EVOLIS
Represent and promote the industry, to analyse the economic situation ans the markets, to produce statistics, to monitor the French, European and international technical regulation, to take part in the standardization work, to facilitate European and international cooperation.
ID: 232460635734-25
Lobbying Activity
Response to Establishing harmonised marking to be used for products in contact with drinking water
10 Nov 2023
EVOLIS is the major organization for manufacturers of machinery and technological equipment for industry. We represent more than 600 companies, 82,000 employees and sales of 19 billion, 65% of which are exported. Thanks to our technological innovations, we contribute to the competitiveness, modernization, digitization and greening of all sectors: construction, nuclear, waste-to-energy, automotive, aeronautics, agri-food, and more. The purpose of this note is to draw the attention of European authorities to the proposed European harmonization of rules governing products in contact with drinking water, in accordance with European Directive (EU) 2020/2184, also known as the Drinking Water Directive. Key facts Drinking Water Directive (DWD): The Drinking Water Directive (EU) 2020/2184 aims to harmonize the rules applicable to products in contact with drinking water in Europe, particularly as regards minimum hygiene requirements for materials coming into contact with water intended for human consumption. Objective of harmonization: Harmonization aims to eliminate obstacles to the European principles of free movement of products and to guarantee a high level of health safety for all European consumers. Conformity assessment procedure: The directive provides for the introduction of a product conformity assessment procedure. However, the provisions envisaged are complex and could lead to distortions between players. We are particularly concerned about the rules governing product classification, and in particular the system based on "Conversion Factors - CF" defining risk levels according to equipment type seems extremely complex to implement, or even to apply and control, and therefore ineffective in the long run. In order to certify in the most efficient way (i.e. applicability and control) of products other than pipes and ducts, in particular assembled products such as pumps, taps and valves, we ask that these products be certified according to the procedure that best corresponds to the widely proven French "ACS accessoires*" system: on the one hand, organic material testing on material samples and not on each finished component; and on the other hand, the conformity assessment procedure according to modules "B+C", based on internal quality control (cf. system B: type testing +C: internal quality control). Thus, repeated testing of individual components and "B+D" assessment, involving third-party audits of the production line, would be reserved for pipes and products with a large surface area in contact with water and presenting the greatest risks. We'd also like to point out that it's impossible to mark products in the way described in the texts, as the symbol is too complex and accompanied by a sentence. As a prelude to all that is written below, we feel it is important to stress that such rapid approval and such short application deadlines, what's more with a document containing multiple errors and inconsistencies, materialize the haste with which this new legislative text is being implemented. We therefore hope that you will take the time to consult and listen to all stakeholders, in order to draw up effective, harmonized European regulations proportionate to the risks for the various types of materials and products in contact with drinking water. In conclusion**: French industry calls for balanced European regulations for products in contact with drinking water. *Today, all products currently marketed for contact with drinking water are subject, in France, to a very strict set of regulations called ACS, set up over 20 years ago, which has evolved considerably and is perfectly in place with all players in the market for products in contact with water intended for human consumption, and managed by two accredited laboratories in France. During these 20 years unless we are mistaken, no system failure has been observed that could have led to a risk to public health. **You will find in the attached file our comments and rationals
Read full responseResponse to Drinking water - conformity assessment procedure
10 Nov 2023
EVOLIS is the major organization for manufacturers of machinery and technological equipment for industry. We represent more than 600 companies, 82,000 employees and sales of 19 billion, 65% of which are exported. Thanks to our technological innovations, we contribute to the competitiveness, modernization, digitization and greening of all sectors: construction, nuclear, waste-to-energy, automotive, aeronautics, agri-food, and more. The purpose of this note is to draw the attention of European authorities to the proposed European harmonization of rules governing products in contact with drinking water, in accordance with European Directive (EU) 2020/2184, also known as the Drinking Water Directive. Key facts Drinking Water Directive (DWD): The Drinking Water Directive (EU) 2020/2184 aims to harmonize the rules applicable to products in contact with drinking water in Europe, particularly as regards minimum hygiene requirements for materials coming into contact with water intended for human consumption. Objective of harmonization: Harmonization aims to eliminate obstacles to the European principles of free movement of products and to guarantee a high level of health safety for all European consumers. Conformity assessment procedure: The directive provides for the introduction of a product conformity assessment procedure. However, the provisions envisaged are complex and could lead to distortions between players. We are particularly concerned about the rules governing product classification, and in particular the system based on "Conversion Factors - CF" defining risk levels according to equipment type seems extremely complex to implement, or even to apply and control, and therefore ineffective in the long run. In order to certify in the most efficient way (i.e. applicability and control) of products other than pipes and ducts, in particular assembled products such as pumps, taps and valves, we ask that these products be certified according to the procedure that best corresponds to the widely proven French "ACS accessoires*" system: on the one hand, organic material testing on material samples and not on each finished component; and on the other hand, the conformity assessment procedure according to modules "B+C", based on internal quality control (cf. system B: type testing +C: internal quality control). Thus, repeated testing of individual components and "B+D" assessment, involving third-party audits of the production line, would be reserved for pipes and products with a large surface area in contact with water and presenting the greatest risks. We'd also like to point out that it's impossible to mark products in the way described in the texts, as the symbol is too complex and accompanied by a sentence. As a prelude to all that is written below, we feel it is important to stress that such rapid approval and such short application deadlines, what's more with a document containing multiple errors and inconsistencies, materialize the haste with which this new legislative text is being implemented. We therefore hope that you will take the time to consult and listen to all stakeholders, in order to draw up effective, harmonized European regulations proportionate to the risks for the various types of materials and products in contact with drinking water. In conclusion**: French industry calls for balanced European regulations for products in contact with drinking water. *Today, all products currently marketed for contact with drinking water are subject, in France, to a very strict set of regulations called ACS, set up over 20 years ago, which has evolved considerably and is perfectly in place with all players in the market for products in contact with water intended for human consumption, and managed by two accredited laboratories in France. During these 20 years unless we are mistaken, no system failure has been observed that could have led to a risk to public health. **You will find in the attached file our comments and rationals.
Read full responseResponse to Drinking water - procedures and methods for testing and accepting final materials
10 Nov 2023
EVOLIS is the major organization for manufacturers of machinery and technological equipment for industry. We represent more than 600 companies, 82,000 employees and sales of 19 billion, 65% of which are exported. Thanks to our technological innovations, we contribute to the competitiveness, modernization, digitization and greening of all sectors: construction, nuclear, waste-to-energy, automotive, aeronautics, agri-food, and more. The purpose of this note is to draw the attention of European authorities to the proposed European harmonization of rules governing products in contact with drinking water, in accordance with European Directive (EU) 2020/2184, also known as the Drinking Water Directive. Key facts Drinking Water Directive (DWD): The Drinking Water Directive (EU) 2020/2184 aims to harmonize the rules applicable to products in contact with drinking water in Europe, particularly as regards minimum hygiene requirements for materials coming into contact with water intended for human consumption. Objective of harmonization: Harmonization aims to eliminate obstacles to the European principles of free movement of products and to guarantee a high level of health safety for all European consumers. Conformity assessment procedure: The directive provides for the introduction of a product conformity assessment procedure. However, the provisions envisaged are complex and could lead to distortions between players. We are particularly concerned about the rules governing product classification, and in particular the system based on "Conversion Factors - CF" defining risk levels according to equipment type seems extremely complex to implement, or even to apply and control, and therefore ineffective in the long run. In order to certify in the most efficient way (i.e. applicability and control) of products other than pipes and ducts, in particular assembled products such as pumps, taps and valves, we ask that these products be certified according to the procedure that best corresponds to the widely proven French "ACS accessoires*" system: on the one hand, organic material testing on material samples and not on each finished component; and on the other hand, the conformity assessment procedure according to modules "B+C", based on internal quality control (cf. system B: type testing +C: internal quality control). Thus, repeated testing of individual components and "B+D" assessment, involving third-party audits of the production line, would be reserved for pipes and products with a large surface area in contact with water and presenting the greatest risks. We'd also like to point out that it's impossible to mark products in the way described in the texts, as the symbol is too complex and accompanied by a sentence. As a prelude to all that is written below, we feel it is important to stress that such rapid approval and such short application deadlines, what's more with a document containing multiple errors and inconsistencies, materialize the haste with which this new legislative text is being implemented. We therefore hope that you will take the time to consult and listen to all stakeholders, in order to draw up effective, harmonized European regulations proportionate to the risks for the various types of materials and products in contact with drinking water. In conclusion**: French industry calls for balanced European regulations for products in contact with drinking water. *Today, all products currently marketed for contact with drinking water are subject, in France, to a very strict set of regulations called ACS, set up over 20 years ago, which has evolved considerably and is perfectly in place with all players in the market for products in contact with water intended for human consumption, and managed by two accredited laboratories in France. During these 20 years unless we are mistaken, no system failure has been observed that could have led to a risk to public health. **You will find in the attached file our comments and rationals
Read full responseResponse to Revision of the Machinery Directive
2 Jul 2021
We have strong concerns about questioning of the fundamental principles of the New Approach, of the New Legal Framework (NLF) and the introduction of vague or undefined concepts that seriously affect the readability of the future Machinery Product Regulation (MPR)
1) MPR is significantly challenging the principle of technical harmonisation through harmonised standards
The proposal to remove the self-certification for high-risk machinery product is not supported by any data and reveals a feeling of mistrust towards harmonised stds. This proposal will:
- reduce the recognition of harmonised stds and expose to many potential divergent interpretations from third party bodies
- create distortion in the market, knowing that all stakeholders will no longer have an interest in applying harmonised stds
- remove a practical tool for Market Surveillance Authorities (MSA)
Moreover, there are concerns that the emergence of technical specifications drawn up by the legislator will be at the expense of a transparent and market-driven standardisation process involving all stakeholders.
2) MPR goes beyond the scopes of the New Approach and the NLF, intended to be limited to ensuring a product compliance, at the time of its placing on the market with a CE marking so far associated with a new product
2 major examples:
a) The introduction of the vague concept of "substantial modification" opens the door to multiple interpretations, whereas modifications are operations in the framework of the Use of Work Equipment Directive 2009/104/CE, which a 2009 evaluation report found to be the right legal instrument to develop this concept. The requirements linked to this fuzzy concept will create huge disruption in the market, confusion and a loss of credibility of the CE marking which will be affixed to modified machinery in service, whereas it has always been linked to the placing on the market of a new product. Finally, this concept is introduced on the grounds of promoting the circular economy (see report accompanying the MPR) when no study demonstrates the positive impact of “substantial modification” and circular economy has never been identified as a new objective to be achieved by the MPR
b) The introduction of cybersecurity requirements creates for the manufacturer new obligation during the lifetime of the machine (cybersecurity requiring a continuous update of the software integrity), which is also in contradiction with the New Approach. While manufacturers can contractually commit to a level of protection depending on the operating sites, they can in no way guarantee that their product is immune to cyber-attacks, unintended external influences or any malicious act
These 2 issues create major confusion about the allocation of responsibility between manufacturers, users and other economic operators throughout the lifetime of the machine and “trample” the established boundaries with other legislations.
3) Finally, the readability of the MPR is strongly affected by other non- or poorly defined notions
The definition of “AI system” in the AI Regulation combined with undefined notions (1) or poor definitions (2) in the MPR raise questions about the articulation of those two regulations and the requirements applicable to manufacturers.
E.g.:
(1) "intended evolution of its fully or partially evolving behaviour or logic [...] with varying levels of autonomy", "learning phase"
(2) "driver", "autonomous mobile machinery"
Furthermore, the weakness of the criteria to define high-risk machine similar to criteria used by an MSA to regulate "products presenting a serious risk" will bring any machine type into Annex I. This will de facto jeopardize the conformity assessment procedure for current and new machinery. Insufficient market surveillance shall not be compensated by adding administrative work on other operators.
Finally, by using AI technology as a criterion to categorize a machine as high-risk machine, MPR moves away from its technological neutrality.
Read full responseResponse to Evaluation of the 'New Legislative Framework' for EU legislation on industrial products
2 Dec 2020
The view of our professional organization is attached.
Read full response