### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from cereal and other starch rich crops , sugars and oil crops shall be no more than 5% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 . ### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from feedstocks listed in parts a and b of annex ix shall be at least 2 , 5% of the final consumption of energy in transport in 2020 . however , as of 1 january 2021 the share of energy from biofuels produced from feedstocks listed in parts a and b of annex ix shall be at least 5% of the final consumption of energy in transport .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by setting a separate target of at least 2 , 5% for advanced biofuels within the 10% target of consumption of energy from renewable sources for transport as established in directive 2009 / 28 / ec . in this context , biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . in such framework the target of 2 , 5% for advanced biofuels should be increased until 5% as of 1 january 2021 . however , to avoid market distortions and frauds related to the production of advanced biofuels also the latter should comply with the relevant sustainability criteria as for conventional biofuels .


### the 5% limit set up in article 3d does not affect the member states ' freedom to arrange their own trajectory as to compliance with this prescribed share of conventional biofuels within the overall 10% target . as a consequence , the access to the market of the biofuels produced by the installations in operation before the end of 2013 remains fully open . therefore this amending directive does not affect the legitimate expectations of the operators of such installations . ### the 7 , 5% limit set up in article 3d allows member states to comply with the overall 10% target without undermining the full access to the market of the biofuels produced by the installations in operation before the end of 2013 . therefore this amending directive does not affect the legitimate expectations of the operators of such installations .


### the potential advantages for officials and other servants of the european union of the application of the method should be balanced by the continuation of the system of special levy , to be renamed as ' solidarity levy ' . while the rate of the special levy in force during the period from 2004 to 2012 increased gradually over time and averaged at 4 . 23 % , it seems appropriate in the present circumstances to increase the solidarity levy at the uniform rate of 6% , so as to take account of a difficult economic context and its ramifications for public finances throughout the european union . such a solidarity levy should apply to all officials and other servants of the european union for the same period as the ' method ' itself . ### the potential advantages for officials and other servants of the european union of the application of the method should be balanced by the continuation of the system of special levy , to be renamed as ‘ solidarity levy’ . while the rate of the special levy in force during the period from 2004 to 2012 increased gradually over time and averaged at 4 . 23 % , it seems appropriate in the present circumstances to increase the solidarity levy at the uniform rate of 6% , so as to help to finance the union’s growth and employment policies from the union ' s budget and to take account of a difficult economic context and its ramifications for public finances throughout the european union , such a solidarity levy should apply to all officials and other servants of the european union for the same period as the ‘ method’ itself .


### working hours applied in the institutions should be aligned to those in force in certain of the member states of the european union to compensate for the reduction of staff in the institutions . the introduction of a minimum number of weekly working hours will ensure that the staff employed by the institutions is able to carry out the work - load resulting from the european union ' s policy objectives while , at the same time , harmonising working conditions in the institutions , in the interest of solidarity throughout the european union ' s civil service . ### working hours applied in the institutions should be aligned to those in force in certain of the member states of the european union . the introduction of a minimum number of weekly working hours will ensure that the staff employed by the institutions is able to carry out the work - load resulting from the european union ' s policy objectives while , at the same time , harmonising working conditions in the institutions , in the interest of solidarity throughout the european union ' s civil service .


### the name , address and signature of the owner ; ### the name , address and signature of the owner and of up to two previous owners if applicable ;


### from a third country or territory listed in the implementing acts adopted pursuant to article 13 after transit through third countries or territories other than those listed in the implementing acts adopted pursuant to article 13 , provided that the owner or a natural person acting on behalf of and in agreement with the owner provides proof that during such transit , the pet animals have had no contact with species susceptible to rabies and remain secured within a means of transport or within the perimeter of an international airport . ### after transit through other third countries or territories , provided that the owner or authorised person provides proof by means of a written declaration that during such transit the pet animals have had no contact with animals of species susceptible to rabies and remain secured within a means of transport or within the perimeter of an international airport .


### the veterinarian issuing the identification document shall record the information referred to in paragraph 1 and and keep records of that information for at least 10 years from the date of issue of the identification document . ### the veterinarian issuing the identification document shall ensure that the information referred to in paragraph 1 and is registered on an authorised database , which is accessible across member states from a central point of access .


### identification documents accompanying pet animals of the species listed in part a of annex i which are moved for non - commercial purposes into member states are necessary to attest compliance with the conditions of this regulation . the regulation should therefore establish the conditions for issuing the identification documents and the requirements for their content , validity and format . ### identification documents accompanying pet animals of the species listed in part a of annex i which are moved for non - commercial purposes into member states are necessary to attest compliance with the conditions of this regulation . the regulation should therefore establish the conditions for issuing the identification documents and the requirements for their content , validity , safety features and format .


### the speed of road vehicles has a strong influence on their fuel consumption and co2 emissions . in addition , in the absence of speed limitation for light commercial vehicles , it is possible that there is an element of competition as regards top speed which could lead to oversized powertrains and associated inefficiencies in slower operating conditions . it is therefore appropriate to investigate the feasibility of extending the scope of council directive 92 / 6 / eec on the installation and use of speed limitation devices for certain categories of motor vehicles in the community , with the aim of including light commercial vehicles covered in this regulation . ### the speed of road vehicles has a strong influence on their fuel consumption and co2 emissions . in addition , in the absence of speed limitation for light commercial vehicles , it is possible that there is an element of competition as regards top speed which could lead to oversized powertrains and associated inefficiencies in slower operating conditions . it is therefore appropriate to extend the scope of council directive 92 / 6 / eec on the installation and use of speed limitation devices for certain categories of motor vehicles in the community , with the aim of including light commercial vehicles covered in this regulation .


### ' specific emissions of co2 ' means the emissions of a light commercial vehicle measured in accordance with regulation no 715 / 2007 and specified as the co2 mass emission in the certificate of conformity ; ### ' specific emissions of co2 ' means the emissions of a light commercial vehicle measured in accordance with regulation no 715 / 2007 and specified as the co2 mass emission in the certificate of conformity of the complete or completed vehicle ;


### support cooperation among competent public bodies in europe , in particular supporting their efforts to develop and exchange good practices and standards ; ### support cooperation among competent regulatory authorities in europe , in particular supporting their efforts to develop and exchange good practices and standards , as well as promote and ensure their full independence ;


### to ensure full achievement of its objectives , the agency should liaise with law enforcement bodies and privacy protection authorities to highlight and properly address the network and information security aspects of fighting cybercrime . representatives of these authorities should become fully fledged stakeholders of the agency and should be represented in the agency’s permanent stakeholders group . ### to ensure full achievement of its objectives , the agency should liaise with law enforcement bodies and privacy and personal data protection authorities to highlight and properly address the network and information security aspects of fighting cybercrime . representatives of these authorities should become fully fledged stakeholders of the agency and should be represented in the agency’s permanent stakeholders group .


### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission may , in accordance with the examination procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . ### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission shall , in accordance with the procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year .


### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission may , in accordance with the examination procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . ### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission shall , in accordance with the examination procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . only reasons of force majeure shall prevent the suspension from being imposed .


### acts as covered by the farmers privilege pursuant to article 14 of regulation no . 2100 / 94 which applies mutatis mutandis ; ### the use by a farmer of the product of his crop for propagation or multiplication on his own holding , provided that the reproductive vegetable material was sold or otherwise commercialised by the patent proprietor or with his consent to the farmer for agricultural purposes . the scope and the detailed methods of such use are laid down in article 14 of regulation no 2100 / 94 ;


### european patents granted with an identical scope of protection in respect of all participating member states shall benefit from unitary effect in the participating member states provided that their unitary effect has been registered in the register for unitary patent protection referred to in article 12 . ### european patents granted with the same set of claims in respect of all the participating member states shall benefit from unitary effect in the participating member states provided that their unitary effect has been registered in the register for unitary patent protection referred to in article 2 .


### without prejudice to article 5 , a european patent with unitary effect may only be limited , licensed , transferred , revoked or lapse in respect of all the participating member states . ### a european patent with unitary effect may only be limited , transferred , revoked or lapse in respect of all the participating member states . a european patent with unitary effect may be licensed in respect of the whole or part of the territories of the participating member states .


### the creation of unitary patent protection should be achieved by giving unitary effect to european patents in the post - grant phase by virtue of this regulation and in respect of the participating member states . the main feature of european patents with unitary effect should be their unitary character , i . e . providing uniform protection and having equal effect in all participating member states . consequently , a european patent with unitary effect should only be limited , licensed , transferred , revoked or lapse in respect of all the participating member states . to ensure the uniform substantive scope of protection conferred by unitary patent protection , only european patents that have been granted for all the participating member states with the same set of claims should benefit from unitary effect . however , to ensure legal certainty in the event of a limitation or revocation on the ground of lack of novelty pursuant to article 54 epc , the limitation or revocation of a european patent with unitary effect should take effect only in respect of the participating member state designated in the earlier european patent application as published . finally , the unitary effect attributed to a european patent should have an accessory nature and should cease to exist or be limited to the extent that the basic european patent has been revoked or limited . ### the creation of unitary patent protection should be achieved by giving unitary effect to european patents in the post - grant phase by virtue of this regulation and in respect of all the participating member states . the main feature of european patents with unitary effect should be their unitary character , i . e . providing uniform protection and having equal effect in all participating member states . consequently , a european patent with unitary effect should only be limited , transferred , revoked or lapse in respect of all the participating member states . it should be possible for a european patent with unitary effect to be licensed in respect of the whole or part of the territories of the participating member states . to ensure the uniform substantive scope of protection conferred by unitary patent protection , only european patents that have been granted for all the participating member states with the same set of claims should benefit from unitary effect . finally , the unitary effect attributed to a european patent should have an accessory nature and should cease to exist or be limited to the extent that the basic european patent has been revoked or limited .


### using a process which is the subject matter of the patent or , where the third party knows , or should have known , that the use of the process is prohibited without the consent of the proprietor of the patent , from offering the process for use within the participating member states ; ### using a process which is the subject matter of the patent or , where the third party knows , or should have known , that the use of the process is prohibited without the consent of the proprietor of the patent , from offering the process for use within the territory of the participating member states ;


### without prejudice to article 5 , a european patent with unitary effect may only be limited , licensed , transferred , revoked or lapse in respect of all the participating member states . ### european patents with unitary effect may only be granted , limited , transferred or revoked , or lapse or become subject to law enforcement , in respect of all the participating member states . a european patent with unitary effect may be licensed in respect of the whole or part of the territories of the participating member states .


### the collection and administration of renewal fees for european patents with unitary effect , in respect of the years following the year in which the register referred to in point b ) mentions their grant ; the collection and administration of additional fees paid in cases of late payment of renewal fees within six months of the due date , as well as the distribution of a part of the collected renewal fees to the participating member states ; and ### the collection and administration of renewal fees for european patents with unitary effect , in respect of the years following the year in which the european patent bulletin mentions their grant ; the collection and administration of additional fees paid in cases of late payment of renewal fees within six months of the due date , as well as the distribution of a part of the collected renewal fees to the participating member states ; and


### the part of the collected renewal fees to be distributed to the participating member states referred to in article 12 shall be 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect minus the costs associated with the administration of the unitary patent protection referred to in article 12 . ### the european patent office shall retain 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect . the remaining amount shall be distributed to the participating member states in accordance with the share of distribution of the renewal fees set in accordance with article 12 .


### in order to reach these objectives set out in this chapter , the commission shall set the level of renewal fees at a level that ### in order to reach these objectives set out in this chapter , the level of renewal fees shall be set at a level that :


### patent proprietors should pay one common annual renewal fee for european patents with unitary effect . renewal fees should be progressive throughout the term of the patent protection and , together with the fees to be paid to the european patent organisation during the pre - grant stage , should cover all costs associated with the grant of the european patent and the administration of the unitary patent protection . the level of the renewal fees should be fixed with the aim of facilitating innovation and fostering the competitiveness of european businesses . it should also reflect the size of the market covered by the patent and be similar to the level of the national renewal fees for an average european patent taking effect in the participating member states at the time where the level of the renewal fees is first fixed by the commission . ### patent proprietors should pay one common annual renewal fee for european patents with unitary effect . renewal fees should be progressive throughout the term of the patent protection and , together with the fees to be paid to the european patent organisation during the pre - grant stage , should cover all costs associated with the grant of the european patent and the administration of the unitary patent protection . the level of the renewal fees should be fixed with the aim of facilitating innovation and fostering the competitiveness of european businesses taking into account the situation of specific entities such as small and medium - sized enterprises for example in the form of lower fees . it should also reflect the size of the market covered by the patent and be similar to the level of the national renewal fees for an average european patent taking effect in the participating member states at the time where the level of the renewal fees is first fixed .


### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently . ### renewal fees should be paid to the european patent organisation . the european patent office should retain an amount to cover the expenses generated at the european patent office in carrying out tasks in relation to the unitary patent protection in accordance with article 146 of the epc . the remaining amount shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market and should guarantee a minimum amount to be redistributed to each participating member state in order to maintain a balanced and sustainable functioning of the system . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity established on the basis of the european innovation scoreboard and having acquired membership of the european patent organisation relatively recently .


### the european patent with unitary effect shall confer on its proprietor the right to prevent any third party from supplying or offering to supply within the participating member states any person without the proprietor ' s consent , other than a party entitled to exploit the patented invention , with means , relating to an essential element of that invention , for putting it into effect therein , when the third party knows , or should have known , that those means are suitable and intended for putting that invention into effect . ### the european patent with unitary effect shall confer on its proprietor the right to prevent any third party not having the proprietor ' s consent from supplying or offering to supply , within the participating member states , any person other than the one entitled to exploit the patented invention , with means , relating to an essential element of that invention , for putting it into effect therein , when the third party knows , or should have known , that those means are suitable and intended for putting that invention into effect .


### the rights conferred by a european patent with unitary effect shall not extend to acts concerning the product covered by that patent which are carried out within the territories of the participating member states after that product has been put on the market in the union by the proprietor of the patent or with his / her consent , unless there are legitimate grounds for the proprietor to oppose further commercialisation of the product . ### the rights conferred by a european patent with unitary effect shall not extend to acts concerning the product covered by that patent which are carried out within the territories of the participating member states in which that patent has unitary effect after that product has been put on the market in the union by the proprietor of the patent or with his / her consent , unless there are legitimate grounds for the proprietor to oppose further commercialisation of the product .


### the creation of unitary patent protection should be achieved by giving unitary effect to european patents in the post - grant phase by virtue of this regulation and in respect of the participating member states . the main feature of european patents with unitary effect should be their unitary character , i . e . providing uniform protection and having equal effect in all participating member states . consequently , a european patent with unitary effect should only be limited , licensed , transferred , revoked or lapse in respect of all the participating member states . to ensure the uniform substantive scope of protection conferred by unitary patent protection , only european patents that have been granted for all the participating member states with the same set of claims should benefit from unitary effect . however , to ensure legal certainty in the event of a limitation or revocation on the ground of lack of novelty pursuant to article 54 epc , the limitation or revocation of a european patent with unitary effect should take effect only in respect of the participating member state designated in the earlier european patent application as published . finally , the unitary effect attributed to a european patent should have an accessory nature and should cease to exist or be limited to the extent that the basic european patent has been revoked or limited . ### the creation of unitary patent protection should be achieved by giving unitary effect to european patents in the post - grant phase by virtue of this regulation and in respect of all the participating member states . the main feature of european patents with unitary effect should be their unitary character , i . e . providing uniform protection and having equal effect in all participating member states . consequently , a european patent with unitary effect should only be granted , limited , transferred or revoked , or lapse or become subject to law enforcement , in respect of all the participating member states . it should be possible for a european patent with unitary effect to be licensed in respect of the whole or part of the territories of the participating member states . to ensure the uniform substantive scope of protection conferred by unitary patent protection , only european patents that have been granted for all the participating member states with the same set of claims should benefit from unitary effect . finally , the unitary effect attributed to a european patent should have an accessory nature and should cease to exist or be limited to the extent that the basic european patent has been revoked or limited .


### european patents granted with an identical scope of protection in respect of all participating member states shall benefit from unitary effect in the participating member states provided that their unitary effect has been registered in the register for unitary patent protection referred to in article 12 . ### european patents granted with the same set of claims in respect of all the participating member states shall benefit from unitary effect in the participating member states provided that their unitary effect has been registered in the register for unitary patent protection .


### the participating member states shall notify the commission of the measures adopted in accordance with articles 4 and 12 by the date set in article 22 . ### the participating member states shall notify the commission of the measures adopted in accordance with article 12 by the date set in article 22 . 1a . each participating member state shall notify the commission of the measures adopted in accordance with article 4by the date of application of this regulation or , in the case of a participating member state in which the unified patent court does not have exclusive jurisdiction with regard to european patents with unitary effect on the date of application of this regulation , the date from which the unified patent court has such exclusive jurisdiction in that participating member state .


### the part of the collected renewal fees to be distributed to the participating member states referred to in article 12 shall be 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect minus the costs associated with the administration of the unitary patent protection referred to in article 12 . ### the european patent office shall retain 50 percent of the renewal fees referred to in article&#160 ; 14 paid for european patents with unitary effect . the remaining amount shall be distributed to the participating member states in accordance with the share of distribution of the renewal fees set in accordance with article 12 .


### it shall apply from [ a specific date will be set and it will coincide with the date of application of council regulation … / … on the implementation of enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements ] . ### it shall apply from 1 january 2014 or the date of entry into force of the agreement on a unified patent court , whichever is the later . by way of derogation from articles 3 - and 4 , a european patent for which unitary effect is registered in the register for unitary patent protection referred to in article 2 shall have unitary effect only in those participating member states in which the unified patent court has exclusive jurisdiction with regard to european patents with unitary effect at the date of registration . 2a . each participating member state shall notify the commission of its ratification of the agreement at the time of deposit of its ratification instrument . the commission shall publish the date of entry into force of the agreement and a list of the member states who have ratified the agreement at the date of entry into force in the official journal of the european union . the commission shall thereafter regularly update the list of the participating member states which have ratified the agreement and publish it in the official journal .


### acts as covered by the farmers privilege pursuant to article 14 of regulation no . 2100 / 94 which applies mutatis mutandis ; ### the use by a farmer of the product of his crop for propagation or multiplication on his own holding , provided that the reproductive vegetable material was sold or otherwise commercialised by the patent proprietor or with his consent to the farmer for agricultural purposes . the scope and the detailed methods of such use are laid down in article 14 of regulation no 2100 / 94 ;


### not later than six years from the date on which the first european patent with unitary effect takes effect in the territories of the participating member states , the commission shall present to the council a report on the operation of this regulation and , where necessary , make appropriate proposals for amending it . subsequent reports on the operation of this regulation shall be presented by the commission every six years . ### not later than three years from the date on which the first european patent with unitary effect takes effect in the territories of the participating member states , the commission shall present to the european parliament and the council a report on the operation of this regulation and , where necessary , make appropriate proposals for amending it . subsequent reports on the operation of this regulation shall be presented by the commission every five years .


### implementation by the participating member states ### administrative tasks in the framework of the european patent organisation


### in order to reach these objectives set out in this chapter , the commission shall set the level of renewal fees at a level that ### in order to reach the objectives set out in this chapter , the select committee shall , taking due account of the position of the commission , set the level of renewal fees at a level that :


### the participating member states should give the european patent office certain administrative tasks relating to european patents with unitary effect , in particular as regards administration of requests for unitary effect , the registration of unitary effect and of any limitation , licence , transfer , revocation or lapse of european patents with unitary effect , the collection and redistribution of renewal fees , the publication of translations for information purposes during a transitional period and the administration of a compensation scheme of translation costs for applicants filing european patent applications in a language other than one of the official languages of the european patent office . the participating member states should ensure that requests for unitary effect are filed with the european patent office within one month of the date of the publication of the mention of the grant in the european patent bulletin and that they are submitted in the language of the proceedings before the european patent office together with the translation prescribed for , during a transitional period , by council regulation… / … [ translation arrangements ] . ### the participating member states should give the european patent office certain administrative tasks relating to european patents with unitary effect , in particular as regards administration of requests for unitary effect , the registration of unitary effect and of any limitation , licence , transfer , revocation or lapse of european patents with unitary effect , the collection and redistribution of renewal fees , the publication of translations for information purposes during a transitional period and the administration of a compensation scheme of translation costs for applicants filing european patent applications in a language other than one of the official languages of the european patent office .


### where no proprietor has his / her residence or a place of business in a participating member state for the purposes of paragraphs 1 or 2 , the european patent with unitary effect as an object of property shall be dealt with in its entirety and in all the participating member states as a national patent of the state where the european patent organisation has its headquarters in accordance with article 6 of the epc . ### where no proprietor has his / her residence , principal place of business or place of business in a participating member state for the purposes of paragraphs 1 or 2 , the european patent with unitary effect as an object of property shall be dealt with in its entirety and in all the participating member states as a national patent of the state where the european patent organisation has its headquarters in accordance with article 6 of the epc .


### in their capacity as contracting states to the epc , the participating member states shall ensure the governance and supervision of the activities related to the tasks referred to in paragraph 1 by the european patent office . to that end they shall set up a select committee of the administrative council of the european patent organisation within the meaning of article 145 of the epc . ### member states shall ensure compliance with the provisions of this regulation in implementing their international obligations undertaken in the epc and shall cooperate amongst themselves to that end . in their capacity as contracting states to the epc , the participating member states shall ensure the governance and supervision of the activities related to the tasks referred to in paragraph 1 by the european patent office and shall ensure the setting of the level of renewal fees in accordance with article 15 and the setting of the share of distribution of the renewal fees in accordance with article 16 . to that end they shall set up a select committee of the administrative council of the european patent organisation within the meaning of article 145 of the epc . the select committee of the administrative council shall consist of the representatives of the member states and a representative of the commission as an observer , as well as alternates who will represent them in their absence . the members of the select committee may be assisted by advisers or by experts . decisions of the select committee of the administrative council shall be taken with due regard for the position of the commission and in accordance with the rules set out in article 35 of the epc .


### unitary patent protection may be requested for any european patent granted on or after the date set out in paragraph 2 . ### unitary patent protection may be requested for any european patent granted on or after the date set out in the first subparagraph of paragraph 2 .


### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently . ### renewal fees should be paid to the european patent organisation . the european patent office shall retain an amount to cover the expenses generated at the european patent office in carrying out tasks in relation to the unitary patent protection in accordance with article 146 epc . the remaining amount shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market and should guarantee a minimum amount to be redistributed to each participating member state in order to maintain a balanced and sustainable functioning of the system . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity established on the basis of the european innovation scoreboard and having acquired membership of the european patent organisation relatively recently .


### the use of the patented invention in the construction or operation of aircraft or land vehicles or other means of transport of states other than participating member states , or of accessories to such aircraft or land vehicles , when these temporarily or accidentally enter participating member states ; ### the use of the patented invention in the construction or operation of aircraft or land vehicles or other means of transport of states other than participating member states , or of accessories to such aircraft or land vehicles , when these temporarily or accidentally enter the territory of the participating member states ;


### patent proprietors should pay one common annual renewal fee for european patents with unitary effect . renewal fees should be progressive throughout the term of the patent protection and , together with the fees to be paid to the european patent organisation during the pre - grant stage , should cover all costs associated with the grant of the european patent and the administration of the unitary patent protection . the level of the renewal fees should be fixed with the aim of facilitating innovation and fostering the competitiveness of european businesses . it should also reflect the size of the market covered by the patent and be similar to the level of the national renewal fees for an average european patent taking effect in the participating member states at the time where the level of the renewal fees is first fixed by the commission . ### patent proprietors should pay one common annual renewal fee for european patents with unitary effect . renewal fees should be progressive throughout the term of the patent protection and , together with the fees to be paid to the european patent organisation during the pre - grant stage , should cover all costs associated with the grant of the european patent and the administration of the unitary patent protection . the level of the renewal fees should be fixed with the aim of facilitating innovation and fostering the competitiveness of european businesses and should take into account the specific situation of small and medium - sized enterprises in the form of lower fees . it should also reflect the size of the market covered by the patent and be similar to the level of the national renewal fees for an average european patent taking effect in the participating member states at the time where the level of the renewal fees is first fixed .


### the size of the market expressed in the number of population , ### the size of the market , while ensuring a minimum amount to be distributed to each participating member state ,


### member states shall ensure that the confidentiality of meetings between the suspect or accused person and his lawyer is guaranteed . they shall also ensure the confidentiality of correspondence , telephone conversations and other forms of communication permitted under national law between the suspect or accused person and his lawyer . ### member states shall ensure that the confidentiality of meetings between the suspect or accused person and his lawyer is guaranteed . they shall also ensure the confidentiality of correspondence , telephone conversations and other forms of communication permitted under national law between the suspect or accused person and his lawyer . confidentiality shall not be subject to any exception ; any infringement thereof shall be sanctioned in accordance with national law .


### member states shall ensure that persons to whom article 2 refers , who are deprived of their liberty and who are non - nationals have the right to have consular or diplomatic authorities of their state of nationality informed of the detention as soon as possible and to communicate with the consular or diplomatic authorities . ### member states shall ensure that persons to whom article 2 refers , who are deprived of their liberty and who are non - nationals have the right to have consular or diplomatic authorities of their state of nationality informed promptly upon their arrest or detention of the detention / arrest and to communicate with the consular or diplomatic authorities . such authorities have the right to visit such persons and to arrange for their legal representation , and to observe court proceedings in relation to the person .


### the lawyer shall have the right to be present at any other investigative or evidence - gathering act at which the suspect or accused person’s presence is required or permitted as a right , in accordance with national law , unless this would prejudice the acquisition of evidence . ### the lawyer shall have the right of access to the materials of the case and to be present at any other investigative or evidence - gathering act at which the suspect or accused person’s presence is required or permitted as a right , in accordance with national law , unless this would prejudice the acquisition of evidence . he shall have the right to request evidence - gathering himself .


### where the person is a child , member states shall ensure that the child’s legal representative or another adult , depending on the interest of the child , is informed as soon as possible of the deprivation of liberty and the reasons pertaining thereto , unless it would be contrary to the best interests of the child , in which case another appropriate adult shall be informed . ### where the person is a child or a vulnerable person , member states shall ensure that the child’s legal representative or another adult , depending on the interest of the child or the vulnerable person , is informed as soon as possible of the deprivation of liberty and the reasons pertaining thereto , unless it would be contrary to the best interests of the child or the vulnerable person , in which case another appropriate adult or legal representative shall be informed .


### the lawyer shall have the right to check the conditions in which the suspect or accused person is detained and to this end shall have access to the place where the person is detained . ### if he or she receives indications of maltreatment , the lawyer shall have the right to examine the specific conditions in which the suspect or accused person is detained and to that end shall have access to the place where the person is detained .


### motion for a resolution ### recalls its resolution of 8 june 2011 on investing in the future : a new multiannual financial framework for a competitive , sustainable and inclusive europe1 ; reiterates that sufficient additional resources are needed in the next mff in order to enable the union to fulfil its existing policy priorities and the new tasks provided for in the treaty of lisbon , as well as to respond to unforeseen events ; points out that even with an increase in the level of resources for the next mff of at least 5 % compared to the 2013 level only a limited contribution can be made to the achievement of the union’s agreed objectives and commitments and the principle of union solidarity ; challenges the council , if it does not share this approach , to clearly identify which of its policy priorities or projects could be dropped altogether , despite their proven european added value ; _____________ texts adopted , p7_ta0266 .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure for intense muscular effort and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes , and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in addition , the concept of ' specialised nutrition ' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market under current union legislation .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for medical purposes and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec and in commission regulation no 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes and foodstuffs for people intolerant to gluten taking into account commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec , and commission regulation no 41 / 2009 .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information , must not be misleading and must be based on scientific data validated by the authority .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for foods for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 which do not allow the use of the statement ‘ very low gluten’ for these foods . such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this regulation , as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for foods for special dietary use for persons intolerant to gluten . also the conditions of use of the claim ‘ gluten - free’ for foods for normal consumption should be maintained in the regulation no 41 / 2009 .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 and shall provide adequate consumer information , must not be misleading and shall not attribute properties to such products for the prevention , treatment or cure of human disease , or imply such properties .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure of intense muscular effort and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure of intense muscular effort and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council .


### the dissemination of any useful information or recommendations with reference to the categories of food referred to in article 1 may be made exclusively by persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care . ### paragraph 3 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine , nutrition and pharmacy or other professionals responsible for maternal and child health care .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and regulation no 41 / 2009 , as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods referred to in article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for special food for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . furthermore , the statement ‘ gluten - free’ may be used for food for normal consumption and for foodstuffs suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 , which does not authorise use of the statement ‘ very low gluten’ for these foods . these foodstuffs for special food for people intolerant to gluten should be retained in this regulation , insofar as provision of such safe foodstuffs for people intolerant to gluten and information for people with coeliac disease on the absence of gluten is essential for management of the disease . this is in accordance with the international standard for foods for special dietary use for persons intolerant to gluten . thus the conditions for using the statement ‘ gluten - free’ for food products for normal consumption should be maintained in regulation no 41 / 2009 .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council .


### infant formula and follow - on formula ; ### infant formula and follow - on formula for infants in good health ;


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directives 2006 / 141 / ec , 2006 / 125 / ec , 1999 / 21 / ec and 96 / 8 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs intended for use in energy - restricted diets for weight reduction should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directives 2006 / 141 / ec , 2006 / 125 / ec , 1999 / 21 / ec and 96 / 8 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , foodstuffs intended for use in energy - restricted diets for weight reduction and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for foods for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 which do not allow the use of the statement ‘ very low gluten’ for these foods . such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this regulation , as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for foods for special dietary use for persons intolerant to gluten .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec , and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries 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 council .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec and in commission regulation no 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information , must not be misleading and must be based on scientific data validated by the authority .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for medical purposes and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec and in commission regulation no 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes and foodstuffs for people intolerant to gluten taking into account commission directives 2006 / 141 / ec , 2006 / 125 / ec and 1999 / 21 / ec , and commission regulation no 41 / 2009 .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and foodstuffs intended for use in energy - restricted diets for weight reduction . experience has shown that the provisions laid down in commission directives 2006 / 141 / ec , 2006 / 125 / ec , 1999 / 21 / ec and 96 / 8 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes and foodstuffs intended for use in energy - restricted diets for weight reduction , taking into account the four directives mentioned above .


### it distributes vehicles or provides repair , maintenance or testing services for vehicles ; ### it builds or distributes vehicles or provides repair , maintenance or testing services for vehicles ;


### it has a good reputation and has the requisite professional competence . ### it has the requisite professional competence .


### the delegation of power referred to in article 10 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in article 10 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation . 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 . provided this report has been drawn up , the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such an extension not later than three months before the end of each period .


### in implementing the regulation , coherence shall be ensured with other areas of union ' s external action and with other relevant union policies . particular attention shall be given to ensure smooth transition between relief , rehabilitation and development . 2 . the commission and the member states shall cooperate to improve the consistency and coherence between relevant national volunteering schemes and the actions of the eu aid volunteers . 3 . the union shall foster cooperation with relevant international organisation , in particular the united nations , and other humanitarian aid partners in implementation of the actions of the eu aid volunteers . ### in implementing the regulation , coherence and complementarity shall be ensured with other areas of the union ' s external action and with other relevant union policies , particularly humanitarian aid policy , development cooperation policy and the union ' s civil protection mechanism , in order , in particular , to ensure the added value of the actions of the eu aid volunteers initiative . particular attention shall be given to ensure smooth transition between relief , rehabilitation and development . 2 . the commission and the member states shall cooperate to improve the consistency and coherence between relevant national volunteering schemes and the actions of the eu aid volunteers . 3 . the union shall foster cooperation with relevant international organisation , in particular the united nations , and other humanitarian aid partners in implementation of the actions of the eu aid volunteers initiative .


### – the number of volunteers trained and the quality of the training on the basis of the reviews and level of satisfaction ; ### – the number of volunteers that successfully completed the training and the assessment of the quality of the training on the basis of the reviews , level of satisfaction .


### the commission may consider the added - value and management advantages of creating an eu trust fund . ### the commission may consider the added - value and management advantages of creating an eu trust fund , in respect of the relevant provisions , and in particular article 187 of regulation no 966 / 2012 on the financial rules applicable to the general budget of the union . in case a trust fund is created by the commission , the adoption of the multiannual or annual working programme of this fund shall be subject to the procedure referred to in article 25 . a trust fund for eu aid volunteers can only be created if a thorough analysis on the of use of eu trust funds for the intended actions proves the added value of such a trust fund .


### for the entire duration of gmes initial operations , a financial envelope of eur 107 million constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial managementshould be established . it is envisaged that this financial envelope will be complemented by an amount of eur 43 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations . ### for the entire duration of gmes initial operations , a financial envelope of eur 500 million constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial managementshould be established . this financial envelope should in particular help to ensure funding for the remaining elements of the initial build - up phase of the gmes space component to ensure a seamless and cost effective transition , without postponing decisions to beyond 2013 . it is envisaged that this financial envelope will be complemented by at least eur 43 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations ; these additional resources should be used for the implementation of the second and the third phase of the space component ;


### the common fisheries policy should contribute to the protection of the marine environment and in particular to the achievement of good environmental status by 2020 the latest as set out in article 1 of directive 2008 / 56 / ec of the european parliament and the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy 23 . ### the common fisheries policy should contribute to the protection of the marine environment , to the sustainable management of all commercially - exploited species , and in particular to the achievement of good environmental status by 2020 the latest as set out in article 1 of directive 2008 / 56 / ec of the european parliament and the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy 23 .