9.4.2015   

EN

Official Journal of the European Union

L 93/1

(1)

Regulation (EU) No 1308/2013 contains in Chapter III of Title I of Part II rules on a scheme of authorisations for vine plantings which repeal and replace the transitional planting rights regime set out in Subsection II of Section IVa of Chapter III of Title I of Part II of Council Regulation (EC) No 1234/2007 (3) as from 1 January 2016. This Chapter lays down rules concerning duration, management and control of the scheme of authorisations for vine plantings and empowers the Commission to adopt delegated acts concerning the management of the scheme. The transitional planting rights regime set out in Subsection II of Section IVa of Chapter III of Title I of Part II of Regulation (EC) No 1234/2007 remains applicable until 31 December 2015 in accordance with Article 230(1)(b)(ii) of Regulation (EU) No 1308/2013.

(2)

Article 62 of Regulation (EU) No 1308/2013 lays down the general requirement for the Member States to grant an authorisation for vine planting upon submission of an application by producers intending to plant or replant vines. However, paragraph 4 of that Article provides that certain areas are exempted from the scheme of authorisations for vine plantings and therefore from this general requirement. It is necessary to lay down rules concerning the conditions of application of that exemption. The areas intended for experimental purposes or for graft nurseries should only be used for the specified purposes in order to avoid the circumvention of the new scheme, and grapevine products made from such areas should not be marketed unless Member States consider there are no risks of market disturbance. Existing wine-growing experiments and graft nurseries should be allowed to continue, subject to the existing rules in order to ensure a smooth transition between the plantings rights regime and the new scheme of authorisations for vine plantings. The areas whose wine or vine products are intended solely for the consumption by the wine grower's household should benefit from such exemption since, under certain conditions, they do not contribute to market disturbances. For the same reason, such exemption should also be extended to organisations without a commercial activity complying with the same conditions. The areas established by a producer having lost a certain area planted with vines due to compulsory purchases in the public interest under national law should also benefit from the exemption given that the loss of the land planted with vines in such cases is independent from the will of the producer. A condition as regards the maximum surface of the new area should however be laid down, so as to avoid undermining the general objectives of the scheme of authorisations for vine plantings.

(3)

Article 64(1) and (2) of Regulation (EU) No 1308/2013 lays down rules concerning the granting of authorisations for new plantings and sets out eligibility and priority criteria that Member States may apply. Specific conditions associated to some of the eligibility and priority criteria should be established in order to establish a level playing field for their implementation and to avoid the circumvention of the system of authorisations by producers being granted authorisations. In addition, three new criteria should be added: a new eligibility criterion on the misappropriation of reputation of protected geographical indications; a new priority criterion favouring those producers that comply with the rules of the scheme and do not have abandoned vineyards in their holding; and a new priority criterion favouring non-profit organisations with a social purpose having received lands confiscated in case of terrorism and other types of crime. The new eligibility criterion responds to the need of protecting the reputation of specific geographical indications in a similar manner as the reputation of specific designations of origin, ensuring that they are not threatened by new plantings. The first new priority criterion favours certain applicants on the basis of their background that shows their respect for the rules of the authorisations scheme and that they are not applying for authorisations for new plantings while having areas planted with vines out of production which could generate authorisations for replanting. The second new priority criterion aims at favouring non-profit organisations with a social purpose having received lands confiscated in case of terrorism and other types of crime, in order to promote the social use of land that could risk otherwise being out of production.

(4)

Taking into account Article 118 of Regulation (EU) No 1306/2013 and in order to address natural and socioeconomic differences and different growth strategies by the economic actors in those different areas within a particular territory, Member States should be permitted to apply the eligibility criteria and priority criteria referred to in Article 64(1) and (2) of Regulation (EU) No 1308/2013, as well as the new eligibility and priority criteria to be added by this Regulation, differently at regional level, for specific areas eligible for protected designation of origin, for specific areas eligible for protected geographical indication or for areas without a geographical indication. Such differences in the application of those criteria in the different areas of a particular territory should always be based on the differences between those areas.

(5)

In order to respond to cases of circumvention not anticipated by this act, Member States should adopt measures to avoid the circumvention of eligibility or priority criteria by applicants of authorisations where their actions are not already covered by the specific anti-circumvention provisions laid down in this Regulation with regard to the specific eligibility and priority criteria.

(6)

Article 66(2) of Regulation (EU) No 1308/2013 provides for the possibility of co-existence of vines that the producer has undertaken to grub up with newly planted vines. In order to prevent irregularities, Member States should have the possibility to ensure by the appropriate means that the undertaking to grub up is carried out, including the requirement to lodge a security accompanying the granting of an authorisation for anticipated replanting. In addition it is necessary to specify that in case the grubbing up is not carried out within the 4-year deadline set out by that provision the vines planted in the pledged area should be considered as non-authorised.

(7)

Article 66(3) of Regulation (EU) No 1308/2013 allows Member States to restrict the replanting in areas eligible for the production of wines with protected designations of origin or protected geographical indications, on the basis of a recommendation from recognised and representative professional organisations. The grounds or reasons for such decisions of restriction should be defined in order to clarify the limits of their scope, while ensuring the coherence of the scheme and avoiding its circumvention. In particular it should be ensured that the automaticity in granting authorisations for replantings established in Article 66(1) of Regulation (EU) No 1308/2013 does not hinder the possibility of Member States to limit the issuing of authorisations for specific areas in accordance with Article 63(2)(b) and Article 63(3). Nevertheless it should be clarified that certain specific cases may not be considered as a circumvention of the scheme.

(8)

Article 64 of Regulation (EU) No 1306/2013 provides for administrative penalties in cases of non-compliance in relation to eligibility criteria, commitments and other obligations resulting from the application of sectoral agricultural legislation. In order to ensure the deterrent effect, Member States should be able to graduate these penalties according to the commercial value of the wines produced in the vineyards concerned. In accordance with Article 71(4) of Regulation (EU) No 1308/2013 administrative penalties should be provided for in relation to non-authorised plantings, in order to provide a deterrent effect. The minimum value of those penalties should correspond to the average yearly income per hectare of vine areas at Union level, measured in gross margin per hectare of vine areas. A progressive graduation should be established from this minimum value, depending of the time of non-compliance. Member States should also be given the possibility to apply higher minimum penalties to producers in a certain area, where the minimum value established at Union level represents less than the estimated average yearly income per hectare of the area concerned. Such increase in the minimum value of penalties should be proportional to the estimated average yearly income per hectare for the area where the non-authorised vine area is located,

(a)

obtain an authorisation in accordance with Article 64 or 68 of Regulation (EU) No 1308/2013 for the area concerned, so that the grapes produced in that area and the grapevine products obtained from those grapes can be marketed; or

(b)

grub up such an area at his own cost in accordance with Article 71(1) of Regulation (EU) No 1308/2013.

(a)

such area does not exceed 0,1 ha;

(b)

the wine grower concerned is not involved in commercial wine production or in the commercial production of other grapevine products.

(a)

the specific area to be replanted is located in the same area of protected designation of origin or geographical indication as the area grubbed up and the replanting of vines complies with the same protected designation of origin or geographical indication specification as the area grubbed up;

(b)

the replanting is aimed at the production of wines without a geographical indication provided that the applicant undertakes the same commitments as those laid down in point (2) of Parts A and B of Annex I to this Regulation in relation to new plantings.

(a)

EUR 6 000 per hectare, if the producer grubs up the totality of the non-authorised planting within the 4 months from the date on which he is notified of the irregularity, as referred to in Article 71(2) of Regulation (EU) No 1308/2013;

(b)

EUR 12 000 per hectare, if the producer grubs up the totality of the non-authorised planting during the first year following the expiry of the 4-month period;

(c)

EUR 20 000 per hectare, if the producer grubs up the totality of the non-authorised planting after the first year following the expiry of the 4-month period.

9.4.2015   

EN

Official Journal of the European Union

L 93/12

(1)

Regulation (EU) No 1308/2013 contains in Chapter III of Title I of Part II rules on a scheme of authorisations for vine plantings which repeal and replace the transitional planting right regime set out in Subsection II of Section IVa of Chapter III of Title I of Part II of Council Regulation (EC) No 1234/2007 (3) as from 1 January 2016. Chapter III of Title I of Part II of Regulation (EU) No 1308/2013 lays down rules concerning duration, management and control of the scheme of authorisations for vine plantings and empowers the Commission to adopt implementing acts concerning the management and also the control of the scheme. The transitional planting right regime set out in Subsection II of Section IVa of Chapter III of Title I of Part II of Regulation (EC) No 1234/2007 remains applicable until 31 December 2015 in accordance with Article 230(1)(b)(ii) of Regulation (EU) No 1308/2013.

(2)

Article 62 of Regulation (EU) No 1308/2013 lays down the general requirement for Member States to grant an authorisation for vine planting upon submission of an application by producers intending to plant or replant vines. Article 63 of Regulation (EU) No 1308/2013 provides for a safeguard mechanism for new plantings, whereby Member States have to grant every year authorisations for new plantings corresponding to 1 % of the total area actually planted with vines in their territory, but where lower limits may be decided on the basis of sound justifications. Article 64 of Regulation (EU) No 1308/2013 lays down rules concerning the granting of authorisations for new plantings and sets out eligibility and priority criteria that Member States may apply.

(3)

Rules should be established at Union level concerning the procedure to follow by the Member States regarding the decisions on the safeguard mechanism and on the choice of eligibility and priority criteria. Such rules should include time limits for decisions to be taken and implications in case certain decisions are not taken.

(4)

In order to provide clarity and a consistent application in all Member States and wine regions, the rules in relation to the granting of authorisations for new plantings should also include the processing of applications, the selection procedure and their granting each year. In that way, producers are subject to similar rules at Union level when applying for authorisations for new plantings. These rules aim at ensuring a transparent, fair, and timely functioning of the system, adapted to the needs of the wine sector. They should also prevent that applicants face unjustified inequalities, excessive delays or disproportionate administrative burden. In particular, since the beginning of the wine year is on 1 August, the granting of authorisations for new plantings by that date seems well adjusted to the needs of the wine sector and ensures that vine plantings can still be undertaken within the same civil year. An appropriate date should be fixed to ensure that all relevant decisions taken by the Member State are made public in due time before the opening of the call for applications and to allow producers to be well aware of the applicable rules before they submit an application.

(5)

Where the total number of hectares requested in the eligible applications largely exceeds the number of hectares made available by Member States, it may lead to a large share of individual applicants obtaining only a fraction of the hectares they applied for and therefore not using the corresponding authorisations and thus being subject to penalties. To address such situations, it is appropriate not to impose such penalties where the authorisations granted correspond to less than a certain percentage of what was applied for. Furthermore, in order to avoid the loss of the corresponding authorisations, it should be made possible for Member States either to transfer them to the following year or to redistribute them within the same year among the applicants who did not see their application fully satisfied and did not reject the authorisations granted.

(6)

Article 66 of Regulation (EU) No 1308/2013 and Articles 3 and 4 of the Commission Delegated Regulation (EU) 2015/560 (4) establish rules concerning the granting of authorisations for replantings in the same holding. Rules should also be established at Union level concerning the procedure to follow by the Member States when granting those authorisations for replantings, and the time frame for Member States to grant these authorisations. In order to enable producers to address constraints as regards replanting in the same holding due to phytosanitary, environmental or operational reasons, Member States should have the possibility to allow the producers to submit an application within a reasonable but limited period after the grubbing up. Furthermore, given the administrative burden for Member States and for the producers implied by the submission and processing of applications for authorisations for replanting, it should also be possible to apply a simplified procedure in the specific cases where the area to be replanted corresponds to the area grubbed up or where no restrictions on replantings are decided.

(7)

Article 68 of Regulation (EU) No 1308/2013 establishes rules on the granting of authorisations on the basis of conversion of plantings rights granted before 31 December 2015. Rules should also be established at Union level concerning the procedure to be followed by the Member States for the granting of such authorisations. Timeframe for submission and treatment of the requests should be established, so that Member States can receive and process the requests for conversion in an appropriate and timely manner.

(8)

Article 62(2) of Regulation (EU) No 1308/2013 establishes that authorisations are to be granted for a specific area of the producer's holding identified in an application. In duly justified cases, applicants should be given the possibility to change such specific area during the period of validity of the authorisation. However, this possibility should be excluded in some cases in order to prevent the circumvention of the scheme of authorisations for vine plantings.

(9)

Articles 63(4), 64(3), 71(3) and Article 145 of Regulation (EU) No 1308/2013 establish the obligation for Member States to notify the Commission of certain aspects of the implementation of the scheme of authorisations for vine plantings. Requirements should be established to facilitate the communication of information by Member States on all relevant aspects of the management and control of this scheme, allowing for a proper monitoring of its implementation.

(10)

Article 62 of Regulation (EU) No 1306/2013 provides for the need to establish control provisions in relation to the implementation of the scheme of authorisations for vine plantings. General rules on control are needed in order to clarify that the main tool for verifying the compliance with the scheme is the vineyard register, and that controls should be carried out in line with the general principles which are laid down in Article 59 of Regulation (EU) No 1306/2013. Such rules should provide the general framework for Member States to develop more detailed provisions at national level in order to avoid non-authorised plantings and to ensure that the rules of the scheme of authorisations are respected, including the respect of the deadline for using the authorisations and for grubbing up in the case of anticipated replanting as well as the respect of the commitments made by the producers to obtain the authorisations.

(11)

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

(a)

the application of one or more of the criteria listed in the second subparagraph of Article 64(1) of Regulation (EU) No 1308/2013, including the due justification in case Member States decide to apply point (d) of Article 64(1), as well as in Article 2(1) of Delegated Regulation (EU) 2015/560;

(b)

the number of hectares available for the granting of authorisations at national level:

(a)

availability of authorisations for new planting corresponding to 1 % of the total area actually planted with vines in their territory, as specified in Article 63(1) of Regulation (EU) No 1308/2013, and without other limits;

(b)

pro-rata distribution of hectares to all eligible applicants on the basis of the area for which they have requested the authorisation, where applications exceed the area made available.

(a)

eligibility criteria referred to in Article 64(1)(c) of Regulation (EU) No 1308/2013 and in Article 2(1) of Delegated Regulation (EU) 2015/560: applications shall indicate the grapevine product(s) the applicant intends to produce in the newly planted area(s) specifying whether the applicant intends to produce one or more of the following:

(b)

priority criterion referred to in Article 64(2)(e) of Regulation (EU) No 1308/2013: applications shall include information of an economic nature demonstrating the economic sustainability of the respective project on the basis of on one or more of the standard methodologies of financial analysis for agricultural investment projects mentioned in Part E of Annex II to Delegated Regulation (EU) 2015/560;

(c)

priority criterion referred to in Article 64(2)(f) of Regulation (EU) No 1308/2013: applications shall include information of an economic nature demonstrating the potential for increased competitiveness on the basis of the considerations laid down in Part F of Annex II to Delegated Regulation (EU) 2015/560;

(d)

priority criterion referred to in Article 64(2)(g) of Regulation (EU) No 1308/2013: applications shall include information demonstrating the potential for the improvement of products with geographical indications on the basis of one of the conditions laid down in Part G of Annex II to Delegated Regulation (EU) 2015/560;

(e)

priority criterion referred to in Article 64(2)(h) of Regulation (EU) No 1308/2013: applications shall include information showing that the size of the applicant's holding at the time of the application complies with thresholds to be established by Member States on the basis of the provisions laid down in Part H of Annex II to Delegated Regulation (EU) 2015/560;

(f)

where Member States require applicants to undertake the commitments referred to in Parts (A) and (B) of Annex I and Parts (A), (B), (D), (E), (F), (G) and in section II of Part (I) of Annex II to Delegated Regulation (EU) 2015/560 in relation to the respective criteria, applications shall include those commitments.

(a)

the communication on wine-growing areas referred to in Article 145(3) of Regulation (EU) No 1308/2013, concerning the situation on 31 July of the previous wine year. This communication shall be made in the form set out in Annex II to this Regulation;

(b)

the notifications referred to in Articles 63(4) and 64(3) of Regulation (EU) No 1308/2013. These notifications shall be made in the form set out in Annex III to this Regulation;

(c)

a notification on the restrictions decided by Member States in relation to replantings in the same holding as referred to in Article 7 of this Regulation. This notification shall be made in the form set out in Annex VI (Table A) to this Regulation;

(d)

an updated national list of professional organisations or interested groups of producers referred to in Articles 2 and 7 of this Regulation;

(e)

the communication on the total size of the areas ascertained as planted with vines without an authorisation as well as the non-authorised areas grubbed up, as referred to in Article 71(3) of Regulation (EU) No 1308/2013. Such communication shall refer to the previous wine year. The first communication shall be submitted for the first time by 1 March 2017 and shall cover the period between 1 January 2016 and 31 July 2016. The communication shall be made in the form set out in Annex IV to this Regulation;

(f)

where Member States decide to apply the priority criterion referred to in Article 64(2)(h) of Regulation (EU) No 1308/2013, the thresholds decided in relation to the minimum and maximum size of holdings as referred to in Part H of Annex II to Delegated Regulation (EU) 2015/560.

(a)

a notification on the applications for authorisations for new plantings requested, on the authorisations effectively granted during the previous wine year pursuant to Article 6(1) or (2) of this Regulation, and on the authorisations refused by the applicants as well as those granted to other applicants before 1 October pursuant to Article 6(3) of this Regulation. These notifications shall be made in the form set out in Annex V to this Regulation;

(b)

a notification on the authorisations for replantings granted during the previous wine year as referred to in Article 8 of this Regulation. The first notification shall be made by 1 November 2016 and shall cover the period between 1 January 2016 and 31 July 2016. The notification shall be made in the form set out in Annex VI (Table B) to this Regulation;

(c)

a notification on the authorisations granted during the previous wine year on the basis of the conversion of valid planting rights as referred to in Article 9 of this Regulation. Such notification shall be made in the form set out in Annex VII (Table B), and be made only until the 1 November of the year following the end of the deadline for conversion referred to in Article 68(1) of Regulation (EU) No 1308/2013 or the deadline decided by the Member State in accordance with Article 9(2) of this Regulation.

9.4.2015   

EN

Official Journal of the European Union

L 93/35

(1)

Regulation (EC) No 661/2009 is a separate Regulation for the purposes of the type-approval procedure provided for by Directive 2007/46/EC of the European Parliament and of the Council (2).

(2)

Regulation (EC) No 661/2009 lays down basic requirements for the type-approval of motor vehicles of categories M2, M3, N2 and N3 with regard to the installation of advanced emergency braking systems (AEBS). It is necessary to set out the specific procedures, tests and requirements for such type-approval.

(3)

Regulation (EC) No 661/2009 lays down a general obligation for vehicles of categories M2, M3, N2 and N3 to be equipped with an AEBS.

(4)

Commission Regulation (EU) No 347/2012 (3) lays down the specific procedures, tests and requirements for the type-approval of motor vehicles with regard to AEBS, and provides for the implementation of those requirements in two stages. As part of the first stage, certain new vehicle types were to be subject, as of 1 November 2013, to approval level 1. As part of the second stage, those vehicle types, together with certain other vehicle types that had not been subject to approval level 1, would be required to obtain approval level 2, entailing compliance with further and more extensive requirements. Regulation (EU) No 347/2012 further provided that approval level 2 would be implemented as of 1 November 2016 for new vehicle types.

(5)

The time-frame for the implementation of approval level 2 was set to ensure there would be sufficient lead-in time for gaining further experience with AEBS systems and to enable further technical developments in this field. In addition, the time-frame was intended to enable the Commission to take account of international harmonised performance and test requirements that the United Nations Economic Commission for Europe (UNECE) was to adopt with respect to the types of vehicle of the categories covered by UN Regulation No 131 relating to AEBS.

(6)

It was therefore envisaged that the Commission would adopt, no later than two years before the implementation date for approval level 2, the warning and braking activation test criteria for types of vehicle of category M2 and of category N2 with a gross vehicle mass equal to or less than 8 tonnes, taking into consideration the further developments at UNECE level on this issue.

(7)

UNECE has specified the target speed value applicable for the moving target scenario in approval level 2 for the testing of types of vehicles of category M2 and of category N2 with a maximum mass not exceeding 8 tonnes. The target speed values have been set conservatively, so as to allow for further experience with AEBS systems to be gained and to enable further technical developments in this field for the vehicle types concerned.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Technical Committee — Motor Vehicles,

9.4.2015   

EN

Official Journal of the European Union

L 93/39

(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,

9.4.2015   

EN

Official Journal of the European Union

L 93/41

(1)

Commission Regulation (EC) No 1918/2006 (2) opened annual tariff quotas for imports of virgin olive oil falling within CN codes 1509 10 10 and 1509 10 90, wholly obtained in Tunisia and transported direct from that country to the European Union. Article 2(2) of Regulation (EC) No 1918/2006 lays down the maximum monthly quantities covered by the import licences to be issued.

(2)

The quantities covered by the applications for import licences lodged from 30 to 31 March 2015 for the month of April 2015 exceed those available. The extent to which 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) Submission of new applications should be suspended for the month of April 2015

(3)

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

9.4.2015   

EN

Official Journal of the European Union

L 93/43

(1)

Directive 2004/23/EC requires that Member States ensure the traceability of human tissues and cells from the donor to the recipient and vice versa.

(2)

In order to facilitate traceability it is necessary to establish a unique identifier applied to tissues and cells distributed in the Union (Single European Code) providing information on the main characteristics and properties of those tissues and cells.

(3)

In order to ensure a uniform implementation of the Single European Code throughout the Union, obligations of the Member States competent authorities and of the tissue establishments for the application of the Single European Code should be set out. Only this approach will guarantee a consistent and coherent application of the code in the Union.

(4)

Traceability from donor to recipient and vice versa should be ensured through coding of tissues and cells and through accompanying documentation. At the recipient end, the Single European Code provides information on the donation and on the tissue establishment responsible for the procurement of tissues and cells. At the donor end, the tissue establishment responsible for the procurement of tissues and cells may track the tissues and cells distributed for human application by requesting the next operators in the chain to provide data related to the use of the tissues and cells based on the donation identification elements of the Single European Code as contained in the accompanying documentation.

(5)

The format of the Single European Code should be harmonised in order to facilitate its application by small and large establishments, whilst allowing some flexibility for establishments to continue using existing codes.

(6)

A Single European Code allowing for donation and product identification should be allocated to all tissues and cells distributed for human application, including those imported from third countries. Member States may allow certain exemptions from the application of the code.

(7)

Where tissues and cells are excluded or exempted from the application of the Single European Code, the Member States should ensure that appropriate traceability of these tissues and cells is guaranteed throughout the entire chain from donation and procurement to human application.

(8)

In situations where tissues and cells are released for circulation, other than for distribution (such as transfer to another operator for further processing with or without return), as a minimum the donation identification sequence should be applied at least in the accompanying documentation. Where tissues and cells are transferred from a tissue establishment to another operator just for storage and/or for further distribution, the tissue establishment may already apply the Single European Code on their final label in addition to the donation identification sequence which should be applied at least in the accompanying documentation.

(9)

In the case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across procurements. This may be ensured by developing a central system for the allocation of the unique donation numbers for each donation event recorded at national level, or by requiring all tissue establishments to ensure robust traceability links between the donation identification numbers allocated by each tissue establishment procuring or receiving tissue and cells originating from the same deceased donor.

(10)

The Commission should ensure the implementation of the Single European Code by providing the appropriate tools to the Member States competent authorities and tissue establishments. The Member States competent authorities should update the register for tissue establishments, reflecting any changes in tissue establishment accreditations, designations, authorisations, or licences and the Commission should ensure the update of the register of the tissues and cells whenever new products need to be included. For this the Commission should consult a group of experts, in particular experts nominated by the Member States competent authorities.

(11)

For the donation identification sequence in the Single European Code, the importing tissue establishment should use the tissue establishment code allocated to it in the EU Tissue Establishment Compendium and should allocate a unique donation number if the donation number on the imported product is not globally unique.

(12)

Pooling of tissues or cells is allowed in some Member States. Therefore, the application of the Single European Code in case of pooling is also addressed by this Directive.

(13)

A transitional regime for tissues and cells already in storage at the end of the transposition period should be introduced.

(14)

This Directive does not prevent Member States from maintaining or introducing more stringent measures relating to coding of tissues and cells, provided that the provisions of the Treaty are met.

(15)

The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 29 of Directive 2004/23/EC,

(1)

In Article 2, the following points (k) to (y) are added:

(2)

Article 9 is replaced by the following:

‘Article 9

Traceability

1.   Member States shall ensure that tissues and cells shall be traceable in particular through documentation and the use of the Single European Code from procurement to human application or disposal and vice versa. Tissues and cells used for advanced therapy medicinal products shall be traceable under this Directive at least until transferred to the ATMP manufacturer.

2.   Member States shall ensure that tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, using an appropriate and readable storage medium.

3.   In case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across the procurements.’

(3)

Article 10 is replaced by the following:

‘Article 10

European coding system

1.   Without prejudice to paragraphs 2 or 3 of this Article, a Single European Code shall be applied to all tissues and cells distributed for human application. For the other situations where tissues and cells are released for circulation, as a minimum the donation identification sequence shall be applied at least in the accompanying documentation.

2.   Paragraph 1 shall not apply to:

3.   Member States may also allow exemptions from the requirement provided for in paragraph 1 for:

(4)

The following Articles are inserted:

‘Article 10a

Format of the Single European Code

1.   The Single European Code referred to in Article 10(1) shall comply with the specifications set out in this Article and in Annex VII.

2.   The Single European Code shall be in eye-readable format and shall be preceded by the acronym “SEC”. The parallel use of other labelling and traceability systems is possible.

3.   The Single European Code shall be printed with the Donation Identification Sequence and Product Identification Sequence separated by a single space or as two successive lines.

Article 10b

Requirements related to the application of the Single European Code

1.   Member States shall ensure that the following minimum requirements are complied with by tissue establishments, including importing tissue establishments as defined by Commission Directive (EU) 2015/566 (3):

2.   Member States shall ensure that the following minimum requirements are applied by all competent authorities:

3.   The application of the Single European Code does not preclude the additional application of other codes in accordance with Member States' national requirements.

Article 10c

Accessibility and maintenance of the European coding system

1.   The Commission shall host and maintain an IT platform (“EU Coding Platform”) which contains:

2.   The Commission shall ensure that the information contained in the EU Coding Platform is publicly available before 29 October 2016.

3.   The Commission shall update when needed the EUTC and ensure the overall update of the EU Tissue and Cell Product Compendium. The Commission considers that it is necessary that agreements are established with the organisations managing ISBT128 and Eurocode to ensure that updated product codes are regularly made available to the Commission for inclusion in the EU Tissue and Cell Product Compendium. If such organisations do not comply with the terms of the memoranda of understanding, the Commission may suspend, partially or in full, the future use of their respective product codes, having considered the sufficient supply of the concerned type of products in the Member States including a transitional period and having consulted the Member State experts through the Competent Authorities on Substances of Human Origin Expert Group.

Article 10d

Transitional period

Tissues and cells already in storage on 29 October 2016 shall be exempted from the obligations relating to the Single European Code, provided the tissues and cells are released for circulation in the Union within five years following that date and under the condition that full traceability is ensured by alternative means. For tissues and cells which remain in storage and which are only released for circulation after the expiry of this five-year period and for which the application of the Single European Code is not possible, in particular because the tissues and cells are stored under deep-freeze conditions, the tissue establishments shall use the procedures applicable to products with small labels as laid down in Article 10b paragraph 1(f).

(3)  Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissue (OJ L 93, 9.4.2015, p. 56).’"

(5)

The Annexes are amended in accordance with Annex I to this Directive.

(6)

A new Annex VIII is added, the text of which is set out in Annex II to this Directive.

9.4.2015   

EN

Official Journal of the European Union

L 93/56

(1)

Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of all human tissues and cells intended for human application, and for the donation, procurement, and testing of human tissues and cells contained in manufactured products intended for human application where those products are covered by other Union legislation, so as to ensure a high level of human health protection in the Union.

(2)

Exchanges of tissues and cells increasingly take place on a worldwide basis and Directive 2004/23/EC therefore requires that imports of tissues and cells are undertaken by tissue establishments accredited, designated, authorised or licensed by Member States for that purpose. Exceptions to that requirement are laid down in Article 9(3) of Directive 2004/23/EC allowing competent authorities to directly authorise the import of specific tissues and cells under the conditions laid down in Article 6 of Commission Directive 2006/17/EC (2) or in case of emergency. These exceptions are regularly used, but not limited to, allowing the import of haematopoietic stem cells from bone marrow, peripheral blood or cord blood which is used in the treatment of a number of life-threatening conditions.

(3)

Directive 2004/23/EC, furthermore, requires Member States and importing tissue establishments to ensure that imports of tissue and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC and calls for the establishment of procedures to verify the equivalency of the quality and safety standards of imports of tissues and cells. Those procedures should be laid down in this Directive without prejudice to the Union legislation on customs.

(4)

In particular, it is appropriate to establish authorisation and inspection schemes mirroring the verification process in place for activities related to tissues and cells carried out within the Union. It is also appropriate to lay down the procedures to be followed by importing tissue establishments in their relations with their third country suppliers.

(5)

With the exception of imports directly authorised by competent authorities pursuant to Article 9(3) of Directive 2004/23/EC, all imports of tissues and cells from third countries must be undertaken by importing tissue establishments. Where competent authorities do directly authorise imports pursuant to Article 9(3) of Directive 2004/23/EC, the responsibility to ensure that such imports meet quality and safety standards equivalent to those laid down in that Directive falls upon the competent authorities.

(6)

Tissues and cells should normally be imported by tissue banks or units of hospitals which are accredited, designated, authorised or licensed as importing tissue establishments for the purpose of their import activities. Tissue banks or units of hospitals should be considered to be importing tissue establishments where they are a party to a contractual agreement with a third country supplier for the import of tissues and cells. Where an organisation offering brokerage services is a party to a contractual agreement with a third country supplier to facilitate the import of tissues and cells but not for the import itself, it should not be considered to be an importing tissue establishment. Member States may choose to regulate such services outside the scope of this Directive.

(7)

Where other bodies such as organisations responsible for human application, manufacturers of advanced therapy medicinal products, clinical practitioners or individuals are a party to a contractual agreement with a third country supplier for the import of tissues and cells, they should be considered to be an importing tissue establishment. They must comply with the requirements of this Directive as well as with all relevant provisions of Directive 2004/23/EC and be accredited, designated, authorised or licensed as importing tissue establishments for the purpose of their import activities by their relevant competent authorities. Where, subsequent to the import, they also undertake testing, processing, preservation, storage or distribution of the imported tissues and cells they must also be accredited, designated, authorised or licensed by their relevant competent authorities for the purpose of those activities and comply with the requirements of Directive 2004/23/EC. Alternatively they may obtain tissues and cells originating from third countries from tissue banks or units of hospitals located within the Union which are accredited, designated, authorised or licensed as importing tissue establishments by their relevant competent authorities.

(8)

Where importing tissue establishments are also accredited, designated, authorised or licensed as tissue establishments for the activities they carry out within the Union, Member States may align their authorisation, inspection and reporting procedures provided the procedures laid down in this Directive are followed.

(9)

In order to facilitate the distribution within the Union of imported tissues and cells including where such distribution is cross-border in nature, the competent authority or authorities should issue the certificate attesting the accreditation, designation, authorisation, or licence of the importing tissue establishment.

(10)

Inspection measures play an important role in the verification of the equivalency of imported tissues and cells with the quality and safety standards laid down in Directive 2004/23/EC. Member States are therefore encouraged, where appropriate to also inspect third country suppliers and cooperate with other Member States into which imported tissues and cells are likely to be distributed. Member States in which the importing tissue establishments are located retain the responsibility for deciding on the most appropriate measures to be undertaken and for decisions on whether on-site inspections of third country suppliers are needed.

(11)

The Operational Manual for Competent Authorities on inspections has been updated to take into account inspections of importing tissue establishments and their third country suppliers and is available to Member States as a guidance document when undertaking such inspection measures.

(12)

Importing tissue establishments should verify that the standards of quality and safety of the tissues and cells they import into the Union are equivalent to the standards of quality and safety laid down in Directive 2004/23/EC. Written agreements with third country suppliers and the documentation to be provided and made available to competent authorities are key elements in ensuring such verification takes place and in particular providing traceability back to the donor and ensuring that the principle of voluntary and unpaid donation is adhered to in line with Directive 2004/23/EC. Importing tissue establishments are also encouraged to audit their third country suppliers as part of this verification process.

(13)

Importing tissue establishments should ensure that the Single European Code is applied to imported tissues and cells in line with Commission Directive 2006/86/EC (3), either by carrying out this task themselves or delegating it to third country suppliers as part of the terms of their written agreements with such suppliers.

(14)

Member States should be allowed to exempt one-off imports from the requirements laid down in this Directive in respect of documentation and written agreements. Such one-off imports should, however, be carried out by accredited, designated, authorised or licensed importing tissue establishments and as a general rule should not take place on a regular or repeated basis from the same third country supplier. The use of such exemptions should be limited to situations where a person or persons has or have had tissues and cells stored in a third country for their future use, in particular in cases of partner donations of reproductive cells, of autologous donations, or donations directed to close relatives, and subsequently, wishes to have such tissues or cells imported into the Union on their behalf. Such an import of any specific type of tissue or cell should normally not occur more than once for any given recipient and should not include tissues or cells for third parties.

(15)

This Directive does not prevent Member States from maintaining or introducing more stringent measures relating to imports of tissues and cells, in particular in order to ensure the principle of voluntary and unpaid donation is respected, provided that the provisions of the Treaty are met.

(16)

The measures provided for in this Directive are in accordance with the opinion of the Tissues and Cells Regulatory Committee established by Article 29(3) of Directive 2004/23/EC,

(a)

human tissues and cells intended for human application; and

(b)

manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other Union legislation.

(a)

the import of tissues and cells referred to in Article 9(3)(a) of Directive 2004/23/EC which are directly authorised by the competent authority or authorities;

(b)

the import of tissues and cells referred to in Article 9(3)(b) of Directive 2004/23/EC which are directly authorised in case of emergencies;

(c)

blood and blood components as defined by Directive 2002/98/EC;

(d)

organs or parts of organs, as defined in Directive 2004/23/EC.

(a)

‘emergency’ means any unforeseen situation in which there is no practical alternative other than to urgently import tissues and cells from a third country into the Union for immediate application to a known recipient or known recipients whose health would be seriously endangered without such an import;

(b)

‘importing tissue establishment’ means a tissue bank or a unit of a hospital or another body established within the Union which is a party to a contractual agreement with a third country supplier for the import into the Union of tissues and cells coming from a third country intended for human application;

(c)

‘one-off import’ means the import of any specific type of tissue or cell which is for the personal use of an intended recipient or recipients known to the importing tissue establishment and the third country supplier before the importation occurs. Such an import of any specific type of tissue or cell shall normally not occur more than once for any given recipient. Imports from the same third country supplier taking place on a regular or repeated basis shall not be considered to be ‘one-off imports’;

(d)

‘third country supplier’ means a tissue establishment or another body, established in a third country, which is responsible for the export to the Union of tissues and cells it supplies to an importing tissue establishment. A third country supplier may also carry out one or more of the activities, which take place outside of the Union, of donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells imported into the Union.

(a)

be empowered to inspect importing tissue establishments and, where appropriate, the activities of any third country suppliers;

(b)

evaluate and verify the procedures and activities carried out in importing tissue establishments and the facilities of third country suppliers that are relevant to ensuring the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC;

(c)

examine any documents or other records that are relevant for this evaluation and verification.

(a)

providing to the competent authority or authorities the required information and documentation as set out in Annex I to this Directive;

(b)

making available and, when requested by the competent authority or authorities, providing the documentation listed in Annex III to this Directive.

(a)

traceability from donor to recipient and vice versa; and

(b)

imported tissues and cells are not applied to anyone other than their intended recipients.

(a)

any revocation or suspension, in part or full, of a third country supplier's authorisation to export tissues and cells; and

(b)

any other decision taken for reasons of non-compliance by the competent authority or authorities of the country in which the third country supplier is based and which may be relevant to the quality and safety of imported tissues and cells.

(a)

traceability from donor to recipient and vice versa; and

(b)

imported tissues and cells are not applied to anyone other than their intended recipients.

9.4.2015   

EN

Official Journal of the European Union

L 93/69

(1)

Directive 64/432/EEC applies to trade within the Union in bovine animals. It lays down the conditions whereby a Member State may be declared officially tuberculosis-free as regards bovine herds.

(2)

Chapter 1 of Annex I to Commission Decision 2003/467/EC (2) lists the Member States which are declared officially tuberculosis-free as regards bovine herds.

(3)

Lithuania has submitted to the Commission documentation demonstrating compliance for its whole territory with the conditions laid down in Directive 64/432/EEC for officially tuberculosis-free status as regards bovine herds. Accordingly, it should be declared an officially tuberculosis-free Member State as regards bovine herds.

(4)

The list set out in Chapter 1 of Annex I to Decision 2003/467/EC should therefore be amended to include Lithuania.

(5)

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

9.4.2015   

EN

Official Journal of the European Union

L 93/71

(1)

Commission Implementing Decision 2012/725/EU (2) authorises the placing on the market of bovine lactoferrin as a novel food ingredient.

(2)

Annex I to Implementing Decision 2012/725/EU lays down the specifications for bovine lactoferrin. Those specifications contain a definition of bovine lactoferrin. This definition should be amended to better describe the authorised novel food ingredient.

(3)

Implementing Decision 2012/725/EU should therefore be amended accordingly.

(4)

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

‘Bovine lactoferrin (bLF) is a protein that occurs naturally in cow's milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.

bLF is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtration steps. Finally it is dried by freeze drying or spraying and the large particles are sieved out.’

9.4.2015   

EN

Official Journal of the European Union

L 93/72

(1)

Annex I to Commission Implementing Decision 2011/630/EU (2) sets out a list of third countries or parts thereof from which Member States are to authorise imports of semen of domestic animals of the bovine species (‘semen’). New Zealand is included in that list. In addition, in Section A of Part 1 of Annex II to that Implementing Decision the model animal health certificate for imports into and transits through the Union of semen dispatched from the semen collection centre where the semen was collected is set out.

(2)

Council Directive 64/432/EEC (3) lays down rules for intra-Union trade in bovine animals and provides for the monitoring and eradication programmes for certain diseases affecting those animals, including tuberculosis. New Zealand has requested for the recognition of its bovine tuberculosis control programme as being equivalent to the monitoring and eradication programmes for bovine tuberculosis that are implemented by the Member States in accordance with the conditions set out in Annex A.I to Directive 64/432/EEC. The information provided by New Zealand on its bovine tuberculosis control programme demonstrates that the bovine tuberculosis status of a bovine herd classified as ‘C2’, under the National Pest Management Strategy for bovine tuberculosis of New Zealand, is equivalent to the bovine tuberculosis status of a bovine herd that is recognised in a Member State as being an ‘officially tuberculosis-free bovine herd’ in accordance with the conditions set out in Annex A.I to Directive 64/432/EEC.

(3)

Therefore, the list of third countries or parts thereof from which Member States are to authorise imports of semen set out in Annex I and the model animal health certificate set out in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU should be amended in order to reflect the special conditions by which the Union recognises the equivalence of the classification of bovine herds as ‘C2’ within the framework of the bovine tuberculosis control programme implemented in New Zealand with the conditions set out in Annex A.I to Directive 64/432/EEC for a bovine herd in a Member State recognised as being an ‘officially tuberculosis-free bovine herd’.

(4)

To further reduce administrative burdens for the centre veterinarian and for the official veterinarian, it is appropriate to remove information on the total quantity of the straws of semen in the consignment from point I.28. of the model animal health certificate set out in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU as this information is already stated in point I.20. of that model animal health certificate.

(5)

In addition, it is necessary to insert in the table in point I.28. of the model animal health certificate set out in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU a column where information can be specified as regards the quantity of straws of semen collected on a particular date from an identified donor bull complying with particular conditions for bluetongue and epizootic haemorrhagic disease.

(6)

Annexes I and II to Implementing Decision 2011/630/EU should therefore be amended accordingly.

(7)

To avoid any disruption of imports into the Union of consignments of semen of domestic animals of the bovine species, the use of animal health certificates issued in accordance with Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU in their version before the entry into force of this Decision should be authorised during a transitional period subject to certain conditions.

(8)

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

9.4.2015   

EN

Official Journal of the European Union

L 93/80

(1)

Directive 2002/60/EC introduces the minimum Union measures for the control of African swine fever, including those to be applied in case of confirmation of the presence of African swine fever in feral pigs.

(2)

In 2014 Estonia and Latvia confirmed the presence of African swine fever in feral pigs and they have adopted disease control measures as provided for in Directive 2002/60/EC. In order to establish appropriate control measures and to prevent disease spread, a Union list of high risk areas has been established in the Annex to Commission Implementing Decision 2014/709/EU (2). Parts I, II and III of that Annex list the areas in Estonia and Latvia where the eradication plans are to be implemented.

(3)

In the light of the epidemiological situation and in accordance with Directive 2002/60/EC Estonia and Latvia submitted to the Commission the plans for the eradication of African swine fever in their respective concerned areas.

(4)

The plans submitted by Estonia and Latvia have been examined by the Commission and found to comply with Directive 2002/60/EC.

(5)

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

9.4.2015   

EN

Official Journal of the European Union

L 93/82

(1)

It is necessary to update the compilation of statistics on the issuance of securities to take into account updates to the European System of Accounts 2010, and to start compiling statistics on the issuance of securities by financial vehicle corporations engaged in securitisation transactions (‘FVCs’) within this framework.

(2)

It is also necessary to amend the reporting requirements for payment transactions involving non-monetary financial institutions laid down in Guideline ECB/2014/15 (4), thereby ensuring the appropriate recording of certain national payment instruments and services not explicitly mentioned or covered by Directive 2007/64/EC of the European Parliament and of the Council (5),

1.

Part 12 is replaced by the text in the Annex to this Guideline;

2.

in Part 16, Table 3 is replaced by the following:

;

3.

in Part 16, the following definition is added:

‘Other services (not included in the Payment Services Directive) — payment related services other than those services defined in Article 4(3) of Directive 2007/64/EC.’