Our post "UFI, PCN and biocidal products" has brought up many questions and responses.
Here's one response interesting for posting that refers to understanding the notes on PCN notification of biocidal products:
"UFI and PCN are not needed until 1 January 2025 or until the formulation change for biocidal products for consumer use, which have been notified in Slovenia as per the national procedure or authorised according to BPR, UFI and PCN, but only if they were or will be entered in the biocidal products register before 1 January 2020."
Questions relating to the statement above:
- Is this an official statement of the competent authority and does this apply only to Slovenia?
- Is this similar in other member states?
- How are new BPR authorisations affected by UFI and PCN – for instance, an administrative change of a currently valid registration or a mutual recognition in sequence?
What follows is the detailed answer to that question.
Paragraph 1.4 of Annex VIII to CLP Regulation No. 1272/2008 determines:
"Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025."
The competent authority in Slovenia, appointed in accordance with CLP Article 45(1) is the Chemical Office. It is also the competent authority for the purposes of enforcement of the Biocidal Product Regulation and handles notification and authorisation procedures for biocidal products. For notifying a biocidal product according to the national procedure, the Chemical Office receives information about the biocidal product that fulfils the conditions as per this paragraph. This information is then available to poison centres via the software database that the Office uses to store information about hazardous chemicals.
For other member states, it is possible that the competent authority handling the provisions of the BPR is not the same as the competent authority appointed in accordance with CLP Article 45(1). In that case, a biocidal product that is authorised / notified according to national procedure would not necessarily be considered as having its information submitted for the purposes of PCN and UFI.
It is also possible that, besides national procedure notification or authorisation, information must also be sent to the competent authority appointed in accordance with Article 45(1). In this case information is provided to the appropriate authority, and this allows you to delay the implementation of UFI/PCN for that product to 1 January 2025. Therefore, it is necessary to get information with regard to UFI/PCN obligations for biocidal products for each member state separately.
This is also why plant protection products for consumer use in Slovenia will have to be labelled with UFI and notified as per PCN immediately as of 1 January 2020. Registration procedures for plant protection products are not managed by the Chemical Office, but by the Administration of the Republic of Slovenia for Food Safety, Veterinary Sector and Plant Protection. Plant protection products are entered in their register, which cannot be accessed by the poison centre.
In case of mutual recognition in sequence for biocidal product authorisations after of 1 January 2020 and the future placement on the market in the member state in question, the UFI and PCN are mandatory immediately, because the requirements as per paragraph 1.4 will not be fulfilled before 1 January 2020 (e.g. a biocidal product in Slovenia has not been listed in the biocidal products register where the poison centres can access information).
The same applies for the current registration modifications that include new trade names and formulation changes.
I hope that my explanation helps you understand the obligations of UFI and PCN when it comes to biocidal products. If you have any other questions with regard to the topic above, please don't hesitate to contact me.