Biocidal Product Regulation Compliance, Registration & Consulting Services

Registration of Biocidal Products under the scope of Biocidal Products Regulation (OG, 27449, 31.12.2009)

Biocidal Products Regulation has been published in the Official Gazette and came into force on the 31st of December 2009. It aims to implement the BPD (98/8/EC) of the European Union and enforced by the Ministry of Health. The scope is identical with the scope of 98/8 EC. 

Active substances that are under EU review program are also listed as applicable active substances under the Turkish BPR. Thus, any Active substance listed in EU supported list or the ones agreed for inclusion can be used with in the same way for the products under the TR BPR.

The aim of the regulation is to ensure that the risks that biocidal products may pose to all living things and the environment are evaluated and that they are produced, imported, licensed and registered, classified, packaged, labeled, placed on the market and inspected within the scope of this evaluation.
 
Turkish BPR also has correlations with other regulations such as; 

• Regulation on Classification, Labelling and Packaging of the Substances and Mixtures (dated 11 December 2013 and numbered 28848) – TR-CLP (SEA)
• Regulation on Safety Data Sheets of Dangerous Substances and Mixtures (dated 13 December 2014 and numbered 29204) 
• Communiqué on Working Procedures and Principles of Biocidal Product Analysis Laboratories (dated 22 June 2015 and numbered 5102)
• Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (dated 23 June 2017 and numbered 30105) – TR-REACH (KKDIK)

Our services within the scope of the Biocidal Products Regulation:
** In line with current regulations and Ministry requests:

• Regulatory compliance support and consultancy
• Acting as representative/registrant
• Label compliance in accordance with TR BPR
• Generation of compliant SDS according to Turkish SDS regulation with our certified team of experts
• Data gap assessment
• Compilation of registration dossier
• Consultancy on frame formulation structure
• Preparation of ANNEX II-A Active Substance Dossier
• Preparation of ANNEX II-B License File
• Preparation of ANNEX VI Risk Assessment Report
• Compilation of documents requested within the scope of the regulation
• Finding appropriate laboratories during the analysis phase of the products / Evaluating existing analysis reports
• Meeting the demands of the Ministry of Health
• Ensuring Company/Supplier/Ministry/Laboratory coordination
• General Consultancy
• Scoping Studies
• Guidance on permitted areas of use in the EU and national markets

Other regulations we serve in connection with biocidal products:
•    COMMUNIQUE ON BIOCIDAL PRODUCTS THAT DO NOT CONTAIN ACTIVE SUBSTANCES
Official Gazette No. 28726 dated 2 August 2013

•    COMMUNIQUE ON IN-SITU GENERATED PRODUCTS SYSTEMS
Official Approval numbered 495 and dated 01/02/2022

•    COMMUNIQUE ON TREATED ARTICLES WITH BIOCIDAL PRODUCTS
Official Gazette No. 30420 dated 13 May 2018

In line with our vision, as CRAD, which aims to guide the Turkish chemical industry in every aspect and to support the harmonization of institutions in the face of the obligations imposed by the legislation, we are at your service with our expert staff and effective solution services.