### passengers should be adequately informed about the relevant procedures for submitting claims and complaints to air carriers and should receive a reply within a reasonable time period . passengers should also have the option to complain about air carriers via out - of - court measures . however , since the right to an effective remedy before a tribunal is a fundamental right recognised in article 47 of the charter of fundamental rights of the european union , those measures should neither prevent nor hinder passengers ' access to courts . ### passengers should be adequately informed about the relevant procedures for submitting claims and complaints to air carriers and should have their attention drawn to the time limits applicable in this connection , particularly those laid down in article 16a . they should receive a reply within two months of the lodging of the claim or complaint . passengers should also have the option to complain about air carriers via out - of - court measures . since the right to an effective remedy before a tribunal is a fundamental right recognised in article 47 of the charter of fundamental rights of the european union , those measures should neither prevent nor hinder passengers ' access to courts . in order to process claims easily , quickly and cheaply in both judicial and extrajudicial procedures , reference should be made , in particular , to the online and alternative dispute resolution procedures and to the european small claims procedure .


### whilst air carriers have full commercial freedom to establish the conditions under which they permit baggage to be carried , they shall clearly indicate , at booking and at the check - in desks , the maximum baggage allowance passengers are permitted to carry within the cabin and hold of the aircraft on each of the flights included within a passenger ' s reservation , including any restrictions on the number of items that would be applied within a given maximum baggage allowance . where additional charges are applied for the carriage of baggage air carriers shall clearly indicate details of those charges at booking and on request at the airport . ### air carriers shall clearly indicate , at booking and at the check - in desks , the maximum baggage allowance passengers are permitted to carry within the cabin and hold of the aircraft on each of the flights included within a passenger ' s reservation , including any restrictions on the number of items that would be applied within a given maximum baggage allowance . where additional charges are applied for the carriage of baggage air carriers shall clearly indicate details of those charges at booking and at the airport .


### ' 3 . if boarding is denied to passengers against their will , the operating air carrier shall immediately compensate them in accordance with article 7 and assist them in accordance with article 8 . where the passenger opts for rerouting at the earliest opportunity pursuant to article 8 and where the departure time is at least two hours after the initial departure time , the operating carrier shall assist the passenger in accordance with article 9 . ' ### ' 3 . if boarding is denied to passengers against their will on the outward or homeward flight , the operating air carrier shall compensate them as soon as possible in accordance with article 7 and assist them in accordance with article 8 . where the passengers opt for rerouting at the earliest opportunity pursuant to article 8 , the operating carrier shall assist the passenger in accordance with article 9 . '


### subject to safety constraints , where a tarmac delay exceeds one hour , the operating air carrier shall provide free of charge access to toilet facilities and drinking water , shall ensure adequate heating or cooling of the passenger cabin , and shall ensure that adequate medical attention is available if needed . where a tarmac delay reaches a maximum of five hours , the aircraft shall return to the gate or another suitable disembarkation point where passengers shall be allowed to disembark and to benefit from the same assistance as specified in paragraph 1 , unless there are safety - related or security - related reasons why the aircraft cannot leave its position on the tarmac . ### subject to safety constraints , where a tarmac delay exceeds one hour , the operating air carrier shall provide free of charge access to toilet facilities and drinking water , shall ensure adequate heating or cooling of the passenger cabin , and shall ensure that adequate medical attention is available if needed . where a tarmac delay reaches a maximum of two hours , the aircraft shall return to the gate or another suitable disembarkation point where passengers shall be allowed to disembark and to benefit from the same assistance as specified in paragraph 1 , unless there are safety - related or security - related reasons why the aircraft cannot leave its position on the tarmac .


### in paragraph 1 , the word ' flights ' is replaced by ' journeys ' . ### in paragraph 1 , point is replaced by the following : ' eur 250 for all journeys within the eu , including the overseas departments , and journeys of 3 500 km or less to or from third countries , '


### five hours or more after the scheduled time of arrival for all intra - community journeys and for journeys to / from third countries of 3500 kilometres or less ; ### three hours or more after the scheduled time of arrival for all journeys within the union , including overseas departments of the member states , and for journeys to / from third countries of 3500 kilometres or less ;


### if a passenger wants to make a complaint to the air carrier with regard to his rights under this regulation , he shall submit it within 3 months from the date on which the flight was performed or was scheduled to be performed . within 7 days of receiving the complaint , the carrier shall confirm the receipt of the complaint to the passenger . within two months of receiving the complaint , the carrier shall provide a full answer to the passenger . ### if a passenger wants to lodge a claim with , or make a complaint to , the air carrier in connection with the rights laid down in this regulation , he shall do so in writing or in electronic form within 3 months from the date on which the flight was scheduled to begin . within 7 days of receiving the claim or complaint , the carrier shall confirm its receipt to the passenger . within two months of receiving the complaint , the carrier shall be required to provide a full answer to the passenger .


### labour disputes at the operating air carrier or at essential service providers such as airports and air navigation service providers . ### labour disputes at essential service providers such as airports and air navigation service providers .


### if the operating air carrier can prove that the cancellation , delay or change of schedule is caused by extraordinary circumstances and that the cancellation , delay or change of schedule could not have been avoided even if all reasonable measures had been taken , it may limit the total cost of accommodation provided according to paragraph 1 to eur 100 per night and per passenger and to a maximum of 3 nights . if the operating air carrier chooses to apply this limitation , it shall nevertheless provide the passengers with information about available accommodation after the three nights , in addition to the continued obligations for information specified in article 14 . ### if the operating air carrier can prove that the cancellation , delay or change of schedule is caused by extraordinary circumstances and that the cancellation , delay or change of schedule could not have been avoided even if all reasonable measures had been taken , it may limit the accommodation provided according to paragraph 1 to a maximum of 3 nights . the operating air carrier shall provide the passengers with information about available accommodation after the three nights , in addition to the continued obligations for information specified in article 14 .


### technical problems inherent in the normal operation of the aircraft , such as a problem identified during the routine maintenance or during the pre - flight check of the aircraft or which arises due to failure to correctly carry out such maintenance or pre - flight check ; and ### technical problems not to be considered as extraordinary for the purposes of point 1 ;


### where a passenger misses a connecting flight as a result of a delay to a preceding connecting flight , the passenger shall have a right to compensation by the community air carrier operating that preceding flight in accordance with article 6 . for these purposes , the delay shall be calculated by reference to the scheduled time of arrival at the final destination . ### where a passenger misses a connecting flight as a result of a delay , cancellation or change of schedule affecting a preceding connecting flight , the passenger shall have a right to compensation by the community air carrier operating that preceding flight in accordance with article 6 . for these purposes , the delay shall be calculated by reference to the scheduled time of arrival at the final destination .


### when the delay is of at least five hours , the assistance specified in article 8 . ### when the delay is of at least three hours and includes one or more nights , the assistance specified in article 9 and 9 ; and


### if a passenger wants to make a complaint to the air carrier with regard to his rights under this regulation , he shall submit it within 3 months from the date on which the flight was performed or was scheduled to be performed . within 7 days of receiving the complaint , the carrier shall confirm the receipt of the complaint to the passenger . within two months of receiving the complaint , the carrier shall provide a full answer to the passenger . ### if a passenger wants to lodge a claim with , or make a complaint to , the air carrier in connection with the rights laid down in this regulation , he shall submit it in writing or in electronic form within 3 months from the date on which the flight was scheduled to begin . within 7 days of receiving the claim or complaint , the carrier shall confirm the receipt of the complaint to the passenger . within two months of receiving the claim or complaint , the air carrier shall provide a full answer to the passenger .


### whilst air carriers have full commercial freedom to establish the conditions under which they permit baggage to be carried , they shall clearly indicate , at booking and at the check - in desks , the maximum baggage allowance passengers are permitted to carry within the cabin and hold of the aircraft on each of the flights included within a passenger ' s reservation , including any restrictions on the number of items that would be applied within a given maximum baggage allowance . where additional charges are applied for the carriage of baggage air carriers shall clearly indicate details of those charges at booking and on request at the airport . ### whilst air carriers have full commercial freedom to establish the conditions under which they permit baggage to be carried , they must clearly indicate , at the beginning of every booking process and at the check - in desks , the maximum baggage allowance passengers are permitted to carry within the cabin and hold of the aircraft on each of the flights included within a passenger ' s reservation , including any restrictions on the number of items that would be applied within a given maximum baggage allowance . where additional charges are applied for the carriage of baggage air carriers must clearly indicate details of those charges at the beginning of every booking process and on request at the airport . additional charges must be communicated clearly and transparently , and it must be possible for them to be paid in conjunction with the actual reservation of the journey , irrespective of the manner in which that reservation is made . this obligation shall also apply to operators offering flights on behalf of air carriers . additional charges are part of the overall fare .


### nine hours or more after the scheduled time of arrival for journeys to / from third countries between 3500 and 6000 kilometres ; ### five hours or more after the scheduled time of arrival for journeys to / from third countries of more than 3 500 kilometres ;


### an operating air carrier shall not be obliged to pay compensation in accordance with article 7 , if it can prove that the delay or change of schedule is caused by extraordinary circumstances and that the delay or change of schedule could not have been avoided even if all reasonable measures had been taken . such extraordinary circumstances can only be invoked insofar they affect the flight concerned or the previous flight operated by the same aircraft . ### an operating air carrier shall not be obliged to pay compensation in accordance with article 7 , if it can prove in writing that the delay or change of schedule is caused by extraordinary circumstances and that the delay or change of schedule could not have been avoided even if all reasonable measures had been taken . such extraordinary circumstances can only be invoked insofar they affect the flight concerned or the previous flight operated by the same aircraft . passengers shall have a right , enforceable by penalties , to adequate information about these extraordinary circumstances .


### technical problems which are not inherent in the normal operation of the aircraft , such as the identification of a defect during the flight operation concerned and which prevents the normal continuation of the operation ; or a hidden manufacturing defect revealed by the manufacturer or a competent authority and which impinges on flight safety ; ### technical problems which are not inherent in the normal operation of the aircraft , such as the identification of a defect during the flight operation concerned and which prevents the normal continuation of the operation ; and a hidden manufacturing defect revealed by the manufacturer or a competent authority and which impinges on flight safety ;


### subject to safety constraints , where a tarmac delay exceeds one hour , the operating air carrier shall provide free of charge access to toilet facilities and drinking water , shall ensure adequate heating or cooling of the passenger cabin , and shall ensure that adequate medical attention is available if needed . where a tarmac delay reaches a maximum of five hours , the aircraft shall return to the gate or another suitable disembarkation point where passengers shall be allowed to disembark and to benefit from the same assistance as specified in paragraph 1 , unless there are safety - related or security - related reasons why the aircraft cannot leave its position on the tarmac . ' ### subject to safety constraints , where a tarmac delay occurs , the operating air carrier shall provide free of charge access to toilet facilities and drinking water , shall ensure adequate heating or cooling of the passenger cabin , and shall ensure that adequate medical attention is available if needed . where a tarmac delay reaches a maximum of two hours , the aircraft shall return to the gate or another suitable disembarkation point where passengers shall be allowed to disembark and to benefit from the same assistance as specified in paragraph 1 , unless there are safety - related or security - related reasons why the aircraft cannot leave its position on the tarmac . '


### passengers should be adequately informed about the relevant procedures for submitting claims and complaints to air carriers and should receive a reply within a reasonable time period . passengers should also have the option to complain about air carriers via out - of - court measures . however , since the right to an effective remedy before a tribunal is a fundamental right recognised in article 47 of the charter of fundamental rights of the european union , those measures should neither prevent nor hinder passengers ' access to courts . ### passengers should be adequately informed about the relevant procedures for submitting claims and complaints to air carriers and should have their attention drawn to the time limits applicable in this connection , particularly those laid down in article 16a . they should receive a reply within two months of the lodging of the claim or complaint . passengers should also have the option to complain about air carriers via out - of - court measures . since the right to an effective remedy before a tribunal is a fundamental right recognised in article 47 of the charter of fundamental rights of the european union , those measures should neither prevent nor hinder passengers ' access to courts . in order to process claims easily , quickly and cheaply in both judicial and extrajudicial procedures , reference should be made , in particular , to the online and alternative dispute resolution procedures and to the european small claims procedure .


### when the delay is of at least two hours , the assistance specified in article 9 and 9 ; and ### the assistance specified in article 9 and 9 ; and


### the assistance specified in article 9 and 9 if the passenger ' s waiting time for the connection is prolonged by at least two hours ; and ### the assistance specified in article 9 and 9 ; and


### an investigation shall be initiated upon request by a member state or on the commission ' s own initiative if it is apparent to the commission that there is sufficient evidence to justify such initiation . ### an investigation shall be initiated upon request by a member state , the european parliament , by any natural or legal person , or any association not having legal personality , acting on behalf of the union industry , or on the commission ' s own initiative if it is apparent to the commission that there is sufficient prima facie evidence as determined on the basis of factors laid down in article 4 , to justify such initiation .


### consultation with the member states shall take place within eight working days of the commission’s sending the information to member states as provided for in paragraph 2 within the committee referred to in article 10 on the basis of the procedure referred to in article 11 . 1 . where , after consultation , it is apparent that there is sufficient evidence to justify the initiation of a proceeding the commission shall publish a notice in the official journal of the european union . initiation shall take place within one month of the receipt of information from a member state . ### consultation with the member states shall take place within eight working days of the commission’s sending the information as provided for in paragraph 2 within the committee referred to in article 10 on the basis of the procedure referred to in article 11 . where , after consultation , it is apparent that there is sufficient prima facie evidence determined on the basis of factors laid down in article 4 to justify the initiation of a proceeding the commission shall publish a notice in the online - platform and in the official journal of the european union . initiation shall take place within one month of the request by a member state , the european parliament , or by the union industry .


### the investigation shall , whenever possible , be concluded within six months of the initiation of the investigation . in exceptional circumstances duly justified by the commission , that time limit may be extended by a further period of three months . ### the investigation shall be concluded within 200 days of the initiation of the investigation .


### following the initiation of the proceeding , the commission shall commence an investigation . ### following the initiation of the proceeding , the commission shall commence an investigation . the investigation period as set in article 4 shall start on the day the decision to initiate the investigation is taken .


### in the investigation the commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the union industry , in particular , the rate and amount of the increase in imports of the product concerned in absolute and relative terms , the share of the domestic market taken by increased imports , changes in the level of sales , production , productivity , capacity utilisation , profits and losses , and employment . ### in the investigation the commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the union industry , in particular , the rate and amount of the increase in imports of the product concerned in absolute and relative terms , the share of the domestic market taken by increased imports , changes in the level of sales , production , productivity , capacity utilisation , profits and losses , and employment . in the event that third - country content commonly accounts for more than 5 percent of the manufacturing cost of the product concerned , the commission shall also evaluate , as bearing on the situation of the union industry , the production capacity , utilization rates , currency practices and labour conditions of the third countries concerned .


### a safeguard measure may be imposed in accordance with the provisions set out in this regulation where a product originating in korea is , as a result of the reduction or the elimination of the customs duties on that product , being imported in the union in such increased quantities , in absolute terms or relative to domestic production , and under such conditions as to cause or threaten to cause serious injury to the union industry producing a like or directly competitive product . ### a safeguard measure may be imposed in accordance with the provisions set out in this regulation where a product originating in korea is , following the reduction or the elimination of the customs duties on that product , being imported in the union in such increased quantities , in absolute terms or relative to domestic production , and under such conditions as to cause or threaten to cause serious injury to the union industry or to the regional industry producing a like or directly competitive product .


### the member states shall inform the commission should trends in imports from the republic of korea appear to call for safeguard measures . that information shall include the evidence available as determined on the basis of factors laid down in article 4 . the commission shall pass that information on to all member states within three working days . ### the member states , or the union industry shall inform the commission should trends in imports from the republic of korea appear to call for safeguard measures . that information shall include the evidence available as determined on the basis of factors laid down in article 4 . the commission shall , within three working days , upload that information on to the online - platform referred to in article 9 , and shall send an upload notification to all member states , the union industry , and the european parliament .


### consultation with the member states shall take place within eight working days of the commission’s sending the information to member states as provided for in paragraph 2 within the committee referred to in article 10 on the basis of the procedure referred to in article 11 . 1 . where , after consultation , it is apparent that there is sufficient evidence to justify the initiation of a proceeding the commission shall publish a notice in the official journal of the european union . initiation shall take place within one month of the receipt of information from a member state . ### consultation with the member states shall take place within eight working days of the commission’s sending the information as provided for in paragraph 2 within the committee referred to in article 10 on the basis of the procedure referred to in article 11 . where , after consultation , it is apparent that there is sufficient evidence determined on the basis of factors laid down in article 4 to justify the initiation of a proceeding the commission shall publish a notice in the online - platform and in the official journal of the european union . initiation shall take place within one month of the request by a member state , the european parliament , or by the union industry .


### diversity of competences and views of the members of administrative , management and supervisory bodies of companies facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ' group - think ' phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards . ### diversity of competences and views of the members of administrative , management and supervisory bodies of companies , including gender diversity , facilitates a good understanding of the business organisation and affairs . it has been acknowledged that gender diversity , especially in top positions , contributes to corporate governance , quality of decision - making and to the company ' s performance . moreover , board diversity represents a benefit for the companies as board composition reflects demographic characteristics of key stakeholder groups such as employee , customer and investor . furthermore , it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ' group - think ' phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy , especially gender diversity , companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards .


### ‘ recreational craft’ means any boat of any type intended for sports and leisure purposes of hull length from 2 , 5 m to 24 m , measured according to the harmonised standard , regardless of the means of propulsion ; ### ‘ recreational craft’ means any vessel of any type intended for sports and leisure purposes of hull length from 2 , 5 m to 24 m , measured according to the harmonised standard , regardless of the means of propulsion ;


### offshore : designed for offshore voyages where conditions up to , and including , wind force 8 and significant wave heights up to , and including , 4 m may be experienced . ### a recreational craft given design category b is considered to be designed for wind force up to , and including , 8 and significant wave heights up to , and including , 4 m .


### sheltered waters : designed for voyages on sheltered coastal waters , small bays , small lakes , rivers and canals when conditions up to , and including , wind force 4 and significant wave heights up to , and including , 0 , 3 m may be experienced , with occasional waves of 0 , 5 m maximum height , for example from passing vessels . ### a watercraft given design category d is considered to be designed for a wind force up to , and including , 4 and significant wave heights up to , and including , 0 , 3 m with occasional waves of 0 , 5 m maximum height .


### offshore : designed for offshore voyages where conditions up to , and including , wind force 8 and significant wave heights up to , and including , 4 m may be experienced . ### a recreational craft given design category b is considered to be designed for waves of up to 4 m significant height and a wind of beaufort force 8 or less . such conditions may be encountered on offshore voyages of sufficient length or on coasts where shelter may not always be immediately available . such conditions may also be experienced on inland seas of sufficient size for the wave height to be generated . winds are assumed to gust to 21 m / s .


### country of manufacture , ### country code of member state issuing the manufacturer ' s code ,


### inshore : designed for voyages in coastal waters , large bays , estuaries , lakes and rivers where conditions up to , and including , wind force 6 and significant wave heights up to , and including , 2 m may be experienced . ### a watercraft given design category c is considered to be designed for waves of up to 2 m significant height and a typical steady wind force of beaufort force 6 or less . such conditions may be encountered on exposed inland waters , in estuaries , and in coastal waters in moderate weather conditions . winds are assumed to gust to 17 m / s .


### ocean : designed for extended voyages where conditions may exceed wind force 8 and significant wave heights of 4 m and above but excluding abnormal conditions , and vessels largely self - sufficient . ### a recreational craft given design category a is considered to be designed for winds that may exceed wind force 8 and significant wave heights of 4 m and above but excluding abnormal conditions such as storm , violent storm , hurricane , tornado and extreme sea conditions or rogue waves .


### sheltered waters : designed for voyages on sheltered coastal waters , small bays , small lakes , rivers and canals when conditions up to , and including , wind force 4 and significant wave heights up to , and including , 0 , 3 m may be experienced , with occasional waves of 0 , 5 m maximum height , for example from passing vessels . ### a watercraft given design category d is considered to be designed for waves of up to 0 , 3 m significant height and occasional waves of 0 , 5 m height and a typical steady wind force of beaufort force 4 or less . such conditions may be encountered on sheltered inland waters , and in coastal waters in fine weather . winds are assumed to gust to 13 m / s .


### inshore : designed for voyages in coastal waters , large bays , estuaries , lakes and rivers where conditions up to , and including , wind force 6 and significant wave heights up to , and including , 2 m may be experienced . ### a watercraft given design category c is considered to be designed for a wind force up to , and including , 6 and significant wave heights up to , and including , 2 m .


### persons referred to in point of article 55 may satisfy these requirements progressively . they shall adopt their financial rules with the commission ' s prior consent . ### persons referred to in point of article 55 may satisfy the requirements laid down in points to of this paragraph progressively within the first six months . they shall adopt their financial rules with the commission ' s prior consent .


### in respect of any measure which may give rise to expenditure chargeable to the budget , the authorising officer responsible must first make a budgetary commitment before entering into a legal obligation with third parties or transferring funds to a trust fund on the basis of article 178 . ### notwithstanding article 82 , in respect of any measure which may give rise to expenditure chargeable to the budget , the authorising officer responsible must first make a budgetary commitment before entering into a legal obligation with third parties or transferring funds to a trust fund on the basis of article 178 . however , in the case of humanitarian aid operations , civil protection operations and crisis management aid , and when the urgency of the situation so demands , the registration of the amounts may be done immediately after the signature of the corresponding individual legal commitment .


### the contributions of the union and the donors shall be entered into a specific bank account . these contributions are not integrated in the budget and are managed by the commission under the responsibility of the authorising officer by delegation . the entities and persons referred to in point of article 55 may be entrusted with budget implementation tasks in accordance with the relevant rules for indirect management . ### the contributions of the union and the donors shall be entered into a specific bank account . these contributions are not integrated in the budget and are managed by the commission under the responsibility of the authorising officer by delegation . article 55 shall apply .


### in respect of any measure which may give rise to expenditure chargeable to the budget , the authorising officer responsible must first make a budgetary commitment before entering into a legal obligation with third parties or transferring funds to a trust fund on the basis of article 178 . ### notwithstanding article 82 , in respect of any measure which may give rise to expenditure chargeable to the budget , the authorising officer responsible must first make a budgetary commitment before entering into a legal obligation with third parties or transferring funds to a trust fund on the basis of article 178 . however , in the case of humanitarian aid operations , civil protection operations and crisis management aid , and when an urgent situation outside the union so demands , the registration of the amounts may be done immediately after the signature of the corresponding individual legal commitment .


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 8 , 9 , 10 , 11 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 8 and 9 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### member states shall not prohibit the use of additives which are essential for the manufacture of tobacco products , as long as the additives do not result in a product with a characterising flavour . ### member states may use additives which are essential for the manufacture of tobacco products .


### member states shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients , and quantities thereof , used in the manufacture of the tobacco products by brand name and type , as well as their emissions and yields . manufacturers or importers shall also inform the competent authorities of the concerned member states if the composition of a product is modified affecting the information provided under this article . information required under this article shall be submitted prior to the placing of the market of a new or modified tobacco product . ### member states shall require manufacturers and importers of tobacco products , nicotine - containing products and herbal products for smoking to submit to their competent authorities a list of all ingredients , and quantities thereof , used in the manufacture of the tobacco products by brand name and type , as well as their emissions and yields . manufacturers or importers shall also inform the competent authorities of the concerned member states if the composition of a product is modified affecting the information provided under this article . information required under this article shall be submitted prior to the placing of the market of a new or modified tobacco product .


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 50 % of the external area of both the front and back surface of the unit packet and any outside packaging ;


### in addition to the unique identifier , member states shall require that all unit packets of tobacco products which are placed on the market carry a visible , tamper proof security feature of at least 1 cm² , which shall be irremovably printed or affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or other elements mandated by legislation . ### in addition to the unique identifier , member states shall require that all unit packets of tobacco products which are placed on the market carry a visible , tamper proof security feature , which shall be irremovably printed or affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or other elements mandated by legislation .


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ' low - tar ' , ' light ' , ' ultra - light ' , ' mild ' , ' natural ' or ' organic ' .


### available scientific studies on toxicity , addictiveness and attractiveness of the product , in particular as regards its ingredients and emissions ; ### relevant scientific studies on the toxicity of the product , in particular as regards its ingredients and emissions ;


### member states shall require manufacturers and importers to submit internal and external studies available to them on market research and preferences of various consumer groups , including young people , relating to ingredients and emissions . member states shall also require manufacturers and importers to report the sales volume data per product , reported in sticks or kilograms , and per member state on a yearly basis starting from the full calendar year following that of the entry into force of this directive . member states shall provide alternative or additional sales data , as appropriate , to ensure that information on sales volume requested under this paragraph is reliable and complete . ### member states shall require manufacturers and importers to submit internal and external studies available to them on market research and preferences of various consumer groups , including young people , relating to ingredients and emissions . member states shall also require manufacturers and importers to report the sales volume data per product , reported in sticks or kilograms , and per member state on a yearly basis starting from the full calendar year following that of the entry into force of this directive . member states shall provide alternative or additional sales data , as appropriate , to ensure that information on sales volume requested under this paragraph is reliable and complete . ingredients shall be defined in a uniform manner in all member states , using a clear list common to the member states .


### in order to ensure uniform conditions for the implementation of this directive , in particular concerning the format of ingredients reporting , the determination of products with characterising flavours or with increased levels of toxicity and addictiveness and the methodology for determining whether a tobacco product has characterising flavour , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 . ### in order to ensure uniform conditions for the implementation of this directive , in particular concerning the format of ingredients reporting , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 6 and 14 , shall be conferred on the commission for a period of five years from [ office of publications : please insert the date of the entry into force of this directive ] .


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , having a characterising flavour other than tobacco and menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns .


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 50 % of the external area of both the front and back surface of the unit packet and any outside packaging ; however in the case of unit packets intended for ' roll - your - own ' tobacco , the front or back surface of which exceeds 75cm2 , each warning referred to in this article should cover an area of 26 . 25cm2 ;


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall verify that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### the placing on the market of reduced - risk tobacco products must be authorised by the competent authorities of the member state in which the producer or importer intends to place the product on the market . member states shall require that manufacturers and importers of tobacco products submit an application to the competent authorities of member states for any reduced risk tobacco product they intend to place on the markets of the member states concerned . member states shall be entitled to charge a proportionate fee . the application shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . manufacturers and importers submitting an application for authorisation for a reduced - risk tobacco product shall also provide the competent authorities in question with :


### cross - border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this directive . common rules on a notification system are necessary to ensure that this directive achieves its full potential . the provision on notification of cross - border distance sales of tobacco in this directive should apply notwithstanding the notification procedure set out in directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services . business to consumer distance sale of tobacco products is further regulated by directive 97 / 7 / ec of the european parliament and the council of 20 may 1997 on the protection of consumers in respect of distance contracts , which will be replaced by directive 2011 / 83 / eu of the european parliament and the council of 25 october 2011 on consumer rights , as of 13 june 2014 . ### cross - border distance sales of tobacco should be prohibited as they facilitate young people ' s access to tobacco products , and risk undermining compliance with the requirements of this directive .


### member states may allow the following products , which are not in compliance with this directive , to be placed on the market until [ publications office , please insert the exact date : entry into force + 24 months ] : ### member states may allow the following products , which are not in compliance with this directive , to be placed on the market until [ 24 months after transposition into national law ] :


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 8 , 9 , 10 , 11 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles , 4 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### member states shall oblige retail outlets intending to engage in cross - border distance sales to consumers located in the union to register with the competent authorities in the member state where the retail outlet is established and in the member state where the actual or potential consumer is located . retail outlets established outside the union have to register with the competent authorities in the member state where the actual or potential consumer is located . all retail outlets intending to engage in cross - border distance sales shall submit at least the following information to the competent authorities : name or corporate name and permanent address of the place of activity from where the tobacco products are supplied ; the starting date of the activity of offering tobacco products for cross - border distance sales to the public by means of information society services ; the address of the website / - s used for that purpose and all relevant information necessary to identify the website . ### member states shall prohibit retail outlets established on their territory from engaging in cross border distance sales .


### member states shall oblige retail outlets intending to engage in cross - border distance sales to consumers located in the union to register with the competent authorities in the member state where the retail outlet is established and in the member state where the actual or potential consumer is located . retail outlets established outside the union have to register with the competent authorities in the member state where the actual or potential consumer is located . all retail outlets intending to engage in cross - border distance sales shall submit at least the following information to the competent authorities : ### member states shall prohibit retail outlets established on their territory from engaging in cross - border distance sales .


### the following nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec : ### nicotine - containing products may only be placed on the market if they are authorised pursuant to directive 2001 / 83 / ec , taking into account the well - established use of nicotine .


### member states shall not prohibit the use of additives which are essential for the manufacture of tobacco products , as long as the additives do not result in a product with a characterising flavour . ### member states shall not authorize the use of additives in tobacco products which : - contribute to the attractiveness and palatability of tobacco products ; - are addictive or contribute to the addictiveness of tobacco products ; - are toxic or carcinogenic or are under suspicion of being carcinogenic ;


### however , a member state may maintain more stringent national provisions , applicable to all products alike , in areas covered by the directive , on grounds of overriding needs relating to the protection of public health . a member state may also introduce more stringent provisions , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . such national provisions shall be notified to the commission together with the grounds for maintaining or introducing them . the commission shall , within six months from the date of receiving the notification , approve or reject the provisions after having verified , taking into account the high level of health protection achieved through this directive , whether or not they are justified , necessary and proportionate to their aim and whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between the member states . in the absence of a decision by the commission within this period the national provisions shall be deemed to be approved . ### however , this directive shall not affect the right of member states to introduce more stringent provisions , provided these provisions are justified by the need to protect public health , in accordance with the principle of subsidiarity . such national provisions shall be notified to the commission together with the grounds for maintaining or introducing them .


### the proposal affects several fundamental rights as laid down in the charter of fundamental rights of the european union , notably the protection of personal data , the freedom of expression and information , freedom of economic operators to conduct business , and the right to property . the obligations imposed on manufacturers , importers and distributors of tobacco products are necessary to improve the functioning of the internal market while ensuring a high level of health and consumer protection as set out in articles 35 and 38 of the charter of fundamental rights of the european union . the application of this directive should respect the eu law and relevant international obligations . ### the proposal affects several fundamental rights as laid down in the charter of fundamental rights of the european union , notably the protection of personal data , the freedom of expression and information , freedom of economic operators to conduct business , and the right to property for trademark holders . it is therefore necessary to ensure that the obligations imposed on manufacturers , importers and distributors of tobacco products not only guarantee a high level of health and consumer protection , but also protect all other fundamental rights and are proportionate with respect to the functioning of the internal market . the application of this directive should respect the eu law and relevant international obligations .


### considering the directive ' s focus on young people , tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco which are mainly consumed by older consumers , should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people . ### considering that the directive focuses on young people , but also protects the health of all consumers , tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco which are mainly consumed by older consumers , should not be granted an exemption from certain ingredients requirements .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards . ### the commission shall be empowered to adopt delegated acts in accordance with article 22 to reduce the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards .


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape . a unit packet of cigarettes shall include at least 20 cigarettes . a unit of ' roll - your - own ' or ' make - your - own ' tobacco shall be packaged in a cuboid or cylindrical composite can or have the form of a pouch i . e . rectangular packet with a flat that covers the opening . a unit packet of ' roll - your - own ' or ' make - your - own ' shall contain tobacco weighing at least 40g .


### the labelling provisions also need to be adapted to new scientific evidence . for example the indication of the yields for tar , nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others . evidence also suggests that large combined health warnings are more effective than text - only warnings . in this light combined health warnings should become mandatory throughout the union and cover significant and visible parts of the packet surface . a minimum size should be set for all health warnings to ensure their visibility and effectiveness . ### the labelling provisions also need to be adapted to new scientific evidence . for example the indication of the yields for tar , nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others . it is essential to carry out an independent study beforehand , in order to establish whether large combined health warnings are more effective than text - only warnings in this light combined health warnings should become mandatory throughout the union and cover significant and visible parts of the packet surface . a minimum size should be set for all health warnings to ensure their visibility and effectiveness .


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states and consistent with wto international obligations . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive .


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of roll - your - own tobacco shall have the form of either a pouch , i . e . a pocket with a flap that covers the opening , or a pack with a cuboid or cylindrical base . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 20 g .


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ' natural ' , ' organic ' , ‘ without additives’ , ‘ without flavours’ , ' slim ' , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features that appear on packaging , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ' natural ' , ' organic ' , ‘ without additives’ , ‘ without flavours’ , ' slim ' , names , pictures , and figurative or other signs .


### directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use provides a legal framework to assess the quality , safety and efficacy of medicinal products including nicotine containing products . a significant number of nicotine - containing products were already authorised under this regulatory regime . the authorisation takes into account the nicotine content of the product in question . subjecting all nicotine - containing products , whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under directive 2001 / 83 / ec , to the same legal framework clarifies the legal situation , levels out differences between national legislations , ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation . this should be without prejudice to the application of directive 2001 / 83 / ec to other products covered by this directive if the conditions set by directive 2001 / 83 / ec are fulfilled . ### directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use provides a legal framework to assess the quality , safety and efficacy of medicinal products including nicotine - containing products . a significant number of nicotine - containing products were already authorised under this regulatory regime . the authorisation takes into account the nicotine content of the product in question . excluding non - tobacco nicotine - containing products authorised under directive 2001 / 83 / ec from the scope of this directive clarifies the legal situation , levels out differences between national legislations , ensures equal treatment of all nicotine - containing products usable for smoking - cessation purposes and creates incentives for research and innovation in smoking cessation . this should be without prejudice to the application of directive 2001 / 83 / ec to other products covered by this directive if the conditions set by directive 2001 / 83 / ec are fulfilled .


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ' natural ' , ' organic ' , ‘ without additives’ , ‘ without flavours’ , ' slim ' , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed .


### tobacco products ; ### cigarettes and roll - your - own tobacco ;


### height : not less than 64 mm ; ### height : not less than 55 mm ;


### each unit packet and any outside packaging of tobacco for smoking shall carry combined health warnings . the combined health warnings shall : ### each unit packet and any outside packaging of tobacco for smoking shall carry health warnings . the health warnings shall :


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned at the edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ;


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### the length of one side of the bottom of a unit packet of cigarettes placed on the market shall be at least double that of its adjacent sides . a unit packet of any other tobacco for smoking shall be packaged in a cuboid or cylindrical composite can or have the form of a pouch i . e . rectangular packet with a flap that covers the opening .


### notification of novel tobacco products ### notification of novel tobacco products and granting of pre - marketing authorisation for reduced - risk tobacco products


### cross - border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this directive . common rules on a notification system are necessary to ensure that this directive achieves its full potential . the provision on notification of cross - border distance sales of tobacco in this directive should apply notwithstanding the notification procedure set out in directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services . business to consumer distance sale of tobacco products is further regulated by directive 97 / 7 / ec of the european parliament and the council of 20 may 1997 on the protection of consumers in respect of distance contracts , which will be replaced by directive 2011 / 83 / eu of the european parliament and the council of 25 october 2011 on consumer rights , as of 13 june 2014 . ### cross - border distance sales of tobacco should be prohibited as they facilitate young people ' s access to tobacco products , and risk undermining compliance with the requirements of this directive .


### cross - border distance sales of tobacco products ; ### the prohibition of cross - border distance sales of tobacco products ;


### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . ### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . in the case of tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products health warnings may be affixed by means of stickers , provided that these cannot be removed .


### the invoice , order number and payment records of all purchasers from manufacturing to the first retail outlet . ### the invoice , order number and payment records of all purchasers from manufacturing to the first purchaser .


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles , 4 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall conduct a market approval system for tobacco products with a lower risk which shall be carried out for a reasonable fee . member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco products and for all tobacco products with a lower risk they intend to place on the markets of the member states concerned by means of an application . this application shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question , all proposed labelling , conditions of use , the product composition , manufacturing and control processes as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers applying for a marketing authorization for tobacco products with a lower risk shall also provide the competent authorities in question with :


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall conclude data storage contracts with a third party , which may be an agency of the member state , and which is legally independent from the tobacco companies or their partners in the supply chain , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . member states shall ensure full transparency . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who shall be appointed by the commission . the costs incurred as a result of the contract with the auditor and the database management services shall be covered by the tobacco manufacturers and importers . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall prohibit the placing on the market of any novel tobacco product .


### tobacco products for smoking , other than cigarettes and roll - your - own tobacco products , which are mainly consumed by older consumers , should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people . the labelling of these other tobacco products should follow specific rules . the visibility of the health warnings on smokeless tobacco products needs to be ensured . warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging . ### tobacco products for smoking , other than cigarettes and roll - your - own tobacco products should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people . the labelling of these other tobacco products should follow specific rules . the visibility of the health warnings on smokeless tobacco products needs to be ensured . warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the methods of measurement of the tar , nicotine and carbon monoxide yields , taking into account scientific and technical developments and internationally agreed standards . ### the commission may put forward proposals to adapt the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards .


### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened , other than the flip - top lid . the flip - top lid of a cigarette packet shall be hinged only at the back of the packet . ### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened .


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a non - tobacco dominant flavour other than tobacco or traditional flavours such as menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns .


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned in the same direction as any other information appearing on the packaging ;


### cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with three official languages . ### cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with more than two official languages .


### member states shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point to of paragraph 1 . member states shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information . member states shall make available to the commission all information received pursuant to this article . member states shall be entitled to introduce an authorisation system and charge a proportionate fee . ### member states shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point to of paragraph 1 . member states shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information . member states shall make available to the commission all information received pursuant to this article . member states shall be entitled to set the scientific requirements for the granting of the authorisation referred to in paragraph 1 . the member states may also establish the procedures for providing product information to the public based on the scientific data submitted by the producer or importer .


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the use of certain texts on tobacco packages , for example ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , or ‘ mild’ , or of names , pictures , and figurative or other signs can mislead consumers by making them think that the products concerned are less harmful , thus inducing them to change their habits . the manner of smoking and the degree of dependence , and not just the levels of given substances contained in a product before it is consumed , also determine how much is inhaled . this aspect involves more than the use of texts such as those mentioned above . it could , indeed , undermine the labelling requirements laid down in this directive .


### the combined health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand . ### the health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each health warning is displayed as nearly as possible on equal numbers of each brand .


### suggests that a particular tobacco product is less harmful than others or has vitalising , energetic , healing , rejuvenating , natural , organic or otherwise positive health or social effects ; ### suggests that a particular tobacco product is less harmful than others or has vitalising , energetic , healing , rejuvenating or otherwise positive health effects ;


### the proposal affects several fundamental rights as laid down in the charter of fundamental rights of the european union , notably the protection of personal data , the freedom of expression and information , freedom of economic operators to conduct business , and the right to property . the obligations imposed on manufacturers , importers and distributors of tobacco products are necessary to improve the functioning of the internal market while ensuring a high level of health and consumer protection as set out in articles 35 and 38 of the charter of fundamental rights of the european union . the application of this directive should respect the eu law and relevant international obligations . ### the proposal affects several fundamental rights as laid down in the charter of fundamental rights of the european union , notably the protection of personal data , the freedom of expression and information , freedom of economic operators to conduct business , and the right to property for trademark holders . it is therefore necessary to ensure that the obligations imposed on manufacturers , importers and distributors of tobacco products not only guarantee a high level of health and consumer protection , but also protect all other fundamental rights and are proportionate with respect to the functioning of the internal market . the application of this directive should respect the eu law and relevant international obligations .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 8 , 9 , 10 , 11 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] .


### tobacco for smoking other than cigarettes and roll - your - own tobacco shall be exempted from the obligations to carry the information message laid down in article&#160 ; 8 and the combined health warnings in article 9 . in addition to the general warning specified in article 8 , each unit packet and any outside packaging of these products shall carry a text warning listed in annex i . the general warning specified in article 8 shall include a reference to the cessation services in accordance with article 9 . the general warning shall be printed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging . 2 . the general warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with three official languages . 3 . the text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 45 % for member states with two official languages and 50 % for member states with three official languages . 4 . the general warning and the text warning referred to in paragraph 1 shall be : printed in black helvetica bold type on a white background . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ; centred in the area in which they are required to be printed , parallel to the top edge of the unit packet and any outside packaging ; surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning . 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 , to withdraw the exemption laid down in paragraph 1 if there is a substantial change of circumstances as established in a commission report . ### tobacco for smoking other than cigarettes and roll - your - own tobacco shall be exempted from the obligations to carry the information message laid down in article&#160 ; 8 and the combined health warnings in article 9 . in addition to the general warning specified in article 8 , each unit packet and any outside packaging of these products shall carry a text warning listed in annex i . the general warning specified in article 8 shall include a reference to the cessation services in accordance with article 9 . the general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed or irremovably affixed on the other most visible surface of the unit packet and any outside packaging . 2 . the general warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with three official languages . 3 . the text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 45 % for member states with two official languages and 50 % for member states with three official languages . 4 . the general warning and the text warning referred to in paragraph 1 shall be : printed in black bold type on a white background . the warnings may be affixed by means of stickers , provided that such stickers cannot be removed . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ; centred in the area in which they are required to be printed or irremovably affixed , parallel to the top edge of the unit packet and any outside packaging ; surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning . deleted


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of roll - your - own tobacco shall have the form of either a pouch , i . e . a pocket with a flap that covers the opening , or a pack with a cuboid or cylindrical base . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 20 g .


### however , a member state may maintain more stringent national provisions , applicable to all products alike , in areas covered by the directive , on grounds of overriding needs relating to the protection of public health . a member state may also introduce more stringent provisions , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . such national provisions shall be notified to the commission together with the grounds for maintaining or introducing them . the commission shall , within six months from the date of receiving the notification , approve or reject the provisions after having verified , taking into account the high level of health protection achieved through this directive , whether or not they are justified , necessary and proportionate to their aim and whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between the member states . in the absence of a decision by the commission within this period the national provisions shall be deemed to be approved . ### however , this directive shall not affect the right of member states to introduce more stringent provisions , provided these provisions are justified by the need to protect public health , in accordance with the principle of subsidiarity . such national provisions shall be notified to the commission together with the grounds for maintaining or introducing them .


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall conduct a market approval system for tobacco products with a lower risk which shall be carried out for a reasonable fee . member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco products and for all tobacco products with a lower risk they intend to place on the markets of the member states concerned by means of an application . this application shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question , all proposed labelling , conditions of use , the product composition , manufacturing and control processes as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers applying for a marketing authorization for tobacco products with a lower risk shall also provide the competent authorities in question with :


### ' tobacco products ' means products usable for consumption by consumers and consisting of , even partly , tobacco , whether genetically modified or not ; ### ' tobacco products ' means products usable for consumption by consumers and consisting of , even partly , tobacco ;


### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed . ### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed .