Health claims dossiers

Health claims dossiers
Dr Ros Miller
British Nutrition Foundation
Best practice workshop, Brussels
OUTLINE
WP1
• Best Practice Guide for Health Claims
• Health Claim dossier template
• BPG extracts
• SME impact survey
2
Around 1 in 4 health claims receives a positive
opinion:
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Aims of the best practice guide
• Provide an introduction to the Nutrition and
Health Claims Regulation
• Review relevant guidance documents
• Review health claims opinions to identify key
issues
• Identify criteria for successful health claims
dossiers.
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Outline of Best Practice Guidance Document
Part
one
A general guide to the nutrition and health claims Regulation
1
Introduction to nutrition and health claims
2
Review of EFSA guidance on health claim applications and key
recommendations for compiling a dossier of evidence
3
BACCHUS health claims template
4
Wording of health claims
5
Other relevant EC Regulation
5
Outline of Best Practice Guidance Document
Part
two
A guide to health claims in the area of cardiovascular disease
1
Criteria for successful health claim dossiers
2
Review of published health claim opinions related to polyphenols or
bioactive peptides and cardiovascular disease
3
Guidance on specific topics from EFSA’s NDA Panel
4
Dietary intake data and the health claims evaluation process
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Template
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Key considerations
8
Checklist
• Before compiling a
health claim
application
• When compiling a
health claim
application
EFSA APDESK input
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Submission process
1. Applicant
2. EFSA
3. EC
4. EU
Register
•Applicant prepares a detailed dossier of evidence to substantiate the claim
•Submission to relevant competent authority
•Competent authority submits dossier to EFSA for scientific review
•EFSA NDA panel provides an opinion
•EFSA submits its opinion to the EC and applicant
•Applicant can provide comments to EC
•EC decides whether to approve or reject the claim
•EC considers consumer understanding and wider implications
•Paliament votes on decision before claim is authorised
•Authorised claims are added to the EU Register along with conditions of use
•Rejected claims are also added along with reasons for rejection
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Consumer
Understanding
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Available via BACCHUS website:
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IMPACT OF THE REGULATION ON
SMEs
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SMEs and the health claims process
• SMEs make up 99% of Europe’s food and drink companies and
contribute 49% of turnover.
• There are potential barriers for SMEs in the process of
developing a health claim dossier (e.g. lack of in-house
regulatory affairs expertise).
• An application for a health claim represents a substantial
investment of time and funds.
• Support for SMEs in developing health claims applications is
important.
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Other
Food supplements
Snacks and
confectionary
Sauces and
spreads
Fruit and
vegetables
Meat, poultry and
fish
Non-alcoholic
drinks
Meals and meal
components
Dairy
Baked goods and
cereals
SME Survey
2015 – 50 SMEs across Europe
30%
25%
20%
15%
10%
5%
0%
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Other
Didn’t know it was
necessary
Have not got the right
expertise to
generate/collate
evidence
Would not add value
to the business
Consumers
uninterested in
product health claims
Process too long
Lack of understanding
of process
Process too complex
Financial cost too high
SME Survey
Why is it unlikely that your company will submit a
health claim dossier of evidence?
80%
70%
60%
50%
40%
30%
20%
10%
0%
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SME Survey
Do you think the benefits of
proprietary claims are
sufficiently great to make
applying for a proprietary
claim worthwhile?
37%
41%
Yes
No
Don’t know
22%
Has the regulation affected the
length of time it takes from
concept to product placement
in market?
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SME Survey
Second phase:
You can access the survey here:
https://www.surveymonkey.com/r/VMPNNVP
Paper copies available
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