EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of benzene -1,2,4 -tricarboxylic acid 1,2 anhydride (trimellitic 
anhydride, TMA) as a substance of very high concern according to Article 57(f) of 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council  
(Text with EEA  relevance)  
(ONLY THE ENGLISH, GERMAN AND FRENCH TEXTS ARE AUTHENTIC)   EN 2   EN COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of benzene -1,2,4 -tricarboxylic acid 1,2  anhydride (trimellitic 
anhydride ) (TMA) as a substance of very high concern according  to Article 57(f) of 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council  
(Text with EEA relevance)  
(ONLY THE ENGLISH, GERMAN AND FRENCH TEXTS ARE AUTHENTIC)  
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 European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluatio n, 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/EE C 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) In accordance with Article 59(3) of Regulation (EC) No 1907/2006, on 8 August 
2016 , the Netherlands  submitted to the European Chemicals Agency ( 'the Agency '),  a 
dossier prepared in accordance with Annex XV to that Regulation ( 'Annex XV 
dossier ') for the identification of benzene -1,2,4 -tricarboxylic acid 1,2 anhydride 
(trimellitic anhydride ) (TMA)  (EC N o. 209-008-0, CAS No. 552-30-7) as a substance 
of very high concern  because it  fulfils the criterion set out in Article 57(f) of 
Regulation (EC) No 1907/2006 . According to the Annex XV dossier , there is scientific 
evidence of probable serious effects to human health  due to the respiratory sensitising 
properties of TMA, 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 M ember State Committee of the Agency (MSC)  adopted 
its opinion2 on the Annex XV dossier. While  a majority of the MSC members 
considered that TMA  meets the conditions for identification  as a substance of very 
high concern in accordance with Article 57(f)  of Regulation (EC) No 1907/2006 , the 
MSC did not reach a unanimous agreement. Three members abstained . Three members 
were of the opinion that there is not sufficient scientific evidence of TMA's probable 
serious effects to human health  which give rise to an e quivalent level of concern to 
those of other substances listed in points (a) to (e) of Article 57 of Regulation (EC) No 
1907/2006. Those three  members expressed doubts about the type, severity, 
                                                 
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   EN 3   EN irreversibility , delay of health effects  of TMA , the social co ncerns linked to its effects 
and the impossibility  to derive a safe level of exposure to TMA .  
(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 decision on the 
identi fication of TMA  on the basis of  Article 57 (f) of that Regulation . 
(4) The Commission notes , in line with the majority opinion of the MSC, that the data 
presented and discussed in the Annex XV dossier show that TMA cause s serious and 
permanent impairment of lung functions, if the exposure is prolonged and  no 
intervention takes place . The cases  of adverse effects  reported vary from occupational 
rhinoconjunctivitis and asthma to severe diseases, such as pulmonary disease -anaemia 
syndrome, allergic laryngitis and allergic alveolitis.  Some of the effects have been so 
severe that subjects were forced to leave their jobs.  The most severe effects can require 
long medical treatment.  
(5) The Commission notes that, while certain effects  of TMA are reversible upon 
cessation of exposure, the first stage of sensitisation (induction) is irreversible.  In 
addition , from the available data on human s, it is not possible to derive a concentration 
level of TMA below which sensitisation does not ha ppen. Furthermore, it seems that 
severe effects have  some latency time . The possibility of irreversible effects occurring 
before a health problem is identified has been recognised in the identification of other 
substances3 of very high concern in accordanc e with Article 57(f) of Regulation (EC) 
No 1907/2006 becaus e of their respiratory sensitising properties , and confirmed by 
European case law4. 
(6) The Commission notes that workers that have been sensitised previously can only be 
relocated to tasks with zero e xposure to TMA, to avoid the re currence of the severe 
adverse effects, causing societal concerns and effects on quality of life of sensitised 
workers.  
(7) The Commission therefore considers , in line with the majority opinion of the MSC , 
that the level of concern posed by TMA  is equivalent to th at of substances referred to 
in points (a) to (e)  of Article 57 of Regulation (EC) No 1907/2006  and, hence , that 
TMA  should be identified as a substance of very high concern according  to Article 
57(f) of that Regulation due to  its respiratory sensitising properties . 
(8) The measures provided for in this Decision are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006,  
                                                 
3  Agreement of the Member States Committee on the identification of Diazene -1,2-dicarboxamide [C,C -
azodi(formamide)] as a su bstance of very high concern   
https://echa.europa.eu/documents/10162/5b3971ca -7683 -414b -b7df-085744c5b327 ; 
Agreement of the Member States Committee on the identification of  Hexahydromethylphthalic anhydride, 
Hexahydro -4-methylphthalic  anhydride, Hexahydro -1-methylphthalic anhydride, Hexahydro -3-methylphthalic 
anhydride  as substances of very high concern  
https://echa.europa.eu/documents/10162/ab858db8 -5467 -429c -a94d -2e563f523d01 ; 
Agreement of the Member States Committee on the identification of cyclohexane -1,2-dicarboxylic anhydride, 
cis-cyclohexane -1,2-dicarboxylic anh ydride, transcyclohexane -1,2-dicarboxylic anhydride as substances of very 
high concern  
https://echa.europa.eu/documents/10162/8a707077 -bf1c-462d -bf25-dd58ffa14cf8 . 
4 Judgment of the General Court of 30 April 2015 , Polynt and Sitre v ECHA , T-134/13 , 
ECLI :EU:T:2015:254,  and Judgment of the General Court of 30 April 2015, Hitachi Chemical Europe 
and others v ECHA , T-135/13 , ECLI:EU:T:2015:253 . EN 4   EN HAS ADOPTED THIS DECISION:  
Article 1  
1.  Benzene -1,2,4 -tricarboxylic acid 1,2 anhydride (trimellitic anhydride ) (TMA)  (EC 
No. 209-008-0, CAS No. 552-30-7) is identified as a substance of very high concern 
according  to Article 57(f) of Regulation (EC) No 1907/2006  due to its respiratory 
sensitising properties . 
2.  The substance specified 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” : “Respiratory sen sitising properties (Article 57 (f)) – 
human health ”. 
Article 2  
This Decision is addressed to the European Chemicals Agency . 
Done at Brussels,  
 For the Commission  
 Elżbieta BIEŃKOWSKA  
 Member of the Commission