CA-March16-Doc.8.3
63rdmeeting of Representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Subject:Products for the treatment of water for human consumption
1.- Background and purpose of the document
(1)At the 62nd CA meeting, Austria requested the views of the Commission and of other Member States (MSs) on whether products used for the purpose ofcontrolling harmful organisms in water for human consumption stored in reservoirs, ship tanks, containers for outdoor, etc… ("reservoirs" hereafter) could be considered as a biocidal product falling under the scope of Regulation (EU) 528/2012[1] (the "BPR"), particularly within product-type (PT) 5.
(2)The Commission provided some feedback to MSs at the CA meeting, but a MS requested a more detailed analysis of the question.
(3)This note outlines a proposal on this scope issue for discussion with Member States in the CA meeting.
2.- Analysis
2.1.- Are productsused for the purpose of treatingwater for human consumption in reservoirs biocidal products?
(4)In accordance with the definition provided for in Article 3(1)(a) of the BPR, a product in the form in which it is supplied to the user, containing one or more active substances, with the intention of destroying, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action, would meet the definition of a biocidal product.
(5)As the products considered by this note aim atkilling or controlling the harmful organisms present on water for human consumption in reservoirs, they fall within the definition ofbiocidal products laid down in Article 3(1)(a) of the BPR.
2.2.- Do these biocidal productsfall under the scope of the BPR?
(6)In terms of scope, Article 2(2) of the BPR establishes that, subject to any explicit provision to the contrary in the BPR or other Union legislation, the BPR shall not apply to biocidal products that are within the scope of a number of legal instruments, including Regulation (EC) No 1333/2008[2] on food additives.
(7)Article 2 of Regulation 178/2002[3] provides for a definition of "food", which includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC[4] and without prejudice to the requirements of Directives 80/778/EEC[5] and 98/83/EC.
(8)It is therefore important to consider whether theseproductsused to treat water for human consumption in reservoirs fall within the scope of Regulation (EC) No 1333/2008.
2.3.- Do thesebiocidal products fall under the scope of Regulation 1333/2008?
(9)Article 3(2)(a) of Regulation 1333/2008 defines a food additive as "any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods".
(10)However, pursuant to Article 2(2)(d) of that Regulation, where such a substance is used "for the treatment of water for human consumption falling within the scope of Council Directive 98/83/EC, Regulation 1333/2008 shall not apply to that substance.
(11)In accordance with Article 2(1)(a) of Directive 98/83/EC, "water intended for human consumption" means "all water either in its original state or after treatment, intended for drinking, cooking, food preparation or other domestic purposes, regardless of its origin and whether it is supplied from a distribution network, from a tanker, or in bottles or containers".
(12)Therefore, water for human consumption in reservoirs to be treated with the products in question is still considered as "water intended for human consumption after the treatment", which still falls under the notion of "water intended for human consumption" within the meaning of Directive98/83/EC.
(13)It has to be noted that Article 6 of Directive 98/83/EC sets the points of compliance for the parametric values set by MSs to water intended for human consumption, but it does not affect the definition of "water intended for human consumption" laid down in Article 2(1)(a).
(14)In the light of this background, the productsused for the treatment of water for human consumption in reservoirs fall out of the scope of Regulation 1333/2008.
3.- Conclusion
(15)As the biocidal products in question fall outside the scope of Regulation (EC) No 1333/2008, theBPR shall apply to them, as theyare exerting a controlling effect on harmful organisms in water for human consumption.
(16)Therefore, products for the purpose of treating water for human consumptionin reservoirs shall fall under the scope of the BPR, particularly within PT 5 as defined in Annex V to that Regulation.
4.- Action requested
(17)The Commission services invite the CA meeting to discuss the proposaloutlined in this note.
1
[1]Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
[2]Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).
[3]Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
[4]Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).
[5]Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (OJ L 229, 30.8.1980, p. 11). This Directive was repealed by Directive 98/83/EC.