EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of resorcinol as a substance of very high concern pursuant to 
Article 57, point (f), of Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of resorcinol as a substance of very high concern pursuant to 
Article 57, point (f), of Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to  Regulation (EC) No 1907/2006 of the Europea n Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
59(9) thereof , 
Whereas:  
(1) On 25 February 20 20, France submitted to the European Chemicals Agency (‘the 
Agency’), in accordance with  Article 59(3) of Regulation (EC) No 1907/2006, a 
dossier prepared in accordance with Annex XV to that Regulation (‘Annex XV 
dossier’) for the identification of resorcinol (EC No 203 -585-2, CAS No 108 -46-3) as 
a substance of very high concern in accordance with  Article 57 , point (f), of that 
Regulation due to its endocrine disrupting properties, for which there is scientific 
evidence of probable serious effects to human health , which give rise to an equivalent 
level of concern to those of other substances listed in Article 57 , points (a) to (e), of 
Regulation (EC) No 1907/2006 . 
(2) On 12 June 2020, the Member State Committee of the Agency (MSC) adopted its 
opinion2 on the Annex XV d ossier. Whil e a majority of the MSC members considered 
that, because of its thyroid disrupting properties causing serious effects to human 
health, resorcinol should be identified as a substance of very high concern pursuant to 
Article 57 , point (f), of Reg ulation (EC) No 1907/2006 , the MSC did not  reach 
unanimous agreement. Eight  members abstained from the vote and three members 
were of the opinion that there is not sufficient scientific evidence of probable serious 
effects to human health which give rise t o an equivalent level of concern to those of 
other substances listed in Article 57 , points (a) to (e) , of Regulation (EC) No 
1907/2006 . Furthermore, two members that abstained from the vote made statements 
expressing concerns that in some studies the admin istration of resorcinol d id not lead 
to adverse effects  and that the specific exposure conditions in the human case studies 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 https://echa.europa.eu/documents/10162/23665416/svhc_msc_opinion_recorcinol_16293_en. 
pdf/5ff2f41c -409e -7ab8 -636e -e74aa17c49f0  
 EN 2  EN impeded a clear conclusion on whether resorcinol give s rise to an equivalent level of 
concern  to those substances listed in Article 57 , points (a) to (e).    
(3) On 16 July 2020 , pursuant to Article 59(9) of Regulation (EC) No 1907/2006, the 
Agency referred the MSC opinion to the Commission for a decision on the 
identification of resorcinol as a substa nce of very high concern on the basis of Article 
57, point (f), of that Regulation.  
(4) The Commission notes, in line with the majority of the MSC  members , that m edical 
case reports provide evidence that the application of ointments containing high 
concentrations of resorcinol to ulcerated or to undamaged skin over long periods led to 
hypothyroidism in patients , which was reversible upon cessation of exposure. 
Although most of these results  were  based on exposure via ulcerated skin , they are of 
high relevance for hazard identification  in a regulatory context  since they provide 
direct information that resorcinol results in serious  adverse  effects in humans.  
(5) The Comm ission considers that inconsistent findings in a two -generation reproductive 
toxicity study as well as the lack of effects seen in  reliable animal studies with dermal 
exposure or with resorcinol administered via gavage, as referred to in the minority 
opinion, do not invalidate the available evidence on serious effects  from other studies . 
Reliable in vivo  studies with animals exposed via drinking water  resulted in  
histopathological chang es in the thyroid gland and in changes of circulating levels of 
thyroid hormones  and thus provide evidence that resorcinol affects the regulation of 
the thyroid function inducing hypothyroidism in humans . Results of those studies  are 
consistent with thyroi d disruption via the inhibition of thyroperoxidase (TPO), a key  
enzyme in the synthesis of thyroid hormones. Furthermore, a reliable study with  
animal s exposed sub -cutaneously caused histopathological changes in the thyroid 
gland . While, a s indicated in th e minority opinion, the sub -cutaneous exposure route is 
considered a non -physiological route of exposure , the Commission notes that it is 
established under Regulation (EC) No 1272 /2008 of the European Parliament and of 
the Council3 for other toxicological endpoints that information received via a non -
physiological route of exposure can be used as supportive evidence for the purpose of 
hazard identification. Moreover, skin absorption has also been demonstrated in vitro . 
Therefore, the  findings provide supportive evidence on the serious  adverse effects of 
resorcinol.  
(6) The Commission notes that  most  MSC members explicitly  agree d that data from in 
vitro  tests show that resorcinol inhibits TPO . Histopathological changes in the thyroid 
gland and changes of circulating levels of thyroid hormones  observed in humans  and 
in animal s support the conclusion that resorcinol acts via an endocrine mode of action 
affecting the thyroid hormone system  by inhibiting TPO .  
(7) The Commission concurs with the  majority of the MSC  members  that the biological 
plausibility between the evidenced thyroid mode of action of resorcinol  and the 
observed adverse effects is strong  and that  resorcinol fulfils the World Health 
Organi sation/International Programme on Chemical  Safety (WHO/IPCS)4 definition 
of an endocrine disruptor.  
                                                 
3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling an d packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008 ). 
4 World Health Organisation/International Programme on Chemical Safety (WHO/IPCS), 2002. Global 
Assessment of the State -of-the-science of Endocrine Disruptors. WHO/PCS/EDC/02.2, publicly 
available at http://www.who.int/ipcs/publications/new_issues/endocrin e_disruptors/en/  EN 3  EN (8) In light of all the above information, the Commission concludes that there is scientific 
evidence of probable serious effects to human health  for resorcinol .  
(9) The Commission  considers that the adve rse effects are of a severity similar to those of 
other substances , which have been identified as substances of very high concern 
pursuant to Article 57 , point (f), of Regulation (EC) No 1907/2006 due to their 
endocrine disrupting properties with probable serious effects to human health. 
Hypothyroidism has clinical implications related to nearly all major organs. Although 
generally considered reversible , hypothyroidism raises concerns due to the delay of the 
onset of symptoms and because it may result in se vere forms that appear after long -
term exposure and that may lead to reduced quality of life.  
(10) It is scientifically accepted that TPO inhibition results in decreased thyroid hormone 
synthesis . That leads to a  reduction  in circulating concentrations  of th ose hormones, 
which are essential for normal human brain development, both prenatally and 
postnatally. Thyroid hormones modulate  the expression of  genes that are critical for a 
normal neuroanatomical develo pment, with subsequent effects on neurophysiolog ical 
and neurological function s. Substances that interfere with the thyroid hormone 
synthesis have thus the potential to affect neural functions controlled by the 
hippocampus, which is involved in cognitive, emotional, and memory function s. The 
fact that reso rcinol inhibits TPO raises therefore a serious concern, for potential 
neurodevelopmental alteration as regards the cognitive, emotional and memory 
function.  
(11) Based on the above information, r esorcinol should be identified pursuant to Article 57 , 
point (f), of Regulation (EC) No 1907/2006  as a substance of very high concern due to 
its endocrine disrupting properties , for which there is scientific evidence of  probable 
serious effects to human health which give rise to an equivalent level of concern to 
those o f other substances listed in that Article , points (a) to (e) . 
(12) The measures provided for in this Decision are in accordance with the opinion of the  
Committee  established pursuant to  Article 133 of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS DECISION:  
Article 1  
1. Resorcinol is identified as a substance of very high concern pursuant to Article 57 , 
point (f), of Regulation (EC) No 1907/2006 due to its endocrine disrupting 
properties , with probable serious effects to human health  which give rise to an 
equivalent level of concern to those of other substances listed in Article 57 , points (a) 
to (e) , of that Regulation.  
2. The substance referred to in paragraph 1 shall be included in the candidate list 
referred to in Article 59(1) of Regulation (EC) No 1907/2 006 with the following 
indication under ‘Reason for inclusion’: ‘Endocrine disrupting properties (Article 57 , 
point (f) – human health)’.  
Article  2 
This Decision is addressed to the European Chemicals Agency . EN 4  EN Done at Brussels,  
 For the Commission  
 Thierry Breton  
 Member of the Commission