• Move to ensure safety, quality standards of locally manufactured, imported cosmetics

Sri Lanka is set to introduce a new law to regulate cosmetics, addressing a long-standing gap in the country’s regulatory framework. The move comes as part of an effort to ensure that cosmetic products, both locally manufactured and imported, meet safety and quality standards. 

This decision follows concerns raised over harmful substances found in certain cosmetic products and the lack of a comprehensive legal mechanism to regulate the industry.

Current regulatory landscape

Under the present system, the National Medicines Regulatory Authority (NMRA) oversees the regulation of drugs, medical devices, and borderline products. Previously, cosmetics were governed under the Cosmetics, Devices, and Drugs Act No.27 of 1980. 

However, when the NMRA Act was enacted in 2015, it was decided that cosmetics should be regulated through a separate law, which never materialised. As a result, there has been a legal vacuum in the regulation of cosmetics for nearly a decade.

Speaking to The Sunday Morning, NMRA Chairman Dr. Ananda Wijewickrama explained that while the Ministry of Health had drafted a bill for cosmetic regulation in the past, it had never been submitted to Parliament. The absence of this law left the industry largely unregulated, creating concerns about the safety of products available in the market. 

Recognising this issue, the Cabinet had approved interim measures to allow the NMRA to register certain cosmetic products, particularly those intended for export. However, there remains no formal legal provision empowering the authority to regulate cosmetics comprehensively.

Deputy Minister of Health and Mass Media Dr. Hansaka Wijemuni confirmed to The Sunday Morning that discussions were ongoing to develop a dedicated regulatory framework for cosmetics. He emphasised that the Government had acknowledged the loopholes in the current system and was committed to enacting new legislation within the year. 

“The matter was raised before Cabinet, and through a Cabinet paper, approval was received for certain guidelines which empowered the NMRA to perform certain functions regarding monitoring cosmetics, including registering products and granting approval. However, this authority is not comprehensive and there remains a considerable gap that should be addressed,” he said.

Dr. Wijewickrama explained that the registration process was done by the Cosmetic Evaluation Subcommittee which was approved by the Cabinet. The process is aimed to benefit local manufacturers who require some form of a certificate of registration to facilitate exports. However, there is no compulsion to acquire such a certificate, according to the NMRA Chairman.

The need for regulation

One of the primary concerns surrounding cosmetics regulation in Sri Lanka is the presence of harmful substances in certain products. 

Studies conducted by various agencies, including the Sri Lanka Standards Institution (SLSI), had revealed high concentrations of hazardous chemicals such as mercury in some cosmetics, Dr. Wijewickrama explained. These substances pose significant health risks, including skin disorders, organ damage, and other long-term effects.

Furthermore, the industry has witnessed a rise in unethical promotions, particularly through social media. Dr. Wijewickrama highlighted concerns about products such as glutathione injections, marketed as skin-whitening treatments, despite their potential for severe side effects. “Without proper regulations, such products continue to be sold freely, putting consumers at risk,” he warned.

Dr. Wijemuni noted that while many cosmetic manufacturers operated in compliance with industry standards, some exploited legal loopholes to bypass regulations. Some companies register their products under alternative categories such as Ayurvedic products or food products to avoid further scrutiny. This further underscores the urgency of establishing a robust regulatory framework.

“The matter also applies to the import of cosmetics. Generally, when a product is being imported into the country, there is a request for NMRA approval. However, this is not mandatory at present. Such products can be imported even without NMRA approval. Therefore, there is a high propensity for such products to enter the country unchecked and introduce potential hazards to users of cosmetic products,” Dr. Wijemuni said.

Steps towards regulation

To address these challenges, the Government has initiated a multi-phase process for drafting the new cosmetics act. According to Dr. Wijemuni, an internal committee has been formed to develop preliminary guidelines for regulating the industry. 

Once these guidelines are established, an expert committee comprising specialists in Ayurveda, science, law, and regulatory affairs will be appointed to refine the legal framework.

The proposed law will cover both locally manufactured and imported cosmetics. At present, cosmetic imports are not subject to stringent regulatory checks, with NMRA approval being requested only in some cases, such as through Customs procedures. 

However, under the new law, NMRA approval would be made mandatory for all cosmetic imports, ensuring that products entering the market complied with safety and quality standards, Dr. Wijemuni stated.

“Undoubtedly, there are challenges, because these are sensitive matters and the law must be drafted carefully to avoid permitting loopholes. However, we aim to act swiftly and introduce the bill to Parliament within the year,” he said.

Dr. Wijemuni indicated further challenges prior to producing the proposed bill to Parliament. “We have introduced a mechanism to enable the NMRA to control medicine prices and we have already forwarded it for the consent of the Attorney General. If we receive consent, we can proceed, but there are inevitable delays from various fronts because these are sensitive topics, but we will proceed with it very soon,” he said.

Challenges in enforcement

Despite the proposed regulatory advancements, challenges also remain in enforcing cosmetic regulations effectively. Dr. Wijewickrama acknowledged that the NMRA had limited resources and was primarily focused on pharmaceuticals and medical devices. 

Given its existing responsibilities, the NMRA may struggle to take on the additional burden of regulating cosmetics unless adequate support and resources are provided.

Dr. Wijemuni also weighed in on the issue. “The NMRA generally checks the ingredients of cosmetic products and the chemicals, but even if there is a detection of unethical or harmful use of chemicals, the NMRA does not have the power to halt such production. Since 2015, the authority has shouldered enormous burdens, and it is also shouldering responsibilities pertaining to cosmetics. 

“Some of the appointments to the NMRA board were only made after we came to power, so the authority needs to be supported. We are hoping that the proposed act to regulate cosmetics will complement the work of the NMRA,” he said.

In the absence of direct NMRA oversight to control the production and supply of cosmetic goods, especially those which may contain harmful substances, consumers currently have the option of reporting concerns to the Consumer Affairs Authority (CAA). 

However, as Dr. Wijemuni pointed out, the CAA lacks the technical expertise to assess scientific and chemical aspects of cosmetic products. This limitation hampers its ability to take decisive action against potentially harmful products. 

“To understand how these chemicals are used in the formulation of different cosmetic goods, it is critical to employ scientific knowledge. The CAA has the authority to act on such subjects, but lacks the knowledge and expertise to deal with the problem. This is another reason why we need to regulate cosmetic products using a separate law,” he said.

To bridge this gap, the new law will likely outline a clearer division of responsibilities between regulatory bodies, ensuring that cosmetic safety assessments are conducted by qualified professionals. Additionally, there are discussions on strengthening collaborations between the NMRA, the CAA, and other relevant authorities to enhance enforcement mechanisms.

Looking ahead

As Sri Lanka moves towards enacting a new cosmetics act, stakeholders across the industry and regulatory bodies will need to work together to ensure its successful implementation. The introduction of this law is expected to bring much-needed oversight to the cosmetics sector, protecting consumers from harmful substances while fostering a safer and more transparent market.

Dr. Wijemuni emphasised the Government’s commitment to closing existing loopholes and ensuring that all cosmetics, regardless of their classification, fall under a standardised regulatory framework. The law will be enacted through Parliament within the year, setting a new precedent for cosmetics regulation in Sri Lanka.