The Botswana Medicines Regulatory Authority (BOMRA) has issued its Guideline for the Regulation of Cosmetics (Issue 1.0, effective 24 November 2025), formally embedding cosmetics within a structured regulatory oversight framework that extends well beyond customs clearance and product availability. While cosmetics remain exempt from pre-market registration, BOMRA has informed the public that the listing process for cosmetic products will become mandatory from 1 April 2026. The Guideline establishes a clear compliance perimeter anchored in mandatory product listing, defined local accountability, post-market surveillance and enforceable controls on ingredients, labelling, claims and advertising., the Guideline confirms BOMRA’s expectation that regulatory responsibility sits locally. Exporters must operate through a Botswana-resident Responsible Person / Cosmetic Notification Holder (usually a distributor if manufacturer is not incorporated locally). Different business arrangements may be put in place. For example, the manufacturer or brand owner may retain the Cosmetic Notification records while the distributor assumes any local responsibility and accountability for safety documentation, compliance during inspections, adverse event reporting and regulatory engagement. This shifts compliance risk upstream, requiring exporters to maintain inspection-ready dossiers, not just market-ready products.

From a strategic perspective, BOMRA’s approach mirrors EU-style cosmetic regulation, adapted for a Southern African context. The Authority has signalled a clear enforcement posture: claims discipline and post-market control will be primary tools, with powers to suspend listings, withdraw products and revoke licences where non-compliance is identified. The absence of current listing fees should therefore be viewed as facilitative, not permissive to allow manufacturers to list as much of their product catalogue as possible. This may change in future.

For cosmetic companies exporting to Botswana, the Guideline represents a structural change in market access risk. Brands positioned as “clinical”, “corrective” or “treatment-adjacent” face possible heightened regulator scrutiny, providing enforcement effort matches regulator ambition while companies with strong regulatory governance gain a defensible advantage through predictability, continuity and reduced enforcement disruption. In effect, Botswana is no longer a low-regulation destination, but an early indicator market for where cosmetic oversight in the region is heading. Zimbabwe and Zambia are developing similar regulatory systems.

Why This Matters for Cosmetic Exporters

Key regulatory requirements for market access include:

• Mandatory cosmetic listing via BOMRA’s BRIMS system prior to market entry.
• Key Listing Requirements (More details as per the listing platform);

All cosmetic products submitted for listing must meet the following criteria:

• Submission of product details via the BoMRA Cosmetics Listing Form (available at https://brims.bomra.co.bw/ )
• Labelled in accordance with the Cosmetics labelling guideline, including full ingredient disclosure and contact details of the Responsible Person
• No claims that would categorize the product as a medicine

The cosmetic ingredients should be in line with Regulation EC 1223/2009 or the Botswana Standard BOS688 Parts 1&2.

1. Enforcement

After the transition period, any cosmetic product found on the market that has not been listed with BoMRA will be subject to regulatory action, including seizure, product recall, and/or administrative penalties in line with the Act.

Appointment of a locally resident Responsible Person / Cosmetic Notification Holder, accountable for safety, compliance and recalls should these arise and the regulator requires a locally resident person to co-ordinate.

• Strict ingredient control aligned to Botswana Standards (prohibited, restricted and allowed substances) that mirror EU ingredient restrictions.
• Zero tolerance for therapeutic or medicinal claims, across labels, inserts and advertising. This will require careful risk management and depend on how strictly the regulator's enforcement capacity efforts will be.
• Post-market surveillance and cosmetovigilance, including adverse event monitoring and product withdrawal powers.

Although no listing fees currently apply, BOMRA has explicitly positioned cosmetics within its inspection, licensing and enforcement architecture, signalling future escalation rather than deregulation.

Predictive impacts for cosmetic companies include:

• Portfolio rationalisation pressure where products straddle cosmetic/medicinal claim boundaries. The current global trend is to medicalise cosmetics. Brand owners adopting this claim strategy need to exercise caution as the regulator may crackdown at any time.
• Labelling and artwork rework costs, particularly for INCI declarations, warnings and Responsible Person details may become necessary depending on regulator enforcement ambition and capacity.
• Increased recall and suspension risk if documentation cannot be produced on demand since manufacturers and brandowners are required to hold all necessary regulatory documentation before market placement of products.
• Reputational exposure for brands positioned as “clinical”, “treatment-based” or “dermatologically corrective” without regulatory alignment if regulator enforcement capacity matches ambition.

Conversely, companies with strong compliance infrastructure gain faster, more defensible access to Botswana and reduced disruption during inspections or consumer complaints.

Botswana Market Entry Strategy Insights

• Botswana is positioning itself as a regulatory reference market in Southern Africa, not an outlier. Zimbabwe and Zambia are developing similar regulatory systems.
• Claims and advertising now represent the highest enforcement risk vector, presently and into the future, not formulation alone.
• BOMRA’s framework strongly favours prepared exporters over opportunistic entrants.

Recommended Remedial & Forward-Looking Actions

To anticipate regulatory impact, companies should:

• Appoint and empower a Botswana-based Responsible Person with clear escalation authority, depending ofcourse on their business model in the country.
• Audit product portfolios for medicinal claim creep and borderline therapeutic positioning. This will depend on regulator enforcement capacity.
• Ensure Product Information Files and Cosmetic Safety Reports are complete and inspection-ready.
• Align labels fully to INCI nomenclature, durability, warnings and Responsible Person disclosure requirements.
• Implement a cosmetovigilance and post-market surveillance plan before launch, not after enforcement.

Bottom Line

BOMRA’s Guideline signals that Botswana is open to cosmetic imports—but only to compliant ones. For exporters, the competitive advantage will lie not in speed to shelf, but in regulatory readiness, claim discipline and traceable accountability. Those who adapt early will secure market continuity; those who delay risk disruption, possible withdrawal and reputational damage.

Contact us for your company's custom Botswana readiness assessment.