cognitive health and performance in the nutrition and...

Innovation | Nutrition | Regulatory | Safety | Insight

Cognitive health and performance in the

nutrition and health claims environment Oliver Leedam, Senior Regulatory Advisor

19 November 2015

www.leatherheadfood.com

2 © Leatherhead Food Research

A healthy brain is one that can perform all the mental

processes that are collectively known as cognition,

including the ability to learn new things, intuition,

judgment, language, and remembering.

What is cognitive health?

Centers for Disease Control and

Prevention

HEALTHY AGING

http://www.cdc.gov/aging/pdf/Pe

rceptions_of_Cog_Hlth_factshe

et.pdf

http://www.cdc.gov/aging/pdf/Perceptions_of_Cog_Hlth_factsheet.pdf






Regulation (EC) No. 1924/2006 on

nutrition and health claims made on foods

• Applicable from 1 July 2007 with various

transition periods for compliance

• Permitted nutrition claims

(applicable since 19 Jan 2010)

• Framework for establishing lists of

permitted health claims

• General conditions of use

Legislation



‘nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:

(a) the energy (calorific value) it

(i) provides;

(ii) provides at a reduced or increased rate; or

(iii) does not provide; and/or

(b) the nutrients or other substances it

(i) contains;

(ii) contains in reduced or increased proportions; or

(iii) does not contain;

Nutrition Claims – Definitions



Health Claims

‘health claim’ means any claim that states,

suggests or implies that a relationship exists

between a food category, a food or one of its

constituents and health;



NUTRITION OR

HEALTH CLAIM?



Nutrition or Health Claim?

Nutrient

Nutrition claim

Function

Health claim

Contains lactobacillus casei Contains probiotics

With added inulin With added prebiotic

Contains lycopene Contains antioxidants



Types of Health Claim

Health Claims

Article 13.1 Article 14.1(a)

Children’s

health and

Development 11 authorised

General Principles

Nutrient profiles

New &/or

protected

Data 6 authorised

-Growth, development &

functions of the body (13.1a)‏

-Psychological and

behavioural functions (13.1b)‏

-Slimming/ weight control/

hunger / satiety/

available energy from the

diet (13.1c)‏

229 authorised

Article 13.5

Reduction of

disease risk 14 authorised

Article 14.1(b)

General

Conditions

Nutrient Profiles

Rejected

Claims n=2026



Health Claim Approval

Health Claims

Article 13.1 Article 14.1(a) Article

13.5

Article 14.1(b)

Community register of accepted and rejected

health claims (6 months transition period)

EFSA evaluation of

consolidated list of 4637

candidate well-established

claims supported with

references to scientific

literature

Pre-market approval

based on EFSA evaluation of

scientific dossiers

(Articles 15–18)



Health Claim Approval

Health Claims

Article 13.1 Article 14.1(a)

Children’s

health and

development

General Principles

Nutrient profiles

New &/or

protected

data

-Growth, development &

functions of the body (13.1a)‏

-Psychological and

behavioural functions (13.1b)‏

-Slimming/ weight control/

hunger / satiety/

available energy from the

diet (13.1c)

Article 13.5

Reduction of

disease risk

Article 14.1(b)

General Conditions

Nutrient Profiles



Currently 229 authorised health claims

Article 13.1 Health Claims Approval

Applied since

14 Dec 2012



Approved cognitive health claims

There are only 5 approved health claims for

cognitive function at present:

Iodine contributes to normal cognitive function

Iron contributes to normal cognitive function

Water contributes to the maintenance of normal

physical and cognitive functions

Zinc contributes to normal cognitive function

Iron contributes to normal cognitive

development of children



Article 13.1 Claims “On Hold”

Still on hold:

• Caffeine claims (5) – safety concerns

• Botanicals (2078 entries in the consolidated list)

• Very low calorie diets and reduced lactose –

pending PARNUTs review



Article 13.1 Claims “On Hold”

DH spreadsheet of Article 13.1 ‘on hold’ health claims

……

Note:

• Cross check against non-authorised claims in EU Register

• Stick to same plant part, wording(s), health relationship and any

proposed conditions of use (e.g. the dose)

• Some foods/ claims may be medicinal

• Check novel status

Botanical substance Health relationship proposed by applicants in 2008 Claim wording proposed by applicants in 2008 Claim ID

1. Green Mate leaf extract (Ilex

paragueariensis St.-Hil.)

2. L-Carnitine

3. conjugated linolic acid

Targets the main causes of cellulite No proposed wording within the EFSA Access database 2843

Abies pectinata fonction ORL et poumon améliore la clarté de la voix et renforce les poumons 3195

Abies pectinata-Buds-Fir needle bone health-mineralization Bone health and structure of teeth (includes bone

structure,bone mineralization,bone density) 4336



DH spreadsheet of Article 13.1 ‘on hold’ health claims

• https://www.gov.uk/government/uploads/system/upl

oads/attachment_data/file/307453/DH_BULLETIN_-

_Searching_Article_13.1_on_hold_health_claims_ac

c.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/307453/DH_BULLETIN_-_Searching_Article_13.1_on_hold_health_claims_acc.pdf











Claims based on new or emerging scientific evidence,

including those submitted with a request for protection of

proprietary data

• Require pre-market authorisation following EFSA

evaluation of scientific dossier

• Maximum time limit of 8 months for a decision by the

Commission

• Approved claims may be used on any product meeting

specified conditions of use….

• Unless data protection granted; in this case the data (and

hence the claim) cannot be used by any other business for

5 years

Article 13.5 Health Claims



Function vs. Disease Risk Reduction

‘Reduction of disease risk claim’ means any health claim

that states, suggests or implies that the consumption of a food

category, a food or one of its constituents significantly reduces

a risk factor in the development of a human disease

Cholesterol

Lowering



Health Claims on Children's Products

Claims referring to children’s development and

health require specific authorisation

• Health claims used on products intended exclusively

for children

• The claims solely refer to the development and health of

children and where scientific data is from studies

conducted only with children

(EU guidance)



Health Professionals?



Medicinal Claims

Regulation (EU) No. 1169/2011 prohibits attributing

to any foodstuff the property of preventing,

treating or curing a human disease, or

any reference to such properties

• Medicinal claims remain prohibited for foods

• Regulation 1924/2006 allows disease risk reduction

claims with prior authorisation

• Disease risk reduction claims were prohibited in most

Member States prior to Regulation 1924/2006



Non-specific Health Claims

Vitality for an active mind

and body



• Vitamin B12 contributes to normal functioning of

the nervous system

• Vitamin B12 contributes to normal psychological

function

• Vitamin B12 contributes to normal energy-yielding

metabolism

Other Approved Claims



European Commission Guidance



Ethics?

• In sports there are a lot of problems with doping to

improve physical performance. Should similar

questions be being asked about the use of

“supplements” to improve mental performance?

Innovation | Nutrition | Regulatory | Safety | Insight

Thank you for your time

Oliver Leedam

[email protected]

cognitive health and performance in the nutrition and...

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