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Per quanto riguarda le domande d’iscrizione nell’elenco delle sostanze e dei fornitori interessati di cui all’articolo 95 del BPR, considerata l’entità del lavoro che il loro trattamento comporta per l’Agenzia, occorre assoggettarle a tariffa. Le tariffe applicabili sono stabilite nel regolamento di esecuzione (UE) n. 564/2013 della Commissione, del 18 giugno 2013, sulle tariffe e sugli oneri spettanti all’ECHA a norma del regolamento (UE) n. 528/2012.
Il carico di lavoro necessario per trattare questo tipo di domande varia in modo significativo secondo che la persona presenti una lettera di accesso oppure un nuovo fascicolo; in quest’ultimo caso, l’ECHA deve infatti verificare che il fascicolo sia conforme all’allegato II del BPR oppure, se necessario, all’allegato II A o IV A della direttiva 98/8/CE e, se del caso, all’allegato III A di tale direttiva.
L’allegato III del suddetto regolamento di esecuzione (UE) n. 564/2013 della Commissione stabilisce le tariffe applicabili in funzione del tipo di presentazione di cui all’articolo 95 del BPR:
- 2 000 EUR per la presentazione della lettera di accesso a un fascicolo già ritenuto completo dall’Agenzia o da un’autorità di valutazione competente;
- 20 000 EUR per la presentazione della lettera di accesso a parte di un fascicolo già ritenuto completo dall’Agenzia o da un’autorità di valutazione competente, corredata di dati complementari;
- 40 000 EUR per la presentazione di un nuovo fascicolo.
Il testo del regolamento di esecuzione (UE) n. 564/2013 della Commissione è disponibile all’indirizzo:
Le società devono presentare una notifica congiunta ai sensi dell’articolo 10, paragrafo 2, del regolamento sul programma di riesame (regolamento (UE) n. 1062/2014) per aggiornare l’identità del partecipante. R4BP 3 attualmente non include tale funzione. Tuttavia, la notifica può essere effettuata utilizzando il seguente modulo web: https://comments.echa.europa.eu/comments_cms/BiocidesJoiningOrReplacingParticipants.aspx
Se l’ECHA ritiene che la notifica sia conforme, le informazioni in R4BP 3 verranno aggiornate di conseguenza. In seguito, la società B verrà classificata al posto della società A nel successivo aggiornamento dell’elenco di cui all’articolo 95.
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.
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).
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.
Following an inquiry and, according to Article 63(1) and (4), the parties involved must:
- make every effort to reach an agreement on the sharing of the results of tests or studies requested (whether involving or not vertebrate animal studies);
- ensure that the costs of sharing these tests or studies are determined in a fair, transparent and non-discriminatory way.
Further information is available in ECHA's Guidance on data sharing
ECHA will not determine what the compensation should be. The parties have the option of settling this matter before a national court.
The obligation to reach an agreement on the sharing of the results of the tests and studies requested is the exclusive responsibility of the negotiating parties which bear the obligation to make every effort to reach an agreement.
Negotiating parties shall consider the following in order to fulfil their data sharing obligations in a timely manner:
- To ensure the sharing of the tests or studies, parties are encouraged to allow a reasonable time for the negotiations between their inquiry to ECHA and before the actual planned submission of the dossier.
- The prospective applicant should define clearly the scope of the negotiations, by being explicit on the studies and tests requested (regarding vertebrate or non-vertebrate studies).
- As it is the responsibility of the parties to make every effort, the argumentation against any claim or element of the negotiation shall be expressed between the parties; ECHA is never a party in the negotiations.
- Both the prospective applicant and the data owner should be constructive, reliable and consistent negotiating partners, make sure to provide precise information and be proactive and transparent at all times in the negotiations.
More information is available in the "Key Messages" document in the BPR Data sharing web page.
Where no agreement is reached during the negotiations, the prospective applicant can, as a last resort, inform ECHA of the failure to reach an agreement with the data owner on the sharing of the data or of its costs, at the earliest one month after the original receipt from ECHA of the contact details of the data owner (or data submitter). The prospective applicant shall also notify the data owner that they have informed ECHA. The ECHA data sharing dispute procedure should be initiated after all possible efforts have been made and the negotiations have failed. Having submitted an inquiry is the pre-requisite before lodging a data sharing dispute claim with ECHA, including in situations where the prospective applicant already knew the data owner(s) or where negotiations had already started before the entry in force of the BPR.
ECHA strongly recommends continuing the negotiations also after a data sharing dispute claim has been filed.
Under the previous legislation (Directive 98/8/EC), there was no mandatory data sharing obligation. The new obligation under the BPR cannot have retroactive effect, and ECHA cannot take into consideration what was discussed prior to 1 September 2013 in a data sharing dispute. Where negotiations started before the entry into application of the BPR, parties should identify the remaining points of disagreement and the points on which they have reached an agreement as of 1 September 2013. This can serve as a basis for the negotiations that must take place after 1 September 2013. It remains mandatory for "any person intending to perform tests or studies on vertebrate animals" to submit an inquiry to ECHA and to negotiate for at least one month after receiving the relevant contact details, before being entitled to submit a data sharing dispute claim. This applies equally to studies not involving tests on vertebrates under Article 95.
The BPR requires as a minimum of 1 month (Article 63(3)) after the prospective applicant receives the name and address of the data submitter from ECHA. However, when submitting the data sharing dispute claim the prospective applicant and data owner have to demonstrate that they have made every effort and exhausted all possibilities in the negotiations.
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.
Article 63(1) states where a request has been made in accordance with Article 62(2) the prospective applicant and the data owner have to make every effort to reach an agreement. This applies also where the prospective applicant requested to share non-vertebrate data.
In the event of failure to reach an agreement, under Article 63(3), ECHA can grant the right to refer to non-vertebrata data where the request to share was made further to an inquiry under Article 62(2) and in the context of an Article 95 application concerning an active substance in the Review Programme.
The BPR data sharing obligation applies to data owners whether they are established in the EU or not. In most cases the data submitter will be based in the EU. The data submitter has the responsibility to facilitate contacts between the prospective applicant and the data owner.
No, the data sharing under BPR is not limited to the same substance. Technical equivalence is not a condition for data sharing under Article 62 and 63 of the BPR (in contrast to the same substance condition under the REACH data sharing provisions). For example, shared data can be used for bridging and read across.
For the purposes of Article 95(2), as per the amendments introduced by Regulation 334/2014, the biocidal product can only remain on the market after 1/9/15 if either the product supplier or the substance supplier is on the list. Therefore not all the affiliates must be on the list. Only those who act as product or substance supplier and are not linked in the supply chain to the legal entity on the list would need to be also on the list.
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.
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).
An application must always be reviewed by ECHA. The time between submitting the application and being placed on the list depends on the type of submission (complete substance dossier, LoA or the combination of both), and, where relevant, the quality of the dossier submitted. For dossiers it might take several months but an application based on a LoA to a complete substance dossier should take less time to process. We will aim at updating the list on a monthly basis.
Either one is enough within a given supply chain, that is to say there must be a clear connection to the product made available on the market.
No. The list will only contain the names of the substances, product type, names of companies and roles (substance or product supplier).
The source of the active substance in a biocidal product will become public when the SPC for the biocidal product is published by ECHA under Article 67(2) of the BPR.
Trades names will not be included in the Article 95 list. We advise you to consult your supplier to better identify the active substance you use in your product.
An application to be included on the Article 95 list can be made by providing a letter of access (LoA) to a "complete substance dossier". Where an alternative dossier has been submitted for Article 95 purposes, a second Article 95 application with a LoA to that dossier can be made as soon as the alternative dossier application fee has been paid. However, the LoA application can only be approved once ECHA has found the alternative dossier as compliant with Article 95(1) and therefore qualifying as a complete substance dossier.
No OR facility is provided for under the provisions of the BPR. According to Article 95(1), a substance supplier or product supplier must be established in the EU.
To ensure equal treatment, ECHA and the Commission have agreed that non EU participants in the Review Programme can be listed in the Article 95 list next to their EU representative. Non-EU manufacturers of active substances or biocidal products may also apply for inclusion on the Article 95 list via a representative based in the EU.
The non EU entity will be listed next to the name of their EU representative.
Under the BPR, only EU companies fall within the definition of substance supplier or product supplier. The role of the EU representative has therefore been created to allow non-EU manufacturers to appoint an EU representative to apply for inclusion on the Article 95 list on their behalf. The list will display both the names of the EU representative and the non-EU supplier.
Unlike the ‘Only Representative' under REACH, the role is not associated with any specific regulatory obligations or responsibilities, and it was developed only for Article 95 purposes. This is also because the obligations under Article 95 are ultimately the responsibility of the parties making the biocidal product available on the market in the EU (Article 95(2)).
In summary, it is entirely up to the non-EU manufacturer to decide if it wishes to appoint an EU representative and who it wishes to appoint. The responsibilities of the EU representative would be set out in a contract with the non-EU manufacturer, and would normally include to make the application for Article 95 inclusion and, for example, further to a reasoned request from a competent authority, to provide it with the information and documentation necessary to demonstrate the role of the non EU company in the supply chain of a product made available on the market.
Yes, a company can have both roles, and if indicated in the application they can be listed for both roles.
In this case an application can be made by the entity which manufactures the biocidal product or who makes it available on the market, for inclusion on the list as a product supplier. The applicant will need to submit either an alternative Annex II dossier, or obtain a letter of access to the Annex II data on the active substance. To receive the contact details of the data submitter of the Annex II complete substance dossier, the applicant should submit an inquiry under Article 62(1) of the BPR. For the purposes of Article 95 and active substances in the Review Programme, mandatory data sharing applies to vertebrate data and also non vertebrate data (toxicological, ecotoxicological, environmental fate and behaviour).
o, the BPR is a different regulation and a separate application needs to be submitted.
ECHA will issue draft decisions on the applications and the applicant will have a possibility to update their application taking ECHA's comments into account.
If, after such update, the application is considered as non-compliant, the applicant will receive a communication in writing stating the deficiencies and reasons. The relevant person will not be included in the Article 95 list. A new application could be submitted to address the issues identified by ECHA in its decision. The rejection decision may also be challenged before the Court of Justice of the European Union (General Court).
ECHA advises companies to submit their applications well in advance of 1 September 2015. Article 95(3) states that as of 1 September 2015, a biocidal product should not be made available on the market unless the substance supplier or product supplier is included on the list. Please note that Article 95 does not indicate any deadline for processing an application but ECHA will process the applications without undue delay through the compliance check as efficiently as possible.
Fees apply per dossier and active substance. Hence several product types can be indicated in one application.
Article 95 does not place any restriction on who can sell (make available on the EU market) the active substance. Therefore a toll manufacture is not prohibited by Article 95 from selling an active substance to a customer in its own right. Article 95(2) provides that a biocidal product may not be made available on the EU market unless either the substance supplier or the product supplier is on the Article 95 list. The responsibility falls on the first person making the product available on the market to ensure there is an appropriate listing among the actors in the supply chain. Where it is the toll manufacturer who manufactures the biocidal product (and who is not on the Article 95 list itself), it can sell (make available on the EU market) a biocidal product to a customer in its own right if the active substance is on the Article 95 list. The toll manufacturing contract would also be relevant as regards agreed conditions applying to the manufacture and supply by the toll manufacturer.
Article 95 does not place any restriction on who can manufacture the active substance. Therefore a toll manufacture is not obliged by Article 95 to only manufacture an active substance on behalf of a substance supplier who is on the Article 95 list.
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.