Kit de Herramientas para el Registro de Plaguicidas

Use of existing classifications of the active ingredient and co-formulants [B2]

31/10/2023

While GHS classifications of specific pesticide products may be difficult to find, several national and regional regulators publish GHS hazard classifications of pesticide active ingredients and major co-formulants. The Registration Authority can decide to use such existing classifications defined by other regulators. There will be no need for the Registration Authority to evaluate most of the physical and (eco-)toxicological data of the active ingredient(s) and relevant co-formulants. Instead, they can make use of the evaluations and the resulting classifications already conducted by reference regulators.

However, since only active ingredients and co-formulants may have been classified by the other regulator, the Registration Authority still needs to classify the formulated pesticide product. This generally requires taking into account the concentrations and classifications of the various individual constituents of the pesticide product. This hybrid approach makes optimal use of existing classifications and as such reduces the work load for the Regulatory Authority. However, in some cases, hazard classifications of certain active ingredients or co-formulants may not have been published by other regulators. In such a case, they have to be classified by the Registration Authority according to approach iii. The assessment process to be followed is summarized in the flow chart below.

 

Step 1. List all the constituents of the pesticide product

1.1 List all the constituents of the pesticide product, i.e. active ingredient(s) and co-formulants, as well as their concentrations. In principle, all co-formulants are relevant – and therefore need to be classified – if their concentration exceeds the cut-off values/concentration limit for each specific hazard.

Step 2. Find existing GHS hazard classifications of the active ingredient(s) and relevant co-formulants in the pesticide product

2.1 Find existing hazard classifications for each of the relevant constituents of the pesticide product. These can be found in the Hazard Classifications section of in the Information Sources module of the Toolkit.

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.

2.2 In addition, it is necessary that the Registration Authority also checks whether relevant data in the actual dossier indicate higher concerns than reported elsewhere.

Step 3. Determine the hazard classifications of unavailable constituents of the pesticide product

3.1 Any constituents of the pesticide product for which no existing hazard classification from a reference regulator can be found, need to be classified by the Registration Authority itself. The methods for hazard classification of a chemical follow approach: Classification by the Registration Authority on the basis of physico-chemical and (eco-)toxicological data

3.2 Two hazards – acute toxicity and hazardous to the aquatic environment – always need to be classified by the Registration Authority. This is because the classification directly depends on the concentration of the chemical in the pesticide product. The methods for classification of acute toxicity and hazardous to the aquatic environment have been summarized elsewhere.

Step 4. Classify the pesticide product

Each of the hazards of the pesticide product is then classified. If the product does not meet any of the criteria for a specific hazard, no classification of that hazard is necessary. The classification of the product (the mixture) will depend on the classification of all individual constituents (the active ingredient and the co-formulants) as well as their concentrations in the product. Often, but not always, the product will be classified according to the most hazardous component in the product. More information about the GHS classification of different types of hazards is provided elsewhere.

 Step 5. 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}.

Many pesticide products will present more than one GHS hazard. In principle, all hazards need to be reflected on the label. However, to avoid confusion, in some cases rules are described in the GHS which symbols and signal words have precedence on the pesticide label (section 1.4.10.5.3 of the GHS). For instance, a pesticide product which is classified as fatal if swallowed AND harmful in contact with skin, will reflect the first (most serious) hazard on the label (= signal word Danger and pictogram of skull and crossbones).