Novel foods and foods for specific groups

What is food

any substance or product, whether processed,

partially processed or unprocessed, intended to be, or reasonably

expected to be ingested by humans.

What is novel food

a food or food ingredient that has not been available

on the EU market to a significant degree prior to May 15th

1997 when the Novel Food Legislation was introduce

What is the novel food legislation

Regulation EC No 2015/2283

What are the key principles of novel food regulation

Be safe for consumers

Be properly labelled so not mislead the consumer

If replace a food must not cause a nutritional problem

what does the novel foods not apply to

Genetically modified foods covered by Regulation (EC) No

1829/2003;

Foods used as enzymes, additives and flavourings covered by Regulations (EC) No 1332/2008,

(EC) No 1333/2008, (EC) No 1334/2008;

Extraction solvents within the scope of Directive 2009/32/EC

What are the different categories in novel food

(i) with a new or intentionally modified

molecular structure;

E.g. Synthetically derived ingredients such as some fibre types

(ii) consisting of or isolated from micro-

organisms, fungi or algae

E.g. herbal root extract

(iii) consisting of or isolated from or produced from plants or their parts, except when

the food has a history of safe use (makes reference to propagating practices

(iv) 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 substance

v) food consisting of, isolated from or produced from

material of mineral origin; e.g. salt containing potassium

& magnesium (Salona)

vi) food consisting of, isolated from or produced from

animals or their parts, except when a history of safe food

use within the Union;

vii) food consisting of, isolated from or produced from cell culture or tissue culture

derived from animals, plants, micro-organisms, fungi or algae;

viii) Food consisting of engineered nanomaterials

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;

x) Food used exclusively in food supplements within the Union before 15 May 1997, but now

intended to be used in foods other than food supplements

What was the previous novel food regulation

Regulation 258/97

Why was there a change in regulation

Long and clunky process, often with

duplication

Botanicals unfairly treated

What if two applicants wanted to use the

same ingredient??

What did the regulation change

Central authorisation procedure - EFSA completes the risk assessment

Notification procedure for traditional foods from 3rd countries based on history of safe use

History of safe use

means that the safety of the food in question confirmed with

compositional data and from experience of continued use for at least 25 years in the

usual diet of a significant number of people in at least one third country

What has changed in terms of types of applications

Emerging future technologies (nanotechnology)

Whole Animals (Insects)

Cloning

Clarity on proprietary data (generic claims approval)

Defined times

What must novel foods not

pose a safety risk to human health

be misleading for consumer

be nutritionally disadvantageous for the

consumer when it replaces another foo

Who can apply for novel food

Member state, the third country or the interested part

What is stage 1 of the notification procedure for novel food

the applicant is required to conduct pre-notification and may request submission advice from EFSA

What is stage 2 of the notification procedure for novel food

The applicant submits the application to EC online and waits for the applicability review results

What is stage 3 of the notification procedure for novel food

If the novel food passes the applicability review, the EC will formally accept the application and transfer it to EFSA for safety assessment

What is stage 4 of the notification procedure for novel food

if the novel food passes the safety assessment, EFSA will release the scientific opinion. Based on EFSA's opinion, the EC will then draft regulations and after approval by the Standing Committee enact the regulations, formally granting approval to the NF

What should a business do if they are not sure whether their food is a novel food

They should consult the MS where the first intend to market the novel food

What are novel food laws like for the rest of the world

As there are no CODEX standards in place all countries have their own rules in place to review new ingredients in food.

What are the novel foods in America like

the rules are based on a self-assessment by the supplier

what is the FSG regulation

Regulation EC 609/2013

What does the FSG regulation cover

Formulate intended for infants and young children

Processed cereal based food and baby food

FSMP

Total diet replacement for weight control

What is the aim of the FSG

Protect vulnerable groups (content and marketing) & clarity for industry

What was the past name for FSGs

PARNUTs

What is covered in the FSG regulation

General compositional &

labelling rules and Single Union list of substances that can be added (inc. vits & mins)

What is covered in the specific requirements and delegated acts

Compositional requirements, pesticide use and residues, labelling requirements, presentation and advertising, notification requirements, requirements concerning commercials relating to IF, requirements in relation to infant and young child feeding and specific requirements for FSMP

Other foods which are for specific groups but not included in the regulation

Gluten free foods, meal replacement products (partial), young child formulae, sports nutrition and foods for diabetics