II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 440/2010  
of 21 May 2010  
on the fees payable to the European Chemicals Agency pursuant to Regulation (EC) No 1272/2008 
of the European Parliament and of the Council on classification, labelling and packaging of 
substances and mixtures  
(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 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 Regu ­
lation (EC) No 1907/2006 (  1 ), and in particular Articles 24(2) 
and 37(3) thereof,  
Whereas:  
(1) A manufacturer, importer or downstream user of a 
substance in a mixture may submit a request to the 
European Chemicals Agency, hereinafter ‘the Agency’, 
to use an alternative chemical name.  
(2) Such requests under Article 24(1) of Regulation (EC) No 
1272/2008 should be accompanied by a fee.  
(3) A manufacturer, importer or downstream user may 
submit a proposal for harmonisation of classification 
and labelling of a substance to the Agency, provided 
there is no entry in part 3 of Annex VI of Regulation 
(EC) No 1272/2008 for that hazard class or differ ­
entiation.  
(4) Such proposals should be accompanied by a fee in cases 
laid down in Article 37(3) of Regulation (EC) No 
1272/2008.  
(5) The level of the fees collected by the Agency as well as 
the rules for payment should be determined.  
(6) The amount of the fees should take account of the work 
required by Regulation (EC) No 1272/2008 to be carried out by the Agency and should be fixed at such a level as 
to ensure that the revenue derived from them when 
combined with other sources of the Agency’s 
revenue pursuant to Article 96(1) of Regulation 
(EC) No 1907/2006 of the European Parliament and of 
the Council (  2 ) is sufficient to cover the cost of the 
services delivered.  
(7) In the ‘Small Business Act’ for Europe (  3 ) the European 
Union has firmly placed the needs of small and medium- 
sized enterprises (‘SMEs’) at the heart of the Lisbon 
Growth and Jobs Strategy. Specifically the Union’s 
capacity to build on the growth and innovation 
potential of SMEs will therefore be decisive for future 
prosperity of the Union. However, SMEs bear a dispro ­
portionate regulatory and administrative burden in 
comparison to larger businesses. Therefore it is appro ­
priate to reduce the level of fees for SMEs.  
(8) It is appropriate for the identification of SMEs to follow 
the definitions set out in Commission 
Recommendation 2003/361/EC of 6 May 2003 
concerning the definition of micro, small and medium- 
sized enterprises (  4 ). 
(9) The reduced fees for proposals for harmonised classifi ­
cation and labelling should be reviewed within 3 years 
after the entry into force of the Regulation with a view to 
reviewing or removing them if deemed necessary.  
(10) This Regulation should enter into force as soon as 
possible, since it has been possible to submit requests 
for use of alternative chemical names and proposals for 
harmonisation of classification and labelling of 
substances to the Agency since 20 January 2009, date 
of the entry into force of Regulation (EC) No 1272/2008.EN 22.5.2010 Official Journal of the European Union L 126/1  
( 1 ) OJ L 353, 31.12.2008, p. 1.  ( 2 ) OJ L 396, 30.12.2006, p. 1.  
( 3 ) COM(2008) 394 final.  
( 4 ) OJ L 124, 20.5.2003, p. 36.(11) The measures provided for in this Regulation are in 
accordance with the opinion of the Committee estab ­
lished under Article 133 of Regulation (EC) 
No 1907/2006,  
HAS ADOPTED THIS REGULATION:  
CHAPTER I  
SUBJECT MATTER AND DEFINITIONS  
Article 1  
Subject matter  
This Regulation lays down the levels, and rules for payment, of 
the fees levied by the European Chemicals Agency, hereinafter 
called the ‘Agency’, as provided for in Regulation (EC) 
No 1272/2008.  
Article 2  
Definitions  
For the purposes of this Regulation, the following definitions 
shall apply:  
1. ‘SME’ means a micro, small or medium-sized enterprise 
within the meaning of the Recommendation 2003/361/EC;  
2. ‘medium-sized enterprise’ means a medium-sized enterprise 
within the meaning of the Recommendation 2003/361/EC;  
3. ‘small enterprise’ means a small enterprise within the 
meaning of the Recommendation 2003/361/EC;  
4. ‘microenterprise’ means a microenterprise within the 
meaning of the Recommendation 2003/361/EC.  
CHAPTER II  
FEES  
Article 3  
Fees for request for use of an alternative chemical name  
1. The Agency shall levy a fee as laid down in Annex I for a 
request to use an alternative chemical name for a substance in 
up to 5 mixtures in accordance with Article 24(1) of Regulation 
(EC) No 1272/2008.  
2. Where the applicant is an SME, the Agency shall levy a 
reduced fee, as set out in Annex I.  
3. For the use of the alternative chemical name of the 
substance in accordance with Article 24(1) of Regulation (EC) 
No 1272/2008 in additional mixtures, an additional fee shall be 
levied for up to 10 additional mixtures and the same additional 
fee shall be levied for every further 10 additional mixtures, as 
set out in Section 3 of Annex I.  
4. The date on which the fee levied for a request is received 
by the Agency shall be considered to be the date of receipt of 
the request.  Article 4  
Fees for submission of proposals for harmonised 
classification and labelling of a substance  
1. The Agency shall levy a fee as laid down in Annex II for 
submission of proposals for harmonisation of classification and 
labelling in accordance with Article 37(3) of Regulation (EC) 
No 1272/2008.  
2. Where the party making the proposal is an SME, the 
Agency shall levy a reduced fee, as set out in Annex II.  
3. The date on which the fee levied for a proposal is received 
by the Agency shall be considered to be the date of receipt of 
the proposal.  
Article 5  
Reductions  
1. A natural or legal person that claims to be entitled to a 
reduced fee under Article 3 and 4 shall inform the Agency 
thereof at the time of submission of the request.  
2. The Agency may request, at any time, evidence that the 
conditions for a reduction of fees apply.  
3. Where a natural or legal person that claims to be entitled 
to a reduction cannot demonstrate that it is entitled to such a 
reduction, the Agency shall levy the full fee.  
Where a natural or legal person that claims to be entitled to a 
reduction has already paid a reduced fee, but cannot demon ­
strate that it is entitled to such a reduction, the Agency shall 
levy the balance of the full fee.  
CHAPTER III  
PAYMENTS  
Article 6  
Mode of payment  
1. The fees shall be paid in Euro.  
2. Payments shall be made only after the Agency has issued 
an invoice.  
3. Payments shall be made by means of a transfer to the 
bank account of the Agency.  
Article 7  
Identification of the payment  
1. Every payment must indicate the invoice number in the 
reference field.  
2. If the purpose of the payment cannot be established, the 
Agency shall set a deadline by which the payer must notify it in 
writing of the purpose of the payment. If the Agency does not 
receive a notification of the purpose of the payment before the 
expiry of the set deadline, the payment shall be considered 
invalid and the amount concerned shall be refunded to the 
payer.EN L 126/2 Official Journal of the European Union 22.5.2010Article 8  
Date of payment  
The date on which the full amount of the payment is deposited 
in the bank account of the Agency shall be considered as the 
date on which the payment has been made.  
Article 9  
Refund of amounts paid in excess  
1. The arrangements for the refund to the payer of amounts 
paid in excess of a fee shall be fixed by the Executive Director of 
the Agency and published on the website of the Agency.  
However, where an amount paid in excess is under EUR 100 
and the party concerned has not expressly requested a refund, 
the amount paid in excess shall not be refunded.  
2. It shall not be possible to credit any amounts paid in 
excess towards future payments to the Agency.  
CHAPTER IV  
FINAL PROVISIONS  
Article 10  
Provisional Estimate  
The Management Board of the Agency shall, when producing 
an estimate of the overall expenditure and income for the 
following financial year in accordance with Article 96(5) of 
Regulation (EC) No 1907/2006, include a specific provisional 
estimate of income from fees which is separate from income 
from any subsidy from the Community.  Article 11  
Reviews  
1. The fees provided for in this Regulation shall be reviewed 
annually by reference to the inflation rate as measured by 
means of the European Index of Consumer Prices as 
published by Eurostat pursuant to Council Regulation (EC) 
No 2494/95 (  1 ). A first review shall be carried out by 
1 June 2011.  
2. The fee reduction for SMEs for harmonised classification 
and labelling shall be reviewed within 3 years after the entry 
into force of this Regulation.  
3. The Commission shall also keep this Regulation under 
continual review in the light of significant information 
becoming available in relation to the underlying assumptions 
for anticipated income and expenditure of the Agency.  
4. At the latest by 1 January 2013, the Commission shall 
review this Regulation with a view to amending it, if appro ­
priate, taking into account in particular the costs of the Agency.  
Article 12  
This Regulation shall enter into force on the third day following 
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, 21 May 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 22.5.2010 Official Journal of the European Union L 126/3  
( 1 ) OJ L 257, 27.10.1995, p. 1.ANNEX I  
Fees for request in accordance with Article 24(1) of Regulation (EC) No 1272/2008:  
Section 1  — Standard fee for a substance in up to five mixtures  
EUR 4 000  
Section 2  — Reduced fees for SMEs for a substance in up to five mixtures  
2.1. Reduced fee for medium-sized enterprises  
EUR 2 800  
2.2. Reduced fee for small enterprises  
EUR 1 600  
2.3. Reduced fee for micro enterprises  
EUR 400  
Section 3  — Fee for use of alternative chemical name per 10 additional mixtures  
3.1. Standard fee  
EUR 500  
3.2.  Reduced fee for medium-sized enterprises  
EUR 350  
3.3.  Reduced fee for small enterprises  
EUR 200  
3.4.  Reduced fee for micro enterprises  
EUR 100EN L 126/4 Official Journal of the European Union 22.5.2010ANNEX II  
Fees for the proposals submitted in accordance with Article 37(3) of Regulation (EC) No 1272/2008:  
Section 1 — Standard fee  
EUR 12 000  
Section 2 — Reduced fees for SMEs  
2.1.  Reduced fees for medium-sized enterprises  
EUR 8 400  
2.2. Reduced fee for small enterprises  
EUR 4 800  
2.3. Reduced fee for micro enterprises  
EUR 1 200EN 22.5.2010 Official Journal of the European Union L 126/5