On 22 May 2012 the European Union adopted the text of the Biocidal Products Regulation (BPR), Regulation (EU) 528/2012. The Regulation is applicable since 1 September 2013, with a transitional period for certain provisions. It repeals and replaces the former Biocidal Products Directive (Directive 98/8/EC). On October 1. 2015 the Manual of Decisions implementing the former Directive 98/8/EC became obsolete.
THE SCOPE
The Regulation applies to biocidal products. It also sets rules for articles treated with, or intentionally incorporating, one or more biocidal products. The biocidal products are classified into 22 biocidal product-types, grouped in four main areas. An overview of the product groups and types can be accessed here.
WHAT'S NEW?
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved.
New is that articles can only be treated with biocidal products containing active substances approved in the EU. This is a change from the former Biocidal Products Directive, where articles imported from third countries could be treated with substances not approved in the EU.
Manufacturers and importers of products excluded from the scope of the former biocides legislation must check whether their product could now fall within the scope of the new Biocidal Products Regulation. Further information can be found here.
IS MY PRODUCT APPROVED?
As of 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, can be made available on the EU market only if the substance supplier or product supplier is included in the list for the product type to which the product belongs.
The current list of suppliers and substances can be accessed here.
THE EXCEPTIONS
The Regulation does not apply to biocidal products or treated articles that are within the scope of other legislations such as:
"..............................
(b) Directive 90/385/EEC (ACTIVE IMPLANTABLE DEVICES), Directive 93/42/EEC (MEDICAL DEVICES) and Directive 98/79/EC (IVD);
(c) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
............................."
To access the full list of exceptions consult Article 2. of the Regulation.
WHAT ABOUT LABORATORY REAGENTS?
Grey zone again! Similar to the Animal By-Products Regulation No. EC 1069/2009 laboratory reagents for general use are not specifically regulated.
Manufacturers and importers of biological products for research, diagnostic use or further manufacturing containing preservatives such as Sodium Azide must take a closer look at the upcoming requirements.
Manufacturers and importers of liquid BOVINE SERUM ALBUMIN must pay special attention to the upcoming deadlines of the regulation. Sodium Azide - a popular BSA preservative at present - may no longer be approved for use in the EU.
WHAT COMES NEXT?
Watch the deadlines, check your product and raw material database! Make sure you are compliant. If you have questions - consult an expert!
