French Public Health Code
In forceI.-Products and processes placed on the market and intended for the treatment of water intended for human consumption, including chemical treatment agents and filter media, must, under normal or foreseeable conditions of use in public or private distribution networks and inside buildings, comply with specific provisions defined by order of the Minister for Health, aimed at ensuring that:
1° They are not likely, either intrinsically or through their residues, to:
a) Cause, directly or indirectly, a risk to human health;
b) Alter the colour, odour or taste of the water;
c) Unintentionally encourage the development of microbial flora;
d) Release contaminants into water at levels that may result in non-compliance with the quality requirements for water intended for human consumption.
2° They are effective for their intended use;
These provisions apply in whole or in part, depending on the groups of products and treatment processes and their uses, and concern in particular :
1° The list of substances and materials authorised for the manufacture of treatment products or media;
2° The purity criteria for certain substances and materials mentioned in 1° ;
3° The specific conditions of use of the substances and materials mentioned in 1° and of the products in which these substances and materials have been used;
4° Where applicable, specific migration limits for constituents or groups of constituents in water;
5° Overall migration limits for constituents in water;
6° Rules relating to the nature of the samples of products to be used and the methods of analysis to be used to check compliance with the provisions of 1° to 5° ;
7° Procedures for verifying the effectiveness of the treatment process and, where applicable, minimum criteria in terms of treatment effectiveness;
8° Minimum consumer information requirements.
II - The order referred to in I specifies the conditions for certifying compliance with the provisions of I. This certificate is produced, depending on the groups of products and treatment processes and their uses:
1° Either by the person responsible for first placing the product on the market ;
2° Or by a laboratory authorised by the Minister for Health.
III - A request for the amendment of an order issued in application of I is addressed to the Minister for Health.
The composition of the application file is determined by order of the Minister for Health, issued after consultation with the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
The Minister's decision is taken after obtaining the opinion of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
IV - The person responsible for placing on the market a product or a treatment process that does not correspond to a group or a use provided for in I must, before it is placed on the market for the first time, submit an application to the Minister for Health.
Proof of the safety and efficacy of the product or treatment process provided by the person responsible for initial marketing is attached to the application file, the composition of which is set by order of the Minister for Health, issued after consultation with the National Agency for Food, Environmental and Occupational Health Safety.
The Minister submits the application to the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail for its opinion.
If the application for authorisation to place treatment products and processes on the market that do not correspond to a group or use provided for in I of Article R. 1321-50 remains unanswered for more than six months, this is deemed to constitute a decision to accept it.
V. - The provisions of this article do not apply to biocidal products authorised following an authorisation procedure for making them available on the market pursuant to Regulation (EU) No 528/2012 of 22 May 2012.
During the transitional period defined by Article 89 of the same Regulation, the provisions of this Article shall apply to active substances and, by way of derogation from the previous paragraph, to biocidal products.
