Input:
COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013
of 14 January 2013
approving the active substance Trichoderma atroviride strain I-1237, 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 the Annex to Implementing Regulation (EU) No 540/2011
(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Articles 13(2) and 78(2) thereof,
Whereas:
(1)
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Trichoderma atroviride strain I-1237 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/565/EC (3).
(2)
In accordance with Article 6(2) of Directive 91/414/EEC France received on 28 August 2007 an application from Agrauxine SA for the inclusion of the active substance Trichoderma atroviride strain I-1237 in Annex I to Directive 91/414/EEC. Decision 2008/565/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(3)
For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 19 April 2011.
(4)
The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance Trichoderma atroviride strain I-1237 (4) on 15 May 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 20 November 2012 in the format of the Commission review report for Trichoderma atroviride strain I-1237.
(5)
It has appeared from the various examinations made that plant protection products containing Trichoderma atroviride strain I-1237 may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Trichoderma atroviride strain I-1237.
(6)
A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.
(7)
Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Trichoderma atroviride strain I-1237. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.
(8)
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.
(9)
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Approval of active substance
The active substance Trichoderma atroviride strain I-1237, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2
Re-evaluation of plant protection products
1. Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing Trichoderma atroviride strain I-1237 as an active substance by 30 November 2013.
By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing Trichoderma atroviride strain I-1237 as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 May 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
(a)
in the case of a product containing Trichoderma atroviride strain I-1237 as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2014 at the latest; or
(b)
in the case of a product containing Trichoderma atroviride strain I-1237 as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2014 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.
Article 3
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4
Entry into force and date of application
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 1 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 January 2013.


Input:
COUNCIL DECISION 2013/43/CFSP
of 22 January 2013
on continued Union activities in support of the Arms Trade Treaty negotiations, in the framework of the European Security Strategy
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Articles 26(2) and 31(1) thereof,
Whereas:
(1)
On 12 December 2003, the European Council adopted a European Security Strategy that called for an international order based on effective multilateralism. The European Security Strategy acknowledges the United Nations (UN) Charter as the fundamental framework for international relations. Strengthening the UN, equipping it to fulfil its responsibilities and to act effectively, is a priority of the Union.
(2)
On 6 December 2006, the UN General Assembly adopted Resolution 61/89 entitled ‘Towards an Arms Trade Treaty: establishing common international standards for the import, export and transfer of conventional arms’, through which it sought the views of UN Member States about a potential Treaty, and established a Group of Governmental Experts (GGE) to continue considering it, thus initiating the UN process for an Arms Trade Treaty (the ‘ATT process’).
(3)
On 2 December 2009, the UN General Assembly adopted Resolution 64/48 entitled ‘The Arms Trade Treaty’, by which it decided to convene in 2012 a UN Conference on the Arms Trade Treaty in order to elaborate a legally binding instrument on the highest possible common international standards for transfers of conventional arms.
(4)
In its conclusions of 11 December 2006, 10 December 2007, 12 July 2010, and 25 June 2012, the Council welcomed the different stages of the ATT process and expressed its strongest commitment to the success of the negotiation of a new legally binding international instrument that should establish the highest possible common international standards to regulate legal trade in conventional weapons, and that should be relevant to all UN Member States and could therefore be universal.
(5)
In order to promote the inclusiveness and relevance of the ATT process, the Council adopted on 19 January 2009 Decision 2009/42/CFSP on support for EU activities in order to promote among third countries the process leading towards an Arms Trade Treaty, in the framework of the European Security Strategy (1), and on 14 June 2010 Decision 2010/336/CFSP on EU activities in support of the Arms Trade Treaty, in the framework of the European Security Strategy (2), consisting of a series of regional seminars of worldwide coverage. The aim of those outreach events was to support the preparatory process leading up to the 2012 UN Conference on the Arms Trade Treaty, by broadening discussions and making concrete recommendations; and to support UN Member States in developing and improving expertise to implement effective arms transfer controls, once the Treaty would enter into force.
(6)
The UN Conference on the Arms Trade Treaty was convened at the UN Headquarters in New York from 2 to 27 July 2012, to elaborate a legally binding instrument on the highest possible common international standards for the transfer of conventional arms. The Conference was not able to agree on a concluding document within the timeframe set for it. However, considerable progress was achieved during the negotiations, as reflected in the draft Treaty text submitted by the President of the Conference on 26 July 2012.
(7)
On 7 November 2012, the UN General Assembly First Committee adopted a draft resolution entitled ‘The Arms Trade Treaty’, that decided to convene in New York from 18 to 28 March 2013 the Final UN Conference on the Arms Trade Treaty, to be governed by the rules of procedure adopted for the July 2012 Conference, in order to finalise the elaboration of the Arms Trade Treaty on the basis of the draft Treaty text submitted by the President of the previous UN Conference on 26 July 2012.
(8)
Considering the outcome of the July 2012 UN Conference, the activities established by Decision 2009/42/CFSP and Decision 2010/336/CFSP, and the need to contribute to the successful conclusion of the negotiations, the Union should continue to support the ATT process to ensure that it leads to the adoption of an effective and implementable legally binding Treaty without delay. The continued Union support to the ATT process should contribute to the successful completion of negotiations at the UN Conference on 18 to 28 March 2013, and promote implementation efforts in third countries that would have to comply with a future Arms Trade Treaty,
HAS ADOPTED THIS DECISION:
Article 1
1. For the purpose of supporting the Arms Trade Treaty (the ‘ATT’), the Union shall undertake activities with the following objectives:
-
to support the successful completion of the UN negotiations on an ATT;
-
to support UN Member States in developing and improving national and regional expertise to implement effective arms transfer controls, in order to ensure that the future ATT when entering into force, will be as effective as possible.
2. In order to achieve the objectives referred to in paragraph 1, the Union shall undertake the following project activity:
-
the organisation of two seminars for government experts aiming at facilitating the conclusion of negotiations and the future implementation of the ATT.
A detailed description of the project activity referred to in this paragraph is set out in the Annex.
Article 2
1. The High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’) shall be responsible for implementing this Decision.
2. The technical implementation of the project activity referred to in Article 1(2) shall be carried out by the EU Non-proliferation Consortium (the ‘Consortium’).
3. The Consortium shall perform its task under the responsibility of the High Representative. For this purpose, the High Representative shall enter into the necessary arrangements with the Consortium.
Article 3
1. The financial reference amount for the implementation of the project activity referred to in Article 1(2) shall be EUR 160 800.
2. The expenditure financed by the amount set out in paragraph 1 shall be managed in accordance with the procedures and rules applicable to the Union’s budget.
3. The Commission shall supervise the proper management of the expenditure referred to in paragraph 1. For this purpose, it shall conclude a financing agreement with the Consortium. The agreement shall stipulate that the Consortium is to ensure the visibility of the Union’s contribution, appropriate to its size.
4. The Commission shall endeavour to conclude the financing agreement referred to in paragraph 3 as soon as possible after the entry into force of this Decision. It shall inform the Council of any difficulties in that process and of the date of conclusion of the financing agreement.
Article 4
1. The High Representative shall report to the Council on the implementation of this Decision on the basis of regular reports following the organisation of each of the seminars. The reports will be prepared by the Consortium and they shall form the basis for the evaluation carried out by the Council.
2. The Commission shall provide information on the financial aspects of the implementation of the project activity referred to in Article 1(2).
Article 5
This Decision shall enter into force on the date of its adoption.
It shall expire 24 months after the date of conclusion of the financing agreement referred to in Article 3(3), or six months after the date of its adoption if no financing agreement has been concluded within that period.
Done at Brussels, 22 January 2013.


Input:
KOMISSION ASETUS (EU) N:o 397/2013,
annettu 30 päivänä huhtikuuta 2013,
Euroopan parlamentin ja neuvoston asetuksen (EU) N:o 443/2009 muuttamisesta uusien henkilöautojen hiilidioksidipäästöjen seurannan osalta
(ETA:n kannalta merkityksellinen teksti)
EUROOPAN KOMISSIO, joka
ottaa huomioon Euroopan unionin toiminnasta tehdyn sopimuksen,
ottaa huomioon päästönormien asettamisesta uusille henkilöautoille osana yhteisön kokonaisvaltaista lähestymistapaa kevyiden hyötyajoneuvojen hiilidioksidipäästöjen vähentämiseksi 23 päivänä huhtikuuta 2009 annetun Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 443/2009 (1) ja erityisesti sen 8 artiklan 9 kohdan toisen alakohdan,
sekä katsoo seuraavaa:
(1)
Uusien henkilöautojen hiilidioksidipäästöjen seurannasta vuosina 2010 ja 2011 saatu kokemus osoittaa, että keskimääräisten päästöjen ja päästötavoitteiden tarkka laskeminen on mahdollista ainoastaan asetuksen (EY) N:o 443/2009 8 artiklan 1 kohdassa tarkoitettujen yksityiskohtaisten tietojen perusteella. Sen vuoksi on asianmukaista mukauttaa asetuksen (EY) N:o 443/2009 liitteen II C osan ensimmäisessä taulukossa esitettyjä tietoja siten, että ne sisältävät ainoastaan ne tiedot, jotka ovat ehdottomasti tarpeen kyseisen asetuksen täytäntöönpanoa varten.
(2)
Jotta voidaan parantaa henkilöautojen hiilidioksidin seurannan laatua ja tarkkuutta, on kuitenkin tarpeen määrittää tarkemmin joitakin vaadituista tietoparametreista ja lisätä muita parametreja, joiden seuranta on tähän asti ollut vapaaehtoista.
(3)
Tyyppihyväksynnän numeron sisällyttäminen tietoparametreihin, joita on seurattava ja joista on raportoitava, voi parantaa valmistajien mahdollisuuksia varmistaa keskimääräisten päästöjen ja päästötavoitteiden alustavat laskelmat ja taata näin paremmin lopullisten tietojen tarkkuus.
(4)
Henkilöautoja, jotka hyväksytään kansallisesti pieninä sarjoina, kuten puitteiden luomisesta moottoriajoneuvojen ja niiden perävaunujen sekä tällaisiin ajoneuvoihin tarkoitettujen järjestelmien, osien ja erillisten teknisten yksiköiden hyväksymiselle 5 päivänä syyskuuta 2007 annetun Euroopan parlamentin ja neuvoston direktiivin 2007/46/EY (2) (puitedirektiivin) 23 artiklassa säädetään, tai autoja, jotka hyväksytään yksittäin, kuten kyseisen direktiivin 24 artiklassa säädetään, ei oteta huomioon valmistajan keskimääräisten päästöjen laskemista varten. On kuitenkin tärkeää seurata kyseisten ajoneuvojen lukumäärää johdonmukaisella tavalla, jotta voidaan arvioida mahdollisia vaikutuksia seurantaprosessiin sekä keskimääräisiä hiilidioksidipäästöjä koskevan unionin tavoitteen saavuttamiseen. Kyseisten rekisteröintien yhdistetyt lukumäärät olisi sen vuoksi toimitettava vuosittain.
(5)
Olisi myös varmistettava, että henkilöautojen hiilidioksidipäästöjen seuranta yhdenmukaistetaan kevyiden kuljetusajoneuvojen seurannan kanssa, josta säädetään päästönormien asettamisesta uusille kevyille kuljetusajoneuvoille osana unionin kokonaisvaltaista lähestymistapaa kevyiden hyötyajoneuvojen hiilidioksidipäästöjen vähentämiseksi 11 päivänä toukokuuta 2011 annetussa asetuksessa (EU) N:o 510/2011 (3), sisällyttämällä pakollisiin seurantaparametreihin tyyppihyväksynnän numeron lisäksi myös moottorin kapasiteetti ja sähköenergian kulutus. Lisäksi mikäli vaatimustenmukaisuustodistusta ei käytetä ensisijaisena tietolähteenä ja tiedot otetaan esimerkiksi tyyppihyväksyntäasiakirjoista, olisi selvennettävä, että näissä tapauksissa tietojen olisi vastattava vaatimustenmukaisuustodistuksissa ilmoitettuja tietoja.
(6)
Jotta voidaan varmistaa, että kyseiset muutokset voidaan ottaa huomioon tietojen seurannassa vuonna 2013, on syytä säätää, että muutokset tulevat voimaan viimeistään seitsemäntenä päivänä siitä, kun tämä säädös julkaistaan Euroopan unionin virallisessa lehdessä.
(7)
Sen vuoksi asetusta (EY) N:o 443/2009 olisi muutettava.
(8)
Tässä asetuksessa säädetyt toimenpiteet ovat ilmastonmuutoskomitean lausunnon mukaiset,
ON HYVÄKSYNYT TÄMÄN ASETUKSEN:
1 artikla
Korvataan asetuksen (EY) N:o 443/2009 liite II tämän asetuksen liitteessä olevalla tekstillä.
2 artikla
Tämä asetus tulee voimaan seitsemäntenä päivänä sen jälkeen, kun se on julkaistu Euroopan unionin virallisessa lehdessä.
Tämä asetus on kaikilta osiltaan velvoittava, ja sitä sovelletaan sellaisenaan kaikissa jäsenvaltioissa.
Tehty Brysselissä 30 päivänä huhtikuuta 2013.


Input:
ROZPORZĄDZENIE WYKONAWCZE KOMISJI (UE) 2015/572
z dnia 9 kwietnia 2015 r.
ustanawiające standardowe wartości w przywozie dla ustalania ceny wejścia niektórych owoców i warzyw
KOMISJA EUROPEJSKA,
uwzględniając Traktat o funkcjonowaniu Unii Europejskiej,
uwzględniając rozporządzenie Parlamentu Europejskiego i Rady (UE) nr 1308/2013 z dnia 17 grudnia 2013 r. ustanawiające wspólną organizację rynków produktów rolnych oraz uchylające rozporządzenia Rady (EWG) nr 922/72, (EWG) nr 234/79, (WE) nr 1037/2001 i (WE) nr 1234/2007 (1),
uwzględniając rozporządzenie wykonawcze Komisji (UE) nr 543/2011 z dnia 7 czerwca 2011 r. ustanawiające szczegółowe zasady stosowania rozporządzenia Rady (WE) nr 1234/2007 w odniesieniu do sektorów owoców i warzyw oraz przetworzonych owoców i warzyw (2), w szczególności jego art. 136 ust. 1,
a także mając na uwadze, co następuje:
(1)
Rozporządzenie wykonawcze (UE) nr 543/2011 przewiduje - zgodnie z wynikami wielostronnych negocjacji handlowych Rundy Urugwajskiej - kryteria, na których podstawie Komisja ustala standardowe wartości dla przywozu z państw trzecich, w odniesieniu do produktów i okresów określonych w części A załącznika XVI do wspomnianego rozporządzenia.
(2)
Standardowa wartość w przywozie jest obliczana każdego dnia roboczego, zgodnie z art. 136 ust. 1 rozporządzenia wykonawczego (UE) nr 543/2011, przy uwzględnieniu podlegających zmianom danych dziennych. Niniejsze rozporządzenie powinno zatem wejść w życie z dniem jego opublikowania w Dzienniku Urzędowym Unii Europejskiej,
PRZYJMUJE NINIEJSZE ROZPORZĄDZENIE:
Artykuł 1
Standardowe wartości celne w przywozie, o których mowa w art. 136 rozporządzenia wykonawczego (UE) nr 543/2011, są ustalone w załączniku do niniejszego rozporządzenia.
Artykuł 2
Niniejsze rozporządzenie wchodzi w życie z dniem jego opublikowania w Dzienniku Urzędowym Unii Europejskiej.
Niniejsze rozporządzenie wiąże w całości i jest bezpośrednio stosowane we wszystkich państwach członkowskich.
Sporządzono w Brukseli dnia 9 kwietnia 2015 r.


Input:
DELEGIERTE RICHTLINIE 2014/8/EU DER KOMMISSION
vom 18. Oktober 2013
zur Änderung - zwecks Anpassung an den technischen Fortschritt - des Anhangs IV der Richtlinie 2011/65/EU des Europäischen Parlaments und des Rates hinsichtlich einer Ausnahme für Blei in Loten zur Befestigung digitaler Cadmiumtellurid- und Cadmiumzinktellurid-Arraydetektoren auf Leiterplatten
(Text von Bedeutung für den EWR)
DIE EUROPÄISCHE KOMMISSION -
gestützt auf den Vertrag über die Arbeitsweise der Europäischen Union,
gestützt auf die Richtlinie 2011/65/EU des Europäischen Parlaments und des Rates vom 8. Juni 2011 zur Beschränkung der Verwendung bestimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten (1), insbesondere auf Artikel 5 Absatz 1 Buchstabe a,
in Erwägung nachstehender Gründe:
(1)
Gemäß der Richtlinie 2011/65/EU ist die Verwendung von Blei in in den Verkehr gebrachten Elektro- und Elektronikgeräten verboten.
(2)
Die Zuverlässigkeit von Substitutionsprodukten für Blei in Loten zur Befestigung digitaler Cadmiumtellurid- und Cadmiumzinktellurid-Arraydetektoren auf Leiterplatten ist nicht gewährleistet.
(3)
Für die Zuverlässigkeitsprüfungen und die Qualifizierung alternativer Lösungen wird noch Zeit benötigt.
(4)
Die Richtlinie 2011/65/EU ist daher entsprechend zu ändern -
HAT FOLGENDE RICHTLINIE ERLASSEN:
Artikel 1
Anhang IV der Richtlinie 2011/65/EU wird entsprechend dem Anhang dieser Richtlinie geändert.
Artikel 2
(1) Die Mitgliedstaaten erlassen und veröffentlichen bis zum letzten Tag des sechsten Monats nach Inkrafttreten dieser Richtlinie die Rechts- und Verwaltungsvorschriften, die erforderlich sind, um dieser Richtlinie nachzukommen. Sie übermitteln der Kommission unverzüglich den Wortlaut dieser Vorschriften.
Wenn die Mitgliedstaaten diese Vorschriften erlassen, nehmen sie in den Vorschriften selbst oder durch einen Hinweis bei der amtlichen Veröffentlichung auf diese Richtlinie Bezug. Die Mitgliedstaaten regeln die Einzelheiten der Bezugnahme.
(2) Die Mitgliedstaaten teilen der Kommission den Wortlaut der wichtigsten einzelstaatlichen Rechtsvorschriften mit, die sie auf dem unter diese Richtlinie fallenden Gebiet erlassen.
Artikel 3
Diese Richtlinie tritt am zwanzigsten Tag nach ihrer Veröffentlichung im Amtsblatt der Europäischen Union in Kraft.
Artikel 4
Diese Richtlinie ist an die Mitgliedstaaten gerichtet.
Brüssel, den 18. Oktober 2013


Input:
DECISÃO DE EXECUÇÃO DA COMISSÃO
de 4 de junho de 2013
que altera a Decisão de Execução 2012/715/UE que estabelece uma lista de países terceiros dotados de um quadro regulamentar aplicável a substâncias destinadas a medicamentos para uso humano e de medidas de controlo e execução correspondentes que asseguram um nível de proteção da saúde pública equivalente ao que vigora na União
(Texto relevante para efeitos do EEE)
(2013/262/UE)
A COMISSÃO EUROPEIA,
Tendo em conta o Tratado sobre o Funcionamento da União Europeia,
Tendo em conta a Diretiva 2001/83/CE do Parlamento Europeu e do Conselho, de 6 de novembro de 2001, que estabelece um código comunitário relativo aos medicamentos para uso humano (1), nomeadamente o artigo 111.o-B, n.o 1,
Considerando o seguinte:
(1)
Em conformidade com o artigo 111.o-B, n.o 1, da Diretiva 2001/83/CE, qualquer país terceiro pode solicitar à Comissão que avalie se o seu quadro regulamentar aplicável às substâncias ativas exportadas para a União e as medidas de controlo e execução correspondentes asseguram um nível de proteção da saúde pública equivalente ao que vigora na União, a fim de ser incluído numa lista de países terceiros que asseguram um nível de proteção da saúde pública equivalente.
(2)
O Japão solicitou, por carta datada de 6 de dezembro de 2012, ser incluído na referida lista em conformidade com o artigo 111.o-B, n.o 1, da Diretiva 2001/83/CE. A avaliação de equivalência efetuada pela Comissão confirmou estarem preenchidos os requisitos previstos no referido artigo.
(3)
A Decisão de Execução 2012/715/UE da Comissão, de 22 de novembro de 2012, que estabelece uma lista de países terceiros dotados de um quadro regulamentar aplicável a substâncias destinadas a medicamentos para uso humano e de medidas de controlo e execução correspondentes que asseguram um nível de proteção da saúde pública equivalente ao que vigora na União, em conformidade com a Diretiva 2001/83/CE do Parlamento Europeu e do Conselho (2), deve ser alterada em conformidade,
ADOTOU A PRESENTE DECISÃO:
Artigo 1.o
O anexo da Decisão de Execução 2012/715/UE é substituído pelo texto constante do anexo da presente decisão.
Artigo 2.o
A presente decisão entra em vigor no vigésimo dia seguinte ao da sua publicação no Jornal Oficial da União Europeia.
Feito em Bruxelas, em 4 de junho de 2013.


Input:
RÈGLEMENT (UE) No 937/2014 DE LA COMMISSION
du 22 août 2014
interdisant la pêche de la sole commune dans les zones VII f et VII g par les navires battant pavillon de l'Irlande
LA COMMISSION EUROPÉENNE,
vu le traité sur le fonctionnement de l'Union européenne,
vu le règlement (CE) no 1224/2009 du Conseil du 20 novembre 2009 instituant un régime communautaire de contrôle afin d'assurer le respect des règles de la politique commune de la pêche (1), et notamment son article 36, paragraphe 2,
considérant ce qui suit:
(1)
Le règlement (UE) no 43/2014 du Conseil (2) fixe des quotas pour 2014.
(2)
Il ressort des informations communiquées à la Commission que les captures effectuées dans le stock visé à l'annexe du présent règlement par les navires battant pavillon de l'État membre mentionné à ladite annexe ou enregistrés dans cet État membre ont épuisé le quota attribué pour 2014.
(3)
Il est donc nécessaire d'interdire les activités de pêche pour ce stock,
A ADOPTÉ LE PRÉSENT RÈGLEMENT:
Article premier
Épuisement du quota
Le quota de pêche attribué pour 2014 à l'État membre visé à l'annexe du présent règlement pour le stock mentionné dans celle-ci est réputé épuisé à compter de la date indiquée dans ladite annexe.
Article 2
Interdictions
Les activités de pêche concernant le stock visé à l'annexe du présent règlement par les navires de pêche battant pavillon de l'État membre mentionné à ladite annexe ou enregistrés dans cet État membre sont interdites à compter de la date fixée dans cette annexe. En particulier, la détention à bord, le transfert, le transbordement et le débarquement de poissons prélevés par lesdits navires dans le stock concerné sont également interdits après cette date.
Article 3
Entrée en vigueur
Le présent règlement entre en vigueur le jour suivant celui de sa publication au Journal officiel de l'Union européenne.
Le présent règlement est obligatoire dans tous ses éléments et directement applicable dans tout État membre.
Fait à Bruxelles, le 22 août 2014.