Borderline between plant protection products and biocides with regard to registration and use SUI Conference 2013, 11th-12th BratislavaLaurent Oger

Overview Scope Legislative evolutions Common elements of both legislations Qualification criteria Examples of borderline biocide cases Examples of borderline PPP cases The example of rodenticides Situations of dual authorisations

Scope Plant Protection Products Biocidal products Horticulture Home & Garden Agriculture Forestry Amenity Preservatives (PT 6-13) For wood For liquid-cooling and processing systems For products during storage For film For construction materials Slimicides For fibre, leather, ribber and polymerised materials Others products (PT 21-22) Antifouling products Embalming and taxidermist fluids Disinfectants (PT 1-5) Food and feed area Veterinary hygiene Drinking water Disinfectants and algeacides Human hygiene Pest control (PT 14-20) Rodenticides Avicides Molluscicides, vermicides… Piscicides Insecticides, acaricides… Repellents and attractants Control of other vertebrates

Legislative evolution Directive 91/414/EEC concerning the placing of plant protection products on the market Directive 98/8/EC on the placing on the market of biocidal products Regulation 528/2012 concerning the placing on the market and use of biocidal products ? ? Regulation 1107/2009 concerning the placing of plant protection products on the market Directive 128/2009 on the sustainable use of pesticides

Common elements  Exclusion criteria and derogations  Candidates for substitution and comparative assessment  Sustainable Use of products  Harmonization and simplifications procedures Active Substance approval at EU level Product authorisation at Member State level

‘biocidal product’ means any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action ‘harmful organism’ means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment; ‘plants’ means live plants and live parts of plants, including fresh fruit, vegetables and seeds; ‘plant products’ means products of plant origin in an unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants; PPPs: products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses: (a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; (b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; (c) preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives; (d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants; (e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants. Qualification criteria Identification of the relevant legislation – some definitions

Criteria for borderline cases  Consideration of the written exclusions within the scope of each legislations (articles 2 and 3 of 1107/2009 and 528/2012)  In case of unclear or borderline situations for a product the European Commission developed specific guidance document on borderline cases: Available at : rderline_en.htm rderline_en.htm Manual of Decision available (regularly updated) Step 1: Define the intended purpose of the product Criteria of the target organism. If detrimental to plant or plant products then it is a PPP If it is detrimental to other areas it is considered as a Biocide

Criteria for borderline cases Prevent introduction of foreign species/pathogens Step 2: The place where the product is applied to achieve the principal intended action.  Protection against harmful organisms to plants and plant products: PPP Directly : where the products are used, even inside or outside Indirectly: PPPs in condition that the purpose is to destroy exclusively and specifically organisms harmful to plants or plant products (e.g storage area)  Products used for a general hygiene purpose: biocide Protection of the wood

Products to control growth or penetration of plant roots and sprouts (radizides) Examples of PPPs  Space disinfectants in growing houses or greenhouses.  Products to control growth or penetration of plant roots and sprouts.  Products for use against garden snails  Products for the disinfection or the disinfestation of empty store rooms or other structures if after the treatment only plants or plant products will be grown or stored there.  Products for post-harvest treatment of fruits and vegetables against plant diseases  Repellents used to treat seed, fruit trees or forestry against birds  Products to protect trees or other plants from damage by squirrels or wildlife  All herbicides regardless of whether they are applied to soil, water or other surfaces  Algaecides applied on soil or water to protect plants  Arthropod growth regulators and other pheromones used to control organisms harmful to plants or plant products.

 Products for hygiene purposes to be used in greenhouses not intended for direct application to plants.  Products used on a hydroponic systems to control harmful organisms.  Products intended for the control of harmful organisms (other than plants), on surfaces like tennis courts, car parks and tombstones, concrete, pavements and walls.  Products used against snails to prevent humans and animals disease transmission.  Products used against snails that clog water pipes.  Products to destroy dust mites from textiles.  Fumigants used in storage rooms for food  Repellents against cats, dogs and snakes  Products added to water to wash fruits for public hygiene  Products for the control of termites when used as a bait or as a soil-drench treatment  Products for the control of birds for hygiene purposes Examples of biocides It should include products used for there general hygiene function. Disinfectants in empty structures when it is not clear which kind of products will be stored after the treatment.

 There main purpose is considered to be for human hygiene  All rodenticides are considered as Biocidal Products: Exclusion of products used in plant growing areas to protect plants, or to protect plant products temporarily stored in the plant growing areas. Products used outside the plant growing areas: in farms, cities, industrial premises are biocidal products. Products used inside the plant growing areas not to protect plant or plant products (agricultural field, greenhouse, forest) are biocidal products. Products used inside the plant growing areas to protect plants or plant products temporarily stored here are PPPs. The example of rodenticides

Situations of dual authorisations A same product can be used in several situations and fall under both legislations. Dual authorisation:  x2 dossiers  x2 contacts with different rapporteur Member states  x2 fees In case of similar conditions of use authorities should coordinate (even internally) and give a clear answer under which legislation to be regulated.  E.g indoor products Coordination at EU level and experience sharing between Member States should allow pragmatic solutions and the limitation of borderline cases.

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