### the european panel shall consist of 12 members . four of the members shall be nominated by the european parliament , four by the council and four by the commission . the panel shall designate its chairman . ### the european panel shall consist of 13 members . four of the members shall be nominated by the european parliament , four by the council , four by the commission and one by the committee of the regions , in accordance with their respective procedures . the panel shall designate its chairman .


### the european panel members shall be independent experts . they shall have substantial experience and expertise in the field of culture , heritage , european history , or other fields relevant to the objectives of the european heritage label . ### the european panel members shall be independent experts . they shall have substantial experience and expertise in the fields relevant to the objectives of the european heritage label . the institutions nominating the experts shall seek to ensure as far as possible the complementarity of their respective fields of expertise and a geographically balanced representation .


### the european panel members shall be nominated for three years . by way of derogation , in the first year during which this decision is in force , four experts shall be nominated by the commission for one year , four by the european parliament for two years and four by the council for three years . ### the european panel members shall be nominated for three years . by way of derogation , in the first year during which this decision is in force , four experts shall be nominated by the commission for one year , four by the european parliament and one by the committee of the regions for two years and four by the council for three years .


### if a conflict of interest between a member of the panel and a specific site comes to light , the member of the panel shall not take part in the evaluation of the said site . ### members of the panel must declare any conflict of interest or potential conflict of interest in respect of a specific site . in the event of such a declaration , or if such a conflict of interest comes to light , the member shall not participate in the evaluation of the said site or of any other sites from the same member state .


### with a view to keeping procedures as streamlined and light as possible , a common application form based on the selection criteria shall be prepared by the commission and used by all the candidates . only applications submitted on the official application form will be considered for selection . ### a common application form based on the selection criteria laid down in article 7 shall be prepared by the commission and used by all the candidates . only applications submitted on the official application form will be considered for selection .


### the pre - selection of the sites for the attribution of the european heritage label shall be under the responsibility of the member states . ### the pre - selection of the sites for the attribution of the european heritage label shall be under the responsibility of the member states , in close cooperation with local and regional authorities .


### each member state shall have the possibility to pre - select up to a maximum of two sites per annum in accordance with the calendar in the annex . no selection procedure shall take place in the years reserved for the monitoring procedure . ### each member state shall have the possibility to pre - select up to a maximum of two sites every two years in accordance with the calendar in the annex .


### each member state shall establish its own procedures and its own calendar for the pre - selection of the sites in accordance with the principle of subsidiarity , ensuring that administrative arrangements remain as light and flexible as possible . it shall however notify the commission of the results of the pre - selection at the latest on 31 january of the year of the selection procedure . ### each member state shall establish its own procedures and its own calendar for the pre - selection of the sites in accordance with the principle of subsidiarity , ensuring that administrative arrangements remain as light and flexible as possible . it shall however notify the commission of the results of the pre - selection at the latest on 1 march of the year of the pre - selection procedure .


### the european panel shall issue a report on the pre - selected sites at the latest on 31 october of the year of the selection procedure . this report shall include a recommendation for the attribution of the european heritage label and a justification for the sites which were not retained in the final list . ### the european panel shall issue a report on the pre - selected sites at the latest on 15 december of the year of the pre - selection procedure . this report shall include a recommendation for the attribution of the european heritage label and a justification for the sites which were not retained in the final list .


### applications for transnational sites shall follow the same procedure as applications for other sites . they shall be pre - selected by one of the member states concerned within the limit of a maximum of two sites as laid down in article 10 , and proposed in the name of all the member states concerned after consultation and agreement of these member states . ### applications for transnational sites shall follow the same procedure as applications for other sites . they shall be pre - selected by all of the member states concerned within their limit of a maximum of two sites as laid down in article 10 . transnational sites shall designate one of the sites involved as their coordinator , which will constitute the single contact point for the commission . the coordinator shall provide information on the transnational candidacy in due time in all the member states so as to ensure the participation of relevant sites all across the union . all the sites participating in a transnational site shall complete the application form referred to in article 9 and shall meet the criteria laid down in article 7 .


### the commission shall officially designate the sites to be awarded the european heritage label during the year following the selection procedure , in the light of the recommendation of the european panel . the commission shall inform the european parliament and the council . ### the commission shall officially designate the sites to be awarded the european heritage label during the year following the selection procedure , having due regard to the recommendation of the european panel . the commission shall inform the european parliament , the council and the committee of the regions of the decisions taken .


### the european heritage label shall be awarded to the sites in principle on a permanent basis under the conditions laid down in articles 14 and 15 and subject to the continuation of the action . ### the european heritage label shall be awarded to the sites on a permanent basis under the conditions laid down in articles 14 and 15 and subject to the continuation of the action .


### article 18 ### article 18 is deleted


### the report shall be sent to the commission and submitted to the european panel for examination at the latest on 31 january of the year of the monitoring procedure . ### the report shall be sent to the commission and submitted to the european panel for examination at the latest on 1 march of the year of the monitoring procedure .


### the european panel shall issue a report on the state of the labelled sites in the member state concerned at the latest on 31 october of the year of the monitoring procedure , including if necessary recommendations to be taken into account for the next monitoring period . ### the european panel shall issue a report on the state of the labelled sites in the member state concerned at the latest on 15 december of the year of the monitoring procedure , including if necessary recommendations to be taken into account for the next monitoring period .


### the commission shall establish common indicators for the member states to ensure a coherent approach for the monitoring procedure . ### the commission , after consulting the european panel , shall establish common indicators for the member states to ensure a coherent approach for the monitoring procedure .


### the commission shall take the final decision to withdraw the european heritage label . the commission shall inform the european parliament and the council . ### the commission shall take the final decision to withdraw the european heritage label having due regard to the recommendation from the european panel . the commission shall inform the european parliament , the council and the committee of the regions thereof .


### - establish guidelines for the selection and monitoring procedures , as well as the application form ; ### - in the light of the objectives set out in article 3 and in accordance with the criteria laid down in article 7 , establish guidelines to assist with the selection and monitoring procedures , as well as the application form ;


### the commission shall ensure the external and independent evaluation of the european heritage label action . this evaluation shall take place every six years in accordance with the calendar set out in the annex and shall examine all elements , including the efficiency of the processes involved in running the action , the number of sites , the impact of the action , how it could be improved and whether the european heritage label should be continued . ### the commission shall ensure the external and independent evaluation of the european heritage label action . this evaluation shall take place every six years in accordance with the calendar set out in the annex and shall examine all elements , including the efficiency of the processes involved in running the action , the number of sites , the geographical scope and impact of the action , how it could be improved and whether the european heritage label should be continued .


### the commission shall present a report on these evaluations to the european parliament and the council within six months of the finalisation of the evaluations . ### the commission shall present a report on these evaluations to the european parliament and the council within six months of the finalisation of the evaluations accompanied , if appropriate , by relevant proposals .


### projects of common interest should be given ‘ priority status’ at national level to ensure rapid administrative treatment . projects of common interest shall be considered by competent authorities as being in public interest . authorisation should be given to projects which have an adverse impact on the environment , for reasons of overriding public interest , when all the conditions provided for under directives 92 / 43 / ec and 2000 / 60 / ec are met . ### projects of common interest should be given ‘ priority status’ at national level to ensure rapid administrative treatment . projects of common interest shall be considered by competent authorities as being in public interest . authorisation should be given to projects when all the conditions provided for under european environmental legislation and especially under directives 92 / 43 / ec and 2000 / 60 / ec are met .


### projects of common interest should be given ' priority status ' at national level to ensure rapid administrative treatment . projects of common interest shall be considered by competent authorities as being in public interest . authorisation should be given to projects which have an adverse impact on the environment , for reasons of overriding public interest , when all the conditions provided for under directives 92 / 43 / ec and 2000 / 60 / ec are met . ### projects of common interest should be given ' priority status ' at national level to ensure rapid administrative treatment . projects of common interest shall be considered by competent authorities as being in public interest . authorisation should not be given to projects which have an adverse impact on the environment . authorisation should be given only to projects meeting all the conditions provided for under directives 92 / 43 / ec , directive 79 / 409 / ec and 2000 / 60 / ec .


### the project involves at least two member states , either by directly crossing the border of one or more member states or by being located on the territory of one member state and having a significant cross - border impact as set out in point 1 of annex iv ; ### the project involves at least two member states if directly crossing the border at land or at sea of one or more member states , or if being located on the territory of one member state but nevertheless has a significant cross - border impact , or in the case of an internal reinforcement , the project is relevant to a cross - border interconnection as set out in point 1 of annex iv , or if it has the purpose of connecting islands and peripheral regions to central regions of the union ;


### concerning electricity transmission and storage projects falling under the categories set out in points 1 to of annex ii , the project shall contribute significantly to at least one of the following specific criteria : ### concerning electricity transmission and storage projects falling under the categories set out in points 1 to of annex ii , the project shall contribute to sustainability and significantly to at least one of the following specific criteria :


### concerning gas projects falling under the categories set out in point 2 of annex ii , the project shall contribute significantly to at least one of the following specific criteria : ### concerning gas projects falling under the categories set out in point 2 of annex ii , the project shall contribute to sustainability and significantly to at least one of the following specific criteria :


### – sustainability , inter alia through transmission of renewable generation to major consumption centres and storage sites ; ### – integration of renewable energy into the grid and transmission of renewable generation to major consumption centres and storage sites ;


### – interoperability and secure system operation ; ### – security of supply , inter alia through interoperability , and secure and reliable system operation , in particular through strengthening of current transmission stability , increasing electricity blackout resilience , and secure integration of intermittent production ;


### concerning oil transport projects falling under the categories set out in point 3 of annex ii , the project shall contribute significantly to the following three specific criteria : ### concerning oil transport projects falling under the categories set out in point 3 of annex ii , the project shall contribute to sustainability and significantly the following three specific criteria :


### concerning electricity smart grid projects falling under the category set out in point 1 of annex ii , the project shall contribute significantly to the following specific functions : ### concerning electricity smart grid projects falling under the category set out in point 1 of annex ii , the project shall contribute to sustainability significantly to the following specific functions :


### concerning carbon dioxide transport projects falling under the categories set out in point 4 of annex ii , the project shall contribute significantly to the following three specific criteria : ### concerning carbon dioxide transport projects falling under the categories set out in point 4 of annex ii , the project shall contribute to sustainability and significantly to the following three specific criteria :


### by the 31 march of each year following the year of selection as project of common interest pursuant to article 4 , project promoters shall submit an annual report , for each project falling under the categories set out in points 1 and 2 of annex ii , to the agency or , for projects falling under the categories set out in points 3 and 4 of annex ii , to the respective group . this report shall detail : ### by the 31 march of each year following the year of selection as project of common interest pursuant to article 4 , project promoters shall submit an annual report , for each project falling under the categories set out in points 1 and 2 of annex ii , to the commission and the agency or , for projects falling under the categories set out in points 3 and 4 of annex ii , to the respective group . this report shall detail :


### projects of common interest shall be allocated the status of the highest national significance possible and be treated as such in permit granting procedures , where and in the manner such treatment is provided for in national legislation applicable to the corresponding type of energy infrastructure . ### projects of common interest shall be allocated the status of the highest national significance possible and be treated as such in permit granting procedures , including spatial planning and environmental assessment , where and in the manner such treatment is provided for in national legislation applicable to the corresponding type of energy infrastructure .


### within one month of the entry into force of this regulation , the entso for electricity and the entso for gas shall submit to the agency and the commission their respective methodology , including on network and market modelling , for a harmonised energy system - wide cost - benefit analysis at union - wide level for projects of common interest falling under the categories set out in points 1 to and 2 of annex ii . the methodology shall be elaborated in line with the principles laid down in annex v . ### within&#160 ; six months of the entry into force of this regulation , the entso for electricity and the entso for gas shall submit to the agency and the commission their respective methodology , including on network and market modelling , for a harmonised energy system - wide cost - benefit analysis at union - wide level for projects of common interest falling under the categories set out in points 1 to and 2 of annex ii . the methodology shall be elaborated in line with the principles laid down in annex v and be consistent with the rules and indicators set out in annex iv . the entsos shall conduct an extensive consultation process involving at least the organisations representing all relevant stakeholders - and , if deemed appropriate , stakeholders directly - , national regulatory authorities and other national authorities


### the methodology shall be updated and improved regularly by following the procedure laid down in paragraphs 1 to 5 . the agency , after formally consulting the organisations representing all relevant stakeholders and the commission , may request such updates and improvements with due justification and timescales . ### the methodology shall be updated and improved every two years by following the procedure laid down in paragraphs 1 to 5 .


### a copy of all decisions , together with all the relevant information with respect to each decision , shall be notified , without delay , by the agency to the commission . that information may be submitted in aggregate form . the commission shall preserve the confidentiality of commercially sensitive information . ### a copy of all decisions issued according to paragraph 6 , together with all the relevant information with respect to each decision , shall be notified , without delay , by the agency to the commission . that information may be submitted in aggregate form . the commission shall preserve the confidentiality of commercially sensitive information .


### general , regularly updated information , including geographic information , for each project of common interest ; ### general , regularly updated information , including necessary geographic information , for each project of common interest ;


### in gas : scenarios for demand , imports , fuel prices , carbon dioxide prices , the composition of the transmission network and its evolution , taking into account all new projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n + 5 ; ### in gas : scenarios for demand , imports , fuel prices , prices of carbon dioxide , the composition of the transmission network and its evolution , taking into account all new projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n + 5 ;


### the cost - benefit analysis shall at least take into account the following costs : capital expenditure , operational and maintenance expenditure over the technical lifecycle of the project and decommissioning and waste management costs , where relevant . the methodology shall give guidance on discount rates to be used for the calculations . ### the cost - benefit analysis , based on costs over the technical lifecyle of the project , shall at least take into account the following costs : capital expenditure , operational and maintenance expenditure and the environmental costs of the construction , operation and decommissioning of energy infrastructure projects and waste management costs , where relevant . the methodology shall give guidance on discount rates to be used for the calculations . .


### system resilience , including disaster and climate resilience , and system security , notably for european critical infrastructures as defined in directive 2008 / 114 / ec ; ### system resilience , including security of supply , disaster and climate resilience , and system security , notably for european critical infrastructures as defined in directive 2008 / 114 / ec ;


### before 30 june each year germany shall submit a report to the commission on the functioning of the monopoly and the aid granted in the framework thereof in the previous year . moreover , the annual reports to be submitted in 2013 to 2016 shall include an annual phasing - out plan for the following year concerning the small - scale flat - rate distilleries , distillery users and fruit cooperative distilleries . ### before 30 june each year germany shall submit a report to the commission on the functioning of the monopoly and the aid granted in the framework thereof in the previous year ; the commission shall forward that report to the european parliament and the council . moreover , the annual reports to be submitted in 2013 to 2016 shall include an annual phasing - out plan for the following year concerning the small - scale flat - rate distilleries , distillery users and fruit cooperative distilleries .


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely collected and stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems , and , in doing so , should involve the european data protection supervisor and the relevant authorities of member states . the commission should also be responsible for the operation of the online collection system .


### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data . ### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that in the event of paper - based collection the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in the event of online collection , in its capacity as data controller , the commission needs to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . ### where the organiser is a natural person , that person shall be a citizen of the union and be at least 16 years old .


### examine the citizens ' initiative and , within 4 months , set out in a communication its conclusions on the initiative , the action it intends to take , if any , and its reasons for doing so . ### examine the citizens ' initiative and , within 4 months , set out in a communication its conclusions on the initiative , as well as the appropriate proposal on the matter where citizens have indicated that a legal act is required . should the commission decide to take some alternative action , or not to take any action , it shall state its reasons for its decision in a communication .


### examine the citizens ' initiative and , within 4 months , set out in a communication its conclusions on the initiative , the action it intends to take , if any , and its reasons for doing so . ### examine the citizens ' initiative and , within 4 months , set out in a communication its conclusions on the initiative , the action it intends to take , if any , and its reasons for doing so . if the commission decides not to submit a proposal for an initiative , the organiser shall be able to appeal against that decision before the court of justice of the european union .


### the communication referred to in paragraph 1 shall be notified to the organiser of the citizens ' initiative as well as to the european parliament and the council and shall be made public . ### the list of citizens ' initiatives tabled , as well as the communication referred to in paragraph 1 , shall be notified to the organiser of the citizens ' initiative as well as to the european parliament and the council and shall be made public .


### form for the submission of statements of support to the member states’ competent authorities full name , postal address and e - mail address of the organiser or , in the case of a legal entity or organisation , its legal representative* : title of citizens ' initiative* : commission registration number* : date of registration* : date of request for a decision on admissibility* : number of signatories coming from [ name of ms ] * : 7 . annexes* : certifying that the conformity of the online collection system with regulation xxxx / xxxx ) 8 . date and signature of the organiser* : * : mandatory fields ### form for the submission of statements of support to the member states’ competent authorities full name , postal address and e - mail address of the organiser or , in the case of a legal entity or organisation , its legal representative* : title of citizens ' initiative* : commission registration number* : date of registration* : date of request for a decision on admissibility* : number of signatories coming from [ name of ms ] * : 7 . annexes* : 8 . date and signature of the organiser* : * : mandatory fields


### any request for import within this quota shall be accompanied by an authenticity certificate issued by the competent authorities of the exporting territory and attesting that the goods originate in the territory concerned and correspond to the definition in annex ii to this regulation . this certificate shall be drawn up by the commission in accordance with the procedure referred to in article 195 of council regulation no 1234 / 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products . ' ### any request for import within this quota shall be accompanied by an authenticity certificate issued by the competent authorities of the exporting territory and attesting that the goods originate in the territory concerned and correspond to the definition in annex ii to this regulation . this certificate shall be drawn up by the commission in accordance with the advisory procedure referred to in articles 3 and 7 of council decision 1999 / 468 / ec laying down the procedures for the exercise of implementing powers conferred on the commission .


### the detailed rules for implementing the tariff quota for ' baby beef ' products shall be determined by the commission in accordance with the procedure referred to in article 195 of council regulation no 1234 / 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products . ### the detailed rules for implementing the tariff quota for ' baby beef ' products shall be determined by the commission in accordance with the advisory procedure referred to in articles 3 and 7 of council decision 1999 / 468 / ec laying down the procedures for the exercise of implementing powers conferred on the commission .


### each european and national standardisation body shall promptly reply to , and take due account of , any comments received from any other european and national standardisation body and the commission with respect to any such draft . ### each european and national standardisation body shall reply within one month to , and take due account of , any comments received from any other european and national standardisation body and the commission with respect to any such draft .


### the publication of draft standards in such a way that parties established in other member states have the opportunity to submit comments ; ### the prompt publication of draft standards in such a way that parties established in other member states have the opportunity to submit comments ;


### european standardisation bodies shall ensure an appropriate representation of small and medium - sized enterprises , consumer organisations and environmental and social stakeholders , in particular through the organisations referred to in annex iii , at the policy development level and at least at the following stages of the development of european standards or european standardisation deliverables : ### european standardisation bodies shall encourage an appropriate representation of small and medium - sized enterprises , consumer organisations , workers and environmental and social stakeholders , in particular through the organisations referred to in annex iii , at the policy development level and at least at the following stages of the development of european standards or european standardisation deliverables :


### european standardisation bodies shall ensure an appropriate representation , at technical level , of undertakings , research centres and universities and other legal entities , in standardisation activities concerning an emerging area with significant policy or technical innovation implications , if the legal entities concerned participated in a project that is related to that area and that is funded by the union under a multiannual framework programme for activities in the area of research and technological development . ### european standardisation bodies shall encourage an appropriate representation , at technical level , of undertakings , research centres and universities and other legal entities , in standardisation activities concerning an emerging area with significant policy or technical innovation implications , if the legal entities concerned participated in a project that is related to that area and that is funded by the union under a multiannual framework programme for activities in the area of research and technological development .


### the commission may request one or several european standardisation bodies to draft a european standard or european standardisation deliverable within a set deadline . they shall be market - driven , take into account the public interest and based on consensus . ### the commission may request one or several european standardisation bodies to draft a european standard or european standardisation , deliverable within a set deadline , which is ambitious and to which are annexed clear lists of requirements , interim objectives and details of public funding . they shall be market - driven , take into account the public interest and based on consensus .


### the commission shall inform the relevant european standardisation body , within three months following the receipt of the acceptance referred to in paragraph 2 , about the award of a grant for drafting a european standard or european standardisation deliverable . ### the commission shall inform the relevant european standardisation body , within one month following the receipt of the acceptance referred to in paragraph 2 , about the award of a grant for drafting a european standard or european standardisation deliverable .


### the commission shall decide on the financing arrangements referred to in paragraphs 1 and 2 , on the amounts of the grants and , where necessary , on the maximum percentage of financing by type of activity . ### the commission shall decide on the financing arrangements referred to in paragraphs 1 and 2 , on the amounts of the grants and , where necessary , on the maximum percentage of financing by type of activity . the commission shall ensure that the eu funding is only supplementary in nature and is made contingent on compliance with specific requirements , so that funding for european standardisation continues to be provided mainly by the private sector .


### the agency , while performing its tasks , and particularly in relation to drafting recommendations , should take upmost account of external railway expertise . this expertise should predominantly consist of professionals from the railway sector and the relevant national authorities . they should form competent and representative working parties of the agency . ### the agency , while performing its tasks , and particularly in relation to drafting recommendations , should take upmost account of external railway expertise . this expertise should predominantly consist of professionals from the railway sector and the relevant national authorities . they should form competent and representative working parties of the agency . the agency should bear in mind the need to maintain balance between the risks and the benefits , in particular as regards the management of conflicts of interest , on the one hand , and the objective of obtaining the best possible expertise , on the other .


### legal status ### legal status and location


### the agency shall issue opinions at request of the national regulatory bodies referred to in article 55 of directive 2012 / 34 / eu [ directive establishing a single european rail area ] concerning safety - related and interoperability - related aspects of matters drawn to their attention . ### the agency shall issue opinions at request either of the national regulatory bodies referred to in article 55 of directive 2012 / 34 / eu [ directive establishing a single european rail area ] , or of a member of the network of representative bodies from the railway sector referred to in article 34of this regulation , concerning safety - related and interoperability - related aspects of matters drawn to their attention .


### the agency shall issue single safety certificates in accordance with articles 10 and 11 of directive … [ the safety directive ] . ### the agency shall issue , renew , suspend , amend or revoke single safety certificates in accordance with articles 10 and 11 of directive … [ the safety directive ] .


### authorisations for placing in service of trackside control - command and signalling sub - systems ### authorisations for placing in service of trackside ertms


### the agency shall issue authorisations for placing in service of the trackside control - command and signalling subsystems located or operated in the entire union in accordance with article 18 of directive … [ the interoperability directive ] . ### the agency shall issue authorisations for placing in service of the trackside ertms located or operated in the entire union in accordance with article 18 of directive … [ the interoperability directive ] .


### the agency shall set up and keep european registers provided for in article 43 , 44 and 45 of directive &#8230 ; [ interoperability directive ] . the agency shall act as the system authority for all registers and databases referred to in the safety , interoperability and train drivers directives . this shall include , in particular : ### the agency shall define european registers provided for in articles 43 , 44 and 45 of directive . . . [ interoperability directive ] in a practical , efficient and user - friendly format to support business and operational needs . the agency shall act as the system authority for all registers and databases referred to in the safety , interoperability and train drivers directives . this shall include , in particular :


### the vehicle registers , including via links to relevant national registers ; ### the european register of authorised vehicles , including via links to relevant national registers ;


### the agency shall establish one or more boards of appeal . ### the agency shall establish one or more independent boards of appeal .


### any natural or legal person may appeal against a decision addressed to that person by the agency pursuant to articles 12 , 16 , 17 and 18 . ### any natural or legal person , or a member of the network of representative bodies from the railway sector referred to in article 34 , may appeal against any decision addressed to them by the agency pursuant to articles 12 , 16 , 17 or 18 .


### when examining the appeal , the board of appeal shall act expeditiously . it shall , as often as necessary , invite the parties to the appeal proceedings to file , within specified time limits , observations on its notifications or on communications from other parties to the appeal proceedings . parties to the appeal proceedings shall be entitled to make oral presentations . ### when examining the appeal , the board of appeal shall decide within two months from receipt of all relevant information . the board of appeal may request this relevant information within one month . it shall , as often as necessary , invite the parties to the appeal proceedings to file , within specified time limits , observations on its notifications or on communications from other parties to the appeal proceedings . parties to the appeal proceedings shall be entitled to make oral presentations .


### the agency shall take appropriate administrative measures to organise its services in order to avoid any conflict of interest . ### the agency shall take appropriate administrative measures , inter alia through training and prevention strategies , to organise its services in order to avoid conflicts of interest , including relating to post - employment issues .


### the management board shall adopt a decision laying down rules on the secondment to the agency of national experts . ### the management board shall adopt a decision laying down rules on the secondment to the agency of national experts and shall adopt and implement a policy to evaluate and manage potential conflicts of interest of seconded national experts including prohibiting them from attending working group meetings when their independence and impartiality could be undermined .


### the host member state shall provide the best possible conditions to ensure the proper functioning of the agency , including multilingual , european - oriented schooling and appropriate transport connections . ### the host member state shall provide the best possible conditions to ensure the proper functioning of the agency , including multilingual , european - oriented schooling and appropriate transport connections , taking in consideration the travel time and costs for staff from the nsa ' s and stakeholders .


### the purpose of this regulation is to increase the free movement of biocidal products within the community . in order to remove as far as possible obstacles to trade in biocidal products stemming from the different levels of protection in the member states , harmonised rules should be laid down for the approval of active substances and the placing on the market and use of biocidal products , including the rules on the mutual recognition of authorisations and on parallel trade . ### the purpose of this regulation is to increase the free movement of biocidal products within the community and to ensure a high level of protection of both human and animal health and the environment . particular attention should be paid to the protection of vulnerable groups of the population , including pregnant women , infants and children . the precautionary principle should be applied to this regulation in order to ensure that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment . in order to remove as far as possible obstacles to trade in biocidal products rules should be laid down for the approval of active substances and the placing on the market and use of biocidal products , including the rules on the mutual recognition of authorisations and on parallel trade .


### ‘ residues’ means substances present in or on plants or products of plant origin , edible animal products , drinking water or elsewhere in the environment and resulting from the use of a biocidal product , including their metabolites , breakdown or reaction products ; ### ‘ residues’ means substances present in or on plants or products of plant origin , edible animal products , water resources drinking water or elsewhere in the environment and resulting from the use of a biocidal product , including their metabolites , breakdown or reaction products ;


### ‘ frame formulation’ means a group of biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products ; ### ‘ frame formulation’ means a group of low - risk biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products ; where the variation is a reduction in the percentage of the active substance and / or a change in percentage composition of one or more of the non - active substances ;


### the commission shall adopt the measures designed to set the criteria defining what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2 . ### the commission shall adopt and publish transparent criteria and guidance for defining what constitutes adequate justification to adapt the data required under paragraph 1 on the grounds referred to in paragraph 2 , also in accordance with the objective that testing on vertebrate animals for the purposes of this regulation shall be undertaken only as a last resort .


### if , when the dossiers are evaluated , it appears that additional information is necessary to carry out the evaluation , the evaluating competent authority shall ask the applicant to submit such information within a specified time limit , and shall inform the agency thereof . ### if , when the dossiers are evaluated , it appears that additional information is necessary to carry out the evaluation , the evaluating competent authority shall ask the applicant to submit such information within a specified time limit , and shall inform the agency thereof . where such additional information includes animal testing , the applicant shall be advised by experts from the agency or competent authorities regarding suitable alternative methods and testing strategies to replace , reduce or refine the use of vertebrate animals .


### it is classified or meets the criteria to be classified , in accordance with regulation no 1272 / 2008 , as carcinogen category 1a or 1b , mutagen category 1a or 1b or toxic for reproduction category 1a or 1b ; ### it is classified or meets the criteria to be classified , in accordance with regulation no 1272 / 2008 , as respiratory sensitizers , carcinogen category 1a or 1b , mutagen category 1a or 1b or toxic for reproduction category 1a or 1b ;


### by way of derogation from article 10 , the inclusion of an active substance in annex i that is considered as a candidate for substitution shall be renewed for a period not exceeding ten years . ### by way of derogation from article 10 , the inclusion of an active substance in annex i that is considered as a candidate for substitution shall be renewed for a period not exceeding five years . member states shall establish and implement a substitution plan in order to ensure that the application of the active substance concerned will be phased out within the authorisation period and that the active substance can be replaced with sound chemical or non - chemical alternatives .


### the commission shall renew the inclusion of an active substance in annex i if the active substance still complies with the requirements referred to in article 4 . ### the commission shall renew the inclusion of an active substance in annex i if the active substance still complies with the requirements referred to in article 4 and article 5 .


### the commission may review the inclusion of an active substance in annex i at any time where there are serious indications that the requirements referred to in article 4 are no longer complied with . where those indications are confirmed , the commission shall adopt a decision amending the inclusion of an active substance in annex i or removing it from that annex . ### the commission may review the inclusion of an active substance in annex i at any time there are indications that any of the requirements in article 4 and article 5 are no longer complied with . where those indications are confirmed , the commission shall adopt a decision amending the inclusion of an active substance in annex i or removing it from that annex .


### the nature , the quantity and the technical equivalence of active substances in the biocidal product and , where appropriate , any toxicologically or ecotoxicologically significant impurities and non - active substances , and its residues of toxicological or environmental significance , which result from uses to be authorised , can be determined according to the relevant requirements in annexes ii and iii ; ### the nature , the quantity and the technical equivalence of active substances in the biocidal product and , where appropriate , any toxicologically or ecotoxicologically significant impurities and non - active substances , and its metabolites and residues of toxicological or environmental significance , which result from uses to be authorised , should be determined according to the relevant requirements in annexes ii and iii ;


### an authorisation to place a low - risk biocidal product on the market shall be subject to compliance with the requirements of points , and of paragraph 1 . ### an authorisation to place a low - risk biocidal product on the market can only be granted if the active substances are evaluated as low - risk active substances and included in annex i in accordance with article 4 and article 5 , further the authorisation shall be subject to compliance with the requirements of points , , and of paragraph 1 .


### it contains one or more active substances which fulfil the criteria for being persistent , bio - accumulative and toxic or very persistent and very bio - accumulative in accordance with annex xiii of regulation no 1907 / 2006 ; ### it releases one / more chemical substances during normal use or it contains one or more active substances which fulfil the criteria for being persistent , bio - accumulative and toxic or very persistent and very bio - accumulative in accordance with annex xiii of regulation no 1907 / 2006 ;


### it contains one or more active substances which fulfil the criteria for being persistent , bio - accumulative and toxic or very persistent and very bio - accumulative in accordance with annex xiii of regulation no 1907 / 2006 ; ### it contains one or more substances which fulfil the criteria for being a pop , persistent , bio - accumulative and toxic or very persistent and very bio - accumulative in accordance with annex xiii of regulation no 1907 / 2006 ;


### it contains one or more active substances which have been classified in accordance with regulation no 1272 / 2008 as or which meets the criteria to be classified as one of the following : ### it releases one / more chemical substances during normal use or it contains one or more active substances which have been classified in accordance with regulation no 1272 / 2008 as or which meets the criteria to be classified as one of the following :


### for the uses specified in the application , another authorised biocidal product or a non - chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment ; ### for the uses specified in the application , other authorised biocidal products or a non - chemical control or prevention method already exist which present significantly lower risk for human or animal health or the environment and which prove equally effective and involve no significant increase in the risks for any other parameter ;


### the authorisation holder or its representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 18 months before the expiry date of the authorisation . ### the authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 12 months before the expiry date of the authorisation .


### the commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . ### the commission shall , after consultation with the applicant , adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . within three months of receiving the notification , the commission shall make a proposal for a decision . should the commission ask the agency for an opinion under the procedure set out in article 30 , the three - month period shall be suspended until the agency has forwarded its opinion .


### by way of derogation from articles 25 and 28 , competent authorities of member states may refuse mutual recognition of national authorisations granted for product types 15 , 17 and 23 of annex v provided that such a refusal can be justified on grounds of the protection of health of humans , animals or plants , the protection of national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . competent authorities of member states shall without delay inform each other and the commission of any decision taken in this respect and shall indicate the reasons thereof . ### by way of derogation from articles 25 - 29 , competent authorities of member states may refuse mutual recognition of national authorisations granted for product types 15 , 17 and 23 of annex v provided that such a refusal can be justified on grounds of the protection of health of humans , particularly of vulnerable groups , the protection of health of animals or plants , the protection of environment national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . competent authorities of member states shall without delay inform each other and the commission of any decision taken in this respect and shall indicate the reasons thereof .


### by way of derogation from articles 25 and 28 , competent authorities of member states may refuse mutual recognition of national authorisations granted for product types 15 , 17 and 23 of annex v provided that such a refusal can be justified on grounds of the protection of health of humans , animals or plants , the protection of national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . competent authorities of member states shall without delay inform each other and the commission of any decision taken in this respect and shall indicate the reasons thereof . ### by way of derogation from article 25 - 29 , competent authorities of member states may refuse mutual recognition of national authorisations granted for product types 15 , 17 and 23 of annex v provided that such a refusal can be justified on grounds of the protection of health of humans , environment , animals or plants , the protection of national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . competent authorities of member states shall without delay inform each other and the commission of any decision taken in this respect and shall indicate the reasons thereof .


### the commission may , on the request of a member state , decide that the community authorisation shall not apply in the territory of that member state for a biocidal product of the product - types 15 , 17 or 23 of annex v provided that such a request can be justified on grounds of the protection of health of humans , animals or plants , the protection of national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . ### the member state shall notify the commission if it restrict or prohibit the community authorisation for a biocidal product of the product - types 15 , 17 or 23 of annex v in the territory of that member state . this must be justified on grounds of the protection of either health of humans , particularly vulnerable groups , or environment , particularly vulnerable ecosystems , or animals , or plants , or national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property .


### the commission may , on the request of a member state , decide that certain conditions of the community authorisation should be adjusted to the different local circumstances in that member state in accordance with article 29 . ### the member states shall inform the commission if it is decided that the community authorisation should be adjusted to the different local circumstances in that member state in accordance with article 29 .


### the requirements referred to in article 16 are not satisfied ; ### the requirements referred to in article 16 are not satisfied or pursuant to community standards for the protection of human health and the environment , particularly established in accordance with directive 2008 / 56 / ec , directive 2006 / 118 / ec , directive 2000 / 60 / ec , directives 98 / 83 / ec and 96 / 61 / ec ;


### a biocidal product shall be considered as substantially identical to the reference product if one of the following conditions is met : ### a biocidal product shall be considered as identical to the reference product if all of the following conditions are met :


### the source of the active substances it contains is the same in terms of manufacturer and location of the production plant ; ### it has been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process ;


### it is either the same or similar with regard to the non - active substances present and the type of formulation ; ### it is identical with regard to the specification and content of the active substances and in the type of formulation ;


### it is either the same or equivalent in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment . ### it is either the same or equivalent with regard to the co - formulants present and the packaging size , material or form , in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment .


### by way of derogation from articles 15 and 16 , a competent authority may authorise for a period not exceeding nine months , the placing on the market of a biocidal product not complying with the provisions of this regulation for a limited and controlled use if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means . ### by way of derogation from articles 15 and 16 , a competent authority may authorise for a period not exceeding four months , the placing on the market of a biocidal product not complying with the provisions of this regulation for a limited and controlled use if all of the following conditions are met : such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means and the active substances concerned are approved for inclusion into annex i or evaluated according to article 4 of this regulation and a full dossier is provided if the relevant active substances are classified as cut - off substances or candidates for substitution , a mandatory substitution plan is established and implemented by the applicant or competent authority in order to replace the relevant substances with non - hazardous chemical or non - chemical alternatives within 2 years after approval and the application of the product is restricted to professional users who are certified pursuant to the requirements for an integrated pest management and the use is appropriately monitored .


### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisation for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions . the competent authority shall without delay inform the commission and other competent authorities about the issued national authorisation . ### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a positive opinion for this purpose and which may impose further conditions . in the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1 , the biocidal product or active substance may be placed on the market for the purpose of the notified experiment or test .


### every three years , starting in 2013 , competent authorities shall submit to the commission a report on the implementation of this regulation in their respective territories . the report shall include : ### every year , starting in 2013 , competent authorities shall submit to the commission a report on the implementation of this regulation in their respective territories . the implementation reports shall be annually published on the relevant website of the commission . the report shall include :


### the following information held by the competent authorities , the agency or , as appropriate , the commission on active substances shall be made , free of charge , publicly available : ### the following information held by the competent authorities , the agency or , as appropriate , the commission on active substances shall be made , free of charge , publicly available in a single database , in a structured format at least on the relevant website of the commission :


### producers , importers and professional users of biocidal products shall keep records of the biocidal products they produce , place on the market or use for at least three years . they shall make available the relevant information contained in these records to the competent authority on request . ### producers , importers and professional users of biocidal products shall keep records of the biocidal products they use , containing the name of the biocide , the time and the dose of application , the area and the articles and materials where the biocide was used , for at least three years . they shall make the relevant information contained in these records available to the competent authority on request . third parties such as the drinking water industry , retailers or residents , may request access to this information by addressing the competent authority . producers of biocidal products shall undertake post - authorisation monitoring on request of the competent authorities . they shall notify the competent authorities of the relevant results .


### a reduced fee shall be set for small and medium - sized enterprises within the meaning of recommendation 2003 / 361 / ec concerning the definition of micro , small and medium - sized enterprises ; ### a reduced fee shall be set for small and medium - sized enterprises within the meaning of recommendation 2003 / 361 / ec concerning the definition of micro , small and medium - sized enterprises ; this shall have no bearing on the responsibility of the relevant competent authority to carry out a careful assessment in accordance with the provisions of this regulation ;


### where , based on new evidence , a member state has justifiable grounds to consider that a biocidal product , although satisfying the requirements of this regulation , constitutes a serious risk to human or animal health or to the environment , it may take appropriate provisional measures . the member state shall without delay inform the commission and the other member states thereof and give reasons for its decision based on the new evidence . ### where , based on new evidence , a member state has justifiable grounds to consider that a biocidal product , although satisfying the requirements of this regulation , constitutes a serious risk to human or animal health or to the environment , particularly to vulnerable groups and to risk a failure of achieving the quality standards of directive 2000 / 60 / ec it may take appropriate provisional measures . the member state shall without delay inform the commission and the other member states thereof and give reasons for its decision .


### dossiers on product shall contain the information needed to establish , where relevant , acceptable daily intake , acceptable operator exposure level , predicted environmental concentration and predicted no - effect concentration . ### dossiers on biocidal products shall contain the information needed to establish that exposure is below the threshold of toxicological concern , or where relevant , to establish acceptable daily intake , acceptable operator exposure level , predicted environmental concentration , and predicted no - effect concentration .


### tests submitted for the purpose of authorisation shall be conducted according to the methods described in regulation no 440 / 2008 . however , if a method is inappropriate or not described , other methods shall be used which are , whenever possible , internationally recognised and must be justified in the application . ### tests submitted for the purpose of authorisation shall be conducted according to the methods described in council regulation no 440 / 2008 . however , if a method is inappropriate or not described , other methods shall be used which are scientifically satisfactory and must be justified in the application .


### 6 . 1 . the short - term toxicity study does not need to be conducted if : – a reliable sub - chronic or chronic toxicity study is available , provided that an appropriate species , dosage , solvent and route of administration were used ; or – where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products ; or – relevant human exposure can be excluded in accordance with annex iv section 3 the appropriate route shall be chosen on the following basis : testing by the dermal route is appropriate if : inhalation of the substance is unlikely ; and skin contact in production and / or use is likely ; and the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin . testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and / or the possibility of exposure to aerosols , particles or droplets of an inhalable size . the sub - chronic toxicity study shall be proposed by the applicant if : the frequency and duration of human exposure indicates that a longer term study is appropriate ; and one of the following conditions is met : – other available data indicate that the substance may have a dangerous property that cannot be detected in a short - term toxicity study ; or – appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short term toxicity study but which are liable to result in adverse effects after prolonged exposure . further studies shall be proposed by the applicant or may be required in case of : – failure to identify a noael in the 28 or the 90 days study , unless the reason for the failure to identify a noael is absence of adverse toxic effects ; or – toxicity of particular concern ; or – indications of an effect for which the available evidence is inadequate for toxicological and / or risk characterisation . in such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects ; or – the route of exposure used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route - to - route extrapolation cannot be made ; or – particular concern regarding exposure ; or – effects shown in substances with a clear relationship in molecular structure with the substance being studied , were not detected in the 28 or the 90 days study . ### 6 . 1 . the short - term toxicity study does not need to be conducted if : – a reliable sub - chronic or chronic toxicity study is available or planned , provided that an appropriate species , dosage , solvent and route of administration were or are to be used ; or – where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products ; or – relevant human exposure can be excluded in accordance with annex iv section 3 . testing shall be conducted via the oral route unless : the primary route of human exposure will be dermal , and one of the following conditions is met : - the physicochemical and toxicological properties , including an in - vitro dermal penetration study , indicate that dermal bioavailability will be substantial ; or - significant dermal toxicity or dermal penetration is recognised for structurally related substances . the primary route of human exposure will be inhalation , taking into account the vapour pressure of the substance and likely frequency , magnitude and duration of exposure to aerosols , particles or droplets of an inhalable size . testing shall only be carried out via one exposure route . estimates of toxicity via other routes shall be based upon pharmacokinetic modelling . the sub - chronic toxicity study shall be proposed by the applicant in lieu of a 28 - day study if : the frequency and duration of human exposure indicates that a study of 1 month and for substances related on a molecular level to known organ - specific toxicants , additional relevant parameters should ideally be examined in the context of a 28 - day or 90 - day study in lieu of a stand - alone , e . g . neurotoxicity study . further stand - alone studies should be limited to exceptional circumstances .


### 6 . 2 . the sub - chronic toxicity study does not need to be conducted if : – a reliable short - term toxicity study is available showing severe toxicity effects according to the criteria for classifying the substance as r48 , for which the observed noael - 28 days , with the application of an appropriate uncertainty factor , allows the extrapolation towards the noael - 90 days for the same route of exposure ; or – a reliable chronic toxicity study is available , provided that an appropriate species and route of administration were used ; or – a substance undergoes immediate disintegration and there are sufficient data on the cleavage products ; or – the substance is unreactive , insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28 - day ' limit test ' , particularly if such a pattern is coupled with limited human exposure . the appropriate route shall be chosen on the following basis : testing by the dermal route is appropriate if : skin contact in production and / or use is likely ; and the physicochemical properties suggest a significant rate of absorption through the skin ; and one of the following conditions is met : – toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test ; or – systemic effects or other evidence of absorption is observed in skin and / or eye irritation studies ; or – in vitro tests indicate significant dermal absorption ; or – significant dermal toxicity or dermal penetration is recognised for structurally related substances . testing by the inhalation route is appropriate if : – exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and / or the possibility of exposure to aerosols , particles or droplets of an inhalable size . further studies shall be proposed by the applicant or may be required in case of : – failure to identify a noael in the 90 days study unless the reason for the failure to identify a noael is absence of adverse toxic effects ; or – toxicity of particular concern ; or – indications of an effect for which the available evidence is inadequate for toxicological and / or risk characterisation . in such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects ; or – particular concern regarding exposure . ### 6 . 2 . the sub - chronic toxicity study does not need to be conducted if : – a reliable short - term toxicity study is available showing severe toxicity effects according to the criteria for classifying the substance as r48 , for which the observed noael - 28 days , with the application of an appropriate uncertainty factor , allows the extrapolation towards the noael - 90 days for the same route of exposure ; or – a reliable chronic toxicity study is available , provided that an appropriate species and route of administration were used ; or – a substance undergoes immediate disintegration and there are sufficient data on the cleavage products ; or – the substance is unreactive , insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28 - day ' limit test ' , particularly if such a pattern is coupled with limited human exposure . testing shall be conducted via the oral route unless : the primary route of human exposure will be dermal , and one of the following conditions is met : - the physicochemical and toxicological properties , including an in - vitro dermal penetration study , indicate that dermal bioavailability will be substantial ; or - significant dermal toxicity or dermal penetration is recognised for structurally related substances . the primary route of human exposure will be inhalation , taking into account the vapour pressure of the substance and the likely frequency , magnitude and duration of exposure to aerosols , particles or droplets of an inhalable size . testing shall be carried out via one exposure route . estimates of toxicity via other routes shall be based upon pharmacokinetic modelling . for substances related on a molecular level to known organ - specific toxicants , additional relevant parameters should ideally be examined in the context of a 28 - day or 90 - day study in lieu of a standalone , e . g . neurotoxicity study . further standalone studies should be limited to exceptional circumstances .


### 6 . 3 . a long - term repeated toxicity study may be proposed by the applicant or required if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met : - serious or severe toxicity effects of particular concern when observed in the 28 - day or 90 - day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation ; or - effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28 - day or 90 - day study ; or - the substance may have a dangerous property that cannot be detected in a 90 - day study . ### 6 . 3 . a long - term repeated dose toxicity study may be proposed by the applicant or required only if : - the frequency , magnitude and duration of human exposure , indicate that a chronic risk assessment is appropriate ; and - if the application of an appropriate uncertainty factor would not be sufficiently protective for risk assessment purposes . if carcinogenicity data are also required and not already available , long - term repeated dose and carcinogenicity studies should be carried out using the oecd tg 453 combination study protocol .


### 7 . 1 . this study does not need to be conducted if : – the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented ; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented ; or – relevant human exposure can be excluded in accordance with annex iv section 3 ; or – a pre - natal developmental toxicity study or a two - generation reproductive toxicity study is available . if a substance is known to have an adverse effect on fertility , meeting the criteria for classification as repr cat 1a or 1b : may damage fertility , and the available data are adequate to support a robust risk assessment , then no further testing for fertility will be necessary . however , testing for development toxicity must be considered . if a substance is known to cause developmental toxicity , meeting the criteria for classification as repr cat 1a or 1b : may damage the unborn child , and the available data are adequate to support a robust risk assessment , then no further testing for developmental toxicity will be necessary . however , testing for effects on fertility must be considered . in cases where there are serious concerns about the potential for adverse effects on fertility or development , either a pre - natal developmental toxicity study or a two generation reproductive toxicity study may be proposed by the applicant instead of the screening study . ### 7 . 1 . this study does not need to be conducted if : – the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented ; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented ; or –there is no significant human exposure in accordance with annex iv section 3 ; or – a pre - natal developmental toxicity study or a one - or two - generation reproductive toxicity study is available . if a substance is known to have an adverse effect on fertility , meeting the criteria for classification as repr cat 1a or 1b : may damage fertility , and the available data are adequate to support a robust risk assessment , then no further testing for fertility will be necessary . however , testing for pre - natal development toxicity must be considered . if a substance is known to cause developmental toxicity , meeting the criteria for classification as repr cat 1a or 1b : may damage the unborn child , and the available data are adequate to support a robust risk assessment , then no further testing for developmental toxicity will be necessary . however , testing for effects on fertility must be considered . in cases where there are serious concerns about the potential for adverse effects on fertility or development , an enhanced one - generation reproductive toxicity study , with or without a pre - natal developmental toxicity module , may be proposed by the applicant instead of the screening study .


### where testing is done , a detailed description of the material used and its impurities must be provided . where necessary , data as established in annex ii shall be required for all the toxicologically / eco - toxicologically relevant chemical components of the biocidal product , in particular if the components are substances of concern as defined in article 3 . ### where testing is done , a detailed description of the material used and its impurities must be provided .


### where test data exist that have been generated before . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] by methods other than those laid down in regulation no 440 / 2008 , the adequacy of such data for the purposes of this regulation and the need to conduct new tests according to the regulation no 440 / 2008 must be decided by the competent authority of the member state , on a case - by - case basis , taking into account , among other factors , the need to minimise testing on vertebrate animals . ### where test data exist that have been generated before . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] by methods other than those laid down in regulation no 440 / 2008 , the adequacy of such data for the purposes of this regulation and the need to conduct new tests according to the regulation no 440 / 2008 must be decided by the competent authority of the member state concerned in agreement with the echa , on a case - by - case basis , taking into account , among other factors , the need to minimise testing on vertebrate animals .


### for studies of sections 6 . 1 . 1 to 6 . 1 . 3 , biocidal products other than gases shall be administered via at least two routes , one of which should be the oral route . the choice of the second route will depend on the nature of the product and the likely route of human exposure . gases and volatile liquids should be administered by the inhalation route ### for studies of sections 6 . 1 . 1 to 6 . 1 . 3 , classification by calculation should be the default approach . only in exceptional cases should additional in - vivo testing be considered , and in such cases , only the single most relevant exposure route should be tested . gases and volatile liquids should be administered by the inhalation route .


### results are adequate for the purpose of classification and labelling and risk assessment ; and ### results are adequate for the purpose of classification and / or labelling and risk assessment ; and


### data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering in its effect on target vertebrates . this shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates ; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated . ### data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering and pain in its effect on target vertebrates . this shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates ; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated . those findings shall for each authorised biocidal product be made publicly available on the agency website .


### the commission shall be empowered to adopt delegated acts in accordance with article 94 concerning measures to specify some technical elements of the definitions laid down in paragraph 1 of this article , to adjust them to market developments . ### the commission shall be empowered to adopt delegated acts in accordance with article 94 concerning measures to specify some technical elements of or amend the definitions laid down in paragraph 1 of this article , if appropriate , to take into account : technical developments in financial markets ; the list of abusive practices referred to in article 34b of regulation no … / … of the european parliament and of the council of . . . [ mar ] in particular with regard to high - frequency trading and including , but not limited to , spoofing , quote stuffing and layering .


### esma shall develop draft implementing technical standards to determine the format of the reports mentioned in point of paragraph 1 , and the content of the information to be provided in accordance with paragraph 2 . ### esma shall develop draft implementing technical standards to determine the format of the reports mentioned in paragraph 1 and in paragraph 1a and the content of the information to be provided in accordance with paragraph 2 .


### the delegation of power referred to in article 21 shall be conferred for an indeterminate period of time [ from the date of entry into force of this regulation . ] ### the delegation of power referred to in article 21 shall be conferred for a period of five years [ from the date of entry into force of this regulation . ] the commission shall submit a report on the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of identical duration unless the european parliament or council opposes such an extension not later than three months before the end of each period .


### on the high seas , the participating units shall take one or more of the following measures when there are reasonable grounds to suspect that a ship is engaged in the smuggling of migrants by sea subject to the authorisation of the flag state in accordance with the protocol against the smuggling of migrants : ### on the high seas , the participating units and , as required , representatives of the consultative forum , shall take one or more of the following measures when there are reasonable grounds to suspect that a ship is engaged in the smuggling of migrants by sea subject to the authorisation of the flag state in accordance with the protocol against the smuggling of migrants :


### participating units shall promptly communicate their assessment of the situation to the responsible rescue coordination centre . while awaiting instructions from the rescue coordination centre , participating units shall take all the appropriate measures to ensure the safety of the persons concerned . ### participating units shall promptly communicate their assessment of the situation to the responsible rescue coordination centre . while awaiting instructions from the rescue coordination centre , participating units shall take all the appropriate measures to ensure the safety and respect of human rights of the persons concerned .


### however , under the current measures regarding the security of gas supply that have been taken at community level , member states still enjoy a large margin of discretion as to the choice of measures . where the security of supply of a member state is threatened , there is a clear risk that measures developed unilaterally by that member state may jeopardise the proper functioning of the internal gas market . recent experience has demonstrated the reality of that risk . to allow the internal gas market to function even in the face of a shortage of supply , it is therefore necessary to provide for a more coordinated response to supply crises , both concerning preventive action and the reaction to concrete disruptions of supply . ### however , under the current measures regarding the security of gas supply that have been taken at community level , member states still enjoy a large margin of discretion as to the choice of measures . where the security of supply of a member state is threatened , there is a clear risk that measures developed unilaterally by that member state may jeopardise the proper functioning of the internal gas market . recent experience has demonstrated the reality of that risk . to allow the internal gas market to function even in the face of a shortage of supply , it is therefore necessary to provide for a more coordinated response to supply crises , especially concerning preventive action such as the reduction of consumption and the integration and connection of renewable energy sources with the power grid , and the reaction to concrete disruptions of supply .


### gas routes and sources for the community should support the security of supply of the community as a whole and its member states individually . security of supply will depend in the future on the evolution of the fuel mix , the development of production in the community and in third countries supplying the community , investments in storage facilities and in routes within and outside the community including liquefied natural gas facilities . ### the diversification of gas routes and sources for the community is essential for strengthening the security of supply of the community as a whole and its member states individually . security of supply will depend in the future on the increase in energy efficiency , the evolution of the fuel mix , the development of production in the community and in third countries supplying the community , investments in storage facilities and in the diversification of routes and sources of supply within and outside the community , including liquefied natural gas facilities .


### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . ### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . efficient energy use should be a permanent priority , as a demand - side measure .


### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . ### sufficient and diversified gas infrastructure in the member states , particularly in regions that are isolated from sources of energy supply , is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption .


### investments in new gas infrastructure should be strongly promoted . they should enhance the security of gas supply while ensuring the proper functioning of the internal market in natural gas . where an infrastructure investment is of cross - border nature the agency for the cooperation of energy regulators established by regulation no . . . / … of the european parliament and of the council and the european network of transmission system operators for gas should be closely involved in order to take better account of the cross - border implications . ### investments in new gas infrastructure must be strongly promoted , particularly in regions that are isolated from sources of energy supply . such investments would reduce dependency on a single supplier and better ensure the security of gas supply and improved functioning of the internal market in natural gas . where an infrastructure investment is of cross - border nature the agency for the cooperation of energy regulators established by regulation no . . . / … of the european parliament and of the council and the european network of transmission system operators for gas should be closely involved in order to take better account of the cross - border implications .


### to strengthen the solidarity between member states in the case of a community emergency and in particular to support member states which are exposed to less favourable geographical or geological conditions , member states should devise specific measures to exercise solidarity , including measures such as commercial agreements between natural gas undertakings , compensation mechanisms , increased gas exports or increased releases from storages . solidarity measures may be particularly appropriate between member states for which the commission recommends the establishment of joint preventive actions plans or emergency plans at regional level . ### the treaty on the functioning of the european union provides for the strengthening of solidarity between member states in the case of a community emergency and in particular to support member states which are exposed to less favourable geographical or geological conditions , member states should devise specific measures to exercise solidarity , including measures such as commercial agreements between natural gas undertakings , compensation mechanisms , increased gas exports or increased releases from storages . solidarity measures may be particularly appropriate between member states for which the commission recommends the establishment of joint preventive actions plans or emergency plans at regional level .


### member states shall ensure that any new transmission infrastructure provides for the security of supply by means of sufficient number of entry and exit points , and contributes to the development of a well connected infrastructure . ### member states shall ensure that national entry capacity and transmission networks are capable of adapting the national gas flows to the disruption of any gas supply infrastructure scenario , removing internal bottlenecks and contributing to the development of a well connected infrastructure .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall introduce appropriate incentives and take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs or their methodologies in line with article 41 of directive 2009 / 73ec . in the case of costs incurred in more than one member state or in one member state for the benefit of other member states , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation before any investment decision is taken . any such investment decision shall be subject to approval and acknowledgement of its retribution once commissioned by the national regulatory authority in relation to its costs and the allocation of such costs among all of the national regulatory authorities concerned . the proportion to which each member state benefits from the investment with regard to security of supply shall be taken into consideration in relation to the allocation of costs among those member states . article 8 of regulation no 715 / 2009 shall apply .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall take into account efficiently incurred costs related to measures imposed as a result of this regulation . in the case of investments that affect more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation of efficiently incurred costs in one or more member states . article 8 of regulation no 715 / 2009 shall apply .


### the competent authority shall allow the natural gas undertakings to meet these criteria on a regional or community level and shall not require that these standards are met based on infrastructure located only within its territory . ### the competent authority shall allow the natural gas undertakings to meet these criteria on a national , regional or community level and shall not require that these standards are met based on infrastructure located only within its territory .


### the commission may declare a community emergency at the request of one competent authority or when the community loses more than 10% of its daily gas import from third countries as calculated by entso - g . it shall declare a community emergency where more than one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a community emergency for specifically affected geographical regions comprising more than one member state . ### the commission , after the consulting the gas coordination group , may declare a union emergency at the request of one competent authority or when the union loses more than 10% of its daily gas import from third countries as calculated by entso - g . it shall declare a union emergency where more than one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a union emergency for specifically affected geographical regions comprising more than one member state .