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EU POPs regulations will add cloning restriction requirements

Time：

2025-06-03

The European Union has revised the Persistent Organic Pollutants (POPs) Regulation (EU) 2019/102 to include new control requirements for cloning.

On May 15, 2025, the European Commission approved an authorization regulation C (2025) 2887 to revise the EU Persistent Organic Pollutants (POPs) Regulation (EU) 2019/1021, proposing to add control requirements for clones in Part A of Appendix I to the POPs Regulation. This authorization regulation will be published in the Official Journal of the European Union (OJEU) and will come into effect on the 20th day from the date of its publication in the Official Journal of the European Union.

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01. Main content of authorization regulations

Material

CAS NO

Special exemptions for intermediate use or other specifications

Dechlorane plus "includes its cis and trans isomers

13560-89-9

135821-03-3

135821-74-8

1. For the purpose of this article, point (b) of Article 4 (1) applies to:

a) When the concentration of clones in a substance, mixture, or item is equal to or lower than 1000 mg/kg (0.1% by weight) [within 30 months after the regulation comes into effect]

b) When the concentration of clones in a substance, mixture, or item is equal to or lower than 1 mg/kg (0.0001% by weight) [30 months after the regulation comes into effect]

2. As an exemption, it is allowed to place the cloned product on the market and use it for the following situations:

(a) Aerospace, space, and defense applications, until [5 years after the regulation comes into effect];

(b) Medical imaging applications, up to 5 years after the regulation comes into effect;

(d) Spare parts and maintenance for the following purposes:

(i) Land based motor vehicles;

(i) Fixed industrial machinery used in agriculture, forestry, and construction industries

(iii) Marine, garden, forestry, and outdoor electrical equipment, except as covered by item (ii);

(iv) Aerospace, space and defense applications; (v) Instruments used for analysis, measurement, control, monitoring, testing, production, and inspection, which are clones of the equipment used for the first time in production until the end of their service life or until December 31, 2043, whichever is earlier.

(e) Spare parts and repairs for any of the following:

(i) Medical devices and their accessories within the scope of Regulation (EU) 2017/745; (ii) In vitro diagnostic medical devices and their accessories within the scope of Regulation (EU) 2017/746; The cloning of the above equipment used for the first time in production until the end of its service life.

3. The European Commission should assess whether specific exemptions in points (a), (b), and (c) need to be extended before April 1, 2028.

4. Items containing clones that have been used within the European Union before or on the expiration date of the relevant exemptions specified in points (a) to (d) of paragraph 2 of this Article may continue to be used.

5. Allow the production or import of spare parts containing cloning as mentioned in point 2 (d) (iv) within the European Union before or on December 31, 2043, for market and use.

02. Dechlorane Plus

Dechlorane is an additive flame retardant, also known as Dechlorane Plus (DCRP), used as a flame retardant in many applications, including wire and cable sheaths, electrical and electronic equipment parts, automotive parts, aircraft and other transportation related parts, hard plastic connectors, and plastic roofing materials.

03. POPs regulations

Persistent Organic Pollutants (POPs) are a type of natural or synthetic organic pollutant that has long-term persistence, bioaccumulation, semi volatility, and high toxicity, and can migrate over long distances through various environmental media (atmosphere, water, organisms, etc.), posing serious hazards to human health and the environment.

The main purpose of POPs regulations is to protect human health and the environment from the hazards of POPs, by reducing their production, use, and emissions, lowering their concentrations in the environment, and thereby reducing potential threats to ecosystems and humans. The regulations also require proper management and disposal of waste containing POPs to prevent secondary pollution to the environment.

04. Jiayu Testing Reminder

In recent years, the EU's POPs regulations have been updated frequently and enforcement efforts have been continuously strengthened. There have also been more and more cases of Chinese products being reported for violating POPs regulations when exporting to the EU. Enterprises should pay timely attention to regulatory developments, respond to adjustment strategies, ensure that products comply with new regulatory requirements, and reduce the risk of violations.

Jiayu Testing has a professional testing technology team equipped with advanced instruments and equipment, proficient in various regulatory standards. We specialize in providing customized testing services for POPs substances and global environmental regulation testing consulting services for various products such as electronic and electrical products, food contact materials, toys, and children's products. We provide you with a comprehensive and complete one-stop testing and certification solution. Welcome to consult.