Biocidal Product Registration
The Turkish Biocidal Products Regulation (BPR, Regulation OG, 27449, 31.12.2009) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
On 31st December 2009, Turkish Biocidal Products Regulation was published in the Official Gazette and harmonized with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market.
Later on a corrigendum "Biocidal Products No. 28939” was published in 2013 in parallel with the Directive 98/8/EC of the European Union and Regulation 528/2012/EU and the last ammendment came into force on 12th March 2020 No:31066 for Biocidal Product Regulation in the Official Gazette by Ministry of Health.
This regulation aims to improve the functioning of the biocidal products market in Turkey, while ensuring a high level of protection for humans and the environment.
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)
Instruction on Biocidal Product Analysis and Authorized Laboratories (dated 28 January 2015 and numbered 19020089-704.99-519)
Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (dated 23 June 2017 and numbered 30105) All biocidal products require an authorisation before they can be placed on the market either after approval of inventory notification or full registration depending on the Product Type. Boicide regulatory consultancy and support,
Acting as appointed only representative of non-TR companies for biocidal registration,
Label creation in accordance with Turkey Biocidal Product Regulation,
Compilation of inventory notification,
Compilation of provisional application dossier,
Communicating with the Ministry of Health and the accredited laboratories during the sampling and analysis stages,
SDS authoring for biocidal products complied with Turkey SDS regulations,
Data gap assessment,
Compilation of biocidal registration dossier,
Consultancy on frame formulation structure.
Biocidal Product Provisional Application Dossier Preparation
Submission of the dossier and information package to online portal
Follow-up of the application file and notifications until the pre-application process is concluded
Stage 2: Sampling process of biocidal product
Laboratory research authorized by the Ministry of Health for analysis
Scientific evaluation and conformity check for analysis methods
Following the Biocidal Product samples to be sealed
Following up each stage of the analysis closely and to eliminate the problems
Stage 3: Licencing Process
Compiling all documents for the license file
Providing technical support if necessary for licensing during the evaluation process
Regularly monitoring the licensing and reporting it to the licence holder
Getting the final licence file for Biocidal Product to place in Turkish market
On 31st December 2009, Turkish Biocidal Products Regulation was published in the Official Gazette and harmonized with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market.
Later on a corrigendum "Biocidal Products No. 28939” was published in 2013 in parallel with the Directive 98/8/EC of the European Union and Regulation 528/2012/EU and the last ammendment came into force on 12th March 2020 No:31066 for Biocidal Product Regulation in the Official Gazette by Ministry of Health.
This regulation aims to improve the functioning of the biocidal products market in Turkey, while ensuring a high level of protection for humans and the environment.
The Turkish BPR is also closely related to 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) Instruction on Biocidal Product Analysis and Authorized Laboratories (dated 28 January 2015 and numbered 19020089-704.99-519) Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (dated 23 June 2017 and numbered 30105)General Requirements and Procedures
All biocidal products require an authorisation before they can be placed on the market either after approval of inventory notification or full registration depending on the Product Type.Our Turkish Biocidal Product Regulation Services:
Boicide regulatory consultancy and support, Acting as appointed only representative of non-TR companies for biocidal registration, Label creation in accordance with Turkey Biocidal Product Regulation, Compilation of inventory notification, Compilation of provisional application dossier, Communicating with the Ministry of Health and the accredited laboratories during the sampling and analysis stages, SDS authoring for biocidal products complied with Turkey SDS regulations, Data gap assessment, Compilation of biocidal registration dossier, Consultancy on frame formulation structure.Turkey Biocidal Product Registration Steps:
Stage 1: Execution of temporary application feasibility Biocidal Product Provisional Application Dossier Preparation Submission of the dossier and information package to online portal Follow-up of the application file and notifications until the pre-application process is concluded Stage 2: Sampling process of biocidal product
Laboratory research authorized by the Ministry of Health for analysis Scientific evaluation and conformity check for analysis methods Following the Biocidal Product samples to be sealed Following up each stage of the analysis closely and to eliminate the problems Stage 3: Licencing Process
Compiling all documents for the license file Providing technical support if necessary for licensing during the evaluation process Regularly monitoring the licensing and reporting it to the licence holder Getting the final licence file for Biocidal Product to place in Turkish marketWhy choose Lisam?
SECURITY
COMPATIBLE
FLEXIBLE
COST EFFICIENT
