Substances of concern are defined in the regulations relating to agricultural remedies as any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in an agricultural remedy in sufficient concentration to present risks of such an effect.

Agricultural remedy active ingredients and their formulations fulfil the substance of concern criteria when such agricultural remedy have one or more of the characteristics:

• Criterion 1: Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS); or
• Criterion 2: Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS); or
• Criterion 3: Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS); or
• Criterion 4: Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention; or
• Criterion 5: Pesticides listed under the Montreal Protocol

Most of these remedies are currently being phased out and, as of 1 June 2024, the Registrar (Act No. 36 of 1947) no longer has the mandate to approve registrations or renew registrations of remedies complying with these criteria, unless the registration holder conducts a risk assessment and applies for a derogation to keep such a remedy on the market for restricted uses, meaning on a temporary basis for certain crop-pest combinations only.

A derogation is an exception to the rule – an exemption that can be granted. Registration holders may only apply for derogations that are specific to a tradename and for specific essential uses. They must conduct a risk assessment, make it available for public comment, and then it will still be dependent on approval from the Registrar (Act No. 36 of 1947). The Registrar may only grant these registrations in exceptional circumstances and only if:

• the risk to humans, animals or the environment from exposure to the agricultural remedy, under realistic worst-case conditions of use, is negligible or,
• there is evidence that the agricultural remedy is essential to prevent or control a serious danger to human health, animal health or the environment; or
• not approving the agricultural remedy would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

These derogations may be granted for a specified period and for restricted uses, until viable alternatives become available. This is in line with what is being done internationally (e.g., EU).

The following resources have been compiled to assist anyone seeking more information on the subject. Please also feel free to reach out to a member of the CropLife SA team via the Connect page if you need more information.

• Resources