G/TBT/N/EU/578  
 
13 June 2018  
(18-3675) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: European Commission  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  European 
Commission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/   
 
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): 
Propiconazole (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the active 
substance propiconazole, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection pr oducts 
on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (5 
pages, in English)    
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance propiconazole is not  renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
propiconazole will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substance for use as a pesticide ac tive substance in the EU under 
Regulation (EC) No 1107/2009. The substance was formerly approved under 
Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, 
following non -approval, separate action may be taken on MRLs. Any subsequent action on 
MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent p roblems where 
applicable:  Protection of human health or safety; protection of animal or plant life or 
health; protection of the environment.  
In order for an active substance to be approved in accordance with Regulation 
(EC) No 1107/2009 (concerning the pla cing of plant protection products on the market), it 
must be demonstrated that the substance is not harmful to human health, animal health or G/TBT/N/EU/578  
 
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  the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in 
Annex  II) which must be met to enable approval.  
During the evaluation and peer -review of propiconazole, a number of concerns and areas 
that could not be finalised were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
Propiconazole i s classified as toxic for reproduction category 1B in accordance with 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council.  
Based on the data available in the dossier the Authority concluded that Maximum Residue 
Levels (‘MRLs’) in ac cordance with Regulation (EC) No 396/2005 of the European 
Parliament and of the Council could not be confirmed for plant and animal products since 
data on the magnitude and toxicity of metabolites that are included in the residue 
definition for risk assess ment was not available. The current MRLs for the proposed uses of 
propiconazole are above the default value in the meaning of Article 18(1)(b) of Regulation 
(EC) No 396/2005. For those reasons, it cannot be considered that exposure of humans to 
the active substance is negligible.  Therefore, the requirements set out in Point 3.6.4 of 
Annex  II to Regulation (EC) No  1107/2009 are not fulfilled.  
A critical concern was identified by the Authority in relation to the contamination of 
groundwater by metabolites o f propiconazole. In particular, metabolite NOA436613 is 
predicted to occur above the paramteric value of 0.1 μg/L in all pertinent scenarios for all 
proposed uses of propiconazole, even when the substance is used biennally. Two other 
metabolites are predic ted to occur in groundwater above 0.1 μg/L in the majority of 
pertinent scenarios.  
Additionally, the Authority concluded that propiconazole caused toxic effects on endocrine 
organs. However, the scientific assessment to determine the endocrine disrupting potential 
of propiconazole could not be finalised by the Authority based on the information available 
in the dossier.  
Furthermore, the assessment of several aspects necessary to conclude on the risk to 
consumers through dietary intake could not be finalis ed based on the information available in 
the dossier.  
These concerns mean that propiconazole does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdraw n; EU Member States must withdraw 
existing plant protection products containing propiconazole at the latest by 6 months from 
the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 
is allowed for and shall expire at the latest 15 months from the entry into force.  
8. Relevant documents:   
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 and 
repealing Council Directives 79/117/EEC and 91/414/EEC: http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
Commission Implementing Regulation (EU) No  540/2011 of 25  May 2011 implementing 
Regulation (EC) No  1107/2009 of the European Parliament and of the Council as regards 
the list of approved active substances ( OJ L 153, 11.6.2011, p. 1 –186) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
Regulation (EC) No 396/2005 of the European Parliament and of the Coun cil of 
23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p.  1) 
https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1528730328713&uri=CELEX:32005R0396  
 EFSA (European Food Safety Authority), Arena M, Auteri D, Barmaz S, Bellisai G, Brancato 
A, Brocca D, Bura L, Byers H, Chiusolo A, Court M arques D, Crivellente F, De Lentdecker C, 
De Maglie M, Egsmose M, Erdos Z, Fait G, Ferreira L, Goumenou M, Greco L, Ippolito A, G/TBT/N/EU/578  
 
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  Istace F, Jarrah S, Kardassi D, Leuschner R, Lythgo C, Magrans JO, Medina P, Miron I, 
Molnar T, Nougadere A, Padovani L, Parra M orte JM, Pedersen R, Reich H, Sacchi A, Santos 
M, Serafimova R, Sharp R, Stanek A, Streissl F, Sturma J, Szentes C, Tarazona J, Terron A, 
Theobald A, Vagenende B, Verani A and Villamar -Bouza L, 2017.  
Conclusion on the peer review of the pesticide risk asse ssment of the active substance 
propiconazole. EFSA Journal 2017;15(7):4887, 28 pp.  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4887   
9. Proposed date of adoption:  4th quarter 2018  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  
10. Final date for comments: 60 days from notification  
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
 
The tex t is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
 
 
https://members.wto.org/crnattachments/2018/TBT/EEC/18_3018_00_e.pdf