CRAD DECEMBER 2015 NEWSLETTER

THSK HAD PUBLISHED A DECLARATION ON THE VIRUS EFFICACY TEST UNDER THE SCOPE OF TR - BPR

In order to register biocidal products under the scope of Biocidal Products Regulation (27449 numbered (4th bis), 31.12.2009 dated), tests on several micro-organisms such as bacteria, fungi, spores and viruses have to be conducted to determine the efficacy of product based on its claim.

It is stated that the biocidal product analysis which cannot be performed in Turkey, can be performed at the laboratories in other countries who have GLP accreditation or accreditation on regarding analysis parameters, by submitting the sample in original packaging with its certificate of analysis.

Number of the accredited laboratories by the Ministry of Health is limited in Turkey and only one of them has the ability to perform virus analysis. Official Approval is published on date of 19.11.2015 (Nr. E8567) which allows performing virus tests at the laboratories in other countries who have accreditation for regarding analysis parameters and follow GLP requirements, due to inability to perform all virus analysis and considerable number of product to be analysed.

In this sense, for the validity of analysis results in the scope of registration dossier, serial or batch number and load volume should be remarked on the product sample; If the volume of package is more than 5 L, product should be sampled in sufficient amount and prepared in smaller packages for the delivery which have same qualifications with the original ones. In addition to this, for the validity of virucidal efficacy tests that will be conducted at the laboratories in other countries, Chemical analysis should be performed priorly regarding specification convenience of the sample and all results should be submitted to the authority together.

Please follow of the link for the declaration.

THSK ANNOUNCES A DECLARATION ON REVOKING OF SOME BIOCIDAL PRODUCT LICENCES BASED ON THE COMMISSION DELEGATED REGULATION (EU) NO 1062/2014

As the 12 month transition term that applies to some of the active substances which are listed on Annex II Part 2 of the 1062/2014/EU ended as of 31.10.2015, Turkish Public Health Institute (THSK) had published a communique on Biocidal Products containing the Active Substances that are no longer supported under the review program.

Within this context, the communique was published on date of 02.12.2015 by THSK with a list of AS and PT combination.

The Biocidal Products that are containing these Active Substances (depending on the PT) can be placed on the market in Turkey until 01.06.2016 and can be used until 01.12.2016.

The Inventory listing and Registration Licence of such Biocidal Products will be revoked as of 01.06.2016.

Click here for the Official Declaration 

Click here for the list of removed active substances.