AESGP Euro OTC News

Issue 286 | November 2016

Medicines

Pharmacovigilance

▪ PRAC Meeting - September / October 2016 6

▪ Explanatory Note to the GVP module VII 8

CMDh

▪ CMDh report - November 2016 8

Paediatrics

▪ Consultation on paediatric 2017 progress

report 10

Documents for comments

▪ WHO Draft Guidance on testing of SFFC

(QAS/15.634/Rev.2) 10

▪ Concept Paper on the revision of the “Guideline

on the Clinical investigation of medicinal

products for the treatment of migraine“ 10

Herbal news

▪ Draft EU monograph on species diureticae 11

More information: www.aesgp.eu/MAL17

Food

Food supplements

▪ Norway notifies Draft Regulation amending

the Regulation on Food Supplements 12

Food additives

▪ EFSA opinion on trimagnesium dicitrate anhydrous

(TMDC) to be used as a food additive in food

supplements in solid and chewable forms 13

Novel Food

▪ EFSA guidance documents published 13

▪ Final EU monograph on Harpagophytum

procumbens DC. and/or Harpagophytum

zeyheri Decne., radix 11

▪ Marisa Delbo elected new EMA HMPC chair 11

Euro OTC News

Monthly news update by the Association of the European Self Medication Industry

Self-care: the first choice in health care 7 avenue de Tervuren, 1040 Brussels, Belgium Tel.: + 32 2 735 51 30 Fax: + 32 2 735 52 22 E-mail: info@aesgp.eu http://www.aesgp.eu

AESGP © 2016 | All rights reserved

2 AESGP Euro OTC News | Issue 286

▪ EFSA opinion on Safety of synthetic

L-ergothioneine (Ergoneine®) 14

Contaminants

▪ EFSA opinion on erucic acid in feed and food 14

DRVs

▪ EFSA Scientific Opinion on DRVs for vitamin D 15

EFSA

▪ Public consultation on EFSA terms of

Reference for a working group of the

Scientific Committee on Chemical mixtures 16

Food Chain

▪ AESGP attends the conference on “Food Chain

in the Digital Single Market” 17

▪ AESGP participates in the plenary meeting of

the Advisory Group on the Food Chain and

Animal and Plant Health 17

Medical devices

▪ Belgian classification of cranberry extract

based capsules as a medicine ruled invalid 19

WSMI General Assembly 2017 The Economics of Self Care

hosted by the Australian Self Medication Industry (ASMI) and the New Zealand Self Medication Industry (NZSMI)

AESGP Ingredients Directory

Objectives of the conference

Self-care is nowadays recognised as a key element of healthcare. The European Commission’s

report on “Good governance of non-prescription medicines”, which was endorsed by all EU

Member States and relevant stakeholders, explains concrete ways forward. It paved the way to

the inclusion of specific recommendations in the first ever European Union Medicines Agencies

Network Strategy and multi-annual work programme calling for improved access to well-

established including non-prescription medicines. In addition, the Co-ordination Group for Mu-

tual Recognition and Decentralised Procedures (CMDh) advocates in its 2020 Strategy easier

access to non-prescription medicines and suggests a number of concrete actions in its Multi-

Annual Work Plan.

All this together is an excellent basis for discussing future priorities with the heads of the EU

authorities and their colleagues taking into account the proposals of the AESGP Self-Care Agen-

da 2020.

These proposals were recently complemented by a multi-annual work plan. It includes concrete

steps on how to make progress in three categories AESGP is following on the European level:

non-prescription medicines, food supplements and self-care medical devices.

Key proposals in the medicines’ sector include:

▪ Full functionality of the marketing authorisation / registration procedures for non-

prescription medicines

▪ Rigorous respect of timelines

▪ Ensure that the issues specific to non-prescription medicines in the Decentralised Mutual

Recognition Procedures are addressed in a special forum

▪ Reduce administrative burdens e.g. related to variations though the adequate use of

telematic systems and supported by the Regulatory Optimisation Group

The conference follows a long standing tradition to facilitate exchange between the Heads of

the EU Medicines Agencies and the European Self-Care industry. Full programme available at:

www.aesgp.eu/MAL17

Defining the priorities for the future development of self-care

AESGP Conference with the Heads of EU Medicines

Agencies (HMA) during the Maltese EU Presidency

3 AESGP Euro OTC News | Issue 286

MALTA | 20-21 February 2017

4 AESGP Euro OTC News | Issue 286

Birgit Schuhbauer

Anthony Serracino Inglott

Ian Hudson

Catarina Andersson Forsman

Xavier de Cuyper

Christa Wirthumer-Hoche

Luca Pani

Hugo Hurts

Kristin Raudsepp

Belén Crespo

Christopher Fearne

Andrzej Ryś

5 AESGP Euro OTC News | Issue 286

Karl Pall

Lilian Azzopardi

Lorraine Nolan

Thomas Senderovitz

Hubertus Cranz

Andreja Cufar

Practical information

Conference venue

Excelsior Grand Hotel Malta

Great Siege Road

Floriana FRN 1810

Malta

Registration

Registration can be made online or by using a

form that can be downloaded from the confer-

ence website: www.aesgp.eu/MAL17. We recom-

mend registration before 30 January 2017.

Helena Dalli

Guido Rasi

June Raine

Karl Broich

Medicines

■ PRAC Meeting - September / October 2016

6 AESGP Euro OTC News | Issue 286

Pharmacovigilance

Signals

New signals detected from EU

spontaneous reporting systems:

esomeprazole

Scope: signal of gastric polyps

Discussion:

The Pharmacovigilance Risk As-

sessment Committee (PRAC) discus-

sed the cases of gastric polyps and

concurred that a plausible pathophy-

siologic mechanism could not be

excluded. In addition, a positive

dechallenge was observed in three

cases of fundic gland polyps (FGP).

PRAC Recommendation:

The PRAC agreed that the Rappor-

teur (Qun-Ying Yue, MPA, Sweden)

shall assess further data from Eu-

draVigilance and relevant literature

as well as available clinical guidance

regarding the potential risk of gastric

polyps associated with the pro-

longed use of esomeprazole and

other proton pump inhibitors (PPI). A

60-day timetable was recommended

for the assessment of this review

leading to a further PRAC recom-

mendation.

New signal detected from other

sources: proton pump inhibitors

(dexlansoprazole, esomeprazole,

lansoprazole, omeprazole, pantopra-

zole, rabeprazole)

Scope: signal of incident chronic

kidney disease (CKD) and progres-

sion to end stage renal disease

(ESRD)

Discussion: The PRAC discussed the

results from three large observatio-

nal studies (Lazarus et al., Xie et al.,

Arora et al.) on the risk of incident

CKD and progression to ESRD. The

MAHs should provide a proposal for

amending their product information

and/or RMP as applicable.

PRAC recommendation: (Rafe Suvar-

na, MHRA as Rapporteur)

The MAHs for pantoprazole-, lanso-

prazole-, dexlansoprazole-, rabepra-

zole-, omeprazole- and esomepra-

zole-containing products (Takeda,

Janssen-Cilag, Eisai, AstraZeneca)

should submit to the EMA, within 60

days, a cumulative review of all cases

of CKD and progression to ESRD,

including all MedDRA SOC investiga-

tions, related terms relevant to kid-

ney function and data on kidney

function measurements.

Others

PSUR procedure - Orlistat

Scope: Evaluation of a Periodic Safe-

ty Update Report Single Assessment

(PSUSA) procedure

PRAC recommendation:

Update of the Summary Product

Characteristics (SmPC) section 4.4

and 4.8. The package leaflet is up-

dated accordingly. The PRAC As-

sessment Report and the PRAC

recommendation are transmitted to

the EMA Committee for Human

Medicinal Products (CHMP) for

adoption of an opinion. In the next

Periodic Safety Update Report

(PSUR), the Marketing Autorisation

Holders (MAHs) should provide

detailed reviews of all cases of hepa-

totoxicity and nephrotoxicity with an

analysis of all serious cases belon-

ging to the MEdDRA SOC33

‘hepatobiliary disorders’ and Med-

DRA HLGT34 ‘nephropathies’, ‘renal

disorders’ and ‘urolithiasis’ respecti-

vely. In addition, the MAHs should

continue to closely monitor hepato-

toxicity and nephrotoxicity as major

safety concerns. The MAHs of Alli

and Xenical should submit to the

EMA, within 180 days, a detailed

cumulative review of all case reports

of nephrotoxicity from clinical trials,

post marketing surveillance and

literature. Moreover, they should

discuss the causal relationship bet-

ween orlistat and reports of nephro-

toxicity, taking into account potential

confounding factors (such as co-

morbidities) and the usage of these

drugs. Based on the analysis of the

cumulative review, the MAHs should

discuss any necessary amendments

to the product information, as ap-

propriate. The frequency of PSUR

submission should be revised from

yearly to three-yearly and the next

PSUR should be submitted to the

EMA within 90 days of the data lock

point. The list of Union reference

dates (EURD list) provided for under

Article 107c(7) of Directive 2001/83/

EC is updated accordingly. In addi-

tion, the PRAC agreed that no

further PSURs are required for pro-

ducts referred to in Articles 10(1),

10a, 14, 16a of Directive 2001/83/EC.

The EURD list is updated accordingly.

7 AESGP Euro OTC News | Issue 286

PSUR procedure - Esmya (ulipristal

acetate)

Scope: Evaluation of a PSUSA proce-

dure

PRAC recommendation:

Based on the review of the data on

safety and efficacy, the risk-benefit

balance of Esmya (ulipristal acetate)

in the approved indication(s) re-

mains unchanged. The current terms

of the marketing authorisation(s)

should be maintained. In the next

PSUR, the MAH should provide a

detailed review on cases of hyper-

sensitivity. The MAH should discuss

causality for hypersensitivity reac-

tions and propose to update the

product information as applicable.

The MAH should submit to the EMA,

within 60 days, a detailed review on

arterial and venous thromboembolic

events (ATE/VTE). The MAH should

also discuss biological plausibility

based on the mechanism of action

of ulipristal acetate, focusing on the

role of oestrogen and progesterone.

The MAH should consider updating

the product information and RMP as

applicable. The next PSUR should be

submitted in accordance with the

requirements set out in the list of

Union reference dates (EURD list)

provided for under Article 107c(7) of

Directive 2001/83/EC.

PASS non-imposed in the marketing

authorisations - Ulipristal acetate

Scope: submission of the final results

of a prospective multicenter non-

interventional post-authorisation

safety study (PASS) of women treat-

ed with ulipristal acetate as preoper-

ative treatment of moderate to

severe symptoms of uterine fibroids.

The RMP is updated accordingly.

The PRAC assessment report will be

updated.

Applicant: Gedeon Richter Plc. PRAC

Rapporteur: Ulla Wändel Liminga

Public hearings – dry-run outcome

for discussion

As a follow-up to the public hearing

dry run exercise held in July 2016

within the framework of the PRAC

meeting to test the process and

procedures for public hearings by

using a fictional scenario of a safety

review (see PRAC minutes July 2016),

the EMA secretariat presented to the

PRAC some lessons learnt. Overall,

all aspects were implemented and

while some fine tuning is needed, no

major aspects were overlooked in

preparing for future public hearings

and the exercise confirmed that the

aims of the dry run were achieved.

As a next step, in line with the PRAC

work plan 2016 and based on the

work of the PRAC topic group, pro-

cedural and best practice guidance

for PRAC members on public hear-

ings’ will be discussed at PRAC in

November 2016.

Strategy on measuring the impact of

pharmacovigilance – draft reflection

paper on PRAC criteria to prioritise

collaborative impact research

PRAC lead: Marieke De Bruin, MBE,

NL

In line with the PRAC work plan 2016

as part of the ‘PRAC strategy on

measuring the impact of pharma-

covigilance activities’, based on the

reflection paper on ‘PRAC criteria for

prioritisation of collaborative impact

research’, the EMA Secretariat pre-

sented to the PRAC, based on the

EMA reviewers’ independently ap-

plied criteria, safety topics discussed

at PRAC since 2012 for which risk

minimisation measures were decid-

ed. Based on the criteria, the PRAC

considered some topics proposed by

the PRAC Interest Group (IG) for

potential impact research through

either a collaborative network study

or as an EMA funded study. Based

on the comments, further discussion

will be scheduled at PRAC in No-

vember 2016.

Effects tables in selected important

benefit/risk reviews – pilot phase for

discussion

PRAC lead: Rafe Suvarna, MHRA, UK

In line with the PRAC work plan 2016

and based on the CHMP experience,

the PRAC was presented with the

second effects table of the pilot that

was recently initiated to explore the

utility of such tables in post-

authorisation procedures. The PRAC

welcomed the initiative and encour-

aged further work on using effects

tables in selected important benefit-

risk reviews as part of the pilot exer-

cise at the level of the PRAC.

Annex 1. Renewals of the marketing

authorisation, conditional renewals

and annual reassessments

Ulipristal acetate (with risk manage-

ment Plan)

Applicant: Gedeon Richter Plc. PRAC

Rapporteur: Ulla Wändel Liminga,

MPA, Sweden

Scope: 5-year renewal of the market-

ing authorization

At its October meeting, the PRAC

discussed four ongoing safety re-

views which include the article 31

referral on paracetamol modified

released. The Committee did not

initiate or conclude a referral.

The PRAC also focused on the broad

spectrum of its responsibilities which

cover all aspects of the risk manage-

ment of the use of medicines. A

record of the discussions held will be

provided in the minutes of this

meeting, which will be published

following the next PRAC meeting at

the end of November.

The minutes of the September meet-

ing are available here and the high-

lights of the October meeting here.

Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human

■ CMDh report - November 2016

8 AESGP Euro OTC News | Issue 286

■ Explanatory Note to the GVP module VII

In the context of the Public Safety Update Reports

(PSUR) roadmap project, the Joint PRAC/CMDh recom-

mendation paper was finalised and adopted at the May

2016 PRAC and CMDh meeting, setting out the com-

mon understanding on the EU PSUR single assessment.

The recommendation paper identified that there were

areas where improvements could be made in terms of

the quality of PSUR submissions and consistency of the

PSUR assessments.

To this end, the Explanatory note to the GVP module VII

(which will ultimately lead to the update of GVP module

VII) has been elaborated by a drafting group composed

of Members from National Competent Authorities nom-

inated by PRAC and CMDh.

Members are asked to provide feedback on the draft

explanatory note to the GVP module VII by 15 Decem-

ber 2016 to allow sufficient time for the trade associa-

tions to coordinate an industry response to the EMA.

At its meeting on 7-9 November 2016, the CMDh has

elected Mrs Virginie Bacquet (FR) as chair of the revital-

ized non-prescription medicinal products Working

Group.

The meeting was also the last meeting of the Process

Improvement Working Party. The CMDh thanked the

WP and its long acting chair Christer Backman. Actions

from the work plan assigned to the working party will

be handled by dedicated working groups in the future.

Other items worth reporting include the following:

EU Work-Sharing Articles 45 & 46 of the Paediatric

regulation – Public Assessment Reports

The CMDh has agreed on a public assessment report for

paediatric studies submitted in accordance with Article

46 of the Paediatric Regulation for Pelargonium Syrup

(pelargonium sidoides root extract)

Certificate of suitability (CEP) suspensions at Zhe-

jiang Hisun Pharmaceutical Co., Ltd

The CMDh has been made aware that following the

issuing of a statement of GMP non-compliance, EDQM

has suspended CEPs for manufacturing sites of Zhejiang

Hisun Pharmaceutical Co., Ltd. (see EDQM CEP web-

page)

Marketing Authorisation Holders are advised to take the

necessary regulatory actions and follow the recommen-

dations stated in the Statement of Non-Compliance

issued by the Spanish Competent Authority in Septem-

ber 2016 (available on the EudraGMP website here;

search for inspection end date: 2016-06-04).

Revision of MRP/RUP flow chart

The CMDh agreed on an updated flow chart for MRP

and RUP procedures. The new flow chart foresees a

shorter period for comments by Member States at the

beginning of the procedure. Time periods for applicants

remain unchanged. The new flow chart also foresees

that RUPs can be closed by day 60 when no potential

serious risk to public health is raised/remains (MRPs

may be closed at day 60 when no potential serious risk

to public health or other concerns remain). The new

flow chart will be applicable to procedures submitted

after 31 January 2017.

Statistics

In October 2016, 9 Mutual Recognition Procedures

(regarding 21 products) started. All these

procedures related to prescription-only medicinal

products in the reference Member State.

In October 2016, 93 Decentralised Procedures

(regarding 203 products) started. Out of the 93

procedures, 83 of these procedures related to pres-

cription-only medicinal products and 10 procedures

related to non-prescription medicinal products in

the reference Member State. Ninety one of those

procedures consisted of chemical substances, 1

biological and 1 herbal.

The above information as well as further details can be

found in the report from the CMDh meeting held on 7-9

November 2016.

MRP

DCP

9 AESGP Euro OTC News | Issue 286

10 AESGP Euro OTC News | Issue 286

Paediatrics

■ Consultation on paediatric 2017 progress report

The Regulation (EC) 141/2000 (so called Paediatric

Regulation) aimed to address a gap in knowledge on

how medicine should best be used by children, reduce

the level of off-label use and increase the number of

medicines specifically developed and tested for children. In 2013, the Commission published a first progress

report on the Paediatric Regulation and while it revealed

some promising signs of progress, it found that, due to

the length of medicinal products' development, it would

take at least 10 years to gain a full understanding of the

situation. The 10 year report to the European Commis-

sion can be downloaded here.

Under Article 50(3) of the Regulation, the Commission’s

second report is due in 2017. It should assess the Regu-

lation's impact on public health and businesses and is to

be presented to the European Parliament and the Coun-

cil. It is aimed at informing EU decision-makers about

the experience with the Regulation.

All stakeholders involved in the development, manufac-

ture and/or commercialisation of paediatric medicines,

as well as paediatric patient/parent groups, healthcare

professionals and academia are invited to provide their

views and feedback on the experience acquired with the

Paediatric Regulation to support the Commission in

drafting its second report.

The consultation document can be downloaded here. It

is also included as an attachment in this email for ease

of reference.

AESGP members are asked to send their input on

the consultation document by 29 January 2017 to the

AESGP offices.

Documents for comments

■ WHO Draft Guidance on testing of SFFC (QAS/15.634/Rev.2)

The World Health Organisation (WHO) working docu-

ment entitled “Draft Guidance on testing of ‘suspect’

spurious/falsely-labelled/falsified/counterfeit medi-

cines” (QAS/15.634-Rev.2)provides technical guidance

on laboratory testing of samples of suspected spurious/

falsely-labelled/falsified/counterfeit (SFFC) products

detected on the market of WHO Member States and

related aspects of sampling and reporting.

The Member State Mechanism on SSFFC medical pro-

ducts, created in 2012, makes recommendations to

support regulatory authorities to prevent, detect and act

against activities and behaviours that result in SSFFC

medical products. This document is intended to com-

plement the Member State Mechanism’s recommenda-

tions in accordance with resolution WHA67.20 on Regu-

latory system strengthening for medical products.

Any input on this draft WHO working document should

reach AESGP by 16 December 2016 using the table for

comments.

■ Concept Paper on the revision of the “Guideline on the Clinical investigation of medicinal products

for the treatment of migraine“

The Concept Paper on the revision of the “Guideline on

the Clinical investigation of medicinal products for the

treatment of migraine“ (EMA/CHMP/179671/2016) has

now been released for public consultation, following a

recommendation for a revision of the current guideline

by the Central Nervous System Working Party (CNSWP).

While the current guideline focusses on evidence

needed in support of treatment claims of acute mi-

graine attacks and migraine prophylaxis, it does not

Herbal news

■ Draft EU monograph on species diureticae

The draft European Union herbal monograph on species

diureticae has been published for consultation. The

draft monograph addresses herbal substances which

may be used in combinations as THMP to increase the

amount of urine to achieve flushing of the urinary tract

as an adjuvant in minor urinary complaints.

The draft assessment report and draft list of references

are also available.

Members are asked to send their comments until 6

January 2017.

11 AESGP Euro OTC News | Issue 286

address the evidence needed to support a claim of

treatment of chronic migraine, which is a relatively new

concept. Recently a number of scientific advice

procedures have been considered for development

programs of medicinal products for the treatment of

chronic migraine. The other parts of the guideline still

apply and are up to date although a slight adaptation

may be discussed.

The proposed guideline will replace the current Guide-

line on clinical investigation of medicinal products in the

treatment of migraine (CPMP/EWP/788/01 Rev.1, 24

January 2007)

It is anticipated that a draft CHMP guidance document

will be released for consultation not later than Q4 2017.

Comments on this concept paper should reach AESGP

by 10 January 2017.

■ Marisa Delbo elected new EMA HMPC chair

Marisa Delbò, head of the Risk Management Office at

the Italian Medicines Agency (AIFA), was elected as the

new chair of the European Medicines Agency’s (EMA)

Committee on Herbal Medicinal Products (HMPC) at its

November meeting.

Maria Delbò was previously vice-chair of the HMPC

(2013-2016) and also vice-chair of the HMPC Working

Party on European Union Monographs and European

Union List (MLWP) (2011-2016).

The full press release is available here.

■ Final EU monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix

Further to its endorsement at the European Medicines

Agency’s (EMA) Committee on Herbal Medicinal Prod-

ucts (HMPC) July 2016 meeting, the final European

Union herbal monograph on Harpagophytum procum-

bens DC. and/or Harpagophytum zeyheri Decne., ra-

dix was released.

The monograph was adopted by consensus. The final

monograph is available on the “harpagophytum page”

under the ‘All documents’ tab, together with the HMPC

Opinion, the Final Assessment Report, the Final List of

references and the Overview of comments received.

Maria Delbò speaking at the AESGP Conference on “Herbal

(medicinal) products, food supplements and self-care medical

devices” in October 2014 in Brussels

Food

Food supplements

■ Norway notifies Draft Regulation amending the Regulation on Food Supplements

Norway has notified a draft regula-

tion amending the Regulation on

Food Supplements to the European

Commission through the TRIS proce-

dure (*).

This draft text amends Regulation of

20 May 2004 No 755 on food supple-

ments setting the national maximum

limits for the amount of folic acid,

magnesium, vitamin C, calcium and

vitamin D in food supplements. It

separates maximum limits for young

children from 1 and up to 3 years old,

children from 3 and up to 11 years

old, adolescents from 11 and up to

18 years old, and adults from 18 years

old. It also introduces particular

requirements for labelling of food

supplements containing specific

amounts of folic acid, calcium, vita-

min C and vitamin D per daily portion

of consumption as recommended by

the manufacturer.

The measures requiring additional

mandatory food labelling have also

been notified according to Article 39

and 45 of Regulation (EU) No

1169/2011 on the provision of food

information to consumers.

The standstill period (**) will end on

13 February 2017. Further informa-

tion on the status of this notification

is available here.

Brief Statement of Grounds:

Norway implemented Directive

2002/46/EC on food supplements in

2004, and existing national maximum

limits for vitamins and minerals per

daily dose were then continued.

These national maximum limits are

set to ensure that food supplements

with vitamins and minerals are safe

for the entire healthy population.

However, since the existing maximum

limits are old, they are now being

revised. We have suggested establis-

hing separate maximum limits for

various age groups (young children,

children, adolescents, adults), in order

to make it possible to produce food

supplements adapted to different

consumer groups.

The existing maximum limits for

magnesium and calcium of 600 mg

and 1500 mg respectively, are propo-

sed reduced in line with the tolerable

upper intake levels (ULs) suggested

by the Norwegian Scientific Com-

mittee for Food Safety (NSCFS) and

updated intake data (see link below).

The existing maximum limits for folic

acid and vitamin D, are proposed to

be decreased for the youngest age

groups, while they are suggested

increased for the older age groups,

based on scientific opinions by the

NSCFS. The maximum limit for vita-

min C is proposed increased for all

age groups, based on a scientific

opinion by the NSCFS.

Differentiating the maximum limits

for separate age groups means that a

food supplement for some age

groups (usually adults) may contain

amounts of vitamins/minerals that

involve a health risk for younger age

groups, since Upper Limits (ULs) for

these age groups will be exceeded.

We have therefore deemed it essen-

tial requiring additional mandatory

food labelling, in order to protect

public health. Particular requirements

for labelling of food supplements

containing specific and high amounts

of folic acid, calcium, vitamin C and

vitamin D per daily portion, in one

measured small unit quantity, shall

ensure that the product reaches its

right age group and that consumers

are provided clear information that

the consumption of certain amounts

of vitamins or minerals might cause

adverse health effects for specific age

groups. The mandatory particulars

are deemed essential in order to

protect public health, in accordance

with Article 39 of Regulation (EU) No

1169/2011.

links to relevant scientific opinions by

the NSCFS for:

1) magnesium; http://www.vkm.no/

dav/f9ef23feb7.pdf ,

2) calcium and vitamin C; http://

www.vkm.no/dav/289a369b0c.pdf ,

3) folic acid; http://www.vkm.no/

dav/86f93d4c96.pdf and

4) vitamin D; http://vkm.no/

dav/422f24e6e0.pdf

12 AESGP Euro OTC News | Issue 286

*It allows the Commission and the Mem-

ber States of the EU to examine the techni-

cal regulations Member States intend to

introduce for products (industrial, agricul-

tural and fishery) and for Information So-

ciety services before their adoption. The

aim is to ensure that these texts are com-

patible with EU law and the Internal Market

principles. It applies in a simplified manner

to the European Free Trade Association

(EFTA) Member States which are signato-

ries to the Agreement on the European

Economic Area (EEA) and to Switzerland

and Turkey.

**Starting from the date of notification of

the draft, a 3-month standstill period –

during which the notifying Member State

cannot adopt the technical regulation in

question – enables the Commission and

the other Member States to examine the

notified text and to respond appropriately.

More information on this procedure and

what happen next can be found here.

i

13 AESGP Euro OTC News | Issue 286

Food additives

■ EFSA opinion on trimagnesium dicitrate anhydrous (TMDC) to be used as a food additive in food

supplements in solid and chewable forms

EFSA has published its opinion on the Safety of trimagnesi-

um dicitrate anhydrous (TMDC) to be used as a food addi-

tive in food supplements in solid and chewable forms.

The Panel concluded that there was no safety concern from

the proposed typical use levels of TMDC as a stabiliser and

anticaking agent in food supplements, whereas at the

proposed maximum use levels, the resulting exposure to

magnesium in adults and the elderly at the high-level

would be above the upper level (UL).

TMDC is a magnesium salt of citric acid in the anhy-

drous form. Following oral ingestion, TMDC is expected

to fully and readily dissociate into magnesium and

citrate ions.

The toxicological data provided in support of the cur-

rent application were not in accordance with the Tier 1

requirement of the ‘ Guidance for submission for food

additive evaluations’; however, this was considered to

be justified by the Panel given that both magnesium

and citrate are natural constituents of the diet and also

the human body.

Exposure estimates to TMDC from its proposed use

were calculated for both typical and maximum use

levels alongside the resulting intake of magnesium and

citrate. At the proposed typical level, the intake of

magnesium resulting from the use of TMDC would be

below the tolerable upper level (UL) of 250 mg/day for

supplemental magnesium. In the worst case scenario of

high-level intakes of TMDC when used at the maximum

proposed use level of 120,000 mg/kg, the maximum

estimated intake of magnesium would be 311 mg/day

per day in the elderly and 389 mg/day in adults, in both

cases above the UL.

The Panel noted that the intake of both magnesium and

citrate resulting from the proposed use and use levels

of TMDC appears to be within the normal dietary intake

in the general population.

Recommendations

In the case of TMDC being used as a food additive in

food supplements containing a source of magnesium,

the total amount of magnesium that could be con-

sumed at a single eating occasion should be below the

UL of 250 mg/day. Therefore, risk managers may wish

to consider whether consumption advice and recom-

mended maximum daily dose of the TMDC being used

as a food additive in food supplements should be

provided to the consumers.

The Panel recommended lower specification limits for

lead, cadmium and arsenic, given that levels proposed

in the specifications could have a significant impact on

the exposure to these toxic elements.

The Panel recommended including in the specifications

a typical particle size distribution of TMDC under its

powder form.

An application has been introduced for the authorisation of the use

of TMDC as a stabiliser and/or anticaking agent in food supplements

in solid and chewable forms (food categories 17.1 and 17.3 of part E

of Annex II to Regulation (EC) No 1333/2008). The technological

function as a stabiliser/anti caking agent is reached by a dosage of 2

–12% TMDC of the final preparation.

Novel Food

■ EFSA guidance documents published

EFSA Panel on Dietetic Products, Nutrition and Allergies

(NDA) published its two guidance documents in the area of

novel foods:

Guidance on the preparation and presentation of an

application for authorisation of a Novel Food

Guidance on the preparation and presentation of a

notification for authorisation of Traditional Foods from

third countries

The final versions have been greatly modified compared

the draft versions subject to consultation earlier this year.

Most of the comments submitted by AESGP in April 2016

have been endorsed. Details of the comments received

may be found in the outcome of the public consultation

on:

Outcome of public consultation on the draft Guidance

on an application for authorisation of a Novel Food

Outcome of public consultation on the draft guidance

on traditional foods from third countries

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14 AESGP Euro OTC News | Issue 286

■ EFSA opinion on Safety of synthetic L-ergothioneine (Ergoneine®)

The EFSA Panel on Dietetic Products, Nutrition and

Allergies (NDA) published an opinion on the Safety of

synthetic L-ergothioneine (Ergoneine®) as a novel food

pursuant to Regulation (EC) No 258/97.

The Panel concludes that the novel food (NF), synthetic

L-ergothioneine (marketed as Ergoneine®), is safe

under the intended conditions of use as specified by the

applicant.

The NF that is the subject of the application is synthetic

L-ergothioneine (ET; marketed as Ergoneine®), which is

produced by a one-pot patented manufacturing pro-

cess. Chemically, ET is a derivative of thiolhistidine, i.e. 2

-thio-L-histidine-betaine. ET is naturally present in a

number of foodstuffs such as mushrooms, some varie-

ties of black and red beans, offal and cereals.

The applicant intends to use the NF in quantities of up

to 5 mg per serving in alcohol-free beverages, cereal

bars, milk, fresh dairy product s and chocolate. The

applicant also proposes to provide the NF as a food

supplement, with a recommended daily dose of up to

30 mg/day for adults and 20 mg/day for children.

The target population proposed by the applicant is

children above 3 years of age and the general adult

population, with the exception of pregnant and breast-

feeding women.

Considering the NOAEL of 800 mg/kg bw per day,

which was based on two subchronic toxicity studies in

rats, and the maximum estimated intake levels for L-

ergothioneine from all sources, the Panel concludes that

the margins of safety of 470 for adults (except pregnant

and breast feeding women) and of 216 for children

above 3 years of age are sufficient.

Contaminants

■ EFSA opinion on erucic acid in feed and food

EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) has published its scientific opinion on the risks for

animal and human health related to the presence of erucic acid in feed and food.

Erucic acid is the trivial name of the fatty acid Z-13-docosenoic acid,

abbreviated as 22:1D13c, although it is more frequently found in the

literature as 22:1 n-9. Erucic acid is mainly present in the seeds of species

of the Brassicaceae, which includes important seed crops such as rape-

seed and mustards, and also important vegetable crops such as the

diverse group of kales, cabbages and turnips. Cultivars of Brassicaceae

with very low erucic acid content have been developed for seed oil pro-

duction for food and feed use in most countries, including the EU. Mus-

tard seed production is based on cultivars with high erucic acid content.

Erucic acid is also present at low concentrations in other food sources

such as fish. Erucic acid is present in Lorenzo’s oil, a drug used for thera-

py for ALD patients. Erucic acid doses range from 0.09 to 0.51 g/kg bw

per day.

According to the most common nomenclature for fatty acids, erucic acid

is abbreviated as 22:1 n-9 or 22:1 x-9. Erucic acid is a natural plant toxin

which is a contaminant according to the definition of the contaminant

provided in Council Regulation (EEC) No 315/93 as the presence of erucic

acid in food is the result of the agricultural production, more in particular

the choice of the variety.

The maximum levels for erucic acid (section 8.1) have been established in

Regulation(EC) 1881/2006, as amended by Commission Regulation (EU)

No 696/2014 for:

Vegetable oils and fats

Foods containing added vegetable oils and fats with the exception

of Infant formulae and follow-on formulae

Infant formulae and follow-on formulae

The appropriateness of setting a maximum level for erucic acid has been

highlighted by the Scientific Committee on Food (SCF) in its opinion

expressed on 17 September 1993 on essential requirements for infant

formulae and follow-on formulae. When the maximum levels of erucic

acid were established by Regulation (EC) 1881/2006, it was found neces-

sary to review the maximum levels in the future based upon an updated

risk assessment and also to consider the appropriateness of establishing

maximum levels for erucic acid in feed.

Reported occurrence in food supplements:

After the quality assessment of the analytical data on

erucic acid, a total of 12,444 food samples were available

to estimate dietary exposure. Before the occurrence data

were used to estimate dietary exposure, the data were

grouped at different FoodEx levels according to their

erucic acid levels and the number of samples reported

(Appendix C, Table C.5). This table shows occurrences in

the following food supplements categories but the num-

ber of samples is rather low (from 1 to 26):

Dietary supplements, unspecified

Mineral supplements

Protein and amino acids supplements

Supplements containing special fatty acids

(e.g.omega-3, essential fatty acids)

Plant extract formula

Algae formula (e.g. Spirulina, Chlorella)

Pollen-based supplement

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15 AESGP Euro OTC News | Issue 286

The Panel concluded (full conclusions from page 72 on-

wards):

For most humans, the main contributor to dietary expo-

sure to erucic acid was the food group ‘Fine bakery

wares’. In ‘Infants’, ‘Food for infants and small children’

was the main contributor to exposure.

The heart is the principal target organ for toxic effects

after exposure. Myocardial lipidosis was identified as the

critical effect for chronic exposure to erucic acid. This

effect is reversible and transient during prolonged expo-

sure.

A tolerable daily intake (TDI) of 7 mg/kg body weight

(bw) per day for erucic acid was established, based on a

no observed adverse effect level of 0.7 g/kg bw per day

for lipidosis in young rats and new born piglets. Mean

chronic exposure of the different groups of the popula-

tion did not exceed the TDI. The 95th percentile dietary

exposure level was highest in infants and other children,

ranging from1.3 to 7.4 mg/kg bw per day; the higher

level being at the level of the TDI. This may indicate a risk

for young individuals with high erucic acid exposure.

In pigs, levels of erucic acid are unlikely to represent a

health concern. However, for poultry, the small margin

between the lowest observed adverse effect level (LOAEL)

and the estimated exposure may indicate a health risk

where maximum inclusion rates are applied. Due to the

absence of adequate data, the risk for ruminants, horses,

fish and rabbits could not be assessed.

The Panel recommended:

To generate more analytical data on the occurrence

of erucic acid in relevant food and feed commodities

using sensitive and specific methods. Special atten-

tion should be paid to processed foods such as ‘Fine

bakery wares ’, ‘Food for infants and small children’

and ‘Composite foods ’

There should be more information on the levels in

animal-derived products (meat, milk and eggs) result-

ing from the transfer of erucic acid from animal feed.

There is a need for a repeated-dose toxicity study in

new born rats or pigs with pure erucic acid in order

to clarify the potential confounding effects of other

fatty acids present in the oil and to provide infor-

mation regarding the dose –response relationship.

Studies should be conducted on species differences

in the cardiac and hepatic metabolism of erucic acid.

Further studies are required to determine reference

points for target livestock animals and fish.

DRVs

■ EFSA Scientific Opinion on DRVs for vitamin D

EFSA Panel on Dietetic Products, Nutrition and Allergies

(NDA) has just published its scientific opinion on dietary

reference values (DRVs) for vitamin D.

EFSA’s assessment for European consumers follows that of

the UK’s Scientific Advisory Committee on Nutrition

(SACN) which has recommended DRVs for vitamin D for

the UK population. A joint explanatory note is attached to

EFSA’s scientific opinion that sets out the respective ap-

proaches taken by the two organisations in deriving DRV

values for Vitamin D – including methodology, the data

used and geographical area covered in the assessment.

In its opinion, the Panel concludes that Average Require-

ment (ARs) and Population Reference Intakes (PRIs) for

vitamin D cannot be derived for adults, infants and chil-

dren, and therefore defines Adequate Intake (AIs), for all

population groups. The DRVs for vitamin D are based on

the assumption of minimal exposure to the sun with re-

sulting limited levels of synthesised vitamin D.

The Panel considers that serum 25(OH)D concentration,

which reflects the amount of vitamin D attained from both

cutaneous synthesis and dietary sources, can be used as a

biomarker of vitamin D intake in adult and children popu-

lations with low exposure to UV-B irradiation and as a

biomarker of vitamin D status. The Panel notes that the

evidence on the relationship between serum 25(OH)D

concentration and the risk of musculoskeletal health out-

comes in (healthy) adults, infants and children, and some

adverse pregnancy-related health outcomes, is widely

variable. Several factors contribute to this, and also include

the large variation in the results from different laboratories

and assays used for measuring serum 25(OH)D concentra-

tions. Taking into account the overall evidence and uncer-

tainties, the Panel considers that a serum 25(OH)D con-

centration of 50 nmol/L is a suitable target value for all

population groups, in view of setting the AIs for vitamin D.

The Panel underlines that the meta-regression was done

on data collected under conditions of assumed minimal

cutaneous vitamin D synthesis. In the presence of cutane-

ous vitamin D synthesis, the requirement for dietary vita-

min D is lower or may even be zero.

Summary of DRVs for vitamin D

The panel makes the following recommendations for

research:

There is a need for further research to study the re-

spective impact of vitamin D dietary intake and sun-

light exposure on serum 25(OH)D concentrations.

Future studies should investigate food-based strate-

gies to ensure adequate vitamin D intakes accounting

for latitude, sunlight exposure and diet.

Studies are needed that are specifically designed to

identify cut-off values for serum 25(OH)D concentra-

tion or other suitable biomarkers for vitamin D status

to derive DRVs for vitamin D for infants, children,

adults, pregnant and lactating women.

Standardised investigations are needed to assess

changes in musculoskeletal health outcomes (and

surrogate markers) in response to vitamin D2 and D3

intake, and in relation to serum 25(OH)D concentra-

tions.

The potential mechanisms of the cause and effect

relationships between vitamin D and nonmusculoskel-

etal health outcomes should be further explored.

There is a need for studies that assess the different

diets of infants, in particular those consuming infant or

follow-on formulas and processed cereal-based foods

fortified with vitamin D in addition to vitamin D sup-

plements.

More data on the effects of genotype and body fat

mass on vitamin D metabolism and the requirements

for vitamin D are warranted.

More precise data on total vitamin D concentration in

foods would also be useful. Studies investigating the

effect of 25(OH)D naturally occurring in foods on

serum 25(OH)D concentration are also suggested

The NDA Panel also published the Outcome of public

consultation on a Draft Scientific Opinion on Dietary

Reference Values for vitamin D

Age Adequate Intakes (µg/day)

7–11 months 10

1–3 years 15(a)

4–6 years 15(a)

7–10 years 15(a)

11–14 years 15(a)

15–17 years 15(a)

≥ 18 years(b) 15(a) (a): under conditions of assumed minimal cutaneous vitamin D synthesis. In the presence of endogenous cutaneous vitamin D synthesis (Section 2.3.1), the requirement for dietary vitamin D is lower or may be even zero. (b): including pregnancy and lactation.

(*) For ease of reference please see below the following defini-

tions:

Dietary Reference Values (DRVs) - quantitative reference values

for nutrient intakes for healthy individuals and populations which

may be used for assessment and planning of diets

Population Reference Intakes (PRI) - the level of (nutrient) in-

take that is adequate for virtually all people in a population group

Average Requirement (AR) - the level of (nutrient) intake that is

adequate for half of the people in a population group, given a

normal distribution of requirement

Adequate Intake (AI) - the value estimated when a Population

Reference Intake cannot be established because an average requi-

rement cannot be determined. An Adequate Intake is the average

observed daily level of intake by a population group (or groups)

of apparently healthy people that is assumed to be adequate.

More information can be found in the EFSA Scientific Opinion on

principles for deriving and applying Dietary Reference Values

(2010)

EFSA

■ Public consultation on EFSA terms of Reference for a working group of the Scientific Committee on Chemical mixtures

EFSA launched a Public consultation on the terms of

reference of the Scientific Committee Working Group on

“Harmonisation of risk assessment methodologies for

human health and ecological risk assessment of combi-

ned exposure to multiple chemicals”.

The working group will develop a draft guidance docu-

ment for human and ecological risk assessment of com-

bined exposure to multiple chemicals using existing

frameworks as starting points and tiered approaches for

each step (problem formulation, hazard identification,

hazard characterisation, exposure assessment, risk char-

acterisation).

Following input from this public consultation, the work-

ing group of the scientific committee will review the

contributions and consider them in developing the guid-

ance document. Once finalised, the draft guidance docu-

ment will be subject to another public consultation be-

fore its finalisation. Written comments might be sub-

mitted to EFSA via this link by 30 November 2016.

Human and ecological risk assessment of combined exposure to

multiple chemicals (“chemical mixtures”) poses a number of chal-

lenges to scientists, risk assessors and risk managers, particularly

because of the complexity of the problem formulation, the huge

number of chemicals involved, and the toxicological profiles and

exposure patterns of these chemicals in humans and species pre-

sent in the environment. The development of harmonised method-

ologies for combined exposure to multiple chemicals has been

identified by EFSA Scientific Committee as a key priority area for

EFSA and a number of EFSA panels and units have initiated activities

to support harmonisation of risk assessment methods for both the

human health and the ecological area.

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16 AESGP Euro OTC News | Issue 286

Food Chain

■ AESGP attends the conference on “Food Chain in the Digital Single Market”

AESGP attended on 9 November 2016 the conference

co-organised by the European Commission and Slovak

Presidency of the Council of the European Union on

“Food Chain in the Digital Single Market”. Among the

various presentations given, Ladislav MIKO (European

Commission, Deputy Director General Food Safety, DG

Health and Food Safety) gave a keynote speech entitled

‘Delivering on EU food safety and nutrition in 2050 –

Future challenges and policy’.

The IT services we are building today will have to adapt

to the longer term perspectives. Long term evolution of

IT tools will need further evolutions of the EU legal

bases. Reviewing regularly the implementing acts of our

base regulations is a realistic option. One of the con-

crete contributions to the Digital Single Market pre-

sented relates to the Paperless Food Chain Control.

Important and “Impacting” changes will be available

from tomorrow (electronic certification in a paperless

control environment starts in 2017). These changes can

already bring a revolution in the way control operations

are managed.

Regarding official eCommerce control of food, the

Commission revealed its action plan. The new Official

Control Regulation will allow online ‘mystery’ sampling

by national competent authorities (i.e. control authori-

ties do not need to identify themselves to purchase

online). Concluding that the legislation as it stands is

harmonized, complete and ready for Digital Single

Market but that the enforcement varies from a Member

State to another, the objective is now to get all Member

States on board in the enforcement of EU Agri-Food law

on internet sales of food so as to allow dedicated train-

ing for control staff and more coordinated actions. With

the examples of the German eCommerce control system

and the Slovakian digital integration official controls

allowing a quick dissemination of results, it is clear that

integration between national and EU environment is

critical for a more clever and predictive control system

foreseen for 2020 (IMSOC through the implementation

of the Official Control Regulation). Synergy in automat-

ed risk based approaches can raise efficiency in inter-

ception of non-compliant goods. Emerging challenges

for the official control are being tackled: The eCom-

merce is an example of how successful and beneficial is

the sharing of knowledge and experience between the

more advanced countries and the other EU Member

States.

International organisations are following the same path

as illustrated by the OIE Digital Action Plan and the IPPC

ePhyto pilot project; EU should join and coordinate

efforts with them.

New legal environment (eIDAS) and associated EU wide

architectures will help us to better interoperate and will

remove barriers to allow the streamlining of our import-

export processes.

International standardisation efforts, both at semantic

and technical level, have made very important progress

in these last years and are allowing our EU IT systems to

speak easily together as well as with non-EU commercial

partners. This is a key asset for future success.

The presentations given at the conference should be

shortly available on the conference webpage. A new

conference on this topic is expected to be held in Brus-

sels in October 2017.

■ AESGP participates in the plenary meeting of the Advisory Group on the Food Chain and Animal and

Plant Health

AESGP attended on Friday 25 November 2016 the ple-

nary meeting of the Advisory Group on the Food Chain

and Animal and Plant Health. Michael Scannell, Director

of Directorate D ‘Food chain: stakeholder and interna-

tional relations’ at DG SANTE was chairing the meeting.

Commission officials from the various DG SANTE’s

directorates and units presented successively the varied

topics on the agenda.

The Commission presented the state of play and next

steps of its strategy to combat antimicrobial resistance

(AMR). The Commission's 2011 Action Plan against the

rising threats from AMR contains 12 actions for imple-

mentation with EU Member States and identifies 7 areas

where measures are most needed:

17 AESGP Euro OTC News | Issue 286

making sure antimicrobials are used appropriately

in both humans and animals

preventing microbial infections and their spread

developing new effective antimicrobials or alterna-

tives for treatment

cooperating with international partners to contain

the risks of AMR

improving monitoring and surveillance in human

and animal medicine

promoting research and innovation

improving communication, education and training

The evaluation of the Action Plan published in October

2016 by the Commission shows that this had a clear

added value acting as a symbol of political commit-

ment, stimulating several actions within Member States,

and has served to strengthen international cooperation.

The Action Plan has also provided a framework to guide

and coordinate activities on AMR at international level

in the area of monitoring and surveillance and on R&D.

The Commission will now continue and scale up its fight

against antimicrobial resistance (AMR), with the launch

in 2017 of a second Action Plan. Feedback on the re-

lated roadmap can still be provided through the online

form until December 2016. The new Action Plan will

take the form of a Commission communication to the

European Parliament and the Council will focus on

supporting Member States, particularly in establishing,

implementing and monitoring their National Action

Plans, bringing together EU funds and instruments in

order to promote innovation and research against AMR

and strengthening its leading role in global fora, nota-

bly within the international organisations and with

major trade partners.

The Commission elaborated further on its action plan

on Food& Feed eCommerce Control. An ad-hoc

Working Group of national authorities (e-commerce

network) has been created to get all Member States on

board in the enforcement of EU Agri-Food law on inter-

net sales of food so as to allow dedicated training for

control staff and more coordinated actions and will

meet for the second time in December 2016.

The proposal for SANTE actions in 2017 includes nota-

bly coordinated control actions on food supplements

and non-authorised novel foods.

As to the Official Control Regulation, the Commission

updated the group on the inter-institutional process,

providing an example of the text currently under revi-

sion with the Council and jurist linguists and presenting

the structure of the Regulation. This presentation was a

short follow-up to the ad-hoc Working Group meeting

on revision of the Official Control Regulation of Friday

30 September 2016 (to which AESGP participated). In

terms of timing, the text will be transmitted officially to

the Council early December for possible adoption by

Council and then Parliament (in Plenary) by March 2017.

More details will be provided at the next Working

Group meeting on revision of the Official Control Regu-

lation to be held once the regulation will be published.

On the implementing rules under Regulation (EU) No

1169/2011, related to origin information, the Commis-

sion presented the latest draft version. It covers all food

products and any statement relating to origin of food

products and clarifies any potential overlaps with other

legal frameworks. The text will soon be put to the feed-

back mechanism, i.e. open for comments from citizens

and stakeholders for 4 weeks.

The current legislative and risk assessment framework

and on the activities foreseen in 2017 in relation to food

contact materials (FCM) were presented. A draft mea-

sure on printed FCM including printing inks and FCM

that are printed may be prioritized in 2017-2018 follo-

wing a German notification raising health concerns.

Regarding the risk for human health of mineral oils

(Mineral Oil Hydrocarbons ‘MOH’ and Mineral Oil Satu-

rated Hydrocarbons ‘MOSH’) in food, the Commission is

to adopt and publish fairly soon a recommendation on

the monitoring of MOH in food and FCM. Since migra-

tion from FCMs such as recycled paper and board food

packaging could contribute significantly to the total

exposure, monitoring should include re-packaged food,

the packaging material and the presence of functional

barriers. The Commission highlighted continuing chal-

lenges in resources and in particular analytical metho-

dology. The results of the monitoring will feed into the

ongoing discussions on the need for a general maxi-

mum level for mineral oil in food.

18 AESGP Euro OTC News | Issue 286

Medical devices

■ Belgian classification of cranberry extract based capsules as a medicine ruled invalid

Judgment of the Belgian Council of State invalida-

ting a decision from the Belgian Federal Agency for

Medicines and Health Products (FAMHP) classifying

a cranberry extract based capsules intended to pre-

vent and treat urinary tract infections as a medicinal

product

By a judgment delivered on 1 September 2016 in a case

opposing BV Medical Brands Innovations to the Belgian

State, the Belgian Council of State ruled that the FAMHP

decision taken on March 18, 2015 classifying the pro-

duct concerned (Cystiberry - capsules containing an

extract of whole cranberries) as a medicinal product for

human use was invalid.

Essentially, the Court ruled that the FAMHP decision

incorrectly implemented the ‘rule of doubt’ set in Article

2(2) of the Medicinal Products Directive 2001/83 and

did not comply with the criteria set out by the Court of

Justice of the EU (CJEU) with regard to the medicinal

product classification.

On the ‘rule of doubt’, the Belgian Council of State

recalled that – per CJEU case law (Case C‑140/07

Hecht‑Pharma) - Article 2(2) of Directive 2001/83 must

be interpreted as meaning that that directive does not

apply to a product in respect of which it has not been

scientifically established that it is a medicinal product by

function, without its being possible to exclude that possi-

bility. On that basis, FAMHP incorrectly concluded that

"where there is doubt about the status of the product, the

product must be regarded as a medicinal product."

The grounds of the contested FAMHP decision stated

that, even if questions would remain open as regards

the precise mechanism, the inhibitory effect of the

product concerned resulting from an interaction bet-

ween the product and the Fimbriae (the hair-like appen-

dages) on the bacterial cell wall of the E-coli bacteria

should be considered a pharmacological, immunologi-

cal or metabolic action.

The Belgian Council of State referred to the following

CJEU case-law:

Case C-308/11 (Chemische Fabrik Kreussler & Co.

GmbH v Sunstar Deutschland GmbH), in which the

Court pointed out at the outset that it is not apparent

either from Directive 2001/83 or from the guidance

document on the demarcation between the Cosmetic

Products Directive and the Medicinal Products Directive

that the molecules of the substance in question must

necessarily interact with a human cellular constituent in

order for it to be regarded as a substance which exerts a

‘pharmacological action’. (paragraph 29).

Case C‑140/07 (Hecht‑Pharma) recalling that it is appa-

rent from Article 1(2)(b) of Directive 2001/83 that the

substance in question must be capable of restoring, cor-

recting or modifying physiological functions by exerting a

pharmacological, immunological or metabolic action and

that that capability must have been scientifically establis-

hed.

According to the Belgian Council of State, FAMHP ap-

pears not to have carried out an assessment of the

product individually, taking into account the pharmaco-

logical properties as they can be established in the

present state of scientific knowledge and all the charac-

teristics of the product, including, inter alia, its composi-

tion, the manner in which it is used, the extent of its

distribution, its familiarity to consumers and the risks

which its use may entail. In other words, with regard to

the establishment of the pharmacological properties,

FAMHP has failed to scientifically establish in the con-

tested decision that the interaction between the pro-

duct and the Fimbriae (the hair-like appendages) on the

bacterial cell wall of the E-coli bacteria is capable of

exerting a pharmacological, immunological or metabolic

action in the meaning of Article 1(2)(b) of Directive

2001/83.

19 AESGP Euro OTC News | Issue 286

20 AESGP Euro OTC News | Issue 286

Vienna 2017

AESGP Conference with the Heads of EU Medicines Agencies (HMA) during the Maltese EU Presidency

Agenda 2017

53rd AESGP Annual Meeting

30 May - 1 June

2017 AESGP Conference

on regulatory challenges for consumer health products

Brussels, Belgium

10-11 October