EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council 
by laying down conformity assessment procedures for products that come into contact 
with water intended for human consumption and the rules for the designation of 
conformi ty assessment bodies involved in those procedures  
 
(Text with EEA relevance)    
EN 1  EN EXPLANATORY MEMORANDUM  
1.  CONTEXT  OF THE  DELEGATED  ACT  
Directive (EU) No 2020/2184 of the European Parliament and of the Council of 16 December 
2020 on the quality of water intended for human consumption includes minimum hygiene 
requirements for materials that come into contact with water intended for human 
consumption.  
This Commission Delegated Regulation establishes the procedure to assess whether  a product 
covered by the regul ation complies with the minimum hygiene  requirements of Article 11 of 
Directive (EU) 2020/2184.   
2. CONSULTATIONS  PRIOR  TO THE  ADOPTIO N OF THE  ACT  
In the context of the development of this Regulation, the Commission carried out targeted 
consultations with stakeholders  in the water sector and consulted Member States ’ experts in 
meetings of the expert group on the implementation of the Dri nking Water Directive. The 
Commission also discussed this Regulation with Member States ’ experts in meetings of the 
aforementioned expert group’s subgroup on materials that come into contact  with drinking 
water. The last Drinking Water Expert Group meeting took place on 16 June 2023, where 
stakeholders were invited to provide comments on this draft act.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
According to Article 11(8) of Directive (EU) 2020/2 184, the Commission is to determine the 
conformity assessment procedure applicable to products covered by th is Article. Th is 
procedure is to be used to demonstrate that those products fulfil  the requirements set out in 
Directive (EU) 2020/2184.  
Article 1 sets out the definitions applicable to this Regulation. Article 2 determines the 
conformity assessment procedure s that will be applicable to products according to their 
classification into certain risk groups (or product category for metallic materials), a s well as to 
assembled products (composed of several products). Articles 3 to 10  lay down requirements 
for assessment bodies to be designated at national level and notify them to the Commission. 
To allow for a progressive application of this Regulation at national level, the application of 
this Regulation is delayed by 2 years after its entry into force (Article 1 1). For the same 
purpose and  taking into account  that notified bodies will have limited testing capacity at the 
date of application of this Regula tion, it is necessary to include specific  provisions so that the 
European conformity procedure is progressively applied to all products placed on the market 
(Article 1 1).  
EN 2  EN COMMISSION DELEGATED REGU LATION (EU) …/...  
of XXX  
supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council 
by laying down conformity assessment procedures for products that come into contact 
with water intended for human consumption and the rules for the designation of 
conformity assessment bodies involved in those procedures  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Directive (EU) 2020/2184  of the European  Parliament and of the Council of 
16 December 2020 on the quality of water intended for human consumption1, and in particular 
Article 11(8)  thereof, 
Whereas:   
(1) Article 11 of Directive (EU) 2020/2184 requires Member States to ensure that certain 
materials th at come into contact with water intended for human consumption do not 
directly or indirectly compromise the protection of human health , adversely affect the 
colour, odour or taste of the water, enhance microbial growth, or leach contaminants 
into the water  at levels that are higher than necessary in view of the intended purpose 
of the material.  
(2) For the purpose of ensuring uniform application of Article 11  of Directive (EU) 
2020/2184 , minimum hygiene requirements for materials that come into contact with 
drinking water have been established in Commission  Implementing Decision  (EU) 
…/… [OP: please fill in the reference of  C(2023)7003 ].  
(3) According to Article 11(8) of Directive (EU) 2020/2184, the Commission is to 
determine the conformity assessment procedure s applicable to products covered by 
that Article. Th ose conformity assessment procedure s are to be used to demonstrate 
that those products fulfil  the requirements set out in Directive (EU) 2020/2184, 
thereby ensuring that only products that use final materi als approved in accordance 
with Directive (EU) 2020/2184 are placed on the market, as required by Article 11(7) 
of that Directive.  
(4) In order to ensure that the i nformation regarding conformity of products with  the 
minimum hygiene requirements established un der Article 11 of Directive  (EU) 
2020/2184 is provided in a uniform manner for all products, that information should 
be provided in the form of a single EU declaration of conformity. By drawing up the 
EU declaration of conformity, the manufacturer, importe r or authorised representative 
should assume responsibility for the compliance of the product with the minimum 
                                                 
1 OJ L 435, 23.12.2020 , p. 1.   
EN 3  EN hygiene requirements  set out  in Commission Implementing Decision (EU) …/… [OP: 
please fill in the reference of C(2023)7003 ].  
(5) Since accreditation  is an essential means of verifying the competence of conformity 
assessment bodies, conformity assessment bodies should be accredited by a national 
accreditation body in accordance with Regulation (EC) No 765/2008  of the European 
Parliament and of the Coun cil2 in order to be authorised as a notified body and 
allowed to carry out the conformity assessment procedures set out in this Regulation .  
(6) To ensure a consistent level of quality in the performance of conformity assessment, it 
is necessary to set require ments for notifying authorities involved in the assessment of 
notified bodies. In particular, it should be ensured that the notifying authority is 
objective and impartial with regard to its activity. Furthermore, notifying authorities 
should be required to  safeguard the confidentiality of the information they obtain, but 
should nonetheless be able to exchange information on notified bodies with national 
authorities, the notifying authorities of other Member States and the Commission to 
ensure consistency in  the conformity assessment.  
(7) Having regard to the resources necessary for setting up the required organisation by 
Member States and conformity assessment bodies, and to ensure that conformity 
assessment bodies meet the requirements for notification, the ap plication of this 
Regulation should be deferred . It is necessary to avoid a situation where all 
applications for conformity assessments of products have to be processed by the 
notified bodies at the same time and to ensure that notified bodies can progressively 
build up appropriate capacity for the carrying out of conformity assessment o f 
products . Therefore, the application of this Regulation should be further deferred for 
products that have been found in conformity with national hygiene requiremen ts for 
products that come into contact with water intended for human consumption before the 
date of entry into force of this Regulation and for which the national conformity 
certificate of the product expires after that date,  
 
HAS ADOPTED THIS DECISION:  
 
Article 1 
Definitions  
For the purposes of this Regulation , the following definitions apply:  
(1) ‘material’ means a solid, semi -solid or liquid that is used for the manufacturing of 
a product and that is:  
(a) an organic composition prepared from one or more st arting substances ; 
or 
(b) a cementitious composition prepared from one or more constituents; or  
(c) a metallic, enamel, ceramic or other inorganic composition ;  
                                                 
2 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and repealing Regulation (EEC) No 339/93  (OJ L 218 13.8.2008, p. 
30).  
EN 4  EN (2) ‘final material’ means material  which is subject to testing and acceptance in 
accordance with the testing requirements and acceptance criteria set out in 
Commission Implementing Decision (EU) …/… [OP: please fill in the reference of 
C(2023)7003 ]; 
(3) ‘product’ means an object  that come s into contact with water intended for human 
consumption, which is m ade of final materials and which is inten ded to be placed on 
the market ;  
(4) ‘assembled product’ means a product that consist s of two or more components, 
possibly made of different materials, that are joined together and can not be 
disassembled  without interfering with the function of the product ;  
(5) ‘component’ means an identifiable object consisting of one or more materials;  
(6) ‘test piece’ means a n object that is representative of the final material that is used 
for testing in accordance with the procedures and methods set out in Commission 
Implementing Decision (EU) …/… [OP: please fill in the reference of 
C(2023)7003 ]; 
(6) ‘minimum h ygien e requirements’ means the hygiene requirements set out in 
Comm ission Implementing Decision (EU) …/… [OP: please fill in the reference of 
C(2023)7003 ]; 
(7) ‘manufacturer’ means any natural or legal person who manufactures products or 
who has products designed or manufactured, and markets those products under its 
name or trademark , or who designs and constructs products for its own use;  
(8) ‘importer’ means any natural or legal person established within the Union who 
makes available products from a third country on the Union market;  
(9) ‘authorised representative’ means any natural or legal person established within 
the Union who has received a written mandate from a manufacturer to act on the 
manufacturer’s  behalf in relation to specified tasks;  
(10) ‘conformity assessment’ means the proce ss demonstrating that a product 
complies with the minimum hygiene requirements;  
(11) ‘conformity assessment body’ means a body that performs conformity 
assessment activities, including testing, certification and inspection;  
(12) ‘notified body’ means a con formity assessment body that has been notified in 
accordance with Article  5; 
(13) ‘accreditation ’ means accreditation as defined in Article 2 , point (10),  of 
Regulation (EC) No 765/2008;  
(14) ‘national accreditation body” means national accreditation body  as defined in 
Article 2 , point (11),  of Regulation (EC) No 765/2008;  
(15) ‘making available on the market’ means any supply of a product for distribution, 
consumption or use on the Union market over the course of a commercial activity, 
whether in return for payment or free of charge;  
(16) ‘placing on the market’ means the first making available of a product on the 
Union market;  
(17) ‘reduced testing’ means carrying out a test where only a part of the procedures 
and methods for testing set out in Commissio n Implementing Decision (EU) …/…  
EN 5  EN [OP: please fill in the reference of C(2023)7003 ] are applied on test pieces which 
have been withdrawn by the notified body during the initial or annual inspection .    
EN 6  EN  
Article 2  
Conformity assessment procedures  
1. Where the product is categorised in risk group 1 or 2 under Commission Implementing 
Decision (EU) …/… [OP: please fill in the reference of C(2023)7003 ] or, in the case of a 
metallic composition , in product group A or B in Table 3 of Annex II to Commission 
Implementing Decision (EU) …/… [OP: please fill in the reference of C(2023)7000 ], both of 
the following conformity assessment procedures  shall apply :  
a) Module B (EU type examination) as set out in Annex II to Decision No 
768/2008/EC carried out by a notified body with the following specifications:  
(i) the conformity assessment shall contain an examination of a test 
piece ( production  type);  
(ii) all relevant tests referred to in Commission Implementing 
Decision (EU) …/… [OP: please fill in the referenc e of C(2023)7003 ] 
shall be performed by the notified body  or on behalf of the notified 
body ;  
(iii) test pieces for examination  shall be  withdrawn by the notified 
body when inspecting  the production site pursuant to point  (b)(ii) or 
(iii), except when the production of products has not yet started;   
b) Module D (Conformity to type based on quality assurance of the production 
process ) as set out in Annex II to Decision No 768/2008/EC with the following 
specifications:  
(i) the quality system shall be assessed  by the notified body that 
has carried out the conformity assessment procedure referred to in point  
(a); 
(ii) an initial inspection of the production site to assess the quality 
system and to withdraw test pieces for type examination shall be 
carried out by  the notified body ; 
(iii) an annual  inspection  of the production site to assess the quality 
system and to withdraw test pieces for the re -assessment of the type 
examination pursuant to point a) or for a reduced test ing pursuant  to 
point  (iv) of this point shall be carried out by the notified body ;  
(iv) annual  reduced testing may be performed by the notified body 
or on behalf of the notified body , and tests may be carried out by the 
manufacturer as part of the quality system.  
Where the conformity assessment  procedures referred to in the first subparagraph demonstrate 
that the product complies with the minimum hygiene requirements, the notified body shall 
issue a certificate for both conformity assessment procedures referred to in points (a) and (b) 
of that s ubparagraph to the manufacturer, the importer or the authorised representative. The 
certificate shall contain the name and address of the manufacturer, the conclusions of the 
conformity assessment, any conditions for the certificate and the necessary data for 
identification of the approved type. The certificate shall have a validity of 5 years.  
Based on the outcome of the annual inspection  referred to in the first subparagraph , point 
(b)(iii), the notified body may withdraw the relevant certificates.   
EN 7  EN  
2. Where the product is categorised in risk group 3 or 4  under Commission Implementing 
Decision (EU) …/… [OP: please fill in the reference of C(2023)7003 ] or, in the case of a 
metallic composition , in product group A or B in Table  3 of Annex II to Commission 
Implementing Decision (EU) …/… [OP: please fill in the reference of C(2023)7000 ], both of 
the following conformity assessment procedures  shall apply : 
a) Module B (EU type examination) as set out in Annex II to Decision No 
768/2008/EC  carried out  by a notified body and with the following specifications:  
(i) the conformity assessment shall contain an examination of a test 
piece ( production type);  
(ii) all relevant tests referred to in Commission Implementing 
Decision (EU) …/… [OP: please fill in th e reference of C(2023)7003 ] 
shall be performed by the notified body  or on behalf of the notified 
body ;  
(iii) test pieces shall be supplied by the manufacturer , the importer 
or the aut horised representative  to the notified body for examination;  
b) Module C  (Conformity to type based on internal production control) as set out 
in Annex II to Decision No 768/2008/EC.  
Where the conformity assessment procedures referred to in the first subparagraph demonstrate 
that the product complies with the minimum hygiene r equirements, the notified body shall 
issue a certificate for the conformity assessment procedure referred to in that subparagraph, 
point (a), to the manufacturer, the importer or the authorised representative. The certificate 
shall contain the name and add ress of the manufacturer, the conclusions of the conformity 
assessment, any conditions for the validity of the certificate and the necessary data for the 
identification of the approved type. The certificate shall have a validity of 5 years. The 
manufacture r shall ensure and declare that the product concerned is in conformity with the 
type described in the EU type examination certificate and satisf ies the requirements set out in 
this Regulation.  
4. Where the product is an assembled product, the applicable co nformity assessment 
procedure shall be determined by the individual component with the highest risk group 
categorisation under Commission Implementing Decision (EU) …/… [OP: please fill in the 
reference of C(2023)7003 ] or, in the case of metallic compositi ons, the highest categorised 
product group in Table 3 of Annex II to Commission Implementing Decision (EU) …/… 
[OP: please fill in the reference of C(2023)7000 ]. 
5. The applicable conformity assessment procedure for the manufacture of an individual 
compone nt of an assembled product shall be determined by the highest risk group 
categorisation under Commission Implementing Decision (EU) …/… [OP: please fill in the 
reference of C(2023)7003 ] or, in the case of metallic compositions, the highest categorised 
product group in Table 3 of Annex II to Commission Implementing Decision (EU) …/… 
[OP: please fill in the reference of C(2023)7000 ]. 
4. Where compliance of a product with the applicable minimum hygiene require ments has 
been demonstrated by the conformity assessment procedure referred to in paragraph 1 or 2, 
manufacturers, or their authorised representatives , shall draw up an EU declaration of 
conformity.    
EN 8  EN By drawing up the EU declaration of conformity , or by ha ving it drawn up by its authorised 
representative, the manufacturer, assume s responsibility for the compliance of the product 
with the minimum hygiene requirements.  
The EU declaration of conformity shall have the model structure set out in the Annex and 
shall be continuously updated. It shall be translated by the manufacturer , or its authorised 
representative , into the language or languages required by the Member State in which the 
product is placed on the market.   
Article 3  
Notifying authorities  
1. Member  States shall designate a notifying authority that shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and notification of 
conformity assessment bodies and the monitoring of notified bodies, including compliance  
with Article 5. 
2.   Member States may decide that the assessment and monitoring referred to in paragraph 1 
shall be carried out by a national accreditation body in accordance with Regulation (EC) No 
765/2008.  
3. Where the notifying authority delegates or  otherwise entrusts the assessment, 
notification or monitoring referred to in paragraph 1 of this Article , to a body which is not a 
governmental entity, that body shall be a legal entity and shall comply mutatis mutandis  with 
the requirements laid down in Article 4. In addition, that body shall have arrangements to 
cover liabilities arising out of its activities.  
4. The notifying authority shall take full responsibility for the tasks performed by the 
body , referred to in paragraph 3. 
 
   
EN 9  EN Article 4  
Requirements relating to notifying authorities  
1. A notifying authority shall be established in such a way that no conflict of interest 
with conformity assessment bodies occurs.  
2. A notifying authority shall be organised and operated so as to safeguard t he objectivity 
and impartiality of its activities.  
3. A notifying authority shall be organised in such a way that each decision relating to 
notification of a conformity assessment body is taken by competent persons different from 
those who carried out the  assessment.  
4. A notifying authority shall not offer or provide any activities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive basis.  
5. A notifying authority shall safeguard the confidentiality of the in formation it obtains.  
6. A notifying authority shall have a sufficient number of competent personnel at its 
disposal for the proper performance of its tasks.  
 
Article 5 
Requirements relating to notified bodies  
1. For the purposes of notification, a confor mity assessment body shall meet the 
requirements laid down in this Article.  
2. A conformity assessment body shall be established under national law and have legal 
personality.  
3. A conformity assessment body shall be a third -party body independent of the 
manufacturer’s, the importer’s or the authorised representative’s organisation or the products 
it assesses.  
4. A conformity assessment body shall be accredited by a national accreditation body in 
accordance with Regulation (EC) No 765/2008. The accreditati on shall be based on 
international standard EN ISO/IEC 17065:2017. The accreditation certificate shall attest that 
the conformity assessment body is competent to perform the conformity assessment 
procedures referred to in Article 2 of this Regulation.  
5. A conformity assessment body, its top -level management and the personnel 
responsible for carrying out the conformity assessment tasks shall not be the designer, 
manufacturer, importer, supplier, purchaser, owner or user of products which they assess, nor 
the authorised representative of any of those parties. This shall not preclude the use of 
products that are necessary for the operations of the conformity assessment body or the use of 
products for personal purposes.  
A conformity assessment body, its top -level management and the personnel responsible for 
carrying out the conformity assessment tasks shall not be directly involved in the design, 
manufacture, marketing or use of products which they assess or represent parties engaged in 
those activities. They shall not engage in any activity that may conflict with their 
independence of judgement or integrity in relation to conformity assessment activities for 
which they are notified. This shall in particular apply to consultancy services.   
EN 10  EN Conformity assessment  bodies shall ensure that the activities of their subsidiaries or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 
assessment activities.  
6. Conformity assessment bodies and their personnel shall carry out the conformity 
assessment activities with the highest degree of professional integrity and the requisite 
technical competence in the specific field and shall be free from all pressures and 
inducements, particularly financial, which might influence their ju dgement or the results of 
their conformity assessment activities, especially as regards persons or groups of persons with 
an interest in the results of those activities.  
7. A conformity assessment body shall be capable of carrying out all the conformity 
assessment tasks which are assigned to it by Article 2 and in relation to which they have been 
notified , whether those tasks are carried out by the conformity assessment body itself or on its 
behalf and under its responsibility.  
At all times and for each conformity assessment procedure and each product in relation to 
which it has been notified, a conformity assessment body shall have at its disposal , or in 
place,  the necessary:  
(a) personnel with technical knowledge and sufficient and appropriate 
experience t o perform the conformity assessment tasks;  
(b) descriptions of procedures in accordance with which the 
conformity assessment is carried out, ensuring the transparency and 
the ability of reproduction of those procedures ; 
(c) policies and procedures that distinguis h between tasks it carries out 
as a notified body and other activities;   
(d) procedures for the performance of activities which take due 
account of the size of an undertaking, the sector in which it 
operates, its structure, the degree of complexity of the prod uct 
technology in question and the mass or serial nature of the 
production process.  
A conformity assessment body shall have the means necessary to perform the technical and 
administrative tasks connected with the conformity assessment activities in an appropriate 
manner and shall have access to all necessary equipment or facilities.  
8. The personnel responsible for carrying out the conformity assessment tasks shall have 
the following:  
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to which the conformity assessment body has been notified;  
(b) satisfactory knowledge of the requirements of the assessments they carry out 
and adequate authority to carry out those assessments;  
(c) appropriate knowledge and understanding of the minimum hygiene 
requirements and their standards set out in the Commission Implementing Decision 
(EU) …/… [OP: please fill in the reference of C(2023)7003 ]; and  
(d) the ability to draw up certificates, records and reports demonstrating that 
assessments have been carried out.   
EN 11  EN 9. The impartiality of the conformi ty assessment bodies, their top -level management and 
of the personnel responsible for carrying out the conformity assessment tasks shall be 
guaranteed.  
The remuneration of the top -level management and the personnel responsible for carrying out 
the conformi ty assessment tasks of a conformity assessment body shall not depend on the 
number of assessments carried out or on the results of those assessments.  
10. Conformity assessment bodies shall take out liability insurance unless liability is 
assumed by the St ate in accordance with national law, or the Member State itself is directly 
responsible for the conformity assessment.  
11. The personnel of a conformity assessment body shall observe professional secrecy 
with regard to all information obtained in carrying  out their tasks under Article 2, except in 
relation to the competent authorities of the Member State in which its activities are carried 
out. Proprietary rights shall be protected.  
12. Conformity assessment bodies shall participate in, or ensure that the ir personnel 
responsible for carrying out the conformity assessment tasks are informed of, relevant 
standardisation activities.  
 
Article 6 
Subsidiaries of and subcontracting by notified bodies  
1. Where a notified body subcontracts specific tasks connected  with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the 
subsidiary meets the requirements set out in Article 5 and shall inform the notifying authority 
accordingly . 
2. Notified bodies shall take full respo nsibility for the tasks performed by subcontractors 
or subsidiaries wherever these are established.  
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement 
of the client.  
4. Notified bodies shall keep at the disposal of the notifying authority the relevant 
documents concerning the assessment of the qualifications of the subcontractor or the 
subsidiary , and the work carried out by them under Article 2. 
 
Article 7  
Application for notification  
1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member State in which it is established.  
2. The application for notification shall be accompanied by the following:  
(a) a description of the conformity  assessment activities ; 
(b) a description of the conformity assessment procedures set out in Article 2 for which 
the conformity assessment body claims to be competent ,  
EN 12  EN (c) accreditation certificates issued by national accreditation bodies attesting that the 
conformity assessment body fulfils the requirements laid down in Article  5 and that 
its subsidiaries or subcontractors fulfil the requirements laid down in Article 6. 
 
   
EN 13  EN Article 8  
Notification procedure  
1. Notifying authorities shall notify only conformit y assessment bodies which have 
satisfied the requirements laid down in Article 5.  
2. They shall notify the Commission and the other Member States using the electronic 
notification tool developed and managed by the Commission.  
3. The notification shall inc lude full details of the conformity assessment activities  and 
of the conformity assessment procedures set out in Article 2 as well as the accreditation 
certificates referred to in Article 7(2), point (c).  
4. The body concerned may perform the activities o f a notified body only where no 
objections are raised by the Commission or the other Member States within two weeks of the 
notification.  
Only such a body shall be considered a notified body for the purposes of this Regulation.  
6. The notifying authority shall notify the Commission and the other Member States of 
any subsequent relevant changes to the notification.  
 
Article 9  
Identification numbers and lists of notified bodies  
1. The Commission shall assign an identification number to a notified body.   
It shall assign a single such number even where the body is notified under several Union acts.  
2. The Commission shall make publicly available the list of the bodies notified under this 
Regulation, including the identification numbers that have been assigned to them and the 
activities for which they have been notified.  
The Commission shall ensure that the list is kept up to date.  
 
Article 1 0 
Changes to notifications  
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Article 5 or that it is failing to fulfil its 
obligations, the notifying authority shall restrict, suspend or withdraw the notification as 
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil 
those obligations. It shall immediately inform the Commission and the other Member States 
accordingly.  
2. In the event of restriction, suspension or withdrawal of the notification, or where the 
notified body has ceased its activity, the notifying Member State shall take appropriate steps 
to ensure that the files of that body are either processed by another notified body or kept 
available for the res ponsible notifying authorities and market surveillance authorities at their 
request.  
 
   
EN 14  EN Article 11 
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 . 
It shall apply from  31 December 2026 .  
However, for products which are assessed to be in conformity with national hygiene 
requirements for products that come into contact with water intended for human consumption 
and for which the national conformity certificate is still valid on 31 December 2026 , it shall 
apply from [OP please insert the date = the last day of the fourth year after the entry into 
force of this Regulation] .  
This Regulation shall be binding in its enti rety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 […] 
  
[Choose between the two options, depending on the person who signs.]  
  
 On behalf of the President  
 […] 
 [Position]