Austrian control system for placing on the market of plant protection products

2. Austrian control system for placing on the market of plant protection products September 27, 2007 Sylvia Hochmann

3. Overview • What does AGES stand for? • Legal basis for placing on the market of PPPs in Austria • Austrian control system • Results • Conclusions

4. Federal Office for Safety in Health Care Medicines Federal Office for Food Safety Company Structure Federal Ministry for Agriculture, Forestry, Environment and Water Management Federal Ministry for Health, Family and Youth 40% 60% Management Board Agriculture Food Veterinery Medicine Human Medicine Analytical Competence Centres Data, Statistics and Risk Assessment Risk Assessment Risk Communications Assessments – Approvals – Advise - Research

5. Risk Analysis in the Food Production Cycle

6. Facts and Figures • 1.350 staff • Locations in Vienna, Graz, Innsbruck, Linz, Mödling, Salzburg • 43 Institutes and Analytical Competence Centers • approx. 900 000 samples with 7.2 million tests per year • Owner: Republic of Austria • Annual budget: approx. € 100 Mio.

7. Legal basis - background • Nearly no new authorisations from 1991-1997 • Competitive disadvantages for the Austrian farmers in the common market • No practical application of Article 10 (91/414/EEC) • Urgent need for new structures and new solutions concerning the whole authorisation process • => Revision of the Austrian Plant Protection Law and reorganisation of the competent authority

8. Accelerated authorisation procedure • 1997 administrative agreement between Austria and Germany. Confirmation of comparability with respect to the use of PPPs • 2002 same procedure applies to the Netherlands • Applicant has to submit a copy of the authorisation, all information and dossiers relevant for the authorisation in the source country • Authority takes into consideration particular national conditions and provisions • Authorisation is granted by way of decision

9. Significant reduction of accelerated authorisations 1997 - 2007 in Austria

10. Unilateral recognition of authorisations by law • PPPs registered in another MS are automatically authorised in Austria without any restrictions if the MS is listed for two years in an ordinance of the BMLFUW • Companies have to notify the first placing on the market • Official statements of the BMLFUW for interpretation of the new provision • 20 July 2002: provision for German PPPs entered into force • 5 February 2004: effective date for Dutch PPPs

11. Organisation of the PPPs evaluation, authorisation and control of marketing Executive director of AGES Director ofBAES Business area agriculture Head of business area agriculture Institute for plant protection products evaluation and authorsation Department for plant protection products authorisation and risk management*) Department for evaluation of efficacy and phytotoxicity Department for residues Department for environmental behaviourand ecotoxicology Department for toxicology *) concerning control of marketing bound by instructions only to the head of business area agriculture and to the director of BAES

12. Controls of the marketing of PPPs • Austria comprises 9 Provinces and 99 Districts • Supervision on the marketing of PPPs are performed by the Federal Office for Food Safety (BAES) with technical assistance from AGES (staff: 7 persons) • In relation to supervision on the use of PPPs, the Provinces are directly in charge of legislation and implemention of control measures • AGES Competence Centre for Residue Analysis in Vienna is responsible for analysis for PPPs

13. Controls of the marketing of PPPs cont‘d • The department drafts an annual inspection plan establishing number of visits of outlets and the number of samples to be taken • Suppliers of PPPs are generally inspected every two to four years • Infringements are reported to the District Authorities which carry out the enforcement procedures • Since August 2007 BAES is party in the enforcement procedure • BAES reports monthly to the provincial inspection authorities on results of the check on marketing of PPPs

14. Results

15. Results cont‘d

16. Conclusions - hard facts Clear evidence that illegal networks distributing PPPs exist Illegal trade in PPPs is similar to the illegal trade in drugs Checks of bookkeeping show, that “roundabout” trade of PPPs between member states is in most cases basis for illegal marketingBorders of EU are open for illegal imports (customs officals are overcharged to identify PPPs) Range of offers comprise sophisticated counterfeit copies to low-quality fakes and copies Different legislation for parallel import/trade of PPPs makes it easier for companies to channel counterfeit pesticides in the EU Penal proceedings of the administrative body have only limited deterrent effects

17. Recommendations European network of authorities Close cooperation between control services of the member states European information system on authorised PPPs Clear legislation concerning parallel imports and generics Establishing a marker technology for quick testing whether a PPP is original or counterfeit Increased border controls and training for custom officals

18. www.ages.at