News

Culture

Essential Pesticide Readings for Beginners (五)

1. Definition of registration

There is an official definition made by FAO in its “Guidelines on data requirements for the registration of pesticides 2013”: 

Pesticide registration: the process whereby the responsible national government or regional authority approves the sale and use of a pesticide following the evaluation of scientific data aimed at demonstrating that the product is effective for its intended purposes and does not pose an unacceptable risk to human or animal health or the environment under the conditions of use in the country or region.

2. Pesticide registration processes

The following diagram illustrates the pesticide registration processes conducted by APVMA, Australia.

 

1. Types of Registration

Basically pesticide registration can be classified into different types in different ways. Table 1 gives the registration types based on different classification ways.

Table 1  Pesticide registration types

Based on registration stage

Based on product existence

Based on registration

purpose

Experimental permit

Temporary registration

Full registration

New registration

Me-too registration

Special use registration

(e.g. research purpose)

Registration for Emergency use

Normal registrations

Mostly, we are applying me-too registrations throughout the world. That is to say we are applying registration of a product that is substantially equivalent to the existing (already registered) product (Technical product or finished product).

For me-too product registration, the data required can be reduced once the product is determined to be equivalent to the registered one.

Me-too registration policy is adopted by the competent authorities in most of the countries. Data requirements for me-too registration are going to be more and more popular throughout the world. The

Table 2  Typical Data (Materials) Requirements for Me-Too Registration of TC/Finished Product

Technical Dossier

(Me-too registration based on equivalence and not specified)

Supporting Documents

Legal documents

Samples

For TC:

1) 5-batch analysis: TC impurity profile;

2) analytical method;

3) 6-pack acute toxicity studies;

4) Ecotoxicity studies;

5) Even some chronic toxicology studies.

For formulated:

1)  6-pack acute toxicity studies;

2)  Analytical method for ai and  residues;

3)  COA, COC, …

1) ICAMA Certificate;

2) LOA (letter of Authorization);

3) Letter of Supply Guarantee;

4) Quality Guarantee;

5) Certificate of Origin;

………

1)  TC sample;

2)  Formulated sample;

3)  Analytical standards.

5. Procedures for Equivalence Determination in EU and Brazil

5.1  Evaluation of equivalence of technical materials (Tier I in EU)

For the evaluation of equivalence of different sources against the reference source, the following criteria should be considered in the Tier I approach.

The new source is deemed to be equivalent to the reference source if:

 • the certified minimum purity is not lower than that of the reference source (taking into account the ratio of isomers, where appropriate),

 • no new impurities are present

 • the limits of relevant impurities, as certified for the reference source, are not increased and

• the certified limits of all non-relevant impurities,  as certified for the reference source, are not exceeded by more than the following levels:

Certified limits of non-relevant impurities in the reference technical specificcations

Acceptable minimum increase

 6g/kg  

3g/kg

>6g/kg

50% of the certified limit

5.2  Evaluation of equivalence of technical materials (Tier II in EU)

(1) Toxicity Evaluation

The objective of the evaluation is to identify whether there is an unacceptable hazard increase for the new source as compared to the reference source as a result of:

• any new impurities or/and

• increased levels of relevant impurities or/and

• increased levels of non-relevant impurities which exceed the limits mentioned as above.

(2) Ecotoxicity evaluation

5.3  Tier Equivalence Determination in brazil

(1) Data requirements for Three-Tier Equivalence Determination in brazil  (Tier I in Brazil)

 

 

 

 

 

Physical-chemistry studies

GLP Study

Suggestion of Internationally Recognized Guidelines

Five Batch Analysis

OPPTS 830.1000, OPPTS 830.1700, OPPTS 830.1800

Vapour Pressure

OECD 104, OPPTS 830.7950, ASTM E 1194

Melting (solid) or Boling (liquid) point

OECD 102, OPPTS 830.7200, OECD 103, OPPTS 830.7220

Solubility (solid) or Miscibility (liquid)

OECD 105, OPPTS 830.6319, OPPTS 830.7860,

Partition Coefficient n-Octanol/Water

OECD 107, OECD 117, OPPTS 830.7560, OPPTS 830.7570

Physical Chemistry Certificate

ABNT NBR 8510

Validation of Analytical Methods for Active Ingredient

ABNT NBR 14029

2Data requirements for Three-Tier Equivalence Determination in brazil (Tier II)

Toxicological and Mutagenic studies

 GLP Study

Suggestion of Internationally Recognized Guidelines

Acute Oral Toxicity in Rat

OECD 423

Acute Inhalation Toxicity in Rat

OECD 403

Acute Dermal Toxicity in Rat

OECD 402

Acute Dermal Irritation/Corrosion

OECD 404

Acute Eye Irritation/Corrosion in Rabbit

OECD 405

Skin Sensitization

OECD 406

Bacteria Reverse Mutation Test (AMES Test)

OECD 471

Mammalian Erythrocyte Micronucleus Test

OECD 474

(3) Three-Tier Equivalence Determination in brazil (Tier III)

If the Equivalence of the Technical-grade Product is not granted in the Phase II either, then the following additional studies may be required for the evaluation on the Phase III: 

Toxicological studies with repeated doses (from sub-acute to chronic) and toxicological studies for evaluating the teratogenicity, carcinogenicity, neurotoxicity and hormonal effects;

Ecotoxicological studies with toxicity to aquatic and terrestrial organisms (fish, daphnia, algae, birds, bees, microorganisms or soil organisms), according to the intended usage of the product.

5.4  Equivalence of formulated products

Basically the equivalence of formulated products depends on the equivalence of the technical materials used in the formulations and the similarity of the co-formulants. Equivalent (registered or recognized) technical materials and closely similar co-formulants is the basis forming equivalent formulations. In most countries the equivalence of formulated products is not clearly defined. However, the APVMA of Australia has clearly set up its criteria for me-too formulated products(Category 7). The criteria are presented as below:

(1) the active constituents must be the same concentration;

(2) the non-active constituents must be the same or equivalent substances at the same or equivalent concentrations;

(3) minor differences may be acceptable if they are not expected to have adverse implications for product quality or biological activity such as efficacy, safety or residues;

(4) the formulation type must be the same;

(5) the label must have the same crops/situations and pests (ie no additional uses) and must include similar use and precautionary/safety instructions; however, there may be fewer or reduced claims compared to the reference product.

Products met the above criteria are considered to be equivalent or identical to the registered reference products (nominated by the applicants).