(1)

Since 1 September 2019 all light commercial vehicles are subject to a new regulatory test procedure for measuring CO2 emissions and fuel consumption, the Worldwide Harmonised Light Vehicles Test Procedure (WLTP) set out in Commission Regulation (EU) 2017/1151 (2), replacing the New European Driving Cycle (NEDC) set out in Commission Regulation (EC) No 692/2008 (3). A new methodology for determining the CO2 emissions and fuel consumption from category N1 vehicles which are type-approved in a multi-stage process has therefore been established and is set out in Annexes I and II to Regulation (EU) No 510/2011 of the European Parliament and of the Council (4).

(2)

In view of the repeal of Regulation (EU) No 510/2011 from 1 January 2020, it is necessary to ensure that the same methodology is set out in Regulation (EU) 2019/631.

(3)

According to point 2 of Part B of Annex III to Regulation (EU) 2019/631, the specific emissions of CO2 of a multi-stage vehicle are to be allocated to the manufacturer of the base vehicle. In order to allow the base vehicle manufacturer to plan effectively and with sufficient certainty its compliance with its specific emissions targets, a methodology should be set up that ensures that the CO2 emissions and mass of the completed vehicles that will be allocated to that manufacturer are known at the moment of the production and sale of the base vehicle whether complete or incomplete, and not only at the moment when the final stage manufacturer places the completed vehicle on the market.

(4)

A specific methodology for determining the CO2 emissions of an incomplete base vehicle is therefore provided according to which the interpolation method provided for in Regulation (EU) 2017/1151 should be used. The CO2 emissions and the mass values thus determined should be as representative as possible of the specific CO2 emissions and mass in running order that will be determined for the completed vehicle. In order to ensure consistency, the calculation of the base vehicle manufacturer’s specific emission target should therefore take into account the mass values determined pursuant to this methodology.

(5)

The base vehicle manufacturer should report the input values used for the interpolation method as well as the resulting CO2 emissions and mass of incomplete base vehicles to the Commission. At the same time, Member States should continue to report to the Commission the specific emissions of CO2 and mass in running order of the completed vehicles.

(6)

On the basis of those reported data, the Commission should continuously assess the representativeness of the monitoring CO2 emissions of the base vehicle and inform the manufacturers of any divergences found. In the case of a significant and continued divergence between the average of the monitoring CO2 values of the base vehicles and the average of the specific emissions of CO2 of the completed vehicles, the values for the completed vehicles should be used for the purposes of determining whether manufacturers comply with their specific emissions targets.

(7)

In order to take into account that Regulation (EU) No 510/2011 is repealed with effect from 1 January 2020, it is appropriate to ensure that this Regulation enters into force as close as possible to that date.

(8)

Annexes I and III to Regulation (EU) 2019/631 should therefore be amended accordingly,

(1)

Commission Directive 2004/99/EC (2) included thiacloprid as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance thiacloprid as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2020.

(4)

An application for the renewal of the approval of thiacloprid was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 31 October 2017.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 22 January 2019 the Authority communicated to the Commission its conclusion (6) on whether thiacloprid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Authority identified a critical concern in relation to the contamination of groundwater by metabolites of thiacloprid. In particular, metabolites M30, M34 and M46 are predicted to occur above the parametric drinking water limit of 0,1 μg/L in all pertinent scenarios for all proposed uses of thiacloprid. These metabolites are considered a priori of concern since it cannot be excluded that they share the same carcinogenic properties of the parent active substance thiacloprid, which is classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) as carcinogenic category 2. Therefore, it cannot currently be established that the presence of metabolites of thiacloprid in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health. The Authority also concluded that the assessment of the risks to aquatic organisms, bees and non-target terrestrial plants could not be finalised based on the information provided in the dossier.

(10)

Additionally, thiacloprid is classified in accordance with Regulation (EC) No 1272/2008 also as toxic for reproduction category 1B. The applicant provided information attempting to demonstrate that exposure of humans to thiacloprid can be considered negligible. The Authority presented the outcome of the assessment of that information in its conclusion. Nevertheless, given the concerns identified in recital 9, a conclusion on whether exposure to humans is negligible for the purposes of point 3.6.4 of Annex II to Regulation (EC) No 1107/2009, is not necessary for the decision on whether the approval of thiacloprid can be renewed.

(11)

Furthermore, given the concerns identified, it is also not possible to provide for an approval in accordance with Article 4(7) to Regulation (EC) No 1107/2009.

(12)

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

(13)

However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

(14)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance thiacloprid in accordance with Article 20(1)(b) of that Regulation.

(15)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(16)

Member States should be given sufficient time to withdraw authorisations for plant protection products containing thiacloprid.

(17)

For plant protection products containing thiacloprid, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months.

(18)

Commission Implementing Regulation (EU) 2019/168 (8) extended the approval period of thiacloprid to 30 April 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.

(19)

This Regulation does not prevent the submission of a further application for the approval of thiacloprid pursuant to Article 7 of Regulation (EC) No 1107/2009.

(20)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising placing on the Union market of a novel food and on the updating of the Union list.

(4)

Commission Decision 2009/827/EC (3) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market in the Union of chia seeds (Salvia hispanica) as a novel food to be used in bread products.

(5)

Commission Implementing Decision 2013/50/EU (4) authorised, in accordance with Regulation (EC) No 258/97, an extension of use of chia seeds (Salvia hispanica) as a novel food to be used in additional food categories as follows: baked products; breakfast cereals; fruit, nut and seed mixes, and pre-packed chia seeds as such.

(6)

On 18 September 2015, an authorisation letter was issued by the competent authority of Ireland (5), in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (6), for an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food categories, namely, in fruit juice and fruit/vegetable blend beverages.

(7)

On 17 October 2017, an authorisation letter was issued by the competent authority of Austria (7), in accordance with Regulation (EC) No 258/97, for an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food category, namely, fruit spreads.

(8)

On 02 November 2017, an authorisation letter was issued by the competent authority of Spain (8), in accordance with Regulation (EC) No 258/97, for an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food categories, namely, sterilised ready meals based on cereal grains, pseudocereal grains and/or pulses.

(9)

Commission Implementing Decision (EU) 2017/2354 (9) authorised, in accordance with Regulation (EC) No 258/97, an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food category, namely, in yoghurt.

(10)

On 13 April 2017, the company Zentis GmbH & Co. KG submitted a request in accordance with Article 4 of Regulation (EC) No 258/97 to the competent authority of Germany to change the conditions of use of the novel food chia seeds (Salvia hispanica). The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories, namely, fruit desserts, mixed fruits with coconut milk for a twin pot, fruit-preparations to underlay dairy products and fruit-preparations to be mixed with dairy products, and to increase maximum use level of chia seeds (Salvia hispanica) in an already authorised food category, namely fruit spreads.

(11)

On 12 September 2017, the company Sanchis Mira S.A. submitted a request in accordance with Article 4 of Regulation (EC) No 258/97 to the competent authority of Spain for an extension of use of the novel food chia seeds (Salvia hispanica) in chocolate. On 25 September 2017, the competent authority of Spain issued its initial assessment report. In that report, it came to the conclusion that the extension of use and proposed maximum use level of chia seeds (Salvia hispanica) meet the criteria for novel foods set out in Article 3(1) of Regulation (EC) No 258/97.

(12)

On 17 October 2017, the Commission forwarded the initial assessment report to the other Member States. One Member State raised objections, questioning the overall safety of the novel food in light of the 2009 European Food Safety Authority (‘the Authority’) NDA Panel assessment (10) as a result of the increasing dietary intake of chia seeds (Salvia hispanica) from the growing number of authorised uses. The objecting Member State underlined that while individual uses, including the proposed use in chocolate at 3 %, may be safe, there is a need to assess the overall dietary intake from all authorised uses since 2009 including the current request for the extension of use and if necessary, revise the 2009 NDA Panel safety assessment.

(13)

Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

(14)

While the requests for an extension of use of chia seeds (Salvia hispanica) were submitted to the Member States in accordance with Article 4 of Regulation (EC) No 258/97, the applications also meet the requirements laid down in Regulation (EU) 2015/2283.

(15)

On 2 February 2018, the company Parry’s Pots Limited (PPL) submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to increase maximum use level of chia seeds (Salvia hispanica) in an already authorised food category, namely fruit spreads.

(16)

On 12 June 2018, the company Naturkost Übelhör GmbH & Co. KG submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories, namely, chocolate and chocolate products.

(17)

On 15 June 2018, the company Majami Sp.zo.o.Sp.k. submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food category, namely, confectionery.

(18)

On 16 July 2018, the company The Chia Co submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories as follows: confectionery, excluding chewing gums; dairy products and analogues; edible ices; fruit and vegetable products; cereal and cereal products; bakery wares; herbs, spices, seasonings, soups and broths, sauces, salads and savoury based sandwich spreads and protein products; total diet replacement foods for weight control; foods bearing statements on the absence or reduced presence of gluten; non-alcoholic beverages; ready-to-eat savouries and snacks; and desserts.

(19)

On 3 August 2018, the company Materne SAS submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories, namely, compotes from fruit and/or vegetables and/or with cereals.

(20)

On 9 January 2019, the company RFH Produktion AB submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food category, namely, puddings.

(21)

In accordance with Article 10(3) of Regulation (EU) 2015/2283 and in the light of the growing number of requests for the authorisation of a number of extended uses of chia seeds (Salvia hispanica), the new authorised uses in recent years, and the resulting potential increase in the dietary intake of chia seeds (Salvia hispanica), the Commission consulted the Authority on 16 July 2018, asking it to carry out an assessment on the overall dietary exposure for all the potential extensions of use of chia seeds (Salvia hispanica) as a novel food.

(22)

On 14 March 2019, the Authority adopted the scientific opinion ‘Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(23)

In that opinion the Authority concluded, in reply to the Commission’s request for a general assessment of the safety without restrictions or precautions regarding the use levels, that the use of chia seeds (Salvia hispanica) in foods which do not require heat treatment at or above 120 °C in their manufacture, processing or preparation, including chocolate, fruit spreads, fruit desserts, mixed fruit with coconut milk in twin pot, fruit-preparations to underlay dairy products, fruit-preparations to be mixed with dairy products, confectionery (excluding chewing gums), dairy products and analogues, edible ices, fruit and vegetables products, non-alcoholic beverages and compotes from fruit and/or vegetables and/or with cereals, are safe without any specific restrictions and precautions regarding their use levels. Therefore, that scientific opinion gives sufficient grounds to establish that the above-mentioned uses of chia seeds (Salvia hispanica) comply with the requirements of Article 12(1) of Regulation (EU) 2015/2283. It is therefore appropriate that the conditions of use of chia seeds (Salvia hispanica) as listed in the Union list of authorised novel foods are amended by including all of the above food categories and to remove the setting of maximum levels and the corresponding specific labelling requirement relating to the maximum daily intake. In addition, although the use of chia seeds (Salvia hispanica) in puddings was not explicitly included in the assessment of the Authority, the opinion gives sufficient grounds to also authorise the extension of use of chia seeds (Salvia hispanica) to puddings that do not require heat treatment at or above 120 °C in their manufacture, processing or preparation. Puddings are to be understood as a subcategory of products commonly known as desserts, which are usually flavoured and sweet in taste.

(24)

In the same opinion, the Authority considered one study, retrieved by the Authority itself from the publicly available scientific literature, and which was not part of the evidence submitted by applicants in support of the proposed extensions of use of chia seeds (Salvia hispanica), which pointed to the possible formation of acrylamide when chia seeds (Salvia hispanica) are used in foods which require heat treatment at or above 120 °C in their manufacture, processing or preparation.

(25)

In that opinion, the Authority considered that additional information is needed from applicants and/or from the public domain, to address the potential for acrylamide formation when foods containing chia seeds (Salvia hispanica) undergo heat treatment at or above 120 °C. In accordance with Article 11(4) of Regulation (EU) 2015/2283 the Authority has requested additional information from the relevant applicant relating to potential formation of process contaminants which may be formed during processing and production of a food (at the level of the manufacturer) and/or when a food with added chia seeds (Salvia hispanica) is subjected to cooking (heat treatment at consumer level). The period set established for the provision of the additional information ends in March 2020. In the absence of such information in the submitted applications, the Authority deferred the evaluation of those extensions of use of chia seeds (Salvia hispanica) in foods which require heat treatment at or above 120 °C in their manufacture, processing or preparation (bakery wares, cereal and cereal products, herbs, spices, seasonings, soups and broths, sauces, salads and savoury based sandwich spreads and protein products, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (12), foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 (13), ready to eat savouries and snacks and desserts) to when the additional information becomes available. It follows, that the Commission, at this stage, does not dispose of the opinion of the Authority necessary pursuant to Article 12(1)(a) and (c) of Regulation (EU) 2015/2283 for the approval of the extension of uses involving the treatment of chia seeds (Salvia hispanica) at or above 120 °C. Therefore, a further decision about such uses will be taken after the publication of the relevant opinion of the Authority.

(26)

The opinion of the Authority also identified two case reports from the available scientific literature which linked the consumption of chia seeds (Salvia hispanica) to allergic reactions and concluded on the basis of this evidence that allergic reactions upon consumption of chia seeds (Salvia hispanica) may occur. Considering that, to date, only those two allergic cases have been reported, in light of the widespread consumption of chia seeds (Salvia hispanica) and their presence on the Union and global market for many years, the Commission considers that no specific labelling requirements concerning potential allergic reactions upon consumption of chia seeds (Salvia hispanica) should be included in the Union list of authorised novel foods, until further scientific evidence on the allergenic potential of chia seeds (Salvia hispanica) is obtained and assessed by the Authority.

(27)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Regulation (EU) 2018/848 of the European Parliament and of the Council (2), establishes that the scheme of control bodies and control authorities recognised by the Commission on the basis of Article 33(3) of Regulation (EC) No 834/2007 to carry out controls and to issue certificates in third countries for the purpose of importing products with equivalent guarantees will be replaced by a scheme of control bodies and control authorities recognised by the Commission for the purpose of importing compliant products. The new import scheme provided in Regulation (EU) 2018/848 will apply from 1 January 2021. In order to ensure that the necessary administrative capacities are available to provide for a timely recognition of control bodies and control authorities under the new scheme, it is appropriate to introduce a final date for receiving new requests for the recognition of control bodies and control authorities for the purpose of equivalence pursuant to Article 10 of Commission Regulation (EC) No 1235/2008 (3) and the inclusion of such control bodies and control authorities in the list set out in Annex IV to that Regulation. Requests received after that date should no longer be admissible.

(2)

Products imported from a third country can be placed on the Union market as organic if they are covered by a certificate of inspection issued by the competent authorities, control authorities or control bodies of a recognised third country or by a recognised control authority or control body. In order to ensure compliance with the second subparagraph of Article 33(1) of Regulation (EC) No 834/2007, which requires the certificate of inspection to accompany the goods to the premises of the first consignee, and with a view to ensuring the traceability of the imported products during distribution, including transport form third countries, it should be clarified that the certificate of inspection is to be issued by the relevant control authority or control body at the moment the consignment leaves the third country of export or origin.

(3)

Annex III to Regulation (EC) No 1235/2008 sets out the list of third countries whose systems of production and control measures for organic production of agricultural products are recognised as equivalent to those laid down in Regulation (EC) No 834/2007.

(4)

Japan has informed the Commission that its competent authority has added the control body ‘Akatonbo’ to the list of control bodies recognised by Japan.

(5)

The Republic of Korea has informed the Commission that its competent authority has changed the name of ‘Neo environmentally-friendly’ and the name and internet address of ‘Association for Agricultural Products Quality Evaluation’. The Republic of Korea has also informed the Commission that the recognition of the control body ‘Korea Agricultural Product and Food Certification’ has been withdrawn.

(6)

The United States has informed the Commission that its competent authority has added seven control bodies to the list of control bodies recognised by the United States for the purpose of the equivalence under Article 33(2) of Regulation (EC) No 834/2007, namely ‘CERES’, ‘EcoLOGICA S.A’, ‘Food Safety S.A.’, ‘IBD Certifications’, ‘Istituto per la Certificazione Etica e Ambientale (ICEA)’, ‘OnMark’ and ‘Perry Johnson Registrar Food Safety, Inc.’. The United States has also requested the removal of ‘Global Culture’, ‘Global Organic Certification Services’, ‘Stellar Certification Services, Inc.’, ‘Institute for Marketecology (IMO)’, and ‘Basin and Range Organics (BARO)’ from the list in Annex III to Regulation (EC) No 1235/2008.

(7)

Annex IV to Regulation (EC) No 1235/2008 sets out the list of control authorities and control bodies competent to carry out controls and issue certificates in third countries for the purpose of equivalence.

(8)

The Commission has received and examined a request from ‘A CERT European Organization for Certification S.A’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition for product categories A and D to Armenia, Ghana, Kosovo (4), Kuwait, Oman, Peru, Sudan, the United Arab Emirates, Uzbekistan and Vietnam.

(9)

The Commission has received and examined a request from ‘Argencert SA’ to be removed from the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to remove that control body from that list.

(10)

The Commission has received and examined a request from ‘Balkan Biocert Skopje’ to amend its legal status. Based on the information received, the Commission has concluded that it is justified to replace the name of that control body by ‘Balkan Biocert Macedonia DOOEL Skopje’.

(11)

The Commission has received a request from ‘Başak Ekolojik Ürünler Kontrol ve Sertifikasyon Hizmetleri Tic. Ltd’ to amend its address.

(12)

The Commission has received and examined a request from ‘Bioagricert S.r.l.’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition for product categories A, B, D and E to Paraguay and Uruguay, for product categories A, B and D to Bolivia and Sri Lanka, for product categories A, D and E to Cameroon, and for product categories A and D to Fiji.

(13)

The Commission has received and examined a request from ‘Biocert International Pvt Ltd’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Afghanistan, Bangladesh, Bhutan, Myanmar/Burma, Egypt, Malaysia, Mauritius, Nepal, Oman, Pakistan, the Philippines, Tanzania, Thailand, the United Arab Emirates and Vietnam for product categories A and D, to Benin, Ethiopia, Mozambique, Nigeria, Qatar, Russia, Sudan, Togo, Uganda and Ukraine for product categories A, D and E, and to Georgia for product categories D and E, and to extend its recognition for Sri Lanka to product category E.

(14)

The Commission has received and examined a request from ‘Bio.inspecta AG’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Montenegro, North Macedonia and Serbia for product categories A, B, D, E and F, and to extend the scope of its recognition for Albania, Bosnia and Herzegovina, Georgia, Iran, Kazakhstan, Kosovo (5), Moldova, Russia, Tajikistan, Ukraine, Uzbekistan and Vietnam to product categories B, E and F, for Armenia, Lebanon and Tanzania to product categories B and E, for Algeria and Kyrgyzstan to product category B, for Turkey to product categories E and F, and for Azerbaijan to product category E.

(15)

The Commission has received and examined a request from ‘Bureau Veritas Certification France SAS’ to amend its internet address and its specifications. Based on the information received, the Commission has concluded that it is justified to withdraw its recognition for product category E in respect of Mauritius.

(16)

The Commission has received and examined a request from ‘CCPB Srl’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Burkina Faso, Cameroon, Comoros and Madagascar for product categories A, C and D, and to extend the scope of its recognition for Côte d’Ivoire to product categories C and D.

(17)

The Commission has received and examined a request from ‘CERES Certification of Environmental Standards GmbH’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to the United States for product category C, and to extend the scope of its recognition for the United Arab Emirates to product category A, for Chile to product category C, and for South Africa to product category F.

(18)

The Commission has received and examined a request from ‘DQS Polska sp. z o.o.’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise that control body for Bosnia and Herzegovina, China and Madagascar for product categories A, B and D.

(19)

The Commission has received and examined a request from ‘Ecocert SA’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition for the United Arab Emirates, Cuba, Kuwait and Malawi to product category B, for Serbia and Zimbabwe to product category E, and for Moldova to product category F.

(20)

The Commission has received and examined a request from ‘FairCert Certification Services Pvt Ltd’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise that control body for Bhutan and Nepal for product categories A, B, D and E, and for India for product categories B, D and E.

(21)

The Commission has received and examined a request from ‘IBD Certificações Ltda.’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Bolivia and Paraguay for product category A and D, and to Mongolia for product categories A and E.

(22)

The Commission has received and examined a request from ‘Kiwa BCS Öko-Garantie GmbH’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Seychelles for product categories A and D, and to the United States for product category C, and to extend the scope of its recognition for Armenia, Georgia, Tajikistan, Uzbekistan and Zambia to product category B, for Guatemala to product categories C and F, and for the Dominican Republic, Ecuador, Honduras, Paraguay, Peru, Serbia, and Turkey to product category F.

(23)

The Commission has received and examined a request from ‘Mayacert’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Panama and Sri Lanka for product categories A and D.

(24)

The Commission has received and examined a request from ‘OneCert International PVT Ltd’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Egypt, Jordan, Malaysia and Qatar for product categories A and D, and to extend the scope of its recognition for the United Arab Emirates to product category A, and for Ethiopia, India, Mozambique, Tanzania and Uganda to product category E.

(25)

The Commission has received and examined a request from ‘Organización International Agropecuaria’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Colombia for product categories A and D, and to extend the scope of its recognition for Chile and Uruguay to product category E, except for those products already covered by Annex III to Regulation (EC) No 1235/2008.

(26)

The Commission has received and examined a request from ‘Servicio de Certificación CAAE S.L.U’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to Colombia, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua and Panama for product categories A and D.

(27)

The Commission has received and examined a request from ‘Suolo e Salute srl’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition for Egypt to product category D.

(28)

The Commission has received and examined a request from ‘Tse-Xin Organic Certification Corporation’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition to the Republic of Korea for product category A, to Hong Kong and Singapore for product category D, and to Cambodia, Indonesia, Laos, Malaysia, Myanmar/Burma, the Philippines, Thailand and Vietnam for product categories A and D.

(29)

The Commission has received and examined a request from ‘Valsts SIA “Sertifikācijas un testēšanas centrs”’ to amend its legal status. Based on the information received, the Commission has concluded that it is justified to replace the name of that control body by ‘SIA “Sertifikācijas un testēšanas centrs”’. In addition, the Commission has received and examined a request from that control body to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the scope of its recognition for Belarus to product categories B, D, E and F, and for Uzbekistan to product categories D, E and F, and to extend the scope of its recognition to Kazakhstan, Moldova and Tajikistan for product categories A, B, D, E and F, and to Kyrgyzstan for product categories A, B, D and E.

(30)

On the basis of the dossier submitted by ‘Agricert — Certificação de Produtos Alimentares lda’, the scope of its recognition was extended to Guinea for product categories A and D by Commission Implementing Regulation (EU) 2019/39 (6). However, in that dossier that control body had wrongly requested an extension for Guinea instead of Guinea Bissau. Based on the information received, the Commission has concluded that it is justified to correct Annex IV to Regulation (EC) No 1235/2008 accordingly. In the interest of clarity and legal certainty, this correction should apply from the date of entry into force of Implementing Regulation (EU) 2019/39.

(31)

Regulation (EC) No 1235/2008 should therefore be amended and corrected accordingly.

(32)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on organic production,

(1)

in Article 11, paragraph 1 is replaced by the following:

(2)

in Article 13(2), the first subparagraph is replaced by the following:

‘The certificate of inspection shall be issued by the relevant control authority or control body before the consignment leaves the third country of export or origin. It shall be endorsed by the relevant Member State’s competent authority and completed by the first consignee on the basis of the model and the notes set out in Annex V and using the electronic Trade Control and Expert System (TRACES) established by Commission Decision 2003/24/EC (*1).

(*1)  Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an integrated computerised veterinary system (OJ L 8, 14.1.2003, p. 44).’;"

(3)

Annex III is amended in accordance with Annex I to this Regulation;

(4)

Annex IV is amended in accordance with Annex II to this Regulation.

(1)

Article 11(2) of the Monetary Agreement between the European Union and the Principality of Monaco (hereinafter ‘the Monetary Agreement’) requires the Principality of Monaco to apply the same rules as those established in the French Republic for the purposes of transposing European legal acts concerning the activities and prudential regulation of credit institutions and the prevention of systemic risks to payment and securities settlement systems contained in Annex A,

(2)

The update of the Annex A is made according to Article 11(3) of the Monetary Agreement which foresees that Annex A needs to be updated by the Commission upon amendment of any relevant texts and also each time a new text is adopted by the European Union,

(3)

New texts have been adopted by the European Union and amendments have been made to the texts already existing in Annex A,

(4)

Annex A to the Monetary Agreement should therefore be amended accordingly,

(1)

The active substance propiconazole was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products of product-type 8, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

(2)

The approval of propiconazole for use in biocidal products of product-type 8 will expire on 31 March 2020. On 1 October 2018, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of propiconazole.

(3)

On 8 February 2019, the evaluating competent authority of Finland informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of Regulation (EU) No 528/2012, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

(4)

The evaluating competent authority may, as appropriate, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of that Regulation. In such case, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.

(5)

Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(6)

Consequently, for reasons beyond the control of the applicant, the approval of propiconazole for use in biocidal products of product-type 8 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of propiconazole for use in biocidal products of product-type 8 for a period of time sufficient to enable the examination of the application.

(7)

Considering that propiconazole is classified as toxic for reproduction category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), and therefore meets the exclusion criterion set out in point (c) of Article 5(1) of Regulation (EU) No 528/2012, after further discussion with Member States, it is considered appropriate to postpone the expiry date of approval for a shorter period of time. It is therefore proposed to extend the duration of approval until 31 March 2021.

(8)

Except for the expiry date of the approval, propiconazole remains approved for use in biocidal products of product-type 8 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC,