biocide closed circuit - belgium

FOD VOLKSGEZONDHEID, VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU

25/2/2016

Biocide

CLOSED CIRCUIT

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Regulatory background and scope

• Biocidal products regulation (EU) nr. 528/2012 (BPR), art. 19 (4):

“A biocidal product shall not be authorised for making available

on the market for use by the general public where…”

• Royal decree 8/05/2014, arts. 41-48:

laying out the general conditions for the making available of

biocides on the BE market.

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Regulatory background and scope

• WHICH BIOCIDES ARE CONCERNED ?

In detail: BPR art. 19(4);

in brief: “products for which PPE are mandatory” (P280 phrase)

• WHICH MARKET AGENTS ARE CONCERNED?

Authorisation holders

Distributors / intermediates

Professional users

In brief: “Everybody who makes available or uses closed circuit

biocides in Belgium”

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4

Objectives

Short term• BE Compliance art 19(4) BPR + Annex 6, 63

• Limit access of general public to biocides with a high risk

• Replace convoluted and outdated “Class A” system

short/mid-term:• Get a view on the flow of dangerous biocides in BE

• from authorization holder to end user

• between traders

• Market segments

• Define training plans for specific groups of users

• Sensibilisation

Long-term:• More efficient risk assessment

• If necessary: targeted enforcement


5 Where to find information?

Main access and information portal:

www.circuitbiocide.be

• Dedicated part of our website:

General information

Brochure

Registration tool manual

Contact form

• Product authorisation certificates (via registration tool)

• Your supplier

http://www.circuitbiocide.be/


6Registration tool: creating an account

• Log In:

• Link personal account to a company & ask for Admin

access:

• FPS gives access to Admin account (written statement

may be asked as a security check)

• Admin account grants access to other user(s) for company

• Only 1 admin account / company

• Unlimited ‘user’ accounts

• All accounts same access rights: be careful!

Each user needs a FPS-account!


7 Registration tool: creating an account

Create an FPS - account

https://apps-acc.health.belgium.be/userregistration/action/public/userRegistrationBeforeAction



• Log In: • Registration tool dedicated log-in page

https://apps.health.belgium.be/biocideFrontOffice/



• Log In: • First log-in: Link the account to a Belgian company:

KBO/CBE-nr

• First user to ask access for a company = admin



• Log In: • Link the account to a foreign company: search by name



• Log In: • Known foreign company (e.g. authorisation holder): ask

access

• Unknown foreign company: enter company details and

ask access for the account

• SPF gives access to Admin account (security)


13 Registration tool: creating an accountYour Account



Your Contact persons• Contact persons ≠ ‘users’



Your favorites• Necessary before manual reporting of

transactions

• Authorization holders automatically

recognised


Registration tool: access management

• FPS grants access to one user / company = admin

• Admins grant access to other users with FPS account

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Registration tool: access management

• FPS grants access to one user / company = admin

• Admins grant / repeals access for other users with FPS account

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Registration tool: Product information

• CLP

• Conditions

• Link authorisation certificate

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19 Registration tool: Reporting transactions

• Types: • IN

• Purchase

• Import

• OUT

• Sales

• Export

• USE

• Frequency:

• Traders: each quarter

• Users: each year

• Manually per transaction

• BULK upload via Excel

template



• Obligation: 20/5/2016

• Register until +/- 6 weeks after end quarter

• Transaction purchase / sale =

o Transaction partner

o Product

o Volume

• Transaction use =

o Product

o Volume

• Compound figures per quarter are allowed

• Bulk upload via excel template


21 Registration tool: Reporting transactionsTransactions Types

3 transaction types

Sale: sale of closed circuit biocides to another trader or user

• On the Belgian market

• Export (optional)

Purchase: purchase of closed circuit biocides from a supplier

• On the Belgian market

• Import (mandatory!)

Use: annual compound figures of use


22 Registration tool: Reporting transactionsBulk upload transactions



Transactions Sales


25 Registration tool: Reporting transactionsTransactions Use


Future developments

• Inclusion of CC conditions on authorisation certificates.

• Modification royal decree:

reporting obligations users

Safety data sheet

Exemption of pool products for private persons

• Registration tool: ongoing development

bulk upload imp / exp

User & access mgmt

• We listen to you ([email protected])

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mailto:[email protected]

biocide closed circuit - belgium

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