### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ date ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a document explaining the relationship between them and this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ date ] at the latest . they shall forthwith communicate to the commission the text of those provisions .


### the use of natural resources , in particular land , soil , water , and biodiversity , including hydromorphological changes ; ### the use of natural resources , in particular land , soil , subsoil , water , and biodiversity , including hydromorphological changes ;


### areas classified or protected under member states ' legislation ; natura 2000 areas designated by member states pursuant to directive 2009 / 147 / eec of the european parliament or of the council and council directive 92 / 43 / eec ; areas protected by international conventions ; ### areas classified or protected under member states ' legislation ; natura 2000 areas designated by member states pursuant to directive 2009 / 147 / eec of the european parliament or of the council and council directive 92 / 43 / eec ; areas protected by international conventions provided that member states have ratified those conventions ;


### areas in which there has already been a failure to meet the environmental quality standards , laid down in union legislation and relevant to the project , or is likely to be such a failure ; ### areas in which there is a failure to meet the environmental quality standards , laid down in union legislation and relevant to the project , or is likely to be such a failure as far as no overall environmental benefit is achieved ;


### the potential significant effects of projects must be considered in relation to criteria set out under 1 and 2 above , with particular regard to : ### the potential significant effects of projects on the factors referred to in article 3 must be considered in relation to criteria set out under 1 and 2 above , with particular regard to :


### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use and land - use requirements during the construction and operational phases ; ### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use and land - use requirements during the construction and operational phases and demolition if relevant ;


### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use and land - use requirements during the construction and operational phases ; ### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , any necessary demolition work and the water use and land - use requirements during the construction and operational phases ;


### a description of the main characteristics of the production processes , for instance , nature and quantity of the materials , energy and natural resources used ; ### a description of the main characteristics of the production processes , for instance , technical capacity , nature and quantity of the materials , energy and natural resources used ;


### a description of the aspects of the environment likely to be significantly affected by the proposed project , including , in particular , population , human health , fauna , flora , biodiversity and the ecosystem services it provides , land , soil , water , air , climatic factors , climate change , material assets , cultural heritage , including architectural and archaeological ones , landscape ; such a description should include the inter - relationship between the above factors , as well as the exposure , vulnerability and resilience of the above factors to natural and man - made disaster risks . ### a description of the factors of the environment likely to be significantly affected by the proposed project , including , in particular , population , human health , fauna , flora , biodiversity , land , soil , water , air , climatic factors , climate change , material assets , cultural heritage , including architectural and archaeological ones , landscape . this description should cover the inter - relationship between the above factors .


### a description of the likely significant effects of the proposed project on the environment resulting from , inter alia : ### a description and assessment of the likely significant effects of the proposed project on the environment resulting from , inter alia :


### hydromorphological changes . ### hydromorphological changes , where relevant .


### a description of the measures envisaged to prevent , reduce and , where possible , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases . ### a description of the measures envisaged to prevent , reduce and , where possible , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases .


### a description of the measures envisaged to prevent , reduce and , where possible , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases . ### a description of the measures envisaged to prevent , reduce and , where possible , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are avoided , reduced or offset and should cover the construction phase , the operational phase and the project - specific risk of natural and man - made disasters which are , on reasoned assessment , regarded as characteristic for the nature of the project .


### the new definition of distance contract should cover all cases where sales and service contracts are concluded using exclusively one or more means of distance communication . this should create a level playing field for all distance traders . it should also improve legal certainty as compared to the current definition requiring the presence of an organised distance selling scheme run by the trader up to the conclusion of the contract . ### the new definition of distance contract should cover all cases where contracts concerning the provision of a good or service are concluded without the simultaneous physical presence of the parties and using exclusively one or more means of distance communication . this should create a level playing field for all distance traders .


### an off - premises contract should be defined as a contract concluded with the simultaneous physical presence of the trader and the consumer , away from business premises , for example at the consumer ' s home or workplace . in an off - premises context , consumers are under psychological pressure no matter whether they have solicited the trader ' s visit or not . furthermore , in order to prevent circumventions of rules when consumers are approached away from business premises , a contract negotiated , for example at the consumer ' s home but concluded in a shop should be regarded as an off - premises contract . ### an off - premises contract should be defined as a contract concluded with the simultaneous physical presence of the trader and the consumer , away from business premises , for example at the consumer ' s home or workplace . an uninvited visit at home or at the workplace may take the consumer by surprise and result in particular psychological buying pressure . in such circumstances , moreover , the consumer has no opportunity to compare price and quality with those of other products . all these factors are not present in the case of a contract concluded in a shop , or where the consumer has sought the contract . consequently the particular protection rules should also not apply in these cases . furthermore , in order to prevent circumventions of rules , contracts which come about after consumers are approached away from business premises , but which are concluded in a shop , or contracts concluded as part of an advertising trip , should be regarded as off - premises contracts .


### consumers should be entitled to receive information before the conclusion of the contract . however traders should not have to provide the information when already apparent from the context . for example in an on - premises transaction , the main characteristics of a product , the identity of the trader and the arrangements for delivery may be apparent from the context . in distance and off - premises transactions , the trader should always provide the information on arrangements for payment , delivery , performance and the complaint handling policy , since these might not be apparent from the context . ### the consumer should be given comprehensive information before he is committed to a distance contract , an off - premises contract or a corresponding contract offer .


### consumers should be entitled to receive information before the conclusion of the contract . however traders should not have to provide the information when already apparent from the context . for example in an on - premises transaction , the main characteristics of a product , the identity of the trader and the arrangements for delivery may be apparent from the context . in distance and off - premises transactions , the trader should always provide the information on arrangements for payment , delivery , performance and the complaint handling policy , since these might not be apparent from the context . ### consumers should be entitled to receive information in good time before the conclusion of the contract .


### since in the case of distance sales , the consumer is not able to see the good before concluding the contract he should have a right of withdrawal , which allows him to ascertain the nature and functioning of the goods . ### since in the case of distance sales , the consumer is not able to see the good before concluding the contract he should , up until the end of the return period , have a right of withdrawal , which allows him to ascertain the nature and quality of the goods and whether they function properly .


### when the consumer orders more than one good from the same trader , he should be entitled to exercise the right of withdrawal in respect of each of these goods . if the goods are delivered separately , the withdrawal period should start when the consumer acquires the material possession of each individual good . where a good is delivered in different lots or pieces , the withdrawal period should start when the consumer or a third party indicated by the consumer acquires the material possession of the last lot or piece . ### where goods are supplied in more than one delivery , the withdrawal period should begin from the day on which the consumer or a third party other than the carrier and indicated by the consumer acquires the material possession of the first partial shipment .


### in case of withdrawal the trader should reimburse all payments received from the consumer , including those covering the expenses born by the trader to deliver goods to the consumer . ### in the case of valid withdrawal the trader should reimburse all payments the consumer has reasonably made .


### certain exemptions should exist from the right of withdrawal , such as in cases where a right of withdrawal would be inappropriate given the nature of the product . that is applicable for example to wine supplied a long time after the conclusion of the contract of a speculative nature where the value is dependent on fluctuations in the market . ### certain exemptions should exist from the right of withdrawal , such as in cases where a right of withdrawal would be inappropriate , given the nature of the product , and exercising a right of withdrawal would unfairly disadvantage the trader . that is applicable in particular to foodstuffs and other hygienically sensitive or perishable goods , for example to wine supplied a long time after the conclusion of the contract of a speculative nature where the value is dependent on fluctuations in the market certain other goods or services whose price is dependent on market fluctuations should also be exempt from the right of withdrawal , e . g . commodities .


### certain exemptions should exist from the right of withdrawal , such as in cases where a right of withdrawal would be inappropriate given the nature of the product . that is applicable for example to wine supplied a long time after the conclusion of the contract of a speculative nature where the value is dependent on fluctuations in the market . ### certain exemptions should exist from the right of withdrawal , such as in cases where a right of withdrawal would be inappropriate , given the nature of the product , and exercising a right of withdrawal would unfairly disadvantage the trader or manufacturer . that is applicable in particular to foodstuffs and other hygienically sensitive or perishable goods , for example to electrical appliances for personal care or electrical appliances that come into contact with food .


### certain exemptions should exist from the right of withdrawal , such as in cases where a right of withdrawal would be inappropriate given the nature of the product . that is applicable for example to wine supplied a long time after the conclusion of the contract of a speculative nature where the value is dependent on fluctuations in the market . ### certain exemptions should exist from the right of withdrawal , such as in cases where a right of withdrawal would be inappropriate , given the nature of the product , and exercising a right of withdrawal would unfairly disadvantage the trader . that is applicable in particular to foodstuffs and other hygienically sensitive or perishable goods , for example to wine supplied a long time after the conclusion of the contract of a speculative nature where the value is dependent on fluctuations in the market .


### for the purpose of simplification and legal certainty , the right of withdrawal should apply to all types of off - premises contracts , except under strictly defined circumstances which can easily be proved . therefore , no right of withdrawal should apply for urgent repairs at the consumer ' s home for which such a right of withdrawal would be incompatible with the emergency situation as well as for supermarket home - delivery schemes which allow consumers to select food , drinks and other goods intended for current consumption in the household through the supermarket ' s website and have them delivered at their home . these are goods , which are inexpensive and bought regularly by consumers for their every day ' s consumption or everyday use in the household and should therefore not be subject to a right of withdrawal . the main difficulties encountered by consumers and the main source of disputes with traders are about delivery of goods , including goods getting lost or damaged during transport and late and partial delivery . therefore it is appropriate to clarify and harmonise the national rules on delivery and passing of risk . ### for the purpose of simplification and legal certainty , the right of withdrawal should apply to all types of distance and off - premises contracts , except under strictly defined circumstances which can easily be proved .


### the trader should be liable to the consumer if the goods are not in conformity with the contract . the goods should be presumed to be in conformity with the contract if they satisfy a number of conditions concerning mainly the qualities of the goods . the quality and performance which consumers can reasonably expect will depend inter alia on whether the goods are new or second - hand as well as on the expected life - span of the goods . ### the trader should be liable to the consumer if the goods are not in conformity with the contract . the goods should be presumed to be in conformity with the contract if they satisfy a number of conditions concerning mainly the qualities of the goods . the quality and performance which consumers can reasonably expect will depend inter alia on whether the goods are new or second - hand as well as on the expected life - span of the goods . where goods other than those ordered have been delivered , or in the event of undershipment , the goods should be presumed not to be in conformity with the contract .


### the consumer should not bear any costs for remedying the lack of conformity , particularly the cost of postage , labour and materials . furthermore , the consumer should not compensate the trader for the use of the defective goods . ### the consumer should not bear any costs for bringing the good into conformity with the contract , particularly the cost of postage , labour and materials . member states may provide that any reimbursement to the consumer may be reduced to take account of the use the consumer has had of the goods since they were delivered to him .


### when the trader has either refused or has more than once failed to remedy the lack of conformity the consumer should be entitled to choose freely any of the available remedies . the trader ' s refusal can be either explicit or implicit , meaning in the latter case that the trader does not respond or ignores the consumer ' s request to remedy the lack of conformity . ### the consumer should be entitled to choose freely any of the available remedies if he is not entitled to have the goods repaired or replaced . it is possible for member states to adopt or maintain provisions of national law on the free choice of remedies in the event of lack of conformity , in order to ensure a higher level of protection for the consumer . however , the relevant provisions of national law must be consistent with the treaty on the functioning of the european union and , in particular , must not run counter to the purpose of the directive , namely that of guaranteeing the smooth functioning of the internal market and preventing distortions of competition in the union . with that aim in view , the provisions of national law must be fit for purpose and proportionate .


### when the trader has either refused or has more than once failed to remedy the lack of conformity the consumer should be entitled to choose freely any of the available remedies . the trader ' s refusal can be either explicit or implicit , meaning in the latter case that the trader does not respond or ignores the consumer ' s request to remedy the lack of conformity . ### the consumer should be entitled to choose freely any of the available remedies if he is not entitled to have the goods repaired or replaced . it should be possible for member states to adopt or maintain provisions of national law on the free choice of remedies in the event of lack of conformity , in order to ensure a higher level of protection for the consumer . however , those measures must be essential for protecting the consumer , proportionate and effective .


### some traders or producers offer consumers commercial guarantees . in order to ensure that consumers are not misled , the commercial guarantees should include certain information , including their duration , territorial scope and a statement that the commercial guarantee does not affect the consumer ' s legal rights . ### some traders or producers offer consumers commercial guarantees . in order to ensure that consumers are not misled , the commercial guarantees should include certain information , including their duration , territorial scope and a statement that the commercial guarantee does not affect the consumer ' s legal rights . this information should be provided in a language which the consumer understands .


### consumer contracts should be drafted in plain , intelligible language and be legible . traders should be free to choose the font type or size in which the contract terms are drafted . the consumer should be given an opportunity to read the terms before concluding the contract . this opportunity could be given to the consumer by providing him with the terms on request or making those terms otherwise available or attaching standard terms to the order form . the trader should seek the consumer ' s express consent to any payment in addition to the remuneration for the trader ' s main contractual obligation . inferring consent by using opt - out systems , such as pre - ticked boxes online should be prohibited . ### consumer contracts should be drafted in plain , intelligible language and be legible . traders should be free to choose the font type or size in which the contract terms are drafted . the consumer should be given an opportunity to read the terms before concluding the contract . this opportunity could be given to the consumer by making the terms available or attaching them to the contract document . the trader should seek the consumer ' s express consent to any payment in addition to the remuneration for the trader ' s main contractual obligation . inferring consent by using opt - out systems , such as pre - ticked boxes online should be prohibited .


### the european commission will look into the most appropriate way to ensure that all consumers are made aware of their rights at the point of sale . ### the european commission , following consultation with the member states and interested parties , will look into the most appropriate way to ensure that all consumers are made aware of their rights at the point of sale .


### the european commission will look into the most appropriate way to ensure that all consumers are made aware of their rights at the point of sale . ### the european commission will look into the most appropriate way to ensure that all consumers are made aware of their rights at the point of sale and in so far as possible elsewhere .


### the purpose of this directive is to contribute to the proper functioning of the internal market and achieve a high level of consumer protection by approximating certain aspects of the laws , regulations and administrative provisions of the member states concerning contracts between consumers and traders . ### does not affect the english version .


### ' consumer ' means any natural person who , in contracts covered by this directive , is acting for purposes which are outside his trade , business , craft or profession ; ### ' consumer ' means any natural or legal person for whom the products or services offered on the market are intended or who uses such products or services in so far as he or she is the final recipient . ' consumer ' also means any recipient of the advertising message . member states may not maintain or introduce , in their national law , provisions diverging from those laid down in this article , including more or less stringent provisions intended to ensure a different level of consumer protection .


### ' trader ' means any natural or legal person who , in contracts covered by this directive , is acting for purposes relating to his trade , business , craft or profession and anyone acting in the name of or on behalf of a trader ; ### ' consumer ' means any natural person who , in contracts covered by this directive , is acting in the exercise of his trade , business , craft or profession ;


### ' public auction ' means a method of sale where goods are offered by the trader to consumers , who attend or are given the possibility to attend the auction in person , through a competitive bidding procedure run by an auctioneer and where the highest bidder is bound to purchase the goods ; ### ' public auction ' means a method of sale where a good or a service is offered by the trader to consumers , during an event which is physically accessible to the public , through a competitive bidding procedure run by a third party for pecuniary consideration ; in an ascending price auction , the good or service goes to the consumer making the highest bid ; in a descending price auction , the good or service goes to the consumer who is first to agree immediately to purchase the good or service for the asking price ;


### ' ancillary contract ' means a contract by which the consumer acquires goods or services related to a distance contract or an off - premises contract and these goods or services are provided by the trader or a third party on the basis of an arrangement between that third party and the trader . ### ' linked contract ' means a contract by which the consumer acquires goods or services and which forms a single commercial transaction with a distance contract or an off - premises contract and these goods or services are provided by the trader or a third party on the basis of an arrangement between that third party and the trader . a single commercial transaction exists where the good or service covered by the linked contract serves to perform the other contract or is intended for use of the good or service covered by the other contract .


### this directive shall apply , under the conditions and to the extent set out in its provisions , to sales and service contracts concluded between the trader and the consumer . ### this directive shall apply , under the conditions and to the extent set out in its provisions , to sales and service contracts concluded between the trader and the consumer . the provisions of this directive applying to service contracts shall apply to utility supply contracts within the meaning of article 2 irrespective of whether they are classified as sales or service contracts .


### this directive shall apply , under the conditions and to the extent set out in its provisions , to sales and service contracts concluded between the trader and the consumer . ### this directive shall apply , under the conditions and to the extent set out in its provisions , to contracts concluded between the trader and the consumer for the provision of a good or service .


### general information requirements ### information requirements for distance and off - premises contracts


### prior to the conclusion of any sales or service contract , the trader shall provide the consumer with the following information , if not already apparent from the context : ### prior to the conclusion of any sales or service contract , the trader shall provide the consumer with the following information , if not already apparent from the context : the fact that it is a sales or service contract , meaning that the intentions of the parties must be established on the basis of this legal arrangement .


### the main characteristics of the product , to an extent appropriate to the medium and the product ; ### the name or description of the good or service ;


### the price inclusive of taxes , or where the nature of the product means that the price cannot reasonably be calculated in advance , the manner in which the price is calculated , as well as , where appropriate , all additional freight , delivery or postal charges or , where these charges cannot reasonably be calculated in advance , the fact that such additional charges may be payable ; ### the price inclusive of taxes , or where the nature of the good or service means that the price cannot reasonably be calculated in advance , the manner in which the price is calculated , as well as , where appropriate , all additional freight , delivery or postal charges and any other cost or , where these charges cannot reasonably be calculated in advance , the fact that such additional charges may be payable ;


### the duration of the contract where applicable or if the contract is open - ended , the conditions for terminating the contract ; ### the duration of the contract where applicable or if the contract is open - ended , the conditions for terminating the contract , where conditions which depart from statutory provisions are to be agreed ;


### formal requirements for off - premises contracts ### pre - contractual formal requirements for off - premises contracts .


### with respect to off - premises contracts , the information provided for in article 9 shall be given in the order form in plain and intelligible language and be legible . the order form shall include the standard withdrawal form set out in annex i . ### in good time and at any event before the conclusion of the off - premises contract , the information referred to in article 5 shall be supplied to the consumer on a durable medium in plain and intelligible language and be legible . the information supplied shall include the standard withdrawal form provided for in annex i . the consumer shall choose the durable medium on which the information is set out and shall at any event have the option of requesting a paper document .


### formal requirements for distance contracts ### pre - contractual formal requirements for distance contracts


### with respect to distance contracts , the information provided for in article 9 shall be given or made available to the consumer prior to the conclusion of the contract , in plain and intelligible language and be legible , in a way appropriate to the means of distance communication used . ### with respect to distance contracts , the information provided for in article 9 shall be given or made available to the consumer in time for the conclusion of the contract , before the consumer is bound by the distance contract or offer . the information shall be provided in plain and intelligible language , including the language of the consumer , and be legible and clear , in a way appropriate to the means of communication used .


### if the trader makes a telephone call to the consumer with a view to concluding a distance contract , he shall disclose his identity and the commercial purpose of the call at the beginning of the conversation with the consumer . ### if the trader contacts the consumer via a long - distance communication medium with a view to concluding a distance contract , he shall disclose his identity and the commercial purpose of the call at the beginning of each conversation with the consumer .


### for distance contracts concluded on the internet , the trader may , in addition to the possibilities referred to in paragraph 1 , give the option to the consumer to electronically fill in and submit the standard withdrawal form on the trader ' s website . in that case the trader shall communicate to the consumer an acknowledgement of receipt of such a withdrawal by email without delay . ### for distance contracts concluded on the internet , the trader may , in addition to the possibilities referred to in paragraph 1 , give the option to the consumer to electronically fill in and submit the standard withdrawal form on the trader ' s website . in that case the trader shall communicate to the consumer an acknowledgement of receipt of such a withdrawal by email without delay , in any case no later than one working day from submiting the withdrawal form .


### for distance contracts concluded on the internet , the trader may , in addition to the possibilities referred to in paragraph 1 , give the option to the consumer to electronically fill in and submit the standard withdrawal form on the trader ' s website . in that case the trader shall communicate to the consumer an acknowledgement of receipt of such a withdrawal by email without delay . ### for distance contracts , the trader may , in addition to the possibilities referred to in paragraph 1 , give the option to the consumer either to email the model withdrawal form in annex i or any other withdrawal statement or to electronically fill in and submit the form on a website . in the latter case the trader shall communicate to the consumer an acknowledgement of receipt of such a withdrawal by email without delay .


### to perform the distance or off - premises contract , or to conclude an off - premises contract , in cases where an offer was made by the consumer . ### does not affect the english version to conclude the distance or off - premises contract , in cases where an offer was made by the consumer .


### for sales contracts for which the material possession of the goods has been transferred to the consumer or at his request , to a third party before the expiration of the withdrawal period , the consumer shall send back the goods or hand them over to the trader or to a person authorised by the trader to receive them , within fourteen days from the day on which he communicates his withdrawal to the trader , unless the trader has offered to collect the goods himself . ### for distance or off - premises contracts for the supply of goods for which the material possession of the goods has been transferred to the consumer or , at his request , to a third party before the expiration of the withdrawal period , the consumer shall send back the goods or hand them over to the trader or to a person authorised by the trader to receive them , within fourteen days from the day on which he communicates his withdrawal to the trader , unless the trader has offered to collect the goods himself . the consumer shall be charged only for the direct cost of returning the goods if the trader has not agreed with the consumer to bear that cost himself .


### for sales contracts for which the material possession of the goods has been transferred to the consumer or at his request , to a third party before the expiration of the withdrawal period , the consumer shall send back the goods or hand them over to the trader or to a person authorised by the trader to receive them , within fourteen days from the day on which he communicates his withdrawal to the trader , unless the trader has offered to collect the goods himself . ### for sales contracts for which the material possession of the goods has been transferred to the consumer or at his request , to a third party before the expiration of the withdrawal period , the consumer shall send back the goods or hand them over to the trader or to a person authorised by the trader to receive them , within seven days within the same country and fourteen days cross - border from the day on which he communicates his withdrawal to the trader , unless the trader has offered to collect the goods himself .


### effects of the exercise of the right of withdrawal on ancillary contracts ### effects of the exercise of the right of withdrawal on linked contracts


### without prejudice to article 15 of directive 2008 / 48 / ec , if the consumer exercises his right of withdrawal from a distance or an off - premises contract in accordance with articles 12 to 17 , any ancillary contracts shall be automatically terminated , without any costs for the consumer . ### without prejudice to article 15 of directive 2008 / 48 / ec , if the consumer exercises his right of withdrawal from a distance or an off - premises contract in accordance with articles 12 to 17 , any linked contracts shall be automatically terminated , without any costs for the consumer which are not provided for in this directive .


### in respect of distance contracts , the right of withdrawal shall not apply as regards the following : ### in respect of distance contracts and off - premises contracts , the consumer shall not enjoy the right of withdrawal from the contract as regards the following :


### in respect of off - premises contracts , the right of withdrawal shall not apply as regards the following : ### in respect of distance contracts , the right of withdrawal shall in addition not apply if :


### the supply of goods made to the consumer ' s specifications or clearly personalized or which are liable to deteriorate or expire rapidly ; ### contracts for which the consumer , in order to respond to an immediate emergency , has requested the immediate performance of the contract by the trader ; if , on this occasion , the trader provides or sells additional services or goods other than those which are strictly necessary to meet the immediate emergency of the consumer , the right of withdrawal shall apply to those additional services or goods ;


### the risk of loss of or damage to the goods shall pass to the consumer when he or a third party , other than the carrier and indicated by the consumer has acquired the material possession of the goods . ### the risk of loss of or damage to the goods shall pass to the consumer when he or a third party , other than the carrier and indicated by the consumer has acquired the material possession of the goods . the risk shall pass to the consumer , upon delivery to the carrier , if the carrier was commissioned to carry the goods by the consumer or if the consumer selected the carrier . member states may not maintain or introduce provisions of national law which depart from the provisions of this article in order to guarantee a different level of consumer protection .


### the risk of loss of or damage to the goods shall pass to the consumer when he or a third party , other than the carrier and indicated by the consumer has acquired the material possession of the goods . ### the risk of loss of or damage to the goods shall pass to the consumer , or a third party other than the carrier and indicated by the consumer , on delivery . in the case of off - premises contracts , this provision shall not apply to the period referred to in article 12 , during which the contract is not enforceable .


### they are fit for any particular purpose for which the consumer requires them and which he made known to the trader at the time of the conclusion of the contract and which the trader has accepted ; ### if , in the absence of an agreement on their nature , they are fit for the purpose for which the parties to the contract intended them at the time of the conclusion of the contract ;


### they are fit for the purposes for which goods of the same type are normally used or ### otherwise , if they are fit for the purposes for which goods of that type are normally used ;


### the guarantee statement shall be drafted in plain intelligible language and be legible . it shall include the following : ### the guarantee statement shall be drafted in plain intelligible language and be legible . it shall include the following : legal rights of the consumer under the applicable provisions of national law , as provided for in article 26 , and a clear statement that those rights are not affected by the commercial guarantee , set the contents of the commercial guarantee and the conditions for making claims , notably the duration , territorial scope and name and address of the guarantor , without prejudice to articles 32 and 35 and annex iii , set out , where applicable , that the commercial guarantee cannot be transferred to a subsequent buyer .


### the guarantee statement shall be drafted in plain intelligible language and be legible . it shall include the following : ### the guarantee statement shall be drafted in plain intelligible language , be legible and in the same font size . the guarantee shall be drafted in the language of the contract . it shall include the following :


### legal rights of the consumer , as provided for in article 26 and a clear statement that those rights are not affected by the commercial guarantee , ### a clear statement that the consumer has legal rights under national law and that those rights are not affected by the commercial guarantee , member states may not maintain or adopt provisions of national law which depart from the provisions of this article in order to guarantee a different level of consumer protection .


### contract terms shall be expressed in plain , intelligible language and be legible . ### contract terms shall be expressed in plain , intelligible language , be legible , in the same font size , easily and permanently accessible ; they should be provided in the language in which the contract is concluded .


### contract terms shall be expressed in plain , intelligible language and be legible . ### contract terms shall be drafted in plain , intelligible language and be legible .


### without prejudice to articles 34 and 38 , the unfairness of a contract term shall be assessed , taking into account the nature of the products for which the contract was concluded and by referring , at the time of the conclusion of the contract , to all the circumstances attending the conclusion and to all the other terms of the contract or of another contract on which the former is dependent . when assessing the fairness of a contract term , the competent national authority shall also take into account the manner in which the contract was drafted and communicated to the consumer by the trader in accordance with article 31 . ### without prejudice to articles 34 and 38 , the unfairness of a contract term shall be assessed , taking into account the nature of the goods or services for which the contract was concluded and by referring , at the time of the conclusion of the contract , to all the circumstances attending the conclusion and to all the other terms of the contract or of another contract on which the former is dependent . when assessing the fairness of a contract term , the competent national authority shall also take into account the manner in which the contract was drafted and communicated to the consumer by the trader in accordance with article 31 .


### member states shall ensure that , in the interests of consumers and competitors , adequate and effective means exist to prevent the continued use of unfair terms in contracts concluded with consumers by traders . ### member states shall ensure that , in the interests of consumers and traders , adequate and effective means exist to prevent traders from continuing to use unfair terms in the contracts they conclude with consumers .


### member states shall take appropriate measures to inform consumers of the national provisions transposing this directive and shall , where appropriate , encourage traders and code owners to inform consumers of their codes of conduct . ### member states and the commission shall take appropriate measures to inform consumers of the national provisions transposing this directive and shall , where appropriate , encourage traders and code owners to inform consumers of their codes of conduct .


### the consumer shall be exempted from the provision of any consideration in cases of unsolicited supply of a product as prohibited by article 5 and point 29 of annex i of directive 2005 / 29 / ec . the absence of a response from the consumer following such an unsolicited supply shall not constitute consent . ### the consumer shall be exempted from the provision of any consideration in cases of unsolicited supply of a product as prohibited by article 5 and point 29 of annex i of directive 2005 / 29 / ec . the absence of a response from the consumer following such an unsolicited supply shall not constitute consent and the consumer may keep or dispose of any good delivered .


### inertia selling the consumer shall be exempted from the provision of any consideration in cases of unsolicited supply of a product as prohibited by article 5 and point 29 of annex i of directive 2005 / 29 / ec . the absence of a response from the consumer following such an unsolicited supply shall not constitute consent . ### inertia selling the consumer shall be exempted from the provision of any consideration in cases of unsolicited supply of goods or services as prohibited by article 5 and point 29 of annex i of directive 2005 / 29 / ec . the absence of a response from the consumer following such an unsolicited supply shall not constitute consent .


### information to be provided with the withdrawal form the name , geographical address and the email address of the trader to whom the withdrawal form must be sent . 2 . a statement that the consumer has a right to withdraw from the contract and that this right can be exercised by sending the withdrawal form below on a durable medium to the trader referred to in paragraph 1 : for off - premises contracts , within a period of fourteen days following his signature of the order form ; for distance sales contracts , within a period of fourteen days following the material possession of the goods by the consumer or a third party , other than the carrier and indicated by the consumer ; for distance service contracts : - within a period of fourteen days following the conclusion of the contract , where the consumer has not given his prior express consent for the performance of the contract to begin before the end of this fourteen day period ; - within a period ending when the performance of the contract begins , where the consumer has given his prior express consent for the performance of the contract to begin before the end of the fourteen day period . 3 . for all sales contracts , a statement informing the consumer about the time - limits and modalities to send back the goods to the trader and the conditions for the reimbursement in accordance with articles 16 and 17 . 4 . for distance contracts concluded on the internet , a statement that the consumer can electronically fill in and submit the standard withdrawal form on the trader ' s website and that he will receive an acknowledgement of receipt of such a withdrawal from the trader by email without delay . 5 . a statement that the consumer can use the withdrawal form set out in part b . ### model instructions on withdrawal right of withdrawal you may withdraw from this contract within a period of 14 days without giving any reason . the period for withdrawal shall begin [ on receipt of the goods ordered ] . the day [ on which the goods are received ] shall not be counted as part of the period for withdrawal . if the last day of the period for withdrawal falls on a public holiday , a saturday or a sunday , the period shall end on the first working day thereafter . the period for withdrawal shall be deemed to have been observed if notice of withdrawal is sent before its expiry . notice of withdrawal should be sent on a durable medium to : . you may use the model withdrawal form below , although you are not required to do so . effects of withdrawal for withdrawal to be valid you must send the goods back , at [ our expense ] , within a period of 14 days of sending your notice of withdrawal . the period for reimbursement shall begin when we receive your notice of withdrawal . the day on which we receive the notice of withdrawal shall not be counted as part of the period for reimbursement . if the last day of this period falls on a public holiday , a saturday or a sunday , the period shall end on the first working day thereafter . if you are unable to return the goods in their original condition , you shall be liable for any deterioration in their value . this provision shall apply only if the deterioration in value is attributable to the goods having been handled in a manner other than that necessary for ascertaining their nature . you can prevent deterioration by refraining from using the goods as you would your own property and by avoiding any form of handling liable to reduce their value . in the case of valid withdrawal , we must reimburse within a period of 14 days any payment you have made to us . the period for reimbursement shall begin when we receive your notice of withdrawal . the day on which we receive the notice of withdrawal shall not be counted as part of the period for reimbursement . if the last day of this period falls on a public holiday , a saturday or a sunday , the period shall end on the first working day thereafter . we may refuse to reimburse you until we have [ received the returned goods or until you have produced proof of sending the goods back , whichever is the earlier ] . advice on alternative wording : in the following specific cases , the text in parentheses should read as indicated : in the case of a distance contract for the provision of services : ' with the conclusion of the contract ' ; in the case of an off - premises contract for the provision of services : ' when you receive a copy of the signed contract document on a durable medium ' . in the following specific cases , the text in parentheses should read as indicated : in the case of a distance contract for the provision of services : ' on which the contract is concluded ' ; in the case of an off - premises contract for the provision of services : ' on which you receive a copy of the signed contract document ' . in the case of distance contracts , additional text should be inserted as follows : if the trader allows the consumer to withdraw from the contract by e - mail : ' or by e - mail ' ; if the trader allows the consumer to fill in a model form electronically on a website : ' or via our website ' . to be inserted : the trader’s name and business address . in the case of distance contracts , the following must also be indicated : the e - mail and / or web address of the trader which the consumer can use to withdraw from the contract . if the price of the goods to be returned is not more than eur 50 , the text in parentheses should read as follows : ' your own expense ' . if the trader offers to collect the goods from the consumer , the text in parentheses should read as follows : ' collected the goods from you ' .


### to : i / we* hereby give notice that i / we* withdraw from my / our* contract of sale of the following goods* / provision of the following service* ordered on* / received on* name of consumer address of consumer signature of consumer date *delete as appropriate . ### to : i / we hereby give notice that i / we withdraw from my / our contract with you . ordered on : name of consumer : address of consumer : consumer’ signature : date : to be filled in by the trader before providing the form to the consumer delete where non - applicable . to be filled in by the consumer if this form is used for withdrawal from the contract .


### limiting the trader ' s obligation to respect commitments undertaken by his agents or making his commitments subject to compliance with a particular condition which depends exclusively on the trader ; ### limiting the trader’s obligation to respect commitments undertaken by his agents or making his commitments subject to compliance with a particular formality ;


### point 1 shall not apply to terms under which a supplier of financial services reserves the right to alter the rate of interest payable by the consumer or due to the latter , or the amount of other charges for financial services without notice where there is a valid reason , provided that the supplier is required to inform the other contracting party or parties thereof at the earliest opportunity and that the latter are free to dissolve the contract immediately ; ### point 1 shall not preclude terms under which a supplier of financial services reserves the right to alter the rate of interest payable by the consumer or due to the latter , or the amount of other charges for financial services without notice where there is a valid reason , provided that the supplier is required to inform the other contracting party or parties thereof at the earliest opportunity and that the latter are free to dissolve the contract immediately ;


### terms under which the trader reserves the right to alter unilaterally the conditions of an open - ended contract , provided that he is required to inform the consumer with reasonable notice and that the consumer is free to terminate the contract . ### the trader reserves the right to alter unilaterally the conditions of an open - ended contract , provided that he is required to inform the consumer with reasonable notice and that the consumer is free to terminate the contract .


### promoting the production and distribution of renewable energy sources ; ### promoting the production and distribution of renewable energy sources and of information technology .


### improving the urban environment , including regeneration of brownfield sites and reduction of air pollution . ### improving the urban environment , including regeneration of brownfield sites , reduction of air pollution , and measures aimed at the protection and preservation of historical and cultural heritage .


### in order to reduce carbon dioxide emissions from shipping at union level the best possible option remains setting up a system for monitoring , reporting and verification of co2 emissions based on the fuel consumption of ships as a first step of a staged approach for the inclusion of maritime transport emissions in the union ' s greenhouse gas reduction commitment . ### in order to reduce carbon dioxide emissions from shipping at union level the best possible option remains setting up a system for monitoring , reporting and verification of only co2 emissions at this stage , based on the fuel consumption of ships as a first step of a staged approach for the inclusion of maritime transport emissions in the union ' s greenhouse gas reduction commitment .


### the results of the stakeholder consultation and discussions with international partners indicate that a staged approach for the inclusion of maritime transport emissions in the union ' s greenhouse gas reduction commitment should be applied with the implementation of a robust mrv system for co2 emissions from maritime transport as a first step and the pricing of these emissions at a later stage . this approach facilitates making significant progress at international level on the agreement of greenhouse gas emission reduction targets and further measures to achieve these reductions at minimum cost . ### the results of the stakeholder consultation and discussions with international partners indicate that a staged approach for the inclusion of maritime transport emissions in the union ' s greenhouse gas reduction commitment should be applied with the implementation of a robust mrv system for only co2 emissions at this stage from maritime transport as a first step and the pricing of these emissions at a later stage . this approach facilitates making significant progress at international level on the agreement of greenhouse gas emission reduction targets and further measures to achieve these reductions at minimum cost .


### regulation no 525 / 2013 of the european parliament and of the council of 21 may 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and union level relevant to climate change22 should be amended to establish requirements for the monitoring and reporting of co2 emissions from maritime transport by member states pursuant to this regulation . __________________ 22 oj l 165 , 18 . 06 . 2013 , p . 13 - 40 . ### regulation no 525 / 2013 of the european parliament and of the council of 21 may 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and union level relevant to climate change22 should be amended to establish requirements for the monitoring and reporting of only co2 emissions from maritime transport by member states pursuant to this regulation . __________________ 22 oj l 165 , 18 . 06 . 2013 , p . 13 - 40 .


### the union mrv system should serve as a model for the implementation of a global mrv system . a global mrv system is preferable as it could be regarded as more effective due to the broader scope . in this context , the commission should share relevant information on the implementation of this regulation with the imo and other relevant international bodies on a regular basis and relevant submissions should be made to the imo . where an agreement on a global mrv system is reached , the commission should review the union mrv system in view of aligning it to the global system . ### the union mrv system should serve as a model for the implementation of a global mrv system . where an agreement on a global mrv system is reached , the commission shall review the union mrv system in view of aligning it to the global system .


### the union mrv system should serve as a model for the implementation of a global mrv system . a global mrv system is preferable as it could be regarded as more effective due to the broader scope . in this context , the commission should share relevant information on the implementation of this regulation with the imo and other relevant international bodies on a regular basis and relevant submissions should be made to the imo . where an agreement on a global mrv system is reached , the commission should review the union mrv system in view of aligning it to the global system . ### the union mrv system should serve as a model for the implementation of a global mrv system . a global mrv system is preferable as it could be regarded as more effective due to the broader scope . where an agreement on a global mrv system is reached , the commission should review the union mrv system in view of aligning it with the global system .


### in order to make use of the best available practices and scientific evidence , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of reviewing certain technical aspects of monitoring and reporting of co2 emissions from ships and of further specifying rules for the verification of emission reports and the accreditation of verifiers . 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 council . ### in order to make use of the best available practices and scientific evidence , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of reviewing certain technical aspects of monitoring and reporting of only co2 emissions at this stage from ships and of further specifying rules for the verification of emission reports and the accreditation of verifiers . 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 council .


### this regulation should enter into force on 1 july 2015 to ensure that the member states and relevant stakeholders have sufficient time to take the necessary measures for the effective application of this regulation before the first reporting period starts on 1 january 2018 . ### this regulation should enter into force on 1 july 2017 to ensure that the member states and relevant stakeholders have sufficient time to take the necessary measures for the effective application of this regulation before the first reporting period starts on 1 january 2022 .


### ' emissions ' means the release of co2 into the atmosphere by ships as provided for in article 2 ; ### ' emissions ' means only the release of co2 into the atmosphere by ships as provided for in article 2 ;


### from 1 january 2018 , companies shall , based on the monitoring plan approved in accordance with article 13 , monitor emissions for each ship on a per - voyage and an annual basis by applying the appropriate method among those set out in part b of annex i and by calculating emissions in accordance with part a of annex i . ### from 1 january 2018 , companies shall , based on the monitoring plan approved in accordance with article 13 , monitor emissions for each ship on a per - voyage basis , or on a monthly basis where ships make several voyages over short periods , and , on an annual basis , applying the appropriate method among those set out in part b of annex i and calculating emissions in accordance with part a of annex i , shall declare and publish the information collected .


### co2 emitted ; ### only co2 emitted ;


### total co2 emitted ; ### only total co2 emitted ;


### aggregated co2 emissions from all voyages between ports under a member state ' s jurisdiction ; ### only aggregated co2 emissions from all voyages between ports under a member state ' s jurisdiction ;


### aggregated co2 emissions from all voyages which departed from ports under a member state ' s jurisdiction ; ### only aggregated co2 emissions from all voyages which departed from ports under a member state ' s jurisdiction ;


### aggregated co2 emissions from all voyages to ports under a member state ' s jurisdiction ; ### only aggregated co2 emissions from all voyages to ports under a member state ' s jurisdiction ;


### co2 emissions which occurred within ports under a member state ' s jurisdiction at berth ; ### only co2 emissions which occurred within ports under a member state ' s jurisdiction at berth ;


### member states shall lay down a system of penalties for failure to comply with the monitoring and reporting requirements set out in articles 8 to 12 and shall take all the measures necessary to ensure that those penalties are applied . the penalties provided for shall be no less stringent than those foreseen under national legislation on greenhouse gas emissions in case of non - compliance with reporting obligations by operators and be effective , proportionate and dissuasive . member states shall notify these provisions to the commission by 1 july 2017 , and shall notify any subsequent amendments affecting these provisions to the commission without delay . ### member states shall lay down a system of penalties for failure to comply with the monitoring and reporting requirements set out in articles 8 to 12 and shall take all the measures necessary to ensure that those penalties are applied . the penalties provided for shall be effective , proportionate and dissuasive . member states shall notify these provisions to the commission by 1 july 2017 , and shall notify any subsequent amendments affecting these provisions to the commission without delay .


### by 30 june each year , the commission shall make publicly available the emissions reported in accordance with article 11 and information on the company ' s compliance with the monitoring and reporting requirements set out in articles 11 and 17 . ### by 30 june each year , the commission shall make publicly available aggregated data on the emissions reported in accordance with article 11 and information on the company ' s compliance with the monitoring and reporting requirements set out in articles 11 and 17 .


### annual co2 emissions ; ### only annual co2 emissions ;


### the commission shall inform the imo and other relevant international bodies on a regular basis of the implementation of this regulation with a view to facilitate the development of international rules within the imo for the monitoring , reporting and verification of greenhouse gas emissions from maritime transport . ### the commission shall inform the imo and other relevant international bodies on a regular basis of the implementation of this regulation with an intention to align the regulation with the progress in imo for the monitoring , reporting and verification of greenhouse gas emissions from maritime transport .


### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where the union has significant interests in accordance with the objectives of this regulation . ### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where the union has significant interests in accordance with the objectives of this regulation . consideration ought therefore to be given to the overseas countries and territories associated with the union throughout the world , in order in particular to enhance knowledge and understanding of the union and improve its visibility in third countries .


### in particular , fighting climate change is recognised as one of the great challenges which the union faces and the area where urgent international action is necessary . in accordance with the intent stated in the commission communication “a budget for europe 2020” of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal . ### eradicating poverty and fighting climate change are recognised as being the two great challenges which the union faces and the areas where urgent international action is necessary . in accordance with the intent stated in the commission communication “a budget for europe 2020” of increasing the climate related proportion of the union budget to at least 20% , this regulation should inter alia contribute to that goal .


### the union is committed to helping to meet the global 2020 biodiversity targets and to deliver on the associated strategy for resource mobilisation . ### the union is committed to helping to meet the global 2020 biodiversity targets and to deliver on the associated strategy for resource mobilisation and their sustainable integrated management .


### under this regulation , the union should support the implementation of the “europe 2020” strategy , in particular objectives relating to climate change , the transition to a greener economy and resource efficiency , trade and investment , business and regulatory cooperation with third countries , and should promote public diplomacy , education / academic cooperation and outreach activities . ### under this regulation , the union should support the implementation of the “europe 2020” strategy , in particular objectives relating to poverty eradication , climate change , the transition to a greener economy and efficient use of natural resources , trade and investment , business and regulatory cooperation with third countries , and should promote public diplomacy , good financial and tax governance , education / academic cooperation and outreach activities , notably in regard to access to healthcare for women and children .


### under this regulation , the union should support the implementation of the ‘ europe 2020’ strategy , in particular objectives relating to climate change , the transition to a greener economy and resource efficiency , trade and investment , business and regulatory cooperation with third countries , and should promote public diplomacy , education / academic cooperation and outreach activities . ### under this regulation , the union should support the implementation of the ‘ europe 2020’ strategy , in particular objectives relating to climate change , the transition to a greener economy and resource efficiency , trade and investment , business and regulatory cooperation with third countries , and policy cohesion for development , and should promote public diplomacy , education / academic cooperation and outreach activities .


### in order to achieve the objectives of this regulation it is necessary to pursue a differentiated and flexible approach by developing models for cooperation with key partner countries which take into account their economic , social and political contexts and also the union’s specific interests , policy priorities and strategies , whilst maintaining the ability to intervene all over the world wherever needed . ### in order to achieve the objectives of this regulation it is necessary to pursue a differentiated and flexible approach by developing models for cooperation with key partner countries and principles of good governance which prevent corruption and which take into account their economic , social and political contexts and also the union’s specific interests , policy priorities and strategies , whilst maintaining the ability to intervene all over the world wherever needed .


### implementing the international dimension of the &#8220 ; europe 2020&#8221 ; strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing collective approaches and responses to challenges of global concern such as energy security , climate change and environment . this objective shall be measured by the uptake of the &#8220 ; europe 2020&#8221 ; policies and objectives by key partner countries ; ### implementing the international dimension of the ' europe 2020 ' strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing principles of good governance and collective responses to challenges of global concern such as the promotion of social cohesion , energy security , climate change and environment . this objective shall be measured by the uptake of the &#8220 ; europe 2020&#8221 ; policies and objectives by key partner countries ;


### enhancing widespread understanding and visibility of the union and its role on the world scene by means of public diplomacy , education / academic cooperation and outreach activities to promote union’s values and interests . this objective may be measured , inter alia , by opinion surveys or evaluations . ### enhancing widespread understanding and visibility of the union and its role on the world scene by means of public diplomacy , education / academic cooperation , training in the principles of good administrative and tax governance for local players and outreach activities to promote the union’s values and interests . this objective may be measured , inter alia , by opinion surveys or evaluations .


### all third countries , regions and territories may be eligible for cooperation under this regulation . ### all third countries , regions and territories associated with the union may be eligible for cooperation under this regulation .


### to enhance the impact of the union’s assistance , a differentiated and flexible approach shall be pursued , where appropriate , in designing cooperation with partner countries to take account of their economic , social and political contexts as and also of the union’s specific interests , policy priorities and strategies . ### to enhance the impact of the union’s assistance , a differentiated and flexible approach shall be pursued , where appropriate , in designing cooperation with partner countries to take account of their economic , social and political contexts , the requirement for good administrative and tax governance , as and also of the union’s specific interests , policy priorities and strategies .


### in order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate member states , the commission , taking into account the experience with the provisions on community authorisations , may decide to extend the scope of the community authorisation procedure to other biocidal products . ### in order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate member states , the commission has decided to introduce a community authorisation procedure for all biocidal products .


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


### in view of ensuring that all proprietary information submitted in support of an inclusion of an active substance or an authorisation of a biocidal product is protected from the moment of its submission and to prevent situations where some information is without protection , the provision on information protection periods should also apply to information submitted for the purposes of directive 98 / 8 / ec . ### in view of ensuring that all proprietary information submitted in support of an inclusion of an active substance in annex i or an authorisation of a biocidal product is protected from the moment of its submission and to prevent situations where some information is without protection , the provision on information protection periods should also apply to information submitted for the purposes of directive 98 / 8 / ec .


### in particular , the commission should be empowered to adopt measures to decide on the application to include the active substance in annex i or to renew or review the inclusion , to specify the procedures related to the renewal and review of an inclusion of an active substance in annex i , to extend the provisions on community authorisations to other categories of biocidal products , to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation , including a dispute settlement mechanism , to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted , to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the agency , to adapt the annexes to scientific and technical progress , to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period . since those measures are of general scope and are designed to amend non - essential elements of this regulation , inter alia , by supplementing this regulation with new non - essential elements , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec . ### in particular , the commission should be empowered to adopt measures to decide on the application to include the active substance in annex i or to renew or review the inclusion , to specify the procedures related to the renewal and review of an inclusion of an active substance in annex i , to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation , including a dispute settlement mechanism , to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted , to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the agency , to adapt the annexes to scientific and technical progress , to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period . since those measures are of general scope and are designed to amend non - essential elements of this regulation , inter alia , by supplementing this regulation with new non - essential elements , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec .


### taking into consideration that some products were not previously covered by the community legislation in the field of biocidal products , it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances , treated articles and materials and food contact materials . ### taking into consideration that some products were not previously covered by the community legislation in the field of biocidal products , it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances , treated articles and materials .


### ' authorisation ' means national authorisation or community authorisation ; ### ' authorisation ' means national authorisation or community authorisation or primary authorisation or duplicate authorisation or additional authorisation ;


### an active substance shall be included in annex i for an initial period not exceeding 10 years if the biocidal products containing that active substance fulfil the conditions laid down in point of article 16 . ### an active substance shall be included in annex i for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point of article 16 .


### an active substance shall , where appropriate , be included in annex i together with any of the following conditions : ### an active substance and a statement of the reference source for the determination of technical equivalence shall , where appropriate , be included in annex i together with any of the following conditions :


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


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


### within two months after the receipt of an application , the agency shall validate the application if it complies with the following requirements : ### within three weeks after the receipt of an application , the agency shall validate the application if it complies with the following requirements :


### article 34 submission and validation of application the person responsible for the placing of a biocidal product on the market , or his representative , shall submit an application for a community authorisation to the agency and inform the agency of the name of the competent authority of the member state of his choice which shall be responsible for the evaluation of the application . the agency shall , within one month after the receipt of the application , notify the evaluating competent authority that the application is available in the agency database . within two months after the receipt of an application , the agency shall validate the application if it complies with the following requirements : the information referred to in article 18 has been submitted ; it is accompanied by the fees payable under article 70 . the validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted . 3 . if the agency considers that the application is incomplete , it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information . the agency shall , within two months from the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the agency shall reject the application if the applicant fails to complete his application within the deadline and inform the applicant and the evaluating competent authority thereof . in such cases a part of the fee paid to the agency in accordance with article 70 shall be reimbursed . 4 . an appeal may be brought , in accordance with article 67 , against agency decisions under the third subparagraph of paragraph 3 . 5 . if the agency , on basis of the validation made pursuant to paragraph 2 , considers that the application is complete , it shall without delay inform the applicant and the evaluating competent authority thereof . ### deleted


### when preparing an opinion on the inclusion or renewal of the inclusion of an active substance in annex i , the agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion . ### when preparing an opinion on the inclusion or renewal of the inclusion of an active substance in annex i , the agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and , if exposure is not adequately controlled , bearing in mind the intrinsic hazards of the substance , shall address the matter in its opinion .


### application for community authorisation shall be submitted to the agency . ### application for authorisation shall be submitted to the agency . the applicant may , in agreement with a member state , have his application validated by that member state and must identify the evaluating competent authority in the application itself , as laid down in article 22 .


### the active substances included therein are listed in annex i and any conditions included in that annex together with those active substances are complied with ; ### the active substances included therein are listed in annex i , a registration number is assigned to them in accordance with article 8 , paragraph 5a , and any conditions included in that annex together with those active substances are complied with ;


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


### in the case of a frame formulation , a reduction in the percentage of the active substance in the reference biocidal product may be allowed , and / or an alteration in percentage composition of one or more non - active substances , and / or the replacement of one or more non - active substances by others presenting the same or lower risk . ### in the case of a frame formulation , the following variations are permitted in respect of one or more reference biocidal products : elimination of an active substance in respect of a reference biocidal product with at least two active substances ; reduction in the percentage of the active substances ; elimination of one or more non - active substances ; variation in the percentage composition of one or more non - active substances ; replacement of one or more non - active substances .


### the applicant for an authorisation shall submit the following documents together with the application : ### the applicant for a primary authorisation shall submit the following documents together with the application :


### the application for authorisation shall be accompanied by the fees payable under article 70 . ### the application for primary authorisation shall be accompanied by the fees payable under article 70 .


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


### qualitative and quantitative composition in terms of the active substances and non - active substances , knowledge of which is essential for proper use of the biocidal product ; ### qualitative and quantitative composition in terms of the active substances and non - active substances , taking into consideration the concentration limit values given in article 16 , in so far as knowledge of these is essential for proper use of the biocidal product ;


### manufacturers of the active substances ; ### manufacturers of the active substances and registration number of the active substance , in accordance with article 8 ;


### the reference biocidal product within the group of products comprising the frame formulation that has the highest allowed concentration of the active substances ; ### the reference biocidal product within the group of products comprising the frame formulation ;


### the receiving competent authority or , in the case of a decision on an application for a community authorisation , the commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with annex vi demonstrates that all the following criteria are met : for the uses specified in the application , another authorised biocidal product or a non - chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment ; the biocidal product or non - chemical control or prevention method referred to in point does not present significant economic or practical disadvantages ; the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism . ### the receiving competent authority or , in the case of a decision on a renewal of a community authorisation , the commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with annex vi demonstrates that all the following criteria are met : for the uses specified in the application , other authorised biocidal products already exist which present significantly lower risk for human or animal health or the environment and which prove equally effective and involve no significant increase in the risks for any other parameter ; the biocidal products referred to in point do not present significant economic or practical disadvantages ; the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism .


### the commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . ### the commission shall , after consultation with the applicant , adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 .


### the competent authority that has granted the national authorisation or in case of community authorisation , the commission , shall cancel the authorisation at the request of its holder , who shall state the reasons for such request . if such a request concerns a community authorisation , it shall be submitted to the agency . ### the competent authority that has granted an authorisation shall cancel the authorisation at the request of its holder , who shall state the reasons for such request if such a request concerns a duplicate or additional community authorisation , it shall be submitted to the agency .


### by way of derogation from article 15 , an experiment or a test for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process - oriented research and development , and under the conditions laid down in the second and third subparagraphs . in the case of scientific research and development , the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start . the person shall draw up and maintain written records detailing the identity of the biocidal product or active substance , labelling data , quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance , and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment . the persons concerned shall , if requested , make this information available to the competent authority . in the case of product and process - oriented research and development , the person who intends to carry out the experiment or the test shall , prior to the placing of the biocidal product or the active substance on the market , notify the information required in the second subparagraph to the competent authority of the member state where the placing on the market occurs . ### by way of derogation from article 15 , an experiment or a test for the purposes of research or development , including product - and process - oriented research and development activities , involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process - oriented research and development , and under the conditions laid down in the second and third subparagraphs . in the case of scientific research and development , the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start . the person shall draw up and maintain written records detailing the identity of the biocidal product or active substance , labelling data and quantities supplied , and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment . the persons concerned shall , if requested , make this information available to the competent authority .


### the subsequent applicant has written agreement in the form of a letter of access from the first applicant that he can use that information , ### the subsequent applicant has written agreement in the form of a letter of access in accordance with the requirements of article 50 ,


### the list referred to in paragraph 2 shall be entered by the agency in the biocides data sharing register . ### every element of information in the list referred to in paragraph 2 , identified by a unique code , shall be entered by the agency in the biocides data sharing register , including all the identifying details and linked to the identity of the first applicant and data owner .


### any person submitting information related to an active substance to the agency or a competent authority for the purposes of this regulation can request that the information in article 56 shall not be made available including a justification as to why the disclosure of the information could be harmful for his or any other concerned party ' s commercial interests . ### any person submitting information related to an active substance or a biocidal product to the agency or a competent authority for the purposes of this regulation can request that the information in article 56 shall not be made available including a justification as to why the disclosure of the information could be harmful for his or any other concerned party ' s commercial interests .


### a reduced fee shall be set for small and medium - sized enterprises within the meaning of recommendation 2003 / 361 / ec concerning the definition of micro , small and medium - sized enterprises ; ### a reduced fee shall be set for small and medium - sized enterprises within the meaning of recommendation 2003 / 361 / ec concerning the definition of micro , small and medium - sized enterprises ; this in no way alters the responsibility of the evaluating competent authority for carrying out an accurate evaluation within the meaning of the regulation ;


### an annual fee shall be paid by persons placing biocidal products on the market ; and ### the fee shall be applied only when it is actually necessary and the structure and amount of the fees shall take account of the work required by this regulation to be carried out by the agency and the competent authorities and shall be fixed at such level as to ensure that the revenue derived from the fees when combined with other sources of the agency ' s revenue pursuant to this regulation is sufficient to cover the cost of the services delivered .


### biocidal products , for which an application for a product authorisation has not been submitted in accordance with the second subparagraph , shall no longer be placed on the market with effect from six months after the date on which the inclusion becomes effective . disposal , storage and use of existing stocks of biocidal products for which an application for authorisation has not been submitted in accordance with the second subparagraph are allowed until eighteen months after the date on which the inclusion becomes effective . ### biocidal products , for which an application for a product authorisation has not been submitted in accordance with the second subparagraph , shall no longer be placed on the market with effect from the date on which the inclusion becomes effective . disposal , storage and use of existing stocks of biocidal products for which an application for authorisation has not been submitted in accordance with the second subparagraph are allowed until six months after the date on which the inclusion becomes effective .


### 2 . detailed quantitative and qualitative information on the composition of the biocidal product , e . g . active substance , impurities , adjutants , inert components ### 2 . detailed quantitative and qualitative information on the composition of the biocidal product , e . g . active substance , impurities , adjutants , inert components , taking into account the concentration limits laid down in article 16


### the nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the convention on biological diversity is an international treaty adopted on 29 october 2010 by the parties to the convention . the nagoya protocol significantly expands the general rules of the convention on access and benefit - sharing for the use of genetic resources and traditional knowledge associated with genetic resources . ### the nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the convention on biological diversity is an international treaty adopted on 29 october 2010 by the parties to the convention . the nagoya protocol significantly expands the general rules of the convention on access and monetary and non - monetary benefit - sharing for the utilisation and any subsequent commercialisation of genetic resources and traditional knowledge associated with genetic resources .


### best practices developed by users should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the nagoya protocol with high legal certainty and at low costs . users should be enabled to build on existing access and benefit - sharing codes of conduct developed for the academic sector and different industries . associations of users should be able to request that the commission determines whether a specific combination of procedures , tools or mechanisms overseen by an association may be recognised as best practice . competent authorities of the member states should consider that the implementation of a recognised best practice by a user reduces that user ' s risk of non - compliance and justifies a reduction in compliance checks . the same should apply to best practices adopted by the collective of the parties to the nagoya protocol . ### the specific choices taken by users on the tools and measures applied for exercising du diligence should be supported through the recognition of best practices . best practices developed by users should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the nagoya protocol with high legal certainty and at low costs , as well as complementary measures in support of sectoral codes of conduct and model - contractual clauses . users should be enabled to build on existing access and benefit - sharing codes of conduct developed for the academic sector and different industries . associations of users should be able to request that the commission determines whether a specific combination of procedures , tools or mechanisms overseen by an association may be recognised as best practice . competent authorities of the member states should consider that the implementation of a recognised best practice by a user reduces that user ' s risk of non - compliance and justifies a reduction in compliance checks . the same should apply to best practices adopted by the collective of the parties to the nagoya protocol .