### banks investing in re - securitisations are required under directive 2006 / 48 / ec to exercise due diligence also with regard to the underlying securitisations and the non - securitisation exposures ultimately underlying the former . depending on the complexity of the layers of securitisation structures and depending on the complexity and the diversity of the non - securitisation exposures that ultimately underlie the re - securitisations , the required due diligence may be impossible or uneconomical to carry out . this is in particular the case where the ultimate underlying exposures are , for example , leveraged buy - out or project finance debt . in these cases , institutions should not invest in such highly complex re - securitisations . in their review of the required due diligence , competent authorities should devote particular attention to such highly complex securitisations and require their full deduction from capital , unless it has been convincingly demonstrated to their satisfaction that in each individual case of highly complex re - securitisation exposures , the institution has performed the due diligence required by directive 2006 / 48 / ec , including with regard to the ultimate underlying exposures . ### banks investing in re - securitisations are required under directive 2006 / 48 / ec to exercise due diligence also with regard to the underlying securitisations and the non - securitisation exposures ultimately underlying the former . for a better understanding of the effectiveness of those provisions for securitisations and re - securitisations , the commission should comply with the tenth paragraph of article 156 of directive 2006 / 48 / ec which provides for a commission report on the expected impact of article 122a , and submit that report to the european parliament and the council , together with any appropriate proposal , by 31 december 2009 . pending such a review , additional requirements for ' highly complex ' re - securitisation should not be covered in this directive .


### paragraph 1 shall apply in respect of positions in new re - securitisations issued after 31 december 2010 . in respect of positions in existing re - securitisations , paragraph 1 shall apply from 31 december 2014 where new underlying exposures are added or substituted after that date . ' ### paragraph 1 shall apply in respect of positions in new re - securitisations issued after 1 january 2012 . in respect of positions in existing re - securitisations , paragraph 1 shall apply from 1 january 2014 where new underlying exposures are added or substituted after that date . '


### impact assessments of union measures of particular relevance for the competitiveness of enterprises , with a view to identifying areas of existing legislation that need to be simplified , or areas in which new legislative measures need to be proposed ; ### fitness checks of existing legislation and impact assessments of union measures of particular relevance for the competitiveness and growth of enterprises , with a view to identifying areas of existing legislation that need to be simplified or repealed and to ensure that burdens on smes are minimised in areas in which new legislative measures are proposed ;


### as outlined in the commission communication of 30 june 2010 , entitled ‘ europe , the world ' s no 1 tourist destination – a new political framework for tourism in europe’ , which was endorsed by the european council conclusions of october 2010 , tourism is an important sector of the union economy . enterprises in this sector substantially contribute to the union ' s gross domestic product and job creation and have significant potential for the development of entrepreneurial activity , since it is run mainly by smes . the lisbon treaty acknowledges the importance of tourism outlining the union specific competences in this field which complement the actions of member states . there is clear added value for the tourism initiative at union level , especially in providing data and analysis , in developing transnational promotion strategies and in exchanging best practices . ### as outlined in the commission communication of 30 june 2010 entitled ‘ europe , the world ' s no 1 tourist destination – a new political framework for tourism in europe’ , which was endorsed by the european council conclusions of october 2010 , tourism is an important sector of the union economy . enterprises in this sector contribute substantially to the union ' s gross domestic product and to job creation and have significant potential for the development of entrepreneurial activity , since it is run mainly by smes . the lisbon treaty acknowledges the importance of tourism , outlining the union ' s specific competences in this field which complement the actions of member states . initiatives in the tourism sector should be supported by the programme where there is clear added value at union level .


### the commission shall contribute to promoting entrepreneurship by improving framework conditions affecting the development of entrepreneurship . the commission shall support a business environment favourable to enterprise development and growth . ### the commission shall contribute to promoting entrepreneurship by improving framework conditions affecting the development of entrepreneurship . the commission shall support a business environment favourable to enterprise start up , development , growth and second chances .


### the commission may support actions to improve smes access to the single market including information provision and awareness - raising . ### the commission may support actions to improve smes access to the single market including information provision , awareness - raising and seeking the removal of existing legal and regulatory barriers .


### the enterprise europe network has proven its added value for european smes as a one - stop - shop for business support by helping enterprises to improve their competitiveness and explore business opportunities in the single market and beyond . the streamlining of methodologies and working methods and provisions of a european dimension to business support services can only be achieved at union level . in particular , the network has helped smes to find cooperation or technology transfer partners , get advice on sources of financing , and on intellectual property and on eco - innovation and sustainable production . it has also obtained feedback on union legislation and standards . its unique expertise is particularly important in overcoming information asymmetries and alleviating transaction costs associated with cross - border transactions . ### the enterprise europe network has proven its added value for european smes as a one - stop - shop for business support by helping enterprises to improve their competitiveness and explore business opportunities in the single market and beyond . the streamlining of methodologies and working methods and provisions of a european dimension to business support services can only be achieved at union level . in particular , the network has helped smes to find cooperation or technology transfer partners , get advice on sources of financing , and on intellectual property and on eco - innovation and sustainable production . it has also obtained feedback on union legislation and standards . its unique expertise is particularly important in overcoming information asymmetries and alleviating transaction costs associated with cross - border transactions . where possible the network should be further optimised through enhanced contact with national contact points and a higher profile in member states .


### financial instruments under the programme shall be operated with the aim of facilitating access to finance for growth - oriented smes . the financial instruments shall include an equity facility and a loan guarantee facility . ### financial instruments under the programme shall be operated with the aim of facilitating access to finance for smes in their start - up , growth and transfer phases . the financial instruments shall include an equity facility and a loan guarantee facility .


### to strengthen the competitiveness and sustainability of the union ' s enterprises including in the tourism sector ### to strengthen the competitiveness and sustainability of the union ' s enterprises


### impact assessments of union measures of particular relevance for the competitiveness of enterprises , with a view to identifying areas of existing legislation that need to be simplified , or areas in which new legislative measures need to be proposed ; ### ‘ fitness checks’ of existing legislation and impact assessments of union measures of particular relevance for the competitiveness and growth of enterprises , and in particular of smes and micro - enterprises , with a view to identifying areas of existing legislation that need to be simplified or repealed and to ensure that burdens on smes are minimised in areas in which new legislative measures are proposed ;


### the programme should particularly address smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises . particular attention should be paid to micro enterprises , enterprises engaged in craft activities and social enterprises . attention should also be paid to the specific characteristics and requirements of young entrepreneurs , new and potential entrepreneurs and female entrepreneurs , as well as specific target groups , such as migrants and entrepreneurs belonging to socially disadvantaged or vulnerable groups such as persons with disabilities . the programme should also encourage senior citizens to become and remain entrepreneurs and promote second chances for entrepreneurs . ### the programme should particularly address smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises . particular attention should be paid to micro enterprises , enterprises engaged in craft activities and social enterprises . attention should also be paid to the specific characteristics and requirements of young entrepreneurs , new and potential entrepreneurs and female entrepreneurs , as well as second chances for entrepreneurs . targeted information should also be provided for specific groups , such as migrants and persons with disabilities . the programme should also encourage senior citizens to become and remain entrepreneurs .


### changes in administrative burden on smes , ### reduction in administrative and regulatory burdens on smes ,


### another factor which affects competitiveness is the relatively weak entrepreneurial spirit in the union . only 45% of the union citizens would like to be self - employed as compared to 55% of the population in the united states and 71% in china . demonstration and catalytic effects , for example european awards and conferences , as well as coherence and consistency enhancing measures such as benchmarking and exchanges of best practices provide a high european added value . ### another factor which affects competitiveness is the relatively weak entrepreneurial spirit in the union . only 45% of the union citizens would like to be self - employed as compared to 55% of the population in the united states and 71% in china . demonstration and catalytic effects , as well as coherence and consistency enhancing measures such as benchmarking and exchanges of best practices provide a high european added value .


### the commission may support actions to improve smes access to the single market including information provision and awareness - raising . ### the commission shall support actions to improve smes access to the single market including information provision , awareness - raising and digitisation of the single market .


### the financial instruments for growth - oriented smes may , where appropriate , be combined with other financial instruments established by member states and their managing authorities in accordance with [ article 33 of regulation no xxx / 201x [ new regulation on structural funds ] ] , and grants funded from the union , including under this regulation . ### the financial instruments for smes may , where appropriate , be combined with other financial instruments established by member states and their managing authorities in accordance with [ article 33 of regulation no xxx / 201x [ new regulation on structural funds ] ] , and grants funded from the union , including under this regulation .


### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the eu regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , level of corruption , trade flows , indicators enabling measuring internal economic disparities , including employment levels . ### the achievement of these specific objectives shall be measured using predefined , clear , transparent and measurable indicators , while avoiding the creation of any unnecessary additional administrative burdens . the list of those indicators shall be established by the commission .


### a number of major developments have taken place since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes in the region . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . it outlines key objectives for union cooperation with neighbourhood countries and provides for greater support to partners committed to building democratic societies and undertaking reforms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles . ### a number of major developments have taken place since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes in the region . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . the review recognized the need for refined key objectives in order to address the previous issue of an insufficiently coordinated link between the european neighbourhood policy framework and the union support under the european neighbourhood instrument . under the concept of ' deep democracy ' , there is greater support provided to partners committed building democratic societies and undertaking reforms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles .


### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the eu regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , level of corruption , trade flows , indicators enabling measuring internal economic disparities , including employment levels . ### the achievement of these specific objectives shall be measured through adequate mechanisms using predefined , clear , transparent and measurable indicators , while avoiding the creation of any unnecessary additional administrative burdens . the list of those indicators shall be established by the commission and the european external action service in close cooperation with the european parliament .


### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ; ### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , public health , transport and logistics , environment , climate action and disaster resilience ;


### in respect of the consumer products subject to this regulation the scope of application of the different parts of it should be clearly delimited from sector - specific union harmonisation legislation . whilst the general product safety requirement and related provisions should be applicable to all consumer products , the obligations of economic operators should not apply where union harmonisation legislation includes equivalent obligations , such as union legislation on cosmetics , toys , electrical appliances or construction products . ### in respect of the consumer products subject to this regulation the scope of its application should be clearly delimited from sector - specific union harmonisation legislation . this regulation should therefore not apply to products subject to union harmonisation legislation such as union legislation on cosmetics , toys , electrical appliances or construction products .


### manufacturers shall keep , for a period of ten years after the product has been placed on the market , the technical documentation and make it available to the market surveillance authorities , upon request . ### manufacturers shall , for a period of five years after the product has been placed on the market , make the relevant parts of technical documentation available to the market surveillance authorities in electronic or physical format , upon reasoned request . the technical documentation does not have to be located in the territory of the union , nor does it have to be permanently available in material form . however , it must be capable of being assembled and made available within a reasonable time - frame .


### importers shall keep , for a period of ten years after the product has been placed on the market , the technical documentation and make it available to the market surveillance authorities , upon request . ### importers shall ensure that , for a period of five years after the product has been placed on the market , the relevant parts of the technical documentation can be made available to the market surveillance authorities in electronic or physical format , upon reasoned request .


### distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with article 8 , and and article 10 and , as applicable , shall make sure that the corrective action necessary to bring that product into conformity is taken , to withdraw it or recall it , if appropriate . furthermore , where the product is not safe , distributors shall immediately inform the manufacturer or importer , as applicable as well as market surveillance authorities of the member states in which they made the product available to that effect , giving details , in particular , of the risk to health and safety and of any corrective action taken . ### distributors who consider or have reason to believe that a product which they have made available on the union or on - line market is not safe or is not in conformity with article 8 , and and article 10 and , as applicable , shall make sure that the corrective action necessary to bring that product into conformity is taken , to withdraw it or recall it . furthermore , where the product is not safe , distributors shall immediately inform the manufacturer or importer , as applicable as well as market surveillance authorities of the member states in which they made the product available to that effect , giving details , in particular , of the risk to health and safety and of any corrective action taken .


### ' safe product ' means any product which , under normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements , does not present any risk or only the minimum risks compatible with the product ' s use , considered acceptable and consistent with a high level of protection of health and safety of persons ; ### ' safe product ' means any product which , under normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation , maintenance , training and supervision requirements , does not present any risk or only the minimum risks compatible with the product ' s use , considered acceptable and consistent with a high level of protection of health and safety of persons ;


### the manufacturer , importer or distributor can demonstrate that the risk has been fully controlled and cannot any more endanger the health and safety of persons ; ### the manufacturer , importer or distributor can demonstrate that the risk has been effectively controlled so as to prevent any dangers to the health and safety of persons ;


### for certain products , categories or groups of products which , due to their specific characteristics or specific conditions of distribution or usage , susceptible to bear a serious risk to health and safety of persons , the commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability . ### for certain products , categories or groups of products which , due to their specific characteristics or specific conditions of distribution or usage , susceptible to bear a serious risk to health and safety of persons , and after consulting relevant stakeholders , as appropriate , the commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability .


### which are likely , under reasonably foreseeable conditions , to be used by consumers even if not intended for them ; ### which are likely , under reasonably foreseeable conditions , to be used by consumers even if , when placed on the market , they were not intended for consumers ;


### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled . ### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products under reasonably foreseeable conditions , taking into account their vulnerability , in particular children , the elderly and the disabled . when assessing the risks for vulnerable consumers , due consideration should be given to the applications intended and described as such by the manufacturer in the product ' s safety instructions and the responsibilities and supervision or training obligations incumbent upon family members , service providers or employers .


### importers shall keep , for a period of ten years after the product has been placed on the market , the technical documentation and make it available to the market surveillance authorities , upon request . ### importers shall ensure that the technical documentation can be made available to the market surveillance authorities , upon request .


### importers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the product or , where that is not possible , on its packaging or in a document accompanying the product . they shall ensure that any additional label does not obscure any information on the label provided by the manufacturer . ### importers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the product or , where that is not possible , on its packaging or in a document accompanying the product or on a website clearly indicated on the product or its packaging or accompanying documents . they shall ensure that any additional label does not obscure any information on the label provided by the manufacturer .


### importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this regulation shall immediately take the corrective action necessary to bring that product into conformity , to withdraw it or recall it , if appropriate . furthermore , where the product is not safe , importers shall immediately inform the market surveillance authorities of the member states in which they made the product available to that effect , giving details , in particular , of the risk to health and safety and of any corrective action taken . ### importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this regulation shall immediately take the corrective action necessary to bring that product into conformity , to withdraw it or recall it , as appropriate . furthermore , where the product is not safe , importers shall immediately inform the market surveillance authorities of the member states in which they made the product available to that effect , giving details , in particular , of the risk to health and safety and of any corrective action taken .


### the indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer . in particular , the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture . such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions . ### ensuring the traceability of a product throughout its life cycle and the use of tracking labels to determine the country of origin and the manufacturer responsible are very important and necessary . at the same time , the measures concerned should not result in a disproportionate administrative burden . the indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer . in particular , the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture . at the same time the indication of origin can help consumers to obtain information about the sustainability of a product with reference to social and ecological standards , as well as about general safety and quality . such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions . the commission should therefore also play a more active role in coordinating the activities of european market surveillance authorities , customs authorities and other competent authorities of the member states and third countries .


### manufacturers shall ensure that their product is accompanied by instructions and safety information in a language which can be easily understood by consumers , as determined by the member state in which the product is made available , except where the product can be used safely and as intended by the manufacturer without such instructions and safety information . ### manufacturers shall ensure that their product is accompanied by instructions and safety information in a language or visual format which can be easily understood by consumers , as determined by the member state in which the product is made available , except where the product can be used safely and as intended by the manufacturer without such instructions and safety information .


### in the absence of requirements laid down in or pursuant to union harmonisation legislation referred to in point and european standards referred to in point , as regards the risks covered by health and safety requirements laid down in the law of the member state where the product is made available on the market , if it conforms to such national requirements . ### in the absence of requirements laid down in or pursuant to european standards referred to in point , as regards the risks covered by health and safety requirements laid down in the law of the member state where the product is made available on the market , if it conforms to such national requirements .


### the procedures to request european standards in support of this regulation , and on formal objections against them , should be laid down in this regulation and be aligned with regulation no 1025 / 2012 . to ensure overall consistency in european standardisation issues , requests for european standards , or objections to a european standard , should therefore be brought before the committee set up by that regulation , after appropriate consultation of experts of the member states in the field of consumer product safety . ### the procedures to request european standards in support of this regulation , and on formal objections against them , should be laid down in this regulation and be aligned with regulation no 1025 / 2012 . to ensure overall consistency in european standardisation issues , requests for european standards , or objections to a european standard , should therefore be brought before the committee set up by that regulation , after appropriate consultation of experts of the member states in the field of consumer product safety and relevant stakeholders .


### the commission may request one or several european standardisation organisations to draft or identify a european standard , which aims at ensuring that products that conform to such standard or parts thereof comply with the general safety requirement laid down in article 4 . the commission shall determine the requirements as to the content to be met by the requested european standard and a deadline for its adoption . ### the commission may request one or several european standardisation organisations to draft or identify a european standard , which aims at ensuring that products that conform to such standard or parts thereof comply with the general safety requirement laid down in article 4 . taking into account the views of relevant stakeholders , as appropriate , the commission shall determine the requirements as to the content to be met by the requested european standard and a deadline for its adoption .


### ' cultural object ' shall mean an object which : is classified , before or after its unlawful removal from the territory of a member state , among the ' national treasures possessing artistic , historic or archaeological value ' under national legislation or administrative procedures within the meaning of article 36 of the treaty . ### ' cultural object ' shall mean an object which : is classified , before or after its unlawful removal from the territory of a member state , among the ' national treasures possessing artistic , historic or archaeological value ' under national legislation or administrative procedures within the meaning of article 36 of the treaty or a private object unlawfully removed from an individual citizen .


### the scope of this directive must extend to any cultural object classified as a national treasure possessing artistic , historic or archaeological value under national legislation or administrative procedures within the meaning of article 36 of the treaty . the criterion of falling under one of the categories referred to in the annex to directive 93 / 7 / eec should therefore be removed and thus the annex itself should be deleted and the criterion of forming an integral part of public collections listed in the inventories of museums , archives and libraries ' conservation collections or the inventories of ecclesiastical institutions should also be removed . the diversity of national arrangements for protecting cultural objects is recognised in article 36 of the treaty . in this context , mutual trust , a willingness to cooperate and mutual understanding between member states are therefore essential . ### the scope of this directive should extend to any cultural object classified or defined as being one of the national treasures possessing artistic , historic or archaeological value under national legislation or administrative procedures within the meaning of article 36 of the treaty . the criterion of falling under one of the categories referred to in the annex to directive 93 / 7 / eec should therefore be removed and thus the annex itself should be deleted and the criterion of forming an integral part of public collections listed in the inventories of museums , archives and libraries ' conservation collections or the inventories of ecclesiastical institutions should also be removed . this directive would thus cover cultural objects such as objects of historical , paleontological , ethnographic , numismatic interest or scientific value , whether or not they form part of public or other collection or are single items , provided that they are classified or defined as national treasures . furthermore , cultural objects classified or defined as national treasures would not have to comply with thresholds related to their age and / or to their financial value to qualify for the return under this directive . taking into account that the diversity of national arrangements for protecting national treasures is recognised in article 36 of the treaty , mutual trust , a willingness to cooperate and mutual understanding between member states are therefore essential .


### ' cultural object ' shall mean an object which : is classified , before or after its unlawful removal from the territory of a member state , among the ' national treasures possessing artistic , historic or archaeological value ' under national legislation or administrative procedures within the meaning of article 36 of the treaty . ### ' cultural object ' shall mean an object which : is classified by the member state to which it belongs , before or after its unlawful removal from the territory of that member state , among the ' national treasures possessing artistic , historic or archaeological value ' under national legislation or administrative procedures within the meaning of article 36 of the treaty .


### without prejudice to the commission ' s role , as defined in paragraph 2 , and respecting the imperative for an immediate operational response through the mechanism , upon activation the commission shall inform the european external action service to allow for consistency between the civil protection operation and the overall union relations with the affected country . ### without prejudice to the commission ' s role , as defined in paragraph 2 , and respecting the imperative for an immediate operational response through the mechanism , upon activation the commission shall inform the european external action service to allow for consistency between the civil protection operation and the overall union relations with the affected country . it shall also ensure the safety and consular protection of european nationals participating in civil protection operations outside the union .


### to ensure that europol is a fully accountable and transparent internal organisation , it is necessary , in the light of article 88 of the treaty on the functioning of the european union , to lay down procedures for scrutiny of europol activities by the european parliament together with national parliaments , taking into due account the need to safeguard confidentiality of operational information . ### to respect the role of the parliaments in the monitoring of the european area of freedom , security and justice and the political responsibilities of the national parliaments and of the european parliament in respecting and exercising their respective powers in the legislation process , it is necessary that europol is a fully accountable and transparent internal organisation . to that end , in the light of article 88 of the treaty on the functioning of the european union , procedures for scrutiny of europol activities by the european parliament together with national parliaments must be established , taking into due account the need to safeguard confidentiality of operational information .


### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services . ### in the light of the overall policy of the union with regard to least - developed countries listed in annex iv of the european parliament and council regulation no 978 / 2012 or developing countries benefitting from the ' everything but arms ' arrangement as well as considered to be vulnerable as defined in annex vii of the european parliament and council regulation no 978 / 2012 applying a scheme of generalised tariff preferences , it is appropriate to assimilate goods and services from these countries to union goods and services .


### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services . ### in the light of the overall policy of the union aimed at supporting the economic growth of developing countries and their integration in the global economy , which underpins the establishment by the union of a generalised preference system as set out in regulation no 978 / 2012 of the european parliament and of the council applying a scheme of generalised tariff preferences , it is appropriate to assimilate goods and services from less - developed countries benefiting from the ‘ everything but arms’ arrangement to union goods and services , and also goods and services originating in developing countries considered to be vulnerable due to a lack of diversification and insufficient integration in the world economy , as defined in annexes iv and vii respectively of regulation no 978 / 2012 of the european parliament and of the council applying a scheme of generalised tariff preferences .


### 4 as regards engines for use in propulsion of locomotives , during the transition period between stage iii a and stage iii b an oem may seek permission for his engine suppliers to place on the market a maximum of 12 engines for use in propulsion of locomotives under the flexibility scheme . ### 4 as regards engines for use in propulsion of locomotives , during the transition period between stage iii a and stage iii b an oem may seek permission for his engine suppliers to place on the market a maximum of 40 engines for use in propulsion of locomotives under the flexibility scheme .


### member states shall monitor each substance in the watch list at selected representative monitoring stations over at least a 12 - month period commencing within 3 months of its inclusion in the watch list . ### member states shall monitor each substance in the watch list at selected representative monitoring stations over at least a 12 - month period commencing within 6 months of its inclusion in the watch list .


### the commission shall be empowered to adopt delegated acts in accordance with article 10 concerning the drawing up of the watch list referred to in paragraph 1 of this article . ### the commission shall be empowered to adopt delegated acts in accordance with article 10 concerning the drawing up of the watch list referred to in paragraph 1 of this article and technical specifications for the monitoring of the substances in the watch list . in preparing delegated acts , the commission shall take account of the recommendations from the stakeholders mentioned in article 16 of directive 2000 / 60 / ec . the watch list shall be valid for four years from the date of its adoption , or until a new list is drawn up by the commission .


### numerous union acts have been adopted since the adoption of directive 2000 / 60 / ec , which constitute emission control measures in accordance with article 16 of that directive for individual priority substances . moreover , many environmental protection measures fall under the scope of other existing union legislation . therefore , priority should be given to implementing and revising existing instruments rather than establishing new controls . the inclusion of a substance in annex x to directive 2000 / 60 / ec is without prejudice to the application of the provisions of regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec . ### numerous union acts have been adopted since the adoption of directive 2000 / 60 / ec , which constitute emission control measures in accordance with article 16 of that directive for individual priority substances . moreover , many environmental protection measures fall under the scope of other existing union legislation . therefore , priority should be given to implementing and revising existing instruments rather than establishing new controls . the inclusion of a substance in annex x to directive 2000 / 60 / ec must not run counter to the application of the provisions of regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec or permits issued on the basis thereof .


### member states shall monitor each substance in the watch list at selected representative monitoring stations over at least a 12 - month period commencing within 3 months of its inclusion in the watch list . ### member states shall monitor each substance in the watch list at selected representative monitoring stations over at least a 24 - month period commencing within 6 months of its inclusion in the watch list .


### the watch list shall contain no more than 25 substances or groups of substances at any given time and shall indicate the monitoring matrix for each substance . the substances shall be selected from among those for which the available information indicates that they may pose a significant risk at union level to or via the aquatic environment . in selecting the substances for the watch list the commission shall take into account all available information including research projects , member states ' characterisation and monitoring programmes under articles 5 and 8 of directive 2000 / 60 / ec and information on production volumes , use patterns , concentrations in the environment and effects , including that gathered in accordance with directives 98 / 8 / ec , 2001 / 82 / ec and 2001 / 83 / ec of the european parliament and of the council , and with regulation no 1907 / 2006 and regulation no 1107 / 2009 of the european parliament and of the council . ### the watch list shall contain no more than 25 substances or groups of substances at any given time and shall indicate the monitoring matrix for each substance . the substances shall be selected from among those for which the available information indicates that they may pose a significant risk at union level to or via the aquatic environment , and insufficient monitoring data for the purposes of prioritisation is available . in selecting the substances for the watch list the commission shall take into account all available information including the results of the prioritisation procedure carried out in the context of the preparation of the present directive , research projects , member states ' characterisation and monitoring programmes under articles 5 and 8 of directive 2000 / 60 / ec and information on production volumes , use patterns , concentrations in the environment and effects , including that gathered in accordance with directives 98 / 8 / ec , 2001 / 82 / ec and 2001 / 83 / ec of the european parliament and of the council , and with regulation no 1907 / 2006 and regulation no 1107 / 2009 of the european parliament and of the council .


### the commission shall draw up a watch list of substances for which union - wide monitoring data shall be gathered for the purpose of supporting future prioritisation exercises in accordance with article 16 of directive 2000 / 60 / ec . ### the commission , in consultation with member states and concerned stakeholders , shall draw up a watch list of substances for which union - wide monitoring data shall be gathered for the purpose of supporting future prioritisation exercises in accordance with article 16 of directive 2000 / 60 / ec . the selection of substances for inclusion in the watch list , including the first watch list , shall be based on objective scientific criteria in accordance with the provisions of the present article .


### numerous union acts have been adopted since the adoption of directive 2000 / 60 / ec , which constitute emission control measures in accordance with article 16 of that directive for individual priority substances . moreover , many environmental protection measures fall under the scope of other existing union legislation . therefore , priority should be given to implementing and revising existing instruments rather than establishing new controls . the inclusion of a substance in annex x to directive 2000 / 60 / ec is without prejudice to the application of the provisions of regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec . ### numerous union acts have been adopted since the adoption of directive 2000 / 60 / ec , which constitute emission control measures in accordance with article 16 of that directive for individual priority substances . moreover , many environmental protection measures fall under the scope of other existing union legislation . therefore , priority should be given to implementing and revising existing instruments rather than establishing new controls . it would be appropriate to take a consistent policy approach regarding pharmaceutical substances , taking into consideration the full societal and medical implications , in full consultation with all relevant stakeholders . to this end , the commission will produce a report with possible legislative proposals on the environmental effects of pharmaceutical substances for human use in waters and soils , under directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use1 and regulation no . 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products2 . the inclusion of a substance in annex x to directive 2000 / 60 / ec is without prejudice to the application of the provisions of regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec . _______________ 1 oj l 348 , 31 . 12 . 2010 , p . 74 2 oj l 348 , 31 . 12 . 2010 , p . 1


### assess a sufficiently large number of insurance products available on the market . the insurance products should be diversified with regard to their type and issuers or product providers and should not be limited to insurance products issued or provided by entities having close links with the insurance intermediary or insurance undertaking ; and ### a sufficiently large number of insurance products available on the market which are sufficiently diversified with regard to their type and issuers or product providers to ensure that the customer ' s insurance investment needs can be suitably met and is not limited to insurance products issued or provided by entities having close links with the insurance intermediary or insurance undertaking ;


### ‘ contingent commission’ means a remuneration in the form of a commission where the amount payable is based on the achievement of agreed targets relating to the business placed by the intermediary with that insurer ; ### ' contingent commission ' means a remuneration in the form of a commission based on the achievement of pre - agreed targets or thresholds relating to the volume of business placed by the intermediary with the insurer ,


### ' advice ' means the provision of a recommendation to a customer , either upon their request or at the initiative of the insurance undertaking or the insurance intermediary ; ### ' advice ' means the provision of a personal recommendation to a customer , either upon their request or at the initiative of the insurance undertaking or the insurance intermediary ;


### this directive should specify the minimum obligations which insurance undertakings and insurance intermediaries should have in providing information to customers . a member state should be able to in this area maintain or adopt more stringent provisions which may be imposed on insurance intermediaries and insurance undertakings independently of the provisions of their home member state where they are pursuing insurance mediation activities on its territory provided that any such more stringent provisions comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . a member state which proposes to apply and applies provisions regulating insurance intermediaries and the sale of insurance products in addition to those set out in this directive should ensure that the administrative burden stemming from these provisions is proportionate for consumer protection . in the interest of consumer protection and in order to prevent mis - selling of insurance products , member states should be permitted to apply exceptionally the more stringent requirements to such insurance intermediaries conducting insurance mediation on an ancillary basis if they consider it necessary and proportionate . ### this directive should specify the minimum obligations for insurance undertakings and insurance intermediaries . a member state should be able to maintain or adopt more stringent provisions which may be imposed on insurance intermediaries and insurance undertakings . such more stringent provisions must comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market .


### when an insurance service or product is offered together with another service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall offer and inform the customer that it is possible to buy the components of the package separately and shall provide information of the costs and charges of each component of the package that may be bought through or from it separately . ### when insurance is offered together with another service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall inform the customer whether it is possible to buy the components of the package separately and , if so shall provide information of the costs and charges of each component of the package that may be bought through or from it separately .


### ' insurance mediation ' means the activities of advising on , proposing or carrying out other work preparatory to the conclusion of contracts of insurance , concluding such contracts or assisting in the administration and performance of such contracts , in particular in the event of a claim , and the activity of professional management of claims and loss adjusting . these activities shall be considered to be insurance mediation also if carried on by an insurance undertaking without the intervention of an insurance intermediary . ### ' insurance mediation ' means the activities of advising on , proposing or carrying out other work preparatory to the conclusion of contracts of insurance , concluding such contracts or assisting in the administration and performance of such contracts , in particular in the event of a claim . these activities shall be considered to be insurance mediation also if carried on by an insurance undertaking without the intervention of an insurance intermediary . each of the following activities shall be considered as insurance mediation within the meaning of the directive : provision of information concerning one ore more insurance contracts according to criteria selected by customers through a website or other media and the compilation of an insurance product ranking list or the discounting of premiums for customers accordingly able to take out insurance contracts directly .


### prior to the conclusion of a contract , whether or not advice is given , the insurance intermediary or insurance undertaking shall give the customer the relevant information about the insurance product in a comprehensible form to allow the customer to make an informed decision , while taking into account the complexity of the insurance product and the type of costumer . ### prior to the conclusion of a contract , whether or not advice is given , the insurance intermediary or insurance undertaking shall give the customer the relevant information about the insurance product in a comprehensible form to allow the customer to make an informed decision , while taking into account the complexity of the insurance product and the type of customer .


### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 3 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 3 months at the initiative of the european parliament or the council .


### when an insurance service or product is offered together with another service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall offer and inform the customer that it is possible to buy the components of the package separately and shall provide information of the costs and charges of each component of the package that may be bought through or from it separately . ### when an insurance service or product is offered together with another service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary should inform the customer whether it is possible to buy the components of the package separately and shall provide information of the costs and charges of each component of the package that may be bought through or from it separately .


### this directive should specify the minimum obligations which insurance undertakings and insurance intermediaries should have in providing information to customers . a member state should be able to in this area maintain or adopt more stringent provisions of their home member state where they are pursuing insurance mediation activities on its territory provided that any such more stringent provisions comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . a member state which proposes to apply and applies provisions regulating insurance intermediaries and the sale of insurance products in addition to those set out in this directive should ensure that the administrative burden stemming from these provisions is proportionate for consumer protection . in the interest of consumer protection and in order to prevent mis - selling of insurance products , member states should be permitted to apply exceptionally the more stringent requirements to such insurance intermediaries conducting insurance mediation on an ancillary basis if they consider it necessary and proportionate . ### this directive should specify the minimum obligations which insurance undertakings and insurance intermediaries should have in providing information to customers . a member state should be able to in this area maintain or adopt more stringent provisions of their home member state where they are pursuing insurance mediation activities on its territory provided that any such more stringent provisions comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . a member state which proposes to apply and applies provisions regulating insurance intermediaries and the sale of insurance products in addition to those set out in this directive should ensure that the administrative burden stemming from these provisions is proportionate for consumer protection . in the interest of consumer protection and in order to prevent mis - selling of insurance products , member states should be permitted to apply the more stringent requirements to such insurance intermediaries conducting insurance mediation on an ancillary basis if they consider it necessary and proportionate .


### this directive should specify the minimum obligations which insurance undertakings and insurance intermediaries should have in providing information to customers . a member state should be able to in this area maintain or adopt more stringent provisions which may be imposed on insurance intermediaries and insurance undertakings independently of the provisions of their home member state where they are pursuing insurance mediation activities on its territory provided that any such more stringent provisions comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . a member state which proposes to apply and applies provisions regulating insurance intermediaries and the sale of insurance products in addition to those set out in this directive should ensure that the administrative burden stemming from these provisions is proportionate for consumer protection . in the interest of consumer protection and in order to prevent mis - selling of insurance products , member states should be permitted to apply exceptionally the more stringent requirements to such insurance intermediaries conducting insurance mediation on an ancillary basis if they consider it necessary and proportionate . ### this directive should specify the minimum obligations for insurance undertakings and insurance intermediaries . a member state should be able to maintain or adopt more stringent provisions which may be imposed on insurance intermediaries and insurance undertakings . such more stringent provisions must comply with union law .


### when the insurance intermediary or the insurance undertaking inform the customer that it gives its advice on the basis of a fair analysis , it is obliged to give that advice on the basis of an analysis of a sufficiently large number of insurance contracts available on the market , to enable it to make a recommendation , in accordance with professional criteria regarding which insurance contract would be adequate to meet the customer ' s needs . ### when the insurance intermediary or the insurance undertaking inform the customer that it provides its advice on the basis of a fair analysis , it is obliged to provide that advice on the basis of an analysis of a significant and sufficiently large number of insurance contracts . insurance intermediaries must also source these contracts from a significant and sufficiently large number of insurance providers available on the market , to enable it to make a recommendation , in accordance with professional criteria regarding which insurance contract would be adequate to meet the customer ' s needs .


### the information referred to in articles 16 , 17 and 18 need not be given when the insurance intermediary or insurance undertaking mediates in the insurance of large risks , in the case of mediation by reinsurance intermediaries or reinsurance undertakings , or in relation to professional customers as specified in the annex . ### the information referred to in articles 16 , 17 and 18 need not be provided when the insurance intermediary or insurance undertaking mediates in the insurance of large risks , in the case of mediation by reinsurance intermediaries or reinsurance undertakings , or in relation to professional customers as specified in the annex .


### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 3 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 3 months at the initiative of the european parliament or the council . when a delegated act is delivered just before or during a holiday , the time shall be deemed to run from the date of the first plenary following the holiday . in all instances , including extension , the time period shall be extendible to encompass three full plenary sessions .


### when an insurance service or product is offered together with another service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall offer and inform the customer that it is possible to buy the components of the package separately and shall provide information of the costs and charges of each component of the package that may be bought through or from it separately . ### when an insurance service or product is offered to a consumer together with another non - insurance service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall offer and inform the customer that whether it is possible to buy the components of the package separately and if possible shall provide information of the costs and charges of each component of the package that may be bought through or from it separately .


### when an insurance service or product is offered together with another service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall offer and inform the customer that it is possible to buy the components of the package separately and shall provide information of the costs and charges of each component of the package that may be bought through or from it separately . ### in case of bundling practices , the insurance undertaking or , where applicable , the insurance intermediary shall inform the consumer that it is possible to buy the main financial service or product of the package separately and shall provide information of the price of the main financial service or product of the package that may be bought through or from it separately .


### the information referred to in this article should be provided in a comprehensible form in such a manner that the customers or potential customers are reasonably able to understand the nature and risks of the specific insurance product that is being offered and , consequently , to take investment decisions on an informed basis . this information may be provided in a standardised format . ### the information referred to in this article should be provided in a comprehensible form in such a manner that the customers or potential customers are reasonably able to understand the nature and risks of the specific insurance product that is being offered and , consequently , to take investment decisions on an informed basis . this information may be provided in a standardised format in a key information document . the key information document shall be complemented by the production of a key services document by the person selling the insurance product reflecting the services provided to the retail investor . a person selling an insurance investment product to retail customers shall provide them with the key information document and the key services document in good time before the conclusion of a transaction relating to the insurance investment product . where an insurance investment product is recommended to a client , the key information document and the key services document shall be provided without delay .


### prior to the conclusion of a contract , whether or not advice is given , the insurance intermediary or insurance undertaking shall give the customer the relevant information about the insurance product in a comprehensible form to allow the customer to make an informed decision , while taking into account the complexity of the insurance product and the type of customers . ### prior to the conclusion of a contract , whether or not advice is provided , the insurance intermediary or insurance undertaking shall provide the customer the relevant information about the insurance product in a comprehensible form to allow the customer to make an informed decision , while taking into account the complexity of the insurance product and the type of customers . it shall be provided in a standardised information sheet , in a plain language , and containing the key information of the insurance contract .


### it gives advice on the basis of a fair analysis , or ### it gives independent advice on the basis of an analysis of a sufficiently large number of insurance products available on the market ; or


### member states may stipulate that , where an insurance or reinsurance intermediary acts under the responsibility of an insurance or reinsurance undertaking or of another registered insurance or reinsurance intermediary , the latter intermediary or the undertaking shall be responsible for ensuring that it meets the conditions for registration set out in this directive . in such a case , the person or entity accepting responsibility shall , having been informed by the member states of the matters set out in paragraph 7 of this article , sub - paragraphs and , be satisfied as to the matter set out in paragraph 7 of this article , sub - paragraph . member states may also stipulate that the person or entity which takes responsibility for the intermediary shall register that intermediary . ### member states may stipulate that , where an insurance or reinsurance intermediary acts under the responsibility of an insurance or reinsurance undertaking or of another registered insurance or reinsurance intermediary , the insurance intermediary shall not be required to provide the competent authority with the information in points and of article 3 and the insurance entity responsible shall ensure that the insurance intermediary meets the conditions for registration and other provisions set out in this directive . member states may also stipulate that the person or entity which takes responsibility for the intermediary shall register that intermediary .


### the details referred to in points and of paragraph 1 shall be modulated according to the complexity of the insurance product being proposed and the level of financial risk to the customer . ### the details referred to in points and of paragraph 1 shall be modulated according to the complexity of the insurance product being proposed and the level of financial risk to the customer and the distribution route .


### ‘ tied insurance intermediary’ means any person who carries on the activity of insurance mediation for and on behalf of one or more insurance undertakings or insurance intermediaries , and who acts under the full responsibility of those insurance undertakings or insurance intermediaries , provided that the insurance intermediaries under whose responsibility the person acts do not themselves act under the responsibility of another insurance undertaking or intermediary ; ### ' tied insurance intermediary ' means any person who carries on the activity of insurance mediation for and on behalf of one or more insurance undertakings or registered insurance intermediary in the case of insurance products which are not in competition and does not collect premiums or amounts intended for the customer and who acts under the full responsibility of those insurance undertakings or registered insurance intermediaries , for the products which concern them respectively provided that the registered insurance intermediary under whose responsibility the person acts does not himself act under the responsibility of another insurance undertaking or intermediary ; any person who carries on the activity of insurance mediation in addition to his principal professional activity is also considered as a tied insurance intermediary acting under the responsibility of one or several insurance undertakings or registered insurance intermediary if the insurance is complementary to the goods or services supplied in the framework of this principal professional activity and the person does not collect premiums or amounts intended for the customer ;


### member states may stipulate that , where an insurance or reinsurance intermediary acts under the responsibility of an insurance or reinsurance undertaking or of another registered insurance or reinsurance intermediary , the latter intermediary or the undertaking shall be responsible for ensuring that it meets the conditions for registration set out in this directive . in such a case , the person or entity accepting responsibility shall , having been informed by the member states of the matters set out in paragraph 7 of this article , sub - paragraphs and , be satisfied as to the matter set out in paragraph 7 of this article , sub - paragraph . member states may also stipulate that the person or entity which takes responsibility for the intermediary shall register that intermediary . ### member states may stipulate that , where an insurance or reinsurance intermediary acts under the responsibility of an insurance or reinsurance undertaking or intermediary , the insurance intermediary shall not provide the competent authority with the registration information in article 3 and the insurance intermediary or undertaking responsible shall ensure that their insurance intermediary meets the conditions for registration and other provisions set out in this directive . member states may also stipulate that the person or entity which takes responsibility for the intermediary shall register that intermediary .


### this directive should specify the minimum obligations which insurance undertakings and insurance intermediaries should have in providing information to customers . a member state should be able to in this area maintain or adopt more stringent provisions which may be imposed on insurance intermediaries and insurance undertakings independently of the provisions of their home member state where they are pursuing insurance mediation activities on its territory provided that any such more stringent provisions comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . a member state which proposes to apply and applies provisions regulating insurance intermediaries and the sale of insurance products in addition to those set out in this directive should ensure that the administrative burden stemming from these provisions is proportionate for consumer protection . in the interest of consumer protection and in order to prevent mis - selling of insurance products , member states should be permitted to apply exceptionally the more stringent requirements to such insurance intermediaries conducting insurance mediation on an ancillary basis if they consider it necessary and proportionate . ### this directive should specify the minimum obligations for insurance undertakings and insurance intermediaries . a member state should be able to maintain or adopt more stringent provisions which may be imposed on insurance intermediaries and insurance undertakings . such more stringent provisions must comply with union law , including directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market .


### it is not under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings and does not give advice on the basis of a fair analysis . in that case , it shall provide the names of the insurance undertakings with which it may and does conduct business ; ### it gives no advice ;


### costs and associated charges . ### costs , including the remuneration of the intermediary , and associated charges including separate charges for advice and the cost of the product where advice is provided .


### chapters ii to iv of this regulation shall not apply to products subject to requirements designed to protect human health and safety laid down in union harmonisation legislation or pursuant to it . ### this regulation shall not apply to products subject to requirements designed to protect human health and safety laid down in union harmonisation legislation or pursuant to it .


### – nuisance . ### – nuisance : noise and exhaust fumes


### the roadside inspections should be implemented via a risk rating system . the member states may use the risk rating system established in accordance with article 9 of directive 2006 / 22 / ec of the european parliament and the council of 15 march 206 on minimum conditions for the implementation of council regulation no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . ### the roadside inspections should be implemented via a risk rating system provided that a sufficient degree of harmonisation of periodic roadworthiness testing has been achieved between all member states and a system of mutual recognition of roadworthiness certificates can be established . the european commission should draft a report on progress in the harmonisation process in order to determine when such a mutual recognition could be established .


### drivers of a vehicle registered in a member state shall keep on board the roadworthiness certificate corresponding to the latest roadworthiness test and the report of the last roadside inspection , when they are available . ### drivers of a vehicle registered in a member state shall keep on board the roadworthiness certificate corresponding to the latest roadworthiness test and the report of the last roadside inspection , when they are available . if the certificate and the report are available electronically in the home country of the vehicle , the authorities cannot ask for paper copies to be kept onboard .


### where the inspections are to be carried out in a testing centre , the place of the initial roadside inspection shall not be fixed more than 10 km away from this centre . ### where the inspections are to be carried out in a testing centre , they must be carried as soon as possible out in the nearest centre .


### each member state shall carry out in every calendar year a total number of initial roadside inspections , corresponding to at least 5% of the total number of vehicles referred to in article 3 that are registered in its territory . ### each member state shall carry out in every calendar year a number of initial roadside inspections of eligible registered vehicles in each of the member states . a target could be corresponding to 5% of the total number of eligible vehicles that are registered in its territory .


### carry out a visual assessment of the condition of the vehicle and of its cargo . ### carry out a visual assessment of the condition of the vehicle .


### with a view to avoid unnecessary administrative burden and costs and to improve the efficiency of inspections , vehicles operated by undertakings not complying with road safety and environmental standards should be selected as a priority , while vehicles operated by responsible and safety - minded operators and properly maintained should be rewarded with less frequent inspections . ### with a view to avoid unnecessary administrative burden and costs and to improve the efficiency of inspections , the competent national authorities may decide that vehicles operated by undertakings not complying with road safety and environmental standards will be selected as a priority , while vehicles operated by responsible and safety - minded operators and properly maintained will be rewarded with less frequent inspections .


### the inspector may authorise the vehicle classified with dangerous deficiencies to be brought directly to the closest location where this vehicle can be repaired or impounded . ### the inspector may authorise the vehicle classified with dangerous deficiencies to be brought directly to the closest available location where this vehicle can be repaired or impounded .


### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s response capabilities should be explicitly extended to cover response to pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution . ### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport , the marine environment and coastal areas . the use of the agency ' s response capabilities should be explicitly extended to cover response to pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution .


### the audited entity shall be free to invite any statutory auditors or audit firms to submit proposals for the provision of the statutory audit service on the condition that article 33 is respected and that at least one of the invited auditors or firms is not one who received more than 15% of the total audit fees from large public - interest entities in the member state concerned in the previous calendar year ; ### any statutory auditor or audit firm is free to submit proposals for the provision of the statutory audit service on the condition that article 33 is respected ;


### the market for the provision of statutory audit services to public - interest entities evolves over time . it is therefore necessary that competent authorities monitor the developments in the market , particularly as regards possible limited choice of auditor and the risks that arise from high market concentration . ### the market for the provision of statutory audit services to public - interest entities evolves over time . it is therefore necessary that member states monitor the developments in the market , particularly as regards possible limited choice of auditor and the risks that arise from high market concentration .


### a statutory auditor or audit firm shall take all necessary steps to ensure that the carrying out of a statutory audit of a public - interest entity is not affected by any existing or potential conflict of interest or business or other relationship involving the statutory auditor or audit firm carrying out the statutory audit and , where appropriate , its network , managers , auditors , employees , any other natural persons whose services are placed at the disposal or under the control of the statutory auditor or audit firm , or any person directly or indirectly linked to the statutory auditor or audit firm by control . ### a statutory auditor or audit firm shall take all reasonable steps to ensure that the independence of the statutory auditor or audit firm carrying out a statutory audit is not compromised by financial , personal , business , employment or other relationships involving the statutory auditor , the audit firm , its network , or any natural person in a position to directly or indirectly influence the outcome of the statutory audit .


### a statutory auditor or audit firm shall take all necessary steps to ensure that the carrying out of a statutory audit of a public - interest entity is not affected by any existing or potential conflict of interest or business or other relationship involving the statutory auditor or audit firm carrying out the statutory audit and , where appropriate , its network , managers , auditors , employees , any other natural persons whose services are placed at the disposal or under the control of the statutory auditor or audit firm , or any person directly or indirectly linked to the statutory auditor or audit firm by control . ### a statutory auditor or audit firm shall take all necessary steps to ensure that the independence of the statutory auditor or audit firm carrying out the statutory audit is not compromised by financial , personal , business , employment or other relationships involving the statutory auditor , the audit firm , its affiliate firms and network , and any natural person in a position to influence the outcome of the statutory audit .


### give an opinion which shall state clearly the opinion of the statutory auditor or the audit firm as to whether the annual or consolidated financial statements give a true and fair view and have been prepared in accordance with the relevant financial reporting framework and , where appropriate , whether the annual or consolidated financial statements comply with statutory requirements ; the audit opinion shall be either unqualified , qualified , an adverse opinion or , if the statutory auditor or audit firm are unable to express an audit opinion , a disclaimer of opinion . in case of a qualified or an adverse opinion or a disclaimer of opinion , the report shall explain the reasons of such decision ; ### give an opinion which shall state clearly the opinion of the statutory auditor or the audit firm as to whether the annual or consolidated financial statements give a true and fair view and have been prepared in accordance with the relevant financial reporting framework and , where appropriate , whether the annual or consolidated financial statements comply with statutory requirements ; the audit opinion shall be either unqualified , qualified , adverse opinion or , if the statutory auditor or audit firm are unable to express an audit opinion , a disclaimer of opinion . in case of a qualified or an adverse opinion or a disclaimer of opinion , the report shall explain the reasons of such decision . in the case of credit institutions and insurance undertakings , in accordance with article16 of regulation no 1093 / 2010 and of regulation no 1094 / 2010 respectively , the opinion of the statutory auditor or the audit firm should state the ' going concern ' of the audited entity , where necessary , and inform the competent authority ;


### it is also important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced , for the benefit of a more informed decision of the general meeting of shareholders or members of the audited entity . hence , when making a proposal to the general meeting , the board should explain whether it follows the recommendation of the audit committee and , if not , why . the recommendation of the audit committee should include at least two possible choices for the audit engagement and a duly justified preference for one of them , so that the general meeting can make a real choice . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a mandatory selection procedure organised by the audited entity , under the responsibility of the audit committee . in such selection procedure , the audited entity should invite statutory auditors or audit firms , including smaller ones , to present proposals for the audit engagement . tender documents should contain transparent and non - discriminatory selection criteria to be used for the evaluation of proposals . considering , however , that this selection procedure could entail disproportionate costs for companies with reduced market capitalisation or small and medium - sized public - interest entities having regard to their dimension , it is appropriate to relieve such entities from this obligation . ### it is also important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced , for the benefit of a more informed decision of the general meeting of shareholders or members of the audited entity . this would lead to more transparency in the selection procedure and to strengthened accountability vis - à - vis shareholders . hence , when making a proposal to the general meeting , the board should explain whether it follows the recommendation of the audit committee and , if not , why . it should equally provide reasons if it proposes to renew an audit engagement following a tender procedure . the recommendation of the audit committee should include at least two possible choices for the audit engagement , a comprehensive assessment of both proposals , and a duly justified preference for one of them , so that the general meeting can make a real choice . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a mandatory tender procedure organised by the audited entity , under the responsibility of the audit committee . in such tender procedure , the audited entity should publish a call to auditors or audit firms to present proposals for the audit engagement . tender documents should contain transparent and non - discriminatory selection criteria to be used for the evaluation of proposals . considering , however , that this tender procedure could entail disproportionate costs for companies with reduced market capitalisation or small and medium - sized public - interest entities having regard to their dimension , it is appropriate to relieve such entities from this obligation .


### the maximum duration of the combined two engagements shall not exceed 6 years . ### the maximum duration of the combined two engagements shall not exceed 14 years . at least one re - rendering process shall take place during this 14 year period .


### in the case of a credit institution or insurance undertaking , the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the competent authority referred to in article 35 shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified . ### the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the draft proposal shall be accompanied by the results of the comprehensive assessment referred to in paragraphs 2 and 3 . the competent authority referred to in article 35 shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified .


### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities may provide to the audited entity , to its parent undertaking and to its controlled undertakings statutory audit services and related financial audit services . ### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities may provide to the audited entity , to its parent undertaking and to its controlled undertakings statutory audit services , related financial audit services and other assurance services , subject to prior approval of the audit committee and as long as these services do not pose a threat to independence that cannot be reduced to an acceptable level by the application of safeguards .


### in order to take account of the technical developments in the financial markets , in auditing and the audit profession and to specify the requirements laid down in this regulation , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union . in particular , the use of delegated acts is necessary to adapt the list of related audit services and of non - audit services as well as to set out the level of fees that esma could charge for delivering the european quality certificate to statutory auditors and audit firms . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to take account of the technical developments in the financial markets , in auditing and the audit profession and to specify the requirements laid down in this regulation , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union . in particular , the use of delegated acts is necessary to adapt the list of related audit services and of prohibited non - audit services as well as to set out the level of fees that esma could charge for delivering the european quality certificate to statutory auditors and audit firms . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level and with esma . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the esma , european parliament and to the council .


### where the statutory auditor belongs to a network , a member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union statutory audit services or related financial audit services . ### where the statutory auditor belongs to a network , a member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings statutory audit services , related financial audit services and other assurance services , subject to prior approval of the audit committee and as long as these services do not pose a threat to independence that cannot be reduced to an acceptable level by the application of safeguards .


### the correspondence with the audited entity related to the statutory audit ; ### the significant correspondence with the audited entity related to the statutory audit ;


### for the purposes of this article , related financial audit services shall mean : ### for the purposes of this article , audit - related and other assurance services shall mean :


### where the statutory auditor belongs to a network , no member of such network shall provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union any non - audit services . ### where the statutory auditor belongs to a network , no member of such network shall provide to the audited entity , to its parent undertaking or to its controlled undertakings within the union any prohibited non - audit services .


### any other statutory duty related to audit work imposed by union legislation to the statutory auditor or audit firm . ### any other statutory duty related to audit work imposed by union and / or national legislation to the statutory auditor or audit firm ;


### the provision of services other than statutory audit to audited entities by statutory auditors , audit firms or members of their networks may compromise their independence . therefore , it is appropriate to require the statutory auditor , the audit firm and the members of their network not to provide non - audit services to their audited entities . the provision of non - audit services by an audit firm to a company would prevent that audit firm from carrying out statutory audit of that company , thus resulting in a reduction of the audit firms available to provide statutory audit , in particular with regard to the audit of large public - interest entities where the market is concentrated . as a result , in order to secure that a minimum number of audit firms is able to provide audit services to large public - interest entities , it is appropriate to request that audit firms of significant dimension focus their professional activity on the carrying out of statutory audit and are not allowed to undertake other services unconnected to their statutory audit function such as consultancy or advisory services . ### the provision of services other than statutory audit to audited entities by statutory auditors , audit firms or members of their networks may compromise their independence . therefore , it is appropriate to require safeguards in the form of a prohibition of certain non - audit services the statutory auditor cannot perform to their audited entities , as well as re - tendering , at the behest of the audit committee , of any non - audit service and financial audit related services above a 30% threshold .


### for the purposes of this article , non - audit services shall mean : ### for the purposes of this article , non - audit services shall mean in particular :


### the public - interest entity shall appoint a statutory auditor or audit firm for an initial engagement that shall not be shorter than two years . the public - interest entity may renew this engagement only once . the maximum duration of the combined two engagements shall not exceed 6 years . where throughout a continuous engagement of 6 years two statutory auditors or audit firms have been appointed , the maximum duration of the engagement of each statutory auditor or audit firm shall not exceed 9 years . ### the public - interest entity shall appoint a statutory auditor or audit firm for an initial engagement that shall not be shorter than three years . the public - interest entity may renew this engagement only once . the maximum duration of the combined engagements shall not exceed 12 years . a public tender shall be conducted at the latest after 6 years of renewed audit engagements . where at least two statutory auditors or audit firms have been appointed , the maximum duration of the combined engagements shall not exceed 15 years .


### designing and implementing internal control or risk management procedure related to the preparation and / or control of financing information included in the financial statements and advice on risk ; ### designing or implementing internal control , risk management or financial information technology systems related to the preparation and / or control of financial information included in the financial statements that : form a significant part of the internal control over financial reporting of the audited entity , or generate information that is significant to the accounting records or financial statements that are subject to the statutory audit ;