Borderline between plant protection products and biocides with regard to registration and use

SUI Conference 2013, 11th-12th Bratislava Laurent OgerLaurent.oger@ecpa.eu

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 :

http://ec.europa.eu/food/plant/protection/evaluation/borderline

_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

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.

Thank you for your attention