10.3.2012   

EN

Official Journal of the European Union

L 72/1

(1)

On 17 March 2008, the Council adopted Regulation (EC) No 241/2008 on the conclusion of the Fisheries Partnership Agreement between the European Community and the Republic of Guinea-Bissau (1).

(2)

The Union has negotiated with the Republic of Guinea-Bissau a new protocol granting EU vessels fishing opportunities in waters in which Guinea-Bissau exercises its sovereignty or jurisdiction as regards fishing (hereinafter ‧the Protocol‧).

(3)

At the end of those negotiations, the Protocol was initialled on 15 June 2011.

(4)

The Protocol was signed in accordance with Council Decision 2011/885/EU (2) and has been applied on a provisional basis since 16 June 2011.

(5)

The Protocol should be concluded,

10.3.2012   

EN

Official Journal of the European Union

L 72/2

(1)

Pursuant to Articles 18 and 26 of Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (2), a manufacturer must ensure that each new light commercial vehicle placed on the market in the Union is accompanied by a valid certificate of conformity and a Member State may not register such a vehicle unless it is accompanied by such a certificate. In accordance with Annex II to Regulation (EU) No 510/2011, data collected by a Member State to monitor the manufacturer’s compliance with Articles 4 and 11 of that Regulation are to be consistent with a certificate of conformity and based on this document only.

(2)

Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community’s integrated approach to reduce CO2 emissions from light-duty vehicles (3) requires the Member States to use the certificate of conformity as a data source but allows for the use of other documents providing equivalent accuracy for the monitoring and reporting of CO2 emissions from passenger cars. In order to ensure cost-efficient and accurate monitoring and reporting of CO2 emissions data for light commercial vehicles, it is appropriate in the short-term to allow Member States to use the same procedure and data sources for the monitoring and reporting under Regulation (EU) No 510/2011 as those used for reporting under Regulation (EC) No 443/2009. Therefore, Annex II to Regulation (EU) No 510/2011 should, where duly justified, allow for the use of other data sources providing equivalent accuracy for CO2 monitoring and reporting purposes. The Member States should put the necessary measures in place to ensure adequate accuracy in the monitoring procedure.

(3)

Based on the experience gained from the monitoring of CO2 emissions from passenger cars, it is appropriate, in order to improve the means for verifying the accuracy of the data, to add type-approval number as a detailed data parameter to be reported by Member States. It has also become evident that there is no need for the parameter ‘commercial name’ which therefore should be deleted from the detailed monitoring data.

(4)

In order to ensure clarity and precision in the monitoring and reporting by Member States, it is also necessary to ensure consistency between the different requirements specified in Annex II to Regulation (EU) No 510/2011. The detailed data requirements are specified in the reporting formats set out in Part C of Annex II. Parts A and B of that Annex should therefore be adjusted to reflect those detailed data requirements accurately.

(5)

Annex II to Regulation (EU) No 510/2011 should therefore be amended accordingly,

10.3.2012   

EN

Official Journal of the European Union

L 72/7

(1)

Under Directive 2009/125/EC ecodesign requirements should be set by the Commission for energy-related products representing significant volumes of sales and trade, having significant environmental impact and presenting significant potential for improvement through design in terms of their environmental impact, without entailing excessive costs.

(2)

Point (a) of Article 16(2) of Directive 2009/125/EC provides that in accordance with the procedure referred to in Article 19(3) and the criteria set out in Article 15(2), and after consulting the Ecodesign Consultation Forum, the Commission shall, as appropriate, introduce implementing measures offering a high potential for cost-effective reduction of greenhouse gas emissions, such as for products in heating, ventilation and air-conditioning systems.

(3)

The Commission has carried out a preparatory study to analyse the technical, environmental and economic aspects of air conditioners and comfort fans typically used in households and small commercial establishments. The study has been developed together with stakeholders and interested parties from the EU and third countries, and the results have been made publicly available.

(4)

The main environmental aspects of the products covered, identified as significant for the purposes of this Regulation, are energy consumption in use phase and sound power level. The preparatory study also identified possible refrigerant leakage as a significant environmental aspect in form of direct greenhouse gas emissions, representing on average 10-20 % of the combined direct and indirect greenhouse gas emissions.

(5)

As shown in the preparatory study and confirmed during the impact assessment, there is a lack of information on the efficiency of comfort fans. However, in order to provide market surveillance authorities important information and allow efficient monitoring of the market for the purposes of setting minimum energy efficiency requirements in the future, product information requirements on comfort fans will ensure that the efficiency of the appliance and the measurement method used be well visible on the product. Furthermore, standby and off mode requirements are set for comfort fans.

(6)

The annual electricity consumption of products subject to this Regulation was estimated to have been 30 TWh in the EU in 2005. Unless specific measures are taken, annual electricity consumption is predicted to be 74 TWh in 2020. The preparatory study shows that the electricity consumption of products subject to this Regulation can be significantly reduced.

(7)

The preparatory study shows that requirements regarding other ecodesign parameters referred to in Annex I, Part 1, to Directive 2009/125/EC are not necessary as electricity consumption and sound power level of air conditioners in the use phase are the most significant environmental aspects.

(8)

As refrigerants are addressed under Regulation (EC) No 842/2006 of the European Parliament and of the Council of 17 May 2006 on certain fluorinated greenhouse gases (2) no specific requirements on refrigerants are set in this Regulation. However, a bonus is proposed under the ecodesign requirements to steer the market towards the use of refrigerants with reduced harmful impact on the environment. The bonus will lead to lower minimum energy efficiency requirements for appliances using low- global warming potential (GWP) refrigerants.

(9)

Air conditioners can be part of systems installed in buildings. National legislation based inter alia on Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (3) may set new stricter requirements on those air conditioning systems, using the calculation and measurement methods defined in this Regulation as regards the efficiency of the air conditioner.

(10)

Standby and off-mode functions can be responsible for an important part of the total power consumption of these appliances. For air conditioners, except for double and single duct air conditioners, power consumption of these functions is part of the minimum energy performance requirements and of the seasonal efficiency measurement method. Standby and off-mode requirements for double and single duct air conditioners are set on the basis of the Ecodesign requirements of Commission Regulation (EC) No 1275/2008 (4).

(11)

The combined effect of ecodesign requirements set out in this Regulation and Commission Delegated Regulation (EU) No 626/2011 of 4 May 2011 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of air conditioners (5) is expected to result in annual electricity savings of 11 TWh by 2020, compared to the situation if no measures are taken.

(12)

Products subject to this Regulation should be made more energy efficient by applying existing non-proprietary cost-effective technologies that can reduce the combined costs of purchasing and operating these products.

(13)

The ecodesign requirements should not affect functionality from the end-user's perspective and should not negatively affect health, safety or the environment. In particular, the benefits of reducing electricity consumption during the use phase should more than offset any possible additional environmental impact during the production phase.

(14)

The ecodesign requirements should be introduced gradually in order to provide a sufficient timeframe for manufacturers to re-design products subject to this Regulation. The timing should be such as to avoid negative impacts on the functionalities of equipment on the market, and to take into account cost impacts for end-users and manufacturers, in particular small and medium-sized enterprises, while ensuring timely achievement of the objectives of this Regulation.

(15)

Measurements of the relevant product parameters should be performed through reliable, accurate and reproducible measurement methods, which take into account the recognised state of the art measurement methods including, where available, harmonised standards adopted by the European standardisation bodies, as listed in Annex I to Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34/EC laying down a procedure for the provision of information in the field of technical standards and regulations (6).

(16)

In accordance with Article 8 of Directive 2009/125/EC, this Regulation specifies the applicable conformity assessment procedures.

(17)

In order to facilitate compliance checks, manufacturers should provide information in the technical documentation referred to in Annexes IV and V to Directive 2009/125/EC in so far as this information relates to the requirements laid down in this Regulation.

(18)

In addition to the legally binding requirements laid down in this Regulation, indicative benchmarks for best available technologies should be identified to ensure the wide availability and easy accessibility of information on the life-cycle environmental performance of products subject to this Regulation.

(19)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 19(1) of Directive 2009/125/EC,

(a)

appliances that use non-electric energy sources;

(b)

air conditioners of which the condenser-side or evaporator-side, or both, do not use air for heat transfer medium.

1.

‘air conditioner’ means a device capable of cooling or heating, or both, indoor air, using a vapour compression cycle driven by an electric compressor, including air conditioners that provide additional functionalities such as dehumidification, air-purification, ventilation or supplemental air-heating by means of electric resistance heating, as well as appliances that may use water (either condensate water that is formed on the evaporator side or externally added water) for evaporation on the condenser, provided that the device is also able to function without the use of additional water, using air only;

2.

‘double duct air conditioner’ means an air conditioner in which, during cooling or heating, the condenser (or evaporator) intake air is introduced from the outdoor environment to the unit by a duct and rejected to the outdoor environment by a second duct, and which is placed wholly inside the space to be conditioned, near a wall;

3.

‘single duct air conditioner’ means an air conditioner in which, during cooling or heating, the condenser (or evaporator) intake air is introduced from the space containing the unit and discharged outside this space;

4.

‘rated capacity’ (Prated) means the cooling or heating capacity of the vapour compression cycle of the unit at standard rating conditions;

5.

‘comfort fan’ means an appliance primarily designed for creating air movement around or on part of a human body for personal cooling comfort, including comfort fans that can perform additional functionalities such as lighting;

6.

‘fan power input’ (PF) means the electric power input of a comfort fan in Watt operating at the declared maximum fan flow rate, measured with the oscillating mechanism active (if/when applicable).

From 1 January 2013:

single duct and double duct air conditioners shall correspond to requirements as indicated in Annex I, point 2(a).

From 1 January 2013:

From 1 January 2014:

10.3.2012   

EN

Official Journal of the European Union

L 72/28

(1)

For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users. It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety.

(2)

Such possibility of providing instructions for use in electronic form instead of in paper form should be limited to certain medical devices and accessories intended to be used in specific conditions. In any case, for reasons of safety and efficiency users should always have the possibility to obtain those instructions for use in paper form on request.

(3)

In order to reduce potential risks as far as possible, the appropriateness of the provision of instructions for use in electronic form should be subject to a specific risk assessment by the manufacturer.

(4)

In order to ensure that users have access to the instructions for use, appropriate information about access to those instructions for use in electronic form and about the right to request the instructions for use in paper form, should be provided.

(5)

To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates and of product alerts, the instructions for use in electronic form should also be available through a website.

(6)

Regardless of the language obligations imposed on manufacturers by the law of the Member States, manufacturers who provide instructions for use in electronic form should indicate on their website in which Union languages those instructions are available.

(7)

Except for medical devices of Class I, as defined in Annex IX to Directive 93/42/EEC, the fulfilment of the obligations laid down in this Regulation should be reviewed by a notified body during the procedure applicable for conformity assessment based on a specific sampling method.

(8)

As the protection of the right to privacy of natural persons with respect to the processing of personal data should be ensured by manufacturers and notified bodies as well, it is appropriate to provide that websites containing instructions for use of a medical device fulfil the requirements of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3).

(9)

In order to ensure safety and consistency, instructions for use in electronic form which are provided in addition to complete instructions for use in paper form should be covered by this Regulation as regards limited requirements in relation to their contents and websites.

(10)

It is appropriate to provide for a deferred application of this Regulation so as to facilitate the smooth transition to the new system and to allow all operators and Member States time to adapt to it.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of Directive 90/385/EEC,

(a)

‘instructions for use’ means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its expected performances and of any precautions to be taken as outlined in the relevant parts of point 15 of Annex 1 to Directive 90/385/EEC and of point 13 of Annex I to Directive 93/42/EEC;

(b)

‘instructions for use in electronic form’ means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or instructions for use available through a website;

(c)

‘professional users’ means persons using the medical device in the course of their work and in the framework of a professional healthcare activity;

(d)

‘fixed installed medical devices’ means devices and their accessories which are intended to be installed, fastened or otherwise secured at a specific location in a healthcare facility so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare facility.

(a)

active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;

(b)

implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;

(c)

fixed installed medical devices covered by Directive 93/42/EEC;

(d)

medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use;

(e)

stand-alone software covered by Directive 93/42/EEC.

(a)

the devices and accessories are intended for exclusive use by professional users;

(b)

the use by other persons is not reasonably foreseeable.

(a)

knowledge and experience of the intended users in particular regarding the use of the device and user needs;

(b)

characteristics of the environment in which the device will be used;

(c)

knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;

(d)

access of the user to the reasonably foreseeable electronic resources needed at the time of use;

(e)

performance of safeguards to ensure that the electronic data and content are protected from tampering;

(f)

safety and back-up mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;

(g)

foreseeable medical emergency situations requiring the provision of information in paper form;

(h)

impact caused by the temporary unavailability of the specific website or of the Internet in general, or of their access in the healthcare facility as well as the safety measures available to cope with such a situation;

(i)

evaluation of the time period within which the instructions for use shall be provided in paper form at the users request.

(1)

the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form;

(2)

they shall provide instructions for use in electronic form in all Member States where the product is made available or put into service, unless duly justified in the risk assessment referred to in Article 4;

(3)

they shall have a system in place to provide the instructions for use in printed paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order;

(4)

they shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device;

(5)

they shall ensure the proper design and functioning of the instructions for use in electronic form and provide verification and validation evidence to this effect;

(6)

for medical devices fitted with a built-in system visually displaying the instructions for use, they shall ensure that displaying the instructions for use does not impede the safe use of the device, in particular life-monitoring or life-supporting functions;

(7)

they shall provide, in their catalogue or in other appropriate device information support, information on software and hardware requirements needed to display the instructions for use;

(8)

they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;

(9)

for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for the users in electronic form for at least 2 years after the end of the expiry date of the last produced device;

(10)

for devices without a defined expiry date and for implantable devices, they shall keep the instructions for use available for the users in electronic form for a period of 15 years after the last device has been manufactured.

(a)

any information needed to view the instructions for use;

(b)

a unique reference, giving direct access, and any other information needed by the user to identify and access the appropriate instructions for use;

(c)

relevant manufacturer contact details;

(d)

where, how and within which time instructions for use in paper form can be requested and shall be obtained at no additional cost in conformity with Article 5.

(a)

the instructions for use shall be provided in a commonly used format that can be read with freely available software;

(b)

it shall be protected against hardware and software intrusion;

(c)

it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;

(d)

it shall mention in which Union languages the manufacturer provides the instructions for use in electronic form;

(e)

it shall fulfil the requirements of Directive 95/46/EC;

(f)

the Internet address as displayed in accordance with Article 6(2) shall be stable and directly accessible during the periods set out in points (9) and (10) of Article 5;

(g)

all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website.

10.3.2012   

EN

Official Journal of the European Union

L 72/32

(1)

Article 27 of Regulation (EC) No 1234/2007 as amended by Regulation (EU) No 121/2012 of the European Parliament and of the Council (3) has established a scheme whereby food products may be distributed to the most deprived persons in the Union. For that purpose, products in intervention stocks may be made available or, where intervention stocks suitable for the food distribution scheme are not available, food products may be purchased on the market. For 2012 and 2013, that scheme is included in the list of measures eligible for financing by the European Agricultural Guarantee Fund (EAGF) set out in Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (4), within an annual ceiling of EUR 500 million.

(2)

In accordance with Article 27(3) of Regulation (EC) No 1234/2007 the Commission has to adopt annual plans. The annual distribution plan for 2012 was adopted on 10 June 2011 by Commission Implementing Regulation (EU) No 562/2011 (5) solely on the basis of products available in intervention stocks. The additional resources made available on the 2012 budget year for the distribution of food products to the most deprived persons in the Union, as a result of the amendment of Article 27 of Regulation (EC) No 1234/2007 by Regulation (EU) No 121/2012, should be allocated to the Member States.

(3)

In order to enforce the annual budgetary ceiling, the intra-Union transfer costs, where relevant, should be included into the total financial allocation made available for each Member State to implement the 2012 distribution plan. Moreover, the deadlines fixed by Article 9 of Commission Regulation (EU) No 807/2010 of 14 September 2010 laying down detailed rules for the supply of food from intervention stocks for the benefit of the most deprived persons in the Union (6) for the requests for payment and the execution of payments by the competent authorities should be adjusted, in order to ensure that the resources allocated within the 2012 distribution plan are only eligible for Union support if those payments are made in the 2012 budget year.

(4)

Taking into account the shortened time-frame left to the Member States for the implementation of the 2012 distribution plan as a consequence of the date of entry into force of Regulation (EU) No 121/2012, it is appropriate to grant an extension of the deadlines provided for in Article 3(1) and (3) of Regulation (EU) No 807/2010 as regards the implementation period of the annual plan and the completion of the payment operations for products mobilised on the market.

(5)

That revision of the distribution plan for 2012 being made at a time when national administrative arrangements for the implementation of the plan should be approaching completion, the quantities of products available in intervention stocks which are reallocated following the decision of Finland to renounce to a part of its allocation of skimmed milk powder or to reassessment of the exact quantities in intervention storage should not be taken into account for calculating whether Member States have respected the obligation laid down in the second and third subparagraphs of Article 3(2) of Regulation (EU) No 807/2010 to have withdrawn 70 % of cereals and skimmed milk powder by the deadlines fixed in that Article.

(6)

In view of the fact that the implementation period of the 2012 distribution plan is already advanced and to allow Member States as much time as possible to proceed to the actions needed for the implementation of the amended plan, this Regulation should enter into force on the day of its publication.

(7)

Implementing Regulation (EU) No 562/2011 should therefore be amended accordingly.

(8)

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

(1)

Articles 1 and 2 are replaced by the following:

‘Article 1

1.   In 2012, the distribution of food to the most deprived persons in the Union under Article 27 of Regulation (EC) No 1234/2007 shall be implemented in accordance with the annual distribution plan set out in Annex I to this Regulation.

Financial resources available to implement the 2012 plan can be used by Member States within the limits set out in point (a) of Annex I.

The quantities of each type of product to be withdrawn from intervention stocks are set out in point (b) of that Annex.

Indicative allocations to Member States for the purchase of food products on the Union market are set out in point (c) of that Annex.

2.   The use of cereals as payment for mobilising rice products on the market is authorised, as referred to in Article 4(2) of Regulation (EU) No 807/2010.

Article 2

The intra-Union transfer of products listed in Annex II to this Regulation shall be authorised, subject to the conditions laid down in Article 8 of Regulation (EU) No 807/2010. Indicative allocations to Member States for the reimbursement of the cost of intra-Union transfers, as required under the annual distribution plan referred to in Article 1, are set out in point (d) of Annex I.’;

(2)

the following Articles 2a to 2d are inserted:

‘Article 2a

By way of derogation from Article 3(1) of Regulation (EU) No 807/2010, the implementation period of the 2012 distribution plan shall end on 28 February 2013.

Article 2b

By way of derogation from Article 3(3) of Regulation (EU) No 807/2010, for the 2012 distribution plan, payment operations for products to be supplied by the operator shall, in case of products to be mobilised on the market under Article 2(3)(a)(iii) and (iv) of Regulation (EU) No 807/2010, be effected before 15 October 2012.

Article 2c

For the 2012 distribution plan, the first sentence of the second subparagraph and the third subparagraph of Article 3(2) of Regulation (EU) No 807/2010, where relevant, shall not apply to the following quantities of intervention stocks:

Article 2d

By way of derogation from Article 9 of Regulation (EU) No 807/2010, for the 2012 distribution plan, requests for payment shall be submitted to the competent authorities of each Member State by 30 September 2012. Except in cases of force majeure, requests submitted after that date shall not be accepted.

Expenditure, within the limits set out in point (a) of Annex I, shall only be eligible for Union financing if it has been paid by the Member State to the beneficiary by 15 October 2012 at the latest.’;

(3)

Annexes I and II are replaced by the text set out in the Annex to this Regulation.

10.3.2012   

EN

Official Journal of the European Union

L 72/39

(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,

10.3.2012   

EN

Official Journal of the European Union

L 72/41

(1)

Article 3(1) and (2) of Protocol No 1 (3) to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part (4), opens a tariff quota at a zero rate of duty for imports of untreated 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, up to the limit laid down for each year.

(2)

Article 2(2) of Commission Regulation (EC) No 1918/2006 of 20 December 2006 opening and providing for the administration of tariff quota for olive oil originating in Tunisia (5) lays down monthly quantitative limits for the issue of import licences.

(3)

Import licence applications have been submitted to the competent authorities under Article 3(1) of Regulation (EC) No 1918/2006 in respect of a total quantity exceeding the limit laid down for the month of March in Article 2(2) of that Regulation.

(4)

In these circumstances, the Commission must set an allocation coefficient allowing import licences to be issued in proportion to the quantity available.

(5)

Since the limit for the month of March has been reached, no more import licences can be issued for that month,