Q&A info

Yes. For applications for Article 95 inclusion based on a submission of a letter of access to a dossier regarded as complete, ECHA levies a fee of 2.000 EUR (see Annex III of the Commission Implementing Regulation (EU) No 564/2013).

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. 

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.

For the purposes of Article 95(2), the biocidal product can only remain on the market 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 companies operating within the same supply chain of another supplier which is listed may need to prove it to enforcement bodies. 

The European Commission has suggested using self-declaration forms as proof of compliance with the Article 95 requirements (see templates in the CA documents: CA-May15-Doc.4.13-Final and CA-May15-Doc.4.13-Annex-Final). 

However, as enforcement falls within the exclusive remit of the Member States, it is advised to discuss with the relevant national authorities on how compliance can be demonstrated. 

The applications 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, a LoA, a combination, or the reference to a complete substance dossier for which all data protection periods have expired) as well as the quality of the dossier or documents submitted. For dossiers, the processing might take several months but an application based on a LoA to a complete substance dossier takes less (in average one month). 

After ECHA issues positive decision, the suppliers will be included on the list within next update. We aim at updating the Article 95 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.

The companies operating within the same supply chain of another supplier which is listed may need to prove it to enforcement bodies. 

The European Commission has suggested using self-declaration forms as proof of compliance with the Article 95 requirements (see templates in the CA documents: CA-May15-Doc.4.13-Final and CA-May15-Doc.4.13-Annex-Final). 

However, as enforcement falls within the exclusive remit of the Member States, it is advised to discuss with the relevant national authorities on how compliance can be demonstrated. 

No. The Art. 95 list only contains the names of the substances, product types, names of companies and roles (substance or product supplier).

The name and address of the manufacturer of the active substance and the location of the manufacturing site(s) will become public when the SPC for the biocidal product is published by ECHA under Article 67(2) of the BPR as a result of product authorisation.

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.

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 active substance supporters located outside the EU 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 and can be listed on the Article 95 list. However, to ensure equal treatment, non-EU manufacturers can appoint an EU representative for the purposes of the Article 95 list where both the EU-Representative and the non-EU manufacturer would be listed.

Accordingly, the role of the EU representative is not associated with any specific regulatory obligations or responsibilities, unlike the ‘Only Representative' under REACH. Any specific responsibilities of the EU representative should be set out in a contract with the non-EU manufacturer.

It is entirely up to the non-EU manufacturer to decide if it wishes to appoint an EU representative and whom it wishes to appoint. The EU representative should be in charge of maintaining the Article 95 list entries related to the non-EU supplier. 

The EU representative, further to a reasoned request from a competent authority, may also need to provide information and documentation to demonstrate the role of the non-EU company in the supply chain of a biocidal product made available on the EU market: 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)).

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).

Before taking a non-approval decision, ECHA will issue a draft decision on the application and the applicant will have a possibility to update their application taking ECHA's comments into account.

If, after such update, the application is still considered non-compliant, the applicant will receive a final decision 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. Non-approval decisions may also be challenged before the Court of Justice of the European Union (General Court).

Fees apply per application. An application can apply only to one active substance. However, it may include more than one product type. It should be noted that the product types applied for cannot be changed after submission of the application in R4BP 3.

A prospective applicant can turn directly to ECHA to get contact details to the data submitter(s) of an active substance or a biocidal product by making an inquiry as described below.

Any person intending to perform tests or studies (or asking for a LoA), for the purposes of an application under the BPR, 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.

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.

Such an inquiry must be submitted to ECHA through R4BP3.

• More information regarding the inquiry process
• Detailed information on how to submit an inquiry can be found in the Biocides Submission Manual 3a: Active substances Part A, Initial submissions

After the inquiry has been assessed, ECHA will give the contact details of the data submitter(s) to the applicant, and, at the same time, communicate the inquirer's contact details to the data submitter(s). This information will be retrieved from dossiers submitted under the BPD and the BPR. ECHA will not provide information on individual tests or studies.

Note: 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.

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.

The Union list of approved active substances mentioned in Article 9(2) of the BPR is publicly available on ECHA dissemination site.

Pursuant to Article 67(1) of the BPR, as amended by Regulation (EU) No 334/2014, approved active substances are added on this list from the date on which the Commission adopts an implementing Regulation providing that an active substance is approved.

No. For biocidal products made available on the market under the Biocidal Product Regulation (the BPR), the term ‘natural’ and/or other similar expressions (e.g. ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘environmentally friendly’, ‘animal friendly’) cannot occur on the label (as per Article 69.2 of the BPR) or advertisement (as per Article 72.3 of the BPR) of a biocidal product. This applies also in cases where the word ‘natural’ and/or other similar terms are part of a registered trademark and regardless of the natural origin of an active substance contained in the product.

No, the BPR is a different regulation and a separate application needs to be submitted.

Yes, an annual fee is payable to ECHA also for a Union Authorisation granted through the Same Biocidal Product Regulation (Commission Implementing Regulation (EU) No 414/2013). 

Fee payable to ECHA (Commission Implementing Regulation No 564/2013 – Biocides Fee Regulation):

A fee for “Union authorisation of a same biocidal product” is specified in Annex II, Table 1 of the Biocides Fee Regulation. Whether the application is for a product or for a whole family, the fee is the same.

In addition, there is an annual fee for all authorised biocidal products (single product and family) specified in Annex III of the Biocides Fee Regulation. It is applicable also to biocidal products authorised via the same biocidal product application.

A fee for “notification to the Agency of an additional product within a biocidal product family” is specified in Annex II, Table 1 and it is applicable also to families authorised via the same biocidal product application.

Fee payable to eCA:

Please note that the fees related to UA applications payable to the evaluating Competent Authority (eCA) may vary between the CAs and are established in the national legal acts of each MS. The applicant is responsible for checking and paying the specified amount of fees to the chosen eCA. For more information about the CA fees, the applicant should contact the CA or its helpdesk. The contact information for national helpdesks is available at the ECHA website. 

Under the BPR, new studies involving vertebrate animals can be conducted only as a last resort and, therefore, mandatory data sharing applies.

The prospective applicants, intending to perform new tests on vertebrate animals, have the obligation to find out which tests and studies are already available, by submitting an inquiry through R4BP 3 to ECHA.

The prospective applicants may also inquire about tests and studies not involving tests on vertebrate animals. Accordingly, an inquiry is mandatory when the intention is to perform tests on vertebrate animals and is optional when the intention is to perform tests which do not involve vertebrate animals. An inquiry is also a pre-requisite before a data sharing dispute claim can be submitted to ECHA under Article 63(3) of the BPR (including in cases where the prospective applicant already knows the identity of the data owner).

Once a request for test data (on vertebrate animals or not) has been made to a data owner (or any data submitter that is entitled to negotiate on behalf of the data owner), the parties must make every effort to reach an agreement to ensure that the cost of sharing the information is determined in a fair, transparent and non-discriminatory way, in accordance with the provisions of Article 63(1) and (4) of the BPR. ECHA will provide the inquirer with the contact details of all previous data submitters, when tests or studies were already submitted to the competent authorities or ECHA in connection with an application under the former Directive 98/8/EC or the BPR. Where applicable, the data submitters are required to facilitate the contacts between prospective applicants and data owners.

Please consult the ECHA website on inquiry and "Inquire to share data for active substances" available at the bottom of this page.

The data sharing obligation also applies to the inclusion in the list of relevant substances and suppliers under Article 95 of the BPR. Note that mandatory data sharing for the purpose of Article 95 extends to all toxicological, eco-toxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrate animals.

Please consult the ECHA website on data sharing (and the related documents), available at Data sharing.

As described in Article 62(1) and Recital 57 of the BPR, the purpose of data sharing is to minimise the number of tests on animals. Accordingly, applicants should not duplicate studies on vertebrate animals for the purposes of the BPR. Instead, applicants should make every effort to share studies in exchange for equitable compensation. 

Data sharing increases the efficiency, reduces costs and reduces testing, in particular, on vertebrate animals.

If no agreement is reached, in certain circumstances for certain types of data, the Agency can help prospective applicants by granting permission to refer to the requested data.

In the context of Article 95, for active substance in the Review programme, this includes certain non-vertebrate studies (toxicological, ecotoxicological, environmental fate and behaviour).

Data sharing obligations only apply for data that is still within the period of data protection. For most active substance in the Review programme, this expires on 31 December 2025.

For more information see the Practical Guide on Biocidal Products Regulation Special Series on Data Sharing - Data Sharing.

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 shall  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.

• BPR Data sharing web page

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.

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.

The regulatory status of in situ generated active substances and their precursors is summarised in the competent authority meeting document "Management of in situ generated active substances in the context of the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012). CA-March15-Doc.5.1-Final (revised 23 June 2015)

While the information requirements for active substances apply to in situ generated active substances, the requirements for precursors have not been specified. These are specified in the document: “WG recommendation - Risk assessment and implications on data requirements for active substances generated in situ and their precursors”.

Both of the documents are published on the ECHA website. 

The recommendations clarify the principles for information requirements and risk assessment of the precursors of in situ generated active substances but also sheds some light on the information requirements for the active substances generated in situ.

Note: the recommendation document is under revision. The revision will include the data requirements for the biocidal products of substances generated in situ.

To submit Annex II data for precursors for each precursor of an in situ active substance, you have to create a separate substance dataset in IUCLID.

Depending on the properties of a substance, you should use the corresponding dataset template in IUCLID for either a "BPR Substance of concern" (if the precursor is considered a substance of concern) or "BPR Basic information" (substance) to insert the required data.

If a study has been waived according to the specific rules for waiving data requirements in Article 21 of the BPR, then you must identify this in an endpoint study record.

For further information, see ECHA's Biocides Submission Manual Technical guide:  “BSM Technical guide: How to prepare a biocides dossier” (Annex II) at the Biocides Submissions Manual page.

You need to provide a comprehensive description of the generation process. This should include the generation conditions as pH value, concentrations of the precursors and all parameters that impact the generation and reaction schemes of each single step in the chemical reaction from the precursors to the in situ generated active substance (i.e. including the active constituents and impurities.

You should report this information under the section "2.8 Method of manufacture" of the data package on the active substance generated in situ, i.e. in the respective "BPR active substance information" dataset template in IUCLID.

For further information, see ECHA's Biocides Submission Manual Technical guide: “BSM Technical guide: How to prepare a biocides dossier” (Annex II) at the Biocides Submission Manuals page.

You can normally derive the reference specification from the five-batch analysis. However, for in situ generated active substances, reliable analytical information might not be achievable. Therefore, you should calculate the concentration of each constituent (active constituent, impurities) in a stoichiometric way based on the precursors and their applied concentrations.

This calculation should indicate the chemical species and their concentrations generated in situ, but it cannot be regarded as the reference specification of the active substance. The specification will be defined through the composition of the precursors.

You should report this information under Sections 2.9 and 2.10 Specification of purity and identity of impurities of the data package on the active substance generated in situ, i.e. in the respective “BPR active substance information” dataset template in IUCLID.

A five-batch analysis is not required for the in situ generated active substance if the generated substance is not stored or isolated. However, for the precursors, certificates of analyses might be acceptable.

If the in situ generated substance is stored, even for a short time, sampling seems to be possible and therefore a five-batch analysis has to be provided. (ref. Section 2.11 Analytical profile of Annex II to the BPR.)

For further information, see ECHA's Biocides Submission Manual Technical guide: “BSM Technical guide: How to prepare a biocides dossier” (Annex II) at the Biocides Submission Manuals page.

Both risk assessment and hazard assessment are required for precursors.

For more information see the “WG recommendation - Risk assessment and implications on data requirements for active substances generated in situ and their precursors”.

You have to provide the efficacy data for the active substance generated in situ. Depending on the system, you could approach assessing the efficacy in different ways. The manufacturer of the in situ generated active substance is best placed to provide ways of demonstrating the substance efficacy.

According to the competent authority meeting document (CA-Nov15-Doc.5.5), only the properties of the in situ generated active substance are considered to define whether the exclusion, substitution and Annex I listing criteria are met during the approval process. 

However, please note that an in situ generated active substance includes pure active substance, solvents which cannot be removed and impurities, where impurities may comprise reaction by-products, unreacted precursors (starting materials) and constituents of secondary or incomplete reactions.

As the harmonised classification plays a key role in assessing the exclusion or substitution criteria, the active substance generated in situ must be classified. 

A harmonised classification will be proposed by the evaluating competent authority (eCA) on the in situ generated active substance.

When the eCA considers that it has appropriate information on the precursors, they may also submit a CLH dossier for the precursors to ECHA to establish or amend the harmonised C&L. This can later help in the product authorisation stage, and could be important for product authorisation. (See competent authority meeting document CA-Nov15-Doc.5.5)

Warnings resulting from the classification of the active substance generated in situ should be added in the instructions of use accompanying the products placed on the market, i.e. the precursors.

The decision making process continues on the basis of the draft CAR (i.e. BPC opinion) and there will be no opportunity for anyone else to take over the role of participant.

Updates of the Article 95 list are foreseen to take place once a month. ECHA intends to take all changes within that month into account.

Article 95 only applies to "relevant substances" i.e. substances for which the application for approval of the active substance has been submitted and validated by the evaluating Competent Authority. Therefore, the submission of a compliant notification to take over the role of participant, has no impact on the Article 95 list until an active substance application is submitted (for the notified substance) and validated by the evaluating Competent Authority has validated the active substance application.

Any natural or legal person can submit a notifications to take over the role of participant.

The notification can be for one active substance in one or more PTs. The notification fee is per notification of an active subsance and covers all PTS notified. The fee is then deducted from the active substance approval fee.

It is the responsibility of the notifier to provide all the necessary data. If the data is not complete (following one request for additional information) the notification will not be compliant. A recovery of fees is not provided for in the legislation.

Yes, a group of companies (e.g. a taskforce) can submit one notification. The active substance will become relevant for Article 95 when the application for approval of the active substance is submitted and validated by the eCA. The companies which apply jointly for the approval of the active substance will then appear on the Article 95 list individually.

If no eCA is mentioned in Annex II of the Review Programme Regulation (EU) No 1062/2014 for the active substance/product-type in question, the applicant may choose any competent authority, as defined under Article 81 of the BPR, that would agree to evaluate the application for approval.

Part II of Annex II of the Review Programme Regulation lists review active substances that are no longer supported which means that these substance are existing active substances (on the market on 14 May 2000). The notification for taking over the role of participant for these substances does not require evidence that the substance is an existing one.

1. A claim is made that the treated article has biocidal properties 
2. It is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article

The requirements of Article 95 do not apply to the placing on the market of treated articles. Article 95 applies only to biocidal products made available on the market.