ISSN 1977-0677
Official Journal
of the European Union
L 367
English edition
Legislation
Volume 63
5 November 2020
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ISSN 1977-0677 |
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Official Journal of the European Union |
L 367 |
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English edition |
Legislation |
Volume 63 |
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III Other acts |
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EUROPEAN ECONOMIC AREA |
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(1) Text with EEA relevance. |
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EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
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5.11.2020 |
EN |
Official Journal of the European Union |
L 367/1 |
COMMISSION REGULATION (EU) 2020/1633
of 27 October 2020
amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azinphos-methyl, bentazone, dimethomorph, fludioxonil, flufenoxuron, oxadiazon, phosalone, pyraclostrobin, repellants: tall oil and teflubenzuron in or on certain products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council 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 (1), and in particular Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,
Whereas:
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(1) |
For bentazone, dimethomorph, fludioxonil, pyraclostrobin and teflubenzuron, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For azinphos-methyl, MRLs were set in Annex II and Part B of Annex III to that Regulation. For flufenoxuron, oxadiazon and phosalone, MRLs were set in Part A of Annex III to that Regulation. Repellants: tall oil was included in Annex IV to that Regulation. |
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(2) |
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance bentazone on potatoes, leeks, herbal infusions from leaves and herbs, poppy seeds and soyabeans, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. |
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(3) |
As regards dimethomorph, such an application was submitted for blackberries and raspberries. As regards fludioxonil, such an application was submitted for strawberries, rhubarbs, linseeds, sesame seeds, rapeseeds/canola seeds, mustard seeds, borage seeds, gold of pleasure seeds and hemp seeds. As regards pyraclostrobin, such an application was submitted for table grapes, sweet corn and coffee beans. As regards teflubenzuron, such an application was submitted for apples, Brussels sprouts and head cabbages. |
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(4) |
In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
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(5) |
The European Food Safety Authority ('the Authority') assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. |
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(6) |
As regards bentazone, the applicant submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005. That information concerns residue trials, analytical methods, storage stability and a feeding study. Based on the new information, the Authority recommended lowering the MRLs for potatoes and products of animal origin and increasing the MRL for herbal infusions from leaves and herbs. For leeks, the missing information on residue trials was not submitted. It is therefore appropriate to delete the MRL set out for leeks in Annex II to Regulation (EC) No 396/2005. |
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(7) |
As regards dimethomorph, the applicant submitted such previously unavailable information on residue trials. Based on the new information, the Authority recommended lowering the MRLs for blackberries and raspberries to the relevant limit of determination (LOD). |
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(8) |
As regards fludioxonil, the applicant submitted such previously unavailable information on residue trials and a feeding study. Based on the new information, the Authority recommended lowering the MRLs for certain products of animal origin to the relevant LOD. |
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(9) |
As regards pyraclostrobin, the applicant submitted such previously unavailable information on residue trials and analytical methods. Based on the new information, the Authority identified an intake concern in relation to the current use of that active substance on table grapes. Member States were consulted to report potential fall-back Good Agricultural Practices (GAPs) that would not lead to an unacceptable risk for consumers. Member States identified a fall-back GAP for table grapes for which the MRL should be set at 0,3 mg/kg. |
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(10) |
As regards teflubenzuron, the applicant submitted such previously unavailable information on hydrolysis, metabolism and analytical methods. Based on the new information, the Authority recommended lowering the MRLs for products of animal origin to the relevant LOD. |
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(11) |
As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. |
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(12) |
The approval of the active substance azinphos-methyl expired on 1 January 2007 (3). The active substance flufenoxuron was non-approved by Commission Implementing Regulation (EU) No 942/2011 (4). The approval of the active substance oxadiazon expired on 31 December 2018 (5). The active substance phosalone was non-approved by the Commission Decision 2006/1010/EC (6). The approval of the active substance tall oil pitch was withdrawn by Commission Implementing Regulation (EU) 2017/1125 (7). The approval of the active substance tall oil crude was withdrawn by Commission Implementing Regulation (EU) 2017/1186 (8). |
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(13) |
All existing authorisations for plant protection products containing those active substances have been revoked. It is therefore appropriate to delete the existing MRLs set out for those substances in Annexes II and III of Regulation (EC) No 396/2005 in accordance with Article 17 of that Regulation in conjunction with Article 14(1)(a) thereof, except for the MRL for flufenoxuron in tea, which is safe to consumers (9) and corresponds to an import tolerance request from Japan, and the MRLs for azinphos-methyl and phosalone in spices which correspond to Codex limits established on the basis of monitoring data and whose dietary exposure is extremely low (10). For repellants: tall oil, it is appropriate to remove the entry in Annex IV to Regulation (EC) No 396/2005 and list default values for that substance in Annex V in accordance with Article 18(1)(b) of that Regulation. |
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(14) |
The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain products technical development permits the setting of lower LODs. For the active substances for which all MRLs should be reduced to the relevant LOD, default values should be listed in Annex V in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(15) |
Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
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(16) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional measure for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. |
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A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. |
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(19) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II, III, IV and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 25 May 2021, except for pyraclostrobin in table grapes and repellants: tall oil in all products.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 25 May 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 October 2020.
For the Commission
The President
Ursula VON DER LEYEN
EFSA scientific reports available online: http://www.efsa.europa.eu:
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Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL review for bentazone. EFSA Journal 2019;17(5):5704. |
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Reasoned opinion on the modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds. EFSA Journal 2019;17(7):5798. |
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Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL review for dimethomorph. EFSA Journal 2018;16(10):5433. |
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Reasoned opinion on the modification of the existing maximum residue levels for fludioxonil in rhubarbs. EFSA Journal 2019;17(9):5815. |
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Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL review for fludioxonil. EFSA Journal 2019;17(9):5812. |
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Reasoned opinion on the modification of the existing maximum residue levels for fludioxonil in certain oilseeds. EFSA Journal 2020;18(1):5994. |
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Reasoned opinion on the modification of the existing maximum residue level for pyraclostrobin in sweet corn. EFSA Journal 2019;17(10):5841. |
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Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin. EFSA Journal 2018;16(11):5472. |
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Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron. EFSA Journal 2018;16(10):5427. |
(3) Commission Regulation (EC) No 1335/2005 of 12 August 2005 amending Regulation (EC) No 2076/2002 and Decisions 2002/928/EC, 2004/129/EC, 2004/140/EC, 2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2) of Council Directive 91/414/EEC and the continued use of certain substances not included in its Annex I (OJ L 211, 13.8.2005, p. 6).
(4) Commission Implementing Regulation (EU) No 942/2011 of 22 September 2011 concerning the non-approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Decision 2008/934/EC (OJ L 246, 23.9.2011, p. 13)
(5) Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances (OJ L 172, 2.7.2008, p. 9).
(6) Commission Decision 2006/1010/EC of 22 December 2006 concerning the non-inclusion of phosalone in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ L 379, 28.12.2006, p. 127).
(7) Commission Implementing Regulation (EU) 2017/1125 of 22 June 2017 withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil pitch, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 163, 24.6.2017, p. 10).
(8) Commission Implementing Regulation (EU) 2017/1186 of 3 July 2017 withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil crude, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 171, 4.7.2017, p. 131).
(9) Reasoned opinion on the modification of the existing MRL for flufenoxuron in tea (dried leaves and stalks, fermented of Camellia sinensis). EFSA Scientific Report (2009); 267.
(10) http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-718-51%252FREPORT%252FFinal%252520Report%252FREP19_PRe.pdf
Report of the 51st session of the Codex Committee on Pesticide Residues. Appendix III. Macao SAR, P.R. China, 8-13 April 2019.
ANNEX
Annexes II, III, IV and V to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
Annex II is amended as follows:
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(2) |
Annex III is amended as follows:
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(3) |
In Annex IV, the entry for ‘repellants: tall oil’ is deleted. |
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(4) |
In Annex V, the following columns for oxadiazon and repellants: tall oil are added: ‘Pesticide residues and maximum residue levels (mg/kg)
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(*1) Limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(*2) Limit of analytical determination
(2) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(*3) Limit of analytical determination
(3) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.’
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5.11.2020 |
EN |
Official Journal of the European Union |
L 367/39 |
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1634
of 4 November 2020
authorising the placing on the market of sugars obtained from cocoa (Theobroma cacao L.) pulp as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
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(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. |
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(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. |
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Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list. |
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(4) |
Commission Implementing Regulation (EU) 2020/206 (3) authorised the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 and amended the Union list of authorised novel foods. |
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(5) |
On 22 November 2019, the company Cabosse Naturals NV (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place sugars obtained from cocoa (Theobroma cacao L.) pulp on the Union market as a novel food. The applicant requested for sugars obtained from cocoa (Theobroma cacao L.) pulp to be used as an ingredient for the general population. |
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The sugars are obtained via a drying process or a purification process which removes the excess moisture and the other components present in the concentrated pulp juice from Theobroma cacao L. |
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The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The sugars obtained from the concentrated pulp juice from Theobroma cacao L. via drying or purification are identical to the sugars naturally present in the cocoa (Theobroma cacao L.) pulp and consist mainly of glucose and fructose that have a long history of safe use in foods, thus their authorisation would not alter the safety considerations that supported the authorisation of concentrated pulp juice from Theobroma cacao L. as a traditional food. |
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The information provided in the application gives sufficient grounds to establish that the proposed uses and use levels of the novel food sugars obtained from cocoa (Theobroma cacao L.) pulp comply with Article 12 of Regulation (EU) 2015/2283. |
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The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
1. Sugars obtained from cocoa (Theobroma cacao L.) pulp as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established by Implementing Regulation (EU) 2017/2470.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
Article 2
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 November 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 327, 11.12.2015, p. 1.
(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
(3) Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorising the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470 (OJ L 43, 17.2.2020, p. 66).
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
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in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:
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(2) |
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
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III Other acts
EUROPEAN ECONOMIC AREA
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5.11.2020 |
EN |
Official Journal of the European Union |
L 367/42 |
EFTA SURVEILLANCE AUTHORITY DECISION
No 102/20/COL
of 31 August 2020
authorising Norway to apply an extension of certain periods specified in Article 2 of Regulation (EU) 2020/698 of the European Parliament and of the Council laying down specific and temporary measures in view of the COVID‐19 outbreak concerning the renewal or extension of certain certificates, licences and authorisations and the postponement of certain periodic checks and periodic training in certain areas of transport legislation (2020/1635)
THE EFTA SURVEILLANCE AUTHORITY,
Having regard to Regulation (EU) 2020/698 of the European Parliament and of the Council of 25 May 2020 laying down specific and temporary measures in view of the COVID‐19 outbreak concerning the renewal or extension of certain certificates, licences and authorisations and the postponement of certain periodic checks and periodic training in certain areas of transport legislation (1) and in particular Article 2 of that Regulation as adapted to the EEA Agreement by Protocol 1 thereto,
Whereas:
According to Directive 2003/59/EC of the European Parliament and of the Council (2), certain professional drivers are required to carry out periodic training and after successfully concluding that training receive a Driver Certificate of Professional Competence (“CPC”) which may either be in form of a driver qualification card or with a corresponding marking of a harmonized Union code, ‘95’ on the driving licence in accordance with Article 10 of that Directive.
Article 2(1) of Regulation (EU) 2020/698 extends the time limits for the completion, by the holder of a certificate of professional competence (CPC), of periodic training, which would otherwise have expired or would otherwise expire between 1 February 2020 and 31 August 2020 by seven months. Article 2(2) of that Regulation in the same manner extends the validity of the corresponding marking of harmonised Union code, ‘95’ and Article 2(3) extends the corresponding driver qualification cards.
Where a Member State considers that the completion of periodic training or its certification, the marking of the harmonised Union code, ‘95’, or the renewal of driver qualification cards is likely to remain impracticable beyond 31 August 2020, due to measures that it has taken to prevent or contain the spread of COVID‐19, it may submit a reasoned request for an authorisation to apply an extension of the periods specified in Article 2(1), (2) and (3) of Regulation (EU) 2020/698, as relevant. That request may concern the period between 1 February 2020 and 31 August 2020 or the periods of seven months specified in Article 2(1), (2) and (3) of that Regulation, as relevant, or both.
Where, upon a request submitted in accordance with Article 2(5) of Regulation (EU) 2020/698, the EFTA Surveillance Authority finds that the requirements laid down in that paragraph are fulfilled, it shall adopt a decision, in accordance with Article 2(6) of that Regulation, authorising the Member State concerned to apply an extension of the periods in question. The extension shall be limited to reflect the period during which completion of the periodic training in question or the certification thereof, the marking of the harmonised Union code, ‘95’, or the renewal of driver qualification cards, is likely to remain impracticable and, in any event, shall not be longer than six months.
By letter dated 15 June 2020 (3), referring to Article 2(1) and (2) of Regulation (EU) 2020/698, Norway submitted a reasoned request pursuant to Article 2(5) for an authorisation to apply an extension by one month of the period specified in Article 2(1) and (2) of that Regulation. Norway provided additional information in support of its request on 26 August 2020 (4).
According to the information provided by Norway, the completion of periodic training and its certification and the marking of the harmonised Union code, ‘95’ is likely to remain impracticable in Norway until 30 September 2020 due to measures that it has taken to prevent or contain the spread of COVID‐19.
In particular, Norway imposed general lockdown measures which included closing down training facilities, including those related to the periodic training of drivers provided for in Directive 2003/59/EC and public services related to the renewal of documents and licences.
The periodic training courses have gradually resumed operation. However, the measures necessary to contain COVID-19 still impose constraints on these facilities. Norway states that the training facilities must meet the relevant national rules on social distancing. As a result, only a reduced number of candidates are able to participate in the training courses at the same time. These measures imposed by Norwegian authorities have resulted in a significant backlog of licence holders, which have not been able to conclude the required periodic training.
After assessing in accordance with Article 2(6) of Regulation (EU) 2020/698, the reasoned submission received from Norway pursuant to Article 2(5) of that Regulation and the additional information provided, the Authority finds that the completion of periodic training or its certification, the marking of the harmonised Union code, ‘95’, or the renewal of driver qualification cards is likely to remain impracticable beyond 31 August 2020, due to measures that Norway has taken to prevent or contain the spread of COVID‐19. The requirements laid down in Article 2(5) of Regulation (EU) 2020/698 are therefore fulfilled.
Norway should consequently be authorised to apply an extension of one month of the respective periods, between 1 February 2020 and 31 August 2020, specified in Article 2(1) and (2) of Regulation (EU) 2020/698,
HAS ADOPTED THIS DECISION:
Norway is authorised to apply an extension of one month of the period between 1 February 2020 and 31 August 2020 specified in Article 2(1) of Regulation (EU) 2020/698 for the purposes of Article 2(1) and (2) of that Regulation.
This Decision is addressed to the Kingdom of Norway.
Done at Brussels, 31 August 2020.
For the EFTA Surveillance Authority
Bente ANGELL-HANSEN
President
Frank J. BÜCHEL
College Member
Högni KRISTJÁNSSON
Responsible College Member
Carsten ZATSCHLER
Countersigning as Director,
Legal and Executive Affairs
(1) OJ L 165, 27.5.2020, p. 10. Incorporated into the EEA Agreement at point 4b of Annex XIII by Decision of the EEA Joint Committee No 91/2020 of 18 June 2020.
(2) Directive 2003/59/EC of the European Parliament and of the Council of 15 July 2003 on the initial qualification and periodic training of drivers of certain road vehicles for the carriage of goods or passengers, amending Council Regulation (EEC) No 3820/85 and Council Directive 91/439/EEC and repealing Council Directive 76/914/EEC (OJ L 226, 10.9.2003, p. 4). Incorporated into the EEA Agreement at point 37 of Annex XIII by Decision of the EEA Joint Committee No 64/2006 (OJ L 245, 7.9.2006, p. 13).
(3) Doc No 1138286.
(4) Doc No 1149283.