Making available on the market and free movement
1. Detergents and surfactants shall only be made available on the market if they comply with this Regulation.
2. Member States shall not prohibit, restrict or impede the making available on the market of detergents or surfactants which comply with this Regulation.
Biodegradability
1. Surfactants and surfactants contained in detergents shall comply with the biodegradability requirements set out in Part A of Annex I.
2. Paragraph 1 of this Article shall not apply to surfactants and surfactants contained in detergents that are active substances within the meaning of Article 3(1), point (c), of Regulation (EU) No 528/2012 and that are used as disinfectants, provided that they meet one of the following conditions:
(a)
they are included in the Union list of approved active substances as referred to in Article 9(2) of Regulation (EU) No 528/2012, or included in Annex I to that Regulation;
(b)
they are included in the review programme as set out in Commission Delegated Regulation (EU) No 1062/2014 ( 19 ) ; or
(c)
they are constituents of disinfectants which can be made available on the market or used in accordance with Article 55 of Regulation (EU) No 528/2012.
3. By 23 March 2032, films or polymers within films shall comply with the biodegradability requirements set out in Part B of Annex I.
4. By 23 March 2034, organic substances intentionally added in detergents in concentration of at least 10 %w/w (weight by weight) of the total mass of substances, excluding water, other than surfactants, films and polymers within films, shall comply with the biodegradability criteria set out in Part C of Annex I, unless a derogation is granted in Part D of that Annex.
Detergents containing micro-organisms
Detergents containing micro-organisms shall comply with the requirements set out in Annex II.
Limitations on the content of phosphates and other phosphorus compounds
Detergents listed in Annex III shall comply with the limitations on the content of phosphates and other phosphorus compounds set out in that Annex.
Animal testing
1. The compliance of detergents and surfactants with this Regulation shall be established by using non-animal testing methods validated at Union or international level.
2. Without prejudice to Article 1(1), the placing on the market of detergents and surfactants for which the final formulation or ingredients or combinations of ingredients have been the object of animal testing with a view to meeting the requirements of this Regulation shall be prohibited.
3. Paragraphs 1 and 2 shall be applicable without prejudice to relevant Union law and shall not prevent the use of data acquired before 22 March 2026.
4. In exceptional circumstances, where concerns arise as regards the safety of an ingredient in a detergent or surfactant, the Commission may adopt an implementing decision granting a derogation from paragraphs 1 and 2, on its own initiative or on the basis of a reasoned request from an economic operator or a Member State.
5. Where the Commission acts on the basis of a reasoned request from an economic operator or a Member State, as referred to in paragraph 4, that request shall contain an evaluation of the situation and indicate the necessary measures. On that basis, the Commission may consult the European Centre for the Validation of Alternative Methods (ECVAM).
6. A decision granting a derogation, as referred to in paragraph 4, shall lay down the conditions associated with that derogation in terms of specific objectives, duration and reporting of the results. A derogation shall only be granted where:
(a)
the ingredient is widely used and cannot be replaced by another ingredient capable of performing a similar function; and
(b)
the human health or environmental problem is substantiated and the need to conduct animal testing is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.
The Commission shall address its decision granting a derogation to all Member States and shall immediately communicate it to them and to the relevant economic operators.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.