EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of 1,7,7 -trimethyl -3-(phenylmethylene)bicyclo[2.2.1]heptan -2-one 
(3-benzylidene camphor) 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    
EN 2  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
on the identification of 1,7,7 -trimethyl -3-(phenylmethylene)bicyclo[2.2.1]heptan -2-one 
(3-benzylidene camphor) 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 Eu ropean Union , 
Having regard to Regulation (EC) No 1907/2006 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 part icular Article 
59(9) thereof,  
Whereas:  
(1) On 25 February 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 Regulati on ( 'Annex XV 
dossier ') for the identification of 1,7,7 -trimethyl -3-
(phenylmethylene)bicyclo[2.2.1]heptan -2-one (3 -benzylidene camphor) (EC No. 239 -
139-9, CAS No. 15087 -24-8) 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 8 June 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 3 -benzylidene camphor 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. Three members abstained  and two members were of the 
opinion  that there is not sufficient scientific evidence of probable serious effects to t he 
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. 
Those two members expressed doubts about the reliability of a key scientific study and 
stated that there is not sufficient evidence to demonstrate that 3 -benz ylidene camphor 
poses an equivalent level of concern.  
                                                 
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-membe r-state-committee    
EN 3  EN (3) On 22 June 2016, pursuant to Article 59(9) of Regulation (EC) No 1907/2006, the 
Agency referred the MSC opinion to the Commission f or a decision on the 
identification of 3 -benzylidene camphor on the basis of Article 57(f)  of that 
Regulation . 
(4) The Commission notes, in line with the majority opinion of the MSC, that multiple 
data, presented and discussed in the Annex XV dossier, includin g the key scientific 
study referred to in the minority MSC opinion, show that 3 -benzylidene camphor 
alters the function of the endocrine system and hence has an endocrine mode of action . 
The Commission further notes that the minority opinion agrees that th ere are strong 
indications that 3 -benzylidene camphor interacts with the endocrine system in fish . 
Furthermore, the key  study demonstrates a serious and irreversible effect on fish 
fecundity relevant for  wildlife populations  while  the available evidence indicate s that 
the adverse effect is a result of the endocrine mode of action. Hence, the Commission 
considers , in line with the majority opinion of the MSC , that 3 -benzylidene camphor 
fulfils the World Health Organization/International Programme on Chemic al Safety 
(WHO/IPCS )3 definition of an endocrine disruptor.  
(5) The Commission notes that the adverse effect is 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 Regula tion (EC) No 1907/2006 due to their endocrine disrupting 
properties with probable serious effects to the environment  and that 3-benzylidene 
camphor induces irreversible effect at a concentration level lower to the one s inducing 
a classification as Category Chronic 1 for long -term aquatic hazards to the aquatic 
environment pursuant to Regulation (EC) No 1272/2008 of the European Parliament 
and of the Council4. The Commission therefore considers that the level of concern of 
the adv erse effects is equivalent to those of substances referred to in points (a) to (e)  of 
Article 57  of Regulation (EC) No 1907/2006 . 
(6) Therefore 3-benzylidene camphor should be identified as a substance of very high 
concern pursuant to  Article 57(f) of Regulati on (EC) No 1907/2006 due to its 
endocrine disrupting properties with probable serious effects to the environment . 
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Committee established pursuant to  Article 133 of Regulati on (EC) No 1907/2006,  
HAS ADOPTED THIS DECISION:  
Article 1  
1. 1,7,7 -trimethyl -3-(phenylmethylene)bicyclo[2.2.1]heptan -2-one (3 -benzylidene 
camphor) (EC No. 239 -139-9, CAS No. 15087 -24-8) is identified as a substance of 
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 . 
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 
                                                 
3 WHO/IPCS, 2002. Global Assessment of the State -of-the-science of Endocrine Disruptors. 
WHO/ IPCS/EDC/02.2, publicly available at 
http://www.who.int /ipcs/publications/new_issues/endocrine_disruptors/en/  
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and 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, p. 
1).  
EN 4  EN indication under “Reason for inclusion”:  “Endocrine disrupting properties (Article 
57(f) - environment)”.  
Article 2  
This Decision is addressed to the European Chemicals Agency . 
Done at Brussels,  
 For the Commission  
 Elżbieta BIEŃKOWSKA  
 Member of the Commission