EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
COM(2008) XXX final 
  
Draft  
COMMISSION REGULATION 
amending Regulation (EC) No 648/2004 of th e European Parliament and of the Council 
on detergents, in order to adapt Annexe s V and VI thereto (surfactant derogation) 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION (EC) No …/.. 
of […] 
amending Regulation (EC) No 648/2004 of th e European Parliament and of the Council 
on detergents, in order to adapt Annexe s V and VI thereto (surfactant derogation) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Regulation (EC) No 648/2004 of the European Parliament and of the 
Council of 31 March 2004 on detergents1, and in particular Article 13(1) thereof, 
Whereas: (1) Regulation (EC) No 648/2004 ensures the fr ee circulation of detergents, and of 
surfactants for detergents, on the internal  market while at the same time providing, 
inter-alia, a high level of protection to the environment by laying down requirements 
for the ultimate biodegradability of  surfactants used in detergents. 
(2) In addition, Articles 5, 6 and 9 of th e Regulation provide a mechanism by which 
surfactants that do not fulfil the above-mentioned requirement of ultimate 
biodegradability may nevertheless be granted a derogation for use in  specific industrial 
or institutional applications providing th at those applications constitute a low-
dispersive use and that the associated risk to the environment is small compared to the 
socio-economic benefit.  
(3) The Regulation stipulates that the risk to the environment is to be assessed by means 
of a complementary risk assessment, de scribed in Annex IV, carried out by the 
manufacturer of the surfactant and submitte d to competent authority of a Member 
State for evaluation. 
(4) Surfactants that are grante d a derogation should be li sted in Annex V to the 
Regulation. Those that are re fused a derogation should be listed in Annex VI to the 
Regulation.  
(5) Derogations should be adopted in accord ance with Council Deci sion 1999/468/EC of 
28 June 1999 laying down the procedures fo r the exercise of implementing powers 
conferred on the Commission
2. 
                                                 
1 OJ L 104, 8.4.2004, p.1.  
2 OJ L 184, 17.7.1999, p. 23.  
EN 3   EN (6) A request for a derogation was made for the surfactant with the IUPAC3 name 
‘alcohols, Guerbet, C16-20, ethoxylated, n- butyl ether (7 -8EO)’, also known by the 
trade name ‘Dehypon G 2084’, with the CAS4 number 147993-59-7, for use in three 
industrial applications, namely: bottle wash ing, cleaning-in-place and metal cleaning.  
(7) The request for a derogation was evaluated by the German competent authority in 
accordance with the procedure described in Article 5 of the Regulation. The request 
was found to fulfil the three conditions requ ired under Article 6.  Firstly, the three 
named uses are low-dispersive applications . Secondly, the applica tions are specific 
industrial applications. Thirdly, there is no risk to the environment as the surfactant 
itself does not pose a risk and the metabolites are not persistent. 
(8) The three named uses were considered to be  low-dispersive industr ial applications in 
view of the total annual consumption of the surfactant and in view of the use of the 
surfactant exclusively in specific ty pes of industrial installations.  
(9) The conclusion concerning lack of risk to  the environment is based on the rapid 
achievement of a high degree of primary biodegradability of the surfactant and on the ultimate biodegradability of the surfactant metabolites. The metabolites therefore meet the same criteria as those surfactants for which the Regulation guarantees free 
circulation on the internal market. 
(10) The Committee for the adaptation to technica l progress of legislation on the removal 
of technical barriers to trade in detergents decided nevertheless to limit the derogation 
to a period of 10 years to encourage the de velopment of surfactan ts of equivalent 
performance which fulfil the criteria of ultimate biodegradability and which therefore would not require a derogation. 
(11) In the past, substances in the Community we re allocated either an EINECS number or 
an ELINCS number. However, in addition, some 700 substances pr eviously identified 
as polymers have been recognised as non-pol ymers and have been assigned NLP (No-
Longer Polymer) numbers. EINECS, ELINCS and NLP numbers are now referred to 
collectively as ‘EC numbers’ a nd the corresponding h eadings in tables in Annex V and 
VI should be changed to re flect the new nomenclature. 
(12) Annexes V and VI to Regulation (EC) No 648/2004 should be amended accordingly. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Detergents Committee, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 648/2004 is amended as follows: 
(1) Annex V is replaced by the text set out in Annex I to this Regulation. 
                                                
 
3 International Union of Pure and Applied Chemistry. 
4 Chemicals Abstracts Service.  
EN 4   EN (2) Annex VI is replaced by the text se t out in Annex II to this Regulation. 
Article 2 
This Regulation shall enter into force on the 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 
 […] 
 Member of the Commission  
EN 5   EN ANNEX I  
‘ANNEX V 
LIST OF SURFACTANTS THAT H AVE OBTAINED A DEROGATION 
By way of derogation granted in accordance with Articles 4 - 6 and in accordance with the 
procedure laid down in Article 12(2), the following detergent surfactants, which pass the tests stipulated in Annex II, but which fail the test s stipulated in Annex III, may be placed on the 
market and used subject to th e limitations mentioned below. 
Name in the IUPAC nomenclature  EC Number CAS number  Limitations 
Alcohols, Guerbet, C16-20, 
ethoxylated, n-butyl ether (7-8EO) None 
(polymer) 147993-59-7 May be used for the following 
industrial applications until [ 10 years 
after the date of entry into force ]: 
– bottle washing 
– cleaning-in-place 
– metal cleaning 
The ‘EC number’ means the EINECS, ELINCS or NL P number and is the official number of 
the substance within the European Union. 
‘EINECS’ means the European Inventory of Ex isting Commercial Chemical Substances. This 
inventory contains the definitive list of all subs tances deemed to be on the Community market 
on 18 September 1981. The EINECS number can be ob tained from the European Inventory of 
Existing Commercial Chemical Substance5  
‘ELINCS’ means the European List of Notif ied Chemical Substances. The ELINCS number 
can be obtained from the European List of Notified Substances, as amended6. 
‘NLP’ means No-Longer Polymer. The term polyme r is defined in Article 3(5) of Regulation 
(EC) 1907/20067. The NLP number can be obtained from  the list of "No-Longer Polymers", 
as amended.8’ 
                                                 
5 OJ C 146A, 15.6.1990, p.1. 
6 Office for Official Publications of the European Communities, 2006, ISSN 1018-5593 EUR 22543 EN. 
7 OJ L 396, 30.12.2006, p.1 
8 Office for Official Publications of the European Communities, 2007,ISSN 1018-5593 EUR 20853 
EN/3.  
EN 6   EN  further defined in the 7th amendment (92/32/ EEC) of the Directive. This change means that some substances which were considere d to be polymers under the 
ANNEX II  
‘ANNEX VI 
LIST OF BANNED OR RESTRICTED DETERGENT SURFACTANTS 
The following detergent surfactants have been id entified as not complying with the provisions 
of this Regulation: 
Name in the IUPAC nomenclature EC Number CAS number  Limitations 
    
 
 The ‘EC number’ means the EINECS, ELINCS or NL P number and is the official number of 
the substance within the European Union.’