Biocidal Products Regulation-Questions and Answers

Questions and Answers

Biocidal Products Regulation

Active substance suppliers

[899] If a company obtains a Letter of Access (LoA) to a dossier and submits the LoA to ECHA for inclusion in the list of relevant substances and suppliers under Article 95 of the BPR, does it have to pay a fee to ECHA?  - FAQ

Biocidal Products Regulation

Active substance suppliers

Version: 1.1

Latest update: 04/06/2015

Given the Agency's work required to analyse submissions for inclusion in the list of relevant substances and suppliers referred to in Article 95 of the BPR, it is appropriate to levy a fee for these types of submissions. The applicable fees are laid down in the Commission Implementing Regulation (EU) No. 564/2013 of 18 June 2013 on the fees and charges payable to ECHA pursuant to Regulation (EU) No 528/2012.

The amount of work required for such a submission will vary significantly depending on whether the person submits a letter of access or a new dossier, since, in the latter case, ECHA will have to check that the dossier complies with Annex II to the BPR or, where appropriate, Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive.

Annex III of the aforementioned Commission Implementing Regulation (EU) No 564/2013 sets the applicable fees depending on the type of the submission under Article 95 of the BPR:

• 2 000 EUR per submission of a letter of access to a dossier already found complete by the Agency or an evaluating competent authority;
• 20 000 EUR per submission of a letter of access to part of a dossier already found complete by the Agency or an evaluating competent authority, together with complementary data;
• 40 000 EUR per submission of a new dossier.

The text of the Commission Implementing Regulation (EU) No 564/2013 is available at:
http://echa.europa.eu/regulations/biocidal-products-regulation/legislation

[990] Under the BPR, can I apply for approval of an active substance for which a non-inclusion decision has been taken under the BPD (Biocidal Product Directive)?  - FAQ

Biocidal Products Regulation

Active substance suppliers

Version: 1.0

Latest update: 04/06/2015

Yes, this is possible. Without prejudice to the transitional arrangements provided by the BPR, an application for the approval of an active substance/product-type combination can be submitted in cases where a non-inclusion decision had previously been taken under the BPD. 

 

Processes and timelines are set out in Articles 7 and 8 of the BPR. Please note that such cases are subject to the data protection period specified in Article 60(2) of the BPR (10 years). 

[819] What is the purpose of data-sharing?

Biocidal Products Regulation

Active substance suppliers

Version: 1.1

Latest update: 04/06/2015

As described in Article 62(1) and Recital 57 of the BPR, the legislator has placed a new objective which is “to minimise the number of tests on animals”.

Hence the BPR sets now a specific obligation on the applicants to “share and not duplicate studies on vertebrate animals in exchange of equitable compensation.” Data sharing increases the efficiency, reduces costs and reduces testing, in particular, on vertebrate animals.

In the context of Article 95, in light of the timeframe for submissions (inclusion on the list by 1/9/15 if the products are to remain on the market), the scope of mandatory data sharing is extended to certain non-vertebrate studies as concerns active substances in the Review Programme in order to allow applicants to prepare their submissions on time.

[820] Which actors have data sharing obligation under Biocidal Products Regulation?

Biocidal Products Regulation

Active substance suppliers

Version: 1.1

Latest update: 04/06/2015

The BPR data sharing obligations apply to data owners and prospective applicants. A prospective applicant is “any person intending to perform tests or studies” (Article 62(2) and Article 63(1). Data submitters have the obligation to facilitate contacts between the prospective applicant and the data owner(s).

[821] What must any person do if they need to perform tests or studies?

Biocidal Products Regulation

Active substance suppliers

Version: 1.1

Latest update: 04/06/2015

Any person intending to perform tests on vertebrates is required to first inquire with ECHA whether such tests or studies have already been submitted to a competent authority under the BPR or Directive 98/8/EC (the previous legislation).

Such an inquiry is optional in case of tests not on vertebrates.

If such tests or studies have been submitted, ECHA will provide the prospective applicant with the contact details of the data submitter. In cases where the data submitter is not entitled to negotiate access to the data, they are required to facilitate the contact between the prospective applicant and the actual data owner.

More information on how to inquire to ECHA (manuals and tools) is available on the ECHA website dedicated to BPR.

Where such an inquiry is made, and the studies have been submitted under either the BPR or Directive 98/8/EC, data sharing obligations apply.

If such tests do not exist and you would like to initiate them then as laid out in the introduction to Annex III to the BPR “The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out” (emphasis added). Therefore, we would encourage you to contact the Member State Competent Authority in charge of your application in order to discuss this test including potentially applicable additional legislative requirements.

[822] What is meant by “compensation for Data Sharing”?

[823] How shall the negotiations be conducted?

[910] What can a prospective applicant do if they do not reach an agreement to share data or costs with the data owner/submitter?

[911] What if the negotiations have started before 1 September 2013?      

[1003] What is a reasonable time for the negotiations for data sharing?

[1004] How is the reference to Article 63(3) of the BPR in Article 95(3) to be understood? Does mandatory data sharing apply to all toxicological and eco-toxicological studies, as well as environmental fate and behaviour studies, including non-vertebrate studies?

Biocidal Products Regulation

Active substance suppliers

Version: 1.0

Latest update: 04/06/2015

In the event of a data sharing dispute claim under Article 63(3), ECHA can grant the prospective applicant permission to refer to vertebrate studies.

For the purpose of Article 95, and studies regarding an active substance in the Review Programme, the scope of the data to which ECHA can grant permission to refer in an Article 63(3) dispute is expanded to include non-vertebrate data on toxicological, ecotoxicological and environmental fate and behaviour studies. This facilitates applicants meeting the Article 95 deadline of 1/9/15.

[1005] Does the data owner have to share non-vertebrate data, if asked for it?

[1006] Does the non-EU data owner have the obligation to share data?

[1007] Is the data sharing obligation limited to situations where the applicant’s substance is the same as the one on which the tests were carried out?

[1008] In case of affiliates/multinational company, do all affiliates need to be listed or is it enough to have one legal entity on the list?

[1010] Where an alternative Annex II dossier is submitted for the purpose of Article 95, will there be a detailed review of efficacy data as already submitted by the existing participants?

Biocidal Products Regulation

Active substance suppliers

Version: 1.0

Latest update: 04/06/2015

The Article 95 compliance check on alternative substance dossiers is not a detailed review. For an alternative dossier submission, basic information on efficacy would be sufficient. Further information will be requested at the product authorisation stage.

[1011] Can you be listed on the Article 95 list for existing active substances after September 2015 if you submit a compliant application after that date?

Biocidal Products Regulation

Active substance suppliers

Version: 1.0

Latest update: 04/06/2015

Yes, applications can be submitted also after September 2015 and inclusion on the list will follow when the application is deemed successful.

However, the entity making biocidal products available on the market must ensure that the relevant substance supplier or product supplier is included on the list as at 1/9/15 or the products will need to be removed from the market from that date (until the substance supplier or product supplier is eventually included on the list).

[1012] How long does it take to be listed on the Article 95 list once a submission is made or the positive compliance check decision is taken? And how often will the list be updated?

[1013] Is it enough if either the manufacturer of the active substance or the manufacturer of the biocidal product is on the list?

[1014] Where a product supplier is listed, will the source of the substance be made public?

[1015] Will trade names or qualities be given in the Article 95 list or how can a formulator be sure that its active substance is on the list?

[1016] Can you make an Article 95 application providing a LoA to another full Article 95 dossier even if that had not been evaluated yet?

[1017] Can non-EU companies be included in the Article 95 list?

[1018] What are the obligations of the EU representative for Article 95 under the BPR?

[1019] Is it possible for the same company to be listed on the Article 95 list as a ‘substance supplier’ and as a ‘product supplier’ for the same substance?

[1020] How can a small company become listed as a "product supplier" if the active substance supplier is not applying to be included in the list of active substances and suppliers?

[1021] Would a submission made under the REACH Regulation satisfy the requirements of the BPR?

[1022] What if my application for inclusion in the Article 95 list is rejected?

[1023] What if ECHA does not manage to run the compliance check before 1 September 2015?

[1024] Are the fees applied per dossier submitted or per number of product types (PT)s for which the listing has been requested?

[1058] How should the draft risk assessment be performed for an Article 95 application?

[1110] Can an EU-based toll manufacturer sell an active substance or a biocidal product (consisting of, containing or generating that active substance) to customers in its own right?

[1111] Can an EU-based toll manufacturer manufacture active substances for a supplier which is not on the Article 95 list?

[1112] Is an EU-based toll manufacturer of active substances obliged to be on the Article 95 list?

Biocidal Products Regulation

Active substance suppliers

Version: 1.0

Latest update: 26/06/2015

Article 95 does not place any restriction on who can manufacture the active substance. Therefore an EU-based toll manufacturer of active substances is not obliged to be on the Article 95 list.

BPR General

[900] When will the Union list of approved active substances be made publicly available?  - FAQ

[906] Should I register an active substance under the REACH Regulation?  - FAQ

[908] Is a safety data sheet required for active substances and biocidal products according to the BPR? - FAQ

[909] Do I need to submit a renewal of national authorisation in R4BP 3 if an application for national authorisation submitted via R4BP2 is under evaluation?  - FAQ

[986] Which active substances ('ASs') in a biocidal product containing more than one AS have to be approved before the product can be authorised under the BPR?  - FAQ

[989] Do ecotoxicological and toxicological tests have to comply with the principles of good laboratory practice (GLP)?  - FAQ

[1057] Is an annual fee payable to ECHA also for a Union Authorisation granted through the Same Biocidal Product regulation?

Data Sharing

[905] What are the data sharing requirements under the BPR?  - FAQ

[1026] How to get contact details of the substance/product supplier under Article 95 to ask for the LoA?

Parallel Trade

[987] Is a parallel trade permit an authorisation for a biocidal product?  - FAQ

Simplified authorisation

[902] How can a company request an amendment of Annex I of the BPR?  - FAQ

[903] How much are the fees for the simplified authorisation procedure according to the provisions of the BPR and how can a company apply for it?  - FAQ

Treated articles

[898] How to comply with the BPR for placing on the market treated articles which have been treated with, or include, biocidal products containing active substances?  - FAQ

[904] Is my product a treated article, a biocidal product or neither?  - FAQ

[988] Does the BPR foresee transitional measures for the labelling and information requirements for treated articles?  - FAQ

[1025] Does Article 95 of the BPR apply to treated articles, i.e. can a mixture or article only be treated with or intentionally incorporate a biocidal product containing an active substance if the supplier has submitted a dossier or a letter of access to ECHA?