Q&As

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BPR

Active substance suppliers

If a company obtains a Letter of Access (LoA) to a complete 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?

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).

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?

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. 

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

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.

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?

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. 

How long does it take to be listed on the Article 95 list once an application for Article 95 inclusion was made or a positive decision has been taken?

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.

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

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. 

Where a product supplier is listed, will the name and the address of the manufacturer of the active substance and the location of the manufacturing sites be made public?

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.

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?

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.

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

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.

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

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)).

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?

Yes, a company can have both roles, and if indicated in the application they can be listed for both roles.

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?

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).

What if my application for inclusion in the Article 95 list is not approved?

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).

Are the fees applied per application or per number of product types (PT)s for which the listing has been requested?

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.

How can a company get contact details of the substance/product supplier under Article 95 to ask for the LoA?

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.

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.

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?

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.

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

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.

Is an EU-based toll manufacturer of active substances obliged to be 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.