Suppliers of biocidal products must be included in the Article 95 List
Conducting studies to establish the risks of using biocidal products is expensive. Applying for a review of an active substance is also expensive. These costs have been paid for by companies who have registered the active substances with the EU Review Programme. In order to share the costs amongst those who sell biocidal products, the Article 95 List has been created.
As of 1 September 2015, a biocidal product that comprises, contains or generates a relevant active substance may not be made available on the market if the substance supplier or product supplier is not registered on the Article 95 List for the correct product type. The requirement applies to all active substances that are registered on the Article 95 List for the respective product type. A substance is considered relevant when a complete dossier for the substance has been submitted and accepted in accordance with Article 95 of the EU Biocides Regulation.
The Swedish Chemicals Agency's position on the Article 95 list regarding disinfectants
For you to be able to sell or release your product on the market, normally you must make sure that your supplier of the substances or the products are listed on the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain. Until 30 June 2021, the Swedish Chemicals Agency accepts manufacturing and selling of disinfectants without the suppliers being on the Article 95 List. After 30 June, anyone who wants to place a product on the market for the first time must be on the Article 95 list. For those who subsequently want to sell a product that was placed on the market before 30 June, the positioning applies until 30 September 2021.
The Swedish Chemicals Agency will not extend the position. After these dates have passed, disinfectant suppliers are expected to be on the Article 95 list.
This position implies that the agency will not check if disinfectant suppliers are on the list. The purpose of this position is to increase the availability of disinfectants in Sweden in the current situation with the spread of the corona virus.
What is the Article 95 list?
The Article 95 List is a register of companies that have submitted documents or permits to access submitted documentation for active substances. The list is available from the European Chemicals Agency (ECHA) website. Company information is listed for the active substance in combination with one or more product types.
Do you sell biocidal products?
If you are selling biocidal products within the EU, your company, substance or product manufacturer or your substance or product supplier must be registered on the Article 95 List. If no member of the supplier chain is registered on the Article 95 List, the biocidal product may not be released on the market, even if the product has been authorised.
In the event of an inspection, you must be able to provide documentation to confirm that somebody in your supplier chain is registered on the Article 95 List.
Please note that it is not sufficient that the substance supplier or product supplier is on the Article 95 List. If you want to import, sell, transfer or use a biocidal product in Sweden, you will in most cases also need to apply for authorisation for the product to the Swedish Chemicals Agency.
Is your supplier on the Article 95 list?
To find out whether the supplier of the active substance or product, or any other member of the supplier chain is registered on the Article 95 List, you should request this documentation from your supplier. It may include written evidence such as invoices or agreements that the active substance in your product originates from a company registered on the Article 95 List for the correct product type.
You do not need to submit this documentation to any government authority, but in the event of an inspection you must be able to produce it.
How do you register with the Article 95 list?
To be registered on the Article 95 List, you or your substance or product supplier must submit documentation to ECHA. Documentation may only be submitted for combinations of substances and product types that are registered on the Article 95 List. ECHA charges a fee for the review of the documentation.
You can submit documents in one of the following ways:
Personal documentation that meets the data requirements set in the Biocidal Products Regulation
If you have your own documentation regarding the active substance of your biocidal product, you may submit this to ECHA for evaluation. Once ECHA has reviewed your dossier, they will decide whether you may be included on the Article 95 List. Please note that you may not repeat tests on vertebrates that have already been conducted. Before you plan to conduct such animal testing, you must establish if they have already been conducted. Information can be obtained from ECHA. If previous studies have been conducted, you have the right to obtain the results and use them as reference. This applies if you provide remuneration to the owner of the studies.
Authorisation for access to previously submitted substance dossier, “Letter of Access”
If you are authorised to access previously submitted and approved documentation concerning the active substance in your biocidal product – a Letter of Access – you must submit this to ECHA.
Referral to submitted substance dossier once the data protection period has expired
If the data protection period for submitted and approved documentation has expired, you only need to provide a reference to the substance dossier for a company to be included in the Article 95 List. Data protection periods are regulated in Articles 60 and 95.5 of the EU Biocidal Products Regulation. At present, no data protection periods have expired for any of these dossiers. ECHA will update its guidelines once this becomes relevant.