(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

(2)

Applications for the renewal of the approval of the active substances included in this Regulation were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those substances may expire for reasons beyond the control of the applicant before a decision has been taken on the renewal of their approval. It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.

(3)

In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C/2016/6104 (4) established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

(4)

The presumed low-risk substances should be prioritised in accordance with Implementing Decision C/2016/6104. The approval of those substances should therefore be extended by a period as short as possible. Taking into account the distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making, that period should be of 1 year for the active substances paraffin oil/(CAS 64742-46-7), paraffin oil/(CAS 72623-86-0), paraffin oil/(CAS 8042-47-5), paraffin oil/(CAS 97862-82-3) and sulphur.

(5)

For active substances which do not fall in the prioritised categories in Implementing Decision C/2016/6104, the approval period should be extended by either 2 or 3 years, taking into account the present date of expiry, the fact that according to Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance shall be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs, and the available resources necessary for assessment and decision-making. It is therefore appropriate to extend the approval periods for 2-phenylphenol (including its salts such as the sodium salt), chlormequat, dimethachlor, etofenprox, penconazole, propaquizafop, tetraconazole, tri-allate, and zeta-cypermethrin by 2 years, and to extend the approval periods of active substances bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad by 3 years.

(6)

The Commission received an application for the renewal of the approval of the active substance quizalofop-P (variant quizalofop-p-ethyl) and a separate application for the renewal of the approval of the active substance quizalofop-P (variant quizalofop-p-tefuryl). Given this fact and due to the different risk profiles of quizalofop-p-ethyl and quizalofop-p-tefuryl, it is appropriate to consider them as two different active substances for the purpose of the renewal procedure. The variant quizalofop-p-ethyl does not fall in the prioritised categories in Implementing Decision C/2016/6104. Therefore, and taking into account the reasons given in recital 5, it is appropriate to extend its approval period by 2 years.

(7)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

(8)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

(9)

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

(10)

Taking into account that the approvals of some of the substances expire on 31 October 2019, and that applicants should submit supplementary dossiers 30 months before the expiry of the approval, this Regulation should enter into force as soon as possible.

(11)

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) No 536/2014 lays down the legal framework for the conduct of clinical trials on medicinal products for human use in the Union to ensure that the rights, safety and well-being of the subjects are protected, and the data generated in clinical trials are robust and reliable. In particular, the sponsor of a clinical trial and the investigator are to ensure that the clinical trial is conducted in accordance with the relevant protocol and the principles of good clinical practice. Compliance with the applicable legal requirements, the protocol and the principles of good clinical practice, including with standards relating to data integrity and ethical conduct of the clinical trial, is to be verified by means of inspections conducted under the responsibility of the Member State where the inspection takes place.

(2)

The inspection in the context of clinical trials may concern good manufacturing practices as regards the manufacturing of the investigational medicinal products or good clinical practice as regards the conduct of clinical trials. Article 63 of Regulation (EU) No 536/2014 empowers the Commission to adopt delegated acts specifying the detailed arrangements for good manufacturing practice inspections as regards investigational medicinal products. Therefore, this Regulation should only lay down detailed arrangements for good clinical practice inspections procedures and requirements regarding training and qualifications of good clinical practice inspectors.

(3)

Member States may conduct inspections of clinical trials performed in third countries, either because a clinical trial is related to a clinical trial authorised in the Union or because the data of the clinical trial is being referred to in a clinical trial authorisation application in the Union. Those inspections should allow verifying whether such clinical trials were conducted in accordance with standards equivalent to Union standards. Inspections of clinical trials in third countries may also be conducted in order to verify whether the clinical trials, whose results are referred to in marketing authorisation applications in the Union, meet the ethical requirements set out in Regulation (EU) No 536/2014. Therefore, provisions on detailed arrangements for the inspection procedures should apply also to inspections conducted outside the Union in accordance with Regulation (EU) No 536/2014.

(4)

The International Conference on Harmonisation (‘ICH’) reached a consensus in 1995 to provide a harmonised approach for good clinical practice. Pursuant to Article 47 of Regulation (EU) No 536/2014, the ICH guidelines should be appropriately taken into account by the sponsor when drafting the clinical trial protocol and conducting the clinical trial. To the extent that those guidelines are compatible with the relevant Union law and EU guidelines, inspectors should refer to the ICH guidelines, taking into account the characteristics of each trial.

(5)

Member States should be required to set up quality systems to ensure that the inspection procedures are observed and consistently monitored. A well-functioning quality system should comprise an organisational structure, clear processes and procedures, including the standard operating procedures to be followed by inspectors when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing training requirements, as well as adequate resources and mechanisms which aim at eliminating non-compliance.

(6)

It is necessary to enable inspectors to ensure the practical effectiveness of provisions on good clinical practice. That objective should be reflected in the minimum requirements for the qualification of inspectors, in particular as regards their education and training. For the same reasons, detailed rules on inspection procedures should be laid down.

(7)

In order to safeguard the effectiveness of inspection, the inspectors should be granted the necessary powers of access to the premises and data. This includes in particular any laboratory used for analysis in the clinical trial, any contract research organisation's facilities or the sponsor's premises. They should also be empowered to contact the trial subjects in justified cases.

(8)

In order to ensure the compliance with arrangements for good clinical practice inspections and in accordance with Article 77 of Regulation (EU) No 536/2014 Member States should take corrective measures if necessary. When during an inspection a major non-compliance or breach is identified, or the inspectors' investigatory powers are not recognised by the sponsors, Member States should have recourse to penalties.

(9)

In order to ensure the protection of confidential information, in particular personal data of clinical trial subjects related to their health as well as commercially confidential information, the inspectors and experts involved in inspections should be bound by the highest standards of confidentiality and the applicable requirements of the Union law, national laws and international agreements. The inspectors and experts involved in inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of the Council (2) when processing personal data.

(10)

Commission Directive 2005/28/EC (3) should be repealed in order to ensure that only one set of rules applies to the conduct of good clinical practice inspections of clinical trials, including clinical trials governed by Directive 2001/20/EC of the European Parliament and of the Council (4). However, in order to ensure consistency with Article 98 of Regulation (EU) No 536/2014 setting up a transitional period maintaining, as regards certain requests for authorisation of a clinical trial, the applicability of Directive 2001/20/EC, Directive 2005/28/EC should, with the exception of its Chapters 5 and 6 referring to good clinical practice inspection procedures and inspectors, remain applicable during that transitional period to all clinical trials authorised on the basis of Directive 2001/20/EC.

(11)

This Regulation should become applicable at the same time as Regulation (EU) No 536/2014.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,

(1)

Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

(2)

On 21 March 2017, the Sanctions Committee of the United Nations Security Council decided to amend two entries in its list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly,

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

The European Globalisation Adjustment Fund (‘EGF’) aims to provide support for workers made redundant and self-employed persons whose activity has ceased as a result of major structural changes in world trade patterns due to globalisation, as a result of a continuation of the global financial and economic crisis, or as a result of a new global financial and economic crisis, and to assist them with their reintegration into the labour market.

(2)

The EGF is not to exceed a maximum annual amount of EUR 150 million (2011 prices), as laid down in Article 12 of Council Regulation (EU, Euratom) No 1311/2013 (3).

(3)

On 12 July 2016 the Netherlands submitted an application to mobilise the EGF, in respect of redundancies in 6 enterprises operating in the retail trade sector in 2 regions (Drenthe and Overijssel) in the Netherlands. It was supplemented by additional information provided in accordance with Article 8(3) of Regulation (EU) No 1309/2013. That application complies with the requirements for determining a financial contribution from the EGF as laid down in Article 13 of Regulation (EU) No 1309/2013.

(4)

The EGF should, therefore, be mobilised in order to provide a financial contribution of EUR 1 818 750 in respect of the application submitted by the Netherlands.

(5)

In order to minimise the time taken to mobilise the EGF, this decision should apply from the date of its adoption,

(1)

Joint Declaration V (1) to Decision No 2/2000 of the EC-Mexico Joint Council (2) established by the Economic Partnership, Political Coordination and Cooperation Agreement between the European Community and its Member States, of the one part, and the United Mexican States, of the other part, signed in Brussels on 8 December 1997 (3) (‘the Agreement’), provides that the EC-Mexico Joint Committee established by the Agreement is to review the necessity to extend beyond 30 June 2003 the application of the rules of origin set out in Notes 2 and 3 of Appendix II(a) to Annex III to Decision No 2/2000 (‘Notes 2 and 3’). That review concerns the product-specific rules in Appendix II to Annex III to Decision No 2/2000 for certain chemical products under the Harmonised System headings 2914 and 2915.

(2)

On 17 September 2010 the EU-Mexico Joint Committee adopted Decision No 1/2010 (4), extending the application of the rules of origin established in Notes 2 and 3 for the third time. Decision No 1/2010 applied until 30 June 2014.

(3)

It is appropriate to extend the application of the rules of origin established in Notes 2 and 3 on a temporary basis with effect from 1 July 2014 until 31 December 2019, in line with the principles of the modernisation of the Agreement, to ensure continuity with future product-specific rules.

(4)

Since the extension of the application of the rules of origin established in Notes 2 and 3 expired on 30 June 2014, it is appropriate to apply the new extension retroactively from 1 July 2014, in order to avoid disrupting existing economic conditions.

(5)

Appendix II to Annex III to Decision No 2/2000 should therefore be amended to extend the application of the rules of origin established in Notes 2 and 3 on a temporary basis with effect from 1 July 2014 until 31 December 2019.

(6)

For the purposes of the retroactive application, the time limit for presentation of the proof of origin by way of a EUR.1 movement certificate or an invoice declaration should be extended from 2 years to 3 years for the relevant chemical products imported into the Union in the period from 1 July 2014 to 30 June 2015.

(7)

Appendix V to Annex III to Decision No 2/2000 should therefore be replaced.

(8)

The position of the Union within the EU-Mexico Joint Committee should therefore be based on the attached draft Decision,

(1)

Annex III to Decision No 2/2000 of the EC-Mexico Joint Council (1) established by the Economic Partnership, Political Coordination and Cooperation Agreement between the European Community and its Member States, of the one part, and the United Mexican States, of the other part (2), signed in Brussels on 8 December 1997 (‘the Agreement’), sets out the rules of origin for the products originating in the territory of the Parties to the Agreement. Article 38 of Annex III to Decision No 2/2000 allows the EU-Mexico Joint Committee to amend that Annex.

(2)

The European Union has in place a customs union with the Principality of Andorra for products falling within Chapters 25 to 97 of the Harmonized System and with the Republic of San Marino for products falling within Chapters 1 to 97 of the Harmonized System. This customs union allows goods originating in Mexico to benefit from preferential treatment under Decision No 2/2000 also when exported to Andorra and San Marino.

(3)

It has been agreed that Mexico will accept products falling within Chapters 25 to 97 of the Harmonized System originating in the Principality of Andorra and products falling within Chapters 1 to 97 of the Harmonised System originating in the Republic of San Marino as products originating in the EU within the meaning of Annex III to Decision No 2/2000.

(4)

An Appendix VI should therefore be added to Annex III to Decision No 2/2000 to allow those products to be treated, when imported into Mexico, in a similar way to products originating in the Union, and to lay down provisions regarding the application of Annex III to those products.

(5)

Joint Declaration V (3) to Decision No 2/2000 provides that the EC-Mexico Joint Committee established by the Agreement is to review the necessity to extend beyond 30 June 2003 the application of the rules of origin set out in Notes 2 and 3 of Appendix II(a) to Annex III to Decision No 2/2000 (‘Notes 2 and 3’). That review concerns the product-specific rules in Appendix II to Annex III to Decision No 2/2000 for certain chemical products under the Harmonised System headings 2914 and 2915.

(6)

The EU-Mexico Joint Committee is to adopt a Decision, extending the application of the rules of origin established in Notes 2 and 3 for the fourth time. That Decision is to apply until 31 December 2019.

(7)

It is appropriate to extend the application of the rules of origin established in Notes 2 and 3 on a permanent basis, because they are in line with the principles of the modernisation of the Agreement.

(8)

Appendix II to Annex III to Decision No 2/2000 should therefore be amended to extend the application of the rules of origin established in Notes 2 and 3 on a permanent basis.

(9)

The position of the Union within the EU-Mexico Joint Committee should therefore be based on the attached draft Decision,

(1)

On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020.

(2)

An alternate member's seat on the Committee of the Regions has become vacant following the end of the term of office of Mr Rodrigo VASCONCELOS DE OLIVEIRA,

—

Mr Rui Jorge DA SILVA LEITE DE BETTENCOURT, Secretário Regional Adjunto da Presidência para as Relações Externas do Governo Regional dos Açores.

(1)

By letter registered with the Commission on 18 May 2016, Estonia requested authorisation to apply a special measure derogating from Article 287 of Directive 2006/112/EC (‘the special measure’), allowing Estonia to exempt from value added tax (VAT) taxable persons whose annual turnover is no higher than EUR 40 000 as of 1 January 2018.

(2)

In accordance with Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States by letter dated 4 October 2016 of the request made by Estonia. The Commission notified Estonia by letter dated 5 October 2016 that it had all the information necessary to consider the request.

(3)

Under point 8 of Article 287 of Directive 2006/112/EC, Estonia may exempt from VAT taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 16 000 at the conversion rate on the day of its accession.

(4)

The requested special measure is in line with the objectives of Commission Communication of 25 June 2008, entitled ‘“Think small first” — a “Small Business Act” for Europe’.

(5)

Given that the special measure will result in reduced VAT obligations for smaller businesses, Estonia should be authorised to apply it for a limited period of time, until 31 December 2020. Taxable persons should still be able to opt for the normal VAT arrangements.

(6)

As Articles 281 to 294 of Directive 2006/112/EC governing the special scheme for small enterprises are subject to review, it is possible that a directive amending those provisions of Directive 2006/112/EC will enter into force before 31 December 2020.

(7)

Based on information provided by Estonia, the increased threshold will have a negligible impact on the overall amount of tax revenue collected at the stage of final consumption.

(8)

The derogation has no impact on the Union's own resources accruing from VAT,

(1)

Commission Implementing Decision 2014/709/EU (4) lays down animal health control measures in relation to African swine fever in certain Member States. The Annex to that Implementing Decision demarcates and lists certain areas of those Members States in Parts I, II, III and IV thereof differentiated by the level of risk based on the epidemiological situation. That list includes, amongst others, certain areas of Lithuania.

(2)

Since November 2016, no outbreaks of African swine fever in domestic pigs have been notified in certain areas of Lithuania which are listed in Part III of the Annex to Implementing Decision 2014/709/EU. In addition, supervision of biosecurity measures has been implemented in a satisfactory manner in holdings in those areas based on the national programme for biosecurity aimed at the prevention of the spread of African swine fever. These facts indicate an improvement in the epidemiological situation. Accordingly, those areas of Lithuania should now be listed in Part II, instead of Part III, of the Annex to Implementing Decision 2014/709/EU.

(3)

The evolution of the current epidemiological situation of African swine fever in the affected domestic and feral pig populations in the Union should be taken into account in the assessment of the animal health risk posed by that situation as regards that disease in Lithuania. In order to focus the animal health control measures provided for in Implementing Decision 2014/709/EU and to prevent the further spread of African swine fever, while preventing any unnecessary disturbance to trade within the Union and avoiding unjustified barriers to trade by third countries, the Union list of areas subject to the animal health control measures set out in the Annex to that Implementing Decision should be amended to take into account the changes in the current epidemiological situation as regards that disease in Lithuania.

(4)

The Annex to Implementing Decision 2014/709/EU should therefore be amended accordingly.

(5)

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