Check whether your authorisation is ready for publication in the ECHA biocidal product database
Authorisation holders are responsible for providing information about their biocidal products, such as characteristics (risks), classification and labelling, permitted use and risk control measures. At the Ctgb this information can be found in the authorisation database. Starting in November, the European Chemicals Agency (ECHA) will also make this information easily accessible through its central database. In doing so, ECHA aims to strike a balance between the need to inform the general public and the right of companies to protect confidential business information. Therefore, please check whether any documents in R4BP that contain confidential data have been wrongly identified as publicly accessible. If you report such documents to the Ctgb before 15 October, we will make the required changes free of charge.
ECHA has started a dissemination project (in accordance with BPR Article 76.1.g) to make existing, authorisation-specific information available by expanding its online database, which currently offers very limited information. Afterwards, the ECHA and Ctgb databases will largely correspond. The difference is that ECHA confines itself to biocidal products that fall under European legislation (the Biocidal Products Regulation), while the Ctgb authorisation database also contains information about authorisations of plant protection products and biocidal products that are subject to transitional legislation.
What is included in the ECHA database for biocidal products?
In November 2018 the comprehensive ECHA biocidal product database will be launched for the regular authorisation types ‘NA’ and ‘SA’/‘SN’. For Union authorisations this may happen sooner. The following documents will be published for each authorisation:
- SPC (completed or updated after 01-01-2016);
- PAR (only the non-confidential part);
- Decisions such as the authorisation decision;
- Only relevant for Union authorisations: BPC opinion.
How can you contribute to effective dissemination of information?
Of course, ECHA carries out its statutory task with great care, but you can help support the non-Dutch speaking ECHA employees in this task. As an authorisation holder, please check your own authorisations in R4BP. There are three access levels in R4BP: ‘public’, ‘restricted’ or ‘restricted for authorities’. Only documents of the first category are eligible for publication. All documents containing confidential information must have the access level 'restricted' or 'restricted for authorities'. The documents that are to be published
- must be available and complete (‘dummy’ xml files without content or incomplete documents are not allowed);
- the document name must correctly reflect the content;
- these documents may not contain confidential information;
- the documents (in particular the SPC) must be of the most recent version.
Please note: R4BP is a secure environment. This explicitly does not apply to the ECHA database. Documents with the authority level 'public' will be published in November, without exception. Therefore, it is in your interest to immediately identify any incomplete documents, documents with the wrong authorisation level or any other mistakes.
What can you do if you notice a mistake?
Please report mistakes as described in the previous paragraph as follows:
- If documents are missing or you encounter a dummy: To complete the essential information about your authorisation, you must provide the complete SPC by e-mail in the xml file type, in which all relevant fields are filled out. You must also add an identical PDF version, which clearly shows, for example with highlighting, which corrections have been made. Please send your e-mail stating 'A. Echa dissemination no/dummy document <product name>'. Do the same for a missing or incomplete PAR and/or authorisation decision. In that case, the PDF version is sufficient.
- If the document name does not reflect the contents: Contact the Ctgb by e-mail stating 'B. Echa dissemination change document name <product name>’ and suggest a correct file name.
- If a document has the wrong access level: If you believe that the access is currently registered incorrectly in R4BP, i.e. public documents are registered as restricted or confidential information is registered as public, then inform the Ctgb about this by e-mail stating ‘C. Echa dissemination access level <product name>’. Each authorisation must have an authorisation decision, SPC and PAR, without containing confidential information. If this does not apply to your authorisation, send two versions to the Ctgb, one with and one without the confidential information, clearly marking the first one. Please substantiate why the particular information is confidential.
- The most up-to-date version of your SPC can be found in the Ctgb database. If the version in R4BP is not in accordance with the authorisation issued by the Ctgb, please contact the Ctgb by e-mail stating ‘D. Echa dissemination version SPC <product name>’.
The Ctgb will then make an administrative request for you in R4BP and correct the error.
If you respond before 15 October 2018, the corrective actions will be free of charge, regardless of the category.
Routine changes, such as adding a production site or withdrawing an authorised use, fall outside the ECHA dissemination project. You can request such changes via the normal procedures.
Two databases in parallel
Despite the partial overlap, the ECHA and Ctgb databases will coexist at least for the foreseeable future. It is therefore advisable to also check the available information about your authorisations on the Ctgb website, so your customers and other website visitors will be informed correctly.