Dimethyl Fumarate Analysis – DMF Testing
What Is Dimethyl Fumarate Analysis?
Dimethyl fumarate (DMF or DMFu, CAS 624-49-7) is a biocide that was used in small desiccant sachets placed inside the packaging of furniture, footwear and leather goods to prevent mould during storage and long-distance shipping. Dimethyl fumarate analysis measures the amount of DMF in a product or its parts in the laboratory and shows whether the product exceeds the limit set in Annex XVII of the EU REACH Regulation.
For companies exporting furniture, footwear, bags or leather goods to the EU, or importing them, DMF testing is the most practical way to document product safety and reduce the risk of recalls.
REACH Annex XVII Entry 61: The Legal Limit Behind Dimethyl Fumarate Analysis
On 17 March 2009 the European Commission adopted Decision 2009/251/EC, which banned products containing DMF from the EU market as an emergency measure. This temporary measure was later made permanent: Commission Regulation (EU) No 412/2012 added dimethyl fumarate to Annex XVII of the REACH Regulation as entry 61. Under this restriction:
- DMF shall not be used in articles or any parts thereof in concentrations greater than 0.1 mg/kg (0.1 ppm).
- Articles or any parts thereof containing DMF in concentrations greater than 0.1 mg/kg shall not be placed on the EU market.
The limit applies to each part of the article separately, not to the product as a whole. This is why the different materials of a product should be assessed individually when planning DMF testing.
Why Is DMF Hazardous?
Dimethyl fumarate was mostly packed in small sachets placed in furniture or shoe boxes to keep products dry and prevent mould. Because DMF evaporates easily, it can migrate from the sachet into the product and reach the skin of consumers who come into contact with it. Skin contact has been reported to cause itching, irritation, redness and burn-like allergic dermatitis, and some cases also reported respiratory complaints. Since DMF can act as a sensitiser even at very low levels, its presence in consumer products is regarded as a serious health risk.
Which Products Need DMF Testing?
If you import or manufacture furniture, bags, footwear, leather or textile products, you need to make sure your products are free of DMF. Dimethyl fumarate analysis is especially recommended for:
- Leather and faux-leather furniture (sofas, armchairs, chairs)
- Shoes, boots and slippers
- Leather accessories such as bags, wallets and belts
- Textile products shipped by sea for long periods or stored in humid conditions
- Products packed with desiccant sachets
Other hazardous substances restricted in furniture, bags and footwear include SVHCs, PAHs, phthalates, PFOS/PFOA, AZO dyes and other substances on the REACH Annex XVII restriction list.
How Is Dimethyl Fumarate Analysis Performed?
DMF testing is carried out in accredited laboratories. The process generally consists of the following steps:
- Sampling plan: Representative samples are selected from the different materials of the product, such as leather, textile, foam, lining and sole.
- Extraction: DMF is extracted from the sample with a suitable solvent.
- Measurement: The amount is determined by gas chromatography–mass spectrometry (GC-MS). For footwear and footwear components, ISO 16186:2021 is widely used.
- Reporting: Results are reported in mg/kg and compared with the 0.1 mg/kg limit of REACH Annex XVII entry 61.
If the packaging contains a desiccant sachet, the contents of the sachet can also be examined separately.
Doruksistem Dimethyl Fumarate Analysis Service
If you are an importer, you can ask your suppliers for an up-to-date test report covering DMF. Doruksistem provides DMF testing services to you or your suppliers and helps you document that your products comply with EU legislation. As a complementary service, we follow regulatory developments related to DMF and keep you informed.
Dimethyl Fumarate Analysis: Frequently Asked Questions
Are DMF and DMFu the same thing?
Yes. Dimethyl fumarate is abbreviated as DMF or DMFu. The abbreviation DMFu is often preferred to avoid confusion with dimethylformamide (DMF), a different substance used as a solvent. It is important to state clearly which substance is meant when requesting a test.
Does the 0.1 mg/kg limit apply to the whole product?
No. The limit applies to each part of the article separately, so separate samples from different materials are recommended.
Do products made in Türkiye need DMF testing?
All products placed on the EU market must comply with REACH Annex XVII entry 61. Restrictions under the Turkish KKDİK regulation should also be assessed for your product group.
How often should DMF testing be done?
It is good practice to test when a supplier, material or packaging changes and before a new product series is placed on the market.
For our other testing services, see our Test and Analysis Services page. For consultancy on EU chemical legislation, visit our REACH and CLP Services page.