Formaldehyde Reclassification Carcinogen Cat1B EU REACH

Are you at risk of exceeding the REACH formaldehyde limit?

Per 1 January 2016 a full Registration is required for formaldehyde if the imported volume exceeds, or is expecting to exceed, 1 ton per year. Registration at the European Chemicals Agency (ECHA) needs to be done by a REACH Only Representative (OR) established in the EU. Without this registration you are no longer allowed to import your product into Europe if it contains formaldehyde. CAPLINQ as your REACH Only Representative, can help determine if you have surpassed the REACH formaldehyde limit, so you may continue serving your European customers.

Some background information

The International Agency for Research on Cancer (IARC) classified formaldehyde as a “known” human carcinogen already in 2004, for nasopharyngeal cancer. In 2009, IARC confirmed the classification and claimed that formaldehyde exposure could also be associated with Leukemia.

Formaldehyde has been reclassified as a Carcinogen Category 1B effective per 1 January 2016

In June 2011, the US Department of Health and Human Services’ (HHS) National Toxicology Program (NTP) controversially listed formaldehyde as a ‘known carcinogen’ in its 12th Report on Carcinogens (12th RoC). The French competent authority for the European classification, labelling and packaging (CLP) Regulation excluded Leukemia as a relevant hazard in its proposed harmonized classification for formaldehyde. France proposed to classify formaldehyde as a “known” human carcinogen (1A) but only for the rare nasopharyngeal cancer.

ECHA did not agree with France’s proposed classification and adopted the lower Carcinogen Category 1B in 2014. For ECHA, the data available on humans did not warrant a carcinogen 1A classification. The new classification entered into force in June 2014 when it was published in the Official Journal of the European Union.

The authorities have foreseen a transition period allowing suppliers to adapt to the new classification. In November 2014 the EU REACH Committee agreed via written procedure to postpone the deadline for the transition period until 1 January 2016. On March 23 2015, the decision was formally confirmed with the publication of the Commission Regulation 2015/491. Industry had therefore until 1 January 2016 to comply with the new classification.

CAPLINQ is a specialty chemicals, plastics and products company that specializes in making foreign companies compete on a level playing field with European suppliers. Visit to learn more about our REACH services including our REACH Only Representation. You can also contact us if you have further questions about whether you risk exceeding the REACH formaldehyde limit.

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