BPR national transitional procedures

BPR national transitional procedures under Art 89 - disclaimer

The information in this page aims to assist parties interested in national transitional procedures under Article 89 of the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). It is collected from the national helpdesks responsible for the BPR. 

Disclaimer

ECHA does not check this information, and it accepts no responsibility and liability for its use. In case of doubt, you can contact the relevant national helpdesk for clarification. 

In accessing links to the national authorities’ websites, you will be subject to the terms of use and conditions of those websites. ECHA does not accept any responsibility for the contents or use of these websites.

BPR national transitional procedures

Austria

 

Summary of national procedures

In Austria, there is no national registration/notification procedure in place for biocidal products containing active substances that are included in the Review Programme Regulation, or covered by Art 93 of the BPR, and which are still under evaluation. 

All relevant provisions of the “Biozidproduktegesetz” (Austrian law on biocides), provisions of the BPR (Art 89 and 93), the Review Programme Regulation and other relevant Austrian and European Regulations (e.g. Austrian Chemicals Act, REACH, CLP) apply to the placing on the market of these products.
 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

No – not before the approval date of the last active substance contained
Legal background:

The most important provisions for the marketing of BP in the transitional period are:

  • § 2 Austrian Biocidal Products Act
  • Article 89, 93, 95, of the BPR, 
  • Article 69 of the BPR in  conjunction with § 12 Austrian Biocidal Products Act

National Regulations/Decrees:
Biocidal Products Act
 
Fees:

No fees as there is no registration or notification duty for BP under the transitional measures
Competent Authority contact information:

Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology
email: biozide(at)bmk.gv.at 
Helpdesk: biozide@umweltbundesamt.at 
 
Additional requirements, or comments:

General note: relevant provisions of REACH (SDS, registration of co-formulants, general restrictions, etc.) and CLP (C&L, Art. 45/Annex VIII, etc.) have to be met.
Label and SDS for BP in German language
 
Belgium

 

Summary of national procedures

If at least one of the active substances in a biocidal product is not yet approved for all the relevant product types, the product has to be registered first before making it available on the Belgian market (according to the Royal Decree of April 4, 2019) . In this case, the product will be thoroughly examined and the risks to the environment and health of users will be evaluated. This may be done via a partial, or full evaluation.

Information on national procedures
Bulgaria

 

Summary of national procedures

The placing on the market of biocidal products during the transitional period is regulated by Art 18 of the law for the Protection from Harmful Impact of the Chemical Substances and Mixtures. A permit is required for BP/PT combinations containing active substances/PTs included in the Review Programme. The prospective applicant (or its representative) needs to submit an application to the Ministry of Health. The data requirements for the application are specified in the Ordinance on the form and content of the documents.  The application and the supporting documents are required to be submitted in principle in Bulgarian language (for the exceptions - see the factsheet below). Within 45 days after receiving the application, the Ministry of Health performs the completeness check of the data. If the application is deemed to be incomplete, the applicant will be informed about the deadline to provide the missing information.
The Ministry of Health issues a permit for the placing on the market of products within 60 days from the date of submission of the complete application.
 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

Yes
Relevant deadline(s):

A completeness check is performed within 45 days from the date of receipt of the application.
A permit to place on the market is granted within 60 days after the date of submission of the complete application
Legal background:

The Law for the Protection from Harmful Impact of the Chemical Substances and Mixtures;

The Ordinance on the form and content of the documents
Fees:

The fees are determined by the Fee Tariff 

BGN 920 for a single product
BGN 1450 for a family 
BGN 50 for an administrative change (for a single product or family)
BGN 150 for a minor change (for a single product or family)
BGN 350 for a major change (for a single product or family)
 
Data requirements:
  1. Data for the unified identification code under Art. 23 of the Law for the Trade Register and the Register for legal persons not-for-profit, or a document for an equivalent registration. 
  2. Proof of compliance with Art. 95 (2) of the BPR;
  3. Technical dossier (including efficacy tests) of the product/family;
  4. Safety data sheets for the biocidal product, active substance(s) and co-formulants, prepared according to the requirements of Annex II of REACH; 
  5. Proof of the fee payment;
  6. The (draft) label of the biocidal product.
     
Competent Authority contact information:

MINISTRY OF HEALTH
5 Sveta Nedelya Sq.
1000 Sofia
Bulgaria
e-mail: biocides (at) mh.government.bg

https://www.mh.government.bg/bg/helpdesk-biocidi/
 
Language requirements for the application:

In Bulgarian: technical dossier, SDS of the biocidal product and label

The declaration of compliance with Article 95, efficacy tests and other SDSs (AS/co-formulants) can be submitted in English.
 
Additional requirements, or comments:

The Ministry of Health, in accordance with the legal requirements, maintains a Register of authorized biocides.
Croatia

 

Summary of national procedures

Biocidal products (in all PTs) must be authorised before placing them on the Croatian market. Applications need to be submitted via the webform. The system will generate the application form, which should be printed, signed and sent to the Ministry of Health, Ksaver 200a, 10000 Zagreb, Croatia. Supporting documents (e.g. SDS, label, proof of the Article 95 compliance and proof of the fee payment) should be uploaded in the webform. The SDS in Croatian language should be sent to the Croatian Public Health Institute (toksikologija (at) hzjz.hr) before submitting the application.

The application fee is EUR 200 per product
 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

Yes, for all PTs
Relevant deadline(s):

The application for authorisation needs to be submitted at the latest 60 days before the active substance approval date. 
Legal background:

Article 89 and 93 of the BPR

The BPR and national laws (OG 39/13, 47/14, 115/18, 62/20 )
 
Fees:

EUR 200 per application
There is no annual fee.
Ordinance on fees (OG 154/2022) is applicable also  to national fees paid for authorisations granted under the BPR.
 
Data requirements:

Available at Upis biocidnih pripravaka u registar
Competent Authority contact information:

Ministry of Health, Ksaver 200a, 10000 Zagreb, Croatia
biocidi (at) miz.hr
Language requirements for the application:

Application, draft label, SDS – in Croatian
Proof of the Article 95 compliance, efficacy tests and other supporting documents – in English
 
Additional requirements, or comments:

Use of the national electronic system is required.

Once the webform has been completed, the generated document needs to be printed, signed and sent to Ministry of Health. Documents uploaded via the webform do not need to be printed.
 
Czech Republic

 

Summary of national procedures

At least 15 days before placing biocidal products on the market, biocidal products, regardless of the PTs, need to be notified to the Ministry of Health of the Czech Republic via the dedicated IT platform. 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all PTs
Is an authorisation required:

No
Relevant deadline(s):

The notification needs to be submitted 15 days before the biocidal product is placed on market of the Czech Republic.
Legal background:

Art 89 and 93 of the BPR.

§13 and § 14 of Act 324/2016 Coll. (Act on Biocides)
 
Fees:

CZK 1500 per notification, for one biocidal product. 
Data requirements:
  • Administrative data
  • Identity of biocidal product
  • Proposed labelling
  • Proposed material safety data sheet
  • Efficacy data for the claimed use
  • If necessary, additional documents, e.g. letter of access to efficacy data.
     
Competent Authority contact information:

Ministry of Health of the Czech Republic
biocidy (at) mzcr.cz
 
Language requirements for the application:

Czech (in exceptional cases English is acceptable)
Additional requirements, or comments:

A notification must be submitted via the information system.

Brief instructions for submitting notifications:

  1. Create a company account according to the instructions available at the abovementioned website. Within one company account, more user accounts may be created, with different privileges.
  2. Notification submission: Administrative data should be filled in the information system. Proposed labelling, proposed MSDS and efficacy data should be attached as a PDF or Word document.
  3. After submitting, the system sends to the registered email address a request to pay an administrative fee. The fee must be paid in 15 days.
  4. After the fee is paid, the notification is subject to completeness and compliance check. New data or amendments may be requested via the system. The user will be notified about this via an email message.
  5. Re-submission can be done by opening a notification and clicking on the button “Additional data”.
  6. After the notification is accepted, confirmation will be sent to the postal address (companies located in the Czech Republic will receive an electronic version via the DataBox system, foreign companies will receive a letter by post).
     
Denmark

 

Summary of national procedures

Certain biocidal products covered by the old Danish authorisation scheme must be authorised under these rules during the transitional period. Only biocidal products containing active substances under review in the Product Type (PT) concerned can be taken into consideration.

Authorisation is required during the transitional period for the following products against:

  • wood-destroying fungi
  • algae growth
  • slime-forming organisms in pulp
  • rabbits, mice and rats
  • pests on domestic animals (lice, fleas and the like)
  • textile pests
  • pests in timber and woodwork
  • insects, snails and slugs, mites, and earthworms, and
  • repellents against mosquitoes and other insects etc. or against wild birds and animals.

This scheme will continue for the individual products until a decision has been taken to approve the active substance(s) for use in the EU. After approval, the products must be authorised under the new BPR rules.

Information on national procedures
Estonia

 

Summary of national procedures

During the transitional period, a biocidal product can be made available on the market and used in Estonia if it has obtained the relevant registration certificate in accordance with the Biocidal Products Act. The biocidal product must be registered with the Estonian Health Board. After submitting an application and the required documents, the biocidal product will be added to the list of the registered biocidal products (available on the Estonian Health Board webpage). The listing of the product indicates that the required information has been submitted to the Health Board and that the product can be made available on the market and used in Estonia. 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all AS/PTs. 
Biocidal products need to be registered during the transitional period in accordance with the Estonian Biocides Act.
Is an authorisation required:

No

Legal background:

Article 89 and 93 of the BPR

National Regulation: Estonian Biocides Act 
 
Fees:
  • From 01.06.2023 new fees apply:
    Registration fee: EUR 400 EUR per single biocidal product, or family.
    Fee for a change  (other than administrative) of the existing registration: EUR 150 per registration certificate.
    Fee for an administrative change of the existing registration: EUR 50 per registration certificate.
    he national regulation on fees is represented by the State Fees Act
Data requirements:

Information on the data requirements is available on the Health Board webpage.
The Estonian Biocides Act.
 
Competent Authority contact information:

Terviseamet/Health Board; Department of Chemicals Safety 
Paldiski mnt 81, 10617 Tallinn 
bpr (at) terviseamet.ee
 
Language requirements for the application:

The application may be submitted in English, but the labelling information according to CLP needs to be in Estonian.
Additional requirements, or comments:

For biocidal products, Article 45 of CLP applies. Questions related to Article 45 notifications should be sent to the CLP Helpdesk: clp (at) terviseamet.ee
Finland

 

Summary of national procedures

Finnish manufacturers, or importers, must submit a notification for their biocidal product to the Chemical Products Register. If the active substance is not yet approved  under the Review Programme, or covered by Art. 93 of the BPR, apart from being notified, some biocidal products, e.g. insecticides, insect repellents and slimicides used in the paper industry, need to be authorised according to the Chemicals Act prior to making them available on the market.

During the transitional period, some products, e.g. disinfectants (PT 1-5), are excluded from the authorisation procedures. If the active substance is included in the Review Program, the product can be made available on the Finnish market until the decision on the approval of the active substance is made.
 

Information on national procedures
Germany

 

Summary of national procedures

Biocidal products which contain solely existing active substances included in the Review Programme for the relevant product type(s), or that are covered by Art. 93 of the BPR may be placed on the German market and used without being authorised as long as no decision on the approval, or non-approval, of the respective active substances has been taken under the BPR. During this transitional period, biocidal products have to be notified according to the German Biocide Law Implementation Ordinance (ChemBiozidDV).  Furthermore, every biocidal product has to be notified to the poison information database, if the biocidal product fulfils the criteria laid down in the CLP regulation.

For further information, see the links below, or contact reach-clp-biozid (at) baua.bund.de
 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, a notification is required for all PTs, for products marketable under Article 89 of the BPR.
No notification is required for products marketable under Article 93 of the BPR.

Products containing a combination of an Article 89 and an Article 93 active substance (AS), and products containing a combination of an AS included in the Review Programme and one that is not included, or a new active substance, are not marketable in Germany during the transitional period.
 
Is an authorisation required:

No
Legal background:

Article 89 of the BPR in conjunction with German Chemicals Act (ChemG) §28(8)
Article 93 of the BPR in conjunction with ChemG §28(11)
German Biocide Law Implementation Ordinance (ChemBiozidDV) 
Fees:

The notification is free of charge.

General information on fees in Germany:
German Special-Fees Ordinance – BMU (Besondere Gebührenverordnung BMU - BMUBGebV)
Data requirements:

General information on prerequisites and requirements

Competent Authority contact information:

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin - Bundesstelle für Chemikalien (BAuA)
Federal Institute for Occupational Safety and Health - Federal Office for Chemicals 

Friedrich-Henkel-Weg 1-25
D-44149 Dortmund
mail: chemG (at) baua.bund.de
technical questions regarding the notification procedure can be directed to chembioziddv (at) baua.bund.de 
Language requirements for the application:

German
Additional requirements, or comments:

The notification platform
Hungary

 

Summary of national procedures

All biocidal products need to be notified to the National Public Health Center. At the same time, biocidal products belonging to PT 1-5, 18 and 19 require authorisation under the transitional measures in Hungary, based on the Governmental Decree No. 316/2013 (VIII.28.). Applications for new authorisations, or changes to the already existing authorisations need to be submitted no later than 3 months prior to the approval date of the active substance. The documentation shall be submitted through the official electronic system established and maintained by the Hungarian Government, called ‘Hivatali Kapu’.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all PTs
Is an authorisation required:

Yes, only for PT 1-5, 18-19
Relevant deadline(s):

For the submission of applications for new authorisations and for changes of existing authorisations: 3 months prior to the date of approval of the last active substance/PT combination contained in the product.
Legal background:

Article 89 and 93 of the BPR

National Decree: Governmental Decree No. 316/2013 (VIII.28.) 
 
 
Fees:

Varies and adds up per PT: HUF 96,000 – 429,500

Annual fees: No  
 
Data requirements:

Annex 2 of the Governmental Decree No. 316/2013 (VIII.28.)
Competent Authority contact information:

National Public Health Center, 1097 Budapest, Albert Flórián út 2-6., Hungary 

email: biocide.helpdesk (at) nnk.gov.hu
 
Language requirements for the application:

Hungarian language.
Additional requirements, or comments:

The use of the official electronic system named ‘Hivatali Kapu’ is mandatory
Ireland

 

Summary of national procedures

Biocidal products can only be distributed and used in Ireland if they have been notified to, or authorised, by the Irish Competent Authority (The Department of Agriculture, Food and the Marine). Before the approval of active substances for a given product-type, biocidal products containing active substances supported in the EU-level Review Programme of existing active substances for the given product-type must be notified under the National Notification System provided under Statutory Instrument No. 427 of 2013. Applications for product notification must be submitted via email to: biocide-notifications (at) agriculture.gov.ie.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all PTs
Is an authorisation required:

Yes, for all PTs
Legal background:

Art. 89 and 93 of the BPR

The BPR enacted into Irish Law by Statutory Instrument No. 427 of 2013. 
 
Fees:

Fees for all National Notification Applications can be found at: 
PRCD - Fees 
 
Data requirements:

Data requirements for all National Notification Applications can be found at: 
PRCD - National Notification Applications
 
Competent Authority contact information:

Department of Agriculture, Food and the Marine. 
Biocides helpdesk: biocides(at) agriculture.gov.ie
National Notification Applications: biocide-notifications (at) griculture.gov.ie
Language requirements for the application:

English
Additional requirements, or comments:

Full details on Biocides are available at: 
PRCD - Biocides 
 
Italy

 

Summary of national procedures

The authorisation of biocidal products pursuant to Article 89 of the BPR is under the regime of the Italian national legislation (D.P.R. 392/98). 
Disinfectants (for human hygiene and for surfaces), insecticides and insect repellents are subject to national authorisation as "Presidio Medico Chirurgico” (PMC). Applications for PMC authorisation may be submitted until 1 year before the active substance approval date.

All other categories of biocidal products are made available on the market and sold freely on the Italian market until the BPR approval of the active substances.
 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

Yes, but only for:

  1. Disinfectants and substances marketed as germicides or bactericides - PT 1-5
  2. Insecticides for domestic and civil use - PT 18
  3. Insect repellents - PT 19
Relevant deadline(s):

Set out in DPR (Decree of President of the Republic) on  6/10/1998 N 392
Applications for PMC authorisation may be submitted until 1 year before the active substance approval date.
 
Legal background:
Fees:

Vary from EUR 95 (Release of free sale certificates) up to EUR 3,827.60

 
Data requirements:

ational Regulations/Decrees are available at:

Decreto del presidente della repubblica 06 ottobre 1998, n. 392

Presidi medico-chirurgici
 
Competent Authority contact information:

Ministry of Health-Medical Devices and Pharmaceutical Services
Department-Biocides and Cosmetics -Office 8
Ribotta 5
00144 Roma
Biocidi (at) sanita.it
Phone number   +39-659-942-520
Language requirements for the application:

Italian or English
Additional requirements, or comments:


Applications need to be submitted via email at: dgfdm (at) postacert.sanita.it
Latvia

 

Summary of national procedures

All biocidal products which are imported or manufactured in Latvia need to receive an inventory number, or authorisation. Biocidal products containing active substance/PT combinations included in the Review Programme need to be registered under the Latvian national registration system (the Inventory).

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

Yes
Relevant deadline(s):

The Latvian national registration system applies in accordance with the deadlines specified in Art 89(2) of the BPR.
Legal background:

Article 89 and 93 of the BPR

Regulation No. 628 of the Cabinet of Ministers of the Republic of Latvia on requirements regarding the handling of biocides of 27 August 2013
 
Fees:

EUR 60.20 per single product and EUR 32.55 per additional  product within a biocidal product family. The fee applicable for change applications is 65.10 EUR. VAT needs to be added to the abovementioned fees. 

Fees may be subject to changes.


 
Data requirements:
  1. An application with the required information about the biocidal product
  2. An example of the biocidal product label, in Latvian, compliant with the CLP requirements and Article 69 of the BPR;  
  3. A safety data sheet (SDS) in Latvian, in accordance with REACH requirements;
  4. Declaration of compliance with the obligations under Article 95 of the BPR. 
     
Competent Authority contact information:

Latvian Environment, Geology and Meteorology Centre (LEGMC)
Maskavas Str. 165, Rīga, LV-1019

biocides (at) lvgmc.lv
Phone: + 371 67770023
 
Language requirements for the application:

The application form and the declaration of compliance with Article 95 can be submitted in Latvian or English. The example of the biocidal product label and the SDS needs to be submitted in Latvian.
Additional requirements, or comments:

For biocidal products, Article 45 of CLP applies. A chemical report and the SDS needs to be submitted to LEGMC. More information is available here. Questions regarding the report can be sent to LEGMC via e-mail: chemdb@lvgmc.lv.
Luxembourg

 

Summary of national procedures

Prior to the placing on the market of new biocidal products still subject to article 89(2) of the BPR, the national law requires the submission of a “product-notification”. This procedure is described in article 4 of the (modified) national law on biocidal products, and covers biocidal products of all biocidal product-types.

The links provided below lead to the CA’s webpage, that contains more detailed information on data requirements for product-notifications as well as templates to be used.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all AS/PTs, a notification is required prior to the placing on the market.
Is an authorisation required:

No
Relevant deadline(s):

Notifications can be submitted until the date of approval of the last AS/PT combination contained in the product.
Legal background:

Article 89 and 93 of the BPR

National law: 
Fees:

EUR 100 per product notification (one BP per notification only).
Data requirements:
  • Notification form; 
  • SDS; 
  • Article 95 compliance declaration(s); 
  • Label, 
  • Excel-sheet listing uses under PTs; 
  • Efficacy test reports – only required for PTs 1-4

Mise sur le marché de produits biocides
 
Competent Authority contact information:

Ministère de l'Environnement, du Climat et du Développement durable Administration de l’environnementUnité Substances chimiques et produits
1, avenue du Rock'n'Roll
L - 4361 Esch/Alzette
 
Language requirements for the application:

French, German, or English
Malta

 

Summary of national procedures

In Malta, the  notification procedure, known as “MCCAA”, needs to be followed. 

Documents requested for a notification are the following:

  • Free sales certificate, or marketing authorisation from an EU Competent Authority (if the product is marketed in another EU Member State),
  • Evidence in the form of an invoice, letter, or a self-declaration form proving that the active substance/s supplier/s are compliant with Article 95,
  • REACH and CLP compliant SDS of the product,
  • REACH and CLP compliant SDSs of the hazardous components,
  • Copies of the product's labels, compliant with CLP and language labelling requirements,
  • Proof of payment of the fee – EUR 100
     
Information on national procedures
Netherlands

 

Summary of national procedures

Biocides in all 22 product types can be placed on the Dutch market after obtaining an authorisation. A full risk assessment is required and dossier requirements are similar to those under the BPR. Applicants are encouraged to request a pre-submission meeting to help prepare for the submission of their application. The limited assessment procedure can be sought if similar products are authorised in the Netherlands. To ensure a timely decision, applications for first authorisations, renewals, or major changes, need to be submitted at the latest 78 weeks before the approval of the last active substance in the biocidal product.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

Yes, for all PTs
Relevant deadline(s):

Applications for new authorisations under transitional law and major changes under transitional law can be submitted up to 78 weeks before the approval date of the last active substance/PT combination contained in the product to be authorised. 
Legal background:

Article 89 and 93 of the BPR,
National Regulations/Decrees :
Wet gewasbeschermingsmiddelen en biociden
Fees:

Vary and starting from EUR 965 for
new derived authorisation, and 
starting from EUR 17,850 for new regular authorisations 
The annual fee for 2023 corresponds to EUR 1,325.

Fees vary and are updated every year. Detailed information on fees is available at: 
Tariffs | Biocides | Board for the Authorisation of Plant Protection Products and Biocides (ctgb.nl)
 
Data requirements:

Information on data requirements can be found at:
Application under transitional legislation | Biocides | Board for the Authorisation of Plant Protection Products and Biocides (ctgb.nl)
Assessment framework and manuals | Biocides | Board for the Authorisation of Plant Protection Products and Biocides (ctgb.nl)
 
Competent Authority contact information:

Ctgb
P.O. box 8030
Zip code: NL 6710 AA Ede 
pone +31 317 - 471 810
servicedesk (at) ctgb.nl
 
Language requirements for the application:

English or Dutch. Instructions for use in Dutch.
Additional requirements, or comments:

Information on the periods of grace is available at Grace period biocidal products on Board for the Authorisation of Plant Protection Products and Biocides website (ctgb.nl)
Norway

 

Summary of national procedures

Biocidal products can be made available on the Norwegian market without an authorisation from the Norwegian Environment Agency if they comply with the transitional measures given in Article 89 and 93 of the BPR, and additional national requirements. The Norwegian Biocides Regulation, the Norwegian Product Control Act, specific national regulations for certain uses of disinfectants, and other relevant regulations apply. Companies placing biocidal products on the Norwegian market are responsible for ensuring that the products are effective and do not pose an unacceptable risk when used in line with the use instructions. 

Information on national procedures
Poland

 

Summary of national procedures

Registration of biocidal products under the transitional regime is carried out in accordance with Article 16 of the Act of  9 October 2015 on Biocidal Products. 

That Act states that only biocidal products for which an authorisation, or a parallel trade permit, have been issued can be made available on the market and used in the territory of Poland. Biocidal products need to be authorised before being placed on the Polish market. The authorisation is issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. 
 

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Mo
Is an authorisation required:

Yes, for all PTs
Relevant deadline(s):

For the submission of applications for new authorisations, at least 6 months prior to the date of approval of the last active substance/PT combination contained in the product.
Legal background:

Article 89 of the BPR, Article 93 of the BPR National Regulations/Decrees:  Act of 9 October 2015 on Biocidal Products 

Polish Act on biocidal products  
 
Fees:
Data requirements:
Competent Authority contact information:

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C 02-222 Warszawa, Polska

Email: pb (at) urpl.gov.pl
 
Language requirements for the application:

Polish

Only in case of efficacy reports: Polish or English
 
Additional requirements, or comments:

Submission of application documents to the Polish Office:

Hard copies (originals or certified copies)

  1. Personally, to the venue of the Office
  2. By post/ courier

Documents signed electronically through the Polish electronic platform for communication called ePUAP. 
Electronic address of ePUAP, for our Office is: /URPLWMiPB/SkrytkaESP 
More information concerning this means of communication is available here.
Romania

 

Summary of national procedures

For the placing on the Romanian market of biocidal products under Article 89 or Article 93 of the BPR (transitional measures), it is necessary to comply with the provisions of the Order 10/11/368/2010.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

No
Is an authorisation required:

Yes
Relevant deadline(s):

The complete application must be submitted at least 3 months before the approval date of the active substance.
Legal background:

Art 89 (2) and Art 93 of the BPR

Order 10/11/368/2010

 
Fees:

The fees for placing biocidal products on the market are found in the Order 870/1170/98/2017
Data requirements:

The application documents are specified in Art. 4(1) of the Order 10/11/368/2010
Competent Authority contact information:

The Technical Secretariat of the National Commission for Biocide Products (ST-CNPB)
INSP, etaj 2, camera 219
Str. Dr. Leonte Anastasievici, nr. 1-3, sector 5, Bucuresti, 050463, Romania
e-mail: biocide (at) insp.gov.ro;
Fax: 004021 311 86 22
Language requirements for the application:

Romanian
Slovakia

 

Summary of national procedures

Transitional measures are implemented in the Slovak Republic via § 20 of the Slovak Biocidal Act No. 319/2013. Registration and publication in the national biocidal registry is mandatory prior to placing a biocidal product on the Slovak market. For registration requirements, you can refer to the application form and Art. 95 of the BPR. Submissions are possible as hard copy, or electronically.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all PTs
Is an authorisation required:

Yes, for all PTs
Relevant deadline(s):

The submission deadline corresponds to the day before the approval date of the latest active substance in a biocidal product.
Legal background:

§ 20 of the Slovak Biocidal Act No. 319/2013
Fees:
  • Paper application fee EUR 300
  • Electronic application fee EUR 230
  • Annual fee per product EUR 150

Item 153a of the Act on Administrative Fees
 
Data requirements:

§ 20 item 2 of the Slovak Biocidal Act; see Application form
 
Competent Authority contact information:

Ministry of Economy of the Slovak Republic Centre for Chemical Substances and Preparations
Mlynské nivy 44/a,
827 15 Bratislava 212

biocides (at) mhsr.sk
+421 907 957 583
 
Language requirements for the application:

See Application form
Additional requirements, or comments:

Crossborder e-submissions
Slovenia

 

Summary of national procedures

An application for notification of a biocidal product that contains an active substance included in the Review Programme, or covered by Art 93 of the BPR, needs to be submitted no later than the approval date of the last active substance/PT combination belonging to the product. Biocidal products can be made available in the territory of the Republic of Slovenia after they have been included into the national register of biocidal products. The application forms for notifications and changes of notifications of a biocidal product are available on the website link hereinafter. The application form should be filled in Slovenian language. The fee is EUR 210 per application.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes, for all AS/PTs
Is an authorisation required:

No
Relevant deadline(s):

Notifications can be submitted until the date of approval of the last AS/PT combination contained in the product
Legal background:
Data requirements:
  • Notification form;
  • Registration in other countries;
  • Article 95 compliance declaration(s);
  • Label,
  • SDS;
  • Efficacy test reports – EN language is also possible
Competent Authority contact information:

Ministry of Health
Chemicals Office of the Republic of Slovenia
Ajdovščina 4
1000 Ljubljana
Slovenia
Tel: +386 1 400 60 51
e-mail: biocidi.uzk (at) gov.si
Language requirements for the application:

Slovenian
Additional requirements, or comments:

Application can be sent also at: gp-ursk.mz (at) gov.si
Spain

 

Summary of national procedures

For placing on the market biocides in Spain under the national transitional procedures according to Article 89 and Art 93 of the BPR, national law is applicable:

  • RD 3349/1983 (registration) - Biocides under the scope of RD 3349/1983 need to be registered (authorised). The competent national body responsible for the registration depends on the product type:
    • Biocides in contact with human skin (PT1 and PT19) and hospital disinfectants for clinical purposes (PT2) need to be registered with the Spanish Agency for Medicines and Medical Devices (AEMPS).
    • Veterinary hygiene biocides (PT3) and biocides used in the environment of animals (PT18 and PT19) need to be registered with the Ministry of Agriculture, Fisheries and Food.
    • Biocides in PT2 (except hospital disinfectants for clinical purposes), PT4, PT8, PT11 (only for Legionella control), PT18 and PT19 (except biocides in contact with human and animal skin and biocides used in the environment of animals) need to be registered with the General Directorate of Public Health of the Ministry of Health. 
  • RD 1054/2002 (notification to General Directorate of Public Health of the Ministry of Health) – for other PTs, not mentioned above.
     
Information on national procedures
Sweden

 

Summary of national procedures

For biocidal products belonging to PT 8, 10, 14-21, authorisation in accordance with the Swedish national regulations is required during the transitional period. For products in PT 2, 9 and 12, the authorisation requirements apply only to certain types of products. Products in PT 1, 3-7, 11, 13 and 22 may be made available on the market without authorisation during the transitional period. However, other national rules apply, for example to labelling and there is an obligation to report to the Swedish Products Register.

Information on national procedures
Information on BPR applications under transitional measures - Fact-sheet
Is a notification required:

Yes – all PTs

Products Register - Kemikalieinspektionen
 
Is an authorisation required:

Yes – for PT 8, 10, 14, 15, 16, 17, 18, 19, 20, 21 and for certain types of products in PT 2, 9 and 12.

Swedish rules during transitional period - Kemikalieinspektionen
 
Relevant deadline(s):

No legal deadlines in national legislation. 

An application is usually processed approximately within one year after the fee was paid, unless any additional information is requested.

The prospective applicants are welcome to contact the Swedish Chemicals Agency preferably one year before the submission of the application.
 
Legal background:

Article 89 and Art. 93 of the BPR

National Regulations: 
Pesticide Ordinance (2014:425)
KIFS 2022:3 - Pesticides Regulations
 
Fees:

Basic fees vary from SEK 8000 up to SEK 300 000 (additional fees may apply).

The annual fee for an authorised chemical biocidal product is 5.5 % of the sales value.

Application fees for biocidal products - Kemikalieinspektionen

Pesticide Fees Ordinance (2013:63)
 
Data requirements:

The data requirements are listed in the application forms.

Application forms and guides for biocidal products - Kemikalieinspektionen
 
Competent Authority contact information:

Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg

E-mail: kemi (at)kemi.se

Telephone: +46 8 519 41 100
Helpdesk: +46 8 519 41 111

Ask the Swedish Chemicals Agency - Kemikalieinspektionen
 
Language requirements for the application:

Swedish or English
Additional requirements, or comments:

Application forms and other documents can be found here:
Apply for authorisation for biocidal products - Kemikalieinspektionen 

A Letter of Access (LoA) is needed to prove that an applicant is   entitled to use documentation in support of a product application:
Guidance on Letter of Access - Kemikalieinspektionen

A registration certificate is needed for the authorisation holder.