For registration holders and applicants with a remedy that could replace a chemical the registrar has identified as a substance of concern. This is information, not legal advice. Checked 26 October 2026.
The short version
Since 1 June 2024 the registrar may not grant or renew a registration that contains a substance of concern, with one narrow exception for exceptional circumstances (below). To help growers who relied on those products, the registrar prioritises suitable replacements. This protocol is for replacements of that kind. It covers an application already with the registrar and one not yet submitted. It does not make an ordinary application faster. The regulations separately allow the registrar to expedite minor-use and low-risk applications.
Who can apply
You can apply if your remedy could fully or partly replace a use that grower associations have identified as essential, where no viable alternative is registered. Your remedy must not itself be a substance of concern, and it must not be banned.
A substance of concern is an active ingredient, and its formulation, that meets the carcinogenicity, mutagenicity or reproductive toxicity categories 1A or 1B in the GHS. It is also an active ingredient listed by the Stockholm Convention in its Annexes A and B, or meeting all the criteria in paragraph 1 of Annex D, except DDT used for malaria vector control by the Department of Health. Or it is an active ingredient listed under the Montreal Protocol.
In exceptional circumstances, where there is no other remedy, the registrar may grant registration of an implicated remedy if the risk under realistic worst-case use is negligible, or the substance is essential to prevent or control a serious danger, or not approving it would do disproportionate harm to society. The regulations say such a registration may be for a specified period and for restricted uses.
If your application is already with the registrar
This route is for applications that are complete and already submitted. Send:
- A covering letter that says the application is for fast-tracking. Include the submission date, the remedy being replaced and the essential uses.
- A copy of your service request form, with the submission date legible.
- Two copies of the updated application form, showing the GHS classification and the registration status in other countries.
- An explanation letter (see below).
- Two copies of the proposed label, if it differs from the one in your dossier. If the dossier label is not in GHS and you have not yet applied to update it, send a GHS label with a rationale and pay the update fee. If you already applied, send a copy of the approved GHS label for reference and pay nothing more.
- A declaration signed by the company representative that the product contains no active ingredient, co-formulant or biological organism regarded as a substance of concern, that no new scientific evidence is available on health effects for vulnerable groups, especially children, and that the information in the application is authentic, accurate and complete. The protocol's template adds "other than what has already been disclosed" to the evidence statement, which the wording in the text does not.
- A second declaration that the product will, to the best of your knowledge, replace the remedy being phased out as set out in the explanation letter.
If you have not yet applied
You send all the data the usual guidelines require, plus a separate list:
- A covering letter that says the application is for fast-tracking and names the remedy being replaced and the essential uses.
- Two copies of the application form, showing the GHS classification and registration status in other countries.
- The explanation letter.
- Signed assessment reports for all applicable trials (efficacy, phytotoxicity and residues). What is applicable depends on your product and the usual guidelines.
- Two copies of the proposed label, with only claims for essential uses. A GHS label with a full classification rationale must go with it. If a GHS label was already submitted, send a copy of the approved one.
- and 7. The same two declarations as above.
The explanation letter
Explain why your remedy is a suitable replacement and how you will manage resistance. For resistance, compare the resistance group of the remedy being phased out with yours and with other remedies registered for the same pest and crop, and consider other pests on the same crop and the same pest on crops grown nearby. Give a short comparison of expected performance under adequate pest pressure against the remedy being replaced. You do not need a data comparison here. That does not remove the ordinary efficacy evidence your registration needs. Say whether it is a full or partial replacement and why, considering whether products are systemic or contact, withholding periods and so on. The protocol gives an example: a biological remedy that only suppresses a disease can count as a partial replacement, but other remedies may need to be registered with it, or a derogation given for high disease pressure. Finally, say what the replacement means for access to export markets. A remedy restricted in an export market cannot count as a replacement for crops going there.
Fees
For an application already submitted, the protocol says there are no extra fees for sending this information, because the fees were paid with the original application. The exception is the GHS classification, where the update fee applies if the label is not yet in GHS. For a new application, the registration fee still applies: the regulations require the prescribed application fee and the 2026 tariff shows R13,956 per application or product from 1 April 2026. The only fee the protocol waives for a new registration is the GHS classification fee.
Check with the registrar
The protocol gives no time frame for fast-tracked decisions. The remedy you want to replace must actually be classed as a substance of concern now: the protocol's examples do not prove that for any particular ingredient. The protocol also does not list which remedies are currently classed as substances of concern, or which uses growers have named as essential. Ask the registrar's office.
The protocol's list for new applications says the explanation letter is "as stipulated in point 3" of the first list. The explanation letter is point 4 there. Follow point 4.
Sources
Protocol for submission of applications for fast-tracking of registrations to replace agricultural remedies identified as substances of concern, issued by the Registrar of Act 36 of 1947, November 2023. Regulations relating to agricultural remedies, 25 August 2023 (regulations 3, 5 to 8). Government Gazette 54123 of 13 February 2026 (tariffs). The protocol is published on the department's guidelines page: https://www.nda.gov.za/index.php/publication/581-guidelines