Pesticide Registration Toolkit

Classification of Environmental Hazards [D3]

Principles of classification 

The procedures for classification and labelling of a pesticide product (a mixture) can be seen as a two-step process where the first step consists of the hazard classification and the second of the preparation of the label.

Hazard classification considers only the intrinsic properties of active ingredients or pesticide products.

It incorporates the following main activities:

  • Identification of relevant data regarding the hazards of an active ingredient or pesticide product.
  • Subsequent review of those data to ascertain the hazards associated with the active ingredient or pesticide product.
  • A decision on whether the active ingredient or product will be classified as a hazardous substance or mixture and the degree of hazard, where appropriate, by comparison of the data with agreed hazard classification criteria.

Generally, the data required in the registration process of pesticides is globally recommended and should consequently be available also for classification of these products. The classification procedure for pesticides can therefore be more straightforward than for chemicals in general. The guidance for classification of environmental hazards in this document is assuming that the major part of the relevant data is available for the pesticide product that is being evaluated.

The GHS contains the following two environmental hazard classes:

1. Hazardous to the aquatic environment

Acute aquatic toxicity means the intrinsic property of a substance to be injurious to an organism in a short-term aquatic exposure to that substance.

Chronic aquatic toxicity means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism.

The acute and the chronic classification categories are applied independently.

2. Hazardous to the ozone layer

Chemicals that are hazardous to the ozone layer are those included and regulated under the Montreal Protocol on Substances that Deplete the Ozone Layer.

The Montreal Protocol is structured around several groups of halogenated hydrocarbons that deplete stratospheric ozone. All the ozone depleting substances controlled by the Montreal Protocol contain either chlorine or bromine (substances containing only fluorine do not harm the ozone layer).

Currently the only pesticide in the Montreal Protocol is methyl bromide which is listed in Annex E.

Hazard categories

Each hazard class is differentiated in hazard categories, with the lower number representing a higher, more serious, hazard. For instance, an acute hazard Category 1 poses a more serious aquatic hazard than an acute hazard Category 3).

Hazard class

Hazard category

← more serious

less serious →

Hazardous to the aquatic environment

 

 

 

 

Short-term (acute) aquatic hazard

1

2

3

 

Long-term (chronic) aquatic hazard

 

 

 

 

Adequate chronic toxicity data – non-rapidly degradable substances

1

2

 

 

Adequate chronic toxicity data – rapidly degradable substances

1

2

3

 

Substances without adequate chronic toxicity data

1

2

3

 

Poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and have a log Kow ≥ 4, indicating a potential to bioaccumulate

 

4

Hazardous to the ozone layer

1

 

 

 

 

Labelling elements

Annex A1 of the GHS contains classification and labelling tables where pictograms, signal words and hazard statements can be found for all hazard classes and hazard categories. A summary table for environmental hazards is provided below:

 

Hazard class

Hazard category

Pictogram

Signal word

Hazard statement

Hazardous to the aquatic environment, short-term (acute)

Acute 1

Warning

Very toxic to aquatic life

Acute 2

No pictogram

No signal word

Toxic to aquatic life

Acute 3

No pictogram

No signal word

Harmful to aquatic life

Hazardous to the aquatic environment, long-term (chronic)

Chronic 1

Warning

Very toxic to aquatic life with long lasting effects

Chronic 2

No signal word

Toxic to aquatic life with long lasting effects

Chronic 3

No pictogram

No signal word

Harmful to aquatic life with long lasting effects

Chronic 4

No pictogram

No signal word

May cause long lasting harmful effects to aquatic life

Hazardous to the ozone layer

1

Warning

Harms public health and the environment by destroying ozone in the upper atmosphere

Data required for environmental classification

Comprehensive data is generally required for pesticides when applications are submitted to authorities for registration. Such data is therefore provided in the submitted dossiers and can be used for classification purposes. Relevant data may also be available on-line in many countries and regions (see the Scientific Reviews or Pesticide Properties in the Information sources module in the Toolkit.

The following data generally need to be available to classify GHS environmental hazards. If data have been generated with the pesticide product, these have preference. Alternatively, toxicity data for the active ingredient, as well as relevant other components of the pesticide product, should be assessed.

Detailed information about the data required for environmental classification can be found in the “data requirement and test guidelines” module of the Toolkit, by clicking on the links in the table below, as well as in Annex 9 of the GHS.

 

Hazard class

Relevant studies as a basis for classification of a pesticide

Hazardous to the aquatic environment

Degradation and potential for bioaccumulation

Route and rate of degradation in soil

Aerobic soil metabolism

Anaerobic soil metabolism

Degradation and reaction products at pH 4, 7 and 9 under sterile conditions

Direct photo transformation of relevant metabolites, degradation and reaction products in water with artificial light under sterile conditions

Degradation in aquatic systems

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Partition coefficient, log Kow

Bioconcentration factor (BCF)

Short term (acute) aquatic hazard1

Freshwater fish toxicity

Acute toxicity crustacea

Fish early-life cycle or equivalent

Algal toxicity  

Aquatic plant toxicity test (Lemna spp)

Long- term (chronic) aquatic hazard2

Fish early life cycle

Aquatic invertebrate life cycle

Hazardous to the ozone layer

No specific studies required. Listing in the Montreal Protocol indicates this hazard

1 These species are considered as surrogate for all aquatic organisms and data on other species such as Lemna may also be considered if the test methodology is suitable.
The algal growth inhibition test is a chronic test but the EC50 is treated as an acute value for classification purposes. This EC50 should normally be based on growth rate inhibition. If only the EC50 based on reduction in biomass is available, or it is not indicated which EC50 is reported, this value may be used in the same way.

2 Chronic toxicity data are less available than acute data and the range of testing procedures less standardized. The NOECs or other equivalent ECx should be used.

 

Assigning hazard categories

The GHS describes in detail how hazard categories should be assigned for each environmental hazard class. A summary of these methods can be found by clicking on the entries below. More detail is provided in the GHS document.

 

Procedures for classification

The Registration Authority can use different approaches to classify the product or verify a proposed classification. Which of these approaches can be applied, depends on the exact pesticide product to be classified and on the human resources available at the Registration Authority.

These different approaches are described in more detail here {INSERTLINK to page A}