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.
 
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)
  • 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)

Procedures and General Principles:
A Biocidal product can be placed on the market either after approval of inventory notification or full registration depending on the PT.

Procedures for several PT’s:
PT 1, 2, 3, 4, 5 (from Main group 1) and PT 14, 16, 18, 19 (from Main group 3): Such products were regulated by several authorities prior to enforcement of TR-BPR. Thus, those PT’s are subject to full registration and cannot benefit from inventory notification to be placed on the market.

A corrigendum to Turkish Biocidal Product Regulation was published on the 12th of March 2014 O.G. 28939 and came into force on the date of publication. Transition period for some PT’s is extended. Key points brought by the corrigendum can be summarized as below:


Biocidal Products that fall under Product Types 6 and 13
Needs to be notified to the Inventory before 1.1.2015, can be placed on the market after the approval of this notification till 1.1.2017. A registration dossier for these products needs to be submitted before 1.1.2016.

Within this period the producers, importers or registrants identified on the label are responsible for compliance of the products to that regulation (in brief as per labelling, SDS and other provisions of the Turkish Biocidal Product Regulation)


Biocidal Products that fall under Product Types 7, 8, 9, 10, 11, 12, 21, 22, 23
Needs to be notified to the Inventory before 1.1.2018, can be placed on the market after the approval of this notification till 1.1.2020. A registration dossier for these products needs to be submitted before 1.1.2019.


Biocidal Products that fall under Product Type 20
No new application for Biocidal Products PT20 will be accepted. If there are products that are registered for PT 20 before 1.9.2013 can be placed on the market till 1.7.2015. After 1.7.2015, no products under PT 20 are allowed to be on the market.

*In can preservatives used in the cosmetic industry are included in the list of products that are out of scope.

Our services under the scope of TR BPR are: 

  • Regulatory compliance support and consultancy,
  • Acting as representative/registrant,
  • Label compliance in accordance with TR BPR,
  • Compilation of inventory notification,
  • Compilation of provisional application dossier,
  • Communicating with the ministry and the accredited laboratories during the sampling and analysis stage,
  • 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.
SERVICE REQUEST FORM

CONTACT INFORMATION