Several amendments/supplements to EU chemical regulations aimed at implementing the CSS include:

Draft amendment to the Classification, Labelling and Packaging (CLP) Regulation:

The draft amendment to the EU CLP Regulation was published by the European Commission on December 19, 2022. The European Parliament and the Council of the European Union adopted the amended CLP Regulation on April 23, 2024, and October 14, 2024, respectively. Following signature by the Presidents of the European Parliament and the Council, the amended CLP Regulation will be published in the Official Journal of the European Union and will enter into force 20 days later.

One key change in the amended CLP Regulation is the addition of new hazard classes to include endocrine disruptors (EDCs); persistent, bioaccumulative and toxic (PBT) substances; very persistent and very bioaccumulative (vPvB) substances; persistent, mobile and toxic (PMT) substances; and very persistent and very mobile (vPvM) substances. Consequently, chemical manufacturers will need to update labels on packaging, Safety Data Sheets, and registration dossiers under REACH.

Changes in classification under CLP will automatically trigger restrictions and bans on chemicals under the Generic Risk Approach (GRA). Being classified in a new hazard class will mean automatic restriction or ban without a substance-specific risk assessment. Although this option already exists in the current REACH regulation, the number of substances subject to generic restrictions and bans will increase significantly with more hazard classes added to CLP.

Additionally, the amended CLP Regulation includes updates to labeling requirements, such as minimum font sizes and allowing for digital labeling. The online Classification and Labelling Inventory, managed by the European Chemicals Agency (ECHA), will streamline hazard communication with clearer and more transparent information and facilitate the classification of substances and mixtures.

Amended Regulation on Mercury:

The amended Regulation on Mercury (Regulation 2024/1849 of June 13, 2024, amending Regulation 2017/852 on mercury as regards dental amalgam and other mercury-added products whose manufacturing, export/import is restricted) entered into force on July 30, 2024.

Under the amended regulation, the import and manufacturing of dental amalgam will be prohibited from July 1, 2026, except for specific medical needs (in these cases, before May 31 each year, importers and manufacturers of dental amalgam must report to the competent authority the quantity of dental amalgam they have imported or manufactured in the preceding year).

Also under the amended regulation, EU Member States will have to phase out the manufacturing, import, and export of certain mercury-containing lamps (starting from December 31, 2025, or December 31, 2026, depending on the lamp type). These lamps will be replaced by alternatives such as LEDs, which are less toxic and more energy-efficient.

Criteria and Principles for Essential Use of Chemicals:

The criteria and principles for determining the essential use of chemicals were published in the EU Official Journal on April 26, 2024.

The overall objective of the essential use concept is to support decision-making and enhance management effectiveness to swiftly phase out the most harmful substances in non-essential uses, while still allowing essential societal uses. Applying the set of criteria and principles for determining essential use will encourage companies to proactively phase out the most harmful substances and focus on researching and innovating safe and sustainable alternatives.

Criteria for determining essential use: The use of a substance of very high concern is considered essential for society if it meets two criteria: (i) the use is necessary for health and safety or critical for the functioning of society, and (ii) there are no suitable alternative solutions.

Core principles of the essential use concept include:

- The aim is to enhance the protection of human health and the environment by phasing out non-essential uses of substances of very high concern.

- The concept aims to determine whether the use of a substance of very high concern is essential for society. In all cases, the context of the use or the purpose it serves for society and the user needs to be considered. A use can be critical in one context but not in another (e.g., the need for a substance with a specific technical function in a surgical lamp in a hospital may be different from the need for that substance in a lamp at home or in a shop).

- The concept does not aim to determine whether a substance, product, product group or service is essential for society, or whether an individual consumer or a company considers the use to be essential.

- To demonstrate essentiality, it must be shown that both criteria mentioned above are met.

- The essentiality of a use is not static and can change over time, depending on new information on hazards, new societal challenges and needs, and the emergence of new alternatives.

The essential use concept only has legal effect when incorporated into specific laws/regulations. Before applying the concept to a specific regulation, careful consideration of its applicability, including the "acceptable alternative" criterion, is required, taking into account the specific objectives, needs, and characteristics of the relevant sectoral legislation. The essential use concept is likely to be applied equally to EU-produced and imported products, thereby maintaining a level playing field for EU businesses.

Source: Center for WTO and International Trade - VCCI 

The following documents are attached for your reference:

• Proposal For A Revision Of The Regulation On Clp
• Regulation 2024.1849
• Guiding Criteria And Principles For The Essential Use

• Export Situation of Affected Vietnamese Goods to the EU?
• Vietnam's Exports Facing Challenges from the Chemicals Strategy for Sustainability (CSS)