Africa Regulatory News

The Pest Control Products Board (PCPB) of Kenya has introduced a new requirement for the submission of Certified Reference Materials (CRMs) as part of the pest control product registration procedure. ...

The Pest Control Products Board (PCPB) of Kenya has introduced a new requirement for the submission of Certified Reference Materials (CRMs) as part of the pest control product registration procedure. Effective immediately, CRMs submitted for registration must be sourced from manufacturers certified by ISO/IEC 17034. This international standard ensures the highest quality and reliability of reference materials, supporting accurate and consistent testing findings.

Labelling Requirements for CRMs

To ensure compliance, all submitted CRMs must be clearly labelled with the following information:

1. CAS Number

2. Expiry Date

3. Lot Number

4. Material Name (Active Ingredient)

5. % Purity

6. Storage Conditions

Certificate of Analysis Requirement

In addition, each CRM must be accompanied by a Certificate of Analysis (CoA) outlining its requirements, uncertainty, intended application, and the matching analytical procedure. This new requirement applies to initial registrations and future applications for label extensions and parallel registrations.

By adhering to this standard, the authority hopes to maintain the highest degree of quality assurance and compliance with industry standards.

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The Pest Control Products Board (PCPB) of Kenya has announced an immediate ban on the use of thiamethoxam and abamectin-based pesticides in open fields. This decision, made during the 178th meeting of...

The Pest Control Products Board (PCPB) of Kenya has announced an immediate ban on the use of thiamethoxam and abamectin-based pesticides in open fields. This decision, made during the 178th meeting of the PCPB on November 28, 2024, aims to mitigate risks to pollinators and promote environmental sustainability.

Key Points of the Ban:

• High Risk to Pollinators: These compounds pose a serious acute risk to adult bees both inside and outside of crop fields, according to recent risk evaluations.

• Practical Limitations: It may not be possible to enforce greenhouse-only use in many agricultural situations, especially in Kenya.

• Regulatory Compliance: The restriction is consistent with Regulation 31(d) and 33(b) of the Pest Control Products Regulation, 2024.

Actions Required for Local Agents and Registrants:

• Immediately modify product labelling to prevent open field use.

• Submit modified labels to PCPB for approval.

• Eliminate current stocks of these products for open field use within 6 months.

•  The PCPB will not register any new Thiamethoxam and Abamectin-based products for open field use.

The PCPB urges all stakeholders to comply with this directive promptly to protect pollinators and ensure the long-term health of agricultural ecosystems.

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On 1 November 2024, the South African Minister of Health published the Regulations Relating to the Use of Food Additives in Foodstuffs, 2024. The regulations, which were developed under the Foodstuffs...

On 1 November 2024, the South African Minister of Health published the Regulations Relating to the Use of Food Additives in Foodstuffs, 2024. The regulations, which were developed under the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), are set to come into force in 2025. These updated regulations introduce new guidelines for the use of additives in foodstuffs, including preservatives, antioxidants, sweeteners, colorants, and emulsifiers. These substances, which are used in food processing and production, must meet strict purity and identity specifications to ensure they do not pose a risk to public health. The aim is to ensure the safe use of food additives in accordance with internationally recognized standards. 

Key points of the Regulations of Food Additives in Foodstuffs 

Scope: This regulation is a significant step towards improving food safety and quality; the South African government has announced the implementation of new regulations. 

Application: This document provides regulations concerning the use of food additives in foodstuffs. It includes definitions, requirements for use, categories of food additives and the conditions for their use in food products. 

Requirements for the Use of Food Additives:  

• Specifications and Purity: Food additives should be manufactured, stored, and handled in accordance with Good Manufacturing Practice (GMP) standards. The quantity used should be limited to the minimum required for the intended effect. 

• Maximum Use Levels (ML): Foodstuffs containing additives must not exceed the maximum levels set by the Codex General Standard for Food Additives (GSFA). 

• Food Categories: Different food categories may have specific rules regarding food additives, e.g. infant formula may not allow certain additives. 

• Carry-over: Food additives can be carried over from raw ingredients into the final product, but must not exceed the allowed limits. 

 Extended Use of Food Additives: 

• Raw Materials: If a food additive is present in raw materials or ingredients, it must comply with the regulations and the amount carried over into the final product must not exceed the limits.  

• Infant Food: Food additives are not allowed to be carried over into foods intended for infants or young children.  

Application to Specific Food Categories: The document specifies how food additives such as color and sweeteners should be used in different food categories, including: 

• Infant foods: Strict limitations on additives like color and sweeteners. 

• Plain bread: No color or sweeteners allowed. 

• Fruit juices: May contain color additives but no sweeteners unless specified. 

• Other unflavored foodstuffs: No color or sweeteners allowed. 

• Other unprocessed foodstuffs: No color or sweeteners allowed. 

• Non-energy-reduced foodstuffs or non- sugar-reduced foodstuffs: No sweeteners are allowed 

Repeal of Previous Regulations: The new regulations repeal several earlier rules regarding colorants, sweeteners, antioxidants, and preservatives that were issued in previous government notices, such as R.733, R.1008 and R.1426. 

Public Consultation 

The Minister of Health has called for public input on the proposed regulations. Interested individuals and organizations are encouraged to submit any substantiated comments or representations to the Director-General of Health within three months of the date of publication of the Notice (i.e. 1 February 2025). 

Implementation Timeline 

• The regulations will come into force 12 months after publication. 

• Food items manufactured before the effective date are not subject to the new regulations. 

Conclusion  

In summary, South Africa’s new regulations aim to enhance food safety by setting strict standards for food additives, including preservatives, sweeteners and colorants. These regulations, which will come into effect in 2025, are in line with international guidelines and ensure the protection of public health. With specific rules for different food categories, such as infant foods and fruit juices, they offer clear guidelines for manufacturers. The public consultation process allows stakeholders to provide input to ensure that the regulations are well-informed and comprehensive. 

On 7 October 2024, the South African Minister of Forestry, Fisheries and the Environment (DFFE) introduced new regulations aimed at creating a national framework for compliance with the Rotterdam Conv...

On 7 October 2024, the South African Minister of Forestry, Fisheries and the Environment (DFFE) introduced new regulations aimed at creating a national framework for compliance with the Rotterdam Convention. These regulations specifically address the Prior Informed Consent (PIC) procedure, which requires countries to be informed and consent before hazardous chemicals are traded internationally. 

Department of Forestry, Fisheries and the Environment  

The DFFE is dedicated to ensuring that all South Africans have the right to a healthy environment. Focusing on sustainability and conservation, the DFFE leads efforts in responsible environmental management, protecting resources for present and future generations. Through these initiatives, the Department aims to promote the wellbeing of communities while contributing to global environmental protection.  

New National Regulations for Trade in Hazardous Chemicals under the Rotterdam Convention  

The National Environmental Management Act (Act No. 107 of 1998) empowers the South African government (DFFE) to regulate the trade of certain chemicals. The new regulations create an appropriate regulatory framework, outlining general prohibitions, notification procedures for chemical commerce, record keeping, and reporting requirements. 

Key Points on New National Regulations for Hazardous Chemicals Trade 

Scope: The regulations apply to chemicals subject to notification under the Rotterdam Convention, covering general prohibitions, notification procedures, record keeping, and reporting. 

Application: The regulations apply to chemicals that are banned or severely restricted as listed in Annexure I. 

Purpose of the Regulations:   

• To implement the provisions of the Rotterdam Convention for hazardous chemicals and pesticides in international trade. 

• To outline the Prior Informed Consent (PIC) procedure for chemicals listed in Annexure I. 

• To promote cooperation in the international movement of chemicals to protect human health and the environment. 

• To facilitate the exchange of information on the safe use of chemicals and ensure international communication of import/export decisions. 

• Exempt chemicals not exceeding 10 kg per year, per country, per chemical. 

Notification Process:   

• Notification Requirement: Importers must notify South African authorities annually of imports from Annexure I, including a Safety Data Sheet (SDS). 

• Documentation: The authorities may request additional documentation after receiving the export notification. 

• Export Notification Form: Complete the official form from Annexure II with the required information. 

• Acknowledgment: The authorities will acknowledge receipt within 10 working days. 

• Processing and Decision Making: Authorities will review notifications and decide whether to grant or deny consent based on the validity of licenses or permits. 

Record Keeping and Reporting:   

• Keep detailed records of quantities, sources, intended use and import/export dates for at least five years. 

• Provide personal and contact details for intended use where applicable. 

• Submit actual amounts imported or exported and customs documents by the end of March each year. 

Penalties for non-compliance :

•  Non-compliance with specific regulations can lead to fines of up to 5 million Rand for first offences and penalties of up to 10 million Rand or imprisonment for subsequent offences. 

Updating of Annexure: Annexure I will be reviewed every two years to align with the Rotterdam Convention. 

Information of Transmission:  The South African Designated National Authority (DNA) must inform the Rotterdam Convention Secretariat of any new regulatory actions within 60 days. 

Repeal of Laws: Previous regulations are repealed, with the new “Prior Informed Consent Procedure Regulations, 2024” taking effect 120 days after publication. 

Prohibition: No import or export of Annexure I chemicals without prior consent under these regulations. 

 Annexes: 

• Annexure I: List of chemicals requiring notification. 

• Annexure II: Rotterdam Convention export notification form. 

 Conclusion 

These new regulations for hazardous chemicals trade represent a significant step towards aligning South Africa's practices with the Rotterdam Convention. By establishing a comprehensive framework for notification, record keeping, and compliance, the DFFE aims to enhance the protection of the environment and public health. These regulations will promote responsible trade in chemicals and ensure that both domestic and international stakeholders are informed and involved in decision-making processes. 

On September 26, 2024, five East African Community countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) jointly notified the World Trade Organization (WTO) of a Draft East African Standard for the ...

On September 26, 2024, five East African Community countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) jointly notified the World Trade Organization (WTO) of a Draft East African Standard for the use of body and face powders (DEAS 425-1: 2023). The notification is open for comments for 60 days from the date of notification. 

East African Standard 

In order to ensure comparable product quality throughout the East African Community, the East African Standard must be adopted. Periodic assessments of these standards are conducted to ensure that they remain current with modern technologies. Users are required to have continuous access to the latest versions of the standards they implement. 

Draft Standard for Body and Face Powders 

To enhance the application of this draft standard, the East African Draft Standard (DEAS 425-1:2023) has been introduced to provide comprehensive specifications for the requirements, packaging, labeling and sampling of cosmetic powders. This initiative is essential to ensure consumer safety, improve market regulation, promote public health and foster economic growth within the cosmetics sector. By addressing both immediate health concerns and long-term industry sustainability, the standard aims to create a safer and more reliable market for consumers. 

 Key Points of the Cosmetic Powders Products Standard 

- Scope: For adult use only, this Draft East African Standard outlines the specifications, sampling and testing procedures for body and face powders, including talc, toilet, deodorant and dusting powders. Powders claiming therapeutic benefits are not covered by this standard. 

- Normative References: This section refers to other standards required by ISO and EAS, including those for requirements, labeling, sampling, testing, and packaging. 

- Terms and Definitions: Terms are defined in accordance with draft EAS 846, covering terms such as body powder. 

- Requirements: All ingredients must comply with EAS 377. Face powder should have a fine particle size, otherwise it should be similar to body powder. The product must not have harmful effects on the skin and should not leave an unpleasant odor, even after aging. Other requirements, such as microbiological and heavy metal content, should be in accordance with ISO and EAS standards. 

- Packaging: The product should be packed in sealed containers that protect the contents and prevent contamination or reaction with the product. 

- Labeling: Product labeling must clearly state “Body Powder” or “Face Powder.” If the powder contains boric acid, the container must bear the caution: "This powder contains boric acid and is NOT to be used on infants." 

- Sampling: Sampling should be conducted in accordance with ISO 24153. 

- Annexes: The Annexes include: 

• Determination of asbestos 

• Determination of boric acid 

 Conclusion 

The East African Draft Standard (DEAS 425-1:2023) provides essential guidelines for body and face powders to ensure safety, quality, and compliance within the cosmetics sector. By outlining requirements for ingredients, packaging, labeling and testing, this standard not only protects consumers, but also promotes responsible industry practices. Regular updates and adherence to these standards will help maintain public health and foster economic growth throughout the East African Community. 

On September 26, 2024, five countries from the East African Community (Burundi, Kenya, Rwanda, Tanzania and Uganda) jointly notified the World Trade Organization (WTO) of a Draft East African Standard...

On September 26, 2024, five countries from the East African Community (Burundi, Kenya, Rwanda, Tanzania and Uganda) jointly notified the World Trade Organization (WTO) of a Draft East African Standard for the use of deodorants and antiperspirants (DEAS 960:2024). This Draft Standard aims to ensure consumer safety and product utility by establishing clear requirements. The notification is open for comments for 60 days from the date of notification. 

East African Standard  

The East African Standard is necessary to harmonize product quality within the East African Community. These standards are subject to regular review to keep pace with technological advances. Users are expected to maintain access to the latest versions of the standards they implement. 

Draft Standard for Deodorants and Antiperspirants 

In an effort to enhance consumer safety and product utility, the East African Draft Standard (DEAS 960:2024) has been introduced to provide detailed specifications for the requirements, packaging, labeling, and sampling of deodorants and antiperspirants. 

Key Points of the Draft Standard 

- Scope: This draft standard specifies the requirements, sampling, and test methods for deodorants and antiperspirants. 

- Normative References: Refers to other standards required by ISO and EAS, including those for requirements, labeling, sampling, testing, and packaging. 

- Terms and Definitions: Defined in accordance with draft EAS 846, covering terms like deodorants, antiperspirants and roll balls. 

- Requirements: 

• Ingredient Compliance: All ingredients, including dyes and pigments, must meet EAS 377 standards. 

• General Requirements: Products must be safe for consumers when used as directed and must comply with ISO 22716 for production and handling. 

• Specific Testing Requirements: Stability of smell, pH levels, and non-volatile matter must meet specified criteria. Aerosol products have additional requirements regarding delivery rates and leakage tests. 

• Heavy Metal Contaminants: Limits for heavy metals, including lead, arsenic, and mercury, are established to ensure consumer safety in accordance with EAS 847-16. 

• Microbiological Standards: Products must meet stringent microbiological limits, including total viable counts and specific pathogen testing according to ISO standards. 

- Packaging: Deodorants and antiperspirants should be packaged as roll-ons, aerosols, squeezable tubes, stick products, or any suitable container that protects the contents from contamination and reactions. If a roll ball is used, it must be made of plastic, allow controlled release, and leave a thin layer of product on the skin during application. 

- Labeling: Labels must conform to EAS 346. Product identification must clearly state “Deodorant” or “Antiperspirant.” Warnings for products containing aluminum zirconium compounds must state: “Do not apply to irritated or damaged skin.” Appropriate safety symbols must follow ISO 7010 standards. 

- Sampling: Sampling shall conform to ISO 24153. 

- Annexes: The Annexes include methods for: 

• Determination of stability of smell 

• Determination of non-volatile matter 

• Determination of delivery rate of dispensers 

• Determination of propellant composition 

• Net weight delivery 

• Spray tests 

Conclusion 

The introduction of DEAS 960:2024 is a significant step towards ensuring the safety and quality of deodorants and antiperspirants in East Africa. By establishing comprehensive guidelines for formulation, packaging, labeling and testing, this standard aims to protect consumers while promoting uniformity across the region. Manufacturers and consumers alike will benefit from clearer expectations and enhanced product integrity, promoting confidence and safety in personal care products. 

On 2 September 2024, the Tanzania Bureau of Standards notified the World Trade Organization (WTO) of a draft standard (DARS 1721:2024) aimed at regulating recycled polyethylene terephthalate (rPET) us...

On 2 September 2024, the Tanzania Bureau of Standards notified the World Trade Organization (WTO) of a draft standard (DARS 1721:2024) aimed at regulating recycled polyethylene terephthalate (rPET) used for food contact.  The purpose is to enhance Africa’s internal trade capacity, increase Africa’s global competitiveness in edible oil bottles and food containers and improve the welfare of African communities by ensuring the safety and quality of PET and rPET. The notification is open for comments for 60 days from the date of notification.

African Organization for Standardization

The African Organization for Standardization (ARSO) is an African intergovernmental organization established in 1977 by the United Nations Economic Commission for Africa in collaboration with the Organization of African Unity. The fundamental mandate of ARSO is the development and harmonization of African standards, which is carried out through technical committees. The main task of technical committees is to prepare ARSO Standards. Draft ARSO Standards adopted by the technical committees are circulated to the member bodies for voting. Publication of a draft ARSO Standard requires approval by the maximum number of the member bodies casting votes.

PET and rPET Quality Evaluation

In an effort to ensure consumer safety and quality control, the Draft African Standard (DARS 1721:2024 and DARS  1730:2024) has been introduced to provide detailed specifications for requirements, standard test methods, packaging and migration for polyethylene terephthalate (PET) and recycled polyethylene terephthalate (rPET) as recyclates for bottle, flakes and pellets used in the food contact application product.

Key points of the PET and rPET food contact applications Standard

• Scope: Specifies the requirements, methods of sampling and testing for PET and rPET bottles for edible oils, flakes and pellets used for food contact applications.

• Normative References: Refers to other standards that are requirements of the ISO and ASTM (American Society for Testing and Materials), including standards for labelling, test, and packaging.

• Terms and Definitions: Defines terms used in the document that relate to plastic products mentioned in ISO 472 and 21067, such as rPET, blow moulding, recyclate, etc.

• Requirements: Must meet precise quality criteria, including particle size, color, and contamination limits, as well as specific chemical levels and intrinsic viscosity. It also mandates strict migration limits for overall and specific substances, including heavy metals to ensure safety for food contact applications test.

•  Labelling and Packaging: The document outlines packaging and labelling requirements for PET and rPET bottles, including the need for protective coverings to prevent contamination. Each bottle must be marked with the manufacturer's name, date of manufacture, disposal and safety instructions, country of origin, dimensions, batch number and the rPET symbol. Packaging must also display the food grade symbol or the phrase "for food grade”.

• Sampling: Describes the sampling procedure in accordance with ISO standards.

• Tests: Must include leakage, stacking, drop impact, and storage stability tests as specified in the approved draft method.

• Annexes: Includes detailed procedures for the determination of leakage, stacking and drop impact tests.

Conclusion

In conclusion, the document provides comprehensive guidelines for the manufacture, packaging, and labelling of recycled PET (rPET) bottles to ensure safety and quality. It mandates hygienic packaging conditions, clear labelling with essential details such as the manufacturer’s information, production date, and safety instructions, and requires specific markings for food grade suitability. These measures, including strict migration limits and quality checks for contaminants and physical properties, are designed to ensure that PET and rPET bottles meet safety standards and are suitable for their intended use in food contact applications.