Food Supplements, botanicals and herbals:

The future post-Brexit

Sam Jennings

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

10th November 2017

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Food Supplements

o ‘food supplements’ means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

FOODSUPPLEMENTS

FOODHYGIENE

ANIMALHYGIENE

NOVELFOODS

PESTICIDERESIDUES

GENERAL FOOD LAW

FOOD SAFETY ACT(UK ONLY)

CONTAMINANTS

FOODSUPPLEMENT

SDIRECTIVE

FOODADDITIVES

FLAVOURINGS

FORTIFICATION

GMOs

INGREDIENTSPECIFIC

LAWS

EXTRACTIONSOLVENTS

LABELLING

IRRADIATION

HEALTHCLAIMS

(inc botanicals)

LOTMARKING

Berry Ottaway & Associates Ltd / CRN UK, 2016

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Some of the many laws controlling food supplements

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Post March 2019…

?Maximum limits for all

contaminants known to

cause harm?

Maximum limits for all (or

most) contaminants known

to cause harm?

Guidance and liaison with

industry to reduce

occurrence of contaminants?

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Food additives

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Post March 2019…

?Chewable tablets with

required sweetener levels?

Syrup food supplements

with preservatives?

Food supplements for

under 3s with appropriate

permitted food additives?

Few acceptable chewable

tablets?

Restricted syrup food

supplements?

Few food supplements for

under 3s?

Appropriate levels for dilutable

food supplements?

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Maximum levels for vitamins & minerals

RDA x 1

RDA x 2

RDA x 3

Present

day

1990s

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Maximum levels for vitamins & minerals

Label

advisory

statements

Fixed maximum

levels

10 statements agreed

with UK industry:Vitamin C

Iron

Calcium

Magnesium

Beta-carotene

Nicotinic acid

Zinc

Manganese

Phosphorus

Vitamin B6

No evidence of risk

to human health:

Thiamin

Riboflavin

Biotin

Vitamin B12

Cobalamin

Pantothenic acid

Vitamin K

Chromium III

e.g. >25mg zinc:

Label statement:

'Long term intake

of this amount of

zinc may lead to

anaemia.'

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Maximum levels for vitamins & minerals

Risk management approaches to the

setting of maximum levels of vitamins

and minerals in food supplements for

adults and for children aged 4–10

years.

Food Supplements Europe, 2014

http://www.foodsupplementseurope.org

/publications-guidelines

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Post March 2019…

?Label advisory

statements?

Harmonised

maximum

levels?

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Health claims and the Botanical-Herbal Conundrum

o Botanicalso Term used to describe plants and plant extracts used in food

supplements and functional foods.

o Herbalso Term used to describe plants and plant extracts used in herbal

medicines registered under the Traditional Herbal Registration (THR) scheme.

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Health claims and the Botanical-Herbal Conundrum

o The same plant can be a botanical in one EU Member State and a THR in another.o e.g. St John’s Wort, Echinacea

o On rare occasions, the same plant can be both a botanical and a THR in the same country. o e.g. milk thistle

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Health claims and the Botanical-Herbal Conundrum

Nutrition and Health Claims

Regulation 1924/2006 (NHCR)

Applied since July 2007

44,000 ‘Article 13.1’ health

claims submitted

Approx 4,000

assessed

Article 13.1 claims =

simplified applications.No dossiers.

2010

Just over 2,000 botanical claims

2017…

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Botanicals

Not harmonised

Many MS

producing own

lists

BE, FR and IT

collaborated on

extensive list

(BELFRIT)

Medicine/Food divide

Quality

Safety

Evidence base

REFIT

assessment

under NHCR

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

REFIT Botanicals

o Consultation still to be finalised.

o Initial findings show polarised positions for many aspects:o Between food and pharma;

o Between industry and consumers;

o Between Member States.

o Harmonisation at EU level seen as best way to progress.

o Harmonisation of national lists could assist with this:o Giving more legal certainty; and

o Helping resolve issues with product classification.

o Safety of products on the market already ensured under existing legislation.

o Suggestions for a way forward to be included in the consultant’s final report.

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Post March 2019…

?Status quo for

classification of botanicals

and herbals?

Assessment of botanical

health claims based on

evidence provided by

company, potentially with

interest taken in EFSA

assessments?

Eventual work

to commence

on new

framework to

harmonise

botanicals?

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Conclusion

o Unlikely to see many, if any, changes in UK legislation affecting food supplements for the period immediately after EU exit.

o Longer term, a divergence in approach between the UK and EU may potentially be seen in relation to certain food additive issues; maximum levels of vitamins and minerals; the positioning of botanicals; and health claims.

o At the moment, only educated guesses can be made...

B E R R Y O T T A W A Y & A S S O C I A T E S L T D

Thank you for your attention!

Sam Jenningsspj@berryottaway.co.uk