WRITTEN QUESTION No. 1761/97 by Jan MULDER to the Commission. Use of biological crop protection products in the European Union
Date: 1997-05-27
Institutions: European Parliament, MULDER
Subjects: OECD, biology, chemical product, environmental protection, marketing, microorganism, plant health product, public health

11. 3. 98

EN

Official Journal of the European Communities

C 76/53

(98/C 76/135)

WRITTEN QUESTION E-1761/97

by Jan Mulder (ELDR) to the Commission

(27 May 1997)

Subject: Use of biological crop protection products in the European Union

1.
Does the Commission agree that the use of biological crop protection products should be encouraged, from
the  environmental  point  of  view  and  from  the  point  of  view  of  consumers?  In  this  connection  can  the
Commission state how many biological and how many chemical crop protection products have been registered
since July 1993?

2.
Does  the  Commission  take  the  view  that  the  existing  directive  for  the  registration  of  biological  crop
protection  products  based  on  bacteria,  viruses  and  other  micro-organisms  can  adequately  satisfy  the
requirements  of  the  market  and,  in  particular,  that  such  products  are  rapid  and  cost  the  same  as  comparable
chemical products?

If the Commission believes that this is not the case, what action is it considering in order to facilitate the use

3.
of biological products in the future?

4.
Is  the  Commission  of  the  opinion  that  from  the  economic  point  of  view  the  systems  for  registering
biological crop protection products in the European Union and in the United States are broadly comparable, and
that  the  two  trading  organizations  provide  their  businesses  with  the  same  encouragement  to  take  part  in
international competition? If not, what action is the Commission considering to improve the competitive position
of European businesses?

Answer given by Mr Fischler on behalf of the Commission

(16 July 1997)

The use and authorization of plant protection products is regulated by Council Directive 91/414/EEC of
1.
15 July 1991 concerning the placing of plant protection products on the market (1). This Directive provides a
Community  decision  for  both  chemical  substances  and  micro-organisms  (inclusion  in  a  positive  list)  used  in
plant protection products and for national authorizations of the preparations containing them. In principle the
criteria  for  both  chemical  substances  and  micro-organisms  are  the  same,  i.e.  the  use  of  the  preparation  and
residues resulting may not  have,  in accordance with  the envisaged conditions  of  use, any  harmful effects on
human or animal health or on groundwater or any unacceptable influence on the environment.

Since  July  1993,  18  dossiers  for  chemical  active  substances  and  3  dossiers  for  micro-organisms  have  been
accepted as complete at Community level. A final decision for inclusion in the positive list can only be taken
after a detailed evaluation on the basis of a report prepared by a Member State. Currently no chemical active
substance  nor  micro-organism  has  been  included  in  the  positive  list,  as  the  examination  procedures  are  still
ongoing.

2. to 4.
The requirements for the dossier to be submitted are different for chemical and microbial preparations.
The data requirements for microbial preparations have so far only been established in general terms. Moreover,
the Directive provides a certain flexibility when the applicant can justify that certain studies are not necessary to
demonstrate  that  for  particular  aspects  human  health  or  the  environment  are  not  at  risk.  The  costs  for  the
preparation of a dossier for micro-organisms are normally lower than for chemical preparations but, in cases
where there is reason for concern, costly testing may be required to demonstrate the absence of any harmful
effects.

The Commission is currently preparing a working document in order to establish in detail the data requirements
for  micro-organisms.  This  document  will  be  discussed  in  the  framework  of  the  Organization  for  economic
cooperation and development (OECD) in order to establish harmonised data requirements for micro-organisms
in all OECD coutries.

Moreover  the  Commission  is  considering  whether  to  propose  a  fast  track  procedure  for  the  authorization  of
certain low risk plant protection products, including biological plant protection products.

(1)  OJ L 230, 19.8.1991.