27.11.2012   

EN

Official Journal of the European Union

L 327/1

(1)

The environmental policy of the Union, as set out in the action programmes on the environment, and in particular in the Sixth Environmental Action Programme adopted by Decision No 1600/2002/EC of the European Parliament and of the Council (3), has as one of its objectives to achieve levels of air quality that do not give rise to significant negative impacts on and risks to human health and the environment.

(2)

Article 191(2) of the Treaty on the Functioning of the European Union (TFEU) provides that Union policy on the environment is to aim at a high level of protection, taking into account the diversity of situations in the various regions of the Union.

(3)

Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels (4) lays down the maximum permitted sulphur content of heavy fuel oil, gas oil, marine gas oil and marine diesel oil used in the Union.

(4)

Emissions from shipping due to the combustion of marine fuels with a high sulphur content contribute to air pollution in the form of sulphur dioxide and particulate matter, which harm human health and the environment and contribute to acid deposition. Without the measures set out in this Directive, emissions from shipping would soon have been higher than emissions from all land-based sources.

(5)

Air pollution caused by ships at berth is a major concern for many harbour cities when it comes to their efforts to meet the Union's air quality limit values.

(6)

Member States should encourage the use of shore-side electricity, as the electricity for present-day ships is usually provided by auxiliary engines.

(7)

Under Directive 1999/32/EC, the Commission is to report to the European Parliament and the Council on the implementation of that Directive and may submit with its report proposals for amending it, in particular as regards the reduction of sulphur limits for marine fuel in SOx Emission Control Areas (SECAs), in accordance with the work of the International Maritime Organisation (IMO).

(8)

In 2008, the IMO adopted a resolution to amend Annex VI of the Protocol of 1997 to amend the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (MARPOL), containing regulations for the prevention of air pollution from ships. The revised Annex VI to MARPOL entered into force on 1 July 2010.

(9)

The revised Annex VI to MARPOL introduces, inter alia, stricter sulphur limits for marine fuel in SECAs (1,00 % as of 1 July 2010 and 0,10 % as of 1 January 2015) as well as in sea areas outside SECAs (3,50 % as of 1 January 2012 and, in principle, 0,50 % as of 1 January 2020). Most Member States are obliged, in accordance with their international commitments, to require ships to use fuel with a maximum sulphur content of 1,00 % in SECAs as of 1 July 2010. In order to ensure coherence with international law as well as to secure proper enforcement of new globally established sulphur standards in the Union, Directive 1999/32/EC should be aligned with the revised Annex VI to MARPOL. In order to ensure a minimum quality of fuel used by ships either for fuel-based or technology-based compliance, marine fuel the sulphur content of which exceeds the general standard of 3,50 % by mass should not be allowed for use in the Union, except for fuels supplied to ships using emission abatement methods operating in closed mode.

(10)

Amendments to Annex VI to MARPOL regarding SECAs are possible under IMO procedures. In the event that further changes, including exemptions, are introduced with regard to the application of SECA limits in Annex VI to MARPOL, the Commission should consider any such changes and, where appropriate, without delay make the necessary proposal in accordance with the TFEU to fully align Directive 1999/32/EC with the IMO rules regarding SECAs.

(11)

The introduction of any new emission control areas should be subject to the IMO process under Annex VI to MARPOL and should be underpinned by a well-founded case based on environmental and economic grounds and supported by scientific data.

(12)

In accordance with regulation 18 of the revised Annex VI to MARPOL, Member States should endeavour to ensure the availability of marine fuels which comply with this Directive.

(13)

In view of the global dimension of environmental politics and shipping emissions, ambitious emission standards should be set at a global level.

(14)

Passenger ships operate mostly in ports or close to coastal areas and their impacts on human health and the environment are significant. In order to improve air quality around ports and coasts, those ships are required to use marine fuel with a maximum sulphur content of 1,50 % until stricter sulphur standards apply to all ships in territorial seas, exclusive economic zones and pollution control zones of Member States.

(15)

In accordance with Article 193 TFEU, this Directive should not prevent any Member State from maintaining or introducing more stringent protective measures in order to encourage early implementation with respect to the maximum sulphur content of marine fuels, for instance using emission abatement methods outside SECAs.

(16)

In order to facilitate the transition to new engine technologies with the potential for significant further emission reductions in the maritime sector, the Commission should further explore opportunities to enable and encourage the uptake of gas-powered engines in ships.

(17)

Proper enforcement of the obligations with regard to the sulphur content of marine fuels is necessary in order to achieve the aims of Directive 1999/32/EC. The experience from the implementation of Directive 1999/32/EC has shown that there is a need for a stronger monitoring and enforcement regime in order to ensure the proper implementation of that Directive. To that end, it is necessary that Member States ensure sufficiently frequent and accurate sampling of marine fuel placed on the market or used on board ship as well as regular verification of ships' log books and bunker delivery notes. It is also necessary for Member States to establish a system of effective, proportionate and dissuasive penalties for non-compliance with the provisions of Directive 1999/32/EC. In order to ensure more transparency of information, it is also appropriate to provide that the register of local suppliers of marine fuel be made publicly available.

(18)

Reporting by Member States under Directive 1999/32/EC has proved insufficient for the purpose of verification of compliance with that Directive due to the lack of harmonised and sufficiently precise provisions on the content and the format of the Member States' reports. Therefore, more detailed indications as regards the content and the format of the report are necessary to ensure more harmonised reporting.

(19)

Following the adoption of Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (5), which recasts the Union legislation on industrial emissions, it is necessary to amend the provisions of Directive 1999/32/EC relating to maximum sulphur content of heavy fuel oil accordingly.

(20)

Complying with the low sulphur limits for marine fuels, particularly in SECAs, can result in a significant increase in the price of such fuels, at least in the short term, and can have a negative effect on the competitiveness of short sea shipping in comparison with other transport modes, as well as on the competitiveness of the industries in the countries bordering SECAs. Suitable solutions are necessary in order to reduce compliance costs for the affected industries, such as allowing for alternative, more cost-effective methods of compliance than fuel-based compliance and providing support, where necessary. The Commission will, based inter alia on reports from Member States, closely monitor the impacts of the shipping sector's compliance with the new fuel quality standards, particularly with respect to possible modal shift from sea to land-based transport and will, if appropriate, propose proper measures to counteract such a trend.

(21)

Limiting modal shift from sea to land-based transport is important given that an increasing share of goods being transported by road would in many cases run counter to the Union's climate change objectives and increase congestion.

(22)

The costs of the new requirements to reduce sulphur dioxide emissions could result in modal shift from sea to land-based transport and could have negative effects on the competitiveness of the industries. The Commission should make full use of instruments such as Marco Polo and the trans-European transport network to provide targeted assistance so as to minimise the risk of modal shift. Member States may consider it necessary to provide support to operators affected by this Directive in accordance with the applicable State aid rules.

(23)

In accordance with existing guidelines on State aid for environmental protection, and without prejudice to future changes thereto, Member States may provide State aid in favour of operators affected by this Directive, including aid for retrofitting operations of existing vessels, if such aid measures are deemed to be compatible with the internal market in accordance with Articles 107 and 108 TFEU, in particular in light of the applicable guidelines on State aid for environmental protection. In this context, the Commission may take into account that the use of some emission abatement methods go beyond the requirements of this Directive by reducing not only the sulphur dioxide emissions but also other emissions.

(24)

Access to emission abatement methods should be facilitated. Those methods can provide emission reductions at least equivalent to, or even greater than, those achievable using low sulphur fuel, provided that they have no significant negative impacts on the environment, such as marine ecosystems, and that they are developed subject to appropriate approval and control mechanisms. The already known alternative methods, such as the use of on-board exhaust gas cleaning systems, the mixture of fuel and liquefied natural gas (LNG) or the use of biofuels should be recognised in the Union. It is important to promote the testing and development of new emission abatement methods in order, among other reasons, to limit modal shift from sea to land-based transport.

(25)

Emission abatement methods hold the potential for significant emission reductions. The Commission should therefore promote the testing and development of these technologies, inter alia by considering the establishment of a co-financed joint programme with industry, based on principles from similar programmes, such as the Clean Sky Programme.

(26)

The Commission, in cooperation with Member States and stakeholders, should further develop measures identified in the Commission's staff working paper of 16 September 2011 entitled ‧Pollutant emission reduction from maritime transport and the sustainable waterborne transport toolbox‧.

(27)

Alternative emission abatement methods such as some types of scrubbers could generate waste that should be handled properly and not be discharged into the sea. Pending the revision of Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (6), Member States should ensure, in accordance with their international commitments, the availability of port reception facilities adequate to meet the needs of ships using exhaust gas cleaning systems. In the revision of Directive 2000/59/EC, the Commission should consider the inclusion of waste from exhaust gas cleaning systems under the principle of no special fee applying to port fees for ship-generated waste provided for in that Directive.

(28)

The Commission should, as part of its air quality policy review in 2013, consider the possibility of reducing air pollution, including in the territorial seas of Member States.

(29)

Effective, proportionate and dissuasive penalties are important for the implementation of Directive 1999/32/EC. Member States should include in those penalties fines calculated in such a way as to ensure that the fines at least deprive those responsible of the economic benefits derived from their infringement and that those fines gradually increase for repeated infringements. Member States should notify the provisions on penalties to the Commission.

(30)

The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the amendment of the equivalent emission values for and the criteria for the use of emission abatement methods in order to adapt the provisions of Directive 1999/32/EC to scientific and technical progress and in such a way as to ensure strict consistency with the relevant instruments of the IMO and in respect of the amendment of points 1, 2, 3, 3a, 3b and 4 of Article 2, point (b) of Article 6(1a) and Article 6(2) of Directive 1999/32/EC in order to adapt the provisions of that Directive to scientific and technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(31)

In order to ensure uniform conditions for the implementation of Directive 1999/32/EC, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (7).

(32)

It is appropriate for the Committee on Safe Seas and the Prevention of Pollution from Ships established by Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) (8) to assist the Commission in the approval of the emission abatement methods which are not covered by Council Directive 96/98/EC of 20 December 1996 on marine equipment (9).

(33)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (10), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

(34)

Directive 1999/32/EC should therefore be amended accordingly,

(1)

in Article 1(2), point (h) is replaced by the following:

(2)

Article 2 is amended as follows:

(3)

Article 3 is amended as follows:

(4)

the following Article is inserted:

‧Article 3a

Maximum sulphur content in marine fuel

Member States shall ensure that marine fuels are not used within their territory if their sulphur content exceeds 3,50 % by mass, except for fuels supplied to ships using emission abatement methods subject to Article 4c operating in closed mode.‧;

(5)

in Article 4, paragraph 1 is replaced by the following:

‧1.   Member States shall ensure that gas oils are not used within their territory if their sulphur content exceeds 0,10 % by mass.‧;

(6)

Article 4a is amended as follows:

(7)

Articles 4b and 4c are replaced by the following:

‧Article 4b

Maximum sulphur content of marine fuels used by ships at berth in Union ports

1.   Member States shall take all necessary measures to ensure that ships at berth in Union ports do not use marine fuels with a sulphur content exceeding 0,10 % by mass, allowing sufficient time for the crew to complete any necessary fuel-changeover operation as soon as possible after arrival at berth and as late as possible before departure.

Member States shall require the time of any fuel-changeover operation to be recorded in ships' logbooks.

2.   Paragraph 1 shall not apply:

3.   Member States shall ensure that marine gas oils are not placed on the market in their territory if the sulphur content of those marine gas oils exceeds 0,10 % by mass.

Article 4c

Emission abatement methods

1.   Member States shall allow the use of emission abatement methods by ships of all flags in their ports, territorial seas, exclusive economic zones and pollution control zones, as an alternative to using marine fuels that meet the requirements of Articles 4a and 4b, subject to paragraphs 2 and 3 of this Article.

2.   Ships using the emission abatement methods referred to in paragraph 1 shall continuously achieve reductions of sulphur dioxide emissions that are at least equivalent to the reductions that would be achieved by using marine fuels that meet the requirements of Articles 4a and 4b. Equivalent emission values shall be determined in accordance with Annex I.

2a.   Member States shall, as an alternative solution for reducing emissions, encourage the use of onshore power supply systems by docked vessels.

3.   The emission abatement methods referred to in paragraph 1 shall comply with the criteria specified in the instruments referred to in Annex II.

4.   Where justified in the light of scientific and technical progress regarding alternative emission abatement methods and in such a way as to ensure strict consistency with the relevant instruments and standards adopted by the IMO, the Commission shall:

(8)

the following Articles are inserted:

‧Article 4d

Approval of emission abatement methods for use on board ships flying the flag of a Member State

1.   Emission abatement methods falling within the scope of Council Directive 96/98/EC (14) shall be approved in accordance with that Directive.

2.   Emission abatement methods not covered by paragraph 1 of this Article shall be approved in accordance with the procedure referred to in Article 3(2) of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) (15), taking into account:

Article 4e

Trials of new emission abatement methods

Member States may, in cooperation with other Member States, as appropriate, approve trials of ship emission abatement methods on vessels flying their flag, or in sea areas within their jurisdiction. During those trials, the use of marine fuels meeting the requirements of Articles 4a and 4b shall not be mandatory, provided that all of the following conditions are fulfilled:

Article 4f

Financial measures

Member States may adopt financial measures in favour of operators affected by this Directive where such financial measures are in accordance with State aid rules applicable and to be adopted in this area.

(9)

Article 6 is replaced by the following:

‧Article 6

Sampling and analysis

1.   Member States shall take all necessary measures to check by sampling that the sulphur content of fuels used complies with Articles 3, 3a, 4, 4a and 4b. The sampling shall commence on the date on which the relevant limit for maximum sulphur content in the fuel comes into force. It shall be carried out periodically with sufficient frequency and quantities in such a way that the samples are representative of the fuel examined, and in the case of marine fuel, of the fuel being used by vessels while in relevant sea areas and ports. The samples shall be analysed without undue delay.

1a.   The following means of sampling, analysis and inspection of marine fuel shall be used:

1b.   The Commission shall be empowered to adopt implementing acts concerning:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).

2.   The reference method adopted for determining the sulphur content shall be ISO method 8754 (2003) or PrEN ISO 14596 (2007).

In order to determine whether marine fuel delivered to and used on board ships is compliant with the sulphur limits required by Articles 3a, 4, 4a and 4b the fuel verification procedure set out in Appendix VI to Annex VI to MARPOL shall be used.‧;

(10)

Article 7 is amended as follows:

(11)

Article 8 is deleted;

(12)

Article 9 is replaced by the following:

‧Article 9

Committee procedure

1.   The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (16).

2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

(13)

the following Article is inserted:

‧Article 9a

Exercise of the delegation

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Article 4c(4) and Article 7(4) shall be conferred on the Commission for a period of five years from 17 December 2012. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.   The delegation of power referred to in Article 4c(4) and Article 7(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.   A delegated act adopted pursuant to Article 4c(4) and Article 7(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.‧;

(14)

Article 11 is replaced by the following:

‧Article 11

Penalties

1.   Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive.

2.   The penalties determined must be effective, proportionate and dissuasive and may include fines calculated in such a way as to ensure that the fines at least deprive those responsible of the economic benefits derived from their infringement and that those fines gradually increase for repeated infringements.‧;

(15)

the Annex to Directive 1999/32/EC is replaced by the Annex to this Directive.

27.11.2012   

EN

Official Journal of the European Union

L 327/14

(1)

Council Regulation (EU) No 270/2011 (2) gives effect to the measures provided for in Decision 2011/172/CFSP.

(2)

Council Decision 2012/723/CFSP (3) provides for an amendment to Decision 2011/172/CFSP in order to permit the release of certain frozen funds or economic resources where they are required to satisfy a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in a Member State.

(3)

Article 9 of Regulation (EU) No 270/2011 concerns information to be supplied by persons, entities and bodies to the competent authorities of Member States, which has to be transmitted to the Commission, in order to facilitate compliance with that Regulation. In accordance with Article 9(2), any information provided or received is to be used only for the purposes for which it was provided or received. However, this should not prevent Member States from sharing such information, in accordance with their national law, with the relevant authorities of Egypt and other Member States where necessary for the purpose of assisting the recovery of misappropriated assets.

(4)

Regulation (EU) No 270/2011 should therefore be amended accordingly,

(1)

Article 5 is replaced by the following:

‘Article 5

1.   By way of derogation from Article 2, the competent authorities in Member States, as indicated on the websites listed in Annex II, may authorise the release of certain frozen funds or economic resources, provided the following conditions are met:

2.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this Article.’;

(2)

Article 6(1) is replaced by the following:

‘1.   Article 2(2) shall not apply to the addition to frozen accounts of:

provided that such interest, other earnings and payments are frozen in accordance with Article 2(1).’;

(3)

in Article 9, the following paragraph is added:

‘3.   Paragraph 2 shall not prevent Member States from sharing that information, in accordance with their national law, with the relevant authorities of Egypt and other Member States where necessary for the purpose of assisting the recovery of misappropriated assets.’.

27.11.2012   

EN

Official Journal of the European Union

L 327/16

(1)

Council Regulation (EU) No 101/2011 (2) gives effect to the measures provided for in Decision 2011/72/CFSP.

(2)

Council Decision 2012/724/CFSP (3) provides for an amendment to Decision 2011/72/CFSP in order to permit the release of certain frozen funds or economic resources where they are required to satisfy a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in a Member State.

(3)

Article 9 of Regulation (EU) No 101/2011 concerns information to be supplied by persons, entities and bodies to the competent authorities of Member States, which has to be transmitted to the Commission, in order to facilitate compliance with that Regulation. In accordance with Article 9(2), any information provided or received is to be used only for the purposes for which it was provided or received. However, this should not prevent Member States from sharing such information, in accordance with their national law, with the relevant authorities of Tunisia and other Member States where necessary for the purpose of assisting the recovery of misappropriated assets.

(4)

Regulation (EU) No 101/2011 should therefore be amended accordingly,

(1)

Article 5 is replaced by the following:

‘Article 5

1.   By way of derogation from Article 2, the competent authorities in Member States, as indicated on the websites listed in Annex II, may authorise the release of certain frozen funds or economic resources, provided the following conditions are met:

2.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this Article.’;

(2)

Article 6(1) is replaced by the following:

‘1.   Article 2(2) shall not apply to the addition to frozen accounts of:

provided that such interest, other earnings and payments are frozen in accordance with Article 2(1).’;

(3)

in Article 9, the following paragraph is added:

‘3.   Paragraph 2 shall not prevent Member States from sharing that information, in accordance with their national law, with the relevant authorities of Tunisia and other Member States where necessary for the purpose of assisting the recovery of misappropriated assets.’.

27.11.2012   

EN

Official Journal of the European Union

L 327/18

(1)

With the entry into force of Commission Regulation (EU) No 1006/2011 of 27 September 2011 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (2), new CN codes apply to gas and fuel oils containing biodiesel. These changes may affect the mineral oil industry because certain mixing operations under the customs warehousing procedure and in free zones are not permitted anymore as ‘usual forms of handling’ because they result in a different eight-digit CN code.

(2)

A solution should be found to allow mixing of gas or fuel oils not containing biodiesel with gas or fuel oils containing biodiesel, classified in Chapter 27 of the CN, under the customs warehousing procedure and in free zones to continue as before the entry into force of Regulation (EU) No 1006/2011 on 1 January 2012.

(3)

Mixing gas or fuel oils with biodiesel should be allowed, so that separate storage of both types of goods is not required. However, taking account of the Additional Note 2 in Chapter 27 of the Combined Nomenclature the mixture obtained should contain less than 0,5 %, by volume, of biodiesel or gas or fuel oils respectively.

(4)

Annex 72 to Commission Regulation (EEC) No 2454/93 (3) should therefore be amended accordingly.

(5)

The amendment should enter into force with retroactive effect in order to allow for extinguishing customs debts which were incurred since 1 January 2012 because of the introduction of the new CN codes.

(6)

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

27.11.2012   

EN

Official Journal of the European Union

L 327/20

(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,

27.11.2012   

EN

Official Journal of the European Union

L 327/22

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2012/13 marketing year are fixed by Commission Implementing Regulation (EU) No 892/2012 (3). Those prices and duties were last amended by Commission Implementing Regulation (EU) No 1092/2012 (4).

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with Article 36 of Regulation (EC) No 951/2006.

(3)

Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

27.11.2012   

EN

Official Journal of the European Union

L 327/24

(1)

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (2) requires that HTLV-I antibody testing must be performed for donors living in, or originating from, high-incidence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas. This testing is required both for donors of reproductive cells, in accordance with Annex III to Directive 2006/17/EC, and for other donors, in accordance with Annex II thereof.

(2)

Recent scientific evidence provided by the European Centre for Disease Prevention and Control (ECDC) and field practice experience showed that it is very difficult, in the current state of scientific knowledge, to determine what is an HTLV-I high-incidence area. This testing requirement is thus not implemented in a uniform manner.

(3)

‘Incidence’ measures the rate of occurrence of new cases of a disease or condition, while ‘prevalence’ is the proportion of a population that is affected by a particular disease at a specific time. In practice, data for prevalence are more available than data on incidence. In addition, prevalence is a more relevant measure than incidence when assessing the impact of a chronic disease within a community and to assess the subsequent needs. It is therefore appropriate to replace references to high-incidence by references to high-prevalence in order to ensure a more consistent implementation of the HTLV-I testing requirements across the Member States.

(4)

Point 4.2 of Annex III to Directive 2006/17/EC requires that blood samples must be obtained at the time of each donation both, for partner donation (not for direct use) and for non-partner donation of reproductive cells.

(5)

As far as partner donation of reproductive cells is concerned, recent scientific evidence has demonstrated that requiring testing at fixed time intervals up to a maximum of 24 months would not diminish the level of safety of the cells concerned as long as appropriate safety and quality systems are in place in tissue establishments using Assisted Reproductive Technology, in accordance with Article 16 of Directive 2004/23/EC. During these time intervals, the results of the previous test carried out on the same donor can be relied upon.

(6)

Whereas testing at the time of each donation does not improve the safety of reproductive cells donated between partners, field practice experience shows that this requirement is costly and cumbersome for both, patients and healthcare systems. In order to act in a more proportionate manner to the safety objective pursued, it is therefore appropriate to allow the Member States to require testing at fixed time intervals which they may determine up to a maximum of 24 months instead of at the time of each donation.

(7)

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

27.11.2012   

EN

Official Journal of the European Union

L 327/26

(1)

Commission Directive 2009/91/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include disodium tetraborate as an active substance in Annex I thereto (2) defines disodium tetraborate by three CAS numbers for three different forms of the substance. The CAS numbers are based on a report submitted to the Commission by the Netherlands on 7 July 2006 and endorsed by the Standing Committee on Biocidal Products on 20 February 2009.

(2)

The Netherlands have informed the Commission that the CAS number for the pentahydrate form in the original report was incorrect, and submitted a revised report to the Commission according to which the correct CAS number for this form is 12179-04-3. The revised report was endorsed by the Standing Committee on Biocidal Products on 25 May 2012.

(3)

Annex I to Directive 98/8/EC should therefore be corrected accordingly.

(4)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

27.11.2012   

EN

Official Journal of the European Union

L 327/28

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes nonanoic acid.

(2)

Commission Directive 2011/13/EU of 8 February 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include nonanoic acid as an active substance in Annex I thereto (3) included nonanoic acid as an active substance in Annex I to Directive 98/8/EC for use in product type 19, repellents and attractants, as defined in Annex V to Directive 98/8/EC.

(3)

Pursuant to Regulation (EC) No 1451/2007, nonanoic acid has now been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive.

(4)

Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 6 August 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(5)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012, in an assessment report.

(6)

It appears from the evaluations that biocidal products used as private area and public health area disinfectants and other biocidal products as defined in Annex V to Directive 98/8/EC and containing nonanoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to extend the inclusion of nonanoic acid in Annex I to that Directive to product type 2.

(7)

Not all potential uses have been evaluated at Union level. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(8)

In view of the irritant properties of the substance, it is appropriate to require that exposure during non-professional use is minimised through the design of the packaging, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.

(9)

The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product type 2 containing the active substance nonanoic acid and also to facilitate the proper operation of the biocidal products market in general.

(10)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

(11)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

(12)

Directive 98/8/EC should therefore be amended accordingly.

(13)

In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011 (4), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(14)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

27.11.2012   

EN

Official Journal of the European Union

L 327/31

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes hydrogen cyanide.

(2)

Pursuant to Regulation (EC) No 1451/2007, hydrogen cyanide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in the following product types, as defined in Annex V to that Directive: product type 8, wood preservatives, product type 14, rodenticides, and product type 18, insecticides, acaricides and products to control other arthropods.

(3)

The Czech Republic was designated as Rapporteur Member State and submitted three competent authority reports, including recommendations, to the Commission on 24 January 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4)

The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012, in three assessment reports.

(5)

It appears from the evaluations that biocidal products used as wood preservatives, rodenticides, insecticides, acaricides and products to control other arthropods and containing hydrogen cyanide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include hydrogen cyanide in Annex I to that Directive.

(6)

Not all potential uses have been evaluated at Union level. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(7)

In view of the highly toxic and flammable properties of the active substance and the assumptions made during the risk assessment, it is appropriate to require that products are only authorised for use by professionals adequately trained to use them and that safe operational procedures during fumigation and venting are established for operators and bystanders, including the following requirements: products shall be used with adequate personal protective equipment including, where appropriate, self-contained breathing apparatus and gas-tight clothing; re-entry into fumigated spaces shall be prohibited until the air concentration has reached safe levels for operators and bystanders by ventilation; exposure during and after ventilation shall be prevented from exceeding safe levels for operators and bystanders by the establishment of a supervised exclusion zone; prior to fumigation, any food and any porous material with a potential to absorb the active substance, except wood intended to be treated, shall either be removed from the space to be fumigated or protected from absorption by adequate means, and the space to be fumigated shall be protected against accidental ignition.

(8)

The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product types 8, 14 and 18 containing the active substance hydrogen cyanide and also to facilitate the proper operation of the biocidal products market in general.

(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

(11)

Directive 98/8/EC should therefore be amended accordingly.

(12)

In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011 (3), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(13)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

27.11.2012   

EN

Official Journal of the European Union

L 327/34

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) provides detailed rules for the evaluations of existing active substances. Article 15(2) of the Regulation provides for peer reviews by experts from the Member States prior to the Commission decisions on inclusion in Annex I.

(2)

Pursuant to Article 10(2)(i) of Directive 98/8/EC, inclusion of an active substance in Annex I shall, where appropriate, be subject to requirements on the minimum degree of purity and the nature and maximum content of certain impurities.

(3)

The first inclusion in Annex I was decided in Commission Directive 2006/140/EC of 20 December 2006 amending Directive 98/8/EC of the European Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto (3). That Directive defined the headings of Annex I to Directive 98/8/EC. Those headings include ‘Minimum purity of the active substance in the biocidal product as placed on the market’.

(4)

In the context of the peer reviews provided for by Article 15(2) of Regulation (EC) No 1451/2007, Member States experts have developed a method for establishing the similarity of the chemical compositions and the hazard profiles, known as ‘technical equivalence’, of substances falling within the same definition but being produced from different sources or manufacturing processes. For this establishment, the degree of purity is only one of the factors that can be decisive. Furthermore, lower purity of an active substance does not necessarily compromise its hazard profile.

(5)

It is therefore appropriate to replace the existing reference to minimum purity in the headings of Annex I to Directive 98/8/EC by a reference to the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11 of the Directive, and indicate that, in the product placed on the market, the active substance may be of a different purity provided that it has been proven technically equivalent with the evaluated substance.

(6)

The first row of Annex I to Directive 98/8/EC established by Commission Directive 2006/140/EC also contains the heading ‘Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)’.

(7)

According to Article 4(1) of Directive 98/8/EC, a Member State receiving an application for mutual recognition of an existing authorisation has a period of 120 days to authorise the product through mutual recognition. However, if the first authorisation of a product is granted less than 120 days before the deadline for compliance with Article 16(3) of the Directive for that product, a Member State receiving a complete application for mutual recognition of that authorisation cannot comply with the deadline for compliance with Article 16(3) of the Directive if it uses the 120-day period provided for by Article 4(1) of the Directive, even if the complete application for mutual recognition was submitted without delay after the granting of the first authorisation.

(8)

For products for which the first authorisation is granted later than 120 days before the original deadline for compliance with Article 16(3) of Directive 98/8/EC, it is therefore appropriate to extend Member States’ deadline for complying with Article 16(3) of the Directive by mutually recognising the first authorisation to 120 days after the submission of the complete application for mutual recognition, provided that the complete application for mutual recognition has been submitted within 60 days of the granting of the first authorisation.

(9)

Furthermore, in a situation where a Member State proposes, within the deadline for compliance with Article 16(3) of Directive 98/8/EC, to derogate from mutual recognition of an authorisation in accordance with Article 4(4) of the Directive, that Member State’s compliance with Article 16(3) of the Directive within that deadline can be impossible, and will depend on the date when the Commission decision on the matter is adopted in accordance with the second subparagraph of Article 4(4) of the Directive. In such cases, the deadline should therefore be suspended until a reasonable period after the Commission decision has been adopted.

(10)

For products for which one or more Member States have proposed to derogate from mutual recognition in accordance with Article 4(4) of Directive 98/8/EC, it is therefore appropriate to extend Member States’ deadline for complying with Article 16(3) of the Directive by mutually recognising the first authorisation to 30 days after the adoption of the Commission decision.

(11)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

27.11.2012   

EN

Official Journal of the European Union

L 327/37

(1)

Commission Directives 2003/90/EC (3) and 2003/91/EC (4) were adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination of the various species and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties those Directives provide that guidelines of the International Union for Protection of new Varieties of Plants (UPOV) are to apply.

(2)

The CPVO and UPOV have since established further guidelines for one other species and have updated existing ones.

(3)

Directives 2003/90/EC and 2003/91/EC should therefore be amended accordingly.

(4)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

27.11.2012   

EN

Official Journal of the European Union

L 327/44

(1)

On 21 March 2011, the Council adopted Decision 2011/172/CFSP (1).

(2)

To facilitate the return of misappropriated funds to the Egyptian State, the derogations under Decision 2011/172/CFSP should be amended to permit the release of certain frozen funds or economic resources where they are required to satisfy a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in a Member State, prior to or after the date of designation of the natural or legal persons, entities and bodies concerned.

(3)

Decision 2011/172/CFSP should therefore be amended accordingly,

(1)

Article 1(4) is replaced by the following:

‘4.   By way of derogation from paragraph 1, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, provided the following conditions are met:

The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this paragraph.’;

(2)

Article 1(6) is replaced by the following:

‘6.   Paragraph 2 shall not apply to the addition to frozen accounts of:

provided that any such interest, other earnings and payments remain subject to the measures provided for in paragraph 1.’.

27.11.2012   

EN

Official Journal of the European Union

L 327/45

(1)

On 31 January 2011, the Council adopted Decision 2011/72/CFSP (1).

(2)

To facilitate the return of misappropriated funds to the Tunisian State, the derogations under Decision 2011/72/CFSP should be amended to permit the release of certain frozen funds or economic resources where they are required to satisfy a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in a Member State, prior to or after the date of designation of the natural or legal persons, entities and bodies concerned.

(3)

Decision 2011/72/CFSP should therefore be amended accordingly,

(1)

Article 1(4) is replaced by the following:

‘4.   By way of derogation from paragraph 1, the competent authorities of a Member State, may authorise the release of certain frozen funds or economic resources, provided the following conditions are met:

The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this paragraph.’;

(2)

Article 1(5) is replaced by the following:

‘5.   Paragraph 2 shall not apply to the addition to frozen accounts of:

provided that any such interest, other earnings and payments remain subject to the measures provided for in paragraph 1.’.

27.11.2012   

EN

Official Journal of the European Union

L 327/46

(1)

On 2 March 2011 the company Morinaga Milk Industry Co. Ltd made a request to the competent authorities of Ireland to place bovine lactoferrin on the market as novel food ingredient. Bovine lactoferrin is an iron binding protein from milk to be added to foods.

(2)

On 22 June 2011 the competent food assessment body of Ireland issued its initial assessment report. In this report they recommended that instead of carrying out an initial assessment an additional assessment was required, because another application concerning bovine lactoferrin was already referred to EFSA.

(3)

The Commission forwarded the initial assessment report to all Member States on 20 July 2011.

(4)

The European Food Safety Authority (EFSA) was consulted on 22 August 2011.

(5)

On 28 June 2012 in their ‘Scientific opinion on bovine lactoferrin’ (2) EFSA came to the conclusion that bovine lactoferrin is safe under the proposed uses and use levels.

(6)

On 27 April 2012 in another ‘Scientific opinion on bovine lactoferrin’ (3) EFSA already came to the conclusion that lactoferrin was safe under the proposed uses and use levels. Therefore it appears appropriate to authorise the same uses for both applications.

(7)

Bovine lactoferrin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

27.11.2012   

EN

Official Journal of the European Union

L 327/49

(1)

On 6 August 2010 the company Ajinomoto Co. Inc., Japan made a request to the competent authorities of the United Kingdom to place dihydrocapsiate on the market as novel food ingredient.

(2)

On 10 March 2011 the competent food assessment body of the United Kingdom issued its initial assessment report. In this report it came to the conclusion that dihydrocapsiate will not present a health risk to consumers.

(3)

The Commission forwarded the initial assessment report to all Member States on 13 April 2011.

(4)

Within the 60 day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections were raised in accordance with that provision.

(5)

Therefore the European Food Safety Authority (EFSA) was consulted on 9 November 2011.

(6)

On 28 June 2012 in their ‘Scientific opinion on dihydrocapsiate’ (2) EFSA came to the conclusion that dihydrocapsiate is safe under the proposed uses and use levels.

(7)

Dihydrocapsiate complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

27.11.2012   

EN

Official Journal of the European Union

L 327/52

(1)

On 2 March 2009 the company FrieslandCampina (formerly DMV International) made a request to the competent authorities of the Netherlands to place lactoferrin on the market as novel food ingredient. Lactoferrin is an iron-binding protein from milk to be added to foods.

(2)

On 31 March 2010 the competent food assessment body of the Netherlands issued its initial assessment report. In this report it came to the conclusion that there was no reason for concern thus lactoferrin may be placed on the market as a novel food ingredient.

(3)

The Commission forwarded the initial assessment report to all Member States on 13 April 2010.

(4)

Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections were raised in accordance with that provision.

(5)

Therefore the European Food Safety Authority (EFSA) was consulted on 9 November 2010.

(6)

On 27 April 2012 in their ‘Scientific opinion on bovine lactoferrin’ (2) EFSA came to the conclusion that bovine lactoferrin is safe under the proposed uses and use levels.

(7)

On 28 June 2012 in another ‘Scientific opinion on bovine lactoferrin’ (3) EFSA also came to the conclusion that bovine lactoferrin is safe under the proposed uses and use levels. Therefore it appears appropriate to authorise the same uses for both applications.

(8)

Bovine lactoferrin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

27.11.2012   

EN

Official Journal of the European Union

L 327/55

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes bifenthrin.

(2)

Pursuant to Regulation (EC) No 1451/2007, bifenthrin has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

(3)

France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 2 November 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012 in an assessment report.

(5)

The assessment has demonstrated that biocidal products used as insecticides, acaricides and products to control other arthropods and containing bifenthrin cannot be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. The scenarios evaluated in the environmental risk assessment showed an unacceptable risk for the aquatic compartment. It is therefore not appropriate to include bifenthrin for use in product type 18 in Annex I, IA or IB to Directive 98/8/EC.

(6)

In the interest of legal certainty, the date as of which biocidal products of product type 18 containing bifenthrin should no longer be placed on the market should be specified, taking into account both the unacceptable effects of those products and the legitimate expectations of manufacturers of those products.

(7)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

27.11.2012   

EN

Official Journal of the European Union

L 327/56

(1)

Regulation (EC) No 178/2002 lays down the general principles governing food and feed in general, and food and feed safety in particular, at Union and national level. It provides for emergency measures where there is evidence that food or feed imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned.

(2)

Commission Decision 2008/866/EC of 12 November 2008 on emergency measures suspending imports from Peru of certain bivalve molluscs intended for human consumption (2) was adopted following an outbreak of hepatitis A in humans related to the consumption of bivalve molluscs imported from Peru contaminated with hepatitis A virus (HAV). That Decision initially applied until 31 March 2009 but this period of application was extended until 30 November 2012 by Commission Implementing Decision 2011/723/EU (3).

(3)

A Commission audit was carried out in June 2011. The inspectors concluded that a well implemented control system and monitoring plan are in place and improvements have been noted since the former inspection visit in 2009.

(4)

The Peruvian competent authority presented an action plan in response to the recommendations included in the final report of the abovementioned audit. However, the monitoring system for virus detection in live bivalve molluscs is not fully implemented yet, hence the possible contamination of live bivalve mollusc with Hepatitis A virus could not be excluded. In addition, the testing method for HAV is still under validation.

(5)

The limit of application of Decision 2008/866/EC should therefore be amended accordingly.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

27.11.2012   

EN

Official Journal of the European Union

L 327/57