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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