................................................................................................ 40
FIGURE 2. CONDITIONS FOR THE GROWTH OF MICROORGANISMS.............................................................................. 41
FIGURE 3. COLD CHAIN ALONG THE PACKAGED FOOD SUPPLY CHAIN .......................................................................... 41
FIGURE 4. PERMEABILITY SCHEME IN PACKAGING ................................................................................................... 45
List of Tables
TABLE 1. LIST OF FOOD SIMULANTS ..................................................................................................................... 24
TABLE 2. CONTACT TIME ................................................................................................................................... 26
3
TABLE 3. CONTACT TEMPERATURE ..................................................................................................................... 26
TABLE 4. FOOD SIMULANT ASSIGNMENT FOR DEMONSTRATING COMPLIANCE WITH THE OVERALL MIGRATION LIMIT ............ 27
TABLE 5. STANDARDISED TESTING CONDITIONS...................................................................................................... 28
TABLE 6. US LEGISLATIVE OVERVIEW .................................................................................................................. 29
TABLE 7. LIST OF FOOD SIMULANTS – NATUREFRESH PROJECT .................................................................................. 42
TABLE 8. CONTACT TIME – NATUREFRESH PROJECT................................................................................................ 43
TABLE 9. CONTACT TEMPERATURE – NATUREFRESH PROJECT ................................................................................... 43
TABLE 10. GLOBAL MIGRATION TEST PROGRAM FOR THE SAMPLE ............................................................................. 50
TABLE 11. FOOD SIMULANT ASSIGNMENT FOR DEMONSTRATING COMPLIANCE WITH THE OVERALL MIGRATION LIMIT –
NATUREFRESH PROJECT .......................................................................................................................... 50
TABLE 12. STANDARDISED TESTING CONDITIONS – NATUREFRESH PROJECT ................................................................ 51
TABLE 13. SPECIFIC MIGRATION TEST PROGRAM FOR THE SAMPLE ............................................................................. 51
TABLE 14. UNION LIST OF AUTHORISED SUBSTANCES .............................................................................................. 56
TABLE 15. GROUP RESTRICTION OF SUBSTANCES ................................................................................................. 129
TABLE 16. SUMMARY OF MIGRATION TESTING ................................................................................................... 142
Deliverable 6.3 3
Glossary
ADI Average Daily Intake
BADGE Bisphenol A diglycidyl ether
BFDGE Bisphenol F diglycidyl ether
BPA Bisphenol A
BPF Bisphenol F
C.F.R. Code of Federal Regulations (in US)
Da Dalton, unified atomic mass unit
DoC Declaration of Compliance
EFSA European Food Safety Authority
ESG Electronic Submission Gateway (in US)
EU European Union
FCM Food Contact Materials
FCN Food Contact Notification (in US)
FDA Food and Drug Administration (in US)
FMF Food Master File (in US)
FRF Fat Consumption Reduction Factor
GMP Good Manufacturing Practice
GRAS Generally Recognized as Safe (in US)
MPPO Poly(2,6-diphenyl-p-phenylene oxide)
ND Non-Detectable
NIAS Non-intentionally added substances
NOGE Novolac glycidyl ethers
OML Overall Migration Limit
PHB Polyhydroxybutyrate
PLA Polylactic acid
PNC Pre-Notification Consultation (in US)
PPA Polymer Production Aids
SML Specific Migration Limit
SML(T) Total Specific Migration Limit
TOR Threshold of regulation
US United States
Deliverable 6.3 4
1 Introduction
This document contains deliverable D6.3 “Food contact compatibility safety testing
according to the relevant regulatory standards” of the NatureFresh project, associated
to the WP6 “Regulatory Approvals, Environmental Impact and Life Cycle Analysis”, Task
6.1 and Task 6.4.
 Task 6.1 Evaluate the European regulatory requirement landscape related to
the compostability; food packaging, food contact, transport and storage (Ref.
Reg. (EC) No 1935/2004, Reg. (EU) No 10/2011, Reg. (EC) No 2023/2006),
transport and storage.
 Task 6.4 Identify the content of the declaration of conformity for film and label
to be published to fully satisfy the regulation in Europe (Ref. Reg. (EU) No
10/2011, Annex IV).
Nature Fresh project is funded under the Grant Agreement number 869301. The
objective of the project is to provide to retailers and food processors with a complete
compostable film packaging solution to improve environmental sustainability of the
fresh food packages sold to the common public and reduce overall the use of plastic.
The Consortium aims to carry out the commercial scale manufacturing of the
compostable film, the design and development of the automatic wrapping machines,
the design and development of compostable label and gain the regulatory approvals.
Food contact materials should be produced in accordance with Good Manufacturing

Practice (GMP) and must be inert and not transfer any of their constituents into food
in quantities which could endanger human health and affect the purity of the food by
causing an unacceptable change in its composition or deterioration in its organoleptic
characteristics.
This document aims at providing guidance and information to be generated and

exchanged in the supply chain in compliance with the Regulation (EU) No 10/2011 of
14 January 2011 on plastic materials and articles intended to come into contact with
food, in the framework of NatureFresh project.
Deliverable 6.3 5
2 EU framework Regulation
Because of its importance to human health, food safety, and thus the safety of food
contact materials (FCM), is a crucial factor for the legislation. There are several
legislative texts concerning the obligations and/or restrictions of food contact
materials:
 European Parliament and Council Directive 94/62/EC of 20 December 1994 on

packaging and packaging waste.
 Regulation (EC) No 178/2002 of the European Parliament and of the Council of

28 January 2002 laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety.
 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of

27 October 2004 on materials and articles intended to come into contact with
food and repealing Directives 80/590/EEC and 89/109/EEC.
 Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the

restriction of use of certain epoxy derivatives in materials and articles intended
to come into contact with food.
 Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good

manufacturing practice for materials and articles intended to come into contact
with food.
 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic

materials and articles intended to come into contact with food Text with EEA
relevance. This Regulation has been changed several times since its publication:
o Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011.
o Commission Regulation (EU) No 1282/2011 of 28 November 2011.
o Commission Regulation (EU) No 1183/2012 of 30 November 2012.
o Commission Regulation (EU) No 202/2014 of 3 March 2014.
o Commission Regulation (EU) No 865/2014 of 8 August 2014.
o Commission Regulation (EU) No 2015/174 of 5 February 2015.
Deliverable 6.3 6
o Commission Regulation (EU) No 2016/1416 of 24 August 2016.

o Commission Regulation (EU) No 2017/752 of 28 April 2017.
o Commission Regulation (EU) 2018/79 of 18 January 2018.
o Commission Regulation (EU) 2018/213 of 12 February 2018.
o Commission Regulation (EU) 2018/831 of 5 June 2018.
o Commission Regulation (EU) 2019/37 of 10 January 2019.
o Commission Regulation (EU) 2019/988 of 17 June 2019.
o Commission Regulation (EU) 2019/1338 of 8 August 2019.
The principle underlying this Regulation is that any material or article intended to
come into contact directly or indirectly with food must be sufficiently inert to preclude
substances from being transferred to food in quantities large enough to endanger
human health.
All plastic materials which are marketed in the European Union should comply, in
addition to the specific regulations (Regulation (EU) No 10/2011), with that established
in the Framework Regulation (EC) No 1935/2004 which lists the general requirements
to be met by materials and articles intended to come into contact with food. In
addition they should be manufactured in accordance with Regulation (EC) No
2023/2006 which lays down good manufacturing practices applicable to all materials in
contact with foods.
Plastic materials and articles must not release their constituents to the food in
quantities higher than those established. Therefore, specific migration limits are
established, for certain substances, and global migration limits, together with
migration tests to demonstrate the compliance of the material. In many cases there is
confusion about how to carry out migration controls, what types of analyses need to
be done or what information should be included in a Declaration of Compliance (DoC).
When business operators wish to use a certain substance in a FCM, they have
to submit an application for authorisation to the competent national authority that
will transmit the application to the European Food Safety Agency (EFSA).
Deliverable 6.3 7
2.1 Definitions
 Traceability: the ability to trace and follow a material or article through all stages
of manufacture, processing and distribution.
 Active food contact materials and article: means materials and articles that are
intended to extend the shelf-life or to maintain or improve the condition of
packaged food. They are designed to deliberately incorporate components that
would release or absorb substances into or from the packaged food or the
environment surrounding the food.
 Intelligent food contact materials and articles: means materials and articles which
monitor the condition of packaged food or the environment surrounding the food.
 Adhesion: is the force of attraction between molecules in different layers.
 Cohesion: is the force of attraction between molecules within the same layer.
 Adhesives: means non-metallic substance capable of joining materials by surface

bonding (adhesion), and the bond possessing adequate internal strength
(cohesion).
 Blend: is any mixture of plastics in the same physical state, each of which is
capable of functioning as a main structural component of finished materials and
articles.
 Coating: means a non-self-supporting layer composed of substances applied on an

already existing substrate in order to impart special properties or improve
technical performances of the finished article.
o Inorganic surface coating: means a non-self-supporting layer composed of

inorganic substances applied on an already existing substrate, e.g. a silicon
dioxide coating.
o Organic surface coating: means any resinous or polymerised preparation

which is converted to a thin, solid polymer layer used to provide a functional
effect on a surface and which is not capable of acting by itself as a main
structural component of a final material and article.
Deliverable 6.3 8
 Coating: means a non-self-supporting layer composed of substances applied on an

already existing substrate in order to impart special properties or improve
technical performances of the finished article.
 Ion exchange resin: covers ion exchange and adsorbent resins, made of synthetic
organic macromolecular components, which can be used in the processing of
foodstuffs to bring about exchange of ions or adsorption of foodstuffs
constituents. They do not include, however, cellulosic ion exchangers.
 Layer: means a homogenous continuous or semi-continuous material of defined

composition that is extended in two dimensions separated by an interface from
another homogenous continuous or semi-continuous material of a defined but
different composition.
 Masterbatch: means a preparation of one or more polymers which encapsulate a

high concentration of ingredients like colorants, fillers, fibres or stabilizers that
influence the physical properties of the final preparation. A masterbatch is
intended to be blended with a polymer and not used to make an article as such.
 Migration modelling: means a calculation of the specific migration level of a

substance based on the residual content of the substance in the material or article
applying generally recognised diffusion models. These are based on scientific
evidence overestimating real migration and taking into account the Guidance
document on migration modelling.
 Migration test: means the determination of the release of substances from the
material or article either into food or into a food simulant.
 Oligomer: means a substance consisting of a finite number of repeating units

which has a molecular weight of less than 1 000 Da.
 Product from intermediate stages of manufacture also referred to as Plastic

intermediate materials: means a plastic powder, granules or flakes (including
masterbatch), pre-polymer (excluding Article 6(3) (d) of the Plastics Regulation),
any semi-finished material and article such as a film, sheet or laminate requiring
further processing/re-formulation steps to become a “finished” material or article.
Deliverable 6.3 9
In short, this is any product which is not a basic chemical and not yet a finished
plastic material or article.
 Polymeric additive: means any polymer which is used as an additive having a

physical or chemical effect in the plastic and which cannot be used in the absence
of other polymers as a main structural component of finished materials and
articles.
 Pre-polymer: is a polymer of relatively low molecular weight, usually an

intermediate between the monomer and the final polymer or resin.
 Printing inks: are mixtures of colorants with other substances which are applied on
materials to form a print design on this material.
 Set-off: is the phenomenon of the transfer of substances from outer layer of

materials and articles to the inner food contact layer through direct contact and
not via diffusion through the material. Set-off may occur, where there is a contact
between the outside and inside of the material or article during, for example,
storage or transport. Such direct contact may occur when materials are wound in
reels or stacked in sheets or when articles such as trays and pots are nested inside
each other. Unlike migration under these conditions, set-off may occur in both
materials and articles with or without a functional barrier.
 Single use article: means an article intended to be used once and coming into
contact with not more than a single portion of foodstuffs during its lifetime. (Food
packaging should be regarded as single use article, even if the consumer may re-
use it. This includes, for example, lids for jars. Disposable gloves should be
regarded as single use articles, even if the user may be in contact with several
portions of food with them).
 Surface biocide: means a substance intended to keep the surface of a material or

article free from microbial contamination, but which is not intended to have a
preservative effect on the food itself.
Deliverable 6.3 10
2.2 Scope of application
Commission Regulation (EC) No 1935/2004 shall apply to materials and articles,

including active and intelligent food contact materials and articles, which in their
finished state:
 Are intended to be brought into contact with food, or
 Are already in contact with food and were intended for that purpose, or
 Can reasonably be expected to be brought into contact with food or to transfer
their constituents to food under normal or foreseeable conditions of use.
Materials and articles, including active and intelligent materials and articles, shall be
manufactured in compliance with good manufacturing practice so that, under normal
or foreseeable conditions of use, they do not transfer their constituents to food in
quantities which could:
 Endanger human health, or
 Bring about an unacceptable change in the composition of the food, or
 Bring about deterioration in the organoleptic characteristics thereof.
Without prejudice to the specific measures, materials and articles, which are not yet in
contact with food when placed on the market, shall be accompanied by:
 The words ‘for food contact’ or a specific indication as to their use,
such as the following symbol. This information shall not, however,
be obligatory for any articles which, because of their
characteristics, are clearly intended to come into contact with food.
 If necessary, special instructions to be observed for safe and appropriate use.
 The name or trade name and, in either case, the address or registered office of
the manufacturer, processor, or seller responsible for placing on the market
established within the Community.
 Adequate labelling or identification to ensure traceability of the material or
article.
Active and intelligent materials and articles already brought into contact with food
shall be adequately labelled to allow identification by the consumer of non-edible
parts.
Deliverable 6.3 11
to be met by materials and articles intended to come into contact with food. In
addition they should be manufactured in accordance with Regulation (EC) No
2023/2006 which lays down good manufacturing practices applicable to all materials in
contact with foods.
Plastic materials and articles include the following types of products:
 Plastic intermediate materials (e.g. resins and films for further conversion) and
those which already have their final composition, but still require mechanical
re-shaping to reach their final article shape, without any modification of the
formulation (e.g. thermo-formable sheets and bottle pre-forms).
 Final plastic food contact material or article ready to come into contact with
food (e.g. packaging material, food storage container, kitchenware or utensil,
plastic part in food-processing machinery, food preparation surface, inner
surface of fridge, baking trays).
 Finished plastic components of the final food contact material or article which
only need to be brought together or assembled, either during packing/filling or
before, to make the final article (e.g. bottle and cap, tray and lid, parts of
kitchenware or food processing machinery).
 Plastic layers inside a finished multi-material multi-layer.
The Plastics Regulation covers bio-based and bio-degradable plastics if they are
manufactured with synthetic polymers, chemically modified natural or synthetic
polymers or polymers manufactured by microbial fermentation. Adding an additive to
a natural macromolecule is not a chemical modification. The chemical modification has
to occur to the macromolecule itself.
2.2.1 Exclusions
The Plastics Regulation does not apply to:
Deliverable 6.3 12
 Varnished or unvarnished regenerated cellulose film, covered by Commission

Directive 2007/42/EC8.
 Rubber.
 Paper and paperboard, whether modified or not by the addition of plastics.
 Surface coatings obtained from:
o Paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline
waxes,
o Mixtures of the waxes listed in the previous indent with each other and/or
with plastics.
 Ion-exchange resins.
 Silicones.
In particular, the Regulation (EC) No 1935/2004 shall not apply to:

 Materials and articles which are supplied as antiques.
 Covering or coating materials, such as the materials covering cheese rinds,
prepared meat products or fruits, which form part of the food and may be
consumed together with this food.
 Fixed public or private water supply equipment.
2.3 Requirements
17 groups of Food Contact Materials are identified:
 Active and intelligent materials  Paper and board

and articles  Plastics
 Adhesives  Printing inks
 Ceramics  Regenerated cellulose
 Cork  Silicones
 Rubbers  Textiles
 Glass  Varnishes and coatings
 Ion-exchange resins  Waxes
 Metals and alloys  Wood
Deliverable 6.3 13
Specific measures are required for these groups of materials and article: “Materials
and articles must be accompanied by a written declaration stating that they comply
with the rules applicable to them”.
Currently, of the 17 groups of food contact materials, specific legislation at EU level,

has only been developed for: active and intelligent materials and articles, ceramics,
plastics and regenerated cellulose.
The business operator must provide the authorities, when requested, with the relevant
documents proving that materials and articles, the products from intermediate
manufacturing processes and the substances for the manufacture of these materials
and articles comply with the requirements contained in the Commission Regulation UE
10/2011. These Supporting Documents are generated and kept by the business
operator who is issuing the Declaration of Compliance. They are not intended to be
passed along the supply chain but should be made available to the competent
authorities on request.
The traceability of materials and articles shall be ensured at all stages in order to
facilitate control, the recall of defective products, consumer information and the
attribution of responsibility.
2.3.1 Declaration of Compliance
The manufacturer of a food contact material should reassure the customer that the
food contact material complies with the applicable EU and national legislation. Each
manufacturer has to declare compliance for the manufacturing steps under his
responsibility.
At the marketing stages, other than at the retail stage, plastic materials must be
accompanied by a statement of compliance. In addition, business operators shall have
the appropriate documentation to demonstrate that the products are compliant.
The Declaration of Compliance shall contain the following information:
Deliverable 6.3 14
 The identity and address of the business operator issuing the declaration of
compliance.
 The identity and address of the business operator which manufactures or

imports the plastic materials or articles or products from intermediate stages
of their manufacturing or the substances intended for the manufacturing of
those materials and articles.
 The identity of the materials, the articles, products from intermediate stages
of manufacture or the substances intended for the manufacturing of those
materials and articles.
 The date of the declaration.
 Confirmation that the plastic materials or articles, products from intermediate

stages of manufacture or the substances meet relevant requirements laid
down in this Regulation and Regulation (EC) No 1935/2004;
 Adequate information relative to the substances used or products of

degradation thereof for which restrictions and/or specifications are set out in
Annexes I and II to the Commission Regulation (EU) No 10/2011 to allow the
downstream business operators to ensure compliance with those restrictions.
 Adequate information relative to the substances which are subject to a

restriction in food, obtained by experimental data or theoretical calculation
about the level of their specific migration and, where appropriate, purity
criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC
to enable the user of these materials or articles to comply with the relevant
EU provisions or, in their absence, with national provisions applicable to food.
 Specifications on the use of the material or article, such as:
o Type or types of food with which it is intended to be put in contact.
o Time and temperature of treatment and storage in contact with the food.
o Ratio of food contact surface area to volume used to establish the

compliance of the material or article.
Deliverable 6.3 15
 When a functional barrier is used in a multi-layer material or article, the

confirmation that the material or article complies with the requirements of
Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.
It is recommended that the DoC and the Adequate Information are issued in one or
more EU languages that are easily understood both by the supplier and by the
customer. The information given has to be clear and distinct.
The DoC does not necessarily need to be physically attached to the goods, nor need it
be sent out every time a customer receives a repeat order of the same goods. Instead
it should be made available to the customer either 12/32 in paper form or
electronically or subject to the agreement of the customer via download from a
website.
National legislation may provide for a DoC for all materials and articles which are not
subject to specific measures at Union level. Therefore, national legislation should be
checked for the necessity to issue a DoC for adhesives, printing inks, coatings and non-
plastic materials used in multi-material multilayers.
2.3.2 Union list of approved active substances
Only the substances included in Annex I of Regulation 10/2011 may be used in the
manufacture of plastic layers in plastic materials and articles, including: monomers or
starting substances, additives (excluding colorants), production aids (except solvents)
and macromolecules obtained from microbial fermentation. However, there are some
exceptions.
Certain substances are not subject to authorisation and listing in the Union list. These
substances include the following substance classes:
 Non-intentionally added substances
o Impurities present in authorised substances
o Reaction products generated during the production of plastic materials
and articles and resulting from the contact with food
Deliverable 6.3 16
o Degradation products generated during the production or storage of

the plastic materials and articles
 Aids to polymerisation
 Polymer production aids including solvents that are not included in the Union
list
 Colorants
 Substances used behind a functional barrier
For these substances, it is within the responsibility of the business operators to ensure
compliance with the general rules of the Framework Regulation. Therefore, business
operators have to be able to demonstrate the absence of risk for human health by
performing a risk assessment based on internationally recognized scientific principles
on risk assessment. These principles include hazard characterisation and exposure.
Information on this risk assessment should be part of the DoC and supporting
documentation.
Each substance has only one unique substance ID consisting of up to 5 digits. This FCM
substance No will be used consistently throughout the food contact materials area.
Substances used in the manufacture of plastic layers in plastic materials and articles
shall be subject to the following restrictions and specifications:
 Specific migration limits. The specific migration in food or food simulant shall
not exceed 60 mg/kg food before application of the Fat Consumption
Reduction Factor (FRF) (Regulation 2016/1416 of 24 August 2016 amending and
correcting Regulation (EU) No 10/2011 on plastic materials and articles
intended to come into contact with food).
As specific migration limits are expressed in mg/kg food, the same
measurement unit should also be used for the verification of compliance of a
cap or closure, as a consistent approach avoids the potential for conflicting
results. It is therefore appropriate to remove the option to express the
migration from caps or closures in mg/dm2.
Deliverable 6.3 17
 Overall migration limit. Plastic materials and articles shall not transfer their
constituents to food simulants in quantities exceeding 10 milligrams of total
constituents released per dm2 of food contact surface. Plastic materials and
articles intended to be brought into contact with food intended for infants and
young children shall not transfer their constituents to food simulants in
quantities exceeding 60 milligrams of total of constituents released per kg of
food simulant.
 Restrictions and specifications. Specific for each substance.
 Restrictions on materials and articles. Plastic materials and articles shall not
release the following substances in quantities exceeding the specific migration
limits below1:
o Aluminium = 1 mg/kg food or food simulant.
o Barium = 1 mg/kg food or food simulant.
o Cobalt = 0.05 mg/kg food or food simulant.
o Copper = 5 mg/kg food or food simulant.
o Iron = 48 mg/kg food or food simulant.
o Lithium = 0.6 mg/kg food or food simulant.
o Manganese = 0.6 mg/kg food or food simulant.
o Nickel = 0.02 mg/kg food or food simulant.
o Zinc = 5 mg/kg food or food simulant.
Primary aromatic amines which are not included in the Union list shall not
migrate or shall not otherwise be released from plastic materials and articles
into food or food simulant in accordance with Article 11(4) of the
Regulation (EU) No 10/2011. The detection limit referred to in the second
subparagraph of Article 11(4) applies to the sum of primary aromatic
amines released.
In these cases conformity is assessed in accordance with internationally
recognised scientific principles on risk assessment.
1
Commission Regulation (EU) No 2016/1416 of 24 August 2016
Deliverable 6.3 18
In a plastic multi-layer material or article, the composition of each plastic layer shall
comply with the Regulation (EU) No 10/2011. Nevertheless, a plastic layer which is not
in direct contact with food and is separated from the food by a functional barrier, may:
 Not comply with the restrictions and specifications set out in this Regulation
except for vinyl chloride monomer as provided in Annex I; and/or
 Be manufactured with substances not listed in the Union list or in the

provisional list.
The Plastics Regulation requires that migration of authorised substances and certain
other substances should not exceed the established migration limits; it is
recommended that Adequate Information is provided by the manufacturers of
adhesives, printing inks and coatings that allows the manufacturer of the final plastic
article to establish compliance with the Plastics Regulation for these substances.
New substances can be added to the Union list. The procedure for authorisation
requires an application which is sent to a national competent authority. The national
contact points will forward the application to the European Food Safety Authority
(EFSA). Following a favourable EFSA opinion, the Commission will make a decision on
the authorisation of the substance, taking into account this opinion, as well as other
relevant factors. If it is concluded that a substance should be authorised, the
Commission will prepare an amendment to the Plastics Regulation to include the
substance in the Union list. Relevant Commission services and Member States will be
consulted and the European Parliament has a right of scrutiny on the proposal. If the
proposal is agreed, it will be adopted by the Commission and published in the Official
Journal.
2.3.2.1 Approvals for non-listed substances
For Polymer Production Aids (PPD), the Union list is not an exhaustive list. This means
that PPAs others than those listed are subject to national legislation and self-
assessment.
Deliverable 6.3 19
In the Union list, only the name of the free acid, alcohol or phenol is mentioned.
However, the use of certain salts of these acids, alcohols or phenols is also authorised.
The salts of the following cations can be used without any restriction: aluminium,
ammonium, calcium, magnesium, potassium, and sodium. By contrast, the salts of the
following cations must comply with the following restrictions:
 Aluminium = 1 mg/kg food or food simulant.
 Barium = 1 mg/kg food or food simulant.
 Cobalt = 0.05 mg/kg food or food simulant.
 Copper = 5 mg/kg food or food simulant.
 Iron = 48 mg/kg food or food simulant.
 Lithium = 0.6 mg/kg food or food simulant.
 Manganese = 0.6 mg/kg food or food simulant.
 Nickel = 0.02 mg/kg food or food simulant.
 Zinc = 5 mg/kg food or food simulant.
The Plastics Regulation explicitly mentions double salts; however, this rule would
equally apply to triple salts and other multiple salts.
Mixtures of authorised substances can be used, provided there is no chemical reaction

of the components.
A macromolecular substance of a molecular weight of at least 1000 Da can be used as

an additive without explicit listing in the Union list, but only if it can function as the
main structural component of a finished material and article and if its monomers and
other starting substances are included in the Union list. This does not apply to
macromolecules obtained from microbial fermentation, which always have to be
included in the Union list. If the substance is not capable of functioning as the main
structural component of a finished material or article, it has to be included in the
Union list, even if the monomers and starting substances to produce the
macromolecular substance are listed. If the substance is capable of functioning as the
main structural component of a finished material or article, but the monomers are not
Deliverable 6.3 20
listed, then an authorisation for the monomers and other starting substances has to be
sought.
The term "polymeric starting substances" covers macromolecular substances, such as

oligomers, pre-polymers and polymers used as monomers or other starting
substances. A macromolecular substance can be used as a monomer or other starting
substances without being included in the Union list if the monomers and other starting
substances to produce it are included in the Union list. This does not apply to
macromolecules obtained from microbial fermentation, which always have to be
included in the Union list. If some of the monomers or other starting substances are
not listed, then an authorisation has to be sought, either for these missing monomers
or other starting substances, or for the macromolecular substance itself.
Other substances not subject to inclusion in the Union list because:

 They are used in minute amounts and not intended to remain in the plastic
 They are used in other layers than plastic layers which are not subject to
compositional requirements of the Plastics Regulation
 They were not subject to an authorisation in the past
This covers the following groups of substances:

 Aids to polymerisation.
 Non-intentionally added substances.
 Monomers, other starting substances, and additives only used in surface
coatings.
 Monomers, other starting substances, and additives only used in epoxy resins.
 Monomers, other starting substances, and additives only used in adhesives and
adhesion promoters.
 Monomers, other starting substances, and additives only used in printing inks.
 Colorants.
 Solvents.
Deliverable 6.3 21
These substances shall be manufactured in compliance with good manufacturing

practice so that, under normal or foreseeable conditions of use, they do not transfer
their constituents to food in quantities which could: a) endanger human health, or b)
bring about an unacceptable change in the composition of the food, or c) bring about
deterioration in the organoleptic characteristics thereof; and are subject to a risk
assessment. Furthermore, some of them are authorised at national level, or subject to
specific national legislation.
2.3.2.2 Specific provisions
Certain substances used in food contact plastics are, at the same time, authorised food
additives or authorised flavourings respectively. These substances are called dual-use
additives. The substances shall not be released into foods in quantities which have a
technological function in the food.
A plastic layer behind the plastic layer in contact with food can be manufactured with
additives or monomers not included in the Union list or does not need to comply with
all restrictions or specifications set out in the Union list if one of the layers separating it
from the food works as a functional barrier. This means that a monomer or additive
not listed in the Union list can be used in the manufacture of the layer behind the
functional barrier if the migration of this substance is not detectable in food with a
detection limit of 0.01 mg/kg (10ppb). They will have to comply with the general safety
requirements and are subject to risk assessment. The functional barrier concept
cannot be applied to substances which are mutagenic, carcinogenic or toxic to
reproduction or to substances in nanoparticulate form.
2.3.3 Good manufacturing practice (GMP)
Good manufacturing practice is defined in Regulation (EC) No 2023/2006 which applies

to all food contact materials and all stages of manufacture, processing and distribution
of materials and articles. The requirements for quality assurance, the control system,
and the documentation, which shall be kept, should provide for the following elements
to verify compliance with good manufacturing practice:
Deliverable 6.3 22
 Risk assessment
 Traceability
 Training
 Documentation
 Internal audits
Printing inks applied to the non-food contact side of materials and articles shall be
formulated and/or applied in such a manner that substances from the printed surface
are not transferred to the food-contact side: a) through the substrate or; b) by set-off
in the stack or the reel. The printed surfaces shall not come into direct contact with
food.
2.3.4 Migration tests
migration tests to demonstrate the compliance of the material.
Regulation (EU) No 10/2011 establishes the controls to verify that a plastic material is
suitable for contact with food products:
 Overall migration limit (OML): means the maximum permitted amount of

non-volatile substances released from a material or article into food
simulants.
 Specific migration limit (SML): means the maximum permitted amount of

a given substance released from a material or article into food or food
simulants:
o Specific migration (metals and primary aromatic amines) according to

Annex II to Regulation 10/2011.
o Specific migration of the substances listed in Annex I to the Regulation

10/2011. These specific substances should be included in the
Deliverable 6.3 23
declaration of compliance to be provided by the suppliers of raw

materials.
For all substances for which no specific migration limit has been set, as well as for
those plastic materials and articles specifically intended for infants and young children
(0-3 years), the specific migration of these substances should not exceed the generic
specific migration limit SML of 60 mg/kg.
As the measurement of the overall migration in food is not feasible, the overall
migration is measured into food simulants, which represent the hydrophilic,
amphiphilic, and lipophilic properties of food and therefore, the chemical
characteristics that lead to a transfer of substances from the food contact material into
the food.
For demonstration of compliance for plastic materials and articles not yet in contact
with food the food simulants listed in Table 1 below are assigned.
Table 1. List of food simulants
Food simulant Abbreviation

Ethanol 10 % (v/v) Food simulant A
Acetic acid 3 % (w/v) Food simulant B
Ethanol 20 % (v/v) Food simulant C
Ethanol 50 % (v/v) Food simulant D1
Vegetable oil (containing less than 1% unsaponifiable matter) Food simulant D2
MPPO, Poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 Food simulant E

mesh, pore size 200 nm2
2
Food simulant E (MPPO) is assigned for testing specific migration into dry foods. It is a porous polymer
with a high molecular weight (500000 to 1000000 Da) a very high temperature stability (T max = 350 C), a
3
high surface area and a low specific mass (0.23 g/cm ). The substance is commercially known as Tenax®.
The pore size range is important and the reference used is 60 mesh to 80 mesh. Caution should be used,
as gas chromatograms obtained from extracts of new commercial MPPO have shown that unacceptably
high levels of impurities may be present. Therefore, prior to its first use in this test procedure, the MPPO
shall be purified by soxhlet extraction, using diethylether or acetone. MPPO cleaned in this way can be
used repeatedly.
Deliverable 6.3 24
 Food simulants A, B and C are assigned for foods that have a hydrophilic
character and are able to extract hydrophilic substances.
o Food simulant B shall be used for those foods which have a pH below
4.5.
o Food simulant C shall be used for alcoholic foods with an alcohol
content of up to 20% and those foods which contain a relevant amount
of organic ingredients that render the food more lipophilic.
 Food simulants D1 and D2 are assigned for foods that have a lipophilic
character and are able to extract lipophilic substances.
o Food simulant D1 shall be used for alcoholic foods with an alcohol
content of above 20 % and for oil in water emulsions.
o Food simulant D2 shall be used for foods which contain free fats at the
surface.
 Food simulant E is assigned for testing specific migration into dry foods.
If the material or article is intended to come into repeated contact with foods, the
migration test(s) shall be carried out three times on a single sample using another
portion of food simulant on each occasion. Its compliance shall be checked on the
basis of the level of the migration found in the third test.
The migration testing conditions should always be at least as strict as the real
conditions of use. Samples should be stored as indicated on the packaging label. If no
instructions are given, they should be stored under conditions suitable for the
packaged food. The food should be removed from contact with the material before the
expiry date.
2.3.4.1 Specific migrations tests. Conditions of contact when using food simulants
The sample shall be placed in contact with the food simulant in a manner representing
the worst of the foreseeable conditions of use as regard contact time in Table 2 and as
regard contact temperature in Table 3.
Deliverable 6.3 25
3
Table 2. Contact time
3
Table 3. Contact temperature
3
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended
Deliverable 6.3 26
2.3.4.2 Overall migrations tests. Food simulant assignment
For tests to demonstrate compliance with the overall migration limit food simulants
shall be chosen as set out in Table 4.
4
Table 4. Food simulant assignment for demonstrating compliance with the overall migration limit
The overall migration test for materials and articles intended for the food contact
conditions described in column 3 of Table 5 shall be performed for the time specified
and at the temperature specified in column 2.
4
Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No
10/2011 on plastic materials and articles intended to come into contact with food.
Deliverable 6.3 27
5
Table 5. Standardised testing conditions
5
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended
Deliverable 6.3 28
3 US framework Regulation
It is important to note, that contrary to the EU, where risk assessment and risk
management are clearly separated between EFSA and European Commission, in the
U.S. the Food and Drug Administration (FDA) charged with the control of food safety,
carries out both risk assessment and risk management. Further the regulation of food
contact materials is based on exposure rather than on migration, as in the EU.
Another differentiating aspect is that the FDA assesses the environmental impact of its
regulatory actions. Therefore, manufacturers must include an environmental
assessment with their petitions and notifications.
The FDA enforces the Food, Drug and Cosmetic Act from 1958, which is the basic
regulation on food contact materials, as well as other relevant acts. Mostly, food
contact materials (FCM) are regulated in the Code of Federal Regulations (C.F.R.) and
further fall under specific regulations depending on their use.
Table 6. US Legislative Overview
General Regulations on FCM

Food, Drug and Cosmetic Act (1958)
Title 21, Code of Federal Regulation
Authorization/Notification required Exempted from authorization
Direct Additive (21 C.F.R. Part 170.3) Threshold of Regulation rule
Indirect Additive (21 C.F.R. Part 174-179) Generally Recognized as Safe (GRAS)
 Common food ingredient before 1958
 Manufacturer self-determined GRAS
 FDA listed GRAS
 FDA approved GRAS
 FDA GRAS notification
Food Contact Notification (FCN) program Sanctioned before 1958

(only notification required)
Upon written request describing the proposed use of an additive and the proposed
experiments to determine its safety, the Commissioner will advise a person who
Deliverable 6.3 29
wishes to establish the safety of a food additive whether he believes the experiments
planned will yield data adequate for an evaluation of the safety of the additive.
The following safety factors will be applied in determining whether the proposed use
of a food additive will be safe: Except where evidence is submitted which justifies use
of a different safety factor, a safety factor in applying animal experimentation data to
man of 100 to 1, will be used; that is, a food additive for use by man will not be
granted a tolerance that will exceed 1⁄100 th of the maximum amount demonstrated
to be without harm to experimental animals.
A substance used in a food-contact article (e.g., food-packaging or food-processing

equipment) that migrates, or that may be expected to migrate, into food will be
exempted from regulation as a food additive because it becomes a component of food
at levels that are below the threshold of regulation if:
 The substance has not been shown to be a carcinogen in humans or animals,

and there is no reason, based on the chemical structure of the substance, to
suspect that the substance is a carcinogen. The substance must also not contain
a carcinogenic impurity or, if it does, must not contain a carcinogenic impurity
with a TD50 value based on chronic feeding studies reported in the scientific
literature or otherwise available to the Food and Drug Administration of less
than 6.25 milligrams per kilogram bodyweight per day (The TD50, for the
purposes of this section, is the feeding dose that causes cancer in 50 percent of
the test animals when corrected for tumours found in control animals. If more
than one TD50 value has been reported in the scientific literature for a
substance, the Food and Drug Administration will use the lowest appropriate
TD50 value in its review).
 The substance presents no other health or safety concerns because:
o The use in question has been shown to result in or may be expected to

result in dietary concentrations at or below 0.5 parts per billion,
corresponding to dietary exposure levels at or below 1.5
Deliverable 6.3 30
micrograms/person/day (based on a diet of 1,500 grams of solid food

and 1,500 grams of liquid food per person per day); or
o The substance is currently regulated for direct addition into food, and
the dietary exposure to the substance resulting from the proposed use
is at or below 1 percent of the acceptable daily intake as determined by
safety data in the Food and Drug Administration's files or from other
appropriate sources.
 The substance has no technical effect in or on the food to which it migrates;

and
 The substance use has no significant adverse impact on the environment.
As for the printing inks, colorants that are permitted for use in food are also permitted
for use in the printing of packaging materials. In the US, waxes used in food contact
materials are regulated in the Code of Federal Regulations. As such, paraffins
(synthetic) are authorized as adhesives and coatings with certain specifications.
Petroleum waxes, synthetic petroleum wax and reinforced wax are permissible in food
contact materials as adjuvants, production aids and sanitizers if they meet certain
specifications.
However, the Administration reserves the right to refuse to grant an exemption in

cases where the available information establishes that the proposed use may pose a
risk to public health. The reasons for the Administration’s decision to refuse to grant
an exemption will be explained in the Administration's response to the requestor.
3.1 Approval of food contact materials
Clearance for food contact materials is required for those that are considered
additives, also referred to as indirect additives, which are those that can reasonably be
expected to migrate into the food stuff.
Companies determine whether migration of a substance can reasonably be expected.

Food additives are regulated under the Food Additive Directive. A substance may be
Deliverable 6.3 31
authorized as a food additive because it is in accordance with an applicable food

additive regulation. If this is not the case it may be expressly approved by the FDA
through an indirect food additive petition. Both of these processes require the FDA to
notify the public in the Federal Registry and allow for comments. However, this
process has practically ceased to be used, as it is very time consuming.
A request for the Food and Drug Administration to exempt a use of a substance from
regulation as a food additive shall include three copies of the following information (If
part of the submitted material is in a foreign language, it must be accompanied by an
English translation verified to be complete and accurate):
 The chemical composition of the substance for which the request is made,
including, whenever possible, the name of the chemical in accordance with
current Chemical Abstract Service (CAS) nomenclature guidelines and a CAS
registry number, if available.
 Detailed information on the conditions of use of the substance (e.g.,

temperature, type of food with which the substance will come into contact, the
duration of the contact, and whether the food-contact article will be for
repeated or single use applications).
 A clear statement as to whether the request for exemption from regulation as a

food additive is based on the fact that the use of the substance in the food-
contact article results in a dietary concentration at or below 0.5 parts per
billion, or on the fact that it involves the use of a regulated direct food additive
for which the dietary exposure is at or below 1 percent of the acceptable
dietary intake (ADI).
 Data that will enable the Food and Drug Administration to estimate the daily
dietary concentration resulting from the proposed use of the substance. These
data should be in the form of:
o Validated migration data obtained under worst-case

(time/temperature) intended use conditions utilizing appropriate food
simulating solvents.
Deliverable 6.3 32
o Information on the amount of the substance used in the manufacture of

the food-contact article; or
o Information on the residual level of the substance in the food-contact

article. For repeat-use articles, an estimate of the amount of food that
contacts a specific unit of surface area over the lifetime of the article
should also be provided. (In cases where data are provided only in the
form of manufacturing use levels or residual levels of the substance
present in the food-contact article, the Food and Drug Administration
will calculate a worst-case dietary concentration level assuming 100
percent migration.) A detailed description of the analytical method used
to quantify the substance should also be submitted along with data
used to validate the detection limit.
o In cases where there is no detectable migration into food or food

simulants, or when no residual level of a substance is detected in the
food-contact article by a suitable analytical method, the Food and Drug
Administration will, for the purposes of estimating the dietary
concentration, consider the validated detection limit of the method
used to analyse for the substance.
 The results of an analysis of existing toxicological information on the substance

and its impurities. This information on the substance is needed to show
whether an animal carcinogen bioassay has been carried out, or whether there
is some other basis for suspecting that the substance is a carcinogen or potent
toxin. This type of information on the impurities is needed to show whether
any of them are carcinogenic, and, if carcinogenic, whether their TD50 values
are greater than 6.25 milligrams per kilogram bodyweight per day.
 Information on the environmental impact that would result from the proposed
use of the substance.
The Food and Drug Administration will inform the requestor by letter whether the
specific food-contact application is exempt from regulation as a food additive or not.
Although a substance that migrates to food at a level that results in a dietary
Deliverable 6.3 33
concentration at or below the threshold of regulation will not be the subject of a

regulation published in the Federal Register and will not appear in the Code of Federal
Regulations, the Food and Drug Administration will maintain a list of substances
exempted from regulation as food additives under this section on display at the
Division of Dockets Management. This list will include the name of the company that
made the request, the chemical name of the substance, the specific use for which it
has received an exemption from regulation as a food additive, and any appropriate
limitations on its use. The list will not include any trade names. This list will enable
interested persons to see the types of uses of food-contact materials being exempted
under the regulation.
If the request for an exemption from regulation as a food additive is not granted, the
requestor may submit a petition to the Food and Drug Administration for
reconsideration of the decision. If the Food and Drug Administration receives
significant new information that raises questions about the dietary concentration or
the safety of a substance that the agency has exempted from regulation, the Food and
Drug Administration may re-evaluate the substance. If the requestors fail to
adequately respond to the new evidence, the agency will notify them that further use
of the substance in question for the particular use will require a food additive
regulation.
3.2 Premarket notification for a food contact substance (FCN)
Today, the most common process is the Premarket notification for a food contact
substance, implemented in 2002. In this program the company must submit to the
Food and Drug Administration (FDA) a Food Contact Notification (FCN) that is reviewed
by an FDA committee. The FDA is required to either object to the FCN within 120 days
or issue a letter of no objection, after which the company can market the substance.
If the FDA does not respond in time, the notifying company can market the product
after 120 days. The special feature of this program is that the manufacturer can
withdraw and FCN if FDA has not completed review of the FCN. In addition, no public
Deliverable 6.3 34
review is conducted prior to notification. FDA will not disclose publicly the information
in an FCN that is withdrawn prior to the completion of FDA's review.
An FCN is effective for the food contact substance manufactured or prepared by the
manufacturer or supplier identified in the FCN submission. If another manufacturer or
supplier wishes to market the same food contact substance for the same use, that
manufacturer or supplier must also submit an FCN to FDA.
An FCN must contain a comprehensive discussion of the basis for the manufacturer's
or supplier's determination that the use of the food contact substance is safe. Data
must include primary biological data and chemical data. An FCN may incorporate
references to any information provided that the manufacturer or supplier is authorized
to reference the information.
In addition, an FCN must contain the following:
 A good laboratory practice statement for each nonclinical laboratory study that
is submitted as part of the FCN, in the form of either:
o A signed statement that the study was conducted in compliance with

the good laboratory practice regulations under part 58 of this chapter;
or
o A brief signed statement listing the reason(s) that the study was not
conducted in compliance with good laboratory practices. Data from any
study must be validated by an independent third party prior to
submission to the Food and Drug Administration (FDA), and the report
and signed certification of the validating party must be submitted as
part of the notification.
 An environmental assessment complying with §25.40 of this chapter.
 A completed and signed FDA Form No. 3480.
If data or other information available to FDA, including data not submitted by the
manufacturer or supplier, demonstrate that the intended use of the food contact
Deliverable 6.3 35
substance is no longer safe, FDA may determine that the authorizing FCN is no longer
effective.
If FDA determines that an FCN is no longer effective, FDA will inform the manufacturer
or supplier in writing of the basis for that determination. FDA will give the
manufacturer or supplier an opportunity to show why the FCN should continue to be
effective and will specify the time that the manufacturer or supplier will have to
respond.
3.3 GRAS Notification Program
A substance that will be added to food is subject to premarket approval by FDA unless
it is generally recognized, among qualified experts, to be safe under the conditions of
its intended use (GRAS is the acronym for generally recognized as safe).
The GRAS notification program allows manufacturers to submit a notification that is

approved by a “no objections” letter. Competitors may rely on such an approval, but
the FDA has no deadlines and further, its decision is based on a summary rather than
the original chemical or biological data.
Alternatively, a GRAS substance may be exempted not only from authorization but also
from notification. This is the case if a substance was a common food ingredient used
before 1958. Further, under the Threshold of Regulation rule (TOR), non-carcinogenic
substances having a dietary concentration below 0.5 ppb are also exempted from the
authorization process. Under this rule, a substance previously regulated as a direct
food additive, and for which the use in food contact materials will not result in an
exposure above 1% of the average daily intake (ADI) can also be exempted.
Finally, a substance can become a GRAS substance if a published study demonstrates

that it is not harmful to health under the intended conditions of use. This approach is
termed manufacturer self-determined GRAS. Irrespective of whether the study was
published independently or commissioned by the company, the company will not have
Deliverable 6.3 36
to notify the FDA of its use. The same is true for those substances used before 1958
and those falling under the Threshold of Regulation rule.
The GRAS approach has recently come under critique, as the FDA consequently has
neither information on applications of the substance nor its effective quantities of use.
Further, manufacturers are not obliged to reassess their risk estimates over time.
Deliverable 6.3 37
4 NatureFresh project
4.1 Packaging
The monomers of cellulose and starch based polymers as well as those of PHB and PLA
are judged to be of no health concern. However, more additives are usually used in
bioplastics than in conventional plastics. The different physicochemical properties of
biobased FCMs may result in higher or lower migration rates of additives.
4.1.1 Procedure for action
The measures to consider that the products developed within the framework of
NatureFresh project are suitable for food use are listed below:
 Obtain a complete list of all materials and substances used in the production of
the product in contact with food.
 Check these against the Union list, a living document that is regularly updated
(Regulation (EU) No 10/2011 and its amendments).
 Establish the specific migration limit of the authorised substances used in the
manufacture of the product, if applicable.
 Identify the contact conditions of the material with the food (type of food,
weather and temperature conditions).
 Confirm compliance with restrictions (global and specific migration tests).

Quantify the substances with restrictions.
 Study of non-intentionally added substances (NIAS) and toxicological risk

assessment.
 Proof of compliance with good manufacturing practices (GMP).
 Establish a Declaration of Conformity (DoC) of product and ensure that all

necessary documentation that complements it is available upon request.
Deliverable 6.3 38
4.1.2 Union list and Specific Migration Limit (SML)
The authorised substances and their specific migration limits are set out in the so-
called Union List, published in Regulation 10/2011 and its subsequent amendments
(listed in Annex I. Union list and SML).
If a substance does not appear on this list, it does not mean that its use is prohibited,
but a comprehensive study must be carried out before it can be used to ensure that
there is no risk to human health. A risk assessment must be carried out in accordance
with internationally recognised scientific principles.
In some cases specific migration limit restrictions are defined for "group of substances"
(listed in Annex II. Group restriction of substances).
4.1.3 Test to be performed
The plastic material to be tested is the one that will be in contact with the food, so in
principle these requirements do not apply to the NatureFresh product label, as it will
not be in contact with the food.
There is no single test method that can be used to determine overall migration, at any
temperature, with all food simulants. Many test methods and variations of different
methods can be used for quantifying the overall migration because of the practical
difficulties associated with testing non-volatile extracts, such as fats, and the multitude
of applications where plastic articles may come into contact with food.
For most plastic articles methods in European Standard Series EN 1186 Materials and
articles in contact with foodstuffs are suitable - Plastics - Test methods for overall
migration are suitable, although updated to the requirements of Regulation 10/2011,
as well as EN 13130 Materials and articles in contact with foodstuffs - Plastics
substances subject to limitation - Test methods for the specific migration of substances
from plastics to foods and food simulants and the determination of substances in
plastics and the selection of conditions of exposure to food simulants and ISO 177
Plastics - Determination of migration of plasticizers.
Deliverable 6.3 39
Figure 1. Decision tree for testing
According to the information provided by Gruppo Fabbri Vignola, S.p.A., the packaged
foods will be: meat, cheese, fish and fruit and vegetables.
The storage and/or preservation time and temperature conditions for the above-
mentioned foods, as a guide, are:
 Meat and fish.

o Beef, Veal, Lamb, & Pork. Minced meat: 1-2 days. Chops: 3-5 days.
Steaks: 3-5 days. Cooked meat leftovers: 3-4 days. Roast meat and
meatballs: 1-2 days. All of them should be, in their original packaging or
in bags under refrigerated (4C) conditions.
o Poultry. Chicken and turkey (whole, parts and giblets): 1-2 days under
refrigerated (4C) conditions.
o Fish. Lean fish: 1-2 days. Fatty fish: 1-2 days. Cooked fish: 3-4 days. All of
them under refrigerated (4C) conditions.
Deliverable 6.3 40
 Dairy products
o Cheese. Cheddar, Swiss 6 months, unopened, in its original packaging to
protect it from mould. Brie, 3-4 weeks opened. Grated cheese, 1 week.
Fresh cheese, ricotta: 7-14 days. It is best to keep this type of cheese in
its original packaging under refrigerated (4C) conditions and to store
upside down to preserve its freshness.
 Fruit and vegetables:

o There is variability in temperature conditions and storage times
depending on the type of fruit or vegetable. There is a wide range from
1-2 days under refrigerated (4C) conditions (e.g. strawberries) to 1
week at room temperature (e.g. bananas or avocados).
Figure 2. Conditions for the growth of microorganisms
As these are fresh foods, another critical aspect of food preservation is the cold chain,
so packaging must ensure that it does not create any problems along the cold chain.
Figure 3. Cold chain along the packaged food supply chain
Deliverable 6.3 41
4.1.3.1 Legal compliance

On the basis of these conditions and according to the requirements of Regulation
10/2011 and its subsequent amendments, the following conditions are established:
 Migration tests
Given the high variability of food products that may come into contact with the
packaging, simulators A, B and D2 should be used in the tests.
Table 7. List of food simulants – NatureFresh project
Food simulant Abbreviation

Ethanol 10 % (v/v) Food simulant A
Acetic acid 3 % (w/v) Food simulant B
Ethanol 20 % (v/v) Food simulant C
Ethanol 50 % (v/v) Food simulant D1
Vegetable oil (containing less than 1% unsaponifiable matter) Food simulant D2
MPPO, Poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 Food simulant E

mesh, pore size 200 nm
The selection of the most suitable type of test for this case is based on the EN 13130-1
standards. Materials and articles in contact with foodstuffs - Plastics substances subject
to limitation - Part 1: Guide to test methods for the specific migration of substances
from plastics to foods and food simulants and the determination of substances in
plastics and the selection of conditions of exposure to food simulants, as well as EN
1186-1. Materials and articles in contact with foodstuffs. Plastics. Part 1: Guide to the
selection of conditions and test methods for overall migration.
According to EN 13130 and EN 1186, for those materials and articles that are labelled,
or clearly intended, to be used at or below room temperature, the test must be
performed at 40°C for 10 days. Tests conditions correspond to the more severe (worst
foreseeable) conditions.
Deliverable 6.3 42
Table 8. Contact time – NatureFresh project
Table 9. Contact temperature – NatureFresh project
Although NatureFresh film will package food that will be mainly under refrigerated
conditions rather than at room temperature, it has been proven that if the specific
limit is not exceeded in a test at 10C, it will not be exceeded at 5C either.
Migration tests shall be carried out in such a way that only those parts of the sample
intended to come into contact with food in actual use will be in contact with the
simulant or food. However, a more severe test, such as the immersion test, is
recommended.
Deliverable 6.3 43
 Other restrictions
User of food contact materials and articles has to pay particular attention to instruct
the consumer via adequate labelling, so that packaged food is handled safely and in an
appropriate manner. This applies, in particular, to any limitations to the conditions of
storage (temperature, contact time etc.).
In addition, the following tests should be carried out to ensure compliance with the
given restrictions:
 Migration of primary aromatic amines.
 Formaldehyde migration.
 Migration of BPA, BPF, BADGE, BFDGE and NOGE.
 Migration of phthalate.
 Specific migration of metals:
- Aluminium.
- Barium.
- Cobalt.
- Copper.
- Iron.
- Lithium
- Manganese.
- Nickel.
- Zinc.
 Determination of heavy metals:
- Lead.
- Cadmium.
- Mercury.
- Hexavalent Chrome.
 Determination of NIAS presence in the material.
 Determination of volatile substances.
 Residual monomer content, residual ink solvents, etc.
Deliverable 6.3 44
4.1.3.2 Complementary tests
When it comes to compliance with legislation for plastic containers, the focus is almost
always exclusively on carrying out tests for migration control (components of the
packaging that can happen to the food). This is obviously an essential step, since it
guarantees both the inertness of the packaging and the no toxicity through the
migration of substances with a risk to the consumers’ health. However, it should not
be forgotten that another of the requirements set by the legislation (in this case by
Regulation 1935/2004 on food contact materials) is that these materials "do not cause
an alteration in the organoleptic characteristics of the food".
So in the interaction between packaging and product it is also important to consider

the following factors:
 Permeability
 Sensory Analysis
 Chemical compatibility
 Permeability
Permeability is the exchange of gases, vapours or radiation between the environment
and the food through the packaging material. It is a critical factor in the preservation of
packaged food. Oxygen and moisture/water vapour are the most critical factors for
most foods, although each food has its own key factor.
Figure 4. Permeability scheme in packaging
Possible effects of oxygen and water vapour on food

 Lipid oxidation.
 Growth of microorganisms: bacteria, moulds, yeast…
Deliverable 6.3 45
 Loss of colour, taste, odour, etc.

 Loss of nutritional properties.
 Browning reactions.
 Enzymatic reactions.
 Gain or loss of moisture.
 Loss of texture.
The variables to be considered in the permeability analysis are mainly: composition

and characteristics of the food, composition of the atmosphere and packaging
material.
The water vapour permeability test can be carried out according to the following
standards:
 ISO 15106. Plastics. Film and sheeting. Determination of water vapour
transmission rate.
 ASTM E96/E96M. Standard Test Methods for Water Vapor Transmission of
Materials.
 ASTM F1249. Standard Test Method for Water Vapor Transmission Rate
Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
 ASTM D6701 Standard Test Method for Determining Water Vapor Transmission
Rates Through Nonwoven and Plastic Barriers.
 ISO 15105. Plastics. Film and sheeting. Determination of gas-transmission rate.
 ISO 2556. Plastics. Determination of the gas transmission rate of films and thin
sheets under atmospheric pressure. Manometric method.
 ASTM D3985. Standard Test Method for Oxygen Gas Transmission Rate
Through Plastic Film and Sheeting Using a Coulometric Sensor.
 ASTM F1927. Standard Test Method for Determination of Oxygen Gas
Transmission Rate, Permeability and Permeance at Controlled Relative
Humidity Through Barrier Materials Using a Coulometric Detector.
Deliverable 6.3 46
 Sensory Analysis
This test is linked to the legislative requirement that any material or article intended to
come into contact directly or indirectly with food must be sufficiently inert to preclude
substances from being transferred to food in quantities large enough to endanger
human health or to bring about an unacceptable change in the composition of the
food or a deterioration in its organoleptic properties.
The determination of the sensory effects that the packaging may cause on the
packaged food it is less widespread as a routine control in companies than the
migration tests, although its importance is evident in the fact that the detection of
odours or strange flavours in packaged food by consumers can lead to health alerts
and / or very important effects on the brand image of the product. In these cases,
subsequent sensory tests are carried out with the objective of determining whether
the origin of the anomalous smell or taste of the food comes from the package or is
due to some other cause.
There are numerous types of sensory tests: discriminative, which are intended to
determine if there are differences between samples; descriptive, which seek to
identify qualitatively and quantitatively the attributes of the sample; scales, which
order different samples according to the intensity of a given attribute; and hedonic,
which are intended to determine the preference between one sample and another.
In all cases, sensory tests must be carried out by judges, who are the people who carry
out the assessments of the samples. These judges may be trained and qualified.
The standards concerning this test are shown below:

 ISO 13302. Sensory analysis. Methods for assessing modifications to the flavour
of foodstuffs due to packaging.
 ISO 4120. Sensory analysis. Methodology. Triangle test.
 ISO 4121. Sensory analysis. Methodology. Evaluation of food products by
methods using scales.
 ASTM E2610. Standard Test Method for Sensory Analysis. Duo-Trio Test.
Deliverable 6.3 47
 ASTM E1870. Standard Test Method for Odor and Taste Transfer from
Polymeric Packaging Film.
 Chemical compatibility
Plastic materials are not inert; they are composed of organic substances, so they can
be affected by contact with chemicals. There are mainly two routes: i) adsorption,
surface incorporation of packaged substances into the packaging, and ii) absorption,
incorporation of the packaged substance into the polymer. This can lead to changes in
the characteristics of the packaging and can remove additives from the packaged food.
It is therefore necessary to ensure that the packaging is stable. On the one hand, that
the product does not react chemically with the packaging and on the other hand, that
the packaging is not altered.
Although there are compatibility tables for chemicals with different types of polymers,
it is advisable to carry out compatibility studies as the tables do not take into account
factors such as packaging geometry and refer to groups of substances.
Given the food products to be packaged in this project, chemical compatibility is not a
problem for NatureFresh packaging.
4.2 Label
The label does not require the same type of study as the packaging because it is not in
direct contact with the food, but it must meet certain requirements.
Labels on food packages must provide clear and legible information about the food
they contain in the language of the country where they are to be marketed. The
mandatory information it must contain is:
 Denomination, name of the packaged product.
 Ingredients.
 Alcoholic strength, if any.
 Weight or units.
 Instructions of care and use.
Deliverable 6.3 48
 Expiration or shelf life expiration date

 Company name or name of the manufacturer or packager and its address.
 Lot, code with which the product can be "traced" in case of problems with it.
The lot is very important, because it relates to the traceability of the food.
It must be guaranteed that the consumer will see the label, that the label will not be
changed, and that no products will be sold without labels.
Moreover, since the label is attached to the film with an adhesive, it is advisable to
analyse the food suitability of the set "label-adhesive-film" (hereinafter referred to as
sample), from the point of view of the composition of the materials. Thus, it is
recommended to carry out the migration test of the sample on the food and/or food
simulant.
The worst-case scenario should be assessed to obtain the best guarantees, and more
specific tests can be carried out depending on the results. Given the particularity of the
sample, it is recommended that labels are attached to the film and that immersion is
used as a means of contacting the simulant with the sample, so that the test only
assesses migration that may occur through the plastic film and edges, similar to the
actual use of the sample.
Deliverable 6.3 49
Table 10. Global migration test program for the sample
Food
Chemical Exposure Contact
simulant
Food Ethanol 10 % (v/v) 10 days at 20C Immersion
simulant A 10 days at 40C
Food Acetic acid 3 % (w/v) 10 days at 20C Immersion

simulant B 10 days at 40C
Food Vegetable oil (containing less 10 days at 20C Immersion

simulant D2 than 1% unsaponifiable matter) 10 days at 40C
Table 11. Food simulant assignment for demonstrating compliance with the overall migration limit –
NatureFresh project
Deliverable 6.3 50
Table 12. Standardised testing conditions – NatureFresh project
Regarding specific migration it is proposed to test the sample with the following test
plan (Table 13).
Table 13. Specific migration test program for the sample
Food
Chemical Exposure Contact
simulant
Food Ethanol 10 % (v/v) 10 days at 20C Immersion
simulant A 10 days at 40C
Deliverable 6.3 51
5 Conclusions
to be met by materials and articles intended to come into contact with food. Moreover
they should be manufactured in accordance with Regulation (EC) No 2023/2006 which
lays down good manufacturing practices applicable to all materials in contact with
foods.
migration tests to demonstrate the compliance of the material.
The manufacturer of a food contact material should reassure the customer that the
food contact material complies with the applicable EU and national legislation. Each
manufacturer has to declare compliance for the manufacturing steps under his
responsibility.
Only the substances included in Annex I (Union list) of Regulation 10/2011 (and its
amendments) may be used in the manufacture of plastic layers in plastic materials and
articles. New substances can be added to the Union list. If a new substance is
authorised, the Commission will prepare an amendment to the Plastics Regulation to
include the substance in the Union list.
It is important to note, that contrary to the EU, where risk assessment and risk
management are clearly separated, in the U.S. the Food and Drug Administration
(FDA) charged with the control of food safety, carries out both risk assessment and risk
management. Further the regulation of food contact materials is based on exposure
rather than on migration, as in the EU. Another differentiating aspect is that the FDA
assesses the environmental impact of its regulatory actions. Therefore, manufacturers
must include an environmental assessment with their petitions and notifications.
Deliverable 6.3 52
According to the requirements of European Regulation 10/2011 and its subsequent

amendments, the measures to consider in the framework of NatureFresh project are:
 Given the high variability of food products that may come into contact with the
NatureFresh packaging, simulators A, B and D2 should be used in the tests.
 According to EN 13130 and EN 1186, for those materials and articles that are
labelled, or clearly intended, to be used at or below room temperature, the test
must be performed at 40°C for 10 days.
 Another of the requirements set by the legislation (in this case by Regulation
1935/2004 on food contact materials) is that these materials "do not cause an
alteration in the organoleptic characteristics of the food". So in the interaction
between packaging and product it is also important to consider: permeability,
sensory analysis and chemical compatibility.
 NatureFresh label must provide clear and legible information about the food
they contain in the language of the country where they are to be marketed.
Since the label is attached to the film with an adhesive, it is advisable to analyse
the food suitability of the set "label-adhesive-film" from the point of view of
the composition of the materials. It is also recommended to carry out the
migration test of the sample on the food and/or food simulant.
6 References
 Food Packaging Forum (2013) Food Packaging Regulation in the US.
 Code of Federal Regulations (C.F.R.). Title 21 on food and drugs.
 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials

and articles intended to come into contact with food.
 EC (2014) Union Guidelines on Regulation (EU) No 10/2011on plastic materials and

articles intended to come into contact with food. European Commission. H ealth
and Consumers Directorate-General.
Deliverable 6.3 53
 Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and

correcting Regulation (EU) No 10/2011 on plastic materials and articles intended
to come into contact with food
 Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting

Regulation (EU) No 10/2011 on plastic materials and articles intended to come
into contact with food.
Deliverable 6.3 54
7 Annex I. Union list and SML

Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fer-mentation, additives and polymer
production aids is shown in Table 14. Table 14 contains the following information:
 Column1 (FCM substance No): the unique identification number of the substance
 Column2 (Ref. No): the EEC packaging material reference number
 Column3 (CAS No): the Chemical Abstracts Service (CAS) registry number
 Column4 (Substance Name): the chemical name
 Column5 (Use as additive or polymer production aid (PPA) (yes/no)): an indication if the substance is authorised to be used as additive or polymer production aid (yes) or if the substance is not
authorised to be used as additive or polymer production aid (no). If the substance is only authorised as PPA it is indicated (yes) and in the specifications the use is restricted to PPA.
 Column6 (Use as monomer or other starting substance or macromolecule obtained from microbial fermentation(yes/no)): an indication if the substance is authorised to be used as
monomer or other starting substance or macromol-ecule obtained from microbial fermentation (yes) or if the substance is not authorised to be used as monomer or other starting substance or
macromolecule obtained from microbial fermentation(no). If the substance is authorised as mac-romolecule obtained from microbial fermentation it is indicated (yes) and in the specifications it is
indicated that the substance is a macromolecule obtained from microbial fermentation.
 Column7 (FRF applicable (yes/no)): an indication if for the substance the migration results can be corrected by the Fat Consumption Reduction Factor (FRF) (yes) or if they cannot be corrected by
the FRF (no).
 Column8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate undetectable
quantities.
 Column9 (SML (T) [mg/kg] (group restriction No)): contains the identification number of the group of substances for which the group restriction in Column1 in Table 15 (Annex II. Group restriction
of substances) applies.
 Column10 (Restrictions and specifications): contains other restrictions than the specific migration limit specifically men-tioned and it contains specifications related to the substance.
 Column11 (Notes on verification of compliance): contains the Notes number which refers to the detailed rules applicable for verification of compliance for this substance included in Column1 in
Table 3 of the Annex I of the Regulation (EU) No 10/2011. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions apply-ing to this
substance shall be those indicated for the individual compound. If in Column8 the specific migration limit is non-detectable (ND) a detection limit of 0.01 mg substance per kg food is applicable
unless specified differently for an individual substance.
Deliverable 6.3 55
Table 14. Union list of authorised substances
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7.1 Modifications and updates
7.1.1 Commission Regulation (EU) No 1282/2011 of 28 November 2011
In Table 14 for the following substance, the content of the columns (2), (5), (6) and (10) is replaced by the following:
In Table 14 for the following substance, the content of the column (3) is replaced by the following:
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In Table 14 for the following substances, the content of the column (8) is replaced by the following:
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In Table 14 for the following substance, the content of the columns (8) and (10) is replaced by the following:
In Table 14 for the following substances, the content of the column (10) is replaced by the following:
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In Table 14 for the following substance, the content of the columns (10) and (11) is replaced by the following:
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In Table 14 for the following substance, the content of the columns (3) is replaced by the following:
In Table 14 for the following substance, the content of the columns (8) and (9) is replaced by the
following:
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In Table 14 the following lines are inserted in numerical order of the FCM substance numbers.
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7.1.3 Commission Regulation (EU) No 202/2014 of 3 March 2014
Table 14 is amended as follows:
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7.1.4 Commission Regulation (EU) 2015/174 of 5 February 2015
Table 14 is amended as follows:
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7.1.5 Commission Regulation (EU) 2016/1416 of 24 August 2016
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7.1.6 Commission Regulation (EU) 2017/752 of 28 April 2017
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7.1.7 Commission Regulation (EU) 2018/79 of 18 January 2018
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7.1.9 Commission Regulation (EU) 2018/831 of 5 June 2018
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8 Annex II. Group restriction of substances

Table 2 on Group restrictions contains the following information:
 Column1 (Group restriction No): contains the identification number of the group of substances for which the
group restriction applies. It is the number referred to in Column9 in Table 1 of this Annex.
 Column2 (FCM substance No): contains the unique identification numbers of the substances for which the group
restriction applies. It is the number referred to inColumn1 in Table 1 of this Annex.
 Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum of substances applicable to
this group. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate
undetectable quantities.
 Column4 (Group restriction specification): contains an indication of the substance whose molecular weight
forms the basis for expression of the result
Table 15. Group restriction of substances
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8.1 Modifications and updates
8.1.3 Commission Regulation (EU) No 202/2014 of 3 March 2014
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9 Annex III. Form 3480 – FCN

Instructions for Completing Form FDA 3480:
OMB No. 0910-0495; Expiration Date: 03/31/2022
Department of Health and Human Services Food and Drug Administration
Food Contact Notification (FCN)
Pre-Notification Consultation (PNC) Food Master File (concerning a Food Contact
Substance) (FMF)
I. Using Form FDA 3480 with FCNs, PNCs and FMFs
II. Steps in Preparing Your Submission
III. Entering Information on the Form
III. Transmitting Your Submission
IV. General Regulatory Instructions for FCNs
V. Specific Instructions for Certain Items on the Form (FCNs, PNCs, FMFs)
A. Part I: General Information
B. Part II: Chemistry Information
1. General Instructions for Part II
2. Entering Chemical Information and Quantities on the Form
3. Entering Information Into Table 4 in Section F.1.b – Summary of the
Migration Testing
C. Part III: Safety Information
D. Part IV: Environmental Information
E. Part V: Certification
F. Part VI: List of Attachments.
VI. Folder Location Quick Reference
VII. FDA Internet Resources
I. Using Form FDA 3480 with FCNs, PNCs and FMFs
 Form FDA 3480 is intended to help you assemble a FCN, PNC, or FMF
concerning a food contact substance (FCS) to FDA.
 Before you complete the form, you should read the appropriate guidance
(administrative, chemistry, toxicology, and environmental) for completion of a
notification for a food contact substance (the guidances are Internet Resources
#3-6 listed at the end of these instructions.)
 For FCNs, a completed Form FDA 3480 is required as part of your submission.
You must provide all applicable information requested in the Form to the
extent that it is known or reasonably ascertainable by you. You should make
reasonable estimates if you do not have actual data.
Deliverable 6.3 134

 For PNCs and FMFs concerning a FCS, a completed Form FDA 3480 is
recommended but not required. Using Form FDA 3480 when you submit PNCs
and FMFs for FCSs will assure uniformity with the arrangement of information
submitted in FCNs. You should provide responses and data on the form only for
those items relevant to the purposes of your submission.
II. Steps in Preparing Your Submission
 For submissions in electronic format, download a FCN folder structure (see

Appendix 15: Links to Downloadable Foldering Structures of Internet Resources
#1, listed at the end of these instructions.)
 Prepare attachment documents (documents responsive to items on Form 3480)
in accordance with FDA guidances for food contact substance submissions,
Internet Resources #3-6 below.
 For submissions in electronic format, place your attachment documents in the
appropriate folders in the folder structure (see Internet Resource #1, Part V.B.:
Food Contact Notification Submissions in Electronic Format for descriptions of
the attachment documents to be placed in each folder in the FCN folder
structure and the basic file-naming format.) For paper submissions, arrange the
documents according to the order of items on the form.
 List your attachment documents and their folder locations (volume and page
numbers for paper submissions) in the List of Attachments (Part VI of the form)
as described in Section V.F. of these instructions, then proceed to filling out all
relevant items on Form 3480, referencing your attachment documents or other
FDA files as appropriate for each item on the form.
III. Entering Information on the Form
(Note: you should frequently save Form 3480 as you enter information because certain actions, e.g.,
executing a digital signature, choosing a write-in choice from a pull-down menu may be irreversible.)
 Entering information on the Form. The form is a PDF document with fillable text
fields. It can be filled in using Adobe Acrobat or Acrobat Reader and possibly
other PDF reading software. We recommend you enter complete information
Deliverable 6.3 135

in all applicable fields that are provided on Form 3480, rather than only
attaching the information. Our systems will “capture” information you enter in
the fields (both for electronic and paper submissions). This enables us to use
this information as searchable index information for your FCN in our database.
o To enter information on the form, you can type the information or paste
it from other sources. In Acrobat or Acrobat Reader you can change the
font to underline, superscript, subscript, bold, etc., by selecting the text,
right-clicking and selecting “text style”, or typing (Ctrl+”E”), or selecting
the button View → Tool Bars →Properties Bar.
o Placing stamps, sticky notes, drawings or other mark-ups on the form is

disabled in order to allow extended functions in Acrobat Reader. As for
the form you actually submit, we request it not be saved as a version
allowing these operations, nor printed as a new PDF, as this will remove
needed functionality and our ability to capture the form data.
 Designating non-disclosable (confidential) information on the form. You should

designate information you enter on the form that you consider trade secret,
confidential commercial, or otherwise non-disclosable to the public under the
Freedom of Information Act. In the text field where the confidential
information is entered, we recommend you place the confidential information
in brackets and precede it with “confidential:”, as: confidential: [your
confidential information].
 Notes. There is space for “notes” under many of the items on the form that
request responsive information be attached. We recommend that you place
any clarifying information here, such as: “We are incorporating by reference
the manufacturing information in FMF 099999.” or “not applicable.”
 Mandatory fields. These “mandatory” fields may have a visible border

highlighting them, indicating an entry of text (or a check in a box) is required
(the form will not permit a signature until they are filled in); this is to help
assure that FCN 3480 is completed (most fields will not be mandatory for PNCs
and FMFs). Entering text in one field may cause others to become mandatory or
become non-mandatory, depending on the logical interrelationships of the
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fields on the form. If you attempt a signature in Part V of Form 3480 with one
or more mandatory fields unfilled, the form will indicate this, not allow the
signature, and change the view (move the cursor) to the location on the form
where entry of text is required. Note: the fact that some fields are designated
as mandatory does not imply other fields are not important; for FCNs, all
portions of Form 3480 relevant to your submission must be completed.
III. Transmitting Your Submission
 To transmit your submission (submission by one of the electronic means is

recommended; first two choices below):
o You may upload the completed FCN folder structure with included
documents to the Electronic Submission Gateway (ESG). For information
on using the ESG, see Internet Resource #2 in Section VII of these
instructions.
o You may send a single copy of the completed FCN folder structure with
included documents on physical media (e.g., CD-ROM, DVD) to:
Notification Control Assistant, Office of Food Additive Safety, HFS-275,
5100 Paint Branch Parkway, College Park, MD 20740-3835.
o You may send the submission in paper format to the above address. You
should submit five copies of a completed FCN if submitted only in paper
format (each with all attachments and a signed original or copy of Form
FDA 3480). For PNCs or FMFs, we recommend that you either send 5
paper copies (each with all attachments and a signed original or copy of
Form FDA 3480), or consult with FDA regarding the number of paper
copies to send. NOTE: Printing the form generates approximately 12 full
pages of (large) bar coded information added at the end of the form;
these represent the data you entered on Form 3480 that we will
electronically capture as index data for your FCN. If you are sending
your submission in paper format only, please include all printed barcode
pages with your completed form.
Deliverable 6.3 137

IV. General Regulatory Instructions for FCNs
(These instructions appeared on page 1 of previous versions of Form 3480)
 Subject of a FCN. Only new uses of a FCS may be the subject of a notification. A
“new” use is one not otherwise authorized. Only one FCS may be the subject of
a particular notification, but multiple new uses of the same FCS may be
combined in one notification. If you seek authorization for new uses of multiple
FCSs that are food additives, you should submit a separate notification for each
FCS.
 Referencing Information. Additional information regarding your FCN may be

provided to FDA, by you or by a third party, in a Food Master File. You may
reference this additional information in your FCN if it is submitted to FDA prior
to the submission of your FCN. If information you refer to is from a third party
and is not publicly available, provide a letter of authorization for such use,
including the name of the authorizing official for the third party and a mailing
address. Authorization is not necessary to reference publicly available
information in FDA’s files.
 Complete Notification. Completion of Form FDA 3480 alone may not constitute
a complete notification for a new use of an FCS. You must also submit all data
and information that forms the basis of your safety determination for the use
that is the subject of the notification and any data and information required by
regulation.
 Confidential Information. By submitting a notification under section 409(h) of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(h)), a notifier waives
any claim to confidentiality for information necessary to describe the food
contact substance and the intended conditions of use that are the subject of
the notification. If you are claiming any information to be confidential, you
should designate the confidential information in writing, or otherwise mark the
confidential information in the notification (e.g., by drawing a line around it or
by following the recommendations in Section II of Internet Resource #1). You
also may submit a separate redacted copy of the notification. However, FDA
may disagree regarding the disclosability of information claimed confidential.
Deliverable 6.3 138

 For additional regulatory information, see “Guidance for Industry: Preparation

of Food Contact Notifications: Administrative” (see Internet Resource #3 in
Section VII of these instructions).
V. Specific Instructions for Certain Items on the Form (FCNs, PNCs, FMFs)
A. Part I: General Information
 Item 1: Enter the date that you transmit the submission to FDA in the format
YYYY-MM-DD (e.g., 2007-12-23). If you include a cover letter, the date you
enter should match the date of the cover letter.
 Item 2: You should check electronic submissions for viruses (with updated virus
protection software) before transmitting them to FDA; check the box to
indicate you have done this.
 Item 3:
a. Indicate the mode of transmission (ESG Gateway or courier/mail) and the

format of your submission if you submit by courier/mail (electronic physical
media or paper).
b. If submitted by courier/mail, describe in the space provided the type of

electronic media (e.g., CD-ROM, DVDs) and the number of discs, or the
number of volumes and copies for paper submissions.
B. Part II: Chemistry Information

1. General Instructions for Part II
 Summarize all pertinent information concerning the FCS that is the subject
of the notification. This should include:
o Chemical identity (Section A);
o Manufacturing process (Section B);
o Impurities and physical/chemical properties and specifications
(Section C);
o Intended use and intended technical effect (Section D);
o Stability (Section E);
Deliverable 6.3 139

o Migration Levels in food (Section F); and

o Estimated daily intake (Section G).
 In addition to the summary information provided, your notification should

include all supporting information or data. For recommendations on
migration testing and presentation of the chemistry information see
“Guidance for Industry: Preparation of Premarket Notifications and Food
Additive Petitions for Food Contact Substances: Chemistry
Recommendations” (see Internet Resource #4 in Section VII of these
instructions). On Form FDA 3480, we refer to this guidance as “Chemistry
Recommendations.”
 Include sufficient supporting information and data to enable FDA to confirm

values and results reported on the Form or in attachments or appendices,
including the estimated daily intake(s) resulting from the intended use of the
substance.
2. Entering Chemical Information and Quantities on the Form
Below, we provide some specific recommendations for entering information in the

fields in Part II of the Form:
 For chemical names in the tables, the Chemical Abstracts Service (CAS)
name, or the International Union of Pure and Applied Chemistry (IUPAC)
name is acceptable. Do not use trade or code names/numbers. Many fields
in the tables allow several lines of text for the entry of long chemical names.
If a chemical name will not fit in the space provided in a text field on the
form, enter terms that will identify the substance in the context of your
submission and refer to the location in your submission where the complete
chemical name can be found. For example, you might enter:
“(Oxidation product of FCS, see attachment 3)”
You should still enter the CAS registry number, if it exists, and other
requested information in the row for the substance.
Deliverable 6.3 140

 To name non-specified total nonvolatile extractives (TNEs) or oligomers for a

given polymeric FCS, enter the FCS chemical name followed, in parentheses,
by (TNEs) or (oligomers), space permitting, and use the FCS CAS number.
 For CAS registry numbers, use the standard CAS format that includes
hyphens, e.g., 12367-78-9. Enter “none” if no CAS number exists for the
given chemical.
 For quantity fields, report values in the units specified in the table column on
the Form, e.g., ppb, mg/in2, and use ordinary base ten, e.g., 0.0000045. Do
not use scientific notation
If you exceed the available number of rows in a table, click the check box below that
table; this causes a continuation page of the table to be generated.
3. Entering Information Into Table 4 in Section F.1.b – Summary of the Migration

Testing
Below is an example of information entered in Table 4 in Part II, Section F.1.b:

Example: A notifier conducted a migration study to support the use of a polymer
adjuvant, Adjuvant X, intended for use at a maximum level of 0.01 wt.% in LDPE. The
example table below shows how the notifier might tabulate migration data obtained
from sample plaques tested in 10% ethanol under conditions of use B.
Deliverable 6.3 141

Table 16. Summary of Migration Testing
C. Part III: Safety Information
 Provide a safety narrative, comprehensive toxicology profile(s) (CTPs), and

list pertinent toxicological studies as directed on the Form.
 Include full study reports of studies that are used as the basis of the safety
determination and current literature search results.
 For more complete recommendations regarding the safety information, see

“Guidance for Industry: Preparation of Premarket Notifications for Food
Contact Substances: Toxicology Recommendations” (see Internet Resource
#5 in Section VII of these instructions). On Form FDA 3480, we refer to this
guidance as “Toxicology Recommendations.”
D. Part IV: Environmental Information
 Either:
o provide a complete claim of categorical exclusion by, under item 1,
checking the box(es) for the exclusion(s) you are claiming, completing
the items below the exclusion, and completing items 2 and 3 if the
proposed use qualifies for exclusion from the need to prepare an
Environmental Assessment (EA) as defined under 21 CFR 25.32; or
Deliverable 6.3 142

o Submit an EA.
 For more information about the environmental information in a FCN, see

“Guidance for Industry: Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety and
Applied Nutrition” (see Internet Resource #6 in Section VII of these
instructions). On Form FDA 3480, we refer to this guidance as
“Environmental Recommendations.”
E. Part V: Certification
In Part V, an authorized official or agent signs and dates the form and provides
his/her title. For information on electronic signatures, see Internet Resource #1,
Part III.G.
F. Part VI: List of Attachments.
 For electronic submissions:

o Click on “Insert” to insert the name of a file from the directory on
your local hard drive that is the FCN folder structure wherein you
have placed the documents for your submission. Clicking on “Clear”
will remove the name if you need to change it. This assures that the
name of the file entered in the table matches the name of the file
included your submission (our system will automatically check the
filenames in the List of Attachments against the filenames of files
actually included in the folder structure of your submission).
Alternatively, type or paste the filename (name files according to the
File Naming Conventions in Appendix 12 of Internet Resource #1,
including the 3 character extension (e.g., .pdf, .mol).
o NOTE: Documents you list are not actually “attached” in any way to
Form 3480; you must place the documents in the appropriate folders
in the FCN foldering structure according to Part V.B. of Internet
Resource #1 and Section VI: Folder Location Quick Reference, below.
Deliverable 6.3 143

o Select the folder location (indicating the folder in the standard FCN
foldering structure in which you placed the document) from the pull
down menu. For example:
 For paper submissions: o List the title of each document included with Form
3480.
o Type in the volume number and inclusive page numbers of each
document, as applicable.
 If a document is responsive to a given item on the Form, the attachment

number adjacent to the document name should match the attachment
number entered under the given item on the Form (note: not all attached
documents will necessarily be responsive to items on Form 3480).
VI. Folder Location Quick Reference
(Note: Chemistry, Safety, Environmental and Administrative information should not be combined in
a single file)
If the file is or contains: Place the file in the folder:

Form FDA 3480, administrative, regulatory Administrative
information, designation of nondisclosable
information, redacted copies
FCS identity, specifications, use, Chemistry
manufacture, impurities, technical effect
Migration, stability or other chemistry study Chemistry/Studies
reports & data
Published chemistry information Chemistry/References
Safety narrative Safety
Comprehensive toxicological profile (CTP) Safety/Chemical Name 1
and/or literature search information for a
given substance (Chemical Name 1)
Safety study reports, data of a given study Safety/Chemical Name 1/Studies/Study
type, for a given substance (Chemical Name Type
1)
Published safety studies/information on a Safety/Chemical Name 1/References
given substance (Chemical Name 1)
Deliverable 6.3 144

If the file is or contains: Place the file in the folder:

EA, categorical exclusion supporting Environmental
information
Environmental study reports & data Environmental/Studies
Published environmental Environmental/References
studies/information
Confidential information referenced in the Environmental/Confidential
EA Environmental Information
Deliverable 6.3 145

Form Approved: OMB No. 0910-0495; Expiration Date: 03/31/2019
DEPARTMENT OF HEALTH AND HUMAN SERVICES (See page 15 for OMB Statement)
Food and Drug Administration
FDA USE ONLY
FCN/PNC/FMF NUMBER
FOOD CONTACT SUBSTANCE:
NOTIFICATION FOR NEW USE
PRE-NOTIFICATION CONSULTATION DATE OF RECEIPT
FOOD MASTER FILE

See instructions for FORM 3480
If mailed, send this form and attachments to: NOTIFICATION CONTROL ASSISTANT
OFFICE OF FOOD ADDITIVE SAFETY HFS-275
5100 PAINT BRANCH PARKWAY, COLLEGE PARK, MD 20740-3835.
PART I – GENERAL INFORMATION
1. Date of this submission (yyyy/mm/dd) All included electronic files checked to be virus free.
2.
(Check box to verify)
3. Type of Submission (Check one)
Food Contact Notification (FCN) Pre-notification Consultation (PNC) Food Master File (FMF)
(For a PNC or FMF, you need only complete those items of the form relevant to the purposes of the submission; see instructions
4a. This form and documents included with this submission transmitted via: (Check appropriate boxe(s))
FDA Electronic Secure Gateway (ESG) Courier/mail (electronic physical media) Courier/mail (paper documents)
b. If transmitted via courier/mail, describe format (e.g., type of media) and number of copies included:
Name of Contact Person Position
5a. Person Company (if applicable)

Submitting This
FCN/PNC/FMF
Mailing Address (number and street)
City State or Province Zip Code/Postal Code Country
Telephone Number Fax Number E-Mail Address
Name of Contact Person Position
5b. Agent or
Attorney or Company (if applicable)
Authorized
Official (if
applicable) Mailing Address (number and street)
City State or Province Zip Code/Postal Code Country
Telephone Number Fax Number E-Mail Address
5c. Identify the Manufacturer/Supplier (s) for whom the food contact notification (FCN) will be effective:
FORM FDA 3480 (3/16) Page 1 of 14 v28

PART I – GENERAL INFORMATION (Continued)
6. List all PNCs, FMFs, correspondence letters, and FCNs not listed under item 7 that are relevant to
this submission (use FDA assigned numbers, e.g., “PNC 099999”) Mark (X) if None
7. If you previously submitted an FCN or FAP for this substance that is not effective or is effective but for a different use,
enter the FCN or FAP number(s) assigned by FDA. Mark (X) if None
8. For PNCs or FMFs , provide a brief description of the information you have provided and state the purpose(s) of your submission (or
attach this description) .
See attachment number in List of Attachments
PART II – CHEMISTRY INFORMATION

SECTION A - IDENTIFICATION OF THE FOOD CONTACT SUBSTANCE See Chemistry Recommendations, Section IIA
1. Chemical Abstracts Service (CAS) name
2. CAS Registry Number
3. Trade or Common Name
4. Other Chemical Names (IUPAC, etc.)
5. Description
Attach a description of the FCS, including chemical formula(s), structure(s) and molecular weight(s). For FCSs that cannot be
represented by a discrete chemical structure, such as new polymers, provide representative chemical structure(s) and the weight
average (Mw) and number average (Mn) molecular weight. For new copolymers, provide the ratio of monomer units in the copolymer.
See attachment number(s) in List of Attachments
See other FDA file

Notes:
FORM FDA 3480 (3/16) Page 2 of 14 v28

PART II – CHEMISTRY INFORMATION (Continued)
SECTION A - IDENTIFICATION OF THE FOOD CONTACT SUBSTANCE (cont.) See Chemistry Recommendations, Section II.A.
6. Characterization
Attach data, such as infrared (IR), ultraviolet (UV), nuclear magnetic resonance (NMR), mass spectra, or other similar data for
identification of the FCS.
See other FDA file

Notes:
7. Molecular Weight Profile (polymer FCSs only)

Provide data that convey the molecular weight distribution, including a value for the maximum percentage of oligomeric species (not
including residual monomers, reactants, or solvents) below 1000 Daltons (low molecular weight oligomers, LMWOs), and report that
percentage below. Analytical methods should be included.
Percentage oligomers below 1000 daltons: % (Ensure that consumer exposures to LMWOs are addressed under Section II.G of this
form.)
See other FDA file

Notes:
8. Specifications
Attach a listing of physical and chemical specifications for the FCS such as density, melting point, maximum impurity levels, and
solubility in food simulants. For new polymers, provide glass transition temperatures, intrinsic or relative viscosity, melt flow indices,
morphology and crystallinity. Provide minimum or maximum specification limits or a range, as appropriate. In addition, include
specification test results for at least three production batches of the FCS and the analytical methods for establishing compliance with
specifications.
See other FDA file

Notes:
SECTION B - MANUFACTURE See Chemistry Recommendations, Section II.A. 4. a through c

1. Manufacturing Process
Attach a description of the manufacturing process for the FCS, including reaction conditions (e.g., amounts, times and temperatures),
and include chemical equations and stoichiometry for all synthetic steps and side reactions. Describe any purification steps.
See other FDA file

Notes:
2. Manufacturing Ingredients
In Table 1 below, list all reagents, monomers, solvents, catalyst systems, purification aids, etc. used to manufacture the FCS. Include
chemical name, CAS Reg. No., and function in the manufacture of the FCS. Note: Because FDA systems will capture information
entered on this form, you should list this information directly on the form, even if you choose to also include this information in an
attachment.
See other FDA file

Notes:
FORM FDA 3480 (3/16) Page 3 of 14 v28

SECTION B - MANUFACTURE See Chemistry Recommendations, Section II.A. 4. a through c

TABLE 1: Manufacturing Ingredients
Is residual
expected
to remain
Chemical Name CAS Reg. No. Function
in the final
food contact
material?**
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
** If yes, include in Table 2. If no, support this conclusion in the manufacturing process description (#1 above).
FORM FDA 3480 (3/16) Page 4 of 14 v28

SECTION C - IMPURITIES See Chemistry Recommendations, Section II.A. 4.d and II.A.5
1. Impurities
In the table below, enter impurities in the FCS including: the chemical names, CAS Reg. Nos., and typical and maximum residual
levels (percent weight) in the FCS as it will be marketed. For FCSs that are polymers, include typical and maximum residual monomer
concentrations. Also attach supporting data for the residual levels, including analytical methods, and validation information. Note:
Because FDA systems will capture information entered on this form, you should list this information directly on the form, even if you
choose to also include this information in an attachment.
See attachment number(s) See other FDA file
Notes:
TABLE 2: Impurities
Typical Maximum Is migration

Chemical Name CAS Reg. No. Residual Residual to food
(%) (%) expected?**
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
** If yes, ensure that exposures to these substances are addressed under Section II.G of this form.
If no, attach an explanation.
FORM FDA 3480 (3/16) Page 5 of 14 v28

SECTION D - INTENDED USE See Chemistry Recommendations, Section II.B. and II.C
1. Intended Use
a. Indicate whether single or repeat use (or both) is intended: single use repeat use
b. Attach a description of the intended use (s) of the FCS. Include:
• Maximum use level (s) in food-contact materials, types of food-contact articles with or in which the FCS is expected
to be used (e.g., films, coatings, molded articles) and maximum thickness, as applicable.
• The food types (refer to food types in Table 1 of Definitions of Food Types and Conditions of Use for Food Contact Substances)
expected to contact the FCS; include specific examples if known.
• The conditions of use: maximum temperatures and times of food contact (refer to conditions of use in Table 2 of
Definitions of Food Types and Conditions of Use for Food Contact Substances.)
2. For repeat-use articles, provide a typical use scenario. Include the highest intended use temperature, maximum food-contact time
for the article, and typical amount of food contacted over the service lifetime of the article.
See other FDA file

Notes:
3. Intended Technical Effect

Attach a description of the intended technical effect of the FCS. Attach data demonstrating that the FCS will achieve the intended
technical effect. Specifically address the minimum amount required to achieve the intended technical effect.
See other FDA file

Notes:
SECTION E - STABILITY OF THE FCS See Chemistry Recommendations, Section II.B. and II.D.2
1. Stability of the FCS
Describe any degradation of decomposition (e.g., oxidation, photolysis, hydrolysis) or other chemical process expected as a result of the
intended use of the FCS, either during its use in the manufacture of a food-contact article, or during migration testing (if performed) of a
test plaque containing the FCS. Attach a description of any such processes.
See other FDA file

Notes:
2. Degradation Products
In Table 3, enter any degradation or other products formed as a result of the use of the FCS, providing CAS names, CAS Reg. Nos.
and attach structures as appropriate. Address the amount of any products that may migrate to food. Ensure that exposures to these
substances are addressed in Section II.G of this form. Note: Because FDA systems will capture information entered on this form, you
should list this information directly on the form, even if you choose to also include this information in an attachment.
See other FDA file

Notes:
FORM FDA 3480 (3/16) Page 6 of 14 v28

SECTION E - STABILITY OF THE FCS (cont.) See Chemistry Recommendations, Section II.D.2
TABLE 3: Degradation or Other Products Formed Due to the Use of the FCS
Is migration
Chemical Name CAS Reg. No. to food
expected?**
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
** If yes, ensure that exposures to these substances are addressed under Section II.G of this form.
If no, attach an explanation per instructions above.
FORM FDA 3480 (3/16) Page 7 of 14 v28

SECTION F - MIGRATION LEVELS IN FOOD
Migration levels of the FCS or any substances (such as impurities, oligomers, degradation products) in food resulting from the intended use
of the FCS may be estimated by migration testing or by calculation. See Chemistry Recommendations, Section II.D.
For repeat-use articles, estimate migrant levels in food using migration testing and/or calculations which take into account the amount of food
contacting the article over its service lifetime. See Chemistry Recommendations, Appendix II, Part 4.
1. Migration Testing Option See Chemistry Recommendations, Section II.D. 1 through 3 and Appendix II
a. Attach the full report of the migration tests, and include:
• A description of test specimen (s) , including full composition (e.g., comonomer composition of base polymer, identities and
concentrations of adjuvants, levels of residual monomer(s)), dimensions (thickness and surface area), and relevant base
polymer properties (e.g., density, Tg, Tm, % crystallinity) . Indicate whether specimens were extracted by total immersion or
exposed to solvent on a single side. See Chemistry Recommendations section II.D.1.a and b.
• Food or food simulants employed, times and temperatures of extraction, volume of simulant used per extraction, and food
simulant volume-to-specimen surface area ratio (e.g., 10% ethanol, conditions of use A [121°C/2 h, then 40°C/238 h], 200 mL
of 10% ethanol solution per extraction, 10 mL/in 2 ) . If the food simulant volume-to-specimen surface area ratio is less than
10 mL/in 2 , provide evidence (e.g., turbidity or precipitation data) showing that saturation of the food simulant has not occurred.
See Chemistry Recommendations Section II.D.1.c,d.
• Detailed descriptions of analytical methods, raw data (e.g., peak areas) , sample instrumental output (e.g., chromatograms
or spectra) , and sample calculations relating the instrumental output to the migration values you report in mg/in 2 , in Table 4.
See Chemistry Recommendations Section II.D.3.a-d.
• A summary of the method validation results. Give average percent recovery for all analytes, food or food simulants, and
fortification (spiking) levels. Full details, including description of spiking procedure and calculations, must be included.
See Chemistry Recommendations Section II.D.3.e.
See other FDA file

Notes:
b. In Table 4, summarize results of migration testing for each test specimen. Give individual and average migration values (mg/in2 ) for all
analytes in each simulant at all time points. For new polymers, provide a measure of oligomer migration and, if possible, characterize the
individual low-molecular weight oligomer components (click here for example) . See Chemistry Recommendations section II.D.2
See other FDA file

Notes:
FORM FDA 3480 (3/16) Page 8 of 14 v28

TABLE 4: Summary of Migration Testing
Test Sample Food or Food Temperature and Migration Average Migration
Migrant
Formulation Simulant Time of Analysis (each replicate) (average of replicates)
FORM FDA 3480 (3/16) Page 9 of 14 v28

SECTION F - MIGRATION LEVELS IN FOOD (cont.)

2. Migration Calculation Option
See Chemistry Recommendations, section II.D.5 for discussions on 100% migration calculations, II.D.4 for information on FDA’s
migration database, and II.D.5 for migration modelling.
a. Was migration for certain migrants estimated by calculation? Yes No
b. Attach a description of the mathematical approach used and the basis for the approach in estimating migration levels to food for the
FCS or any migrants, such as impurities, monomers or breakdown products in the FCS. Fully describe assumptions made in deriving
the estimates and show all calculations.
See other FDA file

Notes:
SECTION G - ESTIMATED DAILY INTAKE (EDI) See Chemistry Recommendations, Section II.E and Appendix IV
The dietary concentration (DC) and EDI for the notified use must be calculated by the notifier for both the FCS and any migrants. The notifier is
also responsible for providing cumulative EDIs (CEDIs) reflecting any previously regulated, notified, or otherwise authorized uses of the FCS.
The notifier may wish to consult FDA to obtain this information prior to submitting a notification.
1. Single-Use Articles
In an attachment, show representative calculations for the EDI for all migrants. Clearly describe the food-type distribution factors (f T )
and consumption factors (CF) used in the calculations (see Chemistry Recommendations Appendix IV) . If f T and/or CF values other
than those assigned by FDA are used, information supporting derivation and use of such factors must be attached. The following
general equation is used to calculate an EDI:
EDI = DC x 3 kg food/p/d
= CF x <M> x 3 kg food/person/day
= CF x [(Maq )(faq )+(Mac )(fac )+(Mal )(fal )+(Mfat )(ffat )] x 3 kg/p/d
where: <M> is the concentration of the migrant in food; M i is the migration value in simulant i; and (aq) is aqueous, (ac) is acidic, (al)
is alcoholic, and (fat) is fatty.
See other FDA file

Notes:
2. Repeat-Use Articles
Using the migration levels to food determined in Section II.F and the repeat use scenario information described in Section II.D.2,
show the calculations used for determining DC and EDI for the FCS and any migrants.
See other FDA file

Notes:
FORM FDA 3480 (3/16) Page 10 of 14 v28

SECTION G - ESTIMATED DAILY INTAKE (EDI) (cont.) See Chemistry Recommendations, Section II.E and Appendix IV
3. Summary of the Chemistry Information
In Table 5, enter the values for <M>, DC , and EDI of the FCS and any migrants, including oligomeric species (for unspecified
oligomers, use the chemical name and CAS Reg. No. of the FCS) and degradation or other products. Provide CEDI to include this use.
Note: Because FDA systems will capture information entered on this form, you should list this information directly on the form, even if
you choose to also include this information in an attachment.

Notes:
TABLE 5: Summary of the Chemistry Information

CAS <M> DC EDI CEDI
Chemical Name
Reg. No. (μg/kg) (μg/kg) (μg/p/d) (μg/p/d)
FORM FDA 3480 (3/16) Page 11 of 14 v28

PART III – SAFETY
A. Safety Narrative
Attach a safety narrative, which is an executive summary describing the scientific basis of your determination that the FCS
is safe under the conditions of use requested in this notification.
Your safety narrative should:
• Summarize the chemistry and toxicology information that justify a conclusion that the intended use of the FCS is safe.
• Address any negative information regarding the safety of the FCS and its constituents.
• Address the safety of any mutagenic or carcinogenic constituents of the FCS.
• Include upper bound lifetime cancer risk levels and acceptable daily intake values as appropriate.
Complete instructions on preparing a Safety Narrative are provided in Toxicology Recommendations, Section VI . Do not provide
detailed study summaries in the safety narrative. Such summaries and supporting documentation should be included in the
Comprehensive Toxicology Profile (s) (item 2 below).
See other FDA file

Notes:
B. Comprehensive Toxicology Profile(s)

Attach Comprehensive Toxicology Profile (s) (CTPs) for the FCS and each constituent (e.g., impurity, degradation product) of potential
toxicological concern that is expected to migrate to food as a result of the intended use (s) of the FCS.
Complete instructions on what to include in a CTP are provided in Toxicology Recommendations, Section VII .
See other FDA file

Notes:
C. Relevant Toxicity Studies

In Table 6, provide information on each published and unpublished toxicity study pertinent to the safety of the FCS in the intended use,
which is included in or referenced in this submission. Note: Because FDA systems will capture information entered on this form, you
should list this information directly on the form, even if you choose to also include this information in an attachment.
· Enter the chemical name of each test substance and its CAS Reg. No., and list each toxicity study on that chemical below the
name of the chemical.
· For each study listed, under "Date", provide the date (YYYY/MM/DD) of the study report or publication.
· Select the toxicity Study Type (based on Redbook terminology) from the pull down menu.
· Select the Info Type from the pull down menu.
· If the study is included in this submission, under “Att. #” in Table 6, provide the attachment number adjacent to the name of the
document containing the study in the List of Attachments {Files names (document names) of toxicity studies included in this
submission should be entered in the List of Attachments, Part VI of this Form}.
· If the study is in other FDA files, provide the type of file (PNC, FCN, FAP, FMF) and the reference number (e.g., FCN 999999).
Notes:
FORM FDA 3480 (3/16) Page 12 of 14 v28

PART III – SAFETY (Continued)
TABLE 6: Relevant Toxicity Studies
Test Substance CAS Reg. No.
Location
Date Study Type Info Type
Att.# in FDA file
Test Substance CAS Reg. No.
Location
Date Study Type Info Type
Att.# in FDA file
FORM FDA 3480 (3/16) Page 13 of 14 v28

PART IV – ENVIRONMENTAL INFORMATION (21 CFR Part 25)
All FCN submissions must contain either a claim of categorical exclusion under 21 CFR 25.32 or an environmental assessment (EA) under
21 CFR 25.40. See Environmental Recommendations
A - CLAIM OF CATEGORICAL EXCLUSION
Items 1, 2 and 3 below must be completed in order for your claim of categorical exclusion to be complete.
1. Mark (X) in the box next to the specific section(s) of the CFR under which the categorical exclusion is claimed, and complete the
information below each section cited as directed:
21 CFR 25.32 (i)

a. Is the FCS expected to remain with finished food-packaging material? Yes No (if "No," then the claim is not valid);
b. Is the FCS a component of a coating of a finished food-packaging material? Yes No
c. Is the FCS a non-coating component in finished food-packaging material? Yes No
d. If the FCS is a non-coating component, what is the percentage of the FCS in finished food-packaging material? %
(If the FCS is a non-coating component contributing more than five percent by weight to finished food-packaging material, then the
claim is not valid.)
21 CFR 25.32 (j)

a. Is the FCS a component of a repeat-use article? Yes No
b. Is the FCS a component of a permanent or semi-permanent food-contact surface? Yes No
21 CFR 25.32 (k)
21 CFR 25.32 (q)

a. Is the current FIFRA label attached? Yes No
b. Is the requested use essentially the same as that specified on the FIFRA label? Yes No
(If the current FIFRA label has a limitation on food-contact uses, then provide a draft copy of a revised label you intend to submit to
EPA to include food-contact uses).
21 CFR 25.32 (r)
2. a. Does your proposed food-contact use comply with the categorical exclusion criteria? Yes No (If "No," go to section B below.)
b. If compliance with the categorical exclusion criteria is not evidenced in other parts of the submission, FDA may request additional
information (See Section II.B of the Environmental Recommendations) . If you have attached such information, indicate location.
3. To the best of your knowledge, are there any extraordinary circumstances that would require your submission of an EA?
(see 21 CFR 25.21) Yes No (If "Yes," go to section B below.)
B - ENVIRONMENTAL ASSESSMENT
See Environmental Recommendations
An EA is required and has been prepared under 21 CFR 25.40 and is attached.
Note: An EA is a public document and should not contain confidential information. Such information should be included in a separate
section of the FCN, labeled confidential and summarized to the extent possible in the EA.
PART V – CERTIFICATION
The accuracy of the statements you make in this submission should reflect your best prediction of the anticipated facts regarding the
chemical substance described herein. Any knowing and willful misinterpretation is subject to criminal penalty pursuant to 18 U.S.C. 1001.
The notifying party certifies that the information provided herein is accurate and complete to the best of his/her knowledge.
Signature of Authorized Official or Agent Printed Name and Title Date (mm/dd/yyyy)
FORM FDA 3480 (3/16) Page 14 of 14 v28

PART VI – LIST OF ATTACHMENTS
List all documents included with this form below. Clearly identify each document with an appropriately descriptive file name (or title for pa-
per documents) . You should name electronic documents according to the File Naming Conventions App. 12 . For electronic submissions,
select the Folder Location from the pull down menu. For paper submissions, write in the volume number and inclusive page numbers.
Attach- Folder Location (select from menu)
ment Attachment File Name (name for paper documents) (Vol. No., page Nos. for paper
Number submissions)
OMB Statement: Public reporting burden for this collection of information is estimated to average between 25 and 150 hours per FCN
depending upon the complexity of the subject matter, 0.5 hour per Pre-notification Consultation, and 0.5 hour per Master File submitted in
support of an FCN, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden to: Department of Health and Human Services, Food and Drug
Administration, Office of Chief Information Officer, 1350 Piccard Drive, Room 400, Rockville, MD 20850 (Please do NOT return the form to
this address.) An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
FORM FDA 3480 (3/16) Page 15 of 14 v28

Food Contact Compatibility Safety

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Food contact compatibility safety

Deliverable nature: Report

Development and Commercialisation of a complete compostable film

2 EU framework Regulation ............................................................................................... 6

2.1 DEFINITIONS ...................................................................................................................................... 8

3.1 APPROVAL OF FOOD CONTACT MATERIALS .............................................................................................. 31

7 Annex I. Union list and SML ......................................................................................... 55

7.1 MODIFICATIONS AND UPDATES .......................................................................................................... 110

8.1 MODIFICATIONS AND UPDATES .......................................................................................................... 132

8.1.5 Commission Regulation (EU) 2016/1416 of 24 August 2016 ............................................ 132

Food contact materials should be produced in accordance with Good Manufacturing

This document aims at providing guidance and information to be generated and

 European Parliament and Council Directive 94/62/EC of 20 December 1994 on

 Regulation (EC) No 178/2002 of the European Parliament and of the Council of

 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of

 Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the

 Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good

 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic

o Commission Regulation (EU) No 2016/1416 of 24 August 2016.

 Adhesion: is the force of attraction between molecules in different layers.

 Adhesives: means non-metallic substance capable of joining materials by surface

 Coating: means a non-self-supporting layer composed of substances applied on an

o Inorganic surface coating: means a non-self-supporting layer composed of

o Organic surface coating: means any resinous or polymerised preparation

 Coating: means a non-self-supporting layer composed of substances applied on an

 Layer: means a homogenous continuous or semi-continuous material of defined

 Masterbatch: means a preparation of one or more polymers which encapsulate a

 Migration modelling: means a calculation of the specific migration level of a

 Oligomer: means a substance consisting of a finite number of repeating units

 Product from intermediate stages of manufacture also referred to as Plastic

 Polymeric additive: means any polymer which is used as an additive having a

 Pre-polymer: is a polymer of relatively low molecular weight, usually an

 Set-off: is the phenomenon of the transfer of substances from outer layer of

 Surface biocide: means a substance intended to keep the surface of a material or

2.2 Scope of application

Commission Regulation (EC) No 1935/2004 shall apply to materials and articles,

 Plastic layers inside a finished multi-material multi-layer.

The Plastics Regulation does not apply to:

 Varnished or unvarnished regenerated cellulose film, covered by Commission

In particular, the Regulation (EC) No 1935/2004 shall not apply to:

17 groups of Food Contact Materials are identified:

 Active and intelligent materials  Paper and board

Currently, of the 17 groups of food contact materials, specific legislation at EU level,

2.3.1 Declaration of Compliance

The Declaration of Compliance shall contain the following information:

 The identity and address of the business operator which manufactures or

 The date of the declaration.

 Confirmation that the plastic materials or articles, products from intermediate

 Adequate information relative to the substances used or products of

 Adequate information relative to the substances which are subject to a

 Specifications on the use of the material or article, such as:

o Type or types of food with which it is intended to be put in contact.

o Ratio of food contact surface area to volume used to establish the

 When a functional barrier is used in a multi-layer material or article, the

2.3.2 Union list of approved active substances

o Degradation products generated during the production or storage of

 Restrictions and specifications. Specific for each substance.

 Be manufactured with substances not listed in the Union list or in the

2.3.2.1 Approvals for non-listed substances

Mixtures of authorised substances can be used, provided there is no chemical reaction

A macromolecular substance of a molecular weight of at least 1000 Da can be used as

The term "polymeric starting substances" covers macromolecular substances, such as