7.1.2015   

EN

Official Journal of the European Union

L 3/1

(1)

The average mass value used for the purpose of calculating the specific emissions of CO2 for each new passenger car is to be adjusted every three years to take into account any changes in the average mass of the new vehicles registered in the Union.

(2)

It is evident from the monitoring of the mass in running order of new passenger cars registered in calendar years 2011, 2012 and 2013 that the average mass has increased and that the figure M0 referred to in point 1(b) of Annex I to Regulation (EC) No 443/2009 should therefore be adjusted.

(3)

Exceptionally for this first adjustment, it is appropriate to take into account that the quality of the data monitored in the years 2011, 2012 and 2013 has differed. The new value should therefore be determined by taking into account only those mass values that it has been possible to verify by the manufacturers concerned, whilst excluding values from the calculation that were obviously incorrect, i.e. values exceeding 2 840 kg or lower than 500 kg as well as values relating to vehicles that did not fall within the scope of Regulation (EC) No 443/2009. The new value is moreover based on the weighted average taking into account the number of new registrations in each of the reference years.

(4)

Against that background, the M0 value to be applied from 1 January 2016 should be increased by 20,4 kg from 1 372,0 to 1 392,4,

7.1.2015   

EN

Official Journal of the European Union

L 3/3

(1)

Regulation (EC) No 1924/2006 provides that health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, Commission Regulation (EU) No 432/2012 (2) was adopted, which established a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health.

(3)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims are to be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’, for a scientific assessment, as well as to the Commission and the Member States for information.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

In order to stimulate innovation, health claims which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data should undergo an accelerated type of authorisation.

(6)

Following an application from Aptonia, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise (Question No EFSA-Q-2013-00234) (3). The claim proposed by the applicant was worded as follows: ‘Glycaemic carbohydrates increase muscle glycogen repletion following strenuous exercise’.

(7)

On 25 October 2013, the Commission and the Member States received the scientific opinion from the Authority which concluded that on the basis of the data presented, a cause and effect relationship had been established between the consumption of glycaemic carbohydrates and the claimed effect. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and should be included in the Union list of permitted claims, established by Regulation (EU) No 432/2012.

(8)

One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that the wording and the presentation are taken into account in that respect. Therefore, where the wording of claims used by the applicant has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, they should be subject to the same conditions of use as those listed in the Annex to this Regulation.

(9)

In accordance with Article 20 of Regulation (EC) No 1924/2006, the Register of nutrition and health claims containing all authorised health claims should be updated in order to take into account this Regulation.

(10)

The comments from the applicant and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(11)

Regulation (EU) No 432/2012 should therefore be amended accordingly.

(12)

The Member States have been consulted,

7.1.2015   

EN

Official Journal of the European Union

L 3/6

(1)

Regulation (EC) No 1924/2006 provides that health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims are to be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’, for a scientific assessment, as well as to the Commission and the Member States for information.

(3)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. In some cases, the scientific risk assessment alone cannot provide all the information on which a risk management decision should be based and therefore other legitimate factors relevant to the matter under consideration should also be taken into account.

(4)

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00266) (2). The claim proposed by the applicant was worded as follows: ‘Glucose is metabolised within body's normal energy metabolism’.

(5)

On 11 May 2012, the Commission and the Member States received the scientific opinion from the Authority which concluded that on the basis of the data presented, a cause and effect relationship had been established between the consumption of glucose and contribution to energy-yielding metabolism. The target population is the general population.

(6)

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00267) (3). The claim proposed by the applicant was worded as follows: ‘Glucose supports normal physical activity’.

(7)

On 11 May 2012, the Commission and the Member States received the scientific opinion from the Authority which concluded that a claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome and referred to its opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00266).

(8)

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00268) (4). The claim proposed by the applicant was worded as follows: ‘Glucose contributes to normal energy-yielding metabolism’.

(9)

On 11 May 2012, the Commission and the Member States received the scientific opinion from the Authority which concluded that a claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome and referred to its opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00266).

(10)

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00269) (5). The claim proposed by the applicant was worded as follows: ‘Glucose contributes to normal energy-yielding metabolism during exercise’.

(11)

On 11 May 2012, the Commission and the Member States received the scientific opinion from the Authority which concluded that a claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome and referred to its opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00266).

(12)

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00270) (6). The claim proposed by the applicant was worded as follows: ‘Glucose contributes to normal muscle function’.

(13)

On 11 May 2012, the Commission and the Member States received the scientific opinion from the Authority which concluded that a claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome and referred to its opinion on a health claim related to glucose and contribution to energy-yielding metabolism (Question No EFSA-Q-2012-00266).

(14)

Pursuant to Articles 6(1) and 13(1) of Regulation (EC) No 1924/2006 health claims need to be based on generally accepted scientific evidence. Authorisation may also legitimately be withheld if health claims do not comply with other general and specific requirements of Regulation (EC) No 1924/2006, even in the case of a favourable scientific assessment by the Authority. Health claims inconsistent with generally accepted nutrition and health principles should not be made. The Authority concluded that a cause and effect relationship has been established between the consumption of glucose and contribution to energy-yielding metabolism. However, the use of such a health claim would convey a conflicting and confusing message to consumers, because it would encourage consumption of sugars for which, on the basis of generally accepted scientific advice, national and international authorities inform the consumer that their intake should be reduced. Therefore, such a health claim does not comply with point (a) of the second paragraph of Article 3 of Regulation (EC) No 1924/2006 which foresees that the use of claims should not be ambiguous or misleading. Furthermore, even if the concerned health claim was to be authorised only under specific conditions of use and/or accompanied by additional statements or warnings, it would not be sufficient to alleviate the confusion of the consumer, and consequently the claim should not be authorised.

(15)

The health claims covered by this Regulation are health claims as referred to in Article 13(1)(a) of Regulation (EC) No 1924/2006, which, provided that they comply with that Regulation, are subject to the transitional period laid down in Article 28(5) of that Regulation until the adoption of the list of permitted health claims.

(16)

The list of permitted health claims has been established by Commission Regulation (EU) No 432/2012 (7) and is applicable since 14 December 2012. As regards claims referred to in Article 13(5) of Regulation (EC) No 1924/2006 for which the evaluation by the Authority or consideration by the Commission has not been completed by 14 December 2012 and which by virtue of this Regulation are not included in the list of permitted health claims, it is appropriate to provide for a transitional period during which they may still be used, in order to allow both food business operators and the competent national authorities to adapt to the prohibition of such claims.

(17)

The comments from the applicant and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(18)

The Member States have been consulted,

7.1.2015   

EN

Official Journal of the European Union

L 3/10

(1)

Regulation (EC) No 1069/2009 lays down public and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products. It also determines an end point in the manufacturing chain for certain derived products, beyond which they are no longer subject to the requirements of that Regulation.

(2)

Commission Regulation (EU) No 142/2011 (2) lays down implementing rules for Regulation (EC) No 1069/2009, including rules on the adoption of alternative methods of use or disposal of animal by-products or derived products and the requirements for placing on the market of organic fertilisers and certain other animal by-products.

(3)

In accordance with Article 19(1)(d) of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of Category 3 materials, as referred to in Article 10(f) of that Regulation, by the other means set out in Chapter IV of Annex VI to Regulation (EU) No 142/2011. In accordance with Article 36(3) of Regulation (EU) No 142/2011, this possibility was limited to the transitional period until 31 December 2014. Certain Member States authorise the collection, transport and disposal by the other means set out in Chapter IV of Annex VI to Regulation (EU) No 142/2011 of small quantities of former foodstuffs up to 20 kg per week.

(4)

In the absence of reported negative consequences for animal health and taking into account that in certain instances the disposal in accordance with Article 14 of Regulation (EC) No 1069/2009 would be unacceptably onerous compared to local disposal, it appears justified to establish the transitional derogation as a permanent option, provided such disposal does not cause unacceptable health risks. Article 15 of Regulation (EU) No 142/2011, providing special rules for the application of Article 19(1)(a), (b), (c), (e) and (f) of Regulation (EC) No 1069/2009, should therefore be supplemented with reference to the measures provided for in Chapter IV of Annex VI to Regulation (EU) No 142/2011, which should also be amended accordingly. After consultation with Member Stats and stakeholders organisations, the option that Member States may decide to increase the volume to a maximum of 50 kg per week shall be removed when the transitional derogation becomes a permanent option. In addition, paragraph 3 of Article 36 of Regulation (EU) No 142/2011 should be deleted.

(5)

Given the low risk of possible contacts of farmed animals with organic fertilisers and soil improvers handled by certain operators and users, in particular when they operate outside the food and feed chain, the competent authorities should be allowed to exempt those operators and users from the registration obligation under Article 23 of Regulation (EC) No 1069/2009. Those operators and users should be added to the list of operators exempted from the obligation to notify the competent authorities in accordance with Article 20(4) of Regulation (EU) No 142/2011. Article 20(4) of Regulation (EU) No 142/2011 should be amended accordingly.

(6)

Growing media, including potting soil, with a small content of animal by-products or derived products packaged for use by the final consumer do not present a risk of being used as feed for farmed animals. The limitation to a content of less than 5 % in volume of derived products of Category 2 or 3 materials in the growing media, including potting soil, mitigates the risk to use it as feed for farmed animals, since the high content of soil and other materials renders such products unpalatable for farmed animals. In the production of growing media, processed manure may be used. However, the processed manure shall not be the only component of the growing media. It should present not more than 50 % in volume in the growing media. Processed manure shall not be used for the production of growing media when the place of origin is subject to prohibition due to a suspected or confirmed outbreak of a serious transmissible disease affecting farmed animals. Therefore, such products may be exempted from veterinary controls for placing on the market other than imports. Article 22(2) of Regulation (EU) No 142/2011 should be amended accordingly.

(7)

The definitions of ‘intermediate products’ and ‘trade samples’ in points 35 and 39 respectively of Annex I to Regulation (EU) No 142/2011 should be clarified in order to avoid unjustified trade barriers. The definition of ‘intermediate products’ includes also a destination of those intermediate products. It is justified to extend the current definition with possible additional uses in the cosmetic industry. Derived products which comply with the requirements of Council Directive 76/768/EEC (3) may be in accordance with Article 5(1) of Regulation (EC) No 1069/2009 declared as the end point in the manufacturing chain. Furthermore, it is necessary to clarify that pet food may be introduced into the EU as a trade sample for purposes of feeding trials, testing of machinery or of equipment. The definition of ‘intermediate products’ and ‘trade samples’ in points 35 and 39 of Annex I to Regulation (EU) No 142/2011 should be amended accordingly.

(8)

Although, in accordance with Article 3(6) of Regulation (EC) No 1069/2009, equidae are considered to be farmed animals, certain individual equine animals enjoy a particular close relationship to their keepers. It is therefore justified to provide the possibility of cremating dead equidae in incinerators approved for that purpose by the competent authority, provided the equidae originate from holdings which are not subject to prohibition orders for notifiable diseases. Council Directive 2009/156/EC (4) provides for animal health conditions governing amongst others the movement of equidae, including conditions for the identification of equidae. Only dead equidae which comply with that Directive may be individually cremated in low-capacity incinerators. Chapter III of Annex III to Regulation (EU) No 142/2011 should be amended accordingly.

(9)

Article 13(g) of Regulation (EC) No 1069/2009 provides that animal by-products originating from aquatic animals of Category 2 material may be ensiled, composted or transformed into biogas. The European Food Safety Authority (‘EFSA’) published a Scientific Opinion on the evaluation of a new processing method for animal by-products of Category 2 materials of fish origin (5). According to EFSA's opinion, risks arising from Category 2 materials of fish origin are adequately reduced by the processing method, and derived products may therefore be used for the production of organic fertilisers, composted, transformed into biogas or used for the manufacture of feed for fur animals or other animals not intended for human consumption. EFSA's opinion concludes that there is no increase in risk, if the processing method is also applied for the processing of by-products originating from aquatic animals of Category 3 materials. Category 3 material obtained from aquatic animals may therefore be destined for purposes listed in Article 14 of Regulation (EC) No 1069/2009.

(10)

Following the successful outcome of EFSA's risk assessment, the ensilage of fish material should be added to the list of alternative processing methods in Chapter IV of Annex IV to Regulation (EU) No 142/2011. Annex IV to Regulation (EU) No 142/2011 should be amended accordingly.

(11)

Digestion residues and compost of animal origin may in practice be mixed with materials of non-animal origin. Operators should know which rules apply for the disposal of such digestion residues and compost. In addition, it is necessary to clarify in which cases compost and digestion residues derived from catering waste may be disposed of in an authorised landfill. Chapter III of Annex V to Regulation (EU) No 142/2011 should be amended accordingly.

(12)

Croatia notified a list of species of wild necrophagous birds which should be subject to the derogation on special feeding purposes laid down in Article 18 of Regulation (EC) No 1069/2009. The list of species of necrophagous birds in Annex VI to Regulation (EU) No 142/2011 should be amended accordingly.

(13)

EFSA assessed the risk posed by composting containment and subsequent incineration of dead-on-farm porcine animals (6) and concluded that the composting containment as referred to in the alternative parameters laid down in Section 2 of Chapter III of Annex V to Regulation (EU) No 142/2011 is not a sufficient treatment for the safe disposal of Category 2 material and can therefore not be described as an alternative processing method in Chapter IV of Annex IV to that Regulation. Following the aforementioned EFSA's assessment the ‘aerobic maturation and storage of dead-on-farm pigs with subsequent incineration or co-incineration’ should be seen as a specific containment method for the storage of animal by-products pending their subsequent disposal in accordance with Regulation (EC) No 1069/2009. In order to differentiate that method from the approved methods of composting and to avoid the approval procedure required for composting plants laid down in Annex V to Regulation (EU) No 142/2011, it is appropriate to include that method in a new Chapter in Annex IX to that Regulation together with the method ‘Hydrolysis with subsequent disposal’, currently referred to in point H of Section II of Chapter IV of Annex IV, which is based on the same principles. Furthermore the reference to Annex IV in Section 11 of Chapter II of Annex XVI should be adapted accordingly. Annexes IV, IX and XVI to Regulation (EU) No 142/2011 should therefore be amended accordingly.

(14)

Rendered fats from Category 3 material are subject to specific requirements under Section 3 of Chapter II of Annex X to Regulation (EU) No 142/2011. However, there are no animal health grounds to prohibit the processing of Category 3 material from aquatic animals and animal by-products from aquatic animals as referred to in Article 10(i) and (j) of Regulation (EC) No 1069/2009 together with Category 3 animal by-products obtained from terrestrial animals into mixed rendered fats. Therefore it should be possible to use Category 3 materials from aquatic animals and animal by-products from aquatic animals as referred to in Article 10(i) and (j) of Regulation (EC) No 1069/2009 for the production of rendered fat. Point A(1) of Section 3 of Chapter II of Annex X to Regulation (EU) No 142/2011 should be amended accordingly.

(15)

Requirements for the heat treatment of centrifuge or separator sludge which may be later used as or in the production of organic fertilisers and placed on the market are set out in Part III of Section 4 of Chapter II in Annex X to Regulation (EU) No 142/2011. It is opportune to introduce a derogation that the competent authority may authorise alternative parameters for the heat treatment of centrifuge or separator sludge destined for uses within the Member States, provided that the operators can demonstrate that the heat treatment carried out according to the alternative parameters guarantees at least the same risk reduction as the treatment carried out according to the already established parameters applicable for placing on the market. Part III of Section 4 of Chapter II of Annex X to Regulation (EU) No 142/2011 should be amended accordingly.

(16)

Intermediate products may be used, inter alia, for the production of laboratory reagents or in vitro diagnostic for animal purposes. After checks at the border inspection post in accordance with Article 4 of Council Directive 97/78/EC (7) the product has to be transported directly to the registered establishment or plant of destination. In order to clarify the requirements for the importation of intermediate products, Annex XII to Regulation (EU) No 142/2011 should be amended accordingly.

(17)

Blood products intended for the production of feed for farmed animals, including spray dried blood and blood plasma of porcine animals, must have been produced in accordance with Section 2 of Chapter II of Annex X to Commission Regulation (EU) No 142/2011. With reference to point B of that Section, blood products are to be submitted to any of the processing methods 1 to 5 or processing method 7 as set out in Chapter III of Annex IV to that Regulation, or another method which ensures that the blood products comply with the microbiological standards for derived products set out in Chapter I of Annex X to Commission Regulation (EU) No 142/2011. Regulation (EU) No 142/2011 also provides, in particular in column 6 of row 2 in Table 1 of Section 1 of Chapter I of Annex XIV, that blood products not intended for human consumption that could be used as feed are to be accompanied by a health certificate in accordance with the model health certificate set out in Chapter 4(B) of Annex XV when they are intended for dispatch to or transit through the Union.

(18)

Porcine epidemic diarrhoea, including infection of pigs with the porcine epidemic diarrhoea virus (PEDv) and swine delta coronavirus (SDCv), has been reported in Asia, North America, the Caribbean, Central and South America. SDCv has never been detected in the Union. Inappropriate heat treatment or contamination after heat treatment of spray dried blood and blood plasma of porcine animals, a traditional ingredient for feed for piglets, is incriminated in the spread of the virus.

(19)

The Commission, acting on its own initiative, adopted Commission Implementing Regulation (EU) No 483/2014 (8) as an interim safeguard measure in respect of the safety of spray dried blood and blood plasma of porcine animals intended for the production of feed for animals of the porcine species. Since the risk for animal health will remain, it is necessary to review the requirements for imports of spray dried blood and blood plasma of porcine animals intended for the production of feed for animals of the porcine species and implement the interim measures as a permanent requirement.

(20)

Scientific observation indicates that porcine coronaviruses are inactivated in swine faeces if heated to and held at a temperature of 71 °C for 10 minutes or left at room temperature of 20 °C for 7 days. The virus did not survive in experimentally infected dry feed stored at room temperature of 24 °C for at least two weeks. In the Union and in third countries the commonly applied temperature for spray drying of blood and blood plasma is 80 °C throughout the substance.

(21)

Based on the available information, it appears opportune to require that spray dried blood and blood plasma of porcine origin introduced from third countries and intended for feeding of porcine animals has been subjected to a high temperature treatment followed by subsequent storage for a certain time at room temperature in order to mitigate the risk of contamination after the treatment.

(22)

Imports of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for uses other than as feed material, organic fertilisers or soil improvers should also be authorised where those materials are transported by plane, provided they comply with requirements laid down in Article 41 of Regulation (EC) No 1069/2009. Annex XIV to Regulation (EU) No 142/2011 should be amended accordingly.

(23)

Following the amendments of the definition of ‘intermediate products’ and the additional requirements for imports of blood products, the model of declaration to be used for imports from third countries of intermediate products and the model of health certificate for imports of blood products intended as feed material should be modified accordingly. Chapter 4(B) and Chapter 20 of Annex XV to Regulation (EU) No 142/2011 should be amended accordingly.

(24)

In order to avoid disruptions of trade, a transitional period should be laid down during which imports of the intermediate products to which the provisions of Regulation (EU) No 142/2011 apply, as amended by this Regulation, should be accepted by Member States in accordance with the rules in force prior to the entry into force of this Regulation.

(25)

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

(1)

In Article 15, the following paragraph is added:

‘By way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of small quantities of Category 3 materials as referred to in Article 10(f) of that Regulation by means referred to in Article 19(1)(d) of that Regulation, subject to compliance with the requirements for disposal by other means set out in Chapter IV of Annex VI hereto.’

(2)

In Article 19, point (c) is replaced by the following:

(3)

Article 20(4) is amended as follows:

(4)

In Article 22, paragraph 2 is replaced by the following:

‘2.   The placing on the market of the following is not subject to any animal health conditions:

(5)

In Article 23, paragraph 3 is replaced by the following:

‘3.   The operator or owner of the establishment or plant of destination of intermediate products or his representative shall use and/or dispatch the intermediate products exclusively for use in manufacturing according to the definition of intermediate products under Point 35 of Annex I.’

(6)

In Article 36, paragraph 3 is deleted.

(7)

Annexes I, III, IV, V, VI, IX, X, XI, XII, XIV, XV and XVI are amended in accordance with the Annex to this Regulation.

7.1.2015   

EN

Official Journal of the European Union

L 3/34

(1)

Article 41(2) of Directive 2012/34/EU provides for the possibility for infrastructure managers to set requirements with regard to applicants to ensure that their legitimate expectations about future revenues and utilisation of the infrastructure are safeguarded.

(2)

Those requirements should be appropriate, transparent and non-discriminatory. They can only include the provision of a financial guarantee that should not exceed an appropriate level proportional to the contemplated level of activity, and assurance of the capability of the applicant to prepare compliant bids for infrastructure capacity.

(3)

Financial guarantees could take the form of advance payments or guarantees provided by financial institutions

(4)

The appropriateness of the requirements referred to in Article 41(2) of Directive 2012/34/EU should take account of the fact that the infrastructure of competing transport modes, such as road and air transport, sea ships and inland waterways, is often free of user charges and hence also free of financial guarantees thereon. In order to ensure fair competition between transport modes, financial guarantees should be limited to the strict minimum in terms of level and duration.

(5)

Those financial guarantees are only appropriate if they are necessary for the purpose of reassuring the infrastructure manager about the future revenues and utilisation of the infrastructure. Considering that infrastructure managers are able to rely on the checks and surveillance of the financial fitness of railway undertakings under the licensing procedure in accordance with Chapter III of Directive 2012/34/EU, and in particular Article 20 of that Directive, the need for financial guarantees is further reduced.

(6)

The principle of non-discrimination applies to those guarantees, therefore there should be no distinction between the guarantee requirements for privately and publicly owned applicants.

(7)

Guarantees should be commensurate with the level of risk posed by the applicant for the infrastructure manager at different stages of capacity allocation. The risk is considered generally to be low as long as the capacity can be re-allocated to other railway undertakings.

(8)

A guarantee which is requested in relation to the preparation of compliant bids can only be considered as appropriate, transparent and non-discriminatory if the infrastructure manager sets out clear and transparent rules for preparing a capacity request in the network statement, and offers the necessary support tools to applicants. Since it is not possible to objectively determine the capability of preparing compliant bids before the application procedure, any lack of capability can only be determined after that procedure, on the basis of a repeated failure to put forward those bids or provide the necessary information to the infrastructure manager. The applicant should be responsible for that failure which carries a sanction involving the exclusion of the applicant from the application for a specific train path.

(9)

Commission Implementing Regulation (EU) No 870/2014 (2) was mistakenly adopted in a version other than that which had received the positive opinion of the Committee. Implementing Regulation (EU) No 870/2014 should accordingly be repealed.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 62(1) of Directive 2012/34/EU,

‘financial guarantee’ means (a) advance payments to reduce and anticipate future obligations to pay infrastructure charges or (b) contractual arrangements by which a financial institution such as bank commits to ensure that such payments are effected once they are due.

(a)

from the designated railway undertaking if a financial guarantee has already been granted or paid by the applicant, which is not a railway undertaking, to cover future payments for the same contemplated activities;

(b)

if the infrastructure charge is to be paid directly to the infrastructure manager by a competent authority pursuant to Regulation (EC) No 1370/2007 of the European Parliament and of the Council (3).

(a)

the applicant has failed to answer two subsequent requests requiring the provision of the missing information or has repeatedly responded in a way that does not satisfy the conditions set out in the network statement referred to in Article 27 of Directive 2012/34/EU and in Annex IV to that Directive regarding the application procedures for train paths and

(b)

the infrastructure manager is able to demonstrate at the request of and to the satisfaction of the regulatory body that it has taken all reasonable steps to support the correct and timely submission of applications.

7.1.2015   

EN

Official Journal of the European Union

L 3/37

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 (2).

(2)

Pursuant to the first subparagraph of Article 6(2), the Slovenian application to register the name ‘Kranjska klobasa’ was published in the Official Journal of the European Union  (3).

(3)

Germany on 3 July 2012, Croatia on 16 August 2012 and Austria on 17 August 2012, submitted oppositions to the registration under Article 7(1) of Regulation (EC) No 510/2006. (4) The oppositions were deemed admissible.

(4)

By letters dated 24 October 2012, the Commission invited the interested parties to engage in appropriate consultations to seek agreement among themselves within six months in accordance with their internal procedures.

(5)

Slovenia and Germany on one side, and Slovenia and Austria on the other side, reached an agreement. In contrast no agreement was reached between Slovenia and Croatia.

(6)

Given that no agreement was reached between Slovenia and Croatia, the Commission should adopt a decision in accordance with the procedure referred to in Article 52(3)(b) of Regulation (EU) No 1151/2012.

(7)

Concerning the alleged failure of compliance with Article 2(1)(b) of Regulation (EC) No 510/2006, replaced by Article 5(2) of Regulation (EU) No 1151/2012, in respect of the delimitation of the geographical area, i.e. that the product does not originate in a specific place, region or country or that the consumer is misled, no obvious error was identified. With regard to the alleged failure concerning use of the name of a country which was allowed in exceptional cases, ‘Kranjska’ is not the name of a country but of a (former) region. Moreover, Regulation (EU) No 1151/2012 does not foresee for protected geographical indications the use of the name of a country in exceptional cases only. Concerning the allegation that the geographical area has no natural characteristics distinguishing it from neighbouring areas, there is no need to assess the substance of this allegation as this is not required by Regulation (EU) No 1151/2012.

(8)

The terms‘Krainer’, ‘Käsekrainer’, ‘Schweinskrainer’, ‘Osterkrainer’ and ‘Bauernkrainer’ on the one hand, and the terms ‘Kranjska’ and ‘Kranjska kobasica’ on the other hand were found to be the names of similar sausages in German and Croatian language respectively and have common historic origins referring to the former Land of ‘Kranjska’ which no longer exists administratively today. As the names have common origins and given the visual similarities between the products, the application of the protection envisaged by Article 13 of Regulation (EU) No 1151/2012, and in particular point (b) of paragraph (1) thereof, could have the result that ‘Kranjska klobasa’, if registered, would prevent producers not complying with the product specification of ‘Kranjska klobasa’ from using the terms ‘Krainer’, ‘Käsekrainer’, ‘Schweinskrainer’, ‘Osterkrainer’, ‘Bauernkrainer’, ‘Kranjska’ and ‘Kranjska kobasica’.

(9)

The evidence shows that the use of the terms ‘Krainer’, ‘Käsekrainer’, ‘Schweinskrainer’, ‘Osterkrainer’, ‘Bauernkrainer’, ‘Kranjska’ and ‘Kranjska kobasica’ referred to products having a common origin with ‘Kranjska klobasa’, was not meant to exploit the reputation of the latter name and that the consumer has not been or couldn't have been misled as to the true origin of the products. In addition, it was shown that these designations have been in legal use consistently and fairly for at least 25 years before the application for registration of the name ‘Kranjska klobasa’ was submitted to the Commission.

(10)

However, it is to be noted that in German language, in two centuries time, the name ‘Krainer’, and its compound names have definitively lost the geographical link to the Carniola Region. This is confirmed by the fact that both in the agreements reached with Germany and Austria respectively Slovenia acknowledged that the use of the terms ‘Krainer’, ‘Käsekrainer’, ‘Schweinskrainer’, ‘Osterkrainer’ and ‘Bauernkrainer’ should not be understood as an abuse of the name ‘Kranjska klobasa’.

(11)

For all the reasons above, in the interests of fairness and traditional usage, irrespectively of whether ‘Krainer’, ‘Käsekrainer’, ‘Schweinskrainer’, ‘Osterkrainer’, ‘Bauernkrainer’, ‘Kranjska’ and ‘Kranjska kobasica’ can be considered as generic under Article 41 of Regulation (EU) No 1151/2012 and provided that principles and rules applicable in the Union's legal order are respected, the free use of the terms ‘Krainer’, ‘Käsekrainer’, ‘Schweinskrainer’, ‘Osterkrainer’ and ‘Bauernkrainer’ should be maintained without time restrictions, and the use of the terms ‘Kranjska’ and ‘Kranjska kobasica’ should be allowed for the maximum transitional period foreseen by Article 15(2) of Regulation (EU) No 1151/2012.

(12)

Article 6(1) of Regulation (EU) No 1151/2012 prohibits the registration of names that have become generic. The oppositions claimed that consumers in Austria, Croatia and Germany do not associate the names used on their market terms such as ‘Krainer’, ‘Krainer Wurst’, ‘Kranjska’ and ‘Kranjska kobasica’ with a particular origin. While the name proposed for registration is ‘Kranjska klobasa’, the evidence provided in the statements of opposition referred to the alleged general use of the term ‘Krainer’, ‘Krainer Wurst’, ‘Kranjska’ and ‘Kranjska kobasica’ in Austria, Croatia and Germany, and not to that of ‘Kranjska klobasa’. The oppositions do not take into consideration the situation in Slovenia. No evidence has been provided in the statements of oppositions to show general usage comprising or including the name proposed for registration. Therefore, on the basis of information provided, the name ‘Kranjska klobasa’ cannot be considered to be generic and there is accordingly no failure of compliance with Article 6(1) of Regulation (EU) No 1151/2012.

(13)

Whereas protection is granted for the term ‘Kranjska klobasa’ as a whole, the non-geographical component of that term may be used, and used in translation, throughout the Union, provided the principles and rules applicable in the Union's legal order are respected.

(14)

In the light of the above, the name ‘Kranjska klobasa’ should be entered in the Register of protected designations of origin and protected geographical indications.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

7.1.2015   

EN

Official Journal of the European Union

L 3/40

(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,

7.1.2015   

EN

Official Journal of the European Union

L 3/42

(1)

Directive 2014/32/EU sets out the requirements that certain measuring instruments have to satisfy with a view to their being placed on the market and/or put to use for specific measuring tasks prescribed by the Member States.

(2)

The first of the specific requirements for water meters (Requirement 1) included in Annex III to Directive 2014/32/EU refers to the rated operating condition for the flowrate range Q3/Q1 ≥ 10.

(3)

On 31 October 2011 an update of the standard EN 14154 which included the flowrate range Q3/Q1 ≥ 40 entered into force. The revised EN 14154 standard reflects the international standard. It is more exigent in relation to the flowrate range than the specific requirements set out in Annex III to Directive 2014/32/EU and results in more precise measurements.

(4)

Prior to the introduction of the flowrate range Q3/Q1 ≥ 10 by means of Directive 2004/22/EC of the European Parliament and of the Council (2) on measuring instruments, the international OIML standard which already contained a requirement for the flowrate range of Q3/Q1 ≥ 40 was applied in all Member States. As a result of the transitional provisions provided for in Article 50(2) of Directive 2014/32/EU, most of the water meters currently placed on the market are already in conformity with the requirement of Q3/Q1 ≥ 40.

(5)

Water meters with the flowrate range Q3/Q1 ≥ 10 may be significantly cheaper than those meeting the requirements of the standard EN 14154 (Q3/Q1 ≥ 40). Directive 2014/32/EU, in point 10 of Annex III thereto, gives discretion to the utility or the person legally designated for installing the water meter to determine, inter alia, what level of flowrate range is appropriate for the accurate measurement of consumption that is foreseen or foreseeable (3). Therefore, water meters not conforming to the standard EN 14154 for flowrate range but in line with the requirements set out in Annex III to Directive 2014/32/EU may be installed. This may, however, increase the possibility of customers having errors in bills resulting from the less precise measurement of the meter.

(6)

The flowrate range of Q3/Q1 ≥ 40 represents the state of the art embodied in the current international standard and manufacturing practice, as well as the minimum quality available at present on the Union market. It provides for more precise measurements thereby ensuring a higher level of protection of consumers. Given that the flowrate range of Q3/Q1 ≥ 40 has for many years been and still is the minimum being installed by the market, compliance does not involve additional costs for users.

(7)

Directive 2014/32/EU should be amended accordingly,

7.1.2015   

EN

Official Journal of the European Union

L 3/44

(1)

With Decision C(2010) 2576 (2), the Commission gave the European Railway Agency (the Agency) a mandate to develop and review the technical specifications for interoperability (TSI) with a view to extending their scope to the entire rail system in the Union in accordance with Article 1(4) of Directive 2008/57/EC. On 10 January 2013 the Agency submitted its recommendation amending the TSI relating to the control-command and signalling subsystems of the trans-European rail system.

(2)

According to Article 8(4) of Directive 2008/57/EC on TSI scope extension, a Member State should not apply the revised TSI in the case of projects at an advanced stage of development or subject to a contract in the course of performance, which was out of the scope of the previous TSI.

(3)

The revised control-command and signalling TSI (CCS TSI) should apply to networks with 1 435 mm, 1 520 mm, 1 524 mm, 1 600 mm, and 1 668 mm nominal track gauge. This would provide interoperability within one-track-gauge systems and make it possible to develop and operate vehicles for multiple metric gauges. It would also make it possible to develop and use control-command and signalling subsystems and interoperability constituents independently of the track gauge. A high percentage of vehicles run both on the trans-European rail network and on the off-TEN rail network. The parameters of the on-board and the track-side control-command and signalling subsystems should therefore be the same for the whole network.

(4)

Certain open points related to the compatibility of train detection systems may be closed, taking into account requirements for different track gauges (specification referenced as Index 77 in Annex A). The open point related to safety requirements for ETCS Driver-Machine Interface (DMI) function may be closed and progress have been made to clarify the open point on ‘reliability/availability’.

(5)

The provisions on assessment of interoperability constituents and subsystems, in the case where requirements are partially fulfilled, need to be clarified.

(6)

In its role of system authority for the European Rail Traffic Management System (ERTMS), the Agency has prepared an update of the mandatory ERTMS specifications referenced in Annex A to the CCS TSI. Until the time the specifications related to train interface (FFFIS — Form Fit Functional Interface Specification) have reached, at both sides of the interface, a level of consensus among all stakeholders to be considered as mandatory, the Agency should refer to them in the application guide so that they can be used in call for tenders.

(7)

The Agency should publish tests specifications related to baseline 3 as soon as possible.

(8)

Errors have been detected in the text of Commission Decision 2012/88/EU (3) and need to be corrected.

(9)

The availability and quality of the GSM-R signals is essential for railway operations.

(10)

GSM-R roaming to public networks is an optional function. If it is used in a Member State, its implementation should be indicated in line number 1.1.1.3.3.3 of the register of railway infrastructure in accordance with Commission Implementing Decision 2014/880/EU (4).

(11)

The measures provided for in this Decision are in conformity with the opinion of the Committee established in accordance with Article 29(1) of Directive 2008/57/EC,

(1)

the title is replaced by the following: ‘Commission Decision 2012/88/EU of 25 January 2012 on the technical specification for interoperability relating to the control-command and signalling subsystems’;

(2)

Annex III is amended as follows:

7.1.2015   

EN

Official Journal of the European Union

L 3/59

(1)

In June 2014, the Finnish authorities notified to the Commission a measure of prohibition of placing on the market of head protectors manufactured by Ribcap AG, Berbegraben 4, CH-3110 Münsingen (Switzerland). The products, called ‘Ribcap’, bore CE marking, according to Directive 89/686/EEC on personal protective equipment.

(2)

The products are marketed as head protectors PPE category I for, among other activities, ice-skating and skiing.

(3)

Under Article 8(3) of Directive 89/686/EEC, EC type-examination shall not be required in the case of PPE models of simple design (Category I) where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time.

(4)

The product is imported and distributed by Brandsense Oy/Classic Bike Finland, Mechelininkatu 15, FI-00100 Helsinki (Finland). According to its website, the company imports and markets bicycles.

(5)

The web page of the importer contains links to the Ribcap brochure made by the manufacturer and to a Ribcap certificate based on tests on the product carried out by the University of Strasbourg, which would prove that Ribcap prevents head injuries; the words ‘Certified Safety’ are present in the packaging and marketing material. The words ‘Certified Safety’ can give the impression that the product has been EC type-examined by a notified body, while the University of Strasbourg is not a notified body.

(6)

According to the claims made in the promotional brochure, Ribcap acts to protect the head during an impact. From the brochure, the consumer may get the impression that the products are suitable for use in various types of sports and as head protection — see, for instance, ‘Ribcap is my comfortable, light and effective head protection for sports.’ Even if the words ‘No protective effect like helmet’ appear on the packaging of the product, the claims give a misleading image of the product's safety characteristics and can give the consumer the impression that the products protect against non-minimal risks.

(7)

According to the categorisation guide included in the guidelines on the application of Directive 89/686/EEC, all helmets, including sports helmets are PPE Category II and therefore subject to an EC type examination by a notified body.

(8)

The products are not accompanied by user instructions in Finnish and Swedish, which are the official languages of Finland.

(9)

In the opinion of the Finnish authorities, as the products are not accompanied by user instructions describing in which situations they are intended to be used or which are the limits of use, the products can give a false feeling of security and mislead the consumer to believe that such products would have the same protective qualities as a helmet (PPE cat. II).

(10)

The declaration of conformity drawn up by the manufacturer was sent by the distributor to Finnish authorities; such declaration is not drawn in accordance with the model given in Annex VI to Directive 89/686/EEC.

(11)

The Commission wrote to the manufacturer and the distributor in Finland inviting them to communicate their observations on the measure taken by the Finnish authorities. In his reply, the manufacturer reaffirmed his view that Ribcap is not a helmet but rather a woollen hat with protectors, which should be categorised as PPE Category I under Directive 89/686/EEC. The manufacturer conceded that the use of the words ‘certified safety’ is perhaps confusing and unfortunate.

(12)

The manufacturer attached to his reply a report issued by the Swiss Authorities. In the report a letter from the Swiss Authorities to Ribcap is mentioned, where they require, among other things, that ‘the product could no longer be advertised in such a way as to give the impression of protecting the head from injury in the event of a fall experienced while moving using equipment (skis, snowboard, bicycle, etc.)’. The updated product description, together with an extensive warning, allowed Ribcap to market its products as ‘hats with sewn-in protectors’, PPE Category I.

(13)

Neither the product description nor the warning for the marketing of the products in Finland appear to comply with the requirements needed to market the products as PPE Category I, as in the former the products are marketed as head protectors for ice-skating, skiing and other outdoor activities.

(14)

In light of the documentation available and the comments expressed by the parties concerned, the Commission considers that the head protectors ‘Ribcap’ failed to comply with the basic health and safety requirements 1.1.2 Level and classes of protection, 1.4 Information supplied by the manufacturers and 3.1.1 Impact caused by falling or projecting objects and collision of parts of the body with an obstacle,

7.1.2015   

EN

Official Journal of the European Union

L 3/61

(1)

Where a national standard transposing a harmonised standard, the reference of which has been published in the Official Journal of the European Union, covers one or more essential health and safety requirements set out in Annex I to Directive 2006/42/EC, the machine built in accordance with this standard is presumed to meet the essential health and safety requirements concerned.

(2)

In May 2013, France lodged a formal objection in accordance with Article 10 of Directive 2006/42/EC in respect of standard EN 1870-17:2012 ‘Safety of woodworking machines — Circular sawing machines — Part 17: Manual horizontal cutting cross-cut sawing machines with one saw unit (radial arm saws)’, proposed by the European Committee for Standardization (CEN) to be harmonized under Directive 2006/42/EC.

(3)

The formal objection is based on the failure of the provisions provided for in paragraph 3 of clause 5.3.6.1 Guarding of the saw blade of the standard which states that the guard may be fixed or movable without indicating when each of them would be necessary, whereas these two categories of devices are different in nature, and offer different levels of safety which correspond to different risk analyses.

(4)

Having examined the standard EN 1870-17:2012 together with the representatives of the committee established by Article 22 of Directive 2006/42/EC, the Commission concluded that the standard fails to meet the essential health and safety requirements provided for in point 1.4.2 ‘Special requirements for guards’ of Annex I to Directive 2006/42/EC, since it allows the designer to choose to install guards offering different levels of safety without referring to a risk analysis.

(5)

The inclusion in a harmonised standard of options, one of which fails to comply with the relevant essential health and safety requirements of Directive 2006/42/EC, is liable to create confusion as to the presumption of conformity conferred by the application of the standard.

(6)

Taking into consideration the need to improve the safety aspects of standard EN 1870-17:2012 and pending a suitable revision of that standard, the publication in the Official Journal of the European Union of the reference of the standard EN 1870-17:2012 should be accompanied by an appropriate warning,