Pesticide Registration Toolkit

HHP Criteria 2, 3 & 4

Definition and reference

Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity, mutagenicity & reproductive toxicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (10th revised edition 2023)

(​Part 3, Health Hazards)

Criteria 2 Carcinogenicity

  • Category 1A = Substances known to have carcinogenic potential for humans; the placing of a substance is largely based on human evidence
  • Category 1B = Substances presumed to have carcinogenic potential for humans; the placing of a substance is largely based on animal evidence


Criteria 3 Germ cell mutagenicity

  • Category 1A = Substances known to induce heritable mutations in germ cells of humans
  • Category 1B = Substances which should be regarded as if they induce heritable mutations in the germ cells of humans


Criteria 4 Reproductive toxicity

  • Category 1A = Known human reproductive toxicant
  • Category 1B = Presumed human reproductive toxicant


Identification procedure

For the CMR criteria, pesticide formulations are classified based on their active ingredient(s), irrespective of its concentration.

However, very diluted formulations, with A.I. concentrations < 0.1%, do not need to be classified for CMR. This is rarely the case for pesticides, but may occur for certain rodenticide formulations or aerosols.

Pesticide active ingredients are not individually classified by the GHS; it only provides the classification criteria. To assess whether a pesticide is a category 1A or 1B for CMR, regulators will need to classify the product themselves.

A single authoritative international database GHS classifications of pesticides does not exist. However, certain intergovernmental or national databases can be used to check the CMR classification of a pesticide. Which source to use is the choice of the regulator.

Data sources

Classification of CMR according to the GHS

  • Pesticide registration dossier → Classification of the formulated product
  • WHO/ILO International Chemical Safety Cards → Classification of a.i.’s. However, not all pesticides have yet been classified by WHO/ILO according to the GHS; sometimes, older classifications are only available. Also, the ICSC provide the hazard statements for the different hazards and not the actual classification. Regulators need to cross-check the hazard statement against the actual hazard class using the GHS Classification document.
  • EU Pesticides database → Classification of pesticide a.i.’s that have been registered in the European Union
  • European Chemicals Agency (ECHA) – C&L Inventory → Classification of a.i.’s of pesticides (and some products)  (both registered and not registered in the EU)

Classifications of CMR using other systems than the GHS

  • IARC Monographs → Carcinogenicity classification (only) of some pesticide a.i.’s; not all pesticides are classified by this agency. IARC applies its own classification system for carcinogenic hazard
  • US-EPA List of carcinogens → Carcinogenicity classification (only) of pesticide a.i.’s. Many pesticides evaluated by the US-EPA are included in the list. The US-EPA applies its own classification system for carcinogenicity.