ISSN 1977-0677 doi:10.3000/19770677.L_2013.179.eng |
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Official Journal of the European Union |
L 179 |
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English edition |
Legislation |
Volume 56 |
Contents |
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I Legislative acts |
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DIRECTIVES |
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(1) Text with EEA relevance |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
I Legislative acts
DIRECTIVES
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/1 |
DIRECTIVE 2013/35/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 26 June 2013
on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 153(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
Under the Treaty, the European Parliament and the Council may, by means of directives, adopt minimum requirements for the encouragement of improvements, in particular of the working environment, to guarantee a better level of protection of the health and safety of workers. Such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. |
(2) |
Article 31(1) of the Charter of Fundamental Rights of the European Union provides that every worker has the right to working conditions which respect his or her health, safety and dignity. |
(3) |
Following the entry into force of Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (3), serious concerns were expressed by stakeholders, in particular those from the medical community, as to the potential impact of the implementation of that Directive on the use of medical procedures based on medical imaging. Concerns were also expressed as to the impact of the Directive on certain industrial activities. |
(4) |
The Commission examined attentively the arguments put forward by stakeholders and, after several consultations, decided to thoroughly reconsider some provisions of Directive 2004/40/EC on the basis of new scientific information produced by internationally recognised experts. |
(5) |
Directive 2004/40/EC was amended by Directive 2008/46/EC of the European Parliament and of the Council (4), with the effect of postponing, by four years, the deadline for the transposition of Directive 2004/40/EC, and subsequently by Directive 2012/11/EU of the European Parliament and of the Council (5), with the effect of postponing that deadline for transposition until 31 October 2013. This was to allow the Commission to present a new proposal, and the co-legislators to adopt a new directive, based on fresher and sounder evidence. |
(6) |
Directive 2004/40/EC should be repealed and more appropriate and proportionate measures to protect workers from the risks associated with electromagnetic fields should be introduced. That Directive did not address the long-term effects, including the possible carcinogenic effects, of exposure to time-varying electric, magnetic and electromagnetic fields, for which there is currently no conclusive scientific evidence establishing a causal relationship. This Directive is intended to address all known direct biophysical effects and indirect effects caused by electromagnetic fields, in order not only to ensure the health and safety of each worker on an individual basis, but also to create a minimum basis of protection for all workers in the Union, while reducing possible distortions of competition. |
(7) |
This Directive does not address suggested long-term effects of exposure to electromagnetic fields, since there is currently no well-established scientific evidence of a causal relationship. However, if such well-established scientific evidence emerges, the Commission should consider the most appropriate means for addressing such effects, and should, through its report on the practical implementation of this Directive, keep the European Parliament and Council informed in this regard. In doing so, the Commission should, in addition to the appropriate information that it receives from Member States, take into account the latest available research and new scientific knowledge arising from the data in this area. |
(8) |
Minimum requirements should be laid down, thereby giving Member States the option of maintaining or adopting more favourable provisions for the protection of workers, in particular by fixing lower values for the action levels (ALs) or the exposure limit values (ELVs) for electromagnetic fields. However, the implementation of this Directive should not serve to justify any regression in relation to the situation already prevailing in each Member State. |
(9) |
The system of protection against electromagnetic fields should be limited to a definition, which should be free of excessive detail, of the objectives to be attained, the principles to be observed and the fundamental values to be applied, in order to enable Member States to apply the minimum requirements in an equivalent manner. |
(10) |
In order to protect workers exposed to electromagnetic fields it is necessary to carry out an effective and efficient risk assessment. However, this obligation should be proportional to the situation encountered at the workplace. Therefore, it is appropriate to design a protection system that groups different risks in a simple, graduated and easily understandable way. Consequently, the reference to a number of indicators and standard situations, to be provided by practical guides, can usefully assist employers in fulfilling their obligations. |
(11) |
The undesired effects on the human body depend on the frequency of the electromagnetic field or radiation to which it is exposed. Therefore, exposure limitation systems need to be exposure-pattern and frequency dependent in order to adequately protect workers exposed to electromagnetic fields. |
(12) |
The level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by giving priority, when selecting work equipment, procedures and methods, to reducing risks at source. Provisions relating to work equipment and methods thereby contribute to the protection of the workers involved. There is, however, a need to avoid duplication of assessments where work equipment meets the requirements of relevant Union law on products that establishes stricter safety levels than those provided for by this Directive. This allows for simplified assessment in a large number of cases. |
(13) |
Employers should make adjustments in the light of technical progress and scientific knowledge regarding the risks related to exposure to electromagnetic fields, with a view to improving the safety and health protection of workers. |
(14) |
Since this Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (6), it follows that Directive 89/391/EEC applies to the exposure of workers to electromagnetic fields, without prejudice to more stringent and/or specific provisions contained in this Directive. |
(15) |
The physical quantities, ELVs and ALs, laid down in this Directive are based on the recommendations of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) and should be considered in accordance with ICNIRP concepts, save where this Directive specifies otherwise. |
(16) |
In order to ensure that this Directive remains up-to-date, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of purely technical amendments of the Annexes, to reflect the adoption of regulations and directives in the field of technical harmonisation and standardisation, technical progress, changes in the most relevant standards or specifications and new scientific findings concerning hazards presented by electromagnetic fields, as well as to adjust ALs. 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. |
(17) |
If amendments of a purely technical nature to the Annexes become necessary, the Commission should work in close cooperation with the Advisory Committee for Safety and Health at Work set up by Council Decision of 22 July 2003 (7). |
(18) |
In exceptional cases, where imperative grounds of urgency so require, such as possible imminent risks to workers’ health and safety arising from their exposure to electromagnetic fields, the possibility should be given to apply the urgency procedure to delegated acts adopted by the Commission. |
(19) |
In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (8), 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. |
(20) |
A system including ELVs and ALs, where applicable, should be seen as a means to facilitate the provision of a high level of protection against the adverse health effects and safety risks that may result from exposure to electromagnetic fields. However, such a system may conflict with specific conditions in certain activities, such as the use of the magnetic resonance technique in the medical sector. It is therefore necessary to take those particular conditions into account. |
(21) |
Given the specificities of the armed forces and in order to allow them to operate and interoperate effectively, including in joint international military exercises, Member States should be able to implement equivalent or more specific protection systems, such as internationally agreed standards, for example NATO standards, provided that adverse health effects and safety risks are prevented. |
(22) |
Employers should be required to ensure that risks arising from electromagnetic fields at work are eliminated or reduced to a minimum. It is nevertheless possible that in specific cases and in duly justified circumstances, the ELVs set out in this Directive are only temporarily exceeded. In such a case, employers should be required to take the necessary actions in order to return to compliance with the ELVs as soon as possible. |
(23) |
A system ensuring a high level of protection as regards the adverse health effects and safety risks that may result from exposure to electromagnetic fields should take due account of specific groups of workers at particular risk and avoid interference problems with, or effects on the functioning of, medical devices such as metallic prostheses, cardiac pacemakers and defibrillators, cochlear implants and other implants or medical devices worn on the body. Interference problems, especially with pacemakers, may occur at levels below the ALs and should therefore be the object of appropriate precautions and protective measures, |
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject-matter and scope
1. This Directive, which is the 20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising, or likely to arise, from exposure to electromagnetic fields during their work.
2. This Directive covers all known direct biophysical effects and indirect effects caused by electromagnetic fields.
3. The exposure limit values (ELVs) laid down in this Directive cover only scientifically well-established links between short-term direct biophysical effects and exposure to electromagnetic fields.
4. This Directive does not cover suggested long-term effects.
The Commission shall keep under review the latest scientific developments. If well-established scientific evidence on suggested long-term effects becomes available, the Commission shall consider a suitable policy response, including, if appropriate, the submission of a legislative proposal to address such effects. The Commission shall, through its report referred to in Article 15, keep the European Parliament and the Council informed in this regard.
5. This Directive does not cover the risks resulting from contact with live conductors.
6. Without prejudice to the more stringent or more specific provisions in this Directive, Directive 89/391/EEC shall continue to apply in full to the whole area referred to in paragraph 1.
Article 2
Definitions
For the purposes of this Directive, the following definitions shall apply:
(a) |
‘electromagnetic fields’ means static electric, static magnetic and time-varying electric, magnetic and electromagnetic fields with frequencies up to 300 GHz; |
(b) |
‘direct biophysical effects’ means effects in the human body directly caused by its presence in an electromagnetic field, including:
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(c) |
‘indirect effects’ means effects, caused by the presence of an object in an electromagnetic field, which may become the cause of a safety or health hazard, such as:
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(d) |
‘exposure limit values (ELVs)’ means values established on the basis of biophysical and biological considerations, in particular on the basis of scientifically well-established short-term and acute direct effects, i.e. thermal effects and electrical stimulation of tissues; |
(e) |
‘health effects ELVs’ means those ELVs above which workers might be subject to adverse health effects, such as thermal heating or stimulation of nerve and muscle tissue; |
(f) |
‘sensory effects ELVs’ means those ELVs above which workers might be subject to transient disturbed sensory perceptions and minor changes in brain functions; |
(g) |
‘action levels (ALs)’ means operational levels established for the purpose of simplifying the process of demonstrating the compliance with relevant ELVs or, where appropriate, to take relevant protection or prevention measures specified in this Directive. The AL terminology used in Annex II is as follows:
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Article 3
Exposure limit values and action levels
1. Physical quantities regarding exposure to electromagnetic fields are indicated in Annex I. Health effects ELVs, sensory effects ELVs and ALs are set out in Annexes II and III.
2. Member States shall require that employers ensure that the exposure of workers to electromagnetic fields is limited to the health effects ELVs and sensory effects ELVs set out in Annex II, for non-thermal effects, and in Annex III, for thermal effects. Compliance with health effects ELVs and sensory effects ELVs must be established by the use of relevant exposure assessment procedures referred to in Article 4. Where the exposure of workers to electromagnetic fields exceeds the ELVs, the employer shall take immediate action in accordance with Article 5(8).
3. For the purpose of this Directive, where it is demonstrated that the relevant ALs set out in Annex II and III are not exceeded, the employer shall be deemed to be in compliance with the health effects ELVs and sensory effects ELVs. Where the exposure exceeds the ALs, the employer shall act in accordance with Article 5(2), unless the assessment carried out in accordance with Article 4(1), (2) and (3) demonstrates that the relevant ELVs are not exceeded and that safety risks can be excluded.
Notwithstanding the first subparagraph, exposure may exceed:
(a) |
low ALs for electric fields (Annex II, Table B1), where justified by the practice or process, provided that either the sensory effects ELVs (Annex II, Table A3) are not exceeded; or
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(b) |
low ALs for magnetic fields (Annex II, Table B2) where justified by the practice or process, including in the head and torso, during the shift, provided that either the sensory effects ELVs (Annex II, Table A3) are not exceeded; or
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4. Notwithstanding paragraphs 2 and 3, exposure may exceed:
(a) |
the sensory effects ELVs (Annex II, Table A1) during the shift, where justified by the practice or process, provided that:
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(b) |
the sensory effects ELVs (Annex II, Table A3 and Annex III, Table A2) during the shift, where justified by the practice or process, provided that:
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CHAPTER II
OBLIGATIONS OF EMPLOYERS
Article 4
Assessment of risks and determination of exposure
1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall assess all risks for workers arising from electromagnetic fields at the workplace and, if necessary, measure or calculate the levels of electromagnetic fields to which workers are exposed.
Without prejudice to Article 10 of Directive 89/391/EEC and Article 6 of this Directive, that assessment can be made public on request in accordance with relevant Union and national laws. In particular, in the case of processing the personal data of employees in the course of such an assessment, any publication shall comply with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (9) and the national laws of the Member States implementing that Directive. Unless there is an overriding public interest in disclosure, public authorities that are in possession of a copy of the assessment may refuse a request for access to it or a request to make it public, where disclosure would undermine the protection of commercial interests of the employer, including those relating to intellectual property. Employers may refuse to disclose or make public the assessment under the same conditions in accordance with the relevant Union and national laws.
2. For the purpose of the assessment provided for in paragraph 1 of this Article the employer shall identify and assess electromagnetic fields at the workplace, taking into account the relevant practical guides referred to in Article 14 and other relevant standards or guidelines provided by the Member State concerned, including exposure databases. Notwithstanding the employer’s obligations under this Article, the employer shall also be entitled, where relevant, to take into account the emission levels and other appropriate safety-related data provided, by the manufacturer or distributor, for the equipment, in accordance with relevant Union law, including an assessment of risks, if applicable to the exposure conditions at the workplace or place of installation.
3. If compliance with the ELVs cannot be reliably determined on the basis of readily accessible information, the assessment of the exposure shall be carried out on the basis of measurements or calculations. In such a case, the assessment shall take into account uncertainties concerning the measurements or calculations, such as numerical errors, source modelling, phantom geometry and the electrical properties of tissues and materials, determined in accordance with relevant good practice.
4. The assessment, measurement and calculations referred to in paragraphs 1, 2 and 3 of this Article shall be planned and carried out by competent services or persons at suitable intervals, taking into account the guidance given under this Directive and taking particular account of Articles 7 and 11 of Directive 89/391/EEC concerning the necessary competent services or persons and the consultation and participation of workers. The data obtained from the assessment, measurement or calculation of the level of exposure shall be preserved in a suitable traceable form so as to permit consultation at a later stage, in accordance with national law and practice.
5. When carrying out the risk assessment pursuant to Article 6(3) of Directive 89/391/EEC, the employer shall give particular attention to the following:
(a) |
the health effects ELVs, the sensory effects ELVs and the ALs referred to in Article 3 and Annexes II and III to this Directive; |
(b) |
the frequency, the level, duration and type of exposure, including the distribution over the worker’s body and over the volume of the workplace; |
(c) |
any direct biophysical effects; |
(d) |
any effects on the health and safety of workers at particular risk, in particular workers who wear active or passive implanted medical devices, such as cardiac pacemakers, workers with medical devices worn on the body, such as insulin pumps, and pregnant workers; |
(e) |
any indirect effects; |
(f) |
the existence of replacement equipment designed to reduce the level of exposure to electromagnetic fields; |
(g) |
appropriate information obtained from the health surveillance referred to in Article 8; |
(h) |
information provided by the manufacturer of equipment; |
(i) |
other relevant health and safety related information; |
(j) |
multiple sources of exposure; |
(k) |
simultaneous exposure to multiple frequency fields. |
6. In workplaces open to the public it is not necessary for the exposure assessment to be carried out if an evaluation has already been undertaken in accordance with the provisions on the limitation of exposure of the general public to electromagnetic fields, if the restrictions specified in those provisions are respected for workers and if the health and safety risks are excluded. Where equipment intended for the public use is used as intended and complies with Union law on products that establishes stricter safety levels than those provided for by this Directive, and no other equipment is used, these conditions are deemed to be met.
7. The employer shall be in possession of an assessment of the risks in accordance with Article 9(1)(a) of Directive 89/391/EEC and shall identify which measures must be taken in accordance with Article 5 of this Directive. The risk assessment may include the reasons why the employer considers that the nature and the extent of the risks related to electromagnetic fields make a further detailed risk assessment unnecessary. The risk assessment shall be updated on a regular basis, particularly if there have been significant changes which could render it out of date, or if the results of the health surveillance referred to in Article 8 show this to be necessary.
Article 5
Provisions aimed at avoiding or reducing risks
1. Taking account of technical progress and the availability of measures to control the production of electromagnetic fields at the source, the employer shall take the necessary actions to ensure that risks arising from electromagnetic fields at the workplace are eliminated or reduced to a minimum.
The reduction of risks arising from exposure to electromagnetic fields shall be based on the general principles of prevention set out in Article 6(2) of Directive 89/391/EEC.
2. On the basis of the risk assessment referred to in Article 4, once the relevant ALs, referred to in Article 3 and in Annexes II and III, are exceeded and unless the assessment carried out in accordance with Article 4(1), (2) and (3) demonstrates that the relevant ELVs are not exceeded and that safety risks can be excluded, the employer shall devise and implement an action plan that shall include technical and/or organisational measures to prevent exposure exceeding the health effects ELVs and sensory effects ELVs, taking into account, in particular:
(a) |
other working methods that entail less exposure to electromagnetic fields; |
(b) |
the choice of equipment emitting less intense electromagnetic fields, taking account of the work to be done; |
(c) |
technical measures to reduce the emission of electromagnetic fields, including, where necessary, the use of interlocks, shielding or similar health protection mechanisms; |
(d) |
appropriate delimitation and access measures, such as signals, labels, floor markings, barriers, in order to limit or control access; |
(e) |
in the case of exposure to electric fields, measures and procedures to manage spark discharges and contact currents through technical means and through the training of workers; |
(f) |
appropriate maintenance programmes for work equipment, workplaces and workstation systems; |
(g) |
the design and layout of workplaces and workstations; |
(h) |
limitations of the duration and intensity of the exposure; and |
(i) |
the availability of adequate personal protection equipment. |
3. On the basis of the risk assessment referred to in Article 4, the employer shall devise and implement an action plan that shall include technical and/or organisational measures to prevent any risks to workers at particular risk, and any risks due to indirect effects, referred to in Article 4.
4. In addition to providing the information set out in Article 6 of this Directive, the employer shall, pursuant to Article 15 of Directive 89/391/EEC, adapt the measures referred to in this Article to the requirements of workers at particular risk and, where applicable, to individual risks assessments, in particular in respect of workers who have declared the use of active or passive implanted medical devices, such as cardiac pacemakers, or the use of medical devices worn on the body, such as insulin pumps, or in respect of pregnant workers who have informed their employer of their condition.
5. On the basis of the risk assessment referred to in Article 4, workplaces where workers are likely to be exposed to electromagnetic fields that exceed the ALs shall be indicated by appropriate signs in accordance with Annexes II and III and with Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (10). The areas in question shall be identified and access to them limited, as appropriate. Where access to these areas is suitably restricted for other reasons and workers are informed of the risks arising from electromagnetic fields, signs and access restrictions specific to electromagnetic fields shall not be required.
6. Where Article 3(3)(a) applies, specific protection measures shall be taken, such as the training of workers in accordance with Article 6 and the use of technical means and personal protection, for example the grounding of work objects, the bonding of workers with work objects (equipotential bonding) and, where appropriate and in accordance with Article 4(1)(a) of Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (11), the use of insulating shoes, gloves and protective clothing.
7. Where Article 3(4)(a) applies, specific protection measures, such as controlling movements, shall be taken.
8. Workers shall not be exposed above the health effects ELVs and sensory effects ELVs, unless the conditions under either Article 10(1)(a) or (c) or Articles 3(3) or (4) are fulfilled. If, despite the measures taken by the employer, the health effects ELVs and sensory effects ELVs are exceeded, the employer shall take immediate action to reduce exposure below these ELVs. The employer shall identify and record the reasons why the health effects ELVs and sensory effects ELVs have been exceeded, and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again. The amended protection and prevention measures shall be preserved in a suitable traceable form so as to permit consultation at a later stage, in accordance with national law and practice.
9. Where paragraphs 3 and 4 of Article 3 apply and where the worker reports transient symptoms, the employer shall, if necessary, update the risk assessment and the prevention measures. Transient symptoms may include:
(a) |
sensory perceptions and effects in the functioning of the central nervous system in the head evoked by time varying magnetic fields; and |
(b) |
static magnetic field effects, such as vertigo and nausea. |
Article 6
Worker information and training
Without prejudice to Articles 10 and 12 of Directive 89/391/EEC, the employer shall ensure that workers who are likely to be exposed to risks from electromagnetic fields at work and/or their representatives receive any necessary information and training relating to the outcome of the risk assessment provided for in Article 4 of this Directive, concerning in particular:
(a) |
measures taken in application of this Directive; |
(b) |
the values and concepts of the ELVs and ALs, the associated possible risks and the preventive measures taken; |
(c) |
the possible indirect effects of exposure; |
(d) |
the results of the assessment, measurement or calculations of the levels of exposure to electromagnetic fields, carried out in accordance with Article 4 of this Directive; |
(e) |
how to detect adverse health effects of exposure and how to report them; |
(f) |
the possibility of transient symptoms and sensations related to effects in the central or peripheral nervous system; |
(g) |
the circumstances in which workers are entitled to health surveillance; |
(h) |
safe working practices to minimise risks resulting from exposure; |
(i) |
workers at particular risk, as referred to in Article 4(5)(d) and Article 5(3) and (4) of this Directive. |
Article 7
Consultation and participation of workers
Consultation and participation of workers and/or their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC.
CHAPTER III
MISCELLANEOUS PROVISIONS
Article 8
Health surveillance
1. With the objective of the prevention and the early diagnosis of any adverse health effects due to exposure to electromagnetic fields, appropriate health surveillance shall be carried out in accordance with Article 14 of Directive 89/391/EEC. Health records and their availability shall be provided for in accordance with national law and/or practice.
2. In accordance with national law and practice, the results of health surveillance shall be preserved in a suitable form that allows them to be consulted at a later date, subject to compliance with confidentiality requirements. Individual workers shall, at their request, have access to their own personal health records.
If any undesired or unexpected health effect is reported by a worker, or in any event where exposure above the ELVs is detected, the employer shall ensure that appropriate medical examinations or individual health surveillance is provided to the worker(s) concerned, in accordance with national law and practice.
Such examinations or surveillance shall be made available during hours chosen by the worker, and any costs arising shall not be borne by the worker.
Article 9
Penalties
Member States shall provide for adequate penalties applicable in the event of infringements of national legislation adopted pursuant to this Directive. These penalties must be effective, proportionate and dissuasive.
Article 10
Derogations
1. By way of derogation from Article 3 but without prejudice to Article 5(1), the following shall apply:
(a) |
exposure may exceed the ELVs if the exposure is related to the installation, testing, use, development, maintenance of or research related to magnetic resonance imaging (MRI) equipment for patients in the health sector, provided that all the following conditions are met:
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(b) |
Member States may allow for an equivalent or more specific protection system to be implemented for personnel working in operational military installations or involved in military activities, including in joint international military exercises, provided that adverse health effects and safety risks are prevented; |
(c) |
Member States may allow, in duly justified circumstances and only for as long as they remain duly justified, for the ELVs to be temporarily exceeded in specific sectors or for specific activities outside the scope of points (a) and (b). For the purposes of this point, ‘duly justified circumstances’ shall mean circumstances in which the following conditions are met:
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2. Member States shall inform the Commission of any derogation under points (b) and (c) of paragraph 1 and shall state the reasons that justify them in the report referred to in Article 15.
Article 11
Technical amendments of the Annexes
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 12 amending, in a purely technical way, the Annexes, so as to:
(a) |
take into account the adoption of regulations and directives in the field of technical harmonisation and standardisation with regard to the design, building, manufacture or construction of work equipment or workplaces; |
(b) |
take into account technical progress, changes in the most relevant standards or specifications, and new scientific findings concerning electromagnetic fields; |
(c) |
make adjustments to the ALs where there is new scientific evidence, provided that employers continue to be bound by the existing ELVs set out in Annexes II and III. |
2. The Commission shall adopt a delegated act, in accordance with Article 12, to insert into Annex II the ICNIRP guidelines for limiting exposure to electric fields induced by movement of the human body in a static magnetic field and by time-varying magnetic fields below 1 Hz as soon as they are available.
3. Where, in the case of the amendments referred to in paragraphs 1 and 2, imperative grounds of urgency so require, the procedure provided for in Article 13 shall apply to delegated acts adopted pursuant to this Article.
Article 12
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 11 shall be conferred on the Commission for a period of five years from 29 June 2013. 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 powers referred to in Article 11 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 power 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 11 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two 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 two months at the initiative of the European Parliament or of the Council.
Article 13
Urgency procedure
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure which shall relate to the health and protection of workers.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 12(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.
CHAPTER IV
FINAL PROVISIONS
Article 14
Practical guides
In order to facilitate the implementation of this Directive the Commission shall make available non-binding practical guides at the latest six months before 1 July 2016. Those practical guides shall, in particular relate to the following issues:
(a) |
the determination of exposure, taking into account appropriate European or international standards, including:
|
(b) |
guidance on demonstrating compliance in special types of non-uniform exposure in specific situations, based on well-established dosimetry; |
(c) |
the description of the ‘weighted peak method’ for the low frequency fields and of the ‘multifrequency fields summation’ for high frequency fields; |
(d) |
the conduct of the risk assessment and, wherever possible, the provision of simplified techniques, taking into account in particular the needs of SMEs; |
(e) |
measures aimed at avoiding or reducing risks, including specific prevention measures depending on the level of exposure and the workplace characteristics; |
(f) |
the establishment of documented working procedures, as well as specific information and training measures for workers exposed to electromagnetic fields during MRI-related activities falling under Article 10(1)(a); |
(g) |
the evaluation of exposures in the frequency range from 100 kHz to 10 MHz, where both thermal and non-thermal effects are to be considered; |
(h) |
the guidance on medical examinations and health surveillance to be provided by the employer in accordance with Article 8(2). |
The Commission shall work in close cooperation with the Advisory Committee for Safety and Health at Work. The European Parliament shall be kept informed.
Article 15
Review and reporting
Taking into account Article 1(4), the report on the practical implementation of this Directive shall be established in accordance with Article 17a of Directive 89/391/EEC.
Article 16
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2016.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 17
Repeal
1. Directive 2004/40/EC is repealed from 29 June 2013.
2. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex IV.
Article 18
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 19
Addressees
This Directive is addressed to the Member States.
Done at Brussels, 26 June 2013.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
A. SHATTER
(1) OJ C 43, 15.2.2012, p. 47.
(2) Position of the European Parliament of 11 June 2013 (not yet published in the Official Journal) and decision of the Council of 20 June 2013.
(3) OJ L 159, 30.4.2004, p. 1.
(4) OJ L 114, 26.4.2008, p. 88.
(5) OJ L 110, 24.4.2012, p. 1.
(6) OJ L 183, 29.6.1989, p. 1.
(7) OJ C 218, 13.9.2003, p. 1.
(8) OJ C 369, 17.12.2011, p. 14.
(9) OJ L 281, 23.11.1995, p. 31.
(10) OJ L 245, 26.8.1992, p. 23.
(11) OJ L 393, 30.12.1989, p. 18.
(12) OJ L 169, 12.7.1993, p. 1.
ANNEX I
PHYSICAL QUANTITIES REGARDING THE EXPOSURE TO ELECTROMAGNETIC FIELDS
The following physical quantities are used to describe the exposure to electromagnetic fields:
|
Electric field strength (E) is a vector quantity that corresponds to the force exerted on a charged particle regardless of its motion in space. It is expressed in volt per metre (Vm–1). A distinction has to be made between the environmental electric field and the electric field present in the body (in situ) as a result of exposure to the environmental electric field. |
|
Limb current (IL) is the current in the limbs of a person exposed to electromagnetic fields in the frequency range from 10 MHz to 110 MHz as a result of contact with an object in an electromagnetic field or the flow of capacitive currents induced in the exposed body. It is expressed in ampere (A). |
|
Contact current (IC) is a current that appears when a person comes into contact with an object in an electromagnetic field. It is expressed in ampere (A). A steady state contact current occurs when a person is in continuous contact with an object in an electromagnetic field. In the process of making such contact, a spark discharge may occur with associated transient currents. |
|
Electric charge (Q) is an appropriate quantity used for spark discharge and is expressed in coulomb (C). |
|
Magnetic field strength (H) is a vector quantity that, together with the magnetic flux density, specifies a magnetic field at any point in space. It is expressed in ampere per metre (Am–1). |
|
Magnetic flux density (B) is a vector quantity resulting in a force that acts on moving charges, expressed in tesla (T). In free space and in biological materials, magnetic flux density and magnetic field strength can be interchanged using the magnetic field strength of H = 1 Am–1 equivalence to magnetic flux density of T (approximately 1,25 microtesla). |
|
Power density (S) is an appropriate quantity used for very high frequencies, where the depth of penetration in the body is low. It is the radiant power incident perpendicular to a surface, divided by the area of the surface. It is expressed in watt per square metre (Wm–2). |
|
Specific energy absorption (SA) is an energy absorbed per unit mass of biological tissue, expressed in joule per kilogram (Jkg–1). In this Directive, it is used for establishing limits for effects from pulsed microwave radiation. |
|
Specific energy absorption rate (SAR), averaged over the whole body or over parts of the body, is the rate at which energy is absorbed per unit mass of body tissue and is expressed in watt per kilogram (Wkg–1). Whole-body SAR is a widely accepted quantity for relating adverse thermal effects to radio frequency (RF) exposure. Besides the whole-body average SAR, local SAR values are necessary to evaluate and limit excessive energy deposition in small parts of the body resulting from special exposure conditions. Examples of such conditions include: an individual exposed to RF in the low MHz range (e.g. from dielectric heaters) and individuals exposed in the near field of an antenna. |
Of these quantities, magnetic flux density (B), contact current (IC), limb current (IL), electric field strength (E), magnetic field strength (H), and power density (S) can be measured directly.
ANNEX II
NON-THERMAL EFFECTS
EXPOSURE LIMIT VALUES AND ACTION LEVELS IN THE FREQUENCY RANGE FROM 0 Hz TO 10 MHz
A. EXPOSURE LIMIT VALUES (ELVs)
ELVs below 1 Hz (Table A1) are limits for static magnetic field which is not affected by the tissue of the body.
ELVs for frequencies from 1 Hz to 10 MHz (Table A2) are limits for electric fields induced in the body from exposure to time-varying electric and magnetic fields.
ELVs for external magnetic flux density from 0 to 1 Hz
The sensory effects ELV is the ELV for normal working conditions (Table A1) and is related to vertigo and other physiological effects related to disturbance of the human balance organ resulting mainly from moving in a static magnetic field
The health effects ELV for controlled working conditions (Table A1) is applicable on a temporary basis during the shift when justified by the practice or process, provided that preventive measures, such as controlling movements and providing information to workers, have been adopted.
Table A1
ELVs for external magnetic flux density (B0) from 0 to 1 Hz
|
Sensory effects ELVs |
Normal working conditions |
2 T |
Localised limbs exposure |
8 T |
|
Health effects ELVs |
Controlled working conditions |
8 T |
Health effects ELVs for internal electric field strength from 1 Hz to 10 MHz
Health effects ELVs (Table A2) are related to electric stimulation of all peripheral and central nervous system tissues in the body, including the head.
Table A2
Health effects ELVs for internal electric field strength from 1 Hz to 10 MHz
Frequency range |
Health effects ELVs |
1 Hz ≤ f < 3 kHz |
1,1 Vm–1 (peak) |
3 kHz ≤ f ≤ 10 MHz |
3,8 × 10– 4 f Vm–1 (peak) |
Note A2-1: |
f is the frequency expressed in hertz (Hz). |
Note A2-2: |
The health effects ELVs for internal electric field are spatial peak values in the entire body of the exposed subject. |
Note A2-3: |
The ELVs are peak values in time which are equal to the Root-Mean-Square (RMS) values multiplied by √2 for sinusoidal fields. In the case of non-sinusoidal fields, exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in the practical guides referred to in Article 14 but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results. |
Sensory effects ELVs for internal electric field strength from 1 Hz to 400 Hz
The sensory effects ELVs (Table A3) are related to electric field effects on the central nervous system in the head, i.e. retinal phosphenes and minor transient changes in some brain functions.
Table A3
Sensory effects ELVs for internal electric field strength from 1 to 400 Hz
Frequency range |
Sensory effects ELVs |
1 ≤ f < 10 Hz |
0,7/f Vm–1 (peak) |
10 ≤ f < 25 Hz |
0,07 Vm–1 (peak) |
25 ≤ f ≤ 400 Hz |
0,0028 f Vm–1 (peak) |
Note A3-1: |
f is the frequency expressed in hertz (Hz). |
Note A3-2: |
The sensory effects ELVs for internal electric field are spatial peak values in the head of the exposed subject. |
Note A3-3: |
The ELVs are peak values in time which are equal to the Root-Mean-Square (RMS) values multiplied by √2 for sinusoidal fields. In the case of non-sinusoidal fields, the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in the practical guides referred to in Article 14, but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results. |
B. ACTION LEVELS (ALs)
The following physical quantities and values are used to specify the action levels (ALs), the magnitude of which are established to ensure by simplified assessment the compliance with relevant ELVs or at which relevant protection or prevention measures specified in Article 5 must be taken:
— |
Low ALs(E) and high ALs(E) for electric field strength E of time varying electric fields as specified in Table B1; |
— |
Low ALs(B) and high ALs(B) for magnetic flux density B of time varying magnetic fields as specified in Table B2; |
— |
ALs(IC) for contact current as specified in Table B3; |
— |
ALs(B0) for magnetic flux density of static magnetic fields as specified in Table B4. |
ALs correspond to calculated or measured electric and magnetic field values at the workplace in the absence of the worker.
Action levels (ALs) for exposure to electric fields
Low ALs (Table B1) for external electric field are based on limiting the internal electric field below the ELVs (Tables A2 and A3) and limiting spark discharges in the working environment.
Below high ALs, the internal electric field does not exceed the ELVs (Tables A2 and A3) and annoying spark discharges are prevented, provided that the protection measures referred to in Article 5(6) are taken.
Table B1
ALs for exposure to electric fields from 1 Hz to 10 MHz
Frequency range |
Electric field strength Low ALs (E)[Vm–1] (RMS) |
Electric field strength High ALs (E) [Vm–1] (RMS) |
1 ≤ f < 25 Hz |
2,0 × 104 |
2,0 × 104 |
25 ≤ f < 50 Hz |
5,0 × 105/f |
2,0 × 104 |
50 Hz ≤ f < 1,64 kHz |
5,0 × 105/f |
1,0 × 106/f |
1,64 ≤ f < 3 kHz |
5,0 × 105/f |
6,1 × 102 |
3 kHz ≤ f ≤ 10 MHz |
1,7 × 102 |
6,1 × 102 |
Note B1-1: |
f is the frequency expressed in hertz (Hz). |
Note B1-2: |
The low ALs (E) and high ALs (E) are the Root-Mean-Square (RMS) values of the electric field strength which are equal to the peak values divided by √2 for sinusoidal fields. In the case of non-sinusoidal fields, the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in the practical guides referred to in Article 14, but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results. |
Note B1-3: |
ALs represent maximum calculated or measured values at the workers’ body position. This results in a conservative exposure assessment and automatic compliance with ELVs in all non-uniform exposure conditions. In order to simplify the assessment of compliance with ELVs, carried out in accordance with Article 4, in specific non-uniform conditions, criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14. In the case of a very localised source within a distance of a few centimetres from the body, the induced electric field shall be determined dosimetrically, case by case. |
Action levels (ALs) for exposure to magnetic fields
Low ALs (Table B2) are, for frequencies below 400 Hz, derived from the sensory effects ELVs (Table A3) and, for frequencies above 400 Hz, from the health effects ELVs for internal electric field (Table A2).
High ALs (Table B2) are derived from the health effects ELVs for internal electric field related to electric stimulation of peripheral and autonomous nerve tissues in head and trunk (Table A2). Compliance with the high ALs ensures that health effects ELVs are not exceeded, but the effects related to retinal phosphenes and minor transient changes in brain activity are possible, if the exposure of the head exceeds the low ALs for exposures up to 400 Hz. In such a case, Article 5(6) applies.
ALs for exposure of limbs are derived from the health effects ELVs for internal electric field related to electric stimulation of the tissues in limbs by taking into account that the magnetic field is coupled more weakly to the limbs than to the whole body.
Table B2
ALs for exposure to magnetic fields from 1 Hz to 10 MHz
Frequency range |
Magnetic flux density Low ALs(B)[μT] (RMS) |
Magnetic flux density High ALs(B) [μT] (RMS) |
Magnetic flux density ALs for exposure of limbs to a localised magnetic field [μT] (RMS) |
1 ≤ f < 8 Hz |
2,0 × 105/f2 |
3,0 × 105/f |
9,0 × 105/f |
8 ≤ f < 25 Hz |
2,5 × 104/f |
3,0 × 105/f |
9,0 × 105/f |
25 ≤ f < 300 Hz |
1,0 × 103 |
3,0 × 105/f |
9,0 × 105/f |
300 Hz ≤ f < 3 kHz |
3,0 × 105/f |
3,0 × 105/f |
9,0 × 105/f |
3 kHz ≤ f ≤ 10 MHz |
1,0 × 102 |
1,0 × 102 |
3,0 × 102 |
Note B2-1: |
f is the frequency expressed in hertz (Hz). |
Note B2-2: |
The low ALs and the high ALs are the Root-Mean-Square (RMS) values which are equal to the peak values divided by √2 for sinusoidal fields. In the case of non-sinusoidal fields the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in practical guides referred to in Article 14, but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results. |
Note B2-3: |
ALs for exposure to magnetic fields represent maximum values at the workers’ body position. This results in a conservative exposure assessment and automatic compliance with ELVs in all non-uniform exposure conditions. In order to simplify the assessment of compliance with ELVs, carried out in accordance with Article 4, in specific non-uniform conditions, criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14. In the case of a very localised source within a distance of a few centimetres from the body, the induced electric field shall be determined dosimetrically, case by case. |
Table B3
ALs for contact current IC
Frequency |
ALs (IC) steady state contact current [mA] (RMS) |
up to 2,5 kHz |
1,0 |
2,5 ≤ f < 100 kHz |
0,4 f |
100 ≤ f ≤ 10 000 kHz |
40 |
Note B3-1: |
f is the frequency expressed in kilohertz (kHz). |
Action levels (ALs) for magnetic flux density of static magnetic fields
Table B4
ALs for magnetic flux density of static magnetic fields
Hazards |
ALs(B0) |
Interference with active implanted devices, e.g. cardiac pacemakers |
0,5 mT |
Attraction and projectile risk in the fringe field of high field strength sources (> 100 mT) |
3 mT |
ANNEX III
THERMAL EFFECTS
EXPOSURE LIMIT VALUES AND ACTION LEVELS IN THE FREQUENCY RANGE FROM 100 kHz TO 300 GHz
A. EXPOSURE LIMIT VALUES (ELVs)
Health effects ELVs for frequencies from 100 kHz to 6 GHz (Table A1) are limits for energy and power absorbed per unit mass of body tissue generated from exposure to electric and magnetic fields.
Sensory effects ELVs for frequencies from 0,3 to 6 GHz (Table A2) are limits on absorbed energy in a small mass of tissue in the head from exposure to electromagnetic fields.
Health effects ELVs for frequencies above 6 GHz (Table A3) are limits for power density of an electromagnetic wave incident on the body surface.
Table A1
Health effects ELVs for exposure to electromagnetic fields from 100 kHz to 6 GHz
Health effects ELVs |
SAR values averaged over any six-minute period |
ELVs related to whole body heat stress expressed as averaged SAR in the body |
0,4 Wkg–1 |
ELVs related to localised heat stress in head and trunk expressed as localised SAR in the body |
10 Wkg–1 |
ELVs related to localised heat stress in the limbs expressed as localised SAR in the limbs |
20 Wkg–1 |
Note A1-1: |
Localised SAR averaging mass is any 10 g of contiguous tissue; the maximum SAR so obtained should be the value used for estimating exposure. This 10 g of tissue is intended to be a mass of contiguous tissue with roughly homogeneous electrical properties. In specifying a contiguous mass of tissue, it is recognised that this concept may be used in computational dosimetry but may present difficulties for direct physical measurements. A simple geometry, such as cubic or spheric tissue mass, can be used. |
Sensory effects ELVs from 0,3 GHz to 6 GHz
This sensory effects ELVs (Table A2) is related to avoiding auditory effects caused by exposures of the head to pulsed microwave radiation.
Table A2
Sensory effects ELVs for exposure to electromagnetic fields from 0,3 to 6 GHz
Frequency range |
Localised specific energy absorption (SA) |
0,3 ≤ f ≤ 6 GHz |
10 mJkg–1 |
Note A2-1: |
Localised SA averaging mass is 10 g of tissue. |
Table A3
Health effects ELVs for exposure to electromagnetic fields from 6 to 300 GHz
Frequency range |
Health effects ELVs related to power density |
6 ≤ f ≤ 300 GHz |
50 Wm–2 |
Note A3-1: |
The power density shall be averaged over any 20 cm2 of exposed area. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 Wm–2. Power densities from 6 to 10 GHz are to be averaged over any six-minute period. Above 10 GHz, the power density shall be averaged over any 68/f1,05-minute period (where f is the frequency in GHz) to compensate for progressively shorter penetration depth, as the frequency increases. |
B. ACTION LEVELS (ALs)
The following physical quantities and values are used to specify the action levels (ALs), the magnitude of which are established to ensure by simplified assessment the compliance with the relevant ELVs or at which relevant protection or prevention measures specified in Article 5 must be taken:
— |
ALs(E) for electric field strength E of time varying electric field, as specified in Table B1; |
— |
ALs(B) for magnetic flux density B of time varying magnetic field, as specified in Table B1; |
— |
ALs(S) for power density of electromagnetic waves, as specified in Table B1; |
— |
ALs(IC) for contact current, as specified in Table B2; |
— |
ALs(IL) for limb current, as specified in Table B2; |
ALs correspond to calculated or measured field values at the workplace in the absence of the worker, as maximum value at the position of the body or specified part of the body.
Action levels (ALs) for exposure to electric and magnetic fields
ALs(E) and ALs(B) are derived from the SAR or power density ELVs (Tables A1 and A3) based on the thresholds related to internal thermal effects caused by exposure to (external) electric and magnetic fields.
Table B1
ALs for exposure to electric and magnetic fields from 100 kHz to 300 GHz
Frequency range |
Electric field strength ALs(E) [Vm–1] (RMS) |
Magnetic flux density ALs(B) [μT] (RMS) |
Power density ALs(S) [Wm–2] |
100 kHz ≤ f < 1 MHz |
6,1 × 102 |
2,0 × 106/f |
— |
1≤ f < 10 MHz |
6,1 × 108/f |
2,0 × 106/f |
— |
10 ≤ f < 400 MHz |
61 |
0,2 |
— |
400 MHz ≤ f < 2 GHz |
3 × 10–3 f½ |
1,0 × 10–5 f½ |
— |
2 ≤ f < 6 GHz |
1,4 × 102 |
4,5 × 10–1 |
— |
6 ≤ f ≤ 300 GHz |
1,4 × 102 |
4,5 × 10–1 |
50 |
Note B1-1: |
f is the frequency expressed in hertz (Hz). |
Note B1-2: |
[ALs(E)]2 and [ALs(B)]2 are to be averaged over a six-minute period. For RF pulses, the peak power density averaged over the pulse width shall not exceed 1 000 times the respective ALs(S) value. For multi-frequency fields, the analysis shall be based on summation, as explained in the practical guides referred to in Article 14. |
Note B1-3: |
ALs(E) and ALs(B) represent maximum calculated or measured values at the workers’ body position. This results in a conservative exposure assessment and automatic compliance with ELVs in all non-uniform exposure conditions. In order to simplify the assessment of compliance with ELVs, carried out in accordance with Article 4, in specific non-uniform conditions, criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14. In the case of a very localised source within a distance of a few centimetres from the body, compliance with ELVs shall be determined dosimetrically, case by case. |
Note B1-4: |
The power density shall be averaged over any 20 cm2 of exposed area. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 Wm–2. Power densities from 6 to 10 GHz are to be averaged over any six-minute period. Above 10 GHz, the power density shall be averaged over any 68/f1,05-minute period (where f is the frequency in GHz) to compensate for progressively shorter penetration depth as the frequency increases. |
Table B2
ALs for steady state contact currents and induced limb currents
Frequency range |
Steady state contact current, ALs(IC) [mA] (RMS) |
Induced limb current in any limb, ALs(IL) [mA] (RMS) |
100 kHz ≤ f < 10 MHz |
40 |
— |
10 ≤ f ≤ 110 MHz |
40 |
100 |
Note B2-1: |
[ALs(IL)]2 is to be averaged over a six-minute period. |
ANNEX IV
Correlation table
Directive 2004/40/EC |
This Directive |
Article 1(1) |
Article 1(1) |
Article 1(2) |
Article 1(2) and (3) |
Article 1(3) |
Article 1(4) |
Article 1(4) |
Article 1(5) |
Article 1(5) |
Article 1(6) |
Article 2(a) |
Article 2(a) |
— |
Article 2(b) |
— |
Article 2(c) |
Article 2(b) |
Article 2(d), (e) and (f) |
Article 2(c) |
Article 2(g) |
Article 3(1) |
Article 3(1) |
Article 3(2) |
Article 3(1) |
— |
Article 3(2) |
Article 3(3) |
Article 3(2) and (3) |
— |
Article 3(4) |
Article 4(1) |
Article 4(1) |
Article 4(2) |
Article 4(2) and (3) |
Article 4(3) |
Article 4(3) |
Article 4(4) |
Article 4(4) |
Article 4(5)(a) |
Article 4(5)(b) |
Article 4(5)(b) |
Article 4(5)(a) |
— |
Article 4(5)(c) |
Article 4(5)(c) |
Article 4(5)(d) |
Article 4(5)(d) |
Article 4(5)(e) |
Article 4(5)(d)(i) |
— |
Article 4(5)(d)(ii) |
— |
Article 4(5)(d)(iii) |
— |
Article 4(5)(d)(iv) |
— |
Article 4(5)(e) |
Article 4(5)(f) |
Article 4(5)(f) |
Article 4(5)(g) |
— |
Article 4(5)(h) |
— |
Article 4(5)(i) |
Article 4(5)(g) |
Article 4(5)(j) |
Article 4(5)(h) |
Article 4(5)(k) |
— |
Article 4(6) |
Article 4(6) |
Article 4(7) |
Article 5(1) |
Article 5(1) |
Article 5(2), introductory wording |
Article 5(2), introductory wording |
Article 5(2)(a) to (c) |
Article 5(2)(a) to (c) |
— |
Article 5(2)(d) |
— |
Article 5(2)(e) |
Article 5(2)(d) to (g) |
Article 5(2)(f) to (i) |
— |
Article 5(4) |
Article 5(3) |
Article 5(5) |
— |
Article 5(6) |
— |
Article 5(7) |
Article 5(4) |
Article 5(8) |
— |
Article 5(9) |
Article 5(5) |
Article 5(3) |
Article 6, introductory wording |
Article 6, introductory wording |
Article 6(a) |
Article 6(a) |
Article 6(b) |
Article 6(b) |
— |
Article 6(c) |
Article 6(c) |
Article 6(d) |
Article 6(d) |
Article 6(e) |
— |
Article 6(f) |
Article 6(e) |
Article 6(g) |
Article 6(f) |
Article 6(h) |
— |
Article 6(i) |
Article 7 |
Article 7 |
Article 8(1) |
Article 8(1) |
Article 8(2) |
— |
Article 8(3) |
Article 8(2) |
Article 9 |
Article 9 |
— |
Article 10 |
Article 10(1) |
Article 11(1)(c) |
Article 10(2)(a) |
Article 11(1)(a) |
Article 10(2)(b) |
Article 11(1)(b) |
Article 11 |
— |
— |
Article 12 |
— |
Article 13 |
— |
Article 14 |
— |
Article 15 |
Article 13(1) |
Article 16(1) |
Article 13(2) |
Article 16(2) |
— |
Article 17 |
Article 14 |
Article 18 |
Article 15 |
Article 19 |
Annex |
Annex I, Annex II and Annex III |
— |
Annex IV |
II Non-legislative acts
REGULATIONS
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/22 |
COUNCIL REGULATION (EU) No 626/2013
of 27 June 2013
amending Regulation (EU) No 1344/2011 suspending the autonomous Common Customs Tariff duties on certain agricultural, fishery and industrial products
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 31 thereof,
Having regard to the proposal from the European Commission,
Whereas:
(1) |
It is in the interest of the Union to suspend totally the autonomous Common Customs Tariff duties on 80 new products which are currently not listed in the Annex to Council Regulation (EU) No 1344/2011 (1). Those products should therefore be inserted in that Annex. |
(2) |
It is no longer in the interest of the Union to maintain the suspension of autonomous Common Customs Tariff duties for 15 of the products which are currently listed in the Annex to Regulation (EU) No 1344/2011. Accordingly, those products should be deleted from that Annex. |
(3) |
It is necessary to modify the product description of 22 suspensions in the Annex to Regulation (EU) No 1344/2011 in order to take account of technical product developments and economic trends on the market as well as linguistic adaptations. Moreover, TARIC codes for eight products should be changed. In addition, for three products multiple classification is considered necessary whereas for 12 products double classification is no longer necessary. |
(4) |
Those suspensions for which technical modifications are necessary should be deleted from the list of suspensions in the Annex to Regulation (EU) No 1344/2011 and should be reinserted in that list with new product descriptions, or new CN or TARIC codes. |
(5) |
For three products it is in the interest of the Union to amend the date for their mandatory review in accordance with Article 2(2) and (3) of Regulation (EU) No 1344/2011. The reviewed suspensions should therefore be deleted from the list of suspensions in the Annex to Regulation (EU) No 1344/2011 and reinserted in that list with new time limits for a mandatory review. |
(6) |
In the interest of clarity, the modified entries should be marked with an asterisk in the lists of inserted and deleted suspensions set out in Annex I and Annex II to this Regulation. |
(7) |
In view of their temporary nature, the suspensions listed in Annex I should be reviewed systematically, at the latest five years after their application or renewal. Moreover, closure of certain suspensions should be warranted at any time, as a result of a proposal of the Commission on the basis of a review carried out on the initiative of the Commission or at the request of one or more Member States, if it is no longer in the Union’s interest to maintain the suspensions, or due to technical product developments, changed circumstances or economic trends on the market. |
(8) |
Since it is necessary that the suspensions laid down in this Regulation take effect from 1 July 2013, this Regulation should apply from that date and should enter into force immediately upon its publication in the Official Journal of the European Union. |
(9) |
Regulation (EU) No 1344/2011 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 1344/2011 is hereby amended as follows:
(1) |
the rows for the products listed in Annex I to this Regulation are inserted; |
(2) |
the rows for the products for which the CN and TARIC codes are set out in Annex II to this Regulation are deleted. |
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 June 2013.
For the Council
The President
E. GILMORE
(1) OJ L 349, 31.12.2011, p. 1.
ANNEX I
Products referred to in point (1) of Article 1
CN code |
TARIC |
Description |
Rate of autonomous duty |
Date foreseen for mandatory review |
||||||||||||||||||||||||||||||||
(3)ex 2007 99 50 |
81 |
Acerola puree concentrate:
for use in the manufacture of products of food and drink industry (1) |
9 % (2) |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 2007 99 50 |
91 |
|||||||||||||||||||||||||||||||||||
ex 2007 99 50 |
82 |
Acidified banana puree concentrate, obtained by cooking:
for use in the manufacture of products of food and drink industry (1) |
11,5 % (2) |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2007 99 50 |
92 |
|||||||||||||||||||||||||||||||||||
(3)ex 2007 99 50 |
83 |
Mango puree concentrate, obtained by cooking:
for use in the manufacture of products of food and drink industry (1) |
6 % (2) |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 2007 99 50 |
93 |
|||||||||||||||||||||||||||||||||||
(3)ex 2007 99 93 |
10 |
|||||||||||||||||||||||||||||||||||
(3)ex 2007 99 50 |
84 |
Papaya puree concentrate, obtained by cooking:
for use in the manufacture of products of food and drink industry (1) |
7,8 % (2) |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 2007 99 50 |
94 |
|||||||||||||||||||||||||||||||||||
ex 2007 99 50 |
85 |
Guava puree concentrate, obtained by cooking:
for use in the manufacture of products of food and drink industry (1) |
6 % (2) |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2007 99 50 |
95 |
|||||||||||||||||||||||||||||||||||
(3)ex 2805 30 90 |
40 |
Rare earth metals, scandium and yttrium of a purity by weight of 95 % or more |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
(3)ex 2805 30 90 |
50 |
|||||||||||||||||||||||||||||||||||
(3)ex 2805 30 90 |
60 |
|||||||||||||||||||||||||||||||||||
(3)ex 2805 30 90 |
70 |
|||||||||||||||||||||||||||||||||||
(3)ex 2805 30 90 |
75 |
|||||||||||||||||||||||||||||||||||
(3)ex 2805 30 90 |
79 |
|||||||||||||||||||||||||||||||||||
ex 2811 19 80 |
30 |
Phosphorous acid (CAS RN 10294-56-1)/phosphonic acid (CAS RN 13598-36-2) used as an ingredient for production of additives used in poly(vinyl chloride) industry (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 2818 10 91 |
10 |
Sintered corundum with micro crystalline structure, containing by weight:
with less than 50 % of the total weight having a particle size of more than 10 mm |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
ex 2903 39 90 |
25 |
2,3,3,3-Tetrafluoroprop-1-ene (CAS RN 754-12-1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2903 89 90 |
50 |
Chlorocyclopentane (CAS RN 930-28-9) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2905 39 95 |
40 |
Decane-1,10-diol (CAS RN 112-47-0) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2906 29 00 |
30 |
2-Phenylethanol (CAS RN 60-12-8) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2907 23 00 |
10 |
4,4’-Isopropylidenediphenol (CAS RN 80-05-7) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2907 29 00 |
55 |
Biphenyl-2,2’-diol (CAS RN 1806-29-7) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2912 29 00 |
50 |
4-Isobutylbenzaldehyde (CAS RN 40150-98-9) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2914 50 00 |
45 |
3,4-Dihydroxybenzophenone (CAS RN 10425-11-3) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2914 70 00 |
20 |
2,4-Difluorobenzophenone (CAS RN 342-25-6) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2915 39 00 |
20 |
Isopentyl acetate (CAS RN 123-92-2) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2915 60 19 |
10 |
Ethyl butyrate (CAS RN 105-54-4) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2915 90 70 |
30 |
3,3-Dimethylbutyryl chloride (CAS RN 7065-46-5) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2916 12 00 |
70 |
2-(2-Vinyloxyethoxy)ethyl acrylate (CAS RN 86273-46-3) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 2917 13 90 |
10 |
Dimethyl sebacate (CAS RN 106-79-6) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2918 29 00 |
35 |
Propyl 3,4,5-trihydroxybenzoate (CAS RN 121-79-9) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2918 30 00 |
50 |
Ethyl acetoacetate (CAS RN 141-97-9) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2918 99 90 |
15 |
Ethyl 2,3-epoxy-3-phenylbutyrate (CAS RN 77-83-8) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 2918 99 90 |
40 |
trans-4-Hydroxy-3-methoxycinnamic acid (CAS RN 537-98-4) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
ex 2920 90 10 |
60 |
2,4-Di-tert-butyl-5-nitrophenyl methyl carbonate (CAS RN 873055-55-1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2921 30 99 |
40 |
Cyclopropylamin (CAS RN 765-30-0) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2922 19 85 |
20 |
2-(2-Methoxyphenoxy)ethylamine hydrochloride (CAS RN 64464-07-9) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2922 19 85 |
25 |
Titanium bis(triethanolamine)diisopropoxide (CAS RN 36673-16-2) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2929 10 00 |
20 |
Butyl isocyanate (CAS RN 111-36-4) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2931 90 90 |
35 |
(Z)-Prop-1-en-1-ylphosphonic acid (CAS RN 25383-06-6) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2932 99 00 |
25 |
1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxylic acid (CAS RN 862574-88-7) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2933 19 90 |
85 |
Allyl 5-amino-4-(2-methylphenyl)-3-oxo-2,3-dihydro-1H-1-pyrazolcarbothioat (CAS RN 473799-16-5) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2933 29 90 |
80 |
Imazalil (ISO) (CAS RN 35554-44-0) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2933 39 99 |
57 |
Tert-butyl 3-(6-amino-3-methylpyridin-2-yl)benzoate (CAS RN 1083057-14-0) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2933 49 10 |
30 |
Ethyl 4-oxo-1,4-dihydroquinoline-3-carboxylate (CAS RN 52980-28-6) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2933 99 80 |
43 |
2,3-Dihydro-1H-pyrrole[3,2,1-ij]quinoline (CAS RN 5840-01-7) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2933 99 80 |
47 |
Paclobutrazol (ISO) (CAS RN 76738-62-0) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 2934 99 90 |
37 |
4-Propan-2-ylmorpholine (CAS RN 1004-14-4) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3204 11 00 |
20 |
Dye C.I. Disperse Yellow 241 (CAS RN 83249-52-9), with a purity of 97 % or more as determined by high pressure liquid chromatography |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
ex 3204 11 00 |
80 |
Dye preparation, non-ionogenic, containing:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3204 12 00 |
20 |
Dye preparation, anionic, containing by weight 75 % or more of disodium-7-((4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((4-((4-sulfophenyl)azo)phenyl)azo)-2-naphthalenesulfonate (CAS RN 145703-76-0) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3204 12 00 |
30 |
Acid dye preparation, anionic, containing:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3204 13 00 |
30 |
Dye C.I. Basic Blue 7 (CAS RN 2390-60-5) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3204 13 00 |
40 |
Dye C.I. Basic Violet 1 (CAS RN 603-47-4)/(CAS RN 8004-87-3) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3204 17 00 |
25 |
Dye C.I. Pigment Yellow 14 (CAS RN 5468-75-7) |
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
(3)ex 3204 17 00 |
60 |
Dye C.I. Pigment Red 53:1 (CAS RN 5160-02-1) |
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
(3)ex 3204 17 00 |
70 |
Dye C.I. Pigment Yellow 13 (CAS RN 5102-83-0) |
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
ex 3204 17 00 |
75 |
Dye C.I. Pigment Orange 5 (CAS RN 3468-63-1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3204 19 00 |
73 |
Dye C.I. Solvent Blue 104 (CAS RN 116-75-6) with a purity of 97 % or more determined by high pressure liquid chromatography |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
ex 3207 40 85 |
40 |
Glass flakes (CAS RN 65997-17-3):
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3215 19 00 |
20 |
Ink:
used to imprint electrodes (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3707 90 20 |
50 |
Dry ink powder or toner blend, consisting of:
for use as a developer in the manufacturing of ink/toner filled bottles or cartridges for facsimile machines, computer printers and copiers (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3802 90 00 |
11 |
Soda flux calcinated diatomaceous earth, acid washed, for use as a filter aid in the manufacture of pharmaceutical and/or biochemical products (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3812 30 80 |
75 |
N,N’-Bis(1,2,2,6,6-pentamethyl-4-piperidinyl)-1,6-hexanediamine, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine (CAS RN 193098-40-7) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3812 30 80 |
80 |
UV-stabiliser, consisting of:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3812 30 80 |
85 |
Mixture containing by weight:
|
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
(3)ex 3824 90 97 |
08 |
Mixture of divinylbenzene-isomers and ethylvinylbenzene-isomers, containing by weight 56 % or more but not more than 85 % of divinylbenzene (CAS RN 1321-74-0) |
0 % |
31.12.2014 |
||||||||||||||||||||||||||||||||
(3)ex 3824 90 97 |
18 |
Poly(tetramethylene glycol) bis[(9-oxo-9H-thioxanthen-1-yloxy)acetate] with an average polymer chain length of less than 5 monomer units (CAS RN 515136-48-8) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
ex 3824 90 97 |
47 |
Platinum oxide (CAS RN 12035-82-4) fixed on a porous support of aluminium oxide (CAS RN 1344-28-1), containing by weight:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3824 90 97 |
49 |
Preparation containing:
in which the gas formation from C,C’-azodi(formamide) occurs at 135 °C |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3824 90 97 |
51 |
Diethylene glycol propylene glycol triethanolamine titanate complexes (CAS RN 68784-48-5) dissolved in diethylene glycol (CAS RN 111-46-6) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3824 90 97 |
87 |
Paste containing by weight:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3824 90 97 |
93 |
Solution containing by weight 80 % or more of 2,4,6-trimethylbenzaldehyde (CAS RN 487-68-3) in acetone |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3824 90 97 |
94 |
Particles of silicon dioxide on which are covalently bonded organic compounds, for use in the manufacture of high performance liquid chromatography columns (HPLC) and sample preparation cartridges (1) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
ex 3905 30 00 |
10 |
Viscous preparation, essentially consisting of poly(vinyl alcohol) (CAS RN 9002-89-5), an organic solvent and water for use as protective coating of wafers during the manufacturing of semiconductors (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3905 91 00 |
20 |
Water soluble copolymer of ethylene and vinyl alcohol (CAS RN 26221-27-2), containing by weight not more than 13 % of the monomer unit ethylene |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3906 90 90 |
27 |
Copolymer of stearyl methacrylate, isooctyl acrylate and acrylic acid, dissolved in isopropyl palmitate |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3907 20 20 |
20 |
Polytetramethylene ether glycol with a weight average molecular weight (Mw) of 2 700 or more but not more than 3 100 (CAS RN 25190-06-1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3907 20 20 |
30 |
Mixture, containing by weight 70 % or more but not more than 80 % of a polymer of glycerol and 1,2-epoxypropane and 20 % or more but not more than 30 % of a copolymer of dibutyl maleate and N-vinyl-2-pyrrolidone |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3907 20 20 |
40 |
Copolymer of tetrahydrofuran and tetrahydro-3-methylfuran with a number average molecular weight (Mn) of 3 500 (± 100) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3907 40 00 |
10 |
Polycarbonate pellets:
|
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
(3)ex 3907 99 90 |
30 |
Poly(hydroxyalkanoate), predominantly consisting of poly(3-hydroxybutyrate) |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
(3)ex 3913 90 00 |
20 |
|||||||||||||||||||||||||||||||||||
(3)ex 3909 50 90 |
10 |
UV curable water soluble liquid photopolymer consisting of a mixture by weight of
|
0 % |
31.12.2014 |
||||||||||||||||||||||||||||||||
ex 3919 10 80 |
47 |
Polyester, polyurethane or polycarbonate foil:
of a kind used for the protection of the surface of products of headings 8521 and 8528 |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3919 90 00 |
32 |
|||||||||||||||||||||||||||||||||||
ex 3919 10 80 |
53 |
Polyethylene foil:
of a kind used for the protection of the surface of products of headings 8521 and 8528 |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3919 90 00 |
34 |
|||||||||||||||||||||||||||||||||||
ex 3920 10 28 |
93 |
|||||||||||||||||||||||||||||||||||
ex 3920 10 89 |
50 |
|||||||||||||||||||||||||||||||||||
ex 3919 90 00 |
36 |
Printed laminated sheet with a central layer of poly(vinyl chloride), coated on both sides with a layer of poly(vinyl fluoride)
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3920 49 10 |
95 |
|||||||||||||||||||||||||||||||||||
ex 3919 90 00 |
38 |
Self-adhesive film composed of:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3919 90 00 |
40 |
Film, with a total thickness of 40 μm or more, consisting of one or more layers of transparent polyester film:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3919 90 00 |
42 |
Self-adhesive film composed of:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3919 90 00 |
44 |
Printed laminated sheet
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3921 90 60 |
95 |
|||||||||||||||||||||||||||||||||||
ex 3920 20 80 |
95 |
Polypropylene sheet, put up in rolls, with:
for use in the manufacture of insulators used in the electronics and electrical industries (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
02 |
Co-extruded opaque sheet of poly(ethylene terephthalate), of a thickness of 50 μm or more but not more than 350 μm, consisting especially of a layer containing carbon black |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
08 |
Poly(ethylene terephthalate) film, not coated with an adhesive, of a thickness of not more than 25 μm, either:
|
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
12 |
Film of poly(ethylene terephthalate) only, of a total thickness of not more than 120 μm, consisting of one or two layers each containing a colouring and/or UV-absorbing material throughout the mass, uncoated with an adhesive or any other material |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
18 |
Laminated film of poly(ethylene terephthalate) only, of a total thickness of not more than 120 μm, consisting of one layer which is metallised only and one or two layers each containing a colouring and/or UV-absorbing material throughout the mass, uncoated with an adhesive or any other material |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
22 |
Film of poly(ethylene terephthalate), coated or covered on one side or on both sides with a layer of modified polyester, of a total thickness of 7 μm or more but not more than 11 μm, for the manufacture of video tapes with a magnetic layer of metallic pigments and a width of 8 mm or of 12,7 mm (1) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
25 |
Film of poly(ethylene terephthalate) of a thickness of 186 μm or more but not more than 191 μm coated on one side with an acrylic layer in a matrix pattern |
0 % |
31.12.2014 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
38 |
Poly(ethylene terephthalate) film, of a thickness of not more than 12 μm, coated on one side with a layer of aluminium oxide of a thickness of not more than 35 nm |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
48 |
Sheets or rolls of poly(ethylene terephthalate):
|
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
52 |
Film of poly(ethylene terephthalate), poly(ethylene naphthalate) or similar polyester, coated on one side with metal and/or metal oxides, containing by weight less than 0,1 % of aluminium, of a thickness of not more than 300 μm and having a surface resistivity of not more than 10 000 ohms (per square) (as determined by the ASTM D 257-99 method) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
55 |
Matt film of poly(ethylene terephthalate), of a specular gloss of 15 measured at an angle of 45° and 18 measured at an angle of 60° using a gloss meter (as determined by the ISO 2813:2000 method) and a width of 1 600 mm or more |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
58 |
Film of white poly(ethylene terephthalate), dyed in the mass, of a thickness of 185 μm or more but not more than 253 μm, coated on both sides with an antistatic layer |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
76 |
Transparent poly(ethylene terephthalate) film:
|
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3920 62 19 |
81 |
Poly(ethylene terephthalate) film:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3920 92 00 |
30 |
Polyamide film:
|
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
ex 3920 99 28 |
55 |
Thermoplastic polyurethane film extruded, with:
of a kind used in the production of laminated safety glass |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 3921 13 10 |
20 |
Rolls of open-cell polyurethane foam:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 3921 90 55 |
20 |
Pre-impregnated reinforced fibreglass containing cyanate ester resin or bismaleimide (B) triazine (T) resin mixed with epoxide resin, measuring:
for use in the manufacture of printed circuit boards (1) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 3926 90 97 |
21 |
Television pedestal stands with or without bracket for fixation to and stabilisation of television cabinet case/body |
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
(3)ex 7020 00 10 |
10 |
|||||||||||||||||||||||||||||||||||
(3)ex 7326 90 98 |
40 |
|||||||||||||||||||||||||||||||||||
(3)ex 7616 99 90 |
77 |
|||||||||||||||||||||||||||||||||||
ex 4104 41 19 |
10 |
Buffalo leather, split, chrome tanned synthetic retanned (“crust”), dry |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 7009 10 00 |
10 |
Mirror-glass for rear-view mirrors:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 7019 12 00 |
05 |
Rovings ranging from 1 980 to 2 033 tex, composed of continuous glass filaments of 9 μm (± 0,5 μm) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 7019 12 00 |
25 |
|||||||||||||||||||||||||||||||||||
(3)ex 7607 11 90 |
30 |
Laminated aluminium foil with:
|
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
(3)ex 7607 20 90 |
20 |
Lubricating entry sheet of a total thickness of not more than 350 μm, comprising of:
|
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
ex 7616 99 90 |
75 |
Parts in the shape of a rectangular frame:
of a kind used in the manufacture of TV sets |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8105 90 00 |
10 |
Bars or wires made of cobalt alloy containing, by weight:
conforming to the material specifications AMS 5842, of a kind used in the aerospace industry |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 8301 60 00 |
10 |
Keypads, wholly of either silicone or polycarbonate, including printed keys with electrical contacting elements |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
(3)ex 8413 91 00 |
20 |
|||||||||||||||||||||||||||||||||||
(3)ex 8419 90 85 |
20 |
|||||||||||||||||||||||||||||||||||
(3)ex 8438 90 00 |
10 |
|||||||||||||||||||||||||||||||||||
(3)ex 8468 90 00 |
10 |
|||||||||||||||||||||||||||||||||||
(3)ex 8476 90 00 |
10 |
|||||||||||||||||||||||||||||||||||
(3)ex 8479 90 80 |
87 |
|||||||||||||||||||||||||||||||||||
(3)ex 8481 90 00 |
20 |
|||||||||||||||||||||||||||||||||||
(3)ex 8503 00 99 |
45 |
|||||||||||||||||||||||||||||||||||
(3)ex 8515 90 00 |
20 |
|||||||||||||||||||||||||||||||||||
(3)ex 8531 90 85 |
20 |
|||||||||||||||||||||||||||||||||||
(3)ex 8536 90 85 |
96 |
|||||||||||||||||||||||||||||||||||
(3)ex 8543 90 00 |
50 |
|||||||||||||||||||||||||||||||||||
(3)ex 8708 91 99 |
10 |
|||||||||||||||||||||||||||||||||||
(3)ex 8708 99 97 |
30 |
|||||||||||||||||||||||||||||||||||
(3)ex 9031 90 85 |
30 |
|||||||||||||||||||||||||||||||||||
(3)ex 8305 20 00 |
10 |
Staples:
packed in a plastic cartridge for use in copiers and printers resulting in a staple of a width of 12 mm (± 1 mm) and a depth of 8 mm (± 1 mm) (1) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
ex 8431 20 00 |
30 |
Drive axle assembly containing differential, reduction gears, crown wheel, drive shafts, wheel hubs, brakes and mast mounting arms for use in the manufacture of vehicles in heading 8427 (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8501 10 99 |
60 |
DC motor
for use in the manufacture of electric fryers (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8503 00 99 |
40 |
Fuel cell membrane, in rolls or sheets, with a width of not more than 150 cm, of a kind used for manufacture of fuel cells in heading 8501 |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 8504 40 82 |
40 |
Printed circuit board equipped with a bridge rectifier circuit and other active and passive components
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 8504 40 82 |
50 |
Rectifier in a housing with
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8505 11 00 |
35 |
Permanent magnets of an alloy of either neodymium, iron and boron, or samarium and cobalt coated having undergone inorganic passivation (inorganic coating) using zinc phosphate for the industrial manufacture of products in motor or sensory applications (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8507 60 00 |
25 |
Rectangular modules for incorporation in lithium-ion rechargeable batteries, with:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8507 60 00 |
35 |
Lithium-ion rechargeable batteries, with:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 8507 60 00 |
50 |
Modules for the assembly of batteries of ion lithium electric accumulators with:
|
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8516 90 00 |
70 |
Inner pot
for use in the manufacture of an electric fryer (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8522 90 80 |
15 |
Heat sinks and cooling fins of aluminium, for maintaining the operating temperature of transistors and/or integrated circuits in products of heading 8521 |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8525 80 19 |
45 |
Camera module with a resolution of 1 280 * 720 P HD, with two microphones, for use in the manufacture of products of heading 8528 (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 8526 91 20 |
80 |
Integrated audio module (IAM) with a digital video output for connection to an LCD touch screen monitor, interfaced over the Media Oriented Systems Transport (MOST) network and transported over the MOST High protocol, with:
for the use in the manufacture of vehicles in Chapter 87 (1) |
0 % |
31.12.2015 |
||||||||||||||||||||||||||||||||
(3)ex 8527 29 00 |
10 |
|||||||||||||||||||||||||||||||||||
ex 8529 90 92 |
70 |
Rectangular fastening and covering frame:
of a kind used for the production of TV sets |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 8529 90 92 |
80 |
Printed circuit board for backlight:
to be incorporated in goods of heading 8528 (1) |
0 % |
31.12.2013 |
||||||||||||||||||||||||||||||||
ex 9405 40 39 |
40 |
|||||||||||||||||||||||||||||||||||
ex 8536 69 90 |
51 |
SCART type connectors, built into a plastic or metal housing, with 21 pins in 2 rows, for use in the manufacture of products falling within headings 8521 and 8528 (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
(3)ex 8540 20 80 |
91 |
Photomultiplier |
0 % |
31.12.2016 |
||||||||||||||||||||||||||||||||
ex 8544 42 90 |
30 |
PET insulated electric conductor with:
for use in the manufacture of products falling within headings 8521 and 8528 (1) |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 9001 90 00 |
25 |
Unmounted optical elements made from moulded infrared transmitting chalcogenide glass, or a combination of infrared transmitting chalcogenide glass and another lens material |
0 % |
31.12.2017 |
||||||||||||||||||||||||||||||||
ex 9002 90 00 |
40 |
Mounted lenses made from infrared transmitting chalcogenide glass, or a combination of infrared transmitting chalcogenide glass and another lens material |
0 % |
31.12.2017 |
(1) Suspension of duties is subject to Articles 291 to 300 of Commission Regulation (EEC) No 2454/93 (OJ L 253 11.10.1993, p. 1).
(2) The specific duty rate is applicable.
(3) Suspension relating to a product in the Annex to Regulation (EU) No 1344/2011 for which the CN or TARIC code or the product description is modified by this Regulation.
ANNEX II
Products referred to in point (2) of Article 1
CN code |
TARIC |
(1)ex 2007 99 50 |
40 |
(1)ex 2007 99 50 |
50 |
(1)ex 2007 99 50 |
60 |
ex 2008 60 19 |
30 |
ex 2008 60 39 |
30 |
(1)ex 2008 99 48 |
20 |
(1)ex 2008 99 48 |
93 |
(1)ex 2008 99 49 |
50 |
(1)ex 2805 30 90 |
40 |
(1)ex 2805 30 90 |
50 |
(1)ex 2805 30 90 |
60 |
(1)ex 2818 10 91 |
10 |
ex 2916 19 95 |
30 |
ex 2917 39 95 |
10 |
(1)ex 2918 99 90 |
40 |
ex 2934 99 90 |
12 |
ex 3204 11 00 |
10 |
(1)ex 3204 11 00 |
20 |
(1)ex 3204 17 00 |
25 |
ex 3204 17 00 |
45 |
ex 3204 17 00 |
55 |
(1)ex 3204 17 00 |
60 |
(1)ex 3204 17 00 |
70 |
ex 3204 19 00 |
72 |
(1)ex 3204 19 00 |
73 |
(1)ex 3802 90 00 |
11 |
(1)ex 3824 90 97 |
08 |
(1)ex 3824 90 97 |
31 |
(1)ex 3824 90 97 |
70 |
(1)ex 3824 90 97 |
72 |
(1)ex 3824 90 97 |
73 |
(1)ex 3824 90 97 |
75 |
(1)ex 3907 20 20 |
11 |
(1)ex 3907 20 20 |
12 |
(1)ex 3907 40 00 |
10 |
(1)ex 3907 99 90 |
30 |
(1)ex 3909 50 90 |
10 |
ex 3911 90 99 |
75 |
(1)ex 3920 62 19 |
01 |
(1)ex 3920 62 19 |
03 |
(1)ex 3920 62 19 |
07 |
(1)ex 3920 62 19 |
09 |
(1)ex 3920 62 19 |
11 |
(1)ex 3920 62 19 |
13 |
(1)ex 3920 62 19 |
17 |
(1)ex 3920 62 19 |
19 |
(1)ex 3920 62 19 |
21 |
(1)ex 3920 62 19 |
23 |
(1)ex 3920 62 19 |
24 |
(1)ex 3920 62 19 |
26 |
(1)ex 3920 62 19 |
37 |
(1)ex 3920 62 19 |
39 |
(1)ex 3920 62 19 |
47 |
(1)ex 3920 62 19 |
49 |
(1)ex 3920 62 19 |
51 |
(1)ex 3920 62 19 |
53 |
(1)ex 3920 62 19 |
54 |
(1)ex 3920 62 19 |
56 |
(1)ex 3920 62 19 |
57 |
(1)ex 3920 62 19 |
59 |
(1)ex 3920 62 19 |
75 |
(1)ex 3920 62 19 |
77 |
(1)ex 3920 62 19 |
81 |
(1)ex 3920 92 00 |
30 |
(1)ex 3921 90 55 |
20 |
(1)ex 7019 12 00 |
05 |
(1)ex 7019 12 00 |
25 |
(1)ex 7326 90 98 |
40 |
(1)ex 7607 11 90 |
30 |
(1)ex 7607 20 90 |
20 |
ex 8108 20 00 |
20 |
ex 8108 90 50 |
40 |
ex 8108 90 50 |
80 |
(1)ex 8305 20 00 |
10 |
(1)ex 8504 40 82 |
40 |
(1)ex 8504 40 82 |
50 |
(1)ex 8507 60 00 |
50 |
(1)ex 8526 91 20 |
80 |
(1)ex 8528 59 80 |
10 |
(1)ex 8536 90 85 |
96 |
(1)ex 8538 90 99 |
94 |
(1)ex 8540 20 80 |
91 |
(1)ex 8543 90 00 |
50 |
ex 8708 80 99 |
10 |
ex 9405 40 39 |
30 |
(1) Suspension relating to a product in the Annex to Regulation (EU) No 1344/2011 for which the CN or TARIC code or the product description is modified by this Regulation.
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/43 |
COUNCIL REGULATION (EU) No 627/2013
of 27 June 2013
amending Regulation (EU) No 7/2010 opening and providing for the management of autonomous tariff quotas of the Union for certain agricultural and industrial products
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 31 thereof,
Having regard to the proposal from the European Commission,
Whereas:
(1) |
In order to ensure sufficient and uninterrupted supplies of certain goods that are insufficiently produced in the Union and to avoid any disturbances on the market for certain agricultural and industrial products, autonomous tariff quotas have been opened by Council Regulation (EU) No 7/2010 (1). Products within those tariff quotas can be imported at reduced or zero duty rates. For the same reasons relating to supplies and disturbances it is necessary to open, with effect from 1 July 2013, new tariff quotas at reduced or zero duty rates for an appropriate volume for the ten products with order numbers 09.2644 and 09.2663 to 09.2671. |
(2) |
Moreover, for the autonomous tariff quotas of the Union with order numbers 09.2620 and 09.2633 the product description should be adapted, and for order number 09.2629 another TARIC code should be added. |
(3) |
For the autonomous tariff quotas of the Union with the order numbers 09.2917 and 09.2632, an end date of 31 December 2013 should be inserted, as it is not in the interest of the Union to continue granting such quotas beyond that date. |
(4) |
Since the new tariff quotas should take effect from 1 July 2013, this Regulation should apply from that date and enter into force immediately upon its publication in the Official Journal of the European Union. |
(5) |
Regulation (EU) No 7/2010 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 7/2010 is hereby amended as follows:
(1) |
the rows with order numbers 09.2644 and 09.2663 to 09.2671 set out in Annex I to this Regulation are inserted; |
(2) |
the rows for the tariff quotas with order numbers 09.2620, 09.2629, 09.2632, 09.2633 and 09.2917 are replaced by the rows set out in Annex II to this Regulation. |
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 June 2013.
For the Council
The President
E. GILMORE
ANNEX I
Tariff quotas referred to in point (1) of Article 1
Order number |
CN code |
TARIC |
Description |
Quota period |
Quota volume |
Quota duty (%) |
||||||||
09.2663 |
ex 1104 29 17 |
10 |
Milled sorghum grains that have been at least hulled and de-germed for use in the manufacture of loose fill packaging products (1) |
1.7-31.12 |
750 tonnes |
0 % |
||||||||
09.2664 |
ex 2008 60 19 |
30 |
Sweet cherries containing added spirit, whether or not with a sugar content of 9 % by weight, of a diameter of not more than 19,9 mm, with stone, for use in chocolate products (1) |
1.7-31.12 |
500 tonnes |
10 % (2) |
||||||||
ex 2008 60 39 |
30 |
|||||||||||||
09.2665 |
ex 2916 19 95 |
30 |
Potassium (E,E)-hexa-2,4-dienoate (CAS RN 24634-61-5) |
1.7-31.12 |
4 000 tonnes |
0 % |
||||||||
09.2666 |
ex 3204 17 00 |
55 |
Dye C.I. Pigment Red 169 (CAS RN 12237-63-7) |
1.7-31.12 |
20 tonnes |
0 % |
||||||||
09.2644 |
ex 3824 90 97 |
96 |
Preparation containing by weight:
|
1.7-31.12 |
3 000 tonnes |
0 % |
||||||||
09.2671 |
ex 3905 99 90 |
81 |
Poly(butyral of vinyl) (CAS RN 63148-65-2):
|
1.7-31.12 |
5 500 tonnes |
0 % |
||||||||
09.2667 |
ex 8537 10 99 |
51 |
Electromechanical switch board:
for use in the manufacture of products falling within headings 8521 and 8528 (1) |
1.7-31.12 |
3 000 000 units |
0 % |
||||||||
09.2668 |
ex 8714 91 10 |
21 |
Bicycle frame, constructed from carbon fibres and artificial resin, painted, lacquered and/or polished, for use in the manufacture of bicycles (1) |
1.7-31.12 |
38 000 units |
0 % |
||||||||
ex 8714 91 10 |
31 |
|||||||||||||
09.2669 |
ex 8714 91 30 |
21 |
Bicycle front fork, constructed from carbon fibres and artificial resin, painted, lacquered and/or polished, for use in the manufacture of bicycles (1) |
1.7-31.12 |
26 000 units |
0 % |
||||||||
ex 8714 91 30 |
31 |
|||||||||||||
09.2670 |
ex 9405 40 39 |
30 |
Electric light assembly containing:
for the manufacture of backlight units for flat TV sets (1) |
1.7-31.12 |
8 500 000 pieces |
0 % |
(1) Suspension of duties is subject to Articles 291 to 300 of Commission Regulation (EEC) No 2454/93 (OJ L 253 11.10.1993, p. 1).
(2) The specific duty shall apply.
ANNEX II
Tariff quotas referred to in point (2) of Article 1
Order number |
CN code |
TARIC |
Description |
Quota period |
Quota volume |
Quota duty (%) |
09.2632 |
ex 2921 22 00 |
10 |
Hexamethylenediamine (CAS RN 124-09-4) |
1.1-31.12.2013 |
40 000 tonnes |
0 % |
09.2917 |
ex 2930 90 13 |
90 |
Cystine (CAS RN 56-89-3) |
1.1-31.12.2013 |
600 tonnes |
0 % |
09.2629 |
ex 7616 99 90 |
85 |
Aluminium telescopic handle for use in the manufacture of luggage (1) |
1.1-31.12 |
800 000 units |
0 % |
ex 8302 49 00 |
91 |
|||||
09.2633 |
ex 8504 40 82 |
20 |
Electric rectifier, with a capacity of not more than 1 kVA, for use in the manufacture of appliances falling within headings 8509 80 and 8510 (1) |
1.1-31.12 |
4 500 000 units |
0 % |
09.2620 |
ex 8526 91 20 |
20 |
Assembly for GPS system having a position determination function, without display, and a weight of not more than 2 500 g |
1.1-31.12 |
3 000 000 units |
0 % |
(1) Suspension of duties is subject to Articles 291 to 300 of Commission Regulation (EEC) No 2454/93 (OJ L 253 11.10.1993, p. 1).
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/46 |
COMMISSION IMPLEMENTING REGULATION (EU) No 628/2013
of 28 June 2013
on working methods of the European Aviation Safety Agency for conducting standardisation inspections and for monitoring the application of the rules of Regulation (EC) No 216/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 736/2006
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), and in particular Article 24(5) thereof,
Whereas:
(1) |
Article 24(1) and Article 54 of Regulation (EC) No 216/2008 require the European Aviation Safety Agency (hereinafter ‘the Agency’), to assist the Commission in monitoring the application of its provisions, as well as its implementing rules, by Member States’ competent authorities, by conducting standardisation inspections. |
(2) |
Article 54(4) of Regulation (EC) No 216/2008 stipulates that where an inspection of a Member State competent authority entails an inspection of an undertaking or an association of undertakings, the Agency should follow the provisions of Article 55. |
(3) |
Commission Regulation (EC) No 736/2006 (2) lays down the working methods of the Agency for conducting standardisation inspections (hereinafter ‘the current working methods’). |
(4) |
Six years have passed since the adoption of the current working methods. Considerable changes to the common rules have been adopted; a number of international agreements have also been adopted; the Agency and the Member States have also accumulated valuable experience that needs to be accounted for. |
(5) |
When Regulation (EC) No 736/2006 was adopted, the common rules in the field of civil aviation were limited to initial and continuing airworthiness. Commission Regulation (EC) No 1702/2003 (3) laid down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations; Commission Regulation (EC) No 2042/2003 (4) laid down implementing rules for the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks. |
(6) |
Since that time, Regulation (EC) No 216/2008 has replaced Regulation (EC) No 1592/2002 of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency (5) and the common rules have been extended twice: first to include air crew, air operations and ramp inspections; secondly to include air traffic management and air navigations services (ATM/ANS) as well as airport safety, as a consequence of which the Commission has adopted several implementing rules corresponding to those new fields of competence such as Commission Regulation (EU) No 805/2011 of 10 August 2011 laying down detailed rules for air traffic controllers’ licences and certain certificates (6), Commission Implementing Regulation (EU) No 1034/2011 (7) laying down administrative procedures for the safety oversight of air traffic management and air navigation services, Commission Implementing Regulation (EU) No 1035/2011 of 17 October 2011 laying down common requirements for the provision of air navigation services (8), Commission Regulation (EU) No 691/2010 of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) No 2096/2005 laying down common requirements for the provision of air navigation services (9), Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonization of technical requirements and administrative procedures in the field of civil aviation (10), amended by Commission Regulation (EC) No 859/2008 (11), Directive 2004/36/EC of the European Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports (12), amended by Commission Directive 2008/49/EC of 16 April 2008 amending Annex II to Directive 2004/36/EC of the European Parliament and of the Council regarding the criteria for the conduct of ramp inspections on aircraft using Community airports (13) Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations (14), and Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew (15). |
(7) |
Regulation (EC) No 216/2008 has also introduced a number of new provisions that need to be reflected in the Agency’s working methods for carrying out standardisation inspections. In particular, Article 11 establishes the conditions for the mutual recognition of certificates issued by competent authorities of Member States, as well as conditions for suspending this recognition, where standardisation inspections constitute an important instrument for such decision-making. Article 15 establishes an information network that provides useful information to be taken into account for standardisation inspections, whilst certain results of such standardisation inspections may need to be made available without delay to this information network. Article 27(3) establishes that the Agency has to support the Member States in discharging their obligations towards ICAO. |
(8) |
Notwithstanding further changes of the common rules as established by Regulation (EC) No 216/2008 and its implementing rules, the Agency should support the Commission in monitoring the implementation of other aviation safety requirements stemming, for instance, from the Single European Sky legislation or the legislation on accident investigation or occurrence reporting. |
(9) |
Since 2006, the European external aviation policy has also experienced significant developments, both regarding International Civil Aviation Organisation (ICAO), States in the neighbourhood of the European Union and certain key partners at global level. |
(10) |
A Memorandum of Cooperation with the International Civil Aviation Organisation (ICAO) was signed in 2010 (16) which creates the framework for a structured cooperation between parties, in particular regarding the exchange of information related to safety, with a view to avoid duplication of tasks where possible, as a consequence of which the Agency’s standardisation inspection programme and the ICAO Universal Safety Oversight Audit Programme (USOAP) should become more inter-related. The inspection working methods should also take into account ICAO Doc 9735 — the USOAP continuous Monitoring Manual. |
(11) |
With regard to the States part of the EU neighbourhood and enlargement policy, including notably States Party to the European Common Aviation Area agreement, standardisation inspections should be organised in accordance with the same working methods and in accordance with the same standards as for the Member States, subject to appropriate Agreements or Working Arrangements. |
(12) |
With regard to the States having signed Bilateral Air Safety Agreements providing for the mutual acceptance of certain certification findings and approvals, standardisation inspections should support the monitoring of the implementation of the agreement and report the results to the appropriate bilateral oversight board in view of possible adjustments. The inspections of those Member States whose certification findings and approvals are accepted in the framework of the bilaterals should include additional verifications to ensure competent authorities discharge correctly their responsibilities stemming from the bilateral agreements. |
(13) |
In order to monitor the application of Regulation (EC) No 216/2008 and its implementing rules, as well as other aviation safety rules stemming from existing Regulations and agreements efficiently, it is necessary to review the current working methods, notably to ensure they become more system oriented, follow a more continuous monitoring approach more focused on safety performance, provide for more efficient use of resources in order not to generate an undue burden on the competent authorities and include a feedback loop to the Agency’s rulemaking activities. Inspection teams should be set up with adequately trained and qualified personnel and the Agency shall endeavour to balance the participation of authorised personnel from different Member States. |
(14) |
The working methods should reflect the definitions and principles of auditing as defined in ISO 19011. |
(15) |
Beyond the inspection-level, the working methods should elaborate on the monitoring at system-level and at finding-level. |
(16) |
The working methods should provide more flexibility to the Agency in taking action where this corresponds to its technical competence whilst maintaining legal certainty on the working methods. |
(17) |
Regulation (EC) No 736/2006 should therefore be repealed accordingly. |
(18) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 65 of Regulation (EC) No 216/2008, |
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
1. This Regulation lays down the working methods for:
(a) |
monitoring the application by competent authorities of the Member States of Regulation (EC) No 216/2008 and its implementing rules in the fields covered by Article 1(1) of that Regulation; |
(b) |
conducting standardisation inspections of the competent authorities of Member States; |
(c) |
verifying that the competent authorities of Member States are issuing and overseeing certificates in accordance with Regulation (EC) No 216/2008 and its implementing rules; |
(d) |
contributing to the assessment of the impact of the implementation by the competent authorities of Member States of Regulation (EC) No 216/2008 and its implementing rules. |
2. The working methods established in this Regulation shall also apply, as far as practicable, when the Agency is charged with the task to monitor the application of aviation safety requirements established by other EU legislation, agreements concluded by the Union or working arrangements concluded by the Agency.
Article 2
Definitions
For the purposes of this Regulation the following definitions apply:
(1) |
‘inspection’ means the standardisation inspection referred to in Article 24(1) and Article 54 of Regulation (EC) No 216/2008, including the inspection of undertakings or associations of undertakings referred to in Article 54(4) and Article 55 of that Regulation, carried out by the Agency; |
(2) |
‘competent authority’ means the entity designated by the Member State as competent for the implementation of Regulation (EC) No 216/2008 and its implementing rules; |
(3) |
‘authorised personnel’ means the persons authorised by the Agency to carry out inspections, including seconded personnel; |
(4) |
‘seconded personnel’ means the officials made available by the competent authorities of Member States, the International Civil Aviation Organisation (ICAO), other international aviation organisations or the competent authorities of Third Countries having agreements with the Union or working arrangements with the Agency, who are nominated by these authorities to assist the Agency in carrying out inspections; |
(5) |
‘evidence’ means records, statements of fact, or other information which are relevant and verifiable; |
(6) |
‘finding’ means the result of the comparison between the available evidence and the applicable requirements; |
(7) |
‘correction’ means an action to eliminate a finding of non-conformity with the applicable requirements; |
(8) |
‘corrective action’ means an action to eliminate the cause of a finding of non-conformity with the applicable requirements in order to prevent recurrence; |
(9) |
‘immediate safety concern’ means a situation where there is evidence that a product, service, system, constituent, equipment or facility is either in such a condition, or is being operated, supplied or maintained in such a manner that harm to persons is likely to occur unless the situation is corrected immediately. |
Article 3
Principles applicable to monitoring
1. The Agency shall monitor the application by competent authorities of the requirements referred in Article 1 as well as their uniform implementation according to the methodology laid down in this Regulation and shall report thereon.
2. The monitoring shall be continuous and risk-based, on the basis of the information available to the Agency. It shall entail assessing the competent authorities’ ability to discharge their safety oversight responsibilities, conducting inspections as necessary, as well as the follow-up of findings stemming from inspections, in order to ensure that appropriate corrections and corrective actions are timely implemented.
3. The monitoring shall follow a system approach. It shall address all domains and critical elements of the safety oversight system as defined by ICAO. Particular attention shall be given to interfaces between domains.
4. The monitoring shall be conducted in a transparent, efficient, effective, harmonised and consistent manner.
5. The Agency shall analyse the outcome of its monitoring activities in order to identify the need for regulatory improvements.
Article 4
Principles applicable to inspections and findings
1. Inspections of competent authorities shall take into account the results of previous inspections and address in particular changes to the regulatory requirements, to the safety oversight capability of the competent authority and be proportionate to the level and complexity of the industry under their oversight, ensuring as a priority a high and uniform level of safety for commercial air transport.
2. Inspections may include inspections of undertakings or associations of undertakings under the oversight of the competent authority inspected.
3. Inspections may include, when so agreed by the parties concerned, inspections of military facilities open to public use or of services provided by military personnel to the public, for the purpose of verifying that the requirements of Article 1(3) of Regulation (EC) No 216/2008 are complied with.
4. Inspections shall be carried out by a team composed of personnel authorised by the Agency, which shall be qualified and trained in their respective domain(s). Authorised personnel shall apply the principles of independence, integrity, ethical conduct, due diligence, fair presentation and confidentiality.
5. Where the Agency finds that one or more certificates do not comply with Regulation (EC) No 216/2008 and its Implementing Rules, that finding of non-conformity shall be reported to the competent authority concerned. Where the finding of non-conformity is not corrected in a timely manner the Agency shall make recommendations pursuant to Article 11(2) of Regulation (EC) No 216/2008 in order to allow a decision on the mutual recognition of the said certificate(s).
6. The Agency shall classify and follow-up the findings of non-conformity identified during inspections referred to in paragraphs 1, 2 and 3 depending on their impact on safety and safety related findings shall be prioritised. The Agency shall also inform without delay the competent authorities of Member States when the correction of an immediate safety concern has not been satisfactorily addressed.
7. This Regulation is without prejudice to Articles 15 and 58 of Regulation (EC) No 216/2008, to Commission Decision 2001/844/EC, ECSC, Euratom (17), to Regulation (EC) No 2111/2005 of the European Parliament and of the Council (18) and Commission Regulation (EC) No 473/2006 (19).
Article 5
Exchange of information
1. Competent authorities of Member States shall provide the Agency with all necessary information relevant to their safety oversight, addressing all the critical elements of their safety oversight system, including the undertakings or associations of undertakings under their oversight. The information shall be provided in a form and a manner specified by the Agency, taking into account the information that has been made available to ICAO.
2. The Agency may also request ad-hoc information from the competent authorities of Member States. When submitting such a request for information the Agency shall state its legal basis and purpose, specify what information is required and set the time-limit within which the information is to be provided.
3. The Agency shall provide competent authorities of Member States with relevant information to support the uniform implementation of the applicable requirements.
Article 6
National Standardisation Coordinator
1. Member States shall designate a national standardisation coordinator, acting as their primary point of contact for all standardisation activities and in particular to coordinate the exchange of information provided for in Article 5(1). The national standardisation coordinator shall be responsible for:
(a) |
maintaining and updating the information provided to the Agency on an on-going basis, including information requested in accordance with Articles 3, 4 and 5, corrections and corrective action plans and evidence of implementation of the agreed corrective actions; |
(b) |
assisting the Agency at all stages of an inspection and ensuring that the inspection team is accompanied throughout the on-site inspections. |
2. Competent authorities shall ensure that there are clear lines of communication between the national standardisation coordinator designated and their internal organisation, in order for him/her to properly discharge his/her responsibilities.
Article 7
Continuous monitoring
1. The continuous monitoring referred to in Article 3 shall comprise the following:
(a) |
the collection and analysis of data and information provided by the competent authorities of Member States, the International Civil Aviation Organisation (ICAO), the Commission or other relevant sources; |
(b) |
the assessment of the competent authority’s ability to discharge its safety oversight responsibilities; |
(c) |
depending on the assessment referred to in point (b), the prioritisation, planning and determination of the scope of inspections; |
(d) |
the conduct of such inspections, including the related reporting; |
(e) |
the follow-up and closure of findings of non-conformity stemming from the inspections. |
2. For the assessment referred to in point (b) of paragraph 1, the Agency shall establish, develop and maintain a single model taking into account at least the following elements:
(a) |
the size and complexity of the aviation industry; |
(b) |
serious incidents, accidents, fatal accidents and related fatalities; |
(c) |
the results of ramp inspections; |
(d) |
the results of previous inspections; |
(e) |
the ability of the competent authorities to implement effectively corrections and corrective actions; |
(f) |
the result of audits carried out under international conventions or State safety assessment programmes; |
(g) |
the existence of measures pursuant to Article 11(2) of Regulation (EC) No 216/2008 or to Article 258 of the Treaty. |
3. The outcome of the model as established in paragraph 2 and the input data and results of the assessment shall be made available to the national standardisation coordinator of the Member State concerned.
4. The Agency shall adapt the inspection programme in the light of its continuous monitoring, reflecting both improvements and deteriorations in safety performance. The Agency shall take appropriate action when there is evidence that the safety performance deteriorates.
Article 8
Inspection programme
1. The Agency shall establish, in coordination with the Commission, a multi-annual programme, indicating the inspections referred to in Article 10(1)(a), as well as an annual programme indicating the inspections referred to in Article 10(1)(a) and (b).
2. The inspection programmes shall specify the Member State(s) concerned, the type of inspection, the domains to be inspected and the foreseen timeframe for the on-site phase, taking into account the model referred to in Article 7.
3. The inspection programmes may be adjusted by the Agency to take into account emerging risks stemming from the continuous monitoring referred to in Article 7.
4. The annual programme shall be communicated to the Commission, to the members of the Management Board of the Agency as part of the Agency’s work programme pursuant to Article 33(2)(c) of Regulation (EC) No 216/2008, and to the national standardisation coordinator of the Member State concerned.
Article 9
Inspection domains
1. The Agency shall carry out inspections addressing each domain defined in Chapter II of Regulation (EC) No 216/2008. These domains shall include:
(a) |
airworthiness, as defined in Article 5 and environmental protection, as defined in Article 6 of the said Regulation |
(b) |
Air crew, as defined in Articles 7 and 8 of the said Regulation; |
(c) |
Air operations, as defined in Articles 8 and 9 of the said Regulation; |
(d) |
Ramp inspections, as defined in Article 10 of the said Regulation; |
(e) |
Aerodromes, as defined in Article 8a of the said Regulation; |
(f) |
ATM/ANS and air traffic controllers, as defined in Articles 8b and 8c of the said Regulation; |
Further domains may be defined depending on the evolutions of Regulation (EC) No 216/2008 or upon the request of the Commission.
2. The Agency shall ensure that its resources are appropriately allocated to monitoring and inspecting the different domains depending on the results of the continuous monitoring referred to in Article 7.
Article 10
Types of inspections
1. The Agency shall conduct:
(a) |
comprehensive inspections, for the purpose of inspecting one or more domains; these inspections shall be performed at intervals determined based on the results of the continuous monitoring; |
(b) |
focused inspections, for the purpose of inspecting specific areas within one or more domains, and/or for the purpose of assessing the implementation status of agreed corrections and corrective actions; |
(c) |
ad hoc inspections, for the purpose of investigating specific concerns arising from the Agency’s continuous monitoring or upon request from the Commission. |
2. Notwithstanding the inspections referred to in paragraph 1, the Agency may raise off-site findings when it has collected sufficient evidence of non-conformity.
Article 11
Training, qualification and authorisation criteria for inspection teams
1. The Agency shall establish qualification criteria for the personnel who participate in inspection teams.
2. The qualification criteria shall include:
(a) |
knowledge of the institutional and regulatory framework, in particular of this Regulation as well as on the relevant international agreements; |
(b) |
knowledge and experience of auditing techniques; |
(c) |
technical competence and practical experience in the relevant domain(s) referred to in Article 9. |
3. Team leaders shall be personnel employed by the Agency. Their qualification criteria shall include in addition to those referred to in paragraph 2, team management and communication capabilities in an international environment and in sensitive situations.
4. Team members shall be personnel employed by the Agency or seconded personnel.
5. Both team leaders and team members shall be trained on the applicable requirements and the Agency’s procedures. The Agency shall ensure the continued competence of team leaders and team members in order to participate in inspections as authorised personnel. The Agency shall establish appropriate continuous training programmes for that purpose.
6. Personnel who meet the qualification criteria and have received appropriate training may be authorised by the Agency to participate in inspection teams.
Article 12
Setting up teams for inspections
1. Inspections shall be carried out by teams set up by the Agency composed by authorised personnel pursuant to Article 11.
2. The Agency shall determine the team composition in order to establish the minimum team size necessary to cover the required technical competencies and workload, taking into account the type of inspection, the scope, the number of domains considered and the expected programme. Each team shall have a team leader and one team member as a minimum. In all cases, the Agency shall ensure the size of the teams remains commensurate to the scope.
3. The Agency shall ensure that, in setting up the teams, there shall be no conflict of interests either with the competent authorities inspected or with the undertakings or associations of undertakings inspected.
4. The Agency shall request in due time before an inspection information from seconding authorities or organisations as to the availability of team members for participating in the on-site phase.
5. Expenses arising from the participation of national standardisation coordinators as provided for in Article 14(2), Article 19(2) and of seconded personnel to inspections carried out by the Agency shall be borne by the Agency, in compliance with Union rules and without prejudice to the annual budgetary procedure of the Union.
Article 13
Conduct of inspections
1. Inspections referred to in Article 10(1)(a) and (b) shall include the following phases:
(a) |
a preparatory phase, lasting a minimum of 10 weeks prior to the inspection; |
(b) |
an on-site phase; |
(c) |
a reporting phase, lasting a maximum of 10 weeks following the end of the on-site phase. |
2. Ad hoc inspections referred to in Article 10(1)(c) shall be announced to the competent authority concerned with a notice of two weeks but need not to comply with the deadlines and the procedures provided for in Articles 14, 15 and 16, except for the need of a final report.
3. Findings of non-conformity identified during inspections referred to in Article 10 shall be reported in accordance with Article 16, followed-up and closed in accordance with Article 17 and classified in accordance with Article 18.
Article 14
Preparatory phase
1. During the preparatory phase of an inspection, the Agency shall:
(a) |
give notice of the inspection to the competent authority at least 10 weeks before the on-site phase, including the intended type, domain(s) and areas for inspection; |
(b) |
collect the necessary information for the preparation of the inspection, taking duly into account the information available from continuous monitoring; |
(c) |
define the scope, the extent and the programme of the inspection, including the inspection of undertakings or association of undertakings, taking into account the information from continuous monitoring; |
(d) |
determine the size and the composition of the inspection team. |
2. Upon notice of the inspection, the competent authority shall cooperate with the Agency in order to prepare the on-site phase swiftly. If deemed necessary, a preliminary meeting may be organised between the inspection team and the national standardisation coordinator.
3. The Agency shall provide the inspection programme and the composition of the team to the competent authority at least 2 weeks before the on-site phase.
Article 15
On-site phase
1. During the on-site phase of an inspection, the Agency shall:
(a) |
organise an opening meeting with the national standardisation coordinator and the competent authority inspected; |
(b) |
follow up findings of non-conformity identified in previous inspections and that remain open, and review the corresponding corrections and corrective actions; |
(c) |
notify the competent authority of any immediate safety concern, where such concern is identified during the inspection; |
(d) |
at a closing session, present to the competent authority inspected a list of preliminary findings of non-conformity identified or followed up in the course of the inspection. |
2. In addition, the Agency may:
(a) |
inspect the main offices and to the extent deemed necessary, any regional offices of the competent authority and of the qualified entities to which the competent authority may have allocated tasks; |
(b) |
inspect undertakings or associations of undertakings under the oversight of the competent authority as part of the inspection of this competent authority; in that case, the competent authority may accompany the inspection team; |
(c) |
carry out interviews with the staff of the competent authority inspected and qualified entities, if any, and of undertakings or association of undertakings visited, if any; |
(d) |
examine legislation, procedures, certificates, records, data and any other relevant material. |
Article 16
Reporting phase
1. During the reporting phase of an inspection, the Agency shall, within 6 weeks after the closing session of the on-site phase, review the preliminary findings, classify them and establish on this basis a draft report addressed to the competent authority inspected.
2. The draft report shall contain at least:
(a) |
an executive summary presenting the conclusions; |
(b) |
details on the conduct of the inspection, including the type of the inspection, domains covered, scope and composition of the team; |
(c) |
an analysis by critical element focusing on the main findings; |
(d) |
a list of findings of non-conformity identified or followed up during the inspection together with their classification; |
(e) |
recommendations, including where necessary on the mutual recognition of certificates. |
3. Findings of non-conformity shall be notified by means of the draft report referred to in paragraph 2, except if already notified in writing by the Agency by other means.
4. The competent authority may submit written comments to the Agency within two weeks from the notification.
5. The Agency shall, within 10 weeks after the closing session, issue a final report on the basis of the draft report mentioned in paragraph 2, reflecting the comments of the competent authority inspected, if any. The Agency may adapt the description of the finding of non-conformity, its legal basis, its classification or its status as appropriate to take into account the comments as well as the corrections or corrective actions submitted during the reporting phase.
6. The Agency shall establish and maintain a continuous monitoring status for each Member State which shall be provided on request to the Member State concerned and to the Commission.
7. The final report shall be addressed to the competent authority inspected and to the Commission, who may subsequently transmit this report to the Member State concerned and other competent authorities as appropriate.
Article 17
Findings follow-up and closure
1. For all findings of non-conformity classified under Article 18(1)(b) and (c), the competent authority shall propose a correction and a corrective action no later than four weeks after receipt of the notification from the Agency.
2. For all findings of non-conformity classified under Article 18(1)(a), the competent authority shall propose a corrective action no later than 10 weeks after receipt of the notification from the Agency;
3. The competent authority shall report to the Agency in due time on the completion of corrective actions and provide evidence thereof.
4. The Agency shall:
(a) |
evaluate the corrections and the corrective actions submitted by the competent authority or request further clarification in a timely manner; |
(b) |
agree with or reject the corrections and/or corrective actions submitted within 16 weeks after the notification; |
(c) |
monitor the satisfactory implementation of corrective actions; |
(d) |
identify any need for supplementary actions in accordance with Article 22; |
(e) |
report on a regular basis to the competent authority and to the Commission the status of findings of non-conformity and the related corrections/corrective actions by means of status reports; |
(f) |
close the findings of non-conformity once satisfied with the completion of the corrective actions and the evidence provided, record the closure of the findings of non-conformity and inform the competent authority accordingly. |
5. For the purposes of point (c), the Agency may request evidence or clarifications to the competent authority. The Agency may also decide to verify the implementation on site by means of an inspection.
6. When findings of non-conformity are subject to an infringement action pursuant to Article 11(2) of Regulation (EC) No 216/2008 or to the Treaties, the Agency shall ensure appropriate follow-up in consultation with the Commission and shall not close any such finding without prior coordination with the Commission.
Article 18
Classification of findings
1. All findings of non-conformity identified by the Agency in the framework of the inspections referred to in Article 10 shall be classified and reported by the Agency, whether they pertain to administrative requirements or to technical requirements, in one of the following classes:
(a) |
Class C: non-conformity with the applicable requirements, raising mainly standardisation concerns; |
(b) |
Class D: non-conformity with the applicable requirements, raising standardisation concerns and safety concerns if not timely corrected; |
(c) |
Class G: immediate safety concern. |
2. The reporting, follow-up and closure shall be prioritised depending on their classification.
Article 19
Immediate safety concern
1. When an immediate safety concern has been notified by the Agency:
(a) |
the Agency shall request the competent authority to take adequate corrective actions, including immediate corrections; |
(b) |
the competent authority shall apply effective corrections to remove the finding and shall provide the Agency with evidence thereof. |
2. The Agency may request within two weeks from the notification of the immediate safety concern the competent authority to attend a meeting to assess the implementation of the immediate corrections.
3. When the corrections do not satisfy the Agency, the Agency shall make recommendations to the Commission, including where necessary a request with regard to the mutual recognition of the certificate(s) issued by the competent authority. The Agency shall also inform the competent authorities of the Member States immediately.
Article 20
Records
1. The Agency shall establish a system of record-keeping providing for adequate storage, accessibility and reliable traceability of changes for:
(a) |
training, qualification and authorisation of team leaders and team members; |
(b) |
inspection programmes; |
(c) |
reports; |
(d) |
findings and related evidence; |
(e) |
agreed corrections and corrective actions; |
(f) |
closure of findings of non-conformity and related evidence; |
(g) |
recommendations regarding the mutual recognition of certificates; |
(h) |
assessments referred to in Article 7(1)(b). |
2. All records shall be kept for a minimum period of 15 years, subject to applicable data protection law.
Article 21
Access to information contained in inspection reports
1. Where information contained in an inspection report concerns an undertaking or association of undertakings under the safety oversight of a third country and falls within the scope of application of a Union agreement concluded pursuant to Article 12 of Regulation (EC) No 216/2008, that information shall be made available to the third country as a party to such an agreement in accordance with its relevant provisions.
2. Where information contained in an inspection report falls within the scope of application of the Memorandum of Cooperation between the Union and ICAO, that information shall be made available to ICAO in accordance with the provisions of this Memorandum of Cooperation and the corresponding safety annex.
3. Where information contained in an inspection report relates to ongoing safety investigations conducted in accordance with Regulation (EU) No 996/2010 of the European Parliament and of the Council (20), that information shall be made available without delay to the authority in charge of the safety investigation.
4. For the purpose of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (21), the decision-making process related to an inspection report shall not be deemed to be concluded before the related findings of non-conformity are closed.
Article 22
Supplementary actions
1. The Agency shall identify any failure to follow up a finding of non-conformity such as:
(a) |
corrective action not submitted within the period referred to in Article 17(1); |
(b) |
corrective action not agreed by the Agency within the period referred to in Article 17(4)(b); |
(c) |
corrective action not duly implemented. |
2. In the cases referred to in paragraph 1, the Agency shall request the competent authority to provide clarifications on the failure and to submit supplementary actions, setting a time-limit for the response.
3. The Agency shall assess the consequence of the failure together with the response provided by the competent authority within the set time-limit. Based on the outcome of such assessment, the Agency may:
(a) |
agree with the supplementary actions submitted; or |
(b) |
issue a supplementary report to the competent authority concerned and to the Commission. That report shall include the Agency’s assessment and recommendations to the Commission, including when deemed necessary recommendations on the mutual recognition of certificate(s) issued by the competent authority. |
4. Without prejudice to Regulation (EC) No 2111/2005, following receipt of the supplementary report referred to in paragraph 3(b), the Commission may take any of the following steps:
(a) |
address comments to the Member State concerned or request further explanation to clarify all or part of the findings of non-conformity; |
(b) |
require the Agency to carry out an ad-hoc inspection to check the satisfactory implementation of corrections and corrective actions; |
(c) |
initiate the procedure referred to in Article 11(2) of Regulation (EC) No 216/2008 to decide whether certificates issued by the competent authority comply with the applicable requirements; |
(d) |
initiate a procedure under Article 258 of the Treaty. |
Article 23
Annual report
The Agency shall submit to the Commission, no later than 31 March of each year, an annual report on the continuous monitoring activities and the inspections carried out in the previous year. The report shall include an analysis of the results of the activities and inspections, reflecting the competent authorities’ ability to discharge their safety oversight responsibilities, as well as recommendations for possible improvements. The recommendations shall in particular identify those technical rules that would need to be established or amended pursuant to Article 17(2)(b) of Regulation (EC) No 216/2008 as well as those Agency measures that would need to be established or amended pursuant to Article 18(c) of Regulation (EC) No 216/2008.
Article 24
Working procedures
The Agency shall revise its working procedures in order to implement the tasks conferred upon it under Articles 3 to 23 within six months following the entry into force of this Regulation at the latest.
Article 25
Transitional arrangements
1. Findings of non-conformity identified by the Agency pursuant to Regulation (EC) No 736/2006 and for which evidence of closure has not been submitted to the Agency at the time of entry into force of this Regulation shall be deemed to have been made in accordance with this Regulation and shall be treated accordingly.
2. Corrective action plans agreed by the Agency pursuant to Regulation (EC) No 736/2006 shall be deemed to have been agreed in accordance with this Regulation.
3. Team members and team leaders authorised by the Agency pursuant to Regulation (EC) No 736/2006 shall be deemed authorised personnel according to this Regulation.
Article 26
Repeal
Regulation (EC) No 736/2006 is repealed.
Article 27
Entry into force and application
This Regulation shall enter into force on the twentieth day following the date of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission
The President
José Manuel BARROSO
(2) OJ L 129, 17.5.2006, p. 10.
(3) OJ L 243, 27.9.2003, p. 6.
(4) OJ L 315, 28.11.2003, p. 1.
(6) OJ L 206, 11.8.2011, p. 21.
(7) OJ L 271, 18.10.2011, p. 15.
(8) OJ L 271, 18.10.2011, p. 23.
(10) OJ L 373, 31.12.1991, p. 4.
(11) OJ L 254, 20.9.2008, p. 1.
(12) OJ L 143, 30.4.2004, p. 76.
(13) OJ L 109, 19.4.2008, p. 17.
(14) OJ L 296, 25.10.2012, p. 1.
(15) OJ L 311, 25.11.2011, p. 1.
(16) Council Decision 2011/531/EU, OJ L 232, 9.9.2011, p. 8.
(17) OJ L 317, 3.12.2001, p. 1.
(18) OJ L 344, 27.12.2005, p. 15.
(19) OJ L 84, 23.3.2006, p. 8.
(20) OJ L 295, 12.11.2010, p. 35.
(21) OJ L 145, 31.5.2001, p. 43.
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/55 |
COMMISSION IMPLEMENTING REGULATION (EU) No 629/2013
of 28 June 2013
laying down further exceptional measures as regards the release of out-of-quota sugar and isoglucose on the Union market at reduced surplus levy during the 2012/13 marketing year
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 64(2) and Article 186, in conjunction with Article 4 thereof,
Whereas:
(1) |
During the 2011/12 sugar marketing year, the Union average bulk white sugar ex-factory price reached a level of 175 % of the reference price of EUR 404/tonne and was approximately EUR 275/tonne higher than the world market price. The Union price is now stable at a level of around EUR 700/tonne, which is the highest level reached since the reform of the sugar market organisation and disturbs the optimal fluidity of the sugar supply on the Union market. The expected increase of this already high price level at the beginning of the 2012/13 marketing year substantiated the risk of serious market disturbances which had to be prevented by the necessary measures. On 18 January, 15 February and 22 March 2013 the Commission adopted Implementing Regulations (EU) No 36/2013 (2), (EU) No 131/2013 (3) and (EU) No 281/2013 (4) providing exceptional measures intended to address the market disturbance. Notwithstanding the measures taken, the current prices registered on the market show that it is necessary to adopt further measures to address the persisting market disturbance. |
(2) |
Based on the estimated supply and demand for 2012/13, the ending stocks for the sugar market are expected to be lower by at least 500 000 tonnes than in 2011/12. This figure already takes into account the imports from third countries benefiting from certain preferential agreements. |
(3) |
On the other hand, the expectations of a good harvest lead to estimate the production of nearly 4 600 000 tonnes in excess of the sugar quota set out in Article 56 of Regulation (EC) No 1234/2007. Taking account of the foreseeable contractual commitments of sugar producers in respect of certain industrial uses provided for in Article 62 of that Regulation and of the 2012/13 export commitments for out-of-quota sugar, substantial quantities of out-of-quota sugar of at least 1 200 000 tonnes would still be available. Part of this sugar could be made available to alleviate the tight supply of the Union sugar food market and to avoid excessive price increases. |
(4) |
In order to ensure the fluidity of the market, it is necessary to release out-of-quota sugar. It should be possible to take such a measure each time it is necessary during the marketing year 2012/13. |
(5) |
Pursuant to Articles 186 and 188 of Regulation (EC) No 1234/2007 measures may be taken, when necessary, to remedy market disturbances or the risk of disturbances, where, in particular, these result from a significant rise of prices in the Union, provided that this objective cannot be reached by means of other measures available under that Regulation. Given the current market circumstances, Regulation (EC) No 1234/2007 does not provide for any specific measures aimed at limiting the high sugar price trend and allowing sugar supply at reasonable prices on the Union market, other than those based on Article 186 of that Regulation. |
(6) |
Article 64(2) of Regulation (EC) No 1234/2007 empowers the Commission to fix the surplus levy on sugar and isoglucose produced in excess of the quota at a sufficiently high level in order to avoid the accumulation of surplus quantities. Article 3(1) of Commission Regulation (EC) No 967/2006 of 29 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 318/2006 as regards sugar production in excess of the quota (5) has fixed that levy at EUR 500 per tonne. |
(7) |
For a limited quantity of sugar produced in excess of the quota, a reduced surplus levy should be fixed at a level per tonne allowing for a fair treatment of Union sugar producers, ensuring the good functioning of the Union sugar market and helping to reduce the difference between Union and world market sugar prices without creating risks of accumulation of surpluses in the Union market. |
(8) |
As Regulation (EC) No 1234/2007 fixes quotas for both sugar and isoglucose, a similar measure should apply for an appropriate quantity of isoglucose produced in excess of the quota because the latter product is, to some extent, a commercial substitute for sugar. |
(9) |
With a view to increasing the supply, sugar and isoglucose producers should apply to the competent authorities of the Member States for certificates allowing them to sell certain quantities, produced above the quota limit, on the Union market with a reduced surplus levy. |
(10) |
The reduced surplus levy should be paid after the application is admitted and before the certificate is issued. |
(11) |
The validity of the certificates should be limited in time to encourage a fast improvement of the supply situation. |
(12) |
Fixing upper limits of the quantities for which each producer can apply in one application period and restricting the certificates to products of the applicant’s own production should prevent speculative actions within the system created by this Regulation. |
(13) |
With their application, sugar producers should commit themselves to pay the minimum price for sugar beet used to produce the quantity of sugar for which they apply. The minimum eligibility requirements for applications should be specified. |
(14) |
The competent authorities of the Member States should notify the Commission of the applications received. In order to simplify and standardise those notifications, models should be made available. |
(15) |
The Commission should ensure that certificates are granted only within the quantitative limits fixed in this Regulation. Therefore, if necessary, the Commission should be able to fix an allocation coefficient applicable to the applications received. |
(16) |
Member States should immediately inform the applicants whether the quantity applied for was fully or partially granted. |
(17) |
The competent authorities should notify the Commission of the quantities for which certificates with a reduction of the surplus levy have been issued. For this purpose, models should be made available by the Commission. |
(18) |
Sugar quantities released on the Union market of quantities in excess of the certificates issued under this Regulation should be subject the surplus levy set out in Article 64(2) of Regulation (EC) No 1234/2007. It is therefore appropriate to provide that any applicant not fulfilling his commitment to release on the Union market the quantity covered by a certificate delivered to him, should also pay an amount of EUR 500 per tonne. This consistent approach is aimed at preventing abuse of the mechanism introduced by this Regulation. |
(19) |
For the purpose of establishing average prices for quota and out-of-quota sugar on the Union market in accordance with Article 13(1) of Commission Regulation (EC) No 952/2006 of 29 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 318/2006 as regards the management of the Community market in sugar and the quota system (6), sugar covered by a certificate issued pursuant to this Regulation should be considered as quota sugar. |
(20) |
In accordance with Article 2(1)(a) of Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities’ own resources (7) contributions and other duties provided for within the framework of the common organisation of the markets in the sugar sector are to constitute own resources. It is therefore necessary to set the date of establishment of the amounts in question within the meaning of Article 2(2) and Article 6(3)(a) of Council Regulation (EC, Euratom) No 1150/2000 of 22 May 2000 implementing Decision 2007/436/EC, Euratom on the system of the Communities’ own resources (8). |
(21) |
The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
HAS ADOPTED THIS REGULATION:
Article 1
Temporary reduction of the surplus levy
1. By way of derogation from Article 3(1) of Regulation (EC) No 967/2006, the amount of the surplus levy for a maximum quantity of 150 000 tonnes of sugar in white sugar equivalent and 8 000 tonnes of isoglucose in dry matter, produced in excess of the quota fixed in Annex VI to Regulation (EC) No 1234/2007 and released on the Union market in the 2012/13 marketing year, shall be fixed at EUR 148 per tonne.
2. The reduced surplus levy provided for in paragraph 1 shall be paid after the application referred to in Article 2 is admitted and before the certificate referred to in Article 6 is issued.
Article 2
Application for certificates
1. In order to benefit from the conditions specified in Article 1, sugar and isoglucose producers shall apply for a certificate.
2. Applicants may be only undertakings producing beet and cane sugar or isoglucose, which are approved in accordance with Article 57 of Regulation (EC) No 1234/2007 and have been allocated a production quota for the 2012/13 marketing year, in accordance with Article 56 of that Regulation.
3. Each applicant may submit not more than one application for sugar and one for isoglucose per application period.
4. Applications for certificates shall be submitted by fax or electronic mail to the competent authority in the Member State in which the undertaking was approved. The competent authorities of the Member States may require that electronic applications be accompanied by an advance electronic signature within the meaning of Directive 1999/93/EC of the European Parliament and of the Council (9).
5. To be admissible, the applications shall fulfil the following conditions:
(a) |
the applications shall indicate:
|
(b) |
the quantities applied for in this application period, expressed in tonnes of white sugar equivalent and tonnes of isoglucose in dry matter, shall not exceed 50 000 tonnes in the case of sugar and 2 500 tonnes in the case of isoglucose; |
(c) |
if the application concerns sugar, the applicant shall commit himself to pay the minimum beet price, set out in Article 49 of Regulation (EC) No 1234/2007, for the quantity of sugar covered by certificates issued in accordance with Article 6 of this Regulation; |
(d) |
the application shall be written in the official language or one of the official languages of the Member State in which the application is lodged; |
(e) |
the application shall indicate a reference to this Regulation and the expiry date for the submission of the applications; |
(f) |
the applicant shall not introduce any additional conditions to those laid down in this Regulation. |
6. An application which is not submitted in accordance with paragraphs 1 to 5 shall not be admissible.
7. An application may not be withdrawn or amended after its submission, even if the quantity applied for is granted only partially.
Article 3
Submission of applications
The period during which applications may be submitted shall end on 10 July 2013 at 12 noon, Brussels time.
Article 4
Transmission of applications by the Member States
1. The competent authorities of the Member States shall decide on the admissibility of applications on the basis of the conditions set out in Article 2. Where the competent authorities decide that an application is inadmissible, they shall inform the applicant without delay.
2. The competent authority shall notify the Commission on Friday at the latest, by fax or electronic mail, of the admissible applications submitted during the preceding application period. That notification shall not contain the data referred to in Article 2(5)(a)(i). Member States that received no applications but have sugar or isoglucose quota allocated to them in the 2012/13 marketing year, shall also send their nil returns notifications to the Commission within the same time limit.
3. The form and content of the notifications shall be defined on the basis of models made available by the Commission to the Member States.
Article 5
Exceeded limits
When the information notified by the competent authorities of the Member States pursuant to Article 4(2) indicates that the quantities applied for exceed the limits set out in Article 1, the Commission shall:
(a) |
fix an allocation coefficient, which the Member States shall apply to the quantities covered by each notified certificate application; |
(b) |
reject applications not yet notified. |
Article 6
Issue of certificates
1. Without prejudice to Article 5, on the 10th working day following a week where the application period ended, the competent authority shall issue certificates for the applications notified to the Commission, in accordance with Article 4(2).
2. Each Monday Member States shall notify the Commission of the quantities of sugar and/or isoglucose for which they issued certificates in the preceding week.
3. A template of the certificate is set out in the Annex.
Article 7
Validity of certificates
Certificates shall be valid until the end of the second month following the month of issue.
Article 8
Transferability of certificates
Neither the rights nor the obligations deriving from the certificates shall be transferable.
Article 9
Price reporting
For the purpose of Article 13(1) of Regulation (EC) No 952/2006, the quantity of sugar sold which is covered by a certificate issued pursuant to this Regulation shall be considered as quota sugar.
Article 10
Monitoring
1. Applicants shall add to their monthly notifications provided for in Article 21(1) of Regulation (EC) No 952/2006 the quantities for which they received certificates in accordance with Article 6 of this Regulation.
2. Before 31 October 2013, each holder of a certificate under this Regulation shall submit to the competent authorities of the Member States proof that all quantities covered by his certificates were released on the Union market. Each tonne covered by a certificate but not released on the Union market for reasons other than force majeure, shall be subject to payment of an amount of EUR 352/tonne.
3. Member States shall notify the Commission of the quantities not released on the Union market.
4. Member States shall calculate and notify the Commission of the difference between the total quantity of sugar and isoglucose produced by each producer in excess of the quota and the quantities which have been disposed by the producers in accordance with the second subparagraph of Article 4(1) of Regulation (EC) No 967/2006. If the remaining quantities of out-of-quota sugar or isoglucose of a producer are less than the quantities issued for that producer for under this Regulation, the producer shall pay an amount of EUR 500/tonne on that difference.
5. The notifications provided for in paragraphs 3 and 4 shall be made not later than 30 June 2014.
Article 11
Date of establishment
For the purposes of Article 2(2) and Article 6(3)(a) of Regulation (EC, Euratom) No 1150/2000, the date of establishment of the Union’s entitlement shall be the date on which the surplus levy is paid by the applicants in accordance with Article 1(2) of this Regulation.
Article 12
Entry into force
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.
It shall expire on 30 June 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 299, 16.11.2007, p. 1.
(4) OJ L 84, 23.3.2013, p. 19.
(5) OJ L 176, 30.6.2006, p. 22.
(6) OJ L 178, 1.7.2006, p. 39.
(7) OJ L 163, 23.6.2007, p. 17.
(8) OJ L 130, 31.5.2000, p. 1.
(9) OJ L 13, 19.1.2000, p. 12.
ANNEX
Model for the certificate referred to in Article 6(3)
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/60 |
COMMISSION REGULATION (EU) No 630/2013
of 28 June 2013
amending the Annexes to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (1), and in particular the first paragraph of Article 23 thereof,
Whereas:
(1) |
Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof. |
(2) |
On 19 January 2011, the European Food Safety Authority (EFSA) published a joint opinion prepared with the European Centre for Disease Prevention and Control (ECDC) on any possible epidemiological or molecular association between TSEs in animals and humans (‘the joint EFSA and ECDC Opinion’) (2). In the joint EFSA and ECDC opinion, the EFSA and ECDC confirmed the identification of atypical forms of bovine spongiform encephalopathy (BSE) in cattle and made the distinction between classical BSE, L-type atypical BSE and H-type atypical BSE. It is therefore appropriate to insert definitions for classical BSE cases and atypical BSE cases in Annex I to Regulation (EC) No 999/2001. |
(3) |
Part I of Chapter A of Annex III to Regulation (EC) No 999/2001 lays down rules for monitoring BSE in bovine animals slaughtered for human consumption. It refers to animals slaughtered in accordance with ‘special emergency slaughter’ as defined in Article 2(n) of Council Directive 64/433/EEC of 26 June 1964 on health conditions for the production and marketing of fresh meat (3). That Directive has since been repealed by Directive 2004/41/EC of the European Parliament and of the Council (4). This has led to legal uncertainty and caused reduced testing in animals that should have been tested. It is therefore necessary to clearly define emergency slaughter in the framework of the rules for monitoring BSE in bovine animals slaughtered for human consumption in Annex III to Regulation (EC) No 999/2001. |
(4) |
Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 lays down rules for monitoring in ovine and caprine animals. The annual reports carried out by the Member States on the monitoring and testing of ruminants for the presence of Transmissible Spongiform Encephalopathy (TSE) in the Union have shown in recent years that the testing of ovine and caprine animals not slaughtered for human consumption is usually more efficient to identify cases of TSE than the testing of animals slaughtered for human consumption. More flexibility should therefore be given to the Member States to focus a larger part of the limited number of tests required by that Annex in the subpopulations where there is a greater chance to identify such cases. |
(5) |
Annex VII to Regulation (EC) No 999/2001 lays down the eradication measures to be carried out following the confirmation of the presence of TSE in bovine, ovine and caprine animals and the minimum requirements for breeding programmes for resistance to TSEs in sheep. That Annex has been amended several times, including by Commission Regulations (EC) No 727/2007 (5) and (EC) No 746/2008 (6). |
(6) |
On 17 July 2007, in Case T-257/07, France brought an action against the Commission before the General Court, applying for the suspension of the operation of point (3) of the Annex to Regulation (EC) No 727/2007 insofar as it introduces point 2.3(b)(iii), point 2.3(d) and point 4 into Chapter A of Annex VII to Regulation (EC) No 999/2001, or alternatively the entire annulment of that Regulation. According to France, those points would authorise less restrictive measures of surveillance and eradication than those earlier prescribed for sheep and goats. In its Order of 28 September 2007 (7), the Court suspended the application of those provisions until judgment would be given in the main action. |
(7) |
The Commission subsequently asked the EFSA to assist it in clarifying the main premises on which Regulation (EC) No 727/2007 was based. In view of the EFSA clarifications, Regulation (EC) No 999/2001 was amended by Regulation (EC) No 746/2008, which reinstated provisions the application of which had been suspended by the General Court. In its Order of 30 October 2008 (8), the General Court suspended the application of point 2.3(b)(iii), point 2.3(d) and point 4 of Chapter A of Annex VII to Regulation (EC) No 999/2001, as amended by Regulation (EC) No 746/2008, until judgment would be given in the main action in Case T-257/07. |
(8) |
In its judgment of 9 September 2011 in Case T-257/07 (9), the General Court dismissed the application by France for the annulment of Regulation (EC) No 746/2008, and lifted the suspension of the application of those provisions of Chapter A of Annex VII to Regulation (EC) No 999/2001. |
(9) |
On 28 November 2011, in Case C-601/11 P (10), an appeal was brought by France against the judgment of the General court in Case T-257/07, requesting the Court to set aside the judgment of the General Court in Case T-257/07 and to give final judgment in the dispute by annulling Regulation (EC) No 746/2008 or to refer the case back to the General Court. |
(10) |
It is appropriate to clarify the very complex construct of management options and derogations for the control and eradication of classical scrapie in ovine and caprine animals set out in Annex VII to Regulation (EC) No 999/2001. Annex VII should only provide for three options in infected flocks or herds of ovine and caprine animals, namely: option 1 for the elimination of all animals; option 2 for the elimination of the susceptible animals only; and option 3 for no mandatory elimination of animals. |
(11) |
The measures to be applied in each of those three options should be re-drafted in order to facilitate comparison between the options and improve awareness of the consequences for the individual holding. As option 1 and option 2 include stringent eradication measures which improve disease control, the post-eradication measures enforced under option 1 and option 2 should be more flexible than under option 3. |
(12) |
It is necessary to clarify the conditions under which the elimination measures set out in option 2 may be delayed. It is appropriate to allow for a short term delay not exceeding three months linked to lambing season considerations. However, a long term delay can only be justified by the need of additional time to increase the level of genetic resistance to classical scrapie in a holding. Since genetic resistance to classical scrapie has so far been proven only in ovine animals, the long term delay should not be permitted for herds comprising only caprine animals. When permitted, it should be limited to a period of three years under certain conditions. |
(13) |
Where classical scrapie is confirmed in holdings keeping a local ovine breed in danger of being lost to farming, the post-eradication measures laid down in Annex VII to Regulation (EC) No 999/2001 should take into consideration the difficulty of introducing and using only resistant ovine animals or ovine germinal products of the same endangered breed. In this particular case, Member States should be permitted to apply more flexible rules regarding the genotype of breeders and germinal products introduced and used in the holdings. |
(14) |
The joint EFSA and ECDC Opinion suggests that atypical scrapie could be little or not contagious at all. That finding mainly relies on the lack of statistical difference of the observed Atypical/Nor98 frequencies between the general population and the flocks where a positive case had been identified. Therefore, restriction measures on the movement of ovine and caprine animals where a case of atypical scrapie has been confirmed are no longer justified. Increased surveillance in those flocks or herds should, however, be maintained in order to gather more scientific data on atypical scrapie. This amendment to Annex VII to Regulation (EC) No 999/2001 is in line with the future policy options envisaged by paragraph 2.4.3 of the Communication from the Commission to the European Parliament and the Council — The TSE Road map 2 — A Strategy paper on Transmissible Spongiform Encephalopathies for 2010-2015 (11). |
(15) |
The participation in breeding programmes has been so far limited to ovine flocks of high genetic merit. Where they have been applied, the breeding programmes have been effective in increasing the resistance to classical scrapie in the high genetic merit sheep population. But the diffusion in the ordinary production population of the hereditary factor (allele) carrying the resistance appears to have been limited so far. Chapter C of Annex VII to Regulation (EC) No 999/2001 should allow the genotyping of the breeding rams of flocks not participating in the breeding programme in order to facilitate a broader diffusion of the resistance factor to classical scrapie in the production population. |
(16) |
Chapter A of Annex VIII to Regulation (EC) No 999/2001 lays down rules governing intra-Union trade in live animals, semen and embryos. As referred to in recital 14, the joint EFSA and ECDC Opinion suggests that atypical scrapie could be little or not contagious at all. The lifting of all restriction measures on the movement of ovine and caprine animals where a case of atypical scrapie has been confirmed should therefore apply to intra-Union trade. This position is also supported by the fact that the Terrestrial Animal Health Code, as voted in 2010 at the 78th General Session of the World Organisation for Animal Health (OIE), does not recommend any trade restriction with regards to atypical scrapie. |
(17) |
The rules set out in Annex VIII to Regulation (EC) No 999/2001 relating to intra-Union trade in ovine and caprine animals and their semen and embryos should be made as consistent as possible with the OIE standards, so that they do not preclude Member States with an approved national control programme for classical scrapie from claiming the country freedom status for classical scrapie according to the conditions laid out in the OIE code. The amended intra-Union trade provisions should however not adversely impact existing intra-Union trade flows among Member States where no national control programme for classical scrapie has been approved. |
(18) |
For that purpose, and as proposed in paragraph 2.4.3 of the TSE Roadmap 2, a framework enabling the Member States to establish an official scheme for the recognition of classical scrapie status in holdings should be set out in Annex VIII to Regulation (EC) No 999/2001. The possibility for a holding to engage in intra-Union trade of ovine and caprine animals, with regards to classical scrapie, should be determined by its classical scrapie status. |
(19) |
A two tiered system for classical scrapie status in holdings should be established in Annex VIII to Regulation (EC) No 999/2001. A negligible risk status, equivalent in technical terms to the scrapie free status in a holding, as laid down in Article 14.9.5. of the OIE Terrestrial Animal Health code and based on compliance with the full list of the OIE requirements for at least seven years (in line with the rule laid down in article 6a and Annex VII to Regulation (EC) No 999/2001 favouring the development of the resistant genotypes in ovines, the proposal however recognises the ARR/ARR genotype as a valid option), should be required for transporting animals for breeding and rearing to the Member States with an approved national control programme for classical scrapie. Animals for breeding intended to other Member States should only be required to come from holdings with a controlled risk of classical scrapie based on compliance with a shorter list of requirements for at least three years, as is presently the case. |
(20) |
Considering the difficulty to demonstrate freedom in the territory of part of the territory of a Member State for a disease as complex as classical scrapie, which is characterised by a long incubation delay, the absence of any in-vivo diagnostic method and a variable individual susceptibility of the animals depending on their genetic profile, the concept of ‘classical scrapie free Member State’ should be replaced in Annex VIII to Regulation (EC) No 999/2001 by that of ‘Member State or zone of a Member State with a negligible risk of classical scrapie’. The conditions for the recognition of a Member State or zone of a Member State with a negligible risk of classical scrapie should also be updated and largely brought in line with the recommendations laid down in Article 14.9.3 of the OIE Terrestrial Animal Health code. |
(21) |
As Annex VIII to Regulation (EC) No 999/2001 should cover all trade aspects related to classical scrapie, and considering that the proposed creation of an official scheme for the recognition of classical scrapie status in holdings constitutes an appropriate basis for establishing differentiated guarantees for animals to be traded with Member States with an approved national control plan for classical scrapie and with other Member States, that Annex should also include the list of Member States with an approved national control plan for classical scrapie. |
(22) |
Chapter C of Annex IX to Regulation (EC) No 999/2001 lays down rules relating to imports into the Union of products of animal origin from bovine, ovine and caprine animals, in particular gelatine intended for human consumption. Section A of Chapter D of Annex IX to Regulation (EC) No 999/2001 lays down rules related to imports into the Union of animal by-products and derived products from bovine, ovine and caprine origin, in particular gelatine intended to be used as feed ingredient. Since collagen intended to be used for food or feed is produced from the same raw materials as gelatine, import conditions for collagen to be used for food or feed should be aligned with those laid down for gelatine intended for the same usage. |
(23) |
Section B of Chapter D of Annex IX to Regulation (EC) No 999/2001 provides specific attestations which are to accompany imports into the Union of certain animal by-products and derived products of bovine, ovine and caprine origin. Those attestations should be amended in order to also apply to products processed in a third country classified as posing a controlled or undetermined BSE risk and made from mixed material originating from this third country as well as from a third country with a negligible BSE risk. The specific attestation regarding the importation of products containing milk of ovine and caprine origin and intended for feeding farmed animals should also be amended to better reflect the restrictions applicable to intra-Union trade in these products. |
(24) |
Chapters E and H of Annex IX to Regulation (EC) No 999/2001 lay down rules for the importation in the Union of ovine and caprine animals, and ovine and caprine semen and embryos. Those import rules should be updated to reflect the conditions for intra-Union trade laid down in Annex VIII to Regulation (EC) No 999/2001, including the general pre-requisites in terms of monitoring and eradication of classical scrapie laid down in Annexes III and VII to Regulation (EC) No 999/2001, as well as feed ban provisions laid down in Annex IV to Regulation (EC) No 999/2001. |
(25) |
Annex X to Regulation (EC) No 999/2001 lays down the methods of analysis applicable to TSE testing in bovine, ovine and caprine animals. The joint EFSA and ECDC Opinion indicated that the L-type Atypical BSE agent has a significant zoonotic potential (transmission from animals to humans), which appears similar or even higher than that of the Classical BSE agent. L-type and H-type cases of atypical BSE have been identified in several countries throughout the world and EFSA indicated that the unusually old age of all H-BSE and L-BSE identified cases and their apparent low prevalence in the population could suggest that these Atypical BSE forms are arising spontaneously. In order to gain more knowledge on atypical BSE, more relevant data need to be gathered. |
(26) |
For that purpose, it is necessary to require that material from all future cases of BSE confirmed in the Union is submitted to discriminatory tests that allow the precise identification of the agent, namely classical BSE, L-type atypical BSE and H-type atypical BSE. As certain Member States and third countries have already published details of the phenotype of their recent BSE cases, discriminatory testing of future BSE cases confirmed in the Union should be made mandatory in Chapter C of Annex X to Regulation (EC) No 999/2001. |
(27) |
Point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001 sets out a list of rapid tests approved for the monitoring of TSEs in bovine, ovine and caprine animals. |
(28) |
Considering that the two following rapid test kits for the monitoring of BSE in bovine animals are not manufactured any more, as confirmed in the letters sent by Enfer Scientific on 21 August 2012 and Roche Diagnostics GmbH on 31 August 2012, they should be deleted from the list of rapid tests set out in Point 4 of Chapter C of Annex X: Enfer test & Enfer TSE Kit version 2.0, automated sample preparation; Roche Applied Science PrionScreen. |
(29) |
As Member States need sufficient time to adapt their national instructions to the new requirements introduced by this Regulation, this Regulation should apply on 1 July 2013. |
(30) |
Regulation (EC) No 999/2001 should therefore be amended accordingly. |
(31) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annexes to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 147, 31.5.2001, p. 1.
(2) EFSA Journal 2011;9(1):1945
(3) OJ 121, 29.7.1964, p. 2012.
(4) OJ L 157, 30.4.2004, p. 33.
(5) OJ L 165, 27.6.2007, p. 8.
(6) OJ L 202, 31.7.2008, p. 11.
(7) OJ C 283, 24.11.2007, p. 28.
(8) OJ C 327, 20.12.2008, p. 26.
(9) OJ C 311, 22.10.2011, p. 33.
(10) OJ C 80, 17.3.2012, p. 5.
(11) COM(2010)384 final.
ANNEX
The Annexes to Regulation (EC) No 999/2001 are amended as follows:
(1) |
In Annex I, point 2 is replaced by the following:
|
(2) |
In Annex III, Chapter A is amended as follows:
|
(3) |
Annex VII is replaced by the following: ‘ANNEX VII CONTROL AND ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES CHAPTER A Measures following the suspicion of the presence of a TSE in ovine and caprine animals If a TSE is suspected in an ovine or caprine animal on a holding in a Member State and until the results of the confirmatory examinations are available, all other ovine and caprine animals on that holding shall be placed under an official movement restriction. If there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the Member State may decide that other holdings or only the holding of exposure shall be placed under official control, depending on the epidemiological information available. The milk and the milk products derived from the ovine and caprine animals of a holding placed under official control, which are present on that holding from the date when the presence of the TSE is suspected until the results of the confirmatory examinations are available, shall only be used within that holding. CHAPTER B Measures following confirmation of the presence of a TSE in bovine, ovine and caprine animals
CHAPTER C Minimum requirements for a breeding programme for resistance to TSEs in ovine animals in accordance with article 6A PART 1 General requirements
PART 2 Specific rules for participating flocks
PART 3 Specific rules for breeding rams sampled in flocks not participating in the breeding programme
PART 4 The framework for the recognition of the TSE-resistant status of flocks of ovine animals
PART 5 Reports to be provided to the Commission by the Member States Member States introducing national breeding programmes to select for resistance to TSE in their ovine populations shall:
The report for each calendar year shall be submitted at the latest by 31 March of the following year. |
(4) |
In Annex VIII, Chapter A is replaced by the following: ‘CHAPTER A Conditions for intra-Union trade in live animals, semen and embryos SECTION A Conditions which apply to ovine and caprine animals and semen and embryos thereof 1. Holdings with a negligible risk of classical scrapie and a controlled risk of classical scrapie:
2. Member States or zones of a Member State with a negligible risk of classical scrapie
3. National control programme for classical scrapie:
4. Intra-Union trade in ovine and caprine animals and semen and embryos thereof The following conditions shall apply:
SECTION B Conditions which apply to bovine animals The United Kingdom shall ensure that bovine animals born or reared on its territory before 1 August 1996 are not dispatched from its territory to other Member States or third countries.’ |
(5) |
Annex IX is amended as follows:
|
(6) |
Annex X is amended as follows
|
(1) http://vla.defra.gov.uk/science/docs/sci_tse_rl_handbookv4jan10.pdf
(2) OJ L 349, 24.12.2002, p. 105.
(3) http://vla.defra.gov.uk/science/docs/sci_tse_rl_2blot.pdf
(5) OJ L 139, 30.4.2004, p. 55.
(6) OJ L 139, 30.4.2004, p. 206.’
(7) OJ L 300, 14.11.2009, p. 1.
(8) OJ L 368, 23.12.2006, p. 15.’
(9) http://vla.defra.gov.uk/science/docs/sci_tse_rl_2blot.pdf‧
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/84 |
COMMISSION IMPLEMENTING REGULATION (EU) No 631/2013
of 28 June 2013
repealing Regulation (EC) No 546/2006 and Implementing Regulation (EU) No 233/2012
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (1), and in particular point (b)(iii) of Section I of Chapter A of Annex VIII thereto,
Whereas:
(1) |
Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (‘TSEs’) in animals. Annex VIII thereto provides for the approval and subsequent amendment of the national scrapie control programmes of the Member States if they comply with certain criteria laid down in that Regulation. |
(2) |
Commission Regulation (EC) No 546/2006 of 31 March 2006 implementing Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national scrapie control programmes and additional guarantees and derogating from certain requirements of Decision 2003/100/EC and repealing Regulation (EC) No 1874/2003 (2) approves the national scrapie control programmes of certain Member States. It also lays down the additional guarantees from which those Member States can benefit regarding the movements of ovine and caprine animals, as well as of their semen and embryos. |
(3) |
Commission Implementing Regulation (EU) No 233/2012 of 16 March 2012 implementing Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the approval of the amended national scrapie control programme for Denmark (3) approves the amended national scrapie control programme for Denmark. |
(4) |
For reasons of clarity and simplification of Union legislation, Annex VIII to Regulation (EC) No 999/2001, as amended by Commission Regulation (EU) No 630/2013 of 28 June 2013 amending the Annexes to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (4), sets out the list of the Member States with an approved national control programme for classical scrapie and the corresponding additional guarantees from which those Member States benefit regarding the movements of ovine and caprine animals, as well as of their semen and embryos. |
(5) |
The amendments to Regulation (EC) No 999/2001 set out in Regulation (EU) No 630/2013 apply from 1 July 2013. The provisions of Regulation (EC) No 546/2006 and Implementing Regulation (EU) No 233/2012 become therefore redundant on that date. In the interest of legal clarity and certainty, those Regulations should therefore be repealed on the same date. |
(6) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 546/2006 and Implementing Regulation (EU) No 233/2012 are repealed with effect from 1 July 2013.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 147, 31.5.2001, p. 1.
(3) OJ L 78, 17.3.2012, p. 13.
(4) See page 60 of this Official Journal.
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/85 |
COMMISSION IMPLEMENTING REGULATION (EU) No 632/2013
of 28 June 2013
amending for the 194th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, (1) and in particular Article 7(1)(a) and 7a(5) thereof,
Whereas:
(1) |
Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation. |
(2) |
On 30 May 2013 the Sanctions Committee of the United Nations Security Council (UNSC) decided to amend one entry on the list of persons, groups and entities to whom the freezing of funds and economic resources should apply. |
(3) |
Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission, On behalf of the President,
Head of the Service for Foreign Policy Instruments
(1) OJ L 139, 29.5.2002, p. 9.
ANNEX
Annex I to Regulation (EC) No 881/2002 is amended as follows:
The entry ‘Al-Qaida in Iraq (alias (a) AQI, (b) al-Tawhid, (c) the Monotheism and Jihad Group, (d) Qaida of the Jihad in the Land of the Two Rivers, (e) Al-Qaida of Jihad in the Land of the Two Rivers, (f) The Organization of Jihad's Base in the Country of the Two Rivers, (g) The Organization Base of Jihad/Country of the Two Rivers, (h) The Organization Base of Jihad/Mesopotamia, (i) Tanzim Qa'idat Al-Jihad fi Bilad al-Rafidayn, (j) Tanzeem Qa'idat al Jihad/Bilad al Raafidaini, (k) Jama'at Al-Tawhid Wa'al-Jihad, (l) JTJ, (m) Islamic State of Iraq, (n) ISI, (o) al-Zarqawi network). Date of designation referred to in Article 2a (4) (b): 18.10.2004.’ under the heading ‘Legal persons, groups and entities’ shall be replaced by the following:
‘Al-Qaida in Iraq (alias (a) AQI, (b) al-Tawhid, (c) the Monotheism and Jihad Group, (d) Qaida of the Jihad in the Land of the Two Rivers, (e) Al-Qaida of Jihad in the Land of the Two Rivers, (f) The Organization of Jihad's Base in the Country of the Two Rivers, (g) The Organization Base of Jihad/Country of the Two Rivers, (h) The Organization Base of Jihad/Mesopotamia, (i) Tanzim Qa'idat Al-Jihad fi Bilad al-Rafidayn, (j) Tanzeem Qa'idat al Jihad/Bilad al Raafidaini, (k) Jama'at Al-Tawhid Wa'al-Jihad, (l) JTJ, (m) Islamic State of Iraq, (n) ISI, (o) al-Zarqawi network, (p) Jabhat al Nusrah, (q) Jabhet al-Nusra, (r) Al-Nusrah Front, (s) The Victory Front, (t) Al-Nusrah Front for the People of the Levant, (u) Islamic State in Iraq and the Levant). Date of designation referred to in Article 2a (4) (b): 18.10.2004.’
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/87 |
COMMISSION IMPLEMENTING REGULATION (EU) No 633/2013
of 28 June 2013
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
Whereas:
(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, |
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission, On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
(1) OJ L 299, 16.11.2007, p. 1.
(2) OJ L 157, 15.6.2011, p. 1.
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
(EUR/100 kg) |
||
CN code |
Third country code (1) |
Standard import value |
0702 00 00 |
AL |
55,3 |
MK |
46,1 |
|
ZZ |
50,7 |
|
0707 00 05 |
MK |
25,2 |
TR |
113,2 |
|
ZZ |
69,2 |
|
0709 93 10 |
TR |
130,5 |
ZZ |
130,5 |
|
0805 50 10 |
AR |
85,5 |
TR |
99,2 |
|
ZA |
107,4 |
|
ZZ |
97,4 |
|
0808 10 80 |
AR |
157,4 |
BR |
111,9 |
|
CL |
114,0 |
|
CN |
115,2 |
|
NZ |
142,9 |
|
TR |
99,8 |
|
ZA |
120,5 |
|
ZZ |
123,1 |
|
0809 10 00 |
IL |
275,4 |
TR |
211,6 |
|
ZZ |
243,5 |
|
0809 29 00 |
TR |
347,1 |
US |
605,0 |
|
ZZ |
476,1 |
|
0809 30 |
TR |
246,3 |
ZZ |
246,3 |
|
0809 40 05 |
CL |
216,9 |
IL |
308,9 |
|
ZA |
377,9 |
|
ZZ |
301,2 |
(1) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/89 |
COMMISSION IMPLEMENTING REGULATION (EU) No 634/2013
of 28 June 2013
fixing the import duties in the cereals sector applicable from 1 July 2013
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
Having regard to Commission Regulation (EU) No 642/2010 of 20 July 2010 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,
Whereas:
(1) |
Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff. |
(2) |
Article 136(2) of Regulation (EC) No 1234/2007 lays down that, in order to calculate the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question. |
(3) |
Under Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is the daily cif representative import price determined as specified in Article 5 of that Regulation. |
(4) |
Import duties should be fixed for the period from 1 July 2013 and should apply until new import duties are fixed and enter into force. |
(5) |
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, |
HAS ADOPTED THIS REGULATION:
Article 1
From 1 July 2013, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission, On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
(1) OJ L 299, 16.11.2007, p. 1.
(2) OJ L 187, 21.7.2010, p. 5.
ANNEX I
Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 1 July 2013
CN code |
Description |
Import duties (1) (EUR/t) |
1001 19 00 1001 11 00 |
Durum wheat, high quality |
0,00 |
medium quality |
0,00 |
|
low quality |
0,00 |
|
ex 1001 91 20 |
Common wheat seed |
0,00 |
ex 1001 99 00 |
High quality common wheat other than for sowing |
0,00 |
1002 10 00 1002 90 00 |
Rye |
0,00 |
1005 10 90 |
Maize seed other than hybrid |
0,00 |
1005 90 00 |
Maize other than seed (2) |
0,00 |
1007 10 90 1007 90 00 |
Grain sorghum other than hybrids for sowing |
0,00 |
(1) The importer may benefit, under Article 2(4) of Regulation (EU) No 642/2010, from a reduction in the duty of:
— |
EUR 3/t, where the port of unloading is located on the Mediterranean Sea (beyond the Strait of Gibraltar) or on the Black Sea, for goods arriving in the Union via the Atlantic Ocean or the Suez Canal, |
— |
EUR 2/t, where the port of unloading is located in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or on the Atlantic coast of the Iberian Peninsula, for goods arriving in the Union via the Atlantic Ocean. |
(2) The importer may benefit from a flat-rate reduction of EUR 24/t where the conditions laid down in Article 3 of Regulation (EU) No 642/2010 are met.
ANNEX II
Factors for calculating the duties laid down in Annex I
14.6.2013-27.6.2013
1. |
Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:
|
2. |
Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:
|
(1) Premium of EUR 14/t incorporated (Article 5(3) of Regulation (EU) No 642/2010).
(2) Discount of EUR 10/t (Article 5(3) of Regulation (EU) No 642/2010).
(3) Discount of EUR 30/t (Article 5(3) of Regulation (EU) No 642/2010).
DECISIONS
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/92 |
COUNCIL DECISION
of 25 June 2013
increasing the number of Advocates-General of the Court of Justice of the European Union
(2013/336/EU)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 252 thereof,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,
Having regard to the request of the President of the Court of Justice of 16 January 2013,
Whereas:
(1) |
The first paragraph of Article 252 of the Treaty on the Functioning of the European Union establishes that the Council, acting unanimously, may increase the number of Advocates-General on the request of the Court of Justice. |
(2) |
On 16 January 2013, the Court of Justice requested that the number of Advocates-General of the Court of Justice be increased by three. That request was motivated by the desire to allow the Court to continue to have an Opinion delivered in every case in which it is required without thereby increasing the overall time taken to deal with the cases concerned. |
(3) |
According to Declaration No 38 on Article 252 of the Treaty on the Functioning of the European Union regarding the number of Advocates-General of the Court of Justice, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, if the Court of Justice requests that the number of Advocates-General be increased by three (eleven instead of eight), the Council will, acting unanimously, agree on such an increase. |
(4) |
In order best to satisfy the concerns expressed in the second recital and to ensure the optimal integration of the additional Advocates-General, the Court of Justice proposed that one Advocate-General take up his duties on 1 July 2013, the planned date of Croatia’s accession, provided that all of the instruments of ratification have been lodged before this date, and that the two other Advocates-General take up their duties on 7 October 2015, on the occasion of the partial replacement of the Members of the Court, |
HAS ADOPTED THIS DECISION:
Article 1
The number of Advocates-General of the Court of Justice of the European Union shall be increased to:
— |
nine, with effect from 1 July 2013; |
— |
eleven, with effect from 7 October 2015. |
Article 2
This Decision shall enter into force on the day following its publication in the Official Journal of the European Union.
Done at Luxembourg, 25 June 2013.
For the Council
The President
E. GILMORE
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/93 |
DECISION OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES
of 26 June 2013
appointing Judges to the General Court
(2013/337/EU)
THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 19 thereof,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,
Whereas:
(1) |
The terms of office of 13 Judges of the General Court are due to expire on 31 August 2013. New appointments should therefore be made for the period from 1 September 2013 to 31 August 2019. |
(2) |
It has been proposed that the terms of office of Mr Guido BERARDIS, Mr Eugène BUTTIGIEG and Mr Carl WETTER as Judges of the General Court should be renewed. |
(3) |
Mr Anthony COLLINS, Mr Stéphane GERVASONI and Mr Ignacio ULLOA RUBIO have been proposed as candidates for the vacant posts of Judges of the General Court. |
(4) |
The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr Guido BERARDIS, Mr Eugène BUTTIGIEG, Mr Anthony COLLINS, Mr Stéphane GERVASONI, Mr Ignacio ULLOA RUBIO and Mr Carl WETTER to perform the duties of Judge of the General Court, |
HAVE ADOPTED THIS DECISION:
Article 1
The following are hereby appointed Judges to the General Court for the period from 1 September 2013 to 31 August 2019:
— |
Mr Guido BERARDIS |
— |
Mr Eugène BUTTIGIEG |
— |
Mr Anthony COLLINS |
— |
Mr Stéphane GERVASONI |
— |
Mr Ignacio ULLOA RUBIO |
— |
Mr Carl WETTER. |
Article 2
This Decision shall enter into force on the day following its publication in the Official Journal of the European Union.
Done at Brussels, 26 June 2013.
The President
R. MONTGOMERY
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/94 |
DECISION OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES
of 26 June 2013
appointing Judges to the Court of Justice
(2013/338/EU)
THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 19 thereof,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 253 and 255 thereof,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,
Whereas:
(1) |
Under Articles 5 and 7 of the Protocol on the Statute of the Court of Justice of the European Union, and following the resignations of Mr Uno LÕHMUS and Mr Jean-Jacques KASEL as of 6 October 2013, two judges should be appointed to the Court of Justice for the remainder of the terms of office of Mr LÕHMUS and Mr KASEL, which run until 6 October 2015. |
(2) |
Ms Küllike JÜRIMÄE and Mr François BILTGEN have been proposed as candidates for the vacant posts. |
(3) |
The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Ms Küllike JÜRIMÄE and Mr François BILTGEN to perform the duties of Judges of the Court of Justice, |
HAVE ADOPTED THIS DECISION:
Article 1
The following are hereby appointed Judges to the Court of Justice for the period from 6 October 2013 to 6 October 2015:
— |
Ms Küllike JÜRIMÄE |
— |
Mr François BILTGEN. |
Article 2
This Decision shall enter into force on the day following its publication in the Official Journal of the European Union.
Done at Brussels, 26 June 2013.
The President
R. MONTGOMERY
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/95 |
DECISION OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES
of 26 June 2013
appointing a Judge to the General Court
(2013/339/EU)
THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 19 thereof,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,
Whereas:
(1) |
Under Articles 5 and 7 of the Protocol on the Statute of the Court of Justice of the European Union, and following the resignation of Mr Josef AZIZI, with effect from 1 September 2013, a Judge should be appointed to the General Court for the remainder of the term of office of Mr AZIZI, which runs until 31 August 2016. |
(2) |
Mr Viktor KREUSCHITZ has been proposed as a candidate for the vacant post. |
(3) |
The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on Mr Viktor KREUSCHITZ's suitability to perform the duties of a Judge of the General Court, |
HAVE ADOPTED THIS DECISION:
Article 1
Mr Viktor KREUSCHITZ is hereby appointed Judge to the General Court for the period from 1 September 2013 to 31 August 2016.
Article 2
This Decision shall enter into force on the day following its publication in the Official Journal of the European Union.
Done at Brussels, 26 June 2013.
The President
R. MONTGOMERY
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/96 |
COMMISSION IMPLEMENTING DECISION
of 27 June 2013
amending Decision 2008/855/EC as regards animal health control measures relating to classical swine fever in Croatia
(notified under document C(2013) 3932)
(Text with EEA relevance)
(2013/340/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (1), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (2), and in particular Article 10(4) thereof,
Whereas:
(1) |
Commission Decision 2008/855/EC of 3 November 2008 concerning animal health control measures relating to classical swine fever in certain Member States (3) lays down certain control measures in relation to classical swine fever in the Member States or regions thereof listed in the Annex thereto. Different epidemiological situations regarding classical swine fever are registered in Member States or areas thereof. The Annex to Decision 2008/855/EC therefore consists of three parts, each listing areas of Member States, to which different measures apply according to the epidemiological situation. |
(2) |
Pursuant to Decision 2008/855/EC, Member States are to ensure that live pigs are dispatched from their territories to other Member States only if the pigs come from areas outside those listed in the Annex to that Decision. |
(3) |
Part I of the Annex to Decision 2008/855/EC lists Member States and areas thereof where the epidemiological situation for classical swine fever is most favourable. Consequently, Decision 2008/855/EC provides that the dispatch of live pigs originating from holdings located within an area listed in Part I of that Annex to holdings or slaughterhouses located in an area listed in that Part and belonging to another Member States may be authorised by the Member States of dispatch provided that certain conditions are complied with. In addition, fresh pigmeat from holdings located in those areas, and meat preparations and meat products consisting of, or containing meat of those pigs, may be dispatched to other Member States. |
(4) |
An outbreak of classical swine fever in domestic pigs was detected in Croatia in 2008 for the last time. However, seropositive cases in wild boars have been detected also in the hunting season 2012-13. Croatia applied appropriate measures to control classical swine fever, in line with the measures provided for in Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (4) and a programme for the eradication of the disease is currently in place. |
(5) |
Croatia is expected to accede the Union on 1 July 2013. Given the epidemiological situation for classical swine fever in that country, it is appropriate to lay down measures for the control of classical swine fever in its territory in order to prevent the spread of the disease to other areas of the Union. On the basis of the information provided by the competent authority of Croatia, it is appropriate to include the territory of the counties of Karlovac, Sisak-Moslavina, Slavonski Brod-Posavina and Vukovar-Srijem in Part I of the Annex to Decision 2008/855/EC. |
(6) |
Decision 2008/855/EC should therefore be amended accordingly. |
(7) |
This Decision should apply from the date of accession of Croatia to the European Union. |
(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, |
HAS ADOPTED THIS DECISION:
Article 1
In Part I of the Annex to Decision 2008/855/EC, the following entry is added:
‘Croatia
The territory of the counties of Karlovac, Sisak-Moslavina, Slavonski Brod-Posavina and Vukovar-Srijem’
Article 2
This Decision shall apply from the date of the entry into force of the Treaty of Accession of Croatia.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 27 June 2013.
For the Commission
Tonio BORG
Member of the Commission
(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 224, 18.8.1990, p. 29.
(3) OJ L 302, 13.11.2008, p. 19.
(4) OJ L 316, 1.12.2001, p. 5.
29.6.2013 |
EN |
Official Journal of the European Union |
L 179/98 |
COMMISSION IMPLEMENTING DECISION
of 27 June 2013
on the approval of the Valeo Efficient Generation Alternator as an innovative technology for reducing CO2 emissions from passenger cars pursuant to Regulation (EC) No 443/2009 of the European Parliament and of the Council
(Text with EEA relevance)
(2013/341/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community’s integrated approach to reduce CO2 emissions from light-duty vehicles (1), and in particular Article 12(4) thereof,
Whereas:
(1) |
The supplier Valeo Equipments Electriques Moteur (the ‘Applicant’) submitted an application for the approval of the Valeo Efficient Generation (EG) Alternator as an innovative technology on 18 December 2012. The completeness of the application was assessed in accordance with Article 4 of Commission Implementing Regulation (EU) No 725/2011 of 25 July 2011 establishing a procedure for the approval and certification of innovative technologies for reducing CO2 emissions from passenger cars pursuant to Regulation (EC) No 443/2009 of the European Parliament and of the Council (2). The application was found to be complete and the period for the Commission’s assessment of the application started on the day following the date of official receipt, i.e. 19 December 2012. |
(2) |
The application has been assessed in accordance with Article 12 of Regulation (EC) No 443/2009, Implementing Regulation (EU) No 725/2011 and the Technical Guidelines for the preparation of applications for the approval of innovative technologies pursuant to Regulation (EC) No 443/2009 (the Technical Guidelines) (3). |
(3) |
The application refers to the Valeo EG Alternator, which is an alternator with an efficiency of at least 77 per cent as determined in accordance with the VDA approach described in point 5.1.2 in Annex I to the Technical Guidelines. The Applicant’s alternator is equipped with synchronous rectification using metal-oxide-semiconductor field-effect transistors thereby ensuring a high level of efficiency. |
(4) |
The Commission finds that the information provided in the application demonstrates that the conditions and criteria referred to in Article 12 of Regulation (EC) No 443/2009 and in Articles 2 and 4 of Implementing Regulation (EU) No 725/2011 have been met. |
(5) |
The Applicant has demonstrated that a high efficiency alternator of the kind described in this application will only be available on the EU market as from 2013 and that consequently the market penetration in 2009 of this type of alternators was below the 3 per cent threshold specified in Article 2(2)(a) of Implementing Regulation (EU) No 725/2011. This claim is also supported by the accompanying verification report. On that basis, the Commission finds that the high efficiency alternator provided by the Applicant should be considered meeting the eligibility criterion set out in Article 2(2)(a) of Implementing Regulation (EU) No 725/2011. |
(6) |
In order to determine the CO2 savings that the innovative technology will deliver when fitted to a vehicle, it is necessary to define the baseline vehicle against which the efficiency of the vehicle equipped with the innovative technology should be compared as provided for in Articles 5 and 8 of Implementing Regulation (EU) No 725/2011. The Commission finds that it is appropriate to consider an alternator with 67 % efficiency as an appropriate baseline technology in the case the innovative technology is fitted on a new vehicle type. Where the Valeo EG Alternator is fitted to an existing vehicle type, the baseline technology should be the alternator of the most recent version of that type placed on the market. |
(7) |
The Applicant has provided a comprehensive methodology for testing the CO2 reductions. It includes formulae that are consistent with the formulae described in the Technical Guidelines for the simplified approach with regard to efficient alternators. The Commission considers that the testing methodology will provide testing results that are verifiable, repeatable and comparable and that it is capable of demonstrating in a realistic manner the CO2 emissions benefits of the innovative technology with strong statistical significance in accordance with Article 6 of Implementing Regulation (EU) No 725/2011. |
(8) |
Against that background the Commission finds that the Applicant has demonstrated satisfactorily that the emission reduction achieved by the innovative technology is at least 1 g CO2/km. |
(9) |
The Commission notes that the savings of the innovative technology may be partially demonstrated on the standard test cycle, and the final total savings to be certified should therefore be determined in accordance with the second subparagraph of Article 8(2) of Implementing Regulation (EU) No 725/2011. |
(10) |
The Commission finds that the verification report has been prepared by UTAC which is an independent and certified body and that the report supports the findings set out in the application. |
(11) |
Against that background, the Commission finds that no objections should be raised as regards the approval of the innovative technology in question. |
(12) |
Any manufacturer wishing to benefit from a reduction of its average specific CO2 emissions for the purpose of meeting its specific emissions target by means of the CO2 savings from the use of the innovative technology approved by this Decision, should in accordance with Article 11(1) of Implementing Regulation (EU) No 725/2011, refer to this Decision in its application for an EC type-approval certificate for the vehicles concerned, |
HAS ADOPTED THIS DECISION:
Article 1
1. The Valeo Efficient Generation Alternator having an efficiency of at least 77 per cent and intended for use in M1 vehicles is approved as an innovative technology within the meaning of Article 12 of Regulation (EC) No 443/2009.
2. The CO2 emissions reduction from the use of the alternator referred to in paragraph 1 shall be determined using the methodology set out in the Annex.
3. In accordance with the second subparagraph of Article 11(2) of Implementing Regulation (EU) No 725/2011, the CO2 emission reduction determined in accordance with paragraph 2 of this Article, may only be certified and entered into the certificate of conformity and relevant type approval documentation specified in Annexes I, VIII and IX to Directive 2007/46/EC of the European Parliament and of the Council (4) where the reductions are on or above the threshold specified in Article 9(1) of Implementing Regulation (EU) No 725/2011.
Article 2
This Decision shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 27 June 2013.
For the Commission
The President
José Manuel BARROSO
(2) OJ L 194, 26.7.2011, p. 19.
(3) http://ec.europa.eu/clima/policies/transport/vehicles/cars/docs/guidelines_en.pdf
(4) OJ L 263, 9.10.2007, p. 1.
ANNEX
Methodology for determining the reduction in CO2 emissions due to the use of the Valeo Efficient Generation Alternator in an M1 vehicle
1. Introduction
In order to determine the CO2 reductions that can be attributed to the use of the Valeo EG Alternator in an M1 vehicle, it is necessary to establish the following:
(a) |
the testing procedure to be followed for determining the efficiency of the alternator; |
(b) |
the setting of the test bench; |
(c) |
the formulae for calculating the standard deviation; |
(d) |
the determination of the CO2 savings for the certification by type approval authorities. |
2. Testing procedure
The efficiency of the alternator must be determined by doing measurements at different speeds: 1 800, 3 000, 6 000, 10 000 revolutions per minute. At each speed the alternator is charged at 50 % of the maximum load. For calculating the efficiency, a time distribution is to be 25 %, 40 %, 25 %, 10 % for respectively 1 800, 3 000, 6 000, 10 000 revolutions per minute (see the VDA approach as described in point 5.1.2 in Annex I to the Technical Guidelines).
This leads to the following formula (1):
With:
— |
ηΑ is the efficiency of the alternator; |
— |
(η @1 800 rpm @0,5·IN) is the efficiency of the alternator at a speed of 1 800 rpm and at a load of 50 %; |
— |
(η @3 000 rpm @0,5·IN) is the efficiency of the alternator at a speed of 3 000 rpm and at a load of 50 %; |
— |
(η @6 000 rpm @0,5·IN) is the efficiency of the alternator at a speed of 6 000 rpm and at a load of 50 %; |
— |
(η @10 000 rpm @0,5·IN) is the efficiency of the alternator at a speed of 10 000 rpm and at a load of 50 %; |
— |
IN = Current (A) |
The set-up of the test bench and the testing procedure is to fulfil the precision requirements specified in ISO 8854:2012 (1).
3. Test bench
The test bench is to be a ‘direct drive’ alternator test bench. The alternator is to be directly linked to the torque meter and to the shaft of the drive train. The alternator is to be loaded with a battery and an electronic load. See the test bench configuration in figure 1.
Figure 1
The test bench configuration
In figure 1 an overview of the test bench configuration is given. The alternator transfers the mechanical power of the brushless motor into electrical power. The brushless motor generates an amount of power which is defined by the torque (Nm) and by the rotational speed (rad.s–1). The torque and the speed are to be measured by the torque meter.
The alternator produces power to overcome the load which is connected to the alternator. This amount of power is equal to the alternator voltage (V) times the alternator current (I).
The efficiency of the alternator is to be defined as the electric power (output of the alternator) divided by the mechanical power (output of the torquemeter).
Formula (2) |
: |
|
Where:
ηΑ |
= |
Efficiency of the alternator; |
V |
= |
Voltage (V); |
I |
= |
Current (A); |
T |
= |
Torque (Nm); |
ω |
= |
Rotational speed of the alternator (rad. s–1) |
4. Measuring the torque and calculating the efficiency of the alternator
The tests are to be carried out in accordance with the ISO 8854:2012.
The load is to be installed at 50 % of the current which is guaranteed by the alternator at 25 °C and a rotor speed of 6 000 rpm, e.g. if the alternator is a 180 A class alternator (at 25 °C and 6 000 rpm), the load is installed at 90 A.
For each speed the voltage and the output current of the alternator are to be kept constant, the voltage at 14,3 V and the current for a 180 A-alternator at 90 A, i.e. for each speed the torque is to be measured by means of the test bench (see figure 1) and the efficiency is to be calculated by means of formula (2).
This test is to provide the efficiencies of the alternator at 4 different speeds in revolutions per minute (rpm):
— |
At a speed of 1 800 rpm; |
— |
At a speed of 3 000 rpm; |
— |
At a speed of 6 000 rpm; |
— |
At a speed of 10 000 rpm. |
The average efficiency of the alternator is to be calculated by means of formula (1).
5. Standard deviation of the arithmetic mean value of the efficiency of the alternator
Statistical errors in the outcomes of the testing methodology caused by the measurements are to be quantified. The format of the error value is to be a standard deviation being equivalent to a two-sided confidence interval of 84 % (see formula (3)).
Formula (3) |
: |
|
Where:
|
: |
standard deviation of arithmetic mean; |
xi |
: |
measurement value; |
|
: |
arithmetic mean; |
n |
: |
number of measurements |
All measurements are to be performed consecutively at least five (5) times. For each speed the standard deviation is calculated.
The standard deviation of the efficiency value of the alternator (ΔηΑ) is calculated by the following formula:
Formula (4) |
: |
|
Where the values 0,25, 0,40, 0,25, and 0,1 are the same weighting values as in formula (2) and S1 800, S3 000, S6 000, and S10 000 are the standard deviations calculated with formula (3).
6. Error in the CO2 savings due to the standard deviation (propagation law)
The standard deviation of the efficiency value of the alternator (ΔηΑ), leads to an error in the CO2 savings. This error is to be calculated by means of the following formula (2):
Formula (5) |
: |
|
Where:
ΔCO2 |
= |
error in CO2 savings (g CO2/km); |
PRW |
= |
750 W; |
PTA |
= |
350 W; |
ηΑ–EI |
= |
Efficiency of the high efficient alternator; |
ΔηΑ |
= |
Standard deviation of the efficiency of the alternator (result of equation in Formula (4); |
VPe |
= |
Willans’ factors (l/kWh); |
CF |
= |
Conversion factors (g CO2/l); |
v |
= |
mean driving speed of the NEDC (km/h) |
7. Calculation of the accountable share of the mechanical power saving
The high efficient alternator leads to the saved mechanical power which is to be calculated in two steps. In the first step the saved mechanical power is to be calculated under ‘real world’ conditions. The second step is to calculate the saved mechanical power under type approval conditions. Subtracting these 2 mechanical power savings is to result in the accountable share of the saved mechanical power.
The saved mechanical power under ‘real world’ conditions is to be calculated with formula (6).
Formula (6) |
: |
|
Where:
ΔΡm–RW |
= |
Saved mechanical power under real world conditions (W); |
PRW |
= |
Electric power under real world conditions, which is 750 W; |
ηΑ |
= |
Efficiency of the baseline alternator; |
ηΑ–EI |
= |
Efficiency of the high efficient alternator |
The saved mechanical power under type-approval conditions is to be calculated with formula (7).
Formula (7) |
: |
|
Where:
ΔΡm–TA |
= |
Saved mechanical power under type approval conditions (W); |
PTA |
= |
Electric power under type approval conditions, which is 350 W; |
ηΑ |
= |
Efficiency of the baseline alternator; |
ηΑ–EI |
= |
Efficiency of the high efficient alternator |
The accountable share of saved mechanical power is calculated with formula (8).
Formula (8) |
: |
|
Where:
ΔΡm |
= |
Accountable share of saved mechanical power (W); |
ΔΡm–RW |
= |
Saved mechanical power under real world conditions (W); |
ΔΡm–TA |
= |
Saved mechanical power under type approval conditions (W); |
8. Formula to calculate the CO2 savings
The CO2 savings are to be calculated with the following formula:
Formula (9) |
: |
|
Where:
CCO2 |
= |
CO2 savings (g CO2/km); |
ΔΡm |
= |
Accountable share of saved mechanical power as per formula (8) (W); |
VPe |
= |
Willans’ factors (l/kWh); |
CF |
= |
Conversion factors (g CO2/l) |
v |
= |
mean driving speed of the NEDC (km/h) |
For the Willans’ factors the data in table 1 is to be used:
Table 1
Willans’ factors
Type of engine |
Consumption of effective power VPe [l/kWh] |
Petrol (VPe-P) |
0,264 |
Petro Turbo |
0,28 |
Diesel (VPe-D) |
0,22 |
For the conversion factors the data in table 2 is to be used:
Table 2
Conversion factors
Type of fuel |
Conversion factor (l/100 km) → (g CO2/km) [100 g/l] |
Petrol |
23,3 (= 2 330 g CO2/l) |
Petro Turbo |
23,3 (= 2 330 g CO2/l) |
Diesel |
26,4 (= 2 640 g CO2/l) |
The mean driving speed of the NEDC is: v = 33,58 km/h
9. Statistical Significance
It has to be demonstrated for each type, variant and version of a vehicle fitted with the Valeo EG Alternator that the error in the CO2 savings calculated with Formula 5 is not greater than the difference between the total CO2 savings and the minimum savings threshold specified in Article 9(1) of Implementing Regulation (EU) No 725/2011 (see Formula (7)).
Formula (10) |
: |
|
Where:
MT |
= |
minimum threshold (g CO2/km); |
CCO2 |
= |
total CO2 saving, (g CO2/km); |
|
= |
error in the CO2 savings (g CO2/km) |
10. The high efficient alternator to be implemented in vehicles
For determining the CO2 savings to be certified due to the use of the Valeo EG Alternator by the type approval authority in accordance with Article 12 of Implementing Regulation (EU) No 725/2011, the manufacturer of the M1 vehicle in which the alternator is fitted has to designate in accordance with Article 5 of that Regulation, an eco-innovation vehicle fitted with the Valeo (EG) Alternator and either of the following baseline vehicles:
(a) |
if the eco-innovation is fitted to a new vehicle type which will be submitted to a new type approval, the baseline vehicle is to be the same as the new vehicle type in all respects except with regard to the alternator which is to be an alternator with an efficiency of 67 %, or |
(b) |
if the eco-innovation is fitted to an existing vehicle version for which the type approval will be extended following the replacement of the existing alternator by the eco-innovation, the base vehicle is to be the same as the eco-innovation vehicle in all respects except with regard to the alternator which is to be the alternator of the existing vehicle version. |
The type approval authority is to certify the CO2 savings based on measurements of the base vehicle and eco-innovation vehicle in accordance with Article 8(1) and the second subparagraph of Article 8(2) of Implementing Regulation (EU) No 725/2011 using the test methodology set out in this Annex. Where the CO2 emission savings are below the threshold specified in Article 9(1), the second subparagraph of Article 11(2) of Implementing Regulation (EU) No 725/2011 shall apply.
11. Eco-innovation code to be entered into type approval documentation
For the purposes of determining the general eco-innovation code to be used in the relevant type approval documents in accordance with Annexes I, VIII and IX to Directive 2007/46/EC, the individual code to be used for the innovative technology approved through this Decision shall be ‘2’.
E.g. the code of the eco-innovation in the case of eco-innovation savings certified by the German type approval authority shall be ‘e1 2’.
(1) ISO 8854. Road vehicles — Alternators with regulators — Test methods and general requirements. Reference number ISO 8854:2012(E).
(2) This formula (5) can be derived from the error propagation law which is explained in the Technical Guidelines (par. 4.2.1).