The placing of Plant Protection Products on the EU market

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AUDACE's presentation at the « International Crop-Science Conference & Exhibition » the Radisson, Bangkok :


click in the picture


By creating a new I.P. right, that is data exclusivity outside the duration of the basic patent and SPCC the « Dominant Industry » has secured for itself the WHOLE CAKE !

This is increasingly misunderstood, unpopular, and like any excessive immoderation, unsustainable. It will run up against its own contradictions and all kinds of dispositions including competition law.

Even a fashionable, though spurious, catchphrase such as « free riders » applied to the independent generic producers will not resist the evidence and the enormity of the CAKE.

Beyond differences of opinion and corporatist interests, a new multilateral approach will have to be invented to reconcile public health and environmental regulations with I.P. rights, consistent with their respective objectives.



ZAPYTANIE PISEMNE skierowane przez P-5824/08  22 października 2008 r. :


Czesława Adama Siekierskiego (PPE-DE) do Komisji

Przedmiot: fałszywe środki ochrony roślin



La question des importations personnelles de Produits PhytoPharmaceutiques (PPP) par les agriculteurs est enfin portée devant la CJCE. (communiqué)

The question of " own-use " parallel imports of Plant Protection Products (PPP) by the users - farmers is finally brought before the European Court of Justice (ECJ). (Press-release)




Assoção Dos Usuários E Distribuidores De Agro-Quimicos Europa



posée par Françoise Grossetête (PPE-DE)

à la Commission

Objet:     Monopole des fabricants de produits phytopharmaceutiques

Un certain nombre de producteurs de produits phytopharmaceutiques comme Bayer, Basf ou Syngenta dominent très largement le marché au sein de L'union européenne et peuvent ainsi profiter de cette situation.

Ces firmes achètent les petites entreprises et l’ensemble de leurs brevets qu'elles détiennent sur des substances actives. Ces brevets sont protégés pour des durées très longues (25 ou 30 ans). La détention d’un brevet d’une substance active leur assure le monopole sur chacun des produits et leur permet de maîtriser en grande partie la gestion de leurs prix. Citons, à titre d'exemple le cas du glyphosate, substance active du Round Up, qui est passé de 3€ le litre en 2007 à 8€ en 2008. Les produits dont les brevets tombent sont soit des traitements obsolètes, soit des produits renouvelés avec des molécules très proches qui font l’objet de nouveaux brevets.

La Commission européenne envisage-t-elle d'examiner attentivement les situations de cette nature qui pourraient être préjudiciables pour les agriculteurs ?


by Ashley Mote (NI)

to the Commission

Subject: Pesticides threat to British farming

Is the Commission fully aware of the negative impact of the proposed directive on pesticides (COM(2008)0093), which threatens to undermine thriving horticultural, fruit and vegetable-growing industries in my constituency and unnecessarily increase the cost of basic fruit and vegetables to consumers by reducing supplies?

The proposal to ban the use of the majority of pesticides, despite the fact that every one has had specific approval in the past, flies in the face of all farming logic and proven scientific facts. Is the proposal the result of lobbying by environmental groups with their own highly contentious political agendas, much of which is funded by the EU itself through NGOs?

If fruit farmers in particular cannot control the pests that infect their orchards they will go out of business. What can be clearer than that? Horticulturalists face identical problems but with different pests. No adequate alternatives exist.

If the cut-off criteria proposed in the Commission's review of Directive 91/414/EC[1] are applied, growers will quite literally have no means of controlling the most serious pest and disease threats to their crops. Once again EU so-called 'law' will close UK businesses and put people out of work.

Is that what the Commission intends?

[1]     OJ L 230, 19.8.1991, p. 1.




Parallel Imports


Zrzeszenie Użytkowników i Dystrybutorów Europejskiej Agrochemii



Import równoległy, a wspólne pochodzenie.


Obserwacje w stosunku do decyzji Trybunału w sprawie C-201/06 z dnia 21 lutego 2008.


Trybunał Sprawiedliwości Unii Europejskiej




Import środków ochrony roślin przez użytkowników, rolników i ogrodników amatorów w granicach ich potrzeb osobistych


Na podstawie ustawy z 1 lipca 1901 i dekretu z 16 sierpnia 1901 zostaje utworzone zrzeszenie o nazwie:


ZRZESZENIE UŻytkownikŌw i DystrybutorŌw Europejskiej Agrochemii


w skrócie : A.U.D.A.C.E *






see also the following pages :


   Implementation stage at member State level :

a number of questions are left opened to interpretation ...



24th November 2009

In the OJEU :  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (PPP Regulation)

balgarskicastellanoceštinadanskDeutscheesti keelellinikáEnglishfrançaisitalianolatviešu valodalietuviu kalbamagyarMaltiNederlandspolskiportuguêsromânaslovenský jazykslovenski jezikSuomiSvenska


13th January 2009

Parliament - Adoption second reading




Texts [en]
Provisional edition (1626 kb) 13/01/2009 18:31

Video of the speeches



Directorate General Internal Policies of the Union

   Policy Department B - Structural and Cohesion Policies

   The Consequences of the "cut off" Criteria for Pesticides: Agronomic and Financial Aspects (Dec 2008)


The PSD's  Assessment of the impact on crop protection in the UK of the ‘cut-off criteria’ and substitution provisions in the proposed Regulation (May 2008)


Analysis on availability of active substances following the addendum to the Interpretation in Sweden of the impact of the “cut-off” criteria”   (Sept 2008)


KEMI's Interpretation in Sweden of the impact of the “cut-off” criteria adopted in the  common position of the Council concerning the Regulation of placing plant protection products on the market (Sept2008)

COM (2006) 388 2006/0136/COD


Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the placing of plant protection products on the market

Monitoring of the decision-making process between institutions :




    COM (2006) 388 2006/0136/COD

   codecision logical link


    legislative observatory : COD/2006/0136    /  

   Committee on Environment, Public Health and Food Safety (food sfety) /  Committees of the European Parliament - AGRI  (agriculture)

Standing Committee on the Food Chain and Animal Health (SCFCAH)  - Sect. PHYTOPHARMACEUTICALS   Scheduled meetings



15th September 2008

Council - Adoption common position


Interinstitutional file 2006/0136 (COD) :

balgarskicastellanoceštinadanskDeutscheesti keelellinikáEnglishfrançaisitalianolatviešu valodalietuviu kalbamagyarMaltiNederlandspolskiportuguêsromânaslovenský jazykslovenski jezikSuomiSvenska

In reference to article 52 on parallel trade:

Alarmist reports from the industry weighs heavily on legislative process :


ECPA estimates that 5% - 7% of annual turnover is affected by counterfeiting and illegal trade.

The Association encourages politicians to recognize this problem and push for urgent actions by all stakeholders - governments, supranational entities, farmers and food chain and the legitimate pesticide industry.


Overzealous ECPA, the industry’s Europe wide association, attempts to capitalize on the Spanish ‘pepper scandal’ and on its investment in Ukraine, much gesticulation after years of passiveness.


Was the industry waiting for the opportunity between 2000 and 2006 when AUDACE was on the trail of counterfeiters and proposed new regulation to stop abuses ?


Scaremongering can easily backfire


How white is the white knight ?


It would be advisable that the industry intervenes on fraud taking place among its own members which European jurisdictions already have stigmatized over the last years and will be able to stigmatize in the future in relation to sources of active substances which do not correspond to the evaluated sources.


  > related topics : (1) (2) (3) ...


11th March 2008

Commission - Adoption amended proposal

balgarskicastellanoceštinadanskDeutscheesti keelellinikáEnglishfrançaisitalianolatviešu valodalietuviu kalbamagyarMaltiNederlandspolskiportuguêsromânaslovenský jazykslovenski jezikSuomiSvenska



In May 2008 the UK Pesticide Safety Directorate (PSD) argued that the Commission proposals could remove up to 15% of the substances assessed, some of which are particularly important in the UK for protection of minor crops such as carrots and parsnips. It is possible that the endocrine disruptor criteria could impact particularly on fungicide availability and might result in 20-30% yield losses in cereals.


A full copy of the UK Pesticide Safety Directorate report can be downloaded from




We are here 



 La réglementation européenne débattue à Kuala Lumpur   AUDACE-PMFAI

Les projets de directive sur l'utilisation durable des PPP et de réglement pour remplacer la dir 91/414/CEE étaient présentés par AUDACE aux acteurs du sud-est asiatique, autorités compétentes et producteurs de génériques. 





23rd October 2007

Parliament first reading - Approval with amendments


European Parliament legislative resolution of 23 October 2007 on the proposal for a regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market (COM(2006)0388 – C6-0245/2006 – 2006/0136(COD))




2006  DG SANCO

included, AUDACE's comments and observations on the proposals for
Regulation [ 2006/0136 ( COD ) - COM ( 2006 ) 388 final ]and
Directive [ 2006/0132 ( COD) - COM ( 2006 ) 373 final ] 
relating to the marketing and sustainable use of Plant Protection Products (PPP)
(0,140 MB)

 Commentaires et observations d'AUDACE sur les propositions de 
règlement [ 2006/0136 ( COD ) - COM ( 2006 ) 388 final ]et
de directive [ 2006/0132 ( COD) - COM ( 2006 ) 373 final ]

concernant la mise sur le marché et l'utilisation durable des Produits PhytoPharmaceutiques ( PPP ) (0,26 MB)



AUDACE's presentation at the


« International Crop-Science Conference & Exhibition » 


the Radisson, Bangkok 27th  - 28th July, 2006 

click in the picture







Rapport relatif aux amendements proposés pour la Directive 91/414/CE du 15 juillet 1991* concernant les articles 13 et 14 et le commerce parallèle


rapport complet  (pdf 1116 KB) 

excerpt and translation






September 2003 AUDACE intervenes at a PMFAI meeting on the following topics:

Is there a future for an independant generic industry ?

  Quel avenir pour l'industrie générique indépendante ?

Of the sustainable use of plant protection products

  De l'utilisation durable des produits phytopharmaceutiques

page India






Contribution d'AUDACE à la « Stratégie Thématique concernant l'Utilisation Durable des Pesticides ». [.pdf - 308 KB]

AUDACE's contribution towards a Thematic Strategy on the Sustainable Use of Pesticides.  [.pdf - 509 KB]

Вклад АДФП в тематическую стратегию об устойчивом использовании пестицидов [.pdf - 575 KB]






Following the Corfu meeting The Commission issued a report.


However, « information that was on both ‘Conclusion of Workshop’ and ‘Report from breakout Group 3’ had quite obviously gone astray or was rephrased in such a way that could be misleading and in one case even had completely the opposite meaning. Further, a statement claimed unanimity on an issue that was vehemently opposed. »


AUDACE made the point that …





Directive 91/414/CEE

de la conception à la mise en oeuvre



Portal to national law


Portal to European Union law




EU directory




infolink Erigone




European Court of Justice




EU Parliament




Council of the European Union









Plant health [en]

  Phytopharmacie [fr]

    Pflanzenschutz [de]





European Chemicals Bureau







Community plant variety office 








Asociación Española de Fitosanitarios y Sanidad Ambiental

Secretary Tel/Fax: + 34 93 318 74 25

 Raúl Nehring Andrade

Secretary General



situation aux USA


AEFISA position paper







Associação Brasileira dos Defensivos Genéricos
Av. Doutor Vieira de Carvalho, 172 - 3° andar cj. 306
CEP: 01210-010 - Vila Buarque - São Paulo / SP
PABx: (11) 3354-0053 / Email: aenda@aenda.org.br


AUDACE in Brazil




Les produits génériques

pdf - 132 KB

amendements à la directive 91/414/CE




by John Bowis (PPE-DE)

to the Commission


Subject: Plant protection products


Several scientists claim that the introduction of hazard-based cut-off criteria to EU plant protection approval legislation and the consequential reduction in the number and use of available synthetic plant protection products will actually increase the total amount of pesticides (natural and synthetic) consumed by Europeans. Can the Commission please give its view?

Can the Commission give specific information on the feedback received from EFSA on this specific issue ?



    1. E-3775/08

      WRITTEN QUESTION by Hiltrud Breyer (Verts/ALE) to the Commission ... My Written Questions P‑5835/06, P‑1416/07 and E‑2575/08 have drawn the Commission's ...


  • Brazil

Associação Brasileira dos Defensivos Genéricos (AENDA)
Av. Doutor Vieira de Carvalho, 172 - 3° andar cj. 306
CEP: 01210-010 - Vila Buarque - São Paulo / SP
PABx: +55 (11) 3354-0053   -   Email: aenda@aenda.org.br

  • India

Pesticides Manufacturers & Formulators Association Of India (PMFAI).

  • Marocco

C'est en particulier dans les accords bilatéraux  que s'immiscent des contraintes excessives tenant à la protection des données.


ALE - L'accord de libre échange entre le MAROC et les USA fait l'objet de nombreuses contestations ...


 COMMUNIQUE [pdf - 82 KB]

It is in first of all through bilateral agreements that excessive constraints pertaining to data protection establishes themselves.


FTA - free trade agreement between MOROCCO and the USA has been widely condemned

 PRESS RELEASE [pdf - 81 KB]

page Maroc



by Sajjad Karim (PPE-DE)

to the Commission


Subject: Biocidal Product Directive 98/8/EC[1]


In the light of the forthcoming consultation due to take place on 23 May 2008 and the Commission’s impact assessment of the legislation to be carried out by 3 different companies, I would like to raise some concerns and questions to the Commission in advance.

I have witnessed direct negative effects of the Directive on SMEs in my constituency which are suffering to a large extent due to the fact that they are under pressure to produce the dossier in support of a substance they wish to continue to use.

They are forced to channel a large majority of their staff into research and writing the report and are thus unable to maintain the normal running of the business. They are losing out on money and business and at present, no reimbursements to companies which are suffering in this way are available.

Is the Commission willing to consider introducing funding for research in order to properly implement the legislation without detriment to EU companies and particularly SMEs? Was the Commission aware of such detrimental effects of the Directive?



  • hiltrud breyer german green mep pesticides Farmers Weekly  30/10/2008 14:00:00

MEP says fears of pesticide rules are unfounded

Next week the European parliament's environment committee will vote on controversial new rules restricting the approvals of pesticides. Hiltrud Breyer, the German Green MEP overseeing the legislation, explains why she thinks the industry's concerns about this are misplaced




AUDACE's presentation at the « CROP PROTECTION  Generics, Patents and Parallel Trade Summit 2006 » conference at the Hilton, Amsterdam :


click in the picture