South Africa is moving toward stricter regulations for managing potentially hazardous agricultural remedies. CropLife SA experts share how the phase-out of certain products and potential exemptions could shape the future of South African farming.
South African agriculture has turned a new page, undergoing significant regulatory changes, particularly concerning the phase-out of certain substances of concern. To understand these changes, Food For Mzansi spoke to Roleen la Grange, regulatory manager at CropLife South Africa, and Chana-Lee White, Agri-Intel manager.
Their insights reveal not only the complexity of the situation but also the far-reaching impact on agriculture and consumers alike.
According to La Grange, agricultural remedies are regulated in South Africa under the Fertilizer, Farm Feeds, Agricultural Remedies, and Stock Remedies Act (Act No. 36 of 1947). More recently, the “Regulations relating to agricultural remedies” published in August 2023 define what are known as “substances of concern”.
“Substances of concern include CMRs that are active ingredients and their formulations that meet the criteria of carcinogenicity, mutagenicity, or reproductive toxicity in categories 1A or 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS),” explained La Grange.
The distinction between categories 1A and 1B is that category 1A refers to substances known to have carcinogenic or mutagenic potential, or are toxic to reproduction, based largely on evidence from humans. Category 1B, on the other hand, involves substances where the harmful effects are presumed, but based primarily on animal studies.
While the GHS classification helps identify potential hazards, La Grange stressed that it is important to remember that a hazard is not the same as a risk.
“Risk only comes into play when also considering exposure. If exposure can be controlled, the risk can be managed.”
What do the new regulations say?
According to White, as of 01 June 2024, the registrar no longer grants registrations or renews existing ones for agricultural remedies that fall into the “substances of concern” category. This means that chemicals classified as CMRs will be phased out unless a derogation is approved.
In addition to these restrictions, the registrar is tasked with prioritising the review of alternative solutions to these substances of concern. “Where suitable alternatives exist, they will be fast-tracked for registration to replace the phased-out substances,” White added.
However, not all products are immediately discontinued. In cases where no viable alternatives exist, the regulations allow for a derogation, but only in the most exceptional and extraordinary circumstances.
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The derogation process: How it works
Derogation, as described by White, is a temporary exemption from the regulation under very exceptional circumstances.
However, why allow exemptions for chemicals that are known to be harmful?
La Grange explained this using a critical distinction between hazard and risk. She says that just because a substance is classified as hazardous does not mean it poses an immediate threat in every situation.
“For example, vitamin A is classified as a reproductive toxin, but it is essential for various biological processes and used daily in skincare products. The key is controlling exposure to these substances to mitigate the risks.”
She added that chemicals with similar classifications are found in everyday items, from medication to rodenticides.
“If the risk of harm under real-world conditions is negligible or outweighed by societal benefits, a derogation may be justified,” White said.
For example, certain rodenticides, used both in pest control and as medical blood thinners, fall into the same hazard categories but continue to be used under strict regulation.
Aligning with international standards
South Africa’s approach aligns closely with international practices, especially those in the European Union.
The EU, since 2012, has prohibited the use of category 1A and 1B carcinogens, mutagens, and reproductive toxins in agricultural products, but with a similar clause for derogations, said White.
“Our regulations are likely based on the EU model, which allows for exemptions under strict conditions, particularly where no alternatives are available, and the risks can be managed.”
This alignment ensures that South African agriculture remains competitive globally while also maintaining high safety standards for human health and the environment.
The future of agricultural chemicals in South Africa
As of 1 June 2024, White said some products may be discontinued if the registration holders do not apply for derogation. It is important to note that products will be discontinued if alternative solutions are available. If no alternatives are available, products will likely not be discontinued.
Furthermore, if a remedy’s co-formulants (inactive ingredients that enhance effectiveness) are the problem, companies may opt to amend the formulation, replacing the harmful co-formulant with a safer alternative.
In cases where no suitable alternatives exist, registration holders may apply for derogation. However, this will only be granted after conducting a risk assessment and allowing for public comment.
The registrar will evaluate all available information before deciding whether to grant a derogation, and these exemptions will be for specific products and limited uses.
“This is not a blanket approval for all products with the same active ingredient,” stressed White.
The road ahead
The phase-out of CMR substances presents challenges but also opportunities for innovation in South African agriculture. As companies work around the clock to find safer alternatives, the industry will likely see the introduction of new, more sustainable agricultural remedies.
The process will ultimately benefit both farmers and consumers.
While the immediate future might seem uncertain, these changes will lead to a safer, more responsible use of agricultural remedies. The industry will have to adapt, but that’s a positive,
For now, the focus is on preparing for the changes, conducting risk assessments, and finding alternatives.
Farmers should start engaging with their suppliers to understand how these regulations will affect them.
It is important to be proactive, rather than reactive, as the industry moves towards a safer future for South African agriculture
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