Biocidal Products Notification in the EU: Best Practices and Regulations

Notification of Biocidal Products in the EU - best practices Jana Eliasova REGARTIS, s.r.o.

Regulations Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products (BPR) Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in BPR List of Active substances (existing AS) National regulations transitional period until end of 2024

Biocide Active substance (AS) Biocidal product (BP) a substance or a micro- organism that has an action on or against harmful organisms (Article 3(a) BPR) any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. (Article 3(c) BPR)

Biocidal product (BP) intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action Biocidal effect Active substance or substances In the supplied form Generated in situ Active substance (AS) Types of biocidal products specified in Annex V BPR Product type (PT) The member state where the BP is placed on the market Market

Product types (PTs) Annex V BPR Pest control Other BP Preservatives Disinfectants PT 1 Human hygiene PT 2 Disinfectants and algaecides not intended for direct application to humans or animals PT 3 Veterinary hygiene PT 4 Food and feed area PT 5 Drinking water PT 21 Antifouling products PT 22 Embalming and taxidermist fluids PT 6 Preservatives for products during storage PT 7 Film preservatives PT 8 Wood preservatives PT 9 Fibre, leather, rubber and polymerised materials preservatives PT 10 Construction material preservatives PT 11 Preservatives for liquid-cooling and processing systems PT 12 Slimicides PT 13 Working or cutting fluid preservatives PT 14 Rodenticides PT 15 Avicides PT 16 Molluscicides, vermicides and products to control other invertebrates PT 17 Piscicides PT 18 Insecticides, acaricides and products to control other arthropods PT 19 Repellents and attractants PT 20 Control of other vertebrates

Active substance (AS) AS Approval Article 95 BPR Active substance must be listed in the list of active substances (Regulation No 1062/2014 Annex II) Status: Approved the BP must be authorized before placing on the EU market Under assessment in Review Programme not in Review Programme the BP can be notified (by the Article 89/2 BPR) before placing on the member state market The other (Cancelled application, Not approved, etc.) Each active substance supplier must be listed in List of active substances and suppliers (Article 95 BPR). Only a company established in the EU can be on the list. Non-EU company representative. can appoint a Note: Important to know Name of company, Address, and contact person)

Biocide The other action required No AS on List? AS Approval Article 4 BPR Yes No AS Under Review? No Approved? Yes Yes No No For the PT? For the PT? Yes Yes BP Notification Article 89/2 BPR BP Authorization Article 17 BPR

Biocidal product notification

The best practice steps 1. Check the active substance status In review program 2. Check national rules National helpdesks Link 3. Collect required documents Documents 4. Prepare notification and notify 5. Communicate with the National Authority Additional requirements Final decision

Check the active substance status

Active substance status List of active substances Annex II Regulation No 1062/2014 Online AS status Approved Initial application for approval in progress Substance in Review Programme Substance not in Review Programme Cancelled application, Expired, No longer supported, Not approved National notification

Check the national rules and requirements

National rules National authority Contact Web page National web National system Application form E-mail Required documents Fees Other requirements Annual re;porting Annual fee Ask REGARTIS for help

Collect required documents

Required documents Active substance supplier Article 95 BPR Label Article 69 BPR (all BPs) Article 17 CLP (hazardous BPs) in official language SDS hazardous BPs in official language Efficacy tests For each PT Guidance Composition 100 % Other

Prepare notification and notify

Notification Application Create an account Fill the required information Upload the documents Send the documents by the official channel Post E-post CD-ROM Pay the fee

Communicate with the Nacional Authority

National Authority Pay the fee The evaluation of the documents starts after payment Additional requirements Documents Declarations Etc. Evaluation by the National Authority Deadlines Final decision Your BP can be placed on the MS s market be patient

Enjoy your victory .but not for a long time

do not forget to do Annual requirements Annual reporting Annual fee Active substance(s) Periodically check AS status When all ASs in the BP are approved the BP authorization is required Other obligations PCN Notification

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