Chapter 2: Legislation of PPP Flashcards
1
Q
Remember the directive 91/414/EEC- Why was this directive important?
A
- Initiated the harmonization of the registration procedures
- Each active substance had to be proofed safe before market entrance (comprehensive risk assessment and authorization procedure)
2
Q
What´s the difference between regulation and a directive?
A
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.
3
Q
Directive 2009/128 EC Sustainable use directive- What is so particular about this one?
A
- 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
4
Q
Who is responsible for the approving of active substances? Of PPP?
A
- Active substances EU level
- PPP member state level
5
Q
Who is responsible to provide all the documentation about risk characteristics?
A
- The industry has to provide all the studies and data
6
Q
What do the required studies focus on?
A
- Human health,
- Environmental risk,
- Residue levels,
- Efficacy data (does it work?)
7
Q
Who makes the final decisions for approval?
A
- EFSA and the EU commission
8
Q
For what period does an approval normally last?
A
- 10 years provided that no new data comes out that makes an other investigation necessary
- Know: Authorization is given only for particular crop/use
9
Q
What are illegal PPP?
A
- Expired, No label, Counterfeited products, Damaged products, Forbidden products etc.
10
Q
What could be reason for a emergency approval for PPPs?
A
- 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
