Kit de Herramientas para el Registro de Plaguicidas

Use of existing classifications of the pesticide product [B1]

31/10/2023

The pesticide product under review may have been classified according to the GHS by regulators in other countries or regions. If the Registration Authority considers certain other regulators as a reference, it may decide to accept the GHS classification by that other regulator. No additional evaluation is then needed by the Registration Authority.

This approach can be relatively quick. However, a pesticide product is a formulation of the active ingredient and several co-formulants, each with their specific hazards. The pesticide product classified by the reference regulator therefore should be identical or equivalent to the product to be classified by the Registration Authority. The assessment process to be followed is summarized in the flow chart below.

 

Step 1. Find existing GHS classifications for the formulated pesticide product

In this particular context, the Regulatory Authority may consider a regulator in another country or regio as a reference if it considers the reference regulator to provide credible pesticide hazard classifications according to the GHS.

The Registration Authority can request the applicant to provide copies of approved labels of the same or an equivalent product from reference countries which apply the GHS. These are generally products that have been registered by the applicant in other countries.

Alternatively, the Registration Authority can consult international or national databases to find an identical or equivalent product. However, this may be difficult because most databases of GHS classifications apply to active ingredients and not to formulated products. It may however be possible to find the GHS classification of a pesticide product by checking the Approved Labels section in the Information Sources module of the Toolkit.

A third option is when an equivalent product is already registered in the country by another registrant; the Registration Authority can then possibly apply the GHS classification of that product also to the newly to be classified product.

 

Step 2. Assess if the pesticide product to be classified is identical or equivalent to the reference pesticide

Essential for this approach is that the reference product is either identical or equivalent to the pesticide product that has to be classified. Only then can the GHS classification of the reference product be copied to the new pesticide product. The following options may be evaluated:

2.1 The pesticide product is identical to a product which has already been classified in another reference country or region.

A product can be considered identical is it contains the same active ingredient(s), is the same formulation, comes from the same manufacturer and the same manufacturing facility. Different manufacturing facilities, even by the same manufacturer, may follow a (slightly) different production process and therefore may not lead to an identical product but an equivalent one.

2.2 The pesticide product is equivalent to an already registered product or to a product which has been classified in a reference country or region.

An equivalent pesticide product will have the same active ingredient, but it is generally produced by different manufacturer in a different manufacturing facility. A pesticide product which is considered equivalent to a reference product will have hazards that are not worse than of the reference product.

Equivalence determination is discussed elsewhere in the Toolkit. It is only possible if the Registration Authority has access to the detailed composition of both the to be classified pesticide product and of the reference product. This will be the case if the reference product has already been registered in the country. However, if the reference product has been registered in another country, the Registration Authority will generally not have access to its detailed composition since that is considered confidential business information and will not be shared by the regulator of the other country.

Alternatively, the Registration Authority can check whether the FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) has identified an equivalent pesticide product to the one to be classified.

 

Step 3. Apply the existing classification

3.1 If the pesticide product to be classified is either identical or equivalent to the reference product, the GHS classification of the reference product can be applied also to the to be classified product.

3.2 If this is not the case, the Registration Authority will need to follow the more complex approaches

 

Step 4. Identify labelling elements

On the basis of the GHS classification, the appropriate label elements can be identified; i.e. signal word, hazard symbol, hazard statement and relevant precautionary statements. These should then be included on the pesticide product label {INSERTLINK to labelling page – when it is elaborated}. More information about the GHS classification of different types of hazards is provided elsewhere.