# C_2012324EN.01000101.xml

| 25.10.2012 | EN | Official Journal of the European Union | C 324/1 |
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25.10.2012

EN

Official Journal of the European Union

C 324/1

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COMMISSION OPINION

of 24 October 2012

on interim measures taken by the government of Germany in respect of life jacket lights of model AquaSpec AQ02 manufactured by AquaSpec Ltd in the United Kingdom

(Text with EEA relevance)

2012/C 324/01

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 96/98/EC of 20 December 1996 on Marine Equipment (1), and in particular Article 13 thereof,

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Whereas:

| (1) | In accordance with Annex A.1 to the above mentioned directive, the applicable performance and construction requirements for life jacket lights are laid down in Resolution MSC.48(66) (LSA Code) of the International Maritime Organization (IMO) and the applicable testing standards for the said equipment are laid down in Resolution MSC.81(70) of the IMO. |
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(1)

In accordance with Annex A.1 to the above mentioned directive, the applicable performance and construction requirements for life jacket lights are laid down in Resolution MSC.48(66) (LSA Code) of the International Maritime Organization (IMO) and the applicable testing standards for the said equipment are laid down in Resolution MSC.81(70) of the IMO.

| (2) | By letter of 25 March 2011 the German Authorities (the Federal Maritime and Hydrographic Agency, hereinafter ‘BSH’) informed the Commission of interim measures taken by this Authority in respect of life jacket lights of model AquaSpec AQ02 (hereinafter, ‘the life jacket lights’) manufactured by AquaSpec Ltd in the United Kingdom (hereinafter, ‘the manufacturer’), whereby the life jacket lights belonging to the batches No D024648 (500 pieces) and No D020010 (350 pieces) were recalled from the German market on grounds of failure to comply with Article 5(1) of Directive 96/98/EC. |
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(2)

By letter of 25 March 2011 the German Authorities (the Federal Maritime and Hydrographic Agency, hereinafter ‘BSH’) informed the Commission of interim measures taken by this Authority in respect of life jacket lights of model AquaSpec AQ02 (hereinafter, ‘the life jacket lights’) manufactured by AquaSpec Ltd in the United Kingdom (hereinafter, ‘the manufacturer’), whereby the life jacket lights belonging to the batches No D024648 (500 pieces) and No D020010 (350 pieces) were recalled from the German market on grounds of failure to comply with Article 5(1) of Directive 96/98/EC.

| (3) | The letter was accompanied by a detailed market surveillance report dated 2 March 2011 and a copy of each of the following documents: (a) the EC Type Examination Certificate (module B) for the life jacket light model AQ02, No BSI/A.1/1.2c/546541, issued on 3 February 2009 by the notified body BSI Product Services, and valid until 2 February 2014; (b) the Quality Assurance Certificate (Module D) for the life jacket light model AQ02, No BSI/MED/PC/546610, issued on 15 June 2009 by the notified body BSI Product Services, and valid until 14 June 2012, and (c) a declaration of Conformity of the life jacket lights model AQ02, batch No D024648, issued on 9 July 2009. |
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(3)

The letter was accompanied by a detailed market surveillance report dated 2 March 2011 and a copy of each of the following documents: (a) the EC Type Examination Certificate (module B) for the life jacket light model AQ02, No BSI/A.1/1.2c/546541, issued on 3 February 2009 by the notified body BSI Product Services, and valid until 2 February 2014; (b) the Quality Assurance Certificate (Module D) for the life jacket light model AQ02, No BSI/MED/PC/546610, issued on 15 June 2009 by the notified body BSI Product Services, and valid until 14 June 2012, and (c) a declaration of Conformity of the life jacket lights model AQ02, batch No D024648, issued on 9 July 2009.

| (4) | The interim measures followed after BSH found that the life jacket lights of the batches No D024648 and No D020010 did not meet the above mentioned applicable requirements during tests which were carried out by BSH within the framework of a market surveillance program. |
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(4)

The interim measures followed after BSH found that the life jacket lights of the batches No D024648 and No D020010 did not meet the above mentioned applicable requirements during tests which were carried out by BSH within the framework of a market surveillance program.

| (5) | More precisely BSH reported that two specimens from batch No D024648 had initially been tested to verify compliance with the requirement in Resolution MSC.48(66) of the International Maritime Organization (IMO), section 2.2.3.1.1, whereby each life jacket light shall have a luminous intensity of not less than 0,75 candela (cd) in all directions of the upper hemisphere. The tests showed that, when measured at ambient temperature, the light output of both specimens did not reach the required intensity in the entire range. After these tests further tests had been carried out on four specimens taken from batch No D020010. The results of these tests showed that the light output of none of the four specimens reached the above mentioned requirement in any direction when measured at ambient temperature in the case of two specimens and at – 1 °C in the case of the remaining two specimens. |
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(5)

More precisely BSH reported that two specimens from batch No D024648 had initially been tested to verify compliance with the requirement in Resolution MSC.48(66) of the International Maritime Organization (IMO), section 2.2.3.1.1, whereby each life jacket light shall have a luminous intensity of not less than 0,75 candela (cd) in all directions of the upper hemisphere. The tests showed that, when measured at ambient temperature, the light output of both specimens did not reach the required intensity in the entire range. After these tests further tests had been carried out on four specimens taken from batch No D020010. The results of these tests showed that the light output of none of the four specimens reached the above mentioned requirement in any direction when measured at ambient temperature in the case of two specimens and at – 1 °C in the case of the remaining two specimens.

| (6) | Upon receipt of the letter from BSH the Commission entered into consultations with the manufacturer, the government of the United Kingdom as the notifying Member State and the above mentioned notified body having issued both the type-examination and the production certificates on the latter's behalf (hereinafter referred to collectively as ‘the parties’). The Commission asked a number of specific questions from each party and invited them to submit any other observations they might deem appropriate. |
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(6)

Upon receipt of the letter from BSH the Commission entered into consultations with the manufacturer, the government of the United Kingdom as the notifying Member State and the above mentioned notified body having issued both the type-examination and the production certificates on the latter's behalf (hereinafter referred to collectively as ‘the parties’). The Commission asked a number of specific questions from each party and invited them to submit any other observations they might deem appropriate.

| (7) | In response to the Commission's consultation the manufacturer submitted that they had been unable to agree with or accept the test results from BSH for the following reasons: (a) the test procedures performed by BSH had not been conducted in accordance with Circular MSC.980 of the IMO; (b) no assurance could have been given that the samples tested had not already been activated prior to being received by BSH; (c) they had been denied access to the test samples for analysis despite a formal request; and (d) light output tests performed on these batches under their approved and audited Module D procedures all passed at the time of manufacture. |
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(7)

In response to the Commission's consultation the manufacturer submitted that they had been unable to agree with or accept the test results from BSH for the following reasons: (a) the test procedures performed by BSH had not been conducted in accordance with Circular MSC.980 of the IMO; (b) no assurance could have been given that the samples tested had not already been activated prior to being received by BSH; (c) they had been denied access to the test samples for analysis despite a formal request; and (d) light output tests performed on these batches under their approved and audited Module D procedures all passed at the time of manufacture.

| (8) | Further to this the manufacturer submitted: (a) that they had taken the decision to voluntarily suspend all sales and marketing of the life jacket lights in Germany and also to instigate a recall of all products from batches No D024648 and No D020010 within the territory, pending completion of further tests carried out by AquaSpec Ltd on archived samples from those batches; (b) copies of the test reports of the said tests (produced by Kendy Electronics), which showed that the lights fulfilled the requirements; (c) that they had challenged the results of the tests that had been performed by BSH; and (d) that the production of the life jacket lights had ceased in 2011, since they had been replaced by lights using LED lights. |
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(8)

Further to this the manufacturer submitted: (a) that they had taken the decision to voluntarily suspend all sales and marketing of the life jacket lights in Germany and also to instigate a recall of all products from batches No D024648 and No D020010 within the territory, pending completion of further tests carried out by AquaSpec Ltd on archived samples from those batches; (b) copies of the test reports of the said tests (produced by Kendy Electronics), which showed that the lights fulfilled the requirements; (c) that they had challenged the results of the tests that had been performed by BSH; and (d) that the production of the life jacket lights had ceased in 2011, since they had been replaced by lights using LED lights.

| (9) | The Commission did not receive any reaction from BSI Product Services, which the Commission had asked them to provide before June 2011. |
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(9)

The Commission did not receive any reaction from BSI Product Services, which the Commission had asked them to provide before June 2011.

| (10) | The Maritime and Coastguard Agency (MCA), for the government of the United Kingdom, replied that: (a) the notified body BSI Product Services had informed MCA that AquaSpec Ltd was in the process of checking the batches that had been recalled; (b) AquaSpec Ltd had disputed the results of the tests performed by BSH for the reasons as stated in recital 7; (c) AquaSpec Ltd had felt that they had no choice but to voluntarily recall the product from the German market; (d) if the lights which failed had been distributed to European countries other than Germany, MCA would agree to the withdrawal of the batches concerned from the entire European market; and (e) it would not be possible to establish if the same problem would occur to lights belonging to other batches without further investigation. |
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(10)

The Maritime and Coastguard Agency (MCA), for the government of the United Kingdom, replied that: (a) the notified body BSI Product Services had informed MCA that AquaSpec Ltd was in the process of checking the batches that had been recalled; (b) AquaSpec Ltd had disputed the results of the tests performed by BSH for the reasons as stated in recital 7; (c) AquaSpec Ltd had felt that they had no choice but to voluntarily recall the product from the German market; (d) if the lights which failed had been distributed to European countries other than Germany, MCA would agree to the withdrawal of the batches concerned from the entire European market; and (e) it would not be possible to establish if the same problem would occur to lights belonging to other batches without further investigation.

| (11) | The Commission asked BSH for their views on the observations received. In their answer, to which a memo explaining how the luminous intensity test had been carried out was attached, BSH stated that: (a) favourable conditions for the manufacturer had been used during the tests; (b) it had not been indicated whether Kendy Electronics was an accredited or recognized laboratory and it could not be verified if the prescribed 20-day lasting temperature cycling test required by Resolution MSC.81(70) of the IMO had been performed; (c) the life jacket lights that had been tested by BSH had been delivered to them in the original packaging and therefore it would be highly unlikely that they would have been activated prior to receipt by BSH; (d) from their point of view it was not correct that AquaSpec Ltd had been denied access to the tested samples, however for reasons of preservation of evidence the wish from AquaSpec Ltd to be returned one of the tested specimens could not be satisfied. However, BSH had stated that they had been willing to meet the request from AquaSpec Ltd for a visit to the laboratory and a meeting; and (e) the results of the tests at the time of manufacture that Aquaspec Ltd had submitted to BSH had shown that these tests had been performed without the 20-day lasting temperature cycling test. BSH concluded that the observations submitted by the manufacturer did not warrant changes to the initial assessment and that the reasons for the recall of the product remained valid. No evidence has been provided to the Commission on any further discussion between the manufacturer and BSH with regard to the former's access to the tested specimens. |
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(11)

The Commission asked BSH for their views on the observations received. In their answer, to which a memo explaining how the luminous intensity test had been carried out was attached, BSH stated that: (a) favourable conditions for the manufacturer had been used during the tests; (b) it had not been indicated whether Kendy Electronics was an accredited or recognized laboratory and it could not be verified if the prescribed 20-day lasting temperature cycling test required by Resolution MSC.81(70) of the IMO had been performed; (c) the life jacket lights that had been tested by BSH had been delivered to them in the original packaging and therefore it would be highly unlikely that they would have been activated prior to receipt by BSH; (d) from their point of view it was not correct that AquaSpec Ltd had been denied access to the tested samples, however for reasons of preservation of evidence the wish from AquaSpec Ltd to be returned one of the tested specimens could not be satisfied. However, BSH had stated that they had been willing to meet the request from AquaSpec Ltd for a visit to the laboratory and a meeting; and (e) the results of the tests at the time of manufacture that Aquaspec Ltd had submitted to BSH had shown that these tests had been performed without the 20-day lasting temperature cycling test. BSH concluded that the observations submitted by the manufacturer did not warrant changes to the initial assessment and that the reasons for the recall of the product remained valid. No evidence has been provided to the Commission on any further discussion between the manufacturer and BSH with regard to the former's access to the tested specimens.

| (12) | BSH acted within the framework of a market surveillance program on life jacket lights, in accordance with Article 12 of Directive 96/98/EC. |
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(12)

BSH acted within the framework of a market surveillance program on life jacket lights, in accordance with Article 12 of Directive 96/98/EC.

| (13) | The manufacturer was informed of the results of the above mentioned tests and was given by BSH the possibility to present its observations and defend itself before the said Authority adopted any measures in respect of the product in question. Similarly, the notified body was informed and was given by BSH the possibility to present its observations. |
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(13)

The manufacturer was informed of the results of the above mentioned tests and was given by BSH the possibility to present its observations and defend itself before the said Authority adopted any measures in respect of the product in question. Similarly, the notified body was informed and was given by BSH the possibility to present its observations.

| (14) | The Commission notes that, in its answer, the manufacturer has stated that BSH had not performed the tests in accordance with Circular MSC.980. However, since this Circular does not form part of the testing standards as referred to in recital (1), this test cannot be considered relevant for the case. Furthermore this Circular only contains a format for the testing reports. |
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(14)

The Commission notes that, in its answer, the manufacturer has stated that BSH had not performed the tests in accordance with Circular MSC.980. However, since this Circular does not form part of the testing standards as referred to in recital (1), this test cannot be considered relevant for the case. Furthermore this Circular only contains a format for the testing reports.

| (15) | The Commission also notes that, according to the information provided by BSH, the tested specimens had been delivered to them in the original packaging. Therefore it is reasonable to expect these specimens to have been exactly in the same specific condition as would have been available to ship owners for placing on board their ships. No objective elements have been provided to support the manufacturer's statement that, in such circumstances, these specimens could have been activated prior to the receipt by BSH. |
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(15)

The Commission also notes that, according to the information provided by BSH, the tested specimens had been delivered to them in the original packaging. Therefore it is reasonable to expect these specimens to have been exactly in the same specific condition as would have been available to ship owners for placing on board their ships. No objective elements have been provided to support the manufacturer's statement that, in such circumstances, these specimens could have been activated prior to the receipt by BSH.

| (16) | The information available to the Commission shows that reasonable diligence was exercised by BSH to facilitate the manufacturer's access to the tested specimens. BSH is accredited in accordance with EN 45011, which contains general requirements for bodies operating product certification systems, including requirements for the quality system and also to EN 17025. This latter standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. Therefore, in the absence of any objective evidence to the contrary, it must be presumed that BSH carried out all relevant tests appropriately and in accordance with the applicable standards. |
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(16)

The information available to the Commission shows that reasonable diligence was exercised by BSH to facilitate the manufacturer's access to the tested specimens. BSH is accredited in accordance with EN 45011, which contains general requirements for bodies operating product certification systems, including requirements for the quality system and also to EN 17025. This latter standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. Therefore, in the absence of any objective evidence to the contrary, it must be presumed that BSH carried out all relevant tests appropriately and in accordance with the applicable standards.

| (17) | Conversely, no proof has been provided, as has been highlighted by BSH, that Kendy Electronics is a duly accredited laboratory and therefore it is not possible for the Commission to accept the test reports issued by this laboratory as an admissible proof in this case. The manufacturer's argument that the specimens tested by this laboratory fulfilled the applicable requirements cannot therefore be retained. |
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(17)

Conversely, no proof has been provided, as has been highlighted by BSH, that Kendy Electronics is a duly accredited laboratory and therefore it is not possible for the Commission to accept the test reports issued by this laboratory as an admissible proof in this case. The manufacturer's argument that the specimens tested by this laboratory fulfilled the applicable requirements cannot therefore be retained.

| (18) | BSH has contended that the tests carried out at the time of manufacture had been performed without the 20-day lasting temperature cycling test, in accordance with Resolution MSC.81(70). However, the documentation submitted by BSH has not allowed the Commission to verify such statement which cannot, therefore, be retained. |
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(18)

BSH has contended that the tests carried out at the time of manufacture had been performed without the 20-day lasting temperature cycling test, in accordance with Resolution MSC.81(70). However, the documentation submitted by BSH has not allowed the Commission to verify such statement which cannot, therefore, be retained.

| (19) | Based on the above considerations and the evidence submitted to the Commission, in particular the above mentioned results of the tests carried out on six specimens taken at random from two different batches of lifejacket lights produced by AquaSpec Ltd, namely batches No D024648 and No D020010, it is reasonable to conclude that at least these two production batches do not conform to the applicable requirements for this type of equipment. |
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(19)

Based on the above considerations and the evidence submitted to the Commission, in particular the above mentioned results of the tests carried out on six specimens taken at random from two different batches of lifejacket lights produced by AquaSpec Ltd, namely batches No D024648 and No D020010, it is reasonable to conclude that at least these two production batches do not conform to the applicable requirements for this type of equipment.

| (20) | Further to this it cannot be established from the evidence submitted whether the cause of the non-conformity of the life jacket lights lies in the production phase, in the type approval phase or in a combination of both. |
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(20)

Further to this it cannot be established from the evidence submitted whether the cause of the non-conformity of the life jacket lights lies in the production phase, in the type approval phase or in a combination of both.

| (21) | Life jacket lights are important safety devices, which are used in emergency situations. The luminous intensity of those lights may be of crucial importance. This is especially true in cases where people in distress have to be located in the dusk or dark. A too low luminous intensity may hamper such location. For these reasons minimum requirements have been set and people in distress, rescuers and seafarers should be able to trust that those requirements are met. |
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(21)

Life jacket lights are important safety devices, which are used in emergency situations. The luminous intensity of those lights may be of crucial importance. This is especially true in cases where people in distress have to be located in the dusk or dark. A too low luminous intensity may hamper such location. For these reasons minimum requirements have been set and people in distress, rescuers and seafarers should be able to trust that those requirements are met.

| (22) | The Commission notes that the recall of the product only concerned the German market. However, it is unknown to what ships under which flags the products may have been further disseminated. |
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(22)

The Commission notes that the recall of the product only concerned the German market. However, it is unknown to what ships under which flags the products may have been further disseminated.

| (23) | The duration of a recall in this particular case does not have to be limited until the moment measures have been taken such that the lights do comply with the applicable requirements and may be placed on the market again, since the model Aquaspec AQ02 has already been replaced by a another model, |
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(23)

The duration of a recall in this particular case does not have to be limited until the moment measures have been taken such that the lights do comply with the applicable requirements and may be placed on the market again, since the model Aquaspec AQ02 has already been replaced by a another model,

HAS ADOPTED THIS OPINION:

| 1. | The interim measures notified by the German government to the Commission by letter of 25 March 2011 in respect of life jacket lights of model AquaSpec AQ02, batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom are adequate and proportionate for the protection of maritime safety and are therefore justified. |
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1.

The interim measures notified by the German government to the Commission by letter of 25 March 2011 in respect of life jacket lights of model AquaSpec AQ02, batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom are adequate and proportionate for the protection of maritime safety and are therefore justified.

| 2. | The Commission recommends that the Member States ensure that life jacket lights of the model AquaSpec AQ02 from batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom, are removed from their markets. |
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2.

The Commission recommends that the Member States ensure that life jacket lights of the model AquaSpec AQ02 from batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom, are removed from their markets.

| 3. | The Commission recommends that the Member States take all appropriate action in order to remove the life jacket lights of the model AquaSpec AQ02 from batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom, from the ships flying their flag and have them replaced by other life jacket lights fulfilling the requirements of Article 5(1) of Directive 96/98/EC. |
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3.

The Commission recommends that the Member States take all appropriate action in order to remove the life jacket lights of the model AquaSpec AQ02 from batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom, from the ships flying their flag and have them replaced by other life jacket lights fulfilling the requirements of Article 5(1) of Directive 96/98/EC.

| 4. | The Commission recommends that the Member States and Notified Body BSI Product Services take the necessary action to verify that life jacket lights model AquaSpec AQ02, other than those belonging to batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom, comply with the requirements of Article 5(1) of Directive 96/98/EC. |
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4.

The Commission recommends that the Member States and Notified Body BSI Product Services take the necessary action to verify that life jacket lights model AquaSpec AQ02, other than those belonging to batches No D024648 and No D020010, manufactured by AquaSpec Ltd in the United Kingdom, comply with the requirements of Article 5(1) of Directive 96/98/EC.

| 5. | The Commission recommends that the government of the United Kingdom and the notified body BSI Product Services take the necessary action to verify that both the tests conducive to the delivery of a type approval certificate and the tests by which it has been established that the product conforms to type have been performed in accordance with Resolution MSC.81(70) of the IMO and, in the negative, take the appropriate actions. |
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5.

The Commission recommends that the government of the United Kingdom and the notified body BSI Product Services take the necessary action to verify that both the tests conducive to the delivery of a type approval certificate and the tests by which it has been established that the product conforms to type have been performed in accordance with Resolution MSC.81(70) of the IMO and, in the negative, take the appropriate actions.

| 6. | The Member States should as soon as possible inform the Commission and the other Member States of any measures taken pursuant to this opinion. |
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6.

The Member States should as soon as possible inform the Commission and the other Member States of any measures taken pursuant to this opinion.

Done at Brussels, 24 October 2012.

For the Commission

Siim KALLAS

Vice-President

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(1)  OJ L 46, 17.2.1997, p. 25.

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