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Annex XVII of the EU REACH regulation adds the 77th item on formaldehyde control

Date:2023-07-21 10:53:39 Classification :【Statute】 Visits:
On July 17, 2023, the European Union published a revised regulation (EU) 2023/1464 in its official gazette, which includes a new clause 77 on formaldehyde and formaldehyde releasing substances in the restricted section (Annex XVII of the REACH regulation). This clause will take effect on the 20th day after its publication in the Official Journal of the European Union. The new clause reads as follows:

Control clause

77. Formaldehyde


CAS number: 50-00-0


EC Number: 200-001-8

And formaldehyde releasing substances


After August 6, 2026, if tested under the testing conditions specified in Appendix 14, the formaldehyde concentration released from the article exceeds the following concentrations, it will not be placed on the market:

(a) 0.062 mg/m3 for furniture and wood products;

(b) Products other than furniture and wooden products are 0.080 mg/m3.

Article 1 does not apply to:

(a) Formaldehyde or formaldehyde releasing substances are only naturally present in the materials used to produce the item;

(b) Items specifically designed for outdoor use under foreseeable conditions;

(c) Building items specifically designed for use outside the building shell and moisture-proof layer without releasing formaldehyde into indoor air;

(d) Articles exclusively intended for industrial or professional use, unless the formaldehyde released causes public exposure under foreseeable conditions of use;

(e) Articles subject to the limitations specified in Article 72;

(f) Articles belonging to sterilization products within the scope of Regulation (EU) No 528/2012 of the European Parliament and Council;

(g) Equipment regulated by (EU) 2017/745 regulations;

(h) Personal protective equipment within the scope of Regulation (EU) 2016/425;

(i) Articles that come into direct or indirect contact with food within the scope of (EC) No 1935/2004;

(j) Used items.

If the formaldehyde concentration inside road vehicles exceeds 0.062 mg/m3 during testing under the test conditions specified in Appendix 14, it shall not be placed on the road vehicle market after August 6, 2027.

Paragraph 1 does not apply to:

(a) Road vehicles designed for industrial or professional use, unless the formaldehyde concentration inside these vehicles causes the public to come into contact with formaldehyde under foreseeable usage conditions;

(b) Used cars.

Add Appendix 14

1. Measurement of formaldehyde released into indoor air by items mentioned in Article 77, Paragraph 1, Item 1

The formaldehyde released by the items mentioned in Article 77, Paragraph 1, Item 1 shall be measured in the air of the test chamber under the following cumulative reference conditions:

(a) The temperature inside the test chamber should be (23 ± 0.5) ℃;

(b) The relative humidity inside the test chamber should be (45 ± 3)%;

(c) The load factor, expressed as the ratio of the total surface area of the specimen to the volume of the test chamber, should be (1 ± 0.02) m2/m3. This load factor is applicable to the test of Engineered wood; For other materials or products, if the load factor is significantly unrealistic under foreseeable usage conditions, a load factor in accordance with section 4.2.2 of EN 16516 can be used;

(d) The air exchange rate in the test chamber should be (1 ± 0,05) h-1;

(e) Appropriate analytical procedures should be used to measure the formaldehyde concentration in the test chamber;

(f) Appropriate sample sampling methods should be used;

(g) During the entire test period, the formaldehyde concentration in the air of the test chamber should be measured at least twice a day, with a time interval of at least 3 hours between two consecutive samples; Measurements should be repeated until sufficient data is available to determine steady-state concentrations;

(h) The test time should be long enough to determine the steady-state concentration, but should not exceed 28 days;

(i) The steady-state concentration of formaldehyde measured in the test chamber shall be used to verify compliance with the formaldehyde emission limits of the items mentioned in Article 77, Paragraph 1, Item 1.

If the data obtained using the test method with the above reference conditions does not have or is not suitable for measuring the formaldehyde release of a specific item, the data obtained using the test method with non reference conditions can be used, but there must be a scientifically valid correlation between the results of the test method used and the reference conditions.

2. Measurement of formaldehyde concentration inside vehicles as described in Article 77, Paragraph 2, Item 1

For road vehicles, including trucks and buses, the concentration of formaldehyde should be measured in environmental mode according to the conditions specified in ISO 12219-1 or ISO 12219-10, and the measured concentration should be used to verify compliance with the limit values mentioned in item 77, paragraph 2, item 1.

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