CA-March16-Doc.8.1
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 to be administered orally to animals
1.- Background and purpose of the document
(1)Belgium requested the views of other Member States (MSs) via Helpex on whether a product used by oral route and serving as a repellent (i.e. chicken eating a product giving a "bad tastes to the blood” to repel ectoparasites) could be considered as a biocidal product falling under the scope of Regulation (EU) 528/2012[1] (the "BPR").
(2)Belgium and three out of the 5 MSs having contributed to Helpex consider that this product to be administered by oral route is out of the scope of the BPR.
(3)As there was no unanimity about the conclusion, Belgium requested the Commission to have a discussion between MSs and the Commission not only on this specific product but, more widely,on whether products for oral administration to animals[2] are excluded from the scope of the BPR.
(4)In accordance with the agreed procedure in documentCA-March14-Doc.7.5[3], this note outlines a proposal on this scope issue for discussion with Member States in the CA meeting.
2.- Analysis and proposed way forward
2.1.- Is the product to be administered orally to animals a biocidal product?
(5)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 (e.g. the animal owner), containing one or more active substances, with the intention of deterringpreventing the action of, or otherwise exerting a controlling effect on any harmful organism (e.g. repellent of insects) by any means other than mere physical or mechanical action, would meet the definition of a biocidal product.
2.2.- Does the biocidal product fall 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.
(7)Among these instruments, it is important to consider whether these products to be administered orally to animals fall within the scope of Directive 2001/82/EC[4] or Regulation (EC) No 1831/2003[5].
2.3.- Does the biocidal product fall under the scope of Directive 2001/82/EC?
(8)Article 1(2) of Directive 2001/82 defines a veterinary medicinal product as:
(a)any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
(b)any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
(9)Where the claimed biocidal function of the product (e.g. repellent effect as a result of "bad taste of blood") is a result of some effects of the ingested product in the physiological functions of the animal, then such product could be regarded as meeting the definition of a veterinary medicinal product "by function" referred to in Article 1(2)(b) of Directive 2001/82.
(10)In such case, the BPR wouldnot apply to that product as it would bewithin the scope of Directive 2001/82/EC.
2.4.- Does the biocidal product fall under the scope of Regulation (EC) No 1831/2003?
(11)Article 2(2)(a) of the feed additives Regulation defines "feed additives" as substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Article 5(3) of that Regulation.
(12)Article 5(3)(e) refers to favourably affect the environmental consequences of animal production, which is connected with a specific feed additive category in Article 6(1)(d) of that Regulation ("zootechnical additives": any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment).
(13)Annex I to the feed additives Regulation sets the functional groups of the different feed additives categories, which for zootechnical additives, includes, among others:
(b)"gut flora stabilisers": micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora;
(d)"other zootechnical additives".
(14)Under these two functional groups, a number of feed additives that are administered to animals to affect the faecal consistency and/or odour are currently under evaluation or have been already authorised[6].
(15)If the product would be regarded as a feed additive, the BPR wouldnot apply to that product as it would fall within the scope of Regulation (EC) No 1831/2003.
3.- Action requested
(16)The Commission services invite the CA meeting to discuss the way forward outlined in this note.
Annex: examples provided by Belgium
1. A product for poultry that, once ingested, gives a bad taste to the blood with the intention to repel flies or red mites on the skin of the poultry:
2. A product to be ingested, it passes the gastro-intestinal tract without metabolisation and is excreted, with the aim to repel insects from the excrements.
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]See in the annex to this document a few examples. The whole document submitted by Belgium to the Commission is available to MSs in the confidential folder of Circabc for the 63rd CA meeting.
[3]CA-March14-Doc.7.5, available at
[4]Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
[5]Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
[6]Commission Implementing Regulation (EU) 2015/1053 of 1 July 2015 concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH) (OJ L 171, 2.07.2015, p. 8).