Africa Regulatory News

On 3 July 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) notified the World Trade Organization (WTO) that the Draft East African Standard for Hair Oils - Specification...

On 3 July 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) notified the World Trade Organization (WTO) that the Draft East African Standard for Hair Oils - Specifications (DEAS 841:2023) was adopted by the East African Community Council of Ministers on 14 June 2024. This second edition of the standard will replace the 2017 edition, and introduces technical revisions aimed at ensuring higher quality and safety standards for hair oil products across the region.

Comprehensive Scope and Requirements

The standard specifies requirements and sampling methods for hair oils, which include products made from vegetable oils, mineral oils or a combination of both. However, hair oils with therapeutic claims are excluded from this standard. All oils used must comply with the relevant raw material standards and any additional ingredients must comply with all parts of EAS 377, which lists substances that are banned or restricted in cosmetic products. The final product should be a clear liquid, free of sediment and suspended matter, and not irritating to the scalp. Any added dyes, pigments or fragrances must be of cosmetic grade.

Safety Standards

To ensure consumer safety, the draft standard sets strict limits on heavy metal content. Hair oils must not contain more than 10 mg/kg of lead, 2 mg/kg of arsenic or 2 mg/kg of mercury. Together, the total heavy metal content must not exceed 10 mg/kg. Microbiological requirements specify limits on total viable counts and the absence of harmful micro-organisms such as Staphylococcus Aureus, Pseudomonas Aeruginosa and Candida Albicans

Packaging and Labelling

DEAS 841:2023 outlines packaging standards to ensure product integrity and prevent contamination. Labels must comply with the general requirements of EAS 346 (Labelling of Cosmetics – General Requirements) and each package must be clearly labelled with the product name "Hair Oil".

Harmonising Regional Trade

The introduction of DEAS 841:2023 is part of the East African Community's ongoing efforts to harmonise product standards across member states to facilitate trade and ensure that consumers receive high quality products. The draft was circulated to stakeholders for review and feedback to ensure a comprehensive and inclusive standard.

The full text of DEAS 841:2023 is available here.

On 3 July 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) notified the World Trade Organization (WTO) that the Draft East African Standard for Henna Powder (DEAS 337:20...

On 3 July 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) notified the World Trade Organization (WTO) that the Draft East African Standard for Henna Powder (DEAS 337:2023) was adopted by the East African Community Council of Ministers on 14 June 2024. This standard, which will replace the 2013 edition, introduces comprehensive specifications to ensure that henna products meet high standards of purity and performance.

Improved Quality Specifications

The updated standard outlines stringent requirements for henna powder, including general and specific quality criteria. Specifically, the new specifications require henna powder to be in the form of a fine, dried powder obtained from fresh leaves of the henna plant and free from extraneous contaminants such as stems, small fruits and other non-plant materials. It also sets precise limits for moisture content, crude fibre, mineral content and the presence of extraneous sand.

Safety and Purity Standards

A key feature of DEAS 337:2023 is its focus on safety and purity. The Standard stipulates that henna powder must not exceed maximum limits for heavy metal contaminants (lead, arsenic and mercury) ensuring the safety of the product for consumer use. In addition, the standard includes microbiological limits to control potential microbial contamination, specifying acceptable levels for several microorganisms including Pseudomonas Aeruginosa and Staphylococcus Aureus.

Updated Labelling Requirements

The Standard also emphasises the importance of accurate labelling. Each package of henna powder must be clearly labelled with the product name and instructions for use, specifically stating that only water should be used as a solvent. The packaging must also be secure and prevent contamination.

Detailed Test Procedures

The standard was developed by the East African Community Technical Committee EASC/TC 071, which oversees cosmetics and related products. The draft has been circulated to stakeholders for feedback to ensure that the final version reflects the needs and concerns of all parties involved.

As part of the implementation of the standard, detailed methods for sampling, testing and analysis are provided, including procedures for determining moisture content, cold water extract levels, and the presence of extraneous dyes by thin layer chromatography.

Moving Towards Harmonization

The introduction of DEAS 337:2023 is a significant step towards harmonising product quality across East African countries, reducing trade barriers and promoting consumer safety. Stakeholders and industry players are encouraged to review the draft and provide feedback to help finalise the standard.

The full text of DEAS 337:2023 can be found here.

The Pest Control Products Board (PCPB) of Kenya has implemented a comprehensive set of new regulations in 2024, to ensure safety, quality, and responsible use of pest control product. These rules addr...

The Pest Control Products Board (PCPB) of Kenya has implemented a comprehensive set of new regulations in 2024, to ensure safety, quality, and responsible use of pest control product. These rules address a wide range of issues including labelling, inspection procedures, import regulations, fees, disposal standards and registration procedures.

Mandatory Compliance for Registrants

All registrants currently operating in the pest control industry are mandated to comply with the new regulations immediately. This will ensure a swift and uniform application of the guidelines across the board.

Phased Implementation for Labelling Updates

While basic standards need immediate compliance, certain implementations, such as labelling requirements, will be phased in through the registration renewal process. This phased strategy will allow old inventory to be reduced while giving manufacturers sufficient time to change their labelling to meet the new criteria.

Key Changes Introduced by the Regulations:

• Provisional certificates: The PCPB will now issue provisional certificates for existing pest control businesses and premises. This will allow for a smoother transition period while ensuring compliance with the new regulations.

• Labelling, storage, and use: Stricter regulations will apply to the labelling, storage, and use of pest control products. These regulations aim to enhance user safety, environmental protection, and product effectiveness.

• Packaging and registration: Manufacturers and distributors will need to meet specific packaging approval and registration requirements before introducing new pest control products to the market.

• Improved inspections and enforcement: The regulations empower inspectors with the authority to seize non-compliant products, ensuring adherence to the new guidelines.

• Transparency and accountability: The PCPB will maintain a public register of certified premises and businesses, allowing for greater transparency in the industry.

• Consequences for non-compliance: Non-compliance can lead to suspension of certificates, promoting responsible conduct within the pest control sector.

Objective and Impact

The main objective of the newly implemented regulations is to ensure the quality and proper storage of pest control products. This comprehensive approach aims to safeguard public health, protect the environment, and promote responsible pest control practices. The regulations also establish clear guidelines for the certification of business premises and handling procedures, ensuring the safe and effective use of these products by professionals.

The primary goal of the recently established regulation is to ensure the quality and correct storage of pest control products. This comprehensive strategy aims to protect public health, the environment, and responsible pest management practices.

By implementing these new regulations, the PCPB is taking an important step towards a more robust and responsible pest control industry in the region.

*Source

The Department of Employment and Labour in South Africa has announced a new draft Regulation (Notice No. 50431) aimed at controlling exposure to Hazardous Chemical Agents (HCAs). These regulations wil...

The Department of Employment and Labour in South Africa has announced a new draft Regulation (Notice No. 50431) aimed at controlling exposure to Hazardous Chemical Agents (HCAs). These regulations will implement the 10th revised edition of the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals by June 2025. Interested parties are invited to submit written comments within 90 days from the publication of the draft regulation. The deadline for submission of comments is July 5, 2024.

Regulatory Overview and Exposure Control

The draft regulations aim to ensure the prevention or adequate control of workers exposure to hazardous chemical agents, with a focus on the primary route of inhalation, in addition to ingestion and skin absorption. Compliance with Hazardous Chemical Agents Regulations is detailed, including requirements for risk assessment, exposure monitoring, and maintenance and testing of control measures.

Global Harmonization and Labeling Standards

Compliance with the Globally Harmonized System (GHS) is mandated by the draft Regulation with phase-in periods for the adoption of new revisions (see table below). The UN GHS Purple Book is updated every two years by the United Nations Sub-committee on GHS. To facilitate transition, South African importers and manufacturers are granted a phase-in period of 2 years and 6 months from the date of approval by the UN Sub-committee until 30 June of the relevant year for new revisions. The regulations specify labelling requirements in accordance with the GHS, including pictogram size, inclusion of ingredient information, and specific labelling requirements for carcinogens and specific target organ toxicity.

Phase-in Timeframes for GHS Purple Book New Revisions

Additional Safety Data Sheet Considerations

Safety Data Sheets (SDSs) are essential for mixtures that are not classified for acute toxicity but contain hazardous ingredients. Detailed guidelines ensure all necessary hazard information is provided, respecting the established cut-off values for different hazard classes.

Setting and Implementing Occupational Exposure Limits

The draft Regulation outlines the process for setting Occupational Exposure Limits (OELs), including maximum and restricted limits, and details the methodology for calculating exposure over specified reference periods. It also addresses the need for regular updates to OELs and the establishment of exposure groups to assess compliance effectively.

Special Considerations for Particulates and Confined Spaces

Guidance is provided on managing exposure to particulates and working safely in confined spaces, highlighting the importance of appropriate personal protective equipment and monitoring strategies.

Medical Surveillance and Biological Monitoring

A robust framework for medical surveillance is outlined, detailing the importance of medical screening, biological monitoring, and the management of exposure-related health findings. This comprehensive approach ensures that both individual and collective health risks from hazardous chemical exposures are proactively managed.

Legal and Ethical Considerations

The draft Regulation underscores the legal obligations for reporting occupational diseases and the ethical considerations in conducting health surveillance, including informed consent and confidentiality of medical records.

Engagement with Health and Safety Committees

Employers will be required to engage with health and safety committees to discuss risk assessments, control measures and training related to HCAs, ensuring a collaborative approach to workplace safety.

Conclusion and Deadline Reminder

These draft regulations represent a significant step forward in the management of hazardous chemical agents in the workplace, emphasizing safety, compliance and the protection of the health of all workers. Stakeholders are encouraged to participate in the consultation process to refine and improve the provisions outlined in the draft. Please note that the final date to submit comments is July 5, 2024.

For more details, please refer to the draft Regulation here

On 9 April 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organization (WTO) of Draft East African standards for special purposes (anti-aging...

On 9 April 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organization (WTO) of Draft East African standards for special purposes (anti-aging and sunscreen) skincare products. The notifications are open for comments for 60 days from the date of notification.

East African Standards

East African Standards (EAS) are developed by the East African Standards Committee (EASC) with the aim of harmonising quality requirements for products and services in the East African Community. The aim is to remove barriers to trade within the Community through harmonised standardisation.

East African Standards are developed by technical committees representative of key stakeholders including government, academia, consumer groups, the private sector and other interested parties. The standards are periodically reviewed to incorporate technological advances. Users of the East African Standards should therefore ensure that they have the latest versions of the standards they are using.

The EAS for skincare products have been prepared by the Technical Committee on Cosmetics and Related Products.

Draft Standard for Special Purpose Skincare

In an effort to ensure consumer safety and quality control, the draft East African Draft Standard (DEAS 1205:2024) has been introduced to provide detailed specifications for anti-aging, anti-wrinkle and sunscreen skincare products. It, however, excludes skincare products regulated under EAS 786, as well as anti-wrinkle and anti-aging products, aromatherapy substances, and hair creams, lotions, and gels.

Key points of the Anti-Aging Draft Standard

• Scope: Specifies requirements, sampling, and test methods for anti-aging/anti-wrinkle products.

• Normative References: Refers to other standards that are requirements of the EAS, including standards for labelling, cosmetics, and microbiology.

• Terms and Definitions: Defines terms used in the document relating to skincare products such as creams, lotions, gels and various skincare formulations.

• Requirements: Details the ingredients, general requirements, specific requirements, microbiological limits, and heavy metal contaminants for anti-aging products.

• Packaging and Labelling: Specifies packaging and labelling requirements, including product name, indication of whether it's anti-aging or anti-wrinkle, and other labeling requirements.

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

• Annexes: Includes detailed procedures for determining total fatty substance content, hydroquinone content, and antioxidant activity.

Specific details can be found in the Draft Standard here.

Key points of the Sunscreen Draft Standard

• Scope: Specifies requirements, sampling, and test methods for sunscreen products intended to protect against ultraviolet (UV) radiation.

• Normative References: Refers to other standards that are essential to the application of the EAS, including standards for labelling, cosmetics, and methods for testing sunscreen efficacy.

• Terms and Definitions: Provides definitions for terms used in the document, such as sunscreen, sun protection factor (SPF), broad-spectrum protection, water resistance and other relevant terms.

• Requirements: Details the general requirements, specific requirements, labelling requirements, microbiological limits, and heavy metal contaminants for sunscreen products.

• Packaging and Labelling: Specifies packaging and labelling requirements, including product name, SPF value, PA rating (for UVA protection), directions for use, and other required labelling information.

• Sampling: Describes the sampling procedure in accordance with ISO standards to ensure that representative samples are obtained for testing purposes.

• Annexes: Provides detailed procedures for determining SPF, UVA protection (PA rating), water resistance and other relevant tests to assess the efficacy and safety of sunscreen products.

Specific details can be found in the Draft Standard here.

Conclusion

In conclusion, the notification of the draft East African Standards for skincare products is an important step towards ensuring consumer safety and quality control in the East African region. By harmonising standards for anti-aging and sunscreen products, East African countries aim to facilitate trade while prioritising the well-being of consumers. Stakeholders now have the opportunity to provide feedback on the draft standards, ultimately contributing to the development of robust regulations that will benefit businesses and consumers alike.

On 11 December 2023, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organization (WTO) of Draft East African Standards for 10 fertilisers. The noti...

On 11 December 2023, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organization (WTO) of Draft East African Standards for 10 fertilisers. The notifications are open for comments for 60 days from the date of notification.

East African Standards

East African Standards (EAS) are developed by the East African Standards Committee (EASC) to harmonise quality requirements for products and services in the East African Community. The aim is to remove trade barriers within the Community through harmonised standardisation.

East African Standards are developed by technical committees that are representative of key stakeholders including government, academia, consumer groups, the private sector, and other interested parties. East African Standards are subject to review, to keep pace with technological advances. Users of the East African Standards are therefore expected to ensure that they always have the latest versions of the standards they are implementing.

Included fertilisers

The draft East African Standards for the 10 fertilisers and biofertilisers are listed in the table below. The purpose of the standards is to protect human and animal health and safety and protection of the environment; to reduce trade barriers; to reduce costs and increase productivity; to prevent deceptive practices and to protect consumers.

Content of the draft standards

The draft standards contain information on the following:

• General requirements (form and particle size)

• Specific requirements (content and test methods)

• Contaminants (limits and test methods for heavy metals)

• Packaging  

• Labelling (in accordance with ISO 7409 in English and/or any other official language of the country of destination).

• Sampling

The non-governmental organization (NGO) Zero Mercury Working Group (ZMWG) has conducted a market monitoring of skin lightening products sold online and found that toxic mercury cosmetics are still bei...

The non-governmental organization (NGO) Zero Mercury Working Group (ZMWG) has conducted a market monitoring of skin lightening products sold online and found that toxic mercury cosmetics are still being marketed as a ‘solution’ for dark skin. The ZMWG is urging the negotiators at the Fifth Conference of the Parties (COP5) to the Minamata Convention to address the enforcement gaps and implementation failures related to mercury-containing cosmetics. 

African proposal 

In May 2023, Botswana, and Burkina Faso on behalf of the African Parties to the Minamata Convention, proposed an amendment to eliminate the use of mercury in cosmetics, removing the current 1ppm threshold for mercury in cosmetics and phasing out the substance completely by 2025. Mercury is used in products such as skin lightening products (SLPs) which are predominantly used by people of colour to obtain lighter skin. The text of the proposal can be found here.

The African amendment seeks to strengthen the Minamata Convention provision by: 

• Banning the production and sale of all ‘mercury-added’ cosmetics, not just those containing more than 1 ppm of mercury.  

• Restricting the trade of ‘mercury-added’ SLPs, including sales, offers for sale, marketing, advertising, and display. 

• Coordinating inter-ministerial, bilateral, and/or regional strategies to phase-out mercury SLPs  

• Increasing public awareness regarding the risks associated with mercury SLPs. 

Report by Zero Mercury Working Group 

On 12 October 2023, the NGO Zero Mercury Working Group (ZMWG) released its report on ‘Online Marketing of Toxic Skin Lighteners’. In the report they state that they have found mercury levels ranging from 1.18 ppm to 74,800 ppm in 191 out of 213 SLPs purchased from online platforms.  

The report highlights the current lack of adequate measures to stop the production and online sale of mercury-added SLPs. Online platforms, continue to avoid their duty to stop unethical sellers from advertising, marketing and selling illegal SLPs. 

Based on information from the packaging of these products ZMWG said that most of these products are manufactured or distributed from Pakistan (34 %), Thailand (17%) and China (13%) and sold on various online platforms such as Amazon, eBay, Shopee, and Flipkart 

In addition, ZMWG has highlighted some other issues with the information on the packaging of SLPs: 

1. The information on the packaging is often inaccurate and misleading information. 

2. Mercury-added SLPs that did not list mercury as an ingredient  

3. Country of origin is not always listed. 

4. Obscure name of manufacturer 

5. Web links that lead to unsafe or unrelated webpages. 

6. Phone numbers that do not connect to the manufacturer.