Keep your products in market after 1st of January 2021.
For hassle free UFI generation & PCN submission service click. HERE >>

BENS's Insider

How you can turn our experiences in your favor – free proffesional materials helping you implement best practices without hassle.

  • All
  • Safety Data Sheet
  • UFI / PCN
  • ADR
  • Biocides
  • REACH
  • Other
Recently by ""

Biocides | June 9, 2020

The Article 95 of the Regulation (EU) No 528/2012 states:

tabela1

To put it more simply, only biocidal products containing an active substance, whose manufacturer or supplier is included in the list under the Article 95 of the Biocidal Products Regulation, can be made available on the market. The list of active substances and their suppliers is published here.

In practice, the supply of an active substance is confirmed with two declarations, both mandatory:

  1. Confirmation of supply as substance supplier

The supply of an active substance must be confirmed by the manufacturer/supplier from the list (Compliance with Article 95(2) of Regulation (EU) No 528/2012).

The confirmation of supply must contain:

  • the name of the company from the list under the Article 95 of the Biocidal Products Regulation,
  • the name, CAS and EC number of the active substance,
  • the name of the company being supplied with the active substance / the name of the company using the active substance.

The confirmation of supply must be signed by the company listed under the Article 95 of the Biocidal Products Regulation.

  1. Self-declaration by reference to a substance supplier

A self-declaration must also be prepared, wherein the manufacturer of the biocidal product confirms the use of an active substance from the listed supplier.

The self-declaration of active substance content must contain:

  • the name of the company manufacturing the biocidal product,
  • the name of the biocidal product,
  • the name, CAS and EC number of the active substance,
  • the name of the company supplying the active substance and listed under the Article 95 of the Biocidal Products Regulation.

The self-declaration must be signed by the company manufacturing the biocidal product. 

If you are a manufacturer or a seller of a biocidal product, you must submit both declarations upon inspection.

The first (Confirmation of supply) must confirm the supply of an active substance by the supplier listed under the Article 95 of the Biocidal Products Regulation. The second (Self-declaration) must state that the product supplied actually contains the supplied active substance.

The Biocidal Products Regulation (EU) No 528/2012 is valid throughout the entire territory of the European Union.

I hope this explanation is comprehensible enough. In case of any more questions, please contact us at info@kemikalije.com.

Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.com

Back to posts

X
To spletno mesto uporablja piškotke za namen izboljšave delovanja spletnega mesta. Več informacij najdete v naših pravilih o rabi piškotkov.