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Finding the right balance for herbal (medicinal) products,
food supplements and self-care medical devices
Introduction
On 7-8 October 2014, the Association of the European Self-
Medication Industry (AESGP) organised a conference in
Brussels on herbal (medicinal) products, food supplements
and substance-based medical devices: Paving the way
towards a coherent system.

The conference was opened by Roger SCARLETTSMITH,
AESGP President, and Markus FERBER, Member of the
European Parliament, who highlighted that the AESGP
event takes place just after the hearings of the designated
new European Commissioners by the newly composed
European Parliament.

The AESGP conference looked at the developments
achieved over the last years in the European legislative
framework for herbal medicinal products and food
supplements but also discussed a number of key issues
which still remain non-harmonised - such as categorisation
of herbal products and health claims on botanicals in food.
The conference also gave an update on the proposed
changes for the legislation on medical devices that are
likely to be finally agreed upon in 2015.
Markus Ferber, Member of the European Parliament
Roger Scarlett-Smith, AESGP President
Herbal (medicinal) products, food supplements, self-care medical devices
Paving the way towards a coherent system
Brussels, 7-8 October 2014
Conference
From left to right: Andreas HENSEL, Harald KANDOLF, Hubertus CRANZ, Ilaria PASSARANI, Joris GEELEN
Harald KANDOLF (Deputy Head of Cabinet, Commis-
sioner Tonio Borg) presented an overall view of the
current situation and the European Commission posi-
tion on three legal categories of consumer-care prod-
ucts: medicines, food supplements and self-care medi-
cal devices.
Mr KANDOLF said that while in the field of herbal me-
dicinal products a framework for traditional herbal
medicinal products has been set up by the Traditional
Herbal Medicines Directive 2004/24/EC since 2004,
there will be changes in the field of medical devices
legislation, which is currently being revised by the EU
Institutions. The Commission proposal for a new legal
measure on medical devices was voted by the European
Parliament in the first reading in April 2014 and it is now
being discussed with the Council of the EU. A possible
second reading agreement is foreseen in the first half of
2015.
Harald KANDOLF
Referring to food and food supplements, Mr KANDOLF
noted that this is a very complex legal category as there
are at least three major pieces of legislation in place: the
Claims Regulation (EC) No 1924/2006 adopted in 2006,
the food supplements Directive 2002/46/EC from 2002
and the newest Food Information to Consumers Regula-
tion (EU) No 1169/2011. He admitted that some legal
issues remain open as they have not been tackled by
the European Commission until now, including: mini-
mum and maximum levels for vitamins and minerals,
nutrient profiles for foods bearing health claims and the
evaluation of botanical health claims on foods and food
supplements.

Mr KANDOLF explained that the evaluation process of
health claims has started in 2008 - initially with a list of
40 000 claims, which was then consolidated by the
European Commission to 4 000 claims. The consolidated
list was submitted in several batches to EFSA for a sci-
entific evaluation. As a result of this process, a list of 222
authorised health claims was published in 2012. Mean-
while, the evaluation of more than 2 000 health claims
on botanicals was put on hold in 2010 and the Europe-
an Commission has - in spite of the clear legal obliga-
tions - considered several options on how to proceed.
The first option was to continue with the scientific as-
sessment by EFSA as it is required by the Claims legisla-
tion. The second was to change the mandate given to
EFSA on the evaluation however it was admitted that
this would need to be legally sound and also any
change of a mandate would need to be accepted by
EFSA. The third possibility was to prepare a new legisla-
tion which would take up to 3-5 years. A consultation of
Member States took place in August 2012, however
given a variety of the opinions expressed by Member
States and the stakeholders, the European Commission
is still reflecting on how to proceed on botanical claims.

He also revealed that the European Commission faces
now three types of court cases on the implementation
of the health claims legislation. Two cases argue that
fundamentally the Commission applied the Claims
Regulation too strictly. The third accused the Commis-
sion of not implementing the Claims Regulation in light
of its decision on putting the botanical claims on hold in
2010. Mr KANDOLF concluded by saying that the new
Commissioner will need to look into the pending issues
and eventually, a decision will need to be taken. He also
reminded that a correct implementation of the legisla-
tion is one of the key obligations of the European Com-
mission.
European Commission position on consumer healthcare products
Andreas HENSEL (Professor, Institute for Pharmaceuti-
cal Biology and Phytochemistry, University of Mnster,
Germany) presented the state of play in the scientific
research on herbal substances and medicinal products.
He highlighted the need for intensified research and
development and increased funding in the field of herb-
al medicinal products in order to help developing new
innovative products.

Professor HENSEL highlighted the differences between
registered medicinal products and food supplements
both with regard to the target populations (patients vs
healthy consumers) as well as with regard to the inno-
vation cost, quality and safety requirements, which are
different for medicines and food. He pointed out that
from a scientific point of view a simple extrapolation of
health claims from the medicinal products to food sup-
plements is not correct.
Andreas HENSEL
Research and innovation in the field of herbal medicinal products
Consumers perspective on health products
Ilaria PASSARANI (Head of the
Food and Health Department,
European Consumer Organisation
(BEUC)) said that finding a right
balance for all three products cate-
gories - herbal medicinal products,
food supplements and self-care
medical devices - is challenging for
the European decision makers. She
noted that while waiting for the
decision on the assessment of
health claims on botanicals, as well
as for finalisation of the new regu-
lation of medical devices, the Euro-
pean consumers are currently ex-
posed to a confusing situation in
the marketplace.

She said that the consumers wish is
to have three principles taken into
account in the policy decisions:
safety, effectiveness and legal clari-
ty. In relation to botanical claims,
she said that consumers organisa-
tions want all claims to be justified
by solid scientific evidence which
needs to be evaluated by EFSA.
Ilaria PASSARANI called for a har-
monised, coherent approach with
regard to product classification and
she said that the current rules al-
lowing Member States to classify a
product as a medicine, food sup-
plement or medical device can lead
to a situation where consumers in
different countries may receive
different information with regard to
the same product.
Meeting report
Belgian perspective on the evaluation of botanicals in food
A Belgian perspective on the evaluation of botanicals in
food was presented by Joris GEELEN (Federal Public
Service, Health, Food Chain Safety and Environment,
Belgium). GEELEN said that the Belgian Royal Decree on
Botanicals of 1997 regulates list of authorised and for-
bidden plants, mandatory warnings and maximum
levels of these substances in food supplements. In
addition, Belgium together with France and Italy has
created a joint Belfrit list of 1000 plants. The joint list
was aimed to accelerate mutual recognition of plant-
based food supplements.
It remains to be seen whether there are any chances for
the Belfrit list to be expanded to other EU Member
States as different approaches to plants categorisation
are still very visible.
Joris GEELEN
Categorisation of herbal products
From left to right: Marisa DELB, Robert ANTON, Vittorio SILANO, Pilar AYUSO,
Werner KNSS, Ioanna CHINOU
Chair: Pilar AYUSO
Robert ANTON (Professor Emeri-
tus, Faculty of Pharmacy, University
of Strasbourg, France) explained
the historical background of the
Traditional Herbal Medicines Di-
rective 2004/24/EC and the estab-
lishment of the Committee on
Herbal Medicinal Products (HMPC)
at the EMA.


Professor ANTON said that while he
would support assessment of bo-
tanical claims on foods based on
the tradition of use of plants, he
would still have concerns with
regard to herbals with well-known
pharmacological proprieties, for
example those containing anthra-
quinone derivatives or Hypericum/
St. John's wort, which can be used
in traditional herbal medicines but
also in food supplements, depend-
ing on the national classification.
Professor ANTON has also ex-
pressed his wish to have a clear
division of herbals traditionally
used as foods (e.g. aromatic plants
such as rosemary or cammomile)
and plants with well-established
use as herbal medicines (e.g. Hy-
pericum/St. John's wort or Ginkgo).
Robert ANTON
Vittorio SILANO (Medical School, II University of Rome, Italy) out-
lined the current complex situation of the herbal products in the EU,
where herbal substances are used both in food supplements and in
medicinal products.

Professor SILANO also explained different legal requirements apply-
ing to herbal medicinal products and food supplements and funda-
mental differences between the two categories. Professor SILANO
noted that while food supplements are intended to complement the
normal diet, medicinal products are intended to treat or prevent
disease therefore indications for these two categories should be
visibly different. He called on the European Commission, Member
States, EFSA and EMA to work on a coherent approach to identify
and characterise botanical species according to their use as food or
as a medicine as well as to develop harmonised criteria for safety
and efficacy assessment of plant substances.
Meeting report
Vittorio SILANO

Werner KNSS (Chair of the Committee on Herbal
Medicinal Products, HMPC, EMA) presented the work of
the Committee on Herbal Medicinal Products (HMPC),
which was established at the EMA in September 2004.

The HMPCs main task is to develop Community herbal
monographs and list entries of herbal substances, prep-
arations and combinations thereof. It also provides
scientific advice on question related to herbal medicinal
products.

Professor KNSS also presented a comparison of the
quality, safety, efficacy, pharmacovigilance requirements
for well-established and traditional herbal medicinal
products.

He also expressed his
wish to have clear defi-
nitions of different legal
categories of products
which would allow
better categorisation/
distinction of medicinal
products, food supple-
ments, medical devices
and cosmetics.

Werner KNSS
Ioanna CHINOU (Chair of the Working Party on
Community Monographs and Community List, MLWP,
EMA) gave an insight into the work of HMPC on
drafting the Community herbal monographs for well-
established use and traditional use of medicines.
She agreed against the concept of traditional use of
herbals in food supplements since the harmonised EU
definition of a food supplement only exist since 2002.
On the contrary, plants have a long tradition of
medicinal use, sometimes even dating from ancient
times. She also reminded that food supplements, by
definition, have different properties than medicines and
she challenged the use of some plants in food.
Professor CHINOU expressed concerns over safety of the
user of plant in food supplements, especially due to possi-
ble side effects or interaction with medicines. She called
for enhanced dialogue between EFSA and EMA to improve
coordination of their work on herbal substances.
Ioanna CHINOU
Marisa DELB (Italian Medicines Agency) presented the
impact of the EMA work on the Italian herbal medicines
market and in particular how the HMPC guidance docu-
ment and the applications for herbal medicinal products
Community herbal monographs are applied by the Italian
Medicines Agency in the assessment process of herbals.
She admitted that the number of registrations and au-
thorisations for herbal medicinal products in Italy is very
low and that one of the reasons for that is the competi-
tion with the botanical food supplements.
Mrs DELB also announced that the current Italian Presi-
dency of the EU will organise a Strategic Presidency
Meeting of HMPC on EMA/EFSA activities in the assess-
ment of traditional herbal medicinal products and botani-
cal food supplements on 4-5 November in Rome. It will
be attended by the European Commission, members of
the EMA HMPC and EFSA representatives. The objective
is to review the current market situation with regard to
safety, efficacy and experience in monitoring and use of
herbals in special population groups.
Marisa DELB
Peter LIESE
Peter LIESE (Member of the European Parliament) shared
the latest on-going developments at the European Institu-
tions including the division of the responsibilities for food,
pharmaceuticals and medical devices between the Euro-
pean Commissioners
EMA work on the Italian
herbal medicines
Developments in the
European institutions
Meeting report
Dr LIESE also shared his views on the pending issues
related to the Claims legislation, including nutrient
profiles and botanical claims. Although he expressed his
reservations to the concept of nutrient profiles on foods
(which in his opinion was undermining the importance
of a personalised diet fitting individual dietary needs for
particular nutrients), he supports a full implementation
of the Claims Regulation on the botanical claims. He
reminded that the Claims Regulation was adopted by all
three EU Institutions, i.e. the European Commission, the
Council and the European Parliament, and that the
Regulation should have been fully implemented by now.
Dr LIESE, who is a medical doctor by profession, high-
lighted the therapeutic importance of herbal medicinal
products and the role of the industry to provide the
highest quality products to the European patients and
consumers. In this context, he was also concerned about
the safety aspects of some botanical food supplements
and he asked the European Commission not to accept
double standards and to acknowledge years of re-
search and investment done by the European compa-
nies to develop high quality herbal medicinal products.
From left to right: Vittorio SILANO, Werner KNSS, Ioanna CHINOU, Peter LIESE, Marisa DELB, Robert ANTON, Hubertus CRANZ
Ensuring the right assessment of food supplements and health claims
Chair: Michle RIVASI From left to right: Evelyn BREITWEG-LEHMANN, Basil MATHIOUDAKIS, Michle RIVASI,
Valeriu CURTUI, Amire MAHMOOD, Hubertus CRANZ
Evelyn BREITWEGLEHMANN (Federal Office of Con-
sumer Protection and Food Safety, Germany) presented
the recent German, List of Substances of Plant and Plant
Parts which is aimed to help the competent authorities
in Germany to categorise plants ingredients, especially
in case of borderline products.
She also presented a decision tree composed of several
questions used to assess a potential use of a plant as a
food, novel food or a medicinal product. It was noted
that the list is not legally binding and can be updated in
the future.
Evelyn BREITWEGLEHMANN
Valeriu CURTUI (Head of the Nutrition Unit, EFSA)
gave an insight into the scientific assessment of
health claims done by the EFSA Panel on Dietetic
Products, Nutrition and Allergies, NDA.










Dr CURTUI explained that while EFSA NDA Panel is in
charge of evaluation of the scientific evidence sub-
mitted to substantiate a health claim, decisions on
authorisation of claims or classification of substances
are not up to EFSA, according to the EU law. He
explained that the Claims Regulation requires EFSA
NDA Panel to apply a single highest possible stand-
ard of evidence for substantiation of all categories of
health claims and all foods, including food supple-
ments.
As an illustration of the EFSA evaluation process of
health claims, Dr CURTUI presented an example of a
recent NDA Panel positive opinion on a health claim
on hydroxyanthracene derivatives and improvement
of bowel function. He explained that NDA Panel
considered all available scientific information, includ-
ing EMA monographs, and concluded that a cause
and effect relationship between consumption of
hydroxyanthracene derivatives and improvement of
bowel function is well-established; however some
restrictions of use (based on possible side effects)
were also proposed.
Valeriu CURTUI
Meeting report
The NDA Panel could not provide any advice on the
safety of hydroxyanthracene derivatives as this would
be outside of its remit in the context of the Claims
Regulation but Dr CURTUI indicated that this could be
done in a separate EFSA opinion following a new
mandate given by the European Commission.
Dr CURTUI also gave an overview of the most com-
mon issues encountered by the applicants while
submitting a dossier to EFSA and he indicated that
EFSA may provide more supports to the applicants in
the future.
The important role of Member States in the risk
management process and in particular in the health
claims authorisation was presented by
Amire MAHMOOD (Federal Ministry of Health,
Austria). Dr MAHMOOD admitted that classification
of food supplements is a major challenge for Mem-
ber States. She said that although the Food Supple-
ments Directive 2002/46/EC was much welcomed by
Austria, a number of non-harmonised issues still
need to be addressed, for example minimum and
maximum levels of vitamins and minerals and cate-
gorisation of other substances such as botanicals.
Dr MAHMOOD also addressed challenges for Mem-
ber States related claims authorisation such as:
classification of claims as a health claim or medicinal
claims; beauty claims linked to skin, hair or nails;
pending issues of the assessment of botanical
health claims and establishment of nutrient profiles
for foods bearing a health claim.

Role of Member States
Amire MAHMOOD


An overview of the current state of implementation of
the Claims Regulation was given by Bas-
il MATHIOUDAKIS (Head of Unit Nutrition, food com-
position and information, European Commission).

Mr MATHIOUDAKIS said that currently 30 nutrition
claims and 254 health claims are authorised, while 1995
health claims are non-authorised and 2095 health
claims remain on hold, including 2078 claims on bo-
tanicals and few claims on caffeine. Caffeine claims
positively went through the EFSA evaluation but during
the authorisation process the European Commission
asked EFSA for an additional safety assessment of caf-
feine (which is expected in 2015).

Concerning botanical claims, Mr MATHIOUDAKIS ex-
plained that as similar plants are used as ingredients of
food supplements and herbal medicinal products the
European Commission decided - in spite of the clear
legal obligations - to stop the evaluation of botanical
health claims and has started a reflection process on
whether the tradition of use can be considered as
sufficient evidence in the assessment process of botani-
cal claims. He acknowledged that this position is now
challenged through new Court cases and that there are
evidently strong legal arguments in favour of continuing
the evaluation. However, MATHIOUDAKIS indicated that
from his perspectives the priorities of the new European
Commission including stimulation of jobs, investment
and economic growth and strengthening of the Europe-
an internal market need to be taken into account and
that this may speak in favour of stopping the process of
evaluating botanical claims. MATHIOUDAKIS was asked
in the discussion why companies should at all invest in
high quality herbal medicines but indicated that from
his perspective herbal medicine manufacturers would
then have to adjust. Many participants at the conference
did not agree with MATHIOUDAKIS and his approach,
and could not understand why the well functioning
system of herbal medicines should be abandoned.
Adjusting the medical device legislation to consumer needs
From left to right: George JESSEN, Judite NEVES, Gesine MEISSNER, Danielle VAN MULUKOM, Hubertus CRANZ
Meeting report
Basil MATHIOUDAKIS
In her introductory statement,
Gesine MEISSNER (Member of the
European Parliament) spoke on the
European Parliaments first-reading
report on medical devices adopted
in April 2014. While the report has
detailed the views of the European
Parliament on medical devices, the
session Adjusting the medical
device legislation to consumer
needs offered an opportunity for
stakeholders such as Industry,
Member States and Patients or-
ganisation to provide their perspec-
tives and exchange views on sub-
stance-based medical devices.
Substance-based
medical devices
As explained by George JESSEN
(Member of the AESGP Committee
on Medical Devices), substance-
based medical devices are devices
composed of substances or combi-
nation of substances intended to
be used in a self-care context by a
lay person and which do not
achieve their principal intended
action by pharmacological, immu-
nological or metabolic means in or
on the human body but which may
be assisted in its function by such
means.
This emerging category includes
toothpastes, dental cleansers, den-
ture adhesives, throat lozenges and
irrigation solutions, which are cur-
rently placed on the market in
accordance with Rule 4, 5 or 17 of
the 93/42/EC Directive on medical
devices. Industry recognised that
the Medical Devices Directives have
not anticipated the emergence of
self-care medical devices and sub-
stance-based medical devices at
the time of the harmonisation of
the safety and performance of
medical devices in the nineties.
Proposal for a
regulation on MD

A proposal for a regulation on
medical devices adapted to todays
and tomorrows needs was thus
adopted by the European Commis-
sion in September 2012. It intro-
duced the following points:

Rule 21 proposing an up-
classification of substance-based
medical devices intended to be
ingested, inhaled or adminis-
tered in the highest-risk class
(class III), and
Compliance of these devices
with the Annex I of the Medici-
nal Product Directive 2001/83/
EC.
The industry representative, George JESSEN, stressed
the need to differentiate a mode of action and a thera-
peutic effect, as a same therapeutic effect can be deliv-
ered via a pharmacological and a non-pharmacological
modes of action.
In November 2012, AESGP suggested a deletion of both
points, resulting in a case-by-case assessment of sub-
stance-based medical devices, based on the risk associ-
ated with the device. In addition, the safety of these
devices would continue to be assured by the application
of established risk management to medical devices such
as the EN ISO standard 14971:2012 on the application
of risk management to medical devices and the relevant
standards from the EN ISO 10993 family on the biologi-
cal evaluation and testing within a risk management.
Under the ordinary legislative procedure, the European
Parliament and the Council of the European Union
(Member States) examine and propose amendments to
the European Commissions proposals. While discus-
sions within the European Parliament are public, discus-
sions within the Councils working party on pharmaceu-
ticals and on medical devices are confidential.
In that sense, the session was a real opportunity to hear
the views of two members of the Councils working
party on pharmaceuticals and medical devices.

Gesine MEISSNER
First to speak then, was the Director
of the Health Products Directorate at
the Portuguese Competent Authority
(Infarmed), Judite NEVES. She recog-
nised that substance-based medical
devices have being historically classi-
fied as medicinal products, while they
do not primarily act by a pharmaco-
logical mode of action.
In line with the better law approach
which supports a proportionate and
risk-based approach, the Portuguese
Competent Authority has proposed
an alternative to Rule 21 on the basis
of the systemic absorption of ingested
medical devices.
This approach is different from the
AESGP one which proposed a stratifi-
cation of the risk on the basis of their
duration of use namely in class IIa if
the devices are intended to be used
for not more than 30 days and in class
IIb if these devices are used for more
than 30 days, as explained by the
industry representative, George
JESSEN.
In addition, the Portuguese Compe-
tent Authority proposes to revise the
essential requirements by taking into
account the particular characteristics
of these products. Manufacturers
should also provide information such
as the general profile of interaction
and the overall qualitative composi-
tion and quantitative information on
the main constituent responsible for
achieving the principal intended ac-
tion. These proposals were in principle
in line with the views of the Dutch
Ministry of Health which were pre-
sented at the session by Danielle
VAN MULUKOM, from the Depart-
ment of Pharmaceuticals and Medical
Technology. However, as far as the
essential requirements are concerned,
the Dutch Authority would prefer
keeping the system flexible, and de-
tailing these in the harmonized stand-
ards instead of the body text of the
regulation.
Meeting report
Judite NEVES
Danielle VAN MULUKOM
The presentation of the European Patients Forum Secre-
tary General, Nicola BEDLINGTON focused on the pro-
posal for a regulation on medical devices and what it will
mean for the EU patients. She highlighted four key priori-
ties, including the need to emulate the model of patient
involvement developed by the European Medicines
Agency to the medical devices sector. According to Nico-
la BEDLINGTON, substance-based medical devices com-
plement the self-management of adverse events that
patient encounter when living with long-lasting condi-
tions. She recognised that there should not be an up-
classification without a proper justification, although
these products may bear a risk due to their dispersion
and/or absorption in or on the human body.
Other issues of concern
George JESSEN highlighted the other AESGP issues of
concern related to self-care medical devices which are
the definitions of pharmacological, immunological and
metabolic means and the Helsinki Procedure. The Hel-
sinki Procedure was created in 2002 to allow exchange
of information and opinions between National Compe-
tent Authorities from the 28 EU Member States, EFTA
countries and Turkey over the classification of a product
as a medical device or not. However, AESGP regrets the
lack of involvement of concerned manufacturers and
notified bodies in these discussions.









Both topics are currently being discussed within the
European Commissions expert group on borderline and
classification composed of representatives from Nation-
al Competent Authorities, Industry, Notified Bodies, and
the European Medicines Agency. On this subject, the
Secretary General of the European Patients Forum,
Nicola BEDLINGTON recognised that the European
Patients Forum may need to be sporadically involved in
these discussions.
The categorisation of medical devices and the border-
line issue with other categories, including medicinal
products were also highlighted by Judite NEVES. The
enclosed qualification process is helpful in determining
whether a product is a medicinal product or a medical
device.
Nicola BEDLINGTON
George JESSEN
Patients perspective on substance-based medical devices
The political action points resulting from the conference
were summarised by the AESGP Director General,
Dr Hubertus CRANZ.
Speaking on behalf of the European Self-Medication
Industry active in all three categories medicines, food
supplements and medical devices Dr CRANZ said that
clear and stable legal frameworks are crucial for the
companies business planning and investment into the
innovative self-care products offered to the European
consumers.
Dr CRANZ noted that while the pharmaceutical industry
has positive experience with the interaction with the
European Medicines Agency, the area of food supple-
ments seems to suffer from a lack of adequate interac-
tion between applicants and the European Food Safety
Authority (EFSA). While AESGP appreciates EFSA efforts
to improve dialogue with the applicants, a real progress
has not been made over the last years. Dr CRANZ high-
lighted that this should be tackled as an issue of urgen-
cy by the new European Commission and all other
parties involved.
Referring to the complex discussions on botanicals, Dr
CRANZ said that it the current situation with 28 EU
Member States of different approaches and views on
the categorisation and status of herbal products, a full
harmonisation at the EU level is very difficult to achieve,
if at all possible.
The Conference also showed that although the regula-
tory situation for herbal medicinal products is well-
established, it is important to ensure that the EMA work
is smoothly implemented by the Member States author-
ities at the national level, without unnecessary adminis-
trative burdens.
Concerning medical devices, Dr CRANZ said that AESGP
is curious to see the results of the negotiations within
the Council, and later on between the Council and the
Parliament.
The conference was concluded by an invitation to the
next AESGP Annual Meeting which will take place in
Barcelona on 26-28 May 2015.
Conclusion
Meeting report
From left to right: Hubertus CRANZ,, George JESSEN, Judite NEVES, Gesine MEISSNER, Danielle VAN MULUKOM
Hubertus CRANZ