### 2. the take back arrangements put in place in accordance with paragraph 1 shall cover the whole territory of a member state taking into account population size and density , expected volume of waste automotive , industrial and electric vehicle batteries , accessibility and vicinity to end-users , not being limited to areas where the collection and subsequent management of waste automotive , industrial and electric vehicle batteries is most profitable. ### 2. the take back arrangements put in place in accordance with paragraph 1 shall cover the whole territory of a member state taking into account population size and density , expected volume of waste automotive , industrial and electric vehicle batteries , accessibility and vicinity to end-users , not being limited to areas where the collection and subsequent management of waste automotive , industrial and electric vehicle batteries is most profitable or least costly.


### provide the collection points referred to in paragraph 1 with suitable collection infrastructure for the separate collection of waste automotive batteries , industrial batteries and electric vehicle batteries meeting the applicable safety requirements and cover the necessary costs incurred by those collection points in relation to the take back activities. the containers to collect and temporarily store such batteries at the collection point shall be adequate to provide for the volume and hazardous nature of waste automotive batteries , industrial batteries and electric vehicle batteries that are likely to be collected through those collection points; ### provide the take back and collection systems referred to in paragraph 1 with suitable collection infrastructure for the separate collection of waste automotive batteries , industrial batteries and electric vehicle batteries meeting the applicable safety requirements and cover the necessary costs incurred by those take back and collection systems in relation to the take back activities. the containers to collect and temporarily store such batteries at the take back and collection systems shall be adequate to provide for the volume and hazardous nature of waste automotive batteries , industrial batteries and electric vehicle batteries that are likely to be collected through those collection points;


### collect waste automotive batteries , industrial batteries and electric vehicle batteries from the collection points referred to in paragraph 1 with a frequency that is proportionate to the storage capacity of the separate collection infrastructure and the volume and hazardous nature of waste batteries that are usually collected through those collection points; ### collect waste automotive batteries , industrial batteries and electric vehicle batteries from the take back and collection systems referred to in paragraph 1 with a frequency that is proportionate to the storage capacity of the separate collection infrastructure and the volume and hazardous nature of waste batteries that are usually collected through those collection points;


### provide for the delivery of waste automotive batteries , industrial batteries and electric vehicle batteries collected from end-users and from the collection points referred to in paragraph 1 to facilities for treatment and recycling in accordance with article 56. ### provide for the delivery of waste automotive batteries , industrial batteries and electric vehicle batteries taken back from end-users and from the take back and collection systems referred to in paragraph 1 to facilities for treatment and recycling in accordance with article 56.


### 1. distributors shall take back waste batteries from the end-user at no charge and without an obligation to buy a new battery , regardless of their chemical composition or origin. take back for portable batteries shall be provided at or in the immediate vicinity of their retail outlet. take back for waste automotive batteries , industrial batteries and electric vehicle batteries shall be provided at or in the vicinity of their retail outlet. this obligation is limited to the types of waste batteries which the distributor has , or had , as new batteries in its offer and , for portable batteries , to the quantity that non professional end-users normally discard. ### 1. distributors shall take back waste batteries from the end-user at no charge and without an obligation to buy a new battery. take back for portable batteries shall be provided at or in the immediate vicinity of their retail outlet. take back for waste automotive batteries , industrial batteries and electric vehicle batteries shall be provided at or in the vicinity of their retail outlet. for industrial batteries , this obligation is limited to the waste batteries of the same chemical composition and brand which the distributor has , as new batteries in its offer and , for portable batteries , to the quantity that non professional end-users normally discard.


### collection rates for waste portable batteries ### collection rates for waste portable and light means of transport batteries


### 45 % by 31 december 2023; ### […] % by 31 december 2023;


### 65 % by 31 december 2025; ### […] % by 31 december 2028;


### 70 % by 31 december 2030. ### […] % by 31 december 2030.


### 3. the commission shall , by 31 december 2030 , review the target laid down in paragraph 1(c) and , as part of that review consider the setting of a collection target for batteries powering light means of transport , in the light of the evolution of the market share , as a separate target or as part of a review of the target laid down in paragraph 1(c) and in article 48(4). this review may also consider introducing a calculation methodology for the calculation of the separate collection rate with a view to reflecting the quantity of waste batteries available for collection. to that end , the commission shall submit a report to the european parliament and the council on the outcome of the review accompanied , if appropriate , by a legislative proposal. ### 3. the commission shall , by 31 december 2023 , consider the setting of a collection target for batteries powering light means of transport , in the light of the evolution of the market share , as a separate target. this review shall also consider introducing a calculation methodology for the calculation of the separate collection rate with a view to reflecting the quantity of waste batteries available for collection. to that end , the commission shall submit a report to the european parliament and the council on the outcome of the review accompanied , if appropriate , by a legislative proposal.


### 3. the commission shall , by 31 december 2030 , review the target laid down in paragraph 1(c) and , as part of that review consider the setting of a collection target for batteries powering light means of transport , in the light of the evolution of the market share , as a separate target or as part of a review of the target laid down in paragraph 1(c) and in article 48(4). this review may also consider introducing a calculation methodology for the calculation of the separate collection rate with a view to reflecting the quantity of waste batteries available for collection. to that end , the commission shall submit a report to the european parliament and the council on the outcome of the review accompanied , if appropriate , by a legislative proposal. ### 3. the commission shall , by 31 december 2025 and by 31 december 2030 , review the targets laid down in paragraph 1(b) and 1(c) and , as part of that review consider the setting of a collection target for batteries powering light means of transport , in the light of the evolution of the market share , as a separate target. this review shall also consider introducing a calculation methodology for the calculation of the separate collection rate with a view to reflecting the quantity of waste batteries available for collection. the review shall be based on independent research conducted by the joint research centre. the commission shall submit a report to the european parliament and the council on the outcome of the review accompanied , if appropriate , by a legislative proposal.


### 1. all waste batteries collected shall enter a recycling process. ### 1. all waste batteries collected and that are not sent to repurposing or remanufacturing shall enter a recycling process.


### 4. the commission shall , by 31 december 2023 , adopt an implementing act to establish detailed rules regarding the calculation and verification of recycling efficiencies and recovery of materials. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 74(3). ### 4. the commission shall , by 31 december 2023 , adopt an implementing act , based on an economic and environmental impact assessment , to establish detailed rules regarding the calculation and verification of recycling efficiencies and recovery of materials. this implementing act shall be adopted in accordance with the examination procedure referred to in article 74(3).


### 3. the commission is empowered to adopt a delegated act , in accordance with article 73 , laying down detailed rules supplementing those in paragraph 2 of this article , by laying down the criteria for the assessment of equivalent conditions. ### 3. the commission is empowered to adopt a delegated act by 31 december 2024 , in accordance with article 73 , laying down detailed rules supplementing those in paragraph 2 of this article , by laying down the criteria for the assessment of equivalent conditions.


### 3. the commission is empowered to adopt a delegated act , in accordance with article 73 , laying down detailed rules supplementing those in paragraph 2 of this article , by laying down the criteria for the assessment of equivalent conditions. ### 3. the commission is empowered to adopt a delegated act , in accordance with article 73 , laying down detailed rules supplementing those in paragraph 2 of this article , by laying down the criteria for the assessment of equivalent conditions , in order to implement a robust , effective certification system , including audit obligations , applicable to recyclers of waste batteries operating in and outside the eu.


### requirements related to the repurposing and remanufacturing of industrial batteries and electric-vehicle batteries ### requirements related to the repurposing of industrial batteries and electric-vehicle batteries


### 1. independent operators shall be given access to the battery management system of rechargeable industrial batteries and electric vehicle batteries with internal storage with a capacity above 2 kwh , on equal terms and conditions , for the purpose of assessing and determining the state of health and remaining lifetime of batteries , according to the parameters laid down in annex vii. ### 1. as part of the application of article 65 , independent operators shall be given read-only access to the battery management system of rechargeable industrial batteries and electric vehicle batteries with internal storage with a capacity above 2 kwh , on equal terms and conditions , for the purpose of assessing and determining the state of health and remaining lifetime of batteries , according to the parameters laid down in annex vii.


### 1. independent operators shall be given access to the battery management system of rechargeable industrial batteries and electric vehicle batteries with internal storage with a capacity above 2 kwh , on equal terms and conditions , for the purpose of assessing and determining the state of health and remaining lifetime of batteries , according to the parameters laid down in annex vii. ### 1. at the end of the first life of the battery , qualified operators shall be given access to the parameters laid down in annex vii available in the battery management system of stationary energy storage batteries and electric vehicle batteries with a capacity above 2 kwh , on equal terms and conditions , for the purpose of assessing and determining the state of health and remaining lifetime of batteries.


### 1. independent operators shall be given access to the battery management system of rechargeable industrial batteries and electric vehicle batteries with internal storage with a capacity above 2 kwh , on equal terms and conditions , for the purpose of assessing and determining the state of health and remaining lifetime of batteries , according to the parameters laid down in annex vii. ### 1. as part of the application of article 65 , authorised operators shall be given read-only access to the relevant state of health information of rechargeable industrial batteries and electric vehicle batteries with a capacity above 2 kwh at the end of their first life , on equal terms and conditions , according to the parameters laid down in annex vii.


### 1. independent operators shall be given access to the battery management system of rechargeable industrial batteries and electric vehicle batteries with internal storage with a capacity above 2 kwh , on equal terms and conditions , for the purpose of assessing and determining the state of health and remaining lifetime of batteries , according to the parameters laid down in annex vii. ### 1. qualified independent operators shall be given access to the parameters laid down in annex vii available in the battery management system of stationary energy storage batteries and electric vehicle batteries on equal terms and conditions , for the sole purpose of assessing and determining the state of health.


### 2. independent operators carrying out repurposing or remanufacturing operations shall be given adequate access on equal terms and conditions , to the information relevant for the handling and testing of rechargeable industrial batteries and electric vehicle batteries , or of appliances and vehicles in which such batteries are incorporated as well as of components of such batteries , appliances or vehicles , including safety aspects. ### 2. independent operators carrying out repurposing or remanufacturing operations shall be given adequate access on equal terms and conditions , to the information relevant for the handling and testing of stationary energy storage batteries and electric vehicle batteries , or of appliances and vehicles in which such batteries are incorporated as well as of components of such batteries , appliances or vehicles , including safety aspects.


### 2. independent operators carrying out repurposing or remanufacturing operations shall be given adequate access on equal terms and conditions , to the information relevant for the handling and testing of rechargeable industrial batteries and electric vehicle batteries , or of appliances and vehicles in which such batteries are incorporated as well as of components of such batteries , appliances or vehicles , including safety aspects. ### 2. qualified independent operators carrying out repurposing operations shall be given adequate access , to the information relevant for the safety of rechargeable industrial batteries and electric vehicle batteries.


### 3. operators carrying out repurposing or remanufacturing operations of batteries shall ensure that the examination , performance testing , packing and shipment of batteries and their components is carried out following adequate quality control and safety instructions. ### 3. operators carrying out repurposing or remanufacturing operations of batteries shall ensure that the examination , performance and safety testing , packing and shipment of batteries and their components is carried out following adequate quality control and safety instructions and that the appropriate performances and conditions are met. .


### 3. operators carrying out repurposing or remanufacturing operations of batteries shall ensure that the examination , performance testing , packing and shipment of batteries and their components is carried out following adequate quality control and safety instructions. ### 3. operators carrying out repurposing operations of batteries shall ensure that the examination , performance testing , packing and shipment of batteries and their components is carried out following adequate quality control and safety instructions.


### 4. operators carrying out repurposing or remanufacturing operations of batteries shall ensure that the repurposed or remanufactured battery complies with this regulation , relevant product , environmental and human health protection requirements in other legislation and technical requirements for its specific purpose of use when placed on the market. ### 4. operators carrying out repurposing or remanufacturing operations of batteries shall ensure that the batteries have been declared as waste , and that the newly placed repurposed or remanufactured battery complies with this regulation , relevant product , environmental and human health protection and safety requirements in other legislation and technical requirements for its specific purpose of use when placed on the market.


### 4. operators carrying out repurposing or remanufacturing operations of batteries shall ensure that the repurposed or remanufactured battery complies with this regulation , relevant product , environmental and human health protection requirements in other legislation and technical requirements for its specific purpose of use when placed on the market. ### 4. operators carrying out repurposing operations of batteries shall ensure that the repurposed battery complies with this regulation , relevant product , environmental and human health protection requirements in other legislation and technical requirements for its specific purpose of use when placed on the market.


### a battery that has been repurposed or remanufactured shall not be subject to the obligations laid down in article 7(1) , (2) and (3) , article 8(1) , (2) and (3) , article 10(1) and (2) and article 39(1) where the economic operator placing a repurposed or remanufactured battery on the market can demonstrate that the battery , before its repurposing or remanufacturing , was placed on the market before the dates on which those obligations become applicable in accordance with those articles. ### a battery that has been repurposed or remanufactured shall not be subject to the obligations laid down in article 7(1) , (2) and (3) , article 8(1) , (2) and (3) , and article 39(1) where the economic operator placing a repurposed or remanufactured battery on the market can demonstrate that the battery , before its repurposing or remanufacturing , was placed on the market before the dates on which those obligations become applicable in accordance with those articles.


### the contribution of end users to waste prevention , including by information on good practices concerning the use of batteries aiming at extending their use phase and the possibilities of preparation for reuse; ### the contribution of end users to waste prevention of a portable batteries , including by information on good practices concerning the use of batteries aiming at extending their use phase;


### in a language , which can be easily understood by consumers and other end-users , as determined by the member state concerned. ### in a language , which can be easily understood by consumers and other end-users , as determined by the member state concerned , or:


### 2. producers shall make available to distributors and operators referred to in articles 50 , 52 and 53 and other waste management operators carrying out repair , remanufacturing , preparing for re-use , treatment and recycling activities information regarding the safety and protective measures , including on occupational safety , applicable to the storage and collection of waste batteries. ### deleted


### the safety and protective measures , including on occupational safety , applicable to the storage , transport , treatment and recycling processes for waste batteries. ### deleted


### that information shall identify the components and materials , and the location of all hazardous substances in a battery , as far as it is needed by operators carrying out repair , remanufacturing , preparing for re-use , treatment and recycling activities in order to enable them to comply with the requirements of this regulation. ### deleted


### 5. the costs covered by the producer under article 47(1)(e) shall be shown separately to the end-user at the point of sale of a new battery. the costs mentioned shall not exceed the best estimate of the actual costs incurred. ### deleted


### 5. the costs covered by the producer under article 47(1)(e) shall be shown separately to the end-user at the point of sale of a new battery. the costs mentioned shall not exceed the best estimate of the actual costs incurred. ### 5. the costs covered by the producer under article 47(1)(e) shall be shown separately to the end-user at the point of sale of a new battery. the costs mentioned shall not exceed the best estimate of the actual costs incurred and shall not be added to the final cost of the battery charged to the consumer at the point of sale.


### 3. where waste management operators collect waste batteries from distributors or other waste automotive , industrial and electric vehicle batteries collection points or end-users , they shall report to the competent authority for each calendar year the following information according to their chemistries and types of batteries: ### deleted


### 5. waste management operators carrying out treatment and recyclers shall report to the competent authorities for each calendar year the following information: ### 5. operators carrying out repurposing or remanufacturing operations and recyclers shall report to the competent authorities for each calendar year the following information only:


### the amount of waste batteries received for treatment and recycling; ### the amount of waste batteries received for treatment and recycling by country of origin;


### the amount of waste batteries entering recycling processes; ### deleted


### recyclers shall report this data within four months of the end of the reporting year for which the data are collected. the first reporting period shall concern the first full calendar year after the adoption of the implementing act that establishes the format for reporting to the commission , in accordance with article 62(6). ### recyclers shall report this data within six months of the end of the reporting year for which the data are collected. the first reporting period shall concern the first full calendar year after the adoption of the implementing act that establishes the format for reporting to the commission , in accordance with article 62(6).


### chapter vii shall apply from 1 july 2023. ### chapter vii shall apply as of (18 months after the entry into force of the regulation).


### 1. by 1 january 2026 , the commission shall set up the electronic exchange system for battery information (“the system”). ### 1. by 1 january 2027 , the commission shall set up the electronic exchange system for battery information (“the system”).


### 2. the system shall contain the information and data on rechargeable industrial batteries and electric vehicle batteries with internal storage and a capacity above 2 kwh as laid down in annex xiii. that information and data shall be sortable and searchable , respecting open standards for third party use. ### 2. the system shall contain the information and data on stationary energy storage batteries and electric vehicle batteries with capacity above 2 kwh as laid down in annex xiii. that information and data shall be sortable and searchable , respecting open standards for third party use.


### 3. the economic operators that place a rechargeable industrial battery or an electric vehicle battery with internal storage on the market shall make the information referred to in paragraph 2 available electronically in a machine readable format using interoperable and easily accessible data services in the format established in accordance with paragraph 5. ### 3. the economic operators that place a stationary energy storage battery or an electric vehicle battery on the market shall make the information referred to in paragraph 2 available electronically in a machine readable format using interoperable and easily accessible data services in the format established in accordance with paragraph 5.


### 1. by 1 january 2026 , each industrial battery and electric vehicle battery placed on the market or put into service and whose capacity is higher than 2 kwh shall have an electronic record (“battery passport”). ### 1. by 1 january 2027 , each stationary energy storage battery and electric vehicle battery placed on the market or put into service and whose capacity is higher than 2 kwh shall have an electronic record (“battery passport”).


### 3. the battery passport shall be linked to the information about the basic characteristics of each battery type and model stored in the data sources of the system established pursuant to article 64. the economic operator that places an industrial battery or an electric vehicle battery on the market shall ensure that the data included in the battery passport is accurate , complete and up-to-date. ### 3. the battery passport shall be linked to the information about the basic characteristics of each battery type and model stored in the data sources of the system established pursuant to article 64. the economic operator that places an industrial battery or an electric vehicle battery on the market shall ensure that the data included in the battery passport is accurate and complete.


### 4. the battery passport shall be accessible online , through electronic systems interoperable with the system established pursuant to article 64. ### 4. the battery passport shall be accessible online , through an api compatible with the system established pursuant to article 64.


### 6. when the change in the status is due to repairing or repurposing activities , the responsibility for the battery record in the battery passport shall be transferred to the economic operator that is considered to place the industrial battery or the electric vehicle battery on the market or that puts it into service. ### 6. when the change in the status is due to remanufacturing or repurposing activities , the responsibility for the battery record in the battery passport shall be transferred to the economic operator that is considered to place the industrial battery or the electric vehicle battery on the market or that puts it into service. the record for remanufactured or repurposed batteries shall be linked to the record of the original battery or batteries.


### [...] ### deleted


### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive. member states shall , without delay , notify the commission of those rules and of those measures and shall notify it , without delay , of any subsequent amendment affecting them. ### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive. the penalties provided for shall be proportionally linked to the revenue of the offender , where applicable. member states shall , without delay , notify the commission of those rules and of those measures and shall notify it , without delay , of any subsequent amendment affecting them.


### 1. by 31 december 2030 , the commission shall draw up a report on the application of this regulation and its impact on the environment and the functioning of the internal market. ### 1. by 31 december 2030 and every 5 years thereafter the commission shall publish a report on the application of this regulation and its impact on the environment and the functioning of the internal market. the report shall take particular account of the competitiveness of the battery sector within the union and the position of smes across the entire value chain.


### where appropriate , the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this regulation. ### where necessary , the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this regulation , while taking due account of the value of a predictable legal framework and protecting investor certainty.


### it shall apply from 1 january 2022. ### it shall apply from 24 months after entry into force.


### (56) distributors and importers , being close to the market place , should be involved in market surveillance tasks carried out by the national authorities , and should be prepared to participate actively , providing those authorities with all necessary information relating to the battery concerned. ### (56) distributors and importers , being close to the market place , should be involved in market surveillance tasks carried out by the national authorities , and should be prepared to participate actively , providing those authorities with all necessary information relating to the battery concerned , including the country of origin of key components , such as cobalt and lithium.


### (59) only few countries supply those materials and , in some cases , low standards of governance may exacerbate environmental and social problems. both cobalt and nickel mining and refining are related to a large range of social and environmental issues , including environmental hazard potential and human health. while the social and environmental impacts for natural graphite are less severe , its mining has high shares of artisanal and small scale operations , which mostly takes place in informal settings and can lead to serious health and environmental impacts , including no regular mine closure and no rehabilitation , which results in the destruction of ecosystems and soils. for lithium , the expected increase in its use in battery manufacturing is likely to put additional pressure on extraction and refining operations , what would recommend including lithium in the scope of the supply chain due diligence obligations. the expected massive increase in demand for batteries in the union should not contribute to an increase of such environmental and social risks. ### (59) only few countries supply those materials and , in some cases , low standards of governance may exacerbate environmental and social problems. both cobalt and nickel mining and refining are related to a large range of social and environmental issues , including environmental hazard potential and human health. while the social and environmental impacts for natural graphite are less severe , its mining has high shares of artisanal and small scale operations , which mostly takes place in informal settings and can lead to serious health and environmental impacts , including no regular mine closure and no rehabilitation , which results in the destruction of ecosystems and soils. for lithium , the expected increase in its use in battery manufacturing is likely to put additional pressure on extraction and refining operations , what would recommend including lithium in the scope of the supply chain due diligence obligations. a massive increase in demand for batteries in the union is likely to contribute to an increase of such environmental and social risks and the targets for e-mobility should be adapted accordingly.


### (8) ‘portable batteries of general use’ means portable batteries with the following common formats: 4 ,5 volts (3r12) , d , c , aa , aaa , aaaa , a23 , 9 volts (pp3); ### (8) ‘portable batteries of general use’ means portable batteries with the following common formats: d , c , aa , aaa , 9 volts (pp3) , and button batteries;


### 1. electric vehicle batteries and rechargeable industrial batteries with internal storage and a capacity above 2 kwh shall be accompanied by technical documentation that includes , for each battery model and batch per manufacturing plant , a carbon footprint declaration drawn up in accordance with the delegated act referred to in the second sub-paragraph and containing , at least , the following information: ### 1. electric vehicle batteries and rechargeable industrial batteries with internal storage and a capacity above 2 kwh shall be accompanied by technical documentation that includes , for each battery model and batch per manufacturing plant , a carbon footprint declaration , which shall be based on the bill of material , the energy , and auxiliary materials used in a specific plant to produce a specific battery model , drawn up in accordance with the delegated act referred to in the second sub-paragraph and containing , at least , the following information:


### the carbon footprint declaration requirement in the first subparagraph shall apply as of 1 july 2024 to electric vehicle batteries and to rechargeable industrial batteries. ### the carbon footprint declaration requirement in the first subparagraph shall apply as of 1 july 2027 to electric vehicle batteries and to rechargeable industrial batteries.


### the commission shall , no later than 1 july 2023 , adopt: ### the commission shall , no later than 1 july 2025 , adopt:


### the commission shall be empowered to adopt delegated acts in accordance with article 73 to amend the information requirements set out in the first subparagraph. ### following the establishment of the methodology referred to in point (a) of the second sub-paragraph , the commission shall verify the dates laid down in this article , and if found beyond what is achievable , shall adopt a delegated act in accordance with article 73 to amend them.


### the carbon footprint performance class requirements in the first subparagraph shall apply as of 1 january 2026 for electric vehicle batteries and for rechargeable industrial batteries. ### the carbon footprint performance class requirements in the first subparagraph shall apply as of 1 january 2029 for electric vehicle batteries and for rechargeable industrial batteries.


### the commission shall , no later than 31 december 2024 , adopt ### the commission shall , no later than 31 december 2026 , adopt


### 1. as of [12 months after the entry into force of the regulation] the economic operator that places rechargeable industrial batteries and electric-vehicle batteries with internal storage and a capacity above 2 kwh on the market shall comply with the supply chain due diligence obligations set out in paragraphs 2 to 5 of this article and shall keep documentation demonstrating its respective compliance with those obligations , including the results of the third-party verification carried out by notified bodies. ### 1. as of [36 months after the entry into force of the regulation] the economic operator that places rechargeable industrial batteries and electric-vehicle batteries with internal storage and a capacity above 2 kwh on the market shall comply with the supply chain due diligence obligations set out in paragraphs 2 to 5 of this article and shall keep documentation demonstrating its respective compliance with those obligations , including the results of the third-party verification carried out by notified bodies.


### (iii) country of origin of the raw material and the market transactions from the raw material’s extraction to the immediate supplier to the economic operator; ### (iii) country of origin of the raw material;


### (iv) quantities of the raw material present in the battery placed on the market , expressed in percentage or weight. ### (iv) quantities of the raw material present in the battery models placed on the market , expressed in percentage or weight.


### a battery that has been repurposed or remanufactured shall not be subject to the obligations laid down in article 7(1) , (2) and (3) , article 8(1) , (2) and (3) , article 10(1) and (2) and article 39(1) where the economic operator placing a repurposed or remanufactured battery on the market can demonstrate that the battery , before its repurposing or remanufacturing , was placed on the market before the dates on which those obligations become applicable in accordance with those articles. ### a battery that has been repurposed or remanufactured shall not be subject to the obligations laid down in article 7(1) , (2) and (3) , article 8(1) , (2) and (3) , and article 39(1) where the economic operator placing a repurposed battery on the market can demonstrate that the battery , before its repurposing , was placed on the market before the dates on which those obligations become applicable in accordance with those articles.


### 5. in order to document that a waste battery , subject to a repurposing or remanufacturing operation , is no longer waste , the battery holder shall demonstrate the following upon request by a competent authority: ### 5. in order to document that a waste battery , subject to a repurposing operation , is no longer waste , the battery holder shall demonstrate the following upon request by a competent authority:


### evidence of state of health evaluation or testing carried out in a member state in the form of a copy of the record confirming the capability of the battery to deliver the performance relevant for its use following a repurposing or remanufacturing operation; ### evidence of state of health evaluation or testing carried out in a member state in the form of a copy of the record confirming the capability of the battery to deliver the performance relevant for its use following a repurposing operation;


### further use of the battery that is subject to repurposing or remanufacturing , is documented by means of an invoice or a contract for the sale or transfer of ownership of the battery; ### further use of the battery that is subject to repurposing , is documented by means of an invoice or a contract for the sale or transfer of ownership of the battery;


### 6. information referred to in paragraph 4 and point (a) of paragraph 5 shall be made available to end users and third parties acting on their behalf , on equal terms and conditions , as part of the technical documentation accompanying the repurposed or remanufactured battery when placed on the market or put into service. ### 6. information referred to in paragraph 4 and point (a) of paragraph 5 shall be made available to end users and third parties acting on their behalf , on equal terms and conditions , as part of the technical documentation accompanying the repurposed battery when placed on the market or put into service.


### 1. governments , industry associations and groupings of interested organisations that have developed and oversee due diligence schemes (“scheme owners”) may apply to the commission to have their supply chain due diligence schemes recognised by the commission. the commission is empowered to adopt implementing acts establishing the information requirements that the application to the commission shall contain. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 74(3). ### 1. governments , industry associations and groupings of interested organisations that have developed and oversee due diligence schemes (“scheme owners”) or producers or a grouping of producers that participate in these schemes may apply to the commission to have their supply chain due diligence schemes recognised by the commission. the commission is empowered to adopt implementing acts establishing the information requirements that the application to the commission shall contain. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 74(3).


### 2. no later than 1 january 2030 , recycling processes shall achieve the following minimum recycling efficiencies: ### 2. no later than 9 years after the adoption of the implementing act referred to in article 57 (4) , recycling processes shall achieve the following minimum recycling efficiencies:


### a. whereas the toy safety directive (tsd) was adopted in 2009 to ensure a high level of health and safety for children and guarantee the functioning of the internal market for toys; ### a. whereas the toy safety directive (tsd) was adopted in 2009 to ensure a high level of health and safety for children and improve the functioning of the internal market for toys , and in particular to facilitate the exchange of goods between member states by removing barriers to trade;


### a. whereas intellectual property (ip) registrations are constantly increasing and the single market remains fragmented by differences in national legislation , which are hindering the development of companies , in particular smes , and consumers’ access to innovative and safe products; ### a. whereas global intellectual property (ip) registrations are constantly increasing; whereas legislation applying across the single market for intellectual property protection creates a solid framework for european companies; whereas gaps remain , in particular in enforcement , which can hinder development of companies , in particular smes , and consumers’ access to innovative and safe products;


### 3. strongly encourages the commission to assist producers and their associations as well as local authorities in developing countries in unlocking the potential of ip and reaping the economic value of local innovations , geographical indications and traditional knowledge; reiterates its call , in this regard , to respect the progress achieved in the international protection of indigenous peoples’ rights over their genetic resources and associated traditional knowledge; ### 3. strongly encourages the commission to assist producers and their associations as well as local authorities in developing countries in unlocking the potential of ip and reaping the economic value of local innovations , geographical indications and traditional knowledge; encourages , moreover , consultation with business representatives and their associations , as well as with other interested groups , in order to collect and analyse the available data and information , with a view to ensuring that decisions taken in this field take into account the interests of all stakeholders in the broadest and most favourable manner possible; reiterates its call , in this regard , to respect the progress achieved in the international protection of indigenous peoples’ rights over their genetic resources and associated traditional knowledge;


### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that strong iprs may limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing countries; ### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that strong iprs may limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing countries; stresses at the same time that producers of generic medicines , unlike producers of innovative medicines , tend to be more regional; asks the commission in particular to promote regulatory solutions that encourage competition in generic medicine production while maintaining a balance between generic and innovative medicines;


### c. whereas many barriers affecting the single market derive from incorrect or incomplete application of eu legislation; ### c. whereas many barriers affecting the single market derive from incorrect or incomplete application of eu legislation , lack of harmonised transposition of eu law into national legal frameworks or lack of appropriate eu law measures aimed at tackling the existing barriers;


### d. whereas insufficient or incorrect implementation and lack of enforcement have damaging consequences both at eu and national level for citizens and businesses; ### d. whereas insufficient or incorrect implementation and lack of enforcement or lack of appropriate eu law measures tackling the barriers have damaging consequences both at eu and national level for citizens and businesses;


### g. whereas thecovid-19 crisis has been a shock both to production and consumption , and has reshaped domestic and cross-border activities; whereas some of these effects may be temporary , but others will have lasting consequences on the shape and needs of the single market; ### g. whereas the covid-19 crisis has been a shock both to production and consumption , and has reshaped domestic and cross-border activities including the provision of services; whereas some of these effects may be temporary , but others will have lasting consequences on the shape and needs of the single market; whereas the response to the pandemic has speed up a shift to digital services;


### 1. welcomes the single market governance package of march 2020 , which aims to improve the implementation and enforcement of european legislation; considers that it is only a partial answer to the deficiencies hampering the proper functioning of the common market; ### 1. welcomes the single market governance package of march 2020 , which aims to improve the implementation and enforcement of european legislation by mainly presenting an overview of existing and upcoming initiatives; considers that it is only a partial answer to the deficiencies hampering the proper functioning of the common market and that especially initiative to improve the single market for services are lacking;


### 3. highlights the importance of enhancing the resilience of regional and local food systems , as well as of short supply chains , as set out in the farm to fork strategy; stresses , however , that the strategy should not lead to additional barriers and greater fragmentation within the single market; ### 3. highlights the importance of enhancing the resilience of regional and local food systems , as well as of short supply chains , as set out in the farm to fork strategy; stresses , however , that the strategy should not lead to additional barriers and greater fragmentation within the single market; stresses that smart and integrated food supply chains are indispensable for ensuring continuous food supplies throughout the union;


### 8. recalls that a considerable number of problems with the cross-border provision of services stem from administrative practices introduced by the country of destination , and not from incompatibility with eu law; ### 8. recalls that a considerable number of problems with the cross-border provision of services stem from administrative practices introduced by the country of destination , and not from incompatibility with eu law; calls on the commission to continue developing guidelines addressing underperforming legislation and scrutinise actions of the member states administration; points out the lack of harmonised interpretation of eu law by member states such as the recently revised posting of workers directive 2018/957/eu , which leads to lack of legal clarity and bureaucratic burdens for companies providing services in various member states; calls on the commission to support member states in the transposition process to guarantee a more harmonised approach;


### 9. recognises the insufficient use of the notification procedure under the services directive; calls on the commission to reflect on improving this framework , possibly by means of a new initiative which would increase clarity and transparency on the measures that need to be notified , while remaining cautious in order to not undermine the services directive and avoiding the situation which led to the withdrawal of the previous proposal; ### 9. recognises the insufficient use of the notification procedure under the services directive because still most member states do not notify or do not notify everything they should; highlights that this undermines the commission’s ability to ensure new services laws are compliant with the services directive; calls upon the member states to fulfil their notification obligations under the services directive; calls on the commission to bring forward an action plan by mid-2022 on improving the current framework , possibly by means of a new initiative which would increase clarity and transparency on the measures that need to be notified , while remaining cautious in order to not undermine the services directive and avoiding the situation which led to the withdrawal of the previous proposal;


### 12. considers that mutual recognition of professional qualification is seriously affected by administrative barriers imposed by member states; ### 12. considers that mutual recognition of professional qualification is seriously affected by administrative barriers imposed by member states; calls on the commission and the member states to better identify gold-plating and other obstacles and either remove such measures or launch infringement , where eu legislation is violated; recalls that any delay in recognising a qualification hinders a european citizen in exercising their profession;


### 13. is concerned by the insufficient access to information on mobility of services , as well as by the burdensome procedures to obtain essential documents such as the a1 form; underlines that access to information , such as on domestic collective agreements where applicable and relevant , should be improved to facilitate compliance for businesses; ### 13. is concerned by the insufficient access to information on mobility of services on the single official national websites , as well as by the burdensome procedures to obtain essential documents such as the a1 form; underlines that access to information , such as on domestic collective agreements where applicable and relevant , should be improved to facilitate compliance for businesses; calls on the european commission and the european labour authority to take appropriate steps in order to improve access to information and to come up with a single template for single official national websites;


### 16. welcomes the commission proposal to make solvit the default tool for single market dispute resolution; ### 16. highlights that solvit has a high potential to become the main informal problem solving tool for businesses and consumers in cases of misapplication of eu law; welcomes the commission proposal to make solvit the default tool for single market dispute resolution; notes that still many solvit centres are understaffed , lack resources , skills and knowledge; calls upon the commission and member states to ensure solvit centres have adequate resources to operate;


### 18. welcomes in principle the single market enforcement taskforce (smet) , which aims to assess compliance of national law with single market rules and to prioritise the most pressing barriers; points out that the smet should not just identify problems , but also provide solutions; ### 18. welcomes in principle the single market enforcement taskforce (smet) which aims to assess compliance of national law with single market rules and prioritise the most pressing barriers , address unjustified gold plating and discuss horizontal enforcement issues; points out that the smet should not just identify problems but also provide solutions;


### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; calls on the commission to present in due time concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions; ### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; calls on the commission to present by the end of 2022 concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions;


### 20. calls on the commission to present an annual report on ntbs and establish an open and transparent database compiling specific national ntbs together with ongoing infringement procedures; ### 20. calls on the commission to present an annual report on ntbs and establish an open and transparent database compiling specific national ntbs together with ongoing infringement procedures; believes that there is a need for a tool allowing for anonymous contributions so as to provide protections for those raising concerns;


### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; ### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; notes that especially regarding national product and services rules proper impact assessments and well-explained justifications are missing; calls on the commission to make quick decisions on complaints to ensure that relevant issues from an end-user perspective are promptly handled and efficiently settled;


### 23. points to the importance of surveillance , inspection and sanctioning by relevant authorities of economic operators who do not comply with legislation; ### 23. points to the importance of proportionate surveillance , inspection and sanctioning by relevant authorities of economic operators , regardless of the member state of establishment , who do not comply with legislation;


### 25. recalls that the initial response to the pandemic by member states and the commission did not take into account the needs of the single market , and recalls the serious impact this has had on the free cross-border movement of goods and services; ### 25. recalls that the initial response to the pandemic by member states and the commission did not take into account the needs of the single market , and recalls the serious impact this has had on the free cross-border movement of goods and services; believes that further assessment of the pandemic's impact on the single market will be necessary , in order to draw conclusions from the covid-19 crisis;


### 27. calls on the commission and member states to proactively use the lessons learned and to develop a response plan for emergencies , which should aim to safeguard as far as possible the free movement of services and goods; ### 27. calls on the commission and member states to proactively use the lessons learned and to develop a response plan for emergencies , which should aim to safeguard as far as possible the free movement of services and goods also in crisis situations; recalls the need for prompt notification by member states of national measures , which are limiting the free movement of goods and services;


### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation by member states with the european centre for disease prevention and control (ecdc). moreover , in order to ensure effective union response to novel cross- border threats to health , the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of eu reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. the capacity for contact tracing should be strengthened via the creation of an automated system , using modern technologies. ### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation by member states with the european centre for disease prevention and control (ecdc). moreover , in order to ensure effective union response to novel cross- border threats to health , the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of eu reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. the capacity for contact tracing should be strengthened via the creation of an automated system , using modern technologies while respecting the data protection rules.


### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec. ### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , , as well as in close dialogue with industry and supply chain actors , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec.


### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec. ### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. these mechanisms should look for synergies between measures taken at the eu and national levels , as well as try to avoid duplications with measures undertaken in the context with the who framework. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec.


### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. ### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , evaluations of member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning.


### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the exclusivity clause should entail that countries participating in the joint procurement procedure are not allowed to negotiate and sign parallel contracts with producers , and define clear consequences for those that do. the commission should ensure coordination and information exchange between the entities organizing and participating in any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council. “national stockpiles should be coordinated and discouraged in view of the creation of an eu strategic reserve of medical countermeasure and to prevent imbalances in the internal market. the functioning of the joint procurement agreement and resceu should abide by high standards of transparency , including in relation to the disclosure of the exact amount ordered and provided to each participating country , and delivery of procured products , and details of the liability of participating countries.


### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu to strengthen the negotiating position of the member states and allow for preferable purchasing conditions concerning the quantity , availability or price of a procured medical countermeasure. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 .


### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing and participating in any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 .


### (11) the commission should strengthen cooperation and activities with the member states , the ecdc , the european medicines agency (‘ema’) , other union agencies , research infrastructures and the who to improve the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance. ### (11) the commission should strengthen cooperation and activities with the member states , the ecdc , the european medicines agency (‘ema’) , other union agencies , research infrastructures and the who to improve the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance or major non-communicable diseases.


### (ii) reporting and auditing on preparedness; ### (ii) reporting and evaluation on preparedness;


### threats of environmental or climate origin; ### deleted


### 4. in exceptional emergency situations , a member state or the commission may request the coordination of response within the hsc as referred to in article 21 , for serious cross-border threats to health other than those referred to in article 2(1) , if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health. ### 4. in exceptional emergency situations , a member state or the commission may request the coordination of response within the hsc as referred to in article 21 , for serious cross-border threats to health other than those referred to in article 2(1) , especially in relation to major non-communicable diseases , if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health.


### 5. the commission shall , in liaison with the member states , ensure coordination and information exchange between the mechanisms and structures established under this regulation and similar mechanisms and structures established at union level or under the euratom treaty whose activities are relevant for preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. ### 5. the commission shall , in liaison with the member states , ensure coordination and information exchange between the mechanisms and structures established under this regulation and similar mechanisms and structures established at international level , union level or under the euratom treaty whose activities are relevant for preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health.


### (7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological , chemical , environmental , climate or unknown origin which spreads or entails a significant risk of spreading across the national borders of member states , and which may necessitate coordination at union level in order to ensure a high level of human health protection; ### (7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological , chemical , environmental , climate or unknown origin which spreads or entails a significant risk of coming from third countries to the territories of member states and/or spreading across the national borders of member states , and which may necessitate coordination at union level in order to ensure a high level of human health protection;


### (7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological , chemical , environmental , climate or unknown origin which spreads or entails a significant risk of spreading across the national borders of member states , and which may necessitate coordination at union level in order to ensure a high level of human health protection; ### 7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological , chemical or unknown origin which spreads or entails a significant risk of spreading across the national borders of member states , and which may necessitate coordination at union level in order to ensure a high level of human health protection;


### enabling of coordinated action by the commission and the member states for the implementation of this regulation; ### enabling of coordinated action by the commission and the member states , including the national health authorities , for the implementation of this regulation;


### coordination in liaison with the commission of the preparedness and response planning of the member states in accordance with article 10; ### coordination in liaison with the commission and the member states of the preparedness and response planning of the member states in accordance with article 10;


### coordination in liaison with the commission of the risk and crisis communication and responses of the member states to serious cross-border threats to health , in accordance with article 21; ### coordination in liaison with the commission and the member states of the risk and crisis communication and responses of the member states to serious cross-border threats to health , in accordance with article 21;


### 4. the hsc shall be chaired by a representative of the commission. the hsc shall meet at regular intervals and whenever the situation requires , on a request from the commission or a member state. ### 4. the hsc shall be chaired by a representative of the commission without the right to vote. the hsc shall meet at regular intervals and whenever the situation requires , on a request from the commission or a member state.


### 6. the hsc shall adopt , by a majority of two thirds of its members , its rules of procedure. those rules of procedure shall establish working arrangements , in particular with regard to: ### 6. the hsc shall adopt , by a majority of two thirds of its members , its rules of procedure. those rules of procedure shall establish working arrangements and competences without prejudice to the principle of proportionality and subsidiarity , in particular with regard to:


### 1. the commission , in cooperation with member states and the relevant union agencies , shall establish a union health crisis and pandemic plan (‘the union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at union level. ### 1. the commission , in cooperation with member states and the relevant union agencies and taking into account the who framework , shall establish a union health crisis and pandemic plan (‘the union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at union level.


### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. ### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach synergies and consistency of the union preparedness and response plan and national plans and shall also inform without delay the commission and the hsc of any substantial revision of the national plan.


### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; coordination mechanisms; ### governance: including national and , if appropriate , regional policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; coordination mechanisms;


### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; details on the exiting national stockpile of medical countermeasures held by supply chain distributors; and access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;


### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;


### auditing on preparedness and response planning ### evaluating on preparedness and response planning


### 1. every 3 years , the ecdc shall conduct audits in the member states aimed at ascertaining the state of implementation of the national plans and their coherence with the union plan. such audits shall be implemented with the relevant union agencies , aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in article 7(1). ### 1. every 3 years , the ecdc shall conduct evaluations in the member states aimed at ascertaining the state of implementation of the national plans and synergies and consistency between them and the union plan. such evaluations shall be conducted with the relevant union agencies , aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in article 7(1).


### overview reports of audits series , which present cases of good practice. ### overview reports , which present cases of good practice.


### 1. on the basis of the information provided by the member states in accordance with article 7 , and of the results of the audits referred to in article 8 , the commission shall by july 2022 and every 2 years afterwards , transmit to the european parliament and to the council a report on the state of play and progress on preparedness and response planning at union level. ### 1. on the basis of the information provided by the member states in accordance with article 7 , and of the results of the evaluations referred to in article 8 , the commission shall by july 2022 and every 2 years afterwards , transmit to the european parliament and to the council a report on the state of play and progress on preparedness and response planning at union level and national levels.


### 1. the commission and the member states shall work together within the hsc to coordinate their efforts to develop , strengthen and maintain their capacities for the monitoring , early warning and assessment of , and response to serious cross-border threats to health. ### 1. the commission and the member states shall work together within the hsc to coordinate their efforts to develop , strengthen or at least maintain their capacities for the monitoring , early warning and assessment of , and response to serious cross-border threats to health.


### member states , efta states and union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels , and shall not run parallel negotiation processes for that product; ### member states , efta states and union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels , and shall not run parallel negotiation processes for that product. in addition , joint procurement shall not exempt participating countries from honouring existing contractual agreements nor shall replace countries regular procurement processes;


### the joint procurement shall not affect the internal market , shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition; ### the joint procurement shall not affect the internal market , shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition , nor replace existing procurement procedures implemented by participating countries;


### 3. the commission shall , in liaison with the member states , ensure coordination and information exchange between the entities organizing any action , including , but not limited to joint procurement procedures , stockpiling and donation of medical countermeasures under different mechanisms established at union level , in particular under: ### 3. the commission shall , in liaison with the member states , ensure coordination and information exchange between the entities organizing and participating in any action , including , but not limited to joint procurement procedures , stockpiling and donation of medical countermeasures under different mechanisms established at union level , in particular under:


### 1. the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of article 2(1) shall ensure a permanent communication between the commission , the ecdc , and the competent authorities responsible at national level for epidemiological surveillance. ### 1. the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of article 2(1) shall ensure a permanent communication between the commission , the ecdc , the competent authorities responsible at national level for epidemiological surveillance and the main operators in the field of health and medicinal products.


### 5. the commission and the member states shall work together to define disease-specific european surveillance standards based on the proposal of the ecdc , in consultation with the relevant surveillance networks. ### 5. the commission and the member states shall work together to define disease-specific european surveillance standards that may serve as a guide based on the proposal of the ecdc , in consultation with the relevant surveillance networks.


### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , for the purpose of supporting communicable disease prevention and control. ### 1. the ecdc shall ensure the continuous development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , based on a data protection impact assessment (dpia) to be conducted prior to their deployment , for the purpose of supporting communicable disease prevention and control.


### 3. each member state shall designate the competent authorities responsible within their territory for the services supporting transfusion , transplantation and medically assisted reproduction as referred to in paragraph 1. ### 3. member states willing to participate shall designate the competent authorities responsible within their territory for the services supporting transfusion , transplantation and medically assisted reproduction as referred to in paragraph 1. if the participation in the network is made mandatory in accordance with articles 5(8) and 31 of the [ecdc regulation] , this obligation shall be extended to each member state.


### public health risks; ### public health risks , to the extent feasible including impacts on the major con-communicable diseases;


### the ecdc in accordance with article 8a of regulation (eu) …/… [oj: please insert the number of regulation ecdc [isc/2020/ 12527]] in the case of a threat referred to in points (i) and (ii) of point (a) of article 2(1) including substances of human origin: blood , organs , tissues and cells potentially impacted by communicable diseases; or point (d) of article 2(1); and/or ### the ecdc in accordance with article 8a of regulation (eu) …/… [oj: please insert the number of regulation ecdc [isc/2020/ 12527]] in the case of a threat referred to in point (a) of article 2(1) including substances of human origin: blood , organs , tissues and cells potentially impacted by communicable diseases; or point (d) of article 2(1); and/or


### 2. where a member state intends to adopt public health measures to combat a serious cross-border threat to health , it shall , before adopting those measures , inform and consult the other member states and the commission on the nature , purpose and scope of the measures , unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary. ### 2. where a member state intends to adopt public health measures to combat a serious cross-border threat to health , it shall , before adopting those measures , inform and consult the other member states , in particular neighbouring member states , and the commission on the nature , purpose and scope of the measures , unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary.


### 3. before recognising a situation of public health emergency at union level , the commission should liaise with the who in order to share the commission’s analysis of the situation of the outbreak and to inform the who of its intention to adopt such a decision. ### 3. before recognising a situation of public health emergency at union level , the commission shall liaise with the who in order to share the commission’s analysis of the situation of the outbreak and to inform the who of its intention to adopt such a decision.


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27(2). ### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27(3).


### on duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread among member states , the commission may recognise situations of public health emergency pursuant to paragraph 1 through immediately applicable implementing acts in accordance with the procedure referred to in article 27(3). ### deleted


### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis. ### 2. the advisory committee shall be composed of experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. member states may propose experts to the commission. the committee shall have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects and shall , as far as possible , respect the geographical balance of the union. the representatives of the ecdc and of the ema shall participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis.


### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis. ### 2. the advisory committee shall be composed of independent experts , selected by the commission , after prior consultation of the member states , according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on public health aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to public health matters on the agenda to take part in the work of the advisory committee on an ad-hoc basis.


### by 2025 and every 5 years thereafter the commission shall carry out an evaluation of this regulation and present a report on the main findings to the european parliament and the council. the evaluation shall be conducted in accordance with the commission’s better regulation guidelines. the evaluation shall include , in particular , an assessment of the operation of the ewrs and the epidemiological surveillance network , as well as the coordination of the response with the hsc. ### by … [please insert date five years after the date of entry into force of this regulation] , and every 5 years thereafter the commission shall carry out an evaluation of this regulation and present a report on the main findings to the european parliament and the council. the evaluation shall be conducted in accordance with the commission’s better regulation guidelines. the evaluation shall include , in particular , an assessment of the operation of the ewrs and the epidemiological surveillance network , as well as the coordination of the response with the hsc.


### (2) in accordance with article 4(6) of decision no 70/2008/ec of the european parliament and of the council31 , the member states and the commission are to endeavour to establish and make operational a framework of single window services. as stated in the final report on evaluation of the electronic customs implementation in the eu of 21 january 201532 , while certain elements of that decision remain highly relevant , other parts either have been superseded or are not concrete enough to encourage and incentivise further advances , in particular on the single window initiative. following up on this , the council conclusions of 17 december 2014 on electronic customs and single window implementation in the european union33 endorsed the venice declaration of 15 october 201434 and invited the commission to present a proposal for the revision of decision no 70/2008/ec. ### (2) in accordance with article 4(6) of decision no 70/2008/ec of the european parliament and of the council31 , the member states and the commission are to endeavour to establish and make operational a framework of single window services providing for the seamless flow of data between economic operators and customs authorities , between customs authorities and the commission , between customs authorities and other administrations or agencies , and between one customs system and another throughout the union and enabling economic operators to submit all information required for import , export or transit clearance to customs , including information required by non-customs related legislation. certain elements of that decision have been either superseded or are not concrete enough to encourage and incentivise further advances , in particular on the single window initiative. following up on this , and in line with the final report on evaluation of the electronic customs implementation in the eu of 21 january 201532 , the council conclusions of 17 december 2014 on electronic customs and single window implementation in the european union33 endorsed the venice declaration of 15 october 201434 and invited the commission to present a proposal for the revision of decision no 70/2008/ec.