EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of 4 -tert-butylphenol (PTBP) as a substance of very high concern 
pursuant to Article 57(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 4 -tert-butylphenol (PTBP) as a substance of very high concern 
pursuant to Article 57(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 1907/20 06 of the European 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 30 August 2016 , Germany 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 4 -tert-butyl phenol [(PTBP ) (EC No 202 -679-0, CAS 
No 98 -54-4) as a substance of very high concern according to  Article 57(f) of that 
Regulation due to its endocrine disrupting properties , for which there is scientific 
evidence of probable serious effects to the environment which give rise to an 
equivalent level of concern to those of other substances listed in points (a) to (e) of 
Article 57  of Regulation (EC) No 1907/2006 . 
(2) On 15 December 2016, the Member State Committee of the Agency (MSC) adopted 
its opinion2 on the Annex XV dossier. While a majority of the MSC members 
considered that PTBP should be identified as a substance of very high concern 
pursuant to Article 57(f) of Regulation (EC ) No 1907/2006, the MSC did not reach 
unanimous agreement.  Two members expressed doubts about the reliability of the key 
scientific study3 and were of the opinion that the available evidence does not allow to 
conclude that there is an equivalent level of c oncern to those of other substances listed 
in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006 . A third member, 
while supporting the identification of PTBP  as a substance of very high concern , also 
                                                 
1 OJ L 396, 30.12.2006 , p. 1.  
2 http://echa.europa.eu/role -of-the-member -state-committee -in-the-authorisation -process/svhc -opinions -
of-the-member -state-committee  
3 Demska -Zakęś, K. (2005). Wpływ wybranych ksenobiotyków na rozwój układu płciowego ryb.  
(Olsztyn, Uniwersytet Warminsko -Mazu rski w Olsztynie - UWM Olsztyn), p. 61.  EN 2  EN expressed doubts about the reliability of t he key study.  The Commission disagrees 
with the doubts expressed about the reliability of the key scientific study . 
(3) On 17 January 2017, pursuant to Article 59(9) of Regulation (EC) No 1907/2006, the 
Agency referred the MSC opinion to the Commission for a d ecision on the 
identification of PTBP on the basis of Article 57(f) of that Regulation.  
(4) The Commission concurs with the MSC opinion expressing its unanimous agreement 
on that there is scientific evidence of adverse effects in fish linked to an estrogen mode 
of action of PTBP, which demonstrates that th e substance meets the World Health 
Organization/International Programme on Chemical Safety (WHO/IPCS)4 definition 
of an endocrine disruptor. E xposure to PTBP leads to serious and irreversible adverse 
effect s on sexual development of fish , namely a complete and irreversible sex reversal 
of affected fish populations resulting in all -female populations . The conclusion  that 
PTBP exerts endocrine disruptive properties  is further supported by read -across from 
other substances5 belonging to the same chemical class of alkylphenols as PTBP.   For 
these reasons,  the Commission concludes that for PTBP there is scientific evidence of 
probable serious effect s to the environment.  
(5) The Commission considers that the adverse ef fects are of a severity similar to those of 
other substances which have been identified as substances of very high concern 
pursuant to Article 57(f) of Regulation (EC) No 1907/2006 due to their endocrine 
disrupting properties with probable serious effects to the environment. Effects 
observed in fish are irreversible and may be relevant for wildlife populations.  The 
majority of the MSC was of the opinion  that, on the basis of the available information , 
it appears difficult to derive a safe level of exposure to adequately assess the risks 
although it may exist. The Commission concurs with that assessment . The 
Commission therefore considers that the level of concern of the adverse effects is 
equivalent to those of substances referred to in points (a) to (e) of Article 57 of 
Regulation (EC) No 1907/2006.  The fact that the adverse effects on the sexual 
develo pment of fish were observed in the key study at low concentration levels 
(lowest observed effect concentration: 1 µg/l) further strengthens the concern.  
(6) PTBP should be identified pursuant to  Article 57(f) of Regulation (EC) No 1907/2006 
as a substance of very high concern due to its endocrine disrupting properties with 
probable serious effects to the environment  which give rise to an equivalent level of 
concern to those of other substances listed in points (a) to (e) . 
(7) The measures provided for in this Deci sion 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. 4-tert-butylphenol (PTBP) (EC  No 202 -679-0, CAS No 98 -54-4) is identified as a 
substance o f very high concern pursuant  to Article 57(f) of Regulation (EC) No 1907/2006 
due to its  endocrine disrupting properties with probable serious effects to the environment  
                                                 
4 World Health Organization/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/endocrine_disruptors/en/  
5 4-nonylphenol, branched and linear; 4 -tert-octylphenol (CAS -No.: 140 -66-1; EC -No.: 205 -426-2); 4 - -
heptylphe nol, branched and linear; 4 -tert-pentylphenol (CAS -No.: 80 -46-6; EC -No.: 201 -280-9); EN 3  EN which give rise to an equivalent level of concern  to those of other substances listed in Article 
57(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 1907/2006 with the following indication under “Reason 
for inclusion”: “Endoc rine disrupting properties (Article 57(f) - environment)”.  
Article 2 [The addressees are named in the final article of the act ] 
This Decision is addressed to the European Chemicals Agency . 
Done at Brussels,  
 For the Commission  
 Elżbieta BIEŃKOWSKA  
 Member  of the Commission