CA-July17.Doc.7.3
DRAFT NOTE FOR DISCUSSION WITH MEMBER STATES' COMPETENT AUTHORITIES FOR BIOCIDAL PRODUCTS
This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission. The information transmitted is intended only for the Member State or entity to which it is addressed for discussions and may contain confidential and/or privileged material.
Subject: Reporting on the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (BPR)
1.- Background and purpose of the document
(1)According to Article 65 (3) of the Biocides Products Regulation (Regulation (EU) No 528/2012, BPR), every five years from 1st September 2015, Member States shall report to the Commission on the implementation of the BPR.
(2)For being able to analyse and compare the data of Member States, and to obtain a proper indication of the implementation of the BPR in the Union, it is necessary that Member States collect in a harmonised way similar types of data and report it by using the same template.
(3)The objective of this note is to discuss between Member States' competent authorities the information to be collected and reported to the Commission.
2.- Relevant provisions in the BPR and proposed way forward
(4)According to Article 65 (3) of the BPR Member States shall report to the Commission on the implementation of the BPR. The 30th of June 2020 is the first round of reporting.
(5)According to Article 65(3) the report shall include in particular the following information:
- Results of official controls,
- Poisoning, and occupational diseases involving biocidal products,
- Adverse environmental effects thorough the use of biocidal products, and
- Use of nanomaterials in the biocidal products and potential risks.
(6)According to article 65 (4) of the BPR, 12 months later the Commission shall submit a composite report to the European Parliament and to the Council.
(7)The reporting will indicate the progress made within the Member States, and in the European Union, with implementing the provisions of the BPR. The report will also provide stakeholders and the general public valuable information on the authorisation and the use of biocidal products in the Union and an indication of the level of reaching the objectives of the BPR. The objectives of the BPR are i) to improve the functioning of the internal market; and ii) to ensure a high level of protection of both human and animal health and the environment.
(8)While Article 65(3) clearly sets the obligation of reporting and indicates certain information that should be included (see paragraph 5), the BPR does not specify in detail the type of information that should be reported to the Commission.
(9)The Agency and the Commission have available certain information on the implementation of the BPR. Member States should focus on the collection of information that is necessary to be obtained and currently lacking. Therefore the present note proposes which information should be collected by Member States, and the information that is currently, or will be,available at the Agency and/or the Commission.
(10)The impact assessment attached to the proposal of the Commission[1], resulting in the BPR, proposed indicators to evaluate the implementation of the BPR in the European Union. The indicators in the IA were analysed and completed with additional indicators in order to take into account the changes that took place during the legal procedure in Council and EP. Table 1 lists the indicators, the link with the objectives in the Commission proposal and the provider of the relevant data during the reporting exercise in 2020.
Table 1. Indicators, objectives and data providers in the 2020 reporting exercise
Objective / Indicator / Data sourceFacilitate the harmonisation of the EU market for biocidal products / Number of active substances evaluated under the BPR, and number approved / Commission/Agency
Speed of product authorisation / Commission/Agency
Number of conflicts in Mutual Recognition that require resolution at Community level / Commission/Agency
Continue to provide high level of protection for humans, animals and the environment / Number of biocidal products on the market / Member States
Number of low risk biocidal products on the market / Commission/Agency
Number of poisoning incidents / Member States
Number of environmental incidents * / Member States
Number of data sharing failures (linked to animal testing) / Commission/Agency
Increase the competitiveness of the EU industries affected by this Regulation / Number of new active substances / Commission/Agency
Number of unfavourable controls in the market surveillance activities in particular for the treated materials / Member States
Number of helpdesk questions * / Member States
Number of queries from SMEs * / Member States
*Indicators that were not included in the BPR impact assessment
(11)Following agreement on the type of information to be collected and reported in the context of Article 65, the Commission will analyse the possibilities to develop an Information Technology (IT) tool that would allow MSs to submit the information electronically.
(12)To alleviate the burden on MSs and to improve the efficiency of the reporting processesunder Regulations No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP) and No1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),it is being explored whether the BPR reporting could be integrated in the reporting tool/system for CLP and REACH.
(13)Annex 1 provides an overview of the information that is proposed to be collected and provided by the Member States. Annex 2 details the information that should be collected by the ECHA and the Commission. Annex 3 is a glossary of the terms used in the Annexes.
4.- Action requested
(14)The Member States' Competent Authorities are invited to discuss the way forward outlined in the note.
5.- Annexes
ANNEX I. Template for information to be collected and provided by the Member States
1. General Information
This section includes the information to be reported by Member States in the context of Article 65 of the BPR.
1.1. Member state (MS) [2]
Which MS are you reporting for?
Please cross mark the correspondent information (table 2)
Table 2.
Overview of Member States that shall report to the Commission on the implementation of the BPR
Austria / LatviaBelgium / Liechenstein
Bulgaria / Lithuania
Croatia / Luxembourg
Cyprus / Malta
Czech Republic / Netherlands
Denmark / Norway
Estonia / Poland
Finland / Portugal
France / Romania
Germany / Slovak Republic
Greece / Slovenia
Hungary / Spain
Iceland / Sweden
Ireland / Switzerland
Italy
1.2. Contact details of the person/s responsible/s for the reporting[3]
Please specify the person/s responsible/s for the reporting, and its contact/s.
Fill in the following table (table 3)
Table 3.
Contact details of the responsible person/s for reporting
Last name and name / Organisation / e-mail / Phone(s)1.3. Information on the Competent Authority (CA)
1.3.1. CAs involved in the implementation of the BPR
How many CAs are responsible for the BPR in your Member State?. Please do not include enforcement authorities at this place, as they are specifically covered in section 4
Please cross mark the relevant box (table 4)
Table 4
Number of competent authorities responsible for the BPR
12
3
4
5
6
7
8
9
10
More (please specifynumber)
1.3.2. Contact of the CAs involved in the BPR
Please provide the names and contact of the CAs in accordance with article. 81 of the BPR.
Fill in the following table (table 5).
Table 5.
Details of competent Authorities involved in the BPR
Subject / BPR Competent authority authorities involved / WebsiteAdvice to applicants- helpdesks / Active substances
Biocidal products
Treated articles
Assessment of active substances (eCA)
Assessment and authorisation of biocidal products (eCA)
Other
1.3.3. Other body (bodies) involved in the implementation of BPR
If other bodies/authorities/ institutions are involved in the implementation of the BRP, please specify (table 6)
Table 6
Other authorities involved in the implementation of the BPR
Subject / Authority/organisaiton involved / WebsitePoison control centre
Animal poison control centre
Other
2. Relevant national measures and Member State specific measures
This section is about national measures and/ or MS specific legislation related to the implementation of the BPR in the reporting MS. Probably most of this information is available on national websites, therefore, it is requested to provide a brief overview of the measures with the corresponding links to electronic information.
2.1. Transitional period (art. 89 BPR)
Do you have specific national measures or legislation for making available on the market biocidal products during the transitional period in which a MS may continue to apply its current system or practice of using biocidal products?
Yes/ No
If yes, please specify the national regulation (s) and/ or requirement (s) during the transitional period or refer to the corresponding link of the relevant website with the requested information.
2.2. Applicable fees
Do you have specific national measures or legislation regarding fees for any kind of BPR procedure?
Yes/ No
If yes, please specify the national regulation (s) and/ or requirement (s) or refer to the corresponding link of the relevant website with the requested information.
2.2.1.Fee amounts
Please, provide information on the applicable fees for each of the procedures listed in the table below (table 7)
Table 7
Applicable fees per BPR procedure in the Member State
Fee amountEvaluation of Active Substances
Authorisation of Biocidal Products
Mutual recognition of authorisations
Annual fee
Others (please specify)
2.3 Measures in favour of Small and Medium- Sized Enterprises (SMEs)
Do you have specific national measures or legislation favouring SMEs?
Yes/ No
If yes, please specify the national regulation (s) and/ or requirement (s) or refer to the corresponding link of the relevant website with the requested information.
2.4 Non compliance and penalties (article. 87)
Do you have specific national measures or legislation concerning non-compliance and penalties, applicable to infringements on the implementation of the BPR?
Yes/ No
If yes, please specify the national regulation (s) and/ or requirement (s) or refer to the corresponding link of the relevant website with the requested information.
2.5 Imported treated articles
Do you have specific national measures or legislation that regulates whether imported treated articles contain only approved active substances?
Yes/ No
If yes, please specify the national regulation (s) and/ or requirement (s) or refer to the corresponding link of the relevant website with the requested information.
3. Placing and making available on the market of biocidal products
This section is about the authorisation procedures and placing and/or making available on the market of biocidal products in the reporting Member State.
3.1. Authorisation procedures
Please give the number of applicable authorisation procedures for the specific calendar year in relation to the specific articles of the BPR for biocidal products.
3.1.1. Authorisations
Please fill in the table below (table 8) with the results of the procedures since the entry into force of the BPR (applications received in accordance with BPR after 1st September 2013)
Table 8.
Procedures for biocidal products
2013 / 2014 / 2015 / 2016 / 2017 / 2018 / 2019 / Total numberNational authorisations (articles 29, 33 and 24)
Total number of applications received
Total number of granted authorisations**
Exemptions (article 19 (5))
Derogations (article 55 (2))
Mutual recognition– cMS* (articles 33 and 34)
Total number of applications received
Total number of granted authorisations**
Exemptions (article19 (5))
Derogations (article 55 (2))
Derogations (article 37)
Simplified authorisation – eMS* (article 25)
Total number of requests received
Number of authorisations (article 26)**
Notifications from authorisation holders (article 27 (1))
Authorisations for products containing active substances meeting exclusion criteria (article 5.2.)
Total number of assessments carried out
Condition (s) met
Condition (s) not met
Comparative assessments (article 23)
Number of applications/procedures affected
Number of applications/procedures affected resulting in a granted authorisation
Number of applications/procedures affected resulting in restrictions (article 23 (3))
Number of applications/procedures affected resulting in prohibitions (article 23 (3))
Number of applications/procedures at Union level (article 23 (5))
*If no information is available for a specific year, please indicate N/A in the corresponding box
* cMS, concerned Member State; eMS, evaluating Member State
**No need to provide this information as the data is already included by the competent authority in R4BP3.
3.1.2. Renewals of authorisations
Please fill in the tablebelow (table 9) with the results of the renewals of authorisations for making available on the market biocidal products
Table 9.
Number of renewal authorisation of biocidal products
2013 / 2014 / 2015 / 2016 / 2017 / 2018 / 2019 / Total numberNational authorisations (articles 29, 33 and 24)
Total number of applications received
Total number of granted authorisations
Derogations (article 19 (5))
Derogations new active substance (article 55 (2))
Mutual recognition– cMS* (articles 33 and 34)
Total number of applications received
Total number of granted authorisations
Derogations (article19 (5))
Derogations new active substance (article 55 (2))
Derogations of mutual recognition (article 37)
Simplified authorisation – eMS* (article 25)
Total number of requests received
Number of authorisations (article 26)
Notifications from authorisation holders (article 27 (1))
Authorisations for products containing active substances meeting exclusion criteria (article 5.2.)
Total number of assessments carried out
Derogation condition (s) met
Derogation ondition (s) not met
Comparative assessments (article 23)
Number of applications/procedures affected
Number of applications/procedures affected resulting in a granted authorisation
Number of applications/procedures affected resulting in restrictions (article 23 (3))
Number of applications/procedures affected resulting in prohibitions (article 23 (3))
Number of applications/procedures affected resulting in derogations (article 23 (5))
*If no information is available for a specific year, please indicate N/A in the corresponding box
* cMS, concerned Member State; eMS, evaluating Member State
3.1.3. Specific BPR procedures for biocidal products
The BPR contains specific procedures that allow the making available on the market of products without an authorisation and for parallel trade. Please fill in the table below (table 10).
Table 10.
Number of biocidal products made available on the Member State market under specific BPR procedures
2013 / 2014 / 2015 / 2016 / 2017 / 2018 / 2019 / Total numberParallel trade (art. 53)
Total number of applications received
Authorisations
Rejections
Derogations (Art. 55.1)
Total number of received requests
Permits granted
Permits rejected
Derogations (Art. 55.3)
Total number of received requests
Permits granted
Permits rejected
Research & Development (Art. 56)
Total number of notifications received
Rejected
* If no information is available for a specific year, please indicate N/A in the corresponding box
1
CA-July17.Doc.7.3
3.1.4. Number of biocidal products made available on the Member State market
3.1.4.1. Biocidal products made available on the market authorised under transitional measures
Please provide the number of product types of biocidal products per year that are available on the market authorised under transitional measures (table 11).
Table 11
Number of biocidal products available on the Member State market authorised under transitional measures
2013 / 2014 / 2015 / 2016 / 2017 / 2018 / 2019 / Total numberMain group 1: Disinfectants
PT 1
PT 2
PT 3
PT 4
PT 5
Main group 2: Preservatives
PT 6
PT 7
PT 8
PT 9
PT 10
PT 11
PT 12
PT 13
Main group 3: Pest control
PT 14
PT 15
PT 16
PT 17
PT 18
PT 19
PT 20
Main group 4: Other biocidal products
PT 21
PT 22
3.1.4.2. Biocidal products made available under the simplified procedure
Please provide the number of biocidal products per product type that are made available on the market authorised in accordance with the BPR simplified authorisation procedure (article 25) (table 12)
Table 12
Number of biocidal products authorised under the simplified authorisation process available on the Member State market
2013 / 2014 / 2015 / 2016 / 2017 / 2018 / 2019 / Total numberMG 1: Disinfectants
PT 1
PT 2
PT 3
PT 4
PT 5
MG 2: Preservatives
PT 6
PT 7
PT 8
PT 9
PT 10
PT 11
PT 12
PT 13
MG 3: Pest control
PT 14
PT 15
PT 16
PT 17
PT 18
PT 19
PT 20
MG 4: Other biocidal products
PT 21
PT 22
4. Information on enforcement activities
4.1. BPR enforcement strategy
Has an overall strategy being implemented in the MS for the enforcement of the BPR?
Yes/ No
If this strategy is publicly available, please provide the corresponding link.
4.2. Control system in the Member and results of official controls
4.2.1 Description of the controls system
Please, give a brief overview on the way official controls are carried out in your MS, with special emphasis to the following processes:
- Making available on the market of biocidal products
- Use of biocidal products
- Placing on the market treated articles
4.3. Enforcement authorities involved in official controls
Please provide of the denomination of the enforcement authorities involved in official controls. If applicable, give also the links to the relevant websites (table 13).
Table 13
Information regarding the enforcement authorities involved in official controls
Subject / BPR enforcement authority involved / WebsiteControls on placing and making biocidal products available on the market
Controls on placing on the market of treated articles
4.3.1. Have there been complaints received by enforcement authorities in relation to the implementation of the BPR Regulation? (table 14)
Yes/ No
Table 14
Number of complaints received by enforcement authorities of te Member Stae in relation with the BPR Regulation
2013 / 2014 / 2015 / 2016 / 2017 / 2018 / 2019 / TotalNumber of complaints
4.4. Controls addressing the different parts of the supply chain
The reporting MS is requested to provide the number of official controls on the implementation of the BPR that have been performed since the entry into force of the regulation.
4.4.1Official controls on compliances with BPR rules for making available on the market of biocidal products.
Please provide the number of controls performed per year, and the number of non- compliances found:
- Controls on unauthorised biocidal products made available on the market (table 15)
- Controls on recordskept by authorisation holders, in concordance with article 68 of the BPR (table 16)
- Controls on the classification, packaging and labelling of biocidal products (article 69 of the BPR, and Regulation 1272/2008 on the classification, labelling and packaging of substances and mixtures (hereafter CLP)) (table 17)
- Controls on safety data sheets (article 70 of the BPR, and article 31 of Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (hereafter REACH)) (table 18)
- Controls on advertisement of biocidal products (art. 72 and CLP) (table 19)
- Controls on the inclusion of active substances suppliers in the official list, as specified in article 95 (2) of the BPR (table 20)
4.4.2. Official controls on biocidal products made available on the market during transitional period