The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/

1. www.intertek.com1
The New EU Novel
Food Regulation –
What happens next?
Nigel Baldwin, BSc, CSci
Director, Scientific and Regulatory Consulting, Europe
Food and Nutrition
Intertek Scientific & Regulatory Consultancy

2. www.intertek.com2
Agenda
• The New EU Novel Foods Regulation
• Main Changes
• What Happens Next?

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The New Novel Foods Regulation
• REGULATION (EU) 2015/2283 on novel foods (The New
EU Novel Foods Regulations)
• Adopted 25 November 2015
• Amends
• Regulation (EU) No 1169/2011 food information to consumers
(amended definition of “engineered nanomaterial”)
• Repeals (effective Jan 1, 2018)
• Regulation (EC) No 258/97 concerning novel foods and novel
food ingredients
• Commission Regulation (EC) No 1852/2001 rules for making
certain information available to the public

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REGULATION (EU) 2015/2283
• Definition
• ‘novel food’ means any food that was not used for human
consumption to a significant degree within the Union before
15 May 1997
• Does not apply to:
• GM foods or foods produced from GM organisms
• Food enzymes
• Food additives
• Food flavourings
• Extraction solvents

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Main Changes
• Addition of
• Engineered nanomaterials (including definition)
• Vitamins, minerals, other substances where a new production
procedure is applied or contains engineered nanomaterials
• Food supplements (exclusively) to be used in foods other than
food supplements

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Original vs. New Categories of Novel Foods
Existing Regulation (EC) No 258/97 New Regulation
(a) foods and food ingredients containing or
consisting of genetically modified organisms
within the meaning of Directive 90/220/EEC;
(b) foods and food ingredients produced from,
but not containing, genetically modified
organisms;
(c) foods and food ingredients with a new or
intentionally modified primary molecular
structure;
(i) food with a new or intentionally modified
molecular structure, where that structure was not
used as, or in, a food within the Union before 15 May
1997;
(d) foods and food ingredients consisting of or
isolated from micro-organisms, fungi or algae;
(ii) food consisting of, isolated from or produced from
microorganisms, fungi or algae;
(vi) food consisting of, isolated from or produced
from cell culture or tissue culture derived from
animals, plants, micro-organisms, fungi or algae;
…and food ingredients isolated from animals,
except for foods and food ingredients obtained
by traditional propagating or breeding practices
and having a history of safe food use;
(v) food consisting of, isolated from or produced
from animals or their parts, 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;

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Original vs. New Categories of Novel Foods
Cont’d
Existing Regulation (EC) No 258/97 New Regulation
(f) foods and food ingredients to which has been
applied a production process not currently used,
where that process gives rise to significant
changes in the composition or structure of the
foods or food ingredients which affect their
nutritional value, metabolism or level of
undesirable substances.
(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 undesirable
substances;
(iii) food consisting of, isolated from or produced from
material of mineral origin;
(viii) food consisting of engineered nanomaterials as
defined in point (f) of this paragraph;
(f) "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.

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Original vs. New Categories of Novel Foods
Cont’d
Existing Regulation (EC) No 258/97 New Regulation
(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:
– a production process not used for food production
within the Union before 15 May 1997 has been
applied as referred to in point (a) (vii) of this
paragraph; or
– they contain or consist of engineered
nanomaterials as defined in point (f) of this
paragraph ;
(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;

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Main Changes
• Union list – established by 01 January 2018
• Approval is generic (unless data protection authorised) and lays
out product specifications
• Permits 5 year exclusivity with data protection
• Data protection
• On request by applicant
• Must be based on proprietary scientific evidence
• Only the applicant may place the novel food on the market until
end of 5 years
• Should another food business wish to place identical food on
market before end of 5 years, must submit subsequent
application (proprietary data cannot be used for subsequent
application within 5 years)

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Main Changes
• Procedure fully centralised at EU level
• Scientific review will be much quicker for full applications
• Application (full) made directly to the Commission instead of
a member state

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Novel Foods Submission Procedure
Applicant
• Prepares
and submits
dossier
Member State
• Conducts full
scientific
review
All Member
States
• Review the
scientific
review
EFSA
• If mandated
by
Commission
Standing
Committee
• Votes on
decision
(Commission
draft)
Commission
• Adopts
decision
• Publication in
the Official
Journal
New Novel Foods Regulation (EU) 2015/2283
Old Novel Foods Regulation (EC) No 258/97
Applicant
•Prepares and
submits
dossier
Commission
•Makes
application
available to
Member
states
•Makes
summary of
application
EFSA
•If requested
by
Commission,
provides
opinion (9
months +
stop clocks)
Standing
Committee
•Votes on
decision
(Commission
draft)
Commission
•Adoption via
comitology
into Union
List
•Publication in
the Official
Journal

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Main Changes
• Simplified Procedures
• Eliminated substantial equivalence
• Since approval is now generic
• Added notification for traditional food from a third country
• “ ‘traditional food from a third country’ means novel food as defined
in point (a) of this paragraph, other than novel food as referred to in
points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof which is derived from
primary production as defined in point 17 of Article 3 of Regulation
(EC) No 178/2002 with a history of safe food use in a third country”
• Submit documented data demonstrating history of safe use in third
country (at least 25 years in the diet of a significant number of
people)

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Traditional Food from Third Country Notification
Procedure
Applicant
• Prepares and
submits
simplified
dossier
Commission
• Forward
application to
Member states
and EFSA
Member States
and EFSA
• Submit to the
Commission
duly reasoned
safety
objections, if
any
Commission
• Inform
applicant of
any duly
reasoned
safety
objection
Commission
• If no safety
objection,
adoption via
comitology
into Union List
• If safety
objection,
Commission
shall not
authorise, new
application
required under
the full novel
food
procedure

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What Happens Next?
• 2-year transition period
• Converting existing approvals and notifications into
consolidated Union List by 01 January 2018
• Adoption of an implementing act regarding the Union List
• Adoption of implementing acts laying down administrative and
scientific requirements for applications and notifications
• Commission to draw procedural steps for the consultation
process to determine if a food falls within the scope of the
regulation

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What Happens Next?
• New scientific guidance to be released by EFSA for full
novel foods and traditional food from a third country
• Draft early 2016
• Public consultation expected end of Jan 2016 for 8 weeks
• Full novel food dossier likely to align with tiered approach for
additives and enzymes
• Must consider harmonisation with SCF addition of nutrient
guidance which also covers assessment of new vitamin and
mineral forms

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What Happens Next?
• Any novel food application submitted in accordance with the
old novel food regulations (258/97) for which the final
decision has not been taken before 01 January 2018 will be
treated as an application under the new novel food
regulations (2015/2283) (i.e., the Commission will finalise
these requests)
• Where a risk assessment has already been provided by a
Member State on the basis of the old regulation (258/97),
the Commission shall not request an opinion from EFSA

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What Happens Next?
• Foods not falling within the scope of the old regulation
(258/97) but are lawfully on the market and fall within the
scope of the new regulation (2015/2283) may continue to be
placed on the market until a decision is taken in following an
application for authorisation of a novel food or a notification
of a traditional food from a third country submitted by the
date of implementation, but no later than 02 January 2020.

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Issues to be Addressed
• Sort out new vitamins and minerals
• All are now novel food ingredients also so 2 procedures currently
apply
• 2 sets of guidance and 2 sets of comitology
• New enzymes used to make novel foods must also be
approved as enzymes
• New extraction solvents need approval as extraction solvents
as well

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Issues to be Addressed
• Compromises must be made for specifications of
substances included on Union List to cover all stakeholders
• Example: A number of substantial equivalence have been
made in comparison to an existing whole-algal product
containing the dried biomass of H. pluvialis. AstaCarotene
AB/AstaReal AB, has marketed its Astaxin™/AstaCarox™
product in the EU since at least 1995

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Astaxanthin Comparison
Company Cyanotech
Corporation
Parry Neutraceuticals Algatec
hnologies
U.S. Nutra
Trade name BioAstin
(5%)
BioAstin
(10%)
AstaNatural
2.5%
AstaNatural
5%
AstaNatural
7.0%
Algatec
hnologies
Astaxanthin
Zanthin
Substance A CO2-extracted
oleoresin of the green
algae Haematococcus
pluvialis.
Oleoresin of H. pluvialis microalga A CO2-
extracted
oleoresin of
the green
algae H.
pluvialis.
A CO2-
extracted
oleoresin of
the green
algae H.
pluvialis.
Production
process
Extracted using
supercritical CO2
Extracted using ethyl acetate Extracted
using
supercritical
CO2
Extracted
using
supercritical
CO2
Protein <3% <5% <3% <3% <3% - -
Carbohydrates <30% <55% <2% <2% <2% - -
Fat >60% >40% 90 to 95% 90 to 95% 90 to 95% - 89.8%
Moisture <8% <8% <5% <5% <5% <5%
Dietary fiber <1% <1% - - - - -
Ash <2% <2% 2 to 4% 2 to 4% 2 to 4% - -
Total
astaxanthin
>5% >10% >2.5% >5.0% >7.0% ≥10%
Total
carotenoids
- - - - - - 10.2%

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Astaxanthin Comparison
• Algatechnology’s Astaxanthin comparison to other
astaxanthin products
Fatty Acid Profile Comparison Carotinoid Profile Comparison

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Summary
• REGULATION (EU) 2015/2283 on novel foods (The New
EU Novel Foods Regulations)
• Union list – generic approvals but 5-year data protection in
some cases
• Centralised process with applications made directly to the
Commission
• 2-year transition period – becomes law 01 January 2018
• EFSA to release guidance
• Issues to address
• Sort out new vitamins and minerals
• New enzymes and extraction solvents still also need approval
• Compromises must be made in Union List to cover all
stakeholders

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Thank you!
Nigel Baldwin
Director of Scientific and Regulatory Consulting
Intertek Scientific & Regulatory Consulting
www.intertek.com/food/consulting
nigel.baldwin@intertek.com

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