### the treaty also establishes citizenship of the union , which complements national citizenship of the respective member states , and which is an important element in safeguarding and strengthening the process of european integration . for citizens to give their full support to european integration , greater emphasis should be placed on their common values , history and culture as key elements of their membership of a society founded on the principles of freedom , democracy , respect for human rights , cultural diversity , tolerance and solidarity . ### the treaty also establishes citizenship of the union , which complements national citizenship of the respective member states , and which is an important element in safeguarding and strengthening the process of european integration . for citizens to give their full support to european integration , greater emphasis should be placed on their common values , history and culture as key elements of their membership of a society founded on the principles of freedom , democracy , respect for human rights , cultural and linguistic diversity , tolerance and solidarity .


### the european heritage label should seek synergies and complementarities with other initiatives such as the unesco world heritage list and the council of europe’s ‘ european cultural routes’ . the added value of the new european heritage label should be based on the contribution made by the selected sites to european history and culture , on a clear educational dimension reaching out to citizens , including young people , and on networking between the sites to share experiences and best practices . the main focus of the initiative should be on the promotion and the access of the sites , and on the quality of the explanations given and of the activities proposed , rather than on the conservation of the sites , which should be guaranteed by existing protection regimes . ### the european heritage label should seek synergies and complementarities with other initiatives such as the unesco world heritage list and the council of europe’s ‘ european cultural routes’ . the added value of the new european heritage label should be based on the contribution made by the selected sites to european history and culture , on a clear educational dimension reaching out to citizens , especially young people , and on networking between the sites to share experiences and best practices . the main focus of the initiative should be on the promotion and the access of the sites , and on the quality of the explanations given and of the activities proposed , rather than on the conservation of the sites , which should be guaranteed by existing protection regimes .


### for the purposes of this decision , ‘ sites’ shall mean monuments , natural or urban sites , cultural landscapes , places of remembrance , cultural goods and objects , intangible heritage attached to a place , including contemporary heritage . ### for the purposes of this decision , ‘ sites’ shall mean monuments , natural or urban sites , cultural landscapes , places of remembrance , cultural goods and objects , cultural routes and intangible heritage attached to a place , including contemporary heritage .


### – increase intercultural dialogue , especially among young people , through artistic , cultural and historical education ; ### – increase intercultural dialogue , especially among young people , through artistic , cultural , historical and interactive online education ;


### and / or the place and role of a site in european history and european integration , and its links with key european events or personalities , as well as with cultural , artistic , political , social , scientific , technological or industrial movements ; ### and / or the place and role of a site in european history and european integration , and its links with key european events or personalities , as well as with cultural , artistic , political , social , scientific , technological , environmental or industrial movements ;


### – and / or the place and role of a site in european history and european integration , and its links with key european events or personalities , as well as with cultural , artistic , political , social , scientific , technological or industrial movements ; ### – and / or the place and role of a site in european history and european integration , and its links with key european events or personalities , as well as with cultural , artistic , political , social , scientific , technological or industrial developments ;


### – taking part in the activities of networks of sites awarded the european heritage label in order to exchange experiences and initiate common projects ; ### – cooperation with sites already awarded the label ;


### – the organisation of artistic and cultural activities which foster the mobility of european artists and collections , stimulate intercultural dialogue and encourage linkage between heritage and contemporary creation and creativity are welcomed whenever the specificity of the site allows it . ### – the organisation of artistic and cultural activities which foster the mobility of european cultural agents , artists and collections , stimulate intercultural dialogue and encourage linkage between heritage and contemporary creation and creativity are welcomed whenever the specificity of the site allows it .


### – ensuring the management plan is as environmentally friendly as possible in order to limit potential negative impacts of tourism . ### &#8211 ; taking account of the extent to which the management plan is environmentally friendly .


### the pre - selection of the sites for the attribution of the european heritage label shall be under the responsibility of the member states . ### the standardised pre - selection of the sites for the attribution of the european heritage label shall be under the responsibility of the member states .


### 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 , in the light of the recommendation of the european panel , and after consulting the european parliament and the council .


### 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 extent to which the action contributes to achieving the basic objective which is to foster among european citizens a greater sense of belonging to the eu and to encourage intercultural dialogue , the number of sites , the impact of the action , how it could be improved and whether the european heritage label should be continued .


### the identification of projects of common interest should be based on common , transparent and objective criteria in view of their contribution to the energy policy objectives . for electricity and gas , proposed projects should be part of the latest available ten - year network development plan . this plan should notably take account of the conclusions of the 4 february european council with regard to the need to integrate peripheral energy markets . ### the identification of projects of common interest should comply with common , transparent and objective criteria in view of their contribution to the energy policy objectives . projects for electricity and gas should be part of the latest available ten - year network development plan . this plan should notably take account of the conclusions of the 4 february european council with regard to the need to integrate peripheral energy markets .


### despite the existence of established standards for the participation of the public in environmental decision - making procedures , additional measures are needed to ensure highest possible standards of transparency and public participation for all relevant issues in the permit granting process for projects of common interest . ### despite the existence of established standards for the participation of the public in environmental decision - making procedures , additional measures are needed to ensure highest possible standards of transparency and appropriate public participation for all relevant issues in the permit granting process for projects of common interest .


### the commission shall establish a union - wide list of projects of common interest . the list shall be reviewed and updated as necessary every two years . the first list shall be adopted by 31 july 2013 at the latest . ### the commission shall establish a union - wide list of projects of common interest . the list shall be reviewed and updated as necessary every two years . the first list shall be adopted by 31 july 2013 at the latest . the commission shall also take into account the specific characteristics of small island member states to ensure that no eu member state remains isolated from the european gas and electricity networks after 2015 or see its energy security jeopardised by lack of the appropriate connections , in terms of timely development of projects . the union - wide list shall also include such projects .


### the commission shall establish a union - wide list of projects of common interest . the list shall be reviewed and updated as necessary every two years . the first list shall be adopted by 31 july 2013 at the latest . ### the commission adopts delegated acts concerning the establishment and&#160 ; reviewing of the union - wide list of projects of common interest . the list shall be reviewed and updated every two years on the basis of the regional lists adopted and reviewed by the groups following the provisions set out in this article . the first list shall be adopted by 31 july 2013 at the latest .


### the commission shall establish a union - wide list of projects of common interest . the list shall be reviewed and updated as necessary every two years . the first list shall be adopted by 31 july 2013 at the latest . ### the commission shall establish a union - wide list of projects of common interest , classifying them in order of importance . the list shall be reviewed and updated as necessary every two years . the first list shall be adopted by 31 july 2013 at the latest .


### for the purpose of identifying projects of common interest , the commission shall establish a regional group as defined in section 1 of annex iii based on each priority corridor and area and their respective geographical coverage as set out in annex i . ### for the purpose of identifying projects of common interest , the commission shall establish twelve regional groups based on each priority corridor and area and their respective geographical coverage as set out in annex i . the composition of each group should be based on the rules defined in section 1 of annex iii . each group will carry out its workload based on previously agreed terms of reference or rules of procedure , having regard to any guidance provided by the commission on this subject .


### each group shall draw up its proposed list of projects of common interest according to the process set out in section 2 of annex iii , according to the contribution of each project to implementing the energy infrastructure priority corridors and areas set out in annex i and according to their fulfilment of the criteria set out in . each individual proposal for a project shall require the approval of the member state , to the territory of which the project relates . ### each group shall adopt its regional list of projects of common interest , drawn up in accordance to the process set out in section 2 of annex iii , according to the contribution of each project to implementing the energy infrastructure priority corridors and areas set out in annex i and according to their fulfilment of the criteria set out in . each individual proposal for a project shall require the approval of the member state , to the territory of which the project relates .


### for electricity and gas projects falling under the categories set out in points 1 and 2 of annex ii , the agency shall submit , within two months from the date of receipt of the proposed lists of projects of common interest set out in the first subparagraph of paragraph 4 , an opinion to the commission on the proposed lists of projects of common interest , in particular taking into account the consistent application of the criteria set out in across the groups , and the results of the analysis carried out by the entsos for electricity and gas in accordance with point 2 . 6 of annex iii . ### for electricity and gas projects falling under the categories set out in points 1 and 2 of annex ii , the agency shall submit , within two months from the date of receipt of the proposed lists of projects of common interest set out in the first subparagraph of paragraph 4 , an opinion to the commission on the proposed lists of projects of common interest , in particular taking into account the consistent application of the criteria set out in across the groups , and the results of the analysis carried out by the entsos for electricity and gas in accordance with point 2 . 6 of annex iii . the commission shall finalise the list of projects of common interest , providing detailed analysis for its decision on each project .


### when a project of common interest encounters significant implementation difficulties , the commission may designate a european coordinator for a period of up to one year renewable twice . ### when a project of common interest encounters significant implementation difficulties , the commission , in agreement with the member states concerned , may designate a european coordinator for a period of up to one year renewable twice .


### coordinated scheme : the comprehensive decision may encompass multiple individual legally binding decisions issued by the competent authority and other authorities concerned . the competent authority shall establish , on a case - by - case basis , a reasonable time limit within which the individual decisions must be issued . the competent authority may take an individual decision on behalf of another national authority concerned , if the decision by that authority is not delivered within the time limit and if the delay cannot be adequately justified . the competent authority may overrule an individual decision of another national authority , if it considers that the decision is not sufficiently substantiated with regard to the underlying evidence presented by the authority concerned . the competent authority shall ensure that the relevant requirements under international and union legislation are respected and must duly justify its decision . ### coordinated scheme : the comprehensive decision may encompass multiple individual legally binding decisions issued by the competent authority and other authorities concerned . the competent authority shall , in consultation with the other authorities concerned , establish , on a case - by - case basis , a reasonable time limit within which the individual decisions can be issued , as well as the resulting total permitting time limit . the competent authority shall monitor the compliance of the time limits by the authorities concerned . if the decision by the authority involved is expected not to be delivered within the time limit , that authority shall inform the competent authority forthwith and include a justification for the delay . the competent authority may take an individual decision on behalf of another national authority concerned , if the delay cannot be adequately justified . the competent authority may overrule an individual decision of another national authority , if it considers that the decision is not sufficiently substantiated with regard to the underlying evidence presented by the authority concerned . the competent authority shall ensure that the relevant requirements under international and union legislation are respected and must duly justify its decision .


### for projects likely to have significant adverse cross - border impacts in one or more neighbouring member states , where article 7 of directive 85 / 337 / eec and the espoo convention are applicable , the relevant information shall be made available to the competent authority of the neighbouring member state . the competent authority of the neighbouring member state shall indicate whether it wishes to participate in the relevant public consultation procedures . ### for projects likely to have significant adverse cross - border environmental impacts in one or more neighbouring member states , where article 7 of directive 85 / 337 / eec and the espoo convention are applicable , the relevant information shall be made available to the competent authority of the neighbouring member state . the competent authority of the neighbouring member state shall indicate whether it wishes to participate in the relevant public consultation procedures .


### 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 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 the preparation of each ten year network development plan developed by the entsos for electricity or gas pursuant art . 8 of regulation 714 / 2009 and regulation 715 / 2009 , including 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 . the methodology shall employ criteria , relevant to the cost benefit analysis , consistent with the criteria from article 4 and annex iv . &#160 ;


### for electricity projects falling under the categories set out in point 1 of annex ii , each group shall be composed of representatives of the member states , national regulatory authorities , transmission system operators following their obligation to cooperate on a regional level in accordance with article 6 of directive 2009 / 72 / ec and article 12 of regulation no 714 / 2009 and project promoters concerned by each of the relevant priorities designated in annex i , as well as the commission , the agency and the entso for electricity . ### for electricity projects falling under the categories set out in point 1 of annex ii , each group shall be composed of representatives of the competent authorities of&#160 ; the member states , national regulatory authorities , transmission system operators following their obligation to cooperate on a regional level in accordance with article 6 of directive 2009 / 72 / ec and article 12 of regulation no 714 / 2009 and project promoters concerned by each of the relevant priorities designated in annex i , as well as the commission , the agency and the entso for electricity .


### for gas projects falling under the categories set out in point 2 of annex ii , each group shall be composed of representatives of the member states , national regulatory authorities , transmission system operators following their obligation to cooperate on a regional level in accordance with article 7 of directive 2009 / 73 / ec and article 12 of regulation no 715 / 2009 and project promoters concerned by each of the relevant priorities designated in annex 1 , as well as the commission , the agency and the entso for gas . ### for gas projects falling under the categories set out in point 2 of annex ii , each group shall be composed of representatives of the competent authorities of the member states , national regulatory authorities , transmission system operators following their obligation to cooperate on a regional level in accordance with article 7 of directive 2009 / 73 / ec and article 12 of regulation no 715 / 2009 and project promoters concerned by each of the relevant priorities designated in annex 1 , as well as the commission , the agency and the entso for gas .


### for oil and carbon dioxide transport projects falling under the categories referred to in annex ii and , each group shall be composed of the representatives of the member states , project promoters concerned by each of the relevant priorities designated in annex 1 and the commission . ### for oil and carbon dioxide transport projects falling under the categories referred to in annex ii and , each group shall be composed of the representatives of the competent authorities of the member states , project promoters concerned by each of the relevant priorities designated in annex 1 and the commission .


### proposed electricity transmission and storage projects falling under the categories set out in point 1 to of annex ii shall be part of the latest available ten - year network development plan for electricity , developed by the entso for electricity pursuant article 8 of regulation 714 / 2009 . ### for all of projects of common interest included in the union - wide list after 1 august 2013 , electricity transmission and storage projects falling under the categories set out in point 1 to of annex ii shall be part of the latest available ten - year network development plan for electricity , developed by the entso for electricity pursuant article 8 of regulation 714 / 2009 .


### for all union - wide lists of projects of common interest adopted after 1 august 2013 , proposed gas transmission and storage projects falling under the categories set out in point 2 of annex ii shall be part of the latest available ten - year network development plan for gas , developed by the entso for gas pursuant article 8 of regulation 715 / 2009 . ### for all of projects of common interest included in the union - wide list after 1 august 2013 , gas transmission and storage projects falling under the categories set out in point 2 of annex ii shall be part of the latest available ten - year network development plan for gas , developed by the entso for gas pursuant article 8 of regulation 715 / 2009 .


### these procedures and conditions should be clear , simple , user - friendly and proportionate to the nature of the citizens ' initiative . ### these procedures and conditions should be clear , simple , user - friendly and proportionate to the nature of the citizens ' initiative , so as to encourage participation by citizens and to make the union more accessible .


### ' organiser ' means a natural or legal person or organisation responsible for the preparation and submission of a citizens ' initiative to the commission . ### ' organiser ' means a natural person responsible for the preparation and submission of a citizens initiative to the commission .


### “organiser” means a natural or legal person or organisation responsible for the preparation and submission of a citizens’ initiative to the commission . ### “organiser” means a natural or legal person or organisation responsible for the preparation and submission of a citizens’ initiative to the commission . , with the exception of political parties , trade unions and lobby groups .


### 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 . ### the organisers shall be citizens of the union and be of the age to be entitled to vote in the european elections . they should not be currently serving as directly elected politicians . the organisers shall form a citizens ' committee of at least seven persons coming from at least one fourth of the member states . the organisers shall designate a contact person for the organising committee .


### registration of a proposed citizens’ initiative ### registration and admissibility of a proposed citizens’ initiative


### except in the cases foreseen in paragraphs 3 and 4 , the commission shall register without delay the proposed initiative under a unique registration number and send a confirmation to the organiser . ### the commission shall , within two months from the request for registration referred to in paragraph 1 , take a decision on admissibility . the proposed citizens ' initiative shall be considered admissible and therefore registered if it satisfies the following conditions : – it cannot be reasonably regarded as improper because it is abusive or devoid of seriousness ; – it does not run counter to the values of the union ; – it concerns a matter where a legal act of the union can be adopted for the purpose of implementing the treaties ; and – it falls within the framework of the powers of the commission to make a proposal .


### a proposed citizens ' initiative that has been registered shall be made public in the register . ### the decision on admissibility shall be notified to the organisers of the proposed citizens ' initiative and shall be made public . it shall also include an indication as to which legal act or measures the commission considers that it is appropriate to take if one million statements of support are collected in favour of that citizens ' initiative . the commission may always modify that indication at the moment when it adopts its decision on whether or not to go forward with a citizens ' initiative .


### the organiser shall be responsible for the collection of the necessary statements of support from signatories for a proposed citizens ' initiative which has been registered in accordance with article 4 . ### the organiser shall be responsible for the collection of the necessary statements of support from signatories for a proposed citizens ' initiative which has been registered and declared admissible in accordance with article 4 .


### after having collected the necessary statements of support from signatories in accordance with articles 5 and 7 , and provided that the commission has decided that a proposed citizens ' initiative is admissible in accordance with article 8 , the organiser shall submit the statements of support , in paper or in electronic form , to the relevant competent authorities provided for in article 14 for verification and certification . for this purpose the organiser shall use the form set out in annex vi . ### after having collected the necessary statements of support from signatories in accordance with articles 5 and 7 , and provided that the commission has decided that a proposed citizens ' initiative is admissible in accordance with article 4 , the organiser shall submit the statements of support , in paper or in electronic form , to the relevant competent authorities provided for in article 14 for verification and certification . for this purpose the organiser shall use the form set out in annex vi .


### publish the citizens ' initiative without delay on its website ; ### publish the citizens ' initiative without delay on its website , in all the official languages of the union ;


### 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 three 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 .


### five years after the entry into force of this regulation , the commission shall present a report to the european parliament and the council on the implementation of this regulation . ### two years after the entry into force of this regulation , the commission shall present a report to the european parliament and the council on the implementation of this regulation .


### full name , postal address and e - mail address of the organiser or , in the case of a legal entity or organisation , its legal representative* : ### full name , postal address and e - mail address of the organiser .


### full name , postal address and e - mail address of the organiser or , in the case of a legal entity or organisation , its legal representative . ### full name , postal address and e - mail address of the organiser .


### european standards should continue to be adopted by the european standardisation bodies , namely european committee for standardisation , the european committee for electrotechnical standardisation and the european telecommunications standards institute . ### does not affect the english version .


### european standards are of vital interest for the competitiveness of smes which , however , are in general under - represented in standardisation activities , in particular at european level . thus , this regulation should ensure an appropriate representation of sme in the european standardisation process by an entity with appropriate qualifications . ### european standards are of vital interest for the competitiveness of smes which , however , are in general under - represented in standardisation activities , in particular at european level . thus , this regulation should ensure an appropriate representation of sme in the european standardisation process by an entity with appropriate qualifications . special attention should be devoted to the representation and needs of smes with regard to international standardisation work .


### public authorities should make best use of the full range of relevant standards when procuring hardware , software and information technology services , for example by selecting standards which can be implemented by all interested suppliers , allowing for more competition and reduced risk of lock - in . directive 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors and directive 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts specify that technical specifications in public procurement should be formulated by reference to national standards transposing european standards , european technical approvals , common technical specifications , international standards , other technical reference systems established by the european standardisation bodies or - when these do not exist - to national standards , national technical approvals or national technical specifications relating to the design , calculation and execution of the works and use of the products , or equivalent . standards in the field of information and communication technologies , however , are often developed by other standard developing organisations and do not fall in any of the categories of standards and approvals laid down in directives 2004 / 17 / ec and 2004 / 18 / ec . therefore , it is necessary to provide for the possibility that technical specifications for public procurement could refer to standards in the field of information and communication technologies , in order to respond to the fast evolution in the field of information and communication technologies , facilitate the provision of cross - border services , encourage competition and promote interoperability and innovation . ### public authorities should make best use of the full range of relevant standards when procuring hardware , software and information technology services , for example by selecting standards which can be implemented by all interested suppliers , allowing for more competition and reduced risk of lock - in . directive 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors and directive 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts specify that technical specifications in public procurement should be formulated by reference to national standards transposing european standards , european technical approvals , common technical specifications , international standards , other technical reference systems established by the european standardisation bodies or - when these do not exist - to national standards , national technical approvals or national technical specifications relating to the design , calculation and execution of the works and use of the products , or equivalent . standards in the field of information and communication technologies , however , are often developed by other standard developing organisations and do not fall in any of the categories of standards and approvals laid down in directives 2004 / 17 / ec and 2004 / 18 / ec . therefore , it is necessary to provide for the possibility that invitations to tender for public procurement could refer to certain technical specifications in the field of information and communication technologies , in order to respond to the fast evolution in the field of information and communication technologies , facilitate the provision of cross - border services , encourage competition and promote interoperability and innovation .


### some standards in the field of information and communication technologies are not developed according to the criteria set out in annex 3 of the agreement on technical barriers to trade . therefore , this regulation should lay down a procedure for the selection of the standards in the field of information and communication technologies that could be used in public procurement , involving a broad consultation of a large spectrum of stakeholders , including the european standardisation bodies , enterprises and public authorities . this regulation should also lay down requirements , in the form of a list of attributes , for such standards and their associated standardisation processes . these attributes should ensure that public policy objectives and societal needs are respected , and should be founded on the criteria developed within the world trade organisation for international standardisation organisations . ### some technical specifications in the field of information and communication technologies are not developed according to the criteria set out in annex 3 of the agreement on technical barriers to trade . therefore , this regulation should lay down a procedure for the selection of the technical specifications in the field of information and communication technologies that could be used in public procurement , involving a broad consultation of a large spectrum of stakeholders , including the european standardisation bodies , enterprises and public authorities . this regulation should also lay down requirements , in the form of a list of attributes , for such technical specifications and their associated standardisation processes . these attributes should ensure that public policy objectives and societal needs are respected , and should be founded on the criteria developed within the world trade organisation for international standardisation organisations .


### the selected standards in the field of information and communication technologies could contribute to the implementation of decision no 922 / 2009 / ec of the european parliament and of the council of 16 september 2009 on interoperability solutions for european public administrations which establishes , for the period 2010 - 2015 , a programme on interoperability solutions for european public administrations and institutions and bodies of the union , providing common and shared solutions facilitating interoperability . ### the selected technical specifications in the field of information and communication technologies could contribute to the implementation of decision no 922 / 2009 / ec of the european parliament and of the council of 16 september 2009 on interoperability solutions for european public administrations which establishes , for the period 2010 - 2015 , a programme on interoperability solutions for european public administrations and institutions and bodies of the union , providing common and shared solutions facilitating interoperability .


### standards in the field of ict ### technical specifications in the field of ict


### recognition of technical specifications in the field of ict ### use of technical specifications in the field of ict


### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission may decide to recognise technical specifications which are not national , european or international standards and meet the requirements set out in annex ii , as ict standards . ### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission , after consulting the european multi - stakeholder platform on ict standardisation , may decide to recognise technical specifications in the field of ict which are not national , european or international standards and meet the requirements set out in annex ii for the purpose of awarding public contracts or implementing union policies .


### the translation , where required , of european standards or european standardisation deliverables used in support of union policies and legislation into the official union languages other than the working languages of the european standardisation bodies or , in duly justified cases into languages other than the official union languages , ### the translation , where required , of european standards or european standardisation deliverables used in support of union policies and legislation into the official union languages other than the working languages of the european standardisation bodies or into languages other than the official union languages when that makes it possible to promote european standards in third countries ,


### adapt the criteria for recognising standards in the field of ict set out in annex ii to technical developments ; ### adapt the criteria for recognising standards in the field of ict set out in annex ii to technical developments , without , however , creating or abandoning any of the criteria ;


### adapt the criteria for organisations representing sme and societal stakeholders set out in annex iii to further developments as regards their non - profit making nature and representativity . ### adapt the criteria for organisations representing sme and societal stakeholders set out in annex iii to further developments as regards their non - profit making nature and representativity without , however , creating or abandoning / abolishing any criterion or organisation .


### the technical specifications were developed by a non - profit making organisation which is a professional society , industry or trade association or any other membership organisation that within its area of expertise develops standards in the field of information and communication technologies and which is not a european , national or international standardisation body , through processes which fulfil the following criteria : ### the technical specifications were developed by a non - profit making organisation which is a professional society , industry or trade association or any other membership organisation that within its area of expertise develops technical specifications in the field of information and communication technologies and which is not a european , national or international standardisation body , through processes which fulfil the following criteria :


### the technical specifications were developed on the basis of open decision - making accessible to all interested operators in the market or markets affected by the standard . ### the technical specifications were developed on the basis of open decision - making accessible to all parties concerned in the market or markets affected by the technical specification .


### the standardisation process was collaborative and consensus based and did not favour any particular stakeholder . consensus means a general agreement , characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments . consensus does not imply unanimity . ### the process of drafting technical specifications was collaborative and consensus based and did not favour any particular stakeholder . consensus means a general agreement , characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments . consensus does not imply unanimity .


### adopt an anti - fraud strategy , which is proportionate to the fraud risks having regard to cost - benefit of the measures to be implemented ; ### adopt an anti - fraud and transparency strategy , which is proportionate to the fraud risks having regard to cost - benefit of the measures to be implemented ;


### the management board shall adopt , in accordance with the procedure provided for in article 110 of the staff regulations , a decision based on article 2 of the staff regulations and on article 6 of the conditions of employment of other servants delegating the relevant appointing authority powers to the executive director and defining the conditions under which this delegation of powers can be suspended . the executive director is authorised to sub - delegate these powers . ### the management board shall adopt , in accordance with the procedure provided for in article 110 of the staff regulations , a decision based on article 2 of the staff regulations and on article 6 of the conditions of employment of other servants delegating the relevant appointing authority powers to the executive director and defining the conditions under which this delegation of powers can be suspended . the executive director is authorised to sub - delegate these powers . this shall not affect his or her liability . the executive director shall inform the management board of such delegations and sub - delegations .


### in application of the previous subparagraph , where exceptional circumstances so require , the management board may , by way of a decision , suspend temporarily the delegation of appointing authority powers to the executive director and those sub - delegated by the latter and exercise them itself or delegate them to one of its members or to a staff member other than the executive director . ### in application of the previous subparagraph , where exceptional circumstances so require , the management board may , by way of a decision , suspend temporarily the delegation of appointing authority powers to the executive director and those sub - delegated by the latter and exercise them itself or delegate them to one of its members or to a staff member other than the executive director . the delegatee shall inform the management board of such a delegation .


### the agency shall be managed by its executive director , who shall be completely independent in the performance of his / her duties . the executive director shall be accountable to the management board for his / her activities . ### the agency shall be managed by its executive director , who shall be completely independent in the performance of his / her duties . the executive director shall be accountable to the management board for his / her activities . prior to his appointment , the executive director should be invited to make a statement and engage in a debate with members of the european parliament .


### on receipt of the court of auditors’ observations on the agency’s provisional accounts , under article 148 of the general financial regulation , the executive director shall draw up the agency’s final accounts under his own responsibility and submit them to the management board for an opinion . ### based , where necessary , on the court of auditors’ observations on the agency’s provisional accounts , under article 148 of the general financial regulation , the executive director shall draw up the agency’s final accounts under his own responsibility and submit them , together with a statement of assurance , to the management board for approval .


### containers used at work for chemical substances or mixtures classified as hazardous according to the criteria for any of the hazard classes or categories 2 . 1 to 2 . 4 , 2 . 6 and 2 . 7 , 2 . 8 types a and b , 2 . 9 , 2 . 10 , 2 . 12 , 2 . 13 categories 1 and 2 , 2 . 14 categories 1 and 2 , 2 . 15 types a to f , 3 . 1 to 3 . 6 , 3 . 7 adverse effects on sexual function and fertility or on development , 3 . 8 effects other than narcotic effects , 3 . 9 and 3 . 10 in accordance with regulation no 1272 / 2008 of the european parliament and of the council on classification , labelling and packaging of substances and mixtures , and containers used for the storage of such hazardous substances or mixtures , together with the visible pipes containing or transporting hazardous substances and mixtures , must be labelled with appropriate pictograms in accordance with that regulation ### containers used at work for chemical substances or mixtures classified as hazardous according to the criteria for any of the hazard classes or categories 2 . 1 to 2 . 16 , 3 . 1 to 3 . 6 , 3 . 7 adverse effects on sexual function and fertility or on development , 3 . 8 effects other than narcotic effects , 3 . 9 and 3 . 10 in accordance with regulation no 1272 / 2008 of the european parliament and of the council on classification , labelling and packaging of substances and mixtures , and containers used for the storage of such hazardous substances or mixtures , together with the visible pipes containing or transporting hazardous substances and mixtures , must be labelled with appropriate pictograms in accordance with that regulation . the first subparagraph does not apply to containers used at work for brief periods or to containers whose contents change frequently , unless alternative adequate measures are taken , in particular for information and / or training , which guarantee the same level of protection . the labels referred to in paragraph 1 may be : – replaced by warning signs as provided for in annex ii , using the same pictograms or symbols , – supplemented by additional information , such as the name and / or formula of the hazardous substance or mixture and details of the hazard , – in connection with the transporting of containers at the place of work , supplemented or replaced by signs applicable throughout the union for the transport of hazardous substances or mixtures .


### chemical agents labelled as carcinogen category 1a , 1b , germ cell mutagen category 1a or 1b , toxic to reproduction category 1a or 1b , or toxic to reproduction with effects on or via lactation in accordance with regulation no 1272 / 2008 of the european parliament and of the council on classification , labelling and packaging of substances and mixtures in so far as they do not yet appear in annex ii ; ### chemical agents classified as carcinogen category 1a , 1b , germ cell mutagen category 1a or 1b , toxic to reproduction category 1a or 1b , or toxic to reproduction with effects on or via lactation in accordance with regulation no 1272 / 2008 of the european parliament and of the council on classification , labelling and packaging of substances and mixtures in so far as they do not yet appear in annex ii ;


### - skin corrosion , category 1a , 1b , 1c ### - skin corrosion , subcategories 1a , 1b , 1c


### - explosive , category “unstable explosive” , or divisions 1 . 1 , 1 . 2 , 1 . 3 , 1 . 5 ### - explosive , category “unstable explosive” , or divisions 1 . 1 , 1 . 2 , 1 . 3 , 1 . 4 , 1 . 5


### - specific target organ toxicity , category 1 ### - specific target organ toxicity , categories 1 and 2


### - respiratory sensitiser , category 1 ### - respiratory sensitiser , categories 1a and 1b


### - skin sensitiser , category 1 ### - skin sensitiser , categories 1a and 1b


### any chemical agent which meets the criteria laid down in regulation 1272 / 2008 for classification within any of the hazard classes or categories 2 . 1 to 2 . 4 , 2 . 6 and 2 . 7 , 2 . 8 types a and b , 2 . 9 , 2 . 10 , 2 . 12 , 2 . 13 categories 1 and 2 , 2 . 14 categories 1 and 2 , 2 . 15 types a to f , 3 . 1 to 3 . 6 , 3 . 7 adverse effects on sexual function and fertility or on development , 3 . 8 effects other than narcotic effects , 3 . 9 and 3 . 10 , whether or not that chemical agent is classified under that regulation ; ### any chemical agent which meets the criteria laid down in regulation 1272 / 2008 for classification within any of the hazard classes or categories 2 . 1 to 2 . 4 , 2 . 6 to 2 . 15 types a to f , 3 . 1 to 3 . 6 , 3 . 7 adverse effects on sexual function and fertility or on development , 3 . 8 effects other than narcotic effects , 3 . 9 and 3 . 10 , whether or not that chemical agent is classified under that regulation ;


### any chemical agent which , whilst not meeting the criteria for classification as hazardous in accordance with may , because of its physical , chemical or toxicological properties and the way it is used or is present in the workplace , present a risk to the safety and health of workers , including any chemical agent assigned an occupational exposure limit value under article 3 . ### any chemical agent which , whilst not meeting the criteria for classification as hazardous in accordance with may , because of its physicochemical , chemical or toxicological properties and the way it is used or is present in the workplace , present a risk to the safety and health of workers , including any chemical agent assigned an occupational exposure limit value under article 3 .


### member states shall bring into force , by [ … ] at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions . ### member states shall bring into force , by 1st june 2015 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions .


### applicants that have invested in supporting the inclusion of an active substance in annex i or in the authorisation of a biocidal product in accordance with the provisions of this regulation should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants . ### applicants who have invested in supporting the inclusion of an active substance in annex i or in the authorisation of a biocidal product in accordance with the provisions of this regulation or those of directive 98 / 8 / ec should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants .


### it is essential to minimise the number of tests on animals and to ensure that testing should be made dependent on the purpose and use of a product . applicants should share , and not duplicate , vertebrate animal studies in exchange for equitable compensation . in absence of an agreement on sharing of vertebrate animal studies between the data owner and the prospective applicant , the agency should allow the use of the studies by the prospective applicant without prejudice to the decision on the compensation made by national courts . a community register listing the contact details of the owners of such studies should be established and put at the disposal of all authorities to inform prospective applicants . ### it is essential to minimise the number of tests on animals and to ensure that testing with biocidal products and / or active substances contained in biocidal products should be made dependent on the purpose and use of a product . applicants should share , and not duplicate , vertebrate animal studies in exchange for equitable compensation . in absence of an agreement on sharing of vertebrate animal studies between the data owner and the prospective applicant , the agency should allow the use of the studies by the prospective applicant without prejudice to the decision on the compensation made by national courts . a community register listing the contact details of the owners of such studies should be established and put at the disposal of all authorities to inform prospective applicants .


### active substances or mixtures containing one or more active substances , put up in the form in which they are supplied to the user , intended to destroy , deter , render harmless , prevent the action of , or otherwise exert a controlling effect on any harmful organism by chemical or biological means . ### active substances or mixtures containing one or more active substances , put up in the form in which they are supplied to the user , primarily intended to destroy , deter , render harmless , prevent the action of , or otherwise exert a controlling effect on any harmful organism by chemical or biological means .


### ' substance of concern ' means any substance , other than the active substance , which has an inherent capacity to cause an adverse effect on humans , animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect ; ### ' substance of concern ' means any substance , other than the active substance , which has an inherent capacity to cause an adverse effect , immediately or in the more distant future on humans , especially children , animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect ;


### ' harmful organism ' means organisms , including pathogenic agents , which have an unwanted presence or a detrimental effect on humans , their activities or the products they use or produce , or on animals or the environment ; ### ' harmful organism ' means organisms , including pathogenic agents , which have an unwanted presence or a detrimental effect immediately or in the more distant future on humans , especially children , human activities or the products they use or produce , or on animals or the environment ;


### commission proposal ### characterisation of the chemical identity with regard to stereoisomers ;


### commission proposal a dossier for the active substance satisfying the requirements set out in annex ii ; ### a dossier , or a letter of access to a dossier , for the active substance satisfying the requirements set out in annex ii ;


### commission proposal a dossier for at least one representative biocidal product that contains the active substance satisfying the requirements set out in annex iii . ### a dossier or a letter of access for at least one representative biocidal product that contains the active substance satisfying the requirements set out in annex iii .


### the commission shall adopt the measures designed to set the criteria defining what constitutes adequate justification to adapt the data required under article 18 on the ground referred to in paragraph 1 . ### in order to define what constitutes adequate justification to adapt the data required under article 18 on the ground referred to in paragraph 1 , the commission shall adapt the criteria by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c .


### the applicant shall submit an application to include an active substance in annex i , or to make subsequent amendments to the conditions of inclusion of an active substance , to the european chemicals agency and inform it of the name of the competent authority of the member state that he chooses to evaluate his application . that competent authority shall be responsible for the evaluation of the application . ### the applicant shall submit an application to include an active substance in annex i , or to make subsequent amendments to the conditions of inclusion of an active substance , to the european chemicals agency . the agency shall indicate the name of the competent authority of the member state that it has chosen to evaluate the application . that competent authority shall be responsible for the evaluation of the application .


### commission proposal ### the agency shall provide a submission number to be used in all correspondence relating to the application until the active substance is included in annex i , and a submission date , which shall be the date on which the application is received by the agency .


### commission proposal the agency shall , within two months after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . ### the agency shall , within three weeks after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application .


### commission proposal ### within two months of receiving the application , the agency shall assign a unique identification code to all the information in the dossier .


### on receipt of the opinion of the agency , the commission shall adopt a decision on the application to include the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### in order to keep the list of authorised active substances updated , on receipt of the opinion of the agency , the commission shall adopt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , a decision to include the active substance in annex i . if the commission decides to include the substance in annex i , the name of the applicants shall be given .


### commission proposal 5 . on receipt of the opinion of the agency , the commission shall adopt a decision on the application to include the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### on receipt of the opinion of the agency , the commission shall adopt a decision on the application to include the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . if the commission decides to include the substance in annex i , the names of the applicants shall be given .


### on receipt of the opinion of the agency , the commission shall adopt a decision on the application to include the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### on receipt of the opinion of the agency , the commission shall adopt a decision on the application to include the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . when the commission decides to include the active substance in annex i , the name of the applicant shall be indicated .


### it meets two of the criteria to be considered as a persistent , bio - accumulative and toxic substance as set out in annex xiii of regulation no 1907 / 2006 ; ### it is considered as a persistent , bio - accumulative and toxic substance in accordance with the criteria set out in annex xiii of regulation no 1907 / 2006 ; , and , and .


### at the end of the period referred to in paragraph 3 or on receipt of the opinion of the agency , the commission shall adopt a decision concerning a renewal of the inclusion of the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### in order to keep the list of authorised active substances updated , at the end of the period referred to in paragraph 3 or on receipt of the opinion of the agency , the commission shall adopt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , a decision concerning a renewal of the inclusion of the active substance in annex i . if the commission decides to renew the inclusion of an active substance in annex i , the name of the applicants shall be mentioned .


### commission proposal 5 . at the end of the period referred to in paragraph 3 or on receipt of the opinion of the agency , the commission shall adopt a decision concerning a renewal of the inclusion of the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### at the end of the period referred to in paragraph 3 or on receipt of the opinion of the agency , the commission shall adopt a decision concerning a renewal of the inclusion of the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . if the commission decides to renew the inclusion of an active substance in annex i , the name of the applicant shall be mentioned .


### 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 . ### in order to keep the list of authorised active substances updated , 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 , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , a decision amending the inclusion of an active substance in annex i or removing it from that annex .


### commission proposal 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 where there are serious indications that the requirements referred to in article 4 are no longer complied with . it shall review inclusion also in cases where there are indications that the objectives of article&#160 ; 4 and and article 7 and of directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy1 may not be achieved . 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 . 1 oj l 327 , 22 . 12 . 2000 , p . 1 .


### implementing measures ### detailed procedures on cancellation and amendments


### implementing measures ### detailed procedures for renewal and review


### the commission may adopt detailed measures for the implementation of articles 10 to 13 of this regulation specifying the procedures related to the renewal and review of an inclusion of an active substance in annex i . ### in order to ensure the smooth functioning of the renewal and review procedures , the commission may adopt further detailed measures by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c .


### application for authorisation shall be made by , or on behalf of , the person who shall be responsible for the placing on the market of a biocidal product in a particular member state or in the community . ### application for authorisation shall be made by , or on behalf of , the person who shall be responsible for the initial placing on the market of a biocidal product in a particular member state or in the community .


### annex ii – paragraph 2 – subparagraph 3 2 . application for authorisation shall be made by , or on behalf of , the person who shall be responsible for the placing on the market of a biocidal product in a particular member state or in the community . ### application for authorisation shall be made by , or on behalf of , the person who will be the holder of the authorisation . the person may be , but is not necessarily , the person responsible for the placing on the market of a biocidal product in a particular member state or in the community .


### commission proposal ### the evaluation of whether the biocidal product fulfils the criteria in paragraph 1 and need not be carried out for a substance that is a component of the biocidal product if the concentration of the substance in the biocidal product is lower than the lowest value referred to in article 14 to of regulation no 1907 / 2006 .


### commission proposal ### when using nanomaterials in biocidal products , the risk to the environment and to health has been reviewed separately .


### commission proposal ### each prospective applicant for inclusion of an active substance in annex i should ask the agency whether : - an application for inclusion in annex i has already been submitted for the same active substance ; - the same active substance has been included in annex i ; - the same substance is registered in accordance with regulation no 1907 / 2006 . 2 . each potential applicant should provide the following information when making enquiries of the agency : information on the applicant ' s identity as laid down in section 1 of annex vi to regulation no 1907 / 2006 , with the exception of 1 . 2 and 1 . 3 ; information on the identity of the active substance , as laid down in section 2 of annex vi to regulation no 1907 / 2006 ; what data requirements have been set for new vertebrate animal studies that it would have to carry out ; what data requirements have been set for other new studies that it would have to carry out . 3 . if the same active substance is not included in annex i or not registered in accordance with regulation no 1907 / 2006 , the agency shall inform the prospective applicant accordingly . 4 . if an application for inclusion for the same active substance in annex i has already been submitted or if the same active substance has already been included in annex i or registered in accordance with regulation no 1907 / 2006 , the agency shall inform the prospective applicant immediately of the names and addresses of the former applicants and registrants and about the relevant study summaries or robust study summaries , if these have already been submitted . 5 . at the same time , the agency shall inform the former applicants or registrants of the names and addresses of the prospective applicant for an inclusion in annex i . the available vertebrate animal studies shall be shared with the prospective applicant in accordance with chapter xi of this regulation .


### commission proposal ### when considering whether to include an active substance in annex i , the agency shall assign the active substance in question an inclusion number that is specific to the substance and to the applicant . the agency shall inform the applicant in question of the inclusion number and the inclusion date immediately . the inclusion number shall be used for all subsequent correspondence concerning the active substance and for the product authorisation in accordance with chapter iv of this regulation .


### commission proposal ### when evaluating whether the criteria in paragraph 1 have been fulfilled , information should whenever possible be derived from information already available on the substance of concern contained in the biocidal product , in order to keep tests on animals to a minimum . in particular , the provisions of directive 1999 / 45 / ec or regulation no 1272 / 2008 should wherever possible be applied for the purpose of ascertaining the adverse effects of the biocidal product and for the subsequent risk assessment .


### commission proposal 6 . in the case of a frame formulation , a reduction in the percentage of the active substance in the reference biocidal product may be allowed , and / or an alteration in percentage composition of one or more non - active substances , and / or the replacement of one or more non - active substances by others presenting the same or lower risk . ### in the case of a frame formulation , the following variations in composition with regard to a reference biocidal product are possible : authorisation of an active substance in a reference biocidal product with at least two active substances ; a reduction in the percentage of the active substances ; authorisation of one or more non - active substances ; alteration in percentage composition of one or more non - active substances ; the replacement of one or more non - active substances .


### commission proposal ### the commission should , in accordance with the procedure set out in article 72 , provide technical and scientific guidance for product authorisation , with particular regard to harmonised data requirements , evaluation procedures and decisions by the member states .


### commission proposal ### if the low - risk active substance contained in the biocidal product has been included in annex i , it shall also be necessary to provide the relevant inclusion number . an access letter must be submitted if the appropriate periods of protection of information according to article 49 have not expired .


### commission proposal 3 . the receiving competent authority may require that applications for a national authorisation be submitted in one or more of the official languages of the member state where that competent authority is situated . ### the agency may require that applications for a national authorisation be submitted in an official language of the member state where the competent authority is situated .


### commission proposal 5 . the commission , in accordance with the procedure referred to in article 72 , shall draw up technical notes for guidance to facilitate the implementation of point of paragraph 1 . the technical notes shall be published in the ‘ c’ series of the official journal of the european union . ### the commission , in accordance with the procedure referred to in article 72 , shall draw up technical notes for guidance to facilitate the implementation of point of paragraph 1 . the commission should , in accordance with the procedure set out in article 72 , provide technical and scientific guidance and tools , in particular to support applications for authorisation under articles 18 , 19 and 20 , above all for smes . the technical notes shall be published in the ‘ c’ series of the official journal of the european union .


### commission proposal qualitative and quantitative composition in terms of the active substances and non - active substances , knowledge of which is essential for proper use of the biocidal product ; ### qualitative and quantitative composition in terms of the active substances and non - active substances , taking account of the concentration limits in article 16 and in so far as this information is required for proper use of the biocidal product ;


### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 . ### the receiving competent authority or , in the case of evaluation of an application for renewal of a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 .


### 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 , another authorised biocidal product or a non - chemical control or prevention method already exists which presents significantly lower risk immediately or in the more distant future for the health of human beings , especially children , or animals or for the environment ;


### the commission shall adopt implementing rules specifying the procedures related to comparative assessments involving questions of community interest . those rules , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### in order to specify the procedures related to comparative assessments involving questions of community interest , the commission shall adapt the criteria by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c .


### if the receiving competent authority , on basis of the validation made pursuant to paragraph 1 , considers that the application is complete , it shall without delay inform the applicant thereof . ### if the agency considers that the application is incomplete , it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information . the agency shall , within three weeks after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the agency shall reject the application if the applicant does not submit the required additional information on time , and shall notify the applicant and the evaluating competent authority of the rejection . in such cases , part of the fees payable to the agency under article 70 shall be reimbursed .


### if the receiving competent authority , on basis of the validation made pursuant to paragraph 1 , considers that the application is complete , it shall without delay inform the applicant thereof . ### if the agency considers that the application is incomplete , it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for forwarding that information . the agency shall , within three weeks of receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the agency shall reject the application if the applicant does not submit the required additional information on time , and shall notify the applicant and the evaluating competent authority of the rejection . in such cases , part of the fees payable to the agency under article 70 shall be reimbursed .


### the receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority . ### the receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority , unless specific national circumstances justify a deviation according to article 29 .


### the commission shall adopt implementing measures specifying the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation under articles 39 to 41 , including a dispute settlement mechanism . ### in order to ensure the smooth functioning of the cancellation and amendment procedures , the commission shall adopt further detailed measures specifying the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation under articles 39 to 41 , including a dispute settlement mechanism by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c .


### 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 in terms of the potential adverse impact , whether occurring immediately or with a time lag , on the safety of the product with regard to human health , with particular reference to children , animal health , or the environment .


### 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 .


### 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 delivered a favourable opinion for this purpose which may impose further conditions . in the absence of an opinion from the competent authority delivered within 30 days after notification of the information required in paragraph 1 , the biocidal product or active substance should be placed on the market for the purposes of the notified experiment or test .


### 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 .


### if the proposed experiments or tests referred to in paragraphs 1 and 2 may have harmful effects on human or animal health or any unacceptable adverse effect on the environment , the competent authority of the member state concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences . the competent authority shall without delay inform the commission and other competent authorities about such measures . ### if the proposed experiments or tests referred to in paragraphs 1 and 2 may have harmful effects , whether occurring immediately or with a time lag , on human health , in particular as regards children , or animal health or any unacceptable adverse effect on the environment , humans , or animals , the competent authority of the member state concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences . the competent authority shall without delay inform the commission and other competent authorities about such measures .


### the commission shall adopt measures to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted in accordance with paragraph 2 . ### in order to encourage the research and development in active substances and biocidal products , the commission shall adopt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , measures to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted in accordance with paragraph 2 .


### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product used for treating the materials or articles are authorised for this use in the community or in at least one member state . ### treated materials or articles that incorporate one or more active substances shall not be placed on the market unless the active substance used for treating the materials or articles are listed in annex i and from a source supported by the named applicant listed alongside the annex i inclusion for that active substance . authorised for this use in the community or in at least one member state .


### where relevant , the biocidal property attributed to treated articles or materials ; ### the biocidal properties attributed to treated materials or products if the biocidal product is intended to be released under normal conditions of use which can reasonably be foreseen ;


### where this is necessary because of the size or the function of the treated article or material , the labelling shall be printed on the packaging , on the instructions for use or on the warranty of the treated article or material . ### where this is necessary because of the size or the function of the treated article or material , the labelling shall be printed on the packaging , on the instructions for use or on the warranty of the treated article or material . in the case of treated materials or articles which are not produced as part of a series , but rather designed and manufactured to meet a specific order , the manufacturer may agree other methods of providing the relevant information with the customer .


### the list referred to in paragraph 2 shall be entered by the agency in the biocides data sharing register . ### each item of information in the list referred to in paragraph 2 shall be identified by a unique code and entered by the agency – with all relevant details and linked to the identity of the initial applicant and the information owner – in the biocides data sharing register .


### in order to avoid animal testing , testing on vertebrate animals for the purposes of this regulation shall be undertaken only as a last resort . testing on vertebrate animals shall not be repeated for the purposes of this regulation . ### given that animal testing should be avoided , testing on vertebrate animals for the purposes of this regulation shall be undertaken only as a last resort where no alternative solution can be employed without producing an impact on humans or animals . testing on vertebrate animals shall not be repeated for the purposes of this regulation .


### where those tests or studies have already been submitted in connection with a previous application , the competent authority or the agency shall without delay communicate the name and contact details of the owner of the information to the prospective applicant . ### where those tests or studies have already been submitted in connection with a previous application , the competent authority or the agency shall without delay assess technical equivalence in relation to the comparison source . if the technical equivalence assessment is positive , the competent authority or the agency shall without delay communicate the name and contact details of the owner of the information to the prospective applicant .


### in the case of a biocidal product which has already been authorised in accordance with articles 15 , 25 or 28 , and where all periods of protection of information according to article 49 have expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised , including degree of purity and nature of impurities . ### in the case of a biocidal product which has already been authorised in accordance with articles 15 , 25 or 28 , and where all periods of protection of information according to article 49 have expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant , and if the periods of protection of information according to article 49 have not expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant pursuant to article 52 , in both cases in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised , including degree of purity and nature of impurities .


### in the case of a biocidal product which has already been authorised in accordance with articles 15 , 25 or 28 , and where all periods of protection of information according to article 49 have expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised , including degree of purity and nature of impurities . ### in the case of a biocidal product which has already been authorised in accordance with articles 15 , 25 or 28 , and where all periods of protection of information according to article 49 have expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant , and if the periods of protection of information according to article 49 have not expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may share the data provided by the first applicant pursuant to article 52 , in both cases in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised , including degree of purity and nature of impurities .


### the commission may adopt detailed rules on the types of information to be entered in the community register for biocidal products and the procedures related to it , in accordance with the procedure referred to in article 72 . ### in order to ensure the proper functioning of the community register for biocidal products , the commission may adopt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , detailed rules on the types of information to be entered in the register and the procedures related to it .


### the commission may adapt the annexes to scientific and technical progress . ### in order to take account of technical progress , the commission may adapt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , the annexes to scientific and technical progress .


### the commission may adapt the annexes to scientific and technical progress . ### the commission shall adapt the annexes to scientific and technical progress .


### 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 , on the basis of new evidence , a member state has justifiable grounds to consider that a biocidal product , although satisfying the requirements of this regulation , constitutes a serious immediate or long - term risk to human health , in particular as regards children , 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 .


### the commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with article 16 of directive 98 / 8 / ec and achieve it by 14 may 2014 . the commission may adopt implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme . those measures , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### the commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with article 16 of directive 98 / 8 / ec and achieve it by 14 may 2014 . in order to ensure the smooth transition , the commission may adopt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme ; and , depending upon the progress of the work programme , a decision to extend the duration of the work programme for a determined period .


### during the work programme , the commission shall decide pursuant to the procedure laid down in article 72 that an active substance shall be included in annex i of this regulation and under which conditions , or , in cases where the requirements of article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period , that such active substance shall not be included in annex i of this regulation . the decision shall specify the date on which the inclusion in annex i becomes effective . ### in order to progress with the work programme , the commission shall decide , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , that an active substance shall be included in annex i of this regulation and under which conditions , or , in cases where the requirements of article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period , that such active substance shall not be included in annex i of this regulation . the decision shall specify the date on which the inclusion in annex i becomes effective .


### applications for the authorisation of substances , mixtures and devices considered as biocidal products in accordance with the second sentence of point of article 3 which were available on the market on . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] shall be submitted at the latest by 1 january 2017 . ### applications for the authorisation of substances , mixtures and devices considered as biocidal products in accordance with the second sentence of point of article 3 which were available on the market on . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] shall be submitted at the latest by 1 january 2017 . this paragraph shall not apply to active substances generated in situ for the purpose of disinfecting drinking water .


### by way of derogation from article 47 , treated articles and materials that incorporate biocidal products which are not authorised in the community or in at least one member state and which were available on the market on . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] may , until the date of a decision granting authorisation to these biocidal products , continue to be placed on the market if the application for authorisation is submitted at the latest by 1 january 2017 . in the case of a refusal to grant an authorisation to place a biocidal product on the market , treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six months after such decision . ### by way of derogation from article 47 , treated articles and materials that incorporate biocidal products which are not authorised in the community or in at least one member state and which were available on the market on . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] may , until the date of a decision granting authorisation to these biocidal products , continue to be placed on the market if the application for authorisation is submitted at the latest by 1 january 2017 . in the case of a refusal to grant an authorisation to place a biocidal product on the market , treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within 12 months after such decision .


### 7 . storage stability - stability and shelf - life . effects of light , temperature and humidity on technical characteristics of the biocidal product ; reactivity towards container material ### 7 . storage stability - stability and shelf - life . effects of light , temperature and humidity on technical characteristics of the biocidal product ; reactivity towards container material storage stability and shelf life will be generally determined based on the stability of the active substance . in the case of readily decomposable active substances , the storage stability and the shelf life may be determined by other valid scientific means , such as extrapolating the analytical data of the active substance from product aging experiments until reaching the efficacy threshold .