Questions Flashcards
What is a pesticide?
- A pesticide is something that prevents, destroys, or controls a harmful organism (‘pest’) or disease
- Protects plants or plant products during production, storage and transport.
What is an active substance?
- Any chemical, plant extract, pheromone or microorganism (including viruses), that has action against pests or on plants, parts of plants or plant products.
- Before an active substance can be used within a plant protection product in the EU, it must be approved by the European Commission.
What is a plant protection product?
- Plant protection products are ‘pesticides’ that protect crops or desirable or useful plants.
- They are primarily used in the agricultural sector but also in forestry, horticulture, amenity areas and in home gardens.
- They contain at least one active substance and have one of the following functions:
- protect plants or plant products against pests/diseases before or after harvest
- influence the life processes of plants (such as substances influencing their growth, excluding nutrients)
- preserve plant products
- destroy or prevent growth of undesired plants or parts of plants.
What is a plant protection product formulation?
- A homogeneous and stable mixture of active and inert ingredients which make the final product simpler, safer, and more efficacious to apply to a target pest.
The inert ingredients may involve:
- The carrier (e.g. organic solvent or mineral clay)
- Surface active ingredients (e.g. stickers or spreaders)
- Other ingredients, such as stabilizers, dyes and chemicals that improve or enhance the activity of the plant protection product
Remember the directive 91/414/EEC- Why was this directive important?
- Initiated the harmonization of the registration procedures
- Each active substance had to be proofed safe before market entrance (comprehensive risk assessment and authorization procedure)
What´s the difference between regulation and a directive?
Regulation:
- A regulation is a binding legislative act. It must be applied in its entirety across the EU.
Directive:
- A directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals.
Directive 2009/128 EC Sustainable use directive- What is so particular about this one?
- It is the first directive focusing on the use phase
- encourages a low input agriculture (PPP should only be used as a last instance)
- Sustainable use, IPM
Who is responsible for the approving of active substances? Of PPP?
- Active substances EU level
- PPP member state level
Who is responsible to provide all the documentation about risk characteristics?
- The industry has to provide all the studies and data
What do the required studies focus on?
- Human health,
- Environmental risk,
- Residue levels,
- Efficacy data (does it work?)
Who makes the final decisions for approval?
- EFSA and the EU commission
For what period does an approval normally last?
- 10 years provided that no new data comes out that makes an other investigation necessary
- Know: Authorization is given only for particular crop/use
What are illegal PPP?
- Expired
- No label
- Counterfeited products
- Damaged products
- Forbidden products etc.
What could be reason for a emergency approval for PPPs?
- Emergency approval of plant protection products is foreseen by Article 53 of Regulation (EC) 1107/2009
- Under special circumstances for a period not exceeding 120 days
- In the case of new alien pests
Define risk assessment?
- a comprehensive evaluation process following scientific principles carried out in cooperation with experts
What is risk?
Risk= f(x) hazard (toxicity) x exposure
- Risk: The potential for injury to take place
- Hazard (toxicity): The capacity of a pesticide to cause injury
- Exposure: The amount of pesticide entering or contacting the body
What is the difference between acute and chronic effects?
- Toxicological testing evaluates whether short-term exposure to a plant protection product will produce:
1. acute effects (e.g., eye and skin irritation, death)
and whether long-term, continual exposure will cause
2.chronic effects (e.g., impaired liver function, reproductive abnormalities, cancer)
Define duration and magnitude of exposure?
- The duration and magnitude of exposure determine the severity of the adverse effect
Duration: increment of time during which exposure to the dose occurs
Magnitude of exposure: size and number of doses received