1 25/2/2016 Biocide CLOSED CIRCUIT
2 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.
3 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
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art 19(4) BPR + Annex 6, 63 Limit access of general public to biocides with a high risk Replace convoluted and outdated Class A system short/mid-term: Get a view on the flow of dangerous biocides in BE from authorization holder to end user between traders Market segments Define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
6 Registration tool: creating an account Each user needs a FPS-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!
7 Registration tool: creating an account Create an FPS - account
8 Registration tool: creating an account Log In: Registration tool dedicated log-in page
9 Registration tool: creating an account Log In: First log-in: Link the account to a Belgian company: KBO/CBE-nr First user to ask access for a company = admin
10 Registration tool: creating an account Log In: First log-in: Link the account to a Belgian company: KBO/CBE-nr First user to ask access for a company = admin
11 Registration tool: creating an account Log In: Link the account to a foreign company: search by name
12 Registration tool: creating an account 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 account Your Account
14 Registration tool: creating an account Your Contact persons Contact persons users
15 Registration tool: creating an account Your favorites Necessary before manual reporting of transactions Authorization holders automatically recognised
16 Registration tool: access management FPS grants access to one user / company = admin Admins grant access to other users with FPS account
17 Registration tool: access management FPS grants access to one user / company = admin Admins grant / repeals access for other users with FPS account 1 2
18 Registration tool: Product information CLP Conditions Link authorisation certificate
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
20 Registration tool: Reporting transactions 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 transactions Transactions 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 transactions Bulk upload transactions
23 Registration tool: Reporting transactions
24 Registration tool: Reporting transactions Transactions Sales
25 Registration tool: Reporting transactions Transactions Use
26 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 (closedcircuit.biocides@health.belgium.be)