The EU Health Claims Regulation
- Background
- Implementation and enforcement
- Practical examples
Dr. Gert Krabichler, FSE Board Member & Treasurer
Food Supplements Europe
International Non-Profit Organisation
Recital 3
This Regulation […] lay down specific provisions
concerning the use of nutrition and health claims
concerning foods to be delivered as
such to the consumer
Recital 4
This Regulation should apply to all nutrition and
The Nutrition & health claims made in commercial
communications, including inter alia generic
Health Claims advertising of food and promotional
campaigns, such as those supported in whole or
Regulation in part by public authorities. [..]
Recital 4
This Regulation should also apply to trade marks
and other brand names which may be construed
as nutrition or health claims
1. Only health claims included in the EU
Register of authorised health claims, or
claims submitted for authorisation and
awaiting a decision, can be made on food.
2. Health claims referring to general,
The Nutrition & nonspecific benefits of the nutrient to overall
good health, such as ‘good for you” must be
Health Claims accompanied by an authorised health
claim (Article 10)
Regulation 3. Health claims must be accompanied by
additional labelling requirements, such as
What is allowed ? a statement indicating the importance of a
varied and balanced diet and a healthy
lifestyle.
4. Trademarks and brand names in use
before January 2005 are allowed up to June
2022. Otherwise, all trademarks and brands
which could be construed as claims must be
accompanied by an authorised health or
nutrition claim.
About on- hold claims
Health claims still on hold can be made until a
decision is taken as long as they comply with the
Nutrition & Health claims regulation and national
provisions
The Nutrition & Remarks
Health Claims 1. Some of proposed claim wordings may not be
acceptable under the general provisions of
Regulation (EC) 1924/2006 or general food
Regulation labelling rules
What is allowed ? 2. Some of the proposed health relationships and
claim wordings may be construed as medicinal
claims and must not be made on foods.
3. Some of the substances listed may be
unauthorised novel substances
The only generic health claims permitted now are
those listed as ‘authorised’ in the EU Register of
claims; and those put ‘on hold’ by the European
Commission
Claims on hold can continue to be used on the
market under the responsibility of the food
Claims on hold business operator provided they comply with the
claims Regulation and existing national provisions
applicable to them.
A list of all the ‘on hold’ claim ID numbers can be
found on the EC website.
http://ec.europa.eu/nuhclaims/resources/docs/cl
aims_pending.pdf
Claims on hold, remarks
• Botanical are only considered to be an ‘on hold’ claim if it relates to the
same plant part(s), to the same health relationship and, if applicable, to
the same proposed conditions of use (e.g. the dose). Information can be
found in the EFSA Access database.
• Many of the proposed claim wordings may not be acceptable under the
NHCR or general food labelling rules (e.g. Prevention of disease)
• Some substances for which a claim is on hold may not be authorised in
food supplement.
• Some of these substances can also be non-authorised novel ingredients
Claimed effects should be linked to the substance (not
product) for which claims have been authorised
Authorised health claim:
“X contributes to the normal function of the immune system”.
In relation to product Y containing the relevant amount of nutrient X it is acceptable to
say:
“X contributes to the normal function of the immune system” or
“Y contains X which contributes to the normal function of the immune system”
But not:
Y contributes to the normal function of the immune system. Y contains X”
Flexibility of wordings
Due to linguistic or cultural differences, flexibility is
permitted provided that those adjusted claims have
the same meaning for consumers as that of a the
permitted claims. Final judgment on consumer
The Nutrition & understanding is made by enforcement authorities
Health Claims
Regulation
What is allowed ?
EU Register of
Nutrition & Health
Claims
In the legislation : example of wording
Due to linguistic or cultural differences,
flexibility is permitted
Wording Provided that those adjusted claims have the
of the claims same meaning for consumers as that of a the
permitted claims
Final judgment on consumer
understanding is made by enforcement
authorities
General principles on
flexibility of wording for
health claims
EU member states have informally
agreed some recommendations on
the general principles to be taken
into account by businesses if they
adapt the wording of an authorised
health claim.
January 2013
Adapted wording must mean same to consumers
as authorised claims
X contributes to the normal function of
•
•
•
•
yes
Plays a role in the normal function of the immune system” or
“X supports the normal function of the immune system” or
“X contributes to maintaining
The product Y contains X which …
• Austria, Belgium, Denmark, Finland, France, Germany, Estonia, Hungary, Ireland, Lithuania, Luxembourg, Netherlands,
Norway, Poland, Portugal, Sweden, United Kingdom
Adapted wording must mean same to consumers
as authorised claims
• Stimulates the normal function of or
• “X optimises…
• The product Y contributes to normal function
Difference between „substance“ and „product“!
Presentation of general, non-specific health claims
Art. 10(3)
When reference is made to general, non-specific benefits of a nutrient or
food for overall good health or health-related well-being such claims are
permitted but must be accompanied by a specific, authorised Article 13 or
Article 14 health claim.
• If a claim were made for ‘GOOD FOR YOUR SKIN’ on the front of a product
pack (product ‘Y’ which contains a substance ‘X’) it would be acceptable to
present this as:
• ‘GOOD FOR YOUR SKIN’ - X contributes to the maintenance of normal skin’
or
• ‘GOOD FOR YOUR SKIN’ - Y contains X which contributes to the
maintenance of normal skin’
Recital 4
Claims which are made in non-
commercial communications, such as
Outside the scope • Dietary guidelines and advice issued
by public health authorities and bodies
of the Nutrition & (e.g. folate and neural tube defect,
Lutein in relation to AMD)
Health Claims
Regulation • non-commercial communications
• Information in the press and in
scientific publications. E.g. combined
with advert?
Cannot be made:
The Nutrition & 1. Health claims which suggest
that health could be affected
Health Claims by not consuming the food
Regulation 2. Health claims which make
reference to the rate or
What is not allowed ? amount of weight loss
3. Health claims which make
reference to
recommendations of
individual doctors or health
professionals
1. What is the primary object of the claim and its
Commercial context?
If the primary object is to induce the final
communication/ non consumer to eat a specific product, to the benefit of the
manufacturer or retailer (either directly financial or
commercial indirectly, e.g. reputation), it is commercial.
communication? 2. If a third party makes the claim, have they been
paid to make the claim (commercial) or are they
(UK FSA guidelines, doing it to provide “information” (not
commercial)?
2009) 3. If the third party has not been paid, is the claim
within the information they give likely to lead to
Download Nutrition and health claims - some intangible future benefit (indirectly
Guidance to compliance with Regulation commercial, in the sense that the inducement
(EC) 1924/2006 on nutrition and health may call into question the independence of the
claims made on foods information)
Examples:
Example:
Joint Health
Joint Plus Vitamin C - Zinc –
Devil‘s Claw
Joint – Bone
Plus Antioxidants
Only 1x daily
With Vit C for Joints
Supports a Healthy
Cartilage function
Meaningful Nutrient
Example: Combination for Joints
Joint Health Vit C contributes to collagen
formation and supports
therefore a normal cartilage
Joint Plus and bone function
Zinc supports the activity of
specific cells, which are
responsible for bone formation
The antioxidants Selenium and
Abtei Joint Plus - selected Vit E contributes to protect
vitamins and trace elements cells and their components
for your health against anti-oxidative stress
Additionally, Abtei Joint Plus
contains the extract from
Devil‘s Claw as well as
Glucosamine- and Chondroitin
sulfate
Abtei Joint Plus – selected
Vitamins and trace elements
for your health
Example:
Male Active
B-Vits support the energy
Male Active metabolism and
contribute to the
Complex-Capsules reduction of tiredness
Zinc supports normal
fertility
Vit B1 contributes to
normal heart function
For active men’s health
Male Active Capsules contribute to
the supply of Vits and Mins as well as
further high value ingredients
specifically adapted for male
Example: requirements
Vits B6, B12 and C contribute to a
normal energy metabolism and a
Male Active reduction of tiredness and fatigue
Vit B1 supports the heart function
Vit B6 contributes to the regulation
of hormone activity
Vit C, Selenium and Zinc contribute
to a normal function of the immune
system and help to protect body cells
against oxidative stress
Male Active Zinc is proven to support the
maintenance of normal skin
Complex-Capsules Zinc is proven to support a normal
testosterone level
Not only women, but also men have
influence on the topic “fertility” as
Zinc contributes to normal fertility
and normal reproduction and
Selenium supports sperm formation
Additional high quality ingredients
like pumpkinseed oil, L-carnitin and
astaxanthin as a strong antioxidans
complement this innovative
formulation
Example:
Meno Active
Meno Active
for Balance and
Vitality during and
after Menopause
+ B-Vitamin B6
+ Calcium and Vitamin D
+ Soy Isoflavones
In the age between 40 and 50 years
the hormonal alteration of the
Example: female organism begins. The
production of Estrogen will be
reduced, which frequently leads to
Male Active unpleasant symptoms like hot
flashes, tiredness, and loss of bone
minerals.
Das gesunde Plus Meno Aktiv
contains Vitamin B6, which supports
the regulation of the balance and
contributes to the reduction of
tiredness and fatigue. Calcium is
required for the maintenance of
normal bones. Vitamin D supports
Meno Active the Calcium uptake and action.
Vitamin E contributes to protect cells
for Balance and against oxidative stress. Biotin
Vitality during and supports the maintenance of normal
skin and hair and of the nervous
after Menopause system. Folic acid has a function in
the division of cells. The product
contains soy isoflavones as well,
which are also called plant hormones
or phyto- estrogens.
1. x
Example:
New product
based on new
claim for
Cocoa
flavonoids
Conservative
version
1. x
Example:
New product
based on new
claim for
Cocoa
flavonoids
Conservative
version
Probiotic Unauthorised Health Claim
term “probiotic”
Enforcement Examples:
1. France
2. UK
3. Germany
1. Organisation
• National Level : DGCCRF
Law inforcement • Set up and vote French & EU regulations
• No power of control but train local inspectors
in France: • Local Level : DDPP
• Under regional prefect authority
Implementation of the • In charge of controls (local judgment)
NHCR 2. Inspection
• Regular local inspection according to a control plan (1-5y)
• Local inspection due to « denunciation » (competitors,
inspectors from other regions, …)
• National inspection on a specific / hot topic
3. Sanctions
• Educational
- Discussion + modification
- Regulatory reminder letter
• Preventive/corrective
- Administrative injunction to comply.
- Payments in case of delay : € 3,000 for the Natural Person and
€ 15,000 for the Legal Entity
• Repressive
- Ticket : fine to up to € 450 (NP) and € 2250 (LE) by offense
(eg x20.000 for 20.000 packaging)
- Statements with regard of deception: fine to up to 300K €
(NP), € 1.500k € (LE) or 10% based on the annual turnover
and up to 2 years imprisonment
1. Organisation
• National Level:
Law inforcement Advertising Standards Authority (ASA)
• Self Regulation Body
in UK: Trading Standards (TS)
• Government
Implementation of the • Local Level:
• Food inspection
NHCR • In charge of controls
2. Complaint generation and handling
• General principle: self-regulation first
• Complaints may be issued by
• Local inspections
• Competitors
• Consumers
• Complaints are issued to ASA
• Some complaints to ASA are a result from referrals from
Trading Standards
• There can also be times where if a company refuses to
comply with ASA’s rulings, the ASA can refer them to
Trading Standards where action will be taken including via
the courts.
UK Self Regulation by Advertising Standards Agency
Examples:
1. https://www.asa.org.uk/Rulings/Adjudications/2015/9/Forever-Living-Products-(UK)-Ltd/SHP_ADJ_293201.aspx#.VxPQeIf2bVI
• Website: “This carefully created formula contains a special combination of vitamins, including B6, B12 and C, which
contributes to the reduction of tiredness and fatigue. Perfect for anyone who is interested in metabolism
2. https://www.asa.org.uk/Rulings/Adjudications/2015/5/Water-for-Health-Ltd/SHP_ADJ_292311.aspx#.VxPQk4f2bVI
• Website: "Clean Chlorella" stated "Chlorella … Detoxifies and helps purify the body"
3. https://www.asa.org.uk/Rulings/Adjudications/2014/10/Vitabiotics-Ltd/SHP_ADJ_246039.aspx#.VxPQ6Yf2bVI
• Advertisement: made a health claim that referred to the recommendation of an individual health professional
4. https://www.asa.org.uk/Rulings/Adjudications/2014/3/Vitabiotics-Ltd/SHP_ADJ_244070.aspx#.VxPSZIf2bVI
• Website: The ASA considered that in the context of a website for a food supplement the claim "with particular relevance to
people with diabetes"
5. https://www.asa.org.uk/Rulings/Adjudications/2015/4/Protein-World-Ltd/SHP_ADJ_288571.aspx#.VxPRj4f2bVI
• Product Info?: Northamptonshire Trading Standards challenged whether the following 9 health and nutrition claims listed
were authorised on the EU Register
6. https://www.asa.org.uk/Rulings/Adjudications/2016/1/PharmaCare-(Europe)-Ltd/SHP_ADJ_297561.aspx#.VxPTeYf2bVI
• A national press ad and a website: for Promensil MENOPAUSE
7. https://www.asa.org.uk/Rulings/Adjudications/2013/3/Pfizer-Consumer-Healthcare-Ltd/SHP_ADJ_212962.aspx#.VxPVl4f2bVI
• A TV ad: for Centrum multivitamins, included a voice-over that stated "What do you want from a multivitamin? She'd like
help with energy release, …
1. Organisation
• National Level : BMEL & BVL
Law inforcement • BMEL: Ministry, official participant in EU StCom
• BVL: Notification of FS, training or supervision of
in Germany: local/regional agencies
• Regional Level: inspection coordination by RP / LUA
Implementation of the office
• LUAs coordinate partly on national level
NHCR • Training of county inspectors
• In charge of controls: county offices
2. Inspection
• Regular local inspection according to a control plan (1-5y)
Target: Legal Entity, warehouse, etc.
Done by agency responsible for location
• Local inspection of product, anywhere, based on location of
complaint, but no company site control:
due to « denunciation » (competitors, lawyers of
“warning society”, food inspectors, …)
• National inspection on a specific / hot topic
3. Decision:
1. Either: Agreement between parties involved
2. Or: By Court Case
Thank you for your attention!
Back-up slides
Brand names - Recital 3
But Article 28(2)
Transition measure apply to brand registered or used prior
to 1 January 2005.
Reference to excerpts from EFSA opinions
Reference to excerpts from EFSA opinions possible but should be done with
caution
E.g. from the Belgian Authorities. It will be possible to reword those claims as
follows:
• Regulation: Magnesium contributes to normal function of the nervous system
• EFSA: Magnesium contributes to normal nerve transmission
• Reworded claims: Magnesium contributes to normal nerve transmission
• Regulation: Folate contributes to maternal tissue growth during pregnancy
• EFSA: During pregnancy, folate is needed to increase the mass of red blood cells of the mother,
for the formation of the placenta and the growing fetus, uterus, breasts and other maternal
tissues
• Reworded claims: Folates contribute to placenta formation and growth of the uterus during
pregnancy
Preliminary ruling from the Court of Munich to the
Commercial European Court of Justice on the interpretation of
Article 1(2) of Regulation 1924/2006: nutrition and
communication/ non health claims made in commercial communications
from businesses to health care professionals (HCPs).
commercial
communication? Advocate General of the view that Article 1(2 ) of
Regulation 1924/2006 should include commercial
communications when those are exclusively intended
to professionals but which have the objective to
indirectly reach the consumers through those
professionals.
March 2016
