20.4.2017   

EN

Official Journal of the European Union

L 104/1

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy's application to register the name ‘Marche’ was published in the Official Journal of the European Union  (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Marche’ should therefore be entered in the register,

20.4.2017   

EN

Official Journal of the European Union

L 104/3

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy's application to register the name ‘Vitelloni Piemontesi della coscia’ was published in the Official Journal of the European Union  (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Vitelloni Piemontesi della coscia’ should therefore be entered in the register,

20.4.2017   

EN

Official Journal of the European Union

L 104/4

(1)

The Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Bosnia and Herzegovina, of the other part (2) (‘the SAA’) was signed on 16 June 2008 and entered into force on 1 June 2015. Article 27(3) of the SAA provides for a duty-free access on imports into the Union for products originating in Bosnia and Herzegovina of headings 1701 and 1702 of the Combined Nomenclature, within the limit of an annual tariff quota of 12 000 tonnes.

(2)

The Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Bosnia and Herzegovina, of the other part, to take account of the accession of the Republic of Croatia to the European Union (3) (‘the Protocol’) was signed on 15 December 2016. Its signature on behalf of the European Union and the Member States and its provisional application has been authorised by Council Decision (EU) 2017/75 (4).

(3)

Article 2(1) of the Protocol provides for changes to the existing tariff quotas for sugar originating in Bosnia and Herzegovina with effect from 1 February 2017. The relevant annual tariff quota for sugar is being increased from 12 000 tonnes to 13 210 tonnes.

(4)

Commission Regulation (EC) No 891/2009 (5) provides for the opening and the administration of tariff quotas in the sugar sector, including those originating in Bosnia and Herzegovina. To implement the tariff quotas for sugar laid down in the Protocol, it is therefore necessary to amend that Regulation accordingly.

(5)

Since the Protocol applies from 1 February 2017, the proposed amendments should apply from the same date and enter into force on the day of its publication.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

(1)

In Article 1, point (f) is replaced by the following:

(*1)  OJ L 164, 30.6.2015, p. 2."

(*2)  OJ L 12, 17.1.2017, p. 3.’"

(2)

In Annex I, Part II is replaced by the text in the Annex to this Regulation.

20.4.2017   

EN

Official Journal of the European Union

L 104/6

(1)

Regulation (EEC) No 2658/87 established a nomenclature of goods (hereinafter referred to as the ‘Combined Nomenclature’ or the ‘CN’), which is set out in Annex I to that Regulation.

(2)

The current text of CN code 1905 90 60 refers to added sweetening matter, which gives rise to doubt as to the coverage of that CN code and is not precise enough to allow classification on the basis of laboratory analysis. The wording ‘with added’ should be deleted, because it is impossible to ascertain whether the sugar content is natural, so that the product must be classified under CN code 1905 90 90, or if the sugar has been added, so that the product must be classified under CN code 1905 90 60. The wording ‘sweetening matter’ is too vague, as it covers all natural and artificial substances with a sweet taste without indicating any threshold for the content of sweetener in the product. This could lead to different minimum thresholds being applied or to a lack of objectivity in proving the presence of sweetening matter in a product.

(3)

A statistical analysis as regards current CN codes 1905 90 60 and 1905 90 90 was undertaken to assess the amounts of customs duties collected at the import of products containing less than 5 %, by weight, of sucrose, invert sugar or isoglucose under each of those CN codes. The statistical analysis showed that in a significant number of imports, products classified in CN code 1905 90 60 should have been classified in CN code 1905 90 90 or vice versa, having regard to the criterion of ‘sweetening matter’. Hence, the text of CN code 1905 90 60 needs to be amended in order to introduce a clear criterion for the distinction between the two product groups. The percentage, by weight, of sucrose, invert sugar or isoglucose provides a more objective criterion and is therefore more easily applied for the purposes of laboratory analysis.

(4)

As the CN is also a statistical nomenclature, it is necessary to alter the seventh and eighth digit of the CN codes in question at the same time as the change of the coverage of those CN codes in order to allow proper statistical data handling after the change.

(5)

Taking into account that, in accordance with Article 12 of Regulation (EEC) No 2658/87, Annex I to that Regulation is to be replaced with effect from 1 January 2018, those new CN codes should only apply from 1 January 2018.

(6)

Regulation (EEC) No 2658/87 should therefore be amended accordingly.

(7)

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

(a)

the rows for CN codes 1905 90 60 and 1905 90 90 are deleted;

(b)

the following rows are inserted:

20.4.2017   

EN

Official Journal of the European Union

L 104/8

(1)

Regulation (EC) No 1907/2006 establishes requirements for the registration of substances manufactured or imported in the Union on their own, in mixtures or articles. The registrants have to provide the information required by Regulation (EC) No 1907/2006, as appropriate, in order to fulfil the registration requirements.

(2)

Article 13(2) of Regulation (EC) No 1907/2006 provides that test methods used to generate information on intrinsic properties of substances required by that Regulation are to be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. When appropriate validated test methods become available, the Commission Regulation (EC) No 440/2008 (2) and the Annexes to Regulation (EC) No 1907/2006 should be amended, if relevant, so as to replace, reduce or refine animal testing. The principles of replacement, reduction and refinement, enshrined in Directive 2010/63/EU of the European Parliament and of the Council (3) should be taken into account.

(3)

Pursuant to Regulation (EC) No 1907/2006, in vivo studies are required for the generation of information on skin sensitisation in point 8.3 of Annex VII to Regulation (EC) No 1907/2006.

(4)

In recent years, significant scientific progress has been made in the development of alternative test methods for skin sensitisation. Several in chemico/in vitro test methods have been validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and/or internationally agreed by the Organisation for Economic Cooperation and Development (OECD). These test methods may allow the generation of adequate information to assess whether a substance causes skin sensitisation without the need to resort to in vivo testing, when applied in an appropriate combination in the framework of an integrated approach to testing and assessment (IATA).

(5)

To reduce animal testing, point 8.3 of Annex VII to Regulation (EC) No 1907/2006 should be amended to allow the use of these alternative methods, where adequate information can be obtained through this approach and where the available test methods are applicable for the substance to be tested.

(6)

The currently available alternative test methods agreed by OECD are based on an adverse outcome pathway (AOP) describing the mechanistic knowledge about the development of skin sensitisation. These methods are not intended to be used on their own, but to be applied in combination. For the comprehensive assessment of skin sensitisation, typically methods addressing the first three key events of the AOP should be used.

(7)

However, under certain conditions, it may be possible to derive sufficient information without explicitly addressing all three key events by separate test methods. Therefore, the possibility should be given to registrants to scientifically justify the omission of tests addressing certain key events.

(8)

The test method indicated as the first choice for in vivo testing, the local lymph node assay (LLNA), provides information on the strength of the sensitisation potential of a substance. The identification of strong skin sensitisers is important to allow appropriate classification and risk assessment of such substances. It therefore should be clarified that the requirement for information allowing an assessment whether a substance should be presumed to be a strong sensitiser applies to all data, irrespective whether they are generated in vivo or in vitro.

(9)

However, in order to avoid animal testing and the repetition of already performed tests, existing in vivo skin sensitisation studies performed according to valid OECD test guidelines or EU test methods and in compliance to good laboratory practice (4) should be considered valid to fulfil the standard information requirement for skin sensitisation, even if the information derived from them is not sufficient for a conclusion whether a substance can be presumed to be a strong sensitiser.

(10)

In addition, the standard information requirements and adaptation rules in 8.3 of Annex VII to Regulation (EC) No 1907/2006 should be revised in order to remove redundancies with rules set by Annex VI and Annex XI and in the introductory parts of Annex VII to that Regulation as regards the review of available data, the waiving of studies for a toxicological endpoint if the available information indicates that the substance meets the criteria for classification for that toxicological endpoint, or to clarify the intended meaning as regards the waiving of studies for substances that are flammable under certain conditions. Where reference is made to the classification of substances, adaptation rules should be updated to reflect the terminology used in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5).

(11)

ECHA, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this Regulation for the purposes of Regulation (EC) No 1907/2006. In doing so, ECHA should take full account of the work carried out in OECD, as well as in other relevant scientific and expert groups.

(12)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006

(14)

Commission Regulation (EU) 2016/1688 (6) has been adopted without submission of the draft measure for scrutiny to the Council. In order to remedy this omission, the Commission should repeal Regulation (EU) 2016/1688 and replace it by the present Regulation which was submitted in draft for scrutiny to the European Parliament and the Council. Acts adopted under Regulation (EU) 2016/1688 remain valid,

20.4.2017   

EN

Official Journal of the European Union

L 104/12

(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,

20.4.2017   

EN

Official Journal of the European Union

L 104/14

(1)

Commission Regulation (EC) No 341/2007 (2) opened annual tariff quotas for imports of garlic.

(2)

The quantities covered by the applications for ‘A’ import licences lodged in the first seven calendar days of April 2017, for the subperiod from 1 June 2017 to 31 August 2017, for certain quotas, exceed those available. The extent to which ‘A’ import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

(3)

In order to ensure the efficient management of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

20.4.2017   

EN

Official Journal of the European Union

L 104/16

(1)

Commission Regulation (EC) No 616/2007 (2) opened annual tariff quotas for imports of poultrymeat products originating in Brazil, Thailand and other third countries.

(2)

The quantities on which applications for import licences lodged from 1 to 7 April 2017 for the sub-period from 1 July to 30 September 2017 and for the period from 1 July 2017 to 30 June 2018 are based relate, for some quotas, to quantities exceeding those available. The extent to which import licences may be issued should therefore be determined by fixing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

(3)

The quantities on which applications for import rights lodged from 1 to 7 April 2017 for the sub-period from 1 July to 30 September 2017 and for the period from 1 July 2017 to 30 June 2018 are based relate, for some quotas, to quantities exceeding those available. The extent to which import rights may be issued should therefore be determined by fixing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 6(3) in conjunction with Article 7(2) of Regulation (EC) No 1301/2006.

(4)

The quantities on which applications for import licences lodged from 1 to 7 April 2017 for the sub-period from 1 July to 30 September 2017 are based relate, for some quotas, to quantities less than those available. The quantities for which applications have not been lodged should therefore be determined, and these should be added to the quantity fixed for the following quota sub-period.

(5)

In order to ensure the efficient management of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

20.4.2017   

EN

Official Journal of the European Union

L 104/20

(1)

The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

(2)

Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex XX (Environment) to the EEA Agreement.

(3)

Regulation (EC) No 443/2009 of the European Parliament and of the Council (3) is to be incorporated into the EEA Agreement.

(4)

Commission Regulation (EU) No 1014/2010 (4) is to be incorporated into the EEA Agreement.

(5)

Commission Regulation (EU) No 63/2011 (5) is to be incorporated into the EEA Agreement.

(6)

Commission Implementing Regulation (EU) No 725/2011 (6) is to be incorporated into the EEA Agreement.

(7)

Commission Implementing Regulation (EU) No 429/2012 (7) is to be incorporated into the EEA Agreement.

(8)

Commission Implementing Regulation (EU) No 396/2013 (8) is to be incorporated into the EEA Agreement.

(9)

Commission Regulation (EU) No 397/2013 (9) is to be incorporated into the EEA Agreement.

(10)

Regulation (EU) No 333/2014 of the European Parliament and of the Council (10) is to be incorporated into the EEA Agreement.

(11)

Commission Delegated Regulation (EU) 2015/6 (11) is to be incorporated into the EEA Agreement.

(12)

Regulation (EC) No 443/2009 repeals Decision No 1753/2000/EC of the European Parliament and of the Council (12), which is incorporated into the EEA Agreement and is consequently to be repealed under the EEA Agreement.

(13)

Annex XX (Environment) to the EEA Agreement should therefore be amended accordingly.

(14)

The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,

20.4.2017   

EN

Official Journal of the European Union

L 104/26

(1)

Directive 98/41/EC aims at enhancing the safety and possibilities of rescue of passengers and crew on board passenger ships and ensuring that search and rescue and the aftermath of any accident can be dealt with more effectively.

(2)

Article 5(1) of Directive 98/41/EC requires certain information to be recorded regarding every passenger ship that departs from a port located in a Member State to undertake a voyage of more than twenty miles from the point of departure.

(3)

Article 9(4) of Directive 98/41/EC allows Member States to request the Commission to derogate from this requirement.

(4)

By letter of 29 September 2015, the Kingdom of Denmark and the Federal Republic of Germany transmitted to the Commission a request to derogate from the requirement to record information specified in Article 5(1) of Directive 98/41/EC concerning persons on board all passenger ships travelling on the route Rostock-Gedser and vice versa.

(5)

The Commission requested on 5 November 2015 additional information from the Kingdom of Denmark and the Federal Republic of Germany, in order to allow it to assess the request. On 25 May 2016, the Kingdom of Denmark and the Federal Republic of Germany submitted their response.

(6)

The Commission, assisted by EMSA, assessed the derogation request on the basis of the information at its disposal.

(7)

The Kingdom of Denmark and the Federal Republic of Germany provided the following information: (1) the annual probability of the significant wave height's exceeding two metres is less than 10 % on the identified routes; (2) the ships to which the derogation would apply are engaged in regular services; (3) the voyages do not exceed thirty miles from the point of departure; (4) the sea area where the passenger ships are sailing is provided with shore-based navigational guidance and reliable weather forecast services as well as adequate and sufficient search and rescue facilities; (5) the profile of the journey and the schedule of the voyages are not compatible with registering passenger details in a synchronised way with land transport; and (6) the derogation request would not have any adverse effect on competition.

(8)

The final outcome of the assessment demonstrates that all the conditions for the approving the derogation are fulfilled.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Committee on Safe Seas and the Prevention of Pollution from Ships,