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1. Member States may derogate from Article 3 only if the establishment of a collecting system or the connection to a collecting system is not justified because it would produce no environmental or human health benefit, is not technically feasible or would involve excessive cost. If derogating from Article 3, Member States shall ensure that individual systems for the collection, storage and when applicable, treatment of urban wastewater are used in agglomerations of 1 000 p.e. and above, or part of those agglomerations.

2. Member States shall ensure that the individual systems referred to in paragraph 1 are designed, operated and maintained in a manner that achieves the same level of environmental and human health protection as the secondary and tertiary treatments referred to in Articles 6 and 7.

3. Member States shall ensure that individual systems that are used in agglomerations of 1 000 p.e. and above are registered in a registry. Member States shall ensure that regular inspections of those systems, or regular checks or controls of those systems by other means, are carried out by the competent authority or any other body authorised at national, regional or local level, on the basis of a risk-based approach.

4. The Commission is empowered to adopt implementing acts to specify minimum requirements for:

(a) the design, operation and maintenance of individual systems referred to in paragraphs 1 and 2; and (b) the regular inspections referred to in paragraph 3, including the establishment of a minimum frequency for such inspections depending on the type of individual system, and based on a risk-based approach. Those implementing acts shall be adopted by 2 January 2028 in accordance with the examination procedure referred to in Article 28(2). The requirements related to design referred to in paragraph 2 and this paragraph shall not apply to individual systems referred to in paragraph 1 which were established before 1 January 2025.

5. Member States that use individual systems to collect and/or treat more than 2 % of the urban wastewater load at national level from agglomerations of 2 000 p.e. and above shall provide the Commission with a justification for the use of individual systems. That justification shall:

(a) demonstrate that the conditions for using individual systems set out in paragraph 1 are fulfilled;

(b) describe the measures taken in accordance with paragraphs 2 and 3;

(c) demonstrate compliance with the minimum requirements referred to in paragraph 4 where the Commission has exercised its implementing powers under that paragraph;

(d) demonstrate that the use of the individual systems does not prevent Member States from complying with the environmental objectives established in Article 4 of Directive 2000/60/EC.

6. The Commission is empowered to adopt implementing acts establishing the format for submitting the information referred to in paragraph 5. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 28(2).