Regulation (EC) No 648/2004 on detergents is short compared with REACH, but it sets the two rules that shape every European cleaning formulation: surfactants must be ultimately biodegradable, and consumers must be able to see what is in the bottle. Its ongoing revision, aligned with the Chemicals Strategy for Sustainability, is tightening the direction rather than changing it.
- Instrument
- Regulation (EC) No 648/2004
- Core duty
- Ultimate aerobic biodegradability of surfactants
- Interacts with
- REACH, CLP, Biocidal Products Regulation
- PureSurf status
- Readily biodegradable, OECD 301F (GLP)
What the regulation covers
The regulation applies to detergents and to the surfactants placed on the market for use in them, across consumer and professional products. It harmonises the biodegradability requirement, the labelling of ingredients, the information that must be available to medical personnel, and the technical dossier a manufacturer has to keep available for authorities.
It sits alongside rather than inside REACH. REACH governs substance registration and hazard data, while the Detergents Regulation governs how those substances may be used and communicated in a detergent context. Antimicrobial claims move a product further into the scope of the Biocidal Products Regulation.
The biodegradability requirement
All surfactants used in detergents must satisfy ultimate aerobic biodegradability. Ultimate means mineralisation to carbon dioxide, water and mineral salts, not merely the loss of surface activity, which is primary biodegradation and is no longer sufficient on its own.
Compliance is demonstrated with recognised test methods. Passing a ready biodegradability test from the OECD 301 series is the cleanest evidence, because ready biodegradability is a stricter category than the minimum requirement. NEXOVANT is readily biodegradable under OECD 301F, tested to GLP.
Labelling and documentation duties
Ingredient declaration follows defined concentration bands and naming conventions, with additional rules for allergenic fragrances, preservatives and enzymes. A full ingredient data sheet must be publicly accessible, and a separate medical data sheet must be available to poison centres and medical personnel.
- Ingredient listing by concentration band on pack or in an accessible datasheet.
- Named declaration of allergenic fragrance components above the threshold.
- Manufacturer technical dossier held available for national authorities.
- Consistency with CLP classification and labelling of the finished mixture.
Where the revision is heading
The revision programme points towards digital labelling, refill formats, clearer rules for microorganism-containing products and closer alignment with the safe and sustainable by design framework. Substances that only just clear the biodegradability threshold, or that rely on weak inherent biodegradability data, will face the most pressure.
The practical hedge is to specify actives that already exceed the current requirement. Grades with GLP-backed OECD 301F results and documented aquatic toxicity data do not need to be revisited when the threshold moves.
How PureSurf grades position against it
NEXOVANT is readily biodegradable under OECD 301F (GLP), non-mutagenic under OECD 471, not corrosive to skin under OECD 431 and classified Aquatic Cat. 2. Aquatic toxicity is 14× lower for F Pro and 57× lower for F Eco than conventional amine oxide benchmarks (EC50, Aliivibrio fischeri, ISO 11348-3:2007, 30 min, GLP).
For disinfectant applications, SYLVAXIS is DIN EN 1276 compliant and currently at TRL 4. Products making biocidal claims additionally require authorisation under the Biocidal Products Regulation, which is a separate pathway from detergent compliance.
Frequently asked questions
Does the Detergents Regulation replace REACH?
No. REACH governs substance registration and hazard data. The Detergents Regulation adds sector-specific duties on biodegradability, labelling and documentation.
Is primary biodegradation enough?
No. The requirement is ultimate aerobic biodegradability. Losing surface activity alone does not satisfy it.
Do PureSurf surfactants meet the biodegradability requirement?
NEXOVANT is readily biodegradable under OECD 301F, tested to GLP, which is a stricter category than the minimum the regulation demands.















