26.7.2016   

EN

Official Journal of the European Union

L 199/1

(1)

The Protocol to the Partnership and Cooperation Agreement between the European Communities and their Member States, of the one part, and the Republic of Azerbaijan, of the other part, on a Framework Agreement between the European Union and the Republic of Azerbaijan on the general principles for the participation of the Republic of Azerbaijan in Union programmes (‘the Protocol’) was signed on behalf of the Union on 14 June 2014.

(2)

The objective of the Protocol is to lay down the financial and technical rules enabling the Republic of Azerbaijan to participate in certain Union programmes. The horizontal framework established by the Protocol constitutes an economic, financial and technical cooperation measure which allows for access to assistance, in particular financial assistance, to be provided by the Union pursuant to those Union programmes. That framework applies only to those Union programmes for which the relevant constitutive legal acts provide for the possibility of the participation of the Republic of Azerbaijan. The conclusion of the Protocol therefore does not entail the exercise of powers under the various sectoral policies pursued by the programmes, which are exercised when establishing the programmes.

(3)

The Protocol should be approved,

26.7.2016   

EN

Official Journal of the European Union

L 199/3

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4)

It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

26.7.2016   

EN

Official Journal of the European Union

L 199/6

(1)

It is appropriate to set out common procedures and forms for submitting information to the European Securities and Markets Authority (ESMA) by competent authorities with regard to penalties and measures they impose as referred to in Article 99e of Directive 2009/65/EC.

(2)

In order to enable ESMA to correctly identify and register the information on penalties and measures imposed in accordance with Article 99 of Directive 2009/65/EC, it is appropriate to require competent authorities to provide it with detailed and harmonised information on penalties and measures notified.

(3)

It is necessary to avoid potential double entries and negative conflicts of competence between multiple reporting authorities within a Member State. Designating a single contact point per Member State with ESMA is the most effective and least onerous means of pursuing such objective.

(4)

With a view to including meaningful information in the annual report on penalties and measures to be published by ESMA in accordance with Article 99e(1) of Directive 2009/65/EC, competent authorities should report the information by using specific forms clearly indicating which Articles of Directive 2009/65/EC were infringed.

(5)

The reporting of administrative penalties and measures disclosed to the public in accordance with Article 99e(2) of Directive 2009/65/EC should clearly identify penalties and measures by offering sufficient details. It is therefore appropriate to set out a form to be used by competent authorities for this purpose.

(6)

This Regulation is based on the draft implementing technical standards submitted by ESMA to the Commission.

(7)

ESMA did not conduct open public consultations on the draft implementing technical standards on which this Regulation is based, nor did it analyse potential related costs and benefits of introducing the standard forms and procedures for the relevant competent authorities, as this would have been disproportionate in relation to their scope and impact, taking into account that the addressees of the implementing technical standards would only be the national competent authorities of the Member States and not market participants. ESMA requested the opinion of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (2),

26.7.2016   

EN

Official Journal of the European Union

L 199/12

(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,

26.7.2016   

EN

Official Journal of the European Union

L 199/14

(1)

Article 2 of Commission Directive 2005/62/EC (2) requires Member States to ensure that the quality system in place in all blood establishments complies with the standards and specifications set out in the Annex to that Directive.

(2)

Article 2 of Directive 2005/62/EC also requires the Commission to develop good practice guidelines for the interpretation of the standards and specifications referred to in that Article.

(3)

Good Practice Guidelines (the ‘GPG’) have been jointly developed by the Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe (3).

(4)

The GPG have been developed and are updated taking into account scientific and technical expertise. The GPG fully reflect the detailed principles and guidelines of good manufacturing practice established under Article 47 of Directive 2001/83/EC (4) which are relevant for blood establishments and their quality systems, and are already successfully used in blood establishments in the Union. Accordingly, they should be taken into account when implementing the standards and specifications set out in the Annex to Directive 2005/62/EC. Paragraph 2 of Article 2 of that Directive should therefore be amended accordingly.

(5)

The Commission, which actively participates in the process leading to amendments of the GPG together with experts from the Member States, should inform the competent authorities designated by the Member States of any significant changes to the GPG, which should also be taken into account.

(6)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

26.7.2016   

EN

Official Journal of the European Union

L 199/16

(1)

On 24 June 2011, Bayer CropScience AG submitted to the competent authority of Belgium an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from FG72 soybean (‘the application’).

(2)

The application also covers the placing on the market of genetically modified soybean FG72 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 16 July 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified soybean FG72, as described in the application, is as safe as its conventional counterpart and other non-genetically modified soybean varieties with respect to potential adverse effects on human and animal health and the environment in the context of the scope of the application.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean FG72.

(8)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for food, food ingredients and feed containing, consisting of, or produced from genetically modified soybean FG72. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of soybean FG72, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(13)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MST-FGØ72-2 soybean;

(b)

feed containing, consisting of, or produced from MST-FGØ72-2 soybean;

(c)

MST-FGØ72-2 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.

26.7.2016   

EN

Official Journal of the European Union

L 199/22

(1)

On 23 March 2012, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON 87708 × MON 89788 (‘the application’).

(2)

The application also covers the placing on the market of genetically modified soybean MON 87708 × MON 89788 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 18 June 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that genetically modified soybean MON 87708 × MON 89788, as described in the application, is as safe as its conventional counterpart and other non-genetically modified soybean varieties with respect to potential adverse effects on human and animal health and the environment in the context of the scope of the application (3).

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788.

(8)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of soybean MON 87708 × MON 89788, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(13)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-877Ø8-9 × MON-89788-1 soybean;

(b)

feed containing, consisting of, or produced from MON-877Ø8-9 × MON-89788-1 soybean;

(c)

MON-877Ø8-9 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.

26.7.2016   

EN

Official Journal of the European Union

L 199/28

(1)

On 11 August 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean (‘the application’).

(2)

The application also covers the placing on the market of genetically modified soybean MON 87705 × MON 89788 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 16 July 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified soybean MON 87705 × MON 89788, as described in the application, is as safe as its non-genetically modified counterpart and other non-genetically modified soybean reference varieties with respect to potential adverse effects on human and animal health and the environment in the context of the scope of the application.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.

(8)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788.

(9)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(10)

Food, food ingredients and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

(11)

On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87705 × MON 89788 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

(12)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(13)

In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products should be complemented by a clear indication that the products in question must not be used for cultivation.

(14)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(15)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(16)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed provided for in Regulation (EC) No 1829/2003.

(17)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(18)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

(b)

feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

(c)

MON-877Ø5-6 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.