TR-BPR (BUY)
Consulting Services to Turkish Biocidal Products Regulation
Registration of Biocidal Products under the scope of Biocidal Products Regulation (OG, 27449, 31.12.2009)
Harmonization of Turkish legislation with European Union regulations and biocidal products intended to provide a more effective control of the Biocidal Products Regulations, Ministry of Health of the Republic of Turkey by the European Union Directive No. 98/8/EC prepared according to No. 27449 dated December 31, 2009 and published in the Official Gazette and entered into force.
Regulation of the target biocidal products all living beings and the environment created on they can risk assessment and evaluation within the scope of the production, imported to, license and registered to, the classification, packaging to be, labeling, marketing to be, to be checked to ensure.
Biocidal Products Regulation has been published in the Official Gazette and came into force on December 31st 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. However the new concepts and approach brought by the new EU BPR (528/2012 EC) such as treated article, in situ generation and Product family is not yet adopted to the Turkish BPR.
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 “Biocidal Products Directive” is linked with the related regulations such as;
- Regulation on Classification, Labelling and Packaging of the Substances and Mixtures (dated 11 December 2013 and numbered 28848)
- Regulation on SDS's of Dangerous Substances and Mixtures (dated 13 December 2014 and numbered 29204)
- Regulation on Prevention of Exposure Risks of Biological Factors
- Regulation on Restriction for Manufacture, use and Placing on the Market of Certain Substances and Articles
- Regulation on Principles on Good Laboratory Practices and accreditation of Test Laboratories
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:
- Main group (1) PT 1,2,3,4,5, 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 12 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:
TR-BPR REGULATION
Harmonization of Turkish legislation with European Union regulations and biocidal products intended to provide a more effective control of the Biocidal Products Regulations, Ministry of Health of the Republic of Turkey by the European Union Directive No. 98/8/EC prepared according to No. 27449 dated December 31, 2009 and published in the Official Gazette and entered into force.
Regulation of the target biocidal products all living beings and the environment created on they can risk assessment and evaluation within the scope of the production, imported to, license and registered to, the classification, packaging to be, labeling, marketing to be, to be checked to ensure.
PRINCIPLES AND PROCEDURES
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:
- Main group (1) PT 1,2,3,4,5, 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 12 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:
OUR SERVICES FOR TR-BPR
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,
- 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.
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.
Please contact for our TR-BPR Services