Entrepreneurs responsible for the placing on the market of detergents or surfactants in detergents may apply for a derogation regarding the requirement for ultimate aerobic biodegradation. A derogation can be requested for surfactants on the basis of the following criteria:
- use in low-dispersive applications;
- use in specific industrial and/or institutional applications only;
- the risk to the environment or to health posed by the volume of sales and the pattern of use is small compared to the socio-economic benefits.
Applying for a derogation
Applications for a derogation are made to the competent authority (Tukes) and the European Commission. Each application must contain the following information:
- justifications necessary for evaluating the safety aspects (the risk to the environment or to health is small compared to the benefits);
- the results of ultimate aerobic biodegradability tests (in accordance with Annex III to the Detergent Regulation);
- the results of primary biodegradability tests (in accordance with Annex II to the Detergent Regulation);
- complementary risk assessment in accordance with Annex IV to the Detergent Regulation.
The technical guidance document published in Commission Recommendation C (2005) 5677 defines a tiered approach on the basis of which the tests laid down in Annex IV, point 4 must be carried out and specifies those tests to which the principles of good laboratory practice (GLP) must be applied.
Derogation applications must be made using the designated form. Tukes will levy a charge for the processing of derogation applications.
Derogation request processing
On the basis of the information provided in the application, Tukes will consider each application for a derogation and submit a proposal on the basis of its evaluation to the European Commission within six months of receiving the complete application. The competent authority must request any further information or tests required for the evaluation within three months of receiving the application. The applicant must provide the requested information within 12 months. The European Commission will take its decision on whether or not to grant a derogation within 12 months of receiving the evaluation and proposal from the Member State. A derogation may contain conditions and restrictions, and it may be reviewed, if necessary.
Lists of surfactants
The Commission publishes a list of surfactants that have obtained a derogation and a list of banned or restricted detergent surfactants (Annexes V and VI to the Detergent Regulation).
Detergent Regulation (EC) No 648/2004
- Article 4: Limitations based on the biodegradability of surfactants
- Article 5: Granting of derogation
- Article 6: Conditions for granting a derogation
- Annex II: Primary biodegradability test methods for surfactants in detergents
- Annex III: Ultimate biodegradability (mineralisation) test methods for surfactants in detergents
- Annex IV: Complementary risk assessment for surfactants in detergents
- Annex V: List of surfactants that have obtained a derogation
- Annex VI: List of banned or restricted detergent surfactants