WORLD TRADE  
ORGANIZATION  G/SPS/GEN/557 
29 March 2005 
 (05-1269) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
QUESTIONS AND ANSWERS ON THE PROCEDURE TO OBTAIN IMPORT 
TOLERANCES AND THE INCLUSION OF ACTIVE SUBSTANCES FOR PLANT 
PROTECTION USES IN THE EUROPEAN COMMUNITIES LIST 
Communication from the European Communities
 
 
 
 The following communication, dated 21 March 2005, is being circulated at the request of the Delegation of the European Communities. 
_______________ 
Purpose of this paper 
 The European Communities (EC) SPS Enquiry Point has received recently numerous 
questions related to the withdrawal of ac tive substances from Council Directive 91/414/EEC1 on plant 
protection products (PPP).  The questions have come  as comments to EC proposals being notified to 
the Agreement and during the WTO Trade Policy Review Mechanism (TPRM) of the European 
Communities.  This is also a recu rrent issue in the regular meetings of the Committee on Sanitary and 
Phytosanitary Measures (SPS).  
 A majority of questions show concern on whether Maximum Residue Levels (MRL) set by 
Codex would be systematically dropped when a ma rketing authorization for an active substance is 
withdrawn.  Others deal with the establishment of an MRL for a combination of PPP and imported agricultural product (i.e. "import tolerances") or the registration of active substances.  
 This paper aims to summarize the questions and responses provided by the EC SPS Enquiry 
Point and provides greater details th an in the original responses.  
  
                                                     
 
1 On the placing of plant protection products on the market (Official Journal L 230, 19/08/1991 pp.:1-
32).  G/SPS/GEN/557 
Page 2  
 
 T
ABLE OF CONTENT  
 
PAGE   
I.
 THE PRESENT EC SYSTEM TO REGISTER PLANT PROTECTION 
PRODUCTS ....................................................................................................................... .......3  
A. WHAT IS CONTROLLED ?...............................................................................................................3  
B. HOW IS THIS INFORMATION FOUND .............................................................................................4  
C. WHO IS HELD RESPONSIBLE FOR ACTIVE  SUBSTANCE PRODUCED OUTSIDE THE 
EUROPEAN COMMUNITIES ? .........................................................................................................4  
D. HOW CAN A TRADING PARTNER FIND GUIDANCE DOCUMENTS FOR REGISTERING 
ACTIVE SUBSTANCES OR RE QUESTING IMPORT TOLERANCES ? ...................................................4  
II. THE FUTURE SYSTEM AS NOTIFI ED IN G/SPS/N/EEC/196 (11 APRIL 
2003) .......................................................................................................................... .................5  
A. HOW WILL THE PROPOSAL AFFECT FEEDINGSTUFFS AND FOOD PRODUCE FROM 
OUTSIDE THE EUROPEAN COMMUNITIES ? ...................................................................................5  
B. HOW ARE IMPORT TOLERANCES SET IN THE NEW PROPOSAL ?.....................................................5  
C. WHO CAN APPLY FOR IMPORT TOLERANCES ?..............................................................................5  
D. WHEN DO IMPORT TOLERANCES HAVE TO BE REQUESTED ? ........................................................5  
E. WHY THE EUROPEAN COMMUNITIES CHOOSE 0.01  MG/KG AS A DEFAULT MRL FOR 
CONTROL PURPOSES ON NON AUTHORIZED SUBSTANCES ...........................................................6  
F. WHAT IS THE MEANING OF SETTING A MRL AT THE LIMIT OF DETERMINATION (LOD)................7  
G. DATA TO BE SUBMITTED FOR REGISTRATION OF MOLECULES .....................................................8  
Number of dossiers to  be submitted ............................................................................................. ........9  
TABLE I - ESSENTIAL COMPONENTS OF A DOSSIER .................................................................................11  
TEMPLATE TO DESCRIBE GOOD AGRICULTURAL PR ACTICE IN SUPPORT OF AN APPLICATION 
FOR AN IMPORT TOLERANCE IN THE EUROPEAN COMMUNITY ..................................................13  
SUMMARY DATA SHEET TO BE INCLUDED WITH AN APPLICATION FOR AN IMPORT TOLERANCE ...........15  
 
 
 
  G/SPS/GEN/557 
 Page 3 
 
 
 I. THE PRESENT EC SYSTEM TO REGISTER PLANT PROTECTION PRODUCTS 
 
1. The main policy instrument to ensure safet y of a crop protection product is the Plant 
Protection Products (PPP) Directive 91/414/EEC.  This  Directive concerns the authorization, placing 
on the market; use and control within the Europ ean Communities of PPP in commercial form and of 
active substances used to protect plants or plant products against harmful organisms.  EC member 
States will not allow a PPP to be placed on the mark et and used in its territory unless it has been 
authorized in accordance with the principles and pro cedures set out in this Directive.  EC member 
States also ensure that a PPP is not authorized unl ess its active substances are listed in Annex I to the 
Directive and any conditions laid down therein are fu lfilled.  Under Article 15 of this Directive the 
conditions for packaging and labelling of PPP are listed .  Modifications to this Directive are notified 
to the WTO Agreement on Technical Barriers to Trade (TBT). 
2. Pesticide residues in food are regulated by four Council Directives: 76/895/EEC, 
86/362/EEC, 86/363/EEC and 90/642/EC.  A Commi ssion proposal notified in G/SPS/N/EEC/196 
(11 April 2003) to consolidate and amend these is cu rrently being discussed in the Parliament and the 
Council.2  The legislation covers the setting, monitori ng and control of pesticide residues in products 
of plant and animal origin that may ar ise from their use in plant protection.  
3. The maximum levels set are those consistent with good agricultural practice in EC member 
States and third countries.  The levels are set after an  evaluation of any risks to consumers of different 
age groups and they are only set if they are consider ed safe.  The levels are intended to facilitate trade 
and are not toxicological limits.  Any level that excee ds a maximum level is more an indication of an 
incorrect use of a pesticide than a risk to the consumer.  Nonethel ess, excedence is closely monitored, 
evaluated and communicated to the authorities in the EC member States through the Rapid Alert system for food whenever there is  a potential risk to consumers. 
4. More information can be found in the SANCO web in: 
 
http://europa.eu.int/comm/dgs/h ealth_consumer/index_en.htm
 
 
 An overview of the existing system is available in:  
http://europa.eu.int/comm/food/plant/protection/index_en.htm
  
 
A. WHAT IS CONTROLLED ? 
5. In a pesticide there is an active ingredient  that is effective against a target pest (insect, weed 
or fungus) and that usually is the only component of the formulation listed on the pesticide label.  
Nevertheless, active or inactive isomers  of the main active substance, contaminants  and impurities  are 
often a part of the pesticide product and can also cause adverse effects and are also responsible for 
product hazards.  As a way of example, Dioxin a nd DDT are contaminants, which have not been 
purposefully added to pesticide formulae, but are a by-product of the "production process".  In the 
European Communities, the control falls on the "Marker residue".   
6. Marker residues  are important for determining co mpliance with MRLs and related 
enforcement purposes; in virtually all instances it is a single compound although an exception would 
be stereo-isomers with the same general chemical structure but different geometrical configurations.  
                                                      
2 An interactive Policy Making (IPM) online cons ultation on the Proposal concerning Amendments 
made to the Council Directive 91/414/EEC of 15 July 1991 concerning the Placing of Plant Protection Products 
on the Market has just been launched by DG SANCO of the European Commission. This consultation is open to all stakeholders both within the EU and outside and can be found at: 
http://europa.eu.int/yourvoice/f orms/dispatch?form=392&lang=EN  G/SPS/GEN/557 
Page 4  
 
 Adherence to a single marker residue has several advantages for food control authorities: (1) results 
on a single analytical method control, (2) allows more monitoring and surveillance of residues in 
vegetables and food animals, and (3) reduces the an alytical uncertainties a ssociated with residue 
analysis when compared with tho se situations in which more than one analysis may be required to 
determine compliance with an MRL.  
B. 
HOW IS THIS INFORMATION FOUND  
7. This information (i.e. the "product profil e") is obtained from the molecule sponsor3 who, in 
submitting an application, includes in the data studies of total residue depletion  and metabolism 
studies with radiolabel compound in species for whic h approval is sought.  The carryover to animal 
products  is studied in eggs, milk, and target tissues (usually liver, kidney, or fat) because residues 
generally deplete from these tissues more slowly than from other.  These data will remain the 
intellectual property of the submitte r and be of confidential nature. 
 
C. WHO IS HELD RESPONSIBLE FOR ACTIVE SUBSTANCE PRODUCED OUTSIDE  THE EUROPEAN 
COMMUNITIES ?  
 
8. For an active substance produced outside  the European Communities "produce r" means  the 
person established within the Community and designat ed by the manufacturer of an active substance 
as his sole representative  or where no such person has been so designated, the importer into the 
European Communities of that active substance.4 
D. HOW CAN A TRADING PARTNER FIND GUIDANCE DOCUMENTS FOR REGISTERING ACTIVE 
SUBSTANCES OR REQUESTING IMPORT TOLERANCES ? 
9. In the SANCO website described above, there is a specific page on GUIDANCE 
DOCUMENTS for the implementation of Council Direc tive 91/414/EEC (Plant Protection Products).  
Its internet address is: 
http://europa.eu.int/comm/food/plant/pr otection/resources/publications_en.htm   
10. Two documents have special relevance;  one is document  7196/VI/9938 "Working document 
guidance notes on Import Tolerances".  This document describes the current situation in the European 
Communities regarding situations, procedures, timetab les, data requirements, and financial provisions 
related to the setting of import tolerances for pe sticides residues in foodstuffs and agricultural 
commodities entering the European Communities.  This document contains, among other information: 
• a template to describe Good Agricultural Prac tice in support of an application for an 
import tolerance in the European Communities;  
• a template to report results of supervised resi due trials in support of an application for 
an import tolerance in the European Communities;  and 
• a summary data sheet to be included with an application for an import tolerance. 
 
                                                      
3 "Producer" or "legal representative" if the produc er is established outside the European Communities. 
4 Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the 
programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products.   G/SPS/GEN/557 
 Page 5 
 
 
 II. THE FUTURE SYSTEM AS NOTIFIED  IN G/SPS/N/EEC/196 (11 APRIL 2003) 
11. The European Communities notified a proposal for a Regulation that will replace the four 
basic Council Directives on MRLs for PPP (i.e. Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC
5) and will harmonize all MRLs through all EC member States after a transitional 
period.  As of its enforcement MRLs  will only be set at the EC level. 
A. HOW WILL THE PROPOSAL AFFECT FEEDINGSTUFFS AND FOOD PRODUCE FROM OUTSIDE THE 
EUROPEAN COMMUNITIES ?  
12. It is a matter of fact that different Good Ag ricultural Practices (GAP) as regards the use of 
PPP may be legally applied by trade partners of th e European Communities and that these GAP result 
in MRLs differing from those resulting from uses legally applied in the European Communities.  A 
consequence of this is that to ensure trade as well as facilitate control purposes, there is a need to fix 
MRLs for imported products that take these GAP into  consideration, provided these  approved uses 
(and resulting MRLs) fulfil the same criteria as follo wed for European Communities.  Article 29 of 
the proposal deals with the setting of "import tolerances" . 
B. HOW ARE IMPORT TOLERANCES SET IN THE NEW PROPOSAL ? 
13. Import tolerance  is defined as "a MRL based on a Codex MRL or on a GAP implemented in a 
third country for the legal use of an active substanc e in that third country where (a) the use of the 
active substance in a plant protection product on a commodity is not authorised in the European 
Communities; or (b) an existing MRL is not sufficien t to meet the needs of international trade".  
C. WHO CAN APPLY FOR IMPORT TOLERANCES ? 
14. Applications for import tolerances  may be made by the EC member States, interested parties, 
including manufacturers, growers, importers  and producers  of plant protection products applied 
outside the European Communities.  
D. WHEN DO IMPORT TOLERANCES HAVE TO BE REQUESTED ?  
15. There are three cases where "import tolerances" would be required (Article 29 of proposal), 
namely if a trader wants to import a commodity: 
(a) containing residues of a substance used in  the European Communities but where the 
commodity is not produced in the European Communities e.g. papayas.  In this case 
there would usually be expertise (Rapporteur member State); 
(b) treated with a substance no longer or not ye t used in the European Communities.  In 
this case, there would normally not be e xpertise in the European Communities and 
full toxicological and residues data would be required.  A significant workload would 
                                                      
5 Council Directive 76/895/EEC of 23 November 1976, on the fixing of maximum levels for pesticide 
residues in and on fruit and vegetables. Official Journal L 340, 09/12/1976 pp.:26-31) 
Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues 
in and on cereals (Official Journal L 221, 07/08/1986 pp.:37 -42) 
Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues 
in and on foodstuffs of animal origin (Official Journal L221, 07/08/1986 pp.:43 -47) 
Council Directive 90/642/EEC of 27 November 1990  on the fixing of maximum levels for pesticide 
residues in and on certain products of plant origin, including fruit and vegetables (Official Journal L 350, 14/12/1990 pp.:71-79) G/SPS/GEN/557 
Page 6  
 
 be expected for each individual evaluation - for which there could be many due to our 
withdrawal of numerous substances from the market
6; 
(c) treated with a substance in use  in the European Communities but where the foreign 
GAP allows higher residues than the European  Communities’ critical GAP.  In this 
case, marginal data specific to the GAP for the crop would be needed since a dossier 
and Rapporteur member State would be availa ble.  The additional workload would be 
slight. 
16. In all cases where a particular PPP is not  authorized on a commodity or when no data are 
available to demonstrate that its residues do not  endanger consumer health, no residues may be 
permitted on this commodity at levels higher than 0.01 mg/kg which is an enforceable default for 
zero.7  Exceptions will be made for substances wher e a level of 0.01 mg/kg is not safe for the 
consumer by setting MRLs at a lower level. 
E. WHY THE EUROPEAN COMMUNITIES CHOOSE 0.01  MG/KG AS A DEFAULT MRL FOR CONTROL 
PURPOSES ON NON AUTHORIZED SUBSTANCES  
17. When a PPP is not  authorized no residues may be permitted on any commodity at levels 
higher than 0.01 mg/kg.  Since many residues can be detected with modern sophisticated methods at 
levels lower than 0.01 mg/kg, the question is often asked as to why this control level is conventionally 
set at 0.01 mg/kg.  
18. Firstly, it is not possible to set MRLs at zero  because there is no analytical method that is 
capable of detecting 'zero' levels of residues and uncertainty increases as zero is approached, in fact, 
detection limits are dependent on the matrix, the s ubstance and the analytical method.  It is not 
practical to determine and to certify these individually for the more than 160,000 possible 
combinations of marker residues and agricultural pr oduce.  Therefore a default needs to be selected 
and from practical experience this is 0.01 mg/kg.  A lower value may not be attainable for certain 
substance/matrix combinations and a hi gher default value is not necessary. 
19. Secondly, for almost all pestic ides in use, a MRL at 0.01 mg/kg protects sufficiently the 
consumer from misuses (excessive use) although in exceptional cases where this is not the case a 
lower level should be explicitly set. 
20. Thirdly, monitoring laboratories do not have  the resources to routinely examine every 
possible crop/substance combination and they have to prioritize their efforts.  They normally use 
certified multi-residue methods for screening levels of more than a hundred substances at a time in any one commodity and can look at e.g. up to 50 samples in one run but
 multi-residue methods are not 
as sensitive as methods targeted to detect a specifie d  marker residue at a time but at much lower 
levels.  For verification of comp liance it is considered that scre ening 50 different samples using a 
multi-residue method screening more than a hundred s ubstances per sample is more protective for the 
consumer than spending the same time analyzing 10 samples for one substance. 
                                                      
6 An exception would be for substances that had been evaluated at EC level and which were withdrawn 
for reasons of consumer protection e.g. because they were genotoxic. For the small number of cases where this has happened, no import tolerance could be considered.  
7 This also applies to products used outside the European Communities and for which an import 
tolerance has not been requested.  G/SPS/GEN/557 
 Page 7 
 
 
 F. WHAT IS THE MEANING OF SETTING A MRL AT THE LIMIT OF DETERMINATION (LOD) 
21. The LOD is the lower limit of analytical dete rmination, i.e. the limit below which residues 
cannot be detected using suitable analytical met hods in accredited laboratories and following agreed 
quality assurance guidelines and criteria.  The LOD is therefore dependent on the substance, the 
method and the matrix.  For example, LODs for subs tances in oily crops such as nuts or oilseeds are 
often higher than those in 'watery crops' because of  analytical difficulties.  The LOD needs to be 
carefully defined to ensure that legal enforcemen t measures are not arbitrary.  Setting a MRL at the 
LOD is not  equivalent to banning a subs tance and conversely, banning a substance does not mean that 
the MRL is set at the LOD.  For many of the cases where MRLs are set at LOD, the MRLs could be increased without compromising consumer safety .  There are eight cases where MRLs would 
normally be set at the LOD: 
(a) No residue expected because the active substance is obsolete and no longer used 
anywhere although illegal uses and/or contamination cannot be excluded; 
(b) No residue is expected and no residues are wanted: e.g. its residues are genotoxic, 
carcinogenic; 
(c) No residues expected because of use patte rn: the authorized uses of the substance do 
not leave residues in the harvested crop, e.g.  it is used as a soil or seed dressing or 
any residues degrade quickly; 
(d) No residues expected because the substance is not (yet) used on certain crops:  
particularly for new substances, in early years of use only a few major crops (e.g. 
cereals) would be treated.  For untreated cr ops, no residues would be expected.  As 
new uses are developed, the LODs for tho se latter crops would have to be reviewed
8; 
(e) No residue expected because no longer authorized for use in the European 
Communities: In 2003, about 400 substan ces will have been withdrawn from the 
market and most withdrawals will have been for economic reasons.9  They might still 
be used by EC trade partners and residu es could still be present on imported produce; 
(f) New data indicates that a substance is not as safe as formerly thought and existing 
MRLs are possibly unsafe although lower leve ls would be acceptable.  In these cases, 
the MRLs need to be reduced to safe levels .  If a GAP exists - giving rise to the lower 
safe levels- then the MRL can be reduced.  If not, the MRL is temporarily set at LOD until a new GAP is developed giving rise to low, but safe, residue levels then the MRL can be increased again; 
(g) Where a substance is banned because of environmental or worker safety 
considerations, then MRLs would also norma lly be set at the LOD.  However, there 
may be safe consumer exposure levels and residues could be accepted on (i) imported produce and (ii) domestic or imported produce where soil is contaminated and persistent residues are taken up by crops (e.g. DDT).  In both cases a consumer safety 
assessment would be required.  In additi on, in the former case, one cannot under 
WTO rules use MRLs to block trade where an assessment shows that allowing the 
imports would protect the consumer.  In the latter case the MRLs would be set using 
monitoring data that is regularly reviewed;  and 
                                                     
 
8 This will also be true in future for present-day substances because, w ith the loss of half of all existing 
substances in 2003, the others will find wider uses. 
9 Producing companies are not interested anymore in  manufacturing the molecule because its use has 
declined or is being replaced by a ne w (more efficient) molecule often w ith less toxic residues. A consequence 
of the withdrawal is that the control authorities are left without a "standard" to calibrate the analytical method to be used in control of compliance. G/SPS/GEN/557 
Page 8  
 
 (h) Insufficient data: Minimum data requirements to set a MRL are not met for a 
substance/crop combination. 
G. 
DATA TO BE SUBMITTED FOR REGISTRATION OF MOLECULES  
22. Since October 2001 the EC member States agreed that as from 31 December 2004,  all 
dossiers submitted by notifiers wishing to have ac tive substances included in Annex I to Directive 
91/414/EEC (the Directive), or other interested part ies wishing to have other information taken into 
account by the relevant regulatory authorities should be presented in OECD-format (see below for reference). 
23. Applicants and interested parties should use the OECD guidelines and criteria for industry for 
the preparation and presentation of complete dossiers and of summary dossiers for plant protection 
products and their active substances in support of regulatory Decisions in OECD countries (Revision 
1 March 2001).  For new active substances, dossiers in the OECD format are already acceptable.  The 
OECD guidance document is based on and is cons istent with the previous European Commission 
Guidance Document approved by the 11
th meeting of the OECD Working Group on pesticides 
(November 2000).  
24. To help industry and other interested parti es understand any differences between the existing 
EC format and the OECD format, a document th at compares the two numbering systems has been 
prepared as a background document to this guidance.  This "Comparison List" is available from the 
SANCO home page10 under "Guideline on the Preparation and Presentation of Complete Dossiers for 
the Inclusion  of Active Substances in Annex I of Direc tive 91/414/EEC (Article 5.3 and 8.2), (doc. 
SANCO/10518/2004, 8 October 2004)". 
25. This document provides guidance on the submission of dossiers to support the inclusion of an 
active substance in Annex I.  In particular, this document provides guidance on the number and 
format of dossiers, addresses to which they shoul d be submitted and general contact points.  For 
guidance on the submission of dossiers to support na tional authorizations, prospective applicants 
should consult the competent authorities of the releva nt EC member States.  In preparing Annex III 
submissions, the OECD guidelines should be followe d from 1 July 2006.  This document has been 
conceived as an opinion of the Commission Services a nd elaborated in co-operation with the member 
States.  The Commission also had comments rece ived from the European Crop Protection Industry 
(ECPA).  This document does not, however, produce lega lly binding effects and by its nature does not 
prejudice any measure taken by an EC member State, nor any case-law developed by the European Court of Justice with regard to the interpretati on of Directive 91/414/EEC and the legislation made 
under it. 
26. Article 8 (2) of the Directive provides that the Commission will set out all the provisions 
necessary for the implementation of the review pr ogramme for existing active substances.  For new 
active substances it is also in th e interest of all parties involved to provide similar guidance.  
Therefore the Commission and the member States expect  that the approach proposed in this document 
will also be followed for new active substances.  Wh en preparing dossiers for submission, applicants 
and other interested parties are advised to consult the most recent texts of data requirements as set out in Annexes II and III of the Directive.  These  can be obtained from the SANCO home page under 
Guidance Documents for the implementa tion of Council Directive 91/414/EEC. 
27. Where additional or more detailed guidance is required on technical points, applicants and 
other interested parties are advised to refer to  the Guidance documents which can be obtained from 
the SANCO home page under Guidance Documents for the implementation of Council Directive 
                                                     
 
10 http://europa.eu.int/comm/food/plant/pro tection/resources/publications_en.htm    G/SPS/GEN/557 
 Page 9 
 
 
 91/414/EEC.  If necessary, they should contact the designated authority of the EC member State to 
which the documentation is to be submitted. 
Format  
28. The OECD formatting guidelines are available on the OECD homepage.11  The essential 
components of the application file12 ("dossier") are described in Table 1. 
CADDY-Format  
29. Several EC member States, the European Food  Safety Authority (EFSA) and the Commission 
request that dossiers be submitted in electronic form .  Such dossiers will only be accepted if they are 
compiled in accordance with the Fo rmat Specification for CADDY Document Interchange Format for 
Pesticides Registration Applications.13  
30. The RMS will check the format of electronic subm issions to ensure that they comply with the 
CADDY format.  Submissions in electronic form will inter alia  reduce the number of paper copies to 
be submitted.  Further information on CADD Y is available from the CADDY website at: 
 http://caddy.ecpa.be    
31. Dossiers for new and existing active substanc es should be submitted to the European 
Commission and to EFSA in the form of a signed c overing letter plus an electronic version of the 
remainder of the dossier. 
Number of dossiers to be submitted  
32. Information on the number of copies of do ssiers relating to existing and new active 
substances is available on the DG SANCO home page.  
 For new active substances: 
http://europa.eu.int/comm/food/plan t/protection/evaluation/nas_2004.pdf  
 For existing active substances:  
http://europa.eu.int/comm/food/plant/protection/evaluation/eas_2004.pdf   
                                                      
11 http://www1.oecd.org/ehs/pesticid.htm   
12 Advise on how a dossier should be compiled and structured is available in the OCDE guidance 
document (see address in footnote 3). 
13 CADDY is an electronic format for the exchange , archiving and evaluation of complex dossiers, 
developed jointly by industry and regula tory authorities. It was developed fo r the interchange of plant protection 
products dossiers, and is currently adopted by the European Commission and memb er States as the only 
electronic dossier interchange format. CADDY is a dynamic format; it is continuously improved to follow 
developments in the evaluation process. In order to harmonize the submissions and to avoid compatibility 
problems, it is recommended that the standard "table of contents" that is available on the CADDY website is used in all CADDY dossiers. G/SPS/GEN/557 
Page 10  
 
 Addresses and contact points
 
33. The addresses to which the dossier(s) should be  sent are available on the DG SANCO home 
page under "Contact Points": 
http://europa.eu.int/comm/food/plant/ protection/evaluation/index_en.htm   
Completeness check  
34. Electronic versions of the Completeness Check Forms are available on the DG SANCO home 
page. They should be used for new active subs tances as well as for dossiers of existing active 
substances.  Link to completeness check evaluation forms at: 
 http://europa.eu.int/comm/food/plant/pr otection/evaluation/completeness_en.htm    G/SPS/GEN/557 
 Page 11 
 
 
 TABLE I - ESSENTIAL COMPONENTS OF A DOSSIER  
 Information requested 
A Statement of the context in which the dossier is submitted 
B Task force information: Where in the context of Article 8 (2) of Directive 91/414/EEC and 
Commission Regulations made pursuant to that Ar ticle, there is an obligation on notifiers of 
particular existing active substances to take all reasonable steps to pr esent collectively the dossiers 
concerned and, where it is not possible to so presen t the dossiers - a claim that all reasonable steps 
were taken to present the dossiers collectively, and documentation to justify the claim made. 
C  Where requested, copies of existing or proposed label(s) and where relevant leaflets (see Article 16 
(2) of the Directive) for each of the preparations for which an Annex III dossier is submitted and in 
addition, labels and leaflets relevant to the uses on the basis of which import tolerances are 
supported or proposed.  Where relevant, a translation of the texts of labels and leaflets submitted.  
D1  Details of the intended uses (GAPs) (uses that are being supported by the applicant, for which data 
have been provided or for which data are to be provided by a specified date) and conditions of use 
(GAPs), on both food and feed crops and on non food and feed crops in the territory of the EU, 
supported in relation to the proposed inclusion of the active substance in Annex I.  
D2  Details of registered uses (GAPs) in EU Member States and an indication of whether, or not, 
actually used.  The listing provided should include those uses which are currently authorized but 
which are not being supported by the applicant.  The information provided with respect to actual 
use, should identify those authori zations that are not currently ava iled of (some uses or all uses), 
and further should describe those instances where the rate and manner of use in practice is more 
restrictive than is provided for in the existing authorization (e.g. authorized uses of a plant protection product for which the product is not currently commercialized; uses for which the 
maximum authorized application rate is seldom if ever availed of).  
D3  Details of supported uses (GAPs) in exporti ng countries (non-EU Member  States) Details of the 
intended uses (GAPs) that are being supported by the applicant on both food and feed crops which 
are imported in significant quantities into the territory of the EU from non-EU Member States and 
for which import tolerances are required.  
E1  Details of existing EU MRLs.  Where relevant, details of MRLs established by Member States and 
details of MRLs established by the CAC or proposed by the CCPR, should also be provided.  
E2  Where an import tolerance is required , a listing of the MRLs established for the active substance in 
countries that export the plants and plant produc ts concerned and in addition, where relevant, a 
listing of MRLs and import tolerances established in non-EU OECD countries, should be provided.  
F  Where relevant, in the case of existing active su bstances, a copy of each notification submitted to 
the Commission in the context of the programme of work undert aken for the examination of 
existing active substances pursuant to  Article 8 (2) of the Directive.  
G  Unless a dossier in accordance with Annex II is submitted for every formulant included in the 
preparation (ingredient other than active substanc e): A statement as to whether the substance is 
permitted in food, animal feeding stuffs, medici nes or cosmetics in acco rdance with Community 
legislation.  
H  Unless a dossier in accordance with Annex II is submitted for every formulant included in the 
preparation (ingredient other than active substance): A copy of the safety data sheet prepared in accordance with Direc tive 67/548/EEC.  
I  Unless a dossier in accordance with Annex II is submitted for every formulant included in the 
preparation (ingredient other than active substan ce): Where requested, other available toxicological 
and environmental data.  
J  Where relevant and desired, a statement to indicate the data and information involving industrial 
and commercial secrets fo r which confidentiality is requested,  in accordance with Article 14 of 
Directive 91/414/EEC.  To facilitate the secure handling of such information, it should be included 
in a separate file, where it is feasible to do so  (e.g. details of manufacturing processes, detailed 
specifications of active substance and preparations and individual medical records).  The file should 
be identified as containing industrial and commercial secrets.  
K  Individual test and study repo rts in accordance with the requirements of 91/414/EEC.  Separate 
dossiers should be provided for the active substance and formulated products.  Where dossiers are 
submitted that concern more than one formulation, a separate Annex III dossier must be provided G/SPS/GEN/557 
Page 12  
 
  Information requested 
for each plant protection product.  Dossiers for additional pl ant protection products should be 
identified and numbered as indicated below.  
- KIIA  Individual test and study reports for the active substance 
- KIIIA1 Individual test and study reports for the 1st formulated product 
- KIIIA214  Individual test and study reports for the 2nd formulated product 
Note:  Dossiers containing from supervised residue trials data (Annex point IIA 6.3) for more than 
one crop, it is recommended that the data are organized as follows: 
- IIA 6.3.1 Crop 1 (e.g. wheat) 
- IIA 6.3.2 Crop 2(e.g. oilseed rape) 
- IIA 6.3.3 Crop 3 
- IIA 6.3.4 Crop 4, etc.  
L- 
N A summary, evaluation and assessment of the dossier of data submitted by the applicant, prepared 
in accordance with the tiered structure outlined below: Wher e dossiers are submitted that concern 
more than one formulation, a separate Annex III dossier must be provided for each plant protection product.  Dossiers for additional plant protecti on products should be identified and numbered as 
indicated below.  
L Reports (Tier 1 Summaries) as to the quality of the individual tests and studies submitted and a list 
of study reports and documents submitted.  
- LIIA Tier 1 Summaries for the active substance 
- LIIIA1 Tier 1 Summaries for the 1st formulated product 
- LIIIA2*  Tier 1 Summaries for the 2nd formulated product 
Reference lists for the active substance, 1st formulated product and from 2nd formulated product* 
(sorted according annex points and authors)  
M Tier 2 summaries.  Comprehens ive summaries and assessments of individual tests and studies’ and 
groups of tests and studies, as appropriate, in the light of relevant evaluative and decision making 
criteria. 
- MIIA - Tier 2 Summaries for the active substance 
- MIIIA1 - Tier 2 Summaries for the 1st formulated product 
- MIIIA2* - Tier 2 Summaries for the 2nd formulated product  
N Tier 3 Summary.  An overall summary and assessment of the application in the light of relevant 
evaluative and decision making criteria, the conclusi on reached by the applicant on the basis of the 
data and information submitted.  This summary should include a complete list of regulatory end points and a key to the metabolites and breakdown products identified in animal metabolism 
studies, crop metabolism studies and appropriate studies conducted with soil, water, sediment etc.  
O A completed set of the forms for checking the completeness of the dossier. 
1. for Doc. A – J 
2. for Doc. L – N (for active and formulated products together, possibility to include more 
than one FL is already included) 
3. for Doc. KIIA (for active substance 
4. for Doc. KIIIA1 (for 1st formulated product)  
for Doc. KIIIA2* (for 2nd formulated product) 
 
 
                                                      
14 Where a data package contains more than one Annex III dossier.  
  G/SPS/GEN/557
 Page 13TEMPLATE TO DESCRIBE GOOD AGRICULTURAL PRACTI CE IN SUPPORT OF AN APPLICATION FOR AN IMPORT TOLERANCE IN THE EUROPEAN COMMUNITY  
Crop and/ 
or situation  
 
 
(a) Country  Product 
name  F 
G 
or 
I 
(b) Pests or 
Group of pests 
controlled  
 
(c)  
Formulation   
Application   
Application rate per treatment  PHI 
(days) 
 
 
(l) Remarks:  
 
 
 
(m) 
     Type 
 
 
(d-f) Conc. 
of as 
 
(i) method 
kind 
 
(f-h) Growth 
Stage & 
season 
(j) Number 
Min   max 
 
(k) interval 
between 
applications 
(min) kg as/hL 
 
min   max water L/ha 
 
min   max kg as/ha 
 
min   max   
 
  
 
  
 
  
 
   
 
 
                
Remarks: (a) For crops, the EU and Codex classifications (both) should be  used; where  (i) g/kg or g/l 
  relevant, the use situa tion should be described ( e.g. fumigation of a structure)  (j) Growth stage at last treatment (BBCH Monograph, Grow th Stages of Plants, 1997,  
 (b) Outdoor or field use (F), glasshous e application (G) or indoor application ( I)   Blackwell, ISBN 3-8263-3152-4), including  where relevant, information on season at time of 
 (c) e.g. biting and sucking insects, soilborne in sects, foliar fungi, weeds  application 
 (d) e.g. wettable powder (WP), emulsifiable  concentrate (EC), granule (GR) (k) The minimu m and maximum number of applications possible under practical conditions of 
 (e) GCPF Codes - GIFAP Technical Monogra ph No 2, 1989   use must be provided 
 (f) All abbreviations used must be explai ned (l) PHI - minimum pre-harvest interval 
 (g) Method,  e.g. high volume spraying, low volume spraying, spreading, dusting, (m) Remarks may include: Extent  of use/economic importance/rest rictions 
  drench etc. 
 (h) Kind, e.g. overall, broadcast, aerial spraying,  row, individual plant, between  
  the plants - type of equipment used must be indicated   
 G/SPS/GEN/557 
Page 14 Template to report results of supervised resi due trials in support of an application fo r an import tolerance in the European Co mmunity 
Active substance (common name)  :   Commercial Product (name)  : 
Crop/crop group    :   Producer of commercial product : 
Responsible body for reporting (name, address) :   Indoor/Glasshouse/Outdoor  : 
Country     :   Other active substance in the   Content of active substance (g/kg or g/L)  :   formulation (common name and content): 
Formulation ( e.g. W P )    :    R e s i d u e s  c a l c u l a t e d  a s   :  
 
1 2 3 4 5 6 7 8 9 10 11 
Report No. 
Location 
(region) 
 Commodity/ 
Variety 
   Date of 
1. Sowing or 
    Planting 2. Flowering 3. Harvest Method of 
 treatment 
  
  
 Application rate 
 per treatment Dates of 
treatment(s) 
or no of 
treatment(s) 
and last date Growth 
stage at 
  last 
treatment 
or date Portion 
analyzed 
   Residues 
 
(mg/kg) 
 PHI 
(days) 
   Remarks: 
 
   
 (a) (b) (c) kg as/hL Water (L/ha) kg as/ha (d) (e) (a)  (f) (g) 
 
 
 
 
  
 
   
 
  
 
  
 
  
 
  
 
             
 
(a) According to EEC and Codex classificati ons (both) should be used (e)  BBCH Monograph, Growth Stages of Plants,  1997, Black well, ISBN 3-8263-3152-4), 
(b) Only if relevant      (f)   Minimum number of days af ter last application (Label pre-harvest interval, PHI, underline) 
(c) High or low volume spaying, spreading, dusting etc.,  overall,  (g)  Remarks may include: Climatic conditions; Reference to analytical method;  Information concerning 
       broadcast, type of equipment used must be indicated         the metabolites included, the method of storage, storage sta bility, analysis date 
(d) Year  must be indicated   
        
      Note: All entries to be filled as appropriate G/SPS/GEN/557 
 Page 15 
 
 
 SUMMARY DATA SHEET TO BE INCLUDED WITH AN APPLICATION FOR AN IMPORT TOLERANCE  
 
Active substance:     
Residue definition: Commodity for which MRL to be set:  
The requested import tolerance is: 
The (proposed) ADI is: The (proposed) ARfD is: 
 
Existing data 
 
There is no/an EC MRL     (value =       mg/kg; fixed in Directive      ) 
 
The ADI for this substance of       mg/kg bw/day was fixed in 19      by      .  The ARfD for this substance of       mg/kg bw was fixed in 19      by      .  
Implication of granting import tolerance 
 
Granting this import tolerance:       % ADI (adult) based on       and 
     % ADI (infant/child) based on      . 
 and:          % ARfD (adult) based on      and 
     % ARfD (infant/child) based on      . 
 
Supporting data provided 
 
1. Residue definition and analytical methods      
2. Description of GAP         
3. Supervised trials data         
4. Residue behaviour data         
5. Proposed import tolerance/MRL        
6. Toxicological summaries/full data package      
7. Consumer intake assessments (adult and children)      
8. Other information         
 
Background to the request 
 
 
 
Additional information 
 
 
__________