### a new mechanism is needed to provide the commission with targeted high - quality monitoring information on the concentration of substances in the aquatic environment , with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment . the new mechanism should facilitate the gathering of that information across union river basins . in order to maintain the monitoring costs at reasonable levels , the mechanism should focus on a limited number of substances , included temporarily in a watch list , and a limited number of monitoring sites , but deliver representative data that are fit for the purpose of the union prioritisation process . the list should be dynamic , to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary . ### a new mechanism is needed to provide the commission with targeted high - quality monitoring information on the concentration of substances in the aquatic environment , with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment . the new mechanism should facilitate the gathering of that information across union river basins and complement monitoring data from programmes under articles 5 and 8 of directive 2000 / 60 / ec . in order to maintain the monitoring costs at reasonable levels , the mechanism should focus on a limited number of substances , included temporarily in a watch list , and a limited number of monitoring sites , but deliver representative and statistically significant data that are fit for the purpose of the union prioritisation process . the list should be dynamic and its validity in time should be limited , to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary . a substance should be removed from the watch list if the risk assessment in accordance with article 16 of directive 2000 / 60 / ec shows that the substance does not pose a significant risk at union level to or via the aquatic environment .


### 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 may adopt implementing acts laying down technical specifications for the monitoring of the substances in the watch list and technical formats for the reporting to the commission of the monitoring results and related information . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 9 . ### the commission may adopt implementing acts laying down technical formats for the reporting to the commission of the monitoring results and related information . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 9 .


### 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 , provided that the objectives laid down in article 16 of directive 2000 / 60 / ec can be effectively achieved in the context of existing instruments . 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 . strategies to control the chemical pollution of surface waters at source , including substance - specific measures under regulation no 1907 / 2006 , regulation no 1107 / 2009 , and regulation no 528 / 2012 of the european parliament and of the council of 22 may 2012 concerning the making available on the market and use of biocidal products1 , directive 2010 / 75 / eu of the european parliament and of the council of 24 november 2010 on industrial emissions 2 or directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use3 , put in place taking into account socio - economic factors , may allow member states to achieve the objectives of directive 2000 / 60 / ec in an economically , socially and environmentally effective way , avoiding disproportionate costs . coherence between directive 2000 / 60 / ec , the above mentioned legislation and other relevant legislation should therefore be strengthened to ensure the appropriate application of source - control mechanisms . where the outcome of the regular review of annex x to directive 2000 / 60 / ec and available monitoring data show that the measures in place at union level and in member states are not sufficient to achieve the quality standards for certain priority substances or the cessation objective for certain priority hazardous substances , appropriate action should be taken at the level of the relevant union or national acts with a view to achieving the objectives of directive 2000 / 60 / ec . __________________________ 1 oj l 167 , 27 . 6 . 2012 , p . 1 2 oj l 334 , 17 . 12 . 2010 , p . 17 3 oj l 311 , 28 . 11 . 2001 , p . 67


### each member state shall select at least one station per , on average , 15000 km2 geographical area , with a minimum of one per member state . ### each member state shall select at least one monitoring station , plus one station per , on average , 20000 km2 geographical area .


### 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 inclusion of substances in the watch list referred to in paragraph 1 of this article and their removal from it .


### 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 .


### 112 months after the adoption of this directive . ### 112 months after the entry into force of this directive .


### in order to ensure uniform conditions for the implementation of this directive , of the monitoring methods used for monitoring the substances on the watch list and of the reporting formats for the reporting to the commission of the monitoring data and information , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure uniform conditions for the implementation of this directive and of the reporting formats for the reporting to the commission of the monitoring data and information , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### 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 shall draw up a watch list of substances for which union - wide monitoring data shall be gathered for the purpose of supporting , in addition to data from characterisations and monitoring programmes under articles 5 and 8 of directive 2000 / 60 / ec , future prioritisation exercises in accordance with article 16 of directive 2000 / 60 / ec .


### 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 10 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 .


### in selecting the representative stations , the monitoring frequency and timing for each substance , member states shall take into account the use patterns of the substance . the frequency of monitoring shall not be less than once per year . ### in selecting the representative stations , the monitoring frequency and timing for each substance , member states shall take into account the use patterns of the substance . the frequency of monitoring shall not be less than twice per year .


### 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


### the commission may adopt implementing acts laying down technical specifications for the monitoring of the substances in the watch list and technical formats for the reporting to the commission of the monitoring results and related information . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 9 . ### the commission shall adopt technical formats for the reporting to the commission of the monitoring results and related information . the commission shall develop guidelines , including technical specifications , with a view to facilitating the monitoring of the substances in the watch list .


### furthermore , in order to improve the information basis for future identification of priority substances , in particular as regards emerging pollutants , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the drawing up of a watch list . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### furthermore , in order to improve the information basis for future identification of priority substances , in particular as regards emerging pollutants , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the drawing up of a watch list . it is of particular importance that the commission carry out appropriate consultations with all relevant stakeholders during its preparatory work , including at expert level .


### a new mechanism is needed to provide the commission with targeted high - quality monitoring information on the concentration of substances in the aquatic environment , with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment . the new mechanism should facilitate the gathering of that information across union river basins . in order to maintain the monitoring costs at reasonable levels , the mechanism should focus on a limited number of substances , included temporarily in a watch list , and a limited number of monitoring sites , but deliver representative data that are fit for the purpose of the union prioritisation process . the list should be dynamic , to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary . ### a new mechanism is needed to provide the commission with targeted high - quality monitoring information on the concentration of substances in the aquatic environment , with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment . the new mechanism should facilitate the gathering of that information across union river basins . in order to maintain the monitoring costs at reasonable levels , the mechanism should focus on a limited number of substances , included temporarily in a watch list , and a limited number of monitoring sites , but deliver representative and statistically significant data that are fit for the purpose of the union prioritisation process . the list should be dynamic and its validity in time should be limited , to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary . in order to facilitate the setting up of the mechanism , it is useful to already indicate a number of substances , for which monitoring data is insufficient and available information indicates that they may pose a risk to or via the aquatic environment , to be included in the first watch list .


### the second subparagraph of article 18 of regulation no 247 / 2006 foresees gradual elimination , by 31 december 2013 , of vineyards planted with prohibited direct - producer hybrid vine varieties in the azores and madeira . the third subparagraph of article 18 of that regulation obliges portugal to notify each year progress made in converting and restructuring areas planted with such vine varieties . these provisions are stricter than the rules laid down in article 120a of regulation no 1234 / 2007 , namely that prohibited direct - producer hybrid vine varieties shall be grubbed up except when the resulting wine is intended exclusively for the wine producers ' family . therefore article 18 and 18 of regulation no 247 / 2006 should be deleted in order to eliminate the disparity of treatment between the regions of the azores and madeira on one hand and the rest of the community on the other . ### the second subparagraph of article 18 of regulation no 247 / 2006 foresees gradual elimination , by 31 december 2013 , of vineyards planted with prohibited direct - producer hybrid vine varieties in the azores and madeira . the third subparagraph of article 18 of that regulation obliges portugal to notify each year progress made in converting and restructuring areas planted with such vine varieties . these provisions are stricter than the rules laid down in article 120a of regulation no 1234 / 2007 , namely that prohibited direct - producer hybrid vine varieties shall be grubbed up except when the resulting wine is intended exclusively for the wine producers ' family . therefore the date of 31 december 2013 in article 18 of regulation no 247 / 2006 should be deleted in order to eliminate the disparity of treatment between the regions of the azores and madeira on one hand and the rest of the community on the other .


### statistics provided on safety , health and disability ; ### statistics provided on safety , health and disability , including accessibility ;


### – objective 2 : implement new methods of production of european statistics aiming at efficiency gains and quality improvements ; ### – objective 2 : implement new methods of production of european statistics aiming at efficiency gains and quality improvements and ensuring comparability ;


### not accept or receive fees , commissions or any monetary benefits paid or provided by any third party or a person acting on behalf of a third party in relation to the provision of the service to customers . ### whether a fee is payable by the customer for the advice ;


### member states shall ensure that insurance and reinsurance undertakings and intermediaries use the insurance and reinsurance mediation services only of registered insurance and reinsurance intermediaries or of the persons referred to in article 1 or of the persons who have fulfilled the declaration procedure referred to in article 4 . ### member states shall ensure that insurance and reinsurance undertakings and intermediaries use the insurance and reinsurance mediation services only of registered insurance and reinsurance intermediaries or of the persons referred to in article 1 .


### ' 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 ;


### 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 ### assess a range 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


### ' 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 , in the case of insurance products not in competition , several insurance undertakings or insurance intermediaries , but does not collect premiums or amounts intended for the customer 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 ;


### 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 .


### 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 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 .


### ' 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 .


### ‘ reinsurance mediation’ means the activities of advising on , proposing or carrying out other work preparatory to the conclusion of contracts of reinsurance , of 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 reinsurance mediation also if carried on by a reinsurance undertaking without the intervention of a reinsurance intermediary . ### ‘ reinsurance mediation’ means the activities , for remuneration , of advising on , proposing or carrying out other work preparatory to the conclusion of contracts of reinsurance , of concluding such contracts or assisting in the administration and performance of such contracts , in particular in the event of a claim .


### 8 ‘ 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 ; ### 8 ‘ 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 ;


### the insurance intermediary or insurance undertaking and its services . when advice is provided , information shall specify whether the advice is provided on an independent basis and whether it is based on a broad or on a more restricted analysis of the market and shall indicate whether the insurance intermediary or insurance undertaking will provide the customer with the on - going assessment of the suitability of the insurance product recommended to the customer ; ### the insurance intermediary and its services . information shall specify whether the advice is provided on an independent basis and whether it is based on a broad or on a more restricted analysis of the market and shall indicate whether the insurance intermediary will provide the customer with the on - going assessment of the suitability of the insurance product recommended to the customer ;


### 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 .


### 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 ### the range of insurance products on which the recommendation will be based and , in particular , whether the range is limited to insurance products issued or provided by entities having close links with the intermediary who represents the customer ; and


### consumers should be provided in advance with clear information about the status of the persons who sell the insurance product and about the remuneration which they receive . there is a need to introduce a mandatory status disclosure for european insurance intermediaries and insurance undertakings . this information should be given to the consumer at the pre - contractual stage . its role is to show the relationship between the insurance undertaking and the intermediary as well as the structure and the content of the intermediaries ' remuneration . ### consumers should be provided in advance with clear information about the status of the persons who sell the insurance product and whether they are being given personal advice . there is a need to introduce a mandatory status disclosure for european insurance intermediaries and insurance undertakings . this information should be given to the consumer at the pre - contractual stage . its role is to show the relationship between the insurance undertaking and the intermediary as well as the structure of the intermediaries ' remuneration .


### 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 .


### 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 type that is being offered and , consequently , to take investment decisions on an informed basis . this information may be provided in a standardised format .


### 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 .


### insurance and reinsurance intermediaries shall hold professional indemnity insurance covering the whole territory of the union or some other comparable guarantee against liability arising from professional negligence , for at least eur 1 , 120 , 000 applying to each claim and in aggregate eur 1 , 680 , 000 per year for all claims , unless such insurance or comparable guarantee is already provided by an insurance undertaking , reinsurance undertaking or other undertaking on whose behalf the insurance or reinsurance intermediary is acting or for which the insurance or reinsurance intermediary is empowered to act or such undertaking has taken on full responsibility for the intermediary ' s actions . ### insurance and reinsurance intermediaries shall hold professional indemnity insurance covering the whole territory of the union or some other comparable guarantee against liability arising from professional negligence , for at least eur 1 , 000 , 000 applying to each claim and in aggregate eur 2 , 000 , 000 per year for all claims , unless such insurance or comparable guarantee is already provided by an insurance undertaking , reinsurance undertaking or other undertaking on whose behalf the insurance or reinsurance intermediary is acting or for which the insurance or reinsurance intermediary is empowered to act or such undertaking has taken on full responsibility for the intermediary ' s actions .


### the insurance intermediary or insurance undertaking and its services . when advice is provided , information shall specify whether the advice is provided on an independent basis and whether it is based on a broad or on a more restricted analysis of the market and shall indicate whether the insurance intermediary or insurance undertaking will provide the customer with the on - going assessment of the suitability of the insurance product recommended to the customer ; ### the insurance intermediary or insurance undertaking and its services .


### not accept or receive fees , commissions or any monetary benefits paid or provided by any third party or a person acting on behalf of a third party in relation to the provision of the service to customers . ### whether a fee is payable by the customer for the advice ;


### member states may adjust the required conditions with regard to knowledge and ability in line with the particular activity of insurance or reinsurance mediation and the products mediated , particularly if the principal professional activity of the intermediary is other than insurance mediation . in such cases , that intermediary may pursue an activity of insurance mediation only if an insurance intermediary fulfilling the conditions of this article or an insurance undertaking assumes full responsibility for the intermediary ' s actions . member states may provide that in the cases referred to in the second subparagraph of article 3 , the insurance undertaking or intermediary shall verify that the knowledge and ability of the intermediaries are in conformity with the obligations set out in the first subparagraph of this paragraph and , if need be , shall provide such intermediaries with training which corresponds to the requirements concerning the products sold by the intermediaries . ### member states shall adjust the required conditions with regard to knowledge and ability in line with the particular activity of insurance or reinsurance mediation and the products mediated , particularly if the principal professional activity of the intermediary is other than insurance mediation . member states may provide that , in the cases referred to in the second subparagraph of article 3 and with regard to the employees of insurance companies engaged in insurance mediation , the insurance undertaking or intermediary shall verify that the knowledge and ability of the intermediaries are in conformity with the obligations set out in the first subparagraph of this paragraph and , if need be , shall provide such intermediaries with training which corresponds to the requirements concerning the products sold by the intermediaries .


### ‘ 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 , or of 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 .


### ' 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 , in the case of insurance products not in competition , several insurance undertakings or insurance intermediaries , but does not collect premiums or amounts intended for the customer 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 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 ;


### ‘ 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 activities of advising on , proposing or carrying out other work preparatory to the conclusion of contracts of insurance , or of concluding such contracts , shall also be considered to be insurance mediation if carried out by an employee of an insurance undertaking in direct contact with the client without the intervention of an insurance intermediary .


### 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 offer and inform the customer whether it is possible to buy the components of the package separately and shall at the customer’s request provide information of the costs and charges of each component of the package that may be bought through or from it separately


### 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


### 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 shall be provided in a readily comprehensible and clear 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 shall be provided on a standardised key information document .


### member states shall ensure the setting - up of appropriate , effective , impartial and independent complaints and redress procedures for the out - of - court settlement of disputes between insurance intermediaries and customers , and between insurance undertakings and customers , using existing bodies where appropriate . member states shall further ensure that all insurance undertakings and insurance intermediaries participate in the procedures for the out - of - court settlement of disputes where the following conditions are met : ### member states shall ensure the setting - up of appropriate , effective , impartial and independent complaints and redress procedures for the out - of - court settlement of disputes between insurance intermediaries and customers , and between insurance undertakings and customers , using existing bodies where appropriate .


### 8 ‘ 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 ; ### 8 ‘ 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 ;


### member states may adjust the required conditions with regard to knowledge and ability in line with the particular activity of insurance or reinsurance mediation and the products mediated , particularly if the principal professional activity of the intermediary is other than insurance mediation . in such cases , that intermediary may pursue an activity of insurance mediation only if an insurance intermediary fulfilling the conditions of this article or an insurance undertaking assumes full responsibility for the intermediary ' s actions . member states may provide that in the cases referred to in the second subparagraph of article 3 , the insurance undertaking or intermediary shall verify that the knowledge and ability of the intermediaries are in conformity with the obligations set out in the first subparagraph of this paragraph and , if need be , shall provide such intermediaries with training which corresponds to the requirements concerning the products sold by the intermediaries . ### member states shall adjust the required conditions with regard to knowledge and ability in line with the particular activity of insurance or reinsurance mediation and the products mediated , particularly if the principal professional activity of the intermediary is other than insurance mediation . the training and monitoring requirements of this article should not directly apply to those intermediaries who provide insurance mediation on an ancillary basis , but to the insurance undertakings or other intermediaries under whose responsibility they act and who themselves fulfil these obligations . member states may provide that in the cases referred to in the second subparagraph of article 3 , the insurance undertaking or intermediary shall verify that the knowledge and ability of the intermediaries are in conformity with the obligations set out in the first subparagraph of this paragraph and , if need be , shall provide such intermediaries with training which corresponds to the requirements concerning the products sold by the intermediaries .


### ‘ 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 , for remuneration , 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 with the distribution of insurance products .


### the scope of this regulation should not be limited to any selling technique of consumer products , and thus also cover distance selling . ### the scope of this regulation should not be limited to any selling technique of consumer products , and thus also cover distance selling such as online sales .


### before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in article 8 , and and article 10 and , as applicable . ### before making a product available on the market distributors shall verify that the product bears the required marking set out in article 8 , and 10 and is accompanied with the information set out in articles 8 and 10 , as applicable .


### check the roadworthiness certificate and roadside inspection report , where available , kept on board in accordance with article 7 ; ### check the roadworthiness certificate corresponding to the latest roadworthiness test and roadside inspection report , where available , kept on board in accordance with article 7 ;


### 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 union - wide 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 .


### 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 .


### 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 total number of initial roadside inspections , corresponding to at least 5% of the traffic volume in its territory accounted for by vehicles referred to in article 2 . vehicles that are not registered in its territory shall be included in the inspection quota in proportion to their contribution to the total volume of traffic .


### a roadside inspections risk rating system based on the number and severity of deficiencies found on vehicles operated by individual undertakings shall be introduced at national level . the risk rating system shall be operated by the competent authority of the member state . ### a roadside inspections risk rating system based on the number and severity of deficiencies found on vehicles operated by individual undertakings shall be introduced at union level . the risk rating system in each member state shall be operated by the competent authority of the member state . the data on inspections should be collected at the union level and the rating of each undertaking determined on basis of aggregated union - wide data on the results of roadside inspections and roadworthiness tests .


### with a view to implement the roadside inspections risk rating system , 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 . ### with a view to implementing the roadside inspections risk rating system , member states will make maximum use of existing risk rating systems at european level and ensure that a sufficient degree of harmonisation of periodic roadworthiness testing has been achieved between member states ;


### 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 .


### 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 an adequate number of initial roadside inspections , in order to achieve the objectives stated in article 1 regards commercial vehicles covered by this directive .


### when identifying vehicles to be subject to a roadside inspection , inspectors shall select as a priority vehicles operated by undertakings with a high - risk profile as referred to in article 6 . other vehicles may be selected for inspection when there is a suspicion that the vehicle presents a risk to road safety . ### when identifying vehicles to be subject to a roadside inspection , inspectors shall select as a priority vehicles which give rise to the suspicion that the vehicle presents a risk to road safety .


### individual undertakings shall ensure that the vehicles which they operate are in a good roadworthy condition at all times . ### individual undertakings shall ensure that the condition of the vehicles which they operate meets all legal requirements , guaranteeing that the vehicles are road safe throughout their period of use .


### 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 .


### the use of mobile inspection units reduces the delay and costs for operators as more detailed inspections can be performed directly at the roadside . testing centres may also be used in certain circumstances to carry out more detailed inspections . ### the use of mobile inspection units reduces the delay and costs for operators as more detailed inspections can be performed directly at the roadside . testing centres may also be used to carry out more detailed inspections if they are in close vicinity .


### 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 .


### standards are important tools for undertakings and especially small and medium - sized enterprises which , however , are not adequately involved in the standardisation system so that the risk exists that standards do not take into account the needs and concerns of sme . consequently , it is essential to improve their representation and participation in the standardisation process , particularly in the technical committees . ### standards are important tools for undertakings and especially small and medium - sized enterprises which , however , are not adequately involved in the standardisation system so that the risk exists that standards do not take into account the needs and concerns of sme or their potential for contributing innovative technologies . standardisation rules should encourage smes to actively contribute their innovative technology solutions to standardisation efforts . consequently , it is essential to improve their representation and participation in the standardisation process , particularly in the technical committees .


### 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 , production and transport 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 .


### by x x 20xx [ 2 years after the entry into force of the regulation ] , and at least on a two - year basis thereafter , each competent authority shall draw up a report on this issue and submit it to esma , eba and eiopa . ### by x x 20xx [ 3 years after the entry into force of the regulation ] , and at least on a two - year basis thereafter , each competent authority shall draw up a report on this issue and submit it to esma , eba and eiopa .


### 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 non - audit services pursuant to this regulation .


### monitor the statutory audit of the annual and consolidated financial statements and supervise the completeness and integrity of the draft audit reports in accordance with articles 22 to 23 ; ### monitor the statutory audit of the annual and consolidated financial statements and receives the draft audit reports in accordance with articles 22 to 23 ;


### an audit plan setting out the probable scope and method of the statutory audit ; ### an audit plan setting out the probable scope and method of the statutory audit and , where more than one statutory auditor or audit firm have been appointed , the distribution of tasks among the appointed statutory auditors or audit firms and the rotation plan established in accordance with article 33 .


### the audit report shall not be longer than four pages or 10000 characters . it shall not contain any cross - references to the additional report to the audit committee referred to in article 23 . ### the audit report shall not contain any cross - references to the additional report to the audit committee referred to in article 23 .


### esma shall develop draft regulatory technical standards to specify technical requirements on the content of the handover file referred to in paragraph 6 . ### esma shall develop draft regulatory technical standards to specify technical requirements on the performance of statutory audits by more than one statutory auditor or audit firm including the rotation of tasks referred to in paragraph 1 and the content of the handover file referred to in paragraph 5 .


### authorise , on a case by case basis , the provision by the statutory auditor or audit firm of the services referred to in article 10 and of this regulation to the audited entity . ### authorise , on a case by case basis , the provision by the statutory auditor or audit firm of the non - audit services referred to in article 10 of this regulation to the audited entity .


### 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 . 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 , including its statement on the nominee ' s independence , shall be communicated to shareholders along with the resolution to appoint the statutory auditor or audit firm . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a 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 . selection 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 .


### the public - interest entity may renew this engagement only once . ### the public - interest entity may renew the audit engagement provided this is based on a proposal of the audit committee and approved at the annual general meeting .


### 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 of the financial position of the individual entity or consolidated group and of its financial performance and its cash flows in accordance with the relevant financial reporting framework and , comply with statutory accounting requirements ; the audit opinion shall be either unmodified , qualified , an adverse opinion or , if the statutory auditor or audit firm are unable to express an audit opinion , a disclaimer of opinion . in the case of a qualified or an adverse opinion or a disclaimer of opinion , the audit report shall explain the reasons of such decision ;


### public - interest entities which meet the criteria set out in points and of article 2 of directive 2003 / 71 / ec shall not be required to apply the selection procedure referred to in paragraph 4 . ### public - interest entities which meet the criteria set out in points and of article 2 of directive 2003 / 71 / ec , cooperatives within the meaning of article 2 of directive 2006 / 43 / ec , a savings bank or a similar entity as referred to in article 45 of the directive 86 / 635 / eec shall not be required to apply the selection procedure referred to in paragraph 4 .


### 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 ; ### 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 invitation should not preclude in any way that firms who received less than 15% of the total audit fees from public - interest entities in the member state concerned in the previous calendar year , to participate in the selection procedure .


### 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 .


### the risks arising from high concentration , including the demise of audit firms with significant market share , the disruption in the provision of statutory audit services whether in a specific sector or across sectors , the further accumulation of risk in the market and the impact on the overall stability of the financial sector ; ### the risks arising from high concentration of quality deficiencies of a statutory auditor or audit firm , including systematic deficiencies within an audit firm network , which may lead to the demise of audit firms , the disruption in the provision of statutory audit services whether in a specific sector or across sectors , the further accumulation of risk of audit deficiencies and the impact on the overall stability of the financial sector ;


### 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 .


### esma shall create a permanent internal committee pursuant to article 41 of regulation no 1095 / 2010 for this purpose . such internal committee shall be at least composed of the competent authorities referred to in article 35 of this regulation . the competent authorities referred to in article 32 of directive 2006 / 43 / ec shall be invited to attend the meetings of such internal committee concerning matters related to approval and registration of statutory auditors and audit firms and relations with third countries in so far as relevant to the statutory audit of public - interest entities . ### pursuant to article 41 of regulation no 1095 / 2010 , esma shall create a permanent internal committee to which it shall delegate the duties and decisions entailed in carrying out the tasks referred to in the first subparagraph . such internal committee shall be at least composed of the competent authorities referred to in article 35 of this regulation . the competent authorities referred to in article 32 of directive 2006 / 43 / ec shall be invited to attend the meetings of such internal committee concerning matters related to approval and registration of statutory auditors and audit firms and relations with third countries in so far as relevant to the statutory audit of public - interest entities .


### in order to address the familiarity threat and therefore reinforce the independence of auditors and audit firms , it is important to establish a maximum duration of the audit engagement of a statutory auditor or audit firm in a particular audited entity . an appropriate gradual rotation mechanism should also be established with regard to the most senior personnel involved in the statutory audit , including the key audit partners carrying out the statutory audit on behalf of the audit firm . it is also important to provide for an appropriate period within which such statutory auditor or audit firm may not carry out the statutory audit of the same entity . in order to ensure a smooth transition , the former auditor should transfer a handover file with relevant information to the incoming auditor . ### in order to address the familiarity threat and therefore reinforce the independence of auditors and audit firms , gradual rotation should be ensured with regard to the most senior personnel involved in the statutory audit , including the key audit partners carrying out the statutory audit on behalf of the audit firm .


### 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 shall appoint a statutory auditor or audit firm for a period of four consecutive years .


### 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 the statutory auditor , the audit firm and the members of their network not to provide given services to their audited entities .


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


### being involved in the decision - taking of the audited entity and the provision of the services referred to in points and of paragraph 3 shall be considered as affecting such independence in all cases . ### the involvement of the member of the network in the decision - taking of the audited entity and shall be considered as affecting such independence in all cases .


### each member state shall designate a competent authority responsible for carrying out the tasks provided for in this regulation and for ensuring that the provisions of this regulation are applied . ### each member state shall designate competent authorities responsible for carrying out the tasks provided for in this regulation and for ensuring that the provisions of this regulation are applied .


### the statutory auditor or the audit firm shall comply with the international auditing standards referred to in article 26 of directive 2006 / 43 / ec when carrying out the statutory audit of public - interest entities as long as those standards are in conformity with the requirements of this regulation . ### the statutory auditor or the audit firm shall comply with the international auditing standards referred to in article 26 of directive 2006 / 43 / ec when carrying out the statutory audit of public - interest entities .


### 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 . ### where more than one statutory auditor or audit firm have been appointed , rotation of tasks individually allocated to each of the statutory auditors or audit firms shall occur at least every 6 years . in the event such a rotation does not occur , renewal of an engagement is not allowed .


### however , article 32 shall apply from [ … ] [ the date of the entry into force of the regulation ] and article 10 shall apply from [ … ] [ 3 years after the entry into force of the regulation ] . ### however , article 32 shall apply from [ … ] [ the date of the entry into force of the regulation ] .


### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities shall not directly or indirectly provide to the audited entity , to its parent undertaking and to its controlled undertakings non - audit services . ### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities shall not directly or indirectly provide to the audited entity , to its parent undertaking or to its controlled undertakings prohibited non - audit services .


### esma shall create a permanent internal committee pursuant to article 41 of regulation no 1095 / 2010 for this purpose . such internal committee shall be at least composed of the competent authorities referred to in article 35 of this regulation . the competent authorities referred to in article 32 of directive 2006 / 43 / ec shall be invited to attend the meetings of such internal committee concerning matters related to approval and registration of statutory auditors and audit firms and relations with third countries in so far as relevant to the statutory audit of public - interest entities . ### the egaob shall be composed of the competent authorities designated by member states in accordance with article 35 of this regulation .


### a statutory auditor or an audit firm shall have adequate remuneration policies providing sufficient performance incentives to secure audit quality . in particular , compensation and performance evaluation of employees shall not be contingent on the amount of revenue that the statutory auditor or the audit firm derives from the audited entity ; ### a statutory auditor or an audit firm shall have adequate remuneration or profit - sharing policies providing sufficient performance incentives to secure audit quality . in particular , the amount of revenue that the statutory auditor or the audit firm derives from selling non - assurance services to the audited entity shall not form part of the performance evaluation and compensation of any person involved in or able to influence the conduct of the audit ;


### in order to address the familiarity threat and therefore reinforce the independence of auditors and audit firms , it is important to establish a maximum duration of the audit engagement of a statutory auditor or audit firm in a particular audited entity . an appropriate gradual rotation mechanism should also be established with regard to the most senior personnel involved in the statutory audit , including the key audit partners carrying out the statutory audit on behalf of the audit firm . it is also important to provide for an appropriate period within which such statutory auditor or audit firm may not carry out the statutory audit of the same entity . in order to ensure a smooth transition , the former auditor should transfer a handover file with relevant information to the incoming auditor . ### in order to address the familiarity threat and therefore reinforce the independence of auditors and audit firms , it is important to establish a maximum duration of the audit engagement of a statutory auditor or audit firm in a particular audited entity . furthermore , a comprehensive , transparent and independent evaluation of audit quality should be regularly and appropriately documented . this comprehensive evaluation should form the basis for the auditor selection by the general meeting , which follows a tender procedure at least every 7 years . moreover , an appropriate gradual rotation mechanism should be established with regard to the most senior personnel involved in the statutory audit , including the key audit partners carrying out the statutory audit on behalf of the audit firm .


### a statutory auditor or an audit firm shall have adequate remuneration policies providing sufficient performance incentives to secure audit quality . in particular , compensation and performance evaluation of employees shall not be contingent on the amount of revenue that the statutory auditor or the audit firm derives from the audited entity ; ### a statutory auditor or an audit firm shall have adequate remuneration policies providing sufficient performance incentives to secure audit quality . in particular , the compensation and performance evaluation of employees , including key audit partners , shall not be contingent on the amount of revenue that the statutory auditor or the audit firm derives from selling non - assurance services to the audited entity ; this does not preclude normal profit - sharing arrangements between partners of a firm ;


### at least one member of the audit committee shall have competence in auditing and another member in accounting and / or auditing . the committee members as a whole shall have competence relevant to the sector in which the audited entity is operating . ### at least two members of the audit committee shall have competences in auditing , finance , taxation or accounting .


### 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 . 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 administrative or supervisory board 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 . selection 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 .


### authorise , on a case by case basis , the provision by the statutory auditor or audit firm of the services referred to in article 10 and of this regulation to the audited entity . ### authorise , on a case by case basis , the provision by the statutory auditor or audit firm of the non - audit services referred to in article 10 of this regulation to the audited entity .


### 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 in particular :


### declare that the non - audit services referred to in article 10 were not provided and that the statutory auditor or the audit firm remained completely independent in conducting the audit . where the statutory audit was carried out by an audit firm , the report shall identify each member of the audit engagement team and shall state that all members remained completely independent and had no direct or indirect interest in the audited entity ; ### declare that the prohibited non - audit services referred to in article 10 were not provided and that the statutory auditor or the audit firm remained independent in conducting the audit ; declare that non - audit and non - assurance services provided to the audited public - interest entity other than those referred to in article 10 had appropriate involvement of the audit committee or have been approved by the audit committee . where the statutory audit was carried out by an audit firm , the report shall state that all members of the engagement team remained independent of the audited entity ;


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


### the statutory auditor or the audit firm shall also have a duty to report any facts and decisions of which he , she or it becomes aware in the course of carrying out the statutory audit of an undertaking having close links with the public - interest entity for which he , she or it is also carrying out the statutory audit . ### the statutory auditor or the audit firm shall also have a duty to report any information of which he , she or it becomes aware in the normal course of carrying out the statutory audit of an undertaking having close links with the public - interest entity for which he , she or it is also carrying out the statutory audit .


### esma shall provide advice to the competent authorities in the cases provided for in this regulation . the competent authorities shall consider that advice before taking any final decision under this regulation . ### egaob shall provide advice to the competent authorities in the cases provided for in this regulation . the competent authorities shall consider that advice before taking any final decision under this regulation .


### the commission may consider the added - value and management advantages of creating an eu trust fund . ### the commission may consider the added - value and management advantages of creating an eu trust fund . a trust fund for eu aid volunteers can only be created if a thorough analysis on the of use of eu trust funds for eu humanitarian actions proves the added value of such a trust fund .


### increase by at least 15&#160 ; % in quantity , as compared with the previous calendar year ; or ### increase by at least 12 , 5&#160 ; % in quantity , as compared with the previous calendar year ; or


### it has ratified all the conventions listed in annex viii and the most recent available conclusions of the relevant monitoring bodies do not identify a serious failure to effectively implement any of these conventions ; ### it has ratified all the conventions listed in annex viii without any reservations which are inconsistent with their objectives and purposes and the most recent available conclusions of the relevant monitoring bodies , or any evidence available , do not identify a serious failure to effectively implement any of these conventions ;


### every two years the commission shall present , to the council and the european parliament , a report on the effects of the scheme covering the most recent two - year period and all of the preferential arrangements referred to in article 1 . ### the commission shall present an annual report on the application and implementation of this regulation to the european parliament . the report shall cover all of the preferential arrangements referred to in article 1 , including obligations concerning barriers to trade , and present a summary of the statistics and the evolution of trade with the beneficiary countries and territories . 2 . the generalised preferences committee and the european parliament shall examine the effects of the scheme , on the basis of the report . the european parliament may invite the commission to a meeting of its responsible committee to present and explain any issues related to the implementation of this regulation . 3 . no later than six months after presenting the report to the generalised preferences committee and the european parliament , the commission shall make the report public .


### an investigation , including the procedural steps referred to in articles 25 , 26 and 27 , shall be concluded within 12 months from its initiation . ### an investigation , including the procedural steps referred to in articles 25 , 26 and 27 , shall be concluded within six months from its initiation . in exceptional circumstances , such as an unusually high number of interested parties or complex market situations , this time limit may be extended by a further period of three months . the commission shall notify all interested parties of any such extension and explain the reasons leading to it .


### council regulation no 732 / 2008 applying a scheme of generalised tariff preferences for the period from 1 january 2009 to 31 december 2011 , as extended by regulation no…… of the european parliament and of the council amending council regulation no 732 / 2008 applies the scheme of generalised tariff preferences until this regulation is applied . thereafter , the scheme should continue to apply with no expiry date . however , it shall be reviewed five years after its entry into force . ### council regulation no 732 / 2008 applying a scheme of generalised tariff preferences for the period from 1 january 2009 to 31 december 2011 , as extended by regulation no…… of the european parliament and of the council amending council regulation no 732 / 2008 applies the scheme of generalised tariff preferences until this regulation is applied . thereafter , the scheme should continue to apply for a period of 10 years , except for the special arrangement for the least - developed countries , which should continue to be applied without any expiry date . the scheme shall be reviewed five years after its entry into force .


### paragraph 1 shall not apply to eba beneficiary countries , nor shall it apply to countries with a share not exceeding 8 % of european union imports of products listed in annex v or ix , whichever is applicable . ### paragraph 1 shall not apply to eba beneficiary countries , nor shall it apply to countries with a share not exceeding 6 % of european union imports of products listed in annex v or ix , whichever is applicable


### the commission shall notify the requesting country of a decision taken in accordance with paragraphs 4 and 5 . where the requesting country is granted the special incentive arrangement , it shall be informed of the date on which that decision enters into force . ### the commission shall notify the requesting country of a decision taken in accordance with paragraphs 4 and 5 after the annex is amended . where the requesting country is granted the special incentive arrangement , it shall be informed of the date on which the respective delegated act enters into force .


### paragraph 1 shall not apply to eba beneficiary countries , nor shall it apply to countries with a share not exceeding 8 % of european union imports of products listed in annex v or ix , whichever is applicable . ### paragraph 1 shall not apply to eba beneficiary countries , nor shall it apply to countries with a share for the relevant products referred to in article 29 not exceeding 6 % of total european union imports of the same products listed in annex v or ix , whichever is applicable .


### as intra - corporate transfers consist of temporary migration , the applicant should provide evidence that the third - country national will be able to transfer back to an entity belonging to the same group and established in a third country at the end of the assignment . that evidence may consist of the relevant provisions under the work contract . an assignment letter should be produced providing evidence that the third - country national manager or specialist possesses the professional qualifications needed in the member state to which they have been admitted to occupy the post or the regulated profession . ### as intra - corporate transfers consist of temporary migration , the applicant should provide evidence that the third - country national will transfer back to an entity belonging to the same group and established in a third country at the end of the assignment , in accordance with the contract that he / she has with the group . that evidence may consist of the relevant provisions under the work contract . an assignment letter should be produced providing evidence that the third - country national manager or specialist possesses the professional qualifications or the experience needed in the member state to which they have been admitted to occupy the post or the regulated profession .


### ‘ intra - corporate transfer’ means the temporary secondment of a third - country national from an undertaking established outside the territory of a member state and to which the third - country national is bound by a work contract , to an entity belonging to the undertaking or to the same group of undertakings which is established inside this territory ; ### ‘ intra - corporate transfer’ means the temporary secondment of a third - country national not resident within the territory of the european union from an undertaking that is established outside the territory of a member state and to which the third - country national will return owing to a binding work contract , to an entity belonging to the undertaking or to the same group of undertakings which is established inside this territory ;


### ‘ intra - corporate transfer’ means the temporary secondment of a third - country national from an undertaking established outside the territory of a member state and to which the third - country national is bound by a work contract , to an entity belonging to the undertaking or to the same group of undertakings which is established inside this territory ; ### ‘ intra - corporate transfer’ means the temporary secondment of a third - country national not resident within the territory of the member states from an undertaking established outside the territory of a member state and to which the third - country national is bound by a work contract , to an entity belonging to the undertaking or to the same group of undertakings which is established inside this territory ; this transfer is intended to cover similar situations as provided for in article 1 of directive 96 / 71 / ec .