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


### the appearance of the product and in particular where a product , although not foodstuff , resembles foodstuff and is likely to be confused with foodstuff due to its form , odour , colour , appearance , packaging , labelling , volume , size or other characteristics . ### the appearance and characteristics of the product , its packaging and its presentation to consumers or other purchasers . this includes potentially misleading appearances , in particular where a product , although not designed for use by them , resembles in any way to another object commonly recognised as appealing to , or intended for use by , children , because of its design and characteristics .


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


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


### no later than [ five ] years after the date of application , the commission shall assess the application of this regulation and transmit an evaluation report to the european parliament and the council . this report shall assess if this regulation achieved its objectives , in particular with regard to enhancing the protection of consumers against unsafe products , taking into account its impact on business and in particular on small and medium - sized enterprises . ### no later than . . . * , the commission shall assess the application of this regulation and transmit an evaluation report to the european parliament and the council . this report shall assess if this regulation achieved its objectives , in particular with regard to enhancing the protection of consumers against unsafe products in accordance with article 4 of this regulation , taking into account its impact on business and in particular on small and medium - sized enterprises . that report shall assess inter alia the implications and interactions of regulation no 1025 / 2012 with this regulation . _____________ * oj : please insert the date : five years after the date of application of this regulation .


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


### this regulation should not cover services . however , in order to secure the attainment of the protection of health and safety of consumers , it should apply to products that are supplied or made available to consumers in the context of the provision of services , including products to which consumers are directly exposed during a service provision . equipment on which consumers ride or travel which is operated by a service provider should be excluded from the scope of this regulation since it has to be dealt with in conjunction with the safety of the service provided . ### this regulation should not cover services . however , in order to secure the attainment of the protection of health and safety of consumers , it should apply to all products that are used , supplied or made available to consumers in the context of the provision of services , including products to which consumers are directly exposed during a service provision by a service provider .


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


### the indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer . in particular , the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture . such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions . ### the indication of origin is a necessary supplement to the basic traceability requirements laid down in this regulation concerning the name and address of the manufacturer . furthermore , the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted , where its given address is different from the actual place of manufacture , where the name and address of the manufacturer is missing altogether or because the address was on the packaging that cannot be found . such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions .


### determining the products , categories or groups of products susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1 ; ### determining the products notified via the rapex system or in the pan - european injury database and the products , categories or groups of products that can be deemed susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1 .


### proportionate to the possible risks of a product , manufacturers shall draw up a technical documentation . the technical documentation shall contain , as appropriate : ### proportionate to the possible risks of a product , manufacturers shall draw up a technical documentation . the technical documentation shall contain :


### proportionate to the possible risks presented by a product , importers shall , to protect the health and safety of persons , carry out sample testing of marketed products , investigate complaints , and keep a register of complaints , of non - conforming products and of product recalls , and shall keep the manufacturer and distributors informed of such monitoring . ### proportionate to the possible risks presented by a product , importers shall , to protect the health and safety of persons , carry out sample testing of marketed products , at least once a year on representative samples of the products put up for sale picked randomly under the control of a judicial officer , an authority or any other qualified person designated by each member state , investigate complaints , and keep a register of complaints , of non - conforming products and of product recalls , and shall keep the manufacturer and distributors informed of such monitoring .


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


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


### no later than [ five ] years after the date of application , the commission shall assess the application of this regulation and transmit an evaluation report to the european parliament and the council . this report shall assess if this regulation achieved its objectives , in particular with regard to enhancing the protection of consumers against unsafe products , taking into account its impact on business and in particular on small and medium - sized enterprises . ### no later than [ five ] years after the date of application , and every five years from the first report , the commission shall assess the application of this regulation and transmit an evaluation report to the european parliament and the council . this report shall assess if this regulation achieved its objectives , in particular with regard to enhancing the protection of consumers against unsafe products within the meaning of article 4 of this regulation , taking into account its impact on business and in particular on small and medium - sized enterprises . also , this report shall assess the implications and contributions of regulation no 1025 / 2012 within the scope of this regulation .


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


### adjusting production to market requirements ; ### adjusting production on the basis of the stocks available ;


### promoting sustainable aquaculture activities of their members by providing opportunities for their development ; ### promoting environmentally sustainable aquaculture activities of their members by providing opportunities for their development ;


### each member state may apply the arrangements provided for by this directive to requests for the return of cultural objects unlawfully removed from the territory of other member states prior to 1 january 1993 . ### in order to serve the objectives of this directive , each member state shall use the appropriately adjusted imi system in addressing requests for the return of cultural objects unlawfully removed from the territory of other member states prior to 1 january 1993 .


### in order to guarantee the opening up to competition of procurement by entities operating in the water , energy , transport and postal services sectors , provisions should be drawn up coordinating procurement procedures in respect of contracts above a certain value . such coordination is needed to ensure the effect of the principles of the treaty on the functioning of the european union and in particular the free movement of goods , the freedom of establishment and the freedom to provide services as well as the principles deriving therefrom , such as equal treatment , non - discrimination , mutual recognition , proportionality and transparency . in view of the nature of the sectors affected by such coordination , the latter should , while safeguarding the application of those principles , establish a framework for sound commercial practice and should allow maximum flexibility . ### in order to guarantee the opening up to competition of procurement by entities operating in the water , energy , transport and postal services sectors , provisions should be drawn up coordinating procurement procedures in respect of contracts above a certain value . such coordination is needed to ensure the effect of the principles of the treaty on the functioning of the european union and in particular the free movement of goods , the freedom of establishment and the freedom to provide services as well as the principles deriving therefrom , such as equal treatment , non - discrimination , mutual recognition , proportionality and transparency . in view of the nature of the sectors affected by such coordination , the latter should , while safeguarding the application of those principles , establish a framework for sound commercial practice and should allow maximum flexibility . public procurement rules have to respect the distribution of competences as enshrined in article 14 tfeu and protocol no 26 . the application of those rules should not interfere with the freedom of public authorities to decide how they carry out their public service tasks .


### under article 11 of the treaty on the functioning of the european union , environmental protection requirements must be integrated into the definition and implementation of the union policies and activities , in particular with a view to promoting sustainable development . this directive clarifies how the contracting entities may contribute to the protection of the environment and the promotion of sustainable development , whilst ensuring that they can obtain the best value for money for their contracts . ### under article 9 , 10 and 11 of the treaty on the functioning of the european union , environmental protection requirements and social considerations must be integrated into the definition and implementation of the union policies and activities , in particular with a view to promoting sustainable development . this directive clarifies how the contracting entities may contribute to the protection of the environment and the promotion of sustainable development and how they can use their discretionary power to select technical specifications and award criteria with the aim of achieving sustainable public procurement , whilst ensuring the link to the subject matter of the contract and obtaining the best value for money for their contracts .


### member states shall ensure that third parties which have , in accordance with the criteria laid down by their national law , a legitimate interest in ensuring compliance with this directive , may engage either on behalf of or in support of a seasonal worker , with his / her approval , in any administrative or civil proceedings provided for with the objective of implementing this directive . ### member states shall ensure that third parties which have , in accordance with the criteria laid down by their national law , a legitimate interest in ensuring compliance with this directive , may engage either on behalf of or in support of a seasonal worker , with his / her approval , in any administrative or civil proceedings provided for with the objective of implementing this directive . member states shall inform seasonal workers of the existence of complaints mechanisms , thereby providing complainants with easy access to legal redress for infringement of their rights , ill - treatment or harassment .


### working conditions , including pay and dismissal as well as health and safety requirements at the workplace , applicable to seasonal work as laid down by law , regulation or administrative provision and / or universally applicable collective agreements in the member state to which they have been admitted according to this directive . ### working conditions , including pay and dismissal as well as health and safety requirements at the workplace , applicable to seasonal work as laid down by law , regulation or administrative provision and / or universally applicable collective agreements in the member state to which they have been admitted according to this directive , without discrimination based on gender and in full compliance with health and safety protection standards in respect of seasonal workers who are pregnant , have just given birth or are breastfeeding .


### since 2006 , requirements in essential products have increased in some outermost regions , particularly in the azores and in the french overseas departments , as a result of the increasing livestock population and demographic pressure . the proportion of the budget which member states may use for the specific supply arrangements for the regions concerned should therefore be increased . ### since 2006 , requirements in essential products have increased in some outermost regions , particularly in the azores and in the french overseas departments , as a result of the increasing livestock population and demographic pressure . the annual budgetary allocation for the posei programmes and the proportion of the budget which member states may use for the specific supply arrangements for the regions concerned should therefore be increased .


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


### the flexibility scheme , in accordance with the provisions of section 1 . 2 of annex xiii , shall apply only for the transition from stage iii a to stage iii b and expire on 31 december 2013 . ### the flexibility scheme , in accordance with the provisions of section 1 . 2 of annex xiii , shall apply only for the transition from stage iii a to stage iii b and expire on 31 december 2013 . by way of exception , for locomotives capable of operating on the uk rail network , the flexibility scheme shall expire on 31 december 2015 .


### 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 at least 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 . priority should be given to those substances where the available monitoring data for the purposes of prioritisation is insufficient . in selecting the substances for the watch list the commission shall take into account all available information including the results of the prioritisation procedure carried out in the context of the present directive , research projects , member states ' characterisation and monitoring programmes under articles 5 and 8 of directive 2000 / 60 / ec and information on production volumes , use patterns , concentrations in the environment and effects , including that gathered in accordance with directives 98 / 8 / ec , 2001 / 82 / ec and 2001 / 83 / ec of the european parliament and of the council , and with regulation no 1907 / 2006 and regulation no 1107 / 2009 of the european parliament and of the council .


### 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 be at least twice per year taking into account the use patterns of the substance .


### 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 .


### monitor less intensively than required for priority substances in accordance with article 3 of this directive and annex v to directive 2000 / 60 / ec , provided that the monitoring is representative and a statistically robust baseline regarding the presence of those substances in the aquatic environment already exists , covering at least one river basin management planning cycle of six years . ### monitor less intensively than required for priority substances in accordance with article 3 of this directive and annex v to directive 2000 / 60 / ec , provided that the monitoring is representative and a statistically robust baseline regarding the presence of those substances in the aquatic environment already exists , covering at least one river basin management planning cycle of six years . monitoring may be carried out only once per planning cycle if no increase in the concentration and trend of these substances is registered during the first 6 years .


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


### in the development , production and dissemination of european statistics under this regulation , the national and european statistical authorities should respect the principles set out in the european statistics code of practice , attached to the recommendation of the commission of 25 may 2005 on the independence , integrity and accountability of the national and community statistical authorities , and the commission communication to the european parliament and the council of 15 april 2011 on robust quality management for european statistics . ### to ensure the integrity and quality management in the development , production and dissemination of european statistics under this regulation , the national and european statistical authorities should formally adopt a commitment to take all necessary measures at national level to maintain public confidence in statistics and to allow for more rigorous enforcement of the european statistics code of practice , attached to the recommendation of the commission of 25 may 2005 on the independence , integrity and accountability of the national and community statistical authorities , and the commission communication to the european parliament and the council of 15 april 2011 on robust quality management for european statistics .


### the programme represents the added value of ensuring that european statistics are focused on the information needed to design , implement , monitor and evaluate union policies . in addition , it contributes to the effective use of resources by fostering actions which provide an essential contribution to the development , production and dissemination of harmonised , comparable and reliable statistical information . ### the programme represents the added value of ensuring that european statistics are focused on the information needed to design , implement , monitor and evaluate union policies . in addition , it contributes to the effective use of resources by fostering actions which provide an essential contribution to the development , production and dissemination of harmonised , comparable , reliable , user - friendly and accessible statistical information .


### statistics developed , produced and disseminated under this programme should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value . ### high - quality statistics developed , produced and disseminated under this programme are vital for evidence based decision - making and should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value .


### the programme shall be implemented in accordance with the principles of the european statistics code of practice with a view to producing and disseminating high - quality , harmonised european statistics and ensuring the proper functioning of the european statistical system as a whole . appropriate measures shall be taken to ensure good coordination and effective priority setting within the ess in order to contribute to the reduction of administrative burden on statistical respondents . national authorities and the union statistical authority shall ensure that european statistics comply with the european quality standards and serve the needs of european union institutional users , governments , regional authorities , research institutions , civil society organisations , enterprises and the public . ### the programme shall be implemented in accordance with the principles of the european statistics code of practice with a view to producing and disseminating high - quality , harmonised and comparable european statistics and ensuring the proper functioning of the european statistical system as a whole . appropriate measures shall be taken and resources provided to ensure good coordination and effective priority setting within the ess in order to contribute to the reduction of burden on respondents and better use the limited resources at the eu and the member states level . in introducing new actions , the commission shall duly justify those actions and shall provide information in accordance with article 14 of regulation no 223 / 2009 . national authorities competent for european statistics and the union statistical authority shall ensure that european statistics comply with the european statistics code of practice and serve the needs of european union institutional users , governments , regional authorities , research institutions , civil society organisations , enterprises and the public and that european statistics are based on well - defined priorities in compliance with the principle of a free and transparent access to european statistics .


### ' 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 ;


### ‘ 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 ;


### 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 the insurance intermediary or the insurance undertaking inform the customer that it gives its advice on the basis of a fair analysis , it is obliged to give that advice on the basis of an analysis of a sufficiently large number of insurance contracts available on the market , to enable it to make a recommendation , in accordance with professional criteria , regarding which insurance contract would be adequate to meet the customer ' s needs . ### when the insurance intermediary or insurance undertaking informs the customer that insurance advice is provided on an independent basis , it shall : carry out a comprehensive analysis of the relevant market , to enable it to make a recommendation , in accordance with professional criteria , regarding which insurance contract would be adequate to meet the customer ' s needs . the 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 ; give the customer full and unbiased advice ; not accept or receive fees , commissions or any monetary benefits , benefits in money’s worth or other incentives 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 .


### 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 .


### if any payments are made by the customer under the insurance contract after its conclusion , the insurance undertaking or intermediary shall also make the disclosures in accordance with this article for each such payment . ### with the exception of cases where a regular monthly direct debit of the exact same amount has been fully disclosed , including the number of months the direct debit will be debited before the signing of a contract , if any payments are made by the customer under the insurance contract after its conclusion , the insurance undertaking or intermediary shall also make the disclosures in accordance with this article for each such payment .


### costs and associated charges . ### costs and associated charges . where charges are made on more than one occasion , and of a varying amount , an estimate of the cost will be provided , including when such charges can be expected .


### 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 about the remuneration which they receive . there is an urgent 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 purpose is to help make the relationship between the insurance undertaking and the intermediary as well as the structure and the content of the intermediaries ' remuneration more transparent to the consumer .


### if the amount of the commission is based on the achievement of agreed targets or thresholds relating to the business placed by the intermediary with an insurer , the targets or thresholds as well as the amounts payable on the achievement of them . ### that the consumer has the right to request the information referred to in point


### ' 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 . comparing information regarding insurance products and prices on a commercial basis on a website should be considered as insurance intermediation .


### the amount of the annual premium for the insurance contract , when pro - rated to produce an annual amount , does not exceed eur 600 . ### the amount of the annual premium for the insurance contract , when pro - rated to produce an annual amount , does not exceed eur 600 . eiopa shall review the amount referred to in point of paragraph 2 regularly in order to take account of changes in the european index of consumer prices as published by eurostat . the first review shall take place five years after the entry into force of this directive and the successive reviews every five years after the previous review date . eiopa shall develop draft regulatory standards which adapt the base amount in euro referred to in point of paragraph 2 by the percentage change in that index over the period between the entry into force of this directive and the first review date or between the last review date and the new review date and rounded up to the nearest euro . eiopa shall submit those draft regulatory technical standards to the commission five years after the entry into force of this directive and the successive reviews every five years after the previous review date . power is conferred on the commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with article 15 of regulation no 1094 / 2010 .


### to provide information to their competent authorities of the identities of persons who have close links with the insurance or reinsurance intermediary ; ### intermediaries where another insurance entity takes responsibility for ensuring that the intermediary meet these requirements in accordance with subparagraph 3 of article 3 . member states shall ensure that their competent authorities require that insurance and reinsurance intermediaries to whom article 3 applies inform them without undue delay where information provided under points and of article 3 changes .


### 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 any other service or product as a package , the insurance undertaking or , where applicable , the insurance intermediary shall inform the customer that it is possible to buy the components of the package separately and shall offer this possibility and provide information of the costs and charges of each component of the package that may be bought through or from it separately .


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


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


### costs and associated charges . ### costs and associated charges , including the net insurance premium .


### member states shall ensure that the competent authorities do not register an insurance or reinsurance intermediary unless it is satisfied that the intermediary meets the requirements laid down in article 8 . ### member states shall ensure that the competent authorities do not register an insurance or reinsurance intermediary unless it is satisfied that the intermediary meets the requirements laid down in article 8 , or that another intermediary or undertaking will take the responsibility for ensuring that the intermediary meets these requirements in accordance with subparagraph 3 of article 3 .


### where steps taken by the insurance intermediary or insurance undertaking in compliance with articles 15 , 16 and 17 are not sufficient to ensure , with reasonable confidence , that risks of damage to the interests of customers and potential customers arising from conflicts of interest will be prevented , the insurance intermediary or insurance undertaking shall clearly disclose the general nature or sources of conflicts of interest to the customer before undertaking business on the customer ' s behalf . ### an insurance intermediary or insurance undertaking shall maintain and operate effective organisational and administrative arrangements with a view to taking all reasonable steps designed to prevent conflicts of interest from adversely affecting the interests of its customers . where steps taken by the insurance intermediary or insurance undertaking are not sufficient to ensure , with reasonable confidence , that risks of damage to the interests of customers and potential customers arising from conflicts of interest will be prevented , the insurance intermediary or insurance undertaking shall clearly disclose the general nature and sources of conflicts of interest and the steps taken to mitigate those risks to the customer .


### 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 . 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 and latest information about the suitability of the insurance product recommended to the customer ;


### where the host member state has grounds for concluding that an insurance or reinsurance intermediary acting within its territory under the freedom to provide services or through an establishment is in breach of any obligation set out in this directive it shall refer those findings to the competent authority of the home member state which shall take the appropriate measures . in cases where , despite measures taken by the competent authority of the home member state , an insurance or reinsurance intermediary persists in acting in a manner that is clearly prejudicial to the interests of host member state consumers or the orderly functioning of insurance and reinsurance markets , the insurance or reinsurance intermediary shall be subject to the following measures : ### where the host member state has grounds for concluding that an insurance or reinsurance intermediary acting within its territory under the freedom to provide services or through an establishment is in breach of any obligation set out in this directive , and where the host member state does not have powers under this directive to take action in response to such breaches , it shall refer those findings to the competent authority of the home member state which shall take the appropriate measures . in cases where , despite measures taken by the competent authority of the home member state , an insurance or reinsurance intermediary persists in acting in a manner that is clearly prejudicial to the interests of host member state consumers or the orderly functioning of insurance and reinsurance markets , the insurance or reinsurance intermediary shall be subject to the following measures :


### insurance products and proposed investment strategies . this should include appropriate guidance on and warnings of the risks associated with investments in those products or in respect of particular investment strategies ; and ### insurance products and proposed investment strategies . this should include appropriate guidance on and warnings of the risks associated with investments in those products or in respect of particular investment strategies including the risk that there may be no return on , or a loss of the initial investment ; and


### member states shall allow bundling practices but not tying practices . ### member states shall allow bundling practices 1a . member states may require that national competent authorities in cooperation with eiopa shall intervene on a case - by - case basis to forbid certain tying practices when they can demonstrate that such practices are detrimental to consumers .


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


### it gives advice on the basis of a fair analysis , or ### it must disclose whether it gives advice on the basis of a fair and personal analysis , or


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


### if the amount of the commission is based on the achievement of agreed targets or thresholds relating to the business placed by the intermediary with an insurer , the targets or thresholds as well as the amounts payable on the achievement of them . ### that the consumer has the right to request the information referred to in point


### 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 an easily comprehensible and clear form on a key information document to allow the customer to make an informed decision , while taking into account the complexity of the insurance product and the type of costumer .


### it is not under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings and does not give advice on the basis of a fair analysis . in that case , it shall provide the names of the insurance undertakings with which it may and does conduct business ; ### it is not under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings and does not give advice on the basis of a fair and personal analysis . in that case , it shall provide the names of the insurance undertakings with which it may and does conduct business ;


### 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 .


### 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 about the remuneration which they receive . there is an urgent 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 purpose is to help make the relationship between the insurance undertaking and the intermediary as well as the structure and the content of the intermediaries ' remuneration more transparent to the consumer .


### if the intermediary will receive a fee or a commission of any kind , the full amount of the remuneration concerning the insurance products being offered or considered or , where the precise amount is not capable of being given , the basis of calculation of all the fee or commission or the combination of both ; ### if the intermediary will receive remuneration of any kind in relation to the insurance contract , the full amount of the remuneration concerning the insurance products being offered or considered or , where the precise amount is not capable of being given , the basis of calculation of all remuneration , upon request of the consumer ;


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


### to provide information to their competent authorities of the identities of shareholders or members , whether natural or legal persons , that have a holding in the intermediary that exceeds 10% and the amounts of those holdings ; ### tied intermediaries ; and


### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled . ### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics , their composition , and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled .


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


### individual undertakings shall ensure that the vehicles which they operate are in a good roadworthy condition at all times . ### undertakings that operate vehicles which fall within the scope of this regulation shall ensure that the vehicles which they operate are in good roadworthy condition at all times and that the roadworthiness certificate corresponding to the latest roadworthiness test is kept on board .


### 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 . ### in order to improve the efficiency of technical roadside inspections , a risk rating system based on the number and severity of deficiencies found on commercial vehicles during periodic roadworthiness tests and technical roadside inspections shall be introduced . the risk rating system shall be operated by the competent authority in each member state .


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


### 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 technical roadside inspection , inspectors shall select as a priority vehicles operated by undertakings or operators 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 .


### the roadside inspection system shall include initial roadside inspections as referred to in article 9 and more detailed roadside inspections as referred to in article 10 . ### the technical roadside inspection system shall include initial roadside inspections and , when necessary due to the existence of potential safety risks , more detailed roadside inspections .


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


### 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 . ### technical 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 inspector may subject a vehicle to an inspection of the cargo securing in accordance with annex iv . the follow - up procedures referred to in article 14 shall also apply in case of major or dangerous deficiencies related to cargo securing . ### the inspector shall systematically subject a vehicle to an inspection of the cargo securing in accordance with annex iv , except in cases where this is technically impossible . the follow - up procedures referred to in article 14 shall also apply in case of major or dangerous deficiencies related to cargo securing .


### 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 .


### ‘ roadside inspection’ means an unexpected inspection of the roadworthiness of a commercial vehicle circulating on roads open to public traffic within the territory of a member state carried out by the authorities , or under their direct supervision ; ### ‘ technical roadside inspection’ means an unexpected inspection of the roadworthiness of a commercial vehicle , and of the securing of its cargo , whilst that vehicle is circulating on roads open to public traffic within the territory of a member state carried out by the authorities , or under their direct supervision ;


### individual undertakings shall ensure that the vehicles which they operate are in a good roadworthy condition at all times . ### does not affect english version


### the examination procedure should be used for the implementing decisions with respect to the objections to harmonised standards which the commission considers justified and where the references to the harmonised standard concerned were already published in the official journal of the european union , given that such a decision could have consequences on the presumption of conformity with the applicable essential requirements . ### the examination procedure should be used in relation to all standardisation notifications with european standardisation organisations , recognition of technical specifications in the areas of information and communication technology , nanotechnology , biotechnology and nuclear technology , for the implementing decisions with respect to the objections to harmonised standards which the commission considers justified and where the references to the harmonised standard concerned were already published in the official journal of the european union , given that such decisions could have consequences on the presumption of conformity with the applicable essential requirements .


### the translation , where required , of european standards or european standardisation deliverables used in support of union policies and legislation into the official union languages other than the working languages of the european standardisation bodies or , in duly justified cases into languages other than the official union languages , ### the translation of european standards or european standardisation deliverables used in support of union policies and legislation into the official union languages other than the working languages of the european standardisation bodies or , in duly justified cases into languages other than the official union languages ,


### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission may decide to recognise technical specifications which are not national , european or international standards and meet the requirements set out in annex ii , as ict standards . ### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission may decide to recognise technical specifications in the field of ict which are not national , european or international standards and meet the requirements set out in annex ii . 2 . the decision referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in article 18 ; moreover , european standardisation organisations shall be included in the adoption process .


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


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


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


### the commission may request one or several european standardisation bodies to draft a european standard or european standardisation deliverable within a set deadline . they shall be market - driven , take into account the public interest and based on consensus . ### the commission may request one or several european standardisation bodies to draft a european standard or european standardisation deliverable within a set deadline . they shall be market - driven , take into account the public interest and based on consensus . requests for drafting standards shall be based on consultations with all the main interested parties .


### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . ### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . the committee shall meet at least two times per year with european and national standardisation organisations and member states .


### additional report to the audit committee ### additional report to the supervisory or administrative body


### 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 .


### 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 .


### 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 at least one statutory auditor or audit firm for an engagement that shall not be shorter than two years or longer than six years .


### the audit committee or the body performing equivalent functions shall be allowed to transmit the additional report to the management , administrative or supervisory body of the audited entity . ### the supervisory or administrative body of the entity or the body performing equivalent functions shall be allowed to transmit the additional report to the management body of the audited entity .


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


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


### 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 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 non - dominant 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 .


### the public - interest entity shall inform the competent authorities referred to in article 35 of any attempt by a third party to impose such a contractual clause or to otherwise influence the decision of the general meeting of shareholders on the selection of a statutory auditor or audit firm . ### the public - interest entity shall inform directly and without delay the competent authorities referred to in article 35 of any attempt by a third party to impose such a contractual clause or to otherwise influence the decision of the general meeting of shareholders on the selection of a statutory auditor or audit firm .


### 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 audit firm shall provide annually to his , her or its competent authority a list of the audited public - interest entities by revenue generated from them . ### a statutory auditor or audit firm shall provide annually to his , her or its competent authority a list of the audited public - interest entities by revenue generated from them . this list concerns revenues generated by audit and non audit services .


### where article 37 of directive 2006 / 43 / ec applies , the public - interest entity shall inform the competent authority of the use of the alternative systems or modalities referred to in that article . ### where article 37 of directive 2006 / 43 / ec applies , the public - interest entity shall only inform the competent authority of the use of the alternative systems or modalities referred to in that article ; in this case paragraphs 2 to 6 of this article shall not apply .


### in order to take account of the technical developments in the financial markets , in auditing and the audit profession and to specify the requirements laid down in this regulation , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union . in particular , the use of delegated acts is necessary to adapt the list of related audit services and of non - audit services as well as to set out the level of fees that esma could charge for delivering the european quality certificate to statutory auditors and audit firms . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to take account of the technical developments in the financial markets , in auditing and the audit profession and to specify the requirements laid down in this regulation , the commission should be empowered to adopt implementing acts in accordance with article 291 of the treaty on the functioning of the european union . in particular , the use of implementing acts is necessary to adapt the list of related audit services and of prohibited non - audit services . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### 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 , preparation of a decision by the supervisory or administrative body on 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 .


### the financial reference amount for the implementation of this regulation for the period 2014 to 2020 shall be eur 239 . 100 . 000 at current prices . if necessary , appropriations could be entered in the budget beyond 2020 to cover similar expenses , in order to enable the management of actions not yet completed by 31 december 2020 . ### the indicative financial reference amount as defined in the point [ 17 ] of the interinstitutional agreement of xx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management shall be eur 239 . 100 . 000 at current prices . annual appropriations shall be authorised by budgetary authority without prejudice to the provisions of the regulation on the multiannual financial framework for the years 2014 - 2020 and the interinstitutional agreement xxx / 201z between the european parliament , council and the commission on cooperation in budgetary matters and sound financial management . if necessary , payment appropriations could be entered in the budget beyond 2020 to cover similar expenses , in order to enable the payment management of actions not yet completed by 31 december 2020 ,


### the union ' s humanitarian aid is delivered in situations where other instruments related to development cooperation , crisis management and civil protection operate . the eu aid volunteers should work in a coherent and complementarity manner with relevant policies and instruments in order to make the most effective use of these instruments while systematically promoting humanitarian principles and long - term development goals . synergies of the actions of the eu aid volunteers should be sought with the union civil protection mechanism , the emergency response centre established by decision xx / xxxx15 and with the eeas and the eu delegations in order to coordinate the union ' s response to humanitarian crises in third countries . ### the union ' s humanitarian aid is delivered in situations where other instruments related to development cooperation , crisis management and civil protection operate . the eu aid volunteers should work in a coherent and complementarity manner with relevant policies and instruments in order to make the most effective use of these instruments and avoid overlaps , while systematically promoting humanitarian principles and long - term development goals . synergies of the actions of the eu aid volunteers should be sought in particular with the union civil protection mechanism , the emergency response centre established by decision xx / xxxx15 , with the eeas , the eu delegations , regional and local actors and international organisations in order to coordinate the union ' s response to humanitarian crises in third countries .


### it is necessary to ensure the continuity of the functioning of union delegations and in particular the continuity and efficiency in the management of external aid by the delegations . therefore the commission should be authorised to subdelegate its powers of budget implementation of operational expenditure to heads of union delegations belonging to eeas as a separate institution . furthermore , where the commission implements the budget under direct centralised management , it should be allowed to do so also through sub - delegation to heads of union delegations . the authorising officers by delegation of the commission should continue to be responsible for the definition of internal management and control systems , while the heads of union delegations should be responsible for the adequate set up and functioning of internal management and control systems and for the management of the funds and the operations carried out within their delegations and they should report twice a year to that effect . ### it is necessary to ensure the continuity of the functioning of union delegations and in particular the continuity and efficiency in the management of external aid by the delegations . therefore the commission should be authorised to subdelegate its powers of budget implementation of operational expenditure to heads of union delegations belonging to eeas as a separate institution . furthermore , where the commission implements the budget under direct centralised management , it should be allowed to do so also through sub - delegation to heads of union delegations . the authorising officers by delegation of the commission should continue to be responsible for the definition of internal management and control systems , while the heads of union delegations should be responsible for the adequate set up and functioning of internal management and control systems and for the management of the funds and the operations carried out within their delegations and they should report twice a year to that effect . the commission shall have the right to withdraw specific subdelegations in accordance with its own rules .