EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Regulation (EC) No 340/2008 on the fees and charges payable to the 
European Chemicals Agency  
(Text with EEA relevance)    
EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending  Regulation (EC) No 340/2008 on the fees and charges payable to the 
European Chemicals Agency  
(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 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 repealin g 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/EC,1 and in particular 
Article  74(1) thereof,  
Whereas:  
(1) Pursuant  to Regulation (EC) No 1907/2006 , the structure  and amount  of the fees 
provided for in that Regulation sh all take account of the work required to be carried 
out by the European Chemicals Agency (ʻthe Agencyʼ) and the competent authorities 
and shall be fixed a t such a level as to ensure that the revenue derived from them when 
combined with other sources of the Agency's revenue is sufficient to cover the cost of 
the services delivered.  
(2) The experience gained so far by the Agency and its Committees for Risk Asses sment 
and for Socio -economic Analysis in  assessing applications for authorisation has shown 
that the amount of work involved in such assessment is driven by the number of uses 
applied for  in one application , rather than the number of applicants having join tly 
submitted  the application. Consequently, the fee  applicable to a given application 
should be the  same , regardless of the number of applicants ; no additional fee should be 
levied for each additional applicant . The same reasoning applies also to the charge s for 
submission of any review report.  Modifying the fee s and charge s accordingly could 
allow easing  the financial burden for smaller operators , such as small and medium -
sized enterprises . 
(3) Where enterprises having submitted a joint application  for authorisation  belong to 
different size categories for which different base fees would apply, the highest fee 
should be levied .  
(4) Furthermore, following the review of Commission Regulation (EC) No 340/20082, 
conducted in 2015 , and in the light of the experience gained in treating authorisation 
                                                 
1 OJ L  396, 30.12.2006, p.  1. 
2 Commission Regulation (EC) No 340/2008  of 16 April 2008 on the fees and charges payable to the 
European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament  
EN 3  EN applications, it is appropriate that the authorisation fees and charges be adjusted to 
reflect the workload of the Agency . To that end , the additional fees and charges 
applicable per addi tional use should be only slightly lower than the amount of the 
basic fee or charge . Those additional fee s or charge s per additional use  should 
therefore be increased.  
(5) Regulation (EC) No 340/2008 should therefore be amended accordingly.  
(6) For reasons of lega l certainty, this Regulation should not apply to applications 
submi tted before the day of entry into force of this Regulation.  
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established under Article  133 of  Regulation (EC) No  1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No  340/2008 is amended  as follows:  
(1) In Article 8 , paragraph 2  is replaced by the following:  
ʻ2. The Agency shall levy a base fee for any application for an authorisation o f a 
substance, as set out in point 1 of Annex VI. The base fee shall cover the application 
for an authorisation for one substance and one use.  
The Agency shall levy an additional fee, as set out in Annex VI to this Regulation, 
for each additional use and f or each additional substance that meets the definition of 
a group of substances as defined in point 1 .5. of Annex XI to Regulation (EC) No 
1907/2006 and that is covered by the application. No additional fee shall be levied 
where more than one applicant is party to the application for an authorisation. Where 
the applicants that are party to a joint application for an authorisation are of different 
sizes, the highest fee applicable to any of those applicants shall be levied for that 
application.  
The Agency sh all issue one invoice covering the base fee and any applicable 
additional fees. ʼ 
(2) In Article 9, paragraph 2 is  replaced by the  follow ing: 
ʻ2. The Agency shall levy a base charge for submission of any review report, as 
set out in point  1 of Annex VII. The base charge shall cover the submission of a 
review report for one substance and one use.  
The Agency shall levy an additional charge, as set out in Annex VII to this 
Regulation, for each additional use and for each additional substance that meets the 
definition of a group of substances as defined in point  1.5. of Annex XI to Regulation 
(EC) No 1907/2006 and that is covered by the review report.  No additional charge 
shall be levied where there is more than one party to a review report. Where the 
entities that are party to the submission of a joint review  report are of different size s, 
the highest charge applicable to any of those applicants shall be levied to that 
submission.  
 The Agency shall issue one invoice covering the base charge and any applicable 
additional charges. ʼ 
                                                                                                                                                         
and of the  Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH)  (OJ L 107, 17.4.2008, p. 6 ).  
EN 4  EN (3) Annexes VI and VII  are replaced by the text set out in  the Annex to this Regulation . 
Article 2  
Regulation (EC) No  340/2008  as amended by  Commission Implementing Regulation  (EU) No 
254/20133 shall apply to  applications submi tted before [the date of entry into force of this 
Regulation ]. 
Article 3 
This Regulation shall enter into force on the twentieth day following  that of its publication in 
the Official Journal of the European Union .  
This Regulation shall be binding in its entirety and directly applicable in all Member  States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker  
                                                 
3 Commission Implementing Regulation (E U) No 254/2013  of 20 March 2013  amending Regulation 
(EC) No 340/2008 on the fees and charges pa yable to the European Chemicals Agency pursuant to 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH)  (OJ L 79, 21.3.2013, p. 7).