Article 95 list
A biocidal product can be sold on the EU market only if the manufacturer or supplier of the relevant substance in the biocidal product, or the manufacturer or supplier of the biocidal product for the applicable product type, is included on the Article 95 list of the Biocidal Products Regulation.
ECHA compiles and updates the Article 95 list. The list contains three aspects: 1. the active substances (‘relevant substances’), which can be traded as active substance or as part of a biocidal product only by 2. the EU-based suppliers on the list for 3. the listed product types. The list includes only suppliers (or their representatives within the EU) who demonstrably possess or have access to a complete EU substance dossier or equivalent. The aim of this scheme is to counter 'free riding' and thereby to promote fair competition. As a result, after 1 September 2015 it will no longer be possible to sell a biocidal product without having invested in a substance dossier.
Inclusion in the Article 95 list is an extra requirement, which applies in addition to the regular authorisation requirements. You can download the Article 95 list on the ECHA website. Additional information about the procedure for being included on the Article 95 is available on the website of ECHA.
Ctgb procedure to implement Article 95
For the implementation of Article 95, the Ctgb has decided to follow the recommendations of the European Commission and applications for new authorisations will be immediately reviewed for compliance with Article 95. Non-compliance with Article 95 means that the application will not being taken into consideration; as a result, the Ctgb will not grant a new authorisation or an extension, amendment or renewal of an existing authorisation.
Because Article 95 does not require the withdrawal of authorisations, the Ctgb has no grounds from 1 September 2015 to take measures with respect to existing authorisations that fail to comply with Article 95. It is up to the enforcement authority to make decisions on the enforcement of Article 95. Existing authorisations will therefore be reviewed in the light of the European rules, including Article 95, at the time of re-registration, following approval of the active substance.
Obligations for authorisation holders
A biocidal product can be placed on the market only if - in the chain from producer to substance applicant - at least one party is included on the Article 95 list. From 1 September 2015, each authorisation holder must demonstrate compliance with Article 95 for all biocidal products for which he or she holds the authorisation; this must be done at the following times:
- During an inspection by/at the request of the Inspectorate
- During an application for authorisation, re-registration of the authorisation, renewal of the authorisation, applications for major changes of the authorisation and when changing the supplier of the active substance.
The proof of compliance with Article 95 should be kept in the applicant's authorisation dossier. Do not send proof of compliance to the Ctgb except as part of an application, during which this proof is requested. If compliance with Article 95 cannot be demonstrated in an application, then this application will not be processed by the Ctgb.
Demonstrating compliance with Article 95
The authorisation holder must convince the Inspectorate or the Ctgb that he or she has complied with Article 95. This can be done with a written and signed statement. The European commission has developed a format for such a statement. This format can be used to demonstrate compliance with Article 95 for a specific biocidal product.
Relevant substances are all active substances for which an EU substance dossier has been submitted. These substances are on the Article 95 list. A derogation applies to products and active substances that did not fall under the authorisation requirement of Directive 98/8 (the Biocidal Products Directive), but are now subject to the Biocidal Products Regulation. This derogation is described in Article 93 of the Regulation. For active substances and biocidal products that fall under Article 93 of the Regulation, a substance dossier could be submitted till september 1, 2016. From this date the requirement for inclusion of these substances and products on the Article 95 list is in force.
For substances that have been included in Annex I in categories 1-5 or 7 of Biocidal Products Regulation 528/2012, inclusion on the Article 95 list is not required. This concerns substances that have been acknowledged as low-risk substances EU-wide.
Request for inclusion on the Article 95 list
Parties who have submitted substance dossiers for the review programme are obligated to cooperate with the inclusion of substance or product suppliers on the article 95 list by providing a Letter of Access (LoA) to all toxicological, ecotoxicological, fate and behaviour studies; a reasonable fee can be charged for providing this access. The contact details of these parties can be requested from ECHA. If the negotiations between suppliers and customers about a LoA fail, then ECHA sets the fee. Appendix 1 of ECHA's Practical Guide Special Series on Data Sharing containts a template for a Letter of Access for submitting an Article 95 notification.
Application form after September 1
For an application for authorization or amendment of the authorization of a biocidal product under Dutch transitional legislation Form B, Form AB or Form PAB must be used. In these forms an additional appendix (Appendix Article 95) is available in which you can specify whether your application complies with Section 95. For applications submitted via R4BP this additional document must be uploaded under the tab "documents'.
For more information
If you have any questions on this topic, please contact the Service Desk of the Ctgb.