### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of risk , the nature of the risk and its potential public health impact , who and what are directly or indirectly affected by the risk , the levels of risk exposure , the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication . ### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of hazard and risk , the nature of the hazard and its potential public health and environmental impacts , what groups of the population can directly or indirectly be affected by the risk , the levels of risk exposure , the ability to control exposure and risk and other factors that influence risk understanding including the level of urgency as well as the applicable legislative framework . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure accurate risk communication .


### where an applicant submits a request for confidentiality , it shall provide a non - confidential version and a confidential version of the information submitted in accordance with standard data formats , where they exist , pursuant to article 39f . the non - confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of article 39 . the confidential version shall contain all information submitted , including information the applicant deems confidential . information requested to be treated as confidential in the confidential version shall be clearly marked . the applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information . ### where an applicant submits a request for confidentiality , it shall provide a non - confidential version and a confidential version of the information submitted in accordance with standard data formats , where they exist , pursuant to article 39f . the non - confidential version shall redact with black bars the information the applicant requests the confidential treatment of in accordance with paragraphs 2 and 3 of article39 . the confidential version shall contain all information submitted , including in formation the applicant considers confidential . information requested to be treated as confidential in the confidential version shall be clearly marked . the applicant shall clearly indicate the verifiable justifications on the basis of which confidentiality is requested for each of the different pieces of information .


### article 32a general advice at the request of a potential applicant for a food law authorisation , the staff of the authority shall advise on the relevant provisions and the required content of the application for authorisation . the advice provided by the staff of the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . ### deleted


### accordingly and with respect to the procedures governing requests for authorisation procedures provided in union food law , experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures . it is appropriate to lay down in regulation no 178 / 2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public , . only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health , animal health or the environment , such information should be disclosed . ### any information relating to impacts on health or the environment must therefore always be made public . it is appropriate to lay down in regulation no 178 / 2002 a horizontal exhaustive list of information items which could be kept confidential on the ground that they would significantly undermine the protection of commercial interest . however , this information can only be kept secret if the company opposing its dissemination proves , with verifiable justifications , that the dissemination would significantly undermine its commercial interests . the exceptions to the principle of transparency must be interpreted strictly . in any event , even in a case the disclosure of the information is considered to undermine the commercial interests of an economic operator , if there is an overriding public interest in the disclosure , the information cannot be kept secret . it is appropriate to lay down in regulation no178 / 2002 a horizontal non - exhaustive list of information items which can never be kept secret , an overriding public interest in their disclosure being deemed .


### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter . ### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market . moreover , public money should never be used to cover the costs of studies that will in the end help the private entities to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit - and cover all the costs relating to - relevant studies , including tests , to demonstrate the safety and the efficacy of a subject matter where relevant .


### in order to enable the authority and the business operators to adapt to the new requirements while ensuring that the authority continues its smooth operation , it is necessary to provide for transitional measures for the application of this regulation . ### in order to enable the authority , member states , the commission and the business operators to adapt to the new requirements while ensuring that the authority continues its smooth operation , it is necessary to provide for transitional measures for the application of this regulation .


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually refer to internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , non - compliance with the applicable standards may arise and this is why national systems are in place to verify such compliance . in order to ensure the quality of studies it is appropriate to enhance the auditing system whereby member states control and ensure the implementation of those principles by the laboratories carrying out such studies and tests and whereby member states’ controls would be verified by the commission .


### in order to further strengthen the link between risk assessors and risk managers at union and national levels as well as the coherence and consistency of risk communication , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission to adopt a general plan on risk communication on matters covering the agri - food chain . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . ### in order to safeguard the independence of the risk assessment and risk management stages at union and national levels as well as the accuracy and consistency of risk communication , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission to adopt a general plan on risk communication on matters covering the agri - food chain . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts .


### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . ### there are public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to a ensure that the authority includes all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a public consultation , once a corresponding application for authorisation or renewal has been made public , in order to identify whether other relevant scientific data or studies are available .


### four members with the right to vote representing civil society and food chain interests namely , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members . ### five members with the right to vote representing civil society and food chain workers interests namely , one from health organisations , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members .


### the disclosure to the public of the information mentioned in paragraph shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used , reproduced , or otherwise exploited and its use by third parties shall not engage the responsibility of the european union . ### the disclosure to the public of the information mentioned in paragraph shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be commercially used , reproduced , or otherwise exploited for commercial purposes . for the avoidance of doubt , the information published can be used for the purpose of public scrutiny of the results , including abetter understanding of the potential adverse effects on health and the environment and its use by third parties for that purpose shall not engage the responsibility of the european union . ”


### the fitness check of the general food law demonstrated that although the authority has made considerable progress in terms of transparency , the risk assessment process , especially in the context of authorisation procedures covering the agri - food chain , is not always perceived as fully transparent . this is also partly due to the different transparency and confidentiality rules that are laid down not only in regulation no 178 / 2002 but also in other union legislative acts covering the agri - food chain . their interplay can impact on the acceptability of the risk assessment by the general public . ### the fitness check of the general food law demonstrated that although the authority has made considerable progress in terms of transparency , the risk assessment process , especially in the context of authorisation procedures covering the agri - food chain , is not yet fully transparent .


### the evaluation of regulation no 178 / 200221 , , found that risk communication is overall , not considered to be effective enough , which has an impact on consumers’ confidence on the outcome of the risk analysis process . __________________ 21 commission staff working document , “the refit evaluation of the general food law no 178 / 2002 ) ” , swd38 final , dated 15 . 1 . 2018 . ### the evaluation of regulation no 178 / 200221 , , found that risk communication is overall , not considered to be effective enough , which can have an impact on the outcome of the risk analysis process . __________________ 21 commission staff working document , “the refit evaluation of the general food law no 178 / 2002 ) ” , swd38 final , dated 15 . 1 . 2018 .


### to determine what level of disclosure strikes the appropriate balance , the relevant rights of the public to transparency in the risk assessment process , should be weighted up against the rights of commercial applicants , taking into account the objectives of regulation no 178 / 2002 . ### the present regulation is intended to give the fullest possible effect to the right of public access to documents of the authority and must be read in conjunction with regulation no 1049 / 2001 and 1367 / 2006 .


### make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place , pursuant to point . ### make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks and no later than four weeks after the notification of its decision to the applicant has taken place , pursuant to point .


### one member appointed by the european parliament , with the right to vote . ### two members and two alternate members appointed by the european parliament , with the right to vote .


### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently . ### to preserve the independence of the risk assessment from risk management and from vested private interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to safeguard efsa’s accountability , and in particular the independence of its expertise , has a role in excluding scientific experts who oppose the publication of their name or who have conflicts of interest , from risk assessment . adequate budgetary measures should be put in place to ensure that scientific experts have the means to act independently .


### the authority shall carry out its activities with a high level of transparency . it shall in particular make public without delay : ### the authority shall carry out its activities with a high level of transparency in line with a high level of transparency in line with the aarhus convention and regulation 1367 / 2006 and without prejudice to regulation 1049 / 2001 as well as with directive 2003 / 4 , providing for an active and systematic dissemination to the public of environmental information . it shall in particular make public without delay :


### the executing authority may decide not to recognise and not to execute the freezing order only if : ### the executing authority must decide not to recognise and not to execute the freezing order if :


### the notification shall contain information , at least briefly , on the reasons of the freezing order , on the authority who issued the order and on the existing legal remedies under the national law of the executing state . ### the notification shall contain information on the reasons of the freezing order , on the authority who issued the order and on the existing legal remedies under the national law of the executing state .


### a confiscation order should be transmitted together with a standard certificate . ### a confiscation or freezing order should be transmitted together with a standard certificate .


### this regulation does not have the effect of modifying the obligation to respect fundamental rights and fundamental legal principles as enshrined in article 6 of the teu . ### this regulation does not have the effect of modifying the obligation to respect fundamental rights and fundamental legal principles as enshrined in article 6 of the teu and in the charter of fundamental rights of the european union .


### in the execution of a freezing order , the issuing authority and the executing authority should take due account of the confidentiality of the investigation . in particular , the executing authority should guarantee the confidentiality of the facts and the substance of the freezing order . ### without prejudice to the right to information of any person concerned , in the execution of a freezing order , the issuing authority and the executing authority should take due account of the confidentiality of the investigation . in particular , the executing authority should guarantee the confidentiality of the facts and the substance of the freezing order .


### carry - over may occur during production , processing , storage and transport of feed where the same production and processing equipment , storage facilities or means of transport are used for feed with different components . for the purposes of this regulation , the concept of ‘ carry - over ' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non - target feed , while the term ‘ cross - contamination ' is to be considered as a contamination resulting from a carry - over or from the transfer in feed of any unintended substance . carry - over of active substances contained in medicated feed to non - target feed should be avoided or kept as low as possible . in order to protect animal health , human health and the environment , maximum levels of carry - over for active substances contained in medicated feed should be established , based on a scientific risk assessment performed by the european food safety authority and taking into account the application of good manufacturing practice and the alara principle . general limits should be set out in this regulation , taking into account the unavoidable carry - over and the risk caused by the active substances concerned . ### carry - over may occur during production , processing , storage and transport of feed where the same production and processing equipment , storage facilities or means of transport are used for feed with different components . for the purposes of this regulation , the concept of ‘ carry - over ' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non - target feed , while the term ‘ cross - contamination ' is to be considered as a contamination resulting from a carry - over or from the transfer in feed of any unintended substance . carry - over of active substances contained in medicated feed to non - target feed should be prohibited in order to protect animal health , human health and the environment .


### medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food - producing animals or to enhance their performance . ### medicated feed containing antibiotic veterinary medicinal products shall not be used to prevent diseases in food - producing animals unless such use is permitted under regulation 2015 / . . . .


### feed business operators manufacturing , storing , transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority . ### feed business operators manufacturing , storing , transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent public authority . where on - farm mixers include medicinal products solely for use on their own farms , they shall notify their activity to the competent authority .


### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed . ### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should be prohibited .


### in order to ensure the safe use of medicated feed , its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated . however , the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded . ### in order to ensure the safe use of medicated feed , its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated .


### medicated feed and intermediate products may be manufactured and stored before the prescription referred to in article 15 is issued . this provision shall not apply to on - farm mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with articles 10 or 11 of directive 2001 / 82 / ec . ### medicated feed and intermediate products may not be manufactured and stored before the prescription referred to in article 15 is issued .


### member states shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription . ### member states shall develop appropriate collection systems in cooperation with the operators of the sector for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription .


### it is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process . ### it is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should regain citizens ' trust that the whole process is underpinned by the objective of this regulation , which is to ensure high level of human life and health and the protection of consumers ' interests . therefore it should be combined with an open dialogue between all interested parties , particularly the public to ensure coherence , consistency and accountability within the risk analysis process .


### provide a sound basis for understanding risk management decisions ; ### provide a sound scientific basis for understanding risk management decisions ;


### one member appointed by the european parliament , with the right to vote . ### two members and two alternate members appointed by the european parliament , with the right to vote .


### it is essential to ensure the efficient operation of the authority and to improve the sustainability of its expertise . it is therefore necessary to strengthen the support provided by the authority and the member states to the work of the authority’s scientific panels . in particular , the authority should organise the preparatory work supporting the panels’ tasks , including by requesting the authority’s staff or national scientific organisations networking with the authority to draft preparatory scientific opinions to be peer - reviewed and adopted by the panels . ### it is essential to ensure the efficient operation of the authority and to improve the sustainability of its expertise . it is therefore necessary to strengthen the support provided by the authority and the member states to the work of the authority’s scientific panels . in particular , the authority should organise the preparatory work supporting the panels’ tasks , including by requesting the authority’s staff to draft preparatory scientific opinions to be peer - reviewed and adopted by the panels .


### four members with the right to vote representing civil society and food chain interests namely , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members . ### five members with the right to vote representing civil society and the food chain namely , one from consumers organisations , one from environmental non - governmental organisations , one from public health non - governmental organisations , one from animal health organisations and one from the agri - food business industry . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members .


### experience shows that the role of the management board of the authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states in the management board of the authority , while providing that those representatives should have experience in particular on risk assessment . ### experience shows that the role of the management board of the authority apart from risk assessment is also focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states , as well from the commission , the parliament in the management board of the authority , while providing that those representatives should have experience in particular on risk assessment and that the absence of any conflict of interest is avoided .


### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . ### there are public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority must makes searches in scientific literature systematically to be able to consider other data and studies existing on the subject matter submitted to its assessment . in this respect , the authority must implement the necessary means , structures and applications to provide access to all relevant scientific literature on the matter . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to also provide for a consultation of third independent parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation .


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually refer to internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , non - compliance with the applicable standards may arise and this is why national systems are in place to verify such compliance . in order to ensure the quality of studies it is appropriate to enhance the auditing system whereby member states control and ensure the implementation of those principles by the laboratories carrying out such studies and tests and whereby member states’ controls are to be verified by the commission .


### transparency of the risk assessment process contributes to the authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission , increases their confidence in its work and ensures that the authority is more accountable to the union citizens in a democratic system . it is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning union food law and in particular in the risk assessment , including the organisation and independence of the authority and transparency . ### improving transparency of the risk assessment process would contributes to the authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission , would increase their confidence in its work and would ensure that the authority is more accountable to the union citizens in a democratic system .


### foster public understanding of the risk analysis process so as to enhance confidence in its outcome ; ### foster public understanding of the risk analysis process so as to enhance accountability in its outcome , and restore consumer trust in the union and its institutions ;


### it is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account regulation no 45 / 2001 of the european parliament and of the council24 and regulation 2016 / 679 of the european parliament and of the council25 . accordingly , no personal data should be made publicly available under this regulation , unless it is necessary and proportionate for the purposes of ensuring the transparency , independence and the reliability of the risk assessment process , while preventing conflicts of interests . __________________ 24 regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . 25 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . ### it is also necessary to refer , for the protection and confidentiality of personal data for the purposes of the transparency of the risk assessment process , to regulation no 45 / 2001 of the european parliament and of the council and regulation 2016 / 679 of the european parliament and of the council25 . accordingly , no personal data should be made publicly available under this regulation , unless it is necessary and proportionate for the purposes of ensuring the transparency , independence and the reliability of the risk assessment process , while preventing conflicts of interests . for the purpose of ensuring the transparency , independence , sustainability and reliability of the risk assessment process , in particular to avoid conflicts of interest , it is considered necessary and proportionate to publish the names of any individual designated by the authority to contribute to the authority’s decision making process , including in the context of the adoption of guidance documents . __________________ 24 regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . 25 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of risk , the nature of the risk and its potential public health impact , who and what are directly or indirectly affected by the risk , the levels of risk exposure , the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication . ### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of hazard and risk , the nature of the hazard and its potential environmental and public health and environmental impacts , what groups of the population can directly or indirectly be affected by the risk , the levels of risk exposure , the ability to control exposure and risk , the ways of managing it and other factors that influence risk understanding including the level of urgency as well as the applicable legislative framework . the general plan should also identify the tools and channels to be used and should establish appropriate , exhaustive and expeditious mechanisms to ensure accurate risk communication .


### food safety is a sensitive matter of prime interest for all union citizens . while maintaining the principle that the burden is on the industry to prove compliance with union requirements , it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues , namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment . considering that it would be financed by the union budget and that the use of this exceptional verification tool should remain proportionate , the commission should be responsible for triggering the commissioning of such verification studies . account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake . ### food safety is a sensitive matter of prime interest for all union citizens . while maintaining the principle that the burden is on the industry to prove compliance with union requirements , it is prerequisite to establish an additional verification tool to address , as a minimum , cases where there is uncertainty or controversy on safety issues and potential risks , namely the commissioning of additional independent studies with the objective of verifying evidence used in the context of risk assessment . considering that it would be financed by the union budget and that the use of this exceptional verification tool should remain proportionate , the commission should be responsible for triggering the commissioning of such verification studies , particularly so upon the request of civil society . account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake .


### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . ### there are public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to ensure that the authority includes all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a public consultation , once a corresponding application for authorisation or renewal has been made public , in order to identify whether other relevant scientific data or studies are available .


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted by business operators in support of applications for authorisations under union sectorial food law shall comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced control and auditing system whereby member state and third countries controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission .


### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently . ### preserve the independence of the risk assessment from risk management and from vested private interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict , transparent criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to safeguard efsa’s accountability , and in particular the independence of its expertise , has a role in excluding scientific experts who oppose the publication of their name or who have conflicts of interest , from risk assessment . adequate budgetary measures should be put in place to ensure that scientific experts have the means to act independently . to this effect , it is necessary to implement new and adequate budgetary measures .


### establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties . ### establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue and constant interaction amongst all interested parties , while acknowledging scientific divergent opinions where they exist .


### four members with the right to vote representing civil society and food chain interests namely , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members . ### five members with the right to vote representing civil society and food chain workers interests namely , one from medical / health organisations , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from agrochemical or food industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members .


### promote consistency and transparency in formulating risk management recommendations ; ### promote consistency and transparency in formulating risk management recommendations in order to reach the highest level of protection of human and animal health and the environment ;


### it is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process . ### it is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should regain citizens ' trust that the whole process is underpinned by the objective of this regulation , which is to ensure high level of human life and health and the protection of consumers ' interests . therefore it should be combined with an open dialogue between all interested parties , particularly the public to ensure coherence , consistency and accountability within the risk analysis process .


### at the request of a potential applicant for a food law authorisation , the staff of the authority shall advise on the relevant provisions and the required content of the application for authorisation . the advice provided by the staff of the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . ### at the request of a potential applicant for a food law authorisation , the staff of the authority shall advise on the relevant provisions and the required content of the application for authorisation . the advice provided by the staff of the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . to ensure the transparency of this process , the advise should be made public .


### the authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under union food law . to this end , it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the authority when commissioned . information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency . ### the authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under union food law . to this end , it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the authority when commissioned . information about the notified studies should be made public only once a corresponding application for authorisation or renewal has been submitted and the authority has published its official scientific opinion .


### make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place , pursuant to point . ### make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks and no later than four weeks after the notification of its decision to the applicant has taken place , pursuant to point .


### promote awareness and understanding of the specific issues under consideration during the entire risk analysis process ; ### promote transparency , clarity , awareness and understanding of the specific issues under consideration during the entire risk analysis and management processes ;


### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently . ### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence , integrity and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director , who is the legal representative of efsa and whose function is to be responsible for the performance of the works of the authority and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently .


### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter . ### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter .


### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . ### there are public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority must makes searches in scientific literature systematically to be able to consider other data and studies existing on the subject matter submitted to its assessment . in this respect , the authority must implement the necessary means , structures and applications to provide access to all relevant scientific literature on the matter . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to also provide for a consultation of third independent parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation .


### each year the institution shall forward a report to the european parliament and the council containing a summary of the number and type of internal audits carried out , the recommendations made and the action taken on those recommendations . ### article 99 is replaced by the following : ' 5 . each year the institution shall report to the european parliament and the council on internal audits carried out , the recommendations made and the action taken on those recommendations . '


### a single sector interoperability perspective is associated with the risk that the adoption of different or incompatible solutions at national or sectoral levels will throw up new e - barriers that impede the proper functioning of the internal market and the associated freedoms of movement , and undermine the openness and competitiveness of markets and the delivery of services of general interest to citizens and enterprises . in order to mitigate this risk , member states and the union should step up joint efforts to avoid market fragmentation and ensure cross - border or cross - sector interoperability in the implementation of legislation , while reducing administrative burdens and costs , and promote commonly agreed ict solutions , while ensuring appropriate governance . ### a single sector interoperability perspective is associated with the risk that the adoption of different or incompatible solutions at national or sectoral levels will throw up new e - barriers that impede the proper functioning of the internal market and the associated freedoms of movement , and undermine the openness and good functioning of markets and the delivery of services of general interest to citizens and enterprises . in order to mitigate this risk , member states and the union should step up joint efforts to avoid market fragmentation , the digital divide and ensure cross - border or cross - sector interoperability in the implementation of legislation , while improving efficiency , and promote commonly agreed ict solutions , while ensuring appropriate governance .


### the modernisation of public administrations is one of the key priorities for successful implementation of the europe 2020 strategy . in this context , the annual growth surveys published by the commission in 2011 , 2012 and 2013 show that the quality of european public administrations has a direct impact on the economic environment and is therefore crucial to stimulating productivity , competitiveness and growth . this is clearly reflected in the country - specific recommendations , which call for specific action aimed at public administration reform . ### the modernisation of public administrations is one of the key priorities for successful implementation of the europe 2020 strategy . in this context , the annual growth surveys published by the commission in 2011 , 2012 and 2013 show that the quality of european public administrations has a direct impact on the economic environment and is therefore crucial to stimulating productivity , economic cooperation and growth . this is clearly reflected in the country - specific recommendations , which call for specific action aimed at public administration reform .


### ' conflict - affected and high - risk areas ' means areas in a state of armed conflict , fragile post - conflict as well as areas witnessing weak or non - existent governance and security , such as failed states , and widespread and systematic violations of international law , including human rights abuses ; ### ‘ conflict - affected and high - risk areas’ means areas identified by the presence of armed conflict , widespread violence or other risks of harm to people and , for these purposes , it is recognized that : armed conflict may take a variety of forms , such as a conflict of international or non - international character , which may involve two or more states , or may consist of wars of liberation , or insurgencies , civil wars ; and high - - risk areas may include areas of political instability or repression , institutional weakness , insecurity , collapse of civil infrastructure and widespread violence , both of which areas are often characterized by widespread human rights abuses and violations of national or international law ;


### the commission shall identify on the list referred to in paragraph 1 those responsible smelters and refiners that source – at least partially – from conflict - affected and high - risk areas . ### the commission shall identify on the list referred to in paragraph 1 those responsible annex ii actors that source – at least partially – from conflict - affected and high - risk areas .


### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict regions . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd . ### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of natural resources from conflict regions . the consequence is that such natural resources , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd .


### the commission should report regularly to the council and the european parliament on the effects of the scheme . no later than three years after entering into force and every six years thereafter , the commission should review the functioning and the effectiveness of this regulation , including as regards the promotion of responsible sourcing of the minerals within its scope from conflict - affected and high - risk areas . the reports may be accompanied , if necessary , by appropriate legislative proposals , which may include mandatory measures , ### the commission should report regularly to the council and the european parliament on the effects of the scheme . no later than three years after entering into force and every six years thereafter , the commission should review the functioning and the effectiveness of this regulation ,


### independent third - party audits regarding each of the responsible smelters or refiners in its supply chain carried out in accordance with the scope , objective and principles set out in article 6 of the regulation , ### independent third - party audits carried out in accordance with article 6 of this regulation ; and


### smelters and refiners are an important point in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting , disclosing and verifying information on the mineral ' s origin and chain of custody . after this stage of transformation it is often considered unfeasible to trace back the origins of minerals . a union list of responsible smelters and refiners could therefore provide transparency and certainty to downstream companies as regards supply chain due diligence practices . ### smelters and refiners are recognised choke points in their respective supply chains with substantial influence over the due diligence that is conducted along the supply chain in the sourcing countries . a union list of responsible choke - point actors could therefore provide transparency and certainty to companies in the downstream with a view to carrying out supply chain due diligence practices . consistently with the oecd due diligence guidance , choke - point actors should undergo independent third - party audit of their supply chain due diligence practices , also with a view to being included in the list of responsible actors . choke point actors based outside the european union should also have a possibility for being included in the list to ensure its global scope .


### the commission shall update the information included in the list in a timely manner . the commission shall remove from the list the names of the smelters and refiners that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers . ### the commission shall update the information included in the list in a timely manner but no later than every six months . the commission shall remove from the list the names of upstream actors that are no longer recognised as responsible upstream actors by member states in accordance with article 14 .


### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . however , union companies have also reported countless difficulties in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of operators that are often insufficiently aware or ethically unconcerned . the cost of responsible sourcing and their potential impact on competitiveness notably on smes should be monitored by the commission . ### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . in accordance with the oecd due diligence guidance it is recognized that due diligence in conflict - affected and high - risk areas presents practical challenges and that flexibility is therefore needed in the application thereof . the nature and extent of due diligence that is appropriate for an undertakings´ individual circumstances depend on a number of factors , including its size and position in the supply chain , fully taking account of the challenges faced by smes .


### in the context of this regulation , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales with a view to ensuring that they do not contribute to conflict and adverse impacts thereof . ### in the context of this regulation , and in accordance with the oecd due diligence guidance , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales upstream and downstream of the supply chain with a view to ensuring that they respect human rights and do not contribute to conflict and adverse impacts thereof , both directly in the mining sector and indirectly in the wider communities .


### natural mineral resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining national endeavours towards development , good governance and the rule of law . in these areas , breaking the nexus between conflict and illegal exploitation of minerals is critical to peace and stability . ### natural resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining national endeavours towards development , good governance and the rule of law . in these areas , breaking the nexus between conflict and illegal exploitation of natural resources is critical to peace and stability .


### in the context of this regulation , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales with a view to ensuring that they do not contribute to conflict and adverse impacts thereof . ### in the context of this regulation , and in line with the oecd due diligence guidance , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales with a view to ensuring that they respect human rights and do not contribute to conflict and adverse impacts thereof .


### the responsible importer of the minerals or metals within the scope of this regulation shall carry out audits via an independent third - party . ### annex ii operators shall have their due diligence practices audited by an independent third - party in accordance with the oecd due diligence guidance .


### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict regions . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd . ### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of natural resources from conflict regions . the consequence is that such natural resources , potentially present in consumer products , link consumers to conflicts outside the union . as such , consumers are indirectly linked to conflicts that have severe impacts on human rights , notably the rights of women as armed groups often use mass rape as a deliberate strategy to intimidate and control local populations in order to protect their interests . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd .


### three years after the entry into force of this regulation and every six years thereafter , the commission shall review the functioning and effectiveness of this regulation , including on the promotion and cost of responsible sourcing of the minerals within its scope from conflict - affected and high - risk areas . the commission shall submit a review report to the european parliament and to the council . ### three years after the entry into force of this regulation and every six years thereafter , the commission shall review the functioning and effectiveness of this regulation , including on the promotion and cost of responsible sourcing of the resources within its scope from conflict - affected and high - risk areas . the commission shall submit a review report to the european parliament and to the council .


### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . however , union companies have also reported countless difficulties in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of operators that are often insufficiently aware or ethically unconcerned . the cost of responsible sourcing and their potential impact on competitiveness notably on smes should be monitored by the commission . ### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . in accordance with the oecd due diligence guidance it is recognized that due diligence in conflict - affected and high - risk areas presents practical challenges and that flexibility is therefore needed in the application thereof . the nature and extent of due diligence that is appropriate for an enterprises ' individual circumstances depend on a number of factors , including its size and position in the supply chain , fully taking account of the challenges faced by smes .


### the commission shall update the information included in the list in a timely manner . the commission shall remove from the list the names of the smelters and refiners that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers . ### the commission shall update the information included in the list in a timely manner but no later than every six months . the commission shall remove from the list the names of annex ii actors that are no longer recognised as responsible annex ii actors by member states in accordance with article 14 .


### the responsible importer of the minerals or metals within the scope of this regulation shall carry out audits via an independent third - party . ### annex ia operators shall have their due diligence practices audited by an independent third - party in accordance with the oecd due diligence guidance .


### the number and geographic coverage of terminals servicing combined transport operations and the yearly number of transhipments on those terminals ; ### the number and geographic location coverage of terminals servicing combined transport operations and the yearly number of transhipments on those terminals related to their respective used capacity ;


### without prejudice to paragraph 9 , from 1 january 2018 , member states shall not introduce user charges for heavy duty vehicles . user charges introduced before that date may be maintained until 31 december 2023 . ### without prejudice to paragraph 9 , from 1 january 2018 , member states shall not introduce user charges for heavy duty vehicles . user charges introduced before that date may be maintained until 31 december 2021 .


### road congestion , to which all motor vehicles contribute in different proportions , represents a cost of about 1% of gdp . a significant part of this cost can be attributed to interurban congestion . a specific congestion charge should therefore be allowed , on condition that it is applied to all vehicle categories . in order to be effective and proportionate , the charge should be calculated on the basis of the marginal congestion cost and differentiated according to location , time and vehicle category . in order to maximise the positive effect of congestion charges , corresponding revenues should be allocated to projects addressing the sources of the problem . ### road congestion , to which all motor vehicles contribute in different proportions , represents a cost of about 1% of gdp . a significant part of this cost can be attributed to interurban congestion . a specific congestion charge should therefore be allowed , on condition that it is applied to all vehicle categories . in order to be effective and proportionate , the charge should be calculated on the basis of the marginal congestion cost and differentiated according to location , time and vehicle category . in order to maximise the positive effect of congestion charges , corresponding revenues should be ring - fenced and allocated to projects addressing the sources of the problem .


### road charges can mobilise resources that contribute to the financing of the maintenance and development of high quality transport infrastructure . it is therefore appropriate to incentivise member states to use revenues from road charges accordingly and , to this end , to require that they adequately report on the use of such revenues . that should in particular help identifying possible financing gaps , and raising the public acceptance of road charging . ### road charges can mobilise resources that contribute to the financing of the maintenance and development of high quality transport infrastructure . it is therefore appropriate to incentivise member states to ring - fence and use those revenues from road charges accordingly and , to this end , to require that they adequately report on the use of such revenues . that should in particular help identifying possible financing gaps , and raising the public acceptance of road charging .


### by providing for a period of supplementary protection of up to five years , regulation no 469 / 2009 seeks to promote , within the union , the research and innovation that is necessary to develop medicinal products , and to contribute to preventing the relocation of pharmaceutical research outside the union to countries that may offer greater protection . ### while regrettable in an overall context , by providing for a period of supplementary protection of up to five years , regulation no 469 / 2009 seeks to promote , within the union , the research and innovation that is necessary to develop medicinal products , and to contribute to preventing the relocation of pharmaceutical research outside the union to countries that may offer greater protection .


### the consumer shall return , at the seller ' s expense , to the seller the goods without undue delay and in any event not later than 14 days from sending the notice of termination ; ### the consumer shall return , at the seller ' s expense , to the seller the goods without undue delay and in any event not later than 28 days from sending the notice of termination ;


### member states shall not maintain or introduce provisions diverging from those laid down in this directive including more or less stringent provisions to ensure a different level of consumer protection . ### member states may adopt or maintain in force more stringent provisions than those laid down in this directive for the protection of consumers , and the implementation of this directive shall under no circumstances constitute grounds for the reduction of protection for consumers in fields covered by the scope of union law .


### in cases where the goods were installed by the seller or under the seller’s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired the physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired the physical possession of the goods . ### in a case governed by point of article 6 , the time when the installation is complete shall be considered as the time when the consumer has acquired physical possession of the goods . in a case governed by point of article 6 , the time when the consumer has had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired physical possession of the goods .


### where the seller is liable to the consumer because of a lack of conformity with the contract resulting from an act or omission by a person in earlier links of the chain of transactions , the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions . the person against whom the seller may pursue remedies and the relevant actions and conditions of exercise , shall be determined by national law . ### where the seller is liable to the consumer because of a lack of conformity with the contract resulting from an act or omission by a person in earlier links of the chain of transactions , the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions . the person against whom the seller may pursue remedies , and the relevant actions and conditions of exercise , shall be determined by national law . however , the seller shall be entitled to pursue remedies for at least the duration of the legal guarantee period , and the period during which a presumption exists that any lack of conformity with the contract already existed at the time indicated in article 8 and shall be no shorter than as provided for in article 8 .


### where the seller is liable to the consumer because of a lack of conformity with the contract resulting from an act or omission by a person in earlier links of the chain of transactions , the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions . the person against whom the seller may pursue remedies and the relevant actions and conditions of exercise , shall be determined by national law . ### where the seller is liable to the consumer because of a lack of conformity with the contract resulting from an act or omission by a person in earlier links of the chain of transactions , or for any other reason , the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions . the person against whom the seller may pursue remedies , and the relevant actions and conditions of exercise , shall be determined by national law . member states shall ensure that their national laws adequately protect the seller when determining the person against whom the seller may pursue remedies , the time periods and the relevant actions and conditions of exercise of the right of redress .


### the goods are handed over to the carrier chosen by the consumer , where that carrier was not proposed by the seller or where the seller proposes no means of carriage . ### the goods are handed over to the carrier chosen by the consumer , where that carrier was not proposed by the seller .


### in cases where the goods were installed by the seller or under the seller’s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired the physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired the physical possession of the goods . ### in cases where the goods were installed by the seller or under the seller ' s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired physical possession of the goods . in a case where the goods were intended to be installed by the consumer , 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired physical possession of the goods .


### the return of third - country nationals who do not fulfil or no longer fulfil the conditions for entry , stay or residence in the member states , in full respect of fundamental rights , in particular of the principle of non - refoulement , and in compliance with the provisions of directive 2008 / 115 / ec9 , is an essential part of the comprehensive efforts to ensure the credibility and proper functioning of the union migration policies and to reduce and deter irregular migration . _________________ 9directive 2008 / 115 / ec of the european parliament and of the council of 16 december 2008 on common standards and procedures in member states for returning illegally staying third - country nationals . ### any procedure for the return of third - country nationals should be carried out on a voluntary basis , in full respect of fundamental rights , and such nationals should on no account be returned to countries where they face death or inhuman and degrading treatment .


### the current standard travel document for the expulsion of third - country nationals , established by council recommendation of 30 november 199410 , is not widely accepted by authorities of third countries , for reasons including its inadequate security standards . _________________ 10council recommendation of 30 november 1994 concerning the adoption of a standard travel document for the expulsion of third - country nationals . ### the current standard travel document for the expulsion of third - country nationals , established by council recommendation of 30 november 199410 , is not widely accepted by authorities of third countries and its effectiveness has not been assessed . _________________ 10council recommendation of 30 november 1994 concerning the adoption of a standard travel document for the expulsion of third - country nationals .


### a more secure european travel document for the return of third - country nationals should be established to facilitate return and readmission of illegally staying third - country nationals . its enhanced security features should facilitate its recognition by third countries . such document should help carry out returns in the context of readmission agreements or other arrangements with third countries , as well as in the context of return - related co - operation with third countries not covered by formal agreements . ### an impact assessment should be carried out before a european travel document is introduced .


### member states have also begun work at national level on establishing and promoting project pipelines for projects of national significance . the information prepared by the commission and the eib should provide links to the accompanying national project pipelines . ### member states have also begun work at national level on establishing and promoting project pipelines for projects of national significance . the information prepared by the commission and the eib should provide links to the accompanying national , regional and macroregional project pipelines and the proposals which might be put forward locally .


### the efsi should support strategic investments with high economic value added contributing to achieving union policy objectives . ### the efsi should support strategic investments with high economic , environmental and territorial value added contributing to achieving union policy objectives . the investments should be channelled primarily to new and innovative sources of growth and allow the transition of the eu’s economy towards a truly sustainable economy .


### development of infrastructure , including in the areas of transport , particularly in industrial centres ; energy , in particular energy interconnections ; and digital infrastructure ; ### development of sustainable and eco - friendly infrastructure , including in the areas of transport , particularly in industrial centres and in remote regions ; renewable energy , in particular energy interconnections , smart grids and digital infrastructure ;


### alongside the financing operations that will be conducted through the efsi , a european investment advisory hub should be created . the eiah should provide strengthened support for project development and preparation across the union , by building on the expertise of the commission , the eib , national promotional banks and the managing authorities of the european structural and investment funds . this should establish a single point of entry for questions related to technical assistance for investments within the union . ### alongside the financing operations that will be conducted through the efsi , a european investment advisory hub should be created . the eiah should provide strengthened support for project development and preparation across the union , by building on the expertise of the commission , the eib , national promotional banks and the managing authorities of the european structural and investment funds . the eiah should propose innovative investment projects with a view to achieving the sustainable and harmonious development of the union . this should establish a single point of entry for questions related to technical assistance for investments within the union .


### documents access to which is excluded or restricted by virtue of the access regimes on the grounds of protection of personal data , and parts of documents accessible by virtue of those regimes which contain personal data the re - use of which has been defined by law as being incompatible with the law concerning the protection of individuals with regard to the processing of personal data ; ### documents or parts of documents access to which is excluded or restricted by access regimes on the grounds of protection of personal data , or which contain personal data the re - use of which could undermine the protection of privacy and integrity of the individual , in particular in accordance with union legislation regarding the protection of personal data ;


### improving access to inclusive and quality services in education , training and life long learning through developing infrastructure ; ### improving access to inclusive and quality services in education , preschool , training and life long learning through developing infrastructure ;


### enhancing the effectiveness of labour markets and access to quality employment through developing social innovation and infrastructure ; ### enhancing the effectiveness of labour markets and access to quality employment through developing social innovation and infrastructure that&#160 ; encourages balanced territorial development across the whole eu&#160 ; ;


### in addition , investments under the erdf should contribute to the development of a comprehensive high - speed digital infrastructure network , and to promoting clean and sustainable multimodal urban mobility . ### in addition , investments under the erdf should contribute to the development of a comprehensive high - speed digital infrastructure network , and to promoting clean and sustainable multimodal urban and rural mobility .


### enhancing biodiversity , green infrastructure in the urban environment , and reducing pollution ; ### enhancing biodiversity , green infrastructure in the urban and rural environment , and reducing pollution ;


### fostering the integrated social , economic and environmental local development , cultural heritage and security , including for rural and coastal areas also through community - led local development . ### fostering the integrated social , economic and environmental local development and cultural heritage , including for rural and coastal areas also through community - led local development .


### fostering the integrated social , economic and environmental local development , cultural heritage and security , including for rural and coastal areas also through community - led local development . ### fostering integrated social , economic and environmental development and the cultural heritage , including for rural and coastal areas , through community - led local development .