Legal provisions of COM(2023)217 - Detergents and surfactants - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)217 - Detergents and surfactants. |
|---|---|
| document | COM(2023)217 |
| date | April 28, 2023 |
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
1. This Regulation establishes rules for the free movement of detergents and surfactants in the internal market while, at the same time, ensuring a high degree of protection of health and the environment.
2. This Regulation does not affect the application of the following legal acts:
(a) Regulation (EC) No 1907/2006 of the European Parliament and of the Council41;
(b) Regulation (EC) No 1272/2008 of the European Parliament and of the Council42;
(c) Regulation (EU) No 528/2012 of the European Parliament and of the Council43.
Article 2
Definitions
For the purpose of this Regulation, the following definitions apply:
(1) ‘detergent’ means any of the following:
- a substance, mixture or micro-organism, or two or more such materials in combination, which is intended for cleaning of fabrics, dishes or surfaces;
- a mixture intended for soaking (pre-washing), rinsing or bleaching fabrics or dishes;
- a mixture intended to modify the feel of fabrics in processes which are to complement the washing of fabrics;
(2) ‘consumer laundry detergent’ means a detergent for laundry placed on the market for use by non-professionals, including in public laundrettes;
(3) ‘consumer automatic dishwasher detergent’ means a detergent placed on the market for use in automatic dishwashers by non-professionals;
(4) ‘detergent containing micro-organisms’ means a detergent in which one or more micro-organisms has been intentionally added, either on its own or via one of the components of the detergent;
(5) ‘professional detergent’ means a detergent for cleaning outside the domestic sphere, carried out by specialised personnel using specific products;
(6) ‘cleaning’ means the process by which an undesirable deposit is dislodged from a substrate or from within a substrate and brought into a state of solution or dispersion;
(7) ‘substance’ means a substance as defined in Article 3, point (1), of Regulation (EC) No 1907/2006;
(8) ‘mixture’ means a mixture as defined in Article 3, point (2), of Regulation (EC) No 1907/2006;
(9) ‘micro-organism’ means a micro-organism as defined in Article 3(1), point (b), of Regulation (EU) No 528/2012;
(10) ‘genetically modified micro-organisms’ means micro-organisms in which the genetic material has been altered using gene or cell technology or in any other way that does not occur naturally by mating or natural recombination.
(11) ‘surfactant’ means any organic substance or mixture used in detergents, which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable to perform all of the following actions:
- to reduce the surface tension of water below 45 mN/m;
- to form spreading or adsorption monolayers at the water-air interface;
- to form emulsions and/or microemulsions and/or micelles;
- to adsorpt at water-solid interfaces;
(12) ‘ultimate aerobic biodegradation’ means the level of biodegradation achieved when the substance or mixture is totally used by micro-organisms in the presence of oxygen resulting in its breakdown to carbon dioxide, water and mineral salts of any other elements present, as measured by test methods listed in Annex I, and new microbial cellular constituents;
(13) ‘making available on the market’ means any supply for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(14) ‘placing on the market’ means the first making available on the Union market;
(15) ‘manufacturer’ means any natural or legal persons that manufacture or have a detergent or a surfactant designed or manufactured, and place that detergent or surfactant on the market under their name or trademark;
(16) ‘authorised representative’ means any natural or legal persons established within the Union that have received a written mandate from a manufacturer to act on their behalf in relation to specified tasks;
(17) ‘importer’ means any natural or legal persons established within the Union that place a detergent or surfactant from a third country on the Union market;
(18) ‘distributor’ means any natural or legal persons in the supply chain, other than the manufacturer or the importer, that make a detergent or surfactant available on the market;
(19) ‘economic operator’ means the manufacturer, the authorised representative, the importer or the distributor;
(20) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in this Regulation;
(21) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point 4, of Regulation (EU) 2019/1020;
(22) ‘recall’ means a recall as defined Article 3, point 22, of Regulation (EU) 2019/1020;
(23) ‘withdrawal’ means a withdrawal as defined in Article 3, point 23, of Regulation (EU) 2019/1020;
(24) ‘CE marking’ means a marking by which the manufacturer indicates that the detergent is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
(25) ‘corrective measure’ means a measure as defined in Article 3, point 16, of Regulation (EU) 2019/1020;
(26) ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;
(27) ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;
(28) ‘unique product identifier’ means a unique string of characters that allows the identification of a product and enables a web link to the product passport;
(29) ‘unique operator identifier’ means a unique string of characters for the identification of economic operators involved in the value chain of products;
(30) ‘customs authorities’ means customs authorities as defined in Article 5, point 1, of Regulation (EU) No 952/2013;
(31) ‘EU Customs Single Window Certificates Exchange System’ means the system referred to in Article 4 of the Regulation (EU) 2022/2399 of the European Parliament and of the Council 44;
(32) ‘individual packaging’ means packaging in which the detergent or surfactant is made available on the market and which is intended to accompany the content to the place of use;
(33) ‘refill’ means the operation by which the detergent is filled in-store from a large container in the end-users’ own package either manually or through automatic or semi-automatic equipment;
(34) ‘batch’ means a defined quantity of finished products that meets the following conditions:
- is produced in a single manufacturing process or a series of processes during the same manufacturing cycle;
- is intended to have a uniform composition when tested in accordance with the same test methods; and
- is clearly defined by a type number, batch number or other element allowing its identification.
(35) ‘end-user’ means any natural or legal person residing or established in the Union, to whom a detergent or surfactant has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end-user in the course of its industrial or professional activities.
CHAPTER II
PRODUCT REQUIREMENTS
Article 3
Free movement
1. Detergents and surfactants may only be placed on the market if they comply with this Regulation.
2. Member States shall not prohibit, restrict or impede the placing on the market of detergents or surfactants which comply with this Regulation.
Article 4
Biodegradability
1. Detergents and surfactants shall comply with the biodegradability requirements laid down in Annex I.
2. Paragraph 1 shall not apply to the following:
(a) surfactants 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 where they meet any of the following conditions:
(i) the surfactants are included in the Union list of approved active substances as laid down in Article 9(2) of Regulation (EU) No 528/2012;
(ii) the surfactants are included in the review programme as set out in Commission Delegated Regulation (EU) No 1062/201445;
(b) surfactants that are constituents of biocidal products authorised in accordance with Regulation (EU) No 528/2012;
(c) surfactants that are constituents of biocidal products and which may be made available on the market or used in accordance with Article 89(2) of Regulation (EU) No 528/2012.
Article 5
Detergents containing micro-organisms
Detergents containing micro-organisms shall comply with the requirements laid down in Annex II.
Article 6
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 laid down in that Annex.
CHAPTER III
OBLIGATIONS OF ECONOMIC OPERATORS
Article 7
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 referred to in Annex IV and carry out the conformity assessment procedure referred to in that Annex.
Where compliance of a detergent or surfactant with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall:
(a) create a product passport in accordance with Article 18,
(b) ensure that the data carrier is printed or otherwise placed on the label or on the packaging of the detergent or surfactant in a visible and legible manner in accordance with Article 18(3),
(c) where relevant, affix the CE marking in accordance with Article 14,
(d) before placing detergents or surfactants on the market, manufacturers shall include a reference of the product passport in the registry referred to in Article 20(1).
3. Manufacturers shall keep the technical documentation and the product passport for 10 years after the detergent or the surfactant covered by that documentation or product passport 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 characteristics and changes in the test methods by reference to which 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 detergents or surfactants, investigate, and, if necessary, keep a register of complaints, of non-conforming detergents or surfactants and recalls of such detergent or surfactants, and shall keep distributors informed of any such monitoring.
5. Manufacturers placing on the market detergents or surfactants shall ensure that they comply with the labelling requirements laid down in Articles 15, 16 and 17.
6. Manufacturers placing on the market detergents that do not meet the criteria for classification as hazardous within the meaning of Regulation (EC) No 1272/2008, shall provide to Member States’ appointed bodies referred to in Article 45 of that Regulation, the ingredient datasheet referred to in point 2.2 (e) of Annex IV.
Manufacturers shall provide the ingredient data sheet to the Member States’ appointed bodies referred to in the first subparagraph in the following cases:
(a) upon request from the Member States’ appointed bodies;
(b) when the detergent for which a data sheet has already been requested no longer corresponds to the information included in that datasheet.
The appointed body referred to in the first subparagraph and the medical personnel to which the information contained in the datasheet has been provided shall keep it confidential and use it for medical purposes only.
7. Manufacturers that consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that 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 presents a risk to health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
8. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the detergent or surfactant with this Regulation, in a language which can be easily understood by that authority. They 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.
Article 8
Authorised representative
1. Manufacturers may, by a written mandate, appoint an authorised representative.
2. Where the manufacturer is not established in the Union, the detergent or surfactant may only be placed on the Union market if the manufacturer designates, by a written mandate, an authorised representative.
3. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
The mandate shall allow the authorised representative to do at least the following:
(a) verify that the product passport has been created in accordance with Article 7(2), point (a), that the technical documentation has been drawn up and the conformity assessment procedure has been carried out by the manufacturer in accordance with Article 7(2);
(b) keep the product passport and technical documentation at the disposal of national market surveillance authorities for 10 years after 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 conformity of the detergent or surfactant with the requirements laid down in this Regulation;
(d) 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 authorised representative’s mandate.
(e) terminate the mandate if the manufacturer does not comply with the obligations of the manufacturer under this Regulation.
4. The obligations laid down in Article 7(1) and the obligation to draw up technical documentation referred to in Article 7(2) shall not form part of the authorised representative’s mandate.
Article 9
Obligations of importers
1. Importers shall place only compliant detergents or surfactants on the market.
2. Before placing a detergent or surfactant on the market importers shall ensure the following:
(a) the manufacturer has carried out the conformity assessment procedure and drawn up the technical documentation referred to in Article 7(2);
(b) the detergent bears the CE marking referred to in Article 14;
(c) the manufacturer has created the product passport referred to in Article 7(2);
(d) the relevant information on the product passport has been included in the registry referred to in Article 20(1);
3. Where an importer considers or has reason to believe that a detergent or surfactant is not in conformity with this Regulation, the importer shall not place the detergent or surfactant on the market until it has been brought into conformity. Furthermore, where the detergent or surfactant presents a risk to health or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
4. Importers shall indicate their name, registered trade name or registered trade mark and the postal and email address at which they can be contacted on the label of the detergent or surfactant. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
5. Importers shall ensure that detergents and surfactants that they place on the market comply with the labelling requirements laid down in Articles 15, 16 and 17.
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. When deemed appropriate with regard to the performance of a detergent or surfactant or the risks presented by them, importers shall carry out sample testing of such detergents and surfactants, investigate, and, if necessary, keep a register of complaints, of non-conforming detergents and surfactants and recalls of such detergents and surfactants, and shall keep distributors informed of any such monitoring.
8. Importers that consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that 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 presents a risk to health or the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
9. Importers shall keep the reference to the unique product identifier at the disposal of the market surveillance authorities for a period of 10 years after the detergent or surfactant has been placed on the market and shall ensure that the technical documentation can be made available to those authorities, upon request.
10. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the detergent or surfactant with this Regulation in a language which can be easily understood by that authority. They 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.
Article 10
Obligations of distributors
1. When 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 the following conditions have been met:
(a) the detergent or surfactant is accompanied by the required documents and by a label that meets the requirements laid down in Articles 15, 16 and 17;
(b) the detergent bears the CE marking referred to in Article 14;
(c) the manufacturer has complied with the requirements set out in Article 7(2) and (3) or, as applicable, the importer has complied with the requirements set out in Article 9(2).
3. Where a distributor considers or has reason to believe that a detergent or surfactant is not in conformity with this Regulation, the distributor shall not make the detergent or surfactant available on the market until it has been brought into conformity. Furthermore, where the detergent or surfactant presents a risk to health or the environment, the distributor shall inform the manufacturer and, where relevant, the authorised representative or the importer to that effect as well as the market surveillance authorities.
4. 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.
5. Distributors that consider or have reason to believe that a detergent or a surfactant which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where distributors consider or have reason to believe that a detergent or surfactant which they have made available on the market presents a risk to health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
6. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the detergent or surfactant with this Regulation. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by detergents and surfactants which they have made available on the market.
Article 11
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 7 where that importer or distributor places a detergent or surfactant on the market under his or her name or trademark or modifies a detergent or surfactant already placed on the market in such a way that compliance with this Regulation may be affected.
Article 12
Packaging and repackaging by importers and distributors
Where an importer or distributor packages or repackages a detergent or surfactant and is not subject to the obligations of the manufacturer pursuant to Article 11, that importer or distributor, as applicable, shall have the following obligations:
(a) to ensure that the package bears his or her name, registered trade name or registered trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged by’;
(b) to ensure compliance with Articles 14 to 17;
(c) to keep the reference to the unique product identifier at the disposal of the market surveillance authorities for 10 years after having made the detergent or surfactant available on the market.
Article 13
Identification of economic operators
1. Economic operators shall, on request, identify the following to the market surveillance authorities:
(a) any economic operator who has supplied them with a detergent or a surfactant;
(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.
CHAPTER IV
CE MARKING AND LABELLING
Article 14
Rules and conditions for affixing the CE marking
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. The CE marking shall be affixed visibly, legibly and indelibly before a detergent is placed on the market.
The CE marking shall be affixed either to the label or the packaging of a detergent or, where the detergent is supplied in bulk, to a document accompanying the detergent.
Where, in accordance with Article 16(2), economic operators may provide a digital label only, the CE marking shall be provided on the digital label.
3. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Article 15
General labelling requirements
1. Detergents and surfactants that are made available on the market in individual packaging or in a refill format shall be accompanied by a label.
2. An economic operator making a detergent available on the market directly to an end-user in a refill format shall provide the physical label or the data carrier through which the digital label is accessible to the end-user.
3. The label of detergents and surfactants shall contain the following information:
(a) a type number, batch number or other element allowing their identification;
(b) the manufacturer’s name, registered trade name or registered trade mark and the postal and email address at which they can be contacted. The postal address shall indicate a single point at which the manufacturer can be contacted;
(c) the name and trade name of the product;
(d) the content of the detergent or surfactant in accordance with part A of Annex V;
(e) instructions for use and special precautions, where necessary and relevant.
The information referred to in points (a), (b) and (c) of the first subparagraph shall appear on all documents accompanying detergents and surfactants transported in bulk.
4. In addition to the information referred to in paragraph 3, the label of consumer laundry detergents and consumer automatic dishwasher detergents shall contain dosage information in accordance with part B of Annex V.
5. The information referred to in paragraphs 3 and 4 shall be in a language which can be easily understood by end-users, as determined by the Member State concerned, and shall be clear, understandable and intelligible. The label shall be accessible for inspection purposes where the detergent or surfactant is made available on the market.
Article 16
Forms of labelling
1. Where detergents or surfactants are made available on the market, they shall be accompanied by the label elements set out in Article 15(3) and, where applicable, Article 15(4) in the following form:
(a) on a physical label;
(b) on a digital label and duplicated on a physical label.
By way of derogation from point (b) of the first subparagraph, the labelling elements set out in part C of Annex V do not have to be duplicated on the physical label. In addition, where the dosage information for consumer laundry detergents in accordance with points 1 and 2 of part B of Annex V is provided on the digital label, a simplified dosage grid as set out in part D of Annex V may be provided on the physical label.
2. By way of derogation from paragraph 1, where detergents are made available on the market directly to an end-user in a refill format, the label elements set out in Article 15(3) and (4) may be provided in a digital label only, with the exception of dosage information for consumer laundry detergents as set out in point 1 and 2 of part B of Annex V, which needs to be provided also on a physical label.
Article 17
Requirements for digital labelling
1. Where detergents and surfactants carry a digital label in accordance with Article 16, the following rules shall apply to that label:
(a) all label elements referred to in Article 15(3) and, where applicable, Article 15(4) shall be provided in one place and separated from other information;
(b) the information on the digital label shall be searchable;
(c) the information on the digital label shall be accessible to all users in the Union;
(d) the digital label shall be accessible free of charge, without the need for prior registration, download or installation of applications, or to provide a password;
(e) the information on the digital label shall be presented in a way that addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups;
(f) the digital label shall be accessible through digital technologies widely used and compatible with all major operating systems and browsers;
(g) when the digital label is available in more than one language, the choice of language shall not be conditioned on the geographical location of the end-user;
(h) the digital label shall remain available for a period of 10 years from the moment the detergent or surfactant is placed on the market, also in cases of an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created it, or for a longer period as required under other Union legislation covering the information that it contains;
(i) the information on the digital label shall be accessible via the data carrier.
2. The data carrier shall be physically present on the detergent or surfactant, their packaging or the documentation accompanying them.
In addition to the requirement in the first subparagraph, where detergents and surfactants are made available on the market in a refill format, the data carrier shall be present on the refill station.
The data carrier shall be clearly visible to the end-user before any purchase and to market surveillance authorities, including, where applicable, in cases where the detergent or surfactant is made available through distance sales.
3. Where economic operators provide a digital label, the data carrier shall be accompanied by the statement ‘More comprehensive information on the product is available online’ or by a similar statement.
4. Economic operators providing a digital label shall not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the information on the digital label online.
5. Economic operators providing a digital label shall provide the information present in the digital label by other means in any of the following cases:
(a) upon oral or written request by the end-user;
(b) when the digital label is temporarily unavailable, including at the time of purchase.
Economic operators shall provide the information referred to in the first subparagraph independently from a purchase of a detergent or surfactant and free of charge.
CHAPTER V
PRODUCT PASSPORT
Article 18
Product passport
1. Before placing a detergent or surfactant on the market, manufacturers shall create a product passport for those products. The product passport shall meet the requirements laid down in this Article and Article 19.
2. The product passport shall meet the following requirements:
(a) it shall correspond to a specific batch of the detergent or surfactant;
(b) it shall state that compliance of the detergent or surfactant with the requirements set out in this Regulation has been demonstrated, and, where relevant, indicate the test methods used;
(c) it shall contain at least the information included in Annex VI;
(d) it shall be up-to date;
(e) it shall be available in the language or languages required by the Member State where the detergent or surfactant is placed or made available on the market;
(f) it shall be accessible to end-users, market surveillance authorities, customs authorities, the Commission and other economic operators;
(g) it shall be available for a period of 10 years after the detergent or surfactant is placed on the market, also in cases of an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
(h) it shall be accessible through a data carrier;
(i) it shall fulfil the specific and technical requirements laid down pursuant to paragraph 8.
3. The data carrier shall be physically present on the detergent or surfactant, their packaging or the documentation accompanying them, in accordance with the implementing act referred to in paragraph 8.
In addition to the requirement in the first subparagraph, where detergents and surfactants are made available on the market in a refill format, the data carrier shall be present on the refill station.
The data carrier shall be clearly visible to the end-user before any purchase and to market surveillance authorities, including, where applicable, in cases where the detergent or surfactant is made available through distance sales.
4. Where economic operators provide a digital label, a single data carrier shall be used to access the product passport and the digital label.
5. Where other Union legislation requires information on the detergent or surfactant to be available via a data carrier, a single data carrier shall be used to provide the information required under this Regulation and the other Union legislation.
6. Where other Union legislation applying to detergents and surfactants requires a product passport, a single product passport shall be created for detergents and surfactants, containing the information set out in paragraph 2 as well as any other information required for the product passport by that other Union legislation.
7. Economic operators may, in addition to the information referred to in paragraphs 5 and 6, make other information accessible through the data carrier referred to in paragraph 6. Where this is the case, that information shall be clearly separated from the information required under this Regulation and, where relevant, under other Union legislation.
8. By creating the product passport, the manufacturer shall assume the responsibility for the compliance of the detergent or surfactant with this Regulation.
9. The Commission shall adopt an implementing act determining the specific and technical requirements related to the product passport for detergents and surfactants. Those requirements shall set out at least the following:
(a) the types of data carrier to be used;
(b) the layout in which the data carrier shall be presented and its positioning;
(c) the technical elements of the passport for which defined European or international standards shall be used;
(d) the actors that may introduce or update the information in the product passport, including where needed the creation of a new product passport, including manufacturers, competent national authorities, and the Commission, or any organisation acting on their behalf, and the types of information they may introduce or update;
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 28(2).
Article 19
Technical design and operation of the product passport
The technical design and operation of the product passport shall comply with the following requirements:
(a) product passports created under this Regulation shall be fully interoperable with product passports required by other Union legislation in relation to the technical, semantic and organisational aspects of end-to-end communication and data transfer;
(b) all information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable;
(c) end-users, economic operators and other relevant actors shall have access to the product passport free of charge;
(d) the data included in the product passport shall be stored by the economic operator responsible for its creation or by operators authorised to act on their behalf;
(e) if the data included in the product passport is stored or otherwise processed by operators authorised to act on behalf of economic operators placing the detergent or surfactant on the market, those operators shall not be allowed to sell, re-use or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services;
(f) economic operators may not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the information on the product passport online.
Article 20
Product passport registry
1. Before placing a detergent or surfactant on the market, economic operators shall upload, in the registry established under Article 12(1) of Regulation (EU) …/… on Ecodesign for Sustainable Products the unique product identifier and the unique operator identifier for the detergent or surfactant.
2. The Commission, the market surveillance authorities and the customs authorities shall have access to the registry referred to in paragraph 1 for carrying out their duties pursuant to this Regulation.
Article 21
Customs controls relating to the product passport
1. Detergents and surfactants entering the Union market shall be subject to verifications and other measures laid down in this Article.
2. Declarants as defined in Article 5, point (15), of Regulation (EU) 952/2013 shall include the unique product identifier in the customs declaration for release for free circulation of any detergent or surfactant.
3. Customs authorities shall verify whether the unique product identifier indicated by the declarant in accordance with paragraph 2 of this Article matches a unique product identifier included in the registry in accordance with Article 20(1).
4. In addition to the verification referred to in paragraph 3, customs authorities shall verify the consistency of information made available to customs by declarants with other information stored in the registry referred to in Article 20(1) listed in the delegated act referred to in Article 26(3).
5. The verifications referred to in paragraph 3 and 4 shall take place electronically and automatically before the release for free circulation.
6. For the purpose of paragraphs 3 to 5, the interconnection between the registry referred to in Article 20(1) and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of Regulation (EU) …/… on Ecodesign for Sustainable Products] shall be used.
7. Paragraphs 3, 4 and 5 shall apply from the day when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of Regulation (EU) …/… on Ecodesign for Sustainable Products] becomes operational.
The Commission shall publish a notice in the Official Journal of the European Union to that effect indicating the date when the interconnection becomes operational.
8. Customs authorities may retrieve and use the information included in the product passport and the registry referred to in Article 20(1) for carrying out their duties pursuant to Union legislation, including for risk management in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.
9. The verifications and other measures laid down in this Article shall be carried out on the basis of a list of Combined Nomenclature codes, as set out in Annex I to Regulation (EEC) No 2658/87, under which detergents and surfactants are classified as well as the product descriptions of those detergents and surfactants.
10. The verifications and measures laid down in this Article shall not affect the application of other Union legal acts governing the release for free circulation of products, including Articles 46, 47 and 134 of Regulation (EU) No 952/2013, as well as the controls referred to in Chapter VII of Regulation (EU) 2019/1020.
CHAPTER VI
MARKET SURVEILLANCE
Article 22
Procedure at national level for dealing with detergents and surfactants presenting a risk
1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a detergent or surfactant presents a risk to health or the environment, they shall carry out an evaluation in relation to the detergent or surfactant concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.
2. Where the market surveillance authorities of one Member State have sufficient reason to believe that a test carried out in accordance with the methods listed in Annex I or Annex II has produced false results, they shall perform controls to verify the compliance of the detergent or surfactant with this Regulation in accordance with the reference methods set out in Annexes I, II and VII. Economic operators shall not be obliged to pay for any repeat or additional test, provided that the initial test has shown compliance of detergents, or surfactants, with this Regulation.
3. Where, in the course of the controls referred to in paragraph 1 or paragraph 2, the market surveillance authorities find that the detergent or surfactant does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operators to take all appropriate corrective action to bring the detergent or surfactant into compliance with those requirements, to withdraw it from the market, or to recall it within a reasonable period which is commensurate with the nature of the risk referred to in paragraph 1.
4. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the market surveillance authorities of other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
5. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the concerned detergents or surfactants that the economic operator has made available on the market throughout the Union.
6. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 3, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict making available on their national market of the detergent or surfactant, to withdraw the detergent or surfactant from that market or to recall it.
The market surveillance authorities shall inform the Commission and the market surveillance authorities of other Member States, without delay, of those measures.
The information referred to in the second subparagraph shall include all available details, in particular the data necessary for the identification of the non-compliant detergent or surfactant, the origin of that detergent or surfactant, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
7. Market surveillance authorities of Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the market surveillance authorities of other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the detergent or surfactant concerned, and, in the event of disagreement with the adopted national measure, of their objections.
8. Where, within three months of receipt of the information referred to in paragraph 6, second subparagraph, no objection has been raised by either a market surveillance authority or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
9. Market surveillance authorities shall ensure that appropriate restrictive measures, such as withdrawal of the detergent or surfactant from the market, are taken in respect of the detergent or surfactant concerned without delay.
10. Where, for the purposes of paragraphs 4, 6, 7 and 8, information is communicated to the Commission or other market surveillance authorities that information shall be communicated through the information and communication system referred to in Article 34(1) of Regulation (EU) 2019/1020.
Article 23
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 22(3), (4) and (5), objections are raised against a measure taken by a market surveillance authority, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the market surveillance authorities and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.
The Commission shall address its decision to all Member States and shall without delay communicate it to them and the relevant economic operator or operators.
2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant detergent or surfactant is withdrawn from their market, and shall inform the Commission accordingly.
3. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.
Article 24
Compliant detergents and surfactants which present a risk to health or to the environment
1. Where, having carried out an evaluation under Article 22(1), a market surveillance authority finds that although a detergent or surfactant is in compliance with this Regulation, it presents a risk to health or to the environment, it shall require the relevant economic operator to take all appropriate measures to ensure that the detergent or surfactant concerned, when placed on the market, no longer presents that risk, to withdraw the detergent or surfactant from the market or to recall it, within a reasonable period which is commensurate with the nature of that risk.
2. The economic operator shall ensure that corrective action is taken in respect of all the concerned detergents or surfactants that the economic operator has made available on the market throughout the Union.
3. The market surveillance authority shall immediately inform the Commission and the market surveillance authorities of the other Member States. That information shall include all available details, in particular the data necessary for the identification of the detergents or surfactants concerned, the origin and the supply chain of the detergent or surfactant, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the market surveillance authorities and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not and, where necessary, propose appropriate measures.
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Article 25
Formal non-compliance
1. Without prejudice to Article 22, where a market surveillance authority makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the CE marking has been affixed in violation of Article 14 or not affixed at all;
(b) the product passport has not been drawn up in accordance with Articles 18 and 19;
(c) the technical documentation referred to in Article 7(2) is either not available or incomplete;
(d) the data carrier through which the product passport and, where relevant, the digital label is accessible is not present on the detergent or surfactant, their packaging, the documentation accompanying them or on the refill station, as applicable;
(e) the label has not been provided or the labelling information referred to in Articles 15 and Annex V is false or incomplete;
2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the detergent or surfactant being made available on the market or ensure that it is recalled or withdrawn from the market.
CHAPTER VII
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 26
Delegated powers
1. The Commission is empowered to adopt delegated acts in accordance with Article 27 amending Annex VI, as regards the information to be provided in the product passport, for the purposes of adapting it to technical and scientific progress and to the level of digital readiness of market surveillance authorities and of end-users.
2. The Commission is empowered to adopt delegated acts in accordance with Article 27, amending Article 20(1) by requiring that additional information among the information listed in Annex VI be stored in the registry.
When adopting the delegated acts in accordance with the first subparagraph, the Commission shall take into account the following criteria:
(a) coherence with other relevant Union acts where relevant;
(b) the need to allow for the verification of the authenticity of the product passport;
(c) the relevance of information for improving the efficiency and effectiveness of market surveillance checks and customs controls for detergents and surfactants;
(d) the need to avoid disproportionate administrative burden for economic operators.
3. The Commission is empowered to adopt delegated acts in accordance with Article 27 supplementing this Regulation by determining additional information stored in the registry referred to in Article 20(1) that is to be controlled by customs authorities.
4. The Commission is empowered to adopt delegated acts in accordance with Article 27 amending this Regulation by providing an Annex containing a list of Combined Nomenclature codes, as set out in Annex I to Regulation (EEC) No 2658/87, and product descriptions of detergents and surfactants and by updating such Annex.
5. The Commission is empowered to adopt delegated acts in accordance with Article 27 amending Annexes I to VII to take into account scientific and technical progress.
6. Where new scientific evidence points to the need to introduce biodegradability requirements for substances and mixtures other than surfactants in detergents, including detergent capsules, the Commission is empowered to adopt delegated acts in accordance with Article 27 amending Annex I to lay down biodegradability criteria for those substances and mixtures and test methods to verify compliance with them.
When adopting delegated acts in accordance with the first subparagraph, the Commission shall take into account the current manufacturing practices, the availability of technically and economically feasible alternatives and the impacts to small and medium-sized enterprises.
7. Where individual risk-based concentration limits for fragrance allergens are established in Regulation (EC) No 1223/2009 of the European Parliament and of the Council46, the Commission shall adopt delegated acts in accordance with Article 27 amending Annex V in order to adapt the limit of the allergenic fragrances listed in Annex III to that Regulation accordingly.
8. By [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation], the Commission shall adopt delegated acts in accordance with Article 27 to supplement this Regulation, by determining the specific requirements for the digital labelling of detergents. Those requirements shall at least establish the types of IT solutions, which economic operators may use, and the alternative means for providing the information on the digital label, referred to in Article 17.
When adopting the delegated act referred to in the first subparagraph, the Commission shall take into account the following criteria:
(a) coherence with other relevant Union acts where relevant;
(b) the need to encourage innovation;
(c) technological neutrality characterised by absence of constraints or prescriptions on the choice of technology or equipment, within the bounds of compatibility and avoidance of interference;
(d) the need for the digital labelling not to compromise the safety of the end-users and the environment.
(e) the level of digital readiness among all population groups in the Union.
9. The Commission is empowered to adopt delegated acts in accordance with Article 27 amending Annex V, as regards the labelling information, which economic operators are allowed to provide only digitally in accordance with Article 16, for the purposes of adapting it to technical and scientific progress and to the level of digital readiness among the end-users of detergents. When adopting those delegated acts, the Commission shall take into account the need to ensure a high level of protection of health and environment.
Article 27
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 26 shall be conferred on the Commission for an indeterminate period of time.
3. The delegation of power referred to in Article 26 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 26 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
Article 28
Committee procedure
1. The Commission shall be assisted by the Committee on detergents. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 29
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those measures and of any subsequent amendment affecting them.
Article 30
Amendment of Regulation (EU) 2019/1020
In Annex I of Regulation (EU) 2019/1020, point 15 is replaced by the following:
‘15. Regulation (EU) …/… of the European Parliament and of the Council of … on the making available on the market of detergents and surfactants (OJ L …)’.
Article 31
Report
By [OP: please insert the date = 5 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives, including an assessment on the impact on small and medium-sized enterprises.
Article 32
Micro-organisms review
By [OP: please insert the date = 3 years from the date of application of this Regulation], the Commission shall assess the effectiveness and relevance of the requirements of this Regulation for detergents containing micro-organisms as well as the possibility to include new micro-organisms or strains of micro-organisms allowed in detergents in Annex II.
Article 33
Repeal of Regulation (EC) No 648/2004
Regulation (EC) No 648/2004 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VIII.
Article 34
Transitional provisions
Member States shall not impede the making available on the market of detergents and surfactants which are placed on the market before [OP: please insert the date = 30 months from the date of entry into force of this Regulation] in conformity with Regulation (EC) No 648/2004 as applicable on … [OP: please insert the date = one day before 30 months from the date of entry into force of this Regulation]
Detergents and surfactants which, are placed on the market after [OP: please insert the date of application = one day before 30 months from the date of entry into force of this Regulation] and which at the moment of their placing on the market comply with Regulation (EC) No 648/2004 as applicable on [OP: please insert the date of application = one day before 30 months from the date of entry into force of this Regulation], may be made available on the market until [OP: please insert the date = 36 months from the date of entry into force of this Regulation].
Article 35
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall apply as of [OP: please insert the date = 30 months from the date of entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.