Draft guidelines/notifications on Biostimulant issued by DAC&FW
Oct. 2019

Amendment in the Fertiliser ( Control) Order,1985 for inclusion of Bio-Stimulant

(1). In clause 2(h) the term fertiliser is defined. The term Biostimulant is required to be included. The revised definition is as under:

Existing Definition of “Fertiliser” means any essential substance, either in straight or mixed form and derived from either inorganic, organic or mixed sources, that is used or intended to be used to provide essential plant nutrients or beneficial elements or both for the soil or for the crop or makes essential plant nutrients available to the plants either directly or by biological process or by both in the soil or plant as notified from time to time by Central Government and specified in the schedules appended to this order or as may be notified by the State Governments*. Explanation: For the purpose of Fertiliser:

(i)m “the essential plant nutrients” include Primary Nutrients (Nitrogen, Phosphorous and Potassium), Secondary Nutrients (Calcium, Magnesium and Sulphur) and Micro Nutrients (Zinc, Manganese, Copper, Iron, Boron and Molybdenum);

(ii) “Beneficial element” means any element as notified by Central Government from time to time.’:

Amendment * In the existing definition the word [Or such substances which enhances a crops physiological processes] shall be inserted.

(2). Insertion of new provision “ (ab) Bio stimulant Definition:

(1) Bio stimulants means compounds, substances and products including microorganisms whose functions when applied to plants/seeds/ rhizosphere is to regulate and enhance a crops physiological processes independent of the products nutrient contents to improve input use efficiency, growth, yield, quality and/or stress tolerance. The bio stimulants may include products of plants /animals or microbial origin*.

*The primary function of the products should be other than that for pesticidal use and Nutrient source. Heavy metal and other contaminants if any, may be within the prescribed limits given under clause 20 C.

(3). New provision 20 C may be included “20 (C) specification in respect of Biostimulants

(i) Not withstanding anything contained in this Order, the central Government shall specify the name, active ingredient(s), name of the crop and name of manufacturer / importer and method of analysis for determination of various components, claim benefit(s) of the Bio-Stimulant in Schedule VI of the FCO.;

(ii) Bio- stimulants notified under sub-clause (i) shall be under any of the following category namely,-

1. Botanical extracts, including seaweed extracts 2. Bio -chemicals
3. Protein hydrolysates and amino acids
4. Vitamins

5. Cell free Microbials products
6. Antioxidants
7. Anti-transpirants
8. Humic & fulvic acid and their derivations”

(iii) No person shall manufacture /import any Biostimulant unless it is notified under the above said clause and conform to the standard set out in the said notification and it contains no traces of Insecticide.

(iv) Every Person desiring to manufacture/import any Biostimulant shall apply to the Controller fertiliser in Form R for its notification and such manufacturer shall submit along with application the following data/details relating to product:-

(a) Chemistry:

1. Source (natural extracts of plant/microbe/animal / synthetic)
2. Chemical composition (chemical analysis from GLP/NABL accredited lab) 3. Physical & Chemical properties of active ingredients and adjuvants, if any. 4. Method of analysis conforming to the specifications.
5. Shelf-life claim.

(b) Bio- efficacy trials:

Agronomic Bio-efficiency trials be conducted at National Agriculture Research System ( SAU and ICAR) at 3 different doses for minimum one season from 3 locations.

(c) Toxicity: Name of the Institute need to be indicated from where the manufacturer of Biostimulant should obtain certificate in respect of this

1. Acute oral
2. Acute dermal
3. Acute Inhalation
4. Primary skin Irritation 5. Eye irritation
6. Toxicity to bird
7. Toxicity to Fish
8. Toxicity to honeybee

9. Toxicity to earthworm
(Test report from CIBRC approved laboratories for toxicity test should only be accepted)

(d) Heavy metal limit prescribed

(e) The sample of the product along with an Affidavit by the manufacturer/importer on non- judicial stamp paper stating that the product is not laced with pesticide (> 0.01ppm).

(v)The Heavy metals of the product present in the product shall not exceed the following maximum limit prescribed for various metals, namely

Cadmium ( as Cd) Chromium (VI) (as Cr) Copper (as Cu)
Zinc (as Zn)

Lead (as Pb) Arsenic (as As2O3)

In mg/kg maximum 5.00

50.00 300.00 1000.00 100.00 10.0

(vi) No Biostimulant shall contain any pesticides beyond a permissible limit of 0.01ppm.”

(4). Label and leaflet requirements- new provision may be included in FCO “(4) In Clause 21 the following sub clause shall be inserted, namely,-

(ab) Every container in which any Biostimulant is packed shall conspicuously superscribed with Word Bio-Stimulant and shall bear only such particulars and unless

otherwise required under any law nothing else , as may from time to time be specified by the Controller in this behalf.”

Under the above said clause Notification:-

The Controller under above said notification notify for following particulars for printing of particulars on the bags of Bio-Stimulant. If it is in small pack then a separate leaf let shall be placed in the bag

1. Name of the manufacturer/importer 2. Name of the marketer, if any

3. Name of the bio-stimulant (brand name or trade mark under which the bio-stimulant is sold) and its active ingredient(s) and its percentage content

4. Use recommendations(dosage, crops,label expansion as applicable) 5. Precautions/storage conditions
6. Net content
7. Batch number and date of manufacturing/repacking

8. Expiry date
9. The label shall be so affixed to the containers that it cannot be ordinarily removed.

10. The label to be affixed or attached to the package shall be printed in English/ Hindi/regional language.

11. Maximum Retail Price of the product.

12. Label claim of the product

(5). New provision :- Under clause 38, a separate CFC for Biostimulant with following members shall be constituted under the chairmanship of Agriculture Commissioner with following other members :

(1) DG Health Services, (2) ADG(NRM) , ICAR,

(3) Head Plant Physiology, IARI,
(4) Head Chemical Division, IARI,
(5) Deputy Secretary / Director (INM)- Member Secretary.

Schedule VI A Specification of Bio Stimulant

Schedule VI B Tolerance limit

1. General Requirements of Sampling

1.0 In drawing preparing and handling the samples, the following precautions and directions shall be observed.

1.1 Sampling shall be carried out by a trained and experienced person as it is essential that the sample should be representative of the lot to be examined.

1.2 Samples in their original unopened packets should be drawn and sent to the laboratory to prevent possible contamination of sample during handling and to help in revealing the true condition of the material.

1.3 Intact packets shall be drawn from a protected place not exposed to dampness, air, light, dust or soot.

2. Scale of Sampling

2.1 Lot
All units (containers in a single consignment of type of material belonging to the same batch of manufacture) shall constitute a lot. If a consignment consists of different batches of the manufacture, the containers of the same batch shall be separated and shall constitute a separate lot.

2.2 Batch:- All biostimulants prepared in a same process constitute a batch.

2.3 For ascertaining conformity of the material to the requirements of the specification, samples shall be tested from each lot separately.

2.4 The number of packets to be selected from a lot shall depend on the size of the lot and these packets shall be selected at random.

3. Drawal of Samples

3.1 The Inspector shall take three packets as sample from the same batch. Each sample constitutes a test sample.

3.2 These samples should be sealed in cloth bags and be sealed with the
Inspector’s seal after putting inside Form P. Identifiable details such as sample number, code number or any other details which enable its identification shall be marked on the cloth bags.

3.3 Out of the three samples collected, one sample so sealed shall be sent to incharge of the laboratory notified by the State Government under the clause 29 or the Central Government labs. Another sample shall be given to the manufacturer or importer or dealer as the case may be. The third sample shall be sent by the Inspector to his next higher authority for keeping in safe custody. Any of the latter two samples shall be sent for referee analysis under sub-clause (2) of clause 29B.

3.4. The number of samples to be drawn from the lot

 

Lot / Batch Number of Samples
Upto 5,000 packets 03
5,001 – 10,000 packets 04
More than 10,000 packets 05

BASAI Proposed Suggestive Amends
On
Draft Guidelines for Biostimulants
(Amendment in the Fertiliser (Control) Order,1985 for inclusion of Bio- Stimulant)

BASAI General Comments:

  1. To safeguard present the present marketing of biostimulants, it is proposed that a provisional marketing approval for 2 years may be granted. This will help avoid disruption of availability of such products in the market. Subject, to the fact that apply within 3-6 months with all presently available information, including data. This will be the basis of granting a provisional marketing approval. Refer S.No. 2 (3) (iii) for further details.
  2. Since, the products may not be listed under ECA as there is no subsidy on the same, unlike as in the case of fertilizers.
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We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

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  • Our professionals know how to handle a wide range of car services
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We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

  • We make auto repair and maintenance more convenient for you
  • We are a friendly, helpful and professional group of people
  • Our professionals know how to handle a wide range of car services
  • We get the job done right — the first time
  • Same day service for most repairs and maintenance
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