- Latest available (Revised)
- Point in Time (31/01/2020)
- Original (As adopted by EU)
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Version Superseded: 31/12/2020
Point in time view as at 31/01/2020.
There are currently no known outstanding effects for the Regulation (EC) No 648/2004 of the European Parliament and of the Council, ANNEX IV.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
For those surfactants for which an environmental risk assessment is available in the context of Directive 93/67/EEC, or Regulation (EEC) No 793/93 and Regulation (EC) No 1488/94, and Technical Guidance Documents, this risk assessment shall be considered together with the complementary risk assessment run in the scope of this Regulation.
The complementary risk assessment run in the scope of this Regulation, in case it is likely that recalcitrant metabolites are produced, shall be considered in the context of assessments made on the basis of Directive 93/67/EEC or Regulation (EEC) No 793/93. This is to be assessed case by case and in particular on the basis of the results of the tests referred to in part 3.
The study shall cover the aquatic environmental compartment. Additional information relating to specific risk assessment concerns might be required by the Committee referred to in Article 12(2) on a case by case basis. Additional information might include other environmental compartments such as sewage sludge and soil. A tiered approach shall be adopted concerning the information required for the technical file referred to in Articles 5 and 9. The file shall contain at least the information described under points 1, 2 and 3 below.
However, to minimise testing, and especially to avoid unnecessary animal testing, the additional studies listed under point 4.2.2 should be requested only where such information is necessary and proportionate. In case of dispute concerning the extent of additional information required, a Decision may be taken in accordance with the procedure laid down in Article 12(2).
As noted in Article 13, the guidelines included in this Annex for the Decisions on derogation may be adapted as appropriate on the basis of the accumulated experience.
importance of the application (societal value),
use conditions (release scenario),
use volume,
availability and suitability of alternatives (performance and economic considerations),
assessment of relevant environmental information.
Toxicity information on test liquors shall be provided. If no data are available on residue identity, the information referred to in point 4.2.1 may be requested, depending on the potential risk, the importance and the quantity of the surfactant used in detergents. In conflicting cases concerning this information, a Decision may be taken in accordance with the procedure laid down in Article 12(2).
Any of the tests described in Annex III, may be run with pre adapted inoculum in order to provide evidence of the relevance of pre-adaptation for the surfactant.
At least one of the tests referred to below shall be included:
method of the Directive 67/548/EEC, Annex V.C.12 (Modified SCAS test),
method of the Directive 67/548/EEC, Annex V.C.9 (Zahn-Wellens).
Failure to pass the inherent biodegradability test would indicate potential for persistency which may be considered, in general terms, as sufficient to prohibit the placing on the market of such a surfactant except in cases where the criteria set out in Article 6 indicate that there is no justification for refusing a derogation.
The following tests referred below shall be included:
method of the Directive 67/548/EEC, Annex V.C.10 (including possible changes in operating conditions as proposed in EN ISO 11733).
Failure to pass the activated sludge simulation biodegradability test would indicate potential for the release of the metabolites by sewage treatment, which may be considered, in general terms, as evidence of need for a more complete risk assessment.
Toxicity information on test liquors is to be provided on:
identity of the metabolite (and analytical means by which it was obtained);
key physical chemical properties (water solubility, Octanol: Water partition coefficient (Log Po/w, etc.).
Fish: the test recommended is that in Annex V.C.1 of Directive 67/548/EEC
Daphnia: the test recommended is that in Annex V.C.2 of Directive 67/548/EEC
Algae: the test recommended is that in Annex V.C.3 of Directive 67/548/EEC
Bacteria: the test recommended is that in Annex V.C.11 of Directive 67/548/EEC
Biotic: the test recommended is that in Annex V.C.5 of Directive 67/548/EEC
Abiotic: the test recommended is that in Annex V.C.7 of Directive 67/548/EEC. The information to be provided will consider as well the potential of metabolites for bio-concentration and their partitioning to the sediment phase.
Moreover, if some metabolites are suspected for endocrine disrupting activity, it is recommended to determine if these have potential to result in adverse affects as soon as validated testing schemes to assess such adverse effects are available.
All the abovementioned tests can also be consulted in the publication Classification, Packaging and Labelling of Dangerous Substances in the European Union; Part 2: ‘Testing Methods’. European Commission 1997. ISBN 92-828-0076-8.U.K.
European Inventory of Existing Commercial Substances.
European List of Notified Chemical Substances.
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: