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 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).