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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

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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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