Written by Alison Levesley, supplied by Adams & Adams
In terms of these amended regulations, the following changes are notable.
Additional definitions have been included in the revised regulations.
Part I of the Regulations deals with the application, information to accompany the application, minor use and low risk registrations, prioritisation and the approval process.
It is worth noting that Section 3 which provides the information to accompany the application, now includes additional requirements. Section 3 of the regulations come into effect 6 months from the date of publication. As such, these become a requirement for all applications submitted from 25 February 2024.
Section 3(f) requires that the safety data sheet is GHS compliant and in accordance with sub-regulation 14A (3) of the Hazardous Chemical Agents, 2021.
Section 3(h)vii requires that toxicological, metabolism and exposure data of the active ingredient and agricultural remedy are generated in accordance with OECD GLP. Section 3(h)viii requires that data on the effect of exposure on children be provided. Section 3(h)ix requires that data on ecotoxicological data on wildlife, aquatic organisms and non-target organisms of the active ingredient be generated in accordance with OECD GLP. Section 3(h)x requires environmental fate date of the agricultural remedy including data on the degree of persistence, retention, movement, bio-accumulation and metabolic breakdown of its active ingredient in the environment. Such data must be generated in accordance with OECD GLP. Furthermore, residue studies are also required for the agricultural remedy and active ingredient on the crop and feed as well as methods of extraction, detection, and analysis of such reside must be in accordance with OECD GLP.
Efficacy and phytotoxicity data, as well as data on the effect on bees and other pollinators are to be generated under the supervision of a person registered in terms of the South African Council for Natural Scientific Professions (SACNASP) Act, 2003. Each assessment report for each study is required to be signed by a person registered with SACNASP. Additionally, the efficacy and phytotoxicity data must be generated according to GEP.
In cases where the product may be applied through aerial application, a risk assessment report must be provided that demonstrates clear advantage in terms of reduced impact on human health and the environment when compared to other spraying methods.
Where required, proof of compliance with the waste management measures as published on 23 March 2023 must be submitted.
Applicants are now required to submit details of any limitation on foreign registrations, refusals for registrations or bans on the agricultural remedy when filing an application for registration in South Africa.
Applicants are also required to sign declarations that the agricultural remedy does not contain an active ingredient, co-formulants or biological organisms that is regarded as a substance of concern or no new scientific evidence is available on the agricultural remedy’s potential health effects for vulnerable groups, especially children.
Applicants may be required to submit samples of the agricultural remedy along with the technical grade and a laboratory standard of the active ingredient.
The new regulations make provision for the expedited review of minor use registrations and low-risk agricultural remedies. This section of the regulations, like most sections came into force on 25 August 2023.
A minor use registration is a product where the use for which the demand originates with a grower or group of growers for a remedy intended to be used on a particular pest in connection with a particular host organism and the use in for an agricultural purpose, the government supports the use and the use is supported by crop residue data and extrapolation of supporting efficacy data.
A low risk agricultural remedy is a substance that has been evaluated as having a low risk. There is an annexure provided that sets out the criteria for this category. These characteristics of the active ingredient or microorganism include one or more of the following:
Additionally, Section 7 of the regulations now provides a mechanism for prioritisation of the review and registration of suitable alternatives for substances of concern.
The regulations appear to provide a simplified mechanism for the approval or minor changes. Section 8(4) provides that the Registrar may advise the registration holder of an approval of a minor changes if the holder notifies the registrar of an administrative minor change and provides a declaration confirming that no other changes in the registration details have been made. Administrative minor changes include changes to the registration holder details, changing brand names and artwork, updating warning or voluntary restrictions, removal of claims, adding resistance codes or changing distributor details, inclusion of foreign languages and changing packaging specification.
Section 8 provides the requirements for registration and states that a registration must be granted if requirements are met. Section 8(1)(d) provides that an application must be granted by the registrar if the registrar is satisfied that the agricultural remedy does not contain substances of concern and is not an agricultural remedy banned in the Republic of South Africa. Whilst most sections of the regulations came into force on 25 August 2023, Section 8(1)(d) specifically only comes into force on 1 June 2024.
Section 8(6) also provides that in exceptional circumstances, where there are no other agricultural remedies, the registrar may grant registration of an implicated agricultural remedy when:
(a) The risk to humans, animals or the environment from exposure to the active substance in an agricultural remedy, under realistic worst-case conditions of use, is negligible; or
(b) There is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or
(c) Not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment.
Section 8(7) provides that “in this case, approval of an agricultural remedy may be granted for a specific period, and for restricted uses following publication of the risk assessment report for public comments by the applicant. It is not clear if this is intended to apply only to approvals issued in terms of Section 8(6) or all approvals.
Previously the renewal process for agricultural remedies was administrative in nature. However, now an application for renewal, due every three years, requires a signed declaration that the remedy does not contain an active ingredient, co-formulant or biological organism that is regarded as a substance of concern and that there is no new scientific evidence on the remedy’s potential health effects for vulnerable groups, especially children.
The labelling and classification of the agricultural remedies shall be in accordance with GHS and the Hazardous Chemical Agents, 2021.
Only registered agricultural remedies may be advertised in South Africa. The adverts may not contain images of children or representations of potential dangerous practices. Warnings on television must be shown for 10 seconds and in print the warnings must be at least font size 10. No guarantees may be made of implied, unless there is evidence to substantiate such claims.
The regulations have been updated to include requirements on waste management as required by the Extended Producer Responsibility Scheme of 2023.
The regulations now require an annual reporting requirement that obliges registration holders to submit details on quantities sold and this includes product sold by distributors. These reports are required to be submitted by 31 May of each calendar year. All original records and supporting data are to be maintained by the registration holder for 5 years from the date of submission of the report. The registrar is further authorised to require the registration holder to submit a report by an independent auditor if the registrar reasonably believes that, on the basis of information available to the registrar, us inaccurate or incomplete.
We trust you will find this information useful and do not hesitate to contact the Adams & Adams Patent department on [email protected] should you require any assistance.
Read the original article as it appeared on GoLegal here.
Relevant Agribook pages include “Crop protection“, “Animal health” and “Chemicals and agriculture“.
Photo by Chris Charles on Unsplash
