Singapore Regulatory News

Effective 1 July 2024, Singapore’s Health Sciences Authority (HSA) has announced a revision to its fee structure for cosmetic product notifications and Good Manufacturing Practice (GMP) certificatio...

Effective 1 July 2024, Singapore’s Health Sciences Authority (HSA) has announced a revision to its fee structure for cosmetic product notifications and Good Manufacturing Practice (GMP) certifications. The adjustment, which represents an average increase of 5%, is made under the Health Products (Fees) Amendment Regulations 2024. The move aims to recover a portion of the operational costs incurred by the HSA in providing these services to businesses.

Revised Cosmetic Notification Fees

The changes will impact a number of cosmetic products, including those applied to the eyes or lips, oral or dental care items, and hair dyes containing diamine compounds. For these specific products, the notification or renotification fee has increased by S$1 to S$28 for a single product or the first three variants of a product.

For other cosmetic products, businesses will now pay S$13 per product or the first three variants, compared to the previous fee of S$12. The notification fee for the fourth and subsequent variants has also increased slightly, from S$7 to S$8 per additional variant.

Updates to GMP Certification Fees

In addition to cosmetic notifications, GMP certification fees have also been revised. The application fee for GMP certification has increased by S$200 to S$4,440. For each additional GMP certificate that does not require further assessment of compliance with GMP standards, the fee has increased by S$8 to S$220.

HSA’s Rationale and Business Impact

The HSA has emphasized that these adjustments are necessary to maintain the quality of services provided to businesses, while ensuring a fair distribution of costs. While modes, these revisions reflect the authority’s commitment to sustaining high regulatory standards while adapting to operational needs.

Key Takeaways for Businesses

For businesses in the cosmetics and healthcare industries, these changes underline the importance of reviewing their cost structures and ensuring compliance with the updated regulations. While the increases are incremental, they serve as a reminder of the ongoing costs associated with maintaining high-quality and safe products in the marketplace.

Next Steps for Compliance

As these new fees take effect, businesses are encouraged to stay informed and plan accordingly to avoid any disruptions to their operations. This update is not just a fee adjustment, but a step towards ensuring the long-term sustainability of regulatory processes that protect public health.

On 14 June 2024, Enterprise Singapore invited public feedback on revisions to standards on N-nitroso diethanolamine (NDELA) and cosmetic raw materials.   Enterprise Singapore Enterprise Sing...

On 14 June 2024, Enterprise Singapore invited public feedback on revisions to standards on N-nitroso diethanolamine (NDELA) and cosmetic raw materials.

Enterprise Singapore

Enterprise Singapore (ESG), a statutory board under the Ministry of Trade and Industry, manages Singapore's national standards. Through the industry-led Singapore Standards Council, ESG manages the Singapore Standardisation Programme, promoting standards to meet industry needs and government objectives. As the national accreditation body, ESG also manages the Singapore Accreditation Council (SAC), which develops accreditation schemes to support market access, security, and health and safety initiatives.

Background on NDELA

NDELA, a type of nitrosamine, is a potential human carcinogen found in cosmetics. It is formed when nitrosating agents react with diethanolamine (DEA) and triethanolamine (TEA).

DEA and TEA are both used in skin care and cosmetic formulations, as well as many other goods. Dermal studies by the US National Toxicology Program have linked these substances to carcinogenic activity in mice.

The proposed standards aim to study analytical methods for the detection and quantification of NDELA, such as high-performance liquid chromatography (HPLC) combined with post-column photolysis and derivatization.

The standards released for public feedback are as follows:

• The SS ISO 10130:2017 standard outlines a method for the detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics and cosmetic raw materials using high-performance liquid chromatography (HPLC) combined with post-column photolysis and derivatization.

• The SS ISO 12787:2017 standard defines validation criteria for chromatographic results to ensure confidence in performance, reliability and quality.

• The SS ISO 15819:2017 standard describes a single laboratory approach to chromatographic analysis.

Additional Standards for Review

ESG is also seeking public feedback on the following standards related to cosmetics:

Guidelines on Technical Definitions and Criteria for Natural and Organic Cosmetic Ingredients and Products

• Part 1: Ingredient Definitions (SS ISO 16128-1:2016): This standard provides guidance on definitions for natural and organic cosmetic ingredients. It also defines other ingredient categories necessary for the development of natural and organic products with associated restrictions.

• Part 2: Criteria for Ingredients and Products (SS ISO 16128-2:2017): This standard specifies methods for determining natural, natural origin, organic and organic origin indexes for the ingredient categories defined in ISO 16128-1.

Cosmetic Microbiology – Guidelines for the Risk Assessment and Identification of Microbiologically Low-Risk Products (SS ISO 29621:2017)

• This standard guides for cosmetic manufacturers to identify finished products that present a low risk of microbial contamination during production and use, and for which microbiological testing standards for cosmetics are not required.

These standards are under review with the intention of confirming them.

Deadline for Comments

The deadline for public comments on the mentioned standards is 15 July 2024.

On 6 May 2024, Singapore’s National Environment Agency (NEA) announced revised compliance dates for Dechlorane Plus, Methoxychlor, and UV-328 under the Stockholm Convention.   Chemicals Added...

On 6 May 2024, Singapore’s National Environment Agency (NEA) announced revised compliance dates for Dechlorane Plus, Methoxychlor, and UV-328 under the Stockholm Convention.

Chemicals Added to Annex A to the Stockholm Convention

At the 11th Conference of the Parties (COP) to the Stockholm Convention in May 2023, the Parties agreed to include Dechlorane Plus, Methoxychlor and UV-328 in Annex A for elimination, subject to certain exemptions. Following this decision, the NEA issued a circular to industry stakeholders on 24 July 2023 that the manufacture, import and export of these chemicals and products containing them would be prohibited in Singapore with effect from 12 May 2024.

Revised Compliance Date

However, the listing of Dechlorane Plus, Methoxychlor and UV-328 in Annex A to the Stockholm Convention was not officially communicated via a Depositary Notification until 26 February 2024. According to the rules of the Stockholm Convention, amendments to the Annexes take effect for all Parties one year after the date of notification. Consequently, the effective date for Singapore to cease the manufacture, import, and export of Dechlorane Plus, Methoxychlor and UV-328 has been revised to 26 February 2025 to meet the Convention deadline.

Details on Exemptions and HS Codes to Follow

The NEA will provide further details on specific exemptions in due course. Industry stakeholders are advised to refer to the annex attached to the announcement for the list of applicable Harmonized System (HS) and Product Codes required for the declaration of  import and export TradeNet® licence applications. All such applications will be subject to approval by the Chemical Control and Management Department (CCMD).

On 6 May 2024, Singapore’s National Environment Agency (NEA) announced revised compliance dates for Dechlorane Plus, Methoxychlor, and UV-328 under the Stockholm Convention.   Chemicals Added...

On 6 May 2024, Singapore’s National Environment Agency (NEA) announced revised compliance dates for Dechlorane Plus, Methoxychlor, and UV-328 under the Stockholm Convention.

Chemicals Added to Annex A to the Stockholm Convention

At the 11th Conference of the Parties (COP) to the Stockholm Convention in May 2023, the Parties agreed to include Dechlorane Plus, Methoxychlor and UV-328 in Annex A for elimination, subject to certain exemptions. Following this decision, the NEA issued a circular to industry stakeholders on 24 July 2023 that the manufacture, import and export of these chemicals and products containing them would be prohibited in Singapore with effect from 12 May 2024.

Revised Compliance Date

However, the listing of Dechlorane Plus, Methoxychlor and UV-328 in Annex A to the Stockholm Convention was not officially communicated via a Depositary Notification until 26 February 2024. According to the rules of the Stockholm Convention, amendments to the Annexes take effect for all Parties one year after the date of notification. Consequently, the effective date for Singapore to cease the manufacture, import, and export of Dechlorane Plus, Methoxychlor and UV-328 has been revised to 26 February 2025 to meet the Convention deadline.

Details on Exemptions and HS Codes to Follow

The NEA will provide further details on specific exemptions in due course. Industry stakeholders are advised to refer to the annex attached to the announcement for the list of applicable Harmonized System (HS) and Product Codes required for the declaration of  import and export TradeNet® licence applications. All such applications will be subject to approval by the Chemical Control and Management Department (CCMD).

On 15 March 2024, Singapore has announced plans to phase out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS) listed under the Stockholm Convention. Singapore is a p...

On 15 March 2024, Singapore has announced plans to phase out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS) listed under the Stockholm Convention. Singapore is a party to the Stockholm Convention which aims to eliminate Persistent Organic Pollutants (POPs) such as PFAS.

Implementation and Threshold Limits

Effective from 1 January 2026, Singapore will phase out the import and use of fire-fighting foams containing perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), along with their salts and related compounds. However, companies can continue to use these foams after 1 January 2026 if the concentrations of trace contaminants in them are below certain threshold limits: 25 ppb for PFOA and 10,000 ppb for PFOS. For perfluorohexane sulfonic acid (PFHxS) and related compounds the threshold limit is 100 ppb.

Mandatory Compliance Measures

Companies storing or using firefighting foams containing PFOA, PFOA and PFHxS above the threshold concentrations are required to engage Toxic Industrial Waste Collectors (TIWCs) licensed by the National Environment Agency (NEA) for the safe collection and disposal of these chemicals. Traders are also advised to use appropriate Harmonized System (HS) and product codes when declaring imports and exports of affected materials in TradeNet® permit applications. Applications will be subject to processing and approval by the Chemical Control and Management Department (CCMD).

A list of HS and product codes of the affected materials can be found in the table below:

Conclusion

This announcement demonstrates Singapore's commitment to environmental protection and is in line with global efforts to reduce the use of harmful chemicals in fire-fighting foams. For further enquiries, stakeholders can contact Ms. Nikki Lee via email at Nikki_Lee@nea.gov.sg.

The National Environment Agency (NEA) of Singapore launched a public consultation on 18 January 2024. The consultation seeks public input on the proposed regulation of medium-chain chlorinated paraffi...

The National Environment Agency (NEA) of Singapore launched a public consultation on 18 January 2024. The consultation seeks public input on the proposed regulation of medium-chain chlorinated paraffins (MCCPs), long-chain perfluorocarboxylic acids (LC-PFCAs) and nine mercury-added products under the Environmental Protection and Management Act (EPMA) and the Environmental Protection and Management (Hazardous Substances) Regulations (EPM(HS) Regulations). The consultation closes on 15 February 2024.

Aim of the consultation

As a signatory to the Stockholm and Minamata Conventions, Singapore is committed to reducing the use of persistent organic pollutants (POPs) and mercury emissions. As the competent authority, NEA ensures compliance with these international agreements.

NEA's primary objective with the proposed controls is to regulate two groups of chemicals and nine mercury-added products by classifying them as hazardous substances. This is in line with international obligations under the Stockholm and Minamata Conventions, which aim to reduce the environmental and health risks posed by these substances.

Two groups of chemicals proposed for control

NEA has identified two groups of chemicals to be regulated:

• Medium-chain chlorinated paraffins (MCCPs): Chlorinated paraffins with carbon chain lengths in the range C14-C17 and chlorination level equal to or exceeding 45 % chlorine by weight. MCCPs are considered to be persistent and may be long-range transported in the environment.

• Long-chain perfluorocarboxylic acids (LC-PFCAs): Perfluorocarboxylic acids with chain lengths in the range C9-C21, their salts and related compounds. LC-PFCAs are characterised by their persistence and bioaccumulation in the environment. Moreover, long-chain PFCAs, their salts and related compounds may be long-range transported in the environment.

MCCPs and LC-PFCAs are expected to be added to Annex A of the Stockholm Convention at the 12th Conference of the Parties (COP12) to be held in 2025. NEA plans to introduce strict controls on the import, export, and use of these chemicals, allowing current operations under specific licences until a ban by the Stockholm Convention is adopted in 2025.

Proposed controls on mercury-added products

NEA also focuses on nine specific mercury-added products to be phased out by the end of 2024. These products, which include certain types of lamps, measuring devices, and electronic components, are recognised as being harmful to the environmental because they can release mercury.

The list includes the following products:

• Compact fluorescent lamps with an integrated ballast (CFL.i) for general lighting purposes that are ≤ 30 watts with a mercury content not exceeding 5 mg per lamp burner 

• Cold cathode fluorescent lamps and external electrode fluorescent lamps of all lengths for electronic displays

• Mercury vacuum pumps

• Tyre balancers and wheel weights

• Photographic film and paper

• Propellant for satellites and spacecraft 

The full list of products is available here. The ban on their manufacture, import, and export will take effect from 1 January 2025.

Call for public participation

Feedback to the consultation can be submitted via NEA’s online form here or by sending an email to Primus_ONG@nea.gov.sg and Nikki_LEE@nea.gov.sg by 15 February 2024.  NEA looking for clear, concise, and constructive comments. Respondents are encouraged to identify their affiliations and provide substantiated suggestions or data to enrich the consultation process. 

The National Environment Agency (NEA) of Singapore is seeking feedback on proposed regulations regarding formaldehyde content in paints. The aim is to restrict the availability (both in retail stores ...

The National Environment Agency (NEA) of Singapore is seeking feedback on proposed regulations regarding formaldehyde content in paints. The aim is to restrict the availability (both in retail stores and online) of formaldehyde-containing paints that are intended for indoor use. The consultation closes on 13 December 2023.

Formaldehyde (CAS No. 50-00-0)) is widely used in the manufacture of resins, as a disinfectant, or as a preservative in building materials. It is added to paints to inhibit bacterial and fungal growth. Exposure to formaldehyde can cause adverse health effects.

The following controls have been proposed by NEA:

• Only indoor paints without added formaldehyde will be allowed to be sold in Singapore (the measured formaldehyde content must be less than 0.01 % w/w).

• A Hazardous Substance (HS) licence will be required for companies manufacturing and/or importing indoor paints with added formaldehyde for export or re-export purposes.

• Labelling requirements will be imposed on industrial paints and outdoor paints containing formaldehyde.

The proposed controls are expected to take effect from 1 July 2025 to allow industry time to prepare.