Fertiliser
(Inorganic, Organic Or Mixed) (Control) Amendment Order, 2021
[23 February 2021]
In
exercise of the powers conferred by section 3 of the Essential Commodities Act,
1955 (10 of 1955), the Central Government hereby makes the following Order
further to amend the Fertiliser (Inorganic, Organic or Mixed) (Control) Order,
1985, namely.
Order - 1.
(1)
This Order may be
called the Fertiliser (Inorganic, Organic or Mixed) (Control) Amendment Order,
2021.
(2)
It shall come
into force on the date of its publication in the Official Gazette.
Order - 2.
In the
Fertiliser (Inorganic, Organic or Mixed) (Control) Order, 1985 (hereinafter
referred to as the said Order), in clause 2,-
(i)
after sub-clause
(aa), the following sub-clause shall be inserted, namely
(ab) "biostimulant" means a substance or
microorganism or a combination of both whose primary function when applied to
plants, seeds or rhizosphere is to stimulate physiological processes in plants
and to enhance its nutrient uptake, growth, yield, nutrition efficiency, crop
quality and tolerance to stress, regardless of its nutrient content, but does
not include pesticides or plant growth regulators which are regulated under the
Insecticide Act, 1968 (46 of 1968);
(ii)
in sub-clause
(h), after the words "State Governments", the words "and
includes a biostimulant" shall be inserted;
(iii)
in sub-clause
(q), after item (vii), the following item shall be inserted, namely
"(viii) in relation to a biostimulant included in
column (2) of Part-A of Schedule VI, the standard set out in the corresponding
entry in column (3), subject to the limits of permissible variations as specified
in Part-B of the said Schedule;"
Order - 3.
In the
said order, after clause 20B, the following clause shall be inserted, namely
"20C. Specifications in respect of
biostimulants.-
(1)
Notwithstanding
anything contained in this Order, the specifications of biostimulants,
including its name, active ingredients or where it is not possible to indicate
its active ingredients, then its chemical composition, name of the crop to
which it may be applied, its benefits and the method of analysis for
determination of its active ingredients or chemical composition shall be
specified by the Central Government in Schedule VI.
(2)
The biostimulants
specified in Schedule VI shall be classified under any of the following
categories, namely
(a)
botanical
extracts, including seaweed extracts;
(b)
bio-chemicals;
(c)
protein
hydrolysates and amino acids;
(d)
vitamins;
(e)
cell free
microbial products;
(f)
antioxidants;
(g)
anti-transpirants;
(h)
humic and fulvic
acid and their derivatives.
(3)
Notwithstanding
anything contained in this order, every manufacturer or importer of a
biostimulant shall make an application to the Controller in Form G along with
the following data relating to such product for specifying it as a biostimulant
in Schedule VI, namely;-
A.
Chemistry:
1.
Source (natural
extracts of plant/microbe/animal / synthetic)
2.
Product
Specification (with analysis from Good Laboratory Practice(GLP) or National
Accreditation Board for Testing and Calibration Laboratory (NABL) accredited
laboratory, Physical and Chemical properties of active ingredients and
adjuvants, if any.
3.
Method of
analysis conforming to the specifications.
4.
Shelf-life;
B.
Bio-efficacy
Trials:
1.
Agronomic
Bio-efficiency trials shall be conducted at National Agricultural Research
System, including Indian Council of Agricultural Research, State Agricultural
Universities.
2.
Bio-efficacy
trials shall be conducted at minimum three different doses for one season at
three agroecological locations;
C.
Toxicity: Name of
the Institute (where the manufacturer of biostimulant obtained the certificate)
The
test report along with recommendation of following five basic acute toxicity
tests (i) to (v) and four Eco toxicity tests (vi) to (ix) of GLP accredited laboratory
shall be submitted along with the application, namely
(i)
Acute oral (Rat)
(ii)
Acute dermal
(Rat)
(iii)
Acute Inhalation
(Rat)
(iv)
Primary skin
Irritation (Rabbit)
(v)
Eye irritation
(Rabbit)
(vi)
Toxicity to bird
(vii)
Toxicity to Fish
(Freshwater)
(viii)
Toxicity to
honeybee
(ix)
Toxicity to
earthworm
Note
Long-term chronic studies as in case of pesticides are not needed to be
conducted;
D.
Heavy metal
analysis report;
E.
The sample of the
product along with an Affidavit by the manufacturer or importer on nonjudicial
stamp paper of rupees ten stating that the product is not laced with pesticide
beyond permissible limit of 0.01ppm
Provided
that in case of a biostimulant having natural origin or other, the requirement
of necessary data shall be as decided by the Central Biostimulants Committee as
per the guidelines formulated by it in this regard:
Provided
further that every manufacturer or importer of a biostimulant shall,
notwithstanding that such biostimulant has been specified in Schedule VI, be
required to make an application under this sub-clause.
(4)
Notwithstanding
anything contained in this order, any person manufacturing a biostimulant as on
the date of publication of this order for which no standards have been
specified, may, subject to making an application for grant of provisional
registration under sub-clause (5), continue to manufacture for sale, sell,
offer for sale, stock or exhibit such biostimulant for a period of two years
from the date of publication of this order.
(5)
The manufacturer
referred to in sub-clause (4) shall, within a period of six months from the
date of publication of this order, submit an application to the Controller for
grant of provisional registration in Form G-1 along with-
(a)
details of the
product, its specifications, label and such other particulars as may be
required;
(b)
a certificate
issued by the State Government in Form G-2 to the effect that-
(i)
the product is
available in the market prior to the publication of the said order; and
(ii)
no incident has
come to its notice about harmful effect of the product.
(6)
On receipt of an
application under sub-clause (5) for provisional registration, the Controller
shall, by an order in writing, grant a provisional certificate of registration
of biostimulant in Form G-3.
(7)
No person shall
manufacture or import any biostimulant unless such biostimulant is included in
schedule VI.
(8)
The Controller
shall, by notification in the Official Gazette, publish the name of the
manufacturer or importer of the biostimulant included in Schedule VI.
(9)
No biostimulant
shall contain heavy metals content over and above the following maximum limit
prescribed for various metals, namely,-
|
In mg/kg
(maximum)
|
|
Cadmium (as
Cd)
|
50.00
|
|
Chromium (VI)
(as Cr)
|
50.00
|
|
Copper (as
Cu)
|
300.00
|
|
Zinc (as Zn)
|
1000.00
|
|
Lead (as Pb)
|
100.00
|
|
Arsenic (as
As2O3)
|
10.0.
|
(10)
No biostimulant shall contain any pesticide beyond the
permissible limit of 0.01ppm.
Order - 4.
In
the said Order, in clause 21, -
(i)
in
the opening portion, for the words "fertiliser or non-edible de-oiled cake
fertiliser", the words "fertiliser, non-edible de-oiled cake
fertiliser or biostimulant" shall be substituted;
(ii)
after
item (c), the following item shall be inserted, namely (d) every container in
which any biostimulant is packed shall be conspicuously superscribed with the
word "Biostimulant" and shall bear only such particulars as the
Central Government may, by notification in the Official Gazette, specify in
this behalf, unless any other particulars are required under any other law for
the time being in force.
Order - 5.
In
the said Order, in clause 28, in sub-clause (1), after item (bc), the following
item shall be inserted, namely
"(bd) draw samples of any
biostimulants in accordance with the procedure of drawal of samples laid down
inSchedule VI;
Provided
that the Inspector shall prepare the sampling details in duplicate in Form-J
and handover one copy of the same to the dealer or his representative from whom
the sample has been drawn;".
Order - 6.
In
the said order, in clause 29, after sub-clause (1B), the following sub-clause shall
be inserted, namely
"(1C) A biostimulant sample
drawn by an inspector shall be analysed in accordance with the procedure
contained in Part C of Schedule VI in the Central Fertiliser Quality Control
and Training Institute, Faridabad or its regional laboratories or in any other
laboratory notified for this purpose by the State Government with prior
approval of Central Government.".
Order - 7.
In
the said order, after clause 38, the following clause shall be inserted, namely
"38A. Central Biostimulant Committee.-
(1)
The
Central Government may, by notification in the Official Gazette, constitute a
Committee to be called Central Biostimulant Committee with the Agriculture
Commissioner as its Chairperson and seven other members, subject to such terms
and conditions, as may be specified therein.
(2)
The
Central Biostimulant Committee shall advise the Central Government on the
following issues, namely.
(i)
inclusion
of a new biostimulant;
(ii)
specifications
of various biostimulants;
(iii)
methods
of drawing of samples and its analysis;
(iv)
minimum
requirements of laboratory;
(v)
method
of testing of biostimulants;
(vi)
any
other matter referred to the Committee by the Central Government.
(3)
The
Committee may, subject to the previous approval of the Central Government, make
bye-laws fixing the quorum and regulating its own procedure and the conduct of
all business to be transacted by it.
(4)
The
committee may co-opt such number of experts and for such purposes or periods as
it may deem fit, but any expert so co-opted shall not have the right to vote.
(5)
The
committee may appoint one or more sub-committees, consisting wholly of its
members or partly of its members and co-opted members, as it thinks fit, for
the purpose of discharging such for its functions as may be delegated to such
sub-committee.
(6)
The
Central Biostimulants Committee shall frame guidelines laying down the
requirements of toxicology testing and other related tests.
Order - 8.
In
the said Order, after Schedule V, the following Schedules shall be inserted,
namely.
"Schedule VI
[See clause 2(ab) and (q) and clause
20C]
Part-A
SPECIFICATIONS OF BIOSTIMULANTS
|
Sl.
No
|
Biostimulants
|
Standard
|
|
(1)
|
(2)
|
(3)
|
|
|
|
|
Part-B
TOLERANCE LIMIT
|
Sl.
No
|
Biostimulants
|
Tolerance
limit
|
|
(1)
|
(2)
|
(3)
|
|
|
|
|
Part-C
PROCEDURE FOR DRAWAL OF SAMPLES OF
BIOSTIMULANTS
1.
General
Requirements of Sampling
1.0 In drawing, preparing and
handling of 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
simultaneously in the 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 samples from the same batch. Each sample constitutes a test sample.
3.2 Each sample shall be sealed in a
cloth bag and be sealed with the Inspectors seal. The sealed cloth bag
containing the sample and Form-P shall be kept in another cloth bag which shall
also be sealed with the Inspectors seal. Identifiable details such as sample
number, code number or any other details shall be put on the cloth bag
containing sample and Form-P which enable its identification.
3.3 Out of the three samples
collected, one sample so sealed shall be sent to in-charge of the laboratory
notified by the State Government under the sub-clause (1C) of clause 29 or any
laboratory notified by the Central Government. 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 reference 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
|
3
|
|
5,001-10,000
packets
|
4
|
|
More than
10,000 packets
|
5
|
Part-D
METHODOLOGY OF TESTING."
Order - 9.
In
the said Order, in Forms and Registration,-
(i)
in
Form-J, for the words "[See clause 28(1) (b) and 28 (1) (bb)], the words
"[See clause 28(1)(b),28(1)(ba), 28(1) (bb), 28(1)(bc) and 28(1)(bd)]
shall be substituted.
(ii)
after
Form-F, the following Forms shall be inserted, namely.
FORM- G
[See clause 20C(3)]
APPLICATION FOR INCLUSION OF
BIOSTIMULANTS IN SCHEDULE VI
To,
The
Controller of Fertiliser
-------------------------
------------------------
(i)
Name
of manufacturer along with address of unit where it is located:
(ii)
Address
of the Registered office of the company:
(iii)
Location
and full address of storage / godown(s):
(iv)
Name
and address of the applicant along with his designation, contact number and
email ID:
(v)
PAN
and Adhaar number of the authorized person:
(vi)
Name
of biostimulant (indicate the category of biostimulant as specified in
sub-clause (2) of clause 20C):
(vii)
Brand
Name:
(viii)
In
case of importer, following additional information shall be provided:
(a)
country
of origin:
(b)
is
biostimulant registered under country of origin (provide the copy):
(c)
(d)
whether
the agronomic efficacy trials and toxicity trials are conducted in the country
of origin:
(ix)
Technical
details of product:
(x)
Labels
and leaflet details:
(xi)
Quantity
manufactured and sold during last three years (attach sale document):
Verification
I
do hereby solemnly verify that to the best of my knowledge and belief the
statement given above is correct and complete.
I
clearly understand that the certificate of registration is liable to be
canceled if any information or data, submitted with application is found
incorrect or false at any stage.
Signature
of the applicant
FORM- G-1
[See clause 20C(5)]
APPLICATION FOR PROVISIONAL
REGISTRATION OF BIOSTIMULANTS
To,
The
Controller of Fertiliser
-------------------------
------------------------
(i)
Name
of manufacturer along with address of unit where it is located:
(ii)
Address
of the Registered office of the company:
(iii)
Location
and full address of storage / godown(s):
(iv)
Name
and address of the applicant along with his designation, contact number and
email ID:
(v)
PAN
and Adhaar number of the authorized person:
(vi)
Name
of biostimulant (indicate the category of biostimulant as specified in
sub-clause (2) of clause 20C):
(vii)
Brand
Name:
(viii)
In
case of importer, following additional information shall be provided:
(a)
country
of origin:
(b)
is
biostimulant registered under country of origin (provide the copy):
(c)
whether
the agronomic efficacy trials and toxicity trials are conducted in the country
of origin:
(ix)
Technical
details of product:
(x)
Labels
and leaflet details:
(xi)
Quantity
manufactured and sold during last three years (attach sale document):
(xii)
Date
and year when introduced in market:
(xiii)
State(s)
in which product is sold:
Verification
I
do hereby solemnly verify that to the best of my knowledge and belief the
statement given above is correct and complete.
I
clearly understand that the certificate of registration is liable to be
canceled if any information or data, submitted with application is found
incorrect or false at any stage.
Signature
of the applicant
FORM- G-2
[See clause 20C(5)(b)]
(To be issued by the State
Government(s))
This
is to certify that M/s is selling biostimulant (Name) brand name prior to the
(date of publication of notification) and during last three years, ----- metric
ton/ litre of biostimulant were sold in the state.
This
is further certified that no complaint has so far been reported of ill effects
or hazardous effects of the said biostimulant on humans as well as on animals
or environment.
Director
of Agriculture
FORM G-3
[See clause 20C(6)]
(To be issued by Controller)
Certificate
of Provisional Registration
M/s......
(name) and (address) is hereby given the Certificate of Provisional
Registration to manufacture the biostimulant (Name) under sub-clause (6) of
clause 20C of the Fertiliser (Inorganic, Organic or Mixed) (Control)
Order,
1985, details of which are as under
1.
Name
of the bio-stimulant:
2.
Brand
Name of the bio-stimulant:
3.
Location
of manufacturing unit:
4.
Place
of storage:
5.
Certificate
Registration Number:
Book
No. and Page No.
The
provisional registration shall be valid upto......day of August, 2022.
The
provisional registration shall be subject to the following terms and conditions
1.
The
holder shall manufacture only the biostimulant for which the registration is
provided.
2.
The
heavy metal content and Pesticide content shall not exceed the limit prescribed
under the Order.
3.
The
holder shall comply with the provisions of the said Order and notification
issued thereunder.
4.
For
selling of biostimulant, the authorization letter shall be obtained from the
Notified Authority of the concerned State Government.
5.
Any
information provided in Form G-1 if found incorrect, or on violation of any
terms and conditions, the Controller of Fertiliser shall cancel the provisional
registration.