Obligations of manufacturers
1. When placing detergents or surfactants on the market, manufacturers shall ensure that those detergents or surfactants have been designed and manufactured in accordance with this Regulation.
2. Manufacturers shall draw up the technical documentation set out in Annex IV and carry out the conformity assessment procedure set out in that Annex.
Where compliance of a detergent or end-user surfactant with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, before placing the product on the market manufacturers shall:
(a)
create a digital product passport in accordance with Article 21;
(b)
ensure that the data carrier is available in accordance with Article 21(4); and
(c)
include a reference of the digital product passport in the registry referred to in Article 24(1) (the ‘registry’).
3. Manufacturers shall keep and, where necessary, update the technical documentation and the digital product passport for 10 years from the date on which the detergent or the surfactant has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or in characteristics, as well as changes in the test methods by reference to which the conformity of a product is declared, shall be adequately taken into account.
When deemed appropriate with regard to the performance of, or the risks presented by, a detergent or surfactant, manufacturers shall carry out sample testing of such detergent or surfactant, investigate, and, if necessary, keep a register of complaints, of non-compliant detergents or surfactants and of recalls of such detergents or surfactants, and shall keep distributors informed of any such monitoring.
5. Manufacturers placing on the market detergents or surfactants shall ensure that those detergents or surfactants comply with Article 17(1), (3), (4) and (5), Article 18(1) and Article 19(1) and(2) and, where applicable, Article 17(2), Article 18(2) and Article 19(3).
6. Before placing on the market detergents or end-user surfactants which are mixtures for which there is no obligation to provide information in accordance with Article 45 of Regulation (EC) No 1272/2008, the manufacturers established within the Union shall provide to the bodies appointed by Member States in accordance with that Article (the ‘appointed bodies’) the ingredient data sheet referred to in point 2.2 (e) of Annex IV to this Regulation (the ‘ingredients data sheet’). Where the detergent or end-user surfactant for which an ingredients data sheet has already been submitted no longer corresponds to the information included in that ingredients data sheet, the manufacturers shall submit an updated ingredients data sheet. The ingredients data sheet shall be submitted by electronic means in the format provided by the European Chemicals Agency and made available free of charge for notifications in accordance with Part A, Section 3.1, second paragraph, of Annex VIII to Regulation (EC) No 1272/2008. The submission shall be in a language easily understood by the appointed bodies, as determined by the Member State in which the product is made available on the market.
7. Manufacturers established outside the Union shall provide the authorised representative or the importer with all the information and documentation necessary to demonstrate the compliance with this Regulation of the detergent or surfactant.
8. Where manufacturers consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in compliance with this Regulation, they shall immediately take the corrective action necessary to bring the detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where manufacturers consider or have reason to believe that a detergent or surfactant which they have placed on the market poses a risk to human health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made it available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective action taken.
9. Manufacturers shall ensure that other economic operators in the supply chain concerned are kept informed without undue delay regarding any non-compliance or risk to human health or the environment that they have identified and of any consequent corrective action, recall or withdrawal.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in electronic format and, on request, in paper format, necessary to demonstrate the compliance with this Regulation of a detergent or surfactant which they have placed on the market, in a language which can be easily understood by that authority. Manufacturers shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by that detergent or surfactant.
11. Manufacturers shall make their communication channels, such as a telephone number, an electronic address or a dedicated section of their website, publicly available on their website, taking into account the accessibility needs of persons with disabilities and enabling end-users to submit complaints about potential non-compliance of products or safety issues.
Authorised representative
1. Manufacturers may, by a written mandate, appoint an authorised representative. That mandate shall only be valid when accepted in writing by the authorised representative. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
2. Manufacturers established outside the Union, placing a detergent or surfactant on the Union market, shall appoint an authorised representative pursuant to the conditions laid down in paragraph 1.
3. The authorised representative shall perform the tasks specified in the mandate referred to in paragraph 1.
The mandate shall require the authorised representative to do at least the following:
(a)
verify that, in accordance with Article 8(2), the digital product passport has been created, the relevant information on the digital product passport has been included in the registry, the technical documentation has been drawn up and the conformity assessment procedure has been carried out;
(b)
keep the technical documentation at the disposal of national market surveillance authorities, and the digital product passport available, for 10 years from the date on which the detergent or surfactant covered by those documents has been placed on the market;
(c)
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the compliance with this Regulation of the detergent or surfactant, in a language that can be easily understood by that authority;
(d)
where it has reason to believe that a detergent or surfactant covered by the mandate poses a risk to human health or to the environment, inform the manufacturer and the market surveillance authorities thereof;
(e)
cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by a detergent or surfactant covered by the mandate; and
(f)
terminate the mandate and inform the competent national authorities of such termination if the manufacturer does not comply with its obligations under this Regulation.
4. In addition to the tasks referred to in paragraph 3 of this Article, the mandate of the authorised representative appointed in accordance with paragraph 2 of this Article shall require that authorised representative to do the following as regards detergents and surfactants covered by that mandate:
(a)
provide and, where needed, update the ingredients data sheet in accordance with Article 8(6);
(b)
keep the information contained in the ingredients data sheet confidential;
(c)
verify that detergents and surfactants comply with the labelling requirements set out in Article 17(1), (3), (4) and (5), Article 18(1), Article 19(1) and (2) and, where applicable, Article 17(2), Article 18(2) and Article 19(3); and
(d)
make best efforts to verify that the documentation and information provided by the manufacturer in accordance with Article 8(7) demonstrates compliance of the products with this Regulation.
5. The obligations laid down in Article 8(1) and the obligation to draw up technical documentation referred to in Article 8(2) shall not form part of the authorised representative’s mandate.
Obligations of importers
1. Importers shall only place compliant detergents or surfactants on the market.
2. Before placing a detergent or surfactant on the market, importers shall ensure that:
(a)
the manufacturer has carried out the conformity assessment procedure and drawn up the technical documentation referred to in Article 8(2);
(b)
the information and documentation provided by the manufacturer in accordance with Article 8(7) demonstrate compliance with this Regulation; and
(c)
the manufacturer has created the digital product passport referred to in Article 8(2), point (a), the data carrier is available in accordance with Article 21(4) and the relevant information on the digital product passport has been included in the registry.
3. Importers shall provide the ingredients data sheet before placing detergents or end-users surfactants on the market and, where needed, update the ingredients data sheet, in accordance with Article 8(6). The importer shall keep the information contained in the ingredients data sheet confidential.
4. Where importers consider or have reason to believe that a detergent or surfactant is not in compliance with this Regulation, they shall not place it on the market until it has been brought into conformity. Furthermore, where the detergent or surfactant poses a risk to human health or to the environment, importers shall inform the manufacturer and the market surveillance authorities to that effect.
5. Importers shall ensure that detergents and surfactants that they place on the market comply with Article 17(1), (3), (4) and (5), Article 18(1), Article 19(1) and (2) and, where applicable, Article 17(2), Article 18(2) and Article 19(3).
6. Importers shall ensure that, while a detergent or surfactant is under their responsibility, its storage or transport conditions do not jeopardise its compliance with this Regulation.
7. Where deemed appropriate with regard to the performance of a detergent or surfactant or to the risks presented by them, importers shall carry out sample testing of such detergent or surfactant, investigate, and, if necessary, keep a register of complaints, of non-compliant detergents and surfactants and of recalls of such detergents and surfactants, and shall keep distributors informed of any such monitoring.
8. Where importers consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in compliance with this Regulation, they shall inform immediately and cooperate with the manufacturer and the competent authorities and shall immediately take the corrective action necessary to bring the detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where importers consider or have reason to believe that a detergent or surfactant which they have placed on the market poses a risk to human health or the environment, they shall immediately inform the manufacturer and the competent national authorities of the Member States in which they made it available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective action taken.
9. Importers shall ensure that other economic operators in the supply chain concerned are kept informed without delay regarding any non-compliance or risk to human health or the environment that they have identified and of any consequent corrective action, recall or withdrawal.
10. Importers shall keep the reference to the unique product identifier and the technical documentation referred to in Article 8(2) at the disposal of the market surveillance authorities for a period of 10 years from the date on which the detergent or surfactant has been placed on the market.
11. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in electronic format and, on request, in paper format, necessary to demonstrate the compliance with this Regulation of a detergent or surfactant, in a language which can be easily understood by that authority. Importers shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by a detergent or surfactant which they have placed on the market.
12. Importers shall verify whether the communication channels referred to in Article 8(11) are publicly available to consumers and other end-users. Where they are not available, importers shall provide for such channels, taking into account the accessibility needs of persons with disabilities.
Obligations of distributors
1. Where making a detergent or surfactant available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. Before making a detergent or surfactant available on the market, distributors shall verify that:
(a)
the detergent or surfactant is accompanied by the required documents and by a label containing the information referred to in Article 17(3) and (4), in the conditions set out in Article 17(5);
(b)
where a digital label is provided, the requirements in Article 19(1), points (a), (d), (e) and (h), Article 19(2) and, where applicable, Article 17(2), Article 18(2) and Article 19(3) are met; and
(c)
the data carrier is available in accordance with Article 21(4).
3. Distributors making available on the market in another Member State detergents or end-user surfactants for which an ingredients data sheet is to be provided in accordance with Article 8(6) shall submit to the appointed body in that Member State the ingredients data sheet before making the product available therein, and update the ingredients data sheet where needed, unless they can demonstrate that the appointed body already received the same information from another economic operator. Distributors shall keep the information contained in the ingredients data sheet confidential.
4. Where distributors consider or have reason to believe that a detergent or surfactant is not in compliance with this Regulation, they shall not make it available on the market until it has been brought into conformity. Furthermore, where the detergent or surfactant poses a risk to human health or the environment, distributors shall inform the market surveillance authorities, the manufacturer and, where relevant, the authorised representative or the importer to that effect.
5. Distributors shall ensure that, while a detergent or surfactant is under their responsibility, its storage or transport conditions do not jeopardise its compliance with this Regulation.
6. Where distributors consider or have reason to believe that a detergent or a surfactant which they have made available on the market is not in compliance with this Regulation, they shall inform immediately and cooperate with the manufacturer or importer, as applicable, and the competent national authorities and shall ensure that the corrective action necessary to bring the detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate, is taken. Furthermore, where distributors consider or have reason to believe that a detergent or surfactant which they have made available on the market poses a risk to human health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made it available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective action taken.
7. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in electronic format and, on request, in paper format, necessary to demonstrate the compliance with this Regulation of a detergent or surfactant. Distributors shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by a detergent or surfactant which they have made available on the market.
Supply through refill
Without prejudice to Regulations (EU) 2023/988 ( 20 ) and (EU) 2025/40 ( 21 ) of the European Parliament and of the Council as regards safety and hygiene requirements for refill including the risk of confusion with foodstuff, where detergents or end-user surfactants are made available on the market through refill, the economic operator making the product available to end-users shall ensure that:
(a)
risk mitigation measures are applied to minimise the exposure of humans, especially of children, including by preventing children from using the refill station unsupervised and by training appropriately their staff; and
(b)
the detergents or end-user surfactants provided through a refill station do not react with each other in a way that could endanger human health.
Cases in which obligations of manufacturers apply to importers and distributors
Importers or distributors shall be considered manufacturers for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 8 where they:
(a)
place a detergent or surfactant on the market under their name or trade mark;
(b)
modify a detergent or surfactant already placed on the market in such a way that compliance with this Regulation could be affected; or
(c)
make a surfactant that is not an end-user surfactant available on the market to end-users.
Packaging and repackaging by importers and distributors
1. Where importers or distributors package or repackage a detergent or surfactant and those importers or distributors are not subject to the obligations of the manufacturer pursuant to Article 13, they shall, as applicable and in addition to their obligations under Article 10 or 11:
(a)
ensure that the package bears the importer’s or distributor’s name, registered trade name or registered trade mark, postal and electronic address and telephone number, preceded by the words ‘packaged by’ or ‘repackaged by’;
(b)
keep a specimen of the original information referred to in Article 17(3) or (4) at the disposal of the market surveillance authorities for 10 years from the date on which the detergent or surfactant has been placed on the market; and
(c)
keep the reference to the unique product identifier at the disposal of the market surveillance authorities for 10 years from the date on which the detergent or end-user surfactant has been placed on the market.
2. The making available on the market of detergents or end-user surfactants at refill stations is not considered as packaging or repackaging for the purposes of this Article.
Identification of economic operators
1. Economic operators shall, on request from a market surveillance authority, identify the following:
(a)
any economic operator who has supplied them with a detergent or a surfactant; and
(b)
any economic operator to whom they have supplied a detergent or a surfactant.
2. Economic operators shall be able to provide the information referred to in paragraph 1 for 10 years after they have been supplied with the detergent or surfactant and for 10 years after they have supplied the detergent or surfactant.
Confidentiality of the ingredients data sheet
Appointed bodies and medical personnel shall keep confidential the information included in the ingredients data sheet. They may only use such information:
(a)
to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency; or
(b)
where requested by a Member State, the Commission or the European Chemicals Agency, to undertake a statistical analysis to identify where improved risk management measures might be needed.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
