Scientific regulatory affairs
Regulatory support for biostimulants
List of registered fertilisers (1. 9. 2020)
The Bulgarian situation is an interesting one. For starters, according to the Plant Protection Act, fertilisers, soil improvers, growth substrates and other biologically active substances have to be registered with the Bulgarian Food Safety Authority. How this registration has to be done is provided in Ordinance n° 36 of 18 August 2004 (but this one was replaced by a newer one: Ordinance n° 21 of 23 November 2016 on the registration, labelling and control of fertilisers, soil improvers, organic active substances and growth substrates. Simply said: fertilisers and biostimulants have to be registered before placing on the market. When your product is already on another EU Member State market, that's good, but you still have to register. Only it's quicker - You find the translated form below this short summary. The registration of a product is valid for 10 years. Any change as regards to the conditions of the registration have to be notified to the authorities. You need more details? I prepared an overview on the regulatory situation in Bulgaria as regards to biostimulants.Otherwise, things are pretty straightforward: Each batch of fertiliser must be accompanied by a quality certificate (in Bulgarian language).Fertilisers to be used in organic farming must be registered (unless they fall under the types of fertilisers mentioned in the paragraph just above), modified organic products of natural origin, modified chemical fertilisers and national fertilisers on the market in other Member States. The Bulgarian authorities have issued an information note for applicants.Information on regulatory documents, biological test procedure and registration and applications submitted to the BFSA can be found on the website of BFSA: www.babh.government.bgThe regulatory overview for Bulgaria has been finalised, you find it here right under this summary. If you don't want to miss their publication, subscribe here.
This document provides an overview on the regulatory framework for biostimulants in Bulgaria, including the definition of biostimulants in the country, applicable legislation, label requirements and what is to be done to obtain a registration and certificate to place a product on the market.
Document Reference: 7BGRSV00120200807Number of pages: 10Date of publication: 21 August 2021
To ensure correct application of national and European legislation in the field of fertilizers, the Bulgarian Food Safety Agency considers it necessary to inform you about the terms and conditions for placing on the market or offering for sale fertilizers, soil improvers, biologically active substances and growth substrates.
This document it the translation of a note from the Bulgarian authorities "Concerning the marketing of fertilisers, soil improvers, biologically active substances and growth substrates".
Original title: УСЛОВИЯ И РЕД ЗА ПУСКАНЕ НА ПАЗАРА НА ТОРОВЕ, ПОДОБРИТЕЛИ НА ПОЧВАТА, БИОЛОГИЧНО АКТИВНИ ВЕЩЕСТВА И ХРАНИТЕЛНИ СУБСТРАТИ
Number of pages: 7Date of publication: 07 August 2020
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This document is the english translation of the Bulgarian ordinance n°21 of 23.11.2016 on the registration, labelling and control of fertilisers, soil improvers, organic active substances and growth substrates.
Original title: НАРЕДБА No 21 от 23.11.2016 г. за условията и реда за регистрацията, етикетирането и контрола на торове, подобрители на почвата, биологично активни вещества и хранителни субстрати
Number of pages: 16Date of publication: 05 August 2020
Content:Chapter One - GENERALChapter two – Registration of fertilizers, soil improvers, organic active substances and growth substratesChapter three – Labelling and MarketingChapter four – Control of fertilizers, soil improvers, biologically active substances and growth substrates
ADDITIONAL PROVISIONSTRANSITIONAL AND FINAL PROVISIONSAnnex No 1 - samplingAnnex No 2 - Tolerances
Organic fertilizersOrgano-mineral fertilizersFertilizers with microelementsInorganic fertilizerInorganic fertilizer with microelementsSoil improvers
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This document is the english translation of the Bulgarian form to apply for the registration of fertilisers, soil improvers, biologically active substance and growth substrates and to obtain the market certificate
Original document: З А Я В Л Е Н И Е. ЗА РЕГИСТРАЦИЯ НА ТОРОВЕ, ОДОБРИТЕЛИ НА ПОЧВАТА, БИОЛОГИЧНО АКТИВНИ ВЕЩЕСТВА И ХРАНИТЕЛНИ СУБСТРАТИ И ПОЛУЧАВАНЕ НА УДОСТОВЕРЕНИЕ ЗА ПУСКАНЕ НА ПАЗАРА И УПОТРЕБА
Document Reference: 22BGTFV00120200815Date of publication: 15 August 2020Number of pages: 14
This document contains the english translation, as well as the original form to be completed and submitted to the authorities.
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This document is the english translation of the information notice prepared by the Bulgarian authorities, entitled: Procedure for the registration of fertilisers, soil improvers, biologically active substances and growth substrates.
The information notice contains three annexes, which have been translated as well and which make it very clear what kind of data and information you have to submit. We have added also the original document for your reference (last annex)
Original title: ПРОЦЕДУРА ЗА РЕГИСТРАЦИЯ НА ТОРОВЕ, ПОДОБРИТЕЛИ НА ПОЧВАТА, БИОЛОГИЧНО АКТИВНИ ВЕЩЕСТВА И ХРАНИТЕЛНИ СУБСТРАТИ
Document Reference: 23BGTIV00120200815Date of publication: 15 August 2020Number pages: 34
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This document is the translation of the Bulgarian form that needs to be submitted in case there is a change to the existing registration and related certificate for a fertiliser, soil improver, biologically active substance (biostimulant) or growth substrate.
Title: APPLICATION FOR A CHANGE ACTIVE SUBSTANCE REGARDS TO THE REGISTRATION AND CERTIFICATE FOR A FERTILISER, SOIL IMPROVER, BIOLOGICALLY ACTIVE SUBSTANCE AND GROWTH SUBSTRATE UNDER ARTICLE 133(1) OF THE PLANT PROTECTION ACT
A link where the original document can be downloaded is provided, the original document is also attached to the translation. The translation should help you completing the original file.
Original title of the form: З А Я В Л Е Н И Е за промяна в обстоятелствата, свързани с регистрацията на торове, подобрители на почвата, биологично активни
вещества и хранителни субстрати и издадено Удостоверение по чл. 133, ал. 1 от Закона за защита на растенията
Document Reference: 25BGTFV00120200818Number of pages: 6Date of publication: 18 August 2020
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This document is the english translation of the Bulgarian explanation of the procedure concerning fertliser testing for effiacy (and safety). It explains what the applicant has to do and by when and what the related fees are. Title: PROCEDURE FOR THE BIOLOGICAL TESTING OF FERTILIZERS, SOIL IMPROVERS, BIOLOGICALLY ACTIVE SUBSTANCES AND GROWTH SUBSTRATES
Original title: ПРОЦЕДУРА ЗА БИОЛОГИЧНО ИЗПИТВАНЕ НА ТОРОВЕ, ПОДОБРИТЕЛИ НА ПОЧВАТА, БИОЛОГИЧНО АКТИВНИ ВЕЩЕСТВА И ХРАНИТЕЛНИ СУБСТРАТИ
Document Reference: 24BGTFV00120200817Number of pages: 12Date of publication: 19 August 2020
scientific regulatory affairs | regulatory support for biostimulants
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