G/TBT/W/754  
 
27 May 2021  
(21-4420) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
 
COMMENTS OF THE DOMINICAN REPUBLIC  TO THE  
EU'S NOTIFICATION G/TBT/N/EU/791  
The following c ommunication, dated 26 May 2021, is being circulated at the request of the delegation 
of the Dominican Republic . 
 
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The issues raised here address serious concerns about the impact that this Regulation will have on 
organic operators in the Dominican Republic who export to the EU.  
1  ARTICLE 1 OF THE REGULATION: ACTIVE SUBSTANCES IN PLANT PROTECTION 
PRODUCTS  
1.1.  This states that:  
"For the purposes of point (a) of Article 24(1) of Regulation (EU) 2018/848, only the 
active substances listed in Annex  I to this Regulation may be contained in plant 
protection products used in organic production as set out in that Annex, provided that 
those plant protection products:   
a) have been authorised pursuant to Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council;  
b) are used in accordance with the conditions for use as specified in the 
authorisations of the products containing them, granted by the Member 
State s; and  
c) are used in compliance with the conditions set out in the Annex to Commission 
Implementing Regulation (EU) No 540/2011".  
1.2.  This means, in effect, that only plant protection products (and their uses) that are approved in 
the EU for conventional agricu lture can be used in organic production in third countries. These 
provisions are particularly restrictive and problematic for tropical and sub -tropical countries where 
the crops, pests, pest pressure, socio -economic and agroecological conditions are very d ifferent from 
those in Europe. They risk leaving organic producers (notably those in low -income countries) with 
inadequate or inappropriate solutions to manage pests on crops that are grown for export to the EU, 
and could put them at a disadvantage compare d to EU organic growers.  
QUESTION 1:  
1.3.  Considering these serious implications, the European Commission is asked to clarify the scope 
of application of Article 1 of this draft implementing regulation, and in particular the application of 
Regulation (EC) No.  1107/2009 in third countries. We refer specifically to Article 1 (1) of Regulation 
(EC) No. 1107/2009, which states: "This Regulation lays down rules for the authorisation of plant 
protection products in commercial form and for their placing on the market , use and control within 
the Community ." indicating that provisions contained within this regulation do not have extra -
territorial application.  G/TBT/W/754  
 
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  2   ARTICLE 10 OF THE REGULATION: PROCEDURE TO GRANT SPECIFIC AUTHORISATIONS 
FOR THE USE OF PRODUCTS AND SUBSTANCES  IN CERTAIN AREAS OF THIRD COUNTRIES  
2.1.  The provisions under Article 10 refer to Article 45 (2) of Regulation (EU) 2018/848 on the 
Import of Organic and In -Conversion Products:  
"The Commission may, in accordance with the procedure set out in Article 24(9), grant 
specific authorisations for the use of products and substances in third countries and in 
the outermost regions of the Union, taking into account differences in the ecological 
balance in plant or animal production, specific climatic conditions, tradit ions and local 
conditions in those areas. Such specific authorisations may be granted for a renewable 
period of two years and shall be subject to the principles laid down in Chapter II and 
to the criteria set out in Article 24(3) and (6).  
2.2.  Article 10 Point 1 states that:  
"Where a control authority or control body recognised under Article 46(1) of Regulation 
(EU) 2018/848 considers that a product or substance should be granted a specific 
authorisation for use in a certain area outside the Union due to the sp ecific conditions 
set out in Article 45(2) of that Regulation, it may request the Commission to carry out 
an assessment. For that purpose, it shall notify the Commission of a dossier describing 
the product or substance concerned, giving the reasons for suc h specific authorisation, 
and explaining why the products and substances authorised under this Regulation are 
not adequate to be used due to the specific conditions in the relevant area. It shall 
ensure that the dossier is fit to be made publicly available  subject to Union and national 
legislation of the Member States on data protection.  
2.3.  The option to apply for specific authorisations to use products and substances in certain areas 
of third countries that are adapted to the local context, is very positive. However, the information 
currently provided to guide those who will need to prepare the dossiers, and those who will evaluate 
them, is not sufficient. It leaves too much latitude for subjective interpretation and could lead to 
inconsistent and arbitrary decision -making.  
QUESTION 2:  
2.4.  Does Article 10 specific authorisations for third countries, or is additional secondary legislation 
still pending? If the former, then the information provided under Article 10 (1) needs to be 
sufficiently detailed as to enable third countries to confident ly and successfully compile the required 
dossiers. this draft implementing regulation set out the full procedure for requesting  
QUESTION 3:   
2.5.  Why is the authorisation granted for a period of just 2 years? This is very short, considering 
the investments tha t will have to be made in order to compile the relevant dossiers.  
2.6.  Article 10 also contains the following provisions:  
Point 3 . The Commission shall analyse the dossier referred to in paragraph 1. The 
Commission shall authorise the product or substance in the light of the specific 
conditions referred to in the dossier only if its analysis concludes, as a whole that:   
a) such specific authorisation is justified in the area concerned;  
b) the product or substance described in the dossier complies with the principle s 
laid down in Chapter II, the criteria set out in Article 24(3) and the condition 
set out in Article 24(5) of Regulation (EU) 2018/848; and  
c) the use of the product or substance is in accordance with the relevant 
provisions of Union law, in particular for active substances contained in plant 
protection products with Regulation (EC) No 396/2005 of the European 
Parliament and of the Council. The authorised produci or substance shall be 
included in Annex VI to this Regulation.  G/TBT/W/754  
 
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  QUESTION 4:  
2.7.  The European Commis sion is asked to clarify Point 3 (c). In particular, it needs to clarify 
whether the relevant provisions of Union law for the inclusion of additional products and substances 
under Annex VI to this draft refer to Regulation (EU) 396/2005 (on pesticide maxim um residue 
levels), so that the requirement for authorisation pursuant to Regulation (EC) No 1107/2009 does 
not apply.  
3  RESTRICTIONS AFFECTING THE PRODUCTION OF ORGANIC PINEAPPLE  
3.1.  Flower induction in pineapple is essential for production on a commercial scal e. In many ACP 
countries, small -scale operators use calcium carbide for flower induction. However, it cannot be used 
on organic pineapple for export to the EU market as calcium carbide is not listed as a growth 
regulator under Regulation (EC) No 1107/2009.  In larger -scale ACP operations, and elsewhere in 
the world, flower induction in organic pineapple is achieved using ethylene. According to Annex 1 
(4) of this draft regulation, active substances "may be used as plant protection product is in organic 
produ ction only when they are used in accordance with the uses, conditions and restrictions pursuant 
to Regulation (EC) No 1107/2009 and taking into account the additional restrictions" . In the case of 
ethylene, its use is further restricted to: "only on banana s and potatoes; it may also be used on 
citrus as part of a strategy for the prevention of fruit fly."   
3.2.  According to these rules, there is no substance that can be used for flower induction on organic 
pineapple, meaning that production for the EU market wil l no longer be commercially viable.  
QUESTION 5:  
3.3.  Given that pineapple is not exempted under the additional restrictions, does this preclude the 
use of ethylene for flower induction under Article 10 of this regulation?  
 
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