Board for the Authorisation of Plant Protection Products and Biocides

EU Regulation for biocidal products

The Biocidal Products Regulation (EU) 528/2012 (this link forwards to the aggregated text with successive amendments and corrigenda) came into force on 1 September 2013, replacing the Biocidal Directive (98/8/EC).

The Biocidal Products Regulation (EU) 528/2012 (the BPR) applies directly to all citizens in the Member States of the European Union. The BPR has the same effect as a national law in any one of the Member States. However the Regulation does provides room for Member States to take into account the specific situation in their own country.

EU has repealed guidance provided in the MoD

However as the EU Biocides Regulation (EU BPR) has repealed and replaced the BPD, the guidance provided in the MoD is now obsolete as of 1 October 2015. If you have relied on the guidance previously provided by the MoD to conclude that your product(s) were out of the scope of the biocides legislation, but your product might now be within the scope of the EU BPR, there is an opportunity to support the relevant active substance/product type combination. The EU Commission has specifically identified the issue of products that only work by indirect means on the target organism. Due to a decision by the European Court of Justice such products may now be within the scope of the EU BPR and therefore the active substances will need to be supported. Additional information on the declaration, notification, submission processes can be found on the European Chemicals Agency website. Please note the deadline for the first step in the process to support the relevant active substance/product type combination is 1 October 2016.   

If you are unsure if your product now falls within the scope of the EU BPR please contact the  National helpdesk or the ECHA helpdesk

Biocidal Products Regulation (EU) 528/2012

Since 1 September 2013, an application for authorisation of a biocidal product containing approved active substances or renewal of an authorisation under the Biocidal Products Regulation (EU) 528/2012 should be submitted through the information system provided by the European Chemicals Agency(ECHA).

The application itself must be submitted via R4BP 3, but the dossier is created in IUCLID format. ECHA is responsible for the development of these systems, and has also prepared instructions for their use. To obtain an authorisation or extension of an authorisation for a biocidal product, you can choose from the following types of applications:

 

Amendments to Biocidal Products Regulation (EU) 528/2012

On 11 March 2014, Regulation 334/2014 was officially published. This includes the amendments to Biocidal Products Regulation (EU) 528/2012. The changes are primarily clarifications, but a number are more substantive.
Read about the amendments here.

Changes

The purpose of the Biocidal Products Regulation (EU) 528/2012 is to improve the functioning of the biocides market in the EU while at the same time providing a high degree of protection for people and the environment. With the arrival of the Regulation, a number of aspects have changed. You can find more information about these changes here.

SPC

The Summary of Product Characteristics (SPC) is a standard component of an authorisation decision for applications submitted under the Regulation. Biocidal Products Regulation (EU) 528/2012 applies to biocidal products that are based on approved substances. Read more about the SPC.

Role of ECHA

The Biocidal Products Regulation (EU) 528/2012 provides that the European Chemicals Agency (ECHA) should carry out specified tasks with regard to the evaluation of active substances as well as the Union authorisation of certain categories of biocidal products and related tasks. It also provides that a Biocidal Products Committee should be established within the Agency to carry out certain tasks conferred on the Agency by this Regulation. Read more about the role of ECHA.

Important dates

The Biocidal Products Regulation (EU) 528/2012 went into force on 1 September 2013. All national legislation is being adapted to the Regulation. It is important to keep a number of important dates in mind which have been set down in the Biocidal Products Regulation: View the important dates.

Digital access

Based on the provisions in Biocidal Products Regulation (EU) 528/2012, information can be disclosed publicly only after an active substance has been approved or an authorisation is issued. ECHA provides digital access to all non-confidential information. Regarding applications for authorisation of biocidal products under transitional legislation in the Netherlands (Wgb), the previous arrangement remains in force: data must be submitted directly to the Ctgb, both digitally and on paper. Read more about digital access.

ECHA leaflet

Following the entry into force of Biocidal Products Regulation (EU) 528/2012, a number of aspects have changed. ECHA has published a leaflet explaining these changes. Ctgb has adapted this text to the situation in the Netherlands. Read the version for the Netherlands.