SESSION (Planning and management of Official controls)

“Evaluation of n otification dossiers in Belgium”

BRAMA training for technicians & authorities – Modul e V I& V, Aqaba (16-19 November 2015)

Joris GeelenFood Law Consult

Food

Law

Consult

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

1. Evaluation of notification dossiers by FPS: FOODSUP

2. Field controls by the controlling agency (FASFC)

3. Autocontrol guide sector organisation (NAREDI)

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

- Extensive notification dossier submitted at market intro

- Thorough technical and scientific evaluation of all the characteristics of the product

- Check conformity vertical & horizontal legislation

- Expert advice if necessary

- Within month letter of receipt + possibly with remarks

- Paper notification (200€)

- Online notification system: FOODSUP (180€)

1. Belgian Royal Decree on plants: Notification

1500 firms � > 6500 dossiers /year

4 + 2 Team for notifications

2 Experts on Additives, Contaminants, Flavourings…

1 Labeling & Claims

2 Novel Food

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

Online notification system FOODSUP: www.health.belgium.be/foodsup

> Home > Food safety > Foodstuffs > Food supplements

• Less paper, faster treatment

• more transparent communication between sector, gov. & control

• Documents all digitally available, searchable, distance working possible,…

• Paper version still possible, but cost more, has to be scanned into system

• Archives have been scanned into the system

• 1e time use : firm or consultancy (responsible for the notification)

has to request access as local admin by means of a form

FPS grand access : login with email and password

� a notifications can be created

• A manual is available (NL/FR/EN)

1. Belgian Royal Decree on plants: Notification

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

3 stages of notification:

1. draft: notifier is encoding all details, dossier not yet submitted

2. waiting for decision: submitted, has to be treated by the FPS, dossier is ‘frozen’

3. decided: FPS has sent the letter of receipt with possibly remarks

Different statuses:

• 1st notification waiting for decision: introduced but not yet treated by the administration

• Attributed: a notification number has been granted

• Not attributed: a notification number has not been granted

• Not applicable: the product should not have been notified

• Temporarily attributed: a notification number was attributed but only valid for 3 months

• Extended temporary attribution: temporary notification number stays valid until adapted notification is evaluated

• Expired after a temporary attribution: no adapted notification within the 3 months , nr° invalid

• Withdrawn from the market by producer/importer/reseller

• Withdrawn by the administration

1. Belgian Royal Decree on plants: Notification

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

FoodSup

Enterprise

DB

Extranet

FoodSup

Back Office

FoodSup

Front Office

Public Web Site

Document

management

Bill & Pay

Industry

Sector

1. Digital notification system: FoodSup

Control

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

Clear overview of workflow

Bill & Pay - automated

Fast search & filter in dossiers

3 languages

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)8

Info about firm

Give access to colleagues or consultancy

Create a dossier for new product

Overview of dossiers

Change data, print draft pdf

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)9

History of actions and status of dossiers

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)10

Tabs with details on product, ingredients (nutrients, plants, other subst.)nutritional analyses, data on toxicity & stability and annexes

Clarify food supplement or fortified foodChoose language of product (NL/FR)

Give contact personAdress

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)11

Product discription:Form (capsule, tablet,…)

PresentationPackaging

Recommended daily portion

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)12

Overview of all ingredients, E numbers, doses, function

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)13

Search for ingredients with drop-down lists

Create newOther ingredient,

Plant orOther substance

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

Detailed info on ingredients

Active Ingredients

Possibility to add comments

Possibility to add attachements: data onstability, toxicity, datasheets, certificate of analyses…

# AI / daily dose

Plant part used

Scientific name

Type & quantityof preparation

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)15

‘view’ � Legal conditions displayed

Mentioned on which list

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)16

Nutritional analyses in detail(not important for botanicals)

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)17

Toxicity of the product is guaranteedbased on tests or other info

Stability of the product is guaranteedbased on tests or other info

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)18

Uploading addtional documentsLabeling, leaflets, analyses,

proof of payment, scientific dossier,Info on novel food, stability, toxicity

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

• Notification team will check all new dossiers and adaptations

• If needed they will ask feedback of experts on

additives, labelling, claims, novel food, botanicals,…

• After positive advice of the experts, new ingredients can be approved

(Publication in legal texts can take much longer though)

• From a list of preset remarks can be chosen & added to letter of receipt

• They answer to many questions by phone and sometimes meet in person

� Transparency : accessibility, clear procedures, e-gov.

� Accountability : responsive

1. Belgian Royal Decree on plants: Notification

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

1. Notification : Botanicals

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Name on list ?

NO

Synonym on list ?

YES Check conditions RD OK Notif.nr° attributed

NO

History of

Consumption

NO

Novel Food

YES Fill in guideline Evaluation by

Advisory Commission

on Botanicals

OK

BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

• Federal Agency for the Safety of the Food Chain (FASFC)

Does regular administrative controls of the premises and products

Also more extensive audits

if need be products can be ceased, or destroyed

• Close contact with FPS – notification team – access to notification system

• Yearly planning of controls together with FPS

• Analytical controls of supplements is limited

due to budget restraints and difficulties with labs and analytical methods

focus on supplements with vitamins, on contaminants and illegal medicine

(!) Need to fill the gaps for analyzes � certification of labs, network of labs

• Control of internet market should be strengthened

2. Field controls by the controlling agency (FASFC)

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

Sector organisation published a guide for the introduction of a auto control of the

production of food supplements - Approved by the Belgian controling agency (FASFC)

• Legal framework

• Management of the auto control system:

Management of documents, non-conformities & complaints, performing internal audit

• Good hygienic practices

Structure, design and layout of the premises, design and arrangement of the equipment,

maintenance of premises & equipment, water quality, pest control, waste management,

cleaning and disinfection, health and hygiene of the staff, training and conduct of staff

• Good production practices

Development of a new dietary supplement, purchase of goods, reception, storage and

quarantine of products, production, wrapping and outer packaging, labelling, transport

• HACCP

• Traceability

• Duty to report and handle non-conformities

• Validation of the autocontrol system

3. Autocontrol guide sector organisation (NAREDI)

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BRAMA training for technicians & authorities – Modul e VI & V, Aqaba (16-19 November 2015)

�را �ز��

For questions regarding legislation on food, supplements,

botanicals, notification of products, etc… :

Joris.Geelen@FoodLawConsult.com

+32 499 74 14 67

Food

Law

Consult

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