(1)

Regulation (EC) No 194/2008 of 25 February 2008 renewing and strengthening the restrictive measures in respect of Burma/Myanmar (2) provides for certain measures to be taken in relation to Myanmar/Burma, including restrictions on certain exports from Myanmar/Burma and a freezing of the assets of certain individuals and entities.

(2)

By Decision 2013/184/CFSP, the Council agreed, as a means of encouraging positive changes to continue, that all those restrictive measures should be lifted, with the exception of the arms embargo and the embargo on equipment which might be used for internal repression.

(3)

Council Regulation (EC) No 194/2008 should therefore be repealed, and certain of its provisions replaced by this Regulation.

(4)

In order to ensure that the measures provided for in this Regulation are effective, this Regulation should enter into force on the day of its publication,

(1)

‧import‧ means any entry of goods into the customs territory of the Union or other territories to which the Treaty applies, under the conditions laid down in Articles 349 and 355 thereof. It includes, within the meaning of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (3), placing in a free zone or free warehouse, placing under a suspensive procedure and release for free circulation, but it excludes transit and temporary storage;

(2)

‧export‧ means any departure of goods from the customs territory of the Union or other territories to which the Treaty applies, under the conditions laid down in Articles 349 and 355 thereof. It includes, within the meaning of Regulation (EEC) No 2913/92, the departure of goods that requires a customs declaration and the departure of goods after their storage in a free zone of control type I or free warehouse, but it excludes transit;

(3)

‧exporter‧ means any natural or legal person on whose behalf an export declaration is made, being the person who, at the time when the declaration is accepted, holds the contract with the consignee in the third country and has the power for determining the sending of the item out of the customs territory of the Union or other territories to which the Treaty applies;

(4)

‧technical assistance‧ means any technical support related to repairs, development, manufacture, assembly, testing, maintenance, or any other technical service, and may take such forms as instruction, advice, training, transmission of working knowledge or skills or consulting services; technical assistance shall include verbal forms of assistance;

(5)

‧territory of the Union‧ means the territories to which the Treaty is applicable, under the conditions laid down in the Treaty.

(1)

In accordance with Directive 2004/49/EC, common safety methods (CSMs) should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved.

(2)

On 12 October 2010 the Commission issued a mandate to the European Railway Agency (the ‘Agency’) in accordance with Directive 2004/49/EC to revise Commission Regulation (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council (2). The revision should cover the results of the analysis by the Agency under Article 9(4) of the Regulation of the overall effectiveness of the CSM for risk evaluation and assessment and experience with its application as well as further developments in the roles and the responsibilities of the assessment body referred to in Article 6 of that Regulation. The revision should also include the qualification requirements (by developing a recognition/accreditation scheme) for the assessment body according to its role in the CSM, with a view to improving clarity in order to avoid differences in application across the Member States, taking into account the interfaces with existing Union authorisation/certification procedures in the railway sector. If feasible, the revision of Regulation (EC) No 352/2009 should also cover further developments in risk acceptance criteria that could be used to assess the acceptability of a risk during explicit risk estimation and evaluation. The Agency submitted its recommendation on the revision of the CSM to the Commission, supported by an impact assessment report to address the mandate of the Commission. This Regulation is based on that Agency recommendation.

(3)

In accordance with Directive 2004/49/EC the basic elements for the safety management system should include procedures and methods for carrying out risk evaluation and implementing risk control measures whenever a change in operating conditions or new material imposes new risks on the infrastructure or on operations. That basic element of the safety management system is covered by this Regulation.

(4)

Article 14a(3) of Directive 2004/49/EC requires entities in charge of maintenance to establish a system of maintenance in order to ensure that the vehicles for which they are in charge of maintenance are in a safe state of running. To manage changes in equipment, procedures, organisation, staffing or interfaces, the entities in charge of maintenance should have in place risk assessment procedures. That requirement for the system of maintenance is also covered by this Regulation.

(5)

As a consequence of the application of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways (3) and of Article 9(2) of Directive 2004/49/EC, particular attention should be paid to risk management at the interfaces between the actors which are involved in the application of this Regulation.

(6)

Article 15 of Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (4) requires Member States to take all appropriate steps to ensure that the structural subsystems constituting the rail system may be placed in service only if they are designed, constructed and installed in such a way as to meet the essential requirements concerning them when integrated into the rail system. In particular, the Member States must check the technical compatibility of these subsystems with the railway system into which they are being integrated and the safe integration of these subsystems in accordance with the scope of this Regulation.

(7)

The absence of a common approach for specifying and demonstrating compliance with safety levels and requirements of the railway system among the Member States has proved to be one of the obstacles to liberalisation of the railway market. Such a common approach should be established through this Regulation.

(8)

To facilitate mutual recognition between Member States, the methods used for identifying and managing risks and the methods for demonstrating that the railway system in the territory of the Union conforms to safety requirements should be harmonised among the actors involved in the development and operation of the railway system. As a first step, it is necessary to harmonise the procedures and methods for carrying out risk evaluation and implementing control measures whenever a change in operating conditions or new material imposes new risks on the infrastructure or on operations, as referred to in point (2)(d) of Annex III to Directive 2004/49/EC.

(9)

If there is no existing notified national rule for defining whether or not a change is significant for the safety in a Member State, the company or organisation in charge of implementing the change (the ‘proposer’) should initially consider the potential impact of the change in question on the safety of the railway system. If the proposed change has an impact on safety, the proposer should assess, by expert judgement, the significance of the change based on a set of criteria that should be set out in this Regulation. This assessment should lead to one of three conclusions. In the first situation the change is not considered to be significant and the proposer should implement the change by applying its own safety method. In the second situation the change is considered to be significant and the proposer should implement the change by applying this Regulation, without the need for a specific intervention of the national safety authority. In the third situation the change is considered to be significant but there are provisions at the level of the European Union which require a specific intervention of the relevant national safety authority, such as a new authorisation for placing in service of a vehicle or a revision/update of the safety certificate of a railway undertaking or a revision/update of the safety authorisation of an infrastructure manager.

(10)

Whenever the railway system already in use is subject to a change, the significance of the change should also be assessed taking into account all safety-related changes affecting the same part of the system since the entry into force of this Regulation or since the last application of the risk management process set out in this Regulation, whichever is the latest. The purpose is to assess whether or not the totality of such changes amounts to a significant change requiring the full application of the CSM for risk evaluation and assessment.

(11)

The risk acceptability of a significant change should be evaluated by using one or more of the following risk acceptance principles: the application of codes of practice, a comparison with similar parts of the railway system, or an explicit risk estimation. All principles have been used successfully in a number of railway applications, as well as in other transport modes and other industries. The ‘explicit risk estimation’ principle is frequently used for complex or innovative changes. The proposer should be responsible for the choice of the principle to apply.

(12)

When a widely recognised code of practice is applied, it should therefore be possible to reduce the impact of applying the CSM, in accordance with the principle of proportionality. In the same way, where there are provisions at the level of the Union which require specific intervention by the national safety authority, that authority should be allowed to act as the independent assessment body in order to reduce double checking, undue costs to the industry and time to market.

(13)

To report to the Commission on the effectiveness and application of this Regulation, and where applicable to make recommendations to improve it, the Agency should be able to gather relevant information from the various actors involved, including from the national safety authorities, from the certification bodies of entities in charge of maintenance of freight wagons and from other entities in charge of maintenance that do not fall within the scope of Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons (5).

(14)

Accreditation of an assessment body should normally be granted by the national accreditation body which has exclusive competence to assess if the assessment body meets the requirements set by harmonised standards. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (6) contains detailed provisions on the competence of such national accreditation bodies.

(15)

Where harmonised Union legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in Regulation (EC) No 765/2008, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means to carry out this evaluation themselves. In such cases, the Member State should provide the Commission and the other Member States with all the documentary evidence necessary for verification of the competence of the recognition body it selects for implementation of the Union legislation. In order to achieve a similar level of quality and trust as expected through accreditation, the requirements and rules for the evaluation and surveillance of assessment bodies in the case of recognition should be equivalent to those used for accreditation.

(16)

An independent and competent external or internal individual, organisation or entity, a national safety authority, a notified body or a body designated according to Article 17 of Directive 2008/57/EC could act as an assessment body provided it fulfils the criteria required in Annex II.

(17)

Recognition of internal assessment bodies in compliance with this Regulation does not require an immediate revision of already delivered safety certificates to railway undertakings, safety authorisations to infrastructure managers and certificates to entities in charge of maintenance. Their revision can be made at the next application for renewal or update of the safety certificate, safety authorisation or certificate of the entity in charge of maintenance.

(18)

In existing legislation there are no limits in the number of assessment bodies accredited or recognised in each Member State and there are no obligations to have at least one. Where the assessment body is not already designated by existing Union or national legislation, the proposer may appoint any assessment body in the Union or in a third country accredited under equivalent criteria and meeting equivalent requirements to those contained in this regulation. The Member State should be able to use accreditation or recognition or any combination of these two options.

(19)

Regulation (EC) No 352/2009 has become obsolete and should therefore be replaced by this Regulation.

(20)

In view of the new requirements introduced by the present Regulation in terms of accreditation and recognition of the assessment body, the implementation of this Regulation should be deferred in order to give sufficient time to the actors concerned to put in place and implement this new common approach.

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 27(1) of Directive 2004/49/EC,

(1)

‘risk’ means the frequency of occurrence of accidents and incidents resulting in harm (caused by a hazard) and the degree of severity of that harm;

(2)

‘risk analysis’ means systematic use of all available information to identify hazards and to estimate the risk;

(3)

‘risk evaluation’ means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;

(4)

‘risk assessment’ means the overall process comprising a risk analysis and a risk evaluation;

(5)

‘safety’ means freedom from unacceptable risk of harm;

(6)

‘risk management’ means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;

(7)

‘interfaces’ means all points of interaction during a system or subsystem life cycle, including operation and maintenance where different actors of the rail sector will work together in order to manage the risks;

(8)

‘actors’ means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;

(9)

‘safety requirements’ means the safety characteristics (qualitative or quantitative) of a system and its operation (including operational rules) and maintenance necessary in order to meet legal or company safety targets;

(10)

‘safety measures’ means a set of actions either reducing the frequency of occurrence of a hazard or mitigating its consequences in order to achieve and/or maintain an acceptable level of risk;

(11)

‘proposer’ means one of the following:

(12)

‘safety assessment report’ means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;

(13)

‘hazard’ means a condition that could lead to an accident;

(14)

‘assessment body’ means the independent and competent external or internal individual, organisation or entity which undertakes investigation to provide a judgement, based on evidence, of the suitability of a system to fulfil its safety requirements;

(15)

‘risk acceptance criteria’ means the terms of reference by which the acceptability of a specific risk is assessed; these criteria are used to determine that the level of a risk is sufficiently low that it is not necessary to take any immediate action to reduce it further;

(16)

‘hazard record’ means the document in which identified hazards, their related measures, their origin and the reference to the organisation which has to manage them are recorded and referenced;

(17)

‘hazard identification’ means the process of finding, listing and characterising hazards;

(18)

‘risk acceptance principle’ means the rules used in order to arrive at the conclusion whether or not the risk related to one or more specific hazards is acceptable;

(19)

‘code of practice’ means a written set of rules that, when correctly applied, can be used to control one or more specific hazards;

(20)

‘reference system’ means a system proven in use to have an acceptable safety level and against which the acceptability of the risks from a system under assessment can be evaluated by comparison;

(21)

‘risk estimation’ means the process used to produce a measure of the level of risks being analysed, consisting of the following steps: estimation of frequency, consequence analysis and their integration;

(22)

‘technical system’ means a product or an assembly of products including the design, implementation and support documentation; the development of a technical system starts with its requirements specification and ends with its acceptance; although the design of relevant interfaces with human behaviour is considered, human operators and their actions are not included in a technical system; the maintenance process is described in the maintenance manuals but is not itself part of the technical system;

(23)

‘catastrophic consequence’ means fatalities and/or multiple severe injuries and/or major damage to the environment resulting from an accident;

(24)

‘safety acceptance’ means status given to the change by the proposer based on the safety assessment report provided by the assessment body;

(25)

‘system’ means any part of the railway system which is subjected to a change whereby the change may be of a technical, operational or organisational nature;

(26)

‘notified national rule’ means any national rule notified by Member States under Council Directive 96/48/EC (7) or, Directive 2001/16/EC of the European Parliament and of the Council (8) and Directives 2004/49/EC and 2008/57/EC;

(27)

‘certification body’ means a certification body as defined in Article 3 of Regulation (EU) No 445/2011;

(28)

‘conformity assessment body’ means a conformity assessment body as defined in Article 2 of Regulation (EC) No 765/2008;

(29)

‘accreditation’ means accreditation as defined in Article 2 of Regulation (EC) No 765/2008;

(30)

‘national accreditation body’ means a national accreditation body as defined in Article 2 of Regulation (EC) No 765/2008;

(31)

‘recognition’ means an attestation by a national body other than the national accreditation body that the assessment body meets the requirements set out in Annex II to this Regulation to carry out the independent assessment activity specified in Article 6(1) and (2).

(a)

accredited by the national accreditation body referred to in Article 13(1) using the criteria defined in Annex II; or

(b)

recognised by the recognition body referred to in Article 13(1) using the criteria defined in Annex II; or

(c)

the national safety authority under the requirement of Article 9(2).

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

A preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 74252) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on chickens for fattening by Commission Regulation (EC) No 1259/2004 (3), on turkeys for fattening by Commission Regulation (EC) No 1206/2005 (4), and on laying hens and weaned piglets by Commission Regulation (EC) No 1876/2006 (5). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of that preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) (formerly ATCC 74252), as a feed additive for chickens for fattening, turkeys for fattening, laying hens and piglets and, in accordance with Article 7 of that Regulation, for a new use for all poultry species for fattening and laying, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 October 2012 (6) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in target species. However, based on the incomplete information provided by the applicant, the Authority was not in a position to specify the minimum enzyme activities. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

(6)

As a new authorisation is granted in accordance with Regulation (EC) No 1831/2003, Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 should therefore be amended accordingly.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

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

1.

Article 2 is replaced by the following:

2.

Annex II is deleted.

1.

Article 3 is deleted;

2.

Annex III is deleted.

(1)

By Decision 2012/735/EU, the Council authorised the signature, on behalf of the Union, of the Trade Agreement between the European Union and its Member States, of the one part, and Colombia and Peru, of the other part (‘the Agreement’). Pursuant to Decision 2012/735/EU, the Agreement is to be applied on a provisional basis, pending the completion of the procedures for its conclusion. The Agreement applies on a provisional basis from 1 March 2013.

(2)

Annex II to the Agreement concerns the definition of the concept of ‘originating products’ and methods of administrative cooperation. For a number of products, Appendix 2A and Appendix 5 to that Annex provide for derogations from the rules of origin set out in that Annex in the framework of annual quotas. It is therefore necessary to lay down the conditions for the application of those derogations for imports from Peru.

(3)

The quotas set out in Appendix 2A and Appendix 5 to Annex II to the Agreement should be managed by the Commission on a first-come, first-served basis in accordance with Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (2).

(4)

Entitlement to benefit from the tariff concessions should be subject to the presentation of the relevant proof of origin to the customs authorities, as provided for in the Agreement.

(5)

Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (3), as amended by Commission Implementing Regulation (EU) No 927/2012 (4), contains new CN codes which are different from those referred to in the Agreement. Those new codes should therefore be reflected in Part B of the Annex to this Regulation.

(6)

Since the Agreement takes effect on 1 March 2013, this Regulation should apply from the same date.

(7)

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

(1)

By Decision 2012/735/EU, the Council authorised the signing, on behalf of the Union, of the Trade Agreement between the European Union and its Member States, of the one part, and Colombia and Peru, of the other part (‘the Agreement’). Pursuant to Decision 2012/735/EU, the Agreement is to be applied on a provisional basis, pending the completion of the procedures for its conclusion. The Agreement applies on a provisional basis from 1 March 2013.

(2)

Subsection 2 of Section B of Appendix 1 to Annex I to the Agreement concerns the tariff elimination schedule of the EU party for goods originating in Peru. For a number of specific products, it provides for the application of tariff quotas. It is therefore necessary to open tariff quotas for such products.

(3)

The tariff quotas should be managed by the Commission on a first-come, first-served basis in accordance with Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (2).

(4)

Entitlement to benefit from the tariff concessions should be subject to the presentation of the relevant proof of origin to the customs authorities, as provided for in the Agreement.

(5)

Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (3), as amended by Commission Implementing Regulation (EU) No 927/2012 (4), contains new CN codes which are different from those referred to in the Agreement. The new codes should therefore be reflected in the Annex to this Regulation.

(6)

Since the Agreement takes effect on 1 March 2013, this Regulation should apply from the same date.

(7)

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

(1)

The maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009.

(2)

Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).

(3)

Prednisolone is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine species, applicable to muscle, fat, liver, kidney and milk.

(4)

An application for the extension of the existing entry for prednisolone applicable to equidae has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for prednisolone for equidae species, applicable to muscle, fat, liver and kidney.

(6)

The entry for prednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for equidae.

(7)

It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

(1)

Errors appear in the Spanish and in the Swedish language versions of Commission Regulation (EU) No 475/2012 (2), more precisely in Article 2 thereof as regards the application date of the amendments made by that Regulation to Commission Regulation (EC) No 1126/2008 (3).

(2)

The Swedish language version of that Regulation also contains some misprints.

(3)

Regulation (EU) No 475/2012 should therefore be corrected accordingly.

(4)

As companies are required to apply the amendments made by points 1 and 2 of Article 1 of Regulation (EU) No 475/2012, at the latest, as from the commencement date of their first financial year starting on or after 1 July 2012, this Regulation should apply retroactively from 1 July 2012.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Accounting Regulatory Committee,

(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,