EU Food Regulation on Additives, Novel Foods and Food Contact Materials

www.lexalimentraia.euwww.lexalimentaria.eu
Luxembourg, 7&13 of July 2016
 FOOD ADDITIVES
 FOOD CONTACTS MATERIALS
 NOVEL FOODS
EIPA’s Seminar
Introduction to the
fundamentals of EU
Food Law: principles,
procedures & main
regulatory components
Setting the scene (II)

Avv. Daniele Pisanello
Speaker’s presentation
 Daniele Pisanello is an independent food lawyer legal expert in food regulation
 He is owner at LEX ALIMENTARIA LAW OFFICE (www.lexalimentaria.eu)
 He sits on the Food Ingredient and Health Research Institute’s Board of
Directors (www.foodingredient.info)
 Daniele authored
 Chemistry of Foods: EU Legal and Regulatory Approaches”, Springer, 2014
 Guida alla Legislazione alimentare, EPC Libri, 2010 and
 Italian Food Law, in “Foreign Food Law: Guideline for Safe Im- and Export””,
Behr’s Verlag, Hamburg, 2010
 He was co-founder and Executive Director of the 1st EFFL Summer Academy on
Global Food Law & Policy
 From 2005 to 2007 He was charged with the scientific planning and
implementation of the Master in Food Law established by the University of Turin
– Faculty of Law.
 Daniele also trained at EIPA’s seminars in the field of EU Food Law and Official
Controls.
2

Avv. Daniele Pisanello3
Food Additives
B Food Contact Materials
Setting the scene (II): Contents
A
C Novel Foods

FOOD ADDITIVESA

1
Scope and fundamentals of EU Regulation relating to
Food Additives (FAs)
2 Authorization and the Positive List Principle
3 Conditions of use for food additives
4 Labelling requirements
(A) Food Additives: Table of contents

Scope and fundamentals of EU
Regulation on Food Additives (FAs)
6

Chemistry in food: EU perspective
7
CHEMISTRY
INTENTIONALLY ADDED
(TECHNICAL PURPOSE)
NOT INTENTIONALLY
ADDED AND TECHNICALLY
INEVITABLE
FOOD ADDITIVES
ENZYMES
FOOD FLAVOURINGS
FOOD CONTACT MATERIALS
(FCM)
CONTAMINANTS
PESTICIDE RESIDUES
RESIDUES OF
VETERINARY MEDICINAL
PRODUCTS
FOOD
IMPROVEMENT
AGENTS
PACKAGE
(FIAP)

Overview of FAs Regulations
1) Pre-market authorization (Positive List Principle)
 inclusion in the Union’s lists of food additives
• in accordance with the procedure referred to in Regulation (EC) No
1331/2008 [establishing a common authorization procedure for food
additives, food enzymes and food flavorings] which consists of
 a risk analisys based process consisting of
o a preliminary risk assessment (by EFSA); and
o decision making process centralised at the EU level:
 EU Commission assisted by
 Standing Committee on the Food Chain and Animal
Health (hereinafter SCFCAH or Standing Committee)
established by Article 58 of Regulation (EC) No 178/2002
(GFL).
and ruled by an examination procedure under the
provisions of Reg. (EU) 182/2011
8

Overview of FAs Regulations
2) Since food additives must be approved for use in food, conditions of use are
usually addressed as regards
 Food categories, in which a FA can be used; and
 Maximum level of dosage (mg/l or mg/kg) as appropriate
 Restrictions/exceptions to use of a FA if appropriate
3) Since consumer information/protection is a goal of all EU policies, a number of
provisions relate to
 Labelling of FA on food delivered to consumer
9

FAs Legislation in detail: safety evaluation and
authorization procedures
 Regulation (EC) No 1331/2008 by the European Parliament and by the Council
on 16th December, 2008 establishing a common authorisation procedure for
food additives, food enzymes and food flavourings
 Commission Regulation (EU) No 234/2011 from 10 March 2011
implementing European Parliament and the Council Regulation (EC) No
1331/2008 establishing a common authorisation procedure for food
additives, food enzymes and food flavourings Text with EEA relevance
10

FAs Legislation in detail: conditions of use
(marketability)
 Regulation (EC) No 1333/2008 ,European Parliament and the Council, 16
December 2008 on food additives (G.U.U.E. L series 354 of 31 december 2008)
– in the consolidated version
 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down
specifications for food additives listed in Annexes II and III to
Regulation (EC) No 1333/2008 of the European Parliament and the
Council (G.U.U.E. L 83 of 22 march 2012) Adjustment G.U.U.E L 50 of 20
February 2014 – in the consolidated version, which establishes
• Specifications relating to
 origin,
 purity criteria and
 any other necessary information
on food additives as listed in the Union’s lists in Annex II and III to
Regulation (EC) No 1333/2008.
11

EU Regulation on food additives (Fas)
12

Contents of Regulation (EC) No 1333/2008
 Object, application field and definitions, [1-3]
 Community list of authorized additives [4-15]
 Use of additives in food [15-20]
 Labelling [21-25]
 Procedural and actualization, transitory and final dispositions [26-35]
 Annexes
o Annex I – Functional cathegories of food additives in foods, in
food additives and in food enzymes
o Annex II – UE List of authorized additives in foods and use
conditions
o Annex III – Union list of food additives, included supports,
authorized in food additives, in food enzymes, in food aromas
and nutrients and use conditions
o Annex IV - Traditional foods for which certain Member States may
continue to prohibit the use of certain categories of food additives
o Annex V - List of the food colours referred to in Article 24 for which
the labelling of foods shall include additional information
13

Authorisation procedure as ruled by FIAP
 EU common procedure for the assessment and authorisation of
 food additives,
 food enzymes,
 food flavourings and source materials of food flavourings and of food
ingredients with flavouring properties
used or intended for use in or on foodstuffs (hereinafter FIA) is ruled by above
mentioned Regulation (EC) No 1331/2008
 Regulation (EC) No 1331/2008 is applicable from 20 January 2009
 Its goals are to contribute to the free movement of food within the
Community and to a high level of protection of human health and to a
high level of consumer protection, including the protection of consumer
interests
 The procedure of Reg. (EC) No 1331/2008 does not apply to smoke
flavourings falling within the scope of Regulation (EC) No 2065/2003 of
the European Parliament and of the Council of 10 November 2003 on
smoke flavourings used or intended for use in or on foods
14

How the listing procedure should start
 The common procedure for updating the Community list can be started
 either on the initiative of the Commission; or
 following an application from
• a Member State or
• an interested party, who may represent several interested parties
15

How the procedure runs [Articles 4-8]
16
Application Commission
A
acknowledge receipt in writing within
14 working days (wds) from A
EFSA
MSs
YES
No Opposition to
the extention
expressed in 8
wds?
extended period is granted B
EFSA OPINION
within 9 months of A (or
extended period, see B)
Additional information
concerning risk
assessment?
In duly justified
cases, after
consulting the
Applicant, an
extended period
can be granted
Commission EFSA informs
YES
No
Commission
DRAFT REGULATION
updating the Community
list
Within 9 Months of C
C
SCFCAH
Voluntary Additional information may be sent,
without prejudice to ordinary terms (see C)

Food additives: a matter of … definition
 FAs are substances used for different purposes as, for example, conservation,
sweetening, coloring, etc., during the preparation of food, ingredients, other
additives, flavorings, enzymes, etc.
17
Science Law&Regulation
Public

EU definition of FA
 EU law defines food additive as follows:
 “[a]ny substance not normally consumed as a food in itself and not
normally used as a characteristic ingredient of food, whether or not it has
nutritive value, the intentional addition of which to food for a technological
purpose in the manufacture, processing, preparation, treatment,
packaging, transport or storage of such food results, or may be
reasonably expected to result, in it or its by-products the intentional
addition of which to food for a technological purpose”
• Article 3.2(a) Reg. 1333/2008, FAR.
 3 conditions for a substance to be considered as food additive in the EU:
1) Substance not normally consumed as a food in itself
2) Intentional addition to food for a technological purpose
3) Shows up or may show up in the end product
18

What falls in and out of the FAR scope (1 of 4)
 As mentioned, the FA regulatory framework applies if the substance is
 intentionally added to food;
 needed for a technological purpose; and
 appears in the finalized product
 except for those expressly excluded from the scope of FAR
1. The first set of exclusions is given by substances which, falling under
the FA’s legal definition, are not used as food additives in a particular
food manufacturing process;
2. A second set of exclusions are those food additives expressly
excluded by the Legislator’s will
 In case a given substance falls out of the scope of FAR, it may lead to important
consequences. Regarding:
 Different applicable rules about safety (i.e. conditions of use);
 Different rules on labelling
• In regard to processing aids, it is not mandatory to indicate them in
the ingredients list.
19

What falls in and out of FAR scope (2 of 4)
 The first set of exclusions is composed by substances (listed below) which are
not used as food additives in a particular food processing; namely:
 processing aids;
 substances used for the protection of plants and plant products in
accordance with Community rules relating to plant health;
 substances added to foods as nutrients;
 substances used for the treatment of water for human consumption falling
within the scope of Council Directive 98/83/EC of 3 November 1998 on
the quality of water intended for human consumption (29);
 flavourings falling within the scope of Regulation (EC) No 1334/2008 [on
flavourings and certain food ingredients with flavouring properties for use
in and on foods].
20

 A second set of exclusions is composed by those food additives expressly
excluded by the Legislator’s will, namely
1. monosaccharides, disaccharides or oligosaccharides and foods
containing these substances used for their sweetening properties;
2. foods, whether dried or in concentrated form, including flavourings
incorporated during the manufacturing of compound foods, because of
their aromatic, sapid or nutritive properties together with a secondary
colouring effect;
3. substances used in covering or coating materials, which do not form
part of foods and are not intended to be consumed together with those
foods;
4. products containing pectin and derived from dried apple pomace or peel
of citrus fruits or quinces, or from a mixture of them, by the action of dilute
acid followed by partial neutralisation with sodium or potassium salts
(liquid pectin);
21

 A second set of exclusions is composed by those food additives expressly
excluded by the Legislator’s will, namely
5. chewing gum bases;
6. white or yellow dextrin, roasted or dextrinated starch, starch modified by
acid or alkali treatment, bleached starch, physically modified starch and
starch treated by amylolitic enzymes;
7. ammonium chloride;
8. blood plasma, edible gelatin, protein hydrolysates and their salts, milk
protein and gluten;
9. amino acids and their salts other than glutamic acid, glycine, cysteine
and cystine and their salts having no technological function;
10. caseinates and casein;
11. inulin;
22

The strange case of … processing aids
 Processing aids improve and simplify the food producing process; for instance
 carnauba wax or paraffin are normally used in chewing gum, sauce and
candy industry
 Oil (hydrocarbons mixtures, completely saturated and therefore not
radioactive) traded as “white mineral oil of pharmaceutical level” is
sometimes used to whiten food
23

The strange case of … processing aids
 FAR [Art. 3(2)(b)] defines processing aid as any substance which:
i. is not consumed as a food by itself;
ii. is intentionally used in the processing of raw materials, foods or their
ingredients, to fulfil a certain technological purpose during treatment or
processing; and
iii. may result in the unintentional but technically unavoidable presence in the
final product of residues of the substance or its derivatives provided they
do not present any health risk and do not have any technological effect on
the final product;
 The difference between food additive and processing aid depends, finally, on
the way the substance is used and the inactivity of its residues in the final
product.
 In case a substance is deemed to be a Processing Aid
• According to Regulation n.1169/2011 on food information, the
processing aid is not due to be listed in the ingredient list, unless the
substance is allergen related, in which case information is due.
24

Processing aid: regulatory issues in lack of EU
harmonization (1 of 2)
 As there is not EU harmonization for Processing aids, MSs can regulate the
matter, consistenlty with the mutual recognition principle.
 By laying down, for processing aids and foodstuffs whose preparation
involved the use of processing aids from other Member States where they
are lawfully manufactured and/or marketed, a prior authorisation
scheme not complying with the principle of proportionality, the French
Republic has failed to fulfil its obligations under Article 28 EC
• JUDGMENT OF THE COURT (Third Chamber), 28 January 2010, in
Case C-333/08, European Commission v French Republic
25

Processing aid: regulatory issues in lack of EU
harmonization (2 of 2)
 Other national legislations covering processing aids:
26
Denmark: Executive Order No. 542 of 27.05.2013,
concerning Processing Aids, PAs): “PAs can only be used
in food production as long as they are safe”. It also
allows national authorities to specify requirements
concerning the use of certain processing aids. Denmark
does not have a positive list of approved PAs.
Ministry of Health’s Circular (not legally binding) sets
guidelines in order to assess whether sodium
tripolyphosphate, sodium hydroxide and hydrogen
peroxide, used to soften and whiten tripe can be deemed
as processing aids
Germany: A national regulatory act (Technische
Hilfsstoffe Verordnung) enforces the positive list principle

Authorisation: conditions for listing FA
27
2

Conditions for the authorization of FAs
 FA can be authorized by the EU Commission as result of a procedure
composed of two phases
1) Risk Assessment phase:
• a scientific evaluation is carried out by EFSA, whose output does not
show evidence of health concerns,under the light of Article 14 of GFL;
2) Risk Management phase:
• a decision making process of weighing policy alternatives. Should
take into consideration science-based evidence and “other legitimate
factors” [GFL, 3(12)]
28

Conditions for the authorization of a FAs
 For sake of precision, FAR [6] sets general conditions for authorization as listed
below:
a) Risk assessment concluding that the substance, its likely use and its
consumption do not pose safety concerns for human heath (safe use)
b) Its use can be reasonably considered a technical necessity which
cannot be satisfied with other means;
• under this requirement it is required advantages and benefits for the consumer
as: (a) preserving the nutritional quality of the food; (b) providing necessary
ingredients or constituents for foods with special dietary needs; (c) enhancing
the keeping quality or stability of a food or improving its organoleptic
properties, consistently with fair information to consumer; (d) aiding in the
manufacture, processing, preparation, treatment, packing, transport or storage
of food, provided it is not used to disguise faulty raw materials or of any
undesirable practices or techniques, including unhygienic practices or
techniques, during the course of any such activities.
c) Its use is not misleading and entails advantages for the consumer
d) No legitimate factors, including environmental factors, obstaculate or
advise against the listing
29

Health concerns and authorisation with restrictions
 Where EFSA scientific evaluation points out health concerns, the substance
may be authorized with limitations relating to certain food category and/or
dosage and/or technical purposes:
 natamycin may be used for the surface treatment of semi-hard and semi-
soft cheese and dry, cured sausage at a maximum level of 1 mg/dm2 in
the outer 5 mm of the surface
 Eritrobic acid (E315) can be used only as antioxidant in certain meat and
fish products
 Sodium ferrocyanide (E535) can be used only as anti-cake agent in salt
and its substitutes
 Southampton Colours (Quinoline Yellow (E 104), Sunset Yellow
FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E
124))
• A European Union-wide mandatory warning must be put on any food
and drink (except drinks with more than 1.2% alcohol) containing any
of the six colours: ‘name or E number of the colour(s)’: may have an
adverse effect on activity and attention in children [FAR-V]
30

Use of food additives: Quantum Satis
 In case maximum dosage is not addressed by law, FA may be used Quantum
satis;
 It is a latin term for “necessary quantity” used in pharmacology, meaning
an ingredient to be added as much as “it is necessary to achieve the
wanted result, but not more” ;
 FAR, Art. 3.2(h) defines quantum satis as follows:
• ‘quantum satis’ shall mean that no maximum numerical level is
specified and substances shall be used in accordance with good
manufacturing practices, at a level not higher than is necessary to
achieve the intended purpose and provided the consumer is not
misled.
31

Use of food additives: requirements
 In case an authorisation is granted, FA can be used
 in food consistently with the conditions provided for by Annex II to FAR
• Specific conditions of use are applicable to products (also) regulated
by Regulation (UE) n. 609/2013 of the UE Parliament and the Council
of 12 june 2013 (wich replaced Directive 89/398/CEE):
 infants and early-childhood foods
 dietary foods for infants and
 Foods for special medical purposes intended for infants and
young children
 In ADDITIVES, FLAVOURINGS or ENZYMES depending on the
conditions of Annex III to FAR
32

Functional classes of Food Additives
 Functional classes of food additives in foods and of food additives in food
additives and food enzymes are listed in Annex I to FAR:
 1. ‘sweeteners’ are substances used to impart a sweet taste to foods or in
table-top sweeteners;
 2. ‘colours’ are substances which add or restore colour in a food, and
include natural constituents of foods and natural sources which are
normally not consumed as foods as such and not normally used as
characteristic ingredients of food. Preparations obtained from foods and
other edible natural source materials obtained by physical and/or
chemical extraction resulting in a selective extraction of the pigments
relative to the nutritive or aromatic constituents are colours within the
meaning of this Regulation;
 3. ‘preservatives’ are substances which prolong the shelf-life of foods by
protecting them against deterioration caused by micro-organisms and/or
which protect against growth of pathogenic micro-organisms;
 4. ‘antioxidants’ are substances which prolong the shelf-life of foods by
protecting them against deterioration caused by oxidation, such as fat
rancidity and colour changes;
33

 5. ‘carriers’ are substances used to dissolve, dilute, disperse or otherwise
physically modify a food additive or a flavouring, food enzyme, nutrient and/or
other substance added for nutritional or physiological purposes to a food without
altering its function (and without exerting any technological effect themselves) in
order to facilitate its handling, application or use;
 6. ‘acids’ are substances which increase the acidity of a foodstuff and/or impart
a sour taste to it;
 7. ‘acidity regulators’ are substances which alter or control the acidity or
alkalinity of a foodstuff;
 8. ‘anti-caking agents’ are substances which reduce the tendency of individual
particles of a foodstuff to adhere to one another;
 9. ‘anti-foaming agents’ are substances which prevent or reduce foaming;
 10. ‘bulking agents’ are substances which contribute to the volume of a foodstuff
without contributing significantly to its available energy value;
 11. ‘emulsifiers’ are substances which make it possible to form or maintain a
homogenous mixture of two or more immiscible phases such as oil and water in
a foodstuff; 34

 12. ‘emulsifying salts’ are substances which convert proteins contained in
cheese into a dispersed form and thereby bring about homogenous distribution
of fat and other components;
 13. ‘firming agents’ are substances which make or keep tissues of fruit or
vegetables firm or crisp, or interact with gelling agents to produce or strengthen
a gel;
 14. ‘flavour enhancers’ are substances which enhance the existing taste and/or
odour of a foodstuff;
 15. ‘foaming agents’ are substances which make it possible to form a
homogenous dispersion of a gaseous phase in a liquid or solid foodstuff;
 16. ‘gelling agents’ are substances which give a foodstuff texture through
formation of a gel;
 17. ‘glazing agents’ (including lubricants) are substances which, when applied to
the external surface of a foodstuff, impart a shiny appearance or provide a
protective coating;
35

 18. ‘humectants’ are substances which prevent foods from drying out by
counteracting the effect of an atmosphere having a low degree of humidity, or
promote the dissolution of a powder in an aqueous medium;
 19. ‘modified starches’ are substances obtained by one or more chemical
treatments of edible starches, which may have undergone a physical or
enzymatic treatment, and may be acid or alkali thinned or bleached;
 20. ‘packaging gases’ are gases other than air, introduced into a container
before, during or after the placing of a foodstuff in that container;
 21. ‘propellants’ are gases other than air which expel a foodstuff from a
container;
 22. ‘raising agents’ are substances or combinations of substances which
liberate gas and thereby increase the volume of a dough or a batter;
 23. ‘sequestrants’ are substances which form chemical complexes with metallic
ions;
36

 24. ‘stabilisers’ are substances which make it possible to maintain the physico-
chemical state of a foodstuff; stabilisers include substances which enable the
maintenance of a homogenous dispersion of two or more immiscible substances
in a foodstuff, substances which stabilise, retain or intensify an existing colour of
a foodstuff and substances which increase the binding capacity of the food,
including the formation of cross-links between proteins enabling the binding of
food pieces into re-constituted food;
 25. ‘thickeners’ are substances which increase the viscosity of a foodstuff;
 26. ‘flour treatment agents’ are substances, other than emulsifiers, which are
added to flour or dough to improve its baking quality;
 By virtue of Commission Regulation (EU) No 510/2013: 27. ‘contrast enhancers’
are substances which, when applied to the external surface of fruit or
vegetables following depigmentation of predefined parts (e.g. by laser
treatment), help to distinguish these parts from the remaining surface by
imparting colour following interaction with certain components of the epidermis.
37

Use of the additives admitted in food
 Union list of food additives approved for use in food and conditions of use are
now contained in Annex II to FAR;
 Annex II includes
• the name of the food additive and its E-number
 Due to difficulties encountered during the transfer of food
additives to the new categorisation system provided in Annex II to
FAR, certain errors have been occurred and were corrected by
means of detected and should be corrected by Commission
Regulation (EU) 2015/647: the latter included as an alternative,
more specific E-numbers and names listed in Commission
Regulation (EU) No 231/2012 may be used, excluding synonyms,
if the named food additives have indeed been added to a certain
food
• the foods to which the food additive may be added,
• the conditions under which the food additive may be used,
• restrictions on the sale of the food additive directly to the final
consumer
38

Annex II to FAR: contents
 Annex II to FAR is composed by
 Part A: Introductive dispositions with some important clarifications about
carry over principle
 Part B: LIST OF ALL ADDITIVES
 Part C: DEFINITIONS OF GROUPS OF ADDITIVES
• Group I
• Group II – Food colours authorised at quantum satis
• Group III – Food colours with combined maximum limit
• Group IV – Polyols
• Other additives that may be regulated combined
 PART D: FOOD CATEGORIES (currently are 18, the ultime being
«Processed foods not covered by categories 1 to 17, excluding foods for
infants and young children»
 PART E: AUTHORISED FOOD ADDITIVES AND CONDITIONS OF USE
IN FOOD CATEGORIES
39

Authorised use via Carry Over Principle
 FAs are allowed in foods provided that
 Their use is compliant with conditions of Annex II to FAR;
or
 their presence is covered by the carry over principle (Art. 18, FAR)
accordingly to which the presence of a food additive is permitted:
• (a) in a compound food other than as referred to in Annex II, where the
FA is permitted in one of the ingredients of the compound food;
• (b) in a food to which a food additive, food enzyme or food flavouring has
been added, where the FA:
 (i) is permitted in the food additive, food enzyme or food flavouring in
accordance with this Regulation; and
 (ii) has been carried over to the food via the food additive, food enzyme or
food flavouring; and
 (iii) has no technological function in the final food;
• (c) in a food which is to be used solely in the preparation of a compound
food and provided that the compound food complies with FAR.
 Carry Over Principle does not apply to infant formulae, follow-on
formulae, processed cereal-based foods and baby foods and dietary
foods for special medical purposes intended for infants and young
children, except where specifically provided for. 40

Principle of Carry Over (1 of 3)
 Article 18.1(a) allows the presence of a food additive:
 in a compound food other than as referred to in Annex II, where the food
additive is permitted in one of the ingredients of the compound food;
• Compound food means food for which no one of the food cathegories
listed by Annex II is applicable:
 Products evocating «pizza»
 sandwiches,
 Tartine
 Fruit yogurth
• When FA is admitted via carry over, technological function (in the end
product) is out of relevance;
• In any case, content of FA via carry over must not be upper than the
authorized level in the ingredient, except the reverse carry over [Art.
18.1(c)]
41

Principle of Carry Over (2 of 3)
 Article 18.1(b) allows the presence of a food additive
 (b) in a food to which a food additive, food enzyme or food flavouring has
been added, where the food additive:
 (i) is permitted in the food additive, food enzyme or food flavouring
in accordance with this Regulation; and
 (ii) has been carried over to the food via the food additive, food
enzyme or food flavouring; and
 (iii) has no technological function in the final food;
 To be noted that, conditions of use are those provided for by Annex III to
FAR
 Where a maximum level for that use is not set, FA must not have a
technological function in the end product, unless it is authorized also for
that food or it is allowed according to the reverse carry over principle. (art.
18.1 (c)).
42

Principle of Carry Over (3 of 3): reverse carry over
 The reverse carry over is of importance in B2B transactions
 Usually FA is in half-products intended to be used exclusively in the
preparation of another food;
 Article 18.1(c) of FAR establishes that the presence of a food additive may be
allowed:
 c) in a food which is to be used solely in the preparation of a compound
food and provided that the compound food complies with this Regulation.
• In other terms, an intermediate ingredient can contain an additive that
wouldn’t normally be allowed, provided such additive is permitted be
present in the final foodstuff, and that the intermediate ingredient is
solely used for that, and that only final foodstuff
43

Labelling Requirements for food
additives
44
3

Labelling rules for Fodd Additives
 Regulation No 1333/2008/EC
 Labelling of food additives not intended for sale to the final consumer
• Article 21
 General labelling requirements for food additives not intended for sale to
the final consumer
• Article 22
 Labelling of food additives intended for sale to the final consumer
• Article 23
 Labelling requirement for foods containing certain food colours
• Article 24
 Regulation No 1169/2011 concerning food informations provided to the final
consumer
45

Additives not intended for sale to the final
consumer (1 of 3)
 Food additives not intended for sale to the final consumer sold singly or mixed
with each other and/or other food ingredients and/or with other substances
added to them, their packaging or containers must bear the following
informations [Article 22]:
A. the name and/or E-number laid down in this Regulation in respect of each
food additive or a sales description which includes the name and/or E-
number of each food additive;
B. the statement ‘for food’ or the statement ‘restricted use in food’ or a more
specific reference to its intended food use;
C. if necessary, the special conditions of storage and/or use;
D. a mark identifying the batch or lot;
E. instructions for use, if the omission thereof would preclude appropriate
use of the food additive;
F. the name or business name and address of the manufacturer, packager
or seller;
46

consumer (2 of 3)
 Food additives not intended for sale to the final consumer sold singly or mixed
with each other and/or other food ingredients and/or with other substances
added to them, their packaging or containers must bear the following
informations [Article 22]:
G. an indication of the maximum quantity of each component or group of
components subject to quantitative limitation in food and/or appropriate
information in clear and easily understandable terms enabling the
purchaser to comply with this Regulation or other relevant Community
law; where the same limit on quantity applies to a group of components
used singly or in combination, the combined percentage may be given as
a single figure; the limit on quantity shall be expressed either numerically
or by the quantum satis principle;
H. the net quantity;
I. the date of minimum durability or use-by-date;
J. where relevant, information on a food additive or other substances
referred to in this Article and listed in Annex II to Reg. (EU) No 1169/2011
47

consumer (3 of 3)
 Accordingly to Article 22.4 instructions for use, if present, the name or business
name and address of the manufacturer, packager or seller and the maximum
quantities in case of restrictions may appear merely on the documents relating
to the consignment which are to be supplied with or prior to the delivery,
provided that the indication ‘not for retail sale’ appears on an easily visible part
of the packaging or container of the product in question.
 Where food additives are sold mixed with each other and/or with other
food ingredients:
• Their packaging or containers shall bear a list of all ingredients in
descending order of their percentage by weight of the total.
 The same counts where substances (including food additives or other food
ingredients) are added to food additives to facilitate their storage, sale,
standardisation, dilution or dissolution.
 Where food additives are supplied in tankers, all of the information may appear
merely on the accompanying documents relating to the consignment which are
to be supplied with the delivery.
48

Additives sold as they are to the final
consumer (1 of 2)
 Food additives sold singly or mixed with each other and/or other food
ingredients intended for sale to the final consumer may be marketed only if their
packaging contains the following information [Article 23]::
 a) the name and E-number laid down in this Regulation in respect of each
food additive or a sales description which includes the name and E-
number of each food additive;
 (b) the statement ‘for food’ or the statement ‘restricted use in food’ or a
more specific reference to its intended food use.
 Plus all information required by Reg. (EU) No 1169/2011 and/or the
specifc requirements stated by Regulation (EC) No 1829/2003;
 To be noted that nutrition declaration is not mandatory for additives sold
to the final consumer [Annex V to Reg. (EU) No 1169/2011)
49

Additives sold as they are to the final
consumer (2 of 2)
 The sales description of a table-top sweetener shall include the term ‘… -based
table-top sweetener’, using the name of the sweetener used in its composition.
 The labelling of a table-top sweetener containing polyols and/or
aspartame and/or aspartame-acesulfame salt shall bear the following
warnings:
• (a) polyols: <<excessive consumption may induce laxative
effects>>;
• (b) aspartame/aspartame-acesulfame salt: <<contains a source of
phenylalanine>>.
50

Additional Information for labelling of certain
food colours
 Article 24 requires that the labelling of food containing the food colours listed in
Annex V to FAR must include the additional information set out in that Annex:
 ‘name or E number of the colour(s)’: may have an adverse effect on
activity and attention in children.
51

Food Information Regulation and Food
Additives Regulation
 Taking into account the general legal framework on food information, as
provided for by Reg. (EU) No 1169/2011, on food information (FIR), FAs are
ingredients
 The legal definition of “ingredient” is: any substance or product,
including flavourings, food additives and food enzymes, and any
constituent of a compound ingredient, used in the manufacture or
preparation of a food and still present in the finished product, even if in an
altered form; residues shall not be considered as ‘ingredients’;
 Therefore FAs must be declared in the ingredients list, in descending order of
weight, as recorded at the time of their use in the manufacture of the food [Art.
18, FIR]
 Except FA is a carry over (but if it is allergen related mandatory
information applies) [Art. 20.1(b), FIR]; and
 In accordance with Part C of Annex VII to FIR, namely
• FAs and food enzymes (other than those whose presence is due to
Carry Over) must be designated by the name of the functional class,
followed by their specific name or, if appropriate, E number.
• If an ingredient belongs to more than one of the class, only the
principal function can be indicated.
52

FOOD CONTACT MATERIALS (FCM)B

Food Contact Materials
 Food Contact Materials (FCM) are all materials and articles intended to come
into contact with food, such as packaging and containers, kitchen equipment,
cutlery and dishes.
 These can be made from a variety of materials including plastics, rubber,
paper and metal.
 Food contact materials also include those used in processing equipments, such
as coffee makers or production machinery as well as containers used in
transport.
 EU legislation for FCM covers materials in contact with water intended for
human consumption,
 e.g. bottles, with the exception of fixed public or private water supply
equipment.
54

 The safety of food contact materials must be evaluated as chemicals can
migrate from the materials into food.
 The materials must be manufactured in compliance with EU regulations,
including good manufacturing practices, so that any potential transfer to foods
does not raise safety concerns, change the composition of the food in an
unacceptable way or have adverse effects on the taste and/or odour of foods.
55

 Framework Regulation (EC) No 1935/2004 - general requirements for all food
contact materials
 Legislation on specific materials - groups of materials and articles listed
in the Framework Regulation
• Directives on Individual Substances or groups of substances used in
the manufacture of materials and articles intended for food contact
 National legislation covering groups of materials and articles for which EU
legislation is not yet in place
56

Framework Regulation EC No 1935/2004 (in
force since 3-XII-2004)
 It sets general principles
 It addresses Groups of food contact materials and articles
 The Regulation establishes 17 groups of materials and articles which may
be covered by specific measures.
 The specific measures may cover also combinations of different materials
or recycled materials:
• active and intelligent materials and articles; adhesives; ceramics;
cork; rubbers; glass; ion-exchange resins; metals and alloys; paper
and board; plastics; printing inks; regenerated cellulose; silicones;
textiles; varnishes and coatings; Waxes; wood
 It introduces Procedure for authorisation
 Establishes an European Reference Laboratory for food contact materials
57

EU legislation on specific materials
 Ceramics
 Directive 84/500/EEC :
• Setting migration limits for cadmium and lead which might be released
from decoration and/or glazing;
• Establishing the analytical method determining the migration of these
substances.
 Regenerated cellulose film
 Directive 2007/42/EC :
• Listing authorised substances and conditions for their use;
• Regulating plastic coated regenerated cellulose film.
 Recycled plastic materials
 Regulation EC 282/2008 :
• Setting requirements for recycled plastics to be used in food contact
materials; and
• Setting an authorisation procedure of recycling processes used in the
manufacture of recycled plastics for food contact use.
58

 Active and intelligent materials and articles
 Regulation EC 450/2009:
• Adding requirements to Regulation EC 1935/2004 for their safe use;
• Introduces an authorisation scheme for substances used for active
and intelligent functions in food contact materials.
 Plastics
 Regulation EU/10/2011 setting rules for plastic food contact materials.
 Regulation EU 321/2011
• Banning the use of Bishenol A in plastic infant feeding bottles.
 Regulation EU 1282/2011
• Reformulating list of regulated substances and amending restrictions
and specifications of already authorised substances in the Union list.
 Covered products and items are: Printed or coated plastic
materials and articles; Printed or coated plastic multi-layer
materials and articles held together by adhesives or other; Plastic
layers or coatings forming gaskets in caps and closures that make
a set of 2 or more layers of different types of materials; Plastic
layers in multi-material, multi-layer materials and articles.
59

NOVEL FOOD REGULATIONC

Novel Foods (NFs): a comparative overview
2 From Reg. (EC) No. 258/97 to Reg. (EU) No 2015/2283
Contents
1
3 Insights of new EU Regulatory framework on NFs
• Scope and field of application
• New centralised authorisation procedures
• Data Protection and other provisions

Novel Foods (NFs): a comparative
overview
1

Novel foods ante litteram
63
Potatoes were
brought from Perù to
Europe in the
second half of the
16th century.
Tomatoes, native
from Andean region,
were introduced in
Europe (Spain) in
1595.

Food amid tradition and innovation
 What we normally consume for nutritive purposes, “food”, is the result of a
number of factors
 environmental,
 cultural and religious,
 Economical,
 Legislative.
 Ordinary Food, which is the result of “customary selection", is deemed safe
unless proved otherwise (new scientific data).
 The hybridization of the social and economic models (globalization) and
increased population flow have increased the rate of movement of food and
diets among the various geographical areas of the world.
 As a result, in complex modern societies such as those we live in, a kind
of reversed burden of proof occurs: the new food, as it is not widely
consumed, must be taken as safe in order to access the market.
64

Regulation on NFs as a TBT measure
 Since a legislative/administrative act covering «novel foods» (NFs) introduces
conditions, requirements and procedures for market access, it can be deemed
as a technical regulation according to the Agreement on Technical Barriers to
Trade, TBT):
• ANNEX 1 - Terms and their Definitions for the Purpose of this
Agreement
• 1. Technical regulation
 Document which lays down product characteristics or their related
processes and production methods, including the applicable
administrative provisions, with which compliance is
mandatory. It may also include or deal exclusively with
terminology, symbols, packaging, marking or labelling
requirements as they apply to a product, process or production
method.
 As a consequence, regulation on NFs must be compliant with TBT
Agreement.
65

Regulation on NFs as SPS measure
 In as far a legislative/administrative act laying down market access for NFs
aiming at protecting human health, Agreement on the Application of Sanitary
and Phytosanitary Measures (SPS) may apply;
 ANNEX A - DEFINITIONS
• 1. Sanitary or phytosanitary measure — Any measure applied:
• (b) to protect human or animal life or health within the territory of the
Member from risks arising from additives, contaminants, toxins or
disease-causing organisms in foods, beverages or feedstuffs;
• Sanitary or phytosanitary measures include all relevant laws, decrees,
regulations, requirements and procedures including, inter alia, end
product criteria; processes and production methods; testing,
inspection, certification and approval procedures; quarantine
treatments including relevant requirements associated with the
transport of animals or plants, or with the materials necessary for their
survival during transport; provisions on relevant statistical methods,
sampling procedures and methods of risk assessment; and
packaging and labelling requirements directly related to food safety.
66

A comparative outlook to regulations on NFs
67
Adopted Regulation on NFS Proposed Regulation on NFS

Canada’s regulation
 Canada’s Food and Drug Regulations (C.R.C., c.870) – B.28.001 fornisce la
seguente definizione generale: “a substance, including a microorganism, that
does not have a history of safe use as food”.
 (a) a substance, including a microorganism, that does not have a history
of safe use as a food;
 (b) a food that has been manufactured, prepared, preserved or packaged
by a process that
• (i) has not been previously applied to that food, and
• (ii) causes the food to undergo a major change; and
 (c) a food that is derived from a plant, animal or microorganism that has
been genetically modified such that
• (i) the plant, animal or microorganism exhibits characteristics that
were not previously observed in that plant, animal or microorganism,
• (ii) the plant, animal or microorganism no longer exhibits
characteristics that were previously observed in that plant, animal or
microorganism, or
• (iii) one or more characteristics of the plant, animal or microorganism
no longer fall within the anticipated range for that plant, animal or
microorganism. 68

Sequitur
 Canadian Food Regulation requires a pre-market notification, including the
following information:
 (a) the common name under which the novel food will be sold;
 (b) the name and address of the principal place of business of the
manufacturer and, if the address is outside Canada, the name and
address of the principal place of business of the importer;
 (c) a description of the novel food, together with
• (i) information respecting its development,
• (ii) details of the method by which it is manufactured, prepared,
preserved, packaged and stored,
• (iii) details of the major change, if any,
• (iv) information respecting its intended use and directions for its
preparation,
• (v) information respecting its history of use as a food in a country
other than Canada, if applicable, and
• (vi) information relied on to establish that the novel food is safe for
consumption;
69

Sequitur
 Canadian Food Regulation requires a pre-market notification, including the
following information:
 (d) information respecting the estimated levels of consumption by
consumers of the novel food;
 (e) the text of all labels to be used in connection with the novel food;
 and (f) the name and title of the person who signed the notification and
the date of signing.
 Within 45 days after receiving a notification, the Authority review the information
included in the notification and if the information establishes that the novel food
is safe for consumption, notify the manufacturer or importer in writing that the
information is sufficient.
 Where additional information of a scientific nature is necessary in order to
assess the safety of the novel food, request in writing that the
manufacturer or importer submit that information.
• In this case, the Director must conclude the assessment within 90
days after receiving the additional information requested.
70

Australia-New Zealand regulation on NFs
 Australia New Zealand Food Standards Code - Standard 1.5.1 - Novel Foods:
 “a food that does not have a history of human consumption in Australia or
New Zealand” (Australia New Zealand Food Standards Code – Standard
1.5.1); https://www.comlaw.gov.au/Details/F2013C00142
71

China’s regulation on NFs
 China’s Administrative Measures for Safety Review of New Food Materials in
vigore dal 2007, fornisce la seguente definizione:
 New food materials refer to the following objects/materials that are not
traditionally consumed in China:
• 1. Animal, plant and microorganisms;
• 2. Substances derived from animals, plants and microorganisms;
• 3. Food substances whose structure has changed;
• 4. Other newly developed food materials
72

Pending notifications on NFs: SPS and TBT (at
30 march 2016)
73

From Reg. (EC) No 258/97 to Reg. (EU)
No 2015/2283
2

EU Regulatory Framework as of 31 December 2015
 Until 31/12/2015, the EU regulatory framework on NFs was based on:
 Regulation (EC) No 258/97 of the European Parliament and of the
Council of 27 January 1997 concerning novel foods and novel food
ingredients
 Commission Recommendation of 29 July 1997 concerning the scientific
aspects and the presentation of information necessary to support
applications for the placing on the market of novel foods and novel food
ingredients and the preparation of initial assessment reports under
Regulation (EC) No 258/97 of the European Parliament and of the
Council (97/618/CE)
 Commission Regulation (EC) No 1852/2001 of 20 September 2001
laying down detailed rules for making certain information available to the
public and for the protection of information submitted pursuant to
European Parliament and Council Regulation (EC) No 258/97
 Apart from a wide set of decisions authorising the placing on the market within
the Union of a novel food
75

The Novel Food Catalogue
 DG Sanco website provides the Novel Food Catalogue listing products which,
according to information by MSs, fall within or outside the scope of Reg. (EC)
No 258/97.
 It is a guide, not a binding tool
76
Arthrospira
platensis
(Nordstedt)
Gomont, o
Spirulina
platensis

Current authorisation procedure for NFs
 Current authorisation procedure, as ruled by Reg. (EC) No 258/97, is a co-
amministration procedure, between National and EU Authorities:
 Request for authorisation should be filed to a MS’s competent authority. It
should carry a first assessment (including the legal qualification of the
foodstuff’s status as novel food);
 The next step is to be carried on by the EU Commission which assesses
the consistency with Reg. (EC) No 258/97.
77

The new Novel Food Regulation (NFR)
78

Rationale of the new NFR
 Alligment with new food regulatory framework, adopted since 2002, deriving
from
 Regulation (EC) No 178/2002 (General Food Law, GFL); and
 Treaty on the Functioning the European Union
• Regulation (EU) No 182/2011 of the European Parliament and of the
Council of 16 February 2011 laying down the rules and general
principles concerning mechanisms for control by Member States of
the Commission’s exercise of implementing powers
 In order to clarify and update the categories of food which constitute novel
foods, taking into account scientific and technological developments
 Avoid potential WTO Dispute with Andean Countries (Perù) in terms of market
access for exotic traditional products or foods;
 Upgrading the regulatory framework consistently with
 Jurisprudence from EU Court
 Passing from procedures ending up in decisions to procedures ending up
in regulations
79

Main changes in Reg. (EU) No 2283/2015
 Procedure for determining the novel food status [4]
 New authorisation procedures centralised at EU level
 Procedure for authorising the placing on the market within the Union of a
novel food and updating the Union list [10-13];
 Specific rules for traditional foods from third countries (TFTC) [14-20];
 Setting up a time framework for concluding the authorisation procedures;
 Establishment of the Union list of NFs [8];
 Passing from procedures ending up in (particular) decision, which is binding
whom it is addressed, to procedures ending up in (more general) regulation,
which is binding for all;
 Better definition of the scope and field of application, in particular in terms of:
 Nanofoods
 Edible insects
 Provisions on Data protection [26-28]
 Market monitoring and Official Controls
80

Time frame
81
11/12/15 1/1/1631/12/15
Pubblication
on OJ
ECCEPTIONS:
• Art.4.4 (Procedure for determination of novel food status); 8 (Initial establishment of the
Union list); 13 (Implementing acts laying down administrative and scientific requirements for
applications), 20 (Implementing acts laying down administrative and scientific requirements
concerning traditional foods from third countries), 23.8 (implementing acts on Confidentiality
of applications); 30 (Committee procedure); 31 (Delegated acts regarding nano-foods);
35.3 (Transitional measures): applicable from 31/12/2015;
Entry into
force [36.1]
1/1/18
Date of
application
[36.1(2)] expect
exceptions

Implementation of RNF
 A number of implementing acts are to be adopted by the Commission, almost
consistently with the examination procedure as ruled out by Reg. (EU) No
182/2011; By 1 January 2018, implementing act are expected concerning:
 Article 4: Procedure for determination of novel food status
 Article 8: Initial establishment of the Union list
• This implementing act must be adopted in accordance with the
advisory procedure as referred to in Article 30(2) of NFR;
 Articles 13 and 20: Implementing acts laying down administrative and
scientific requirements for applications for NFs and TFFTC
• the content, drafting and presentation of the application for
authorization of NF/ TFFTC;
• the arrangements for verifying the validity, without delay, of those
applications for NF/ TFFTC ;
• the type of information to be included in the opinion of the Authority on
an application for authorisation for NF as referred to in Article 11.
• the arrangements for the exchange of information with the MSs and
with EFSA for submitting duly reasoned safety objections as referred
to in Article 15(2) of NFR
82

Implementing RNF trough delegated act
 NFR [Article 31] allows the Commission to adopt delegated acts to adjust and
adapt the definition of engineered nanomaterials [see Article 3(2)(f), NFR] to
technical and scientific progress or to definitions agreed at international level.
 Ad hoc requirements the delegated act must meet:
• The power to adopt delegated acts is conferred for a period of five
years (extensible) from 31 December 2015
• To carry out consultations with experts, including MSs’ experts, before
adopting those delegated acts;
• Simultaneous notification of the delegated act to the European
Parliament and to the Council
• The delegated act enters into force only if no objection has been
expressed either by the European Parliament (EP) or the Council
within a period of two months of notification or if, before the expiry of
that period, the European Parliament and to the Council have both
informed the Commission that they will not object. That period shall
be extended by two months at the initiative of the European
Parliament or of the Council
83

Scope and field of application of the new
Reg. (EU) No 2015/2283
3

What is out of the scope of NFR
 The NFR does not apply to:
1. genetically modified foods falling within the scope of Regulation (EC) No
1829/2003;
2. foods when and in so far as they are used as:
• (i) food enzymes falling within the scope of Regulation (EC) No
1332/2008;
• (ii) food additives falling within the scope of Regulation (EC) No
1333/2008;
• (iii) food flavourings falling within the scope of Regulation (EC) No
1334/2008;
• (iv) extraction solvents used or intended to be used in the production
of foodstuffs or food ingredients and falling within the scope of
Directive 2009/32/EC.
85

Surrounding disciplines
 NFR may overlpas with other regulations concerning food;
 Provided that the substance and/or vitamin and/or mineral falls with the
definition of novel food, the NFR applies notwithstanding specific
regulation on:
• Food supplements are regulated by Directive 2002/46/EC
• Vitamins, minerals and other substances as regulated by Regulation
(EC) No 1925/2006
• infant formula and follow-on formulae, processed cereal-based food
and baby food for infants and young children, food for special medical
purposes, and total diet replacement for weight control as regulated
by Regulation (EU) No 609/2013
 should also be assessed in accordance with the rules laid down in
this Regulation when they fall within the definition of novel food
set out therein
86

General conditions for a food to be a «novel food»
 Article 3 of NFR indicates two conditions for a food to fall within the legal
definition of «novel food»:
A. that food that was not used for human consumption to a significant
degree within the Union before 15 May 1997, irrespective of the dates of
accession of Member States to the Union; and
B. that it falls under at least one of the following categories
87

1° condition: the significant degree of consumption
 According to Article 3(2)(a), the first condition for a food to be legally considered
«novel food» is the lack of a significant degree of consumption within the UE
before 15 May 1997, irrespective of the dates of accession of MSs to the UE
 The significance level of human consumption is to be assessed taking
into consideration the degree of intake occurred (i.e., daily intake portion)
• Assessing the significant degree of consumption is different in terms
of
 a spice seasoning
Compared to
 a food constituting a higher food ration on the nutritional plan.
88

2nd condition: meeting at least one of the settled
categories
 The second condition for a food to be considered a «novel food» is that it falls
under at least one of the ten categories as addressed by Article 3(2)(a) of NFR:
 There are ten categories of «novel food» compared to six categories
resulting from the Reg. (EC) No 258/1997;
89

The new NFs categories (1 of 7)
 The second condition for a food to be considered a «novel food» is that it falls
under at least one of the ten categories as addressed by Article 3(2)(a) of NFR.
i. food with a new or intentionally modified molecular structure, where that
structure was not used as, or in, a food within the UE before 15/05/1997;
o Example: Dec. No 2011/882
ii. food consisting of, isolated from or produced from microorganisms, fungi
or algae;
o Example: Dec. 2011/73
iii. food consisting of, isolated from or produced from material of mineral
origin;
o No corresponding category from Reg. (EC) No 258/97;
90

iv. food consisting of, isolated from or produced from plants or their parts,
except when
1) the food has a history of safe food use within the UE
and
2) (It) is consisting of, isolated from or produced from a plant or a variety of
the same species obtained by:
• traditional propagating practices which have been used for food
production within the Union before 15 May 1997; or
• non-traditional propagating practices which have not been used for
food production within the Union before 15 May 1997, where those
practices do not give rise to significant changes in the composition or
structure of the food affecting its nutritional value, metabolism or level
of undesirable substances;
91

v. food consisting of, isolated from or produced from animals or their parts,
o Example: Dec. 2016/598 on lipid extract from Antarctic Krill (Euphausia
superba) as a novel food ingredient to be used in certain foods and
foodstuffs
o Food from animal clones [see whereas 14 of NFR]
 except for animals obtained by traditional breeding practices which
have been used for food production within the Union before 15 May 1997
and the food from those animals has a history of safe food use within the
Union;
92

vi. food consisting of, isolated from or produced from cell culture or tissue culture
derived from animals, plants, micro-organisms, fungi or algae;
o Coltured meat
93

vii. food resulting from a production process not used for food production within
the Union before 15 May 1997, which gives rise to significant changes in the
composition or structure of a food, affecting its nutritional value, metabolism or
level of undesired substances;
 foods and food ingredients which have been subjected to a process not
currently used in food production. Novel processes for food production
may encompass for example, new types of
 heat processing,
 non-thermal preservation methods,
 new processes to chill or freeze products,
 to dehydrate products, and
 the application of new processes catalyzed by enzymes.
 The resulting product is only considered to be an NF, if the process
results in changes in the chemical composition or structure of the food or
food ingredient, which affect its
• nutritional value,
• metabolism or
• level of undesirable substances
94

Recently authorized novel process under Reg.
(EC) No 258/1997
 Commission Implementing Decision (EU) 2016/398 of 16 March 2016,
authorising the placing on the market of UV-treated bread as a novel food
95

viii. food consisting of engineered nanomaterials as defined in Article 3(2)(f) of NFR
 Article 3(2)(f) of NFR reads: ‘engineered nanomaterial’ means any
intentionally produced material that has one or more dimensions of the
order of 100 nm or less or that is composed of discrete functional parts,
either internally or at the surface, many of which have one or more
dimensions of the order of 100 nm or less, including structures,
agglomerates or aggregates, which may have a size above the order of
100 nm but retain properties that are characteristic of the nanoscale.
Properties that are characteristic of the nanoscale include:
• (i) those related to the large specific surface area of the materials
considered; and/or
• (ii) specific physico-chemical properties that are different from those
of the non-nanoform of the same material.
 From 1st Jannuary 2018, this definition will replace the current
definition of ENMs provided for by Reg. (EU) No 1169/2011, on
food information, Article 2(2)(t)
96

(sequitur): nano on the label
 Reg. No 1169/2011, on food information, establishes that all ingredients present
in the form of engineered nanomaterials must be clearly indicated in the list of
ingredients. The names of such ingredients must be followed by the word ‘nano’
in brackets.
 The matter has been addressed by delegated Regulation No 1363/2013
which defined ENMs those new technological developments under ISO
and EU standards, but excluding nano-additives from the mandatory
information, mentioned above
 Responding to protest from the EU Parlamentm the delegated regulation
was withdrawn
97

ix. vitamins, minerals and other substances used in accordance with Directive
2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013,
where:
 Are the result of a new production process, under the meaning of point vii
of Art. 3(2)(a) (i.e. production process not used for food production
within the Union before 15 May 1997, which gives rise to significant
changes in the composition or structure of a food, affecting its nutritional
value, metabolism or level of undesirable substances);
or
 they contain or consist of engineered nanomaterials as defined by NFR
(see above)
x. food used exclusively in food supplements within the Union before 15 May
1997, where it is intended to be used in foods other than food supplements as
defined in point (a) of Article 2 of Directive 2002/46/EC
98

New centralised authorisation
procedures

EU Procedures for granting market access
 Reg. (EU) No 2015/2283 establishes two different procedures intended to grant
market access to a novel food.
 They both are now centralised at the Commision level
 The new established procedures are
 Procedure for authorising the placing on the market within the
Union of a novel food and updating the Union list
• [Articles 10-13, NFR]
 Notification of a traditional food from a third country (TFFTC)
• [Articles 14-20, NFR]
100

General conditions for inclusion of novel foods
in the Union list
 General conditions for a novel food being authorised for the EU market are
 (a) the food does not, on the basis of the scientific evidence available,
pose a safety risk to human health;
 (b) the food's intended use does not mislead the consumer, especially
when the food is intended to replace another food and there is a
significant change in the nutritional value;
 (c) where the food is intended to replace another food, it does not differ
from that food in such a way that its normal consumption would be
nutritionally disadvantageous for the consumer.
101

Who can file an application?
 The procedure for authorisation of a NF may be filed
 By the Commission’s own initiative
 By an «applicant»
• the «applicant» means the
 Member State,
 the third country or
 the interested party,
which may represent several interested parties and has submitted to
the Commission an application in accordance with Article 10 or 16 or
a notification in accordance with Article 14; [see Article 3(2)(d) of
NFR]
102

Authorisation Procedure of NFs
103
APPLICATION
[10.1]
Commission
VERIFICATION OF
VALIDITY of the application
= it contains the
information required for
risk assessment and
authorisation procedure
[3(2)(e)]
B
A
YES
NO
effect on human health?
[10.3]
No YES
Request to
EFSA
(within 1
month from
«B»)
C
additional information
required?
YESNo
After consulting the
applicant, EFSA specifies
the period within which
that additional
information is to be
provided and inform the
Commission
No opposition
within 8
days:
extended
period is
granted
Commission
opposes to
the
extended
period
D
EFSA’s OPINION
Within 9 months from «A», except
extended period as «D»
Pubblication of the
Opionion
E
DRAFT IMPLEMENTING ACT
Within 7 months from «A»
(unless «D» applies) or «E»
COMMITTEE
ART.30.3
Applicant

Additional remarks on the authorisation
procedure
 The Commission may terminate the procedure at any stage, and decide not to
proceed with an update, where it considers that such an update is not justified
[10.6].
 In such cases, where applicable, the Commission shall take account of
the views of Member States, the EFSA's opinion and any other legitimate
factors relevant to the update under consideration.
 The Commission shall inform the applicant and all Member States directly
of the reasons for not considering the update to be justified. The
Commission shall make the list of such applications publicly available.
 In exceptional circumstances, the Commission may extend the time periods
provided for in Articles 11(1), 12(1) or (2), 17(1) and 18(1) on its own initiative
or, where applicable, at the EFSA's request, where the nature of the matter in
question justifies an appropriate extension.
 The Commission shall inform the applicant and the Member States of the
extension and the reasons therefor.
104

Sequitur
 The applicant may withdraw its application at any time, thereby terminating the
procedure.
 On request by the applicant, the Commission can put on stay an authorisation
procedure for a novel food, if the applicant has submitted:
 (a) a request for data protection in accordance with Article 26; and
 (b) an application for the authorisation of a health claim on the same
novel food in accordance with Article 15 or 18 of Regulation (EC) No
1924/2006, in conjunction with a request for data protection in
accordance with Article 21 of that Regulation.
105

General aspects to be taken into consideration
by the Committee in authorising a NF
 Article 12 requires the following elements to be into account when adopting an
implementing act authorising the placing on the market within the Union of a
novel food and updating the Union list:
a. the food does not, on the basis of the scientific evidence available, pose a
safety risk to human health;
b. the food's intended use does not mislead the consumer, especially when
the food is intended to replace another food and there is a significant
change in the nutritional value;
c. where the food is intended to replace another food, it does not differ from
that food in such a way that its normal consumption would be nutritionally
disadvantageous for the consumer
d. any relevant provision of Union law, including the precautionary principle
as referred to in Article 7 of Regulation (EC) No 178/2002;
e. the Authority's opinion;
f. any other legitimate factors relevant to the application under
consideration.
 That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 30(3).
. 106

General aspects to be taken into consideration
by the Committee in authorising a NF
 The implementing act authorising the placing on the market within the Union of
a novel food and updating the Union list, includes the specification of the novel
food and, where appropriate:
a. the conditions under which the novel food may be used, including in
particular any requirements necessary to avoid possible adverse
effects on particular groups of the population, the exceeding of maximum
intake levels and risks in case of excessive consumption;
b. additional specific labelling requirements to inform the final consumer
of any specific characteristic or food property, such as the composition,
nutritional value or nutritional effects and intended use of the food, which
renders a novel food no longer equivalent to an existing food or of
implications for the health of specific groups of the population;
c. post-market monitoring requirements can be ruled out, in accordance
with Article 24 of NFR:
• If food safety reasons requires so; and
• taking into account the opinion of the Authority,
 Such requirements may include, on a case-by-case basis, the
identification of the relevant food business operators.
107

Notification of exotic foods (TFFTC)
 The notification procedure, which consists of a faster track to the market access,
only applies to
 ‘traditional food from a third country’ means
• novel food
 Of specified categories, namely
o food consisting of, isolated from or produced from
microorganisms, fungi or algae [Art.3(2)(a)((ii)]
o food consisting of, isolated from or produced from plants or
their parts [Art.3(2)(a)((iv)]
o food consisting of, isolated from or produced from animals or
their parts [Art.3(2)(a)((v)]
o food consisting of, isolated from or produced from cell culture
or tissue culture derived from animals, plants, micro-
organisms, fungi or algae [Art.3(2)(a)((vi)]
• which is derived from primary production
• with a history of safe food use in a third country;
108

The notification procedure for a TFFTC
109
Applicant
NOTIFICATION
[14]
APPLICATION
[10.1]
Commission
A
VERIFICATION OF
VALIDITY of the
notification = it contains
the information required
for risk assessment and
procedure [3(2)(e)]
B
YES
NO
FORWARD
without delay, and
not later than 1
month from B
MSs
EFSA
C
duly reasoned safety
objections? [15.2]
YES No
4 months
Commission
APPLICATION
for the
authorisation
of a TFFTC
[16]
Commission
D
EFSA
additional
information
required?
After consulting the
applicant, EFSA
specifies the period
within which that
additional information
is to be provided and
inform the
Commission
No opposition from the
Com. within 8 days:
extended period is granted
Commission
opposes to the
extended
period
YES
No
EFSA’s OPINION
Within 6 months from
«D», except extended
period as «E» E
Pubblication of the
OpionionF
DRAFT
IMPLEMENTING ACT
Within 3 months
from «F»

Why a notification and shortneed procedure?
110

I trade concerns del Perù (& Co.)
111

Segue
112
[2.2] SPS based on
scientific principles
and is not maintained
without sufficient
scientific evidence,
except as provided for
in par. 7 of Art. 5
[5.1] SPS based on an
assessment, as appropriate to
the circumstances, of the risks
to human/animal/plant life or
health, taking into account risk
assessment techniques
developed by the relevant
International Organization
[5.4] SPS when
determining the
appropriate level of
sanitary or phytosanitary
protection, take into
account the objective of
minimizing negative
trade effects
[5.5] SPS are not more
trade-restrictive than
required to achieve
their appropriate level
of sanitary or
phytosanitary
protection, taking into
account technical and
economic feasibility

THE EU Commission’s response
113

(Segue):
 B. COMPLIANCE WITH THE SPS AGREEMENT
 6. First of all, the European Communities believes the scope of this
legislation falls mostly within the scope of the WTO Agreement on Technical
Barriers to Trade (the TBT Agreement), together with much food and drink
legislation that aims at a clear product identification and labeling; this area is
being harmonized at international level by several Codex Committees.
 7. In spite of the above, any food concerns based on toxicity information
eventually leading to a marketing suspension of the alleged products may fall
within the scope of the SPS Agreement, but this is not the case at hand since
this regulation deals with registration requirements and not prohibitions. (See
also paragraph 13 and footnote 7 of this text.)
 8. Further to what is mentioned above, the European Communities cannot
accept the statement made by Peru in paragraph 8 of G/SPS/GEN/681 (sic)
"inconsistency in the application of Regulation 258/97 with the principles and
obligations set forth in the WTO Agreement on the Application of Sanitary and
Phytosanitary Measures, in particular Articles 2.2, 5.1, 5.4 and 5.6 and Annex C
of the Agreement, and at the implications of this legislation for the joint efforts of
the European Communities and Peru to facilitate sustainable trade."
114

 EU granted shortneed timing for market access procedures applicable to
traditional exotic foods by menas of
 A fatser track and
 If authorisation procedure applies, with reduced timing
 But EU Ratified that exotic products, even if consumed traditionally in their
original areas, still have to be confronted with safety measures.
115

Data protection and quinquennial reservation
 Upon applicant’s request, duly supported by appropriate and verifiable
information, the Commission can grant that newly developed scientific evidence
or scientific data supporting the application shall not be used, without the
consent of the applicant, for the benefit of a subsequent application in the five
years following the date of authorisation of new food.
116

www.lexalimentaria.eu
Grazie per l’attenzione

EU Food Regulation on Additives, Novel Foods and Food Contact Materials

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